Surgical instrument counting device

Abstract

The invention relates to a surgical instrument counting device for counting one or more different types of tools (h) for use in a surgical procedure, which comprises: an image-capturing camera (2); an electronic device (3) connected to the camera (2) and linked to a processing unit (3.1) that processes the images captured by the camera and executes counting algorithms; software with image recognition algorithms that uses artificial intelligence and computer vision, which is installed in the processing unit (3.1) and is capable of detecting and counting one or more different types of tools (h), including groups or families of tools, and capable of self-learning; and a support (4) suitable for mounting and positioning the camera (2) on a surface (5) on which tools (h) forming the set of instruments necessary for a surgical procedure are disposed.

Description

[0001] DESCRIPTION

[0002] SURGICAL INSTRUMENT COUNTING EQUIPMENT

[0003] OBJECT OF THE INVENTION

[0004] The invention, as stated in the present descriptive report, refers to a surgical instrument counting device that provides advantages and characteristics to the function for which it is intended, which are described in detail below.

[0005] The object of the present invention is an electronic device comprising, essentially, an image capture camera connected to a device linked to a processing unit, which may be remote, equipped with software featuring Artificial Intelligence and image recognition with self-learning capabilities. The camera is incorporated into a support suitable for installation on the tray where the instruments necessary for a surgical procedure are placed. Furthermore, in one embodiment, the support is configured with a robotic arm to move and transport the instruments, and in other embodiments, the device also includes a barcode reader equipped with another camera to read instrument identifiers.The main purpose of the equipment is to perform the automatic counting of said instruments, allowing it to be carried out before and after surgery, before and after sterilization, and as training for surgical nursing staff, reducing the risk of human errors, optimizing the time of healthcare personnel, and improving the training of nursing staff specialized in the operating room.

[0006] FIELD OF APPLICATION OF THE INVENTION

[0007] The field of application of the present invention is within the sector of the industry dedicated to the manufacture of medical accessories, encompassing at the same time the field of electronic image capture equipment.

[0008] BACKGROUND OF THE INVENTION

[0009] As is well known, it is necessary to count the surgical instruments before and after an operation for various reasons such as patient safety, to check that no object has been left inside their body, to prevent medical errors during the operation, by ensuring that all the necessary instruments are present and ready, and for compliance with protocols and regulations, among others.

[0010] In addition, it is also mandatory to count the surgical instruments before and after sterilization, for inventory control to prevent loss or to detect damage or defects.

[0011] Until now, this count, in both cases, has been done manually by healthcare staff, which, in addition to the risk of mistakes, involves the investment of a considerable amount of time that staff could use for other tasks.

[0012] The objective of the present invention is, therefore, to take advantage of the current technological advance in the field of image recognition to develop equipment that allows the aforementioned task of counting surgical instruments to be performed automatically, much faster and also more safely, also allowing this capacity to be used for other functionalities, such as staff training or the control and traceability of the tools that constitute said instruments.

[0013] Furthermore, and with reference to the current state of the art, it should be noted that the applicant is aware of the existence of some related documents which are summarized below.

[0014] Document LIS2016042130A1 discloses a computer device for tracking surgical instruments in a hospital environment with a support platform for receiving an instrument; a digital camera for capturing a digital image; an electronic image processing circuit for detecting in said image at least one visual feature of the surgical instrument and for determining a visual data; and a scale for measuring the weight of the surgical instrument.

[0015] US2013336554A1, relating to an apparatus for the automatic identification of a surgical instrument comprising a capture module, an attribute database, a comparison module and an export module, wherein said capture module comprises hardware capable of capturing multiple attributes of the surgical instrument and the attribute database comprises multiple stored attributes of various reference surgical instruments.

[0016] And document EP4022499A1 describing a method and apparatus for reassembling a surgical instrument kit, which consists of arranging a plurality of surgical instruments on a support plane comprising a support device; acquiring an image of the surgical instruments by means of at least one optical detection device; and recognizing each surgical instrument by processing the acquired images.

[0017] However, it does not appear that any of the documents indicated, taken independently or in combination, describe the object of the present invention, as claimed.

[0018] EXPLANATION OF THE INVENTION

[0019] The surgical instrument counting equipment proposed by the invention is configured as an optimal solution to the objectives indicated above, with the characterizing details that make it possible and that distinguish it being conveniently included in the final claims that accompany this description.

[0020] Specifically, what the invention proposes, as previously mentioned, is an electronic device whose main purpose is to perform the automatic counting of surgical instruments, to be carried out before and after surgery, before and after sterilization, as well as to serve as training for surgical nursing staff.

