WO2002045874A1 - Recycling system for disposable medical device - Google Patents

Recycling system for disposable medical device Download PDF

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Publication number
WO2002045874A1
WO2002045874A1 PCT/JP2001/007790 JP0107790W WO0245874A1 WO 2002045874 A1 WO2002045874 A1 WO 2002045874A1 JP 0107790 W JP0107790 W JP 0107790W WO 0245874 A1 WO0245874 A1 WO 0245874A1
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WO
WIPO (PCT)
Prior art keywords
disposable medical
parts
disposable
medical device
medical devices
Prior art date
Application number
PCT/JP2001/007790
Other languages
French (fr)
Japanese (ja)
Inventor
Keijiro Masui
Keiichiro Yoshida
Original Assignee
Inprest., Co. Ltd.
National Institute Of Advanced Industrial Science And Technology
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inprest., Co. Ltd., National Institute Of Advanced Industrial Science And Technology filed Critical Inprest., Co. Ltd.
Publication of WO2002045874A1 publication Critical patent/WO2002045874A1/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B09DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
    • B09BDISPOSAL OF SOLID WASTE
    • B09B5/00Operations not covered by a single other subclass or by a single other group in this subclass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0023Surgical instruments, devices or methods, e.g. tourniquets disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0813Accessories designed for easy sterilising, i.e. re-usable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70Cleaning devices specially adapted for surgical instruments

Definitions

  • the present invention relates to a disposable medical device configured by combining a metal functional component and other components including a plastic component (hereinafter, referred to as a plastic component, etc.), and particularly to manufacturing the disposable curry medical device.
  • the present invention relates to a recycling system for disposable medical devices, including manufacturers that use them and multiple medical institutions that use them. Background art
  • Disposable medical devices are disposed of as medical waste after being used for medical treatment. If a disposable medical device used once is used for other patients, it may cause infection. It seems that disposable medical devices used once can be reused if they are sterilized. In the medical field, a sterilization method using a disinfectant or a disinfecting gas or a sterilization method using high-pressure steam such as an autoclave is generally used. However, it is extremely difficult to completely sterilize disposable medical devices after use with these sterilization methods.
  • Fig. 11 The flow of production, sales, use, and disposal of this conventional disposable medical device is illustrated in Fig. 11.
  • Manufacturing system 3 1 a supply system 3 2 for selling the disposable medical device directly to a medical institution from a manufacturer or via a sales company, and a used disposable medical device for medical waste
  • This is a non-recycling system consisting of a disposal system where the processing company collects from medical institutions and disposes of it.
  • a conventional disposable medical device composed of functional metal parts and plastic parts is sold from a manufacturer 25 to a medical institution 26, and After being used at the institution 26, it was collected by a medical waste disposal company 27, incinerated in an incinerator, or disposed of at a landfill site for disposal. Therefore, conventionally, as shown in Figure 10, the medical institution 26 pays the purchase price to the manufacturer 25 when purchasing disposable medical devices, and furthermore, a disposal fee to the medical waste disposal company 27 when disposing. The problem is that you have to pay the double cost of paying.
  • a disposable medical device disclosed in Japanese Patent Application Laid-Open No. Hei 7-95982 discloses a method in which at least a part of a portion that does not directly contact a mucous membrane in a body cavity is made of a material containing a hydrophilic polymer. By disposing disposable medical devices, they cannot be reused.
  • Japanese Unexamined Patent Publication No. Hei 8-574742 discloses a disposable medical device used in a special collection container that can be heated at a temperature lower than the ignition point of the plastic material and higher than the melting point of the plastic material. , High temperature sterilization, and plastic material A method for treating waste is disclosed. According to this treatment method, disposable medical devices after use can be sterilized, and plastic materials and non-plastic materials (rubber and metal materials) can be separated and collected. Therefore, it is possible to ensure the safety of those involved in collection and disposal work, and to reuse them as materials.
  • Japanese Patent Application Laid-Open No. 9-99019 discloses that a plastic disposable medical device as a medical waste to which a biochemical substance having an amino group is attached, and an epoxy compound having an oxylan ring are mixed.
  • a method for treating medical waste in which a ring-opening reaction of the oxysilane ring of the epoxy compound is caused by the amino group, and a solidified product of the medical waste and the epoxy cured resin is generated as a final product. ing.
  • the disposable medical device after use can be sterilized, and the plastic material can be collected. Therefore, it is possible to ensure the safety of those involved in the collection and disposal work, and to reuse the material.
  • Some disposable medical devices are expensive, such as endoscopic surgical devices that cost tens of thousands of yen.
  • Such an expensive disposable medical device is a disposable medical device configured by combining a metal functional component and a plastic component, etc., and the functional component of the metal occupies most of the component cost.
  • the conventional medical device disposal method described above has a problem that it is extremely uneconomical for the medical industry because expensive metal functional components of disposable medical devices can be reused only for simple metallic materials. is there.
  • the first problem to be solved by the present invention is that a disposable pull medical device composed of a combination of a metal functional component and a plastic component, etc. is used at a medical institution, and is not discarded as it is, but is recycled. It is to be reused through the process.
  • a second problem to be solved by the present invention is that after a disposable medical device composed of a combination of a functional component made of metal and a plastic component is used in a medical institution, the disposable medical device goes through a regeneration process, and This is to reuse functional components as recycled products. Disclosure of the invention
  • the disposable medical device recycling system which solves the above-mentioned problems, includes a disposable medical device manufacturing system for manufacturing disposable medical devices through a process of assembling metal functional components and plastic components, and a disposable medical device for medical institutions.
  • Supply system that supplies disposable medical devices, disassembling used disposable medical devices, and sterilizing only metal functional parts and collecting them to the manufacturer, and sorting collected metallic functional parts within the number of service life It consists of a parts recycling system that recycles metallic functional parts through a sorting process and an inspection process.
  • the object of recycling is a disposable medical device having a structure in which a metal functional component and a plastic component can be disassembled. More specifically, the disposable medical device is a disposable endoscopic surgical instrument having a structure in which a metal functional component and a plastic component can be disassembled.
  • the disposable medical device manufacturing system described above is a manufacturing system for manufacturing disposable medical devices through an assembling process of metal functional components and plastic components.
  • recycled metal functional components supplied from the component recycling system are used in addition to new metal functional components.
  • the disposable medical device supply system described above is a system in which a manufacturer sells or lends disposable medical devices to a medical institution, which is the user, and supplies the disposable medical devices.
  • the disposable medical device can be supplied to a medical institution in a separate case provided with a product number and identification means for identifying whether or not the medical device has been used.
  • the supply of disposable medical equipment includes not only direct supply from a manufacturer to a medical institution, but also supply through a sales company or leasing company. The above service life was determined experimentally by repeating the cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device.
  • Sterilization treatment in the above recovery system is typically radiation sterilization treatment.
  • whether or not the functional component is a metal functional component within the service life is determined based on the usage history data of the metallic functional component included in the collected used disposable medical device.
  • the supply of disposable medical devices to medical institutions in the supply system described above and the collection of used disposable medical devices or metal functional parts from medical institutions in the collection system are performed by dedicated storage with identification numbers. It can be done with tools.
  • This special storage device is a special case or a special bag, and it is preferable that a chemical indicator is attached thereto.
  • the product number of the disposable medical device, the part number of the component constituting the disposable medical device, the use history data of the metallic functional component to be recycled, and the exclusive storage Data such as identification numbers given to tools should be managed by the data management system provided in the manufacturer.
  • FIG. 1 is a block diagram of a recycling system for disposable medical devices according to one embodiment of the present invention.
  • FIG. 2 is a block diagram of a disposable medical device recycling system according to another embodiment of the present invention.
  • FIG. 3 is a flowchart of a disposable medical device recycling system according to the present invention.
  • FIG. 4 is a flowchart of an experiment in the first stage of the method for determining the number of times of use of a metal functional component.
  • FIG. 5 is a flowchart of the second stage experiment of the method of judging the number of times of use of a metallic functional component.
  • FIG. 6 is a perspective view showing a disassembled state of a handle portion of an embodiment of the disposable medical device in which a metal functional component and a plastic component can be disassembled.
  • FIG. 1 is a block diagram of a recycling system for disposable medical devices according to one embodiment of the present invention.
  • FIG. 2 is a block diagram of a disposable medical device recycling system according to another embodiment of the present invention.
  • FIG. 7 is a diagram showing the positions of manufacturers and medical institutions in the disposable medical device recycling system according to one embodiment of the present invention.
  • FIG. 8 shows a manufacturer and a medical institution in a disposable medical device recycling system according to another embodiment of the present invention.
  • FIG. 9 is a diagram showing a relationship between a maker and a medical institution in the disposable medical device recycling system according to the present invention.
  • FIG. 10 is a diagram showing the relationship between a manufacturer of disposable care medical equipment and a medical institution in a conventional non-recycling system.
  • Fig. 11 shows a conventional non-recycling system for disposable medical devices from manufacturing to use and disposal.
  • FIG. 12 is a diagram showing the positions of manufacturers and medical institutions in a conventional non-recyclable system for disposable medical devices.
  • the disposable medical device recycling system according to the present invention has been invented based on the following three facts regarding an endoscopic surgical instrument configured by combining a metal functional component and a plastic component. Therefore, these three facts will be described before describing the embodiments of the invention.
  • the first fact is that one of the applicants of the present application is a disposable endoscopic surgical instrument configured by combining a metal functional component and a plastic component, etc.
  • the inventor invented a disposable endoscope surgical instrument having a structure that can be easily disassembled, and filed an application as Japanese Patent Application No. 2000-193,207.
  • the disposable endoscopic surgical instrument is a forceps, and one embodiment thereof is as shown in FIG. 6 which is a perspective view of a state where the handle portion 2 is disassembled.
  • the handle portion 2 is configured by combining a right portion 2B including most of the finger ring 2A and a left portion 2C from the left and right. These two parts 2 B and 2 C are press-fitted with small diameter parts on both sides of dowel pins 1 and 2 into dowel holes 10 and 11 formed at two opposing positions on the inside. So that they can be assembled together.
  • the dowel holes 10 and 11 and the dowel pins 12 and 13 constitute a connecting portion.
  • the operation lever 6 is rotatably supported around a shaft 14 protruding inside the right portion 2B of the handle portion 2 and penetrates slidably through the shaft portion 3.
  • the opening / closing finger 15 is rotatably connected to a connecting pipe 16 at the rear end.
  • the front end of the finger opening / closing rod 15 is linked to the pair of fingers 4 so that the rotation of the operation lever 6 is converted to the opening / closing movement of the pair of fingers 4.
  • the vicinity of the rear end of the finger opening / closing rod 15 is electrically connected to the terminal 9 via the conductive plate 17, and electricity is supplied through the finger opening / closing rod 15 from the terminal 9 to the pair of fingers 4. It is like that.
  • a saw tooth tooth T is formed on the operation reporter 6, and the finger tooth 4 is opened by engaging the tooth T with the claw t formed on the ratchet 18. The rotation of the operation lever 6 in the direction is locked.
  • the ratchet 18 is rotatably supported on a shaft 19 protruding inside the right side portion 2B of the handle portion 2 similarly to the shaft 14, and the pawl t is always held by the ratchet panel 20. It is urged to engage the ratchet teeth T.
  • the ratchet 18 is held in a state where the pawl t is separated from the ratchet tooth T by sliding the ratchet release switch 7 forward, and the finger 4 can be opened in this state. ing.
  • the handle part 2 includes metal parts made of metal materials such as terminals 9 ⁇ ratchet spring 20, conductive plate 17, finger opening and closing port 15, etc., and some of these parts, namely The metal functional parts are separated from the handle 2 by disassembling the used forceps 1.
  • a minus dry line is attached to the front and rear sides of the outer periphery of the joint surface of the right part 2B and the left part 2C constituting the handle part 2 respectively.
  • a groove into which a first-class tool can be inserted is formed.
