EP1848360A2 - Systeme multiplex pour la detection d'accessoires chirurgicaux dans la cavite d'une plaie - Google Patents

Systeme multiplex pour la detection d'accessoires chirurgicaux dans la cavite d'une plaie

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Publication number
EP1848360A2
EP1848360A2 EP06734701A EP06734701A EP1848360A2 EP 1848360 A2 EP1848360 A2 EP 1848360A2 EP 06734701 A EP06734701 A EP 06734701A EP 06734701 A EP06734701 A EP 06734701A EP 1848360 A2 EP1848360 A2 EP 1848360A2
Authority
EP
European Patent Office
Prior art keywords
surgical
marker
implements
radiofrequency
metallic
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Withdrawn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
EP06734701A
Other languages
German (de)
English (en)
Inventor
Carl E. M. D. Fabian
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.)
Individual
Original Assignee
Individual
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
Priority claimed from US11/055,348 external-priority patent/US7307530B2/en
Priority claimed from US11/054,844 external-priority patent/US20060241396A1/en
Priority claimed from US11/323,379 external-priority patent/US20060241399A1/en
Application filed by Individual filed Critical Individual
Publication of EP1848360A2 publication Critical patent/EP1848360A2/fr
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders

Definitions

  • the present invention relates to a system comprised of multiple detecting modalities, herein called a "multiplex system” , for detecting non-metallic and metallic surgical implements , and more particularly to a system using at least two different modalities operative for the detection of surgical implements made of metal and/or bearing detectable tags .
  • US Patent 3 , 508 , 551 to Walters et al discloses dressings and production thereof .
  • An x-ray detectable opaque filament is incorporated within the dressing.
  • the patient For use of this device, the patient must be transported from the operating room to an x-ray room. The process is cumbersome and exposes the patient to unnecessary radiation . Detection of a retained dressing tends to be limited due to the small diameter of the x-ray opaque filament . The dressing can be overlooked when orientation of the filament is directly in-line with a bone .
  • US Patent 3 , 587 , 583 to Greenberg discloses a surgical sponge with magnetizable means .
  • the sponge has a flexible thread with magnetizable particles .
  • a plurality of magnetizable barium ferrite particles are embedded in a plastic material, such as nylon, forming a flexible magnetizable thread.
  • the surgical instruments used may also be provided with a small amount of magnetizable material .
  • a surgical cavity is probed using a magnetic detection means such as a magnetodiode .
  • the Greenberg disclosure does not state how the surgical instruments could be made to have magnetizable material .
  • the size of threads is too small to be detected unless the probe is also inserted into the surgical cavity, which procedure would likely present issues involving sterility and tissue damage .
  • US Patent 3, 686, 564 to Mallick, Jr . et al . discloses a multiple frequency magnetic field technique for differentiating between classes of metal obj ects .
  • Low and high frequency oscillators are mixed using multiple frequency excitation .
  • the magnetic field generated is examined by observing the voltage current vectorial relationship .
  • the vectorial relationship is changed according to the size, shape and type of a metallic obj ect .
  • the system is primarily designed to ⁇ O ⁇
  • US Patent 3, 698 , 393 to Stone discloses a surgical pad. A radiopaque plastic ring is attached to the pad. After a surgical procedure is complete, the patient is radiographed to determine whether a sponge having an attached plastic ring has been retained within the surgical cavity. The system requires that the patient be transported to an X-ray facility; it exposes the patient to unnecessary radiation .
  • US Patent 3, 834 , 390 to Hirsch discloses a neurological sponge .
  • the sponge has a double layer comprising a highly absorbent inner layer wrapped by a porous outer layer .
  • An x-ray detectable BaSO4 material wrapped in plastic is placed between the two layers .
  • the x-ray detectable material absorbs x-rays , indicating the presence of the sponge within a surgical cavity .
  • Prior to closure of the surgical incision the patient must be transported to an x-ray facility, at which location the patient is exposed to unnecessary x-ray radiation.
  • US Patent 3, 964 , 041 to Hinds discloses an article detection system and method.
  • Articles such as container ends are sensed and detected to provide count and/ or control outputs representative of the number of such articles detected.
  • a frequency sensitive detector circuit generates a fixed frequency signal, which is utilized to modulate the output from a signal generating transducer or signal source .
  • the modulated output from the source impinges on an article being sensed, which reflects or interrupts this signal .
  • the reflection or interruption is sensed by a suitable transducer or sensor .
  • a feedback signal generated by the transducer or sensor is fed back to the frequency sensitive detector that generated the original fixed frequency signal .
  • the detected signal is the same as the frequency of the original modulating signal .
  • One of these output signals is indicative of the detection of an article, and is applied to suitable counting and/or control circuitry that provides the desired count and/or control outputs .
  • a feedback signal indicates the presence of an article and provides an accurate count of articles, such as can ends .
  • the article detection system and method disclosed by the Hinds patent does not detect metallic objects or non-metallic sponges inadvertently retained within a surgical incision .
  • US Patents 4 , 114 , 601 and 4 , 193, 405 to Abels disclose a medical and surgical implement detection system. Surgical implements , surgical instruments, surgical sponges, surgical implantable devices and indwelling therapeutic devices and materials are detected within the human body or other area of interest by incorporating or adding a radiofrequency transponder .
  • the transponder may be a thin film of a ferrite material exhibiting gyro- magnetic resonance at selected frequencies .
  • the transponder may be a solid-state device containing diodes and field effect transistors .
  • This non-linear transponder signal is received by a receiving antenna and is filtered to remove all fundamental microwave frequencies .
  • Each of the higher order microwave frequencies generated by the transponder is easily absorbed by the human body. Consequently, most of the — o —
  • US Patent 4 , 658 , 818 to Miller, Jr . , et al . discloses an apparatus for tagging and detecting surgical implements .
  • a miniature battery-powered oscillator is attached to each surgical implement and activated prior to its initial use .
  • the output of each oscillator is in the form of a low powered pulse of 1-10 MHZ frequency and is coupled to the body ' s fluids and tissue .
  • a detection system is used to sense for any pulses generated by the oscillator within the body.
  • the surgical implement detection system disclosed by the * 818 patent is not passive . It requires a miniature battery, which remains in the "on" condition from the beginning of the operation . If a sponge is left behind, the microwave radiation is detected. When the operation is complete, the battery might have discharged, in which case the sponge would not be detected.
