Systems and methods for determining surgical device compatibility

Abstract

Surgical systems and methods are provided. The surgical system includes: a manufacturer-sealed sterile surgical package, the manufacturer-sealed sterile surgical package containing a surgical instrument; at least one data processor; and a memory storing instructions configured to enable the at least one data processor to perform operations. The operations include: receiving, from a remote server, data characterizing one or more aspects of a surgical procedure involving the surgical instrument; determining a level of compatibility of the surgical instrument with each of the one or more aspects of the surgical procedure; the determined level of compatibility is provided.

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 by reference 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 around the world and, along the supply chain, 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 mishandling 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 surgical systems and methods. SUMMARY

[0006] Surgical systems and methods are provided. In one embodiment, a surgical system is provided that includes a manufacturer-sealed sterile surgical package containing a surgical instrument configured to be used in a surgical procedure; at least one data processor; and a memory storing instructions. The instructions can be configured to cause the at least one data processor to perform operations including cataloging components of the surgical instrument; determining a disposal procedure for each of the components of the surgical instrument; and providing the disposal procedures at the end of the surgical procedure.

[0007] The surgical system can vary in a number of ways. For example, the memory can store instructions configured to cause the at least one data processor to perform operations comprising: tracking a disposal protocol for each component of a surgical instrument; determining an accuracy level of the disposal protocol for each tracked component; and providing the accuracy level. In other aspects, the memory can store instructions configured to cause the at least one data processor to perform operations comprising: receiving data characterizing available disposal options at a healthcare facility where a surgical procedure is being performed; adjusting a disposal protocol based on the received data; and providing the adjusted disposal protocol. In other embodiments, the memory can store instructions configured to cause the at least one data processor to perform operations comprising: receiving data characterizing a geopolitical location of a healthcare facility where a surgical procedure is being performed; adjusting a disposal protocol based on the received data; and providing the adjusted disposal protocol. In other aspects, the memory can store instructions configured to cause the at least one data processor to perform operations comprising: receiving data characterizing a performance error of a surgical instrument; adjusting a disposal protocol based on the received data; and providing the adjusted disposal protocol. In some variations, the adjusted disposal protocol can include a return address for the surgical instrument. The guidance can include instructions for disassembling, segregating, and / or separating cataloged components of a surgical procedure. In other embodiments, the disposal protocols can be provided via a display located on a manufacturer-sealed sterile surgical package, such as electronic ink indicia and / or colored LEDs located on a manufacturer-sealed sterile surgical package, where the color of the colored LEDs corresponds to the color of one or more disposal bins located within an operating room where a surgical procedure is being performed. In other embodiments, the disposal protocols can be transmitted and displayed on a remote device in electronic communication with a manufacturer-sealed sterile surgical package.

[0008] In another embodiment, a method is provided that includes: cataloging, by a manufacturer-sealed sterile surgical package, components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used for a surgical procedure; determining a disposal protocol for each of the components of the surgical instrument; and providing the disposal protocols at the end of the surgical procedure.

[0009] The method can vary in a number of ways. For example, the method can include tracking a procedure for each component of a surgical instrument; determining an accuracy level of the procedure for each tracked component; and providing the accuracy level. In some variations, the method can include sending data characterizing at least one alert message when the accuracy level falls below a predetermined threshold. For example, the method can include receiving data characterizing available disposal options at a healthcare site where a surgical procedure is being performed; adjusting the procedure based on the received data; and providing the adjusted procedure. In other embodiments, the method can include receiving data characterizing a geopolitical location of a healthcare site where a surgical procedure is being performed; adjusting the procedure based on the received data; and providing the adjusted procedure. In other aspects, the method can include receiving data characterizing a performance error of a surgical instrument; adjusting the procedure based on the received data; and providing the adjusted procedure. In some variations, the adjusted procedure can include a return address for the surgical instrument. The guidance can include instructions for disassembling, segregating, and / or separating cataloged components of a surgical procedure. In other embodiments, the procedure can be provided via a display located on a manufacturer-sealed sterile surgical package, such as a colored LED located on a manufacturer-sealed sterile surgical package. The color of the colored LED can correspond to the color of one or more disposal bins.

[0010] A non-transitory computer program product is provided. 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 part of at least one computing system, cause the at least one data processor to carry out operations comprising: cataloging, by a manufacturer-sealed sterile surgical package, components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used for a surgical procedure; determining a disposal procedure for each of the components of the surgical instrument; and providing the disposal procedures at the end of the surgical procedure.

[0011] A surgical system is also provided. In one embodiment, a surgical system is provided and includes a manufacturer-sealed sterile surgical package containing a surgical instrument; at least one data processor; and a memory storing instructions configured to enable the at least one data processor to perform operations. The operations can include updating a history of the surgical package and / or the surgical instrument based on at least one of a current geopolitical location of the surgical system and a supply chain progress; and providing handling instructions for the surgical system based on at least one of the current geopolitical location of the surgical system and the supply chain progress.

[0012] The surgical system can vary in a number of ways. For example, the handling instructions can include information characterizing at least one of a historical state, a future state, and operational information. In some variations, 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 variations, the future state can include at least one of intended destination information, environmental requirement information, customs information, disposal information, and error reporting procedure information. In further variations, the operational information can include at least one of product compatibility information, expected lifecycle information, and operational instructions. For example, the operations can include providing at least a portion of the historical record based on an on-demand user request. In some variations, the on-demand user request can be pre-authenticated. For example, the handling instructions can be provided via a display located on a manufacturer-sealed sterile surgical package. For example, the handling instructions can include a list of one or more surgical items for a surgical procedure involving the surgical instrument.

[0013] In another implementation, a method is provided and can include updating, with a surgical system, a historical record of the surgical system based on at least one of a current geopolitical location of the surgical system and a supply chain progression; and providing, with the surgical system and based on at least one of the current geopolitical location of the surgical system and the supply chain progression, handling instructions for the surgical system. The surgical system can include a manufacturer-sealed sterile surgical package including a surgical instrument.

[0014] The method can vary in a number of ways. For example, the handling instructions can include information characterizing at least one of a historical state, a future state, and operational information. In some variations, 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. The future state can include at least one of intended destination information, environmental requirement information, customs information, disposal information, and error reporting procedure information. The operational information can include at least one of product compatibility information, expected lifecycle information, and operational instructions. The method can further include providing at least a portion of the historical record based on an on-demand user request. In some variations, the on-demand user request is authenticated prior to providing at least a portion of the historical record. In other aspects, the handling instructions can be provided via a display located on a manufacturer-sealed sterile surgical package. For example, the handling instructions can include a list of one or more surgical items for a surgical procedure involving the surgical instrument. In some variations, the method can further include sending at least one message indicating an absence of at least one of the one or more surgical items.