  • Each of these grooves is formed to have a half width opposite to the same portion of the outer peripheral portion of the joint surface 2B, 2C on both sides of the handle portion 2, and each of these portions 2B, 2C is one. It is formed so that the blade edge of a flat-blade screwdriver or the like becomes a groove with a width that can be inserted when it is adjusted.
  • the joints of the two parts 2 B and 2 C of the handle part 2 are arranged at two places near the upper part of the finger hook 2 A of the handle part 2 and near the rear upper end of the handle part 2. Since the dowel pins 12 and 13 are used, the two grooves 21 and 22 are provided on the outer periphery of the handle portion 2 at positions close to the dowel pins 12 and 13.
  • the disposable curry medical device shown in FIG. 6 is a disposable endoscopic surgical instrument in which the handle portion is composed of a plurality of portions, and these portions are connected to each other by a connecting portion and integrally assembled.
  • a tool can be inserted into at least a part of the outer circumference of the joint surface of the parts connected to each other at the joint part of the handle part to push apart these joint surfaces to forcibly separate the joint part.
  • This is a disposable endoscopic surgical instrument characterized by forming a groove.
  • the second fact is that the disposable endoscopic surgical instrument according to the above-mentioned Japanese Patent Application No. 2000-1993 207 was manufactured and, through scientific experiments, its metallic functional parts could be used several times. The inventor of the present application has confirmed that it can withstand, that is, the durability is several times.
  • the above disposable endoscopic surgical instruments consist of a handle, a tip, a shaft, a rod, a link part, a dial, a lever, an electrode rod, a ratchet, a ratchet part, And a plurality of parts of the insulating bar.
  • Metal parts are tip parts, shafts, rods, link parts, and electrode rods, but metal functional parts to be recycled are the tip parts and electrode rods.
  • FIGS. 4 and 5 This second fact, that is, the fact that the metallic functional parts of an endoscopic surgical instrument can withstand several uses if completely sterilized, is illustrated in FIGS. 4 and 5. It was confirmed by an experimental method using a chart.
  • Fig. 4 shows the experimental method in the first stage. At this stage, it was determined how many times each reusable part can be used. That is, the product was simulated using commercially available meat or the like (201), and the product was contaminated with a dye imitating blood (202). Next, a rough cleaning step was performed (203), and the product was disassembled (204). Subsequently, the disassembled parts are sorted out (205), and the metallic functional parts to be reused are cleaned using an ultrasonic cleaner (206), dried (207), and reused parts are reused. The metal functional parts were inspected (2008).
  • Inspection contents of metal functional parts that are reused parts include shape inspection using a stereomicroscope to check for wear, dimension inspection using an electronic caliper, and clean inspection using a cleanliness determination kit. It is.
  • the kit for determining the degree of washing is a commercially available kit for determining the stain by, for example, a change in color according to the amount of protein.
  • step 201 to 210 described above The cycle from step 201 to 210 described above was repeated, and an experiment was conducted under different conditions to determine how many uses each test passed.
  • the different conditions refer to men, women, hard meat pieces, soft meat pieces, etc., and the average value of each is obtained, and it is recognized that the number of times of use is several times.
  • the above inspections and test results were based on the inspections and test results of products assembled using only unused parts.
  • the second stage experiment shown in Fig. 5 was performed. In the second stage, the products used were used under the same conditions as the final products to be supplied to the hospital, that is, sterilized products. This product was simulated using commercially available meat and the like as in the first stage (301).
  • the metal functional component was inspected (310).
  • the second stage inspection is an inspection of the material status of the functional parts made of metal that will be reused parts that have been radiation sterilized, in addition to the inspection items of the first stage described above.
  • a comparison between test values before and after radiation sterilization was performed using a tensile compression tester and a hardness tester. In this comparative experiment, data was calculated for each number of sterilizations, such as one circulation and two circulations.
  • the third fact is that the metal functional parts of the above-mentioned disposable endoscopic surgical instrument are made durable 5 times, and the disposable endoscopic surgical instrument is recycled in consideration of the collection cost and the component renewal cost.
  • the inventor of the present application has confirmed that the recycled product is approximately 60 to 70% of a new product.
  • the cost of recovery or the cost of component recycling includes the cost of radiation sterilization, and the cost of component recycling includes disassembly costs, cleaning and drying costs, and inspection costs.
  • the inspection cost was the same as the cost of receiving a new product. This is because the inspection to determine whether a product can be used as a recycled product is as strict as the inspection when a new part is received from a parts supplier.
  • the disposable medical device recycling system according to the first invention of the present application, as shown in Fig. 1, has a disposable medical device having a structure in which functional metal parts and plastic parts can be disassembled.
  • Manufacturing manufacturing systems System 21 Supply system for selling or lending the disposable medical device and supplying it to medical institutions 2 2, Collection system 23 for sterilizing used disposable medical devices and collecting them at the manufacturer, and collected
  • the disposable medical device is disassembled, metal functional components within the service life are sorted out, and a component recycling system 24 that inspects and regenerates them is connected in order to form a cycle.
  • the disposable medical device recycling system has a disposable structure in which metal functional parts and plastic parts can be disassembled, as shown in FIG.
  • Disassembling used disposable medical devices and sterilizing only metal functional parts The system consists of a collection system 23, which collects and collects metal functional components from the collected functional parts, and a component reproduction system 24, which inspects and regenerates them, and connects them in order to form a circle. is there.
  • the service life of the metal functional component in the first invention and the second invention is determined experimentally by repeating a cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device.
  • the specific method of determining the number of times of use is substantially the same as the method of confirming the number of uses of the metal functional component described as the second fact, which is the basis of the present invention.
  • the system for recycling the disposable medical device of the first invention of the present invention shown in FIG. 1 is constituted by manufacturers involved in distribution and medical institutions, for example, a closed loop as shown in FIG. 7 is formed.
  • manufacturers 25 that manufacture disposable medical devices, medical institutions 26 that use disposable medical devices supplied by manufacturer 25, and used disposable medical devices that are collected from medical institutions 26 A closed loop is formed with the collection company 28 and the used disposable medical device collected by the collection company 28 after sterilizing it and delivering it to the manufacturer.
  • FIG. A closed loop is formed as shown in FIG.
  • a closed loop is formed with the collection company 28 that collects from the medical institution 26 and the sterilization company 29 that sterilizes the metal functional parts collected by the collection company 28 and then delivers them to the manufacturer.
  • the work of disassembling used disposable medical devices and separating metallic functional parts is performed by medical institutions or collection companies. It should be noted that the medical disposer 27 disposes of the disposable medical devices by disassembling the used disposable medical device and collecting the metallic functional parts.
  • the following five actions are performed in order between the manufacturer 25 and the medical institution 26, for example, as shown in FIG.
  • the first action is for the medical institution 26 to order disposable medical devices from the manufacturer 25.
  • the second action is for the manufacturer 25 to deliver disposable medical devices to the medical institution 26.
  • the third action is that the used disposable medical device is collected from the medical institution 26 to the manufacturer 25, and the fourth action is that the manufacturer 25 charges the medical institution 26 for the disposable medical device.
  • the fifth function is that the medical institution 26 pays the manufacturer 25 for the disposable medical device.
  • the price is a purchase price in the case of sales, and a use price in the case of loan.
  • the assembled disposable curry medical device undergoes a pre-shipment inspection (104).
  • Disposable medical devices that have passed pre-shipment inspection are stored in sterile packs, such as Plister packs, and then stored and packed in special storage devices.
  • the exclusive storage device is, for example, an exclusive case or an exclusive bag. Labels with product numbers are affixed to blister packs, and labels with identification numbers are affixed to dedicated storage devices.
  • the disposable medical device is sterilized by radiation in the packaged state.
  • the chemical indicator is attached to the special storage device, shipped, and delivered to a medical institution either directly from the manufacturer or via a sales company (105). At this stage, the chemical indicator is yellow before emission.
  • Disposable medical devices that have been used for medical practice are returned to blister packs and stored in special storage devices.
  • the used disposable medical device is collected from the medical institution using a special storage device by a collection company (107), and is subjected to radiation sterilization by a sterilization company (108). After radiation sterilization, the chemical linge attached to the special storage device turns red. Disposable medical devices that have been subjected to radiation sterilization are delivered to manufacturers by sterilization contractors.
  • the manufacturer refers to the usage history data managed by the data management system and determines whether the collected metallic functional parts used in the disposable medical device have been used within the service life. Examine (1 0 9). The service life was determined experimentally by repeating a cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device. By checking the number of times of use at this stage, disposable medical devices to be disassembled can be sorted out early, and therefore those that should be discarded as industrial waste without disassembly can be sorted out early.
  • Disposable pull medical devices that use metallic functional components within the life cycle It is separated (110) and separated into functional metal parts and plastic parts (111).
  • the disposable medical device which is the object of the recycling system of the present invention, has a structure in which functional parts made of metal and plastic parts can be disassembled, so that it is easily disassembled, and the time and labor in the disassembly process are extremely small. .
  • the metal functional parts that are disassembled and sorted to become reusable parts undergo a cleaning process (1 1 2) using ultrasonic cleaning, etc., and a drying process (1 13) to remove deposits such as blood and body fluids. You.
  • a cleaning process (1 1 2) using ultrasonic cleaning, etc. and a drying process (1 13) to remove deposits such as blood and body fluids.
  • the inspection in this step is a shape inspection using a stereomicroscope, a dimensional inspection using an electronic caliper, and a cleaning inspection using a cleaning degree determination kit.
  • the kit for determining the degree of washing is a commercially available kit for determining the stain by, for example, a change in color according to the protein mass.
  • the functional metal parts that have passed the inspection in step 114 are stocked as recycled products (115).
  • step 104 and step 114 Those that did not pass the inspection in step 104 and step 114 and those that were not sorted out as metal functional parts in step 111 are separated into plastics and other materials and reused as materials, respectively. Or is discarded (1 18).
  • the disposable medical device recycling system is intended to recycle disposable medical devices having a structure in which functional parts made of metal and plastic parts can be disassembled. Therefore, the time and labor required to disassemble the collected disposable medical device is extremely small. In addition, the metal parts to be recycled are hardly damaged or deformed during the disassembly work, so that a high yield can be recovered. For this reason, the disassembly cost that determines the amount of parts recycling cost can be kept very low, and a low parts recycling cost can be secured. (High quality assurance)
  • the high quality assurance of the disposable medical device according to the present invention is based on the fact that the service life of a metal functional component is a highly reliable value determined by a scientific experiment method, and that it is at least equal to the acceptance inspection of a new component. Strict inspections are performed in the parts recycling system to ensure this. In addition, the data management system, including the management of the use history of functional metal parts, ensures that both the manufacturing system and the parts recycling system are properly managed, which supports high quality assurance.
  • the scientific experiment method for determining the service life described above is basically the same as the two-stage scientific experiment method described in the second fact on which the present invention is based. Each time a new metal part to be reused appears in a new or improved disposable medical device having a structure in which metal functional parts and plastic parts can be disassembled, the above two-step Useful life is determined by scientific testing methods.
  • Used disposable medical devices are returned to the blister bag, stored in a dedicated storage device, and collected by a collection company. Before being delivered to the manufacturer, it is subjected to radiation sterilization. Whether or not radiation sterilization has been completed can be reliably determined by the chemical indicator attached to the special storage device. Therefore, in the present invention, safe recovery of the used disposable medical device is ensured.
  • the disposable medical device recycling system is a recycling system, it is desirable that all functional metal components to be recycled be recovered from the medical institution to the manufacturer. According to the present invention, it is obvious that the medical institution will actively cooperate with the primary collection work since it is not necessary to pay the disposal fee to the medical waste disposal company. Therefore, in the present invention, the recovery rate of the metal functional component to be recycled to the manufacturer is inevitably increased. If disposable medical devices are supplied to medical institutions in loan form, even if they have been used, the disposable medical devices are under the control of the manufacturer, so a higher recovery rate can be secured. Industrial applicability
  • a recycling system for a disposable medical device having a structure in which a metal functional component and a plastic component can be disassembled is provided.