  • the system disclosed by the ⁇ 818 patent does not detect metallic obj ects and, as previously noted, use of microwave frequencies can cause undesired heating of body tissue .
  • US Patent 5, 057 , 095 to Fabian discloses a surgical implement detector utilizing a resonant marker for use in human or animal tissue .
  • the marker is set into resonance by the interrogating field and the resonance frequency signal emitted by the marker is detected by a separate detection circuit adjacent to the interrogating circuit .
  • the marker resonates due to magnetostriction properties of an amorphous ribbon or piezoelectric device or a tuned LRC circuit .
  • the marker is a single function device and the system only detects surgical implements to which a marker has been secured. Its size of approximately 2 inches makes it not optimal for attachment to smaller implements or gauze sponges and its ability to survive heat sterilization makes it suboptimal for use on metallic implements . Furthermore, even when such a marker is secured to a metallic implement, metal in close proximity may cause distortion of the signal, so-called ' shielding ' , reducing the reliability (i . e . , the range) of detection . US Patent 5 , 099, 845 to Besz et al .
  • a powered radiating element is attached to a device appointed for insertion into the body.
  • the location of the radiating element within the body is assessed by moving a handheld receiving unit over the external surface of the body to obtain a maximum radiation value, thereby pointing the receiving sensor directly above the radiating element .
  • the intensity of the radiation energy is assessed to determine how deep the radiating element is located from the surface of the body.
  • the radiating element requires power to operate and, therefore, does not detect unpowered metallic objects or sponges even if they contain a passive tag.
  • Powered tags are also subj ect to considerations of battery life . Should such a tag exceed its battery life during an operation, the tag would become undetectable .
  • a Radiofrequency Identification (RFID) system has an interrogator and a transponder .
  • the interrogator has a first tuned circuit of a powering frequency for sending a powering burst to a transponder .
  • a filter/demodulator receives a wireless , modulated RF response from the transponder .
  • the interrogator also has a second tuned circuit in electrical communication with a modulator .
  • the second tuned circuit has a selected bandwidth about a communication frequency. The selected bandwidth does not substantially overlap the powering frequency; but encompasses the bandwidth of the modulated carrier of the RF response .
  • the carrier is modulated using pulse width modulation (PWM) , pulse position modulation ( PPM) , frequency-shift keying modulation (FSK) , or other modulation method .
  • the interrogator also has a controller in electrical communication with the filter/demodulator and the tuned circuits for enabling the first tuned circuit to send the powering burst during a first time period and of enabling the modulator in electrical communication with the second tuned circuit to receive the RF response during a second time period.
  • the transponder has a tuned circuit, a tuning circuit in electrical communication with the tuned circuit for modifying the frequency characteristics of the tuned circuit such that it is can be tuned during the powering burst to the powering frequency, and be tuned during the RF response to the communication frequency.
  • the transponder also includes a demodulator in electrical communication with the tuned circuit for receiving the RF interrogation therefrom and for demodulating data from the RF interrogation .
  • This current generation RFID device sends a preset code to the interrogator and is powered entirely by the power burst signal provided during the first time period. It is capable of transmitting the code at a high rate to the interrogator .
  • US Patents 5 , 650 , 596 and 5 , 923, 001 to Morris , et al . disclose an automatic surgical sponge counter and blood loss determination system.
  • Each sponge carries an RF tag which is read by a sensor located in proximity with the opening of a soiled sponge-receiving container provided with a disposal bag .
  • the disposal bag is weighed and its dry weight compared based on the ID of the sponge tag .
  • the weight of blood and other body fluids is determined by subtraction .
  • a display is used to provide information about sponges in the container, and the weight of blood and body fluids dispensed within the container .
  • the system of the ' 596 patent does not detect sponges retained within a patient during an operation; it only counts surgical implements when they are disposed within the container .
  • the ' 001 patent discloses a handheld RF reader to be passed over the surgical site by a surgeon to detect the presence of surgical sponges in the body cavity at the time of closure during a surgical procedure .
  • the ' 001 patent states that the handheld RF reader will then identify any sponges which may have been inadvertently left in the wound, thus preventing the retention of sponges inside of the patient .
  • This system is intended to detect only tagged sponges . It does not detect metal instruments or other implements .
  • US Patent 5, 944 , 023 to Johnson et al discloses systems and methods for determining the location of an implanted device including a magnet .
  • the tip of the body- inserted implanted device includes a generating mechanism which may be a permanent magnet or a permanent direct current magnet with a self-induced magnetic field .
  • the location of the magnet is detected outside the patient by a mat, which incorporates a multitude of magnetic field sensors .
  • the magnet positional information is displayed on a video screen .
  • This system disclosed by Johnson does not locate surgical instruments or sponges within a surgical cavity.
  • US Patents 6, 009, 878 and 6, 305 , 381 to Weij and et al disclose a system for locating an implantable medical device .
  • This system has an implanted coil, which transmits electromagnetic radiation and is picked up by an electromagnetic energy receiving device with three symmetrically oriented coils external to the patient . When the energies received by these three coils are equal, the receiving device is directly above the implanted coil, and the drug reservoir in the implant may be filled. This system does not detect medical instruments or sponges accidentally retained by the surgical wound of a patient during an operation .
  • US Patent 6, 057 , 756 to Engellenner discloses electronic locating systems . Coded tags are interrogated at various locations in the intended path of a transportation vehicle . The presence of a vehicle in a specific location is determined and relayed to a central controller .
  • the ⁇ 756 patent discloses a system for managing and tracking a transportation process . No disclosure is contained within the ⁇ 756 patent concerning detection of metallic obj ects or sponges accidentally left behind in a surgical incision after completion of surgery .
  • US Patent 6, 076, 007 to England et al discloses a portable unit for detecting the presence of surgical devices, and their location .
  • a high permeability, low coercivity, wire or strip tag is implanted with a surgical device .
  • the tag is interrogated by a search coil energized by. a high frequency AC field with a DC or low frequency bias filed.
  • Phase information is used to detect the directionality of the tag location.
  • the detection system is based on flying null technology. It is a single functionality detection system, and does not detect metallic obj ects that are not incorporated with a tag .
