WO2011151142A1

WO2011151142A1 - Operating article having a transponder, method for operating a testing arrangement and testing arrangement

Info

Publication number: WO2011151142A1
Application number: PCT/EP2011/057665
Authority: WO
Inventors: Michael Krompholz; Dirk Reuter; Peggy Heel; Michael Gross; Peter Fetsch; Thomas Grabscheit
Original assignee: Paul Hartmann Aktiengesellschaft
Priority date: 2010-05-31
Filing date: 2011-05-12
Publication date: 2011-12-08
Also published as: DE102010022086A1

Abstract

The invention relates to an operating article (11) for temporarily inserting in the body (67) of a patient (69) during a surgical intervention on the patient (69), wherein the operating article (11) comprises: a passive transponder (17) having a coupling device (32) for wirelessly coupling the transponder (17) to a read assembly (43) and having a circuit device (29) electrically connected to the coupling device (32), wherein the transponder (17) is designed to supply power to the circuit device (29) by means of an alternating electromagnetic field generated by the read assembly (43) and to form a communication connection to the read assembly (43) by means of the alternating field. In order to disclose an operating article (11) that can be particularly reliably detected in the body of patient, the alternating field comprises a frequency ranging from 860 MHz to 960 MHz, and the coupling device (32) is implemented as a winding (33) and two ends (31) of the winding (33) are connected to the circuit device (29) such that a magnetic induction field generated by the read assembly (43) in the area of the coupling device (32) supplies energy to the circuit device (29) and forms the communication connection.

Description

Transponder surgical article, method of operating a verification device and verification device

The invention relates to a surgical article for temporary introduction into the body of a patient during a surgical procedure on the patient, the surgical article comprising: a passive transponder comprising a coupling device for wireless coupling of the transponder with a reading device and a circuit device connected to the Coupling device is electrically connected, wherein the transponder is adapted to supply the circuit means via a generated by the reading arrangement electromagnetic alternating field with energy and to form a communication connection with the reading arrangement by means of the alternating field. The invention also relates to a method for operating a verification arrangement comprising a reading arrangement with at least one reading antenna arrangement and at least one such OP article, the method comprising the steps of: detecting the transponders of all surgical articles prior to the intervention, detecting the transponders of all outside After surgery, the patient's body of the patient's body and checking whether the transponders of the same articles have been recorded before and after the procedure. Finally, the invention also relates to a corresponding verification arrangement.

From US 2007/0125392 A1 a surgical disposable article is known, which has a transponder in the form of a radio tag (so-called RFID tag). According to a method described therein, the surgical disposable article is detected prior to a surgical procedure, then the surgical procedure is performed, and after the procedure, the surgical disposable article is detected again. Information about each item collected before and after the procedure is stored in separate lists. Upon completion of the procedure, but preferably prior to the final closure of a wound in the body of the patient into which the articles have been inserted during surgery, the two lists are compared to verify that all surgical disposables are removed from the patient's body have been taken. The purpose of this procedure is to ensure that surgical articles that are temporarily inserted into the patient's body during the surgical procedure are removed from the body at the end of the procedure and are not accidentally left in the body.

The surgical articles as well as the mentioned procedure as well as the corresponding examination arrangement must in particular fulfill three requirements for safe use in hospitals or surgical practices. First, the surgical articles must be manufactured inexpensively, as they are usually disposable items that are disposed of after surgery. Secondly, an article in the body of the patient should be able to be detected there as reliably as possible. Third, there is a need to ensure that both the surgical article and the review procedure are sufficiently simple to handle so that they are accepted by medical personnel. A corresponding procedure for checking whether all surgical articles have been removed from the body of the patient must not interfere with the normal course of the procedure in its execution.

Detecting the surgical articles in the patient's body presents difficulties when using common Radio Frequency Identification (RFID) systems. Are RFID systems operating at relatively low frequencies - for example in a low frequency range (LF range) at 125 kHz or 135 kHz or in a high frequency range (RF range) at 13.56 MHz - with an inductive coupling between a reading device and the Working transponders used, then relatively expensive transponders, which also have relatively large dimensions, are attached to the surgical articles. Are used RFID systems that operate at relatively high frequencies, eg. B. UHF systems (ultra-high frequency systems), then located in the body of the patient surgical articles can not be reliably detected, since the body of the patient strongly absorbs radio waves in these UHF frequency ranges.

The present invention is therefore based on the object of specifying an OP article, a method for operating a checking arrangement or a corresponding checking arrangement, which allow a particularly reliable detection of patient's body OP articles, are easy to apply and cause low costs , especially with regard to consumables in the OR, ie disposable items.

This object is achieved by an OP article of the type mentioned, which is characterized in that the coupling device is designed as a winding and two ends of the winding are connected to the circuit means that the alternating field has a frequency of 860 MHz to 960 MHz , preferably 865 MHz to 960 MHz, that, as the alternating field, a magnetic near field generated by the reading arrangement in the region of the coupling device supplies the circuit device with energy and forms the communication connection. The transponder is an RFID transponder (Radio Frequency Identification Transponder) whose circuit device has a memory area in which an identifier can be stored or stored, which can be read out by the reading device in order to generate the transponder and thus also the OP. Identify items. According to the invention, it is thus provided that in the mentioned frequency range - hereinafter referred to as UHF range (ultra-high frequency range) - the power supply and the communication connection are not produced by means of electromagnetic waves (far field) but via the magnetic alternating field (near field) generated by the reading arrangement , The invention is based on the finding that the patient's body relatively strongly absorbs an electric field of a radio wave in the UHF range, so that a radio link between the reading device and the transponder would be severely impaired. In contrast, the patient's body is at least largely permeable to a magnetic near field whose frequency is in the UHF range.

