Surgical instrument management method and device, and orthodontic mouthpiece management method and device

Abstract

Provided are a surgical instrument management method and device with which individual identification and management of medical surgical instruments can be performed easily and accurately at a low cost. The present invention is a surgical instrument management method for managing medical surgical instruments, and is characterized by having: a step for acquiring the dimensions of a predetermined specific section of each of a plurality of surgical instruments; a step for identifying each surgical instrument on the basis of the acquired dimensions of the specific section; and a step for managing the identified surgical instruments.

Description

Surgical instrument management method and device, and dental orthodontic mouthpiece management method and device

[0001] The present invention relates to a surgical instrument management method and device for managing medical surgical instruments, and a dental orthodontic mouthpiece management method and device for managing dental orthodontic mouthpieces.

[0002] The Creutzfeldt-Jakob disease (CJD) epidemic in the 1990s reaffirmed the importance of managing individual surgical instruments (i.e., which surgical instruments were used, when, on which patient, and in which surgery). In 2006, the Ministry of Health, Labour and Welfare issued a notice requiring the implementation of individual management of small steel surgical instruments. Furthermore, the April 2007 revision of the Medical Care Act mandated evidence-based management and management of small steel instruments, including their service life, cost, number of uses, and frequency, for their safe use. While surgical instruments are often made of metals such as stainless steel or titanium and are therefore referred to as small steel instruments, in recent years, there has been an increase in surgical instruments made from non-metallic materials such as engineering plastics and ceramics.

[0003] Furthermore, in 2014, the US FDA enacted legislation requiring all surgical instruments to be labeled with a Unique Device Identification (UDI), and will mandate that all surgical instruments be labeled with a UDI by 2020. In Europe, the same mandate was enacted in 2017. However, not only in Japan but also on a global level, there are many cases where individual management of medical surgical instruments is not possible.

[0004] Therefore, various methods have been tried and tested to address the need for individual identification and management of medical surgical instruments. One known method is to use two-dimensional codes to identify and manage surgical instruments (Non-Patent Document 1). Another known method is to use RFID (Radio Frequency Identification) tags to identify and manage surgical instruments (Patent Documents 1 to 3 and Non-Patent Document 2).

[0005] JP 2013-033370 A JP 2014-174647 A WO2021 / 075159 A

[0006] Japan Society of Medical Instrumentation, Research Report on the Need for 2D Symbol Display of Small Surgical Items, March 2007. Tsutomu Sawa, Small Surgical Items Individual Management System Using RFID: Case Study of Shimane University Hospital, June 2019.

[0007] However, the above-mentioned method of identifying and managing surgical instruments using two-dimensional codes (e.g., Non-Patent Document 1) has the following problems. First, surgical instruments are used for many years through repeated surgical procedures, disinfection, cleaning, and sterilization, and the two-dimensional codes deteriorate over time, making them unreadable. Furthermore, while two-dimensional codes are laser-engraved on surgical instruments, surgical instruments generally cannot be taken out of the hospital, so a laser engraving machine must be brought into the hospital and engraved on the instruments. In this case, because two-dimensional codes are very small, measuring approximately 3 mm square (e.g., approximately 3.6 mm x 1.2 mm), special technology is required to laser-engraved surgical instruments. Furthermore, because there are so many types of surgical instruments (thousands of types), linking two-dimensional codes to corresponding surgical instruments requires specialized knowledge.

[0008] Laser engraving a two-dimensional code on a surgical instrument in this way poses the problem of significant cost and effort involved in the work of engraving the two-dimensional code and linking the two-dimensional code to the surgical instrument. Furthermore, because there are surgical instruments made of materials that cannot be engraved with a two-dimensional code, and small surgical instruments that do not have the space to engrave a two-dimensional code, it is not possible to engrave a two-dimensional code on all surgical instruments, which means that only some of the surgical machines can be individually managed.

[0009] Due to the above problems, the method of identifying and managing surgical instruments using two-dimensional codes has not become widespread.

[0010] On the other hand, there are methods for identifying and managing surgical instruments using the above-mentioned RFID tags, such as attaching RFID tags with a frequency in the HF band (13.56 MHz) to surgical instruments (see, for example, Non-Patent Document 2). However, this method has the following problems. Surgical instruments are reused through repeated procedures such as surgery, disinfection, cleaning, and sterilization. However, if an RFID tag is attached to a surgical instrument using only adhesive, the adhesive strength deteriorates during the cleaning and sterilization processes, and the RFID tag tends to become detached from the surgical instrument. For this reason, a method is used in which a ceramic RFID tag is placed in a stainless steel housing and then laser-welded to the stainless steel housing. After the RFID tag is placed in the stainless steel housing, the RFID tag and other components are covered with a special engineering plastic to eliminate gaps and improve cleanability. This is a very costly and time-consuming method. Furthermore, in order to laser-weld the surgical instrument to the flat surface of the stainless steel housing, the surgical instrument must be machined before laser welding.

[0011] For these reasons, attaching RFID tags to surgical instruments takes a considerable amount of time. Non-Patent Document 2 reports that it took 2.5 months to attach RFID tags to 19,584 surgical instruments. Furthermore, welding of the surgical instruments to the stainless steel housings must be done by hand, which poses the problem of difficulty in achieving uniform welding quality.

[0012] Furthermore, in the case of a method in which a ceramic RFID tag is placed in a stainless steel housing and then laser-welded to the stainless steel housing and surgical instrument, the welding is performed on flat surfaces with a certain area, limiting the location where the RFID tag can be attached. Furthermore, the RFID tags used in this method cannot be used on metal surfaces, so they protrude from the surgical instrument and may interfere with surgery. Even the smallest RFID tag measures, for example, 5.2 mm in diameter and 2.0 mm in thickness, meaning that a stainless steel housing incorporating an RFID tag protrudes 6.5 mm from the surgical instrument. Metal-compatible tags, which are attached to metal surfaces, are even larger, measuring 11 mm x 10 mm x 3.5 mm, requiring a larger attachment area and protruding beyond the surgical instrument.

