Optical signal element for a medical device

Abstract

A system may include a medical device and an optical signal element associated with the medical device such that when the optical signal element is in a first state, the optical signal element provides a first indication regarding the medical device and when the optical signal element is in a second state, the optical signal element provides a second indication regarding the medical device. The optical signal element provides a second indication with respect to the medical device, the second indication being different from the first indication.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 409,929, filed on September 26, 2022, entitled “Optical Signal Element for Medical Device,” the entire disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Disposable medical devices may include medical instruments or medical devices that are intended to be used once in a medical setting such as a hospital or clinic and then discarded. For example, disposable medical devices may include devices that are authorized by the manufacturer for use on only one patient and one surgery. Disposable medical devices may not be reusable and therefore may have a short lifespan and be limited to one patient. Reusable medical devices may include medical instruments or medical devices that are intended to require reprocessing after procedures such as cleaning, disinfection, and / or sterilization.

[0004] However, the label of medical device may not provide accurate information about whether the medical device is a disposable medical device or a reusable medical device. In addition, the medical device may lack instructions about whether the medical device has been used before or whether the medical device has been reprocessed after surgery. For example, users such as doctors can visually check the label on the packaging of the medical device when removing the packaging from the medical device. In this example, the doctor can use the medical device immediately after removing the packaging. For example, the doctor may not administer the drug from the medical device when the packaging is removed. In the case where another user attempts to use the medical device, the other user may not know the status of the medical device related to use. Therefore, the label without showing the indication of the use or reuse of the medical device may be inaccurate for whether the medical device is used. In addition, the medical device may not be used after the packaging is removed, and if the status of the medical device related to use is unclear, the medical device may be wasted. Summary of the invention

[0005] Thus, improved systems, devices, products, apparatus and / or methods for determining a characteristic of a medical device based on an optical signaling element are provided.

[0006] According to an embodiment of the present invention, a system includes an optical signal element associated with a medical device. When the optical signal element is in a first state, the optical signal element provides a first indication about the medical device, and when the optical signal element is in a second state, the optical signal element provides a second indication about the medical device, wherein the second indication is different from the first indication.

[0007] According to an embodiment of the present invention, the system also includes at least one processor, which is programmed or configured to: receive data associated with the optical signal element, determine characteristics of the medical device based on the data associated with the optical signal element, and perform actions based on the characteristics of the medical device.

[0008] According to an embodiment of the present invention, the optical signal element comprises: a window having a material; and a cover; and wherein, when the optical signal element is in a first state, the window is held in an open position by the cover; and wherein, when the optical signal element is in a second state, the material of the window covers the opening of the window so that the window is in a closed position; and wherein the optical signal element transitions from the first state to the second state based on the cover being removed and the material of the window relaxing on the opening of the window.

[0009] According to an embodiment of the invention, the optical signaling element may be configured to transition from the first state to the second state based on a mechanical operation performed on the optical signaling element.

[0010] According to an embodiment of the invention, the optical signaling element is transferred from the first state to the second state based on a mechanical deformation of the optical signaling element.

[0011] According to an embodiment of the present invention, when an action is performed based on a characteristic of the medical device, the at least one processor is programmed or configured to: provide an alarm, wherein the alarm includes information indicating that the medical device is improperly connected to another component.

[0012] According to an embodiment of the present invention, when performing an action based on the characteristics of the medical device, the at least one processor is programmed or configured to: provide a prompt. The prompt may include information indicating that the connection of the medical device to another component should be corrected to correctly connect the medical device.

[0013] According to an embodiment of the present invention, when performing an action based on a characteristic of the medical device, the at least one processor is programmed or configured to: provide a message, wherein the message includes information indicating that the medical device is correctly connected to another component.

[0014] According to an embodiment of the present invention, when receiving data associated with the optical signal element attached to the medical instrument, the at least one processor is programmed or configured to: receive data associated with the optical signal element attached to the medical instrument from the optical reader device.

[0015] According to an embodiment of the invention, the optical signaling element may be configured to transition from a first state to a second state based on a physical property of a component of the optical signaling element.

[0016] According to an embodiment of the invention, the optical signaling element may be configured to transition from the first state to the second state based on a material change of a component of the optical signaling element.

[0017] According to an embodiment of the present invention, an optical signal element associated with a medical device may be attached to a connector associated with the medical device, and wherein the connector is configured to establish a connection with the medical device.

[0018] According to an embodiment of the invention, the transition of the optical signal element from the first state to the second state is irreversible.

[0019] According to an embodiment of the present invention, an optical signal element associated with a medical device may include a base and a first detachable component, and wherein the base and the first detachable component are configured to be separable. When the optical signal element is in a first state, the base is not separated from the first detachable component, and when the optical signal element is in a second state, the base is separated from the first detachable component.

[0020] According to an embodiment of the present invention, a medical device assembly includes: a medical device; an optical signal element associated with the medical device, wherein the optical signal element includes a dye. When the optical signal element is in a first state, the optical signal element provides a first indication about the medical device, and when the optical signal element is in a second state, the optical signal element provides a second indication about the medical device based on the dye. The second state can be associated with migration of the dye to an observable position of the optical signal element, and wherein the second indication is different from the first indication.

[0021] According to an embodiment of the present invention, the optical signal element may include: a dye layer including a dye; and a non-absorbing layer associated with the dye layer. The optical signal element may be in the second state based on the non-absorbing layer being out of contact with the dye layer.

[0022] According to an embodiment of the invention, the optical signal element may be in the first state based on the non-absorbing layer being in contact with the dye layer.

[0023] According to an embodiment of the present invention, the optical signal element may include an absorption layer, and wherein the optical signal element provides the second indication about the medical device based on the absorption of the dye of the dye layer by the absorption layer.

[0024] According to an embodiment of the present invention, the optical signal element provides a second indication about the medical device based on the absorption of the dye of the dye layer by the absorption layer after a predetermined time interval.

[0025] According to an embodiment of the present invention, the optical signal element is attached to a medical instrument, wherein the optical signal element is in a first state when the medical instrument is not attached to another instrument, and wherein the optical signal element transitions from the first state to a second state based on the attachment of the medical instrument to another instrument.

[0026] According to an embodiment of the invention, the optical signal element comprises: a cover layer attached to the non-absorbing layer in contact with the dye layer, and wherein the cover layer is configured to protect the dye layer and the non-absorbing layer from damage.