Unlike a radiation density of radio waves, which typically decreases quadratically with distance to a transmitting antenna, the near-field magnetic field decreases at least approximately in cubic with the distance to an antenna of the reading array that generates the near field. For this reason, the near field extends approximately up to a distance r _max to the antenna of r _max = 2D ² / λ, where D is the size of the antenna and λ is the wavelength of a radio wave having the same frequency as the near field. The exact range of the near field depends in particular on the exact geometry of the antenna.

Transponders operating in the UHF range can be produced relatively inexpensively and have small dimensions. Overall, this results in a low-cost surgical article, which is easy to handle due to the compact dimensions of its transponder and can be reliably detected due to the use of the magnetic near field, even if it is located in the body of the patient.

It is preferable that the frequency of the alternating field in the form of the near-field magnetic field is 865 MHz to 868 MHz, 902 MHz to 928 MHz or 952 to 954 MHz.

A particularly compact design of the transponder results when the winding comprises a single turn. This turn may be particularly advantageous as a conductor on a circuit carrier, for example, a printed circuit board or a carrier film may be formed.

The circuit device is preferably a monolithically integrated circuit, that is to say a semiconductor chip which is arranged together with the coupling device on a common circuit carrier. As a result, the transponder and thus also the surgical article can be produced inexpensively. Alternatively, it is also conceivable that the circuit device and the coupling device form a common monolithically integrated circuit. That is, the winding may also be part of the integrated circuit. As a result, the dimensions and manufacturing costs of the transponder are further reduced.

Furthermore, it is particularly preferred that the surgical article is a dressing article, in particular an absorbent dressing article, which has a textile, preferably of gauze, in particular cotton gauze. This material is particularly suitable for example because of its absorbency for dressing articles. It is particularly preferred here for the textile to have 10 to 30, preferably 13, 17, 20 or 24 threads / cm along a longitudinal direction and / or a transverse direction. It is also conceivable that the surgical article comprises or consists of nonwovens.

The surgical article is preferably a belly cloth, a compress or a swab such as a sling gauze swab or a dissecting swab.

In order to be able to localize the surgical article within the body preferably additionally with the aid of an x-ray machine, it can be provided that the surgical article has a contrast medium section which at least partially absorbs x-ray radiation. The contrast agent section can be, for example, a thread which has X-ray contrast agents and which is attached to the textile, in particular woven into the gauze. Alternatively or additionally, a chip, preferably a plastic chip, which contains the X-ray contrast agent can be embedded in the textile. Notwithstanding this, the chip can also be simply glued to the textile, sewn to the textile or otherwise fixed to the textile. The X-ray contrast agent may be, for example, barium sulfate (BaSO ₄ ). Preferably, the contrast agent section consists of about 60% contrast agent.

As a further solution, a method with the features of claim 8 is proposed, which is characterized in that the alternating field has a frequency of 860 MHz to 960 MHz, preferably 865 MHz to 960 MHz, and that as an alternating field by means of the reading arrangement, a magnetic near field in Area of the coupling device is generated, which is supplied via a winding of the coupling device whose two ends are connected to the circuit means, the circuit means with energy and forms the communication link. The fact that the reading device generates the magnetic near field present at the coupling device of the transponder enables near-field communication and power supply, which functions reliably even when the transponder is in an environment such as in the body of the patient. in the radio waves whose frequency is in the UHF range, are strongly absorbed.

A simple handling of the checking arrangement results if the transponders of the OP articles are detected before the intervention by means of a first antenna arrangement assigned to a preparation area of an operating room. In other words, the first antenna arrangement is arranged in the operating room such that the transponders of the surgical articles located in the preparation area can be detected.

In addition, it is preferred that the transponders of the surgical articles are detected after the procedure by means of a second reading antenna device associated with an instrument table of the operating room and / or by means of a third reading antenna arrangement assigned to a discharge container of the operating room.

It can be provided that during and / or after the procedure, the transponders of the surgical articles located in the patient's body are detected by means of a fourth reading antenna arrangement assigned to an operating area, preferably an operating table.

In accordance with the method according to the invention, the transponders of the individual surgical articles are thus detected precisely at those locations within the operating room where they are normally encountered, without the need for special operating steps.

In particular, provision may be made for the first reading antenna arrangement assigned to a preparation area of an operating room and / or the second reading antenna arrangement assigned to an instrument table of the operating room and / or the third reading antenna arrangement assigned to a drop box of the operating room and / or the fourth reading antenna arrangement assigned to an operating area, preferably an operating table are permanently assigned. In this context, the fixed allocation is to be understood as meaning that the respective lay-by arrangement is connected to an object of the operating room in such a way that it is at least substantially immovable relative to this object. A fixed association exists in particular when the respective reading antenna is integrated into the object or forms part of the object. The article may, for example, be a storage surface for the surgical articles in the preparation area, the instrument table or a part thereof, the discharge container or a part thereof or an operating table or a part thereof.

Preferably, the first reading antenna device permanently assigned to a preparation area and / or the second reading antenna device and / or the third reading antenna device permanently assigned to a dropping container and / or the fourth reading antenna device permanently assigned to an operating area, preferably to an operating table, are each attached to a preparation area an instrument table, arranged on a discharge container or an operating area preferably an operating table as a separate component, or integrated as a component.

The fourth reading antenna arrangement assigned to an operating area is preferably designed as a mobile reading antenna arrangement, that is to say in the form of a handheld antenna. The mobile reading antenna arrangement can advantageously be adapted to the patient, adapted to the use, in particular as often as desired, in particular in any desired movements.

The process thus provides an even better overview of where the individual surgical articles are at a given time. Checks where the surgical articles are located can be performed not only before or after the procedure, but also at any time during the procedure. If an OP article is lost during the procedure, then this can be detected relatively quickly and the article can be searched in the operating room.