  • the functional parts made of metal are used as recycled products several times, so that the cost of purchasing the parts is reduced.
  • new collection costs, sterilization costs, and disassembly costs are incurred. However, even if these costs are added together, they do not exceed the reduction in parts purchase costs. Can be reduced.

Abstract

A disposable medical device recycling system for not disposing of but recycling a disposable medical device which is constructed by combining metallic functional parts and plastic parts, after the medical device is employed in a medical organ. The recycling system comprises: a manufacture system (21) for manufacturing the disposable medical device through steps of assembling the metallic functional parts and the plastic parts; a feed system (22) for feeding the disposable medical device to the medical organ; a recovery system (23) for recovering the employed disposable medical device to a maker after sterilizing it; and a parts regenerating system (24) for regenerating the metallic functional parts through a step of disassembling the employed disposable medical device recovered and steps of selecting and inspecting the metallic functional parts within a useful life. The target of the recycling system is the disposable medical device of the structure, in which the metallic functional parts and the plastic parts can be disassembled.

Description

明 細 書 ディスポ一ザブル医療用具のリサイクルシステム 技術分野  Description Disposable medical device recycling system Technical field
本発明は、 金属製機能部品とプラスチック部品を含むその他の部品 (以下、 プ ラスチック部品等と記述する) を組合わせて構成されたデイスポ一ザブル医療用 具に関し、 特に前記ディスポーザカレ医療用具を製造するメーカ一とこれを利用 する複数の医療機関とを含むディスポーザブル医療用具のリサイクルシステムに 関する。 背景技術  The present invention relates to a disposable medical device configured by combining a metal functional component and other components including a plastic component (hereinafter, referred to as a plastic component, etc.), and particularly to manufacturing the disposable curry medical device. The present invention relates to a recycling system for disposable medical devices, including manufacturers that use them and multiple medical institutions that use them. Background art
ディスポーザブル医療用具は、 診療行為に使用された後は医療廃棄物として廃 棄処分される。 1回使用したデイスポーザブル医療用具を他の患者等に使用する と、 感染事故を起こす恐れがあるからである。 1回使用したデイスポーザブル医 療用具を滅菌すれば再利用できそうである。 医療分野では、 消毒薬品や消毒ガス 等を用いた殺菌方法、 ォ一トクレーブ等の高圧蒸気を用いた滅菌方法が一般的で ある。 しかしながら、 これらの滅菌方法で使用後のディスポーザブル医療用具を 完全に滅菌することは極めて困難である。  Disposable medical devices are disposed of as medical waste after being used for medical treatment. If a disposable medical device used once is used for other patients, it may cause infection. It seems that disposable medical devices used once can be reused if they are sterilized. In the medical field, a sterilization method using a disinfectant or a disinfecting gas or a sterilization method using high-pressure steam such as an autoclave is generally used. However, it is extremely difficult to completely sterilize disposable medical devices after use with these sterilization methods.
特に、 金属製機能部品とプラスチック部品等が溶接や溶着等によって接合され て分解できないように構成された従来のディスポーザブル医療用具については、 消毒薬品や消毒ガス等を用いた殺菌方法、 オートクレープ等の高圧蒸気を用いた 滅菌方法では使用後のディスボーザブル医療用具の完全な滅菌は不可能である。 しかも、 これらの滅菌方法が施された場合、 プラスチック部品が変形するので、 金属製機能部品とプラスチック部品等とから構成されたディスポ一ザブル医療用 具は本来の機能を果たさなくなる。 結局のところ、 金属製機能部品とプラスチッ ク部品等とから構成された従来のディスポーザブル医療用具は、 使用後は医療廃 棄物として廃棄処分されている。 その結果、 医療廃棄物の量が年々増加し、 社会 問題となっている。 ところが、 これを解決する効果的な方法が未だに実現してい ない。 In particular, with regard to conventional disposable medical devices that are constructed so that metal functional parts and plastic parts are bonded and welded so that they cannot be disassembled, sterilization methods using disinfecting chemicals and gas, autoclave, etc. The sterilization method using high-pressure steam cannot completely sterilize the disposable medical device after use. Moreover, when these sterilization methods are applied, the plastic parts are deformed, so that the disposable medical device composed of the functional parts made of metal and the plastic parts does not perform its original function. After all, conventional disposable medical devices composed of metal functional parts and plastic parts are disposed of as medical waste after use. As a result, the amount of medical waste is increasing year by year, and has become a social problem. However, effective methods to solve this are still available. Absent.
この従来のデイスポーザブル医療用具の生産から販売、 使用、 そして廃棄まで の流れを図示すれば、 第 1 1図に示す如く、 金属製機能部品とプラスチック部品 等が分解困難な構造のディスポーザブル医療用具を製造する製造システム 3 1、 前記ディスポ一ザブル医療用具をメーカーから直接に又は販売会社を経由して医 療機関に販売する供給システム 3 2、 及び、 使用済デイスポーザブル医療用具を 医療廃棄物処理業者が医療機関から回収し廃棄処分する廃棄システム 3 3とから 構成された非リサイクルシステムである。  The flow of production, sales, use, and disposal of this conventional disposable medical device is illustrated in Fig. 11. As shown in Fig. 11, disposable medical devices with a structure in which metal functional parts and plastic parts are difficult to disassemble are shown. Manufacturing system 3 1, a supply system 3 2 for selling the disposable medical device directly to a medical institution from a manufacturer or via a sales company, and a used disposable medical device for medical waste This is a non-recycling system consisting of a disposal system where the processing company collects from medical institutions and disposes of it.
換言すれば、 第 1 2図に示す如く、 金属製機能部品とプラスチック部品等とか ら構成された従来のディスポ一ザブル医療用具は、 メーカ一 2 5から医療機関 2 6に販売され、 そして、 医療機関 2 6で使用された後は医療廃棄物処理業者 2 7 によって回収され、 焼却炉で焼却され、 又は埋立処分場に埋め立てられて廃棄処 分されていた。 従って、 従来は第 1 0図に示す如く、 医療機関 2 6はディスポ一 ザブル医療用具の購入時に購入代金をメーカ一 2 5に支払い、 更に廃棄時には廃 棄手数料を医療廃棄物処理業者 2 7に支払うという二重の費用負担を強いられて いるという問題がある。  In other words, as shown in Fig. 12, a conventional disposable medical device composed of functional metal parts and plastic parts is sold from a manufacturer 25 to a medical institution 26, and After being used at the institution 26, it was collected by a medical waste disposal company 27, incinerated in an incinerator, or disposed of at a landfill site for disposal. Therefore, conventionally, as shown in Figure 10, the medical institution 26 pays the purchase price to the manufacturer 25 when purchasing disposable medical devices, and furthermore, a disposal fee to the medical waste disposal company 27 when disposing. The problem is that you have to pay the double cost of paying.
医療廃棄物として廃棄処分するにしても、 使用後のディスポーザブル医療用具 には有害な病原菌等を含む血液、体液、生体片が付着している可能性があるため、 回収作業や廃棄作業に携わる人達の安全性の確保と不法投棄の防止等に関して 様々な問題がある。 そして、 これらの問題を解決するために、 従来からいくつも の提案がなされている。  Even if they are disposed of as medical waste, blood, body fluids and biological fragments containing harmful pathogens may be attached to the disposable medical device after use, so those who are involved in collection and disposal work There are various problems related to ensuring the safety of buildings and preventing illegal dumping. Several proposals have been made to solve these problems.
例えば、 特開平 7— 9 5 9 8 2号公報に開示されているデイスポーザブル医療 用具は、 体腔内粘膜と直接触れない部分の少なくとも一部の部材を、 親水性を有 するポリマーを含む材料で構成することによって、 ディスポーザブル医療用具を 再使用できないようにしたものである。  For example, a disposable medical device disclosed in Japanese Patent Application Laid-Open No. Hei 7-95982 discloses a method in which at least a part of a portion that does not directly contact a mucous membrane in a body cavity is made of a material containing a hydrophilic polymer. By disposing disposable medical devices, they cannot be reused.
特開平 8— 5 7 4 4 2号公報には、 プラスチック材料の発火点よりも低く且つ プラスチック材料の融点よりも高い温度で加熱できる特殊な回収容器に使用後の デイスポーザブル医療用具を入れて、 高温による滅菌、 及びプラスチック材料の 廃棄物の処理方法が開示されている。 この処理方法によれば、 使用後のディスポ 一ザブル医療用具の滅菌、 及びプラスチック材料と非プラスチック材料 (ゴムや 金属材料) の分別回収ができる。 従って、 回収作業や廃棄作業に携わる人達の安 全性の確保と、 素材としての再利用が可能である。 Japanese Unexamined Patent Publication No. Hei 8-574742 discloses a disposable medical device used in a special collection container that can be heated at a temperature lower than the ignition point of the plastic material and higher than the melting point of the plastic material. , High temperature sterilization, and plastic material A method for treating waste is disclosed. According to this treatment method, disposable medical devices after use can be sterilized, and plastic materials and non-plastic materials (rubber and metal materials) can be separated and collected. Therefore, it is possible to ensure the safety of those involved in collection and disposal work, and to reuse them as materials.
更に、 特開平 9— 9 9 0 1 9号公報には、 アミノ基を有する生化学物質の付着 する医療廃棄物としてのプラスチック製デイスポーザブル医療用具と、 ォキシラ ン環を有するエポキシ化合物を混合することによって、 前記アミノ基によるェポ キシ化合物のォキシラン環の開環反応を生じさせ、 最終処理物として医療廃棄物 とエポキシ硬化樹脂との固結物を生成させる医療廃棄物の処理方法が開示されて いる。 この処理方法によれば、 使用後のディスポーザブル医療用具の滅菌、 及び プラスチック材料の回収ができる。 従って、 回収作業や廃棄作業に携わる人達の 安全性の確保と、 素材としての再利用が可能である。  Further, Japanese Patent Application Laid-Open No. 9-99019 discloses that a plastic disposable medical device as a medical waste to which a biochemical substance having an amino group is attached, and an epoxy compound having an oxylan ring are mixed. Thus, there is disclosed a method for treating medical waste in which a ring-opening reaction of the oxysilane ring of the epoxy compound is caused by the amino group, and a solidified product of the medical waste and the epoxy cured resin is generated as a final product. ing. According to this treatment method, the disposable medical device after use can be sterilized, and the plastic material can be collected. Therefore, it is possible to ensure the safety of those involved in the collection and disposal work, and to reuse the material.
ところで、 デイスポーザブル医療用具の中には、 価格が数万円もする内視鏡手 術用器具の如き高価なものがある。 このような高価なディスポ一ザブル医療用具 は、 金属製機能部品とプラスチック部品等を組合わせて構成されたディスポーザ ブル医療用具であり、 その部品コス卜の大部分を金属製機能部品が占めている。 上述した従来の医療用具の廃棄処理方法では、 ディスポーザブル医療用具の高 価な金属製機能部品も単なる金属材料にしか再利用することが出来ないので、 医 療業界にとって極めて不経済であるという問題がある。  By the way, some disposable medical devices are expensive, such as endoscopic surgical devices that cost tens of thousands of yen. Such an expensive disposable medical device is a disposable medical device configured by combining a metal functional component and a plastic component, etc., and the functional component of the metal occupies most of the component cost. . The conventional medical device disposal method described above has a problem that it is extremely uneconomical for the medical industry because expensive metal functional components of disposable medical devices can be reused only for simple metallic materials. is there.
本発明が解決しょうとする第 1の課題は、 金属製機能部品とプラスチック部品 等を組合わせて構成されたデイスポーザプル医療用具が医療機関で使用された後 に、 そのまま廃棄処分されないで、 再生工程を踏み再利用されるようにすること である。  The first problem to be solved by the present invention is that a disposable pull medical device composed of a combination of a metal functional component and a plastic component, etc. is used at a medical institution, and is not discarded as it is, but is recycled. It is to be reused through the process.