[0027] According to an embodiment of the invention, the optical signaling element is configured to irreversibly transition from the first state to the second state. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Additional advantages and details are explained in more detail below with reference to an exemplary embodiment shown in the attached schematic drawings, in which:

[0029] Figure 1 is a schematic diagram of a non-limiting embodiment or aspect of an environment in which the systems, devices, products, apparatuses and / or methods described herein may be implemented according to the principles of the present disclosure;

[0030] Figure 2 yes Figure 1 Schematic diagrams of non-limiting aspects or embodiments of one or more devices and / or multiple components of one or more systems;

[0031] Figure 3 is a flow chart of a non-limiting aspect or embodiment of a process for determining a characteristic of a medical device based on an optical signal element;

[0032] Figure 4A and Figure 4B is a schematic diagram of an implementation of a non-limiting example of an optical signaling element;

[0033] Figure 5 is a schematic diagram of an implementation of a non-limiting example of an optical signaling element;

[0034] Figure 6 is a schematic diagram of a cross-section of a non-limiting embodiment of a medical device assembly including an optical signaling element attached to a cap device;

[0035] Figure 7 is a schematic diagram of a non-limiting embodiment of another medical device assembly including an optical signaling element attached to a cap device; and

[0036] Figure 8 is a schematic diagram of another non-limiting embodiment of a medical device assembly including an optical signaling element attached to a cap device. DETAILED DESCRIPTION

[0037] It will be understood that, unless expressly stated to the contrary, various alternative variations and various step orders are possible in the present disclosure. It will also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary, non-limiting embodiments. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0038] For the purposes of description hereinafter, the terms "end", "upper", "lower", "right side", "left side", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall refer to the embodiments or aspects as they are oriented in the accompanying drawings. However, it will be understood that various alternative variations and various step orders may be made to the embodiments or aspects unless expressly stated to the contrary. It will also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments or aspects. Therefore, unless otherwise indicated, the specific dimensions and other physical characteristics associated with the embodiments or aspects of the various embodiments or aspects disclosed herein should not be considered limiting.

[0039] Aspects, parts, elements, structures, actions, steps, functions, and / or instructions used herein, etc. should not be interpreted as critical or necessary, unless explicitly described as such. In addition, as used herein, the articles "one" and "an" are intended to include one or more items, and can be used interchangeably with "one or more" and "at least one". As used in the specification and claims, the singular "one", "one" and "the" include plural indicators, such as unless the context clearly indicates otherwise. In addition, as used herein, the terms "combination" and "set" are intended to include one or more items (e.g., related items, unrelated items, combinations of related items and unrelated items, etc.), and can be used interchangeably with "one or more" or "at least one". In the case of only one item, the term "one (one)" or similar terms are used. In addition, as used herein, the terms "having", "having" or "with" etc. are intended to be open terms. In addition, unless otherwise explicitly stated, the phrase "based on" is intended to mean "based at least in part". In addition, unless otherwise explicitly stated, the phrase "based on" is intended to mean "based at least in part". Furthermore, as appropriately referred to herein, the phrase "based on" may mean "in response to" and indicate a condition for automatically triggering a specified operation of an electronic device (eg, a controller, a processor, a computing device, etc.).

[0040] As used herein, the terms "communication" and "communicate" may refer to the reception, collection, sending, transmission, and / or provision of information (e.g., data, signals, messages, instructions, and / or commands, etc.). For a unit (e.g., a device, a system, a component of a device or system, and / or a combination thereof, etc.), communicating with another unit means that the unit is able to directly or indirectly receive information from the other unit and / or send information to the other unit. This may refer to a direct or indirect connection of a wired and / or wireless nature. In addition, even if the data transmitted between the first unit and the second unit can be modified, processed, relayed and / or routed, the two units may communicate with each other. For example, even if the first unit passively receives information and does not actively send information to the second unit, the first unit may communicate with the second unit. As another example, if at least one intermediate unit (e.g., a third unit located between the first unit and the second unit) processes the information received from the first unit and transmits the processed information to the second unit, the first unit may communicate with the second unit. In some non-limiting embodiments, a message may refer to a network packet (e.g., a data packet, etc.) comprising data. It will be appreciated that many other arrangements are possible.

[0041] It will be apparent that the systems and / or methods described herein can be implemented in different forms such as hardware, software, or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods is not limited to the various embodiments. Therefore, the operation and behavior of the systems and / or methods are described herein without reference to specific software code, and it should be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.

[0042] Improved devices, systems, methods, and products for accurately determining characteristics of a medical device based on an optical signal element are provided. Embodiments of the present disclosure may include a medical device management system, the medical device management system including an optical signal element associated with a medical device, wherein when the optical signal element is in a first state, the optical signal element provides a first indication about the medical device, and wherein when the optical signal element is in a second state, the optical signal element provides a second indication about the medical device, wherein the second indication is different from the first indication. In some non-limiting embodiments, the medical device management system also includes at least one processor, the at least one processor being programmed or configured to: receive data associated with the optical signal element, determine the characteristics of the medical device based on the data associated with the optical signal element, and perform an action based on the characteristics of the medical device. In some non-limiting embodiments, when an action is performed based on the characteristics of the medical device, the medical device management system is programmed or configured to provide an alarm, wherein the alarm includes information indicating that the medical device is improperly connected to another component. In some non-limiting embodiments, when an action is performed based on the characteristics of a medical device, the medical device management system is programmed or configured to be programmed or configured to provide a prompt, wherein the prompt may include information indicating that the connection of the medical device to another component should be corrected to correctly connect the medical device. In some non-limiting embodiments, when an action is performed based on the characteristics of a medical device, the medical device management system is programmed or configured to provide a message, wherein the message includes information indicating that the medical device is correctly connected to another component. In some non-limiting embodiments, when receiving data associated with an optical signal element attached to a medical device, the medical device management system is programmed or configured to receive data associated with the optical signal element attached to the medical device from an optical reader device.

[0043] In some non-limiting embodiments, the optical signal element is configured to transition from a first state to a second state based on a mechanical operation performed on the optical signal element. In some non-limiting embodiments, the optical signal element is configured to transition from a first state to a second state based on a physical property of a component of the optical signal element. In some non-limiting embodiments, the optical signal element is configured to transition from a first state to a second state based on a material change of a component of the optical signal element. In some non-limiting embodiments, an optical signal element associated with a medical device is attached to a connector, wherein the connector is configured to establish a connection with the medical device. In some non-limiting embodiments, the transition of the optical signal element from the first state to the second state is irreversible.

[0044] In this way, embodiments of the present disclosure provide an optical signal element that can provide accurate information about the use, non-use, or reuse of a medical device. For example, an individual may be able to receive information from an optical signal element on the packaging of a medical device when removing the packaging from the medical device. In addition, a user may be able to use an optical reader device to read an optical signal element located on a medical device, which will provide information about the use, non-use, or reuse of the medical device. In this way, a medical device management system and / or an optical signal element can provide an accurate and effective way to obtain information about the use, non-use, or reuse of a medical device.

