WO2013038042A1 - Dispositif et procédé électrochirurgical bipolaire de coagulation et de section de tissus biologiques - Google Patents

Dispositif et procédé électrochirurgical bipolaire de coagulation et de section de tissus biologiques 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
Prior art date
Application number
PCT/ES2012/070586
Other languages
English (en)
Spanish (es)
Inventor
Enrique Berjano Zanon
Fernando Burdio Pinilla
Luis GRANDE POSA
Original Assignee
Universidad Politécnica De Valencia
Fundacio Institut Mar D'investigacions Mediques (Imim)
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universidad Politécnica De Valencia, Fundacio Institut Mar D'investigacions Mediques (Imim) filed Critical Universidad Politécnica De Valencia
Publication of WO2013038042A1 publication Critical patent/WO2013038042A1/fr

Links

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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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Plasma & Fusion (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Surgical Instruments (AREA)

Abstract

Dispositif électrochirurgical bipolaire de coagulation et de section de tissus biologiques, qui comprend une lame (4) pour la section du tissu et deux électrodes (2, 2') dotées d'un conduit interne (14) pour un liquide de refroidissement, ce dispositif étant caractérisé en ce qu'il comprend un élément de liaison isolant (3) qui est fixé sur les électrodes (2, 2') et sur la partie inférieure duquel est placée la lame (4), cette dernière faisant saillie entre les deux électrodes. L'élément de liaison (3) comprend un orifice (5) destiné à recevoir un tube d'aspiration des fumées produites lors de la coagulation. L'invention concerne en outre un procédé consistant à refroidir les électrodes (2, 2') et à les placer sur ledit tissu biologique et à appliquer un courant aux électrodes pour produire la coagulation du tissu, puis à réaliser la section dudit tissu biologique coagulé, en déplaçant le dispositif (1) sur le tissu biologique. À mesure que le tissu est sectionné, les électrodes descendent plus profondément dans la zone, augmentant la profondeur de la zone de coagulation avant la section.
PCT/ES2012/070586 2011-09-14 2012-07-30 Dispositif et procédé électrochirurgical bipolaire de coagulation et de section de tissus biologiques WO2013038042A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP201131490 2011-09-14
ES201131490A ES2419159B1 (es) 2011-09-14 2011-09-14 Dispositivo y procedimiento electroquirurgico bipolar para coagulacion y corte de tejidos biologicos

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WO2013038042A1 true WO2013038042A1 (fr) 2013-03-21

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ES (1) ES2419159B1 (fr)
WO (1) WO2013038042A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9775672B2 (en) 2012-08-31 2017-10-03 Nico Corporation Bi-polar surgical instrument
US10383680B2 (en) 2012-08-31 2019-08-20 Nico Corporation Bi-polar surgical instrument
US11607266B2 (en) * 2016-09-26 2023-03-21 Kylix S.R.L. Electrosurgical device

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GB2480498A (en) 2010-05-21 2011-11-23 Ethicon Endo Surgery Inc Medical device comprising RF circuitry
US9333025B2 (en) 2011-10-24 2016-05-10 Ethicon Endo-Surgery, Llc Battery initialization clip
US10159524B2 (en) 2014-12-22 2018-12-25 Ethicon Llc High power battery powered RF amplifier topology
US10959771B2 (en) 2015-10-16 2021-03-30 Ethicon Llc Suction and irrigation sealing grasper
US10959806B2 (en) 2015-12-30 2021-03-30 Ethicon Llc Energized medical device with reusable handle
US10987156B2 (en) 2016-04-29 2021-04-27 Ethicon Llc Electrosurgical instrument with electrically conductive gap setting member and electrically insulative tissue engaging members
US10856934B2 (en) 2016-04-29 2020-12-08 Ethicon Llc Electrosurgical instrument with electrically conductive gap setting and tissue engaging members
US10751117B2 (en) * 2016-09-23 2020-08-25 Ethicon Llc Electrosurgical instrument with fluid diverter
US11033325B2 (en) 2017-02-16 2021-06-15 Cilag Gmbh International Electrosurgical instrument with telescoping suction port and debris cleaner
US10799284B2 (en) 2017-03-15 2020-10-13 Ethicon Llc Electrosurgical instrument with textured jaws
US11497546B2 (en) 2017-03-31 2022-11-15 Cilag Gmbh International Area ratios of patterned coatings on RF electrodes to reduce sticking
US11033323B2 (en) 2017-09-29 2021-06-15 Cilag Gmbh International Systems and methods for managing fluid and suction in electrosurgical systems
US11490951B2 (en) 2017-09-29 2022-11-08 Cilag Gmbh International Saline contact with electrodes
US11484358B2 (en) * 2017-09-29 2022-11-01 Cilag Gmbh International Flexible electrosurgical instrument
US11957342B2 (en) 2021-11-01 2024-04-16 Cilag Gmbh International Devices, systems, and methods for detecting tissue and foreign objects during a surgical operation

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9775672B2 (en) 2012-08-31 2017-10-03 Nico Corporation Bi-polar surgical instrument
US9782220B2 (en) 2012-08-31 2017-10-10 Nico Corporation Bi-polar surgical instrument
US10383680B2 (en) 2012-08-31 2019-08-20 Nico Corporation Bi-polar surgical instrument
US11607266B2 (en) * 2016-09-26 2023-03-21 Kylix S.R.L. Electrosurgical device

Also Published As

Publication number Publication date
ES2419159B1 (es) 2014-06-24
ES2419159A2 (es) 2013-08-19
ES2419159R1 (es) 2013-08-27

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