WO2013038042A1 - Bipolar electrosurgical device and method for cauterizing and cutting biological tissue - Google Patents

Bipolar electrosurgical device and method for cauterizing and cutting biological tissue Download PDF

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Publication number
WO2013038042A1
WO2013038042A1 PCT/ES2012/070586 ES2012070586W WO2013038042A1 WO 2013038042 A1 WO2013038042 A1 WO 2013038042A1 ES 2012070586 W ES2012070586 W ES 2012070586W WO 2013038042 A1 WO2013038042 A1 WO 2013038042A1
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WO
WIPO (PCT)
Prior art keywords
electrodes
cutting
tissue
coagulation
biological
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PCT/ES2012/070586
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Spanish (es)
French (fr)
Inventor
Enrique Berjano Zanon
Fernando Burdio Pinilla
Luis GRANDE POSA
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Universidad Politécnica De Valencia
Fundacio Institut Mar D'investigacions Mediques (Imim)
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Publication of WO2013038042A1 publication Critical patent/WO2013038042A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589—Coagulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007—Aspiration
    • A61B2218/008—Aspiration for smoke evacuation

Definitions

  • the present invention relates in general to the field of surgical instruments for application on biological tissues, and in particular to surgical instruments that combine coagulation by means of radiofrequency currents in bipolar mode with the mechanical cutting made with a blade; and which aims to provide a novel arrangement of bipolar electrodes and a cutting blade that provides an electro-thermal behavior that favors the desired coagulation-cutting effect.
  • the invention provides a new method for coagulation and cutting of biological tissues that improves the results of coagulation and cutting performed.
  • WO 2008/135613-A1 describes an instrument that combines coagulation by means of an internally cooled electrode and mechanical cutting by means of a blade attached to said electrode. Although it allows good coagulation and good cutting effect, its principle of operation is monopolar. This means that the RF current flows from a small electrode called an active electrode (internally cooled electrode) to a dispersive electrode (also called a larger patch or plate, and located on the patient's back or thigh).
  • This monopolar configuration brings with it two major limitations:
  • EP 04005356.3 describes a needle-shaped instrument that has internally cooled electrodes in bipolar configuration.
  • the relative arrangement of these electrodes is oriented to tumor ablation and not resection, since it does not have elements that allow tissue cutting.
  • the patent described here includes an internal cooling medium for the electrodes, that is, a medium based on a closed hydraulic circuit, where the liquid never comes into contact with the tissue.
  • instruments with bipolar electrodes that include means of cooling the tissue surface but with saline serum infusion (irrigated electrodes) have been previously described.
  • US 2003/0084907 describes a bipolar device with an internal system through which a liquid is circulated that is thrown on the surface of the tissue through one or more holes. It is also contemplated that the liquid is cold to facilitate cooling of the tissue to be treated.
  • said liquid is an electrical conductor, and this can improve the efficiency of the surgical procedure.
  • the bipolar electrodes described in these patents may pose a surgical risk because, due to the high temperature that may appear at the inferred between electrode and tissue, close to 100 ° C, the infused liquid may become excessively hot (even boil), and therefore, the tissues near the treatment area may accidentally damage the burn.
  • the present invention does not contemplate in any case the irrigation of liquid to the tissue, but proposes to combine the bipolar application with internal cooling, thus eliminating the risk of hot serum burns.
  • it since it does not infuse liquid over the surgical area, it allows the surgeon a better observation of the coagulation and cutting area.
  • the biological tissue near the electrode does not reach temperatures of 100 ° C, thus avoiding excessive drying and consequent adhesion to the electrode, which allows more electrical current to be distributed and coagulation achieved;
  • the electrosurgical device object of the invention combines the advantages of internally cooled electrodes and an attached blade, with an original arrangement of two electrodes in a bipolar configuration that allows coagulation and cutting of the tissue surface without having to pinch it.
  • it has a smoke extraction system, which can be very disturbing during a laparoscopic procedure.
  • the invention provides a new bipolar electrosurgical device and a method for coagulating and cutting biological tissues.
  • the present invention provides a bipolar electrosurgical device for coagulating and cutting biological tissues that solves the problems posed by the inventive matter included in the attached independent claims.
  • the present invention achieves this objective by combining the effect of internal cooling on the two surface support electrodes, by means of a closed refrigerated fluid circuit, with a blade located in the central part and electrically isolated from the two electrodes.
  • the device in the present invention makes it possible to precoagulate sufficient volume of biological tissue before the knife cuts it, thus minimizing the risk of tissue bleeding after cutting.
  • this refers to an electrosurgical device for coagulating and cutting biological tissues comprising two identical metal electrodes. Said electrodes are separated from each other by a bridge piece of insulating material to which they are fixed. In the lower part of the insulating bridge piece a blade is inserted, which is housed equidistant from the two electrodes, and therefore has no direct contact with either of the two electrodes, to perform the coagulation of a biological tissue, placing the electrodes on said biological tissue and applying a current on said electrodes, and then cutting said coagulated biological tissue, moving the device on the biological tissue.
  • the radiofrequency currents are distributed through the zone of the two electrodes where the blade is not, and they flow through the biological tissue producing a coagulation zone. This can cause the coagulation of the tissue to be small at the beginning of the procedure.
  • the surgeon can further insert the device into the sectioned area, and the electrodes can penetrate more into said zone, which allows the area of contact between the electrodes and the tissue to increase, which decreases the impedance and allows more electrical current to flow through the electrodes, managing to deposit more power and therefore increasing the depth of the clotted area
  • the cooling capacity of the tissue surface also increases and thus again the depth of the coagulated area.
  • the device penetrates the coagulated area, there is an improvement in the electrical and thermal operation of the device that allows more efficient operation, achieving better coagulation prior to cutting.
  • the blade has a configuration of the curved cutting area, selected from a semicircle contour, a semi-ellipse contour and a combination of both.
  • the insulating bridge piece comprises two arched end sections joined by a central section as a yoke, whose lower face of the arched end sections are fixed to the top of the electrodes, and on whose face The lower part of the central section is fixed to the blade, said lower face of the central section being provided to contact the biological tissue and allow current to flow along the lower zone of the electrodes and upper area of the biological tissue with which it contacts, according to It was described.
  • the insulating bridge piece is made of transparent plastic material in order to favor the surgeon's vision during use.
  • each electrode is internally cooled, for which said electrodes comprise an internal conduit through which a cold liquid is circulated to the end of each electrode, by means of a pump that is part of a cooling circuit, and returns it through the outer part of said inner tube towards the handle part of the device, evacuating heat from the tissue surface and thus preventing the burned tissue from adhering to the electrode.
  • the invention provides that the internal conduits of the coolant electrodes are connected according to a connection selected between a serial connection with a single cooling circuit and a parallel connection with independent cooling circuits.
  • a hydraulic circuit is used to infuse the cold liquid inside the electrodes This circuit begins in a cold liquid bag, the contents of which are pumped by a hydraulic pump. The liquid enters and leaves the device through independent circuits, specifically enters through the internal conduits and exits through the periphery of said internal conduits. Finally the liquid goes to a drainage tank. In other embodiments the liquid is recirculated into the bag.
  • the two electrodes are connected to two output terminals of a radiofrequency or electrosurgical generator, to apply the currents that allow the described coagulation to be performed.
  • the insulating bridge piece comprises a hole in which a thin tube is retained that is connected to a vacuum cleaner to allow said smoke to be aspirated.
  • this refers to a method of coagulation and cutting of biological tissues comprising:
  • This phase is carried out by starting the internal cooling of the device by using a pump that takes the cold liquid from a bag and circulates it inside the device, until it is drained in a tank,
  • radiofrequency electrical current is supplied to flow between the two electrodes,
  • the electrodes are dragged over the tissue area so that the blade cuts the previously coagulated area.
