Patent Description:
Surgery is performed on patients, using surgical instruments like scalpels, artery forceps, and suturing instruments, as well as consumables like gauze and cotton pads. Conventionally, a surgical procedure involves dissecting the tissue in the vicinity of a lesion, cutting the lesion, suturing the lesion to stem bleeding from the lesion, removing all surgical instruments and consumables from the patient's body, and finally suturing the dissected tissue.

However, at the end of surgery, some surgeons who are busy or tired forget to remove from their patients' bodies surgical instruments and consumables (retained surgical items, RSIs). RSIs are harmful to human tissue, posing a threat to medical safety and patients' health.

RSIs have a global incidence of <NUM>% and are a major category of medical negligence. Therefore, it is necessary to provide a method and device for preventing RSIs.

<CIT>, which represents the closest prior art, discloses a surgical item managing method for a smart operating room, for use by a surgical item managing system for the smart operating room to manage a surgical item used during a surgical procedure, wherein the surgical item comprises a flexible RFID tag, and wherein the surgical item managing method comprises the steps of: obtaining a tag position of the flexible RFID tag; taking an image of a patient, so as to obtain an image position of the patient; determining whether a position of the flexible RFID tag and the image position of the patient overlap, so as to determine whether the surgical item corresponding to the flexible RFID tag is in a body of the patient; wherein a particular working portion may be selected to be particularly illustrated on a display, wherein specific information relating to the particular working portion can also be specifically displayed or illustrated on the display.

It is an objective of the present disclosure to provide a surgical item managing method for a smart operating room to prevent retained surgical items (RSIs).

In order to achieve the above and other objectives, the present disclosure provides a surgical item managing method for a smart operating room according to independent claim <NUM> and a surgical item managing system for a smart operating room according to independent claim <NUM>. The dependent claims show further embodiments of the said method and system, respectively. The surgical item managing method for a smart operating room, for use by a surgical item managing system for the smart operating room to manage a surgical item used during a surgical procedure, the surgical item including a flexible RFID tag, includes the steps of: obtaining a tag position of the flexible RFID tag; taking an image of a patient, so as to obtain an image position of the patient; determining whether a position of the flexible RFID tag and the image position of the patient overlap, so as to determine whether the surgical item corresponding to the flexible RFID tag is in the patient's body; and sending a warning when the surgical item is in the patient's body. Therefore, the surgical item managing method is effective in sending position-related data to a blockchain system of an external network to record and track the entire surgical procedure.

The step of obtaining the tag position of the flexible RFID tag further includes: scanning the flexible RFID tag and receiving a plurality of return signals.

According to an embodiment of the present disclosure, the step of obtaining the tag position of the flexible RFID tag further includes: computing the tag position of the flexible RFID tag according to levels of signal strength of the return signals.

According to an embodiment of the present disclosure, the surgical item managing method for a smart operating room further includes: transmitting data about the position of the flexible RFID tag to an external computer or a blockchain network.

According to an embodiment of the present disclosure, the flexible RFID tag carries a transportation history, and the surgical item managing method for a smart operating room further includes: recording the transportation history in a blockchain network. Therefore, surgical record cannot be tampered with.

Another objective of the present disclosure is to provide a surgical item managing system for a smart operating room to prevent retained surgical items (RSIs).

The present disclosure further provides the surgical item managing system for use in a smart operating room to manage a surgical item used during a surgical procedure. The surgical item includes a flexible RFID tag. The surgical item managing system for a smart operating room includes an RFID tag reader/writer a video recording module, a processing module and a warning module. The RFID tag reader/writer scans the flexible RFID tag. The video recording module takes images of a patient to obtain a position of the patient. The processing module is in signal connection with the RFID tag reader/writer and a video recording module. The processing module computes a position of the flexible RFID tag according to a data which the RFID tag reader/writer acquires by scanning the flexible RFID tag and determine whether a position of the flexible RFID tag and the image position of the patient overlap, so as to determine whether the position of the flexible RFID tag is in the patient's body. The warning module is in signal connection with the processing module. The warning module sends a warning signal when the processing module determines that the position of the flexible RFID tag is in patient's body.

The RFID tag reader/writer scans the flexible RFID tag and receives a plurality of return signals.

The processing module computes the position of the flexible RFID tag according to levels of signal strength of the return signals.

