Identification system and method for smart packaging system

Abstract

Systems and methods are provided. The system includes: a manufacturer-sealed sterile surgical package; a surgical instrument, the surgical instrument being stored within the manufacturer-sealed sterile package; a first transceiver contained within the manufacturer-sealed sterile surgical package and configured to transmit a first set of data including a first amount of data; a second transceiver contained within the manufacturer-sealed sterile surgical package and configured to transmit a second set of data comprising a second amount of data, the second amount of data being greater than the first amount of data; and a power source contained within the manufacturer-sealed sterile surgical package and connected to the second transceiver, where the second transceiver is intermittently powered by the power source.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 525,572, filed July 7, 2023, the contents of which are incorporated herein in their entirety. TECHNICAL FIELD

[0002] The present disclosure relates generally to intelligent surgical equipment, systems, and methods. BACKGROUND

[0003] Surgical instruments are manufactured to meet certain performance metrics in order to ultimately perform surgical procedures in a safe and efficient manner. After manufacture, surgical instruments are shipped to hospitals and surgical centers throughout the world and along the supply chain, the surgical instruments are handled by various personnel, including shipping operators, warehouse operators, customs officials, hospital staff, surgical teams, etc.

[0004] While safe and efficient performance of surgical instruments is the goal, problems can arise. In some cases, problems with surgical instruments can arise due to manufacturing issues. In other cases, problems can arise due to mis-handling during shipping, such as improper storage techniques or extreme environmental phenomena. In yet other cases, problems can arise due to incompatibility with other surgical equipment or improper use in the operating room during a surgical procedure.

[0005] Accordingly, there remains a need for improved systems and methods. SUMMARY

[0006] In one embodiment, a system is provided, the system comprising: a manufacturer-sealed sterile surgical package containing a surgical instrument configured for use in a surgical procedure; a graphical display; at least one data processor in operable communication with the graphical display; and a memory in operable communication with the at least one data processor and storing instructions configured to enable the at least one data processor to perform operations. The operations can include: storing parameters corresponding to the surgical instrument; receiving a set of data characterizing parameters associated with the surgical instrument; adjusting the cataloging parameters based on the received data; determining a graphical depiction characterizing the adjusted parameters; and providing the graphical depiction of the adjusted parameters on the graphical display.

[0007] The system can vary in a number of ways. For example, the cataloged parameters and the adjusted parameters include information characterizing at least one of a historical state, a future state, and operational information. In other aspects, the historical state can include at least one of manufacturing information, material and component information, geographic origin information, and environmental information experienced by the surgical package. In other embodiments, the future state can include at least one of intended destination information, environmental requirement information, customs information, disposal information, and error reporting surgery information. In other aspects, the operational information can include at least one of product compatibility information, projected life cycle information, and operating instructions. In some variations, the operations can further include providing at least a portion of the cataloged parameters based on an on-demand user request. In other embodiments, the on-demand user request can require authentication to access the cataloged parameters. In some variations, the graphical display can include at least one electronic ink indicia. In some embodiments, the adjusted parameters can be transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed, sterile surgical package.

[0008] In another embodiment, a method is provided that includes storing parameters corresponding to a surgical instrument contained within a manufacturer-sealed, sterile surgical package, the manufacturer-sealed, sterile surgical package including a display disposed thereon; receiving a set of data characterizing parameters associated with the surgical instrument; adjusting the stored parameters based on the received data; determining a graphical depiction characterizing the adjusted parameters; and providing the graphical depiction of the adjusted parameters on the display.

[0009] The method can vary in a number of ways. For example, the cataloged parameters and the adjusted parameters can include information characterizing at least one of a historical state, a future state, and operational information. In other aspects, the historical state can include at least one of manufacturing information, material and component information, geographic origin information, and environmental information experienced by the surgical package. In other embodiments, the future state can include at least one of intended destination information, environmental requirement information, customs information, disposal information, and error reporting surgery information. In other aspects, the operational information can include at least one of product compatibility information, projected life cycle information, and operating instructions. In some variations, the method can include providing at least a portion of the cataloged parameters based on an on-demand user request. In other embodiments, the on-demand user request can be authenticated prior to providing at least a portion of the cataloged parameters. In some variations, the at least one display can include at least one electronic ink indicia.

[0010] Also provided are non-transitory computer program products. In one embodiment, a non-transitory computer program product is provided and can store instructions that, when executed by at least one data processor forming a part of at least one computing system, cause the at least one data processor to perform operations comprising: storing parameters corresponding to a surgical instrument contained within a manufacturer- sealed sterile surgical package, the manufacturer-sealed sterile surgical package including a display disposed thereon; receiving a set of data characterizing parameters associated with the surgical instrument; adjusting the cataloging parameters based on the received data; determining a graphical depiction characterizing the adjusted parameters; and providing the graphical depiction of the adjusted parameters on the display.

[0011] In one embodiment, a system is provided and can include: a manufacturer-sealed sterile surgical package containing a surgical instrument configured for use in a surgical procedure; a graphical display; at least one data processor in operable communication with the graphical display; and a memory in operable communication with the at least one data processor and storing instructions configured to cause the at least one data processor to perform operations. The operations can include: recording historical data points of the surgical instrument; determining a level of degradation of the surgical instrument based on the historical data points; determining a set of changed operating parameters based on the level of degradation of the surgical instrument; and providing the set of changed operating parameters.

[0012] The system can vary in a number of ways. For example, the recording of historical data points can include tracking an amount of sterilization procedures the surgical instrument has undergone. In some variations, the recording of historical data points can include tracking an amount of operations performed by the surgical instrument. In other variations, the recording of historical data points can include tracking environmental conditions in which the surgical instrument is located. In some variations, the set of changed operating parameters can increase an operating accuracy of the surgical instrument. In some aspects, the changed operating parameters can be transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical package.

[0013] In another embodiment, a method is provided and can include: recording historical data points of a surgical instrument contained within a manufacturer-sealed sterile surgical package, the surgical instrument configured for use in a surgical procedure; determining a level of degradation of the surgical instrument based on the historical data points; determining a set of changed operating parameters based on the level of degradation of the surgical instrument; and providing the set of changed operating parameters.

[0014] The method can vary in a number of ways. For example, the recording of historical data points can further include tracking an amount of sterilization protocols applied to the surgical instrument. In some variations, the recording of historical data points can further include tracking an amount of operations performed by the surgical instrument. In some aspects, the recording of historical data points can further include tracking environmental conditions in which the surgical instrument is located. In some variations, the altered set of operating parameters can increase an operating accuracy of the surgical instrument. In other aspects, the altered operating parameters can be transmitted and displayed on a remote device in electronic communication with a manufacturer-sealed sterile surgical package.

[0015] In another embodiment, a non-transitory computer program product is provided. The non-transitory computer program product can store instructions that, when executed by at least one data processor forming a part of at least one computing system, cause the at least one data processor to implement operations. The operations can include recording historical data points of the surgical instrument; determining a level of degradation of the surgical instrument based on the historical data points; determining an altered set of operating parameters based on the level of degradation of the surgical instrument; and providing the altered set of operating parameters.

[0016] The non-transitory computer program product can vary in a number of ways. For example, the recording of historical data points can include tracking an amount of sterilization protocols the surgical instrument has undergone. In some embodiments, the recording of historical data points can include tracking an amount of operations performed by the surgical instrument. In some aspects, the recording of historical data points can include tracking environmental conditions in which the surgical instrument is located. In some aspects, the altered operating parameters can be transmitted and displayed on a remote device in electronic communication with a manufacturer-sealed sterile surgical package.

[0017] In one embodiment, a system is provided that includes a manufacturer-sealed sterile surgical package; a surgical instrument stored within the manufacturer-sealed sterile package; a first transceiver contained within the manufacturer-sealed sterile surgical package and configured to be capable of transmitting a first set of data including a first amount of data; a second transceiver contained within the manufacturer-sealed sterile surgical package and configured to be capable of transmitting a second set of data including a second amount of data, the second amount of data being greater than the first amount of data; and a power source contained within the manufacturer-sealed sterile surgical package and connected to the second transceiver, wherein the second transceiver is intermittently powered by the power source.

[0018] The system can vary in a number of ways. For example, the second transceiver can be inactive while the first transceiver is active. In some embodiments, the second transceiver can be continuously powered by the power source. In some aspects, the second transceiver can be configured to record historical data points. In some variations, the first transceiver can be inactive while the second transceiver is active. In other variations, the first transceiver can be at least one RFID chip embedded within a manufacturer-sealed, sterile surgical package. In some embodiments, the second transceiver can include at least one data processor disposed in the surgical package and a memory disposed in the surgical package, the memory storing instructions configured to enable the at least one data processor to perform operations, which can include recording historical data points of the surgical instrument provided to the second transceiver via at least one sensor disposed in the surgical package. In some variations, a switch can be positioned between the power source and the second transceiver to selectively activate the second transceiver. In some embodiments, the surgical instrument can be positioned within a first compartment within the manufacturer-sealed, sterile surgical package and the power source is positioned within a second compartment within the manufacturer-sealed, sterile surgical package separate from the first compartment.

[0019] In another embodiment, a method is provided and can include activating a first transceiver contained within a manufacturer-sealed, sterile surgical package containing a surgical instrument stored therein, sending a first set of data from the first transceiver, wherein the first set of data comprises a first amount of data, activating a second transceiver contained within the manufacturer-sealed, sterile surgical package by connecting the second transceiver to a power source contained within the manufacturer-sealed, sterile surgical package, intermittently powering the second transceiver via the power source, and sending a second set of data from the second transceiver, wherein the second set of data comprises a second amount of data, the second amount of data being greater than the first amount of data.

[0020] The method can vary in a number of ways. For example, the method can include deactivating the first transceiver prior to activating the second transceiver. In some embodiments, the method can include deactivating the second transceiver prior to activating the first transceiver. The first transceiver can be at least one RFID chip embedded within a manufacturer-sealed sterile surgical package. The method can further include recording historical data points of the surgical instrument provided to the second transceiver via at least one sensor disposed in the surgical package. In some variations, the method can include adjusting operational parameters transmitted by the second transceiver based on the recorded historical data points. In some aspects, the method can include continuously powering the second transceiver via a power source. In some embodiments, the method can include actuating a switch positioned between the power source and the second transceiver to selectively activate the second transceiver. In some variations, the surgical instrument can be positioned within a first compartment within the manufacturer-sealed sterile surgical package and the power source is positioned within a second compartment within the manufacturer-sealed sterile surgical package separate from the first compartment.

[0021] In one embodiment, a system is provided, the system comprising: a manufacturer-sealed sterile surgical package including a surgical instrument; a graphical display disposed on the manufacturer-sealed sterile surgical package; a data processor disposed in the surgical package; and a memory in operable communication with the data processor, the memory storing instructions configured to enable the at least one data processor to perform operations. The operations include: storing a plurality of sets of display information corresponding to the surgical instrument; receiving a set of data including a stage of progress along a supply chain; determining a graphical depiction characterizing at least one of the plurality of stored sets of display information based on the received location of progress along the supply chain; and providing the graphical depiction of the determined at least one set of display information on the graphical display.