It can be provided that a reading antenna arrangement in the form of a mobile reading antenna arrangement, in particular a handheld antenna in the method, is assigned to any area of the operating room, ie the preparation area, and / or the instrument table, and / or the drop-off container, and / or the operating area. In particular, it can be provided that only a single reading antenna arrangement is assigned to any area, several areas or all areas of the operating room, ie the preparation area, and / or the instrument table, and / or the dropping container, and / or the operating area. The mobile reading antenna arrangement, in particular a handheld antenna, may be provided with a sterile coating or a sterile sheath in the sterile area of the operating room.

The detection of the transponders of the surgical articles may be designed such that the surgical articles are successively brought into the range of a reading antenna arrangement, in particular the first reading antenna arrangement and / or the second reading antenna arrangement, and thus the transponders are detected one after the other. The reading arrangement can preferably also be set up in such a way that it automatically detects a plurality of transponders simultaneously located within the range of a specific reading antenna arrangement. The automatic detection of a group of transponders within reach of the particular reader antenna arrays is also referred to as bulk scanning.

It is particularly preferred that upon detection of the transponder of the surgical article located in the preparation area before the procedure, the surgical articles are recorded in an originally sealed outer packaging containing a known number of surgical articles and checked after detection, whether the number of detected transponder corresponds to the known number. By comparing errors can be detected when detecting the individual transponder and corrected if necessary. It is also conceivable that the outer packaging contains a plurality of OP articles of various types and with the aid of detecting the transponders of the individual OP articles it is determined which OP articles are present in which number and this with known information about the intended content of the outer packaging is compared.

The information about the contents of the outer packaging can, for example, be stored as a packing list in a control device assigned to the reading arrangement as a data record. Under an originally packed outer packaging is understood before and / or during the procedure and during the preparation of the procedure not yet opened outer packaging. This may be, for example, a packaging produced by the manufacturer of the surgical article, which contains a specific quantity of surgical articles known during the execution of the method. However, it is also conceivable that the surgical articles are packaged in the outer packaging only within the hospital or the practice in which or which the procedure is performed.

It can be provided that the outer packaging has a further transponder and that upon detection of the transponder of the surgical article prior to surgery and the other transponder is detected and depending on the detected transponder, in particular a stored in another transponder identifier, the nature of Overpack, in particular the contents of the outer packaging, is determined.

However, it is also conceivable that individual surgical articles equipped with a transponder which functions according to the invention, ie without outer packaging, are fed to the method.

It is conceivable that when the transponders of the surgical article are manufactured or only when the surgical articles are manufactured, the individual transponders are assigned a unique identifier, for example in the form of a bit sequence. That a unique identifier is already stored in the transponder prior to detection. On the basis of the identifier, each OP article can then be identified when detecting the transponder.

Alternatively, it can also be provided that the transponders of the finished OP articles initially contain no unique identifier, d. H. especially with respect to data stored in the transponder are identical. In this case, it can be provided that upon detection of the transponder of the surgical article prior to the procedure a part of the detected transponder, preferably each detected transponder, a unique identifier is assigned and this identifier is stored in the transponder. This process of assigning the unique identifier and storing the identifier in the transponder is also referred to as "serializing" the transponders.

In order to always obtain an overview of the surgical articles located in the operating room, it is preferred that the transponders of the surgical articles are also used during the procedure by means of the preparation area, and / or the instrument table, and / or the ejection container and / or the surgical area associated antenna device at least once, preferably regularly, more preferably periodically detected.

Preferably, at least one, in particular a plurality of intermediate controls is performed. The transponders detected in the preparation area, the instrument table, the drop-off container and / or the operating area are checked, and it is adjusted whether the previously detected transponders and thus the OP articles match.

To exploit the advantages of the surgical article according to the invention, it is proposed that the transponder of at least one surgical article be detected as an inventive surgical article according to one of claims 1 to 7.

As a further solution to the above-mentioned object, an inspection arrangement according to claim 17 is proposed, which is characterized in that the coupling device is designed as a winding and two ends of the winding are connected to the circuit device, that the alternating field has a frequency of 860 MHz to 960th MHz, preferably 865 MHz to 960 MHz, has a magnetic near field generated by the reading arrangement in the region of the coupling device supplying energy to the circuit device and forming the communication connection. The transponder is an RFID transponder (Radio Frequency Identification Transponder) whose circuit device has a memory area in which an identifier can be stored or stored, which can be read out by the reading device in order to generate the transponder and thus also the OP. Identify items.

The verification arrangement forms a system usable in an operating room to check whether all surgical articles have been removed from the body of the patient at the end of the procedure. Both the reading arrangement with the reading antenna arrangement and the transponders of the individual surgical articles form part of this system. An operating room equipped with the checking arrangement according to the invention ensures that no surgical articles remain in the body of the patient at the end of the surgical procedure without making the course of the procedure or its preparation significantly more complicated.

It is preferred that the verification arrangement comprise a plurality of reader antenna arrays connected to a reading device of the reading device. With such a checking arrangement located at different locations within the operating room transponder of the individual surgical articles can be detected with little effort.

It is particularly preferred that at least one reading antenna arrangement comprises a plurality of antennas and a coupling circuit, wherein the antenna is connected to the reading device by means of the coupling circuit. Such an antenna arrangement can detect the transponders of the individual OP articles within a relatively large spatial area. The coupling circuit can only consist of passive electronic components. However, it can also be provided that active components are present in the coupling circuit. In an embodiment, a high frequency amplifier may be provided in an active coupling circuit.

It is preferred that the checking arrangement comprises an operation preparation area to which a first reading antenna arrangement is assigned, and / or an instrument table to which a second reading antenna arrangement is assigned, and / or a dropping container to which a third reading antenna arrangement is assigned, and / or an operating area, in particular one Operating table, which is associated with a fourth reading antenna arrangement has. In fact, the OP articles are usually present at said locations within the operating room so that a simple detection of the transponders of all OP articles is possible when the reader antenna arrangements are arranged in the manner indicated.