According to an embodiment of the present disclosure, the surgical item managing system for a smart operating room further includes a network module. The network module is in signal connection with the RFID tag reader/writer. The network module transmits data about the position of the flexible RFID tag to an external computer or a blockchain network.

According to an embodiment of the present disclosure, the surgical item managing system for a smart operating room further includes a blockchain tracking module. The blockchain tracking module is in signal connection with the RFID tag reader/writer. The blockchain tracking module records a transportation history in a blockchain network.

According to an embodiment of the present disclosure, the surgical item further includes at least one surgical instrument and at least one surgical consumable.

The implementation of the present disclosure is illustrated by preferred, specific embodiments to enable persons skilled in the art to easily understand the other advantages and effects of the present disclosure by referring to the disclosure contained therein.

Referring to <FIG>, a surgical item managing system for a smart operating room and a surgical item managing method for the smart operating room are provided in an embodiment of the present disclosure. <FIG> is a schematic view of a patient on an operating table, a surgical item managing system for a smart operating room, and a surgical item according to an embodiment of the present disclosure. <FIG> is a schematic view of the surgical item and flexible RFID tags according to an embodiment of the present disclosure. <FIG> is a schematic view of read regions of an RFID tag reader/writer according to an embodiment of the present disclosure. <FIG> is a block diagram of the surgical item managing system for a smart operating room, a blockchain network and an external computer according to an embodiment of the present disclosure. <FIG> is a flowchart of a surgical item managing method for a smart operating room according to an embodiment of the present disclosure.

As shown in <FIG>, in an embodiment of the present disclosure, a surgical item managing system <NUM> for a smart operating room manages a surgical item <NUM> is used during a surgical procedure to prevent the surgical item <NUM> from being left behind in the body of a patient <NUM> (also known as "retained surgical item (RSI)"), so as to reduce medical negligence and medical disputes, prevent reinfection, and reduce the required healthcare staff. The system <NUM> is a necessary post-operative facility for use in a smart operating room. The patient <NUM> lies on an operating table <NUM> while receiving a surgical operation. The surgical item <NUM> is, for example, a surgical instrument kit whose package comes with a positioning chip and is made of flexible, biodegradable plastic. The surgical item <NUM> includes two flexible RFID tags <NUM>, 901a, a surgical instrument <NUM> and a surgical consumable <NUM>. The surgical instrument <NUM> is, for example, a scalpel, whose handle is made of biodegradable plastic. The surgical consumable <NUM> is, for example, a gauze, which is made of biodegradable plastic. However, the numbers of the surgical instrument <NUM> and surgical consumable <NUM> are not limited thereto but are subject to changes, for example, are changed to at least one. Furthermore, the surgical instrument <NUM> may also be scissors, clamp, retractor, artery forceps, or suturing instrument. Likewise, the surgical consumable <NUM> may also be fabric, surgical sponge, cotton pad or the like.

In an embodiment of the present disclosure, the two flexible RFID tags <NUM>, 901a are sensing chips disposed on the surgical instrument <NUM> and surgical consumable <NUM>, respectively. By radio frequency identification, the two flexible RFID tags <NUM>, 901a carry information about the surgical instrument <NUM> and surgical consumable <NUM>, such as the type, manufacturing date, and transportation process/date of the surgical instrument <NUM> and surgical consumable <NUM>. The information is entered into the flexible RFID tags <NUM>, 901a with an external computer <NUM>. However, the information is not limited thereto but is subject to changes as needed. Furthermore, the number of the flexible RFID tags is not limited thereto but is subject to changes as needed, for example, is changed to at least one, so as to correspond in quantity to the surgical instrument and surgical consumable. The operating radio frequency of the flexible RFID tags <NUM>, 901a falls within a high frequency range of <NUM>~<NUM>. As revealed by experimental data, radio frequency which falls within a high frequency range penetrates the human body effectively without affecting the human body. In an embodiment, the operating radio frequency of the flexible RFID tags <NUM>, 901a is <NUM>, as required by ISM (Industrial Scientific Medical), at a read distance of around <NUM>. The number of the flexible RFID tags <NUM>, 901a is not limited to two but is subject to changes as needed, for example, is changed to at least one, so as to correspond in quantity to the surgical instrument <NUM> and surgical consumable <NUM>. The external computer <NUM> is, for example, a host computer in a surgical central control room. The external computer <NUM> is connected to an external blockchain network, such that a surgical procedure is thoroughly recorded, and the record is not to be tampered with, so as to achieve decentralization and protect the rights and interests of surgeons and patients.