[0022] The system can vary in a number of ways. For example, in some embodiments, the at least one display can comprise at least one electronic ink indicia. In some variations, the plurality of sets of display information can comprise information characterizing at least one of a manufacturing status, a shipping status, and operational information. In some variations, the manufacturing status can comprise at least one of manufacturing information, material and component information, and geographic storage information. In other embodiments, the shipping status can comprise at least one of expected destination information, handling information, and customs information. In some embodiments, the operational information can comprise at least one of expected destination information, expected user information, and operational instructions. In some aspects, a power source can be contained within the manufacturer-sealed sterile surgical package and configured to power the display. In some embodiments, the operations can comprise receiving data characterizing a stage of a supply chain progression of the system, determining a corresponding set of display information from the plurality of sets of display information, and providing the determined set of display information via the display. In some variations, at least one of the sets of display information can comprise a scannable code. In some embodiments, the received set of data can comprise environmental parameters within which the manufacturer-sealed sterile surgical package exists. In some variations, the graphical depiction on the graphical display can be adjusted when the manufacturer-sealed sterile surgical package is passed to a second stage of the supply chain progression.

[0023] In another embodiment, a method is provided that comprises storing a plurality of sets of display information corresponding to a surgical instrument contained within a manufacturer-sealed sterile surgical package, the manufacturer-sealed sterile surgical package comprising a graphical display disposed thereon; receiving a set of data comprising a stage of a supply chain progression; determining a graphical depiction characterizing at least one of the plurality of stored sets of display information based on the received location along the supply chain progression; and providing the graphical depiction of the determined at least one set of display information on the graphical display.

[0024] The method can vary in a number of ways. For example, the at least one display can include at least one e-ink indicia. In some variations, the plurality of sets of display information can include information characterizing at least one of a manufacturing status, a shipping status, and operational information. In some variations, the manufacturing status can include at least one of manufacturing information, material and component information, and geographic storage information. In other embodiments, the shipping status can include at least one of expected destination information, handling information, and customs information. In some embodiments, the operational information can include at least one of expected destination information, expected user information, and operational instructions. In some variations, the power source can be contained within the manufacturer-sealed sterile surgical package and configured to power the display. In some embodiments, the method can include receiving data characterizing a stage of a supply chain progression of the system, determining a corresponding set of display information from the plurality of sets of display information, and providing the determined set of display information via the display. In some variations, at least one of the sets of display information can include a scannable code. In some embodiments, the graphical depiction on the graphical display can be adjusted when the manufacturer-sealed sterile surgical package is passed along the supply chain progression to a second stage.

[0025] In another embodiment, a non-transitory computer program product is provided. The non-transitory computer program product can store instructions that, when executed by at least one data processor forming a part of at least one computing system, cause the at least one data processor to implement operations. The operations can include storing a plurality of sets of display information corresponding to a surgical instrument contained within a manufacturer-sealed sterile surgical package, the manufacturer-sealed sterile surgical package including a graphical display disposed thereon; receiving a set of data including a stage of a supply chain progression; determining a graphical depiction characterizing at least one of the plurality of stored sets of display information based on the received location along the supply chain progression; and providing the graphical depiction of the determined at least one set of display information on the graphical display.

[0026] In one embodiment, a system is provided that includes at least one primary package, at least one graphical display disposed on the primary package, and an electronic management system in electronic communication with the primary package. The electronic management system is configured to: receive data characterizing a list of compatible secondary packages stored on the primary package; determine a compatible secondary package in electronic communication with the electronic management system from the list of compatible secondary packages stored on the primary package; and provide data characterizing the determined compatible secondary package on the at least one graphical display of the primary package.

[0027] The system can vary in a number of ways. For example, the primary package can be configured to determine compatible secondary packages based on surgical procedures in which the primary package can be used. In some variations, the determined compatible secondary packages can be provided on at least one display of the primary package. In some aspects, the at least one display can include at least one e-ink indicia. In other embodiments, the compatible secondary packages can include a second display provided on the compatible secondary packages. In some variations, the electronic management system can be further configured to: receive data characterizing a list of compatible primary packages stored on the secondary package; determine, from the list of compatible primary packages stored on the secondary package, compatible primary packages in electronic communication with the electronic management system; and provide data characterizing the determined compatible primary packages on a second graphical display of the secondary package. In some embodiments, the determined compatible primary packages can be provided on the second display of the secondary package. In other embodiments, the electronic management system can be further configured to provide operational information for the primary package and the compatible secondary package based on the determined compatible secondary package. In some aspects, the operational information can include at least one of product compatibility information and operating instructions.

[0028] In another embodiment, a method is provided. The method can include: receiving data characterizing a list of compatible secondary packages stored on a primary package in electronic communication with an electronic management system; determining, from the list of compatible secondary packages stored on the primary package, compatible secondary packages in electronic communication with the electronic management system; and providing data characterizing the determined compatible secondary packages on at least one graphical display of the primary package.

[0029] The method can vary in a number of ways. For example, the primary package can be configured to determine compatible secondary packages based on surgical procedures in which the primary package can be used. In some variations, the determined compatible secondary packages can be provided on at least one display of the primary package. In some aspects, the at least one display can include at least one e-ink indicia. In other embodiments, the compatible secondary packages can include a second display provided on the compatible secondary packages. In some embodiments, the method can further include: receiving data characterizing a list of compatible primary packages stored on the secondary package; determining, from the list of compatible primary packages stored on the secondary package, compatible primary packages in electronic communication with the electronic management system; and providing data characterizing the determined compatible primary packages on a second graphical display of the secondary package. In further aspects, the determined compatible primary packages can be provided on the second display of the secondary package. In some embodiments, the method can further include providing operational information for the primary package and the compatible secondary package based on the determined compatible secondary package. In some aspects, the operational information can include at least one of product compatibility information and operating instructions.

[0030] In another embodiment, a non-transitory computer program product is provided. The non-transitory computer program product can store instructions that, when executed by at least one data processor forming a part of at least one computing system, cause the at least one data processor to implement operations. The operations can include receiving data characterizing a list of compatible secondary packages stored on a primary package in electronic communication with an electronic management system; determining, from the list of compatible secondary packages stored on the primary package, a compatible secondary package in electronic communication with the electronic management system; and providing data characterizing the determined compatible secondary package on at least one graphical display of the primary package. BRIEF DESCRIPTION OF DRAWINGS

[0031] The application is described with reference to the following figures:

[0032] Figure 1 is a top view of a passive RFID tag according to one embodiment;

[0033] Figure 2 is a side view schematic of a smart packaging system including a surgical instrument according to one embodiment;

[0034] Figure 3A is a diagram of a smart packaging system in electronic communication with a beacon and a HUB in an operating room according to one embodiment;

[0035] Figure 3B is a diagram of a supply chain for a smart packaging system according to one embodiment;

[0036] Figure 4 is a diagram of a supply chain for a smart packaging system including a surgical instrument and the kinds of information exchanged to and from the smart packaging system at various points along the supply chain according to one embodiment;

[0037] Figure 5 is a schematic of a serial number of a smart packaging system including a surgical instrument according to one embodiment;

[0038] Figure 6 is a schematic of a smart packaging system including a surgical instrument according to one embodiment;

[0039] Figure 7 is Figure 6 a schematic of a smart packaging system displaying a first set of information and a second set of information according to one embodiment;

[0040] Figure 8 is a schematic of a smart packaging system including a surgical instrument according to one embodiment;

[0041] Figure 9 is a graphical representation of the degradation of a transducer;

[0042] Figure 10 This is a schematic diagram of an intelligent packaging system containing surgical instruments according to one implementation scheme;

[0043] Figure 11 This is a perspective view of an intelligent packaging system based on an implementation plan;

[0044] Figure 12 yes Figure 11 A side view of an intelligent packaging system;

[0045] Figure 13 yes Figure 11 A side view of an intelligent packaging system;

[0046] Figure 14 This is a schematic diagram of an intelligent packaging system based on one implementation plan;

[0047] Figure 15 yes Figure 14 A schematic diagram of an intelligent packaging system;

[0048] Figure 16 This is a perspective view of an intelligent packaging system based on an implementation plan;

[0049] Figure 17 yes Figure 16 A side view of an intelligent packaging system;

[0050] Figure 18 yes Figure 16 A side view of an intelligent packaging system;

[0051] Figure 19 This is a schematic diagram of an intelligent packaging system based on one implementation plan;

[0052] Figure 20 It is based on an implementation plan. Figure 19 A side view of the mechanical sensors in the intelligent packaging system;

[0053] Figure 21 yes Figure 20 A side view of the mechanical sensor;

[0054] Figure 22 This is a perspective view of the mechanical sensors of an intelligent packaging system according to one implementation scheme;

[0055] Figure 23 yes Figure 22 A side view of the mechanical sensor;

[0056] Figure 24 This is a schematic diagram of sleeve gastric surgery;

[0057] Figure 25This is a schematic diagram of an intelligent packaging system based on one implementation plan;

[0058] Figure 26 yes Figure 25 A schematic diagram of the loading equipment for an intelligent packaging system;

[0059] Figure 27 yes Figure 26 A schematic diagram of the loading equipment; and

[0060] Figure 28 yes Figure 26 A schematic diagram of the loading equipment. Detailed Implementation

[0061] Certain exemplary embodiments will now be described to provide an overall understanding of the structure, function, manufacture, and principles of use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features illustrated or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention.

[0062] Furthermore, in this disclosure, components with similar names in various embodiments often have similar features, and therefore, in specific embodiments, not every feature of every component with a similar name is necessarily fully described. Additionally, the extent to which linear or circular dimensions are used in the description of the disclosed systems, devices, and methods is not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. Those skilled in the art will also understand that dimensions may not be precise values, but are considered approximately to be such values ​​due to any number of factors such as manufacturing tolerances and the sensitivity of measuring equipment. The dimensions and shapes of systems and devices and their components can depend at least on the dimensions and shapes of the components to be used with the systems and devices.

[0063] Intelligent surgical devices, systems, and methods are provided. The use of intelligent devices, systems, and methods typically enables the storage, sharing, and utilization of information throughout the supply chain, as well as aiding in the management of various systems, procedures, and aspects of healthcare facilities in which they are used. Information regarding various aspects of the supply chain and healthcare facilities can be recorded, monitored, and reviewed at any time to allow for real-time adjustments to these aspects. Furthermore, the analysis of compiled information can be used to minimize or avoid defects and problems associated with the supply chain and / or products flowing through it, as well as defects and problems associated with the coordination of surgical procedures and related equipment at the healthcare facility. Overall, intelligent devices, systems, and methods can improve the efficiency of the supply chain by managing information associated with products flowing through it, and they can improve the efficiency of healthcare facilities in which they are deployed for surgical procedures. While the specific types of intelligent devices, systems, and methods can vary, in some aspects, the packaging of the product itself can be used to consistently track, monitor, and record information associated with the product. Additionally, tracking devices (e.g., scanners, beacons, etc.) and / or centralized computer management systems can be used as part of intelligent systems and devices.