  • the process of the invention provides for backward and forward movements of the electrodes of the device over the tissue area to cut the coagulated area, and so on until the biological tissue is completely cut.
  • Figure 1 shows a perspective of the device for coagulation and cutting of biological tissues of the invention.
  • Figure 2 shows a side view of the device of the invention, in which the smoke extraction tube has not been included.
  • Figures 3a and 3b show different front sections A and B of the previous figure corresponding to the sequence of steps to be performed for the use of the device.
  • Figure 4 shows the electrical connections of the device to the radiofrequency or electrosurgical generator, the hydraulic connections to a peristaltic pump, the connection to the smoke aspirator, and a liquid reservoir.
  • the bipolar electrosurgical device 1 of the invention comprises two bipolar electrodes 2 and 2 'of metal with high electrical and thermal conductivity, for example 304 stainless steel. These electrodes have external diameters between 3 and 8 mm and a sufficiently thin wall, between 0.1 and 0.5 mm.
  • the bipolar electrodes 2 and 2 ' are internally cooled, for which an internal cooling conduit 14 of metallic or plastic material is included, with an external diameter between 0.5 and 2 mm and a wall between 0.15 and 0.25 mm.
  • the end of the internal conduits 14 is slightly removed from the tip of the electrode in order to obstruct the liquid outlet, and is connected to a cooling circuit 9, 10, 1 1 and 12, which is described below.
  • the electrodes 2 and 2 ' are separated from each other a distance between 2 and 10 mm, by means of an electrically insulating piece 3 made of plastic material such as an Epotek® 320 resin, or a polycarbonate such as Makrolon® 2558.
  • a knife 4 is interlocked which has a length between 4 and 10 mm, protruding on the surface of the electrodes 2 and 2 'a depth between 2 and 6 mm, to allow the blade 4 to penetrate into a tissue to be cut, said value .
  • the blade has a thickness between 0.1 and 0.25 mm, and is made of a rigid metallic material, such as 304 stainless steel, and has a semilunar shape for allow cutting in both directions, that is, forward and reverse.
  • the insulating bridge 3 comprises two arched end sections 3a joined by a central section 3b as a yoke, whose lower face of the arched end sections are fixed to the upper part of the electrodes 2, 2 ' , and on whose lower side of the section central 3b is fixed the blade 4, said lower face of the central section 3b being provided to contact the biological tissue and allow current to flow along the lower zone of the electrodes 2, 2 ' and upper area of the biological tissue with the which contacts, as described in the "description of the invention" section.
  • the insulating bridge 3 comprises a hole 5 in which a thin tube 6 is retained that is connected to a vacuum cleaner to allow said smoke to be aspirated.
  • the electrodes 2 and 2 ' are connected to terminals 7 and 7' of an RF generator 8 or electrosurgery by means of electrical cables composed of a multitude of cables (in order to achieve greater flexibility), with a total section between 0.5 and 1 mm 2 , and covered with insulating material such as PVC, TPE or silicone. These wires are welded to electrodes 2 and 2 '. All this to allow applying the radiofrequency current.
  • the radiofrequency currents are distributed through the zone of the two electrodes where the blade is not, and they flow through the biological tissue producing a coagulation zone 15. This can cause the coagulation of the tissue to be of small depth at the beginning of the process.
  • the surgeon can further insert the device into the sectioned area, and the electrodes can penetrate more into that area, allowing the area of contact between the electrodes and the tissue increases, which decreases the impedance and allows more electrical current to flow through the electrodes, managing to deposit more power and therefore increasing the depth of the coagulated zone 15.
  • the capacity also increases of cooling the surface of the fabric and thus again the depth of the coagulated zone 15.
  • the cooling circuit comprises conduits 12 connecting the electrodes 2 and 2 'with the hydraulic circuit for transporting the cold liquid.
  • Said conduits 12 may be flexible PVC or silicone conduits with diameters similar to the internal metal tubes described.
  • the hydraulic circuit can be configured in series, that is to say the liquid travels first one electrode and then the other, or in parallel, that is to say the liquid enters simultaneously and leaves the two electrodes.
  • Said hydraulic circuit begins in a cold liquid bag 9, the contents of which are pumped by a hydraulic pump 10.
  • the liquid enters and leaves the device by independent circuits, specifically enters through the internal conduits 14 and exits through the periphery of said internal conduits. . Finally the liquid goes to a drain tank 1 1.
  • the device comprises a handle 13 provided with a switch for closing or opening the electrical circuit, that is, for applying or not applying electrical current to the electrodes and consequently to the tissue.
  • the control of the current is in the RF generator itself or electrosurgery either by some element in the front panel, or by a pedal.

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Abstract

Bipolar electrosurgical device for cauterizing and cutting biological tissue, which comprises a blade (4) for cutting the tissue and two electrodes (2, 2') provided with an internal conduit (14) for a cooling liquid; characterized in that it comprises an insulating bridge component (3) affixed to the electrodes (2, 2'), the blade (4) being arranged in the lower part thereof, projecting between the two electrodes. The bridge component (3) comprises a hole (5) for accommodating a tube for aspirating vapours produced upon cauterization. Furthermore, the invention relates to a method that comprises cooling the electrodes and placing the electrodes (2, 2') over said biological tissue and applying to them a current that gives rise to cauterization of the tissue, and then said cauterized biological tissue is cut, the device (1) being moved over the biological tissue. As the tissue is cut, the electrodes progress more deeply into the sectioned zone, thereby increasing the depth of the cauterization zone prior to cutting.

Description

DISPOSITIVO Y PROCEDIMIENTO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS OBJETO DE LA INVENCIÓN  BIPOLAR ELECTROQUIRURGICAL DEVICE AND PROCEDURE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS OBJECT OF THE INVENTION
La presente invención se relaciona de forma general con el campo de los instrumentos quirúrgicos de aplicación sobre tejidos biológicos, y en particular con los instrumentos quirúrgicos que combinan la coagulación mediante corrientes de radiofrecuencia en modo bipolar con el corte mecánico realizado con una cuchilla; y que tiene por objeto proporcionar una disposición novedosa de los electrodos bipolares y una cuchilla de corte que proporciona un comportamiento electro-térmico que favorece el efecto buscado de coagulación-corte.  The present invention relates in general to the field of surgical instruments for application on biological tissues, and in particular to surgical instruments that combine coagulation by means of radiofrequency currents in bipolar mode with the mechanical cutting made with a blade; and which aims to provide a novel arrangement of bipolar electrodes and a cutting blade that provides an electro-thermal behavior that favors the desired coagulation-cutting effect.
Es otro objeto de la invención el dotar al dispositivo de medios de absorción de humos para favorecer la visión de la zona a cortar, especialmente en procedimientos laparoscópicos.  It is another object of the invention to provide the device with smoke absorption means to promote vision of the area to be cut, especially in laparoscopic procedures.
Además la invención proporciona un nuevo procedimiento para coagulación y corte de tejidos biológicos que mejora los resultados de la coagulación y corte realizados.  In addition, the invention provides a new method for coagulation and cutting of biological tissues that improves the results of coagulation and cutting performed.