本発明が解決しょうとする第 2の課題は、 金属製機能部品とプラスチック部品 等を組合わせて構成されたデイスポーザブル医療用具が医療機関で使用された後 に、 再生工程を踏み前記金属製機能部品を再生品として再利用することである。 発明の開示  A second problem to be solved by the present invention is that after a disposable medical device composed of a combination of a functional component made of metal and a plastic component is used in a medical institution, the disposable medical device goes through a regeneration process, and This is to reuse functional components as recycled products. Disclosure of the invention
上記課題を解決する本願の第 1発明のディスポーザブル医療用具のリサイクル システムを、 金属製機能部品とプラスチック部品等の組立工程を経てディスポー ザブル医療用具を製造する製造システム、 医療機関にディスポーザブル医療用具 を供給する供給システム、 使用済ディスポーザブル医療用具を滅菌処理してメー カーに回収する回収システム、 及び、 回収した使用済デイスポーザブル医療用具 の分解工程と耐用回数以内の金属製機能部品の選別工程と検査工程を経て金属製 機能部品を再生する部品再生システムとで構成した。 Recycling of the disposable medical device of the first invention of the present application that solves the above problems Manufacturing system that manufactures disposable medical devices through the process of assembling metal functional parts and plastic parts, supply system that supplies disposable medical devices to medical institutions, and manufacturers that sterilize used disposable medical devices And a component recycling system that recycles the functional metal components through the disassembly process of the collected disposable medical devices collected, the sorting process of metal functional components within the service life, and the inspection process. did.
上記課題を解決する本願の第 2発明のディスポーザブル医療用具のリサイクル システムを、 金属製機能部品とプラスチック部品等の組立工程を経てディスポー ザブル医療用具を製造する製造システム、 医療機関にデイスポーザブル医療用具 を供給する供給システム、 使用済デイスポーザブル医療用具を分解し金属製機能 部品のみを滅菌処理してメーカ一に回収する回収システム、 及び、 回収した金属 製機能部品から耐用回数以内のものを選別する選別工程と検査工程を経て金属製 機能部品を再生する部品再生システムとで構成した。  The disposable medical device recycling system according to the second aspect of the present invention, which solves the above-mentioned problems, includes a disposable medical device manufacturing system for manufacturing disposable medical devices through a process of assembling metal functional components and plastic components, and a disposable medical device for medical institutions. Supply system that supplies disposable medical devices, disassembling used disposable medical devices, and sterilizing only metal functional parts and collecting them to the manufacturer, and sorting collected metallic functional parts within the number of service life It consists of a parts recycling system that recycles metallic functional parts through a sorting process and an inspection process.
本発明に係るディスポーザブル医療用具のリサイクルシステムにおいて、 リサ イクルの対象は、 金属製機能部品とプラスチック部品等が分解可能な構造である デイスポーザブル医療用具である。 より具体的には、 前記ディスポ一ザブル医療 用具は、 その金属製機能部品とプラスチック部品等とが分解可能な構造であるデ ィスポ一ザブル内視鏡手術用器具である。  In the recycling system for disposable medical devices according to the present invention, the object of recycling is a disposable medical device having a structure in which a metal functional component and a plastic component can be disassembled. More specifically, the disposable medical device is a disposable endoscopic surgical instrument having a structure in which a metal functional component and a plastic component can be disassembled.
そして、 上記のデイスポーザブル医療用具の製造システムは、 金属製機能部品 とプラスチック部品等の組立工程を経てディスポ一ザブル医療用具を製造する製 造システムとした。この製造システムにおいて、新品の金属製機能部品に加えて、 部品再生システムから供給された再生品の金属製機能部品も用いられる。  The disposable medical device manufacturing system described above is a manufacturing system for manufacturing disposable medical devices through an assembling process of metal functional components and plastic components. In this manufacturing system, recycled metal functional components supplied from the component recycling system are used in addition to new metal functional components.
また、 上記のディスポ一ザブル医療用具の供給システムは、 メーカーからユー ザ一である医療機関にデイスポーザブル医療用具を販売又は貸与して供給するシ ステムである。 ディスポ一ザブル医療用具は、 製品番号が付され且つ使用済か否 かを識別する識別手段を備えた個別ケースに収納されて、 医療機関に供給される ことができる。 ディスポ一ザブル医療用具の供給は、 メ一カーから医療機関に直 接に行う場合だけでなく、 販売会社又はリース会社を介して行うことも当然に含 まれる。 上記の耐用回数は、 デイスポーザブル医療用具の模擬使用、 分解、 検査、 及び 組立のサイクルを繰り返すことによつて実験的に求められたものである。 The disposable medical device supply system described above is a system in which a manufacturer sells or lends disposable medical devices to a medical institution, which is the user, and supplies the disposable medical devices. The disposable medical device can be supplied to a medical institution in a separate case provided with a product number and identification means for identifying whether or not the medical device has been used. The supply of disposable medical equipment includes not only direct supply from a manufacturer to a medical institution, but also supply through a sales company or leasing company. The above service life was determined experimentally by repeating the cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device.
上記の回収システムにおける滅菌処理は、 代表的には放射線滅菌処理がある。 上記の部品再生システムにおいては、 回収された使用済ディスポーザブル医療 用具に含まれている金属製機能部品の使用履歴データに基づいて、 耐用回数以内 の金属製機能部品か否かの選別が行われる。  Sterilization treatment in the above recovery system is typically radiation sterilization treatment. In the above-mentioned component recycling system, whether or not the functional component is a metal functional component within the service life is determined based on the usage history data of the metallic functional component included in the collected used disposable medical device.
上記の供給システムにおける医療機関へのディスポ一ザブル医療用具の供給、 及び前記回収システムにおける使用済デイスポーザブル医療用具又は金属製機能 部品の医療機関からの回収は、 識別番号が付された専用収納具によつて行うこと ができる。 この専用収納具は、 専用ケース又は専用袋であって、 ケミカルインジ ケ一夕が貼付されているとよい。  The supply of disposable medical devices to medical institutions in the supply system described above and the collection of used disposable medical devices or metal functional parts from medical institutions in the collection system are performed by dedicated storage with identification numbers. It can be done with tools. This special storage device is a special case or a special bag, and it is preferable that a chemical indicator is attached thereto.
本発明に係るディスポーザブル医療用具のリサイクルシステムにおいて、 ディ スポーザブル医療用具の製品番号、 ディスポ一ザブル医療用具を構成する部品の 部品番号、 再生品の対象となる金属製機能部品の使用履歴データ、 専用収納具に 付された識別番号等のデ一夕は、 メーカー内に設けられているデータ管理システ ムにより管理されているとよい。 図面の簡単な説明  In the disposable medical device recycling system according to the present invention, the product number of the disposable medical device, the part number of the component constituting the disposable medical device, the use history data of the metallic functional component to be recycled, and the exclusive storage Data such as identification numbers given to tools should be managed by the data management system provided in the manufacturer. BRIEF DESCRIPTION OF THE FIGURES
第 1図は本発明の一実施例のディスポーザブル医療用具のリサイクルシステム のブロック構成図である。 第 2図は本発明の他の実施例のデイスポーザブル医療 用具のリサイクルシステムのプロック構成図である。 第 3図は本発明に係るディ スポーザブル医療用具のリサイクルシステムのフローチャートである。 第 4図は 金属製機能部品の耐用回数判定方法の第一段階の実験のフローチャートである。 第 5図は金属製機能部品の耐用回数判定方法の第二段階の実験のフローチヤ一ト である。 第 6図は金属製機能部品とプラスチック部品等が分解可能なディスポー ザブル医療用具の一実施例のハンドル部を分解した状態を示す斜視図である。 第 7図は本発明の一実施例のディスポーザブル医療用具のリサイクルシステムにお けるメーカーと医療機関の位置付を示す図である。 第 8図は本発明の他の実施例 のデイスポーザブル医療用具のリサイクルシステムにおけるメーカ一と医療機関 の位置付を示す図である。 第 9図は本発明に係るディスポーザブル医療用具のリ サイクルシステムにおけるメーカーと医療機関との関係を示す図である。 第 1 0 図は従来の非リサイクルシステムにおけるデイスポーザカレ医療用具のメーカー と医療機関との関係を示す図である。 第 1 1図は従来の製造から使用、 廃棄まで のデイスポーザブル医療用具の非リサイクルシステムを示す図である。 第 1 2図 は従来のディスポ一ザブル医療用具の非リサイクルシステムにおけるメーカ一と 医療機関の位置付を示す図である。 発明を実施するための最良の形態 FIG. 1 is a block diagram of a recycling system for disposable medical devices according to one embodiment of the present invention. FIG. 2 is a block diagram of a disposable medical device recycling system according to another embodiment of the present invention. FIG. 3 is a flowchart of a disposable medical device recycling system according to the present invention. FIG. 4 is a flowchart of an experiment in the first stage of the method for determining the number of times of use of a metal functional component. FIG. 5 is a flowchart of the second stage experiment of the method of judging the number of times of use of a metallic functional component. FIG. 6 is a perspective view showing a disassembled state of a handle portion of an embodiment of the disposable medical device in which a metal functional component and a plastic component can be disassembled. FIG. 7 is a diagram showing the positions of manufacturers and medical institutions in the disposable medical device recycling system according to one embodiment of the present invention. FIG. 8 shows a manufacturer and a medical institution in a disposable medical device recycling system according to another embodiment of the present invention. FIG. FIG. 9 is a diagram showing a relationship between a maker and a medical institution in the disposable medical device recycling system according to the present invention. FIG. 10 is a diagram showing the relationship between a manufacturer of disposable care medical equipment and a medical institution in a conventional non-recycling system. Fig. 11 shows a conventional non-recycling system for disposable medical devices from manufacturing to use and disposal. FIG. 12 is a diagram showing the positions of manufacturers and medical institutions in a conventional non-recyclable system for disposable medical devices. BEST MODE FOR CARRYING OUT THE INVENTION
本発明に係るディスポーザブル医療用具のリサイクルシステムは、 金属製機能 部品とプラスチック部品等を組合わせて構成された内視鏡手術用器具に関する下 記の 3つの事実を基礎として発明されたものである。 従って、 発明の実施の形態 の説明に先立って、 これらの 3つの事実を説明する。  The disposable medical device recycling system according to the present invention has been invented based on the following three facts regarding an endoscopic surgical instrument configured by combining a metal functional component and a plastic component. Therefore, these three facts will be described before describing the embodiments of the invention.
(分解可能な構造のディスポーザブル内視鏡手術用器具)  (Disposable endoscopic surgical instrument with disassembly structure)
第 1の事実は、 本願の出願人の一人が、 金属製機能部品とプラスチック部品等 を組合わせて構成されたディスポーザブル内視鏡手術用器具であって、 金属製機 能部品とプラスチック部品等が容易に分解可能な構造のディスポ一ザブル内視鏡 手術用器具を発明し、 特願平 2 0 0 0 - 1 9 3 2 0 7として出願していることで ある。  The first fact is that one of the applicants of the present application is a disposable endoscopic surgical instrument configured by combining a metal functional component and a plastic component, etc. The inventor invented a disposable endoscope surgical instrument having a structure that can be easily disassembled, and filed an application as Japanese Patent Application No. 2000-193,207.
即ち、 前記ディスポーザブル内視鏡手術用器具は鉗子であって、 その一実施例 はハンドル部 2を分解した状態の斜視図である第 6図に示す通りである。  That is, the disposable endoscopic surgical instrument is a forceps, and one embodiment thereof is as shown in FIG. 6 which is a perspective view of a state where the handle portion 2 is disassembled.
