WO2023048413A1 - Apparatus for reading data matrix code marked on implantable medical device - Google Patents

Apparatus for reading data matrix code marked on implantable medical device Download PDF

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Publication number
WO2023048413A1
WO2023048413A1 PCT/KR2022/012770 KR2022012770W WO2023048413A1 WO 2023048413 A1 WO2023048413 A1 WO 2023048413A1 KR 2022012770 W KR2022012770 W KR 2022012770W WO 2023048413 A1 WO2023048413 A1 WO 2023048413A1
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WIPO (PCT)
Prior art keywords
medical device
code
marked
implantable medical
unit
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PCT/KR2022/012770
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French (fr)
Korean (ko)
Inventor
김민수
허성규
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주식회사 휴벡셀
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Publication of WO2023048413A1 publication Critical patent/WO2023048413A1/en

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K7/00—Methods or arrangements for sensing record carriers, e.g. for reading patterns
    • G06K7/10—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices

Definitions

  • the present invention relates to a datametric code reading device marked on a medical device, and more particularly, to a device capable of reading a 2D datametric code marked on an implantable medical device.
  • the medical device industry Compared to other industries, the medical device industry has a relatively short product cycle, a small-lot production system of various types, an aging population and increased interest in health worldwide, expansion of well-being culture, and new medical technology through the 4th industrial revolution.
  • the medical device industry is showing a trend of steady growth due to the development of new countries and the economic improvement of emerging countries.
  • the medical device standard code system is a system for accurately identifying medical devices, and requires strict recording, management, and storage of data related to the production attributes of medical device products.
  • sterilized implantable medical device products such as implantable medical devices and orthopedic surgical devices have the characteristics of being used in an emergency, so the size of the product must be selected according to the patient, and products of various sizes must be prepared in advance for this purpose. . Also, products that have been opened for selection will be returned.
  • a technical problem to be solved by the present invention is to provide a device capable of reading a 2D data metric code marked on a small implantable medical device.
  • a datametrics code reading device marked on an implantable medical device recognizes a datametrics code marked on a mounting portion holding the medical device and a medical device of the mounting portion, and a unique identification code corresponding to the datametrics code. It includes an operation part displaying the data set of , and a fixing part fixing the operation part and the holding part.
  • the mounting part is fastened to the pillar member of the fixing part and the height is adjusted up and down so that the distance from the operating part is adjusted, and the table is fastened to the side of the control table and guides the jig for holding the medical device to be seated.
  • the table is fixed or folded to the side of the control table according to the operation of the lever, packed with sterile vinyl, and a groove leading to the direction of the jig is formed in the center.
  • the table is rotated within a certain angular range to at least one of right side, left side, and both sides based on the front, and a directional shape for inducing the direction of the jig is displayed on the top.
  • the operation unit is located on the lower part of the body toward the mounting unit and an optical camera that recognizes the data metric code marked on the medical device, and a first sensor and a second sensor located on both sides of the body and detecting the user's motion in a non-contact manner.
  • a display unit for displaying image information of the optical camera and program information to be processed, processing the image information of the optical camera and detection signals of the first sensor and the second sensor, and controlling the display unit to display the image information and program information. includes a control unit.
  • the operation unit emits light for recognizing the data metric code and removing an external light source, an LED light for radiating light, a guide laser for outputting a beam for guiding a medical device to be accurately positioned, and an external device for connecting to an external device. It includes a connection port and a communication module connected to the service server and an external terminal through a network.
  • the controller controls the optical camera to recognize the datametric code of the medical device, and controls the display unit to display a data set of a unique identification code corresponding to the datametric code.
  • control unit receives a detection signal from at least one of the first sensor and the second sensor, and approves or cancels the detection signal through input image information and processed program information according to the detection signal.
  • the fixing part includes a support plate, a pillar member formed in a vertical direction on the support plate and fixing the operation part and the mounting part, and a plurality of wheels installed on the lower part of the support plate to move or fix
  • the pillar member includes a network and A passage for connecting a power cable to the operating unit is formed inside and an external device connection port is formed at the bottom.
  • a 2D data metric code marked on a small implantable medical device can be read.
  • safety information and distribution information of the medical device can be managed by reading the 2D data matrix code marked on the small implantable medical device, and the medical device implanted in the patient can be easily tracked.
  • FIG. 1 is a perspective view of a datametrics code reading device marked on an implantable medical device according to an embodiment.
  • FIG. 2 is a perspective view of the operating unit shown in Figure 1;
  • FIG. 3 is a perspective view of the holder shown in FIG. 1 according to the first embodiment.
  • FIG. 4 is a perspective view of the mounting portion shown in FIG. 1 according to the second embodiment.
  • FIG. 5 is a perspective view of a fixing unit shown in FIG. 1;
  • FIG. 6 is a block diagram of a datametrics code reading device marked on an implantable medical device according to an embodiment.
  • FIG. 7 shows a system for recognizing and processing information about a direct display product of an implantable medical device.
  • FIG. 1 is a perspective view of a datametrics code reading device marked on an implantable medical device according to an embodiment.
  • Figure 2 is a perspective view of the operating unit shown in Figure 1;
  • FIG. 3 is a perspective view of the holder shown in FIG. 1 according to the first embodiment.
  • 4 is a perspective view of the mounting portion shown in FIG. 1 according to the second embodiment.
  • 5 is a perspective view of a fixing unit shown in FIG. 1;
  • the datametric code reading device 400 marked on the implantable medical device recognizes the 2D DataMetrix code, which is a unique identification code of the medical device product, and supports the operation of the unique identifier of the medical device.
  • the data metric code marked on the medical device may be completed by a process of the unique identification code marking system of the medical device.
  • the datametrics code reading device 400 marked on the implantable medical device includes a holding part 420, an operating part 410, and a fixing part 430.
  • the mounting unit 420 mounts the implantable medical device 300 through the jig 310.
  • the mounting part 420 is fastened to the pillar member 434 of the fixing part 430 and is on the side of the control table 422 and the control table 422 whose height is adjusted up and down so that the distance from the operating part 410 is adjusted. It includes a table 424 that guides the jig 310, which is fastened and holds the medical device, to be seated.
  • the table 424 is fixed to the side of the control table 422 or folded according to the manipulation of the lever 426 . And, the table 424 is packed by sterile vinyl. This sterilized vinyl is packed on the table 424 to prevent contamination by user's contact.
  • a groove for inducing the direction of the jig 310 may be formed in the center of the upper part of the table.
  • the jig 310 may be formed in a circular shape, but is not limited thereto.
  • the jig 310 may be formed in a directional shape, for example, a trapezoidal shape.
  • the holder 420 provides a foldable table 424 and a sterilization jig 310 to recognize the 2D datametrics code directly marked on the subminiature implantable medical device 300 that is difficult to visually check.
  • the mounting unit 420 includes a height control bar 422 to adjust the distance between the table 424 and the optical camera 414 of the operation unit 410 for optimal recognition conditions of the optical camera 414. .
  • the table 424 of the mounting unit 420 may have a groove formed or a symbol displayed to support the direction of the guide laser 513 and the jig 310 so that the sterilization jig 310 can be seated thereon.
  • the sterilization jig 310 is configured together with a set of supplied medical devices so that sterilization can proceed together when sterilizing a product.
  • the table 424 may be primarily packed with sterilized vinyl in order to prevent infection by user contact.
  • the foldable table 424 may be folded, and the data metric code marked on the medical device may be recognized through the guide laser 513 and the display unit 412 .
  • the mounting unit 420 may include a rotary table 426 .
  • the rotary table 426 can solve the problem of infection due to user's contact and increase in lighting and product size when the distance between the camera and the table is increased.
  • the rotary table 426 may be rotated when recognizing a medical device other than a miniature medical device.
  • the rotary table 426 may be rotated in a range of 45 to 90 degrees to the right from the front.
  • the rotary table 426 may be rotated in a range of 45 to 90 degrees to the left from the front.
  • the rotary table 426 may rotate in a range of -90 to 90 degrees on both sides based on the front side.
  • a shape having the direction of the jig may be displayed on the rotary table 426 .
  • a trapezoidal shape may be displayed.
  • a directional shape, symbol, or guide letter may be displayed. It recognizes the matrix code and displays the data set of the unique identification code corresponding to the data matrix code.
  • the operation part 410 is located on the lower part of the body facing the holding part 420 and an optical camera 414 for recognizing the data metric code marked on the medical device 300, located on both sides of the body and providing non-contact motion of the user. It includes a first sensor 416 and a second sensor 418 that sense, and a display unit 412 that displays image information of the optical camera 414 and program information to be processed.