The surgical item managing system <NUM> for a smart operating room includes a scanner <NUM>, a warning module <NUM>, a network module <NUM>, a blockchain tracking module <NUM>, a processing module <NUM>, a memory <NUM> and a video recording module <NUM>. As shown in <FIG> and <FIG>, in an embodiment of the present disclosure, the scanner <NUM> is a scanning platform equipped with a built-in RFID tag reader/writer, lies <NUM>-<NUM> above the operating table <NUM>, and faces the operating table <NUM> to scan the flexible RFID tags <NUM>, 901a and receive return signals from the flexible RFID tags <NUM>, 901a. After that, the return signals are transmitted to the processing module <NUM>, such that the positions of the flexible RFID tags <NUM>, 901a can be computed subsequently. The scanner <NUM> has a plurality of read regions <NUM>. Each read region <NUM> has positioning coordinates (X, Y), where X is A to H corresponding to the read regions from bottom to top, and Y is <NUM> to <NUM> corresponding to the read regions from left to right. After the scanner <NUM> has scanned the flexible RFID tags <NUM>, 901a, the scanned flexible RFID tags <NUM>, 901a transmit the return signals to the read regions <NUM> of the scanner <NUM>. Owing to unequal distances between the flexible RFID tags <NUM>, 901a, the level of signal strength of the received return signals varies from read region <NUM> to read region <NUM>. For example, the read region <NUM> with positioning coordinates (E, <NUM>) is nearest to the flexible RFID tag <NUM>, and thus the level of signal strength of the received return signals from the flexible RFID tag <NUM> is the highest. For example, the read regions <NUM> with positioning coordinates (E, <NUM>), (E, <NUM>), (D, <NUM>), (F, <NUM>), which lie in the vicinity of the read region <NUM> with positioning coordinates (E, <NUM>), are far from the flexible RFID tag <NUM>, and thus the level of signal strength of the received return signals is low. Data about the levels of signal strength of the return signals received by the read regions <NUM> is sent to the processing module <NUM>, such that the processing module <NUM> computes the position of the flexible RFID tag <NUM> according to different levels of signal strength. If none of the flexible RFID tags <NUM>, 901a lies on the operating table <NUM>, the flexible RFID tags will be scanned by the read regions <NUM> but with an overly low level of signal strength; alternatively, the flexible RFID tags may not even be scanned, and it can be determined that none of the flexible RFID tags lies on the operating table <NUM> and inside the body of the patient <NUM> either.

In an embodiment of the present disclosure, the warning module <NUM> is, for example, a warning lamp disposed at the scanner <NUM> and in signal connection with the scanner <NUM>. The warning module <NUM> gives a light warning when the scanner <NUM> determines that the position of any one of the flexible RFID tags <NUM>, 901a is in the body of the patient <NUM>. However, the warning module <NUM> may also be any other warning apparatus, for example, a player capable of generating a warning sound.

In an embodiment of the present disclosure, the network module <NUM> is a network card disposed at the scanner <NUM> and in signal connection with the scanner <NUM>. The network module <NUM> transmits data about the positions of the flexible RFID tags <NUM>, 901a to the external computer <NUM>. The external computer <NUM> connects to the network module <NUM> and controls the surgical item managing system <NUM>.

In an embodiment of the present disclosure, the blockchain tracking module <NUM> is disposed at the scanner <NUM> and in signal connection with the scanner <NUM>. The blockchain tracking module <NUM> is a computing chip in signal connection with an external blockchain network <NUM>. The blockchain tracking module <NUM> records a transportation history of the flexible RFID tags <NUM>, 901a in the external blockchain network <NUM>. The record of the transportation history of the flexible RFID tags <NUM>, 901a includes place of surgery, and the process of preserving and transporting the surgical instrument <NUM> and surgical consumable <NUM> of the surgical item <NUM>. Caretakers enter data about the transportation history of the flexible RFID tags <NUM>, 901a into the blockchain tracking module <NUM> with the external computer <NUM>. Then, the blockchain tracking module <NUM> records the transportation history in the external blockchain network <NUM>. Therefore, with a blockchain capable of tracking and its record being unlikely to be tampered with, the transportation history of the surgical instrument <NUM> and surgical consumable <NUM> of the surgical item <NUM> can be clearly recorded and managed.