[0064] The use of smart devices, systems, and methods can also impact healthcare provider operations, such as during surgical procedures involving smart surgical devices. Information can be recorded, stored, monitored, and acted upon before, during, and after surgical procedures involving smart surgical devices to improve performance and minimize operational risks associated with smart surgical devices and future smart surgical devices.

[0065] Smart devices, including smart packaging systems, can act on the information they receive to provide recommendations, warnings, guidelines, and other information to various personnel associated with healthcare facilities. This information can encompass all aspects of routine procedures at the healthcare facility, including scheduling, logistics, surgical coordination, recommended procedures during specific surgical events, and more. Furthermore, the smart devices and smart packaging systems themselves can be designed to include various physical aspects intended to assist personnel in acting upon the information provided.

[0066] As indicated above, in some aspects, smart devices, systems, and methods may utilize smart packaging systems that can be included on an outer packaging containing one or more surgical instruments. In exemplary embodiments, the outer packaging may include a power source, one or more radio frequency identification (“RFID”) tags, and one or more sensors capable of measuring environmental aspects. The one or more RFID tags may take various forms and generally may include passive and active RFID tags. A passive RFID tag may include an RFID chip (or integrated circuit “IC”), an antenna, and a substrate. The IC includes a logic control unit, memory, and transceiver, which can be used for decoding, decryption, and error checking. The antenna is used to receive information (such as electronic data) from / to an external electronic system (e.g., a reader) having its own receiving and / or transmitting capabilities. The substrate holds the chip and antenna together and provides structure for the RFID tag. The passive RFID tag can receive power in the form of electromagnetic energy (e.g., wireless energy) transmitted by the reader and received by the antenna of the passive RFID tag. An example of a passive RFID tag 30 can be seen in Figure 1 In the middle, the passive RFID tag 2 includes an IC 4 electrically coupled to an antenna 6. The IC 4 and the antenna 6 are mounted on a substrate 8.

[0067] Active RFID tags may include components similar to those of passive RFID tags, with the addition of a separate power source (e.g., an integrated battery). Furthermore, in some variations, in addition to or in place of one or more RFID tags, other types of sensors or chips, such as near-field communication (NFC) sensors, may be used.

[0068] In some variations, the outer packaging may include additional memory storage devices and / or one or more additional processors to electronically communicate with one or more RFID tags in order to enhance the capabilities of the RFID tags. The smart packaging system may also include one or more of a display (such as an e-ink display, LCD display, touchscreen, or equivalent) and / or readable media (such as barcodes, QR codes, or equivalents). In some variations, the smart packaging system may include a data port, such as a USB port. Utilizing some or all of these features, the smart packaging system can typically acquire data from external sources (such as computers, computer networks) and data received from one or more of its sensors, and the smart packaging system can typically transmit data and / or present information to computers, computer networks, users, scanning devices, RFID readers, and any devices capable of receiving data from the features of the smart packaging system.

[0069] Surgical instruments and / or components contained within the outer packaging can vary in both form and function. In some variations, the entire surgical instrument can be a “smart” device, where the state and operation of the surgical instrument can be monitored, recorded, and altered at any time. For example, if the surgical instrument is an endoscopic cutter configured to cut into and suture tissue, the amount of torque applied by the instrument’s jaws can be monitored throughout the surgical procedure. If the hub determines that the surgeon has applied too much torque, a maximum torque limit can be wirelessly applied to the instrument in real time to prevent accidents. Furthermore, with such surgical instruments, if an accident does occur during operation involving the instrument, details surrounding the accident can be recorded and stored in the packaging’s memory or virtually stored on the hub. This information can then be used to determine the source of the accident and, for example, whether a recall should be issued for similarly positioned surgical instruments.

[0070] In other variations, a sub-section of the surgical instrument may be "intelligent," while other parts of the instrument may be electrically isolated from the "intelligent" sub-section, making it impossible for the state and operation of the surgical instrument to be monitored, recorded, or altered under any circumstances. For example, in the same endoscopic cutter described above, the jaw actuator subsystem may be "intelligent," but the articulated subsystem involving the axis of the endoscopic cutter may not be "intelligent." Even if the axis may be electronically articulated, it may not communicate electronically with the hub and / or outer packaging, and therefore it may be "hidden" and unmonitorable. These examples are merely illustrative, and more specific examples and variations are described below.

[0071] An example of the intelligent packaging system 10 is in Figure 2The illustrated smart packaging system 10 includes a package 12 containing a surgical instrument 14. The surgical instrument 14 can be any surgical instrument or surgical material, such as an endoscopic cutter as shown. The smart packaging system 10 may include a controller 13 configured to perform the functions of the smart packaging system 10. The controller 13 typically includes a control unit 13A, a logic unit 13B, and a memory 13C to implement the functionality of the controller 13. The smart packaging system 10 may also include an internal power source 15 (such as a battery) capable of providing power to the various components of the smart packaging system 10, including the controller 13 described herein. The package 12 may also include an RFID tag 16 configured to transmit and receive information from external sources. A serial number 18, which may or may not have encrypted data, may be located on the package 12, making it readable by a handler or computer system. The package 12 may also include a scannable or readable medium 20 (such as a QR code or barcode) and a display 22 (such as the previously mentioned type, e.g., an electronic ink display). Although not shown, the smart packaging system 10 may include additional surgical attachments, components, and elements that can be disposed in a separate compartment from the surgical instrument 14. The surgical attachments, components, and elements may be used in conjunction with or separately from the surgical instrument 14. These items may generally be referred to collectively as the contents of the smart packaging system 10. For example, the surgical instrument 14 may be a surgical suture device, and the contents of the smart packaging system 10 may include a staple cartridge compatible with the surgical suture device, which may be packaged separately from the surgical suture device within the smart packaging system 10, such as in a sub-compartment of the package 12. Reference will be made to the smart packaging system 10 and its components for illustrative purposes only.

[0072] The intelligent packaging system 10 can receive and present information relevant to individuals who interact with it throughout the lifecycle of the contained surgical instrument 14, as well as other surgical instruments and products that interface with the contained surgical instrument 14. The type of individuals and the relevance of the information will vary depending on the location of the surgical instrument 14 and the intelligent packaging system 10 within their lifecycle. After manufacturing in the factory, the surgical instrument 14 will be packaged and ready for delivery to ultimately end up at a healthcare facility, such as a hospital or surgical center, for use in surgery. To reach the hospital or surgical center, the intelligent packaging system 10 will interact with a range of individuals, including factory personnel, warehouse personnel, transportation personnel, customs personnel, and hospital personnel. At each stage of its journey, the intelligent packaging system 10 can receive and send relevant information to individuals. Although the intelligent packaging system 10 can store a variety of information, it can selectively provide only relevant information based on context.

[0073] Additionally, during its journey, the smart packaging system 10 can communicate with a central network, also known as a HUB 50, which monitors and coordinates information including and about the smart packaging system 10. The HUB 50 may exist along the smart packaging supply chain in the form of beacons 102 placed in critical locations such as hospital operating rooms (ORs). When the beacon 102 or other aspects of the HUB 50 detect the close proximity of the smart packaging system 10, information can be exchanged between the smart packaging system 10 and the HUB 50, and information can also be exchanged between the HUB 50 and various external networks.

[0074] Each beacon 102 may include a transceiver, a power supply, a processor, and local memory. The beacon 102 typically operates as an RFID reader that communicates electronically with a central network HUB 50. The beacon 102 can communicate via wired or wireless means, such as infrared communication, radio communication, Wi-Fi communication, Bluetooth, etc. The RFID reader can be a passive reader capable of receiving signals transmitted by active RFID tags, or an active reader capable of sending interrogator signals and receiving responses (such as authentication responses) from RFID tags. During operation, the beacon 102 may receive transmitted data from the smart packaging system 10, which characterizes information recorded by the smart packaging system 10 related to its history since manufacturing. The beacon 102 may then transmit the received data to the HUB 50, where the data can be stored, analyzed, and / or manipulated. The beacon 102 may also transmit information from the HUB 50 to nearby smart packaging systems 10.

[0075] exist Figure 3A and Figure 3B The image shows a non-limiting example of information exchange between beacon 102 (or typically HUB 50) and smart packaging system 10. Figure 3A The diagram depicts a general hierarchical structure between HUB 50, beacons 102 (represented individually as beacons 102A-102D), and one or more smart packaging systems 10 (represented individually as smart packaging systems 10A-10L). HUB 50 can communicate with beacons 102, which in turn can communicate with smart packaging systems 10. However, in some variations, smart packaging systems 10 can use their own transmit and receive capabilities to send information directly to and receive information directly from HUB 50. Figure 3BThe diagram illustrates an exemplary supply chain 100 and the different contexts in which a smart packaging system 10 can communicate with a hub 50 via one or more beacons 102. The interaction between the smart packaging system 10 and the hub 50 via beacons 102 can be significant depending on the context in which the smart packaging system 10 is situated. This context can change as the smart packaging system 10 moves through the supply chain from manufacturing to transportation to use.

[0076] Figure 3B and Figure 4 The supply chain 100 shown is a simplified version having key stages along the supply chain of a surgical device or system, such that the depiction of supply chain 100 is illustrative and exemplary, not mandatory or necessary. In reality, actual supply chains may include these stages in a different order, or they may include additional stages, replicate certain stages, or omit stages entirely.

[0077] The first depicted stage in the supply chain 100 is the assembly stage 120, which may include a beacon 102A to facilitate communication with the HUB 50. Assembly stage 120 represents the manufacture of the surgical instrument 14. Information exchanged at assembly stage 120 may include assembly information 112 relating to the surgical instrument 14 itself, including its performance metrics, manufacturing specifications, tolerances, safety, and usage information. Assembly information 112 may also include, for example, sub-assembly information relating to one or more sub-components compatible with the surgical instrument. Additionally, assembly information 112 may include the work-in-process (WIP) stage of the surgical instrument and the assembly date.

[0078] The second depicted stage in supply chain 100 is warehouse stage 110, which may include beacon 102B. Warehouse stage 110 represents the storage of the smart packaging system 10 prior to shipment. Information exchanged at warehouse stage 110 may include warehouse information 122, such as batch number, inventory number and count, FIFO date and shelf location, enabling the smart packaging system 10 to be tracked and located within the warehouse itself.