[0013] In addition, there are problems such as the RFID tag being broken when an external impact is applied directly to the stainless steel housing or RFID tag, or the RFID tag becoming detached due to poor laser welding. Furthermore, when the surgical instrument is made of engineering plastic or ceramic, there is also the problem that a ceramic RFID tag housed in a stainless steel housing cannot be laser welded to the surgical instrument.

[0014] Due to the above problems, the method of identifying and managing surgical instruments using RFID tags has not become widespread.

[0015] For these reasons, since 2007, when the individual management of surgical instruments became mandatory by law in Japan, attempts have been made to imprint two-dimensional codes and attach RFID tags, but although it has been approximately 20 years since the individual management of surgical instruments was first considered and 16 years since it was enacted into law, due to the various issues mentioned above, it has not been achieved in any hospital other than a very small number of hospitals.

[0016] Conventional orthodontic techniques use wires for orthodontics, but this technique suffers from the problem of unsightly appearance due to the visible metal wires. For this reason, in recent years, orthodontic techniques using inconspicuous transparent mouthpieces (orthodontic mouthpieces) have emerged and are rapidly gaining popularity. Multiple orthodontic mouthpieces are made for the same patient at different stages of orthodontic treatment and are used for orthodontics. While accurate individual identification and management of such orthodontic mouthpieces is desirable, their transparency makes it difficult to identify multiple mouthpieces for the same patient. Furthermore, for the same reasons as those for the surgical instruments described above, it is difficult to identify and manage individual mouthpieces using conventional methods such as two-dimensional codes or RFID tags.

[0017] The present invention has been made to solve the problems of the prior art described above, and aims to provide a method and device for managing surgical instruments that can easily, accurately, and at low cost identify and manage medical surgical instruments, as well as a method and device for managing orthodontic dental mouthpieces that can easily, accurately, and at low cost identify and manage orthodontic dental mouthpieces.

[0018] To achieve the above object, the present invention provides a surgical instrument management method for managing medical surgical instruments, comprising the steps of acquiring dimensions of a predetermined specific portion of each of a plurality of surgical instruments, identifying the surgical instruments based on the acquired dimensions of the specific portion, and managing the identified surgical instruments. With this configuration, the present invention identifies a plurality of surgical instruments based on the dimensions of the predetermined specific portion of each of the plurality of surgical instruments, even though individual differences will appear among the plurality of surgical instruments (in other words, it is possible to differentiate between the plurality of surgical instruments). This allows for easy, low-cost, and accurate identification and management of surgical instruments. In other words, the present invention allows for identification and management of surgical instruments without the problems associated with methods of identifying and managing individual surgical instruments using two-dimensional codes or RFID tags, as described in the "Problems to be Solved by the Invention" section.

[0019] In the present invention, preferably, if the dimensions of the specific portion acquired for multiple surgical instruments having the same specific portion are the same, the acquiring step newly acquires one or more dimensions other than the dimensions of the specific portion for each of the multiple surgical instruments, and the identifying step identifies the multiple surgical instruments based on the one or more other dimensions. According to the present invention configured in this manner, even if the dimensions of the specific portion acquired for multiple surgical instruments are the same, it becomes possible to accurately identify the multiple surgical instruments based on the one or more dimensions other than the dimensions of the specific portion.

[0020] In the present invention, preferably, if the dimensions of the specific portion acquired for multiple surgical instruments with the same defined specific portion are the same, the acquiring step newly acquires the dimensions of the specific portion of one or more of the multiple surgical instruments after the specific portion has been removed, and the identifying step identifies the multiple surgical instruments based on the dimensions of the specific portion after removal. According to the present invention configured in this manner, even if the dimensions of the specific portion acquired for multiple surgical instruments are the same, it is possible to accurately identify the multiple surgical instruments based on the dimensions after the specific portion has been removed.

[0021] The present invention preferably further includes a step of determining that the dimensions of the specific portions obtained for the plurality of surgical instruments are the same if the dimensions of the specific portions obtained for the plurality of surgical instruments are within a predetermined tolerance. With the present invention configured in this manner, the dimensions of the specific portions can be considered to be the same if the obtained dimensions of the plurality of specific portions are within a predetermined tolerance.

[0022] In the present invention, preferably, the acquiring step simultaneously acquires dimensions of specific portions of a plurality of surgical instruments, and the identifying step identifies each of the plurality of surgical instruments based on the dimensions of the specific portions simultaneously acquired for the plurality of surgical instruments. According to the present invention configured in this manner, identification of the plurality of surgical instruments can be performed efficiently.

[0023] The present invention preferably further includes a step of pre-storing the dimensions of the specific parts acquired for a plurality of surgical instruments, and the identifying step compares the dimensions of the specific parts stored in the storing step with the dimensions of the specific parts acquired in the acquiring step after the storing step to identify surgical instruments having the dimensions of the specific parts acquired in the acquiring step. According to the present invention configured in this way, surgical instruments can be accurately identified by comparing the dimensions of the specific parts with the dimensions stored in advance.

[0024] In a preferred embodiment of the present invention, the dimension of the specific portion is the width of the protruding portion of the surgical instrument. In another preferred embodiment, the dimension of the specific portion is the width of the end portion of the surgical instrument. In yet another preferred embodiment, the dimension of the specific portion is the width of the portion passing through the center of the rotation axis of the surgical instrument.

[0025] In the present invention, preferably, the identifying step identifies the surgical instrument based on the numerical value of the dimension of the specific portion in micron or submicron units. According to the present invention configured in this manner, the surgical instrument can be identified more accurately because dimensions in micron or submicron units are used.

[0026] In the present invention, preferably, the identifying step and the managing step each use a numerical value corresponding to the dimension of the specific portion as an ID to identify and manage the surgical instrument. According to the present invention configured in this manner, the identification and management of surgical instruments can be performed easily and accurately.

