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WO2007022864A1 - Safety device for a hf-surgery appliance - Google Patents

Safety device for a hf-surgery appliance Download PDF

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Publication number
WO2007022864A1
WO2007022864A1 PCT/EP2006/007844 EP2006007844W WO2007022864A1 WO 2007022864 A1 WO2007022864 A1 WO 2007022864A1 EP 2006007844 W EP2006007844 W EP 2006007844W WO 2007022864 A1 WO2007022864 A1 WO 2007022864A1
Authority
WO
WIPO (PCT)
Prior art keywords
working
safety device
current
generator
instrument
Prior art date
Application number
PCT/EP2006/007844
Other languages
French (fr)
Inventor
Jürgen BELLER
Original Assignee
Erbe Elektromedizin Gmbh
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 Erbe Elektromedizin Gmbh filed Critical Erbe Elektromedizin Gmbh
Priority to JP2008527338A priority Critical patent/JP4970453B2/en
Priority to EP06776681.6A priority patent/EP1937173B1/en
Priority to US12/064,802 priority patent/US20080221563A1/en
Priority to CN2006800306858A priority patent/CN101247767B/en
Publication of WO2007022864A1 publication Critical patent/WO2007022864A1/en

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
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety

Definitions

  • the invention relates to a safety device for a HF-surgery appliance according to the precharacterizing clause of Claim 1.
  • HF-surgery appliances In electrosurgical appliances that operate at high frequency — in the following termed HF-surgery appliances — alternating currents in the range of 300 kHz are employed. In this frequency range capacitive and also inductive couplings play a not inconsiderable role.
  • the said capacitive couplings can allow currents to flow within the "inactive" leads. Then, if these leads make contact with the patient or the surgeon, injuries can result.
  • the IEC standard 60601-1-6 describes measurement procedures with which to determine the limiting value of such a coupled current with respect to the earth potential or to the opposite electrode. This limiting value is 150 mA.
  • the document DE 35 23 871 C3 discloses a safety circuit for a HF-surgery instrument that is intended to provide means by which, if leakage currents should appear, they can be prevented as far as possible from putting the patient at risk of injury.
  • This known device is relatively elaborate.
  • the objective of the present invention is to disclose a safety device of the kind cited at the outset that, by simple means, allows leakage currents to be avoided as completely as possible.
  • the present safety device for a HF-surgery appliance comprises at least one HF generator with an active output and a neutral output to generate a working current, and at least two working connectors to each of which can be connected, by way of electrical leads, at least one instrument through which the working current can be conducted to a biological tissue, such that the safety device at least reduces the danger presented by unintended "fault currents" that can flow through an inactive instrument, the objective of the invention being achieved by constructing the safety device and connecting it to the working connectors as well as the neutral output in such a way that every working connector through which no working current is flowing is connected to the neutral output.
  • the safety device preferably comprises switching elements with which to switch a working connector from the neutral output to an active output of the HF generator and to conduct the working current from the HF generator to an instrument.
  • Such changeover switches are preferably constructed as relays and hence are simple to manufacture and to operate.
  • a control means is provided which preferably is constructed as a microcomputer designed so that in response to an activation signal, the working connector of an instrument to be activated is first connected to an active output of the HF generator, and then the HF generator is triggered so that it delivers the working current.
  • the working connectors are connected to the HF generator; instead, all of them are at the neutral potential.
  • the working current need not immediately flow through the switch, which instead changes state while in a no-current condition. It is only after switching has occurred that the HF generator is triggered so as to deliver a "signal" set by the user, i.e. the actual working current.
  • sampling elements to monitor the current and/or voltage, which are designed to generate a fault-current signal when the current and/or the voltage at a working connector through which no working current is flowing exceeds a pre-adjustable threshold. In this way it is easy to determine whether any fault currents are present. If that is the case, then appropriate measures can be taken. In particular, in such a case (threshold exceeded) a warning signal can be emitted by a signal element to announce an (excessive) fault current. This makes it possible for the user easily to check the operational state of the appliance. When this threshold is reached, or in certain cases a second, higher threshold, the HF generator can be switched off by an appropriate control signal, as a result of which the operational safety of the appliance is further increased.
  • a high-frequency generator 10 is provided, which can be adjusted by way of the customary adjustment organs in a manner known per se.
  • the HF generator 10 comprises an active output 15 and a neutral output 16, the latter being connected to an indifferent electrode 14 by way of a test-circuitry component 25 and a connector 24.
  • the indifferent electrode 14 is attached to the patient 1 in such a way as to ensure that only a slight density of current will be transferred from the indifferent electrode 14 into the tissue 1. The safety of the contact is tested by the test circuitry 25.
  • the signal from the active output 15 is sent to one pole of each of the change-over switches 3O 1 to 3O n .
  • the second pole of each switch 3O 1 to 3O n is connected to the neutral output 16.
  • the third pole (input) of the change-over switches 3O 1 to 3O n is connected to working connectors 22, to 22 n of the safety device 20 by way of transformers 33, to 33 n .
  • the transformers 33 j to 33 n ascertain which currents are flowing through the working connectors 22, to 22 n , or which voltages are present at them.
  • an active instrument 11 i.e. one that is being used at present, is attached to a first working connector 22,.
  • the user actuates a switch 13 on the active instrument 11 or a pedal switch (13), each of which is connected by way of a control connector 23 or 23', respectively, to a control means 21 that is preferably designed as a microprocessor.
  • the control means 21 receives the signals from the switch 13 and the transformers 33, to 33 n .
  • control means 21 is connected to the HF generator 10 in such a way that on one hand the HF generator 10 is controlled by the control means 21, while on the other hand the control means 21 is informed about operational states of the HF generator 10. Furthermore, the control means 21 is in controlling communication with the change-over switches 3O 1 to 3O n , which in the present case are constructed as relays, so that in response to relevant signals from the control means 21 the working connectors 22, to 22 n can be switched by the change-over switches 3O 1 to 3O n either to the active output 15 or to the neutral output 16.
  • the control means 21 changes the state of the change-over switch 3O 1 in such a way that the working connector 22, is applied to the active output 15 of the HF generator 10.
  • the other change-over switches 3O 2 to 3O n remain in the position shown in the drawing, so that the working connectors 22 2 to 22 n remain in communication with the neutral output 16.
  • the control means 21 controls the HF generator 10 accordingly, so that the latter supplies a working current to the active instrument 11 by way of the change-over switch 3O 1 , the transformer 33, and the working connector 22,.
  • the current circuit is closed by the tissue 1, the indifferent electrode 14 and the test circuitry 25, terminating at the neutral output 16 of the HF generator 10.
  • the control means 21 If the fault current (measured by the transformer 33,) exceeds a threshold that has been preset in the control means 21, the latter emits an alarm signal (shown here as a warning lamp). Alternatively or in addition (if a still higher threshold is exceeded) the control means 21 switches off the HF generator 10.