第 6図において、 ハンドル部 2は、 指掛けリング 2 Aの大半を含む右側部分 2 Bと、 残りの左側部分 2 Cとを左右から合わせて構成されている。 これらの 2つ の部分 2 B、 2 Cは、 それぞれの内側の 2箇所の対向位置に形成されているダボ 穴 1 0、 1 1に、 ダボピン 1 2、 1 3の両側の小径部分を圧入して一体に組み立 てられるようになつている。 これらのダボ穴 1 0、 1 1と、 ダボピン 1 2、 1 3 は、 連結部を構成している。  In FIG. 6, the handle portion 2 is configured by combining a right portion 2B including most of the finger ring 2A and a left portion 2C from the left and right. These two parts 2 B and 2 C are press-fitted with small diameter parts on both sides of dowel pins 1 and 2 into dowel holes 10 and 11 formed at two opposing positions on the inside. So that they can be assembled together. The dowel holes 10 and 11 and the dowel pins 12 and 13 constitute a connecting portion.
これらのダボピン 1 2、 1 3の両側付近の小径の部分の外周面には、 細かいセ レ一シヨンが形成されてダボ穴 1 0、 1 1の内周面と摩擦係合する構造になって おり、 ハンドル部 2を構成している 2つの部分 2 B、 2 Cどうしを、 通常の使用 状態では分離しないように強固に結合している。 On the outer peripheral surface of the small-diameter portion near both sides of these dowel pins 12 and 13, a fine cell is formed to frictionally engage the inner peripheral surfaces of the dowel holes 10 and 11. The two parts 2 B and 2 C constituting the handle part 2 are firmly connected to each other so as not to be separated in a normal use state.
操作レバー 6は、 Λンドル部 2の右側部分 2 Bの内側に突出している軸 1 4の 回りに回動自在に支持されており、 また、 軸部 3の内部を摺動自在に貫通してい るフィンガ開閉ロッド 1 5の後端の連結ピポッ卜 1 6に回動自在に連結されてい る。  The operation lever 6 is rotatably supported around a shaft 14 protruding inside the right portion 2B of the handle portion 2 and penetrates slidably through the shaft portion 3. The opening / closing finger 15 is rotatably connected to a connecting pipe 16 at the rear end.
フィンガ開閉ロッド 1 5の前端部は、 一対のフィンガ 4とリンク結合されてい て、 操作レバー 6の回動が一対のフィンガ 4の開閉運動に変換されるように構成 されている。  The front end of the finger opening / closing rod 15 is linked to the pair of fingers 4 so that the rotation of the operation lever 6 is converted to the opening / closing movement of the pair of fingers 4.
また、 フィンガ開閉ロッド 1 5の後端付近は、 導電板 1 7を介して端子 9に電 気的に連結されており、 端子 9から一対のフィンガ 4へのフィンガ開閉ロッド 1 5を通じて通電されるようになつている。  The vicinity of the rear end of the finger opening / closing rod 15 is electrically connected to the terminal 9 via the conductive plate 17, and electricity is supplied through the finger opening / closing rod 15 from the terminal 9 to the pair of fingers 4. It is like that.
一方、 操作レパ一 6には鋸歯状のラチエツト歯 Tが形成されていて、 このラチ エツト歯 Tが、 ラチエツト 1 8に形成されている爪 tと嚙み合うことで、 フィン ガ 4の開く向きの操作レバ一 6の回動がロックされる構造となっている。  On the other hand, a saw tooth tooth T is formed on the operation reporter 6, and the finger tooth 4 is opened by engaging the tooth T with the claw t formed on the ratchet 18. The rotation of the operation lever 6 in the direction is locked.
ラチェット 1 8は、 軸 1 4と同様にハンドル部 2の右側部分 2 Bの内側に突出 している軸 1 9に回動自在に支持されていて、 ラチェットパネ 2 0によって、 常 時爪 tがラチエツト歯 Tに嚙み合うように付勢されている。  The ratchet 18 is rotatably supported on a shaft 19 protruding inside the right side portion 2B of the handle portion 2 similarly to the shaft 14, and the pawl t is always held by the ratchet panel 20. It is urged to engage the ratchet teeth T.
また、 前記ラチエツト 1 8は、 ラチエツト解放スィッチ 7を前方へスライドさ せることによって、 ラチエツト歯 Tに対して爪 tが離間した状態に保持され、 こ の状態でフィンガ 4を開くことが可能となっている。  Further, the ratchet 18 is held in a state where the pawl t is separated from the ratchet tooth T by sliding the ratchet release switch 7 forward, and the finger 4 can be opened in this state. ing.
ハンドル部 2内に端子 9ゃラチエツトバネ 2 0、 導電板 1 7、 フィンガ開閉口 ッド 1 5等の金属材料で製作された金属製部品を含んでおり、 これらの部品の中 の一部、 即ち金属製機能部品は使用済みの鉗子 1を分解して、 ハンドル 2から分 別される。  The handle part 2 includes metal parts made of metal materials such as terminals 9 ゃ ratchet spring 20, conductive plate 17, finger opening and closing port 15, etc., and some of these parts, namely The metal functional parts are separated from the handle 2 by disassembling the used forceps 1.
使用済みの鉗子 1のハンドル部 2を分解する場合は、 ダボピン 1 2、 1 3で結 合されている右側部分 2 Bと左側部分 2 Cを強制的に分離する。 この作業を容易 にするために、 本実施例の鉗子 1においてはハンドル部 2を構成している右側部 分 2 Bと左側部分 2 Cの接合面外周の前側と後側に、 それぞれマイナスドライノ 一等の工具を差込可能な溝部が形成されている。 When disassembling the handle portion 2 of the used forceps 1, forcibly separate the right portion 2 B and the left portion 2 C connected by the dowel pins 12 and 13. In order to facilitate this work, in the forceps 1 of the present embodiment, a minus dry line is attached to the front and rear sides of the outer periphery of the joint surface of the right part 2B and the left part 2C constituting the handle part 2 respectively. A groove into which a first-class tool can be inserted is formed.
これらの溝部は、 ハンドル部 2の両側の部分 2 B、 2 C接合面外周部の同一箇 所に対向してそれぞれ半分の幅ずつ形成されており、 これらの部分 2 B、 2 Cが 一つにあわせられたときに、 マイナスドライバ一等の刃先が差し込可能な幅の溝 になるように形成されている。  Each of these grooves is formed to have a half width opposite to the same portion of the outer peripheral portion of the joint surface 2B, 2C on both sides of the handle portion 2, and each of these portions 2B, 2C is one. It is formed so that the blade edge of a flat-blade screwdriver or the like becomes a groove with a width that can be inserted when it is adjusted.
この実施例においては、ハンドル部 2の 2つの部分 2 B、 2 Cどおしの接合を、 ハンドル部 2の指掛け部 2 A上部付近と、 ハンドル部 2の後方上端付近の 2箇所 に配置されたダボピン 1 2、 1 3によって行っているため、 2箇所の溝部 2 1、 2 2は、 ハンドル部 2の外周のこれらのダボピン 1 2、 1 3に接近した位置に設 けてある。  In this embodiment, the joints of the two parts 2 B and 2 C of the handle part 2 are arranged at two places near the upper part of the finger hook 2 A of the handle part 2 and near the rear upper end of the handle part 2. Since the dowel pins 12 and 13 are used, the two grooves 21 and 22 are provided on the outer periphery of the handle portion 2 at positions close to the dowel pins 12 and 13.
ハンドル部 2を分解する際は、 先ずこれらの溝部のうち、 片方の溝部にマイナ スドライバ一等の工具を差し込んでこじり、 2つの部分 2 B、 2 Cの接合面間に 僅かに隙間が生じたら、 こんどは他方の溝部に工具を差し換えて同様にこじり、 2つの部分 2 B、 2 Cの間の隙間が大体均一に増加するように作業することで、 これらのダボピン 1 2、 1 3はそれぞれのダボ穴 1 0、 1 1から抜けだし、 ハン ドル部 2は容易に 2つの部分 2 B、 2 Cに分解することができる。  When disassembling the handle part 2, first insert a tool such as a minus screwdriver into one of these grooves and pry it to create a slight gap between the joint surfaces of the two parts 2B and 2C. Now, replace the tool in the other groove and pry in the same way, and work so that the gap between the two parts 2B and 2C increases almost uniformly, so that these dowel pins 1 2 and 1 3 Each dowel hole 10, 11 comes out, and the handle part 2 can be easily disassembled into two parts 2 B, 2 C.
要するに、 第 6図に示すディスポーザカレ医療用具は、 ハンドル部が互いに複 数の部分から構成され、 これらの部分が連結部で連結されて一体に組み立てられ ているディスポーザブル内視鏡手術用器具において、 ハンドル部の連結部で互い に連結されている部分の接合面の外周の少なくとも一部に、 これらの接合面どう しを押し広げて連結部を強制的に分離するための工具を差込可能な溝部を形成し たことを特徴とするディスポーザブル内視鏡手術用器具である。  In short, the disposable curry medical device shown in FIG. 6 is a disposable endoscopic surgical instrument in which the handle portion is composed of a plurality of portions, and these portions are connected to each other by a connecting portion and integrally assembled. A tool can be inserted into at least a part of the outer circumference of the joint surface of the parts connected to each other at the joint part of the handle part to push apart these joint surfaces to forcibly separate the joint part This is a disposable endoscopic surgical instrument characterized by forming a groove.
(金属製機能部品の耐用回数の確認)  (Confirmation of service life of functional metal parts)
第 2の事実は、 上記特願平 2 0 0 0— 1 9 3 2 0 7に係るディスポーザブル内 視鏡手術用器具を製作し、 科学的実験により、 その金属製機能部品は数回の使用 に耐えられること、 即ち耐用回数は数回であることを、 本願の発明者が確認した ことである。  The second fact is that the disposable endoscopic surgical instrument according to the above-mentioned Japanese Patent Application No. 2000-1993 207 was manufactured and, through scientific experiments, its metallic functional parts could be used several times. The inventor of the present application has confirmed that it can withstand, that is, the durability is several times.
上記ディスポーザブル内視鏡手術用器具は、 ハンドル、 先端部分、 シャフト、 ロッド、 リンク部品、 ダイヤル、 レバ一、 電極棒、 ラチェット、 ラチェット部品、 及び絶縁力バーの複数の部品を組み立てて構成されたものである。金属製部品は、 先端部分、 シャフト、 ロッド、 リンク部品、 及び電極棒であるが、 再生品の対象 となる金属製機能部品は、 先端部分と電極棒である。 The above disposable endoscopic surgical instruments consist of a handle, a tip, a shaft, a rod, a link part, a dial, a lever, an electrode rod, a ratchet, a ratchet part, And a plurality of parts of the insulating bar. Metal parts are tip parts, shafts, rods, link parts, and electrode rods, but metal functional parts to be recycled are the tip parts and electrode rods.
この第 2の事実、 即ち、 内視鏡手術用器具の金属製機能部品は、 完全な滅菌が なされれば、 数回の使用に耐えられるという事実は、 第 4図及び第 5図に示すフ ローチャートによる実験方法で確認された。  This second fact, that is, the fact that the metallic functional parts of an endoscopic surgical instrument can withstand several uses if completely sterilized, is illustrated in FIGS. 4 and 5. It was confirmed by an experimental method using a chart.
第 4図は、 第一段階での実験方法であって、 この段階でそれぞれの再利用部品 が凡そ何回使用することができるのかを判断した。 即ち、 市販されている肉など を利用して製品を模擬的に使用し(2 0 1 )、血液に真似た染料を用いて製品を汚 染させた (2 0 2 )。 次に、 粗洗浄工程を行い (2 0 3 )、 製品を分解した (2 0 4 )。 続いて分解した部品を選別し (2 0 5 )、 再利用部品となる金属製機能部品 を超音波洗浄機を用いて洗浄し (2 0 6 )、 乾燥させ (2 0 7 )、 再利用部品とな る金属製機能部品の検査を行った (2 0 8 )。  Fig. 4 shows the experimental method in the first stage. At this stage, it was determined how many times each reusable part can be used. That is, the product was simulated using commercially available meat or the like (201), and the product was contaminated with a dye imitating blood (202). Next, a rough cleaning step was performed (203), and the product was disassembled (204). Subsequently, the disassembled parts are sorted out (205), and the metallic functional parts to be reused are cleaned using an ultrasonic cleaner (206), dried (207), and reused parts are reused. The metal functional parts were inspected (2008).