[0027] In the present invention, preferably, the management process manages one or more of the following in association with the ID: the name of the surgical instrument, the dimensions of a specific part of the surgical instrument, the group name of the surgical instrument, the branch type of the surgical instrument, the manufacturer name of the surgical instrument, the usage history of the surgical instrument, the useful life of the surgical instrument, the repair history of the surgical instrument, and the purchase history of the surgical instrument.

[0028] Preferably, the present invention further includes a step of acquiring the heights of each of the plurality of surgical instruments, and the identifying step identifies the surgical instruments based on the acquired heights and the dimensions of the specific portion. According to the present invention configured in this manner, the surgical instruments can be identified more accurately.

[0029] The present invention preferably further includes a step of acquiring one or more of the surface roughness, surface gloss, elemental type and elemental composition ratio of the material constituting the surgical instrument, and the identifying step identifies the surgical instrument based on the acquired one or more of the surface roughness, surface gloss, elemental type and elemental composition ratio and the dimensions of the specific portion. With this configuration, the present invention can more accurately identify surgical instruments.

[0030] In the present invention, preferably, the managing step manages the surgical instruments in units of sterilized containers each containing a plurality of surgical instruments. According to the present invention configured in this manner, it becomes possible to easily and accurately manage a plurality of surgical instruments.

[0031] In another aspect, in order to achieve the above-mentioned object, the present invention is a surgical instrument management device for managing medical surgical instruments, characterized in that it comprises an acquisition means for acquiring dimensions of a predetermined specific part for each of a plurality of surgical instruments, an identification means for identifying the surgical instrument based on the acquired dimensions of the specific part, and a management means for managing the identified surgical instruments.

[0032] In yet another aspect, the present invention is a dental orthodontic mouthpiece management method comprising the steps of acquiring dimensions of a predetermined specific portion for each of a plurality of orthodontic mouthpieces, identifying the orthodontic mouthpiece based on the acquired dimensions of the specific portion, and managing the identified orthodontic mouthpiece. In yet another aspect, the present invention is a dental orthodontic mouthpiece management device comprising: acquisition means for acquiring dimensions of a predetermined specific portion for each of a plurality of orthodontic mouthpieces, identification means for identifying the orthodontic mouthpiece based on the acquired dimensions of the specific portion, and management means for managing the identified orthodontic mouthpiece.

[0033] The surgical instrument management method and device, and dental orthodontic mouthpiece management method and device of the present invention enable easy, low-cost, and accurate individual identification and management of medical surgical instruments, as well as easy, low-cost, and accurate individual identification and management of dental orthodontic mouthpieces.

[0034] FIG. 1 is a block diagram showing a schematic configuration of a surgical instrument management system to which a surgical instrument management method and device according to an embodiment of the present invention is applied. FIG. 1 shows a general view of forceps in an open state and an enlarged view of the forceps ratchet. FIG. 2 shows a further enlarged view of the forceps ratchet. FIG. 3 shows an enlarged view of a groove formed in the forceps ratchet. FIG. 4 shows a general view of scissors in a closed state and an enlarged view of the scissors' rotation axis. FIG. 5 shows a general view of a needle holder in a closed state and an enlarged view of the tip of the needle holder's gripping part. FIG. 6 shows a general view of tweezers and an enlarged view of the rear end of the tweezers' connection part. FIG. 7 is a flowchart showing master registration of surgical instruments performed by a surgical instrument management device in an embodiment of the present invention. FIG. 8 is a flowchart showing individual identification and management of surgical instruments performed by a surgical instrument management device in an embodiment of the present invention. FIG. 9 is a plan view of a dental orthodontic mouthpiece used in a modified embodiment of the present invention.

[0035] Hereinafter, a surgical instrument management method and apparatus according to an embodiment of the present invention will be described with reference to the accompanying drawings.

[0036] <Configuration of Surgical Instrument Management System> Figure 1 is a block diagram showing the general configuration of a surgical instrument management system to which a surgical instrument management method and device according to an embodiment of the present invention is applied. As shown in Figure 1, the surgical instrument management system 1 has a precision dimension measuring device 2 that precisely measures the dimensions of surgical instruments (not shown), and a surgical instrument management device 3 that acquires the dimensions measured by the precision dimension measuring device 2 and individually identifies and manages surgical instruments based on these dimensions.

[0037] The precision dimension measuring instrument 2 is equipped with a table (not shown) and is a device that optically measures the dimensions of a surgical instrument placed on this table. Specifically, the precision dimension measuring instrument 2 measures the dimensions of a specific portion of a surgical instrument that has been designated in advance (a portion designated by the surgical instrument management device 3). For example, the precision dimension measuring instrument 2 captures an image of the surgical instrument placed on the table and determines the dimensions of the specific portion of the surgical instrument by analyzing the captured image. In addition, the precision dimension measuring instrument 2 is capable of measuring dimensions in micron or submicron units, and is configured to provide repeatable measurement accuracy with a tolerance of several microns or submicrons.

[0038] The surgical instrument management device 3 is composed of a general-purpose computer. By sending control signals to the precision dimension measuring instrument 2, the surgical instrument management device 3 controls the precision dimension measuring instrument 2 to measure the dimensions of specific parts predetermined for each of multiple surgical instruments. The surgical instrument management device 3 also receives measurement signals corresponding to the dimensions of the specific parts measured by the precision dimension measuring instrument 2 and performs processing to individually identify and manage the surgical instruments. For example, such specific parts may be characteristic parts of each of multiple surgical instruments (parts that can be said to be distinctive when compared to other parts of a surgical instrument), parts that are less likely to deteriorate or change over time, parts that are easy to measure, etc., and are parts that are designated in advance by the user. Furthermore, the same parts are used as specific parts in surgical instruments of the same group or type.

