System and method for marking and identifying surgical instruments through serialisation and optical reading with polarised light

Abstract

The invention relates to an advanced system for marking and identifying surgical instruments, improving traceability, patient safety and operational efficiency. Each surgical instrument is equipped with a unique serial number, engraved using a laser machine, facilitating detailed monitoring of the instruments' life cycle. The system uses illuminators with polarising filters and a camera to optimise the visibility of serial markings, reducing reflections and improving contrast. A central server manages the generation of serial numbers, image recording and data storage, ensuring unique and comprehensive management of instruments, supported by wired or wireless network technologies.

Description

[0001] Invention Title:

[0002] System and Method for Marking and Identifying Surgical Instruments through Serialisation and Optical Reading with Polarised Light

[0003] Introduction:

[0004] The basketss containing surgical instruments in operating rooms are essential tools for the efficiency and safety of surgical procedures. However, their use can present various common problems, including:

[0005] 1. Contamination and Infections: o Inadequate or incomplete sterilisation of instruments can lead to contamination and post-operative infections. o Accidental opening of the baskets before time can compromise sterility.

[0006] 2. Counting and Inventory Errors: o Mismatch between the instruments listed and those actually present in the basket. o Missing or additional instruments not detected during pre- and post-operative counting, increasing the risk of instruments being accidentally left in the patient.

[0007] 3. Instrument Malfunction: o Damaged or defective instruments not identified during pre-operative checks, o Repeated use leading to wear and tear and malfunction of instruments, compromising the quality of the procedure.

[0008] 4. Instrument selection errors: o Incorrect choice of baskets for the type of procedure planned, delaying the procedure. o Unsuitable or missing instruments in the set, requiring improvisation or replacement during the procedure.

[0009] 5. Organisation and accessibility: o Inefficient organisation of instruments within the baskets, making them difficult and slow to find during the procedure. o Lack of standardisation in instrument sets between different healthcare facilities or even between different surgeons in the same facility.

[0010] 6. Staff training: o Staff not adequately trained in the use and management of baskets. o High staff turnover leading to a lack of familiarity with instrument management protocols.

[0011] 7. Logistics and Transport Issues: o Delays in the delivery of sterilised trays to the operating theatre. o Management issues in the rotation and maintenance of trays between different procedures.

[0012] The device allows a serial number to be affixed to each instrument and implements the relevant technology for reading and writing these serial numbers, as well as their distribution and management of uniqueness at a global level. All this is done using remote servers.

[0013] The implementation of serial numbers on each surgical instrument solves numerous common problems related to the management, traceability and safety of surgical instruments. Here's how:

[0014] 1. Improved Traceability: o Unique Identification: Each instrument can be uniquely identified, facilitating monitoring and management. o Instrument Log: A detailed log of each instrument can be maintained, including its use, maintenance and life cycle. nt Safety: Reduced Risk of Missing Instruments: Serial numbers allow for accurate counting of instruments before and after surgery, reducing the risk of instruments being left inside the patient. Infection Monitoring: In the event of an infection, the instruments used can be traced to identify any sterilisation issues. ntory Management: Inventory Control: With serial numbers, it is possible to know exactly how many instruments are available, which ones are in use and which ones need maintenance or replacement. Reduction of Theft or Loss: Unique traceability makes it more difficult for instruments to be lost or stolen. tenance and Quality: Maintenance History: Each instrument can have a maintenance log documenting when it was sterilised, repaired or replaced. Identification of Defective Instruments: Instruments with recurring problems can be easily identified and withdrawn from service. rational Efficiency: Preparation of Instrument Sets: The preparation of baskets for specific procedures becomes more efficient and accurate, knowing exactly which instruments are needed. Staff Training: Staff can be trained to recognise and use instruments more effectively, having detailed information about them at their disposal. latory Compliance: Documentation and Audits: The ability to track each instrument helps to meet regulatory requirements and provide complete documentation during audits. The benefits in terms of safety, efficiency and quality of care are therefore significant.

[0015] The visibility of a line marked by a laser on stainless steel depends on several factors, including the viewing angle, the quality of the marking and the lighting conditions. In general, the marked line is most visible from certain angles for the following reasons:

[0016] 1 . Angle of Incidence and Reflectivity: o Surface Reflectivity: Stainless steel is highly reflective. When light hits the surface at a specific angle, the marked line may appear lighter or darker than the surrounding material. This depends on the angle of incidence of the light and the angle of observation. o Mirror Angles: Optimal visibility is often achieved when the angle of incidence of the light and the angle of observation are complementary. In other words, the angle between the light source and the observer is such that the light reflected from the marked surface reaches the observer's eye directly.

[0017] 2. Contrast and Light Diffusion:

[0018] • Light Diffusion: A surface marked with a laser can diffuse light differently than a smooth, unmarked surface. When viewed from an angle that maximises this difference in diffusion, the marked line becomes more noticeable.

[0019] • Optimal Contrast Angles: The contrast between the marked line and the surrounding surface is often more pronounced when light is reflected directly in the direction of the observer, creating a clear visual distinction.

[0020] 3. Surface and Marking Quality:

[0021] • Marking Profile: Markings that create a variation in surface texture (e.g., deep engravings or surface colouring) may be more visible from certain angles. This is because light interacts with differences in height and texture differently than it does with a flat surface.

[0022] • Surface Finish: Surfaces with different finishes (glossy, satin, matte) affect how light is reflected and diffused, changing the visibility of the marking. 4. Lighting:

[0023] • Type of Light: The visibility of the marking may vary under natural light compared to artificial light. Diffused lighting conditions can improve the readability of markings.

[0024] • Light Positioning: Illuminating the marked surface from different angles can help identify the optimal viewing angle. An angled light may highlight the marking better than a direct light.

