Safety Management System for Microneedles

Abstract

The present invention relates to a safety management system for micro-needles, and more specifically, to a technology that enables hygienic operation of micro-needles and dedicated management for each user by matching user information to micro-needles to enable individual identification and usage management. That is, the present invention is characterized by comprising: a needle tip inserted into the skin of a patient; a handpiece device to which the needle tip is detachably coupled and which outputs RF energy to the needle tip; a memory unit provided on the needle tip and storing unique identification information capable of individually identifying the needle tip; a patient information input unit for inputting the patient ID of a patient using the needle tip; and a patient matching unit for determining whether the unique identification information of the needle tip read from the memory unit matches the patient ID input from the patient information input unit.

Description

Technology Field

[0001] The present invention relates to a safety management system for micro-needles, and more specifically, to a technology that enables hygienic operation of micro-needles and dedicated management for each user by matching user information to micro-needles to enable individual identification and usage management. Background Technology

[0003] With the recent advancement of medical technology, micro-needles with a diameter and height of only tens to hundreds of micrometers (㎛) are being increasingly utilized to treat skin diseases, wounds, and aging.

[0004] These micro-needles are medical devices that are highly suitable for the above purpose, as they can minimize skin damage and pain and enable even drug injection over a relatively wide area.

[0006] Recently, devices using micro-needles utilize RF (Radio Frequency) energy to deliver energy to the inner layers of the skin or tissue, thereby strengthening collagen fibers and increasing the elasticity of the skin or tissue, and can produce synergistic effects when used in combination with drugs.

[0008] Procedures using these micro-needles are performed by attaching needle tips to a medical handpiece device. Although needle tips are classified as consumables that must be discarded after a certain number of uses, this usage limit represents the number of procedures that can be performed. Therefore, they are managed by storing the needle tips used on a specific patient separately after each procedure and reusing them on the same patient until the usage limit is reached.

[0010] As such, while needle tips possess structural characteristics that allow for multiple reuses, their management is of paramount importance in terms of hygiene and infection prevention, as they are components directly inserted into the human skin during procedures. Accordingly, needle tip management is fundamentally carried out on a patient-by-patient basis.

[0012] However, conventional needle tip management methods rely on manually writing patient names, chart numbers, or usage dates on needle tip storage cases, and no technical means are provided to automatically recognize or verify which patient a needle tip was used on, either at the level of the needle tip itself or the procedure equipment.

[0013] As a result, it is difficult to completely rule out the possibility that a needle tip used on a specific patient may be used on another patient due to human factors such as reduced attention, excessive workload, confusion during storage, or simple mistakes.

[0015] Furthermore, in conventional systems, historical information regarding which patients a needle tip was previously used on is not recorded or linked to the needle tip or the surgical equipment; consequently, it is difficult to implement a function at the equipment level to prevent or warn of cross-use of needle tips. Consequently, existing needle tip management methods have structural limitations in terms of hygiene management and infection prevention, which are directly related to patient safety.

[0017] Some conventional RF needle tips are equipped with memory devices such as EEPROM, RFID, or NFC chips, but the scope of application for such memory is very limited.

[0018] Specifically, in conventional systems, the information stored in memory is limited to the number of needle tip uses (shot count), and this is primarily used to block the use of the needle tip if the preset number of uses is exceeded.

[0019] Furthermore, the information provided by needle tip manufacturers is also mostly limited to simple specification distinctions, such as whether the product is insulated or non-insulated. Prior art literature

[0021] Registered Patent No. 10-2604909 (Microneedle therapy device, system) Registered Patent No. 10-2531152 (Microneedle patch loaded with antigen and skin prick test reading system including the same) The problem to be solved

[0022] The present invention has been devised to solve the above-mentioned problems and aims to provide a micro-needle management system that can technically block the cross-use of needle tips and structurally improve patient safety and the reliability of hygiene management by preventing the operator from subjectively judging whether the needle tip is reusable and whether it matches the patient, thereby fundamentally preventing the cross-use of needle tips caused by manager error in conventional manual needle tip management. means of solving the problem

[0024] The present invention is characterized by comprising: a needle tip inserted into the skin of a patient; a handpiece device to which the needle tip is detachably coupled and which outputs RF energy to the needle tip; a memory unit provided on the needle tip and storing unique identification information capable of individually identifying the needle tip; a patient information input unit for inputting a patient ID of a patient using the needle tip; and a patient matching unit for determining whether the unique identification information of the needle tip read from the memory unit matches the patient ID input from the patient information input unit.

[0026] In addition, the above unique identification information is characterized as being a Unique ID assigned to an EEPROM, RFID, or NFC chip during the semiconductor manufacturing process.