In a preferred embodiment, the verification arrangement may comprise a reading antenna arrangement, which is assigned to a plurality of the areas of the surgical preparation area, and / or instrument table, and / or drop-off area, and / or operating area, in particular to an operating table. In this case, it can be provided that the checking arrangement has only a single reading antenna arrangement, which is assigned to all areas of the surgical preparation area, and / or instrument table, and / or discharge container, and / or operating area, in particular an operating table.

It is further preferred that the arrangement has a control device coupled to the reading arrangement, wherein the control device for implementing the method according to any one of claims 8 to 16 set up, preferably programmed. The control device can have a microcomputer with peripheral devices for user interaction (eg screen, touchscreen and / or keyboard). The computer may have storage means for storing information about the individual surgical articles and / or the outer packaging. The controller may include a printer for printing lists or lists of the surgical articles intended for the procedure. The printer may also be embodied as a label printer for printing labels showing the type and / or number of individual surgical articles present in the operating room.

The reading arrangement can advantageously read out a memory area of the integrated circuit of the transponder. In a further advantageous embodiment, it is provided that the reading arrangement can also describe at least one memory area of the integrated circuit.

Further features and advantages of the invention will become apparent from the following description in which exemplary embodiments of the invention are explained in more detail with reference to the drawings. Showing:

Figure 1 is a schematic representation of a surgical article according to a first embodiment;

Figure 2 is a schematic representation of an operating article according to a second embodiment;

Figure 3 is a plan view of a schematic representation of a transponder of the surgical article of Figure 1 or Figure 2;

Figure 4 is a side view of the transponder of Figure 3;

Figure 5 is a schematic representation of a verification arrangement in an operating room;

FIG. 6 is a flowchart of a method for operating the checking arrangement of FIG. 5;

Figure 7 is a detailed flow diagram of a portion of the method shown in Figure 6;

Figure 8 is a detail of the illustration of Figure 5;

9 shows an illustration of a graphical output of a display device of the checking arrangement from FIG. 5

Figure 10 is a schematic representation of an adhesive label;

FIGS. 11 and 12 representations of further graphic outputs similar to FIG. 9; and

Figure 13 is a schematic representation of a verification arrangement according to another embodiment.

FIG. 1 shows an OP article 11 in the form of a stomach cloth 13 which has a plurality of layers of cotton gauze 15. The gauze 15 has 20 threads / cm, and the abdomen 13 comprises four or six layers of the gauze 15. Attached to the gauze 15 is a transponder 17 which is adapted to communicate with a reading device via an alternating magnetic field whose frequency is in the UHF range. Area is located, is set up. The transponder 17 is therefore a radio tag (RFID tag), which is set up for near field communication in the UHF range with the reading arrangement.

In the gauze 15 is also a contrast agent portion in the form of a contrast agent thread 19 is mounted, in particular woven. Instead of the contrast agent thread 19 or in addition to the contrast agent thread 19, a contrast agent chip 21 can also be provided as the contrast agent section. The

contrast agent portion

19, 21 contains as a contrast agent, for example, barium sulfate in a proportion of, for example, 60%. Furthermore, the contrast agent portion may include plastic material such as PVC or polypropylene. The

contrast agent section

19, 21 allows the location of the surgical article 11 in the body of a patient with the aid of an X-ray device.

The surgical article 11 may also be a compress that has the basic structure shown in FIG. 1 for the embodiment of the abdominal sheet 13.

FIG. 2 shows a further surgical article 11 in the form of a swab 23, which likewise contains the cotton gauze 15 and has the transponder 17. In the gauze 15 of the swab 23 of the contrast agent thread 19 is woven.

Figures 3 and 4 show the transponder 17 in detail. It can be seen that the transponder has a circuit carrier 25 on which a circuit device 29 designed as a monolithically integrated circuit 27 is arranged. Connected to two terminals (without reference numeral) of the circuit device 29 is a coupling device 32 for coupling the transponder 17 to a reading arrangement in the form of a winding 33. In the embodiment shown, the winding 33 comprises a single turn 35 whose ends 31 are connected to the terminals of the circuit means 29.

The circuit carrier 25, the circuit device 29 and the winding 33 are surrounded by protective material 37. The protective material 37 may be, for example, plastic, in which the parts of the transponder 17 are compactly protected. The protective material 37 has the effect that the transponder 17 is at least substantially insensitive, in particular to environmental influences, on the transponder 17 during the use of the surgical article 11 during the surgical procedure, in particular when inserting the surgical article 11 into the body of a patient. occur. In particular, there is no damage to the transponder 17 when it comes in contact with water or body fluids of the patient, or when it encounters mechanical stress, e.g. when gripping with an operating instrument is exposed. Furthermore, the protective material 37 preferably ensures that the surgical article 11 together with the transponder 17 can be sterilized.

The swab 23 may be any type of swab 23 useful in the medical field. For example, the swab 23 may be a dissecting swab or a sling gauze swab. As an operating article 11 is any object that is temporarily introduced during the surgical procedure in the body of the patient and therefore must be ensured that the surgical article 11 has been removed from the body of the patient at the end of the procedure. Thus, the surgical article 11 may not only be a belly sheet 13 or a swab 23, but any article of dress such as a compress.

FIG. 5 shows a checking arrangement 41 with a reading arrangement 43. The reading arrangement 43 is set up to detect the transponder 17 located in the region of a reading antenna arrangement 45 of the reading arrangement 43. The checking arrangement 41 also includes the transponders 17 attached to the surgical articles 11. The checking device 41 thus forms a system for checking whether surgical articles 11 have remained in the body of the patient at the end of the surgical procedure.