[0021] To this end, the equipment that is the subject of the invention essentially comprises an image capture camera, connected to an electronic device that acts as a bridge linked to a processing unit, which may be remote, and which, in any case, is equipped with software that uses Artificial Intelligence with image recognition algorithms, the camera being incorporated in a support suitable to place it on a tray or surface on which the instruments necessary for a surgical intervention are arranged, in such a way that, when connecting the camera to the processing unit through the electronic bridge device, the software is able to recognize the number and type of instruments captured by the image of the camera, being able to even recognize the instruments by groups or phases (families) and, based on a prior programming, determine whether or not all the instruments planned for said intervention are present.

[0022] As mentioned, the software algorithm uses Computer Vision AI (Artificial Intelligence and Computer Vision), and therefore has autonomous learning and improves each time it is used.

[0023] It is important to highlight that, thanks to this AI-powered software, the equipment has self-learning capabilities, which means, for example, that if an instrument is not recognized or there is an error, the user can provide additional information so that the system can update its database and progressively improve.

[0024] Another advantage of the system is that, in a preferred implementation mode, the equipment does not perform the processing locally, but rather, by connecting the bridge device to a remote server where the processing unit is implemented, when the camera captures an image of the instrument tray or box located below, the electronic device uploads the information to the cloud where, managed by a remote server, the detection (instrument identification) and recognition (naming) are performed.

[0025] Furthermore, in a preferred embodiment of the invention, said processing unit includes a specific software application comprising a user training module with two aspects or operating options:

[0026] - One for mandatory initial training, to ensure that the user understands how the equipment works, thus certifying its correct use.

[0027] - And another voluntary training module, as a continuous training module to help staff improve their knowledge of surgical instruments, taking advantage of the classification by phases / families.

[0028] Ideally, the equipment includes a means of manually activating the recognition process, such as a button, key, pedal, or lever. Conveniently connected to the camera's electronic device, this allows the user to activate it at a specific time, triggering image capture and surface analysis with the instruments. This enables real-time validation whenever the user desires.

[0029] Ideally, the equipment also includes at least a touch screen and / or keyboard as a user interface to configure the instrument counting parameters in each intervention, monitor the collected information, and control the operation of the system.

[0030] Furthermore, in a preferred embodiment of the invention, the equipment also comprises an identifier reader device physically connectable to the electronic device that is linked to the processing unit, intended to allow the reading of the identification with which each specific tool must be marked.

[0031] It is known that, in the near future, all medical instruments will need to be marked with a unique identifier for traceability purposes. The function of this reader is therefore to retrieve the identifiers of the instruments that the surgical team will use, both in numerical and QR code format.

[0032] For this purpose, preferably, the electronic device will have a connection to hospital tracking or traceability systems (such as Marvax), to automatically obtain and update information on the instruments to be used and / or surgical boxes and to inventory and / or order the stock of instruments of the hospital center.

[0033] In any case, preferably, said reader will be equipped with a second image capture camera that can be connected, by physical cable or wireless connection, to the electronic device of the equipment to link to the processing unit and work with the Computer Vision algorithm of Artificial Intelligence.

[0034] Furthermore, in one embodiment, in this option the equipment also includes a dual screen system, with an auxiliary screen for the display and identification of the reading made by the described reader and a main screen to visualize the complete process in real time through images.Ideally, the equipment's support for positioning the camera above the instrument tray, so that the lens focuses on the upper surface to capture an image of the instruments, includes at least a support base for stable placement on a table surface. This base may or may not include fastening devices such as suction cups or clamps to prevent imbalances or unwanted movement. It also includes a vertical structure with an adjustable-angle mount at its upper end to secure the camera and allow the lens to be correctly directed downwards, focusing on the table surface. Optionally, this vertical structure may be height-adjustable.

[0035] However, in one implementation option, the support can be configured by a robotic arm that, connected to the electronic device with the camera located at its end, allows the instruments to be moved and transferred.

[0036] Therefore, an example of its use would be the following:

[0037] - The arm with the camera at its end identifies the instrument model.

[0038] - The arm moves closer to capture the unique identifier of the specific instrument (both QR format and digits)

[0039] - An electromagnet located at the tip is activated, which hooks the metal instruments.

[0040] - The arm moves the instrument to the corresponding box and deactivates when you want to "drop" the tool.

[0041] In any case, preferably, the equipment also includes connectivity means, such as USB port, Ethernet communication and / or Wi-Fi connection to transmit data between the camera and the electronic device and between the latter and the processing unit and other external devices.

[0042] In turn, the equipment also has storage means to save the captured images and processed data, either in the processing unit itself or in some other remote management system.

