WO2014017530A1 - Appareil médical sur lequel est fixée une étiquette à circuit intégré et procédé de fixation de celle-ci - Google Patents

Appareil médical sur lequel est fixée une étiquette à circuit intégré et procédé de fixation de celle-ci Download PDF

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Publication number
WO2014017530A1
WO2014017530A1 PCT/JP2013/070023 JP2013070023W WO2014017530A1 WO 2014017530 A1 WO2014017530 A1 WO 2014017530A1 JP 2013070023 W JP2013070023 W JP 2013070023W WO 2014017530 A1 WO2014017530 A1 WO 2014017530A1
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WO
WIPO (PCT)
Prior art keywords
tag
medical
fixed
medical instrument
covering
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PCT/JP2013/070023
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English (en)
Japanese (ja)
Inventor
成富　正徳
功 外門
Original Assignee
株式会社日本インフォメーションシステム
大成プラス株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 株式会社日本インフォメーションシステム, 大成プラス株式会社 filed Critical 株式会社日本インフォメーションシステム
Priority to JP2014526969A priority Critical patent/JPWO2014017530A1/ja
Publication of WO2014017530A1 publication Critical patent/WO2014017530A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders

Definitions

  • an IC tag is attached to, for example, a medical instrument such as a scalpel or forceps, and the usage form of these medical instruments is detected and managed.
  • a medical instrument such as a scalpel or forceps
  • the IC tag can be an endoscopic surgical instrument or ultrasonic diagnostic apparatus such as a scalpel, forceps, scissors, gauze, etc. It is disclosed that it is used by being attached to the like (see, for example, Patent Document 1).
  • a system for preventing the reuse of medical instruments for example, a system that prohibits the reuse of disposable medical equipment, and a system in which an IC tag is attached to the equipment and stored in a chamber of a sterilizer is disclosed.
  • the IC tag is attached to the flange portion of the device by being attached or embedded.
  • a technique of providing an IC tag on a syringe is disclosed (for example, see Patent Document 3).
  • the IC tag is used in the form of being embedded or affixed to an outer cylinder made of heat-resistant polypropylene or cyclic polyolefin resin.
  • the IC tag there are other examples of being used in a manipulator system, an example of being used in a system for facilitating medical procedures, and the like.
  • thermosetting resin thermosetting resin
  • metal thermosetting resin
  • bonding structure in which a fine surface is formed and bonded to provide excellent corrosion resistance, weather resistance, and heat resistance (for example, Patent Documents 4 and 5). reference).
  • a system for managing medical relations using an IC tag has already been constructed in various forms as described above.
  • This IC tag is attached to various medical instruments, medical products, pharmaceuticals, etc., and the information is managed. In particular, it is often used for waste medical products for preventing infection. For example, disposable medical devices and medical products are managed not to be reused. This medical product for the purpose of disposal is managed for a short period of time, and most of them are attached to a medical product or the like by attaching or embedding a barcode or an IC tag.
  • the medical instrument to which the IC tag of the present invention 2 is fixed is characterized in that in the present invention 1, the medical instrument body (1) is a medical instrument that can be used repeatedly.
  • the medical device to which the IC tag of the present invention 3 is fixed is the present invention 1 or 2
  • the covering body (3) is obtained by joining two divided synthetic resin bodies, and each of the joint surfaces of the two-divided covering body (3) has an outer periphery of a space containing the IC tag. Protrusions are formed so as to surround, and these protrusions are in contact with each other and fitted.
  • the medical device to which the IC tag of the present invention 4 is fixed is the present invention 1 or 2, wherein the IC tag (2) is in contact with one surface of the antenna mounted on the IC tag on the medical device body (1). It is characterized by being fixed by.
  • the attaching step comprises an ultrasonic bonding step of bonding the divided cover (3) to each other by ultrasonic waves,
  • Each of the joint surfaces of the cover (3) divided into two is characterized in that a protrusion is formed so as to surround the outer periphery of the space, and the protrusion and recess are fitted to each other by the protrusion.
  • the method of adhering the IC tag of the present invention 7 to a medical device is as follows.
  • the medical device main body (1) is subjected to a micron-order ultra fine uneven surface treatment step, and the covering (3) is It is manufactured through an insert molding process.
  • the medical device of the present invention is such that an IC tag is sealed and sealed between a cover, which is a cover, and a medical device body, and is fixed by an adhesive member.
  • a cover which is a cover
  • a medical device body and is fixed by an adhesive member.