The reading arrangement 43 can read out a memory area of the integrated circuit 27 of the transponder 17. In an embodiment not shown, it is provided that the reading arrangement 43 can also describe at least one memory area of the integrated circuit 27.

In detail, the reading arrangement 43 has a first reading antenna arrangement 45, which is assigned to a preparation area 47 of an operating room 49. A second reading antenna arrangement 51 is assigned to an instrument table 53 of the operating room 49 and, as in the embodiment shown, can be arranged on a tabletop 54 of the instrument table 53 or form part of the tabletop 54. A third reader antenna assembly 55 is associated with a discharge container 57 of the operating room 49 and may be disposed on or integrated with the discharge container 57. Finally, the reading arrangement 43 has a fourth reading antenna arrangement 59, which is assigned to an operating area 61, which also includes an operating table 63. In the exemplary embodiment shown, the fourth reading antenna arrangement is designed as a hand-held antenna 59, which can be moved by the surgical staff into the area at an operating wound 65 in the body 67 of the patient 69, in order to detect any surgical articles 11 there by means of their transponders 17.

The

reader antenna arrays

45, 51, 55, 59 are connected to a common reader 71 via electrical connection lines (not numbered). The reading device 71 is connected to a computer network 73, such as a local area network (LAN), in particular Ethernet. The checking arrangement 41 also has a computer 75, which forms a control device of the checking arrangement 41 and is likewise connected to the computer network 73 and is thus coupled to the reading device 71 of the reading arrangement 43. To the computer 75, a label printer 76 for printing adhesive labels 139 is connected. In the embodiment shown, the computer network 73 has an Ethernet switch 77 to which both the computer 75 and the reader 71 are connected. Deviating from this, the computer network 73 can also be realized in other ways.

As shown schematically in the representation of FIG. 5 and by way of example with reference to the first reading antenna arrangement 45, the reading

antenna arrangements

45, 51, 55 and 59 can have a plurality of antennas, which are embodied, for example, as a further winding 79 and via a coupling circuit 81 with the reading device 71 are connected. In the embodiment shown, the coupling circuit 81 has only passive electronic components. Deviating from this, however, active components can also be provided within the coupling circuit 81. It is Z. B. conceivable that the coupling circuit 81 has a high-frequency amplifier (not shown). If the individual antennas 79 are arranged next to one another within a plane, the entire reader antenna arrangement 45 has a relatively large surface area and thus a relatively large spatial area within which the transponder 17 of the OP articles 11 can be detected by the first reading arrangement 43.

In an embodiment which is not shown, the second reading antenna arrangement 51 assigned to the instrument table 53 has a plurality of antennas 79 and the coupling circuit 81.

In the following, a method for operating the checking arrangement 41 will be explained with reference to FIGS. 6 to 12.

FIG. 6 gives an overview of the method 83. After the start 85 of the method 83, the transponders 17 of all the surgical articles 11 intended for intervention are detected in a step 87, i. H. the computer 75 controls the reading arrangement 43 so that it detects the transponders 17 of the individual OP articles 11 by scanning with the aid of the first reading antenna arrangement 45. For this purpose, the surgical articles 11 are brought into the preparation area 47 so that they are within reach of the first reading antenna array 45. For example, the surgical articles 11 may simply be placed on the overall plate-shaped first reader antenna assembly 45 before the method 83 performs step 87. The method 83 can be configured such that it detects the transponders 17 of a plurality of surgical articles 11 brought into the range of the first reading antenna arrangement 45 one after the other by the surgical staff.

The reading arrangement 43 is set up to automatically detect a plurality of transponders 17 simultaneously located within the range of a specific

reading antenna arrangement

45, 51, 55, 59. The automatic detection of a group of transponders within reach of the particular

reader antenna arrays

45, 51, 55, 59 is also referred to as bulk scanning. Accordingly, when executing step 87, a plurality of transponders 17 located simultaneously in the range of the first reading antenna arrangement 45 are automatically detected by the reading arrangement 43.

During the intervention, an intermediate check 89 may be performed. During the intermediate check 89, the reading arrangement 43 detects, with the aid of the first reading antenna arrangement 45, the second reading antenna arrangement 51 and the third reading antenna arrangement 55, the transponders 17 of the surgical article 11 located outside the patient's body Step 87 detected surgical articles 11 are exactly the same, which have been detected in step 91 plus those surgical articles 11, which are located in the body 67 of the patient 69. The surgical articles 11 located in the body 67 of the patient 69 can either be determined manually and a corresponding user input can be detected in step 91, or in step 91 the reading device 43 can read the surgical articles 11 located in the body 67 of the patient 69 by means of the fourth reading antenna assembly 59 by detecting their transponder 17 determine.

Notwithstanding the sequence shown in Figure 6, instead of the single intermediate control 89 a plurality of intermediate controls 89 can be performed. Furthermore, a variant of the method 83 without the intermediate control 89 is conceivable.

After the procedure, in particular before closing the individual tissue layers, in particular before the final closure of the surgical wound of the patient 69, a final inspection 95 is performed. For this purpose, a step 97 is provided, in which the reading device 43 correspondingly triggered by the computer 75 detects the transponders 17 of all OP articles 11 located outside the body 67 of the patient 69 by means of the first reading antenna arrangement 45, the second reading antenna arrangement 51 and the third reading antenna arrangement 55. Subsequently, a step 99 checks whether before and after the procedure, i. H. in step 87 and in step 97, respectively the transponders of the same OP articles 11 have been detected. If this is the case (Y), the method 83 is ended. Otherwise (N), a step 101 is executed, in which missing OP articles 11 are determined. For this purpose, the method 83 can detect manual user inputs via surgical article 11 remaining in the body 67 of the patient 69 and / or automatically detect the surgical article 11 remaining in the body 67 of the patient 69 by scanning the transponder 17 using the fourth reading antenna arrangement 59.