再利用部品となる金属製機能部品の検査内容は、 損耗の確認のための実体顕微 鏡を用いての形状検査と電子ノギスを用いての寸法検査、 及び洗浄度判定キット を用いての清浄検査である。 前記洗浄度判定キットは、 例えば蛋白質量に応じた 色の変化で、 その汚れを判定する市販のキットである。  Inspection contents of metal functional parts that are reused parts include shape inspection using a stereomicroscope to check for wear, dimension inspection using an electronic caliper, and clean inspection using a cleanliness determination kit. It is. The kit for determining the degree of washing is a commercially available kit for determining the stain by, for example, a change in color according to the amount of protein.
これらの各試験に合格した再利用部品となる金属製機能部品のみを未使用部品 と共に組み立てて製品を完成させ(2 0 9 )、 製品の動作試験(2 1 0 ) を経て、 再度製品を模擬的に使用する工程 (2 0 1 ) に戻った。 製品の動作試験には、 把 持力試験や、 耐久試験なども行った。 なお、 再利用部品となる金属製機能部品以 外の部品と、 検査に合格しなかった金属製機能部品は、 素材として再利用される ( 2 1 1 ) か、 又は廃棄された。  Only the metal functional parts that are reused parts that passed each of these tests were assembled together with unused parts to complete the product (209), and after the product operation test (210), the product was simulated again. It returned to the step (201) which is commonly used. For the operation test of the product, a grip force test and a durability test were also performed. Parts other than metal functional parts that are reused parts and metal functional parts that did not pass the inspection were either reused as materials (2 1 1) or discarded.
上述のステップ 2 0 1から 2 1 0までのサイクルを繰り返し行ない、 各検査に 何回の使用にまで合格するかを、それぞれの異なった条件の下で実験を行なった。 前記異なった条件とは、 男性、 女性、 硬い肉片、 軟らかい肉片などを指し、 それ ぞれの平均値を出し、 耐用回数が数回であることを認識した。 当然の事ではある が、 上記各検査および試験結果は、 未使用部品のみを用いて組み立てた製品によ る各検査および試験結果を参考にした。 耐用回数を確認するために、 第 5図に示す第二段階の実験を行った。 第二段階 では、 使用する製品に病院へ供給する最終製品と同じ条件で、 つまり滅菌をした 状態の製品を用いた。 この製品をやはり、 第一段階と同様に市販されている肉な どを用いて模擬的に使用した(3 0 1 )。使用後、血液を製品に付着させ(3 0 2 )、 放射線滅菌をかけた(3 0 3 )。滅菌処理された製品の粗洗浄(3 0 4 )と乾燥(3 0 5 )を行った後に、製品を分解した(3 0 6 )。続いて分解した部品を選別し(3 0 7 )、再利用部品となる金属製機能部品を超音波洗浄機を用いて洗浄し(3 0 8 )、 乾燥させ(3 0 9 )、再利用部品となる金属製機能部品の検査を行った(3 1 0 )。 第二段階の検査は、 前述した第一段階での検査項目に加え、 放射線滅菌をした 再利用部品となる金属製機能部品の材質状況の検査である。 前記材質検査は、 引 張り圧縮試験機および硬さ試験機を用い、 放射線滅菌前と滅菌後の試験値の比較 を行った。 この比較実験は、 循環回数一回の場合、 二回の場合など、 滅菌をした 回数毎にそれぞれデータとして算出した。 The cycle from step 201 to 210 described above was repeated, and an experiment was conducted under different conditions to determine how many uses each test passed. The different conditions refer to men, women, hard meat pieces, soft meat pieces, etc., and the average value of each is obtained, and it is recognized that the number of times of use is several times. As a matter of course, the above inspections and test results were based on the inspections and test results of products assembled using only unused parts. In order to confirm the number of service life, the second stage experiment shown in Fig. 5 was performed. In the second stage, the products used were used under the same conditions as the final products to be supplied to the hospital, that is, sterilized products. This product was simulated using commercially available meat and the like as in the first stage (301). After use, blood was allowed to adhere to the product (302) and sterilized by radiation (303). After performing the rough washing (304) and drying (305) of the sterilized product, the product was disassembled (306). Subsequently, the disassembled parts are sorted out (307), and the metallic functional parts to be reused parts are cleaned using an ultrasonic cleaner (308), dried (309), and reused parts are reused. The metal functional component was inspected (310). The second stage inspection is an inspection of the material status of the functional parts made of metal that will be reused parts that have been radiation sterilized, in addition to the inspection items of the first stage described above. In the material inspection, a comparison between test values before and after radiation sterilization was performed using a tensile compression tester and a hardness tester. In this comparative experiment, data was calculated for each number of sterilizations, such as one circulation and two circulations.
このように、 第一段階及び第二段階での科学的実験によって、 再生品の対象と なる金属製機能部品の耐用回数は数回であることを確認した。  In this way, the scientific experiments in the first and second stages confirmed that the functional parts to be recycled were used several times.
(再生品としての金属製機能部品のコスト)  (Cost of metal functional parts as recycled products)
第 3の事実は、 上記ディスポーザブル内視鏡手術用器具の金属製機能部品の耐 用回数を 5回とし、 使用済ディスポーザブル内視鏡手術用器具の回収コストと部 品再生コストを考慮して再生品としての金属製機能部品のコストを算出した結果、 再生品は新品の概ね 6 0〜 7 0 %であることを、 本願の発明者が確認したことで ある。 前記回収コスト又は部品再生コストには放射線滅菌処理コストが含まれ、 また、 部品再生コストには分解コスト、 洗浄並びに乾燥コスト、 及び検査コスト が含まれる。 なお、 前記検査コストは新品の受入検査コストと同額とした。 再生 品として利用できるか否かの検査は、 部品業者から新品の部品を受け入れるとき の検査と殆ど変わらない程の厳しいものであるからである。  The third fact is that the metal functional parts of the above-mentioned disposable endoscopic surgical instrument are made durable 5 times, and the disposable endoscopic surgical instrument is recycled in consideration of the collection cost and the component renewal cost. As a result of calculating the cost of the metallic functional component as a product, the inventor of the present application has confirmed that the recycled product is approximately 60 to 70% of a new product. The cost of recovery or the cost of component recycling includes the cost of radiation sterilization, and the cost of component recycling includes disassembly costs, cleaning and drying costs, and inspection costs. The inspection cost was the same as the cost of receiving a new product. This is because the inspection to determine whether a product can be used as a recycled product is as strict as the inspection when a new part is received from a parts supplier.
(第 1発明)  (First invention)
以上の 3つの事実に基づいてなされた本願の第 1発明に係るディスポーザブル 医療用具のリサイクルシステムは、 第 1図に示す如く、 金属製機能部品とプラス チック部品等が分解可能な構造のディスポーザブル医療用具を製造する製造シス テム 2 1、 前記ディスポーザブル医療用具を販売又は貸与して医療機関へ供給す る供給システム 2 2、 使用済デイスポーザブル医療用具を滅菌処理してメーカー に回収する回収システム 2 3、 及び、 回収したデイスポーザブル医療用具を分解 し、 耐用回数以内の金属製機能部品を選別し、 検査して再生する部品再生システ ム 2 4が順に繋がつてサ一クルを構成したものである。 Based on the above three facts, the disposable medical device recycling system according to the first invention of the present application, as shown in Fig. 1, has a disposable medical device having a structure in which functional metal parts and plastic parts can be disassembled. Manufacturing manufacturing systems System 21 1, Supply system for selling or lending the disposable medical device and supplying it to medical institutions 2 2, Collection system 23 for sterilizing used disposable medical devices and collecting them at the manufacturer, and collected The disposable medical device is disassembled, metal functional components within the service life are sorted out, and a component recycling system 24 that inspects and regenerates them is connected in order to form a cycle.
(第 2発明)  (Second invention)
また、 以上の 3つの事実に基づいてなされた本願の第 2発明に係るディスポー ザブル医療用具のリサイクルシステムは、 第 2図に示す如く、 金属製機能部品と プラスチック部品等が分解可能な構造のディスポーザブル医療用具を製造する製 造システム 2 1、 前記ディスポーザブル医療用具を販売又は貸与して医療機関へ 供給する供給システム 2 2、 使用済ディスポ一ザブル医療用具を分解して金属製 機能部品のみを滅菌処理してメーカーに回収する回収システム 2 3、 及び、 回収 した金属製機能部品から耐用回数以内のものを選別し、 検査して再生する部品再 生システム 2 4が順に繋がってサークルを構成したものである。  The disposable medical device recycling system according to the second invention of the present application, based on the above three facts, has a disposable structure in which metal functional parts and plastic parts can be disassembled, as shown in FIG. Manufacturing system for manufacturing medical devices 21 1, Supply system 22 for selling or renting disposable medical devices and supplying them to medical institutions 22 Disassembling used disposable medical devices and sterilizing only metal functional parts The system consists of a collection system 23, which collects and collects metal functional components from the collected functional parts, and a component reproduction system 24, which inspects and regenerates them, and connects them in order to form a circle. is there.
上記第 1発明及び第 2発明における金属製機能部品の耐用回数は、 ディスポー ザブル医療用具の模擬使用、 分解、 検査、 及び組立のサイクルを繰り返すことに よって実験的に求められるものである。 耐用回数決定の具体的な方法は、 本発明 の基礎となつた上記第 2の事実として説明した金属製機能部品の耐用回数の確認 方法と実質的に同じである。  The service life of the metal functional component in the first invention and the second invention is determined experimentally by repeating a cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device. The specific method of determining the number of times of use is substantially the same as the method of confirming the number of uses of the metal functional component described as the second fact, which is the basis of the present invention.
ところで、 第 1図の本願の第 1発明のデイスポーザブル医療用具のリサイクル システムを流通にかかわるメ一カーと医療機関等によつて構成すれば、 例えば第 7図に示す如き閉ループが形成される。 即ち、 デイスポーザブル医療用具を製造 するメーカー 2 5、 メーカー 2 5から供給されたデイスポーザブル医療用具を使 用する医療機関 2 6、 使用済デイスポーザブル医療用具を医療機関 2 6から回収 する回収業者 2 8、 及び回収業者 2 8が回収した使用済ディスポ一ザブル医療用 具に滅菌処理を施した後にこれを前記メーカーに納入する滅菌業者 2 9とで閉ル ープが形成される。  By the way, if the system for recycling the disposable medical device of the first invention of the present invention shown in FIG. 1 is constituted by manufacturers involved in distribution and medical institutions, for example, a closed loop as shown in FIG. 7 is formed. . In other words, manufacturers 25 that manufacture disposable medical devices, medical institutions 26 that use disposable medical devices supplied by manufacturer 25, and used disposable medical devices that are collected from medical institutions 26 A closed loop is formed with the collection company 28 and the used disposable medical device collected by the collection company 28 after sterilizing it and delivering it to the manufacturer.
また、 第 2図の本願の第 2発明のディスポーザブル医療用具のリサィクルシス テムを流通にかかわるメーカーと医療機関等によって構成すれば、 例えば第 8図 に示す如き閉ループが形成される。 即ち、 ディスポ一ザプル医療用具を製造する メーカー 2 5、 メーカー 2 5から供給されたデイスポーザブル医療用具を使用す る医療機関 2 6、 使用済デイスポーザブル医療用具を分解し金属製機能部品を医 療機関 2 6から回収する回収業者 2 8、 及び回収業者 2 8が回収した金属製機能 部品に滅菌処理を施した後にこれを前記メーカーに納入する滅菌業者 2 9とで閉 ループが形成される。 使用済ディスポーザブル医療用具を分解し金属製機能部品 を分別する作業は、 医療機関又は回収業者によって行われる。 尚、 使用済デイス ポーザブル医療用具を分解し、 金属製機能部品を回収した後に残ったプラスチッ ク咅 15品等は医療廃棄物処理業者 2 7によって廃棄処分される。 In addition, if the recycling system of the disposable medical device of the second invention of FIG. 2 of the present application is constituted by a manufacturer and a medical institution involved in distribution, for example, FIG. A closed loop is formed as shown in FIG. In other words, manufacturers 25 that manufacture disposable medical devices, medical institutions 26 that use disposable medical devices supplied by manufacturers 25, disassembled used disposable medical devices, and disassembled metal functional parts A closed loop is formed with the collection company 28 that collects from the medical institution 26 and the sterilization company 29 that sterilizes the metal functional parts collected by the collection company 28 and then delivers them to the manufacturer. You. The work of disassembling used disposable medical devices and separating metallic functional parts is performed by medical institutions or collection companies. It should be noted that the medical disposer 27 disposes of the disposable medical devices by disassembling the used disposable medical device and collecting the metallic functional parts.