  • the IC tag is not completely exposed to the outside of the medical instrument, but is completely fixed to the inside through the cover in a sealed state.
  • the IC tag is configured such that one surface of the antenna mounted on the IC tag is fixed in contact with the metallic medical device body. For this reason, the medical device itself has a function of an antenna for transmitting information on the medical device, and the transmission function is enhanced.
  • FIG. 6 is an external view of the half surface when the one half-divided covering body to which the IC tag is attached is attached to the forceps according to the second embodiment.
  • FIG. 7 is an external view showing the half-split surface of the other half-split body according to the second embodiment.
  • FIG. 8 is a cross-sectional view of the second embodiment, in which the IC tag is fixed to the forceps via a cover.
  • FIG. 9 is an external view of the tweezers to which the IC tag is fixed according to the third embodiment.
  • FIG. 10 is a cross-sectional view taken along the line BB of FIG. 8, and is a cross-sectional view of a configuration in which the IC tag is fixed to the tweezers via a cover.
  • FIG. 1 is an external view showing Embodiment 1 of a medical instrument to which an IC tag 2 is fixed, in an example in which the present invention is applied to a forceps main body.
  • the medical instrument according to the first embodiment has a configuration in which an IC tag 2 is fixed to forceps.
  • the forceps 1 applied in the first embodiment is used for surgery, and is used when grasping, suppressing, or pulling a blood vessel or the like.
  • the forceps 1 are of various types and are not necessarily limited to the shape shown in FIG.
  • various types such as Kelly type, Kochel type, Pean type, and Mosquito type, including an example with the name of the inventor, and various names are given according to the purpose of use. Recently, it is used for endoscopic surgery, and a type having a gripping part of an action part at the end of a shaft as a transmission part is also used.
  • the forceps 1 is mainly composed of a handle portion having a finger portion 1a and a grip portion 1c which rotates around a support shaft 1b by operation of the handle portion and performs a clamping operation. Since this forceps 1 is used for medical practice, it is usually made of stainless steel. In the first embodiment, a short mosquito-type forceps having a length of about 12 cm will be described as an example.
  • the forceps 1 has a structure in which the IC tag 2 is fixed to the finger portion 1a of the forceps main body by retrofitting.
  • the IC tag 2 itself has been used in many fields and is well known, and is an information processing and information storage medium that does not require a power source and can be operated without contact.
  • This IC tag 2 is small and has a large memory capacity, unlike a bar code, and has a high utility value in production management, distribution fields, and the like.
  • a recent IC tag 2 having a high heat-resistant temperature and having a heat-resistant protective material and capable of high-pressure steam sterilization has been proposed.
  • the IC tag 2 has an integrated circuit, can read and write information wirelessly with a reader (R / W), has an information processing and storage function, and is a small electronic device that receives radio waves and works.
  • a reader R / W
  • Various shapes of the IC tag 2 have been proposed, and the shape is adapted to the target medical instrument to be used.
  • the IC tag 2 is properly used depending on the application, and the form of use is used by being affixed or embedded in the target device.
  • a barcode is used for the same purpose as the IC tag 2, the barcode has a drawback that information cannot be read if there is a shielding object. In the case of the IC tag 2, the shielding object is used regardless of the direction in which it is placed. There is an advantage that information can be read even if there is.
  • those using the IC tag 2 are attached to a package such as a medical instrument or pharmaceutical by a relatively simple method such as pasting, and the information management system identifies the medical instrument or package. It is taken in and is used to manage items such as medical instruments and medicines. In the case of forceps, it will be reused rather than a disposable medical instrument, but since it is a surgical instrument, it must be meticulous.
  • the present invention such a situation can be avoided, and all of this information can be stored in the IC tag 2 integrated with the forceps main body, so that collective management is possible.
  • management that does not allow even minor mistakes is required.
  • the reality is that it requires complicated management such as dealing with adverse environments for humans, dealing with new drugs, and has not yet been able to cope completely.
  • attaching the IC tag 2 to a medical device in an exposed manner is extremely dangerous and problematic in terms of safety and hygiene.
  • the present invention takes the form of sealing the IC tag 2 in order to solve this problem.