[0045] Reference now Figure 1 , Figure 1 1 is a schematic diagram of an example environment 100 in which the devices, systems, methods, and / or products described herein may be implemented. Figure 1 As shown, environment 100 includes a medical device management system 102, an optical reader device 104, and an optical signal element 106. Medical device management system 102 and optical reader device 104 may be interconnected (e.g., establish a connection for communication, etc.) via a wired connection, a wireless connection, or a combination of wired and wireless connections.

[0046] The medical device management system 102 may include one or more devices configured to communicate with the optical reader device 104 via the communication network 108. For example, the medical device management system 102 may include a server (e.g., a cloud server), a group of servers, a computing device, such as a mobile device (e.g., a smartphone), a tablet computer, a laptop computer, and / or a desktop computer, etc. In some non-limiting embodiments, the medical device management system 102 may be configured to communicate with the optical reader device 104 via a direct communication connection (e.g., a communication connection independent of a communication network such as the communication network 108), such as a short-range wireless communication connection (e.g., a near-field communication (NFC) communication connection, a radio frequency identification (RFID) communication connection, The medical device management system 102 may be configured to determine the characteristics of the medical device based on the data received from the optical reader device 104. In some non-limiting embodiments, the medical device management system 102 may be a component of the optical reader device 104.

[0047] The optical reader device 104 may include one or more devices configured to communicate with the medical device management system 102 via the communication network 108. For example, the optical reader device 104 may include a server (e.g., a cloud server), a group of servers, a computing device, such as a mobile device (e.g., a smartphone, a wearable device, etc.), a tablet computer, a laptop computer, and / or a desktop computer, etc. In some non-limiting embodiments, the optical reader device 104 may include one or more optical readers, one or more image acquisition devices (e.g., one or more cameras), one or more infrared (IR) scanners, one or more barcode readers, and / or one or more optical sensors, etc. In some non-limiting embodiments, the optical reader device 104 may be configured to communicate with the medical device management system 102 via a direct communication connection (e.g., a communication connection independent of a communication network such as the communication network 108), such as a short-range wireless communication connection (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth communication connection, an infrared communication connection, etc.) or a wired communication connection (e.g., a connection using a cable and a USB communication protocol).

[0048] The optical signal element 106 may include one or more devices configured to provide optical signals such as indications (e.g., light indications, visual indications, etc.). In some non-limiting embodiments, the optical signal may be observable. For example, the optical signal may be read by an optical reader such as an optical reader device 104 (e.g., scanned, recorded, collected, etc., for example, by image acquisition). Additionally or alternatively, the optical signal may be observed visually by an individual. In some non-limiting embodiments, the optical signal element 106 may include a device configured to transition between a first state and a second state. In one example, the optical signal element 106 may include a device configured to irreversibly transition between a first state and a second state. In another example, the optical signal element 106 may include a device configured to reversibly transition between a first state and a second state. In some non-limiting embodiments, the optical signal element 106 may include a base and a first detachable component, wherein the base and the first detachable component are configured to be separable, so that when the optical signal element is in a first state, the base and the first detachable component are not separated, and when the optical signal element is in a second state, the base and the first detachable component are separated. In some non-limiting embodiments, a first optical signal may be provided in the first state, and a second optical signal may be provided in the second state.

[0049] In some non-limiting embodiments, when the optical signal element is in a first state, the optical signal element may provide a first optical signal (e.g., a first indication), and when the optical signal element is in a second state, the optical signal element may provide a second optical signal (e.g., a second indication), wherein the second optical signal is different from the first optical signal. In some non-limiting embodiments, the first optical signal and / or the second optical signal may be an indication of a characteristic of a medical device associated with the optical signal element. In some non-limiting embodiments, the characteristic of the medical device may include characteristics related to the use, non-use, and / or reuse of the medical device. For example, the characteristics of the medical device may include characteristics that identify the medical device as used, characteristics that identify the medical device as unused, and / or characteristics that identify the medical device as capable of being reused.

[0050] In some non-limiting embodiments, the optical signal element 106 can be based on the mechanical operation performed on the optical signal element and change between the first state and the second state. For example, the optical signal element 106 can be based on the change caused by the mechanical element and change between the first state and the second state. In one example, the optical signal element 106 may include a window with a material (e.g., a movable tab), which is kept in a first state (e.g., an open position) by a cover (e.g., during manufacturing, before use, etc.), and the optical signal element 106 is configured so that once the cover is removed, the material of the window is relaxed on the opening of the window, so the window is transformed to a second state (e.g., a closed position). In this way, the color observable in the first state may no longer be observable in the second state, and vice versa. The relaxation characteristics of the material of the window can provide a first optical signal based on a short time interval and a second optical signal based on a longer time interval. In some non-limiting embodiments, the first optical signal and / or the second optical signal can provide an indication of the risk of contamination of the medical device. In some non-limiting embodiments, the material of the window can be configured to transition between a first state and a second state based on an ongoing connection (e.g., attachment) between a medical device associated with the optical signal element 106 and another device (e.g., another medical device configured to connect to the medical device).

[0051] In some non-limiting embodiments, the optical signal element 106 can transition between the first state and the second state based on mechanical deformation (e.g., compression, wear, damage, etc.) of the optical signal element 106 and / or a component of the optical signal element 106 to identify reuse of the medical device. In some non-limiting embodiments, the change from the first indication to the second indication (e.g., based on the transition from the first state to the second state) can occur due to a conformation change or orientation change that causes a change in the amplitude of the optical signal observed by an individual (e.g., a user) or read by the device.

[0052] In some non-limiting embodiments, the optical signal element 106 may include a plastic unit having an undeformed shape (e.g., a bead initially in a circular configuration), and when deformed, for example, based on compression (e.g., based on compression of the plastic unit when the plastic unit is located within a connection between a plurality of mating instruments), the plastic unit is flattened in a second state. In some non-limiting embodiments, the plastic unit may include a deformable material, such as a soft polymer material (e.g., a polymer such as a thermoplastic elastomer (TPE), a polymer blend, a copolymer blend, etc.). In some non-limiting embodiments, the material may include wax. In some non-limiting embodiments, the plastic unit may include encapsulated beads that are configured to release a liquid (e.g., a colored liquid) when the encapsulated beads are ruptured in a controlled or uncontrolled manner. In some non-limiting embodiments, the liquid may be included in the optical signal element 106 as an ink, a coating, or may be located in the structure of the optical signal element 106, such as in nano-dye micelles located in the structure of the optical signal element 106, the nano-dye micelles being configured to rupture.