  • the operating unit 410 processes the image information of the optical camera 414 and the detection signals of the first sensor 16 and the second sensor 18 and controls the display unit 412 to display the image information and program information. It includes a control unit 511 to.
  • the operation unit 410 includes an LED light 419 that irradiates light for datametric code recognition and removal of an external light source, a guide laser 513 that outputs and guides a beam so that the medical device can be accurately positioned, and an external device and It includes an external device input/output port 514 for connection, and a communication module 515 connected to the service server 200 or an external terminal through a network.
  • the operation unit 410 recognizes the data matrix code of the medical device through an optical camera, and displays a data set of a unique identification code corresponding to the data matrix code through the display unit 412 .
  • the operating unit 410 detects the user's motion from at least one of the first sensor 416 and the second sensor 418, and approves or cancels it through image information input and program information to be processed according to the user's motion. .
  • the fixing part 430 includes a support plate 432 and a pillar member 434 and a plurality of wheels 436 .
  • the support plate 432 may be formed in a plate shape, and the pillar member 434 may be formed in a vertical direction on one surface of the support plate 432 .
  • the actuating part 410 and the holding part 420 may be fastened to the pillar member 434 .
  • a plurality of wheels are installed below the support plate 432 to move or fix the support plate.
  • a passage for connecting network and power cables to the operation unit 410 may be formed inside the pillar member 434, and an external device connection port may be formed in the lower cable connection base 438.
  • FIG. 6 is a block diagram of a datametrics code reading device marked on an implantable medical device according to an embodiment.
  • the main hardware of the operating unit 410 includes a control device 511, a display unit 412, an optical camera 414, an LED light 419, a first sensor 416 and a second sensor 418. ), a guide laser 513, a communication module 515, an external device input/output port 514, and a DC power supply unit 512.
  • the DC power supply 512 may supply power for operating the device to each component, and the optical camera 414 may be used as an image input device for recognizing an identification code marked on a product.
  • the first sensor 416 and the second sensor 418 may be configured symmetrically and may be used as a non-contact input device that detects a user's motion and approves or cancels an input image information value.
  • the display unit 412 may display the current input image of the camera and program information being processed.
  • it may be configured as an OLED or LCD display device.
  • the LED light 419 is a device that outputs light for recognizing a code marked on a medical device and removing an external light source, and may be located at the lower part of the body and radiate light toward the holder 420 .
  • the guide laser 513 may irradiate and guide a beam so that the user can accurately position the medical device on the table 424 of the holder 420 .
  • the external device input/output port 514 is connected to a USB type external device to input and output signals to and from the external device.
  • the communication module 515 may include a LAN network port, and may input and output data by being connected to a cloud and an external PC through a network.
  • the entire table 424 may be packed using sterilized vinyl in order to prevent contamination due to device contact.
  • the reading device 400 uses a previously sterilized jig 310 to guide the table 424 marked with directions to the jig 310 so that the optical camera 414 can recognize it with the help of the guide laser 513. can be settled.
  • the reading device 400 compares the 2D datametric code input from the optical camera 414 with the service server 200 or previously input and stored code information, and displays the information on the display unit 412 .
  • the registered and stored data may include patient information in addition to the UDI information of the medical device, and the information displayed on the display unit 412 may display only the UDI information of the medical device.
  • the reading device 400 may ask the user whether to register/cancel with respect to the read code and select registration or cancellation through the first sensors 416 and the second sensors 418 provided on the left and right sides.
  • the reading device 400 stores approved data in the service server 200 through a network, and prints out data including previously registered medical device UDI information and patient information.
  • the reading device 400 may convert the data of the UDI code from 2D code to 1D bar code (BAR Code) to convert it into information that can be recognized by a general scanner.
  • the outputted 1D bar code and patient information can be attached to user (hospital) history storage records.
  • the datametrics code reading device 400 marked on the implantable medical device includes functions for a sterile and non-contact environment, which is a hospital/clinic surgical environment, and supports image data acquisition and operating conditions. monitor support.
  • the reading device 400 supports a network for accessing a user PC and a cloud server, and provides a sterilization jig and table for recognizing a code of a miniature medical device.
  • a directional sterilization jig considering user convenience of the reading device 400 is provided, a folding table function is provided for large medical device code recognition, and sterilization vinyl for table packing is provided to prevent contact infection such as user contact.
  • the medical device UDI code is an automatic identification code displayed on medical devices by manufacturers and importers of medical devices.
  • the UDI code consists of a code for identifying the medical device itself (Device Identifier, DI) and a code for identifying information related to the production of the medical device (Production Identifier, PI).
  • the UDI code includes internationally used numbers and English codes and information recognition technology to solve the problem of identification, which is the basis of safety management such as side effect reporting, recall, and tracking management of medical devices through product-specific codes.
  • the unique identification code marking system generates a UDI code based on the international standard code issuance system, converts it into a marking (Direct Product Marking, DPM) code that can be directly marked on an implantable medical device, and can be marked on the product. .
  • DPM Direct Product Marking
  • the unique identification code marking system recognizes the DPM code marked on the medical device, converts the collected information into data, and reports supply details to the service server 200.
  • the medical device unique identifier information and production identifier information may be generated to meet the standards of the international standard code issuance system and may be stored as a UDI data set including basic information such as raw materials of the product.
  • Medical device unique identifier information may include country of manufacture, manufacturer or importer, item name, etc.
  • the production identifier information of the medical device may include a manufacturing number, an expiration date, a manufacturing date, a serial number, and the like.
  • the service server 200 may be configured as a cloud server, and may be connected to a device 400 that reads a data metric code marked on an implantable medical device through a network to receive medical device-related information, and It is possible to store and manage information about a patient to whom the type medical device 300 has been implanted and information related to the medical device.
  • a client for accessing the service server 200 and an application program for converting datametric codes into UDI codes or ID bar codes may be installed in the reading device 400 .
  • FIG. 7 shows a system for recognizing and processing information about a direct display product of an implantable medical device.
  • It shows information recognition processing in general distribution where the packaging state is maintained when shipped from the manufacturer, product registration for set composition in hospitals and clinics, and methods for recognizing and processing information before use to patients.
  • Distributors can recognize UDI barcode labels printed on packaging.
  • supplier information can be input and selected, and the product can be distributed after scanning the UDI level.
  • a supply details report detail DB can be included and the supply detail DB can be uploaded.
  • the reading device may store usage history data and may encrypt it.
  • the reading device can convert a 2D code into a 1D code with a product usage history support service.
  • the marked 2D code is an edited (converted) code and contains only a part of UDI information.
  • the reading device can display and output all information of the UDI.
  • the reading device can encrypt the UDI code and the data set on the product usage history with a private blockchain.
  • the 1D bar code printer electrically connected to the reading device may output patient Electronic Medical Record (EMR) information and output a product 1D UDI code.
  • EMR Electronic Medical Record
  • a 2D data metric code marked on a small implantable medical device can be read.
  • safety information and distribution information of the medical device can be managed by reading the 2D data matrix code marked on the small implantable medical device, and the medical device implanted in the patient can be easily tracked.
  • the 2D datametric code may be marked on a small implantable medical device through a marking system connected to the service server 200 through a network.
  • the marking system can assign a GTIN to the medical device to be marked, select information by model name and product name, and select information by packaging unit.
  • the marking system can utilize the international standard code issuing service by subscribing to an international standard code issuing institution, and can download the GTIN DB from the issuing institution.
  • the marking system may assign a unique identifier to a target medical device using GTIN DB.
  • the marking system may assign unique identifiers to each model, product, and packaging unit.
  • the marking system may receive production information including manufacturing date, expiration date, lot number, etc., may select an application identifier, and may assign a production identifier corresponding to the production information using the GTIN DB.
  • the marking system may generate a UDI code using a unique medical device identifier and a production identifier, and may store a UDI data set including medical device information and production information linked to the UDI code.

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Abstract

Disclosed is a device capable of reading a 2D data matrix code corresponding to a unique device identifier (UDI) code and marked on a small implantable medical device. The reading device comprises: a mounting unit for mounting a medical device; an operation unit which recognizes a data matrix code marked on the medical device of the mounting unit and displays a data set of a UDI code corresponding to the data matrix code; and a fixing unit for fixing the operation unit and the mounting unit.