[0039] In this embodiment, the surgical instrument management device 3 uses the precision dimension measuring device 2 to measure the dimensions of specific portions of multiple surgical instruments in advance, and then stores the measured dimensions of the specific portions for each of the multiple surgical instruments in advance (hereinafter referred to as "master registration" where appropriate). In this case, the surgical instrument management device 3 uses a numerical value corresponding to the dimension of the specific portion (e.g., a numerical value in micron or submicron units) as an ID to identify and manage each of the multiple surgical instruments. This embodiment is based on the idea that when multiple surgical instruments are viewed based on their precisely measured dimensions, all of the surgical instruments can be differentiated, and in particular, not only different types of surgical instruments but even surgical instruments of the exact same type can be differentiated (because individual differences become apparent when viewed based on precisely measured dimensions).

[0040] Once the master registration described above is complete, after the surgical instrument is actually used, the surgical instrument management device 3 uses the precision dimension measuring device 2 to measure the dimensions of specific parts of the surgical instrument, and compares these measured dimensions with the dimensions (corresponding to the ID number) previously stored through master registration to individually identify the measured surgical instrument. At this time, the surgical instrument management device 3 appropriately updates information about the identified surgical instrument (e.g., usage history) as part of its management. Surgical instruments undergo a repeated cycle of surgery → disinfection → cleaning → sterilization. Typically, this type of individual identification and management of surgical instruments occurs when the surgical instrument is returned to a sterilized container after cleaning. In this case, the surgical instrument management device 3 manages surgical instruments in units of sterilized containers containing multiple surgical instruments.

[0041] More specifically, as shown in FIG. 1, the surgical instrument management device 3 has a processing unit 3a having one or more microprocessors as a central processing unit (CPU) that executes programs, a memory unit 3b composed of RAM (Random Access Memory) and ROM (Read Only Memory) that stores programs and data, an input unit 3c into which information is input by the user using a mouse or keyboard, and a display unit 3d that displays various information.

[0042] In this embodiment, the processing unit 3a executes a program for controlling the measurement of dimensions by the precision dimension measuring instrument 2, and a program for identifying and managing individual surgical instruments based on dimensions measured by the precision dimension measuring instrument 2. The processing unit 3a functions as the "acquisition means," "identification means," and "management means" of the present invention. The memory unit 3b also stores such programs and information related to a plurality of surgical instruments in order to manage the plurality of surgical instruments. Specifically, the memory unit 3b associates the name of the surgical instrument, the dimension of a specific measured portion, the group name of the surgical instrument, the branch type of the surgical instrument, the manufacturer name of the surgical instrument, the usage history of the surgical instrument (history of the patient, cleaning, sterilization, storage, etc.), the useful life of the surgical instrument, the repair history of the surgical instrument, the purchase history of the surgical instrument, etc., in association with an ID (the numerical value of the dimension as described above) identifying each of the plurality of surgical instruments.

[0043] Surgical instrument group names correspond to relatively large classifications of surgical instruments, such as forceps, scissors, tweezers, needle holders, etc. Surgical instrument branch types correspond to further subdivisions of these groups, such as forceps including Kocher forceps, long Kocher forceps, Mosquito Kocher forceps, Pean forceps, Mosquito Pean forceps, Baby Mosquito Pean forceps, Micro Mosquito Pean forceps, Kelly forceps, long Kelly forceps, Mosquito Kelly forceps, Mikulicz forceps, Magill forceps, Bulldog forceps, Allis forceps, lymph node forceps, stomach forceps, and intestinal forceps, and are also divided into hooked and hookless forceps depending on whether they have a hook at the tip. Scissors include Cooper scissors, Mayo scissors, Metchenbaum scissors, and ophthalmic scissors. They are also divided into straight scissors with a straight tip and curved scissors with a curved tip. Forceps are divided into hooked and unhooked forceps, but they have different functions, such as Adson forceps, McCandor forceps, DeBakey forceps, and diamond forceps with diamond-tipped tips. Needle holders include Mathieu needle holders and Hegar needle holders. Furthermore, the types of hooks are classified into muscle hooks, saddle hooks, liver hooks, simple hooks, multiple hooks, staples, etc.

[0044] <Specific Examples of Dimensions of Specific Portions> Next, specific examples of dimensions of specific portions of the surgical instrument used in this embodiment will be described with reference to FIGS. 2 to 7. FIG.

[0045] 2 to 4 are explanatory diagrams illustrating the dimensions of specific portions of the forceps 10. Specifically, Fig. 2 shows an overall view of the forceps 10 in an open state and an enlarged view of the ratchet 12 of the forceps 10, Fig. 3 shows a further enlarged view of the ratchet 12 of the forceps 10, and Fig. 4 shows an enlarged view of the groove 12b formed in the ratchet 12 of the forceps 10. In this embodiment, the surgical instrument management device 3 uses the ratchet 12, which is a protruding portion of the forceps 10, as the specific portion, and identifies each of the multiple forceps 10 based on the width of the ratchet 12.

[0046] Specifically, the surgical instrument management device 3 uses the width of the ratchet 12 at a portion a predetermined distance from the tip 12a. Figures 2 and 3 illustrate a width W11 at a portion 1 mm from the tip 12a, a width W12 at a portion 3 mm from the tip 12a, and a width W13 at a portion 5 mm from the tip 12a. In one example, these widths W11, W12, and W13 are 3.519 mm, 3.774 mm, and 4.036 mm, respectively, when measured with the precision dimension measuring instrument 2. Here, the precision dimension measuring instrument 2 identifies, for example, the ring portion 11 of the forceps 10 into which the user's finger is inserted, from an image of the forceps 10, and then identifies the ratchet 12 and its tip 12a near the ring portion 11, and then measures the widths (one or more of W11, W12, and W13) at a portion a predetermined distance from the tip 12a.