In order to identify the surgical articles 11 on the basis of the identifiers of the transponders 17, in particular in step 87 before the procedure, in step 91 in an intermediate check 89 and in step 97 in the final check 95, the reading arrangement 43 transmits the identifiers after detecting the transponders 17 and numbers of transponders 17 in such a way via the computer network 73 to the computer that the computer 75 receives information about the number of detected transponder 17 with a specific identifier. On the basis of this information about the identifier and the number of transponders 17 having this identifier, the computer 75 identifies the type and number of OP articles 11 whose transponders 17 have been detected. For this purpose, the computer 75 can access a database held in the computer 75 in which a relation between the identifier of the corresponding transponder 17 and information about the type of OP article 11 is stored. The information about the type of surgical article 11 may be an article description in plain text, an article number, a picture of the article or the like. As an alternative or in addition to the access to the database of the computer 75, access to a further information system (eg a further database), for example of the hospital or the practice or of the manufacturer of the surgical article 11, which is not part of the Calculator 75 is. The computer 75 can be connected via the computer network 73 to such an information system.

FIG. 7 shows step 87 in detail. First, the reading arrangement 43 reads in a block 103 with the aid of the first reading antenna arrangement 45 the transponders 17 of the individual OP articles 11 located in the preparation area 47. In this case, initially in a step 105 via the magnetic near field, a communication connection is established with one of the transponders 17 and a clear identifier, for example in the form of a bit sequence, is read from the transponder 17.

If transponders 17 are used in conjunction with method 83, which do not have a unique identifier, then the identification is not read in step 105. Instead, in step 107 transponder 17 is assigned a unique identifier and this identifier is transmitted to transponder 17 via the communication link so that the transponder 17 stores this identifier assigned to it.

If transponders 17 are used in conjunction with method 83, which already have a unique identifier prior to executing method 83, then step 107 can be omitted. It is conceivable to provide the step 107 in the method 83, even if the transponders 17 already have a unique identifier. In this case, the step 107 is used to assign the transponder 17 a further identifier, which is used in the further course of the method 83 for the identification of the surgical article 11. Storing the unique identifiers in the individual transponders 17 is also referred to as "serialization" of the individual transponders 17. A branch 109 ensures that

steps

105 and 107 are executed until all transponders 17 within range of the first reader antenna array 45 have been detected. Depending on the precise embodiment of the method 83 or the checking arrangement 41, it may be provided that only one transponder 11 of an operating article is detected in step 105 (individual detection) or that one or more transponders are detected in step 105 (burst detection). ,

Subsequently, in step 87, an optional block designated as input validation 111 may be provided. During the input validation 111, it is checked whether the transponders 17 of all the OP articles 11 contained in an outer packaging have been detected. The outer packaging 113 placed on the first reading antenna arrangement 45 is shown schematically in FIG. In the outer package 113, five OP articles 11 are packed. In addition, the outer packaging 113 has a further transponder 115, which may be glued to an outer side of the outer packaging 113, for example. The transponder 115 may have the same structure as the transponders 17, i. H. it may also be a transponder, which is designed for operation in the magnetic near field of the first reading antenna arrangement 45 of the reading arrangement 43 and also operates in the UHF frequency range. Deviating from this, the further transponder 115 can also be realized in another way. It may, for example, be a transponder operating in another frequency range, for example 100 KHz to 134 KHz, 10 MHz to 20 MHz, preferably 13.56 MHz. The transponder 115 can also be designed for operation in the far field of a reading antenna arrangement. In this case, the reading arrangement 43 is also set up for operation with the further transponder 115, or it may also be provided a further reading arrangement, which is used specifically for detecting the further transponder 115. It is also conceivable that, instead of the transponder 115, a barcode is provided and the checking arrangement 41 comprises a corresponding barcode reader.

If the originally sealed outer packaging 113 together with the surgical articles 11 is within reach of the first reading antenna arrangement 45, a step 117 detects the further transponder 115 and determines the intended contents of the outer packaging 113, for example by means of a unique identifier stored in the further transponder 115. For example, the number of surgical articles 11. Are packed in the outer packaging 113 surgical articles 11 different types, then in step 117, a list of the type and amount of each surgical article is determined. For this purpose, the computer 75 can access a database which is held either in the computer 75 itself or in a remote computer (not shown) in which the information about the type and / or number of the individual OP articles together with the identifier of the further transponders 115 of the outer packaging are stored. It is conceivable that the computer 75 accesses this via the computer network 73 for this purpose, an information system that also serves, for example, the management of logistical processes within the hospital or the surgical practice.

Subsequently, it is checked in step 119 whether the surgical articles 11 recorded in block 103 correspond to the information determined in step 117 about the type and quantity of the individual surgical articles 11. If there is no match, then it can be provided that the computer 75 outputs a corresponding error message, so that the step 87 can be repeated from the beginning.

After the transponders 17 of all surgical articles 11 have been detected, a step 121 is carried out, in which the computer 75 stores information about the detected surgical articles 11.

In the illustrated embodiment of the method 83, it is provided that individual surgical articles 11, groups of surgical articles 11 and / or individual overpacks 113 can be successively brought into the range of the first reading antenna arrangement 45, in particular placed on the overall plate-shaped first reading antenna arrangement 45 can be.

After the surgical article 11 or the outer packaging 113 has been brought into the range of the first reading antenna arrangement 45, the individual surgical articles 11 are detected as described above, and the computer 75 generates the information about the detected surgical articles 11 a suitable screen output, which is shown schematically in Figure 9. The screen output 123 comprises a graphic representation 125 of the last recorded surgical article 11 and a tabular representation 127 of information about this surgical article 11, namely an article name 129, an article number 131, the number 113 of the surgical articles 11 previously recorded with the corresponding article designation 129 or the corresponding article number 131 as well as the size of the packaging unit 135, d. H. the number of surgical articles 11 present in the outer package 113. In a total list 137 of the screen output 123, it is shown how many surgical articles 11 of the various article types have been recorded in total. In the example shown, ten surgical articles 11 with the article designation A and five surgical articles 11 with the article designation B were registered.