  • a case-like covering 3 as a cover is provided at one end of the finger 1 a of the forceps 1.
  • This covering 3 is a synthetic resin molded article, for example, a PPS resin (polyphenylene sulfide resin), ABS resin, PBT resin, or acrylic resin, which is a thermoplastic resin.
  • the resin is a resin that can withstand boiling disinfection at a temperature of 100 ° C. or higher for a predetermined time.
  • the covering 3 is divided into two parts by half.
  • the two divided covering bodies 3a and 3b surround the one end of the finger portion 1a along the arc shape, and sandwich the ring portion of the finger portion 1a from both sides.
  • the IC tag 2 is enclosed between the two covering bodies 3a and 3b, that is, in the space between them. As shown in FIG. 3, the IC tag 2 is positioned and fixed on the back surface of one cover 3a, and then sealed in a state of covering the other cover 3b shown in FIG.
  • an adhesive is injected into the internal space to enclose the IC tag 2 as will be described later, and the two covering bodies 3a and 3b are also mutually connected by this adhesive. Glued. Therefore, although joining of both by an ultrasonic wave is not indispensable as an assembly process, it is better to carry out in order to ensure adhesion between the two covering bodies 3a and 3b and the finger part 1a.
  • the metal forceps 1 also has a function of the antenna of the IC tag 2. That is, it is a configuration in which one surface of the IC chip side antenna mounted on the IC tag 2 is assembled by contacting the forceps body.
  • the adhesive member 4 is dispensed between the two divided covering bodies 3a and 3b thus combined, that is, in the inner space (cavity) thereof, from the small hole 3c provided in the other covering body 3b, or from the dispenser. Filled by injection with an injection molding machine. As shown in FIG.
  • the adhesive member 4 fills and fills the entire internal space including between the forceps 1 and the two covering bodies 3a and 3b and between the IC tag 2 and the two covering bodies 3a and 3b.
  • the shape in this state is the shape shown in FIG. 2, but the forceps 1 can be inserted into the finger 1a even if the covering 3 is present, and this covering 3 is formed on the finger 1a. However, there is no hindrance to the treatment.
  • the cover 3 is a resin molded product as described above, but it is a heat-resistant, corrosion-resistant, weather-resistant thermoplastic resin that can be injection-molded with high productivity, and can be a PPS resin, ABS resin, or acrylic resin. Resins such as polypropylene other than those may be used.
  • the adhesive member 4 may be any member as long as it has a high adhesive effect on the cover 3 that is a metal body and a resin and does not release a substance harmful to the human body, but an epoxy-based member is preferable.
  • the adhesive member 4 is excellent in adhesion to both the metal constituting the forceps and the resin constituting the covering 3. Hot melt adhesives such as epoxy adhesives and polyester resins are preferred. Since the forceps 1 need to be sterilized, it is preferable that the forceps 1 can withstand boiling disinfection at a temperature of 100 ° C. or higher for a predetermined time.
  • the adhesive performance is improved.
  • the IC tag 2 is inserted into the covering 3a, and then the covering 3a and the other covering 3b are ultrasonically bonded. Thereafter, the adhesive member 4 is filled by injection with a dispenser from the small hole 3c provided in the other cover 3b.
  • the forceps 1 provided with the IC tag 2 can read the data of the individual forceps 1 at a time even if a plurality of forceps 1 are mixed with other medical instruments. Therefore, even if the forceps 1 being used has blood attached during surgery, is being washed, is mixed with other medical instruments, or is being stored and packed, the information can be read. Is possible. In medical instruments such as forceps that are repeatedly used in this way, the user or the like can be specified and managed. This is also possible with other medical devices.
  • this surface has an ultra-fine uneven surface with convex portions with a spacing interval of 10 nm or more and a height, width and length of 10 nm or more.
  • the average roughness (RSm) of the contour curve element constituted by the ultra fine uneven surface is 0.5 to 10 ⁇ m and the maximum height roughness (Rz) is 0.2 to 5 ⁇ m. Is preferable (for example, see WO2008 / 081933).
  • the resin fixing surface of the finger part 1a of the forceps main body, which is a metal, is subjected to an ultra fine uneven surface treatment of micron order, the forceps 1 is inserted into an injection mold, and the covering 3a is molded and taken out. During this molding, a space for mounting the IC tag 2 is formed.
  • the finger 1a of the forceps 1 is inserted into an injection mold, the covering 3a is molded, and the two are integrated in advance. Further, the IC tag 2 is placed in a space between the previously formed covering 3a and forceps body, and these are inserted into another injection mold to form the other covering 3b.