Description

체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치Datametrics code reading device marked on implantable medical devices
본 발명은 의료기기에 마킹된 데이터메트릭스 코드 판독 장치에 관한 것으로, 더 상세하게는 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독할 수 있는 장치에 관한 것이다.The present invention relates to a datametric code reading device marked on a medical device, and more particularly, to a device capable of reading a 2D datametric code marked on an implantable medical device.
의료기기 산업은 타 산업군에 비해 비교적 제품의 순환주기가 짧고, 다품종 소량 생산 체계를 가지며, 전 세계적으로 인구의 고령화 및 건강에 대한 관심 증가, 웰빙 문화의 확대, 4차 산업혁명을 통한 신 의료기술의 발전, 신흥 국가들의 경제적 향상 등의 이유로 의료기기 산업은 꾸준히 성장하고 있는 추세를 보이고 있다.Compared to other industries, the medical device industry has a relatively short product cycle, a small-lot production system of various types, an aging population and increased interest in health worldwide, expansion of well-being culture, and new medical technology through the 4th industrial revolution. The medical device industry is showing a trend of steady growth due to the development of new countries and the economic improvement of emerging countries.
또한 인구의 고령화라는 수요 측면과 기술의 발전이라는 공급 측면의 요인들에 힘입어 대부분의 OECD 회원국에서 보건의료산업이 국가경제에서 차지하는 비중이 증가하고 있다.In addition, the share of the health care industry in national economies is increasing in most OECD member countries, driven by demand-side factors such as population aging and supply-side factors such as technological advances.
한편, 의료기기 표준코드 제도는 의료기기를 정확하게 식별하기 위한 체계로서, 의료기기 제품의 생산 속성과 연계된 데이터를 엄격하게 기록, 관리, 저장하도록 요구하고 있다.On the other hand, the medical device standard code system is a system for accurately identifying medical devices, and requires strict recording, management, and storage of data related to the production attributes of medical device products.
그런데, 체내이식 형 의료기기 및 정형외과 수술기기와 같은 멸균 이식용 의료기기 제품은 응급으로 사용되는 특성이 있어 환자에 따라 제품의 사이즈를 선택해야 하고 그를 위해 다양한 사이즈의 제품이 사전에 준비되어야 한다. 또한 선택을 위해 개봉된 제품은 반납하게 된다. However, sterilized implantable medical device products such as implantable medical devices and orthopedic surgical devices have the characteristics of being used in an emergency, so the size of the product must be selected according to the patient, and products of various sizes must be prepared in advance for this purpose. . Also, products that have been opened for selection will be returned.
그리고, 멸균 포장되어 납품된 제품을 개봉된 제품은 재 멸균하여 바코드를 새로 부착하고 공급내역을 보고해야 하는 상황이 반복되어 공급 기업의 부담이 가중될 수밖에 없다.In addition, the sterilized packaged product and the opened product are re-sterilized, a new barcode is attached, and the supply details are reported repeatedly, which inevitably increases the burden on the supplier.
이러한 문제를 해결하기 위해 공급 기업은 환자 상황에 맞게 다양한 제품 사이즈 및 수술을 위한 기구를 포함하여 세트를 구성하고 환자에게 사용하기 전 멸균을 통해서 감염에 대한 문제를 해결하고자 하였다. 그러나, 소형의 체내이식 형 의료기기의 경우 세트 구성을 위해 개봉 시 추적을 위한 식별이 어려워 적용 예외로 진행되어 왔다.In order to solve this problem, the supplying company tried to solve the problem of infection by constructing a set including various product sizes and surgical instruments to suit the patient's situation and sterilizing it before using it on the patient. However, in the case of small-sized implantable medical devices, it has been difficult to identify for tracking when opening to configure a set, so they have been exceptions to application.
따라서, 소형의 체내이식 형 의료기기에 고유식별코드를 마킹할 수 있는 기술과 소형의 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드를 판독할 수 있는 기술이 요구되고 있다.Therefore, there is a demand for a technology capable of marking a unique identification code on a small implantable medical device and a technology capable of reading a data metric code marked on a small implantable medical device.
본 발명이 해결하고자 하는 기술적 과제는, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독할 수 있는 장치를 제공하는데 있다.A technical problem to be solved by the present invention is to provide a device capable of reading a 2D data metric code marked on a small implantable medical device.
또한, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독하여 의료기기의 안전정보 및 유통정보를 관리할 수 있고 환자에게 이식된 의료기기를 용이하게 추적할 수 있는 장치를 제공하는데 있다.In addition, to provide a device that can manage the safety information and distribution information of the medical device by reading the 2D data matrix code marked on the small implantable medical device and can easily track the medical device implanted in the patient. .
본 발명의 목적들은 이상에서 언급한 목적으로 제한되지 않으며, 언급되지 않은 본 발명의 다른 목적 및 장점들은 하기의 설명에 의해서 이해될 수 있고, 본 발명의 실시예에 의해 보다 분명하게 이해될 것이다. 또한, 본 발명의 목적 및 장점들은 특허 청구 범위에 나타낸 수단 및 그 조합에 의해 실현될 수 있음을 쉽게 알 수 있을 것이다.The objects of the present invention are not limited to the above-mentioned objects, and other objects and advantages of the present invention not mentioned above can be understood by the following description and will be more clearly understood by the examples of the present invention. It will also be readily apparent that the objects and advantages of the present invention may be realized by means of the instrumentalities and combinations indicated in the claims.
일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치는, 의료기기를 거치하는 거치부, 거치부의 의료기기에 마킹된 데이터메트릭스 코드를 인식하고 데이터메트릭스 코드에 대응되는 고유식별코드의 데이터 세트를 표시하는 작동부, 및 작동부와 거치부를 고정하는 고정부를 포함한다.A datametrics code reading device marked on an implantable medical device according to an embodiment recognizes a datametrics code marked on a mounting portion holding the medical device and a medical device of the mounting portion, and a unique identification code corresponding to the datametrics code. It includes an operation part displaying the data set of , and a fixing part fixing the operation part and the holding part.
실시예에서, 거치부는 고정부의 기둥 부재에 체결되고 작동부와의 거리가 조절되도록 상하로 높이가 조절되는 조절대, 및 조절대의 측부에 체결되고 의료기기를 거치하는 지그가 안착되도록 유도하는 테이블을 포함한다.In the embodiment, the mounting part is fastened to the pillar member of the fixing part and the height is adjusted up and down so that the distance from the operating part is adjusted, and the table is fastened to the side of the control table and guides the jig for holding the medical device to be seated. includes
실시예에서, 테이블은 레버의 조작에 따라 조절대의 측부에 고정되거나 폴딩되고, 멸균 비닐에 의해 패킹되며, 지그의 방향성을 유도하는 홈이 중앙에 형성된다In the embodiment, the table is fixed or folded to the side of the control table according to the operation of the lever, packed with sterile vinyl, and a groove leading to the direction of the jig is formed in the center.
실시예에서, 테이블은 정면을 기준으로 우측, 좌측, 양측 중 적어도 하나로 일정 각도 범위 내에서 회전되고, 지그의 방향성을 유도하는 방향성 모양이 상부에 표시된다.In the embodiment, the table is rotated within a certain angular range to at least one of right side, left side, and both sides based on the front, and a directional shape for inducing the direction of the jig is displayed on the top.
실시예에서, 작동부는 몸체의 하부에 거치부를 향하도록 위치하고 의료기기에 마킹된 데이터메트릭스 코드를 인식하는 광학 카메라, 몸체의 양측부에 위치하고 사용자의 모션을 비접촉으로 감지하는 제1 센서 및 제2 센서, 광학 카메라의 영상 정보와 처리되는 프로그램 정보를 표시하는 표시부를 포함하고, 광학 카메라의 영상 정보와 제1 센서 및 제2 센서의 감지 신호를 처리하고 영상 정보와 프로그램 정보를 표시하도록 표시부를 제어하는 제어부를 포함한다.In the embodiment, the operation unit is located on the lower part of the body toward the mounting unit and an optical camera that recognizes the data metric code marked on the medical device, and a first sensor and a second sensor located on both sides of the body and detecting the user's motion in a non-contact manner. , including a display unit for displaying image information of the optical camera and program information to be processed, processing the image information of the optical camera and detection signals of the first sensor and the second sensor, and controlling the display unit to display the image information and program information. includes a control unit.