[0025] The use of polarised light can significantly improve the contrast of laser markings on stainless steel.

[0026] Advantages of Using Polarised Light:

[0027] 1. Reflection Reduction: o Minimising Reflections: Polarised light can reduce reflections from shiny, reflective surfaces such as stainless steel, improving the visibility of markings. o Increased Contrast: By reducing glare, the difference between the light reflected from the marking and that reflected from the surrounding surface becomes more apparent, improving contrast.

[0028] 2. Improved Marking Definition: o Marking Clarity: Polarised light helps to make marked lines sharper, as it reduces diffuse light that can blur the edges of the marking. o Reduction of Stray Light: This type of light eliminates much of the stray light that can interfere with the visibility of the marking.

[0029] 3. Relief Effect: o Greater Perception of Depth: Polarised light can better highlight variations in surface texture, creating a relief effect that makes the marking more visible.

[0030] Description:

[0031] The system is composed of the following elements, as shown in FIG 1 :

[0032] 1 . Two illuminators (1) and (4): These can be of any wavelength, both visible and non-visible, including infrared wavelengths.

[0033] 2. Polarising filters (2) and (3): The direction of polarisation is orthogonal between them.

[0034] 3. Projectors (1) and (4): Arranged at the vertices of a 90° triangle with respect to the camera (6). The projectors illuminate the surgical instrument (5) at an angle of approximately 45° with respect to the vertical where the camera (6) is located.

[0035] 4. Camera (6): Sends data to an ECU control unit (7).

[0036] 5. ECU control unit (7): Can operate projectors (1 ) and (4) simultaneously or alternately.

[0037] 6. Connection (9a) to the server (10): Can be wired or wireless (8a).

[0038] 7. Server (10): Connected via a wired or wireless connection (9b, 8b) to a laser marking machine (1 1 ). The server is also connected to an entropy generator (14) and a database (15).

[0039] 8. Laser marking machine (11): Engraves the surgical instrument (13) positioned below it with serial information using a QR code, barcode, or other types of codes. The engraving is done in strictly parallel lines (15) to facilitate reading with polarised light. The square (16) represents a single pixel of a QR code.

[0040] 9. HID user interface device (5): Equipped with a display and keyboard or touch screen, such as a computer or tablet, connected to the server (9c) via a wired or wireless connection (8c).

[0041] Functioning:

[0042] When deciding to generate a serial number for the surgical instrument, the user sends a request for a new serial number to the server (10) via the HID (5). The server generates the serial number using the entropy generator (14), saves it in the database (15) and sends it to the marking laser (11 ) to be engraved on the surgical instrument (13).

[0043] The laser (11 ) operates in strictly parallel lines (15) to facilitate reading with polarised light produced by filters (2) and (3).

[0044] To identify the instrument, it is positioned as indicated in (5) and the following procedure is followed:

[0045] • The ECU (7) activates the illuminator (1 ) and records an image from the camera (6).

[0046] • The ECU then turns off the illuminator (1 ) and activates the illuminator (4), recording a second image.

[0047] • Both images, via (8a) and (9a), reach the server (10), which processes them by choosing the one with the highest contrast or performing a fusion to optimise the contrast.

[0048] • The acquisition is saved in the database (15).

[0049] • The result of the identified serial number can be sent to the user on the HID (5)

Claims

Independent Claims:

1. System claim: o A system for marking and identifying surgical instruments, comprising:• two illuminators (1 ) and (4) capable of emitting light at visible and non-visible wavelengths, including infrared,• two polarising filters (2) and (3) with orthogonal polarisation directions,• a camera (6) arranged so as to form a 90° angle with the illuminators (1 ) and (4),• an electronic control unit (ECU) (7) configured to selectively operate the aforementioned illuminators,• a connection (9a) between the control unit (7) and a server (10),• a server (10) configured to receive data from the camera (6) and control a laser marking machine (11 ) via a connection (9b),• a laser marking machine (11 ) configured to engrave a surgical instrument (13) with serial information,• an entropy generator (14) connected to the server (10) to generate random numbers,• a database (15) for storing the serial information,• a user interface device (HID) (5) connected to the server (10) for requesting the generation of new serials.

2. Method Claim: o A method for marking and identifying surgical instruments, comprising the following steps:• generating a serial number for a surgical instrument using an entropy generator (14) connected to a server (10),• storing the generated serial number in a database (15),• sending the serial number to a laser marking machine (11 ) to engrave the surgical instrument (13),• activate an illuminator (1 ) and record an image of the surgical instrument (5) using a camera (6),• turn off the illuminator (1 ) and activate a second illuminator (4) to record a second image,• send both images to the server (10) for processing and contrast optimisation.Depended claims:

3. Dependent System Claim: o The system according to claim 1 , wherein the connection (9a) between the control unit (7) and the server (10) is a wireless connection (8a).

4. Dependent Method Claim: o The method according to claim 2, wherein the server (10) processes the received images by selecting the one with the highest contrast or by performing an image fusion to optimise the contrast.

5. Laser Operation Claim:The system according to claim 1 , wherein the laser marking machine (11 ) engraves the surgical instrument (13) with strictly parallel lines (15) to facilitate the reading of serial information with polarised light.

6. HID Connection Claim:The system according to claim 1 , wherein the user interface device (HID) (5) is connected to the server (10) via a wired or wireless connection (8c).Additional claims:

7. Claim for Serial Type: o The system according to claim 1 , wherein the serial information recorded comprises a QR code, a barcode or another type of optically readable code.

8. Image Merging Claim: o The method according to claim 2, wherein the images recorded by the camera (6) are processed to perform image merging and optimise contrast for better identification of the surgical instrument (5).

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