[0028] In addition, the handpiece device is characterized by further including a needle control unit that controls whether to use a needle tip based on whether the patient is matched in the patient matching unit.

[0030] In addition, the memory unit stores usage count information whenever the needle tip is used, and the needle control unit is characterized by controlling the needle tip so that it is not used when the number of uses of the needle tip exceeds a pre-stored limit. Effects of the invention

[0032] According to the present invention, based on unique identification information provided on a needle tip, it is automatically determined whether it matches a patient ID (patient identification information), and depending on the determination result, the needle tip is controlled to prevent use or the operator is notified, thereby technically blocking the cross-use of the needle tip to different patients at the equipment level. Accordingly, human errors that may occur in conventional methods relying on the operator's subjective judgment or manual management can be fundamentally reduced.

[0034] In addition, the present invention is configured to electronically assign a needle tip to a specific patient upon initial use and to automatically verify whether it is the same patient during the subsequent reuse process, thereby significantly improving the reliability of patient-specific hygiene management while maintaining structural characteristics that allow for the reuse of the needle tip.

[0036] In addition, based on the judgment of the patient matching unit, the procedure itself can be prevented from being performed in cases of patient mismatch, thereby providing the effect of preemptively blocking the possibility of infection transmission due to cross-use. Brief explanation of the drawing

[0038] FIG. 1 is a diagram showing the overall configuration of the safety management system for microneedles according to the present invention. FIG. 2 is a diagram showing an example of the operation of a patient matching unit applied to the system of the present invention. FIG. 3 is a drawing showing another embodiment in which a procedure log storage unit is added to the system of the present invention. FIG. 4 is an application screen of a patient's smartphone terminal applied to the system of the present invention. Specific details for implementing the invention

[0039] Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In describing the present invention, specific descriptions of related known functions or configurations are omitted if it is determined that such detailed descriptions may unnecessarily obscure the essence of the invention.

[0041] The safety management system for micro needles according to the present invention is characterized by comprising: a needle tip (100) inserted into the skin of a patient as illustrated in FIG. 1; a handpiece device (200) to which the needle tip (100) is detachably coupled and which outputs RF energy to the needle tip (100); a memory unit (300) provided in the needle tip (100) and storing unique identification information that can individually identify the needle tip (100); a patient information input unit (400) for inputting the patient ID of a patient using the needle tip (100); and a patient matching unit (500) for determining whether the unique identification information of the needle tip (100) read from the memory unit (300) matches the patient ID input from the patient information input unit (400).

[0043] The above needle tip (100) is manufactured in multiple quantities and inserted into each patient, and the handpiece device (200) is installed at the location where the procedure is performed and is detachably coupled to the needle tip (100). The handpiece device (200) is configured to generate RF energy and output it to the patient's skin through the needle tip (100), and the needle tip (100) is formed so that it can be separated from the handpiece device (200) after the procedure is completed.

[0045] In addition, the needle tip (100) is provided with a memory unit (300) for individually identifying the needle tip (100). The memory unit (300) stores unique identification information that is different for each needle tip (100), and the unique identification information may be a Unique ID assigned during the semiconductor manufacturing process to an EEPROM, RFID, or NFC chip. Accordingly, each needle tip (100) can be uniquely identified electronically regardless of its appearance or handwritten markings.

[0046] In addition, the above unique identification information may also be composed of arbitrary identification information entered by the administrator.

[0048] The patient information input unit (400) of the present invention is configured to input the patient ID of a patient using the needle tip (100), and the patient information input unit (400) can be applied as various means capable of inputting the patient's ID information as digital information. For example, it can be implemented in various forms such as a keypad, a touchscreen, a barcode reader, a QR code scanner, or an input means linked to a hospital computer system.

[0049] Preferably, patient information can be entered by typing it into the device, or by inputting and matching it through various methods such as ID cards, fingerprints, iris recognition, facial recognition, or scanning of resident registration cards.

[0051] As illustrated in FIG. 2, the patient matching unit (500) of the present invention determines whether there is a match between the unique identification information of the needle tip (100) read from the memory unit (300) and the patient ID entered through the patient information input unit (400). Specifically, if the needle tip (100) has a history of being used on a specific patient in the past, the patient matching unit (500) determines whether it is the same patient by comparing the patient ID stored by matching the unique identification information of the needle tip (100) with the currently entered patient ID.

[0053] And the patient matching unit (500) is configured to determine when the needle tip (100) is used for the first time in a procedure. Specifically, when the needle tip (100) is mounted on the handpiece device (200) and unique identification information is read from the memory unit (300), the patient matching unit (500) first checks whether a patient ID (patient identification information) corresponding to the unique identification information is previously stored. At this time, if there is no patient ID matched with the unique identification information in the internal storage area of ​​the memory unit (300) or the handpiece device (200), the patient matching unit (500) determines that the needle tip (100) is being used for the first time.