  • Metallic obj ects adj acent to the tag may distort phase information providing an unreliable indication .
  • US Patent 6, 615 , 155 to Gilboa discloses obj ect tracking using a single sensor or a pair of sensors .
  • the three dimensional movement of a moving obj ect is tracked by measuring one or more vector fields assisted by theoretical computations .
  • the system does not track or detect stationary obj ects such as a sponge or metallic obj ect accidentally included in a surgical incision .
  • ⁇ . S . Patent No . 6, 026, 818 to Blair, et al discloses a tag and detection device .
  • An inexpensive tag has the form of a ferrite bead with a coil that resonates at a particular frequency, or a flexible thread composed of a single loop wire and capacitor element .
  • the detection device locates the tag by pulsed emission of a wide-band transmission signal .
  • the tag resonates with a radiated signal, in response to the wide band transmission, at its own single non-predetermined frequency, within the wide band range . This system does not detect untagged metallic surgical implements .
  • US Patent 6, 424 , 262 and US Patent Application publication No . 20040201479 to Garber, et al . disclose applications for radiofrequency identification systems .
  • An RFID target cooperates with a magnetic security element and a bar code reader to check out and manage library materials such as reference books, periodicals, and magnetic and optical media .
  • US Patent Application Publication No . 20030066537 to Fabian, et al discloses surgical implement detection system. Surgical implements used during an operating procedure are detected in human tissue . Markers attached to the surgical implements change their impedance at a preselected frequency in the presence of an electromagnetic field. The system uses a magnetomechanical element which vibrates at a preselected frequency when excited, and this preselected frequency is detected, indicating the presence of a surgical implement to which the magnetomechanical marker element is attached. Such a system does not detect untagged metallic surgical implements .
  • US Patent Application Publication No . 20030176785 to Buckman et al . discloses a method and apparatus for emergency patient tracking .
  • This tracking system attaches a coding device to a patient and is tracked.
  • the coded device utilized is associated with each patient in such a way that the device cannot be removed or disassociated from the patient without a concerted effort .
  • Such a system does not detect accidentally included sponges or metallic obj ects in a surgical incision .
  • PCT Patent Application No . WO 98 /30166 and European Patent Specification 1 232 730 Al to Fabian et al . disclose a surgical implement detector utilizing a smart marker.
  • the marker is coded and the code is transmitted through an antenna to a central microprocessor, which verifies the code .
  • Each marker has to be individually coded and inserted into a sponge surgical pad, etc .
  • the system does not detect untagged metallic obj ects left behind within a surgical incision .
  • PCT Patent Application No . WO 03/032009 to Fabian et al discloses a surgical implement detection system.
  • a marker attached to the surgical implement changes its impedance at a preselected frequency in the presence of an electromagnetic interrogating field.
  • the interrogating electromagnetic field has a preselected frequency, preferably modulated as a series of pulses and the marker, a magnetomechanical element, attached to the surgical implement resonates at a preselected frequency in response to the field.
  • the detector detects a ring-down signal of the marker between the pulses .
  • This system does not detect metallic obj ects that do not have a marker attached .
  • the close proximity of metal may result in distortions of the signal, or "shielding" weakening the signal received, and possibly allowing it to escape detection .
  • PCT Patent Application No . 03/048810 and US Patent Application Publication No . 20030105394 to Fabian et al disclose a portable surgical implement detector .
  • the portable detector interrogates a marker that is attached with a surgical implement which signals a preselected frequency. This system does not detect metallic objects that do not have a marker attached.
  • a metallic surgical implement may shield a marker, causing weakening of the preselected frequency signal .
  • US Patent Application Publication No . 20030192722 to Ballard discloses a system and method of tracking surgical sponges .
  • the sponges have a radiopaque obj ect embedded therein which is visible when the sponge is x-rayed.
  • All sponges removed from the surgical wound are placed into a sponge container which is provided with an internal device to x-ray and identify the sponges after use .
  • Sponges are x-rayed only once, after use, as they are placed in the container for disposal .
  • Sponges are not x-rayed before being inserted into the wound, and cannot, by the device of Ballard, be x-rayed while in the patient . Therefore, the process cannot actively detect whether a sponge has been accidentally left behind in a surgical wound nor does it provide a way of knowing that all the sponges have been removed, or whether any have been left behind in the patient wound .
  • US Patent Application Publication No . 20040129279 to Fabian, et al discloses a miniature magnetomechanical tag for detecting surgical sponges and implements .
  • This tag is a magnetomechanical device, and is excited by the interrogating magnetic field. The interrogating field is switched off and the ring down of the resonant target is detected .
  • This system does not provide means for identifying an individual sponge or surgical pad .
  • US Patent Application No . 20040250819 to Blair, et al discloses an apparatus and method for detecting obj ects using tags and wideband detection devices .
  • the apparatus and method feature interrogates with a transmitter emitting a pulsed, wideband signal . This signal prompts the tag element to provide a return signal, which is received and analyzed.
  • the device features an antenna portion containing a single or a plural ring- shaped antenna .
  • the pulsed wideband interrogation signal may be pulse-width modulated or voltage-modulated.
  • the pulsed signals trigger a continuing response signal from the tag in its response frequency range, which increases in intensity to the point where it becomes differentiable from background noise and is detected within the wideband range by the signal detector as an indication of the presence of the tag .
  • the tag is excited by a wide-band pulsed interrogation signal, which builds up the output of the tag and can be detected over ambient electronic noise .
  • the tag signal has a predetermined frequency . It is a sinusoidal wave, and does not carry digital information identifying the sponges and surgical pads used.
  • US Patent Application Publication No . 20050003757 to Anderson discloses an electromagnetic tracking system and method using a single-coil transmitter.
  • the system includes a single coil transmitter emitting a signal, a receiver receives a signal from the single coil transmitter . Electronics process the signal received by the receiver .
  • the electronics determine a position of the single coil transmitter .
  • the transmitter may be a wireless or wired transmitter .
  • the receiver may be a printed circuit board.
  • the electronics may determine position, orientation, and/or gain of the transmitter .
  • the single coil transmitter is a powered device and may be wired or wireless . It is not a passive device that can be incorporated in a sponge or surgical pad due to the requirement for a reliable power source .
  • Powered tags are also subj ect to considerations of battery life . Should such a tag exceed its battery life during operation, the tag would become undetectable .