[0053] In some non-limiting embodiments, the optical signal element 106 may transition between the first state and the second state based on the following: the optical signal element 106 transitions between the first state and the second state based on the physical properties of the optical signal element 106 or the components of the optical signal element 106. For example, the optical signal element 106 may transition between the first state and the second state based on a material change of the optical signal element 106 or the components of the optical signal element 106. In some non-limiting embodiments, the optical signal element 106 may change one or more optical properties of the optical signal element 106 and / or the components of the optical signal element 106 (e.g., change color, increase light scattering, reduce light scattering, etc.) based on the deformation of the optical signal element 106 and / or the components of the optical signal element 106 (e.g., deformation based on compression). In some non-limiting embodiments, the change of one or more optical properties of the optical signal element 106 may be based on one or more liquids (e.g., one or more colored liquids) that are released based on the deformation of the optical signal element 106 and / or the components of the optical signal element 106. For example, the one or more liquids can be released from one or more cavities of the optical signal element 106 based on deformation of the optical signal element 106 and / or components of the optical signal element 106. In some non-limiting embodiments, the one or more liquids can be released from one or more cavities of the optical signal element 106, and the one or more liquids can be combined to provide a change in the optical properties of the optical signal element 106 (e.g., a change from a first color to a second color, a change in emitted light based on photoluminescence such as phosphorescence and / or chemiluminescence, etc.). In some non-limiting embodiments, the two-dimensional (2D) surface area (e.g., the observable 2D surface area) of the colored material after compression can be greater than the 2D surface area before compression. In some non-limiting embodiments, the optical signal element 106 can rely on color change technology to change from one color to another, (e.g., irreversible photochromism), piezochromism (e.g., pressure sensitive coatings, pressure sensitive films, etc.), strain responsive polymers, chromatography (e.g., diffusion-based inks, migration inks, etc.), electrochromism, negative films, and / or chemical reactions (e.g., a chemical reaction of starch and iodine, where the iodide starts out as a light orange-brown color and then turns blue-black when applied to starch), etc.

[0054] In some non-limiting embodiments, the optical signal element 106 can use color change technology to provide an optical signal that distinguishes first use from subsequent use and / or potential accidental contact. In some non-limiting embodiments, the color change technology can be based on migrated ink, wherein the migration of the ink is activated as a result of initial use (e.g., connecting the medical device associated with the optical signal element to another device such as a connector or a catheter hub, and disconnecting the medical device from the other device). In some non-limiting embodiments, the color change can be visible to the individual and / or can occur at a wavelength that makes the color change invisible to the individual. Additionally or alternatively, the color change can be read by the device. In some non-limiting embodiments, the color change technology can be included in one or two devices that constitute a group of matching devices. In some non-limiting embodiments, multiple color changes can occur to distinguish medical devices that have not been used from medical devices that are initially used and medical devices that are subsequently used (e.g., second use, third use), to provide, for example, an optical signal indicating how many times the medical device has been used (e.g., how many tubes have been connected).

[0055] In some non-limiting embodiments, the optical signal element 106 can provide an optical signal based on a deformation pattern of the optical signal element 106 and / or a component of the optical signal element 106. In some non-limiting embodiments, the deformation pattern can be controlled based on a channel included in the optical signal element 106, and a colored element associated with the optical signal element 106 (e.g., included in the optical signal element 106) can move (e.g., flow) into the channel. In some non-limiting embodiments, the optical signal element 106 (e.g., a plastic unit of the optical signal element 106) can contain a liquid that is released when the optical signal element 106 is compressed and is carried into (e.g., sucked into) the channel or the lateral flow element to provide an optical signal at a specific location (e.g., a predetermined location of a medical device to which the optical signal element 106 is attached).

[0056] In some non-limiting embodiments, the optical signal element 106 can transition between a first state and a second state based on the formation of a connection between a medical device and an instrument (e.g., another medical device) configured to be connected (e.g., mated) with the medical device. In some non-limiting embodiments, the amplitude of an optical signal observable (e.g., visually observable by an individual or readable by a device such as an optical reader device) can be different before and after connecting two mating instruments. In some non-limiting embodiments, the indication (e.g., the observable optical signal provided by the optical signal element 106) can begin as a color column that is flattened and has a smaller surface area due to a smaller cross-functional area perpendicular to the surface, and a larger optical signal can be observed and / or read when the column is flattened or bent. Based on the application of the optical signal element 106, the optical signal element 106 can include appropriate different shapes and / or configurations.

[0057] In some non-limiting embodiments, the optical signal element 106 can transition between a first state and a second state and can provide an optical signal after the medical device is engaged with a mating device (e.g., another medical device intended to mate with the medical device) to distinguish between a first engagement event and subsequent engagement events; or alternatively, upon accidental contact with a mating area of ​​the device, the optical signal element provides an optical signal to indicate when the device may have been contaminated by accidental contact at a mating surface.

[0058] The communication network 108 may include one or more wired networks and / or wireless networks. For example, the communication network 108 may include a cellular network (e.g., a long-term evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, a fiber-based network, and / or a cloud computing network, etc., and / or a combination of some or all of these networks or other types of networks.

[0059] Figure 1 The number and arrangement of systems and / or devices shown are provided as examples. Figure 1 There may be additional systems and / or devices, fewer systems and / or devices, different systems and / or devices, or differently arranged systems and / or devices than those shown. Figure 1 Two or more of the systems and / or devices shown may be implemented in a single system or a single device, or Figure 1 The single system or single device shown may be implemented as multiple distributed systems or devices. Additionally or alternatively, a set of systems or a set of devices (e.g., one or more systems, one or more devices) of environment 100 may perform one or more functions described as being performed by another set of systems or another set of devices of environment 100.

[0060] Reference now Figure 2 , Figure 2 2 is a schematic diagram of multiple example components of the device 200. The device 200 may correspond to the medical device management system 102 (one or more devices of the medical device management system 102) and / or the optical reader device 104. In some non-limiting embodiments, the medical device management system 102 and / or the optical reader device 104 may include at least one device 200 and / or at least one component of the device 200. Figure 2 As shown, device 200 may include a bus 202 , a processor 204 , a memory 206 , a storage component 208 , an input component 210 , an output component 212 , and a communication interface 214 .

[0061] The bus 202 may include components that allow communication between the components of the device 200. In some non-limiting embodiments, the processor 204 may be implemented in hardware, firmware, or a combination of hardware and software. For example, the processor 204 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.). The memory 206 may include a random access memory (RAM), a read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic storage, optical storage, etc.) that stores information and / or instructions for use by the processor 204.

[0062] The storage component 208 may store information and / or software related to the operation and use of the device 200. For example, the storage component 208 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid-state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium along with a corresponding drive.

[0063] Input components 210 may include components that allow device 200 to receive information, such as through user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, a camera, etc.). Additionally or alternatively, input components 210 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). Output components 212 may include components that provide output information from device 200 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).

[0064] The communication interface 214 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables the device 200 to communicate with other devices, for example, via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection. The communication interface 214 may allow the device 200 to receive information from another device and / or provide information to another device. For example, the communication interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, interface, and / or cellular network interface, etc.