[0015] In another implementation, 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 updating, with a surgical system, a historical record of the surgical system based on at least one of a current geopolitical location of the surgical system and a supply chain progress; and providing, with the surgical system and based on at least one of the current geopolitical location of the surgical system and the supply chain progress, a processing instruction for the surgical system. The surgical system can include a manufacturer-sealed sterile surgical package including a surgical instrument.

[0016] In another implementation, a surgical system is provided. The surgical system can include at least one manufacturer-sealed sterile surgical package including a surgical instrument; and an electronic management system in electronic communication with the at least one manufacturer-sealed sterile surgical package. The electronic management system can be configured to: receive inventory data characterizing inventory information of the manufacturer-sealed sterile surgical package; update a master management list with the received inventory data; determine, based on the updated master management list, a procedure inventory list for a surgical procedure utilizing the surgical instrument; and provide the procedure inventory list. The procedure inventory list can include surgical equipment required for the surgical procedure.

[0017] The surgical system can vary in a number of ways. For example, the surgical system can include receiving initial inventory data characterizing inventory information of the detected surgical system upon initial detection of the at least one surgical system by a network system; and appending the initial inventory data to a master management list. For example, the inventory information can include a current location of the at least one surgical system. In some variations, the inventory information can be received at periodic intervals. For example, upon detecting that a first portion of the surgical equipment on the procedure inventory list is at a first location, providing instructions for shipping the first portion to a second location. In some variations, the surgical system can include upon detecting that a second portion of the surgical equipment on the procedure list is at a third location, providing instructions for shipping the second portion to the second location. In some variations, the first location can be a first storage room within a hospital and the second location is an operating room within the hospital. In other variations, the first location can be a first storage room within a hospital, the second location can be an operating room within the hospital, and the third location can be a second storage room within the hospital.

[0018] In another embodiment, a method is provided and can include receiving inventory data characterizing inventory information of at least one surgical system in electronic communication with an electronic management system; updating a master management list with the received inventory data; determining a procedure inventory list for a surgical procedure utilizing surgical instruments based on the updated master management list; and providing the procedure inventory list. The surgical system can include a manufacturer sealed sterile surgical package containing the surgical instruments. The procedure inventory list can include surgical equipment required for the surgical procedure.

[0019] The method can vary in a number of ways. For example, the method can include receiving initial inventory data characterizing inventory information of the detected surgical system upon initial detection of the at least one surgical system by the network system; and appending the initial inventory data to the master management list. The inventory information can include a current location of the at least one surgical system. In some variations, the inventory information can be received at periodic intervals. The method can also include providing instructions for transporting a first portion of the surgical equipment on the procedure inventory list from a first location to a second location upon detecting that the first portion is at the first location. In some variations, the method can include providing instructions for transporting a second portion of the surgical equipment on the procedure list from a third location to the second location upon detecting that the second portion is at the third location. The first location can be a first storage room within a hospital and the second location can be an operating room within the hospital. The third location can be a second storage room within the hospital.

[0020] In one 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 inventory data characterizing inventory information of at least one surgical system in electronic communication with an electronic management system; updating a master management list with the received inventory data; determining a procedure inventory list for a surgical procedure utilizing surgical instruments based on the updated master management list; and providing the procedure inventory list. The surgical system can include a manufacturer sealed sterile surgical package containing the surgical instruments. The procedure inventory list includes surgical equipment required for the surgical procedure.

[0021] In another embodiment, a surgical system is provided and can include: at least one primary surgical system; and an electronic management system in electronic communication with the primary surgical system. The electronic management system can be configured to update a virtual compatibility list stored on the primary surgical system with compatibility information. The compatibility information can: characterize a level of compatibility between the primary surgical system and one or more secondary surgical systems in electronic communication with the electronic management system; create a first virtual kit for a surgical procedure; and provide the first virtual kit. The first virtual kit can include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list.

[0022] The surgical system can vary in a number of ways. For example, the primary surgical system can include a manufacturer sealed sterile surgical package containing a surgical instrument. The electronic management server can be configured to append one or more tertiary systems to the first virtual kit. The one or more tertiary systems can be determined based on a preference of a surgeon performing the surgical procedure. In other aspects, upon receiving a notification characterizing an error related to the selected at least one of the one or more secondary surgical systems, the electronic management server can be configured to replace the selected at least one of the one or more secondary surgical systems with another one of the one or more secondary surgical systems based on the compatibility list. In some variations, the error can be a lack of available inventory of the selected at least one of the one or more secondary surgical systems. For example, the electronic management server can be configured to create a second virtual kit for a second surgical procedure. The second virtual kit can include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list. In some variations, the first surgical procedure and the second surgical procedure can be different types of surgical procedures. In other embodiments, the electronic management server can be further configured to order the surgical systems listed in the first virtual kit from a vendor.

[0023] In another embodiment, a method is provided and can include: updating a virtual compatibility list stored on a primary surgical system in electronic communication with a management server with compatibility information; creating a first virtual kit for a surgical procedure; and providing the first virtual kit. The compatibility information can characterize a level of compatibility between the primary surgical system and one or more secondary surgical systems in electronic communication with the management server. The first virtual kit can include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list.

[0024] The method can vary in a number of ways. For example, the primary surgical system can include a manufacturer-sealed sterile surgical package containing a surgical instrument. The method can further include appending one or more tertiary systems to the first virtual kit, the one or more tertiary systems being determined based on preferences of a surgeon performing the surgical procedure. The method can further include, upon receiving a notification characterizing an error related to a selected at least one of the one or more secondary surgical systems, replacing the selected at least one of the one or more secondary surgical systems with another one of the one or more secondary surgical systems based on the compatibility list. In some variations, the error can be a lack of available inventory of the selected at least one of the one or more secondary surgical systems. The method can further include creating a second virtual kit for a second surgical procedure. The second virtual kit can include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list. In some variations, the first surgical procedure and the second surgical procedure can be different types of surgical procedures. For example, the method can include ordering the surgical systems listed in the first virtual kit from a supplier.

[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 updating a virtual compatibility list stored on a primary surgical system in electronic communication with a management server with compatibility information; creating a first virtual kit for a surgical procedure; and providing the first virtual kit. The compatibility information can characterize a level of compatibility between the primary surgical system and one or more secondary surgical systems in electronic communication with the management server. The first virtual kit can include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list.

[0026] In another embodiment, a surgical system is provided and can include a manufacturer-sealed sterile surgical package containing a surgical instrument; at least one data processor; and a memory storing instructions configured to cause the at least one data processor to perform operations prior to a breach of the manufacturer-sealed sterile surgical package. The operations can include receiving, from a remote server, data characterizing a geopolitical location of at least one of the surgical package and the surgical instrument; and based on the received data, sending an instruction to at least one of the surgical package and the surgical instrument to change one or more aspects of the surgical package and / or the surgical instrument.