ANTECEDENTES DE LA INVENCIÓN  BACKGROUND OF THE INVENTION
En numerosas aplicaciones quirúrgicas es necesario cortar tejidos biológicos minimizando el sangrado ocasionado por el corte mecánico. Como ejemplo podemos citar la resección de un fragmento de hígado. En este tipo de cirugía hepática, la reducción del sangrado y del tiempo operatorio son determinantes del resultado quirúrgico. De hecho, una resección hepática con métodos convencionales puede conllevar una pérdida de sangre superior a los 700 ml_ y requerir un tiempo de resección superior a los 45 minutos. Un mayor sangrado durante la operación implica un mayor número de complicaciones, la necesidad de transfusiones y la disminución de la supervivencia a largo plazo del paciente. Además, un mayor tiempo quirúrgico se ha relacionado con una mayor mortalidad directamente relacionada con el procedimiento quirúrgico. Para solucionar este problema, Weber y colaboradores (Weber JC, Navarra G, Jiao LR et al. New technique for liver resection using heat coagulative necrosis. Ann Surg 2002; 236(5): 560-563) describieron en el año 2002 el concepto de pre-coagular el tejido antes de cortarlo con el objeto de reducir la pérdida de sangre. Dicha pre- coagulación se ha realizado hasta la actualidad mediante corrientes de radiofrecuencia (RF), las cuales son aplicadas al tejido mediante electrodos, algunos de los cuales tienen un sistema de refrigeración interna. La refrigeración interna de los electrodos es realizada habitualmente mediante un circuito hidráulico cerrado que hace fluir líquido frió (5-10°C) a través del interior del electrodo. Esta refrigeración permite que el tejido biológico próximo al electrodo no llegue a temperaturas de 100°C, evitando su excesiva desecación y su consiguiente adhesión al electrodo, lo cual impediría distribuir más corriente eléctrica, y por lo tanto lograr una coagulación eficaz. In many surgical applications it is necessary to cut biological tissues minimizing bleeding caused by mechanical cutting. As an example we can cite the resection of a liver fragment. In this type of liver surgery, the reduction of bleeding and operative time are determinants of the surgical outcome. In fact, a liver resection with conventional methods can lead to a blood loss greater than 700 ml_ and require a resection time greater than 45 minutes. Greater bleeding during the operation implies a greater number of complications, the need for transfusions and the decrease in the long-term survival of the patient. In addition, longer surgical time has been linked to higher mortality directly related to the surgical procedure. To solve this problem, Weber et al. (Weber JC, Navarra G, Jiao LR et al. New technique for liver resection using heat coagulative necrosis. Ann Surg 2002; 236 (5): 560-563) described the concept in 2002 of pre-coagulating the tissue before cutting it in order to reduce blood loss. This precoagulation has been carried out until now by means of radiofrequency (RF) currents, which are applied to the tissue by means of electrodes, some of which have an internal cooling system. The internal cooling of the electrodes is usually carried out by means of a closed hydraulic circuit that makes cold liquid flow (5-10 ° C) at through the inside of the electrode. This cooling allows the biological tissue near the electrode not to reach temperatures of 100 ° C, avoiding excessive drying and consequent adhesion to the electrode, which would prevent the distribution of more electrical current, and therefore achieve efficient coagulation.
Para lograr un mismo efecto de pre-coagulación y corte en el mismo instrumento, la patente WO 2008/135613-A1 describe un instrumento que combina coagulación mediante un electrodo internamente refrigerado y corte mecánico mediante una cuchilla adherida al citado electrodo. Aunque permite una buena coagulación y buen efecto de corte, su principio de funcionamiento es monopolar. Esto significa que la corriente de RF fluye desde un electrodo de pequeñas dimensiones llamado electrodo activo (electrodo internamente refrigerado) hacia un electrodo dispersivo (denominado también parche o placa, de mayor dimensión, y situado en la espalda o muslo del paciente). Esta configuración monopolar trae consigo dos grandes limitaciones:  In order to achieve the same pre-coagulation and cutting effect on the same instrument, WO 2008/135613-A1 describes an instrument that combines coagulation by means of an internally cooled electrode and mechanical cutting by means of a blade attached to said electrode. Although it allows good coagulation and good cutting effect, its principle of operation is monopolar. This means that the RF current flows from a small electrode called an active electrode (internally cooled electrode) to a dispersive electrode (also called a larger patch or plate, and located on the patient's back or thigh). This monopolar configuration brings with it two major limitations:
1) Las lesiones térmicas creadas son de gran profundidad, lo que produce una destrucción excesiva del tejido sano. 1) The thermal lesions created are of great depth, which causes excessive destruction of healthy tissue.
2) Las corrientes de RF pueden producir lesiones térmicas indeseables y peligrosas en órganos intermedios o alejados. Este riesgo es especialmente alto durante el uso laparoscópico, donde la visión del campo quirúrgico es reducida.  2) RF currents can produce undesirable and dangerous thermal lesions in intermediate or remote organs. This risk is especially high during laparoscopic use, where the vision of the surgical field is reduced.
3) Se requiere el uso de un electrodo dispersivo, y su consiguiente vigilancia con objeto de asegurar el buen contacto entre electrodo y piel, y evitar así posibles quemaduras. 3) The use of a dispersive electrode is required, and its subsequent monitoring in order to ensure good contact between electrode and skin, and thus avoid possible burns.
Una configuración bipolar de electrodos permitiría reducir estas limitaciones. En este sentido se han propuesto anteriormente distintas configuraciones bipolares de electrodos internamente refrigerados. Por ejemplo, la patente EP 04005356.3 describe un instrumento en forma de aguja que dispone de electrodos internamente refrigerados en configuración bipolar. Sin embargo, la disposición relativa de estos electrodos (alineados con el eje de la aguja) esta orientada a la ablación de tumores y no a la resección, ya que no dispone de elementos que permitan el corte del tejido.  A bipolar electrode configuration would reduce these limitations. In this sense, different bipolar configurations of internally cooled electrodes have been previously proposed. For example, EP 04005356.3 describes a needle-shaped instrument that has internally cooled electrodes in bipolar configuration. However, the relative arrangement of these electrodes (aligned with the axis of the needle) is oriented to tumor ablation and not resection, since it does not have elements that allow tissue cutting.
Otras configuraciones bipolares sí disponen de elementos de corte, como la patente US4,651 ,734 o la US5,445,638 donde una cuchilla de corte es combinada con un par de electrodos. Este instrumento está claramente orientado a la coagulación y corte de pequeños vasos sanguíneos ya que los electrodos no están internamente refrigerados, y por lo tanto la coagulación es muy superficial. Además, la disposición de los electrodos no permite su uso en resección laparoscópica por el riesgo de cortar tejidos previamente no coagulados. Other bipolar configurations do have cutting elements, such as US4,651, 734 or US5,445,638, where a cutting blade is combined with a pair of electrodes. This instrument is clearly oriented to the coagulation and cutting of small blood vessels since the electrodes are not internally refrigerated, and therefore the coagulation is very superficial. In addition, the arrangement of the electrodes does not allow its use in laparoscopic resection due to the risk of cutting previously uncoagulated tissues.
Previamente han sido descritos algunos instrumentos electroquirúrgicos con configuración bipolar de electrodos internamente refrigerados y dotados de sistemas de corte mecánico. Por ejemplo, la patente US 6,074,389 describe un instrumento con electrodos internamente refrigerados en forma de pinza bipolar que presiona el tejido, aplica corrientes de RF, y posteriormente una cuchilla se desliza para seccionar la zona de tejido previamente coagulada. La disposición de los electrodos en este instrumento requiere que el tejido a seccionar sea pinzado, lo que es complicado en determinados pasos de la resección quirúrgica, como es el acceso a la superficie del órgano.  Previously, some electrosurgical instruments with bipolar configuration of internally cooled electrodes and equipped with mechanical cutting systems have been described. For example, US 6,074,389 describes an instrument with internally cooled electrodes in the form of a bipolar clamp that presses the tissue, applies RF currents, and subsequently a blade slides to section the area of previously coagulated tissue. The arrangement of the electrodes in this instrument requires that the tissue to be sectioned be pinched, which is complicated in certain steps of surgical resection, such as access to the surface of the organ.