[0079] The third stage depicted in supply chain 100 is transportation stage 130, which may include beacon 102C. Transportation stage 130 represents the transportation of the smart packaging system 10 from the warehouse to its final destination at the distribution center. Information exchanged at transportation stage 130 may include transportation information 132, such as sender address, truck ID, recipient address, disposal instructions, and customs data.

[0080] Following the third delineation phase and before ending at the distribution center, the smart packaging system 10 may optionally be shipped across geopolitical boundaries, including to international locations. The fourth delineation phase is the customs phase 140, which may include beacons 102D and indicates those events when the smart packaging system 10 must cross geopolitical boundaries. Information exchanged during the customs phase may include customs information 142, such as declared value, contents, and documentation.

[0081] If the smart packaging system 10 is not an international shipment, it can proceed directly from the transport stage 130 to the distribution stage 150. If the smart packaging system 10 is an international shipment, it can proceed to the distribution stage 150 after the customs stage 140. The distribution stage 150 represents a warehouse or distribution center, which may include a beacon 102E that receives the smart packaging system before delivering it to its final destination, such as a hospital. Information exchanged at the distribution stage 150 may include distribution information 152, such as shelf location, quantity of a specific stock-holding unit (SKU) in inventory, model number, FIFO date, delivery time, and due date.

[0082] The sixth depicted stage in supply chain 100 is local transportation stage 160, which may include beacon 102F. Local transportation stage 160 represents the transportation required to get the smart packaging system 10 to its final destination. Information exchanged at local transportation stage 160 may include local transportation information 162, such as hospital or surgical center location, truck number, delivery time, disposal instructions, and invoice number. During local transportation, if any aspect of the smart packaging system has been recalled, the exchanged information may include, for example, a return address, and the smart packaging system 10 may be recalled and returned for evaluation and / or disposal.

[0083] The seventh depicted stage in supply chain 100 is the hospital stage 170, which may include one or more beacons 102G. Hospital stage 170 represents a hospital or surgical center where surgical instruments 14 will be used during surgical procedures. If local transport is able to deliver the smart packaging system 10, it will deliver the smart packaging system 10 to the hospital, where it can be stored until needed. Information exchanged at the hospital stage may include hospital information 172A, such as the operating room (OR) number, storage location, and item count. If local transport is unable to deliver the smart packaging system 10, such as for recall purposes, the smart packaging system 10 may exchange recall information 172B, such as the return address of the smart packaging system, and warnings with information related to the recall.

[0084] The eighth depiction stage in the supply chain 100 is OR stage 180, which may include beacon 102H. OR stage 180 indicates the operating room where surgical instruments 14, which are part of the smart packaging system 10, will be used. The information exchanged at OR stage 180 may include OR information 182, such as OR room number, surgical kit details, device number in the total equipment required for the operation, surgeon information, and patient information.

[0085] The information described at each stage of the supply chain 100 is merely exemplary and does not represent an exhaustive list of information that can be exchanged at the beginning of a given stage.

[0086] Generally, tracking surgical instruments is important for identifying various factors related to the instruments themselves. These factors may include prior historical events, such as shipping or sterilization dates, which can affect the instrument's operating parameters. Additionally, these factors may include the instrument's location data, as well as the location of any corresponding accessories that can be used with the instrument. Examples of corresponding accessories may include staples for sutures. Traditional tracking of this information is disjointed, and the continuous data collection stream does not flow along a single path from manufacturer to end user, and in some cases, returns to the manufacturer. This can lead to disjointed and incorrect information being passed from one stage of the supply chain to another without correction. This can result in increased errors and inefficiencies for end users when performing surgical procedures.

[0087] Therefore, it is beneficial to include a single data path that travels along the supply chain with the device. However, while some devices include power supplies and transceivers and can send and receive data by making some changes to their systems, many devices may be analog and do not include any form of data transmission. To ensure that any relevant data is recorded and stored, the packaging where the device is stored and transported may include transceivers and memory to record and store data related to the device stored in the packaging. In conjunction with the HUB system described above, the packaging can record and edit metadata for the device and can also communicate with other nearby packaging to guide users to the appropriate operating parameters and corresponding devices and accessories.

[0088] As described above, the data can be used to relay additional information related to the device contained within the packaging to the user. One form of data storage can be a serial number containing a large amount of information. Individual readable data bits contained within the smart packaging can have multiple layers embedded therein, each layer generating different information, and can transmit additional digital information to and from the packaging for use in deep data or meta-data transmission within the product identifier.

[0089] An example of this situation can be found in Figure 5As seen in the document, the cryptographic logic combination of static identifiers and functions is used to allow the serial number placed on the packaging to store additional data about the device and the packaging itself. The increased data density of the serial number's characters serves as a unique product identifier while also conveying functional aspects of the product to aid in establishing communication or setup between the digital device and the HUB 50. The serial number placed on the packaging can use a combination of alphanumeric characters and symbols, which stores more information in a denser and more secure form, allowing the packaging and product ID to serve multiple combined uses. Furthermore, the use of hash encryption can multiply the number of combinations by defining the hash encryption key using several first characters. A hash function is a mathematical function that transforms a numerical input value into another compressed numerical value. The input to a hash function can be of arbitrary length, while the length of its output is always fixed. Hash functions, as described herein, can be used as encryption / decryption components with known keys. Hash functions can be used to encrypt and compress data stored on smart packaging by using mathematical equations and cryptography to reduce the size of data fields, thereby embedding more information. For example, the packaging and product ID can have all metadata stored within the serial number and device, and can include a key that can be removed using a hash function, which decompresses and decrypts the serial number. The remaining characters in the serial number can be reused to create multiples of the main number, significantly increasing the number of unique identifiers. For example, a serial number under a hash decryption can define the product's operational constants. Under a separate hash decryption, the serial number can define component and partial processability. Additionally, all characters and symbols in the serial number in the native format provide the HUB 50 with a unique identifier for the package itself. In this way, product data, its metadata, and its unique identifier can all be embedded within the serial number itself, allowing the serial number to inform the user what equipment is in the package and how to use all equipment simultaneously. Due to the strength of the data within the serial number, this can also result in non-contiguous serial numbers from one product package to the next.

[0090] like Figure 5As shown, serial number 1000 may be located on packaging, such as smart packaging system 10. Serial number 1000 may include authentication portion 1002, multi-layer portion 1004, key portion 1006, and unit serial number portion 1008. Key portion 1006 can be used to perform a hash algorithm to decrypt the other portions of serial number 1000 in order to derive additional data from unit serial number portion 1008. For example, using key portion 1006, the complete serial number of the package can be derived from unit serial number portion 1008. Additionally, the package can be authenticated by deriving an authentication code from authentication portion 1002. For example, although the serial numbers of different packages may be different, the decryption password or private key may be the same on the packaging of a given product. Therefore, an authentication code can be derived from authentication portion 1002 using a universal decryption password or private key to extract both the serial number and any embedded metadata (e.g., calibration data) within the serial number on the device in question. Multi-layer portion 1004 may also be derived to provide additional information, such as the assembly date of the device within the package.

[0091] In addition to embedding product data within the packaging, the serial number 1000 can also embed HUB 50 commands and triggers. When the serial number is scanned into the HUB 50, a portion of the serial number can be configured to update the HUB 50 operating code or trigger an update or data retrieval of the HUB 50 when expected to interconnect with a new system. Furthermore, the serial number can be used as a means to update operating parameters of control algorithms for the operation of actuators in digital systems. These operating parameters may include subsystem adjustment parameters, product capabilities, and device compatibility between systems. The serial number can also be used as a return tag or ID number for traceability and for addressing force, operational, and / or problem queries encountered by the device.

[0092] Metadata stored in the packaging may also relate to the product's initial calibration, assembly, manufacturing, packaging, or sterilization. Any data affecting component performance can be linked to the packaging serial number. Documentation generated from timing, operator, line, environmental, or storage conditions of components or parts that may affect overall device performance can be attached to the master serial number, batch stamp, or production data in context and recorded as historical data points. Examples of stored data types may include the assembly line ID or user ID for product assembly, as well as environmental parameters during manufacturing. Manufacturing or sterilization can affect operability, the irradiation cycle of sterilization, as irradiation degrades the properties of plastics, and excessive sterilization processes can impair performance and durability. Additionally, humidity exposure during device manufacturing and shipping can affect device operation.

[0093] In some respects, data stored in the package can be retrieved by the HUB 50 via a transceiver or by a smart device that establishes a channel with the transceiver in the package. For example... Figure 6As depicted, package 1020 may include a transceiver 1022 and an instrument 1025 disposed within the package. The transceiver may be an RFID tag that can be read by an external device to provide information about the package or the instrument therein. Additionally, package 1020 may include scannable codes 1024 and 1028 and a serial number 1000. Scannable codes 1024 and 1028 can be scanned by an optical sensor to access additional information about package 1020 and instrument 1026 stored in a cloud database. Scannable code 1026 may also be disposed on the instrument itself and can be scanned through the transparent plastic of package 1020.

[0094] When packaging is configured to store the data described above, the packaging itself can modify the metadata stored within it (as described above). This modification can occur as the packaging moves through the supply chain. In one implementation, documentation of any modifications to the metadata can be recorded by the packaging to optimize the performance of the device within it. Examples of recordable historical events include multiple passes through sterilization processes or multiple passes through the factory. This is due to device deterioration under multiple sterilization processes or usage conditions. Therefore, when retrieving the metadata stored in the packaging, the metadata can provide the user with adjusted operating parameters to optimize device performance based on the device's own history.

[0095] For instruments such as sutures, the chamber can be rebuilt and reloaded. The suture and chamber itself may not be aware that the chamber is being reloaded, as the instrument itself does not contain any sensors or electronics to record such events. However, the packaging containing the instrument can record these processes. For example, a given suture's serial number can be assigned or reassigned as part of the suture loading process. The reassigned serial number may include metadata related to the loading process (e.g., which machine is being loaded, when the machine was loaded, suture size and shape, etc.). This reassigned serial number can be printed on a label and / or the chamber. In some implementations, the reassigned serial number may simply include new data added to the end of the previous serial number, indicating that it has been reloaded, along with metadata for that new data. Additionally, for harmonic devices and transducers, similar to those described above, the number of pre-burn-in attempts can be recorded to allow the instrument to identify how many times it has been used, including during manufacturing and testing. Even further, as an example, robotic arms and tools can be reprocessed, which may lead to degradation. Storing and tracking metadata in their packaging allows for a complete picture of the product's usage data. This data can then be used to generate updated operating parameters, which can be provided to users at a later stage of the supply chain process, as described in detail below.

[0096] As mentioned above, in addition to the serial number on the packaging, the packaging may also include a scannable code to access additional information stored in a cloud database. For example... Figure 7 As depicted, once scanned on a smart device, window 1030 appears on the device's display. This window may contain information about the packaging 1020 and the device, such as assembler, assembly date, circuit number, calibration parameters, packaging date, expiration date, sterilization date, batch number, and serial number. However, as mentioned above, the metadata of the packaging 1020 can be modified based on the processes the device has undergone. For example, in some cases, the device may be recycled for later use, and if the device is reused, window 1030 will show a second sterilization date, while also showing the first sterilization date. In this way, the user and system 10 can know that the plastic contained in the device may have deteriorated due to radiation exposure during multiple sterilization processes.