[0027] The surgical system can vary in a number of ways. For example, the manufacturer-sealed sterile surgical package can include a display configured to present visual information. In some variations, the display can be configured to present one or more messages indicating non-compliance with one or more regulations of the geopolitical location. In some aspects, the language of the one or more presented messages can be based on the geopolitical location. For example, one or more aspects can include a capacity to collect medical data and data related to the surgical procedure. The instructions can be configured to disable one or more functions of the surgical package. The one or more functions can not comply with one or more regulations of the geopolitical location. One or more aspects can include one or more operations of a surgical instrument available during the surgical procedure. For example, the geopolitical location can be a customs checkpoint. In other embodiments, one or more aspects can include a capacity to deliver one or more controlled substances, and the one or more controlled substances can be prohibited or controlled at the geopolitical location.

[0028] In another embodiment, a method is provided. The method can include receiving, by a surgical system from a remote server, data characterizing a geopolitical location of the surgical system; and sending instructions to a surgical package to selectively change one or more aspects of the surgical package based on the received data. The surgical system can include a manufacturer-sealed sterile surgical package and a surgical instrument contained within the manufacturer-sealed sterile surgical package.

[0029] The method can vary in a number of ways. For example, the manufacturer-sealed sterile surgical package can include a display configured to present visual information. In some variations, the display can be configured to present one or more messages indicating non-compliance with one or more regulations of the geopolitical location. In some variations, the language of the one or more presented messages can be based on the geopolitical location. One or more aspects can include a capacity to collect medical data and data related to the surgical procedure. The instructions can disable one or more functions of the surgical package. The one or more functions can not comply with one or more regulations of the geopolitical location. In other embodiments, one or more aspects can include one or more operations of a surgical instrument available during the surgical procedure. For example, one or more aspects can include a capacity to deliver one or more controlled substances, and the one or more controlled substances can be prohibited or controlled at the geopolitical location. The geopolitical location can be a customs checkpoint. In some variations, the instructions can be sent prior to crossing a geopolitical boundary into the geopolitical location.

[0030] In another implementation, 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, by a surgical system from a remote server, data characterizing a geopolitical location of the surgical system; and sending instructions to a surgical package to selectively change one or more aspects of the surgical package based on the received data. The surgical system can include a manufacturer-sealed sterile surgical package and a surgical instrument contained within the manufacturer-sealed sterile surgical package.

[0031] In another implementation, a surgical system is provided. The surgical system can include a manufacturer-sealed sterile surgical package containing a surgical instrument; at least one data processor; and at least one memory storing instructions configured to enable the at least one data processor to perform operations. The operations can include receiving, from a remote server, data characterizing one or more aspects of a surgical procedure involving the surgical instrument; determining a level of compatibility of the surgical instrument with each of the one or more aspects of the surgical procedure; and providing the determined levels of compatibility.

[0032] The surgical system can vary in a number of ways. For example, the one or more aspects of the surgical procedure can include one or more surgical instruments, surgical accessories, and surgical techniques. The operations can include sending a notification of incompatibility between the surgical system and the one or more aspects when the determined level of compatibility is below a compatibility threshold. In some aspects, the notification can be sent via a display located on the surgical system. In other aspects, the notification can be sent electronically to a remote server. In further aspects, the notification can include a list of one or more of the aspects of the surgical procedure for which the level of compatibility is below the compatibility threshold. In still further aspects, the operations can include disabling one or more features of the surgical system when the determined level of compatibility is below the compatibility threshold. For example, the providing can occur prior to a manufacturer-sealed sterile surgical package containing the surgical instrument being breached.

[0033] In another implementation, a method is provided. The method can include receiving, by a surgical system from a remote server, data characterizing one or more aspects of a surgical procedure involving the surgical system; determining a level of compatibility of the surgical system with each of the one or more aspects of the surgical procedure; and providing the determined levels of compatibility.

[0034] The method can vary in a number of ways. For example, the one or more aspects of the surgical procedure include one or more surgical instruments, surgical accessories, and surgical techniques. The method can further include transmitting a notification of incompatibility between the surgical system and the one or more aspects when the determined level of compatibility is below the compatibility threshold. In some aspects, the notification can be transmitted via a display located on the surgical system. In other aspects, the notification can be electronically transmitted to a remote server. In still other aspects, the notification can include a list of one or more aspects of the one or more aspects of the surgical procedure for which the level of compatibility is below the compatibility threshold. In yet other aspects, the method can include disabling one or more features of the surgical system when the determined level of compatibility is below the compatibility threshold. For example, the surgical system can include a manufacturer-sealed sterile surgical package containing a surgical instrument. In some variations, the providing can occur prior to a breach of the manufacturer-sealed sterile surgical package containing the surgical instrument.

[0035] 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, by a surgical system from a remote server, data characterizing one or more aspects of a surgical procedure involving the surgical system; determining a level of compatibility of the surgical system with each of the one or more aspects of the surgical procedure; and providing the determined level of compatibility.

[0036] In another embodiment, a package is provided. The package can include a manufacturer-sealed sterile surgical package; a surgical instrument stored within the manufacturer-sealed sterile package; and at least one secondary use package contained within the manufacturer-sealed sterile surgical package and configured to receive and aseptically contain one or more components of the surgical instrument after a surgical procedure. The at least one secondary use package can include at least one authenticator configured to selectively allow access to the at least one secondary use package.

[0037] The method can vary in a number of ways. For example, the authenticator can be a watermark that is not visible to the human eye, and the at least one secondary use package can be configured to open upon detection of the watermark. In other aspects, the authenticator can be at least one RFID chip embedded within the manufacturer-sealed sterile surgical package. The at least one secondary use package can be configured to open upon detection of the at least one RFID chip. In another embodiment, the authenticator can be a timer configured to prevent access to the at least one secondary use package until a predetermined period of time has elapsed. In other aspects, the authenticator can be at least one scannable marker. The at least one scannable marker can be configured to permit access to the at least one secondary use package after being scanned. For example, at least one of the manufacturer-sealed sterile surgical package and the at least one secondary use package can comprise a biodegradable material. For example, at least one of the manufacturer-sealed sterile surgical package and the at least one secondary use package can comprise an ultraviolet light sensitive material configured to darken after exposure to ultraviolet light. For example, at least one of the manufacturer-sealed sterile surgical package and the at least one secondary use package comprises at least one self- compacting feature to facilitate disassembly of at least one of the manufacturer-sealed sterile surgical package and the at least one secondary use package. In some aspects, the at least one compacting feature can comprise two or more separable interlocking panels.