실시예에서, 작동부는 데이터메트릭스 코드의 인식 및 외부 광원 제거를 위하여 광을 조사하는 엘이디 조명, 의료기기를 정확히 위치할 수 있도록 가이드하기 위한 빔을 출력하는 가이드 레이저, 외부기기와 연결하기 위한 외부기기 연결포트, 및 네트워크를 통하여 서비스 서버와 외부 단말기와 연결되는 통신 모듈을 포함한다.In the embodiment, the operation unit emits light for recognizing the data metric code and removing an external light source, an LED light for radiating light, a guide laser for outputting a beam for guiding a medical device to be accurately positioned, and an external device for connecting to an external device. It includes a connection port and a communication module connected to the service server and an external terminal through a network.
실시예에서, 제어부는 의료기기의 데이터메트릭스 코드를 인식하도록 광학 카메라를 제어하고, 데이터메트릭스 코드에 대응되는 고유식별코드의 데이터 세트를 표시하도록 표시부를 제어한다.In an embodiment, the controller controls the optical camera to recognize the datametric code of the medical device, and controls the display unit to display a data set of a unique identification code corresponding to the datametric code.
실시예에서, 제어부는 상기 제1 센서와 상기 제2 센서 중 적어도 하나로부터 감지 신호를 수신하고 감지 신호에 따라 입력된 영상 정보 및 처리되는 프로그램 정보를 통해서 승인 또는 취소시킨다. In an embodiment, the control unit receives a detection signal from at least one of the first sensor and the second sensor, and approves or cancels the detection signal through input image information and processed program information according to the detection signal.
실시예에서, 고정부는 지지판과, 지지판에서 수직 방향으로 형성되며 작동부와 거치부를 고정하는 기둥 부재, 및 지지판의 하부에 설치되어 이동시키거나 고정하는 다수의 바퀴를 포함하고, 기둥 부재는 네트워크 및 전원 케이블을 작동부에 연결시키기 위한 통로가 내부에 형성되고 외부기기 연결 포트가 하부에 형성된다.In the embodiment, the fixing part includes a support plate, a pillar member formed in a vertical direction on the support plate and fixing the operation part and the mounting part, and a plurality of wheels installed on the lower part of the support plate to move or fix, and the pillar member includes a network and A passage for connecting a power cable to the operating unit is formed inside and an external device connection port is formed at the bottom.
실시예에 따르면, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독할 수 있다.According to the embodiment, a 2D data metric code marked on a small implantable medical device can be read.
또한, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독하여 의료기기의 안전정보 및 유통정보를 관리할 수 있고 환자에게 이식된 의료기기를 용이하게 추적할 수 있게 할 수 있다.In addition, safety information and distribution information of the medical device can be managed by reading the 2D data matrix code marked on the small implantable medical device, and the medical device implanted in the patient can be easily tracked.
상술한 효과와 더불어 본 발명의 구체적인 효과는 이하 발명을 실시하기 위한 구체적인 사항을 설명하면서 함께 기술한다.In addition to the effects described above, specific effects of the present invention will be described together while explaining specific details for carrying out the present invention.
도 1은 일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치의 사시도이다.1 is a perspective view of a datametrics code reading device marked on an implantable medical device according to an embodiment.
도 2는 도 1에 도시된 작동부의 사시도이다.Figure 2 is a perspective view of the operating unit shown in Figure 1;
도 3은 제1 실시예에 따른 도 1에 도시된 거치부의 사시도이다.FIG. 3 is a perspective view of the holder shown in FIG. 1 according to the first embodiment.
도 4는 제2 실시예에 따른 도 1에 도시된 거치부의 사시도이다.4 is a perspective view of the mounting portion shown in FIG. 1 according to the second embodiment.
도 5는 도 1에 도시된 고정부의 사시도이다.5 is a perspective view of a fixing unit shown in FIG. 1;
도 6는 일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치의 블록도이다.6 is a block diagram of a datametrics code reading device marked on an implantable medical device according to an embodiment.
도 7은 체내이식 형 의료기기 직접 표시 제품에 대한 정보 인식 및 처리에 대한 시스템을 나타낸다.7 shows a system for recognizing and processing information about a direct display product of an implantable medical device.
전술한 목적, 수단 및 효과는 첨부된 도면을 참조하여 상세하게 후술되며, 이에 따라 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 본 발명의 기술적 사상을 용이하게 실시할 수 있을 것이다. 본 발명을 설명함에 있어서 본 발명과 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 불필요하게 흐릴 수 있다고 판단되는 경우에는 상세한 설명을 생략한다. 이하, 첨부된 도면을 참조하여 본 발명에 따른 바람직한 실시예를 상세히 설명하기로 한다. 도면에서 동일한 참조부호는 동일 또는 유사한 구성요소를 가리키는 것으로 사용된다. The above objects, means and effects will be described in detail with reference to the accompanying drawings, and accordingly, those skilled in the art to which the present invention belongs will be able to easily implement the technical spirit of the present invention. In describing the present invention, if it is determined that the detailed description of the known technology related to the present invention may unnecessarily obscure the subject matter of the present invention, the detailed description will be omitted. Hereinafter, preferred embodiments according to the present invention will be described in detail with reference to the accompanying drawings. In the drawings, the same reference numerals are used to indicate the same or similar components.
이하에서는, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독할 수 있는 장치가 개시된다.Hereinafter, a device capable of reading a 2D data metric code marked on a small implantable medical device is disclosed.
도 1은 일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치의 사시도이다. 도 2는 도 1에 도시된 작동부의 사시도이다. 도 3은 제1 실시예에 따른 도 1에 도시된 거치부의 사시도이다. 도 4는 제2 실시예에 따른 도 1에 도시된 거치부의 사시도이다. 도 5는 도 1에 도시된 고정부의 사시도이다.1 is a perspective view of a datametrics code reading device marked on an implantable medical device according to an embodiment. Figure 2 is a perspective view of the operating unit shown in Figure 1; FIG. 3 is a perspective view of the holder shown in FIG. 1 according to the first embodiment. 4 is a perspective view of the mounting portion shown in FIG. 1 according to the second embodiment. 5 is a perspective view of a fixing unit shown in FIG. 1;
체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치(400)는 의료기기제품의 고유식별코드인 2D 데이터메트릭스(DataMetrix) 코드를 인식하고 의료기기 고유식별자 운영을 지원한다. 여기서, 의료기기에 마킹된 데이터메트릭스 코드는 의료기기의 고유식별코드 마킹 시스템에의 공정에 의해 완료될 수 있다.The datametric code reading device 400 marked on the implantable medical device recognizes the 2D DataMetrix code, which is a unique identification code of the medical device product, and supports the operation of the unique identifier of the medical device. Here, the data metric code marked on the medical device may be completed by a process of the unique identification code marking system of the medical device.
체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치(400)는 거치부(420), 작동부(410) 및 고정부(430)를 포함한다.The datametrics code reading device 400 marked on the implantable medical device includes a holding part 420, an operating part 410, and a fixing part 430.
거치부(420)는 체내이식 형 의료기기(300)를 지그(310)를 통해서 거치한다. The mounting unit 420 mounts the implantable medical device 300 through the jig 310.
거치부(420)는 고정부(430)의 기둥 부재(434)에 체결되고 작동부(410)와의 거리가 조절되도록 상하로 높이가 조절되는 조절대(422) 및 조절대(422)의 측부에 체결되고 의료기기를 거치하는 지그(310)가 안착되도록 유도하는 테이블(424)을 포함한다.The mounting part 420 is fastened to the pillar member 434 of the fixing part 430 and is on the side of the control table 422 and the control table 422 whose height is adjusted up and down so that the distance from the operating part 410 is adjusted. It includes a table 424 that guides the jig 310, which is fastened and holds the medical device, to be seated.
여기서, 테이블(424)은 레버(426)의 조작에 따라 조절대(422)의 측부에 고정되거나 폴딩된다. 그리고, 테이블(424)은 멸균 비닐에 의해 패킹된다. 이러한 멸균 비닐은 사용자의 접촉에 의한 오염을 방지하기 위하여 테이블(424)에 패킹된다. 그리고 테이블의 상부에는 지그(310)의 방향성을 유도하기 위한 홈이 중앙에 형성될 수 있다. 일례로, 지그(310)는 원형으로 형성될 수 있으나, 이에 한정되는 것은 아니다. 다른 일례로, 지그(310)는 방향성 모양 예를 들면 사다리꼴 모양으로 형성될 수 있다. Here, the table 424 is fixed to the side of the control table 422 or folded according to the manipulation of the lever 426 . And, the table 424 is packed by sterile vinyl. This sterilized vinyl is packed on the table 424 to prevent contamination by user's contact. A groove for inducing the direction of the jig 310 may be formed in the center of the upper part of the table. As an example, the jig 310 may be formed in a circular shape, but is not limited thereto. As another example, the jig 310 may be formed in a directional shape, for example, a trapezoidal shape.