  • the adhesive member 4 is not necessary, and when the other covering 3b is molded, the space (cavity) is filled with a molding resin instead of the adhesive member 4 described above.
  • the shape of the other covering body 3b formed at this time is formed into a shape in which the adhesive 4 and the other covering body 3b described above are combined.
  • the molding at this time needs to be performed while setting conditions such as molding temperature and molding pressure so as not to impair the function of the IC tag 2.
  • the feature of this insert molding is that a resin can be directly joined to a metal. Since this bonding method is supported by a proven technology, it can be firmly, stably and reliably fixed without fear of peeling. In addition, when the big adhesive force is not required for adhesion
  • a long bank-like outer peripheral protrusion 8a is formed on the outer peripheral side on the joint surface 7a of one cover 6a.
  • a bank-like inner peripheral projection 9a is formed on the joint surface 7a of the covering 6a and on the inner peripheral side.
  • a long bank-like outer peripheral protrusion 8b is formed on the outer joint surface 7b of the other cover 6b and slightly on the outer peripheral side. That is, when one cover body 6a and the other cover body 6b are joined together, the outer peripheral protrusion 8b of the other cover body 6b is positioned inside the outer peripheral protrusion 8a of the one cover body 6a (see FIG. 8).
  • the outer peripheral protrusion 8a of one cover 6a and the outer protrusion 8b of the other cover 6b are engaged (fitted) with each other, and the inner protrusion of one cover 6a. 9a and the inner peripheral projection 9b of the other cover 6b are engaged with each other. Due to the engagement of these protrusions, the adhesive 4 pressurized during assembly does not flow out from the inside. Even if the injection pressure of the adhesive 4 is high, the sealing performance is improved by the labyrinth effect of these protrusions, so that the adhesive does not flow out from the gap between these protrusions.
  • the covering 6 and the forceps 1 were manufactured from the following materials by the structure and manufacturing method described in the second embodiment.
  • the surface treatment of the forceps 1 was only normal machining for manufacturing the forceps 1, and no special surface treatment was performed for adhesion. When using the adhesive, it was degreased to clean its surface.
  • the molding conditions of the covering 6 were in accordance with ordinary methods. And it sterilized by the following two methods, and confirmed the function of the IC tag.
  • Forceps material SUS304 Material of coating: PPS resin Adhesive: Polyester resin for hot melt molding (Byron Shot (registered trademark)) manufactured by Toyobo Co., Ltd.
  • FIG. 9 is an external view showing a configuration in which the IC tag 11 is fixed to a tweezer body that is a medical instrument, and the tweezers 10 is fixed.
  • 10 is a cross-sectional view taken along the line BB of FIG.
  • a round hole 10b is provided in the fixing portion 10a of the tweezers body, and the two ends of the round hole 10b are shielded and fixed to the round hole 10b by two covering bodies 12a and 12b divided into lids. .
  • the adhesive member 13 is filled through a small hole 12d provided in one of the covering bodies 12b and fills the entire space. At this time, the adhesive member 13 is filled so as to wrap the IC tag 11 across the metal surface around the round hole 10b and the two covering bodies 12a and 12b, and the IC tag 11 passes through the round hole 10b and the covering bodies 12a and 12b. It is firmly fixed to the tweezers body.
  • the tweezers 10 is The antenna function of the IC tag 11 can be achieved. This tweezers example is applicable when the IC tag 11 is small.
  • the third embodiment has a small structure, as described above, the surface of the metal is subjected to an ultra fine uneven surface treatment on the order of microns, and the thermoplastic resin is injection-molded and integrated to this, As described in the first embodiment, the effect is great when the same processing is performed. That is, in this case, since the metal and the resin can be firmly fixed, a desired fixing form can be obtained even with a small bonding area.
  • the metal surfaces to be surface-treated are the periphery of the round hole 10b and the tweezers surface 10c. In particular, in the case of the tweezers 10, the position where the two covering bodies 12a and 12b are attached is restricted, and the area is small.
  • the IC tags 2 and 11 are fixed to the forceps main body and the tweezer main body.
  • other medical instruments can be similarly fixed. It can also be applied to the management of medical waste, and can be applied to a disposable medical device that has a short usage time and is to be discarded, and is not a metal body, for example, a syringe.
  • the present invention can be applied to a medical product storage body or a carrier that can be used repeatedly.
  • this invention is not limited to this form, and can change within the range which does not deviate from the objective of this invention and the meaning.