[0055] In this manner, when the needle tip (100) is determined to be in its initial state of use, the patient matching unit (500) controls the recording of the patient ID entered through the patient information input unit (400) by matching it to correspond to the unique identification information of the needle tip (100). That is, the patient matching unit (500) sets the patient ID of the first patient subject to the procedure as the reference patient information for the corresponding needle tip (100), and subsequently uses it as a comparison standard to determine whether the patient matches when the same needle tip (100) is reused.

[0057] Specifically, when the needle tip (100) is used for the first time, the input patient ID is stored in at least one of the internal storage area of ​​the handpiece device (200) or the memory unit (300) provided in the needle tip (100). Subsequently, when the same needle tip (100) is used for a second or subsequent procedure, the patient matching unit (500) is configured to determine whether the needle tip (100) is usable by checking the patient ID already stored in the storage area and comparing it with a newly input patient ID through the patient information input unit (400).

[0059] In this process, the patient matching unit (500) checks whether the patient ID has been entered correctly, and then stores the unique identification information of the patient ID and the needle tip (100) in conjunction, thereby electronically defining that the needle tip (100) belongs to a specific patient. Accordingly, regardless of the external markings or handwritten records of the needle tip (100), the patient matching criteria are automatically set based on the identification information of the needle tip (100) itself.

[0061] Subsequently, when the needle tip (100) is reused, the patient matching unit (500) compares the patient ID corresponding to the unique identification information stored in the memory unit (300) with the patient ID newly entered through the patient information input unit (400) to determine whether they are the same patient. Accordingly, the matching information set at the time of the initial patient ID input functions as reference data for determining whether the patient matches throughout the entire process of reusing the needle tip (100).

[0063] In this way, the patient matching unit (500) confirms and stores the patient ID as reference information at the time of the first use of the needle tip (100), thereby providing a technical basis for automatically determining whether the needle tip (100) is used cross-referenced between patients during subsequent procedures. Through this, the management of the patient's attribution of the needle tip (100) can be systematically carried out without relying on the subjective judgment or management errors of the operator.

[0065] In addition, the handpiece device (200) in the present invention may further include a needle control unit (600) that controls whether the needle tip (100) is used according to whether the patient matches in the patient matching unit (500).

[0066] The above needle control unit (600) is configured to control the use of the needle tip (100) based on a judgment result transmitted from the patient matching unit (500), and preferably controls the needle tip so that the needle portion of the needle tip (100) is exposed to the outside or not exposed in a manner that moves the needle tip.

[0068] That is, the needle control unit (600) controls the needle tip (100) so that the needle is exposed and can be inserted into the patient only when the patient matching unit (500) determines that the reference patient ID matched to the needle tip (100) and the currently entered patient ID match each other. On the other hand, when the patient matching unit (500) determines that the patient IDs do not match each other, the needle tip (100) is controlled so that the needle is not exposed and cannot be inserted into the patient.

[0069] The above needle control unit (600) is configured to control the use of the needle tip (100), and can be configured in various ways in addition to the method of controlling through the movement of the needle tip (100).

[0071] Accordingly, even if the operator intentionally or accidentally attaches a needle tip (100) that has already been used on a different patient, the actual procedure is not performed through the needle control unit (600). In other words, the cross-use of the needle tip (100) is technically blocked at a stage prior to the operator's judgment.

[0073] Additionally, the needle control unit (600) may be configured to control the use of the needle tip (100) as well as provide a warning signal to the operator, and the warning signal may be output in the form of at least one of a display, an acoustic signal, or a vibration signal. Through this, the operator can immediately recognize the patient mismatch status of the needle tip (100) and take appropriate follow-up measures, such as replacing the needle tip (100) or verifying the patient.

[0075] Furthermore, the needle control unit (600) may be controlled in conjunction with information on the number of uses of the needle tip (100). That is, when the cumulative number of uses of the needle tip (100) reaches or exceeds a preset limit, the use of the needle tip (100) may be blocked regardless of the judgment result of the patient matching unit (500). Accordingly, performance degradation and safety issues caused by excessive reuse of the needle tip (100) can be prevented.

[0076] More specifically, the memory unit (300) stores usage count information whenever the needle tip (100) is used, and the needle control unit (600) can be controlled to restrict the use of the needle tip (100) when the number of uses of the needle tip (100) exceeds a pre-stored limit.

[0078] In this way, the needle control unit (600) directly links the judgment result of the patient matching unit (500) to the procedure energy control, thereby performing the role of converting the cross-use of the needle tip (100) between patients from a simple management procedure into a forced control structure at the equipment level. Through this, the present invention provides the effect of substantially improving patient safety and procedure reliability.