[0038] In another embodiment, a method is provided. The method can comprise accessing a surgical instrument stored within a manufacturer-sealed surgical package; performing at least one surgical procedure with the accessed surgical instrument; storing at least one component within at least one secondary use package contained within the manufacturer-sealed surgical package; and shipping the retained one or more components in the at least one secondary use package after the at least one surgical procedure. The secondary use package can be shaped to retain one or more components of the surgical instrument.

[0039] The method can vary in a number of ways. For example, the method can comprise authenticating at least one authenticator located on the at least one secondary use package to permit access to its interior. In some aspects, the authenticator can be a watermark that is not visible to the human eye, and the at least one secondary use package can be configured to open upon detection of the watermark. In other aspects, the authenticator can be at least one RFID chip embedded within the manufacturer-sealed sterile surgical package. The at least one secondary use package can be configured to open upon detection of the at least one RFID chip. In further aspects, the authenticator can be a timer configured to prevent access to the at least one secondary use package until a predetermined period of time has elapsed. In still further aspects, the authenticator can be at least one scannable marker. The at least one scannable marker can be configured to permit access to the at least one secondary use package after being scanned. BRIEF DESCRIPTION OF DRAWINGS

[0040] The application is described with reference to the following drawings: Figure 1 is a top view of a passive RFID tag according to an embodiment; Figure 2 is a side schematic view of a smart packaging system including a surgical instrument according to an embodiment; 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 an embodiment; Figure 3B is a diagram of a smart packaging system in electronic communication with a beacon and a HUB in an operating room according to an embodiment; 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 an embodiment; Figure 5 is a side schematic view of a smart packaging system including a surgical instrument and two indicators according to an embodiment; Figure 6 is a side schematic view of an indicator of Figure 5 with radiation sensitive ink before and after exposure to radiation; Figure 7 is a side schematic view of an indicator of Figure 5 with a balloon before and after exposure to a change in pressure; Figure 8 is a side schematic view of a smart packaging system including a surgical instrument with an end-of-life switch according to an embodiment; Figure 9 is a side schematic view of the smart packaging system of Figure 8 after the end-of-life switch has been activated according to a first variation; Figure 10 is a side schematic view of the smart packaging system of Figure 8 after the end-of-life switch has been activated according to a second variation; Figure 11A is a perspective view of a smart packaging system including a tracker according to an embodiment; Figure 11B is a top view of a smart packaging system of Figure 11A ; and Figure 12A is a schematic view of components of a tracker of Figure 11A including a switch in a first position; Figure 12B is the tracker of Figure 12Aschematic diagram of a switch; Figure 13 is a perspective view of a nestable smart packaging system according to an embodiment; Figure 14 is a diagram showing a waste bin for receiving different kinds of waste according to a waste management plan; Figure 15 is a perspective view of a PCB and a crowbar configured to remove the PCB from a smart packaging system according to some embodiments; Figure 16 is a schematic diagram of a smart packaging system and components thereof labeled according to a disposal plan according to some embodiments; Figure 17 is a diagram of a recommendation process according to an embodiment; Figure 18 is a simplified side view of a patient's stomach with scar tissue and markers of previous surgical procedures; Figure 19 is a perspective view of a stomach of Figure 18 Figure 20 is a top view of a smart packaging system including surgical instruments and surgical accessories of a first variation according to an embodiment; Figure 21 is a top view of a smart packaging system including surgical instruments and surgical accessories of a second variation according to an embodiment of Figure 20 is a perspective view of a smart packaging system including surgical instruments and surgical accessories and having a tiered tray according to an embodiment; Figure 22 is a side view of a packaging of a smart packaging system of a variation in a nested configuration according to some embodiments; Figure 23A is a side view of a packaging of Figure 23B in a collapsed configuration; Figure 23A Figure 24A is a side view of a packaging of a smart packaging system of a variation according to some embodiments; Figure 24B is a top view of a packaging of Figure 24A in a nested configuration; Figure 25 is a top view of a packaging having a plurality of nested positions according to an embodiment; and Figure 26 is a chart depicting a watermark authentication process according to an embodiment. DETAILED DESCRIPTION

[0041] ​​Certain example embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and 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 accompanying drawings are non-limiting example embodiments and that the scope of the present application is defined solely by the claims. The features illustrated or described in connection with one example embodiment can be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present application.

[0042] Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus the description of those components need not be repeated with each embodiment. Additionally, the use of linear or circular dimensions 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 rectangular and circular dimensions can be readily determined for any geometric shape. Those skilled in the art will appreciate that dimensions can not be exact values, but are considered to be approximately at that value due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The size and shape of the systems and devices, and components thereof, can depend at least on the size and shape of the components that will be used with the systems and devices.

[0043] Intelligent surgical equipment, systems, and methods are provided. The use of the intelligent equipment, systems, and methods can generally enable the storage, sharing, and utilization of information throughout a supply chain, as well as assist in managing various systems, procedures, and aspects of a healthcare facility in which they are used. Information for aspects of the supply chain and healthcare facility can be recorded, monitored, and reviewed at any time in order to adjust aspects of the supply chain and / or healthcare facility in real-time. Additionally, analysis of compiled information can be used in order to minimize or avoid defects and issues associated with the supply chain and / or products flowing through the supply chain, as well as minimize or avoid defects and issues associated with the coordination of surgical procedures and associated equipment at a healthcare facility. Overall, the intelligent equipment, systems, and methods can improve the efficiency of a supply chain by managing information associated with products flowing through the supply chain, and they can improve the efficiency of a healthcare facility in which they are deployed for surgical procedures. While the specific types of intelligent equipment, systems, and methods can vary, in some aspects, the packaging of the products themselves can be utilized in order to consistently track, monitor, and record information associated with the products. Further, tracking equipment (e.g., scanners, beacons, etc.) and / or centralized computer management systems can be used as part of the intelligent systems and equipment.

[0044] 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.

[0045] 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 the healthcare facility's daily routines, 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.

[0046] 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 aspects of the environment. 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.

[0047] 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.

[0048] In some variations, the outer package can include additional memory storage devices and / or one or more additional processors in electronic communication with the one or more RFID tags in order to increase the capabilities of the RFID tags. The smart packaging system can also include one or more of a display, such as an e-ink display, an LCD display, a touchscreen, or equivalent, and / or a readable medium, such as a barcode, a QR code, or equivalent. In some variations, the smart packaging system can include a data port, such as a USB-type port. With some or all of these features, the smart packaging system can generally acquire data from external sources, such as a computer, a computer network, as well as data received from its one or more sensors, and the smart packaging system can generally send data and / or present information to the computer, the computer network, a user, a scanning device, an RFID reader, and any device capable of receiving data from the features of the smart packaging system.