Es necesario destacar que la patente aquí descrita incluye un medio de refrigeración interna para los electrodos, es decir, un medio basado en un circuito hidráulico cerrado, donde el líquido nunca entre en contacto con el tejido. Por contra, se han descrito previamente instrumentos con electrodos bipolares que incluyen medios de refrigeración de la superficie del tejido pero con infusión de suero salino (electrodos irrigados). Por ejemplo, la patente US 2003/0084907 describe un dispositivo bipolar con un sistema interno por el que circula un líquido que es lanzado sobre la superficie del tejido a través de uno o más orificios. Se contempla también que el líquido sea frío para facilitar la refrigeración del tejido a tratar. La idea clave de esta patente es que dicho líquido es conductor eléctrico, y esto puede mejorar la eficiencia del procedimiento quirúrgico. La diferencia básica de la patente US 2003/0084907 respecto a la invención es que en aquella los electrodos son irrigados, y no internamente refrigerados como en nuestra invención. Es decir, que el funcionamiento se basa en infundir en el tejido un líquido muy conductor a través de unos orificios. Por el contrario, nuestra invención se basa en electrodos internamente refrigerados, en los que el líquido circula siempre internamente, no entrando nunca en contacto con el tejido. Otras patentes describen electrodos bipolares para coagular y cortar tejidos, como por ejemplo WO 01/60273, US 5342357, WO 03/061499. Sin embargo, en todas ellas el líquido refrigerante es infundido hacia el tejido con objeto de irrigar su superficie. Los electrodos bipolares descritos en estas patentes pueden suponer un riesgo quirúrgico ya que debido a la alta temperatura que puede aparecer en la inferíase entre electrodo y tejido, cercana a 100°C, el líquido infundido puede llegar a calentarse en exceso (incluso hervir), y por lo tanto, puede llegar a dañar por quemadura de forma accidental los tejidos próximos a la zona de tratamiento. La presente invención, por el contrario, no contempla en ningún caso la irrigación de líquido hacia el tejido, sino que propone combinar la aplicación bipolar con la refrigeración interna, eliminando así el riesgo de quemaduras por suero caliente. Además, dado que no infunde líquido sobre la zona quirúrgica, permite al cirujano una mejor observación de la zona de coagulación y corte. It should be noted that the patent described here includes an internal cooling medium for the electrodes, that is, a medium based on a closed hydraulic circuit, where the liquid never comes into contact with the tissue. On the other hand, instruments with bipolar electrodes that include means of cooling the tissue surface but with saline serum infusion (irrigated electrodes) have been previously described. For example, US 2003/0084907 describes a bipolar device with an internal system through which a liquid is circulated that is thrown on the surface of the tissue through one or more holes. It is also contemplated that the liquid is cold to facilitate cooling of the tissue to be treated. The key idea of this patent is that said liquid is an electrical conductor, and this can improve the efficiency of the surgical procedure. The basic difference of US 2003/0084907 with respect to the invention is that in that the electrodes are irrigated, and not internally cooled as in our invention. That is, the operation is based on infusing into the tissue a very conductive liquid through some holes. On the contrary, our invention is based on internally cooled electrodes, in which the liquid always circulates internally, never coming into contact with the tissue. Other patents describe bipolar electrodes for coagulating and cutting tissues, such as WO 01/60273, US 5342357, WO 03/061499. However, in all of them the coolant is infused into the tissue in order to irrigate its surface. The bipolar electrodes described in these patents may pose a surgical risk because, due to the high temperature that may appear at the inferred between electrode and tissue, close to 100 ° C, the infused liquid may become excessively hot (even boil), and therefore, the tissues near the treatment area may accidentally damage the burn. The present invention, by contrast, does not contemplate in any case the irrigation of liquid to the tissue, but proposes to combine the bipolar application with internal cooling, thus eliminating the risk of hot serum burns. In addition, since it does not infuse liquid over the surgical area, it allows the surgeon a better observation of the coagulation and cutting area.
No existe un dispositivo que combine el uso de electrodos bipolares refrigerados internamente (que no irrigue líquido) con un elemento de corte. En consecuencia, sería deseable disponer de un dispositivo para coagular y cortar tejidos biológicos que combinara las ventajas de la configuración bipolar:  There is no device that combines the use of internally cooled bipolar electrodes (which does not irrigate liquid) with a cutting element. Consequently, it would be desirable to have a device for coagulating and cutting biological tissues that combined the advantages of the bipolar configuration:
1) Minimizar el riesgo de lesión indeseada ya que las corrientes eléctricas fluyen entre los dos electrodos activos, es decir exclusivamente a través del tejido que se desea tratar;  1) Minimize the risk of unwanted injury since electrical currents flow between the two active electrodes, that is, exclusively through the tissue to be treated;
2) Reducir los requerimientos de potencia eléctrica para lograr el mismo efecto que con la configuración monopolar. Esto permite una mayor seguridad, a la vez que aumenta la versatilidad del dispositivo ya que permite ser conectado a un mayor número de unidades electroquirúrgicas y generadores de radiofrecuencia disponibles en el quirófano;  2) Reduce electrical power requirements to achieve the same effect as with the monopolar configuration. This allows greater safety, while increasing the versatility of the device as it allows to be connected to a greater number of electrosurgical units and radiofrequency generators available in the operating room;
3) Evitar el uso de un electrodo dispersivo, facilitando la preparación del paciente, eliminando la necesidad de monitorizar la calidad de contacto y por lo tanto el riesgo de quemaduras bajo la piel, y finalmente minimizando el coste del procedimiento;  3) Avoid the use of a dispersive electrode, facilitating the preparation of the patient, eliminating the need to monitor the quality of contact and therefore the risk of burns under the skin, and finally minimizing the cost of the procedure;
con la ventaja de los electrodos internamente refrigerados: el tejido biológico próximo al electrodo no llega a temperaturas de 100°C, evitando así su excesiva desecación y su consiguiente adhesión al electrodo, lo cual permite distribuir más corriente eléctrica y lograr mayor coagulación;  with the advantage of internally refrigerated electrodes: the biological tissue near the electrode does not reach temperatures of 100 ° C, thus avoiding excessive drying and consequent adhesion to the electrode, which allows more electrical current to be distributed and coagulation achieved;
y con una disposición de los electrodos que permita una resección eficaz del tejido biológico sin tener que pinzarlo, es decir, directamente sobre su superficie.  and with an arrangement of the electrodes that allows an effective resection of the biological tissue without having to clamp it, that is, directly on its surface.
Por todo ello, el dispositivo electroquirúrgico objeto de invención combina las ventajas de los electrodos internamente refrigerados y de una cuchilla adherida, con una disposición original de dos electrodos en configuración bipolar que permite la coagulación y corte de la superficie del tejido sin tener que pinzarlo. Además, dispone de un sistema de aspiración de humo, el cual puede llegar a ser muy perturbador durante un procedimiento laparoscópico.  Therefore, the electrosurgical device object of the invention combines the advantages of internally cooled electrodes and an attached blade, with an original arrangement of two electrodes in a bipolar configuration that allows coagulation and cutting of the tissue surface without having to pinch it. In addition, it has a smoke extraction system, which can be very disturbing during a laparoscopic procedure.