  • PCT Patent Application No . WO 98/30166 to Fabian et al discloses a surgical implement detector utilizing a smart marker .
  • the surgical implement is appointed for disposition within human or animal tissue and is caused to become electronically identifiable by affixing thereto a smart marker, which is an unpowered integrated circuit with an EEPROM memory that carries a code .
  • a smart marker is sufficiently close to the reader antenna, a voltage is generated within the marker antenna that charges the capacitor and powers the integrated circuit .
  • a switch is opened and closed to transmit the stored code in the EEPROM memory, providing identification and recognition of a smart target attached to a surgical sponge .
  • the marker antenna operates at a frequency of near 125 KHz .
  • the smart marker is not encapsulated and is subj ect to damage by blood and other saline fluids . Further, if applied to metallic implements , the smart marker may be subj ect to "shielding" and weakening of the signal, as described above, possibly making detection of tagged metallic implements unreliable .
  • markers or tags secured to surgical implements would be tiny in size, inexpensive, universally detectable through air or tissue at a reasonable distance, unaffected by proximity to metal, biologically inert and harmless to the patient and personnel, robust enough to survive any means of sterilization, and able to carry coded data to provide a record of all items so tagged.
  • the present invention provides a multiplex system employing a plurality of discrete sensing systems for identifying the presence of surgical implements in a surgical wound.
  • the term "implements” includes metal instruments , surgical sponges, gauzes , and other items used during a surgical operation .
  • a highly reliable surgical implement detection system which utilizes together, at least two different modalities of detecting surgical implements including sponges left in a surgical incision or body cavity.
  • One particular embodiment of the instant invention selects at least two modalities from the group of : 1 ) magnetomechanically resonant marker tags ; 2 ) "smart markers" or RFID markers ; and 3 ) a system designed to - detect metallic obj ects solely based upon their metal content, without need for a separate, affixed marker .
  • the invention employs the use of a combination of discrete systems to identify surgical implements . Consequently, the use of such a multiplex system eliminates the possibility that surgical implements, non-metallic or metallic, will be left behind within a surgical cavity.
  • FIG. 1 is a schematic diagram showing an operation in progress in which a multiplex detection system is in use
  • FIG. 2A is a schematic diagram showing a magnetomechanically resonant marker
  • FIG . 2B is a schematic diagram showing details of an RFID marker
  • FIG. 3 is a diagrammatic representation of a surgical sponge provided with a magnetomechanically resonant marker tag
  • FIG . 4 is a diagrammatic representation of a gauze pad provided with an RFID tag ;
  • FIG . 5A is a hemostat provided with an RFID target which is directly secured to the hemostat ;
  • FIG. 5B is a hemostat provided with an RFID target which is secured to the hemostat by a nonmetallic spacer ;
  • FIG . 6A is a plan view of a metallic surgical instrument detectable by a metal-detecting mode of one embodiment of the instant application, without the need for a tag or marker ;
  • FIG. 6B is a plan view of another metallic surgical instrument detectable by a metal-detecting mode of one embodiment of the instant application, without the need for a tag or marker . Best Mode for Carrying out the Invention :
  • the invention comprises a plurality of discrete sensing systems to detect the presence of surgical implements, including surgical sponges , metal instruments, and other implements within the surgical wound, thereby preventing their inadvertent retention as the wound is closed .
  • the term "implements” as used herein, shall encompass all devices that may be left in surgical wound, including, but not limited to, surgical sponges , laparotomy pads, gauze, rubber tubes , and metal instruments, such as clamps , retractors , hemostats and scalpels .
  • a multiplex detection system 1 comprising three separate detecting systems is deployed .
  • the instant invention is not meant to be so limiting . Rather, it is possible that, for purposes of the instant invention, as few as two of the three possible modalities may be used to detect sponges and other implements in a surgical incision or wound cavity. Additionally, if only two modalities are selected for use, any two of the modalities , disclosed here below, may be selected, based on the specific criteria of the user . Further, although only three modalities are illustrated in Fig .
  • the present invention can utilize more than three modalities , if desired. Further, although three very particular modalities are shown in the example of Fig . 1, these modalities are examples, and, as such, other detection modalities not shown in Fig . 1 may be used.
  • the systems 11 , 13 and 15 are incorporated on a rollaway cart 17 , so as to be brought into close proximity to an operating table 18 supporting a patient 19 having an incision 20.
  • the rolling cart 17 as shown in Fig . 1, can be brought close to the patient during the surgical procedure but prior to closing of the incision .
  • Antennae associated with each system may be employed on the cart 17 , or by a handheld antenna 21.
  • a multiplex detection system containing two or more of the systems 11, 13 and 15 can be brought into proximity with the patient in some other way, such as by being built into the table 18 , or into some other permanent piece of equipment in the operating room.
  • the systems 11, 13 and 15 or other modalities can be made small enough and light enough to be personally transported, such as using a backpack or other portable mechanism.
  • the systems 11, 13 and 15 are provided so as to use at least two, and if desired, all three (or more, if desired) , modalities of detection for sponges and other implements that may be placed in the surgical wound 20.
  • the systems 11 and 13 have been chosen in the particular embodiment to be modalities that utilize markers secured to various sponges and/or other surgical implements, which markers are capable of being detected electronically.
  • the system 15 has been selected to provide a possible third detection modality, wherein the ferrous content of a metallic surgical implement is detected by the system 15, without the need for affixing an additional marker or tag . All three possible detection modalities will be described below.
  • Markers As described above, the systems 11 and 13 of Fig . 1 use electronic markers , or tags, affixed to, or otherwise in communication with, a surgical implement (such as a sponge, gauze, clamp, retractor, hemostat, etc . ) Such an electronic marker would, ideally, be : • very small ;
  • the magnetomechanical , resonant marker 23 includes two metal strips 24, 25, a magnetomechanical strip and a biasing strip, contiguous with one another, enclosed in a water-tight casing 26. As presently constituted, the marker is about 43 mm in length, 13 mm in width, and approximately 3 mm in thickness and is enclosed in a plastic casing .
  • the magnetomechanical marker 23 could include a housing 26 made from silicone, such as a silicone pot, in order to permit the magnetomechanical marker 23 to survive heat sterilization .