After capturing the individual surgical articles 11, the label printer 76 prints for each article type an adhesive label 139 that can be used for a surgical documentation in paper form, for example by adhering it to forms provided for the surgical documentation. The adhesive label 139 is shown schematically in FIG. It shows the article number 131, the item name 129, the size S of the packaging unit 135 (target number of OP items 11) and the number I of the actually registered OP items 11 (actual number of OP items 11).

FIGS. 11 and 12 show the screen output 123 of the computer 75 at the final check 95. The screen output 123 shown in FIGS. 9 and 10 can be displayed by the computer 75 in step 99, for example.

In detail, FIG. 11 shows an exemplary embodiment of the screen output 123 in the event that the same OP articles 11 have been detected before and after the intervention, ie step 101 is therefore not executed. In the overall tabular representation 123, a first column 141 shows the article designations 129 of the individual articles. As an example, the two article designations A and B are listed here. A second column 143 shows the number of articles 133 separately for each article designation 129. A third column 145 shows the number of individual surgical articles 11 broken down by the article designations 129 during the final inspection 95 by means of the second reading antenna arrangement 51 in the area of the instrument table 53. A fourth Column 147 contains corresponding article counts for those articles that have been detected during final inspection 95 by the third reader antenna assembly 55 associated with the dump bin 57. Finally, a fifth column 149 shows the difference between the number of articles 133 indicated in the respective row of the tabular representation in the first column 141 and the sum of the numbers in the third column 145 and the fourth column 147 in the same row. Advantageously, in the case of the screen output, each listed surgical article can still be illustrated by an additional pictorial representation (not shown).

According to the example in FIG. 11, exactly those surgical articles 11 which were also detected in step 87 by means of the first reading antenna arrangement 45, which is assigned to the preparation area, were located on the instrument table 53 and in the discharge container 57. Accordingly, the values of the difference in the fifth column 149 are zero for all two types of articles named A and B, respectively.

FIG. 12 shows a representation similar to FIG. 9, but during the final inspection 95 it was not possible to detect all transponders 17 of those OP articles 11 bearing the article designation B, so that in the row of the tabular representation for the article with the article designation B a Difference of 1 results. In this situation, d. H. at least one value other than 0 in the fifth column 149, the step 101 of the method 83 is executed. Depending on the exact configuration of the method 83, the still missing surgical article 11 can either be manually searched by the surgical staff and the number of the missing article can be recorded in step 101 by manually entering the number of missing surgical article 11 into the computer 75 or In step 101, the computer 75 of the reading device 71 can actuate the reading arrangement 43 in such a way that the missing OP article can be searched by means of the fourth reading antenna arrangement 59.

It is conceivable that the two mentioned variants (detection of a user input and detection by means of the fourth reading antenna arrangement 59) are combined with one another. For example, an attempt can initially be made to detect the missing surgical article 11 by means of the fourth reading antenna arrangement 59. If this fails, then the missing OP article 11 can be detected by means of the user input. For example, prior to manually entering the number of missing surgical article 11, the surgical staff may attempt to find the surgical article 11 in the body of the patient using an X-ray machine.

FIG. 13 shows a further embodiment of the invention. For the same elements, the same reference numerals as used in particular in Figure 5 and not explained in detail again. The checking arrangement 41 shown in FIG. 13 has as a single antenna arrangement the hand antenna 59, which is not assigned to a single area of the operating room 49, but for detecting the transponders 17 of the area (preparation area 47, instrument table 53, discharge container 57 and operating area 61) ) of the operating room 49 is provided. In all embodiments shown, the handheld antenna 59 may be provided with a sterile coating or a sterile sheath.

Overall, the present invention provides an operating article 11, a checking arrangement 41 and a method 83, which can be ensured in a particularly simple manner without complicating the course of the surgical procedure, which does not require an OP at the end of the surgical procedure Article 11 accidentally remains in the body 67 of the patient 69. The OR staff is supported in their work so that the OR staff is less stressed and stressed. In particular, surgical staff enrolling in the surgical article need not manually recount the surgical articles by conventional means.