In an embodiment of the present disclosure, the processing module <NUM> is, for example, a CPU (central processing unit). The processing module <NUM> is disposed at the scanner <NUM> and in signal connection with the scanner <NUM>, warning module <NUM>, network module <NUM>, blockchain tracking module <NUM>, memory <NUM> and video recording module <NUM>. The processing module <NUM> coordinates and controls the operation of the scanner <NUM>, warning module <NUM>, network module <NUM>, blockchain tracking module <NUM>, memory <NUM> and video recording module <NUM>. The processing module <NUM> computes the positions of the flexible RFID tags <NUM>, 901a according to the levels of signal strength of the return signals and determines whether the positions of the flexible RFID tags <NUM>, 901a and the position of the patient <NUM> overlap, so as to determine whether the positions of the flexible RFID tags <NUM>, 901a are in the body of the patient <NUM>.

In an embodiment of the present disclosure, the memory <NUM> is in signal connection with the processing module <NUM>. The memory <NUM> stores data and software required to perform the surgical item managing method for a smart operating room. The video recording module <NUM> is a photographic lens disposed at the scanner <NUM> and adapted to take images of the patient <NUM>, so as to obtain a position of the patient <NUM>.

As shown in <FIG>, in an embodiment of the present disclosure, the surgical item managing method for a smart operating room is programmed to become a computer program software stored in the memory <NUM>. When a surgeon has carried out an operation to the patient <NUM> on the operating table <NUM> to such an extent that a suturing process is going to be performed, a nurse connects the external computer <NUM> to the surgical item managing system <NUM>, such that the surgical item managing system <NUM> executes the software of the surgical item managing method, so as to prevent the surgical item <NUM> from being left behind in the body of the patient <NUM>. After that, the surgical item managing system <NUM> performs step <NUM>: scanning flexible RFID tags and receiving a plurality of return signals.

In an embodiment of the present disclosure, the read regions <NUM> of the scanner <NUM> above the operating table <NUM> face the operating table <NUM> so as to scan the flexible RFID tags <NUM>, 901a. The flexible RFID tags <NUM>, 901a thus scanned transmit return signals to the read regions <NUM> of the scanner <NUM>. With the flexible RFID tags <NUM>, 901a being different in position, the read regions <NUM> obtain different levels of signal strength.

Then, the surgical item managing system <NUM> performs step <NUM>: computing positions of the flexible RFID tags according to levels of signal strength of return signals.

The data about levels of signal strength of the return signals received by the read regions <NUM> is transmitted to the processing module <NUM>, such that the processing module <NUM> computes the position of the flexible RFID tag <NUM> according to different levels of signal strength. In this embodiment, the level of signal strength of the return signals received by read region <NUM> with positioning coordinates (E, <NUM>) from the flexible RFID tag <NUM> is the highest, whereas the levels of signal strength of the return signals received by read regions <NUM> with positioning coordinates (E, <NUM>), (E, <NUM>), (D, <NUM>), (F, <NUM>), which lie in the vicinity of read region <NUM> with positioning coordinates (E, <NUM>), are low. Thus, data about different levels of signal strength of the return signals received by the read regions <NUM> is transmitted to the processing module <NUM>, such that the processing module <NUM> determines that read region <NUM> with positioning coordinates (E, <NUM>) is nearest to the flexible RFID tag <NUM> according to different levels of signal strength, so as to compute and confirm that the position of the flexible RFID tag <NUM> lies below read region <NUM> with positioning coordinates (E, <NUM>).

Then, the surgical item managing system <NUM> performs step <NUM>: taking images of a patient, so as to obtain a position of the patient.

The video recording module <NUM> takes images of the patient <NUM> on the operating table <NUM>, so as to obtain an image of a position of the patient <NUM>. The image taken of the position of the patient <NUM> by the video recording module <NUM> is transmitted to the processing module <NUM>. The video recording module <NUM> shoots a video of the entire surgical procedure and takes pictures thereof at important points in time during the surgical procedure and uploads the video and pictures to a blockchain network for evidential purposes.

Then, the surgical item managing system <NUM> performs step <NUM>: determining whether the positions of the flexible RFID tags and the position of the patient overlap, so as to determine whether the positions of the flexible RFID tags are in the patient's body.