거치부(420)는 육안으로 확인이 어려운 초소형 체내이식 형 의료기기(300)에 직접 마킹된 2D 데이터메트릭스 코드를 인식하기 위하여 접이식 테이블(424)과 멸균 지그(310)를 제공한다.The holder 420 provides a foldable table 424 and a sterilization jig 310 to recognize the 2D datametrics code directly marked on the subminiature implantable medical device 300 that is difficult to visually check.
그리고, 거치부(420)는 광학 카메라(414) 최적의 인식 조건을 위하여 테이블(424)과 작동부(410)의 광학 카메라(414) 간의 거리를 조절할 수 있도록 높이 조절대(422)를 포함한다.And, the mounting unit 420 includes a height control bar 422 to adjust the distance between the table 424 and the optical camera 414 of the operation unit 410 for optimal recognition conditions of the optical camera 414. .
거치부(420)의 테이블(424)은 멸균 지그(310)를 안착할 수 있도록 가이드 레이저(513)와 지그(310)의 방향성을 지원하는 홈이 형성되거나 기호가 표시될 수 있다.The table 424 of the mounting unit 420 may have a groove formed or a symbol displayed to support the direction of the guide laser 513 and the jig 310 so that the sterilization jig 310 can be seated thereon.
일례로, 멸균 지그(310)는 공급되는 의료기기 세트에 함께 구성되어 제품 멸균 시 함께 멸균이 진행될 수 있다. 그리고, 사용자의 접촉에 의한 감염을 방지하기 위하여 테이블(424)을 멸균 비닐로 1차 패킹할 수 있다. 그리고, 초소형 의료기기 이외의 의료기기 인식 시 접이식 테이블(424)을 접고, 가이드 레이저(513) 및 표시부(412)를 통하여 의료기기에 마킹된 데이터메트릭스 코드를 인식할 수 있다.For example, the sterilization jig 310 is configured together with a set of supplied medical devices so that sterilization can proceed together when sterilizing a product. In addition, the table 424 may be primarily packed with sterilized vinyl in order to prevent infection by user contact. In addition, when recognizing medical devices other than subminiature medical devices, the foldable table 424 may be folded, and the data metric code marked on the medical device may be recognized through the guide laser 513 and the display unit 412 .
한편, 도 4에 도시한 바와 같이 거치부(420)는 회전식 테이블(426)을 포함할 수 있다. 회전식 테이블(426)은 사용자의 접촉에 의한 감염 우려와 카메라와 테이블 간의 거리를 넓힐 시 조명 및 제품 크기가 커지는 단점을 해소할 수 있다.Meanwhile, as shown in FIG. 4 , the mounting unit 420 may include a rotary table 426 . The rotary table 426 can solve the problem of infection due to user's contact and increase in lighting and product size when the distance between the camera and the table is increased.
일례로, 회전식 테이블(426)은 초소형 의료기기 이외의 의료기기를 인식하는 경우 회전될 수 있다. 일례로, 회전식 테이블(426)은 정면 기준 우측으로 45 ~ 90도 범위에서 회전할 수 있다. 다른 일례로, 회전식 테이블(426)은 정면 기준 좌측으로 45 ~ 90도 범위에서 회전할 수 있다. 또 다른 일례로, 회전식 테이블(426)은 정면 기준 양측으로 -90 ~ 90도 범위에서 회전할 수 있다.For example, the rotary table 426 may be rotated when recognizing a medical device other than a miniature medical device. For example, the rotary table 426 may be rotated in a range of 45 to 90 degrees to the right from the front. As another example, the rotary table 426 may be rotated in a range of 45 to 90 degrees to the left from the front. As another example, the rotary table 426 may rotate in a range of -90 to 90 degrees on both sides based on the front side.
그리고, 회전식 테이블(426) 상에는 지그의 방향성을 갖는 모양이 표시될 수 있다. 일례로, 사다리꼴 모양이 표시될 수 있다. 물론 이에 한정되는 것은 아니다. 지그가 정확한 방향으로 회전식 테이블(426)에 안착되도록 안내하기 위하여 방향성 모양, 기호, 또는 안내 문자 등이 표시될 수 있다.작동부(410)는 거치부(420)에 거치되어 있는 의료기기의 데이터메트릭스 코드를 인식하며 데이터메트릭스 코드에 대응되는 고유식별코드의 데이터 세트를 표시한다. And, a shape having the direction of the jig may be displayed on the rotary table 426 . As an example, a trapezoidal shape may be displayed. Of course, it is not limited thereto. In order to guide the jig to be seated on the rotary table 426 in the correct direction, a directional shape, symbol, or guide letter may be displayed. It recognizes the matrix code and displays the data set of the unique identification code corresponding to the data matrix code.
작동부(410)는 몸체의 하부에 거치부(420)를 향하도록 위치하고 의료기기(300)에 마킹된 데이터메트릭스 코드를 인식하는 광학 카메라(414), 몸체의 양측부에 위치하고 사용자의 모션을 비접촉으로 감지하는 제1 센서(416) 및 제2 센서(418), 광학 카메라(414)의 영상 정보와 처리되는 프로그램 정보를 표시하는 표시부(412)를 포함한다.The operation part 410 is located on the lower part of the body facing the holding part 420 and an optical camera 414 for recognizing the data metric code marked on the medical device 300, located on both sides of the body and providing non-contact motion of the user. It includes a first sensor 416 and a second sensor 418 that sense, and a display unit 412 that displays image information of the optical camera 414 and program information to be processed.
그리고, 작동부(410)는 광학 카메라(414)의 영상 정보와 제1 센서(16) 및 제2 센서(18)의 감지 신호를 처리하고 영상 정보와 프로그램 정보를 표시하도록 표시부(412)를 제어하는 제어부(511)를 포함한다.Then, the operating unit 410 processes the image information of the optical camera 414 and the detection signals of the first sensor 16 and the second sensor 18 and controls the display unit 412 to display the image information and program information. It includes a control unit 511 to.
작동부(410)는 데이터메트릭스 코드의 인식 및 외부 광원 제거를 위하여 광을 조사하는 엘이디 조명(419), 의료기기를 정확히 위치할 수 있도록 빔을 출력하여 가이드하는 가이드 레이저(513), 외부기기와 연결하기 위한 외부기기 입출력포트(514), 및 네트워크를 통하여 서비스 서버(200) 또는 외부 단말기와 연결되는 통신 모듈(515)을 포함한다.The operation unit 410 includes an LED light 419 that irradiates light for datametric code recognition and removal of an external light source, a guide laser 513 that outputs and guides a beam so that the medical device can be accurately positioned, and an external device and It includes an external device input/output port 514 for connection, and a communication module 515 connected to the service server 200 or an external terminal through a network.
작동부(410)는 광학 카메라를 통하여 의료기기의 데이터메트릭스 코드를 인식하고, 데이터메트릭스 코드에 대응되는 고유식별코드의 데이터 세트를 표시부(412)를 통해서 표시한다.The operation unit 410 recognizes the data matrix code of the medical device through an optical camera, and displays a data set of a unique identification code corresponding to the data matrix code through the display unit 412 .
작동부(410)는 제1 센서(416)와 제2 센서(418) 중 적어도 하나로부터 사용자의 모션을 감지하고, 사용자의 모션에 따라 입력된 영상 정보 및 처리되는 프로그램 정보를 통해서 승인 또는 취소시킨다. The operating unit 410 detects the user's motion from at least one of the first sensor 416 and the second sensor 418, and approves or cancels it through image information input and program information to be processed according to the user's motion. .
다음으로, 고정부(430)는 지지판(432) 및 기둥 부재(434) 및 다수의 바퀴(436)를 포함한다.Next, the fixing part 430 includes a support plate 432 and a pillar member 434 and a plurality of wheels 436 .
일례로, 지지판(432)은 판 형상으로 형성될 수 있으며, 기둥 부재(434)는 지지판(432)의 일면에서 수직 방향으로 형성될 수 있다. For example, the support plate 432 may be formed in a plate shape, and the pillar member 434 may be formed in a vertical direction on one surface of the support plate 432 .