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Electromagnetism (AREA)
  • Surgical Instruments (AREA)

Abstract

Selon la présente invention, une étiquette à circuit intégré peut être solidement fixée à l'état scellé de façon à supporter l'ébullition, la stérilisation, etc., et les informations conservées par l'étiquette à circuit intégré peuvent être transmises à coup sûr. L'invention concerne, donc, un appareil médical sur lequel est fixée une étiquette à circuit intégré. Ladite étiquette à circuit intégré, qui abrite toutes les informations nécessaires à la gestion de l'appareil, est utilisée dans un système de gestion d'informations médicales qui lit et gère les informations. L'étiquette à circuit intégré (2) est fixée à l'intérieur d'un couvercle (3) qui est divisé par moitié et qui, est, en même temps, fixé au corps principal d'un appareil médical (1). Un élément adhésif est injecté dans une cavité correspondant à un espace ménagé dans le couvercle (3) depuis le côté du couvercle (3). L'étiquette à circuit intégré (2) est ainsi enfermée à l'intérieur du couvercle (3) et est fixée au corps principal de l'appareil médical (1) à l'état scellé.
PCT/JP2013/070023 2012-07-24 2013-07-24 Appareil médical sur lequel est fixée une étiquette à circuit intégré et procédé de fixation de celle-ci WO2014017530A1 (fr)

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JP2014526969A JPWO2014017530A1 (ja) 2012-07-24 2013-07-24 Ｉｃタグを固着した医療器具とその固着方法

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JP2012-164021 2012-07-24
JP2012164021 2012-07-24

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Cited By (12)

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JP2014026447A (ja) * 2012-07-26 2014-02-06 Toppan Printing Co Ltd Ｉｃタグ内蔵鋏状手動利器
CN104939872A (zh) * 2014-03-31 2015-09-30 上海曜传信息科技有限公司 一种手术器械
JP2016105265A (ja) * 2014-11-20 2016-06-09 ケイ・アール・ディコーポレーション株式会社 作業用具
WO2018181526A1 (fr) 2017-03-31 2018-10-04 ダイセルポリマー株式会社 Appareil médical et procédé de fabrication dudit appareil médical
CN108652709A (zh) * 2018-03-29 2018-10-16 林锦惠 一种新式的肿瘤科专用多功能手术刀
WO2019020693A1 (fr) * 2017-07-28 2019-01-31 Robert Bosch Gmbh Procédé pour intégrer un circuit électrique dans un dispositif et dispositif
JP2019084012A (ja) * 2017-11-06 2019-06-06 株式会社トータルＩｔシステムジャパン Ｉｃタグの取り付け方法及びｉｃタグ内蔵金属体
EP3669814A1 (fr) * 2018-12-20 2020-06-24 W & H Dentalwerk Bürmoos GmbH Instrument médical ou dentaire doté d'une étiquette mémoire rfid
CN112930151A (zh) * 2019-09-05 2021-06-08 株式会社村田制作所 带有无线ic标签的医疗用金属制器具
JP2022168908A (ja) * 2021-04-27 2022-11-09 日精産業株式会社 樹脂製品
JP7438306B1 (ja) 2022-10-17 2024-02-26 日本特殊陶業株式会社 梱包体、プラズマ照射モジュール、及びプラズマ照射システム
WO2024061726A1 (fr) * 2022-09-23 2024-03-28 Aesculap Ag Instrument électrochirurgical ayant un transpondeur, système de communication par transpondeur et procédé de production

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Cited By (20)

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Publication number Priority date Publication date Assignee Title
JP2014026447A (ja) * 2012-07-26 2014-02-06 Toppan Printing Co Ltd Ｉｃタグ内蔵鋏状手動利器
CN104939872A (zh) * 2014-03-31 2015-09-30 上海曜传信息科技有限公司 一种手术器械
EP3125775A4 (fr) * 2014-03-31 2018-03-07 Xerafy Singapore Pte. Ltd. Instrument chirurgical
JP2016105265A (ja) * 2014-11-20 2016-06-09 ケイ・アール・ディコーポレーション株式会社 作業用具
WO2018181526A1 (fr) 2017-03-31 2018-10-04 ダイセルポリマー株式会社 Appareil médical et procédé de fabrication dudit appareil médical
JPWO2018181526A1 (ja) * 2017-03-31 2020-02-06 ダイセルポリマー株式会社 医療器具とその製造方法
EP3603563A4 (fr) * 2017-03-31 2020-12-30 Daicel Polymer Ltd. Appareil médical et procédé de fabrication dudit appareil médical
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