[0097] As described above, the serial number on the packaging can be used to store high-density data using encryption. In some implementations, the serial number may also include a scannable QR code or barcode to pull even more stored data from a remote data source, where the scannable code can be changed by the HUB 50 to display different codes that pull different sets of information when scanned as the packaging moves through the supply chain. Combined with cloud database access, the scannable code can be used to access the device's historical and operational data. Scanning methods may include manual scanning, active wireless transmission via a capable device, direct detection, geofencing, BLE beacons, and through surgical procedures. The packaging or device housing / exterior may contain a single printed code that can be scanned by a smartphone or scanner attached to the HUB 50. When scanned, the code opens a portal that allows the user to view quality information or report quality information to the cloud database. Real-time recall warnings can also be stored on the cloud database. These warnings are issued by the manufacturer to prevent recalled devices from being used in surgical procedures. Additionally, the cloud database can be used to record complaints received from healthcare professionals regarding devices used during surgical procedures.

[0098] Users can access a cloud or hub database by using a scannable code on the packaging. Data stored in the cloud database can include device characteristics and manufacturing history tracking of the instrument. For example, harmonic device data (i.e., frequency, impedance, capacitance, etc.) can be recorded in the cloud database. Additionally, historical data points can include motor and electrical characteristics, pin height, and friction coefficients in the moving shaft, allowing algorithms to be adjusted based on this recorded device data to optimize the device. An example of optimization could be a suture compartment recommendation based on device assembly data of the sutures selected by the surgeon for the surgical procedure.

[0099] In one implementation, the expiration status of an instrument can be passively determined by placing a printed barcode on the axis or jaws of a suture or power device within the laparoscopic field of view. Video imaging from the laparoscope can be used to check for expiration in real time during surgery and then alert the user. This type of monitoring can function in several ways, such as relying on specific visual indicators present on the object to continuously track it. For example, the packaging of a surgical needle may include a specific pattern or scannable code associated with the expiration date. The area of ​​this specific pattern can be visually monitored, even from multiple angles, relying on a camera included in the system. When the pattern is detected, the expiration date of the instrument object can be checked in real time.

[0100] In addition to a single scannable code located on the packaging (which can be scanned to provide the user with additional information about the instruments within the package), multiple scannable codes can be used to determine the compatibility of sub-components contained in separate packages. In some implementations, the packaging code is accessible on the outside of the package when sealed, allowing information to be communicated and indicated before opening the package to maintain sterility in the event that different options are selected once compatibility has been checked. The first code of the combined sub-device prompts the user to scan the code of the compatible sub-device, allowing comparison between the two devices. If compatibility is not determined after scanning the codes, the user can override the request if necessary. If a non-certified device combination is detected (e.g., non-certified reloading on a certified suture, or prevention of the use of reprocessed tips on a certified handpiece, or vice versa), the compatibility check can prevent use.

[0101] Bluetooth Low Energy (“BLE”) beacons can be employed for another class of technologies used for object detection. BLE beacons can repeatedly transmit signals detectable by other devices, such as via radio signals. Signals may include encoded alphanumeric messages transmitted at short intervals, which can be used for specific transmissions and to encode specific messages and data. BLE beacons can be used to register products currently located in the operating room, and they can also be used to communicate changes in the status of detected objects and products. Additionally, multiple communication devices can be disruptive and cause interference between signals transmitted by those communication devices. Various techniques can be employed to minimize disruption. For example, the smart packaging system 10 may include one or more methods for varying the bandwidth of its transmissions, as well as various communication methods. Some communication methods may rely on the internal power supply 15 of the smart packaging system 10. Some methods may obtain power from external sources, such as external electromagnetic fields, such as using near-field communication (NFC), or using external wired connections, such as via a USB cable.

[0102] The smart packaging system 10 can rely on RFID tags to communicate with other devices, but if RFID becomes unavailable, the smart packaging system can rely on auxiliary communication methods. For example, NFC and RFID can be combined, allowing power to be obtained from an external field using RFID and broadcasting only when the system is prompted. Using NFC, an antenna can be used, and other systems (such as Wi-Fi and battery systems) can be deactivated to save power when activated.

[0103] In addition to having users physically scan the code present on the packaging, both active and passive compatibility checks can be included within the packaging. For example... Figure 8 As depicted, package 1052, having an active electronic chip 1053 (powered by a battery located within the package), and another package 1050, having a passive electronic chip 1054 (e.g., an RFID tag), can actively communicate with each other to indicate device compatibility between instrument 1062 and accessory 1064 to the user. In this configuration, the active chip 1053 and the passive chip 1054 act as transceivers that, when brought close together, can communicate with surrounding sub-component packages to automatically check compatibility between sub-components. Additionally, one of the packages (e.g., the package containing the power supply) may include a feedback device in the form of a speaker 1056 or LEDs 1058, 1060 of different colors to provide feedback to the user regarding compatibility. When the two packages 1050, 1052 are brought close together, the feedback device can be activated to warn the user of sub-component compatibility.

[0104] In one implementation, both packages may include a passive chip that the user must scan to determine compatibility between the sub-components. Scanning of the passive chip can be performed in a minimally invasive manner for surgical procedures. For example, the chip in each package can be automatically scanned via a central transceiver (such as HUB 50) upon entry into the operating room. Active global geofencing is another class of technology for object monitoring. Active global geofencing can be assigned to specific geophysical locations and all objects passing through the fence can be tracked. Systems can be combined to monitor objects passing through the fence, such that the combination of systems can detect objects within the combined device or as separate components. Based on this determination, system 10 then provides visual and / or audible feedback regarding device compatibility. Additionally, optical sensors (such as cameras on smart devices) can be used to photograph the package or scan scannable codes or RFID tags with a smart device to determine compatibility. Additional types of technologies that can be used with the package may include radio frequency (RF), high frequency (HF), ultra-high frequency (UHF), and near field communication (NFC), with passive readout ranges up to approximately 25 m and active readout ranges up to approximately 100 m.

[0105] In addition to determining compatibility between sub-components, system 10 may provide a list of additional compatible devices to optimize instrument operation. If system 10 determines that a selected sub-component, while potentially compatible, is not the optimal choice for a particular procedure, system 10 may determine alternative sub-components. Furthermore, the list of compatible components may include trade-offs between the speed, cost, and complexity (e.g., RF contrast endoscope cutter) of different compatible sub-components. Examples of compatibility comparison types for sutures may include compatibility with reload staple material compared to subsequent reload, compatibility between shaft and handle, compatibility between handle and adapter, compatibility between shaft and adapter, or compatibility with support. Additionally, examples of compatibility comparison types for energy devices may include harmonic energy device blades and handpieces, energy RF devices or blades and handpieces, energy devices and generators, and return pads and generators.

[0106] In addition to determining compatibility between selected sub-components, system 10 may provide the user with an indicator for selecting compatible sub-components. System 10 may include a smart storage device that highlights product codes compatible with the retrieved instruments / sub-components. The smart storage device may utilize feedback devices already present in the packaging of the sub-components. For example, each package may have an LED that illuminates in response to a wireless signal transmitted via a smart device when searching for a specific compatible part (e.g., selecting reloading of a specific suture on a telephone application, and then all different types of staple cartridges compatible with that suture can be reloaded on a shelf in the storage area).

[0107] In one embodiment, instead of using a smart device, the suture packaging may also include a transceiver. When the user activates the transceiver via a switch or button, all reloaded packages compatible and wirelessly connected to system 10 light up. In one embodiment, augmented reality can be used to locate compatible packages using a headset or smart device application that highlights the product code being searched or a product code compatible with the product pulled for surgical use.

[0108] Although it has been stated above that the packaging may include a chip for storing data, the chip may alternatively reside on the instrument itself and is not attached to the packaging. For example, a staple retainer may include an RFID tag that remains attached to the stapler during use.

[0109] In addition to checking compatibility, System 10 can also be used to determine if a device has been repackaged. System 10 reads the serial number or scannable code on the packaging and compares it to a database containing all matching combinations of a specific device and its corresponding packaging. If the device is placed in new packaging, the code will not match, and System 10 can provide the customer with visual or audio feedback indicating that the device has been repackaged. This also allows manufacturers to reprocess the device and update the database with the new packaging code.

[0110] Based on data stored in the packaging and accessible via a cloud database, System 10 can provide users with recommendations to improve operational efficiency. Recommendations can be made based on the scanned instruments within the packaging. Information can be based on cloud data available from a large number of users, or it can be customized to a dataset from only that single user, allowing recommendations to be tailored to that individual's experience and skill level. For example, System 10 can recommend reloading or products based on a specific surgeon's historical usage, specialty, surgery, and / or patient demographics. Additionally, System 10 can include virtual companion recommendations based on surgery, patient condition, and / or surgeon preferences (based on the recommended content or content used by the surgeon in similar past experiences). Furthermore, System 10 can provide statistics corresponding to content used by other surgeons during similar procedures. Algorithms can be used to provide surgeons with product recommendations or common practices (e.g., 30% of cases begin with a green reloading on the sleeve).

[0111] In one implementation, system 10 may notify the user whether they are using the product in a manner inconsistent with typical use (e.g., incorrect reloading during the first sleeve firing). Additionally, system 10 may determine whether the energy device is operating outside of recommended operating parameters, as the energy device is scanned earlier during surgery. Furthermore, system 10 may provide recommendations for axis length based on patient characteristics or port placement, particularly in robotic surgery where port placement and anatomical location are known.

[0112] As described above, system 10 is operable to provide additional data corresponding to the instrument selected for surgical procedures. In addition to determining capabilities, system 10 can also determine optimized operating parameters based on the instrument's historical use. Specifically, system 10 can provide optimized operating parameters based on intended use to initiate optimized device customization. For example, a surgical stapler may have customized operating parameters due to the use of an unused chamber instead of a reloaded chamber, where system 10 can enable the device to adapt to the degradation of the reloaded chamber. In a reloaded chamber, the degradation of the slider with use can affect staple height, and thus, in conjunction with waiting time or speed, the impact on staple height can be minimized. For an endoscopic cutter, system 10 can determine a customized device calibration that detects wear on the endoscopic cutter to allow system 10 to instruct motor operation differently, so as to provide the user with a consistent device response to different tissues, even across variable construct instruments.

[0113] Additionally, System 10 offers energy device customization, where transducer customization details are provided to the generator / HUB 50 to update the control program. This customization is due to the fact that each transducer has slightly different harmonic and electronic aspects due to its construction and prior use, which are recorded within the transducer as calibration and operating parameters. These parameters allow the generator to adjust its drive parameters to customize the performance of each individual combination.