[0049] The surgical instruments and / or surgical components contained within the outer package can vary in both form and function. In some variations, the entire surgical instrument can be a "smart" instrument, where the status 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 staple tissue, the amount of torque applied by the jaws of the instrument can be monitored throughout the surgical procedure. If the HUB determines that the surgeon is applying too much torque, a maximum torque limit can be wirelessly imposed on the instrument in real-time to prevent an accident from occurring. Furthermore, with such a surgical instrument, if an accident does occur during the operation involving the instrument, the details surrounding the accident can be recorded and stored within the memory of the package or virtually on the HUB. This information can then be used to determine the source of the accident, and whether, for example, a recall should be issued for similarly positioned surgical instruments.

[0050] In other variations, a sub-portion of the surgical instrument can be "smart," while other portions of the instrument can be electrically isolated from the "smart" sub-portion, such that the status and operation of the surgical instrument cannot be monitored, recorded, or altered in any way. For example, in the same endoscopic cutter described above, the jaw driver subsystem can be "smart," but the subsystems involving the articulation of the shaft of the endoscopic cutter can not be "smart." Even though the shaft can be electronically articulatable, it can not be in electronic communication with the HUB and / or the outer package, and thus it can be "hidden" from monitoring. These examples are merely illustrative, and more specific examples and variations are described below.

[0051] One example of a smart packaging system 10 is described in U.S. Patent No. 9, 1 1 1, 1 1 1, which is incorporated by reference in its entirety. Figure 2An example of a smart packaging system 10 is depicted in FIG. 1. The illustrated smart packaging system 10 includes a package 12 containing a surgical instrument 14 therein. The surgical instrument 14 can be any surgical instrument or surgical material, such as an endocutter as shown. The smart packaging system 10 can include a controller 13 configured to perform the functions of the smart packaging system 10. The controller 13 can generally include a control unit 13A, a logic unit 13B, and a memory 13C that implement the functionality of the controller 13. The smart packaging system 10 can also include an internal power source 15, such as a battery, that is capable of providing power to the various components of the smart packaging system 10, including the controller 13 described herein. The package 12 can also include an RFID tag 16 configured to send and receive information from external sources. A serial number 18, which can or can not have encrypted data, can be located on the package 12 so that it can be read by handlers or computer systems. The package 12 can also include a scannable or readable medium 20, such as a QR code or bar code, and a display 22, such as the previously mentioned variety (e.g., e-ink display). Although not shown, the smart packaging system 10 can contain additional surgical accessories, components, and elements that can be disposed in separate compartments from the surgical instrument 14. The surgical accessories, components, and elements can be used in conjunction with the surgical instrument 14 or separately. These items can generally be referred to together as the contents of the smart packaging system 10. For example, the surgical instrument 14 can be a surgical stapler, and the contents of the smart packaging system 10 can include a staple cartridge compatible with the surgical stapler that can be packaged separately from the surgical stapler within the smart packaging system 10, such as in a sub-compartment of the package 12. For illustrative purposes only, reference will be made to the smart packaging system 10 and its constituent parts.

[0052] The smart packaging system 10 can receive and present information related to personnel that can interact with the smart packaging system 10 along the life cycle of the contained surgical instrument 14, as well as other surgical instruments and products that interface with the contained surgical instrument 14. The variety of personnel and the relevance of the information will vary depending on the location of the surgical instrument 14 and the smart packaging system 10 in its life cycle. After manufacture in a factory, the surgical instrument 14 will be packaged and prepared for delivery to ultimately end at a healthcare facility, such as a hospital or surgical center, for use in a surgical procedure. To reach the hospital or surgical center, the smart packaging system 10 will have a series of interactions with various personnel, including factory personnel, warehouse personnel, shipping personnel, customs personnel, and hospital personnel. At each stage of its journey, the smart packaging system 10 can receive and send relevant information to the personnel. Although the smart packaging system 10 can store a variety of information, the smart packaging system 10 can selectively provide only relevant information based on context.

[0053] Additionally, in its travels, the smart packaging system 10 can communicate with a central network, also referred to as a HUB 50, which can monitor and coordinate information including and about the smart packaging system 10. The HUB 50 can exist along the smart packaging supply chain in the form of beacons 102 placed in key locations, such as hospital operating rooms (ORs). When a beacon 102 or other aspect of the HUB 50 detects that a smart packaging system 10 is in close proximity, information can be exchanged between the smart packaging system 10 and the HUB 50, and information can be exchanged between the HUB 50 and various external networks.

[0054] Each beacon 102 can include a transceiver, a transponder, a power source, a processor, and local memory. The beacon 102 can generally operate as an RFID reader in electronic communication with the central network HUB 50. The beacon 102 can communicate wired or wirelessly, such as via infrared communication, radio communication, Wi-Fi communication, Bluetooth, etc. The RFID reader can be a passive reader that can receive signals sent by an active RFID tag, the RFID reader can be an active reader that can send an interrogator signal and receive a reply, such as an authentication reply, from the RFID tag. During operation, the beacon 102 can receive transmitted data from the smart packaging system 10 that characterizes information recorded by the smart packaging system 10 related to its experiences since manufacture. The beacon 102 can then transmit the received data to the HUB 50, where the data can be stored, analyzed, and / or operated on. The beacon 102 can also transmit information from the HUB 50 to nearby smart packaging systems 10.

[0055] Figure 3A And Figure 3B Non-limiting examples of information exchange between the beacon 102 (or generally the HUB 50) and the smart packaging system 10 are shown in FIGS. 1-4. In Figure 3A In FIG. 4, a chart showing the general hierarchy between the HUB 50, the beacons 102 (individually represented as beacons 102A-102D), and one smart packaging system 10 or multiple smart packaging systems 10 (individually represented as smart packaging systems 10A-10L) is depicted. The HUB 50 can communicate with the beacons 102, which can communicate with the smart packaging systems 10. However, in some variations, the smart packaging systems 10 can use their own transmitting and receiving capabilities to directly transmit information to and receive information from the HUB 50. In Figure 3BIn the context shown, a chart is depicted showing an exemplary supply chain 100 and different contexts in which the smart packaging system 10 can communicate with the HUB 50 via one or more beacons 102. Depending on the context in which the smart packaging system 10 is located, the interaction between the smart packaging system 10 and the HUB 50 via the beacon 102 can be important. The context can change as the smart packaging system 10 moves through the supply chain from manufacturing to shipping to use.

[0056] Figure 3B and Figure 4 The supply chain 100 shown is illustrated as a simplified version with key stages along the supply chain of a surgical device or system, such that the depiction of the supply chain 100 is illustrative and exemplary, but not mandatory and necessary. In reality, actual supply chains can include these stages in different order, or they can include additional stages, replicate certain stages, or omit stages altogether.