[0043] Additionally, the equipment also includes lighting means, preferably based on LED lights, incorporated in the camera itself or next to it, at the upper end of the vertical support structure, to ensure uniform and adequate illumination of the surface with the instruments, allowing the camera to capture clear images with good contrast to ensure the correct interpretation of the software.

[0044] Optionally, the equipment includes proximity sensors, for example, incorporated next to the support base of the stand, to detect the presence of objects and synchronize the camera's image capture.

[0045] With all this in mind, the main functionalities of the device are:

[0046] - Automatic counting before and after surgery: The equipment allows for the automatic counting of surgical instruments before and after an operation, ensuring that no item is left inside the patient or lost. This functionality reduces the risk of human error, increases patient safety, and improves the efficiency of surgical procedures.

[0047] - Automatic counting before and after sterilization: The equipment allows for automatic counting of instruments before and after sterilization. This functionality optimizes the time of healthcare personnel.

[0048] - Training, both to ensure that the user understands how the equipment works and for ongoing training.

[0049] - Training of surgical scrub nurses: The equipment can be used for training specialized operating room nurses. With its ability to recognize and request instruments, it can simulate real-life situations in which the nurse must respond quickly and accurately to the surgeon's needs. This interactive training helps develop the necessary skills and increase staff confidence in real surgical scenarios.

[0050] Additionally, by programming the recognition software to not only identify if the number and type of tools that make up the surgical instruments to be used in an intervention are correct, but also to identify each tool individually, the equipment can provide other functionalities:

[0051] - Surgical instrument tracking and traceability: The system allows for the tracking and traceability of surgical instruments throughout their entire lifecycle. This functionality enables the recording of each instrument's use, the number of times it has been sterilized, and any necessary maintenance. This helps ensure that instruments are kept in good condition and facilitates planning for their replacement or repair, thereby improving safety and service quality.

[0052] - Integration with hospital management systems: The device, through its processing unit, could be integrated with hospital management systems to provide detailed, real-time reports on the inventory of surgical instruments, their uses, and location. This integration allows hospital managers to make informed decisions regarding the purchase, maintenance, and distribution of surgical equipment, thereby optimizing resources and reducing operating costs.

[0053] DESCRIPTION OF THE DRAWINGS

[0054] To complement the description being made and in order to help a better understanding of the characteristics of the invention, a sheet of drawings is attached to this descriptive document as an integral part thereof, in which the following has been represented for illustrative and non-limiting purposes:

[0055] Figure 1 shows a schematic perspective view of an example of the surgical instrument counting device of the invention, illustrating its general configuration and main components; Figure 2 shows a schematic front elevation view of the example of the device of the invention shown in Figure 1, in this case represented in its operating position on the instrument tray; Figure 3 shows a schematic front elevation view of another example of the device of the invention, in this case including a unique identification reader for each instrument and a dual-screen system, also showing remote connectivity with the processing unit; Figure 4 shows a perspective view of an instrument and an enlargement of the label it incorporates as its unique identifier; and Figure 5.- Shows a perspective view of another example of the implementation of the invention, in this case with the support formed by a robotic arm.

[0056] PREFERRED EMBODIMENT OF THE INVENTION

[0057] In view of the aforementioned figures, and in accordance with the numbering adopted, one can observe in them an example of a non-limiting embodiment of the surgical instrument counting equipment of the invention, which comprises what is described in detail below.

[0058] Thus, as can be seen in the figures, the equipment (1) of the invention essentially comprises the following elements:

[0059] - at least one (2) image capture camera,

[0060] - an electronic device (3) connected to the camera (2) and linked to a processing unit (3.1) to process the images captured by the camera and run counting algorithms,

[0061] - software with image recognition algorithms, using Artificial Intelligence and Computer Vision, installed in the processing unit (3.1), having the capacity to detect and count one or more different types of tools (h), including groups or families of tools, likely to constitute necessary instruments for use in surgical interventions, as well as having self-learning capabilities, and

[0062] - a support (4) suitable for mounting and positioning the camera (2) on a surface (5) where tools (h) are arranged that constitute the necessary instruments for a surgical intervention, such that, when connecting the camera (2) and activating the electronic device (3), the software of the processing unit (3.1), at least, counts the number and recognizes the type of tools (h) of surgical instruments located on the surface (5) and captured by the image of the camera (2), and determines whether or not all the instruments planned for the intervention in question are present, based on what has been previously programmed.