Landscapes

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

Abstract

In high-frequency surgical appliances it is possible for unintended fault currents to appear. A safety device (20) for a HF-surgery appliance is disclosed that comprises at least one HF generator (10) with an active output (15) and a neutral output (16) to generate a working current, and at least two working connectors (22/2), to each of which there can be connected, by way of leads, at least one instrument through (11,12) which the working current can be conducted to a biological tissue. The safety device (20) is intended to at least reduce the danger presented by fault currents that can flow through an inactive instrument. To solve this problem it is proposed that the safety device be designed and connected to the active outputs as well as to the neutral output in such a way that every working connector through which no working current is flowing is connected to the neutral output.

Description

Safety device for a HF-surgery appliance
DESCRIPTION
The invention relates to a safety device for a HF-surgery appliance according to the precharacterizing clause of Claim 1.
In electrosurgical appliances that operate at high frequency — in the following termed HF-surgery appliances — alternating currents in the range of 300 kHz are employed. In this frequency range capacitive and also inductive couplings play a not inconsiderable role.
When several instruments are attached to a HF-surgery appliance, for example one for cutting and another for coagulation, the said capacitive couplings can allow currents to flow within the "inactive" leads. Then, if these leads make contact with the patient or the surgeon, injuries can result.
The IEC standard 60601-1-6 describes measurement procedures with which to determine the limiting value of such a coupled current with respect to the earth potential or to the opposite electrode. This limiting value is 150 mA.
The document DE 35 23 871 C3 discloses a safety circuit for a HF-surgery instrument that is intended to provide means by which, if leakage currents should appear, they can be prevented as far as possible from putting the patient at risk of injury. This known device is relatively elaborate. The objective of the present invention is to disclose a safety device of the kind cited at the outset that, by simple means, allows leakage currents to be avoided as completely as possible.
This objective is achieved by a safety device according to Claim 1.
In particular, the present safety device for a HF-surgery appliance comprises at least one HF generator with an active output and a neutral output to generate a working current, and at least two working connectors to each of which can be connected, by way of electrical leads, at least one instrument through which the working current can be conducted to a biological tissue, such that the safety device at least reduces the danger presented by unintended "fault currents" that can flow through an inactive instrument, the objective of the invention being achieved by constructing the safety device and connecting it to the working connectors as well as the neutral output in such a way that every working connector through which no working current is flowing is connected to the neutral output.
Hence the crucial point of the invention resides in the fact that fault currents or leakage currents are not restricted but rather are "annihilated". Thus the risk that injury will be caused by the appliances is reduced.
The safety device preferably comprises switching elements with which to switch a working connector from the neutral output to an active output of the HF generator and to conduct the working current from the HF generator to an instrument. Such changeover switches are preferably constructed as relays and hence are simple to manufacture and to operate.
A control means is provided which preferably is constructed as a microcomputer designed so that in response to an activation signal, the working connector of an instrument to be activated is first connected to an active output of the HF generator, and then the HF generator is triggered so that it delivers the working current. Hence at the outset none of the working connectors are connected to the HF generator; instead, all of them are at the neutral potential. Furthermore, when switching is initiated the working current need not immediately flow through the switch, which instead changes state while in a no-current condition. It is only after switching has occurred that the HF generator is triggered so as to deliver a "signal" set by the user, i.e. the actual working current.
At the working connectors there are preferably provided sampling elements to monitor the current and/or voltage, which are designed to generate a fault-current signal when the current and/or the voltage at a working connector through which no working current is flowing exceeds a pre-adjustable threshold. In this way it is easy to determine whether any fault currents are present. If that is the case, then appropriate measures can be taken. In particular, in such a case (threshold exceeded) a warning signal can be emitted by a signal element to announce an (excessive) fault current. This makes it possible for the user easily to check the operational state of the appliance. When this threshold is reached, or in certain cases a second, higher threshold, the HF generator can be switched off by an appropriate control signal, as a result of which the operational safety of the appliance is further increased.