Es precisamente objeto de la presente patente describir la disposición novedosa de dos electrodos bipolares y una cuchilla de corte. Dicha disposición permite un comportamiento electro-térmico que favorece el efecto buscado de coagulación-corte de forma original. En particular, a medida que la superficie del tejido es cortado por la cuchilla, y por consiguiente los electrodos van profundizando en la zona seccionada, el contacto de dichos electrodos con el tejido favorece el paso de la corriente eléctrica hacia zonas más profundas, aumentando así la profundidad de la zona de coagulación, y por consiguiente la eficacia del instrumento, ya que se asegura que el tejido cortado ha sido previamente coagulado. It is precisely the object of the present patent to describe the novel arrangement of two bipolar electrodes and a cutting blade. This arrangement allows an electro-thermal behavior that favors the desired effect of coagulation-cutting Originally In particular, as the surface of the tissue is cut by the knife, and therefore the electrodes go deeper into the sectioned area, the contact of said electrodes with the tissue favors the passage of the electric current to deeper areas, thus increasing the depth of the coagulation zone, and therefore the effectiveness of the instrument, since it ensures that the cut tissue has been previously coagulated.
DESCRIPCIÓN DE LA INVENCIÓN  DESCRIPTION OF THE INVENTION
Para conseguir las ventajas anteriormente expuestas, la invención proporciona un nuevo dispositivo electroquirúrgico bipolar y un procedimiento para coagular y cortar tejidos biológicos.  To achieve the advantages set forth above, the invention provides a new bipolar electrosurgical device and a method for coagulating and cutting biological tissues.
La presente invención proporciona un dispositivo electroquirúrgico bipolar para coagular y cortar tejidos biológicos que resuelve los problemas planteados mediante la materia inventiva comprendida en las adjuntas reivindicaciones independientes. La presente invención logra este objetivo al combinar el efecto de la refrigeración interna en los dos electrodos de apoyo superficial, mediante un circuito cerrado de fluido refrigerado, con una cuchilla situada en la parte central y aislada eléctricamente de los dos electrodos. De esta forma, el dispositivo en la presente invención permite pre- coagular suficiente volumen de tejido biológico antes de que la cuchilla lo corte, minimizando así el riesgo de que el tejido sangre tras el corte.  The present invention provides a bipolar electrosurgical device for coagulating and cutting biological tissues that solves the problems posed by the inventive matter included in the attached independent claims. The present invention achieves this objective by combining the effect of internal cooling on the two surface support electrodes, by means of a closed refrigerated fluid circuit, with a blade located in the central part and electrically isolated from the two electrodes. In this way, the device in the present invention makes it possible to precoagulate sufficient volume of biological tissue before the knife cuts it, thus minimizing the risk of tissue bleeding after cutting.
De acuerdo con un primer aspecto de la invención, ésta se refiere a un dispositivo electroquirúrgico para coagular y cortar tejidos biológicos que comprende dos electrodos metálicos idénticos. Dichos electrodos están separados entre sí mediante una pieza puente de material aislante a la que están fijados. En la parte inferior de la pieza puente aislante está insertada una cuchilla, la cual queda alojada equidistante de los dos electrodos, y que por lo tanto no tiene contacto directo con ninguno de los dos electrodos, para realizar la coagulación de un tejido biológico, situando los electrodos sobre dicho tejido biológico y aplicando una corriente sobre dichos electrodos, y seguidamente realizar el corte de dicho tejido biológico coagulado, desplazando el dispositivo sobre el tejido biológico.  According to a first aspect of the invention, this refers to an electrosurgical device for coagulating and cutting biological tissues comprising two identical metal electrodes. Said electrodes are separated from each other by a bridge piece of insulating material to which they are fixed. In the lower part of the insulating bridge piece a blade is inserted, which is housed equidistant from the two electrodes, and therefore has no direct contact with either of the two electrodes, to perform the coagulation of a biological tissue, placing the electrodes on said biological tissue and applying a current on said electrodes, and then cutting said coagulated biological tissue, moving the device on the biological tissue.
Las corrientes de radiofrecuencia son distribuidas a través de la zona de los dos electrodos donde no está la cuchilla, y fluyen a través del tejido biológico produciendo una zona de coagulación. Esto puede provocar que la coagulación del tejido sea de pequeña profundidad al principio del procedimiento. Sin embargo, a medida que el tejido va siendo cortado por la cuchilla, el cirujano puede insertar más el dispositivo dentro de la zona seccionada, y los electrodos pueden penetrar más en dicha zona, lo que permite que el área del contacto entre los electrodos y el tejido aumente, lo que disminuye la impedancia y permite que más corriente eléctrica pueda fluir a través de los electrodos, logrando depositar más potencia y por lo tanto aumentando la profundidad de la zona coagulada. Al aumentar el área de contacto, también aumenta la capacidad de refrigeración de la superficie del tejido y así de nuevo la profundidad de la zona coagulada. En resumen, a medida que el dispositivo va penetrando en la zona coagulada, se produce una mejora en el funcionamiento eléctrico y térmico del dispositivo que permite un funcionamiento más eficiente, logrando una coagulación de mejor calidad previa al corte. The radiofrequency currents are distributed through the zone of the two electrodes where the blade is not, and they flow through the biological tissue producing a coagulation zone. This can cause the coagulation of the tissue to be small at the beginning of the procedure. However, as the tissue is being cut by the blade, the surgeon can further insert the device into the sectioned area, and the electrodes can penetrate more into said zone, which allows the area of contact between the electrodes and the tissue to increase, which decreases the impedance and allows more electrical current to flow through the electrodes, managing to deposit more power and therefore increasing the depth of the clotted area By increasing the contact area, the cooling capacity of the tissue surface also increases and thus again the depth of the coagulated area. In summary, as the device penetrates the coagulated area, there is an improvement in the electrical and thermal operation of the device that allows more efficient operation, achieving better coagulation prior to cutting.
Para permitir realizar el corte en sentido de avance y retroceso, la cuchilla presenta una configuración de la zona de corte curvada, seleccionada entre un contorno de un semicírculo, un contorno de una semielípse y combinación de ambos.  To allow cutting in the forward and reverse direction, the blade has a configuration of the curved cutting area, selected from a semicircle contour, a semi-ellipse contour and a combination of both.
Además para permitir realizar la funcionalidad anteriormente comentada, la pieza puente aislante comprende dos tramos extremos arqueados unidos por un tramo central a modo de yugo, cuya cara inferior de los tramos extremos arqueados están fijados a la parte superior de los electrodos, y en cuya cara inferior del tramo central está fijada la cuchilla, quedando dicha cara inferior del tramo central prevista para contactar con el tejido biológico y permitir que fluya corriente a lo largo de la zona inferior de los electrodos y zona superior del tejido biológico con el que contacta, según fue descrito.  In addition to allowing the above-mentioned functionality to be carried out, the insulating bridge piece comprises two arched end sections joined by a central section as a yoke, whose lower face of the arched end sections are fixed to the top of the electrodes, and on whose face The lower part of the central section is fixed to the blade, said lower face of the central section being provided to contact the biological tissue and allow current to flow along the lower zone of the electrodes and upper area of the biological tissue with which it contacts, according to It was described.
En una realización de la invención la pieza puente aislante es de material plástico transparente con objeto de favorecer la visión del cirujano durante su uso.  In one embodiment of the invention, the insulating bridge piece is made of transparent plastic material in order to favor the surgeon's vision during use.
De acuerdo con una realización preferida del dispositivo de la invención cada electrodo es refrigerado internamente, para lo que dichos electrodos comprenden una conducción interna por la que se hace circular un líquido frío hasta el extremo de cada electrodo, mediante una bomba que forma parte de un circuito de refrigeración, y lo retorna a través de la parte externa de dicho tubo interior hacia la parte del mango del dispositivo, evacuando el calor desde la superficie del tejido y evitando así que el tejido quemado se adhiera al electrodo.  According to a preferred embodiment of the device of the invention each electrode is internally cooled, for which said electrodes comprise an internal conduit through which a cold liquid is circulated to the end of each electrode, by means of a pump that is part of a cooling circuit, and returns it through the outer part of said inner tube towards the handle part of the device, evacuating heat from the tissue surface and thus preventing the burned tissue from adhering to the electrode.