  • magnetomechanical markers emit a signal having a frequency of between 50 kHz and 150 kHz .
  • the marker 23 is highly detectable, essentially 100% out to 75 cm and very accurate . It is possible to detect the presence of one or more tags in an instant and false positive signals do not occur . It is unaffected by intervening tissue and resistant to metallic shielding . Testing of this tag has been described in an article printed in the j ournal Surgery in March of 2005.
  • Magnetomechanical resonant markers are very inexpensive and thus virtually ideal for tagging the surgical sponge, which is typically used only once then discarded. Since the surgical sponge is , by far, the implement most commonly left in the body after surgery and when retained likewise causes the most severe complications, universal use of this tag on sponges could virtually eliminate this maj or mishap and benefit thousands of patients .
  • magnetomechanical or resonant tag as it presently exists, however has a few limitations which make it not ideal for tagging all surgical implements - its present size makes it rather cumbersome for attachment to smaller articles such as hemostats , scalpel handles, and possibly the 4" by 4" gauze pads, and the present plastic enclosure is unable to survive heat sterilization, the method generally used on surgical instruments .
  • one proposed embodiment of magnetomechanical marker can include a silicone housing, to enable the marker to survive heat sterilization . It also has the limitation that this type of tag does not carry coded information . Detection of the magnetomechanical resonant marker only indicates whether it is present or not .
  • the marker 30 includes an antenna 31 which receives a power pulse from a remote detector- interrogating antenna (for example, antennas 14 or 21 of Fig . 1) to charge a capacitor 32.
  • This capacitor 32 becomes the power source for the operation of the unpowered radiofrequency marker, which has an integrated switch, having an integrated circuit 33 which has a reading function, a carrier frequency modulating function at 34 and a read-only memory portion 35 with a burned-in code marked here as ' 10010 ' .
  • RFID transponder markers or tags are generally more sophisticated than the earlier magnetomechanically resonant tags , described above and shown if Fig . 2A, and therefore have certain additional advantages over mere magnetomechanical tags .
  • RFID tags generally operate at frequencies ranging from 30 kHz to
  • RFID tags vary " significantly in cost, size, and their resistance to shielding and intervening tissue .
  • RFID tags are now commercially available .
  • a number of manufacturers produce radiofrequency (RFID) markers .
  • RFID radiofrequency
  • Modern RFID tags can also provide significant amounts of user accessible memory, sometimes in the form of read-only memory or write-once memory .
  • the amount of memory provided can vary, and influences the size and cost of the integrated circuit portion of an RFID tag .
  • typically, between 128 bits and 512 bits of total memory can be provided economically.
  • an RFID tag available from Texas Instruments of Dallas , Texas under the designation "Tag-it” provides 256 bits of user programmable memory in addition to 128 bits of memory reserved for items such as the unique tag serial number, version and manufacturing information, and the like .
  • an RFID tag available from Philips Semiconductors of Eindhoven, Netherlands under the designation "I-Code” provides 384 bits of user memory along with an additional 128 bits reserved for the aforementioned types of information .
  • the lower frequency RFID tags generally operate in the range of from 30 kHz - 500 kHz , but more preferably in the range from 100 kHz to 150 kHz .
  • they can be made quite small, for example the size of a grain of rice (about 11mm by 2.5 mm) , and when enclosed in glass , polymer or a silicone pot, are robust in construction, allowing repeated sterilization by virtually any method currently in use - heat, gas , chemical, or gamma radiation .
  • lower frequency RFID tags can be attached to smaller articles such as hemostats (as shown in Fig. 5B) , scalpel handles , and possibly the 4" by 4" gauze pads (as shown in Fig. 4 ) .
  • RFID tags can carry coded data .
  • the lower frequency tags are more resistant to shielding than the upper frequency tags , and are relatively inexpensive to manufacture .
  • these lower frequency RFID tags the relatively simpler members of the RFID family, have a narrow bandwidth and are therefore slower to read. Additionally, the lower frequency tags , generally, only give identifying data when a single tag is in the interrogation zone at a time . Nonetheless these lower frequency RFID tags can still carry enough coded data to give separate identity to many millions of tags, enough to identify every surgical item in a large hospital .
  • the narrow bandwidth of the lower frequency tags prevents bulk reading of multiple tags at once, rather requiring that each tag be read individually, as noted above .
  • This aspect may be regarded as a disadvantage in some surgical departments since, if multiple tags cannot be identified at the same time, surgical implements generally cannot be individually identified while in the patient (as there will likely be more than one tag at a time in the same interrogation zone) . Nonetheless , and more importantly, scanning of the patient at the conclusion of surgery and prior to wound closure can still be used to determine whether there are any tagged items left in the wound, even though not individually identified while still in the wound.
  • Patent Application Serial No (Not Yet Assigned) , filed on December 9, 2005 , and entitled SURGICAL IMPLEMENT DETECTOR.
  • these lower frequency readers will give three responses - 1 ) no tag found, 2 ) one tag found (with its identification number) , and 3 ) more than one tag found, without giving specific identification .
  • This modification to existing technology will allow the reader to positively detect the presence of one or more tags within a wound, even though not identifying each tag specifically. This aspect can be employed at the conclusion of surgery j ust prior to closure of the wound to verify that no tagged items remain behind. If any tags are found at this time, any such retained items, once detected, can be removed, and then individually identified one at a time as they are recovered . Even these small, simple tags can carry a large amount of coded data, sufficient to identify each implement in use within a large hospital .
  • the operating room personnel decide to utilize the lower frequency system, despite the fact that its narrower bandwidth requires that each tag be read individually, they retain the advantages of smaller size, lower cost, and virtual elimination of potential shielding, while still having the ability to take an inventory of individual tagged items removed from the surgical wound. Individual scanning of each tagged item upon removal will assure that each item is detected and read, eliminating concern that a given item may fail detection because of shielding or being out of reading range . Even when one of the lower frequency RFID tags is affixed directly to a large metal instrument such as a retractor, an individual reading can still be obtained as the scanner (or reader) is brought close to the tag . Alternatively, an anti-collision mechanism may be provided in the firmware of the RFID tags to allow a plurality of tags to communicate simultaneously.
  • the upper frequency RFID tags are those that operate above the IMHz range .