In the following, an exemplary embodiment of the invention is explained in greater detail with reference to the enclosed drawing.
As is evident in the drawing, a high-frequency generator 10 is provided, which can be adjusted by way of the customary adjustment organs in a manner known per se. The HF generator 10 comprises an active output 15 and a neutral output 16, the latter being connected to an indifferent electrode 14 by way of a test-circuitry component 25 and a connector 24. The indifferent electrode 14 is attached to the patient 1 in such a way as to ensure that only a slight density of current will be transferred from the indifferent electrode 14 into the tissue 1. The safety of the contact is tested by the test circuitry 25.
The signal from the active output 15 is sent to one pole of each of the change-over switches 3O1 to 3On. The second pole of each switch 3O1 to 3On is connected to the neutral output 16.
The third pole (input) of the change-over switches 3O1 to 3On is connected to working connectors 22, to 22n of the safety device 20 by way of transformers 33, to 33n. The transformers 33 j to 33n ascertain which currents are flowing through the working connectors 22, to 22n, or which voltages are present at them.
In the exemplary embodiment shown here an active instrument 11, i.e. one that is being used at present, is attached to a first working connector 22,. In order to allow a high- frequency current to flow, e.g. for the purpose of cutting, the user actuates a switch 13 on the active instrument 11 or a pedal switch (13), each of which is connected by way of a control connector 23 or 23', respectively, to a control means 21 that is preferably designed as a microprocessor. The control means 21 receives the signals from the switch 13 and the transformers 33, to 33n. In addition, by way of a control lead 17 the control means 21 is connected to the HF generator 10 in such a way that on one hand the HF generator 10 is controlled by the control means 21, while on the other hand the control means 21 is informed about operational states of the HF generator 10. Furthermore, the control means 21 is in controlling communication with the change-over switches 3O1 to 3On, which in the present case are constructed as relays, so that in response to relevant signals from the control means 21 the working connectors 22, to 22n can be switched by the change-over switches 3O1 to 3On either to the active output 15 or to the neutral output 16.
Thus during employment of the appliance when the switch 13 is actuated, the control means 21 changes the state of the change-over switch 3O1 in such a way that the working connector 22, is applied to the active output 15 of the HF generator 10. The other change-over switches 3O2 to 3On remain in the position shown in the drawing, so that the working connectors 222 to 22n remain in communication with the neutral output 16. After a prespecifϊed time has elapsed, a time that is as short as possible while still being long enough to ensure reliable switching of the change-over switches 3O1 to 3On, the control means 21 controls the HF generator 10 accordingly, so that the latter supplies a working current to the active instrument 11 by way of the change-over switch 3O1, the transformer 33, and the working connector 22,. The current circuit is closed by the tissue 1, the indifferent electrode 14 and the test circuitry 25, terminating at the neutral output 16 of the HF generator 10.
When the current flows in this way, currents can be coupled into an inactive instrument 12, or its connector fork, by way of capacitive couplings C, and C2, shown schematically in the drawing. When such a current is coupled into the inactive instrument 12, it flows through the working connector 22,, the transformer 332 and the change-over switch 3O2 to the neutral output 16 of the HF generator 10 or to the indifferent electrode 14. This arrangement prevents any damaging current from flowing through the inactive instrument 12, even if it comes into contact with the user or the patient.
If the fault current (measured by the transformer 33,) exceeds a threshold that has been preset in the control means 21, the latter emits an alarm signal (shown here as a warning lamp). Alternatively or in addition (if a still higher threshold is exceeded) the control means 21 switches off the HF generator 10. List of reference numerals
1 Tissue/patient
10 HF generator
11 Active instrument
12 Inactive instrument
13 Switch
14 Indifferent electrode
15 Active output
16 Neutral output
17 Control lead
20 Safety device
21 Control means
22, to 22n Working connector
23, 23' Control connector
24 Connector for indifferent electrode
25 Test circuitry
3O1 to 3On Change-over switch/relay
33, to 33n Transformer