[0080] In addition, as illustrated in FIG. 3, the present invention may further include a procedure log storage unit (700). The procedure log storage unit (700) is configured to store procedure-related information such as unique identification information of the needle tip (100), a patient ID determined by the patient matching unit (500), the time and date the procedure was performed, and whether RF energy was output and the output conditions. Accordingly, a procedure history regarding when, to which patient, and under what conditions each needle tip (100) was used can be systematically recorded.

[0082] The above procedure log storage unit (700) may be formed in the internal storage area of ​​the handpiece device (200), and may be stored in conjunction with an external management server or a hospital computer system as needed. In this case, the information recorded in the procedure log storage unit (700) may be transmitted to an external system via wired or wireless communication and managed centrally.

[0084] In addition, the procedure log storage unit (700) may be configured to store a history of blocked use of the needle tip (100) when it is determined to be a patient mismatch by the patient matching unit (500). Through this, records are kept not only for cases where the actual procedure was performed, but also for cases where cross-use of the needle tip (100) was attempted but was technically blocked, so they can be utilized for post-procedure management and safety verification.

[0086] Furthermore, the procedure history information stored in the procedure log storage unit (700) can be utilized for managing the number of times the needle tip (100) is used, verifying the procedure history for each patient, analyzing the status of equipment usage, or for quality control purposes. Accordingly, the present invention provides the effect of improving not only real-time safety control of the needle tip (100) but also traceability and management reliability after the procedure.

[0088] In addition, the present invention may be configured such that the handpiece device (200) is operated only when the matching state is maintained after the patient matching unit (500) has performed one patient matching at the start of the procedure, or it may be configured to reconfirm the patient matching state at regular intervals.

[0090] At this time, it is preferable that the patient matching be performed in conjunction with the patient's personal mobile communication terminal, such as a smartphone, as illustrated in FIG. 4. That is, the patient matching unit (500) can be configured to perform matching through a short-range wireless communication module (e.g., Bluetooth, NFC, etc.) and a dedicated application equipped on the terminal of the patient currently undergoing the procedure, and to check the current matching status in real time.

[0092] Accordingly, when the procedure is finished and the patient leaves the procedure location, the communication connection with the terminal is disconnected, and as a result, the use of the corresponding needle tip (100) can be controlled to be automatically restricted.

[0093] This method is capable of fundamentally preventing medical accidents in which the needle tip (100) is not removed from the handpiece device (200) even after the procedure has ended and is then performed on another patient.

[0095] With this configuration, by preventing in advance a situation where a user change occurs while the needle tip (100) is mounted on the handpiece device (200), a dedicated usage system for each user can be stably maintained.

[0097] Although the present invention has been described above with reference to the embodiments, it is understood that various modifications are possible within the scope of the technical spirit of the present invention. Explanation of the symbols

[0105] 100 : Needle Tip 200 : Handpiece device 300 : Memory section 400 : Patient Information Input Section 500 : Patient Matching Department 600 : Needle control unit 700 : Procedure Log Storage

Claims

Claim 1 The handpiece device (200) comprises a needle tip (100) inserted into the skin of a patient, a handpiece device (200) to which the needle tip (100) is detachably coupled and which outputs RF energy to the needle tip (100), a memory unit (300) provided in the needle tip (100) and storing unique identification information that can individually identify the needle tip (100), a patient information input unit (400) for inputting the patient ID of a patient using the needle tip (100), and a patient matching unit (500) for determining whether the unique identification information of the needle tip (100) read from the memory unit (300) matches the patient ID input from the patient information input unit (400); wherein the handpiece device (200) further includes a needle control unit (600) that controls whether the needle tip (100) is used according to whether the patient matches in the patient matching unit (500), and wherein the needle control unit (600) A safety management system for micro needles, characterized by controlling the use of the needle tip (100) by moving the needle tip based on a judgment result transmitted from the patient matching unit (500), wherein the needle control unit (600) controls the needle tip (100) so that the needle is exposed and can be inserted into the patient only when the patient matching unit (500) determines that the reference patient ID matched to the needle tip (100) and the currently entered patient ID match each other, and when the patient matching unit (500) determines that the patient IDs do not match each other, the needle tip (100) is controlled so that the needle is not exposed and cannot be inserted into the patient. Claim 2 delete Claim 3 delete Claim 4 A safety management system for micro needles according to claim 1, wherein the memory unit (300) stores usage count information whenever the needle tip (100) is used, and the needle control unit (600) controls the needle tip (100) so that it is not used when the number of uses of the needle tip (100) exceeds a pre-stored limit.

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