[0065] Device 200 can perform one or more processes described herein. Device 200 can perform these processes based on processor 204 executing software instructions stored by computer-readable media (e.g., memory 206 and / or storage component 208). Computer-readable media (e.g., non-transitory computer-readable media) are defined herein as non-transitory storage devices. Non-transitory storage devices include storage space located inside a single physical storage device or storage space distributed across multiple physical storage devices.

[0066] The software instructions may be read into the memory 206 and / or storage component 208 from another computer-readable medium or from another device through the communication interface 214. The software instructions stored in the memory 206 and / or storage component 208, when executed, may cause the processor 204 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Therefore, the embodiments described herein are not limited to any specific combination of hardware circuitry and software.

[0067] The memory 206 and / or storage component 208 may include a data repository or one or more data structures (e.g., a database, etc.). The device 200 may be capable of receiving information from, storing information in, transmitting information to, or searching for information stored in the data repository or one or more data structures in the memory 206 and / or storage component 208. For example, the information may include data associated with a real-time mobile device application profile, data associated with a historical mobile device application profile, input data, output data, transaction data, account data, or any combination thereof.

[0068] Figure 2The number and arrangement of components shown are provided as examples. In some non-limiting embodiments, Figure 2 The device 200 may include additional components, fewer components, different components, or components arranged differently than the components shown. Additionally or alternatively, a set of components (e.g., one or more components) of the device 200 may perform one or more functions described as being performed by another set of components of the device 200.

[0069] Reference now Figure 3 , Figure 3 300 for determining a characteristic of a medical device. In some non-limiting embodiments, one or more functions described with respect to process 300 may be performed (e.g., fully performed, partially performed, etc.) by the medical device management system 102. In some non-limiting embodiments, one or more steps of process 300 may be performed (e.g., fully performed, partially performed, etc.) by another device or group of devices (e.g., the optical reader device 104) separate from the medical device management system 102.

[0070] like Figure 3 As shown, at step 302, process 300 may include receiving data associated with an optical signal element that is associated with a medical device (e.g., attached to the medical device, located on the medical device, adhered to the medical device, snapped onto the medical device, applied to a surface of the medical device, etc.). For example, the medical device management system 102 may receive (e.g., receive in real time) data associated with an optical signal element 106 associated with a medical device (e.g., a container, a syringe, a catheter, a closure such as a cap, etc.).

[0071] In some non-limiting embodiments, the data associated with the optical signal element 106 (e.g., first data associated with the optical signal element 106, second data associated with the optical signal element 106, additional data associated with the optical signal element 106, etc.) may include data associated with characteristics of the medical device.

[0072] In some non-limiting embodiments, the data associated with the optical signal element 106 may include data associated with a first state of the medical device (e.g., an active state, a state ready for use, an open state, a state in which a substance in the medical device is ready to be administered, an unused state, etc.), and / or data associated with a second state of the medical device (e.g., an inactive state, a state not ready for use, a closed state, a state in which a substance in the medical device cannot yet be administered, a used state, etc.).

[0073] In some non-limiting embodiments, when the optical signal element 106 is in a first state, the optical signal element 106 may provide (e.g., passively provide, visually indicate so that a user can visually observe) a first indication about a medical device, and when the optical signal element is in a second state, the optical signal element 106 may provide a second indication about the medical device.

[0074] In some non-limiting embodiments, the medical device management system 102 may receive data associated with the optical signal element 106 from the optical reader device 104. For example, the optical reader device 104 may read the optical signal element 106 and obtain data associated with the optical signal element 106 based on reading the optical signal element 106. The optical reader device 104 may send the data associated with the optical signal element 106 to the medical device management system 102, and the medical device management system 102 may receive the data associated with the optical signal element 106 from the optical reader device 104 based on the optical reader device 104 reading the optical signal element 106.

[0075] In some non-limiting embodiments, the medical device may include an instrument used in a medical procedure. For example, the medical device may include an instrument for establishing a connection during a medical procedure, such as a Luer instrument (e.g., a Luer connector), a catheter hub, a needleless connector, a port, a manifold, and / or an airflow switch (stopcock), etc. In some non-limiting embodiments, the medical device may include one of the following: a matching medical device (e.g., a plurality of medical devices designed to be connected together) or a group of matching medical devices. For example, the medical device may include a needleless connector and / or a corresponding cap. In another example, the medical device may include a needleless connector and / or a syringe (e.g., a flushing syringe). In another example, the medical device may include a tube element and a syringe. In another example, the medical device may include a test box and a reader (e.g., a test box and a reader for diseases such as diseases or illnesses). In another example, the medical device may include an oral syringe and an oral tube connector. In another example, the medical device may include a syringe and a needle.

[0076] like Figure 3 As shown, process 300 may include determining a characteristic of a medical device at step 304. For example, the medical device management system 102 may determine the characteristic of the medical device based on data associated with the optical signal element 106 attached to the medical device.

[0077] In some non-limiting embodiments, the medical device management system 102 can determine a characteristic of a medical device associated with the optical signal element 106. For example, the medical device management system 102 can determine the characteristic of the medical device based on data associated with the optical signal element 106. In some non-limiting embodiments, the medical device management system 102 can use the optical signal element 106 to determine the characteristic of the medical device, wherein the characteristic may include a state of the medical device. For example, the characteristic may include a first state of the medical device (e.g., an active state, a state ready for use, an open state, a state in which a substance in the medical device is ready to be administered, an unused state, etc.), and / or a second state of the medical device (e.g., an inactive state, a state not ready for use, a closed state, a state in which a substance in the medical device cannot yet be administered, a used state, etc.).

[0078] like Figure 3 As shown, at step 306 , process 300 can include performing an action based on the characteristic of the medical device. For example, the medical device management system 102 can perform an action based on the characteristic of the medical device associated with the optical signal element 106 .

[0079] In some non-limiting embodiments, the medical device management system 102 can send data to a database. In some non-limiting embodiments, the medical device management system 102 can send data to an electronic medical record (EMR) system for automatic logging and / or security confirmation that the medication to be administered matches the individual's medication order.

[0080] refer to Figure 4A and Figure 4B , Figure 4A and Figure 4B 4 is a schematic diagram of a non-limiting example of an embodiment 400 of an optical signal element 406. In some non-limiting embodiments, the optical signal element 406 can be the same as or similar to the optical signal element 106. In some non-limiting embodiments, the optical signal element 406 can be associated with a medical device. For example, the optical signal element 406 can be attached to a syringe, an intravenous (IV) assembly, a luer connector, a catheter, a tube, a container, a drug package, and / or a closure (e.g., a cap), etc.