Claims

1. Safety device for a HF-surgery appliance that comprises at least one HF generator (10) with an active output (15) and a neutral output (16) to generate a working current, and at least two working connectors (22, to 22n) for connection of at least one instrument (11, 12) through which the working current can be conducted to a biological tissue (1), such that the safety device (20) at least reduces the danger presented by fault currents that can flow through an inactive instrument (12), characterized in that the safety device (20) is designed and connected to the working connectors (22, to 22n) as well as to the neutral output (16) in such a way that every working connector (22, to 22J through which no working current is flowing is connected to the neutral output (16).
2. Safety device according to Claim 1, characterized in that change-over switches (30, to 3On) are provided for the purpose of switching a working connector (22, to 22n) from the neutral output (16) to the active output (15) of the HF generator (10) and conducting a working current from the HF generator (10) to an instrument (11).
3. Safety device according to one of the preceding claims, characterized in that a control means (21) is provided and is designed so that in response to an activation signal, initially the working connector (22, to 22n) of an instrument (11, 12) that is to be activated is connected to the active output (15) of the HF generator (10), and then the HF generator (10) is controlled so that it supplies the working current.
4. Safety device according to one of the preceding claims, characterized in that at the working connectors (22, to 22J there are provided sampling elements (33, to 33n) for detecting the magnitude of a current and/or voltage, which are designed to generate a fault-current signal whenever the current and/ or the voltage at a working connector (22, to 22n) through which no working current is flowing exceeds a predetermined threshold.
5. Safety device according to one of the preceding claims, in particular according to Claim 4, characterized in that a signal element is provided to emit a warning signal in response to the fault-current signal.
6. Safety device according to one of the preceding claims, in particular according to one of the claims 4 or 5, characterized in that the sampling elements (33, to 33J are in controlling communication with the HF generator (10), so that in response to the fault-current signal the HF generator (10) is switched off.
PCT/EP2006/007844 2005-08-26 2006-08-08 Safety device for a hf-surgery appliance WO2007022864A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2008527338A JP4970453B2 (en) 2005-08-26 2006-08-08 High frequency surgical instruments
EP06776681.6A EP1937173B1 (en) 2005-08-26 2006-08-08 Safety device for a hf-surgery appliance
US12/064,802 US20080221563A1 (en) 2005-08-26 2006-08-08 Safety Device For a Hf-Surgery Appliance
CN2006800306858A CN101247767B (en) 2005-08-26 2006-08-08 Safety device for a HF-surgery appliance

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005040487.1A DE102005040487B4 (en) 2005-08-26 2005-08-26 Electrosurgical unit
DE102005040487.1 2005-08-26

Publications (1)

Publication Number Publication Date
WO2007022864A1 true WO2007022864A1 (en) 2007-03-01