  • Upper frequency RFID tags exist that operate, for example, at about 13.56 MHz (high frequency) , or from 850 to 950 MHz (ultra-high frequency) , and at microwave frequencies (i . e . , 2.45 to 2.55 GHz ) .
  • the added bandwidth provided by these upper frequency RFID tags permits the system to reliably process multiple tags in the interrogation zone in a short period of time . This will allow a number of implements to be identified and inventoried substantially simultaneously, such as the items lying on the instrument table, or multiple implements contained within the wound cavity.
  • Upper frequency RFID markers tend to be significantly more sophisticated than lower frequency RFID devices .
  • the upper frequency RFID tags have the limitation over those of lower frequencies , in that : they are considerably more expensive to manufacture; they tend to be relatively bulky; and their detection is more affected by intervening tissue and by shielding from adj acent metallic obj ects .
  • RFID tags are designed to withstand repeated sterilization . As such, they can be attached to metal instruments which are sterilized and reused multiple times, which reduces their average cost per use .
  • radiofrequency tags i . e . , RFID and magnetomechanical
  • the detection of such radiofrequency tags can be affected by the close proximity of the tag to metal, i . e . , the "shielding" effect .
  • RFID tags are more likely than magnetomechanical tags to be attached to metal instruments, shielding is more likely to be a problem with them.
  • the effect of shielding can be reduced by using lower frequency tags , or by using a nonmetallic spacer to attach such upper frequency RFID tags to metallic obj ects .
  • another possible detection system may be included in the multiplex detection system 1 of Fig . 1.
  • a detection system 15 which operates as a metal-detection system to detect any metal within the wound, whether a retractor, clamp, hemostat, or the like, based solely on the presence of metal and irrespective of the presence or absence of a marker or tag .
  • the inclusion of a metal detection system 15 can be useful in circumstances wherein there exists the possibility of shielding from metal instruments used in the operation .
  • Using a metal detection system during such an operation, in combination with one or both of the above described marker detection systems provides a further way to prevent any metallic instruments and/or other implements from being overlooked.
  • Such a metal detection system 15 may work to detect metallic obj ects in the wound site, both ferrous and nonferrous .
  • the metal detection system 15 utilizes conventional electronic circuitry adapted for the detection of metal obj ects and includes a field-generating means within the system 15 and an antenna, such as antenna 16 or 21 of Fig . 1, for generating electromagnetic radiation .
  • the electromagnetic radiation generated by the system 15 couples with any metallic instruments within the surgical wound, and the overall inductance of the antenna is accordingly increased.
  • the system 15 analyzes this change in inductance of the antenna to detect the presence of metallic instruments within a surgical wound.
  • the system 15 uses a pulsed interrogating field.
  • the antenna 16 or sensor coil looks for decay in the eddy current of the metallic obj ect .
  • no movement of the sensor coil would be required.
  • One possible limitation of the use of a metal detection system is that, such a system gives no individual identifying information regarding the particular implement detected. Additionally, such a system will not , of course, detect nonmetallic implements .
  • Another possible detection modality that can be used as one of a plurality of modalities in connection with the instant invention is that of x-ray. More particularly, for purposes of the instant invention, it is understood that metallic implements may be detected by the taking of an x-ray. Taking x-rays of surgical patients (not shown) , after surgery, has been a time-honored method of detection for many years and is excellent for detecting all manner of metallic instruments . X-rays however do not reliably detect nonmetallic items, such as retained sponges, which constitute the greatest number of retained implements . Although sponges generally contain radiopaque markings , they are not infrequently overlooked or mistaken for other items present in the postoperative patient .
  • x-ray detection has the disadvantages of being expensive, cumbersome, time-consuming, and involves exposing the patient (and personnel) to radiation .
  • use of x-rays in surgical detection of implements in a wound cavity has never come into widespread usage .
  • x-ray can be reserved as a fail-safe means to ensure that all implements visible on x-ray (i . e . , metallic instruments , sponges having X-ray detectable markers , etc . ) have been located.
  • the multiplex detection system of the embodiment of Fig . 1 can reliably detect a variety of devices in use in a surgical operation, utilizing a combination of separate detection modalities, each having complementary capabilities .
  • the system 11 includes an antenna 12 for detection of magnetomechanical resonant markers that may be in the surgical wound 20.
  • the system 11 detects magnetomechanically resonant marker tags attached to obj ects including surgical sponges (also known as laparotomy pads ) , gauze pads and the like .
  • Antenna 12 may be attached to the system 11 for remote detection or the multiplex detection system of the instant invention may further include a handheld antenna 21 that can be manipulated by a surgeon 22 , in order to provide information to the system 11.
  • the system 11 includes a first detection- circuit, which comprises a first field generating circuit and a first antenna 12 or 21 for generating electromagnetic radiation .
  • the electromagnetic radiation couples with markers affixed to surgical sponges/laparotomy pads ( 43 of Fig . 3 ) , and gauze pads within the surgical wound and the first antenna 12 receives the response from the marker .
  • the system 11 analyzes this response to detect the presence of a marker attached to surgical implements within a surgical wound.
  • a magnetomechanical marker exhibits mechanical resonance at a resonant frequency in response to the incidence thereon of an alternating electromagnetic interrogating field, wherein the marker is provided with a signal-identifying characteristic .
  • the resonance is preferably detected by providing the interrogating field in the form of a pulse and sensing the ring-down decay in amplitude of the electromagnetic signal transmitted by the resonating marker .
  • the system 11 preferably operates at a frequency of 50 KHz to 150 KHz .
  • the magnetomechanical marker may include a magnetostrictive amorphous strip, a piezoelectric crystal circuit or a tuned LCR circuit, which has a characteristic resonance frequency.
  • the RFID detection system 13 of the multiplex detection system 1 detects and reads RFID tags attached to various implements .
  • System 13 includes an antenna 14 providing marker detection functionality, using remote detection .
  • the system 13 can additionally include a handheld antenna 21 manipulated by a surgeon 22.
  • System 15 of the multiplex detection system 1 detects ferrous and non-ferrous metallic objects including surgical instruments and the like .
  • System 15 includes an attached antenna 16 for remote detection or, as with the previous systems, be provided with a handheld antenna 21 manipulated by a surgeon 22.
  • the system 11 is used to detect magnetomechanically resonant marker tags typically affixed to larger, disposable non-metallic surgical items within the surgical wound.