[0057] The first depicted stage in the supply chain 100 is an assembly stage 120, which can include a beacon 102A to facilitate communication with the HUB 50. The assembly stage 120 represents the manufacturing of the surgical instrument 14. Information exchanged at the assembly stage 120 can include assembly information 112 related to the surgical instrument 14 itself, including its performance metrics, manufacturing specifications, tolerances, safety and usage information, etc. The assembly information 112 can also include sub-assembly information related to one or more sub-assemblies that are compatible with the surgical instrument, for example. Additionally, the assembly information 112 can include work-in-process (WIP) steps and assembly dates of the surgical instrument.

[0058] The second depicted stage in the supply chain 100 is a warehouse stage 110, which can include a beacon 102B. The warehouse stage 110 represents the storage of the smart packaging system 10 prior to shipment. Information exchanged at the warehouse stage 110 can include warehouse information 122, such as lot number, inventory number and count, FIFO date, and shelf location, so that the smart packaging system 10 can be tracked and located within the warehouse itself.

[0059] The third depicted stage in the supply chain 100 is a shipping stage 130, which can include a beacon 102C. The shipping stage 130 represents the transportation of the smart packaging system 10 from the warehouse to the end at a distribution center. Information exchanged at the shipping stage 130 can include shipping information 132, such as ship from address, truck ID, ship to address, handling instructions, and customs data.

[0060] After the third depicted stage, the smart packaging system 10 can optionally be shipped across geopolitical boundaries, including to international locations, before ending at a distribution center. The fourth depicted stage is a customs stage 140, which can include a beacon 102D, and it represents those events when the smart packaging system 10 must cross a geopolitical boundary. The information exchanged at the customs stage can include customs information 142, such as declared value, contents, and certification.

[0061] If the smart packaging system 10 is not an international shipment, the smart packaging system can proceed from the transportation stage 130 directly to the distribution stage 150. If the smart packaging system 10 is an international shipment, it can proceed from the customs stage 140 to the distribution stage 150. The distribution stage 150 represents a warehouse or distribution center, which can include a beacon 102E that receives the smart packaging system before it is delivered to its final destination, such as a hospital. The information exchanged at the distribution stage 150 can include distribution information 152, such as a shelf location, a quantity of a particular stock keeping unit (SKU) in inventory, a model number, a FIFO date, a delivery time, and an expiration date.

[0062] The sixth depicted stage in the supply chain 100 is a local transportation stage 160, which can include a beacon 102F. The local transportation stage 160 represents the transportation required to get the smart packaging system 10 to its final destination. The information exchanged at the local transportation stage 160 can include local transportation information 162, such as a hospital or surgical center location, a truck number, a delivery time, handling instructions, and an invoice number. During local transportation, if any aspect of the smart packaging system has been recalled, the information exchanged can include, for example, a return address, and the smart packaging system 10 can be recalled and returned for evaluation and / or disposal.

[0063] The seventh depicted stage in the supply chain 100 is a hospital stage 170, which can include one or more beacons 102G. The hospital stage 170 represents a hospital or surgical center where the surgical instrument 14 will be used during a surgical procedure. If the local transportation is able to deliver the smart packaging system 10, the local transportation delivers the smart packaging system 10 to the hospital, where it can be stored within the hospital until needed. The information exchanged at the hospital stage can include hospital information 172A, such as an operating room (OR) number, a storage location, and an item count. If the local transportation is unable to deliver the smart packaging system 10, such as for a recall, the smart packaging system 10 can exchange recall information 172B, such as a return address for the smart packaging system, and a warning with information related to the recall.

[0064] The eighth depicted stage in the supply chain 100 is an OR stage 180, which can include a beacon 102H. The OR stage 180 represents an operating room in which a surgical instrument 14 will be used as part of the smart packaging system 10. Information exchanged at the OR stage 180 can include OR information 182, such as OR room number, surgical kit details, instrument number of total equipment required for the surgery, surgeon information, and patient information.

[0065] The information described at each stage in the supply chain 100 is merely exemplary and does not represent an exhaustive list of information that can be exchanged at a given stage.

[0066] In general, the smart packaging system 10 can provide information to a user (e.g., a shipping worker, a customs officer, a surgeon, a warehouse worker, etc.) about itself. The information can be delivered by the smart packaging system 10 in a variety of ways, as will be described below, and the information delivered can depend on a variety of factors, including: composition, contents, current location, destination, user identity, authorization level, functional capabilities, external stimuli, etc.

[0067] In some embodiments, the smart packaging system 10 is configured to store its intended destination (e.g., a particular hospital) and document and store its history as it progresses toward its intended destination. Additionally, the smart packaging system 10 can be configured to determine its location within a path to its intended destination.

[0068] The smart packaging system 10 can locate and monitor aspects and components of the smart packaging system 10, such as the surgical instrument 14, surgical accessories and contents contained therein, and other elements within the operating room. This information can be broadcast or otherwise provided as needed. For example, as items enter the operating room containing the smart packaging system 10, these items can be added to a database containing a list of components present in the operating room in real time. This list can be stored on the smart packaging system 10 or on a device in electronic communication with the smart packaging system 10, the HUB 50, or another similar system. If the smart packaging system 10 enters an operating room that already contains items, these items can be added to the list upon first detection. As items on the list leave the operating room or are disposed of, these items can be removed from the list.

[0069] Items can be added to the list through manual entry or through scanning (e.g., via a barcode or QR code, or by remote scanning by an electronic system such as HUB 50), or through any combination of the methods described herein. When items are added to the list using manual entry, the healthcare personnel can enter information characterizing the items present in the operating room. When items are disposed of or otherwise removed from the operating room, the items can be manually deleted from the list. When scanning is the method of entry, various methods can be used. These methods can include manual scanning, active wireless transmission by capable devices, direct detection, geofencing, BLE beacons, and surgical steps.

[0070] Manual scanning can also involve the healthcare personnel, but rather than manually entering attributes of items upon entering the operating room, the healthcare personnel can scan the items using any of the described methods, and the attributes of the scanned items can automatically populate the list. For example, by scanning the barcode of a smart packaging system 10, the attributes of the smart packaging system 10, such as the contents of the smart packaging system (e.g., surgical instruments 14, surgical accessories, etc.) and related details, operational capabilities of the contents, etc., can be obtained from the barcode and added to the list.

[0071] Active wireless transmission is a category of technology for object monitoring. Active wireless transmission can operate between capable devices to transmit information between the devices. A polling device, such as HUB 50 or a smart packaging system 10, can transmit a wireless poll or ping. Capable devices within range of the wireless poll or ping can respond to the wireless poll or ping by transmitting their own signals toward the polling device. Based on the signals transmitted by the polling device, both the direction and distance to each of the detected devices can be determined. With this information, the polling device can further determine whether the detected device or devices are within the operating room or area of interest. Devices determined to be within the operating room can be added to the list.