La invención prevé que las conducciones internas de los electrodos del líquido refrigerante están unidas según una conexión seleccionada entre una conexión serie con un único circuito de refrigeración y una conexión paralelo con circuitos de refrigeración independientes.  The invention provides that the internal conduits of the coolant electrodes are connected according to a connection selected between a serial connection with a single cooling circuit and a parallel connection with independent cooling circuits.
Se utiliza un circuito hidráulico para infundir el líquido frío en el interior de los electrodos. Este circuito comienza en una bolsa de líquido frío, cuyo contenido es bombeado por una bomba hidráulica. El líquido entra y sale al dispositivo por circuitos independientes, en concreto entra por las conducciones internas y sale por la periferia de dichas conducciones internas. Finalmente el líquido va a parar a un depósito de drenaje. En otras realizaciones el líquido es recirculado hacia la bolsa. A hydraulic circuit is used to infuse the cold liquid inside the electrodes This circuit begins in a cold liquid bag, the contents of which are pumped by a hydraulic pump. The liquid enters and leaves the device through independent circuits, specifically enters through the internal conduits and exits through the periphery of said internal conduits. Finally the liquid goes to a drainage tank. In other embodiments the liquid is recirculated into the bag.
En todas las posibles realizaciones descritas, los dos electrodos se conectan a sendos terminales de salida de un generador de radiofrecuencia o electrobisturí, para aplicarle las corrientes que permiten realizar la coagulación descrita.  In all the possible embodiments described, the two electrodes are connected to two output terminals of a radiofrequency or electrosurgical generator, to apply the currents that allow the described coagulation to be performed.
Durante el uso del dispositivo se puede producir humo por el calentamiento de los electrodos, de forma que la invención prevé que si el humo impide ver con claridad la zona tratada, el usuario puede conectar un aspirador de humos. Para ello la pieza puente aislante comprende un orificio en el que se retiene un tubo fino que está conectado a un aspirador para permitir aspirar dicho humo.  During the use of the device, smoke can be produced by heating the electrodes, so that the invention provides that if the smoke prevents seeing clearly the treated area, the user can connect a smoke aspirator. For this, the insulating bridge piece comprises a hole in which a thin tube is retained that is connected to a vacuum cleaner to allow said smoke to be aspirated.
De acuerdo con un segundo aspecto de la invención, ésta se refiere a un procedimiento de coagulación y corte de tejidos biológicos que comprende:  According to a second aspect of the invention, this refers to a method of coagulation and cutting of biological tissues comprising:
- Refrigerar los electrodos. Esta fase se realiza poniendo en marcha la refrigeración interna del dispositivo mediante el empleo de una bomba que toma el líquido frío de una bolsa y lo hace circular por el interior de dispositivo, hasta ser drenado en un depósito,  - Cool the electrodes. This phase is carried out by starting the internal cooling of the device by using a pump that takes the cold liquid from a bag and circulates it inside the device, until it is drained in a tank,
- situar los electrodos sobre dicha zona del tejido a tratar, refrigerando la zona del tejido a tratar,  - placing the electrodes on said area of the tissue to be treated, cooling the area of the tissue to be treated,
- aplicar corriente a los electrodos, para coagular la zona del tejido a tratar. Para ello se suministra corriente eléctrica de radiofrecuencia para que fluya entre los dos electrodos,  - apply current to the electrodes, to coagulate the area of the tissue to be treated. For this, radiofrequency electrical current is supplied to flow between the two electrodes,
- una vez la coagulación ha sido creada, se arrastran los electrodos sobre la zona del tejido para que la cuchilla corte la zona previamente coagulada.  - Once the coagulation has been created, the electrodes are dragged over the tissue area so that the blade cuts the previously coagulated area.
Además el procedimiento de la invención prevé realizar movimientos de retroceso y avance de los electrodos del dispositivo sobre la zona del tejido para cortar la zona coagulada, y así sucesivamente hasta lograr cortar por completo el tejido biológico.  In addition, the process of the invention provides for backward and forward movements of the electrodes of the device over the tissue area to cut the coagulated area, and so on until the biological tissue is completely cut.
Cuando se de el caso de que el humo producido al realizarse la coagulación impida la visión del usuario, se prevé una fase en la que se aspiran los humos mediante el dispositivo a través del tubo de aspiración que está conectado a un aspirador de humos. BREVE DESCRIPCIÓN DE LOS DIBUJOS When it is the case that the smoke produced during coagulation prevents the user's vision, a phase is foreseen in which the fumes are sucked through the device through the suction tube that is connected to a smoke aspirator. BRIEF DESCRIPTION OF THE DRAWINGS
Para complementar la descripción que se está realizando y con objeto de ayudar a una mejor comprensión de las características de la invención, de acuerdo con ejemplos preferentes de realización práctica de la misma, se acompaña como parte integrante de dicha descripción de un juego de dibujos en donde, con carácter ilustrativo y no limitativo, se ha representado lo siguiente:  To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to preferred examples of practical realization thereof, it is accompanied as an integral part of said description of a set of drawings in where, for illustrative and non-limiting purposes, the following has been represented:
La Figura 1 muestra una perspectiva del dispositivo para coagulación y corte de tejidos biológicos de la invención.  Figure 1 shows a perspective of the device for coagulation and cutting of biological tissues of the invention.
La Figura 2 una vista lateral del dispositivo de la invención, en el que no se ha incluido el tubo de aspiración de humos.  Figure 2 shows a side view of the device of the invention, in which the smoke extraction tube has not been included.
Las figuras 3a y 3b muestran diferentes secciones A y B frontales de la figura anterior que corresponden con la secuencia de pasos a realizar para el empleo del dispositivo.  Figures 3a and 3b show different front sections A and B of the previous figure corresponding to the sequence of steps to be performed for the use of the device.
La Figura 4 muestra las conexiones eléctricas del dispositivo al generador de radiofrecuencia o electrobisturí, las conexiones hidráulicas a una bomba peristáltica, la conexión al aspirador de humos, y un reservorio de líquido.  Figure 4 shows the electrical connections of the device to the radiofrequency or electrosurgical generator, the hydraulic connections to a peristaltic pump, the connection to the smoke aspirator, and a liquid reservoir.
EJEMPLO DE REALIZACIÓN  EXAMPLE OF REALIZATION
El dispositivo electroquirúrgico bipolar 1 de la invención comprende dos electrodos bipolares 2 y 2' de metal con alta conductividad eléctrica y térmica, por ejemplo acero inoxidable 304. Estos electrodos tienen diámetros externos comprendidos entre 3 y 8 mm y una pared suficiente fina, entre 0.1 y 0.5 mm. Los electrodos bipolares 2 y 2' están refrigerados internamente, para lo incluyen una conducción interna 14 de refrigeración de material metálico o plástico, con un diámetro externo entre 0.5 y 2 mm y una pared entre 0.15 y 0.25 mm. El extremo de las conducciones internas 14 queda ligeramente retirado de la punta del electrodo con objeto de obstruir la salida del líquido, y está conectado a un circuito de refrigeración 9, 10, 1 1 y 12, que se describe más adelante.  The bipolar electrosurgical device 1 of the invention comprises two bipolar electrodes 2 and 2 'of metal with high electrical and thermal conductivity, for example 304 stainless steel. These electrodes have external diameters between 3 and 8 mm and a sufficiently thin wall, between 0.1 and 0.5 mm. The bipolar electrodes 2 and 2 'are internally cooled, for which an internal cooling conduit 14 of metallic or plastic material is included, with an external diameter between 0.5 and 2 mm and a wall between 0.15 and 0.25 mm. The end of the internal conduits 14 is slightly removed from the tip of the electrode in order to obstruct the liquid outlet, and is connected to a cooling circuit 9, 10, 1 1 and 12, which is described below.