[0081] like Figure 4A As shown, the optical signal element 406 may include a plurality of components 410 configured to change visual appearance based on deformation of the plurality of components 410. Figure 4AIn the example of FIG. 4 , each of the plurality of components 410 may provide a first indication when the optical signal element 406 is in a first state (e.g., when all of the plurality of components 410 are in an undeformed state); and the optical signal element 406 may provide a second indication when the optical signal element 406 is in a second state (e.g., when one or more of the plurality of components 410 are in a deformed state). In some non-limiting embodiments, each of the plurality of components 410 is configured to transition from the first state to the second state based on the deformation of the component 410. In some non-limiting embodiments, the transition of the component 410 from the first state to the second state may be reversible or irreversible.

[0082] like Figure 4A As further shown, each of the plurality of components 410 may include a colored shape (e.g., circular, hemispherical, spherical, beaded, etc.) that will deform (e.g., compressed, flattened, squashed, etc.) to transform a colored area from a first state to a second state, the colored area being visible to an individual and / or readable by a device (e.g., optical reader device 104). In some non-limiting embodiments, each of the plurality of components 410 may include a single color and a colored area (e.g., a window, a visible space, etc.) that is visible in the first state and may be different from a colored area visible in the second state. In one example, a colored area visible in the first state may be larger than a colored area visible in the second state, and vice versa. In some non-limiting embodiments, each of the plurality of components 410 may include multiple colors, and a colored area visible in the first state may be different from a colored area visible in the second state. In one example, a colored area visible in the first state may be a different color than a colored area visible in the second state based on how the multiple colors interact when a component 410 in the plurality of components 410 deforms to transition from the first state to the second state.

[0083] like Figure 4B As shown, component 410 of optical signal element 406 may include a colored area 412, which is configured to transform from a first state to a second state based on deformation of component 410 through mechanical operation (e.g., compression force generated by connecting two components together, compression force generated by disconnecting two components from each other, compression force generated by user interaction with component 410, etc.). In some non-limiting embodiments, component 410 may include a suitable material for achieving this effect. For example, component 410 may include foam wrapped in an elastic shell. As shown in FIG. Figure 4BAs further shown, the colored area 412 visible in the first state may be larger than the colored area 412 visible in the second state.

[0084] refer to Figure 5 , Figure 5 is a schematic diagram of a non-limiting example of an embodiment 500 of an optical signal element 506. In some non-limiting embodiments, the optical signal element 506 can be the same or similar to the optical signal element 106 and / or the optical signal element 406. In some non-limiting embodiments, the optical signal element 506 can be associated with a medical device. For example, the optical signal element 506 can be attached to a syringe, an IV assembly, a luer connector, a catheter, a tube, a container, a drug package, and / or a closure (e.g., a cap), etc.

[0085] like Figure 5 As further shown, the optical signal element 506 may include a plurality of components 510 configured to change visual appearance based on deformation of the plurality of components 510. Figure 5 In the example of , when the optical signal element 506 is in a first state (e.g., when all of the plurality of components 510 are in an undeformed state), each of the plurality of components 510 may provide a first indication; and when the optical signal element 506 is in a second state (e.g., when one or more of the plurality of components 510 are in a deformed state), the optical signal element 506 may provide a second indication. Figure 5 As further shown, each of the plurality of components 510 may include a frangible element having a shape (e.g., column, pillar, spherical, etc.) that will deform (e.g., be compressed, flattened, squashed, bent, reoriented, etc.) to change the appearance of the frangible element, which will be visible to an individual and / or read by a device (e.g., optical reader device 104). In some non-limiting embodiments, the surface of one or more of the frangible elements may be covered with a material that can change the path of light that hits the surface. For example, the surface may have a reflective covering or an absorptive covering. In some non-limiting embodiments, each of the plurality of components 510 may include an area that is visible or readable in the first state, and the area may be different from the area that is visible or readable in the second state. In one example, the area that is visible or readable in the first state may be larger than the area that is visible or readable in the second state, and vice versa.

[0086] refer to Figure 6 , Figure 6600 is a schematic diagram of a cross-section of a non-limiting embodiment of a medical device assembly 600. Figure 6 As shown, the medical device assembly 600 may include an optical signal element 606 attached to a cap device 630. In some non-limiting embodiments, the optical signal element 606 may be the same or similar to the optical signal element 106, the optical signal element 406, and / or the optical signal element 506. In some non-limiting embodiments, the cap device 630 may include a cap (e.g., a mating cap) for the medical device. For example, the cap device 630 may include a mating sterilization cap for a needleless connector. Figure 6 As further shown, the cap instrument 630 may include threads 632 for attaching the cap instrument 630 to a medical instrument configured as a mating instrument for the cap instrument 630 .

[0087] like Figure 6 As further shown, the optical signal element 606 can include a plurality of layers, one or more of which can be removed from the cap device 630. For example, the optical signal element 606 can include a dye layer 612, a non-absorbing layer 614, an absorbing layer 618, and a cover layer 622. In some non-limiting embodiments, the dye layer 612 can include a dye configured to be visible to an individual and / or read by an optical reader device (e.g., the optical reader device 104). In some non-limiting embodiments, the non-absorbing layer 614 can prevent the dye included in the dye layer 612 from migrating. For example, the non-absorbing layer 614 can prevent the dye from being absorbed by the absorbing layer 618.

[0088] like Figure 6 As further shown, the multiple layers of the optical signal element 606 can be constructed as a sandwich structure. Figure 6As further shown, the dye layer 612 can be located in the annular channel 624 at the outer edge surface 626 of the cap device 630, wherein the outer edge surface 626 can be a mating surface that contacts a corresponding surface of an instrument to which the cap device 630 is to be attached. The non-absorbing layer 614 can be located above the dye layer 612 and between the dye layer 612 and the absorbing layer 618. In this way, when the non-absorbing layer 614 is present, the non-absorbing layer 614 can prevent the dye from migrating from the dye layer 612 into the absorbing layer 618, so that the optical signal element 606 does not transition from the first state to the second state before the optical signal element 606 is expected to transition. The absorbing layer 618 can be located above the non-absorbing layer 614 and between the non-absorbing layer 614 and the covering layer 622. In some non-limiting embodiments, the covering layer 622 can be located above the non-absorbing layer 614 and form a final outer-facing layer that protects the underlying layers from damage based on the surrounding environment (e.g., based on contamination from elements in the surrounding environment). According to some non-limiting embodiments, one or more of the plurality of layers of the optical signal element 606 may be sized and configured based on the size and configuration of the medical device to attach the one or more of the plurality of layers to the medical device.