[0072] This method can even be used to detect devices that are not currently within a region of interest, such as an operating room, but should be within the region of interest. For example, if a polling device sends a signal and detects a device that is within range but outside of the operating room, and the polling device knows that the detected device should be in the operating room, a notification can be provided informing the user of this information. Additionally, the user can be provided with a direction and distance to the detected device or devices so that the user can locate the detected device or devices. This information can be provided on the display 22 of the smart packaging system 10, on a display of the polling device, or on a monitor in electronic communication with the sending device, such as a monitor located within the operating room. Furthermore, the detected device or devices can be requested via the sending to provide secondary local feedback to enable location, i.e., the detected device or devices emit their own sending to receive information about their current location, proximate devices, etc., which can then be provided to the initial polling device. If capable, the detected devices can also be made to play an audio signal.

[0073] Directly detecting aspects of a device or component is another class of technology for object monitoring. If a searched device has certain physical properties, detection can utilize these physical properties to locate the searched device. For example, if a searched device is known to be metal, the metal can be detected via impedance or capacitive field monitoring to locate the searched device in a scanned area.

[0074] Active global geo-fencing is another class of technology for object monitoring. An active global geo-fence can be assigned to a particular geographic physical location, and all objects passing through the fence can be tracked. Combinations of systems can be combined to monitor objects passing through the fence, such that combinations of devices or objects as individual elements can be detected by the combination of systems. This monitoring can work in a variety of ways, such as relying on a particular visual indicator present on an object to continuously track the object. For example, a package of surgical needles can include a particular yellow and black striped pattern. A camera included in a system can be relied on to visually monitor the area for the particular yellow and black striped pattern, even under multiple angles. When the pattern is detected, the object can be added to a list of items known to be present within the geo-fence. One example of detecting an object includes a number of surgical sponges that can have integrated RF transmitters. A surgeon or other personnel can use a corresponding device, such as a wand, to determine if sponges were left behind after a surgical procedure. One advantage provided by the geo-fence would include automatically tracking and detecting such sponges to ensure removal of the sponges without requiring active detection by the surgeon or other personnel.

[0075] Bluetooth Low Energy ("BLE") beacons can be employed for another class of technology for object monitoring. BLE beacons can repeatedly send signals that other devices can detect, such as via radio signals. The signals can include coded messages of letters and numbers sent on short intervals, which can be used for specific transmissions and encode specific messages and data. BLE beacons can be used to register products that are currently located in the operating room, and they can also be used to communicate detected changes in status of objects and products. Once an object enters the operating room, an initial detection by a BLE beacon can add the object to a database list. Further, if a status change occurs, that information can be communicated to other networks. For example, if a smart packaging system 10 is opened, the beacon can change its message to indicate that the given product is currently in use in the operating room. A signal can be sent to the HUB 50 to flag the opened smart packaging system 10 out of inventory for the entire healthcare facility to indicate that the opened smart packaging system 10 is no longer inventoried. In another example, if an object leaves the operating room, the BLE beacon can send a message to indicate whether the object is being retired back to a central storage, or whether the object has been consumed and is now entering a waste stream.

[0076] Tracking objects through surgical steps is another class of technology for object monitoring. Tracking objects through surgical steps can require reliance on previously described technologies, such as geofencing, in order to provide additional information for object monitoring. For example, geofencing can be used to specify a sub-region within the operating room (e.g., a surgical field of view). Objects that are known to be required for a surgical procedure but have not been detected to enter the geofenced surgical field of view can provide an indication that a certain step in the surgical procedure has not yet occurred.

[0077] Multiple communication devices in the operating room environment can be disruptive and cause interference between signals sent by these communication devices. A variety of techniques can be employed to minimize disruption. For example, the smart packaging system 10 can incorporate one or more methods for changing the bandwidth of its transmissions, as well as a variety of communication methods. Some communication methods can rely on the internal power source 15 of the smart packaging system 10. Some methods can obtain power from external sources, such as external electromagnetic fields, such as with near field communication (NFC), or with external wired connections, such as via a USB cable, etc.

[0078] The smart packaging system 10 can rely on RFID tags to communicate with other devices, but if the RFID becomes unavailable, the smart packaging system can rely on secondary communication means. For example, NFC and RFID can be combined, such that with RFID, power is obtained from an external field and broadcasting only occurs when the system is prompted. With NFC, an antenna can be used, and upon activation, other systems, such as WIFI and battery systems, can be deactivated to conserve power.

[0079] Other techniques for minimizing interference can vary. For example, a surgical cart (described herein) can be equipped with intelligence and when an intelligent device is placed on the intelligent cart, the intelligent device can detect the intelligent cart and can cede communication capabilities to the intelligent cart, i.e., the intelligent cart can maintain a list of devices placed on it and can handle all location requests sent to the devices on the list. For example, if the intelligent packaging system 10 is opened, location-related communication can be disabled. For example, location-related communication can be disabled based on the current location of the intelligent device. If the intelligent device is in transit for shipment, the location-related request capabilities can be disabled to conserve power. For example, the intelligent device can be limited to a finite number of broadcasts for a given event. If a device is programmed to broadcast its change in location during movement of the device, the device can instead be limited to providing less frequent broadcasts, at least in some scenarios. For example, the intelligent device can operate in a tiered system such that all transmissions of the intelligent device are communicated to a central point (such as the HUB 50) and the HUB 50 routes the transmissions to their correct receivers while prioritizing and coordinating the transmissions to minimize interference.

[0080] In some embodiments, the intelligent packaging system 10 can document information related to its assembly and manufacturing aspects, and the intelligent packaging system 10 can store and provide the information to various personnel interfacing with the intelligent packaging system 10 and make certain decisions based in part on the stored information. The stored information can vary and can include information related to aspects that ultimately affect the use of the intelligent packaging system 10 and its contents, including surgical equipment (e.g., surgical instruments 14) contained therein. For example, the stored information can include information related to calibration and specific settings of the intelligent packaging system 10, which can adjust the operation of the intelligent packaging system 10 based on a combination of settings and equipment interactions; information related to the manufacturing process and manufacturing materials of the intelligent packaging system 10; and information related to special instructions for use of the intelligent packaging system 10 and operational limitations, such as adverse reactions with other equipment.

[0081] When the information relates to calibration and specific settings of the smart packaging system 10, the information can specifically include information related to calibration of the smart packaging system 10 and its contents, which adjusts operation of the contents (e.g., surgical instrument 14) based on other equipment paired with or used with the contents. This can be accomplished by locating or determining key aspects of the smart packaging system 10 and its contents related to various combinations of accessories and equipment combined or grouped with the smart packaging system 10 and its contents. For example, surgical instrument 14 can operate with a variety of surgical needles, each of which can be tagged with an RFID tag (e.g., similar to RFID tag 16) or equivalent. When the surgical instrument is paired with a certain tagged surgical needle, the calibration of the surgical instrument can be adjusted based on the pairing. The information required to make the adjustment can be coordinated via HUB 50, or the surgical instrument 14 can be programmed to recognize the result of pairing with that particular kind of tagged surgical needle.