Los electrodos 2 y 2' están separados entre sí una distancia entre 2 y 10 mm, mediante una pieza eléctricamente aislante 3 hecha de material plástico como por ejemplo una resina Epotek® 320, o un policarbonato como el Makrolon® 2558. En la pieza de plástico 3 está enclavada una cuchilla 4 que tiene una longitud entre 4 y 10 mm, sobresaliendo sobre la superficie de los electrodos 2 y 2' una profundidad entre 2 y 6 mm, para permitir penetrar la cuchilla 4 en un tejido a cortar, dicho valor. La cuchilla tiene un grosor comprendido entre 0.1 y 0.25 mm, y es de un material metálico rígido, como por ejemplo acero inoxidable 304, y tiene una forma semilunar para permitir el corte en los dos sentidos, o sea avance y retroceso. The electrodes 2 and 2 'are separated from each other a distance between 2 and 10 mm, by means of an electrically insulating piece 3 made of plastic material such as an Epotek® 320 resin, or a polycarbonate such as Makrolon® 2558. In the piece of plastic 3 a knife 4 is interlocked which has a length between 4 and 10 mm, protruding on the surface of the electrodes 2 and 2 'a depth between 2 and 6 mm, to allow the blade 4 to penetrate into a tissue to be cut, said value . The blade has a thickness between 0.1 and 0.25 mm, and is made of a rigid metallic material, such as 304 stainless steel, and has a semilunar shape for allow cutting in both directions, that is, forward and reverse.
El puente aislante 3 comprende dos tramos extremos arqueados 3a unidos por un tramo central 3b a modo de yugo, cuya cara inferior de los tramos extremos arqueados están fijados a la parte superior de los electrodos 2, 2', y en cuya cara inferior del tramo central 3b está fijada la cuchilla 4, quedando dicha cara inferior del tramo central 3b prevista para contactar con el tejido biológico y permitir que fluya corriente a lo largo de la zona inferior de los electrodos 2, 2' y zona superior del tejido biológico con el que contacta, tal y como fue descrito en el apartado de "descripción de la invención". El puente aislante 3 comprende un orificio 5 en el que se retiene un tubo fino 6 que está conectado a un aspirador para permitir aspirar dicho humo. The insulating bridge 3 comprises two arched end sections 3a joined by a central section 3b as a yoke, whose lower face of the arched end sections are fixed to the upper part of the electrodes 2, 2 ' , and on whose lower side of the section central 3b is fixed the blade 4, said lower face of the central section 3b being provided to contact the biological tissue and allow current to flow along the lower zone of the electrodes 2, 2 ' and upper area of the biological tissue with the which contacts, as described in the "description of the invention" section. The insulating bridge 3 comprises a hole 5 in which a thin tube 6 is retained that is connected to a vacuum cleaner to allow said smoke to be aspirated.
Los electrodos 2 y 2' están conectados a unos terminales 7 y 7' de un generador de RF 8 o electrobisturí mediante unos cables eléctricos compuestos de multitud de cablecillos (con objeto de lograr mayor flexibilidad), con una sección total entre 0.5 y 1 mm2, y cubiertos con material aislante como PVC, TPE o silicona. Estos cables están soldados a los electrodos 2 y 2'. Todo ello para permitir aplicar la corriente de radiofrecuencia. The electrodes 2 and 2 'are connected to terminals 7 and 7' of an RF generator 8 or electrosurgery by means of electrical cables composed of a multitude of cables (in order to achieve greater flexibility), with a total section between 0.5 and 1 mm 2 , and covered with insulating material such as PVC, TPE or silicone. These wires are welded to electrodes 2 and 2 '. All this to allow applying the radiofrequency current.
Las corrientes de radiofrecuencia son distribuidas a través de la zona de los dos electrodos donde no está la cuchilla, y fluyen a través del tejido biológico produciendo una zona de coagulación 15. Esto puede provocar que la coagulación del tejido sea de pequeña profundidad al principio del procedimiento. Sin embargo, a medida que el tejido es cortado por la cuchilla 4, el cirujano puede insertar más el dispositivo hacia la zona seccionada, y los electrodos pueden penetrar más en dicha zona, lo que permite que el área del contacto entre los electrodos y el tejido aumente, lo que disminuye la impedancia y permite que más corriente eléctrica pueda fluir a través de los electrodos, logrando depositar más potencia y por lo tanto aumentando la profundidad de la zona coagulada 15. Al aumentar el área de contacto, también aumenta la capacidad de refrigeración la superficie del tejido y así de nuevo la profundidad de la zona coagulada 15. En resumen, a medida que el dispositivo va penetrando en la zona coagulada 15, se produce una mejora en el funcionamiento eléctrico y térmico del dispositivo que permite un funcionamiento más eficiente, logrando una coagulación de mejor calidad previa al corte. Este proceso se muestra en la figuras 3a y 3b, en las que la zona de apoyo de los electrodos está dispuesta en correspondencia con la sección B de los electrodos para coagular el tejido, produciendo la zona coagulada 15, cuyo corte se realiza con la cuchilla 4, prevista en la zona de la sección A. Los electrodos se refrigeran mediante un líquido refrigerante que circula a través de los tubos internos y retorna por el interior de los electrodos 2 y 2', esta enfriado entre 0 y 5°C, lo que permite tener el la punta del electrodo una temperatura aproximada de 10°C. Este líquido puede ser salino 0.9%NaCI u otro líquido poco conductor de la electricidad como glicina. Este sistema de refrigeración es el habitual en estos electrodos y ha sido descrito previamente, por ejemplo en la patente WO 2008/135613-A1. The radiofrequency currents are distributed through the zone of the two electrodes where the blade is not, and they flow through the biological tissue producing a coagulation zone 15. This can cause the coagulation of the tissue to be of small depth at the beginning of the process. However, as the tissue is cut by the blade 4, the surgeon can further insert the device into the sectioned area, and the electrodes can penetrate more into that area, allowing the area of contact between the electrodes and the tissue increases, which decreases the impedance and allows more electrical current to flow through the electrodes, managing to deposit more power and therefore increasing the depth of the coagulated zone 15. As the contact area increases, the capacity also increases of cooling the surface of the fabric and thus again the depth of the coagulated zone 15. In summary, as the device penetrates the coagulated zone 15, there is an improvement in the electrical and thermal operation of the device that allows operation more efficient, achieving better coagulation prior to cutting. This process is shown in Figures 3a and 3b, in which the electrode support zone is arranged in correspondence with section B of the electrodes to coagulate the tissue, producing the coagulated zone 15, the cutting of which is made with the blade. 4, provided in the area of section A. The electrodes are cooled by a coolant that circulates through the internal tubes and returns inside the electrodes 2 and 2 ', is cooled between 0 and 5 ° C, which allows the electrode tip to have an approximate temperature of 10 ° C. This liquid may be 0.9% NaCI saline or another liquid that is not very electrically conductive, such as glycine. This cooling system is common in these electrodes and has been previously described, for example in WO 2008/135613-A1.