Claims

Surgical article (11) for temporary introduction into the body (67) of a patient (69) during a surgical procedure on the patient (69), the surgical article (11) comprising: a passive transponder (17) comprising a coupling device ( 32) for wireless coupling of the transponder (17) with a reading device (43) and a circuit device (29) which is electrically connected to the coupling device (32), wherein the transponder (17) is adapted to the circuit device (29) via to supply an electromagnetic alternating field generated by the reading arrangement (43) and to form a communication connection with the reading arrangement (43) by means of the alternating field, characterized in that the alternating field has a frequency of 860 MHz to 960 MHz and the coupling device (32) is formed as a winding (33) and two ends (31) of the winding (33) are connected to the circuit means (29) that as an alternating field of the L electrical arrangement (43) in the region of the coupling device (32) generated magnetic near field, the circuit means (29) energized and forms the communication link.
Surgical article (11) according to claim 1, characterized in that the frequency of the alternating field in the form of the magnetic near field is 865 MHz to 868 MHz, 902 MHz to 928 MHz or 952 MHz to 954 MHz.
Surgical article (11) according to claim 1 or 2, characterized in that the winding (33) is a single turn (35).
Surgical article (11) according to one of the preceding claims, characterized in that the circuit device (29) is a monolithically integrated circuit (27) which, together with the coupling device (32), is arranged on a common circuit carrier (25) is.
Surgical article (11) according to one of the preceding claims, characterized in that the surgical article (11) is a, preferably absorbent, dressing article which has a textile, preferably gauze, in particular cotton gauze (15).
Surgical article (11) according to claim 5, characterized in that it is the surgical article to a belly cloth (13), a compress or a swab (23), in particular a Schlinggazetupfer or a Präpariertupfer acts.
Surgical article (11) according to one of the preceding claims, characterized in that the surgical article (11) has a contrast medium section (19, 21) which at least partially absorbs X-ray radiation.
Method (83) for operating a checking arrangement (41) comprising a reading arrangement (43) with at least one reading antenna arrangement (45, 51, 55, 59) and at least one passive transponder of an operating article (11) for temporary introduction into the body (67 ) of a patient (69) during a surgical procedure on the patient (69), wherein the transponder (17) has a coupling device (32) for wireless coupling of the transponder (17) with a reading device (43) and a circuit device (29) is electrically connected to the coupling device (32), wherein the transponder (17) is adapted to supply the circuit means (29) via an electromagnetic alternating field generated by the reading arrangement (43) and by means of the alternating field a communication connection with the reading arrangement ( 43), the method (83) comprising the steps of: detecting (87) the transponders (17) of all surgical articles (11) before the procedure, Detecting (97) the transponders (17) of all surgical articles (11) located outside the body (67) of the patient (69) after the intervention and checking (99) whether the same surgical articles (11 ), characterized in that the alternating field has a frequency of 860 MHz to 960 MHz and that as an alternating field by means of the reading arrangement (43) a magnetic near field in the region of the coupling device (32) is generated, which via a winding (33) the coupling device (32), the two ends of which are connected to the circuit device (29), supplies the circuit device (29) with energy and forms the communication connection.
Method (83) according to Claim 8, characterized in that the transponders (17) of the surgical articles (11) are detected before the procedure by means of a first reading antenna arrangement (45) assigned to a preparation area (47) of an operating room (49).
Method (83) according to claim 8 or 9, characterized in that the transponders (17) of the surgical articles after the intervention by means of a instrument table (53) of the operating room (49) associated second reading antenna assembly (51) and / or by means of a Abwurfbehälter (57) of the operating room (49) associated third reading antenna arrangement (55) are detected.
Method (83) according to one of claims 8 to 10, characterized in that during and / or after the intervention by means of an operating region (61), preferably an operating table (63), associated fourth reading antenna arrangement (59), the transponder (17) of Body of the patient located OP-article (11) are detected, in particular by means of a mobile trained reading antenna arrangement, in particular in the form of a hand antenna (59).
Method (83) according to any one of claims 8 to 11, characterized in that when detecting (87) the transponder (17) of the surgical article (11) located in the preparation area (47) prior to the intervention, the surgical articles (11) in an original sealed outer package (113) containing a known number of OP articles (11) are detected (91) and after detection (91) is checked (93), whether the number of detected transponder (17) the known number corresponds.
Method (83) according to one of Claims 8 to 12, characterized in that transponders (17) of such surgical articles (11) are detected (87) in which a unique identifier is stored prior to the procedure.
Method (83) according to any one of claims 8 to 12, characterized in that upon detection (87) of the transponder (17) of the surgical article (11) prior to the intervention each detected transponder (17) is assigned a unique identifier and this identifier is stored in the transponder (17).
Method (83) according to one of claims 8 to 14, characterized in that also during the procedure, the transponders (17) of the surgical articles (11) by means of the preparation area (47), and / or the instrument table (53), and / or the ejection container (57), and / or the reading area arrangement (45, 51, 55, 59) assigned to the operating area (61) are detected at least once, preferably regularly.
Method (83) according to one of Claims 8 to 15, characterized in that the transponder (17) of at least one surgical article (11) according to one of Claims 1 to 7 is detected.
A verification arrangement (41) comprising a reading arrangement (43) with at least one reading antenna arrangement (45, 51, 55, 59) and at least one passive transponder (17) of an operating article (11) for temporary introduction into the body (67) of a patient ( 69) during a surgical procedure on the patient (69), wherein the transponder (17) has a coupling device (32) for wireless coupling of the transponder (17) to a reading device (43) and a circuit device (29) connected to the coupling device ( 32) is electrically connected, wherein the transponder (17) is adapted to supply the circuit means (29) via an electromagnetic alternating field generated by the reading arrangement (43) and to form a communication connection with the reading arrangement (43) by means of the alternating field , characterized in that the alternating field has a frequency of 860 MHz to 960 MHz and that the coupling device (32) as such a winding (33 ) and two ends (31) of the winding are connected to the circuit device (29) such that a magnetic near field generated by the reading device (43) in the region of the coupling device (32) supplies the circuit device (29) with energy and the magnetic field generated Forms communication link.
Arrangement (41) according to claim 17, characterized in that the checking arrangement (41) comprises a plurality of reading antenna arrays (45, 51, 55, 59) connected to a reading device (71) of the reading device (43).
Arrangement (41) according to claim 17 or 18, characterized in that at least one reading antenna arrangement (45) comprises a plurality of antennas (79) and a coupling circuit (81), wherein the antennas (79) by means of the coupling circuit (81) with the reading device (71 ) are connected.
Arrangement (41) according to one of Claims 17 to 19, characterized in that the arrangement (41) has an operation preparation area (47) to which a first reading antenna arrangement (45) is assigned, and / or an instrument table (53) to which a second reading antenna arrangement (47). 51), and / or a dropping container (57) to which a third reading antenna arrangement (55) is associated, and / or an operating area (61), in particular an operating table (63) containing a fourth reading antenna arrangement (59), preferably a handheld antenna (59).
Arrangement (41) according to one of Claims 17 to 20, characterized in that the arrangement (41) has a control device (75) coupled to the reading arrangement (43), wherein the control device (75) is designed to carry out a method (83) according to of claims 8 to 16 set up, preferably programmed, is.