[0047] The ratchet 12 of the forceps 10 has a plurality of grooves 12b as shown in Figure 4 (in Figure 4, the upper diagram shows the ratchet 12 in a closed state, and the lower diagram shows the ratchet 12 in an open state). The grooves 12b are used to fix the forceps 10 at a position where it pinches a blood vessel. The width of the ratchet 12 is measured on the surface of the ratchet 12 opposite to the surface on which the grooves 12b are formed. Specifically, the dimension measurement is performed by the precision dimension measuring instrument 2 in a state in which the surface of the ratchet 12 on which the grooves 12b are formed faces downward and the surface on which the grooves 12b are not formed faces upward.

[0048] Next, FIG. 5 is an explanatory diagram of the dimensions of a specific portion of the scissors 20. FIG. 5 shows an overall view of the scissors 20 in a closed state and an enlarged view of the rotation axis 22 of the scissors 20. In this embodiment, the surgical instrument management device 3 uses the rotation axis 22 of the scissors 20 as the specific portion and identifies each of the multiple scissors 20 based on the width W2 of the portion passing through the center 22a of the rotation axis 22. In one example, this width W2 is 7.801 mm when measured with the precision dimension measuring instrument 2. Here, the precision dimension measuring instrument 2 identifies, for example, the blade portion 21 of the scissors 20 from an image captured of the scissors 20, and then identifies the rotation axis 22 and its center 22a near the blade portion 21, and measures the width W2 of the portion passing through the center 22a. Note that instead of identifying the blade portion 21 and then identifying the rotation axis 22, the rotation axis 22 may be identified directly.

[0049] Next, FIG. 6 is an explanatory diagram of the dimensions of a specific portion of the needle holder 30. FIG. 6 shows an overall view of the needle holder 30 in a closed state and an enlarged view of the tip 31a of the gripping portion 31 of the needle holder 30. In this embodiment, the surgical instrument management device 3 uses the tip 31a at the end of the gripping portion 31 as the specific portion, and identifies each of the multiple needle holders 30 based on the width around this tip 31a. Specifically, the surgical instrument management device 3 uses the width of a portion of the gripping portion 31 a predetermined distance away from the tip 31a. FIG. 6 illustrates a width W31 at a portion 3 mm away from the tip 31a, a width W32 at a portion 5 mm away from the tip 31a, and a width W33 at a portion 10 mm away from the tip 31a. In one example, these widths W31, W32, and W33 are 5.428 mm, 6.683 mm, and 7.125 mm, respectively, when measured with the precision dimension measuring device 2. Here, the precision dimension measuring instrument 2, for example, identifies the gripping portion 31 of the needle holder 30 from an image captured of the needle holder 30, then identifies the tip 31a of this gripping portion 31, and then measures the width (one or more of W31, W32, W33) of a portion a predetermined distance away from this tip 31a.

[0050] Next, FIG. 7 is an explanatory diagram of the dimensions of a specific portion of the forceps 40. FIG. 7 shows an overall view of the forceps 40 and an enlarged view of the rear end 42a of the connecting portion 42 of the forceps 40. In this embodiment, the surgical instrument management device 3 uses the rear end 42a of the connecting portion 42 of the two members, rather than the tip 41a of the gripping portion 41 of the forceps 40, as the specific portion. The surgical instrument management device 3 identifies each of the multiple forceps 40 based on the width of the rear end 42a. Specifically, the surgical instrument management device 3 uses the width of a portion a predetermined distance from the rear end 42a of the connecting portion 42. FIG. 7 illustrates the width W41 at a portion 3 mm away from the rear end 42a, the width W42 at a portion 5 mm away from the rear end 42a, and the width W43 at a portion 10 mm away from the rear end 42a. In one example, these widths W41, W42, and W43 are 12.317 mm, 11.572 mm, and 10.236 mm, respectively, when measured by the precision dimension measuring instrument 2. Here, the precision dimension measuring instrument 2 identifies, for example, the connection portion 42 of the forceps 40 from the image captured of the forceps 40, and then identifies the rear end 42a of this connection portion 42, and measures the width (one or more of W41, W42, and W43) of a portion that is a predetermined distance away from the rear end 42a.

[0051] 2 to 7, the measurement range of the precision dimension measuring instrument 2 is narrowed, that is, the dimension measurement is performed only on a narrow portion of the surgical instrument (specifically, a narrow portion including a specific portion) rather than on the entire surgical instrument. This shortens the measurement time using the precision dimension measuring instrument 2. Therefore, the precision dimension measuring instrument 2 can perform simultaneous dimension measurements on multiple surgical instruments in a relatively short time. As a result, by placing multiple surgical instruments on the table of the precision dimension measuring instrument 2 and measuring them simultaneously, it becomes possible to efficiently perform dimension measurements on multiple surgical instruments.

[0052] Since the needle holder 30 also has a ratchet similar to that of the forceps 10, the width of the ratchet of the needle holder 30 may be used as the dimension of the specific portion. Furthermore, since the forceps 10 and the needle holder 30 also have a rotation axis similar to that of the scissors 20, the width of the portion passing through the center of the rotation axis of the forceps 10 or the needle holder 30 may be used as the dimension of the specific portion. Furthermore, as with the needle holder 30 and the tweezers 40, the width of the end portion (typically the tip) of the forceps 10 or the scissors 20 may be used as the dimension of the specific portion.

[0053] The above examples show forceps 10, scissors 20, needle holder 30, and tweezers 40, which are commonly used surgical instruments. However, there are thousands of other types of medical surgical instruments in addition to the common instruments. Similar to the common instruments, dimensions of specific parts of these other surgical instruments can be determined and individual identification and management can be performed based on these dimensions. In this case, it is advisable to measure, identify, and manage the thousands of types of surgical instruments by dividing them into common instruments and other specialized instruments. Scalpels (scalpel blades) are disposable after surgery and do not need to be identified or managed, but scalpel holders are reusable and therefore require identification and management.