[0063] The processing unit (3.1), although it may be installed in the electronic device (3) itself, this being a computer or other analogous computing device, preferably, said electronic device (3) is only a bridge device or acquisition terminal that is physically connected to the camera (2) and remotely connects to the processing unit (3.1) which, in turn, is implemented in the cloud (n) being managed by a remote server to which it connects via a communication modem.

[0064] In addition, preferably, the processing unit (3.1) includes a specific software application comprising a user training module with two aspects: one for mandatory initial training to ensure that the user understands how the equipment works, and another for voluntary training as ongoing training to help staff improve their knowledge of the equipment.

[0065] Preferably, the equipment (1) comprises the existence of a button, key, pedal, lever or other manual activation means (3.2) connected to the electronic device (3) to activate the camera recognition (2), so that the user can activate it at a specific time.

[0066] Preferably, the equipment (1) also comprises at least a touch screen (6) configured as a user interface with the processing unit (3) to enter the instrumental counting parameters in each intervention, monitor the collected information and control the operation of the system.

[0067] Furthermore, in a preferred embodiment of the invention, the equipment also comprises a reading device (8) for unique labels or other identifiers (i) with which each tool (h) of the instrument is marked, as shown in the representation of figure 4, which reader (8) is physically or wirelessly connectable to the electronic device (3) that is linked to the processing unit (3.1).

[0068] Optionally, the equipment also includes a device that reads labels or other unique identifiers used to mark each surgical box. The surgical box reader can be connected physically or wirelessly to the electronic device (3) that is linked to the processing unit (3.1).

[0069] For this purpose, preferably, the electronic device (3) has a connection to hospital tracking or traceability systems that allow obtaining and automatically updating information on the instruments to be used and / or surgical boxes and to carry out inventory and / or order the stock.

[0070] In any case, preferably, said reader (8) incorporates a second image capture camera (6.1) and can be connected, by physical cable or wireless connection, to the electronic device (3) linking to the processing unit (3.1).

[0071] Furthermore, in one implementation mode, the equipment comprises two screens, an auxiliary screen

[0072] (6.1), for the display and identification of the reading to be done by the reader (8) and a main screen (6) to visualize in real time the complete process through images that may or may not be touch-sensitive.

[0073] For its part, the support (4) preferably comprises a lower support base (4.1) suitable for stable placement on the surface (5) where the surgical instruments (h) are located, which is preferably a horizontal surface (5), such as a tabletop or similar piece of furniture, and a vertical structure (4.2) with an adjustable angle anchor at its upper end for securing the camera (2) and orienting it with the lens (2.1) towards the surface (5). The instruments are placed on the surface (5) on a disposable hygienic protective sheet.

[0074] Preferably, the touch screen (6), or the dual screen if applicable, is incorporated fixed rigidly to the support (4), between the support base (4.1) and the vertical structure

[0075] (4.2), the cabling that connects said screen (6) to the processing unit (3) being incorporated and hidden inside the hollow tube that constitutes said vertical structure (4.2).

[0076] Optionally, the support base (4.1) of the support (4) includes removable means of fixing to the surface (5) on which it rests, such as suction cups or clamps.

[0077] Optionally, the support base (4.1) is rigidly attached to the board that defines the surface (5) where the tools (h) of the counting instruments are incorporated, so that it forms part of the equipment itself.

[0078] Furthermore, in one embodiment, such as that shown in Figure 5, the support (4) is configured by a robotic arm connected to the electronic device (3) to move and transfer tools (h), incorporating at its end, in addition to the image capture camera (2), an electromagnet (9) with which it holds and transfers the tools (h).

[0079] Furthermore, preferably in this implementation option, the base

[0080] In any case, preferably, the equipment (1) also includes connectivity means, such as a USB port, Ethernet communication modem and / or Wi-Fi connection (not shown in the figures) for data transmission between the camera (2) and the processing unit (3) and other external devices, as well as storage means to save the captured images and processed data.

[0081] Additionally, the equipment (1) also comprises lighting means (7) for the surface (5), preferably based on LED lights, which are incorporated into the camera (2) itself and / or installed next to it, on the support (4).

[0082] Optionally, the equipment may comprise sensors (not shown) to detect the presence of tools (h) on the surface (5), for example incorporated next to the support base (4.2) of the support (4) or under the surface (5) itself if it is integrated as part of the equipment (1).

[0083] In any case, the equipment (1) is a compact and portable set that, although not represented, has an electrical power supply system by means of a mains connection cable and / or rechargeable battery to provide power to the camera (2) and other components of the equipment.

[0084] Having sufficiently described the nature of the present invention, as well as the manner of putting it into practice, it is not considered necessary to make its explanation more extensive so that any expert in the field can understand its scope and the advantages that derive from it.