The processing module <NUM> computes the position of the flexible RFID tag <NUM> according to different levels of signal strength and receives the image of the position of the patient <NUM> from the video recording module <NUM>. After that, the processing module <NUM> compares the position of the flexible RFID tag <NUM> and the image (sent from the video recording module <NUM>) of the position of the patient <NUM> to determine whether the position of the flexible RFID tag <NUM> and the position of the body of the patient <NUM> overlap. If they overlap, it will confirm that the position of the flexible RFID tag <NUM> is in the patient's body. If they do not overlap, it will confirm that the position of the flexible RFID tag <NUM> is not in the patient's body.

Upon determination that the position of the flexible RFID tag <NUM> is not in the patient's body, the surgeon performs a suturing process on the body of the patient <NUM> to finalize the surgical operation and terminate the process flow of the method. Upon determination that the position of the flexible RFID tag <NUM> is in the patient's body, the surgical item managing system <NUM> performs step <NUM>: giving a warning.

The processing module <NUM> sends the message of determining that the position of the flexible RFID tag <NUM> is in the patient's body to the warning module <NUM> to cause the warning module <NUM> to give a light warning and thus instantly warn the surgeon of the presence of the surgical instrument <NUM> with the flexible RFID tag <NUM> in the body of the patient <NUM>. Therefore, the surgeon removes the surgical instrument <NUM> with the flexible RFID tag <NUM> from the body of the patient <NUM> before performing the suturing process on the body of the patient <NUM>.

Then, the surgical item managing system <NUM> performs step <NUM>: transmitting data about the positions of the flexible RFID tags to an external computer.

After computing the position of the flexible RFID tag <NUM>, the processing module <NUM> transmits data about the position of the flexible RFID tag <NUM> to the network module <NUM>. The network module <NUM> transmits the data about the position of the flexible RFID tag <NUM> to the external computer <NUM>. Then, the position of the flexible RFID tag <NUM> is recorded in the external computer <NUM> to serve as surgical reference data.

Finally, the surgical item managing system <NUM> performs step <NUM>: recording transportation history in a blockchain network.

The nurse operates the external computer <NUM>, such that the external computer <NUM> enters the transportation history of the flexible RFID tags <NUM>, 901a into the blockchain tracking module <NUM>. Then, the blockchain tracking module <NUM> records the transportation history of the flexible RFID tags <NUM>, 901a in the external blockchain network <NUM>. With a blockchain being capable of tracking item transportation history, a process of preservation and transportation and the place of surgery corresponding to the surgical instrument <NUM> and surgical consumable <NUM> of the surgical item <NUM> are recorded in the external blockchain network <NUM>. Consequently, with a blockchain capable of tracking and its record being unlikely to be tampered with, the transportation history of the surgical instrument <NUM> and surgical consumable <NUM> of the surgical item <NUM> can be clearly recorded and managed.

Claim 1:
A surgical item managing method for a smart operating room, for use by a surgical item managing system (<NUM>) for the smart operating room to manage a surgical item (<NUM>) used during a surgical procedure, the surgical item (<NUM>) comprising a flexible RFID tag (<NUM>, 901a), wherein the surgical item managing system (<NUM>) for the smart operating room further comprises a scanner (<NUM>), the scanner (<NUM>) comprises a plurality of read regions (<NUM>), and each region (<NUM>) of the plurality of read regions (<NUM>) has positioning coordinates (X, Y),
wherein the surgical item managing method comprises the steps of:
scanning the flexible RFID tag (<NUM>. 901a) with the scanner (<NUM>) and receiving a plurality of return signals from the flexible RFID tag (<NUM>. 901a) by the plurality of read regions (<NUM>), computing a tag position of the flexible RFID tag (<NUM>. 901a) according to different levels of signal strength of the return signals received by the read regions (<NUM>) between the flexible RFID tag (<NUM>. 901a) and the read regions (<NUM>), to obtain the tag position of the flexible RFID tag (<NUM>, 901a);
taking an image of a patient (<NUM>), so as to obtain an image position of the patient (<NUM>);
determining whether a position of the flexible RFID tag (<NUM>, 901a) and the image position of the patient (<NUM>) overlap, so as to determine whether the surgical item (<NUM>) corresponding to the flexible RFID tag (<NUM>, 901a) is in a body of the patient (<NUM>); and
giving a warning if the surgical item (<NUM>) is in the body of the patient (<NUM>).