EP1538982A1 - Systeme de detection - Google Patents

Systeme de detection

Info

Publication number
EP1538982A1
EP1538982A1 EP03743439A EP03743439A EP1538982A1 EP 1538982 A1 EP1538982 A1 EP 1538982A1 EP 03743439 A EP03743439 A EP 03743439A EP 03743439 A EP03743439 A EP 03743439A EP 1538982 A1 EP1538982 A1 EP 1538982A1
Authority
EP
European Patent Office
Prior art keywords
detection sensor
swab
surgical instrument
magnetic material
detecting
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP03743439A
Other languages
German (de)
English (en)
Inventor
Lee Imperial College Innovations Ltd Edwards
Ara Imperial College Innovations Ltd Darzi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ip2ipo Innovations Ltd
Original Assignee
Imperial College Innovations Ltd
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 Imperial College Innovations Ltd filed Critical Imperial College Innovations Ltd
Publication of EP1538982A1 publication Critical patent/EP1538982A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/0507—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves using microwaves or terahertz waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers

Definitions

  • the present invention relates to surgical swabs and methods for detecting surgical swabs and instruments during or following surgery.
  • Medical swabs are generally made of absorbent, multi-layered cotton or cotton/lint-based material with a woven in PNC thread, coated in 55 % Barium Phosphate, which is detectable under X ray.
  • EP 0 244 992 describes a process of manufacturing swabs to include a layer of X ray detectable material, allowing the detection of retained swabs under X ray control.
  • Suture needles and instruments are most commonly made of high grade 622-625 surgical steel, and are magnetic.
  • the present invention provides alternative detection systems suitable for routine practice or as a method for preventive retained item scanning and swabs suitable for use in such detection systems.
  • a first aspect of the invention provides a method for detecting and/or locating within a body cavity (or otherwise during a surgical operation) a swab or surgical instrument (which may be a needle) which comprises a metal (material with high electrical conductivity) or magnetic material (or less preferably other detectable material), the method comprising the step of passing a detection sensor over the wound site, wherein the method does not involve the use of X-ray radiation.
  • the detection sensor comprises a multi sensor array.
  • a single sensor is considered sufficient to provide useful information.
  • the multi sensor approach would allow individual sensors to be tuned at different frequencies (which may allow more detailed positional information to be obtained) and may allow wider beam spread. Multiple sensors may provide a more accurate location indication, which may be useful in larger cavities.
  • the detection sensor is not intended to be inserted into the body.
  • the method indicates the presence or possibly the number of marked swabs or other metallic items within the wound or cavity body cavity. It is preferred that the detection sensor is capable of detecting magnetic materials, for example surgical steel. The detection sensor may preferably generate and/or detect microwave radiation.
  • the detection sensor may employ ultrasonic, radio/wireless proximity, thermal, luminescence, infrared, piezoelectric or fmoroscopy methods.
  • the detection sensor has the following properties: 1. it is preferably in the form of a 'wand' which may be passed over the wound site
  • It preferably has an audible and/or visible and/or vibrating warning system ie provides an audible or visible signal when a metallic or magnetic material is detected.
  • the senor is preferably of a construction that will allow it to be fully sterilised (autoclaveable) or sheathed with a sterile covering (which may be purpose- designed for the sensor, and which may be disposable). 5. Alternatively or in addition the sensor may be fully disposable.
  • Suitable detection sensors may be based on metal detector instruments used in law enforcement or security operations (for example in airport security), for example adapted to be sterilisable or to have a sterile covering, as discussed above. Such instruments will be well known to those skilled in the art.
  • WO 01/51948 relates to a hand-mounted instrument and describes other instruments, for example in the form of wands. Such instruments may be particularly suitable for use in the present invention.
  • US 5,936,586 and US 2002/0017904 also describe non-metal and metal detection instruments embodying principles which may be useful in instruments for use in the present invention.
  • the senor comprises a (preferably battery operated and hand portable) wave guide (A) which includes a microwave oscillator for generating microwaves and (at least) two resonating slots on a wall of the wave-guide, and a microwave detector capable of detecting reflected microwaves.
  • A preferably battery operated and hand portable wave guide
  • Suitable detection sensors may also be based on Electronic Article Surveillance (EAS) systems used in retail environments. These have the advantage that they are designed to be substantially unaffected by the presence of steel or ferromagnetic objects such as the operating theatre bed structure.
  • EAS Electronic Article Surveillance
  • One embodiment of such a sensor system uses tags made of a soft magnetic material that is easily saturated.
  • the detector contains a coil which generates a low (a few kHz) frequency alternating magnetic field.
  • the tag magnetisation is a clipped waveform rich in harmonics which are detected by a receive coil in the detector.
  • the tags can be in a number of forms, but typically can be a thin foil laminate either in a patch or in a thread about 1mm wide.
  • the senor comprises a transmit coil and a receive coil, connected to a battery operated transmit and receive circuit capable of detecting harmonics in the magnetisation of the tag.
  • a second (or further) detection sensor (which may also comprise a multi- sensor array) may be used. This may preferably be positioned on the opposite side of the patient to the first detection sensor. For example, the second detection sensor may be placed underneath the patient whilst the first detection sensor is used above (including to the side of) the patient.