  • These magnetomechanically resonant markers 43 are very inexpensive in cost, reliably detectable, and particularly suited for use on disposable implements, such as surgical sponges or laparotomy pads or gauze pads .
  • FIG. 3 there is shown at 40 attachment of magnetomechanical resonant marker 43 (which may be of the same type as marker 23 of Fig . 2A) to a surgical sponge (laparotomy pad) 42 , which is typically fabricated of soft absorbent cotton cloth, generally 14 or 18 inches square .
  • the system 13 is designed to detect and read RFID transponder tags attached to metal instruments which are reused and sterilized repeatedly, such as clamps, hemostats , scalpels , and, may also attached to other smaller implements on which tracking is desired, such as 4" by 4" gauze pads, rubber tubing and the like . Additionally, the system 13 can be designed to detect and read individual RFID tags, which can be coded with identifying data, allowing electronic inventory of all RFID-bearing implements .
  • FIG. 5A Illustrated in FIG. 5A is a hemostat 60 provided with an RFID tag 61 , directly attached to the body of the instrument .
  • FIG. 5B shows a hemostat 70 provided with a RFID marker 72 , attached by nonmetallic spacer 70.
  • the system 13 of Fig . 1 detects and reads "smart" RF markers ; or commercially available RFID targets, integrally enclosed in a glass , silicone or polymeric liquid-tight package that is resistant to washing and laundering as well as any sterilization procedures in use .
  • the RFID marker has an antenna 31 and a memory 35 for storing a predetermined code .
  • the RFID marker is powered by a voltage induced in the antenna by the electromagnetic interrogating field and is operative in the presence of the interrogating field to transmit the predetermined code as a change in the impedance of the antenna .
  • One embodiment of an RFID marker detection system is disclosed by EP 0 967 927 Bl to Fabian and Anderson, incorporated herein by reference .
  • the marker may be a commercial RFID tag.
  • Commercial RFID tags operate without need for a battery, because they include a capacitor circuit which is charged by an interrogating electromagnetic field carrier wave, which powers an integrated chip, typically including a burned-in code in a read-only memory. The capacitor power is additionally used to modulate the carrier wave to encode and broadcast the code . The modulated carrier wave is received by the interrogating antenna and is decoded to identify the code and relating it to the identity of an object using a lookup table .
  • RFID tags transmit their code as a modification of a carrier frequency. Carrier frequencies in the lower frequency range vary from 30 to 500 kHz, but are most preferably between about 100 kHz to 150 kHz .
  • Carrier frequencies in the upper frequency range are, most preferably about 13.56 MHz in the high-frequency range, and in ultra-high carrier frequencies, most preferably between 850 MHz to 950 MHz .
  • Microwave frequencies between 2.4 GHz to 2.5 GHz are also used in different applications , but may cause heating of tissue and are not, necessarily, envisioned in this application.
  • Carrier frequencies can be modulated by pulse width modulation ( PWM) , pulse position modulation ( PPM) , frequency-shift keying modulation ( FSK) .
  • PWM pulse width modulation
  • PPM pulse position modulation
  • FSK frequency-shift keying modulation
  • both the system 11 and the system 13 detect obj ects to which an electronic marker or tag has been attached .
  • the marker is interrogated by an antenna which generally uses radiofrequency electromagnetic waves .
  • the presence of metal can attenuate the electromagnetic field of a tag in its immediate vicinity and interfere with its detection, whether the tag is magnetomechanically resonant or RFID.
  • This phenomenon of signal attenuation by metal is referred to herein as "shielding" and its potential interference with detection by the systems 11 and 13 is a determining factor for including the metal detection system 15 in a multiplex detection system, in addition to, or in place of one of the systems 11 or 13.
  • the system 15 of Fig . 1 is designed to detect metallic obj ects solely based upon their metal content without need for an affixed marker .
  • Figs . 6A and 6B there are shown examples of two different metallic instruments , a clamp 80 and a retractor 90 , either of which would be detected by the metal-detection system 15 of the embodiment of Fig. 1.
  • the instruments 80 , 90 are detected by the system 15 solely based on their metal content, irrespective of the presence of an electronic tag, and as such, no radiofrequency markers are needed for their detection, by this system.
  • Metal detectors use different physical principles to detect a metallic obj ect .
  • an AC circuit with a coil acts as a transmitting antenna .
  • eddy currents are induced in the metallic obj ect, thereby increasing the inductance of the search coil .
  • the electronic circuit of the metallic obj ect detection system 15 may detect the change in the inductance of the sensor coil; the change of phase of voltage impressed, or current passing through the search coil, or rate of change of current or voltage as a sensor coil is swept over a metallic obj ect .
  • the increase in induction is detected as a change in the voltage-current characteristics , wherein the system 15 is looking for changes in the voltage-current relationships .
  • System 15 may more reliably detect a metallic obj ect when the sensor coil is swept across the target area . If the sensor coil is maintained stationary, depending on the system, it may no longer observe a change of inductance in the coil .
  • a metal detector of the system 15 of Fig . 1 using this type of sensor coil circuit generally some movement of the antenna with respect to the surgical cavity is required.
  • the antenna of the system 15 mounted upon a cart may be energized as the cart is moved into position next to the patient 19. Such movement is sufficient to establish whether a metallic instrument is left behind within a surgical cavity.
  • Another embodiment of the instant invention may use a handheld version of the sensor coil (21 of Fig . 1 ) with the system 15. In such an embodiment, movement of the sensor coil over the surgical cavity detects any remaining metallic surgical instrument . The same antenna or sensor coil looks for decay in the eddy current of the metallic obj ect .
  • a pulsed interrogating field is used, which does not require movement of the sensor coil .
  • the search coil is energized by a current pulse .
  • the decaying magnetic field emanating from the coil induces eddy currents in a nearby conductive obj ect .
  • Those currents in turn, produce a decaying magnetic field, which may be detected by voltage induced in a detection coil . In this way, an indication is provided that metal remains in the surgical wound 20.
  • the metal detection system 15 can provide further assurance that a tagged metallic item has not escaped detection because of shielding, by detecting the actual metal in the instruments, and not relying on the presence of a tag .
  • the ' AUTO SCAN SECURITY DETECTOR ' metal detector system manufactured by WHITE ELECTRONICS, INC .