기둥 부재(434)에는 작동부(410)와 거치부(420)가 체결될 수 있다. 지지판(432)의 하부에는 다수의 바퀴가 설치되어 지지판을 이동하거나 고정할 수 있다. The actuating part 410 and the holding part 420 may be fastened to the pillar member 434 . A plurality of wheels are installed below the support plate 432 to move or fix the support plate.
그리고, 기둥 부재(434)에는 네트워크 및 전원 케이블을 작동부(410)에 연결시키기 위한 통로가 내부에 형성될 수 있고 외부기기 연결 포트가 하부의 케이블 연결대(438)에 형성될 수 있다.In addition, a passage for connecting network and power cables to the operation unit 410 may be formed inside the pillar member 434, and an external device connection port may be formed in the lower cable connection base 438.
도 6은 일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치의 블록도이다.6 is a block diagram of a datametrics code reading device marked on an implantable medical device according to an embodiment.
도 6을 참고하면, 작동부(410)의 주요 하드웨어는 제어 장치(511), 표시부(412), 광학 카메라(414), LED 조명(419), 제1 센서(416) 및 제2 센서(418), 가이드 레이저(513), 통신 모듈(515), 외부기기 입출력 포트(514), DC 전원부(512)를 포함할 수 있다.Referring to FIG. 6 , the main hardware of the operating unit 410 includes a control device 511, a display unit 412, an optical camera 414, an LED light 419, a first sensor 416 and a second sensor 418. ), a guide laser 513, a communication module 515, an external device input/output port 514, and a DC power supply unit 512.
DC 전원부(512)는 기기를 동작하기 위한 전원을 각 구성 요소에 공급할 수 있고, 광학 카메라(414)는 제품에 마킹된 식별코드를 인식하기 위한 영상 입력 장치로 이용될 수 있다.The DC power supply 512 may supply power for operating the device to each component, and the optical camera 414 may be used as an image input device for recognizing an identification code marked on a product.
제1 센서(416) 및 제2 센서(418)는 좌우 대칭으로 구성될 수 있고 사용자의 모션을 감지하여 입력된 영상 정보 값을 승인 또는 취소하는 비접촉 입력 장치로 이용될 수 있다.The first sensor 416 and the second sensor 418 may be configured symmetrically and may be used as a non-contact input device that detects a user's motion and approves or cancels an input image information value.
표시부(412)는 카메라의 현재 입력 영상 및 처리되는 프로그램 정보 등을 디스플레이할 수 있다. 일례로 OLED 또는 LCD 표시 장치로 구성될 수 있다.The display unit 412 may display the current input image of the camera and program information being processed. For example, it may be configured as an OLED or LCD display device.
LED 조명(419)은 의료기기에 마킹된 코드 인식 및 외부 광원 제거를 위한 광을 출력하는 장치로, 몸체의 하부에 위치하여 거치부(420)를 향하여 광을 조사할 수 있다.The LED light 419 is a device that outputs light for recognizing a code marked on a medical device and removing an external light source, and may be located at the lower part of the body and radiate light toward the holder 420 .
가이드 레이저(513)는 사용자가 의료기기를 거치부(420)의 테이블(424)에 정확히 위치할 수 있도록 빔을 조사하여 유도할 수 있다.The guide laser 513 may irradiate and guide a beam so that the user can accurately position the medical device on the table 424 of the holder 420 .
외부기기 입출력 포트(514)는 USB 형태의 외부장치와 연결되어 외부장치에 신호를 입력 및 출력할 수 있다.The external device input/output port 514 is connected to a USB type external device to input and output signals to and from the external device.
통신 모듈(515)은 LAN 네트워크 포트를 포함할 수 있으며, 네트워크를 통한 클라우드 및 외부 PC와 연결되어 데이터를 입력 및 출력할 수 있다.The communication module 515 may include a LAN network port, and may input and output data by being connected to a cloud and an external PC through a network.
판독 장치(400)는 사용자가 이용 시 기기접촉에 의한 오염을 방지하기 위하여 멸균 비닐을 사용하여 테이블(424) 전체가 패킹될 수 있다. 또한 판독 장치(400)는 사전에 멸균된 지그(310)를 이용하여 방향성이 표지된 테이블(424)에 가이드 레이저(513)의 도움을 받아 광학 카메라(414)가 인식할 수 있도록 지그(310)를 안착할 수 있다.When the reading device 400 is used by a user, the entire table 424 may be packed using sterilized vinyl in order to prevent contamination due to device contact. In addition, the reading device 400 uses a previously sterilized jig 310 to guide the table 424 marked with directions to the jig 310 so that the optical camera 414 can recognize it with the help of the guide laser 513. can be settled.
판독 장치(400)는 광학 카메라(414)로부터 입력된 2D 데이터메트릭스 코드는 서비스 서버(200) 또는 기존에 입력 저장된 코드 정보와 비교하여 표시부(412)에 정보를 표시한다.The reading device 400 compares the 2D datametric code input from the optical camera 414 with the service server 200 or previously input and stored code information, and displays the information on the display unit 412 .
등록 저장된 데이터는 의료기기의 UDI 정보 이외에 환자의 정보 등이 포함될 수 있으며, 표시부(412) 상에 표시되는 정보는 의료기기의 UDI 정보만을 표시할 수 있다.The registered and stored data may include patient information in addition to the UDI information of the medical device, and the information displayed on the display unit 412 may display only the UDI information of the medical device.
판독 장치(400)는 판독된 코드에 대하여 사용자에게 등록/취소 여부를 묻고 좌측 및 우측에 마련된 제1 센서(416) 및 제2 센서(418)를 통해 등록 및 취소를 선택할 수 있다.The reading device 400 may ask the user whether to register/cancel with respect to the read code and select registration or cancellation through the first sensors 416 and the second sensors 418 provided on the left and right sides.
의료기기 등록 및 수술이 완료되면 사용자는 최종 등록 현황을 검토하고 승인한다. 판독 장치(400)는 승인 완료된 데이터를 네트워크를 통해 서비스 서버(200)에 저장하며, 기존에 등록된 의료기기 UDI 정보와 환자 정보를 포함한 데이터를 인쇄 출력한다.When the medical device registration and surgery are completed, the user reviews and approves the final registration status. The reading device 400 stores approved data in the service server 200 through a network, and prints out data including previously registered medical device UDI information and patient information.
이때 판독 장치(400)는 UDI 코드에 대한 데이터를 2D 코드에서 1D 바 코드(BAR Code)로 변환하여 일반 스캐너에서도 인식할 수 있는 정보로 변환할 수 있다. 출력된 1D 바 코드 및 환자 정보는 사용자(병원)이력 보관 기록물에 첨부될 수 있다.In this case, the reading device 400 may convert the data of the UDI code from 2D code to 1D bar code (BAR Code) to convert it into information that can be recognized by a general scanner. The outputted 1D bar code and patient information can be attached to user (hospital) history storage records.
이와 같이 일 실시예에 따른 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치(400)는 병/의원 수술 환경인 멸균 및 비접촉 환경을 위한 기능을 포함하고, 영상 데이터 취득 지원 및 운영 상황을 위한 모니터를 지원한다. In this way, the datametrics code reading device 400 marked on the implantable medical device according to an embodiment includes functions for a sterile and non-contact environment, which is a hospital/clinic surgical environment, and supports image data acquisition and operating conditions. monitor support.
그리고, 판독 장치(400)는 사용자 PC 및 클라우드 서버 접속을 위한 네트워크를 지원하고, 초소형 의료기기 코드 인식을 위한 멸균 지그 및 테이블 제공한다. In addition, the reading device 400 supports a network for accessing a user PC and a cloud server, and provides a sterilization jig and table for recognizing a code of a miniature medical device.
그리고, 판독 장치(400) 사용자 편의성을 고려한 방향성 멸균 지그를 제공하고, 대형 의료기기 코드 인식을 위한 접이식 테이블 기능을 제공하며, 사용자 접촉 등 접촉 감염 예방을 위하여 테이블 패킹을 위한 멸균 비닐을 제공한다.In addition, a directional sterilization jig considering user convenience of the reading device 400 is provided, a folding table function is provided for large medical device code recognition, and sterilization vinyl for table packing is provided to prevent contact infection such as user contact.
한편, 의료기기 UDI 코드는 의료기기 제조 및 수입자가 의료기기에 표시하는 자동식별코드로서 제조, 수입, 유통, 사용 등의 의료기기 제품의 전주기에 대한 정보 수집 및 관리하는 시스템에 적용될 수 있다.On the other hand, the medical device UDI code is an automatic identification code displayed on medical devices by manufacturers and importers of medical devices.