[0114] Examples of adjustable operating parameters include operating temperature or impedance / frequency data as a means of limiting or calibrating thermal effects. Additionally, the blade construction and specific dimensions / tolerances / connections of the blade and transducer can be provided to system 10 to update the control program of the endoscopic cutter. Furthermore, initial clamping force measurements can be used to update the control program.

[0115] System 10 can also be used to compare expected measurements with actual measurements. For example, a transducer has a specific number of cycles that it can be energized. The transducer has internal electronics that count each reuse, where reuse is counted after a predetermined amount of energization time has elapsed, such that simply inserting and immediately removing the transducer does not trigger the reuse count. When the transducer is in use, system 10 can capture the total power passing through system 10 and record frequency, impedance, capacitance, phase margin, and power displacement.

[0116] Once a transducer is in use, it must be sterilized. However, improper sterilization energy (such as non-OEM sterilization) can degrade the internal components of the transducer, thus using up a portion of the product's "full lifespan." To prevent improper sterilization, a UPC code can be placed on the transducer and logged in a cloud database. This can be cross-referenced with the generator used with the transducer. For example, if the generator interacts with the transducer 26 times, but the cloud database only records a single use of the transducer, the transducer can be disabled due to unknown degradation of internal components, even though the HUB 50 does not allow the generator to supply power to the transducer.

[0117] Additionally, the packaging may include a memory card for expanding parameters to ensure proper sterilization. To enable users to receive credit for reusable transducers, the memory card can be inserted into the generator's USB port, which will periodically mark the memory card and assign generator credit to the user for their next transducer. The memory card can be returned to the manufacturer in a return package. Furthermore, system 10 can track the last-use output data of the transducer recorded by the transducer, and system 10 can disable the transducer if the last recorded use of the transducer differs from the last use stored in the cloud.

[0118] In one implementation, the generator may cross-check the serial numbers of transducers attempting to be used in conjunction with the generator from a list of approved serial numbers stored in a cloud database. Each time a transducer is used with the generator, the usage cycle is tracked and added to the cloud database. Additional data recorded by the generator and uploaded to the database may include the transducer serial number, device serial number, frequency, impedance, displacement, capacitance, cutoff amount, mode, and power level.

[0119] As mentioned above, product sterilization can lead to degradation. To determine whether a component has been sterilized, the transducer's phase margin can be tracked over time, such as... Figure 9 As depicted. Phase margin is an aspect of ultrasonic transducers that defines the device's ability to find and maintain the natural frequencies of the waveguide and blade during use. As transducers age, the phase margin shifts. In this case, the generator can write information from its last use into the data in the shipping mark to allow for remanufacturing of the transducer for the next use or recovery at the factory. As shown in graph 1090, the phase margin of the transducer decreases after each sterilization. If the part is sent back to the manufacturer, the decrease in phase margin can be seen during testing and compared with previously recorded data and / or requirements / limitations from that part. Additionally, the phase margin of the transducer can be determined by monitoring the transducer's temperature during the sterilization procedure in order to track and adjust the transducer's lifespan accordingly.

[0120] When the device is connected to the generator, the phase margin is recorded to a cloud database. After each sterilization cycle, the phase margin in the transducer decreases. If the transducer is retuned to the manufacturer, the phase margin parameter can be updated in the database after reusability testing. If a transducer is inserted into the generator and the recorded phase margin is not within the expected threshold range, the generator will not supply power to the device, as this is evidence of non-OEM sterilization.

[0121] In one embodiment, to enable communication between the packaging and system 10, the packaging may include a multi-stage power supply to achieve variable data communication capabilities via at least two transceivers having high and low power levels. The power supply may be included in the packaging circuitry to enable interaction between the transceivers and system 10. Two wireless communication arrays may be located within the same packaging. Communication of the data portion may be achieved via a first system transceiver (such as an RFID tag) and a second, more complex transceiver connected to the power supply. In some embodiments, only one transceiver may be active at a time. The power supply contained within the packaging may be a wireless receiver for transmitting energy to the packaging, or the power supply may be in the form of a battery. In some embodiments, the power supply is rechargeable.

[0122] To determine what type of instrument is contained within the packaging, physical landmarks within the packaging can be used for device identification. The type of physical landmark may include specific patterns at certain locations relating to the packaging or the instrument itself. For example, a suture may include a scannable pattern that can be determined by a nearby camera (such as an operating room or laparoscope). Using measured physical landmarks, calibration, or predefined device lengths can help system 10 determine the type of device / packaging. In some embodiments, a discrete set of predefined points can be used to determine the location of the instrument using optical sensors (such as cameras in an operating room). In some embodiments, multiple cameras may work together to observe the packaging and the instrument to determine the type of instrument used.

[0123] In some embodiments, using the techniques described herein to track the position of instruments can help prevent accidental activation of the instruments. For example, system 10 can determine that a harmonic device is placed on a table in the operating room. This can be achieved, for example, by using an accelerometer in the device. Alternatively, when using a camera sensor, the camera sensor can be configured to track the position and movement of the device. In this case, if the movement of the device stops for a predetermined amount of time, as sensed by the camera sensor, the tracking algorithm can be configured to determine that the device has been placed. Therefore, if a trigger is accidentally activated while the device is on the table, the device will not be activated because it is not being held. Additionally, since system 10 can use a camera (or other methods) to determine the position of the device, the graphical user interface (GUI) or interface displayed on a screen displaying the surgical site, such as a camera on a laparoscope, can be adjusted based on the size of the device. In some embodiments, vision system 10 identifies the instrument and / or packaging serial number to correctly configure the GUI.

[0124] In addition to using physical landmarks to track instruments, the package may include calibrations and parameters for local interpretation of digital raw data feeds from the devices within the package. For example, the package may determine whether a trigger on a surgical instrument has been fully depressed. The trigger may be continuously tracked throughout its entire range of motion (e.g., via a Hall effect sensor rather than a contact switch), which can be used to scale the output range to the mechanical limits of the actual trigger motion (including tolerance stacking, meaning slight differences between different devices throughout the range of motion). This recorded data can then be used to adjust the energy output / energization via a threshold of a program-selected transition point.

[0125] In some implementations, system 10 may authenticate packaging and instruments based on received input. The authentication process may include system 10 generating a unique, randomized serial number using an algorithm based on the current date. If an unidentifiable / inauthentic serial number is present on the packaging, system 10 will provide a warning. In one implementation, if multiple cartridges in a row have consecutive serial numbers, system 10 will verify the authenticity of the cartridge if the serial number of one of the cartridges is abnormal. If it is determined that a "counterfeit cartridge" is currently in use and unavailable—for example, a cartridge is identified as a 45mm cartridge but is instead a 60mm cartridge—the instrument will not fire. However, if it is determined that a generic cartridge can be used with the instrument, a generic operating mode can be activated on the instrument to enable use with the generic cartridge.

[0126] As described above, package 1200 may include a transceiver and a power supply. Figure 10In the depicted embodiment, package 1200 may include a housing 1202, a sterile medical device 1204, and a power source 1206, wherein the package uses the included power source to operate control circuitry 1208 associated with the package to sense and indicate the state of package 1200 or the device 1204 contained within the package. The power source 1206 may be a primary battery or a rechargeable battery. The battery itself may have a dedicated compartment 1207 within the tray of package 1200, and compartment 1207 is equipped with conductive contacts 1209 to draw energy from the battery to power the control circuitry 1208 associated with package 1200. Control circuitry 1208 may include a timer 1201, a sensor 1212, a processor 1214, and a transceiver 1216. Sensor 1212 may also be arranged within the package to measure external factors that may affect the device within the package. The package may be continuously powered, intermittently sensed, or powered on demand.

[0127] With the packaging continuously powered, the battery compartment circuitry remains in constant contact with the battery and powers sensors without interruption to track sensors or transceivers that record shipping or storage events throughout the product's lifespan. Examples include temperature history, countdown timers for shelf-life tracking, and accelerometers for vibration / shock levels.

[0128] On one hand, when the packaging is intermittently powered by sensing, a duty cycle timer inside the packaging activates the components only for a portion of the cycle. For example, to conserve battery life, a portion of the packaging tracking circuitry will activate the sensors inside the packaging for 5 minutes every hour to track unexpected, sudden events (such as temperature). For more sudden events, such as those powering an accelerometer, the circuitry can be activated more frequently, or it can be activated by a change in state, where it uses external movement of the packaging to activate the sensors themselves.

[0129] When the packaging is powered on demand, the connection between the battery and the packaging circuitry occurs only at a meaningful time when activated by the user. This can be a switch or electronic signal used to initiate transmission and tracking. This conserves battery capacity and can be used for specific on-demand indicators (such as displaying battery level) or for time-sensitive activities (such as connecting to the HUB 50 for surgery). When activated, the packaging can actively seek out the HUB 50 system and automatically register the device with the hub tracking system to identify the device type, verify expiration status, and check compatibility with other associated accessories (such as compatibility between sutures and pods). Electronic activation can occur via a passive tag (RFID or NFC) within the packaging, held at a short distance from the battery and antenna. When the tag is activated, the user physically alters the packaging configuration to transmit current through the circuitry to make the tag emit an audible signal, which then wirelessly transmits a signal containing packaging or device information from the packaging outwards to the HUB 50 or other receiver systems.

[0130] An example of activating the power supply to the package could be in the form of a magnetic switch. For example... Figure 11 to Figure 15 As illustrated, the magnetic element within the aseptic packaging can be configured to slide between a first configuration and a second configuration. The delivery system 1300 may include a delivery container 1302 containing multiple packages 1308. Packages 1308 are stacked on top of each other such that when package 1308 is removed from the lower compartment 1304, the next package slides down into compartment 1034. Compartment 1304 can be accessed by opening door 1306. When needed, a user places magnet 1310 close to the outside of package 1308 and slides the element to change configuration and connect a battery. Figure 14 As shown, package 1038 may include an instrument compartment 1354, a battery compartment 1356, a battery 1358 with leads 1359, and a control circuit 1360. A magnet 1310 may be embedded in a door 1306 and positioned such that the battery 1358 and leads 1359 slide toward the control circuit 1360 to complete the circuitry when package 1308 is removed from transport container 1302. In one embodiment, a spring-loaded switch may be held by a magnet in the storage container, and then the magnet stops holding the circuit open when the package is removed from the storage container. In one aspect, the spring is made from a folded portion of the package itself.

[0131] In one embodiment, the packaging has a dedicated battery separate from the device arranged within the packaging, wherein the dedicated battery is used solely to power the packaging. In one aspect, the battery compartment may contain an indicator for the battery's charge level, such as a small LED indicating that there is sufficient current remaining in the dedicated battery to transmit information.