  • the AUTO SCAN SECURITY DETECTOR was positioned over the body surface and scanned back and forth . This movement enhanced the detection of metallic obj ects, since movement causes a change in the magnetic coupling between the detector and metallic obj ect which change is indicated by an audible signal .
  • Sensitivity of the detector can vary with the spatial relationship between detector and the metallic obj ect, and can be somewhat reduced if the metallic obj ect is oriented perpendicularly to the detector .
  • the surgical cavity is generally flat and has a limited depth, retained surgical instruments tend to lie flat in the cavity and were easily, quickly, and reliably detected by this device .
  • the invention employs a combination of discrete systems to identify surgical implements within a surgical wound.
  • two or more of the modes may be chosen to work together to electronically “inspect” or “interrogate” the surgical wound, in complementary fashion, to detect surgical implements .
  • the two radio marker systems may work in complementary form to use the inexpensive magnetomechanical markers on sponges, while using the more expensive RFID markers on smaller implements, such as gauze pads or hemostats , not suited for larger magnetomechanical markers . In this way the systems can be chosen to cost effectively provide detection of all devices .
  • one of the two radio marker types may be provided on all non-metallic implements, while the metallic include no marker, such that the non-metallic devices are detected by the chosen one of systems 11 or 13 , while the metallic devices are detected by the metal detection system 15.
  • the multiplex detection system can be optimized using at least two of the disclosed detection modalities, and possibly three, if desired .
  • any two or more of the described modalities may be included in the present multiplex detection system to vastly reduce the possibility that surgical implements , non-metallic or metallic, will be left behind within a surgical cavity.
  • the chosen modes of operation of the systems 11, 13 and 15 can operate sequentially or simultaneously .
  • system 11 , system 13 , and system 15 all use electromagnetic waves to interrogate the surgical wound for the presence of electronically tagged items and metallic obj ects prior to wound closure, there exists the potential for electromagnetic interaction between the three systems .
  • the different modalities can be chosen to operate in any order .
  • such interference can be minimized by operating the systems 11, 13 and 15 at different electromagnetic radiation frequencies , thereby preventing deleterious interference between the systems in detecting implements present in the surgical wound.
  • metal detection modality can be used in advance of RFID detection .
  • magnetomechanical, RFID and metal detection such modalities can be operated as desired.
  • metal detection system 15 may be employed to specifically detect any metallic implement present in the surgical cavity .
  • the three systems interrogate the surgical wound during alternating time periods so that they each detect their appointed implements independently of one another .
  • the systems of the selected detection detectors may be conveniently mounted on a rollaway cart 17 , with antennae that are fixed to the detection devices and/or attached to a handheld sensor coil/antenna that is scanned or moved over the surgical cavity.
  • any or all three systems 11, 13 and 15 can be powered by a battery, preferably a rechargeable battery, or AC power . Further, if desired, any or all three systems can be mounted upon a rollaway cart, and/or may include handheld antennae .
  • the multiplex detection system 1 of Fig . 1 does not use any X-ray equipment or require radiation protection and thus is lightweight and highly portable, allowing it to be easily brought into an operating room, and into close proximity to the patient, when needed.

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Abstract

La présente invention concerne un système multiplex destiné à identifier la présence d'éponges chirurgicales, d'instruments métalliques et d'autres accessoires dans une plaie chirurgicale par utilisation d'une pluralité de systèmes de détection discrets. Au moins deux modalités de fonctionnement sont choisies parmi une pluralité de modalités de détection, lesquelles peuvent comprendre (1) des étiquettes de marquage à résonance magnéto-mécanique, (2) des 'marqueurs intelligents' ou des marqueurs RFID, et (3) un système conçu pour détecter des objets métalliques uniquement sur la base de leur teneur en métal sans qu'il soit nécessaire de recourir à un marqueur fixé séparé. Les modes de fonctionnement sélectionnés peuvent être mis en oeuvre séquentiellement ou simultanément. Par conséquent, l'utilisation de ce système multiplex permet de supprimer le risque d'oublier des accessoires chirurgicaux métalliques ou non métalliques dans une cavité chirurgicale.
EP06734701A 2005-02-10 2006-02-10 Systeme multiplex pour la detection d'accessoires chirurgicaux dans la cavite d'une plaie Withdrawn EP1848360A2 (fr)

Applications Claiming Priority (4)

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US11/055,348 US7307530B2 (en) 2005-02-10 2005-02-10 Surgical implement detector utilizing a radio-frequency identification marker
US11/054,844 US20060241396A1 (en) 2005-02-10 2005-02-10 Multi-modal detection of surgical sponges and implements
US11/323,379 US20060241399A1 (en) 2005-02-10 2005-12-30 Multiplex system for the detection of surgical implements within the wound cavity
PCT/US2006/004670 WO2006086603A2 (fr) 2005-02-10 2006-02-10 Systeme multiplex pour la detection d'accessoires chirurgicaux dans la cavite d'une plaie

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WO2008033574A2 (fr) 2006-09-13 2008-03-20 Clearcount Medical Solutions, Inc. appareil et procédés pour surveiller des objets dans un champ chirurgical
DE102010022086A1 (de) * 2010-05-31 2011-12-01 Paul Hartmann Aktiengesellschaft OP-Artikel mit Transponder, Verfahren zum Betreiben einer Überprüfungsanordnung und Überprüfungsanordnung
DE102012107274A1 (de) * 2012-08-08 2014-03-06 Aesculap Ag Einrichtung und Verfahren zum gleichzeitigen Identifizieren einer Vielzahl chirurgischer Instrumente
WO2015120308A1 (fr) * 2014-02-06 2015-08-13 Augustine Biomedical And Design, Llc Système, appareil et procédés de comptage et de détection de tampons pour dissection
WO2016157180A1 (fr) * 2015-04-01 2016-10-06 Haldor Advanced Technologies Ltd Étiquette interchangeable et élément de fixation
ITUB20160638A1 (it) * 2016-02-10 2017-08-10 Servizi Ospedalieri S P A Procedimento per l’allestimento ed il confezionamento di un pacco o kit procedurale sterile ad uso sala operatoria
US10461397B2 (en) 2017-09-05 2019-10-29 Augustine Biomedical And Design, Llc Surgical sponges with flexible RFID tags
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