UDI 코드는 의료기기 자체를 식별하기 위한 코드(Device Identifier, DI)와 해당 의료기기 생산 관련 정보를 식별하기 위한 코드(Production Identifier, PI)로 구성된다.The UDI code consists of a code for identifying the medical device itself (Device Identifier, DI) and a code for identifying information related to the production of the medical device (Production Identifier, PI).
UDI 코드는 제품별 코드를 통하여 의료기기의 부작용 보고, 회수, 추적관리 등의 안전관리의 기본이 되는 식별의 문제를 해결하기 위하여 국제적으로 통용되는 숫자와 영문의 코드와 정보인식기술을 포함한다.The UDI code includes internationally used numbers and English codes and information recognition technology to solve the problem of identification, which is the basis of safety management such as side effect reporting, recall, and tracking management of medical devices through product-specific codes.
한편, 고유식별코드 마킹 시스템은 국제표준코드 발급 체계를 기초로 UDI 코드를 생성하고 이를 체내이식 형 의료기기에 직접 마킹이 가능한 마킹(Direct Product Marking, DPM) 코드로 변환하여 제품에 마킹할 수 있다.On the other hand, the unique identification code marking system generates a UDI code based on the international standard code issuance system, converts it into a marking (Direct Product Marking, DPM) code that can be directly marked on an implantable medical device, and can be marked on the product. .
고유식별코드 마킹 시스템은 의료기기에 마킹되어 있는 DPM 코드를 인식하고, 수집된 정보를 데이터화하여 공급내역을 서비스 서버(200)에 보고할 수 있다. 여기서, 의료기기 고유식별자 정보와 생산식별자 정보는 국제표준코드 발급체계의 기준에 부합되도록 생성될 수 있고 제품의 원자재 등 기본정보 등을 포함한 UDI 데이터 세트로 저장될 수 있다.The unique identification code marking system recognizes the DPM code marked on the medical device, converts the collected information into data, and reports supply details to the service server 200. Here, the medical device unique identifier information and production identifier information may be generated to meet the standards of the international standard code issuance system and may be stored as a UDI data set including basic information such as raw materials of the product.
의료기기 고유식별자 정보에는 제조국가, 제조 또는 수입 업체, 품목명 등이 포함될 수 있다. 그리고, 의료기기 생산식별자 정보에는 제조번호, 사용기한, 제조년월일, 일련번호 등이 포함될 수 있다. Medical device unique identifier information may include country of manufacture, manufacturer or importer, item name, etc. In addition, the production identifier information of the medical device may include a manufacturing number, an expiration date, a manufacturing date, a serial number, and the like.
서비스 서버(200)는 클라우스 서버로 구성될 수 있으며, 네트워크를 통해 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드를 판독하는 장치(400)와 연결되어 의료기기 관련 정보를 수신할 수 있고, 체내이식 형 의료기기(300)가 이식된 환자에 대한 정보와 의료기기 관련 정보를 저장 및 관리할 수 있다. The service server 200 may be configured as a cloud server, and may be connected to a device 400 that reads a data metric code marked on an implantable medical device through a network to receive medical device-related information, and It is possible to store and manage information about a patient to whom the type medical device 300 has been implanted and information related to the medical device.
판독 장치(400)에는 서비스 서버(200) 접속을 위한 클라이언트, 데이터메트릭스 코드를 UDI 코드 또는 1D 바 코드로 변환하는 응용프로그램이 설치될 수 있다.A client for accessing the service server 200 and an application program for converting datametric codes into UDI codes or ID bar codes may be installed in the reading device 400 .
도 7은 체내이식 형 의료기기 직접 표시 제품에 대한 정보 인식 및 처리에 대한 시스템을 나타낸다.7 shows a system for recognizing and processing information about a direct display product of an implantable medical device.
제조사 출고 시 포장상태가 유지되는 일반 유통에서 정보 인식 처리와 병원 및 의원에서 세트 구성을 위한 제품 등록 및 환자에게 사용 전 정보를 인식하고 처리하는 방법을 나타낸다.It shows information recognition processing in general distribution where the packaging state is maintained when shipped from the manufacturer, product registration for set composition in hospitals and clinics, and methods for recognizing and processing information before use to patients.
유통 대리점은 포장에 인쇄되어 있는 UDI 바코드 라벨을 인식할 수 있다. 여기서, 공급자 정보를 입력 및 선택할 수 있으며, 제품 UDI 레벨 스캔 후 유통할 수 있다. 유통 및 공급 이력 서비스로 공급내역신고 내역 DB를 포함할 수 있고 공급 내역 DB를 업로드할 수 있다.Distributors can recognize UDI barcode labels printed on packaging. Here, supplier information can be input and selected, and the product can be distributed after scanning the UDI level. As a distribution and supply history service, a supply details report detail DB can be included and the supply detail DB can be uploaded.
병 의원은 판독 장치를 통해서 사용 제품 인식 및 등록을 처리하고, 총 사용 정보를 확인할 수 있다. 판독 장치는 사용 내역 데이터를 저장할 수 있고 암호화할 수 있다. Through the reading device, hospitals and clinics can process used product recognition and registration, and check total usage information. The reading device may store usage history data and may encrypt it.
판독 장치는 제품 사용 내역 지원 서비스로 2D 코드를 1D 코드로 변환할 수 있다. 마킹된 2D 코드는 편집(변환)된 코드로 UDI 정보의 일부만 포함하고 있어, 판독 장치의 내부 프로그램에 의해 1D 코드로 변환 시 판독 장치는 UDI의 전체 정보를 표시할 수 있고 출력할 수 있다.The reading device can convert a 2D code into a 1D code with a product usage history support service. The marked 2D code is an edited (converted) code and contains only a part of UDI information. When converted to 1D code by an internal program of the reading device, the reading device can display and output all information of the UDI.
그리고, 판독 장치는 UDI 코드 및 제품 사용 내역에 대한 데이터 세트를 프라이빗 블록체인으로 암호화할 수 있다. 그리고 판독 장치와 전기적으로 연결된 1D 바 코드 프린터는 환자 EMR(Electronic Medical Record) 정보를 출력하고 사용 제품 1D UDI 코드를 출력할 수 있다.And, the reading device can encrypt the UDI code and the data set on the product usage history with a private blockchain. In addition, the 1D bar code printer electrically connected to the reading device may output patient Electronic Medical Record (EMR) information and output a product 1D UDI code.
상술한 실시예에 따르면, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독할 수 있다.According to the above-described embodiment, a 2D data metric code marked on a small implantable medical device can be read.
또한, 소형의 체내이식 형 의료기기에 마킹된 2D 데이터메트릭스 코드를 판독하여 의료기기의 안전정보 및 유통정보를 관리할 수 있고 환자에게 이식된 의료기기를 용이하게 추적할 수 있게 할 수 있다.In addition, safety information and distribution information of the medical device can be managed by reading the 2D data matrix code marked on the small implantable medical device, and the medical device implanted in the patient can be easily tracked.
한편, 2D 데이터메트릭스 코드는 서비스 서버(200)와 네트워크를 통해 연결된 마킹 시스템을 통해서 소형의 체내이식 형 의료기기에 마킹될 수 있다. Meanwhile, the 2D datametric code may be marked on a small implantable medical device through a marking system connected to the service server 200 through a network.
마킹 시스템은 마킹 대상인 의료기기에 대하여 국제표준상표코드(GTIN)를 부여할 수 있고, 모델명 및 제품명 별 정보를 선택할 수 있으며 포장단위 별 정보를 선택할 수 있다. 마킹 시스템은 국제 표준 코드 발급 기관에 가입하여 국제 표준 코드 발급 서비스를 활용할 수 있으며, 발급 기관으로부터 GTIN DB를 다운로드 할 수 있다.The marking system can assign a GTIN to the medical device to be marked, select information by model name and product name, and select information by packaging unit. The marking system can utilize the international standard code issuing service by subscribing to an international standard code issuing institution, and can download the GTIN DB from the issuing institution.
마킹 시스템은 대상 의료기기에 대하여 GTIN DB를 이용하여 고유 식별자를 부여할 수 있다. 일례로, 마킹 시스템은 모델, 제품, 포장단위 별로 고유 식별자를 부여할 수 있다.The marking system may assign a unique identifier to a target medical device using GTIN DB. For example, the marking system may assign unique identifiers to each model, product, and packaging unit.