[0054] <Processing Flow> Next, specific processing performed by the surgical instrument management device 3 in this embodiment will be described with reference to Figures 8 and 9. Figure 8 is a flowchart showing the master registration of surgical instruments performed by the surgical instrument management device 3 in this embodiment, and Figure 9 is a flowchart showing the individual identification and management of surgical instruments performed by the surgical instrument management device 3 in this embodiment. These flows are realized in the surgical instrument management device 3 by the processing unit 3a reading and executing a program stored in the memory unit 3b.

[0055] First, in step S11 of the flow chart of FIG. 8 , the surgical instrument management device 3 acquires the group name, specified by the user via the input unit 3c or the like, to which the multiple surgical instruments to be measured by the precision dimension measuring device 2 (i.e., placed on the table of the precision dimension measuring device 2) belong. Essentially, these multiple surgical instruments belong to the same group and have the same specific parts. As described above, in this embodiment, the precision dimension measuring device 2 simultaneously measures the dimensions of specific parts of multiple surgical instruments, and the surgical instrument management device 3 simultaneously acquires the dimensions of these multiple specific parts. In another example, instead of using the group name specified by the user, the image captured by the precision dimension measuring device 2 may be analyzed to identify the group name to which the multiple surgical instruments belong. In yet another example, the branch type of the surgical instruments, as described above, may be used instead of or in addition to the group name of the surgical instruments.

[0056] Next, in step S12, the surgical instrument management device 3 identifies a predetermined specific part of the surgical instruments belonging to that group based on the group name obtained in step S11, and controls the precision dimension measuring instrument 2 to measure the dimensions of this specific part. The surgical instrument management device 3 then obtains the dimensions of the specific part measured by the precision dimension measuring instrument 2. In this case, the surgical instrument management device 3 obtains the dimensions of each specific part of multiple surgical instruments measured simultaneously by the precision dimension measuring instrument 2.

[0057] Next, in step S13, the surgical instrument management device 3 determines whether any of the acquired dimensions of the multiple specific parts have the same measurement dimensions. In this case, if the dimensions of the multiple specific parts are within a predetermined tolerance (e.g., ±5 microns), the surgical instrument management device 3 determines that the dimensions of the specific parts are the same.

[0058] If, as a result of step S13, there is no instrument with the same measured dimensions (step S13: No), the surgical instrument management device 3 proceeds to step S15, assigns a numerical value (for example, a numerical value in microns or submicrons) corresponding to the dimension of the specific portion of each of the multiple surgical instruments as an ID, and manages these multiple surgical instruments based on the IDs. In this case, the surgical instrument management device 3 associates with the ID identifying each of the multiple surgical instruments the name of the surgical instrument, the measured dimension of the specific portion, the group name of the surgical instrument, the branch type of the surgical instrument, the name of the surgical instrument manufacturer, the surgical instrument usage history, the surgical instrument useful life, the surgical instrument repair history, the surgical instrument purchase history, etc., and stores them in the memory unit 3b.

[0059] On the other hand, if the result of step S13 shows that there are instruments with the same measurement dimensions (step S13: Yes), the surgical instrument management device 3 proceeds to step S 14. As described above, the precision dimension measuring instrument 2 has a repeatability measurement accuracy within a tolerance of a few microns or submicrons, so the possibility of the measurement dimensions being the same is extremely low, but it is possible that the dimensions of surgical instruments made in the same lot by the same manufacturer will be the same down to the micron or submicron level.

[0060] In step S14, the surgical instrument management device 3 has the precision dimension measuring device 2 measure a different dimension from the specific portion of multiple surgical instruments that have the same dimension initially measured by the precision dimension measuring device 2, and obtains this new dimension. In a typical example, the surgical instrument management device 3 has the precision dimension measuring device 2 measure a different dimension of the same specific portion (in one example, as shown in Figures 2 and 3, if the width W11 of the forceps 10 was initially used, then the new width W12 or width W12 is used). After step S14, the surgical instrument management device 3 performs the same process as in step S15 described above. If the new dimension is also the same, then another dimension can be used. In other words, multiple different dimensions can be measured until the measured dimensions are different.

[0061] In another example, in step S14, for multiple surgical instruments with the same dimensions of the specific portion, instead of using a dimension different from the specific portion, the specific portion may be removed by several microns to several tens of microns to create a difference in the dimension of the specific portion of the surgical instrument, and the dimension of the specific portion after removal (the difference in dimension) may be used. In this case, there is no need to bring a cutting machine or the like into the hospital; the specific portion of the surgical instrument can be removed simply with a precision file or abrasive. It is also preferable to remove a portion that will have minimal impact on the function of the surgical instrument.

[0062] Next, the flow of Fig. 9 will be described. This flow is executed when disinfected and cleaned surgical instruments are returned to the sterilization container after surgery. It is also executed for the set of instruments being returned to the sterilization container or for each sterilization container unit.

[0063] First, in step S21, the surgical instrument management device 3 acquires the group name, specified by the user via the input unit 3c or the like, to which the multiple surgical instruments to be measured by the precision dimension measuring device 2 (i.e., placed on the table of the precision dimension measuring device 2) belong. Essentially, these multiple surgical instruments belong to the same group and have the same specific parts. As described above, in this embodiment, the precision dimension measuring device 2 simultaneously measures the dimensions of specific parts of multiple surgical instruments, and the surgical instrument management device 3 simultaneously acquires the dimensions of these multiple specific parts. In another example, instead of using the group name specified by the user, the image captured by the precision dimension measuring device 2 may be analyzed to identify the group name to which the multiple surgical instruments belong. In yet another example, the branch type of the surgical instruments, as described above, may be acquired instead of or in addition to the group name of the surgical instruments.

[0064] Next, in step S22, the surgical instrument management device 3 identifies a predetermined specific part of the surgical instruments belonging to that group based on the group name obtained in step S21, and controls the precision dimension measuring instrument 2 to measure the dimensions of this specific part. The surgical instrument management device 3 then obtains the dimensions of the specific part measured by the precision dimension measuring instrument 2. In this case, the surgical instrument management device 3 obtains the dimensions of each specific part of multiple surgical instruments measured simultaneously by the precision dimension measuring instrument 2.