  • the second or further detection sensor may be oriented so that its multi- sensor array is rotated relative to the multi-sensor array of the first detection sensor.
  • two or more detection sensors may be useful in creating a constant detection zone, for example by combining the signals received from the two or more detection sensors or multi-sensor arrays, as well known to those skilled in the art.
  • a re-useable mat comprising a second multi- sensor array may be placed underneath the patient (Fig 2).
  • the array may be similar to that in the first detection sensor but constructed to be 180 degrees out-of-phase. This arrangement may create a constant 'detection zone'.
  • a still further aspect of the invention provides a detection sensor as defined above for use in medicine.
  • a still further aspect of the invention provides a detection sensor as defined above for use in a method for detecting and/or locating within a body cavity (or otherwise during a surgical procedure) a swab or surgical instrument which comprises a metal or magnetic material (or other detectable material).
  • a further aspect of the invention provides a detection sensor as defined above in the form of a mat.
  • the invention provides a mat comprising a detection sense, preferably comprising a multi-sensor array.
  • a further aspect of the invention provides a swab or surgical instrument which comprises a metal or magnetic material (or other detectable material) for use in a method for detecting and/or locating within a body cavity (or otherwise during a surgical procedure) the swab or surgical instrument, the method comprising the step of passing a detection sensor over the wound site, wherein the method does not involve the use of X-ray radiation.
  • the detection sensor preferably comprises a multi sensor array, as discussed above.
  • a further aspect of the invention provides a surgical swab comprising a magnetic material.
  • the magnetic material does not comprise a noble metal, such as gold or silver as described in GB 805082.
  • the magnetic material preferably comprises paramagnetic atoms or ions, for example comprises Fe, Co or Ni atoms or ions (which are ferromagnetic elements).
  • the magnetic material may preferably comprise a ferromagnetic compound, for example a ferromagnetic compound listed in the CRC Handbook of Chemistry and Physics, 82 nd Edition 2001-2002 CRC Press LLC, Ed David R Lide. Magnetic materials are discussed extensively in the CRC Handbook (supra) and in references cited therein.
  • the magnetic material is or comprises stainless steel, preferably surgical grade stainless steel, for example 622-625 stainless steel.
  • the magnetic material or (in relation to the first aspect of the invention) metallic material or other detectable material may be incorporated in or round a thread embedded in the swab (which term includes any surgical dressing) structure.
  • medical and surgical swabs generally have a PNC thread, coated in 55 % Barium Phosphate woven into the swab.
  • the Barium Phosphate coating may be replaced by a metallic coating (Fig 1).
  • This metallic coating (or other detectable material) allows detection via multi-sensor sensing devices including: a. Magnetic; b. Ultrasonic; c. Radio/wireless proximity; d.
  • the thread may be woven into the gauze during manufacture of the swab or it may be sewn through the finished gauze or glued or otherwise attached thereto.
  • the magnetic material may consist of a low-coercivity alloy such as AtalanteTM (Bekaert NDS n.v.Sputtered Films, Karreweg 18,B - 9870 Zulte, Belgium, with a coercivity typically less than 1 Oersted. This is available as a thin (less than 1 micron) layer sputtered onto a flexible polymer substrate.
  • AtalanteTM Bekaert NDS n.v.Sputtered Films, Karreweg 18,B - 9870 Zulte, Belgium
  • the magnetic material or metal is non-toxic, unaffected by sterilisation and by body fluids (or less preferably is coated or contained in such a material), incapable of causing abrasion or irritation, non-fraying and flexible. It is further desirable that it is easily obtainable and manipulable and is preferably cheap. In the case of steel needles and other foreign bodies, it may be necessary to coat the items with a thin layer of soft magnetic material if the harmonic magnetic field detection system is used.
  • a further aspect of the invention provides a method for making a swab of the invention, comprising the step of incorporating a magnetic material into the swab.
  • the magnetic material may be incorporated during formation of the material from which the swab is constructed, after formation of the material but before the swab is assembled, or after assembly of the structure of the swab.
  • the magnetic material is incorporated on a thread on which the magnetic material is coated.
  • a further aspect of the invention provides a swab of the invention for use in medicine.
  • a still further aspect of the invention provides a swab of the invention for use in a method for detecting and/or locating within a body cavity the swab or surgical instrument, the method comprising the step of passing a detection sensor over the wound site, wherein the method does not involve the use of X-ray radiation.
  • the detection sensor comprises a multi sensor array.
  • Fig 2 If a foreign body (metal needle/instrument) or Swab manufactured with a flexible, metal coated PNC thread, is within Zone 'C it will create interference with one of the radiating slots and result in a signal being sent from the detecting diode resulting in an alarm signal (audio/visual). If no metallic or foreign bodies are within Zone 'C the balance of A and B is maintained causing no resultant alarm signal.
  • Example 1 Patient monitoring during surgery.
  • surgeon or an assistant scans the surgical zone prior to wound closer. This may be done in conjunction with existing swab and instrument checks.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Human Computer Interaction (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Geophysics And Detection Of Objects (AREA)