本発明によれば、 メーカー 2 5と医療機関 2 6との間では、 例えば第 9図に示 す如く、 以下の 5つのアクションが順になされる。 第 1のアクションは医療機関 2 6がメーカー 2 5にデイスポーザブル医療用具を発注すること、 第 2のァクシ ヨンはメーカー 2 5が医療機関 2 6にデイスポーザブル医療用具を納入すること、 第 3のァクションは使用済ディスポ一ザブル医療用具が医療機関 2 6からメーカ 一 2 5に回収されること、 第 4のアクションはメーカー 2 5が医療機関 2 6にデ イスポーザブル医療用具の代金を請求すること、 及び第 5のァクションは医療機 関 2 6がメーカ一 2 5にディスポ一ザブル医療用具の代金を支払うことの 5つで ある。 前記代金は、 販売の場合に購入代金であり、 貸与の場合には利用代金であ る。  According to the present invention, the following five actions are performed in order between the manufacturer 25 and the medical institution 26, for example, as shown in FIG. The first action is for the medical institution 26 to order disposable medical devices from the manufacturer 25.The second action is for the manufacturer 25 to deliver disposable medical devices to the medical institution 26. The third action is that the used disposable medical device is collected from the medical institution 26 to the manufacturer 25, and the fourth action is that the manufacturer 25 charges the medical institution 26 for the disposable medical device. The fifth function is that the medical institution 26 pays the manufacturer 25 for the disposable medical device. The price is a purchase price in the case of sales, and a use price in the case of loan.
メーカ一 2 5と医療機関 2 6と医療廃棄物処理業者 2 7との従来の関係を示す 第 1 0図と比較すれば明らかな如く、 本発明に係るディスポーザブル医療用具の リサイクルシステムにおいては、 医療機関 2 6の費用負担が軽減されていること が明らかである。  As apparent from comparison with FIG. 10 showing the conventional relationship between the manufacturer 25, the medical institution 26, and the medical waste disposal company 27, the recycling system of the disposable medical device according to the present invention has It is clear that the cost burden of institution 26 has been reduced.
次に、 第 1図の本願の第 1発明に係るディスポーザブル医療用具のリサイクル システムを具体的な一実施例を、 第 3図のフローチャートを参照して説明する。 第 3図において、 デイスポーザブル医療用具の組立ステップ 1 0 3では、 新品 プラスチック部品等のストック (1 0 1 ) からの新品プラスチック部品等と、 新 品金属製機能部品のストック (1 0 2 ) 又は再生金属製機能部品のストック (1 1 5 ) からの金属製機能部品が組み立てられる。 新品プラスチック部品等と、 新 品金属製機能部品は、 図示しないが、 部品メーカーから受け入れた後、 受入検査 をパスして保管されているものである。 Next, a specific embodiment of the recycling system for disposable medical devices according to the first invention of the present application in FIG. 1 will be described with reference to the flowchart in FIG. In Fig. 3, in the disposable medical device assembling step 103, the new plastic parts from the stock of new plastic parts (101) and the stock of new metal functional parts (102) Alternatively, the metal functional component from the recycled metal functional component stock (1 15) is assembled. New plastic parts etc. Although not shown, the functional parts made of metal are stored after passing the acceptance inspection after being received from the parts manufacturer.
組立てられたデイスポーザカレ医療用具は、出荷前の検査を受ける(1 0 4 )。 出荷前の検査をパスしたデイスポーザブル医療用具は、 滅菌パック、 例えばプリ スターパックに収納され、 更に専用収納具へ収納並びに梱包される。 この専用収 納具は、 例えば、 専用ケース又は専用袋である。 ブリスターパックには製品番号 が付されたラベルが貼付され、 専用収納具には識別番号が付されたラベルが貼付 される。 その後、 梱包された状態で、 デイスポーザブル医療用具には放射線によ る滅菌処理が施される。 放射線滅菌処理が施された後、 専用収納具にはケミカル インジケーターが貼付され、 出荷され、 メーカーから直接に又は販売会社を経て 医療機関に納品される (1 0 5 )。 この段階では、 ケミカルインジケータ一は放射 前の黄色を呈している。  The assembled disposable curry medical device undergoes a pre-shipment inspection (104). Disposable medical devices that have passed pre-shipment inspection are stored in sterile packs, such as Plister packs, and then stored and packed in special storage devices. The exclusive storage device is, for example, an exclusive case or an exclusive bag. Labels with product numbers are affixed to blister packs, and labels with identification numbers are affixed to dedicated storage devices. Thereafter, the disposable medical device is sterilized by radiation in the packaged state. After radiation sterilization, the chemical indicator is attached to the special storage device, shipped, and delivered to a medical institution either directly from the manufacturer or via a sales company (105). At this stage, the chemical indicator is yellow before emission.
病院では、 ディスポ一ザブル医療用具が専用収納具から取出され、 包装を外さ れ、医師により医療行為に使用される (1 0 6 )。医療行為への使用が終わったデ イスポーザブル医療用具は、 ブリスターパックに戻され、 専用収納具に収納され る。  In hospitals, disposable medical devices are removed from special storage devices, unpackaged, and used by doctors for medical procedures (106). Disposable medical devices that have been used for medical practice are returned to blister packs and stored in special storage devices.
使用済ディスポ一ザブル医療用具は、 回収業者により専用収納具を使って医療 機関から回収され(1 0 7 )、滅菌処理業者によって放射線滅菌処理を施される(1 0 8 )。放射線滅菌処理を施されると、専用収納具に貼付されているたケミカルィ ンジケ一夕一が赤色に変色する。 放射線滅菌処理を施されたデイスポーザブル医 療用具は、 滅菌処理業者によってメ一カーに納入される。  The used disposable medical device is collected from the medical institution using a special storage device by a collection company (107), and is subjected to radiation sterilization by a sterilization company (108). After radiation sterilization, the chemical linge attached to the special storage device turns red. Disposable medical devices that have been subjected to radiation sterilization are delivered to manufacturers by sterilization contractors.
メーカーでは、デ一タ管理システムで管理されている使用履歴データを参照し、 回収されたデイスポーザブル医療用具に使われている金属製機能部品が耐用回数 以内の使用がなされたものか否かを調べる (1 0 9 )。前記耐用回数は、ディスポ —ザブル医療用具の模擬使用、 分解、 検査、 及び組立のサイクルを繰り返すこと によつて実験的に求められたものである。 耐用回数のチェックをこの段階で行う ことにより、 分解すべきデイスポーザブル医療用具を早期に選別でき、 従って分 解しないで産業廃棄物として廃棄すべきものを早期に選別できる。  The manufacturer refers to the usage history data managed by the data management system and determines whether the collected metallic functional parts used in the disposable medical device have been used within the service life. Examine (1 0 9). The service life was determined experimentally by repeating a cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device. By checking the number of times of use at this stage, disposable medical devices to be disassembled can be sorted out early, and therefore those that should be discarded as industrial waste without disassembly can be sorted out early.
耐用回数以内の金属製機能部品が使われているディスポーザプル医療用具は分 解され(1 1 0 )、金属製機能部品とプラスチック部品等に分別される (1 1 1 )。 本発明のリサイクルシステムの対象であるディスポーザブル医療用具は、 その金 属製機能部品とプラスチック部品等が分解可能な構造を有するものであるため、 分解が容易で、 分解工程における時間や労力は極めて少ない。 Disposable pull medical devices that use metallic functional components within the life cycle It is separated (110) and separated into functional metal parts and plastic parts (111). The disposable medical device, which is the object of the recycling system of the present invention, has a structure in which functional parts made of metal and plastic parts can be disassembled, so that it is easily disassembled, and the time and labor in the disassembly process are extremely small. .
分解されて選別された再利用部品となる金属製機能部品は超音波洗浄等による 洗浄工程 (1 1 2 ) と乾燥工程 (1 1 3 ) を経て、 血液や体液などの付着物が除 去される。 次に、 洗浄工程 (1 1 2 ) と乾燥工程 (1 1 3 ) を経た金属製機能部 品は、部品として利用できるか否かを検耷される (1 1 4 )。 このステップでの検 査は、 実体顕微鏡を用いての形状検査と電子ノギスを用いての寸法検査、 及び洗 浄度判定キットを用いての清浄検査である。 前記洗浄度判定キットは、 例えば蛋 白質量に応じた色の変化で、 その汚れを判定する市販のキットである。  The metal functional parts that are disassembled and sorted to become reusable parts undergo a cleaning process (1 1 2) using ultrasonic cleaning, etc., and a drying process (1 13) to remove deposits such as blood and body fluids. You. Next, it is checked whether or not the metal functional component that has passed through the washing step (112) and the drying step (113) can be used as a part (111). The inspection in this step is a shape inspection using a stereomicroscope, a dimensional inspection using an electronic caliper, and a cleaning inspection using a cleaning degree determination kit. The kit for determining the degree of washing is a commercially available kit for determining the stain by, for example, a change in color according to the protein mass.
ステップ 1 1 4の検査をパスした金属製機能部品は、 再生品としてストックさ れる (1 1 5 )。  The functional metal parts that have passed the inspection in step 114 are stocked as recycled products (115).
ステップ 1 0 4とステップ 1 1 4で検査をパスしなかったもの、 ステップ 1 1 1で金属製機能部品として選別されなかったものは、 プラスチックとその他に分 別され、 夫々素材として再利用されるか、 又は廃棄される (1 1 8 )。  Those that did not pass the inspection in step 104 and step 114 and those that were not sorted out as metal functional parts in step 111 are separated into plastics and other materials and reused as materials, respectively. Or is discarded (1 18).
以上、 本発明に係るディスポーザブル医療用具のリサイクルシステムの実施の 形態について詳細に説明した。 ここで、 本発明に係るディスポーザブル医療用具 のリサイクルシステムが成立するための 4つの要点、即ち、低い部品再生コス卜、 高い品質保証、 安全な回収、 及び高い回収率について、 改めて以下に説明する。  The embodiment of the disposable medical device recycling system according to the present invention has been described above in detail. Here, four points for establishing a recycling system for disposable medical devices according to the present invention, that is, low parts recycling cost, high quality assurance, safe recovery, and high recovery rate will be described again below.