[0065] Next, in step S23, the surgical instrument management device 3 compares the dimensions measured by the precision dimension measuring device 2 with the dimensions (corresponding to the ID value) previously stored in the master registration to individually identify the measured surgical instrument (i.e., specify the ID). At this time, the surgical instrument management device 3 appropriately updates stored information about the surgical instrument (such as usage history, cleaning history, and sterilization history) in order to manage the individually identified surgical instrument.

[0066] It should be noted that the processes shown in Figures 8 and 9 should be carried out in an environment maintained at a constant, predetermined temperature in order to suppress the effects of thermal expansion and contraction of the surgical instruments (i.e., dimensional changes due to temperature). In other words, it is desirable to carry out the processes on surgical instruments maintained at a constant, predetermined temperature.

[0067] <Operations and Effects> As described above, in this embodiment, the surgical instrument management device 3 is configured to acquire the dimensions of a predetermined specific portion of each of a plurality of surgical instruments, identify the surgical instruments based on the acquired dimensions of the specific portion, and manage the identified surgical instruments. In this embodiment, since individual differences will appear among the plurality of surgical instruments (in other words, it is possible to differentiate between the plurality of surgical instruments), the plurality of surgical instruments are identified based on the dimensions of the predetermined specific portion of each of the plurality of surgical instruments. This makes it possible to accurately identify and manage surgical instruments easily and at low cost. In other words, according to this embodiment, it is possible to identify and manage surgical instruments without the problems associated with methods of identifying and managing individual surgical instruments using two-dimensional codes or RFID tags, as described in the section "Problems to be Solved by the Invention."

[0068] Specifically, according to this embodiment, the dimensions of the surgical instrument are measured as is, so that it is possible to accurately identify and manage individual surgical instruments, even those made of materials other than metal, such as ceramic or engineering plastic, to which RFID tags cannot be attached, and small surgical instruments that do not have space to attach RFID tags or two-dimensional codes.

[0069] Furthermore, this embodiment does not require a laser marking machine to mark the two-dimensional code on the surgical instrument or a laser welding machine to attach the RFID tag to the surgical instrument, so there is no need to bring marking machines or welding machines into the hospital.In addition, since there is no need for labor costs for such work, total costs can be significantly reduced.

[0070] Furthermore, this embodiment reduces manual work and eliminates quality differences due to the level of skill of the person performing the work. In particular, this embodiment enables individual identification and management of surgical instruments simply by placing them on the table of the precision dimension measuring instrument 2 and measuring them.

[0071] Thus, according to this embodiment, surgical instruments can be individually identified as they are without processing them to imprint a two-dimensional code or attach an RFID tag, and all surgical instruments can be individually identified and managed regardless of their material, shape, or size.

[0072] The surgical instrument management device 3 preferably manages surgical instruments by sterilization container, which contains multiple surgical instruments. In this case, it is recommended to attach RFID tags or two-dimensional codes that can withstand the sterilization environment to the sterilization containers and use them to build a system that displays the type and number of surgical instruments contained in each sterilization container. Typically, experienced instrument assembly staff retrieve surgical instruments from the surgical instrument storage shelves and assemble them. This assembly process relies on the experience and knowledge of the staff, but even so, shortages, errors, and excesses of surgical instruments can occur during assembly. Managing surgical instruments in this manner allows for separating unused instruments from used ones after surgery and removing unused instruments from the set, thereby streamlining the set contents. Furthermore, recognizing the surgical instrument IDs and deleting them from the computer screen during surgical assembly improves the accuracy of the assembly process. Furthermore, even staff with little specialized surgical instrument knowledge can assemble instruments, eliminating labor shortages and reducing labor costs. Currently, without surgical instrument management, inventory management is not possible. Specifically, the quantity, cost, replenishment, repairs, number of uses, and useful life of surgical instruments within the hospital are not known. However, if surgical instruments are managed as described above, ordering operations can be automated, resulting in labor savings. Ultimately, it will be possible to eliminate the assembly process and use sterilized containers as surgical sets. Although common surgical instruments will increase the number of surgical instruments compared to the current situation where instruments are reused between sets, it will enable surgical instrument management with many advantages, such as streamlining the set contents, reducing labor costs through labor savings, improving the accuracy of set assembly, preventing excess inventory through inventory management, and preventing unnecessary and non-urgent purchases through appropriate useful life management.

[0073] <Modification> Next, a modification of the above-described embodiment will be described.

[0074] In the above-described embodiment, identification is performed using the dimensions (typically width) of a specific portion of the surgical instrument, but in other examples, the height of the surgical instrument may be obtained by three-dimensional measurement, and the height may be used in addition to the dimensions of the specific portion to identify the surgical instrument. For example, for a surgical instrument that includes a hook, the surgical instrument may be identified based on the width and height of the hook.

[0075] In yet another example, in addition to the dimensions of a particular part (height may also be used), a surgical instrument may be identified using one or more of the surface roughness, surface gloss, the type of elements in the material that makes up the surgical instrument, and the composition ratio of these elements.