Abstract

L'invention a trait à un procédé de détection et/ou de repérage, dans une cavité corporelle, d'un tampon ou d'un instrument chirurgical consistant en une matière métallique ou magnétique ou en une autre matière détectable. Ce procédé consiste à passer un détecteur au-dessus de la plaie, le détecteur comprenant de préférence une mosaïque de capteurs et le procédé ne comportant pas l'utilisation de rayons X. Deux détecteurs peuvent être utilisés ; l'un pouvant être en forme de tapis réutilisable placé sous le patient, et l'autre pouvant être en forme de dispositif portatif ou de baguette. Le tampon peut comprendre un fil présentant un revêtement métallique.
EP03743439A 2002-03-06 2003-03-06 Systeme de detection Withdrawn EP1538982A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB0205188.6A GB0205188D0 (en) 2002-03-06 2002-03-06 Detection system
GB0205188 2002-03-06
PCT/GB2003/000945 WO2003073934A1 (fr) 2002-03-06 2003-03-06 Systeme de detection

Publications (1)

Publication Number Publication Date
EP1538982A1 true EP1538982A1 (fr) 2005-06-15

Family

ID=9932349

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03743439A Withdrawn EP1538982A1 (fr) 2002-03-06 2003-03-06 Systeme de detection

Country Status (4)

Country Link
EP (1) EP1538982A1 (fr)
AU (1) AU2003209466A1 (fr)
GB (1) GB0205188D0 (fr)
WO (1) WO2003073934A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2434872A (en) * 2006-02-03 2007-08-08 Christopher Paul Hancock Microwave system for locating inserts in biological tissue

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004078039A1 (fr) * 2003-03-07 2004-09-16 Philips Intellectual Property & Standards Gmbh Dispositif et procede destines a localiser un instrument dans un corps
US20070247318A1 (en) * 2006-04-11 2007-10-25 Medical D-Tect-Or Llc Retained Foreign Object Detection System
US8181860B2 (en) 2006-09-13 2012-05-22 Clearcount Medical Solutions, Inc. Apparatus and methods for monitoring objects in a surgical field
US9168104B2 (en) 2008-06-23 2015-10-27 John Richard Dein Intra-operative system for identifying and tracking surgical sharp objects, instruments, and sponges
US8726911B2 (en) 2008-10-28 2014-05-20 Rf Surgical Systems, Inc. Wirelessly detectable objects for use in medical procedures and methods of making same
US8264342B2 (en) 2008-10-28 2012-09-11 RF Surgical Systems, Inc Method and apparatus to detect transponder tagged objects, for example during medical procedures
US9226686B2 (en) 2009-11-23 2016-01-05 Rf Surgical Systems, Inc. Method and apparatus to account for transponder tagged objects used during medical procedures
US9514341B2 (en) 2014-03-31 2016-12-06 Covidien Lp Method, apparatus and article for detection of transponder tagged objects, for example during surgery
EP3125804B1 (fr) 2014-03-31 2019-05-01 Covidien LP Système d'antenne sphérique tenu à la main pour détecter des objets marqués par transpondeur, par exemple pendant une chirurgie
AU2016200113B2 (en) 2015-01-21 2019-10-31 Covidien Lp Wirelessly detectable objects for use in medical procedures and methods of making same
CN107205793B (zh) 2015-01-21 2021-09-14 柯惠Lp公司 用于在医疗操作中使用的可检测海绵及其制造、封装和核算的方法
US10660726B2 (en) 2015-01-21 2020-05-26 Covidien Lp Sterilizable wirelessly detectable objects for use in medical procedures and methods of making same
US9690963B2 (en) 2015-03-02 2017-06-27 Covidien Lp Hand-held dual spherical antenna system
US10193209B2 (en) 2015-04-06 2019-01-29 Covidien Lp Mat based antenna and heater system, for use during medical procedures
USD1051399S1 (en) 2021-02-26 2024-11-12 Stryker Corporation Reader cradle for a surgical stand

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CH666606A5 (de) * 1984-11-01 1988-08-15 Pekka Johannes Dr Med Nyberg Vorrichtung zur lokalisierung von metallischen gegenstaenden im menschlichen oder tierischen koerper.
FR2624620A1 (fr) * 1987-12-10 1989-06-16 Imtec Sa Dispositif pour la detection d'objets etrangers au moins partiellement metalliques, notamment en milieu operatoire
US5090410A (en) * 1989-06-28 1992-02-25 Datascope Investment Corp. Fastener for attaching sensor to the body
US5842986A (en) * 1995-08-16 1998-12-01 Proton Sciences Corp. Ferromagnetic foreign body screening method and apparatus

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2434872A (en) * 2006-02-03 2007-08-08 Christopher Paul Hancock Microwave system for locating inserts in biological tissue

Also Published As

Publication number Publication date
AU2003209466A1 (en) 2003-09-16
GB0205188D0 (en) 2002-04-17
WO2003073934A1 (fr) 2003-09-12

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