[0132] In one embodiment, the dedicated battery packaging may include a pull tab to protect the battery from depletion when not needed, such as during shipment. The pull tab remains within a sterile barrier but is accessed by manipulating the outer surface to allow coverage of the battery contacts until the user removes the pull tab.

[0133] like Figure 16 to Figure 18 As depicted, in another embodiment, the packaging system 1400 may include a package 1402. Bubbles 1404 may be formed in the package 1402. A portion of the blister pack of the package 1402 is formed as a bubble 1404 that allows it to be popped in or out. Figure 17 The first configuration depicted (where bubble 1404 pops out) allows battery 1406 to be disconnected from circuit lead 1408. Figure 18In the depicted press-fit second configuration, bubble 1404 is pressed into package 1402, resulting in a physical connection between battery 1406 and lead 1408, thereby allowing the circuitry within package 1402 to be powered. The bubble position can be reversible to connect or disconnect battery 1406 (e.g., if unintentionally pressed or deactivated for signal transmission). In one embodiment, the packaged battery can be a rechargeable battery capable of being rapidly charged to the level required for signal transmission. Charging can be achieved by placing the package on a wireless battery charger in the operating room using wireless charging technology as part of the standard procedure for bringing the device into the operating room.

[0134] As described above, the packaging may contain batteries to power the transceiver and sensors. However, batteries directly exposed to radiation during the sterilization process may be damaged. In one embodiment, the packaging includes a separate connection and reactive power source, electrically isolated within a sub-packaging compartment. This separate power source supplies power to the transceiver and sensors but can be removed during the sterilization process.

[0135] In one implementation, the power supply can be reconnectable in a reusable manner. For example, two physical entities that need to be reconnected within the sterile boundary of the packaging itself (such as loose batteries and battery plugs in different compartments) can be reconnected by manipulating the outside of the packaging. In one implementation, inserting the primary packaging into the secondary packaging connects the battery and its corresponding leads together to provide power without compromising sterility. The action of combining the primary and secondary packaging physically connects the packaging and mechanically completes the circuitry. The user can push them together and then slide them to disconnect the plastic area, which will open the connector to allow the circuitry to complete.

[0136] In one embodiment, the power supply can be reconnected reactively. For example, all the wires can be constructed into the packaging wall, including a plastic pull tab, which acts as a barrier to interrupt the electrical connection between the power supply and the sensor until the pull tab is removed. During gamma radiation, a current is created within the conductive components via the radiation, which can damage sensitive electrical components within the circuit. Therefore, the circuit is configured to remain disconnected while the packaging is receiving gamma radiation. Alternatively, in one embodiment, instead of the plastic pull tab, an acid container can be arranged between the two barriers such that if the container is crushed, the chemical acid dissolves the barriers and melts the circuit.

[0137] While packaging serves many primary purposes (such as compatibility and certification inspection processes as outlined above), it can also be multipurpose packaging with secondary uses independent of its primary purpose. The primary purpose of packaging may be product identification. In one embodiment, secondary uses of packaging may include reusability prevention and detection, equipment disassembly assistance, equipment return, equipment cleaning (such as including basins or chemicals to clean harmonic blades during user use or in post-procedure procedures before return), rapid troubleshooting, and / or assembly or disassembly guidance. For example, assembly or disassembly guidance may include a separate compartment with text / images indicating where parts need to be placed for return, and may include replaceable parts with instructions on how to replace / install those parts.

[0138] In one implementation, a single scanable code may be included on both the device and the packaging. The single code is printed on two different substrates, each containing an incomplete portion. The first portion may be printed on a transparent or see-through substrate. A positional reference may also be present to orient substrate 1 to substrate 2 below it. Substrate 2 contains missing information about the single code, such that when scanned, the complete code is provided only if both are present and correctly oriented. The code is required to activate or track the device system. Without the code, the system does not register. Each scanable static code may be arranged on at least two components (e.g., packaging and endoscope cutter), where each code can be read individually to provide a set of information (such as manufacturing date, device type, and expiration date). However, when two codes are stacked or arranged for reading together, additional information (such as an authentication code ensuring the device has not been reprocessed) becomes accessible. For example, a nearly transparent packaging tray has a partial QR code printed on it. The device within the packaging has a partial QR code, such that the two codes combined form a complete code.

[0139] System 10 also prevents the reuse of data stored in the packaging. A disposable sensor may be positioned on the packaging and destroyed when the packaging is opened. The packaging peel-off layer may contain a portion of the sensor or circuitry, which is destroyed when the packaging is opened. For example, the cap peels off from a plastic tray, where the circuitry is partially printed on the tray, with an interruption in the area where the cap is glued. The cap contains conductive filaments that interconnect the interruption when sealed. The peeling action removes the jumper wires and interrupts the circuitry. In one embodiment, the cap may contain a barcode printed on the area of ​​the peeled cap, making the code unreadable once the packaging is opened. The code is positioned on two different sides of the pouch within the glued area. Once the code is destroyed and difficult to read, the device cannot be scanned during surgery, thus limiting its ability to utilize information from digital solutions.

[0140] System 10 may include features that change once the packaging is opened. In one embodiment, opening the packaging may expose an initially hidden additional bar (as part of a barcode) that alters how it is read. In one embodiment, a portion of the barcode may become visible after sterilization. Photochromic ink may also be required to be used on the exterior of the packaging. Additionally, in one embodiment, exposure to oxidizing chemicals may cause a change in the barcode, wherein the packaging includes a portion of a barcode that is sealed relative to both the internal and external environments. During packaging, this portion is purged with an inert gas, and opening exposes the portion to O2 or CO2, which erases the ink and causes the barcode to change.

[0141] In some implementations, as explained herein, the packaging itself may include a display to show metadata stored within the packaging. In this implementation, the smart packaging label displays only the information needed by the current user (i.e., the packaging may store all kinds of information about its own supply chain, but the doctor only receives information relevant to the doctor). The packaging “knows” what to present to the doctor based on various factors, such as its position in the supply chain, interactions with certain individuals, the type of surgery to be performed, and the corresponding accessories and instruments.

[0142] Typically, the smart packaging system 10 can provide users (e.g., delivery workers, customs officers, warehouse personnel, hospital / facility staff, medical teams, etc.) with information about themselves. This information can be delivered by the smart packaging system 10 in various ways, as described below, and the delivered information can depend on a variety of factors, including: composition, contents, current location, destination, user identity, authorization level, functional capabilities, external stimuli, etc.

[0143] Typically, the smart packaging system 10 can understand its historical and future status and its intended use throughout its entire lifecycle. Essentially, the smart packaging system 10 can have self-awareness during its lifecycle. This awareness allows the smart packaging system to know: 1) its location within the facility supply chain; 2) when it is received at a medical facility; 3) when it enters a storage room or storage area at the medical facility; 4) when it is requested for use in a medical procedure; and 5) when it enters the operating room for the requested medical procedure. Each of these aspects of awareness will be described further.

[0144] Locations that trigger different markers or information transmissions can typically include: warehouses, storage, transportation, sterilization, supplier distribution centers, transportation modes, customs, regional distribution centers, local delivery, healthcare facility receiving, storage rooms, operating rooms, repackaging in operating rooms, healthcare facility cleaning / sorting, disposal, reuse, return shipments, etc. In some implementations, the smart packaging system 10 is configured to store its intended destination (e.g., a specific hospital) and record and store a history of its journey as it moves toward its intended destination. Additionally, the smart packaging system 10 can be configured to determine its position within the path to its intended destination.

[0145] Based on the packaging's location within the supply chain, labeling can present different information to the current user. Supply chain progress is... Figure 4 The following descriptions are provided: In the assembly stage 110, the display may show the part, part acceptance date, revision number, and calibration / certification data (for parts and equipment). In the warehouse stage 120, the display may show sterilization data, batch number, inventory, FIFO date, and shelf location. In the shipping stage 130, the display may show the sender address, truck ID, receiving address, disposal instructions, customs data (e.g., declared value), assembly order, and general header. In the allocation stage 150, the display may show shelf location, inventory quantity number (e.g., 1 out of 5, 2 out of 5, etc., currently in stock), model number, FIFO data, and due date. In the local shipping stage 160, the display may show location, truck number, delivery time, and distributor invoice. When in the hospital stage 170, the display may show the order number, storage location, and item number of the inventory quantity. When in the operating room stage 180, the display may show the operating room number, surgery time, surgeon ID, patient ID, and equipment number in the number of surgeries (e.g., 1 out of 4 required for a given surgery).

[0146] In some implementations, the displayed data can be updated along the supply chain and can be read by the user without connection to HUB 50 or aggregation system 10. For example, an e-ink display can be updated based on internal electronic storage information or sensing aspects of the packaging when exposed to wireless power (e.g., an external electric field). A separate device battery can be used to update the electronics. It may have a separate circuit, which may be part of the packaging with which the user interacts, to create a short-term power connection that allows the display to be updated.

[0147] While displays can be updated on packaging based on its location within the supply chain, packaging can also include environmentally adaptive designs to provide additional information to the user. In one embodiment, a portion of the label has aspects adapted to environmental conditions inside or outside the packaging. For example, portions of the label may be updated due to chemical or thermal reaction events, such as different aspects of the contents' exposure to temperature, humidity, exposure, or energy radiation. This allows the element to change based on maximum short-term dose or cumulative exposure levels.

[0148] In addition to electronic sensors, simplified mechanical sensors can be used in conjunction with or as a replacement for power-operated sensors on the packaging. For example... Figure 19 As depicted, a mechanical, discontinuously powered sensor 1506 may be arranged within the package 1502 of the packaging system 1500. The sensor 1506 may be located in a separate compartment from the instrument 1504 and may be activated by user action at specific times (such as when scanning the device before use or when placed in inventory), and can be used to immediately check the integrity of the package and the instrument. The type of physical indicator that can replace the powered sensor may include an accelerometer.

[0149] like Figure 20 to Figure 21 As depicted, in one embodiment, sensor 1506 may include a magnet 1501 arranged on a post 1512, which is movable in all directions. A spring 1516 is connected to the post 1512, which helps to keep the post 1512 centered relative to a surrounding wall 1514. The surrounding wall 1514 is made of an ferrous material, such that if the magnet 1510 comes into close contact with the surrounding wall 1514, the magnetic force will overcome the force applied to the spring 1516, and the magnet 1510 will adhere to the surrounding wall 1514. With the magnet 1510 attached to the surrounding wall 1514, a user can visually see that the packaging has experienced a high force load exceeding a threshold amount. Additionally, the packaging may include circuitry that, once the magnet 1510 contacts the surrounding wall 1514, sends a signal to a memory within the packaging, recording the exceeding threshold as a historical data point. Once the packaging sends any form of data, a warning may be presented to the user, or the warning may be displayed directly on a display on the packaging.

[0150] On the other hand, a spring can be suspended between the circuit and the battery to trip the circuit when a force exceeding a threshold level is applied to the package. If the force experienced exceeds the threshold amount, the spring can disconnect the battery from the circuit.