[0076] In the above-described embodiment, an example of applying the present invention to a surgical instrument (surgical instrument management method and device) was shown. However, the present invention can also be applied to orthodontic mouthpieces. In other words, the above-described surgical instrument management method and device can be configured as an orthodontic mouthpiece management method and device. This modified example will be described with reference to FIG. 10 . FIG. 10 is a plan view of an orthodontic mouthpiece 50 used in the modified example. The orthodontic mouthpiece 50 is made of, for example, polyurethane and is formed to be transparent. In the modified example, the orthodontic mouthpiece management device identifies multiple orthodontic mouthpieces 50 based on at least one of the following specific features of the orthodontic mouthpiece 50: the length W50 of one side in the vertical direction, the length W51 of the other side in the vertical direction, and the length W52 of the horizontal direction perpendicular to the vertical directions. For example, the above-described precision dimension measuring instrument 2 identifies a molar portion 51 and a front tooth portion 52 on one side from an image captured of the orthodontic mouthpiece 50, and then measures a length W50 between these portions 51 and 52. Similarly, the precision dimension measuring instrument 2 identifies a molar portion 53 and a front tooth portion 54 on the other side, and then measures a length W51 between these portions 53 and 54. Also, after identifying portions 55 and 56 of a pair of teeth aligned laterally, the precision dimension measuring instrument 2 measures a length W52 between these portions 55 and 56. Although multiple orthodontic mouthpieces 50 are made for the same patient depending on the orthodontic stage, measuring at least one of the above lengths W50, W51, and W52 makes it possible to accurately identify which orthodontic stage the orthodontic mouthpiece 50 was used in.

[0077] As described above, the above-described embodiments are merely examples for explaining the present invention, and the present invention is not limited to these embodiments. The present invention can be embodied in various forms without departing from the gist of the present invention.

[0078] REFERENCE SIGNS LIST 1 Surgical instrument management system 2 Precision dimension measuring instrument 3 Surgical instrument management device 10 Forceps 12 Ratchet 20 Scissors 22 Rotating shaft 30 Needle holder 40 Forceps 50 Dental orthodontic mouthpiece

Claims

1. A surgical instrument management method for managing medical surgical instruments, comprising the steps of: acquiring dimensions of a predetermined specific part for each of a plurality of surgical instruments; identifying the surgical instruments based on the acquired dimensions of the specific parts; and managing the identified surgical instruments.

2. A surgical instrument management method as described in claim 1, wherein the acquiring step acquires one or more new dimensions other than the dimensions of the specific part for each of the plurality of surgical instruments when the dimensions of the specific part acquired for the plurality of surgical instruments having the same specific part are the same, and the identifying step identifies the plurality of surgical instruments based on the one or more new dimensions.

3. A surgical instrument management method as described in claim 1, wherein the acquiring step, when the dimensions of the specific part acquired for multiple surgical instruments having the same specific part are the same, acquires new dimensions after the specific part has been cut for one or more of the multiple surgical instruments, and the identifying step identifies the multiple surgical instruments based on the dimensions of the specific part after it has been cut.

4. A surgical instrument management method as described in claim 2 or 3, further comprising a step of determining that the dimensions of the specific parts obtained for the multiple surgical instruments are the same if the dimensions of the specific parts obtained for the multiple surgical instruments are within a predetermined tolerance.

5. A surgical instrument management method as described in claim 1, wherein the acquiring step acquires dimensions of the specific parts of a plurality of the surgical instruments simultaneously, and the identifying step identifies each of the plurality of surgical instruments based on the dimensions of the specific parts acquired simultaneously for the plurality of surgical instruments.

6. A surgical instrument management method as described in claim 1, further comprising a step of pre-storing the dimensions of the specific part acquired for a plurality of the surgical instruments, and the identification step identifies the surgical instrument having the dimensions of the specific part acquired in the acquisition step by comparing the dimensions of the specific part stored in the storage step with the dimensions of the specific part acquired in the acquisition step after the storage step.

7. A surgical instrument management method as described in claim 1, wherein the dimension of the specific part is the width of a protruding portion of the surgical instrument.

8. A surgical instrument management method as described in claim 1, wherein the dimension of the specific part is the width of an end of the surgical instrument.

9. A surgical instrument management method as described in claim 1, wherein the dimension of the specific part is the width of the part passing through the center of the rotation axis of the surgical instrument.

10. A surgical instrument management method as described in claim 1, wherein the identifying step identifies the surgical instrument based on a numerical value in microns or submicrons of a dimension of the specific portion.

11. A surgical instrument management method as described in claim 1, wherein the identifying step and the managing step each use a numerical value corresponding to a dimension of the specific portion as an ID to identify and manage the surgical instrument.

12. A surgical instrument management method as described in claim 11, wherein the management step manages one or more of the name of the surgical instrument, the dimensions of the specific part of the surgical instrument, the group name of the surgical instrument, the branch type of the surgical instrument, the manufacturer name of the surgical instrument, the usage history of the surgical instrument, the useful life of the surgical instrument, the repair history of the surgical instrument, and the purchase history of the surgical instrument in association with the ID.

13. A surgical instrument management method as described in claim 1, further comprising a step of acquiring the height of each of the plurality of surgical instruments, and the identifying step identifying the surgical instrument based on the acquired height and the dimension of the specific part.

14. A surgical instrument management method as described in claim 1, further comprising a step of acquiring one or more of the surface roughness, surface gloss, type of element of the material constituting the surgical instrument, and composition ratio of these elements, and the identifying step identifies the surgical instrument based on the acquired one or more of the surface roughness, surface gloss, type of element, and composition ratio of the element, and the dimensions of the specific portion.

15. A surgical instrument management method according to claim 1, wherein the managing step manages the surgical instruments in units of sterilized containers each containing a plurality of the surgical instruments.

16. A surgical instrument management device for managing medical surgical instruments, comprising: an acquisition means for acquiring dimensions of a predetermined specific part for each of a plurality of surgical instruments; an identification means for identifying the surgical instruments based on the acquired dimensions of the specific part; and a management means for managing the identified surgical instruments.

17. A method for managing orthodontic mouthpieces, comprising the steps of: acquiring dimensions of a predetermined specific part for each of a plurality of orthodontic mouthpieces; identifying the orthodontic mouthpiece based on the acquired dimensions of the specific part; and managing the identified orthodontic mouthpiece.

18. A dental orthodontic mouthpiece management device comprising: an acquisition means for acquiring dimensions of a predetermined specific part for each of a plurality of dental orthodontic mouthpieces; an identification means for identifying the dental orthodontic mouthpiece based on the acquired dimensions of the specific part; and a management means for managing the identified dental orthodontic mouthpiece.

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