Claims

CLAIMS 1. Surgical instrument counting equipment, particularly applicable for counting at least one or more different types of tools (h) likely to constitute instruments necessary for use in a surgical procedure, characterized by comprising: - an image capture camera (2), - an electronic device (3) connected to the camera (2) and linked to a processing unit (3.1) that processes the images captured by the camera and executes counting algorithms, - software with image recognition algorithms, using Artificial Intelligence and Computer Vision, installed in the processing unit (3.1), having the capacity to detect and count one or more different types of tools (h), including groups or families of tools, likely to constitute necessary instruments for use in surgical interventions, as well as having self-learning capabilities, and - a support (4) suitable for mounting and positioning the camera (2) on a surface (5) where tools (h) are arranged that constitute the necessary instruments for a surgical intervention.

2. Surgical instrument counting equipment, according to claim 1, characterized in that the electronic device (3) is a bridge device or acquisition terminal that is physically connected to the camera (2) and the processing unit (3.1) is implemented in the cloud (n) or on a remote server with which it connects via a communication modem.

3. Surgical instrument counting equipment, according to claim 1 or 2, characterized in that the processing unit (3.1) includes a specific software application comprising a user training module.

4. Surgical instrument counting equipment, according to any of the preceding claims, characterized in that it comprises a button, key, pedal, lever or other means of manual activation (3.2) of the electronic device (3) to activate the recognition.

5. Surgical instrument counting equipment, according to any of the preceding claims, characterized by comprising at least a touch screen (6) configured as a user interface with the electronic device (3) and the processing unit (3.1) to enter instrument counting parameters in each intervention, monitor the collected information and control the operation of the system.

6. Surgical instrument counting equipment, according to any of the preceding claims, characterized in that it comprises a reader (8) of identifiers (i) of the instruments and / or of the surgical boxes connectable to the electronic device (3).

7. Surgical instrument counting equipment, according to claim 6, characterized in that the identifier reader (8) includes a second image capture camera (2.2).

8. Surgical instrument counting equipment, according to claim 6 or 7, characterized in that the electronic device (3) connects the reader (8) with hospital tracking or traceability systems.

9. Surgical instrument counting equipment, according to any of claims 6 to 8, characterized in that it comprises two screens (6, 6.1), where one acts as an auxiliary for the display and identification carried out by the reader (8), and the other to visualize in real time the complete process by means of images.

10. Surgical instrument counting equipment, according to any of the preceding claims, characterized in that the support (4) comprises a lower support base (4.1), suitable for its stable incorporation on the surface (5) where the surgical instrument tools (h) are incorporated and a vertical structure (4.2) with an adjustable angle anchor at its upper end to fix the camera (2) and orient it with the objective (2.1) towards the surface (5).

11. Surgical instrument counting equipment, according to any of claims 5 to 10, characterized in that the touch screen (6) is incorporated fixed rigidly to the support (4), between the support base (4.1) and the vertical structure (4.2), the wiring that connects said screen (6) with the electronic device (3) being incorporated and hidden inside the hollow tube that constitutes said vertical structure (4.2).

12. Surgical instrument counting equipment, according to claim 11, characterized in that the support base (4.1) of the support (4) includes removable fixing means to the surface (5), such as suction cups or clamps.

13. Surgical instrument counting equipment, according to claim 11, characterized in that the support base (4.1) is rigidly attached to the board that defines the surface (5) where the tools (h) of the instruments are incorporated.

14. Surgical instrument counting equipment, according to any of the preceding claims, characterized in that the support (4) is configured by a robotic arm connected to the electronic device (3) for moving and transferring tools (h).

15. Surgical instrument counting equipment, according to claim 14, characterized in that the support (4) is incorporated on a support base (4.1) in the form of a guide on which it can be moved laterally.

16. Surgical instrument counting equipment, according to any of the preceding claims, characterized by comprising connectivity means, such as USB port, Ethernet communication modem and / or Wi-Fi connection for data transmission between the camera (2) and the electronic device (3) and between the latter and the processing unit (3.1) and other external devices, as well as storage means for saving the captured images and the processed data. 17.- Surgical instrument counting equipment, according to any of the preceding claims, characterized by comprising lighting means (7) of the surface (5) incorporated in the chamber itself (2) and / or installed next to it, on the support (4).

18. Surgical instrument counting equipment, according to any of the preceding claims, characterized by comprising sensors to detect the presence of tools (h) on the surface (5).

19. Surgical instrument counting equipment, according to any of the previous claims, characterized by being a portable unit with electrical power supply via mains connection cable and / or rechargeable battery.

Images