그리고, 마킹 시스템은 제조연월, 사용기한, 롯트 넘버 등을 포함하는 생산 정보를 수신할 수 있으며, 응용식별자를 선택할 수 있고, GTIN DB를 이용하여 생산정보에 대응되는 생산 식별자를 부여할 수 있다.And, the marking system may receive production information including manufacturing date, expiration date, lot number, etc., may select an application identifier, and may assign a production identifier corresponding to the production information using the GTIN DB.
마킹 시스템은 의료기기 고유 식별자와 생산 식별자를 이용하여 UDI 코드를 생성할 수 있고, UDI 코드에 연계되는 의료기기 정보와 생산 정보를 포함하는 UDI 데이터 세트를 저장할 수 있다.The marking system may generate a UDI code using a unique medical device identifier and a production identifier, and may store a UDI data set including medical device information and production information linked to the UDI code.
이상과 같이 본 발명에 대해서 예시한 도면을 참조로 하여 설명하였으나, 본 명세서에 개시된 실시 예와 도면에 의해 본 발명이 한정되는 것은 아니며, 본 발명의 기술사상의 범위 내에서 통상의 기술자에 의해 다양한 변형이 이루어질 수 있음은 자명하다. 아울러 앞서 본 발명의 실시 예를 설명하면서 본 발명의 구성에 따른 작용 효과를 명시적으로 기재하여 설명하지 않았을 지라도, 해당 구성에 의해 예측 가능한 효과 또한 인정되어야 함은 당연하다.As described above, the present invention has been described with reference to the drawings illustrated, but the present invention is not limited by the embodiments and drawings disclosed in this specification, and various modifications are made by those skilled in the art within the scope of the technical idea of the present invention. It is obvious that variations can be made. In addition, although the operational effects according to the configuration of the present invention have not been explicitly described and described while describing the embodiments of the present invention, it is natural that the effects predictable by the corresponding configuration should also be recognized.

Claims (11)

  1. 의료기기를 거치하는 거치부;A mounting unit for mounting medical devices;
    상기 거치부의 상기 의료기기에 마킹된 데이터메트릭스 코드를 인식하고, 상기 데이터메트릭스 코드에 대응되는 고유식별(Unique Device Identifier, UDI) 코드의 데이터 세트를 표시하는 작동부; 및an operating unit that recognizes a data metric code marked on the medical device of the holding unit and displays a data set of a Unique Device Identifier (UDI) code corresponding to the data metric code; and
    상기 작동부와 상기 거치부를 고정하는 고정부를 포함하는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.A datametrics code reading device marked on an implantable medical device including a fixing part fixing the operation part and the holding part.
  2. 제 1 항에 있어서,According to claim 1,
    상기 거치부는, The holding part,
    상기 고정부의 기둥 부재에 체결되고 상기 작동부와의 거리가 조절되도록 상하로 높이가 조절되는 조절대; 및a control table fastened to the pillar member of the fixing unit and having a height adjusted up and down so as to adjust a distance from the operating unit; and
    상기 조절대의 측부에 체결되고 상기 의료기기를 거치하는 지그가 안착되도록 유도하는 테이블을 포함하는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.A datametrics code reading device marked on an implantable medical device including a table fastened to a side of the control table and guiding a jig for holding the medical device to be seated.
  3. 제 2 항에 있어서,According to claim 2,
    상기 테이블은 레버의 조작에 따라 상기 조절대의 측부에 고정되거나 폴딩되는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The table is a data metric code reading device marked on an implantable medical device that is fixed or folded to the side of the control table according to the operation of the lever.
  4. 제 2 항에 있어서,According to claim 2,
    상기 테이블은 정면을 기준으로 우측, 좌측, 양측 중 적어도 하나로 일정 각도 범위 내에서 회전되는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The table is a data metric code reading device marked on an implantable medical device that is rotated within a certain angle range to at least one of the right side, left side, and both sides based on the front side.
  5. 제 2 항에 있어서,According to claim 2,
    상기 테이블은, 멸균 비닐에 의해 패킹되는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The table is a data metric code reading device marked on an implantable medical device packed with sterile vinyl.
  6. 제 2 항에 있어서,According to claim 2,
    상기 테이블은, 상기 지그의 방향성을 유도하는 방향성 모양이 상부에 표시되는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The table is a data metric code reading device marked on an implantable medical device in which a directional shape for inducing the direction of the jig is displayed on the top.
  7. 제 1 항에 있어서,According to claim 1,
    상기 작동부는, The operating part,
    몸체의 하부에 상기 거치부를 향하도록 위치하고 상기 의료기기에 마킹된 상기 데이터메트릭스 코드를 인식하는 광학 카메라;an optical camera positioned at a lower portion of the body toward the mounting portion and recognizing the datametric code marked on the medical device;
    상기 몸체의 양측부에 위치하고 사용자의 모션을 비접촉으로 감지하는 제1 센서 및 제2 센서;first and second sensors located on both sides of the body and detecting motion of the user in a non-contact manner;
    상기 광학 카메라의 상기 영상 정보와 처리되는 프로그램 정보를 표시하는 표시부; 및a display unit for displaying the image information of the optical camera and program information to be processed; and
    상기 광학 카메라의 상기 영상 정보와, 제1 센서 및 제2 센서의 감지 신호를 처리하고, 상기 영상 정보와 상기 프로그램 정보를 표시하도록 상기 표시부를 제어하는 제어부를 포함하는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.Marked on an implantable medical device including a control unit for processing the image information of the optical camera and detection signals of the first sensor and the second sensor, and controlling the display unit to display the image information and the program information Datametrics code reading device.
  8. 제 7 항에 있어서,According to claim 7,
    상기 작동부는, The operating part,
    상기 데이터메트릭스 코드의 인식 및 외부 광원 제거를 위하여 광을 조사하는 엘이디 조명;LED lighting for radiating light to recognize the data metric code and remove an external light source;
    상기 의료기기를 정확히 위치할 수 있도록 가이드하기 위한 빔을 출력하는 가이드 레이저;a guide laser outputting a beam for guiding the medical device to be positioned accurately;
    외부기기와 연결하기 위한 외부기기 연결포트; 및An external device connection port for connecting with an external device; and
    네트워크를 통하여 서버 및 외부 단말기와 연결되는 통신 모듈을 더 포함하는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.A datametrics code reading device marked on an implantable medical device further comprising a communication module connected to a server and an external terminal through a network.
  9. 제 7 항에 있어서,According to claim 7,
    상기 제어부는, 상기 의료기기의 상기 데이터메트릭스 코드를 인식하도록 상기 광학 카메라를 제어하고, 상기 데이터메트릭스 코드에 대응되는 상기 UDI 코드의 데이터 세트를 표시하도록 상기 표시부를 제어하는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The controller controls the optical camera to recognize the datametric code of the medical device, and controls the display unit to display a data set of the UDI code corresponding to the datametric code. datametrics code reading device.
  10. 제 7 항에 있어서,According to claim 7,
    상기 제어부는, 상기 제1 센서와 상기 제2 센서 중 적어도 하나로부터 감지 신호를 수신하고, 상기 감지 신호에 따라 입력된 영상 정보 및 처리되는 프로그램 정보를 통해서 승인 또는 취소시키는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The control unit receives a detection signal from at least one of the first sensor and the second sensor, and marks the implantable medical device for approval or cancellation through image information input according to the detection signal and program information to be processed. datametrics code reading device.
  11. 제 1 항에 있어서,According to claim 1,
    상기 고정부는, The fixing part,
    상기 작동부 및 상기 거치부를 지지하는 지지판;a support plate supporting the operation unit and the holding unit;
    상기 지지판에서 수직 방향으로 형성되며, 상기 작동부와 상기 거치부를 고정하는 기둥 부재; 및a pillar member formed in a vertical direction from the support plate and fixing the operating part and the holding part; and
    상기 지지판의 하부에 설치되어 이동시키거나 고정하는 다수의 바퀴를 포함하고,It includes a plurality of wheels installed on the lower part of the support plate to move or fix,
    상기 기둥 부재는 네트워크 및 전원 케이블을 상기 작동부에 연결시키기 위한 통로가 내부에 형성되고 외부기기 연결 포트가 하부에 형성되는 체내이식 형 의료기기에 마킹된 데이터메트릭스 코드 판독 장치.The datametrics code reading device marked on an implantable medical device in which a passage for connecting a network and a power cable to the operation unit is formed in the pillar member and an external device connection port is formed in the lower portion.
PCT/KR2022/012770 2021-09-24 2022-08-25 Apparatus for reading data matrix code marked on implantable medical device WO2023048413A1 (en)

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