(低い部品再生コスト)  (Low parts recycling cost)
本発明に係るディスポ一ザブル医療用具のリサイクルシステムは、 その金属製 機能部品とプラスチック部品等が分解可能な構造を有するディスポーザブル医療 用具をリサイクルの対象とするものである。 従って、 回収されたデイスポーザブ ル医療用具を分解する時間と手間が極めて少ない。 しかも、 分解作業で再生品の 対象となる金属製部品が損傷を受けたり、 変形することが非常に少なく、 従って 歩留まりの高い回収ができる。 このため、 部品再生コストの多寡を決定する分解 コス卜が非常に低く押さえることができ、 低い部品再生コストを確保することが できた。 (高い品質保証) The disposable medical device recycling system according to the present invention is intended to recycle disposable medical devices having a structure in which functional parts made of metal and plastic parts can be disassembled. Therefore, the time and labor required to disassemble the collected disposable medical device is extremely small. In addition, the metal parts to be recycled are hardly damaged or deformed during the disassembly work, so that a high yield can be recovered. For this reason, the disassembly cost that determines the amount of parts recycling cost can be kept very low, and a low parts recycling cost can be secured. (High quality assurance)
本発明に係るディスポーザブル医療用具の高い品質保証は、 金属製機能部品の 耐用回数が科学的な実験方法で決定された信頼性の高い値であること、 及び新品 の部品の受入検査と同等以上の厳しい検査を部品再生システムにおいて実施して いることによって、 確保されている。 また、 金属製機能部品の使用履歴管理を含 むデータ管理システムにより、 製造システムも部品再生システムも適切に管理さ れていることも、 高い品質保証をサポートしている。 上記の耐用回数を決定する 科学的な実験方法は、 本発明の基礎とした第 2の事実で説明した 2段階の科学的 実験方法と基本的には同じである。 金属製機能部品とプラスチック部品等が分解 可能な構造を有するディスポ一ザブル医療用具の新製品又は改良製品において、 再利用の対象となる新たな金属製部品が出現する度に、 上記の 2段階の科学的実 験方法により、 耐用回数が決定される。  The high quality assurance of the disposable medical device according to the present invention is based on the fact that the service life of a metal functional component is a highly reliable value determined by a scientific experiment method, and that it is at least equal to the acceptance inspection of a new component. Strict inspections are performed in the parts recycling system to ensure this. In addition, the data management system, including the management of the use history of functional metal parts, ensures that both the manufacturing system and the parts recycling system are properly managed, which supports high quality assurance. The scientific experiment method for determining the service life described above is basically the same as the two-stage scientific experiment method described in the second fact on which the present invention is based. Each time a new metal part to be reused appears in a new or improved disposable medical device having a structure in which metal functional parts and plastic parts can be disassembled, the above two-step Useful life is determined by scientific testing methods.
(安全な回収)  (Safe collection)
使用済デイスポーザブル医療用具は、 ブリスターバックに戻され、 更に専用収 納具に収納されて回収業者により回収される。 そして、 メ一カーに納入される前 に、 放射線滅菌処理が施される。 放射線滅菌処理済か否かは、 専用収納具に貼付 されたケミカルインジケータにより、 確実に判定できる。 従って、 本発明におい ては、 使用済ディスポ一ザブル医療用具の安全な回収が確保されている。  Used disposable medical devices are returned to the blister bag, stored in a dedicated storage device, and collected by a collection company. Before being delivered to the manufacturer, it is subjected to radiation sterilization. Whether or not radiation sterilization has been completed can be reliably determined by the chemical indicator attached to the special storage device. Therefore, in the present invention, safe recovery of the used disposable medical device is ensured.
(高い回収率)  (High recovery rate)
本発明に係るディスポーザブル医療用具のリサイクルシステムはリサイクルシ ステムであるから、 リサイクルの対象となる金属製機能部品が医療機関からメー カーに全量回収されることが望ましい。 本発明によれば、 医療廃棄物処理業者に 廃棄手数料を支払う必要がなくなるから、 医療機関がメ一力一の回収作業に積極 的に協力することは明らかである。 従って、 本発明においては、 リサイクルの対 象となる金属製機能部品のメーカーへの回収率は必然的に高くなる。 また、 ディ スポーザブル医療用具を、 貸与の形態で医療機関に供給すれば、 使用済であって も当該ディスポーザブル医療用具はメーカ一側の管理下にあるから、 更に高い回 収率が確保される。 産業上の利用可能性 Since the disposable medical device recycling system according to the present invention is a recycling system, it is desirable that all functional metal components to be recycled be recovered from the medical institution to the manufacturer. According to the present invention, it is obvious that the medical institution will actively cooperate with the primary collection work since it is not necessary to pay the disposal fee to the medical waste disposal company. Therefore, in the present invention, the recovery rate of the metal functional component to be recycled to the manufacturer is inevitably increased. If disposable medical devices are supplied to medical institutions in loan form, even if they have been used, the disposable medical devices are under the control of the manufacturer, so a higher recovery rate can be secured. Industrial applicability
本発明により、 金属製機能部品とプラスチック部品等が分解可能な構造のディ スポーザプル医療用具のリサイクルシステムが提供された。 本発明によれば、 金 属製機能部品が数回にわたって再生品として利用されるから、 部品購入コストが 低減された。 本発明のリサイクルシステムでは新たに回収コストと滅菌コスト及 び分解コストが発生するが、 これらのコストは合算しても、 部品購入コストの低 減額を上回ることはないので、 メ一カーにおける製造コス卜が低減できた。  According to the present invention, a recycling system for a disposable medical device having a structure in which a metal functional component and a plastic component can be disassembled is provided. According to the present invention, the functional parts made of metal are used as recycled products several times, so that the cost of purchasing the parts is reduced. In the recycling system of the present invention, new collection costs, sterilization costs, and disassembly costs are incurred. However, even if these costs are added together, they do not exceed the reduction in parts purchase costs. Can be reduced.
また、 金属製機能部品とプラスチック部品等が分解可能な構造のディスポーザ ブル医療用具が医療廃棄物処理業者によって回収されることは原則としてなくな るから、医療廃棄物の量が削減されると共に、医療機関の廃棄費用が削減された。 従って、 金属製機能部品とプラスチック部品等が分解可能な構造のディスポ一ザ ブル医療用具のリサイクルシステムにおけるトータルコストは従来の非リサイク ルシステムにおけるトータルコストに比較しても小さくなり、 資源の再利用が効 率的に行われるようになつた。  In addition, disposable medical devices that can be disassembled into metal functional parts and plastic parts will not be collected by medical waste disposal companies in principle, reducing the amount of medical waste. The cost of disposing of medical institutions has been reduced. Therefore, the total cost of the recycling system for disposable medical devices that can be disassembled into metallic functional parts and plastic parts is smaller than the total cost of conventional non-recycling systems, and the resources are reused. Has been implemented efficiently.

Claims

請 求 の 範 囲 The scope of the claims
1 . 金属製機能部品とプラスチック部品等の組立工程を経てディスポーザブル 医療用具を製造する製造システム、 医療機関にディスポーザプル医療用具を供給 する供給システム、 使用済デイスポーザブル医療用具を滅菌処理してメーカーに 回収する回収システム、 及び、 回収した使用済デイスポーザブル医療用具の分解 工程と耐用回数以内の金属製機能部品の選別工程と検査工程を経て金属製機能部 品を再生する部品再生システムとから構成されたデイスポーザブル医療用具のリ サイクルシステムであって、 前記ディスポーザブル医療用具は金属製機能部品と プラスチック部品等が分解可能な構造であることを特徴とするディスポーザブル 医療用具のリサイクルシステム。  1. Manufacturing system for manufacturing disposable medical devices through the process of assembling metal functional parts and plastic parts, supply system for supplying disposable pull medical devices to medical institutions, and sterilizing used disposable medical devices for manufacturers And a parts recycling system that recycles functional metal components through the disassembly process of collected used disposable medical devices, the sorting process of metal functional components within the service life and the inspection process. A recycling system for a disposable medical device, comprising: a disposable medical device having a structure in which a metal functional component and a plastic component can be disassembled.
2. 金属製機能部品とプラスチック部品等の組立工程を経てディスポーザブル 医療用具を製造する製造システム、 医療機関にディスポーザブル医療用具を供給 する供給システム、 使用済ディスポ一ザブル医療用具を分解し金属製機能部品の みを滅菌処理してメーカーに回収する回収システム、 及び、 回収した金属製機倉 g 部品から耐用回数以内のものを選別する選別工程と検査工程を経て金属製機能部 品を再生する部品再生システムとから構成されたデイスポーザブル医療用具のリ サイクルシステムであって、 前記ディスポーザブル医療用具は金属製機能部品と プラスチック部品等が分解可能な構造であることを特徴とするディスポーザブル 医療用具のリサイクルシステム。  2. Manufacturing system for manufacturing disposable medical devices through the process of assembling metal functional parts and plastic parts, supply system for supplying disposable medical devices to medical institutions, disassembled used disposable medical devices, and metal functional components A recovery system that sterilizes and collects only the refuse to the manufacturer, and a parts recycling that recycles the metal functional parts through the sorting process and the inspection process that select the components within the service life from the collected metal machinery g parts A disposable medical device recycling system comprising: a disposable medical device recycling system, wherein the disposable medical device has a structure in which a metal functional component and a plastic component can be disassembled. .
3. 前記供給システムは、 医療機関へのデイスポーザブル医療用具の貸与シス テムであることを特徴とする請求項 1又は 2のディスポ一ザブル医療用具のリサ ィクルシステム。  3. The recycling system for disposable medical devices according to claim 1, wherein the supply system is a lending system for disposable medical devices to a medical institution.
4. 前記耐用回数は、 デイスポーザブル医療用具の模擬使用、 分解、 検査、 及 び組立のサイクルを繰り返すことによって実験的に求められるものであることを 特徴とする請求項 1又は 2のディスポ一ザブル医療用具のリサィクルシステム。 4. The disposable medical device according to claim 1, wherein the number of times of use is determined experimentally by repeating a cycle of simulated use, disassembly, inspection, and assembly of the disposable medical device. Recycling system for zable medical devices.
5 . 前記回収システムにおける滅菌処理は、 放射線滅菌処理であることを特徴 とする請求項 1又は 2のディスポーザブル医療用具のリサイクルシステム。 5. The recycling system for disposable medical devices according to claim 1, wherein the sterilization process in the collection system is a radiation sterilization process.
6 . 前記部品再生システムにおいては、 回収された使用済デイスポーザカレ医 療用具に含まれている金属製機能部品の使用履歴データに基づいて、 耐用回数以 内の金属製機能部品か否かの選別が行われることを特徴とする請求項 1又は 2の ディスポーザブル医療用具のリサイクルシステム。 6. In the parts recycling system, based on the usage history data of the metallic functional parts contained in the collected used disposer care medical device, 3. The recycling system for disposable medical devices according to claim 1 or 2, wherein whether or not the functional component is a metal functional component is selected.
7 . 前記供給システムにおける医療機関へのディスポーザブル医療用具の供給、 及び前記回収システムにおける使用済デイスポーザプル医療用具又は金属製機能 部品の医療機関からの回収は、 識別番号が付された専用収納具によつて行われる ことを特徴とする請求項 1又は 2のディスポーザブル医療用具のリサイクルシス テム。  7. The supply of disposable medical devices to medical institutions in the supply system, and the collection of used disposable medical devices or metal functional parts from medical institutions in the collection system are performed using dedicated storage devices with identification numbers. The disposable medical device recycling system according to claim 1, wherein the disposable medical device is recycled.
8 . 前記専用収納具には、 ケミカルインジケータが取り付けられていることを 特徴とする請求項 7のデイスポーザプル医療用具のリサイクルシステム。  8. The disposer pull medical device recycling system according to claim 7, wherein a chemical indicator is attached to the dedicated storage device.
9 . デイスポーザブル医療用具の製品番号、 デイスポーザブル医療用具を構成 する部品の部品番号、 再生品の対象となる金属製機能部品の使用履歴データ、 専 用収納具に付された識別番号等のデータは、 メーカ一内に設けられているデータ 管理システムにより管理されていることを特徴とする請求項 1又は 2のディスポ —ザブル医療用具のリサイクルシステム。  9. Product numbers of disposable medical devices, part numbers of components that make up disposable medical devices, usage history data of metal functional parts to be recycled, identification numbers attached to special-purpose storage devices, etc. 3. The disposable medical device recycling system according to claim 1, wherein said data is managed by a data management system provided in a manufacturer.
1 0 . 前記ディスポーザカレ医療用具はその金属製機能部品とプラスチック部 品等とが分解可能な構造であるディスポ一ザブル内視鏡手術用器具であることを 特徴とする請求項 1又は 2のディスポーザブル医療用具のリサイクルシステム。  10. The disposable medical instrument according to claim 1 or 2, wherein the medical instrument is a disposable endoscopic surgical instrument having a structure in which a metal functional component and a plastic component can be disassembled. Medical equipment recycling system.
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