[0089] In some non-limiting embodiments, the dye layer 612 can be configured such that the dye included in the dye layer 612 can migrate toward the absorbent layer 618 (e.g., into or through the absorbent layer, so that the dye is saturated) based on a predetermined time interval (e.g., 1 minute, 2 minutes, about 5 minutes, less than 5 minutes, etc.). For example, the dye layer 612 can be configured such that the dye can migrate toward the absorbent layer 618 based on a predetermined time interval, so that there can be no color change in the absorbent layer 618 within a predetermined time interval after the cap device 630 is used for the first time (e.g., the cap device 630 is connected to another device such as a needleless connector or a catheter hub, and the cap device 630 is disconnected from the other device). In some non-limiting embodiments, before the cap device 630 is used for the first time, the optical signal element 606 can be in a first state, and the optical signal element 606 can provide a first indication about the cap device 630 (e.g., an indication that the cap device 630 has not been used before). In some non-limiting embodiments, the color change is visually observable and / or readable (e.g., readable by the optical reader device 104) upon a second use (e.g., after the cap instrument 630 is disconnected from another instrument after the first use of the cap instrument 630). In some non-limiting embodiments, after the expiration of a predetermined time interval and after the first use of the cap instrument 630, the optical signal element 606 can be in a second state, and the optical signal element 606 can provide a second indication about the cap instrument 630 (e.g., an indication that the cap instrument 630 has been used before). In some non-limiting embodiments, the color change of the absorbent layer 618 occurs gradually based on the dye. In some non-limiting embodiments, after the expiration of the predetermined time interval, the color change can be at a high intensity (e.g., an observability magnitude related to a measurement of observability). After the desired time is reached, the color will remain at its darkest color. In some non-limiting embodiments, upon reading the optical signal element 606, the medical device management system 102 may store data indicating that the cap device 630 has been previously used (eg, in a data structure such as a database associated with the medical device management system 102).

[0090] In some non-limiting embodiments, the non-absorbent layer 614 and the cover layer 622 can be attached to each other (e.g., by an adhesive, by heat sealing, etc.). In this way, as the cover layer 622 is removed (e.g., by a peeling action of the cover layer 622 from the cap device 630), the non-absorbent layer 614 will also be removed. Upon removal of the cover layer 622 and the non-absorbent layer 614, the cap device 630 can be threadedly connected to another device, thereby bringing the absorbent layer 618 and the dye layer 612 into contact with each other.

[0091] In some non-limiting embodiments, the non-absorbing layer 614 may include (e.g., be composed of) a material that (e.g., a non-porous material) prevents the dye from migrating into the non-absorbing layer 614. In some non-limiting embodiments, the non-absorbing layer 614 may include a transparent material. In some non-limiting embodiments, the non-absorbing layer 614 may include an indicator 616 located on an outer surface of the non-absorbing layer 614. In some non-limiting embodiments, (e.g., in the case where the non-absorbing layer 614 is composed of a transparent material) the indicator 616 may provide an indication (e.g., a visible indication) that the non-absorbing layer 614 is in the proper position. In some non-limiting embodiments, the absorbing layer 618 may include a material (e.g., paper) configured to absorb dye from the dye layer 612. For example, the absorbing layer 618 may include a material configured to absorb dye when the absorbing layer 618 contacts the dye layer 612. In some non-limiting embodiments, the covering layer 622 may include a material (e.g., metal) configured to protect the underlying layer from damage based on the surrounding environment.

[0092] refer to Figure 7 , Figure 7 is a schematic diagram of a non-limiting embodiment of a medical device assembly 700. Figure 7 As shown, medical device assembly 700 can include optical signal element 706 attached to cap device 630. In some non-limiting embodiments, optical signal element 706 can be the same or similar to optical signal element 106, optical signal element 406, optical signal element 506, and / or optical signal element 606.

[0093] like Figure 7 As further shown, the optical signal element 706 can include multiple layers, one or more of which can be removed from the cap device 630. For example, the optical signal element 706 can include a dye layer 712, a non-absorbing layer 714, an absorbing layer 718, and a covering layer 722. In some non-limiting embodiments, the dye layer 712 can be the same or similar to the dye layer 612. In some non-limiting embodiments, the dye layer 712 can be located on the outer edge surface 626 of the cap device 630. The non-absorbing layer 714 can be located above the dye layer 712 and between the dye layer 712 and the absorbing layer 718. In this way, when the non-absorbing layer 714 is present, the non-absorbing layer 714 can prevent the dye from migrating from the dye layer 712 to the absorbing layer 718, so that the optical signal element 706 does not transition from the first state to the second state before the optical signal element 706 is expected to transition.

[0094] The absorbing layer 718 can be located above the non-absorbing layer 714 and between the non-absorbing layer 714 and the covering layer 722. In some non-limiting embodiments, the covering layer 722 can be located above the non-absorbing layer 714 and form a final outward-facing layer that protects the underlying layers from damage based on the surrounding environment (e.g., based on contamination from elements in the surrounding environment). According to some non-limiting embodiments, the size and configuration of one or more of the multiple layers of the optical signal element 706 can be adjusted based on the size and configuration of the medical device so that the one or more of the multiple layers are attached to the medical device. For example, the size and configuration of the non-absorbing layer 714 and / or the absorbing layer 718 can be adjusted so that the non-absorbing layer 714 and / or the absorbing layer 718 have an annular shape corresponding to the outer edge surface 626 of the cap device 630.

[0095] In some non-limiting embodiments, the removal of the non-absorbent layer 714 may not be completed with the removal of the dust cover 722. Figure 7 As further shown, the non-absorbing layer 714 can be attached to the dust cover 722 by tabs 716 of the non-absorbing layer 714 and tabs 724 of the cover layer 722, wherein the tabs 716 and tabs 721 are attached to each other. In this way, when the cover layer 722 is completely removed, the cover layer 722 can still be attached to the non-absorbing layer 714, and by pulling in a centripetal motion, the individual can completely remove the non-absorbing layer 714, which exposes the dye layer 712. In this way, this design of the optical signal element 706 provides the benefit of keeping the opening of the cover device 630 unobstructed except for the cover layer 722.

[0096] refer to Figure 8 , Figure 8 8 is a schematic diagram of a non-limiting embodiment of a medical device assembly 800. Figure 8 As shown, medical device assembly 800 can include optical signal element 806 attached to cap device 630. In some non-limiting embodiments, optical signal element 806 can be the same or similar to optical signal element 106, optical signal element 406, optical signal element 506, optical signal element 606, and / or optical signal element 706.

[0097] like Figure 8As further shown, the optical signal element 806 may include a plurality of layers, one or more of which may be removed from the cap device 630. For example, the optical signal element 806 may include a dye layer 812, a non-absorbing layer 814, an absorbing layer 818, and a covering layer 822. In some non-limiting embodiments, the dye layer 812 may be the same or similar to the dye layer 612 and / or the dye layer 712. In some non-limiting embodiments, the dye layer 812 may be located on the outer edge surface 626 of the cap device 630. In some non-limiting embodiments, the non-absorbing layer 814 may be located above the dye layer 812 and between the dye layer 812 and the absorbing layer 818 (e.g., the structure is Figure 8 818). In this way, when the non-absorbing layer 814 is present, the non-absorbing layer 814 can prevent the dye from migrating from the dye layer 812 into the absorbing layer 818, so that the optical signal element 806 does not transition from the first state to the second state before the optical signal element 806 is expected to transition. In some non-limiting embodiments, the non-absorbing layer 814 can be configured as a removable closure (e.g., a cap).