Family

ID=37056567

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/007844 WO2007022864A1 (en) 2005-08-26 2006-08-08 Safety device for a hf-surgery appliance

Country Status (6)

Country Link
US (1) US20080221563A1 (en)
EP (1) EP1937173B1 (en)
JP (1) JP4970453B2 (en)
CN (1) CN101247767B (en)
DE (1) DE102005040487B4 (en)
WO (1) WO2007022864A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010037446A2 (en) * 2008-10-01 2010-04-08 Erbe Elektromedizin Gmbh Electrosurgical hf generator
EP2323578A4 (en) * 2008-08-18 2016-07-27 Encision Inc Enhanced control systems including flexible shielding and support systems for electrosurgical applications
US9833281B2 (en) 2008-08-18 2017-12-05 Encision Inc. Enhanced control systems including flexible shielding and support systems for electrosurgical applications

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8600334B2 (en) * 2011-07-13 2013-12-03 Biosense Webster (Israel), Ltd. Patient leakage current limitation
CN109374952B (en) * 2018-12-03 2024-02-02 四川中测仪器科技有限公司 Full-automatic measurement system and measurement method for leakage current of high-frequency electrotome
US12137986B2 (en) 2021-09-29 2024-11-12 Cilag Gmbh International Methods for controlling cooperative surgical instruments

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US4171700A (en) * 1976-10-13 1979-10-23 Erbe Elektromedizin Gmbh & Co. Kg High-frequency surgical apparatus
US5152762A (en) * 1990-11-16 1992-10-06 Birtcher Medical Systems, Inc. Current leakage control for electrosurgical generator
DE3523871C2 (en) 1985-07-04 1994-07-28 Erbe Elektromedizin Gmbh, 7400 Tuebingen, De
US5496312A (en) 1993-10-07 1996-03-05 Valleylab Inc. Impedance and temperature generator control
WO2004045436A1 (en) 2002-11-18 2004-06-03 Storz Endoskop Produktions Gmbh Electrosurgical device and method for the operation thereof

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US5688269A (en) * 1991-07-10 1997-11-18 Electroscope, Inc. Electrosurgical apparatus for laparoscopic and like procedures
US5372596A (en) * 1993-07-27 1994-12-13 Valleylab Inc. Apparatus for leakage control and method for its use
US6039732A (en) * 1995-04-18 2000-03-21 Olympus Optical Co., Ltd. Electric operation apparatus
US5830212A (en) * 1996-10-21 1998-11-03 Ndm, Inc. Electrosurgical generator and electrode
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Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4171700A (en) * 1976-10-13 1979-10-23 Erbe Elektromedizin Gmbh & Co. Kg High-frequency surgical apparatus
DE3523871C2 (en) 1985-07-04 1994-07-28 Erbe Elektromedizin Gmbh, 7400 Tuebingen, De
US5152762A (en) * 1990-11-16 1992-10-06 Birtcher Medical Systems, Inc. Current leakage control for electrosurgical generator
US5496312A (en) 1993-10-07 1996-03-05 Valleylab Inc. Impedance and temperature generator control
WO2004045436A1 (en) 2002-11-18 2004-06-03 Storz Endoskop Produktions Gmbh Electrosurgical device and method for the operation thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2323578A4 (en) * 2008-08-18 2016-07-27 Encision Inc Enhanced control systems including flexible shielding and support systems for electrosurgical applications
US9833281B2 (en) 2008-08-18 2017-12-05 Encision Inc. Enhanced control systems including flexible shielding and support systems for electrosurgical applications
WO2010037446A2 (en) * 2008-10-01 2010-04-08 Erbe Elektromedizin Gmbh Electrosurgical hf generator
WO2010037446A3 (en) * 2008-10-01 2010-07-08 Erbe Elektromedizin Gmbh Electrosurgical hf generator
US9375248B2 (en) 2008-10-01 2016-06-28 Erbe Elektromedizin Gmbh Electrosurgical HF generator

Also Published As

Publication number Publication date
JP2009505702A (en) 2009-02-12
EP1937173B1 (en) 2016-06-29
CN101247767A (en) 2008-08-20
EP1937173A1 (en) 2008-07-02
DE102005040487B4 (en) 2014-02-06
CN101247767B (en) 2010-09-01
DE102005040487A1 (en) 2007-04-05
US20080221563A1 (en) 2008-09-11
JP4970453B2 (en) 2012-07-04

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