[0151] like Figure 22 to Figure 23 In another embodiment, as depicted, a thermally reactive element 1550 may be used. The thermally reactive element 1550 may be in the form of a waxy element disposed within a package. The waxy element 1550 may initially have a specific shape (i.e., rectangular, circular, or a specific logo), such as... Figure 22As shown, if the packaging is exposed to temperatures exceeding the minimum or maximum threshold, it will change form (such as melting, warping, and / or cracking), as... Figure 23 As shown.

[0152] In another embodiment, an optical UV detector can be used on the packaging. A thin, transparent polycarbonate sheet can be arranged within the packaging such that, upon exposure to light, the polycarbonate yellows or becomes cloudy above a UV threshold. The thickness of such polycarbonate sheets can range from 0.015" to 0.025" in thickness. As mentioned above, UV exposure can weaken certain components of the packaging and surgical instruments (e.g., some plastics can become very brittle). UV exposure above a certain threshold can warn the operator that the packaging and / or surgical instruments may be damaged.

[0153] Power alternatives for these mechanical devices may include accelerometers included in the packaging, thermometers within the device powered by batteries in the packaging, and optical sensors, barometers, humidity sensors, or GPS devices for recording UV exposure.

[0154] As described above, each package may include a transceiver in the form of an RFID tag to facilitate communication with external systems (e.g., to allow the inventory room to know the location of a given device). The RFID tag needs to be brought close enough to be powered. In the context of an inventory room layout, as a user walks along the aisles of the inventory space with a smart device, the RFID tags in the packages arranged on the shelves can be powered to read the data stored on the RFID tags. This passive reading can be used to notify users of product recalls. The HUB 50 may utilize an interface or inventory room layout that powers a display on the package to change the e-ink display on the package to indicate to the user that the specific device is not in use.

[0155] The display itself can have multi-level menus that can be navigated to provide additional data not shown on the display's initial screen. Additionally, the display may include scannable codes that direct the user to additional information stored in a cloud database. Some of this information may be region-specific, such as optimal device performance instructions, other surgeons or specialists using the device in your region, top users in the region, local representative contact information, personal messages / videos from the assembly line, device builds or components originating from the local area, connections to Real-World Evidence (RWE) studies, complaint automation, geolocation (language-specific), generic complaint icons, misuse credit provision (e.g., delivery of alternatives), reward points, treatment instructions, compatible devices (such as buttresses, reloading devices, cannulas), best practice documentation, YouTube instructional videos, or marketing materials. RWE is a method of collecting information from medical records and other sources to determine how treatment works in practice. The display may also include multiple languages ​​that can be automatically changed via GPS or user commands. For example, when the product is in the US before shipment, the product reads English, providing all English shipping instructions, and once the packaging detects that it has landed, for example, in Germany, the display language immediately switches to German.

[0156] While the above discussion has shown that packaging can provide additional data using smart devices or scanners, other packages themselves can also provide additional data to each other, allowing the combination of packages to offer more information than a single package could provide individually. For example, a user can group several packages together, where each package can provide a collection of user information related to the package (i.e., compatibility or operational limitations), something a single package cannot do on its own.

[0157] like Figure 24 to Figure 28 As depicted, System 10 ensures that collaborative packages interlock, nest, or are positioned together for use in surgical procedures. Once the packages are scanned or enter the operating room, System 10 can detect the color, shape, outline, subject matter, and characteristics of the equipment using any of the methods described herein. This allows System 10 to confirm that all pulled packages contain compatible instruments and accessories. The displays on the packages themselves can also provide the user with information about which compartments require use with specific suture devices. In this way, the user can collect all necessary compatible packages before the start of the surgical procedure.

[0158] Figure 24 This is a schematic diagram of stomach 1600 undergoing sleeve gastric surgery. To perform the surgery, multiple staple groups 1602, 1604, 1606, and 1608 need to be sutured to the stomach. Due to the volume of the staples used in the surgery, the stapler will need to be reloaded to complete the procedure. Furthermore, the staple groups may vary depending on their required operating parameters, which correspond to their positions on stomach 1600. Figure 25As depicted, to ensure the appropriate staples are used with the correct suture device, when the user collects the package 1610 containing the suture device, the system 10 can change the display 1612 on the package to warn the user to also collect the corresponding staples, and for the surgical procedure requiring both the suture device and the staples. The display 1612 can also show the user the corresponding location in the operating room where the package 1610 can be placed.

[0159] To ensure the use of appropriate staple sets, in one embodiment, the operating room may include a table 1620 with an opening 1626 into which the package 1610 is placed to confirm the presence of all compatible products in the operating room. Figure 26 As depicted, the table 1620 may include an upper portion 1622 and a lower portion 1624. In one embodiment, an accessory (such as a nail) may be disposed in the upper portion 1622, and an instrument utilizing the accessory may be disposed in the lower portion 1624. The table 1620 may also be used to load accessories into an instrument.

[0160] like Figure 27 As depicted, once the package 1610 is positioned within the opening 1626, the displays 1630, 1632, 1634, and 1636 on each package can provide the user with the firing sequence of each staple cartridge, and can also provide a warning if an incorrect package is positioned in the table 1620. Additionally, as mentioned above, there may be multiple compatible options for the instruments to be used during surgery. For example... Figure 28 As depicted, two compatible packages 1640 and 1642 can be used for surgery. If the user has removed package 1640, the display 1644 of package 1640 can provide a warning to the user to return package 1640 to the opening 1626. Simultaneously, the system 10 can change the message provided on the display 1646 of package 1642 to insert package 1642 into the opening 1626, since both packages 1640 and 1642 can be used for surgical procedures.

[0161] After the surgical procedure is completed, System 10 can track the combination of product usage pairs to optimize patient outcomes. System 10 can provide feedback, such as a comparison of which packages were pulled compared to those that were returned / unused. This information can be used to inform hospital administrators of device usage trends. To provide more data, when a package is returned unused, it can include reasons why it was pulled / returned. Examples of messages could include (1) the device was pulled "just in case," (2) redundant pull, (3) I usually use it, (4) alternative device found.

[0162] Certain exemplary embodiments have been described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these embodiments have been illustrated in the accompanying drawings. Those skilled in the art will understand that the systems, devices, and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Features illustrated or described in one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention. Furthermore, in this disclosure, components with similar names in the embodiments generally have similar features, and therefore, in a particular embodiment, not every feature of every component with a similar name is necessarily fully described.

[0163] As used herein and throughout the specification and claims, approximate language may be applied to modify any quantitative representation that may be permitted to change without altering its associated essential function. Therefore, values ​​modified by one or more terms (such as “about,” “approximate,” and “substantially”) are not limited to the specified precise values. In at least some cases, approximate language may correspond to the precision of the instrument used to measure that value. Scope limitations may be combined and / or interchanged herein and throughout the specification and claims, and such scopes are identified and include all subscopes contained herein unless otherwise indicated by context or language.

[0164] Based on the specific embodiments described above, those skilled in the art will understand further features and advantages of the present invention. Therefore, this application should not be limited to the specific illustrations and descriptions except as indicated in the appended claims. All publications and references cited herein are expressly incorporated by way of reference in their entirety.

Claims

1. A system comprising: Manufacturer-sealed sterile surgical packaging; Surgical instruments, wherein the surgical instruments are stored in sterile packaging sealed by the manufacturer; A first transceiver, the first transceiver being contained within a sterile surgical package sealed by the manufacturer and configured to transmit a first set of data including a first amount of data; A second transceiver, contained within a manufacturer-sealed sterile surgical package and configured to transmit a second data set including a second data volume greater than the first data volume; and A power source, contained within a sterile surgical package sealed by the manufacturer and connected to the second transceiver, wherein the second transceiver is intermittently powered by the power source.

2. The system according to claim 1, wherein, The second transceiver is inactive, while the first transceiver is active.

3. The system according to claim 1 or 2, wherein, The first transceiver is inactive, while the second transceiver is active.

4. The system according to any one of claims 1 to 3, wherein, The first transceiver is at least one RFID chip embedded within the manufacturer's sealed sterile surgical packaging.

5. The system according to any one of the preceding claims, wherein, The second transceiver also includes: At least one data processor, wherein the at least one data processor is disposed in the surgical package; and A memory disposed within the surgical package, the memory storing instructions configured to cause the at least one data processor to perform operations including: Historical data points of the surgical instruments are recorded and provided to the second transceiver via at least one sensor disposed in the surgical package.

6. The system according to claim 5, wherein, The historical data points include force measurements applied to the manufacturer-sealed sterile surgical packaging.

7. The system according to any one of the preceding claims, wherein, The second transceiver is continuously powered by the power source.

8. The system according to claim 7, wherein, The second transceiver is configured to record historical data points.

9. The system according to any one of the preceding claims, wherein, A switch is positioned between the power source and the second transceiver to selectively activate the second transceiver.

10. The system according to any of the preceding claims, wherein, The surgical instrument is positioned in a first compartment within the manufacturer-sealed sterile surgical package, and the power source is positioned in a second compartment within the manufacturer-sealed sterile surgical package, separate from the first compartment.

11. A method comprising: Activate a first transceiver contained within a manufacturer-sealed sterile surgical package containing surgical instruments stored therein; A first data set is sent from the first transceiver, wherein the first data set includes a first data volume; The second transceiver is activated by connecting the second transceiver contained within the manufacturer-sealed sterile surgical package to a power source contained within the manufacturer-sealed sterile surgical package. The second transceiver is intermittently powered via the power source; and A second data set is sent from the second transceiver, wherein the second data set includes a second data volume, and the second data volume is greater than the first data volume.

12. The method of claim 11, further comprising: The first transceiver is deactivated before the second transceiver is activated.

13. The method according to claim 11 or 12, further comprising: The second transceiver is deactivated before the first transceiver is activated.

14. The method according to any one of claims 11 to 13, wherein, The first transceiver is at least one RFID chip embedded within the manufacturer's sealed sterile surgical packaging.

15. The method according to any one of claims 11 to 14, further comprising: Historical data points of the surgical instruments are recorded and provided to the second transceiver via at least one sensor disposed in the surgical package.

16. The method according to claim 15, wherein, The historical data points include force measurements applied to the manufacturer-sealed sterile surgical packaging.

17. The method according to claim 15 or 16, further comprising: The operating parameters sent by the second transceiver are adjusted based on the recorded historical data points.

18. The method according to any one of claims 11 to 17, further comprising: The second transceiver is continuously powered by the power source.

19. The method according to any one of claims 11 to 18, further comprising: An actuation switch positioned between the power source and the second transceiver is used to selectively activate the second transceiver.

20. The method according to any one of claims 11 to 19, wherein, The surgical instrument is positioned in a first compartment within the manufacturer-sealed sterile surgical package, and the power source is positioned in a second compartment within the manufacturer-sealed sterile surgical package, separate from the first compartment.

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