[0098] The absorbing layer 818 can be located above the non-absorbing layer 814 and between the non-absorbing layer 814 and the covering layer 822. In some non-limiting embodiments, the covering layer 822 can be located above the non-absorbing layer 814 and form a final outward-facing layer that protects the underlying layers from damage based on the surrounding environment (e.g., based on contamination from elements in the surrounding environment). According to some non-limiting embodiments, the size and configuration of one or more of the multiple layers of the optical signal element 806 can be adjusted based on the size and configuration of the medical device so that one or more of the multiple layers are attached to the medical device. For example, the size and configuration of the non-absorbing layer 814 and / or the absorbing layer 818 can be adjusted so that the non-absorbing layer 814 and / or the absorbing layer 818 have a disconnected annular shape (e.g., a C-shape) corresponding to the outer edge surface 626 of the cap device 630. As shown in FIG. Figure 8 As further shown, the absorbent layer 818 may include gaps 820, and the absorbent layer 818 may be attached to the cover layer 822 via tabs 824. In some non-limiting embodiments, the non-absorbent layer 814 may replace the cover layer 822. Figure 8 Absorbent layer 818 is shown. For example, non-absorbent layer 814 may include a gap that can be attached to cover layer 822 via a tab. In this way, removal of either absorbent layer 818 or non-absorbent layer 814 may be accomplished by removal of dust cover 822 for optical signal element 806.

[0099] Although non-limiting embodiments have been described in detail for purposes of illustration and description, it will be understood that such detail is for that purpose only, and that the embodiments are not limited to the disclosed embodiments, but, on the contrary, are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it will be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, many of these features may be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed may be directly dependent on only one claim, the disclosure of possible implementations includes each dependent claim in combination with each other claim in the claim group.

Claims

1. An optical signal element for a disposable medical device, comprising: an optical signaling element, the optical signaling element being associated with the medical device; wherein, when the optical signal element is in a first state, the optical signal element provides a first indication about the medical device; and wherein, when the optical signal element is in a second state, the optical signal element provides a second indication about the medical device, wherein the second indication is different from the first indication; wherein the optical signal element is configured to: transition from the first state to the second state based on a mechanical operation performed on the optical signal element; and at least one processor programmed or configured to: receiving data associated with the optical signal element; determining a characteristic of the medical device based on the data associated with the optical signal element; and An action is performed based on the characteristic of the medical device.

2. The system according to claim 1, wherein: The optical signal element comprises: a window having a material; and cover; and wherein, when the optical signal element is in the first state, the window is held in an open position by the cover; and wherein, when the optical signal element is in the second state, the material of the window covers the opening of the window, so that the window is in a closed position; and Therein, the optical signal element changes from the first state to the second state upon the cover being removed and the material of the window relaxing over the opening of the window.

3. The system according to claim 2, wherein: When performing the actions based on the characteristics of the medical device, the at least one processor is programmed or configured to: An alert is provided, wherein the alert includes information indicating that the medical device is improperly connected to another component.

4. The system according to claim 2, wherein: When performing the actions based on the characteristics of the medical device, the at least one processor is programmed or configured to: A prompt is provided, wherein the prompt includes information indicating that connection of the medical device to another component should be corrected to properly connect the medical device.

5. The system according to claim 2, wherein: When performing the actions based on the characteristics of the medical device, the at least one processor is programmed or configured to: A message is provided, wherein the message includes information indicating that the medical device is properly connected to another component.

6. The system according to claim 2, wherein: When receiving the data associated with the optical signal element attached to the medical device, the at least one processor is programmed or configured to: The data associated with the optical signal element attached to the medical instrument is received from an optical reader device.

7. The system according to claim 1, wherein: The optical signaling element transitions from the first state to the second state based on a mechanical deformation of the optical signaling element.

8. The system according to claim 1, wherein: The optical signaling element is configured to transition from the first state to the second state based on a physical property of a component of the optical signaling element.

9. The system according to claim 1, wherein: The optical signaling element is configured to transition from the first state to the second state based on a material change of a component of the optical signaling element.

10. The system according to claim 1, wherein: The optical signal element associated with the medical device is attached to a connector associated with the medical device, and wherein the connector is configured to establish a connection with the medical device.

11. The system according to claim 1, wherein: The transition of the optical signaling element from the first state to the second state is irreversible.

12. The system of claim 1, wherein: The optical signal element associated with the medical device comprises a base and a first detachable component, and wherein the base and the first detachable component are configured to be separable; wherein, when the optical signal element is in the first state, the base is not separated from the first detachable component; and Wherein, when the optical signal element is in the second state, the base is separated from the first detachable component.

13. A medical device assembly comprising: Medical devices; an optical signal element associated with the medical device, wherein the optical signal element comprises a dye; wherein, when the optical signal element is in a first state, the optical signal element provides a first indication about the medical device; and Wherein, when the optical signal element is in a second state, the optical signal element provides a second indication about the medical device based on the dye, wherein the second state is associated with migration of the dye to an observable position of the optical signal element, and wherein the second indication is different from the first indication.

14. The medical device assembly according to claim 13, wherein: The optical signal element comprises: a dye layer, the dye layer comprising the dye, and a non-absorbing layer associated with the dye layer; and The optical signal element is in the second state based on the non-absorbing layer being out of contact with the dye layer.

15. The medical device assembly according to claim 14, wherein: The optical signal element is in the first state based on the non-absorbing layer being in contact with the dye layer.

16. The medical device assembly of claim 14, wherein: The optical signal element comprises an absorption layer, and wherein the optical signal element provides the second indication regarding the medical device based on absorption of the dye of the dye layer by the absorption layer.

17. The medical device assembly according to claim 16, wherein: The optical signal element provides the second indication regarding the medical device based on the dye of the dye layer being absorbed by the absorption layer after a predetermined time interval.

18. The medical device assembly of claim 17, wherein: The optical signal element is attached to the medical instrument, wherein the optical signal element is in the first state when the medical instrument is not attached to another instrument, and wherein the optical signal element transitions from the first state to the second state upon attachment of the medical instrument to another instrument.

19. The medical device assembly of claim 14, wherein: The optical signal element comprises: A cover layer is attached to the non-absorbing layer in contact with the dye layer, and wherein the cover layer is configured to protect the dye layer and the non-absorbing layer from damage.

20. The medical device assembly of claim 13, wherein: The optical signaling element is configured to irreversibly transition from the first state to the second state.

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