El circuito de refrigeración comprende unos conductos 12 de conexión de los electrodos 2 y 2' con el circuito hidráulico para transportar el líquido frío. Dichos conductos 12 pueden ser conductos flexibles de PVC o silicona con los diámetros similares a los tubos metálicos internos descritos. El circuito hidráulico puede estar configurado en serie, es decir el líquido recorre primero un electrodo y luego el otro, o bien en paralelo, es decir el líquido entre simultáneamente y sale de los dos electrodos. Dicho circuito hidráulico comienza en una bolsa 9 de líquido frío, cuyo contenido es bombeado por una bomba hidráulica 10. El líquido entra y sale al dispositivo por circuitos independientes, en concreto entra por las conducciones internas 14 y sale por la periferia de dichas conducciones internas. Finalmente el líquido va a parar a un depósito de drenaje 1 1.  The cooling circuit comprises conduits 12 connecting the electrodes 2 and 2 'with the hydraulic circuit for transporting the cold liquid. Said conduits 12 may be flexible PVC or silicone conduits with diameters similar to the internal metal tubes described. The hydraulic circuit can be configured in series, that is to say the liquid travels first one electrode and then the other, or in parallel, that is to say the liquid enters simultaneously and leaves the two electrodes. Said hydraulic circuit begins in a cold liquid bag 9, the contents of which are pumped by a hydraulic pump 10. The liquid enters and leaves the device by independent circuits, specifically enters through the internal conduits 14 and exits through the periphery of said internal conduits. . Finally the liquid goes to a drain tank 1 1.
El dispositivo comprende un mango 13 dotado de un interruptor para cerrar o abrir el circuito eléctrico, es decir, para aplicar o no corriente eléctrica a los electrodos y en consecuencia al tejido. En otra configuración el control de la corriente está en el propio generador de RF o electrobisturí ya sea por algún elemento en el panel frontal, o por un pedal.  The device comprises a handle 13 provided with a switch for closing or opening the electrical circuit, that is, for applying or not applying electrical current to the electrodes and consequently to the tissue. In another configuration the control of the current is in the RF generator itself or electrosurgery either by some element in the front panel, or by a pedal.

Claims

REIVINDICACIONES
DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, que comprende dos electrodos (2, 2') que están dispuestos paralelos y una cuchilla de corte mecánico del tejido; se caracteriza por que comprende una pieza puente aislante (3) que está fijada a los electrodos (2, 2'), y en cuya parte inferior está dispuesta la cuchilla (4) sobresaliendo entre los dos electrodos, para realizar la coagulación de un tejido biológico, situando los electrodos (2, 2') sobre dicho tejido biológico y aplicando una corriente sobre dichos electrodos (2, 2'), y seguidamente realizar el corte de dicho tejido biológico coagulado, desplazando el dispositivo (1) sobre el tejido biológico. BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, comprising two electrodes (2, 2 ') that are arranged parallel and a mechanical cutting blade of the tissue; It is characterized in that it comprises an insulating bridge piece (3) that is fixed to the electrodes (2, 2 '), and in whose lower part the blade (4) is arranged protruding between the two electrodes, to perform the coagulation of a tissue biological, placing the electrodes (2, 2 ' ) on said biological tissue and applying a current on said electrodes (2, 2 ' ), and then cutting said coagulated biological tissue, moving the device (1) on the biological tissue .
DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 1 , caracterizado por que la cuchilla (4) presenta una configuración de la zona de corte curvada para permitir el corte en sentido de avance y retroceso.  BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 1, characterized in that the blade (4) has a configuration of the curved cutting area to allow cutting in the forward and reverse direction.
DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 2, caracterizado por que la zona de corte curvada de la cuchilla (4) está seleccionada entre un contorno de un semicírculo, un contorno de una semielípse y combinación de ambos.  BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 2, characterized in that the curved cutting area of the blade (4) is selected between a contour of a semicircle, a contour of a semi-ellipse and a combination of both.
DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 1 , caracterizado por que la pieza puente aislante (3) comprende dos tramos extremos arqueados (3a) unidos por un tramo central (3b) a modo de yugo, cuya cara inferior de los tramos extremos arqueados están fijados a la parte superior de los electrodos (2, 2'), y en cuya cara inferior del tramo central (3b) está fijada la cuchilla (4), quedando dicha cara inferior del tramo central (3b) prevista para contactar con el tejido biológico y permitir que fluya corriente a lo largo de la zona inferior de los electrodos (2, 2') y zona superior del tejido biológico con el que contacta. BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 1, characterized in that the insulating bridge piece (3) comprises two arched end sections (3a) joined by a central section (3b) as a yoke, whose underside of the arcuate end sections are fixed to the upper part of the electrodes (2, 2 ' ), and on whose lower face of the central section (3b) the blade (4) is fixed, said lower face of the central section (3b) being provided to contact the biological tissue and allow current to flow along the lower zone of the electrodes (2, 2 ' ) and upper area of the biological tissue with which it contacts.
DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 1 , en el que los electrodos (2, 2') presentan una configuración tubular, en cuyo interior comprenden una conducción de un líquido refrigerante, que forma parte de un circuito de refrigeración; se caracteriza por que las conducciones internas de los electrodos (2, 2') del líquido refrigerante están unidas según una conexión seleccionada entre una conexión serie con un único circuito de refrigeración y una conexión paralelo con circuitos de refrigeración independientes. BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 1, wherein the electrodes (2, 2 ' ) have a tubular configuration, inside which comprise a conduction of a coolant, which is part of a cooling circuit ; It is characterized in that the internal conduits of the electrodes (2, 2 ' ) of the coolant are connected according to a connection selected between a serial connection with a single cooling circuit and a parallel connection with independent cooling circuits.
6. DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 1 , caracterizado por que la pieza puente (3) comprende en su parte superior un orificio (5) de alojamiento de un tubo que está conectado a un aspirador de humos.  6. BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 1, characterized in that the bridge part (3) comprises in its upper part a hole (5) for housing a tube that is connected to a smoke aspirator.
7. DISPOSITIVO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, según reivindicación 1 , caracterizado por que la pieza puente aislante (3) es de material plástico transparente.  7. BIPOLAR ELECTROQUIRURGICAL DEVICE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 1, characterized in that the insulating bridge piece (3) is made of transparent plastic material.
8. PROCEDIMIENTO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, de acuerdo con la reivindicación 5, caracterizado por que comprende: 8. BIPOLAR ELECTROCHIRURICAL PROCEDURE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 5, characterized in that it comprises:
- Refrigerar los electrodos,  - Cool the electrodes,
- Situar los electrodos sobre una zona de tejido a tratar, refrigerando dicha zona del tejido a tratar,  - Place the electrodes on an area of tissue to be treated, cooling said area of the tissue to be treated,
- Aplicar corriente a los electrodos, para coagular la zona del tejido a tratar, - Apply current to the electrodes, to coagulate the area of the tissue to be treated,
- Arrastrar los electrodos sobre la zona del tejido previamente coagulada, para cortar dicha zona de tejido previamente coagulada. - Drag the electrodes over the previously coagulated tissue area, to cut said previously coagulated tissue area.
9. PROCEDIMIENTO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, de acuerdo con la reivindicación 8, caracterizado por que además comprende realizar movimientos de avance y retroceso del dispositivo para cortar la zona previamente coagulada, hasta cortar por completo el tejido biológico.  9. BIPOLAR ELECTROQUIRURGICAL PROCEDURE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 8, characterized in that it also comprises performing forward and reverse movements of the device for cutting the previously coagulated area, until the biological tissue is completely cut.
10. PROCEDIMIENTO ELECTROQUIRÚRGICO BIPOLAR PARA COAGULACIÓN Y CORTE DE TEJIDOS BIOLÓGICOS, de acuerdo con la reivindicación 8, caracterizado por que una fase de extracción de humos cuando al realizar la coagulación del tejido biológico se producen humos que impiden la visión del usuario.  10. BIPOLAR ELECTROQUIRURGICAL PROCEDURE FOR COAGULATION AND CUTTING OF BIOLOGICAL FABRICS, according to claim 8, characterized in that a phase of smoke extraction when the coagulation of the biological tissue produces fumes that prevent the vision of the user.
PCT/ES2012/070586 2011-09-14 2012-07-30 Bipolar electrosurgical device and method for cauterizing and cutting biological tissue WO2013038042A1 (en)

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