[0082] Locating or determining key aspects of the smart packaging system 10 and its contents related to various combinations can improve traceability of the constituent components making up the smart packaging system 10. Such traceability can be beneficial for sustainability efforts, safety efforts, and the like. The smart packaging system 10 can store a log or inventory of the constituent components of the smart packaging system 10, such as various needles, blades, batteries, sensors, housings, and the like. Separable components can be identified as special elements that must be accounted for after a surgical procedure or other procedure. Additionally, the manufacturing source of each component of the smart packaging system 10 can be included in the metadata of the smart packaging system 10. This information and its use are set forth in greater detail below.

[0083] When the information relates to manufacturing processes and materials, the information can specifically include information related to manufacturing processes of the components of the smart packaging system 10 and the component composition.

[0084] Manufacturing tracking information can include information related to the procedures experienced by the components of the smart packaging system 10 from assembly to shipment. For example, once the components are assembled, the tracking information can record when the components are compiled into the smart packaging system 10. The smart packaging system 10 can be marked with a base serial number as well as any other special identifying information necessary. The smart packaging system 10 can also be marked with one or more additional serial numbers related to the particular components contained therein, as well as additional data to assist in post-assembly procedures, such as information to assist in evaluating the smart packaging system 10 after a potential recall. The smart packaging system 10 can also be marked with information related to manufacturing data and location.

[0085] Manufacturing tracking information can also include sterilization counts and procedures, as well as related sterilization information, including sterilization data.

[0086] Manufacturing tracking information can also include information related to the entry of the smart packaging system 10 into the bulk packaging / shipping protocol. For example, in a variation of the smart packaging system 10 that relies on the smart display 22, the smart display 22 can be configured to display information related to the current status of the smart packaging system 10, and if the smart packaging system 10 does not know or cannot discern the current status, the display 22 can default to displaying the last known location. The display 22 can also be configured to display information related to the contact information of the manufacturer.

[0087] Component composition information can include information related to the composition of a given component of the smart packaging system 10. This information can include any notable materials of the component, or in the case where two alternative compositions can be employed, the specific composition of the component can be included so that there is no ambiguity. For example, the smart packaging system 10 can include a surgical instrument 14 in the form of an endoscopic cutter. Certain endoscopic cutters can include a channel retainer that can be either plastic or aluminum, which can affect the decontamination process of the endoscopic cutter and affect disposal protocols, among other things. The component composition information can specifically include an indication of whether the channel retainer is plastic or aluminum to clarify ambiguities surrounding the decontamination protocol of the endoscopic cutter.

[0088] In another example, the component composition information can convey whether a radioactive needle is included in the smart packaging system 10. Such inclusions can affect the labeling requirements and travel restrictions of the smart packaging system 10 when applied to certain jurisdictions. The component composition information can also include information related to other regulated components that can face restrictions when transported internationally. For example, cobalt is subject to certain regulations in Europe, and this information would be notable in the context of European regulations.

[0089] In general, the smart packaging system 10 can know its history and future state, as well as its intended use throughout its life cycle. In essence, the smart packaging system 10 can have a sense of self awareness during its life cycle. This awareness can result in the smart packaging system knowing: 1) its location within the facility supply chain; 2) when it is received at a healthcare facility; 3) when it enters a storage room or storage location at a healthcare facility; 4) when it is requested for use in a medical procedure; and 5) when it enters an operating room for the requested medical procedure. Each of these aspects of awareness will be further described.

[0090] The locations that trigger different labeling or information transmissions can generally include: a warehouse, a storage device, in transit, a sterilization zone, a supplier distribution center, a mode of transportation, customs, a regional distribution center, in local delivery, a healthcare facility receiving area, a storage room, an operating room, a re-packaging area in an operating room, a healthcare facility cleaning / sorting area, a disposal area, a re-use area, a return shipping area, etc.

[0091] The smart packaging system 10 can be aware of its location in the facility supply chain. Specifically, as described herein, the smart packaging system 10 can be aware of the virtual kit. The smart packaging system 10 can also identify connectivity components to enable interfacing with various facility equipment, protocols, etc. The smart packaging system 10 can also identify missing capital equipment within the operating room. For example, if a certain software is outdated, it can be flagged by the smart packaging system 10 such as by a notification on the display 22 or via a transmission by the smart packaging system 10 to devices in electronic communication with the smart packaging system 10. The smart packaging system 10 can identify attempted communications with incompatible systems. The smart packaging system 10 can relay information to other devices that identify incompatible systems to prevent the identified systems from attempting communications with those other devices. The information can also be relayed to the HUB 50, which can alert the correct user.

[0092] The smart packaging system can include at least two separate sterile visual indicators, for example, as seen in Figure 5 Figure 5 A smart packaging system 10 according to another variation is depicted. The smart packaging system 10 can include a first indicator 2011 and a second indicator 2012. The indicators 2011, 2012 can convey a change in sterility, such as a loss of sterility within the smart packaging system 10. Each indicator 2011, 2012 can be an element that changes appearance, changing color or from invisible to visible. The first indicator 2011 can indicate whether the smart packaging system 10 has been adequately sterilized. The second indicator 2012 can indicate whether sterility has been lost. Each indicator 2011, 2012 can initially be triggered by a sterilization event, but the second indicator 2012 can be triggered in the event of a loss of sterility while the first indicator 2011 remains unchanged.

[0093] The first indicator 2011, also seen in Figure 6 The first indicator 2011, also seen in

[0094] For the second indicator 2012 (in Figure 7 ​As seen in FIG. 20, for example, the packaging process can include a step of capturing an inert gas or vacuum within a balloon 2030 or similar device stored in the smart packaging system 10 at a pressure (Pi) other than atmospheric pressure. The balloon 2030 is placed within the sealed smart packaging system 10, and the interior of the balloon 2030 is maintained at atmospheric pressure (P2). If the outer seal is broken such that P2 is now equal to Pi at atmospheric pressure, the size of the balloon 2030 or similar device will thus change, thereby indicating that the smart packaging system is broken and sterility is lost.

[0095] An alternative second indicator (not shown) can involve a double-walled balloon located within the smart packaging system 10. The inner balloon contains a volume at a first pressure Pi, and the outer balloon contains the inner balloon and is maintained between the outer and inner balloons at a second pressure P2. The outer balloon is made of a thin material and ruptures upon sterilization, releasing its contents into the smart packaging system 10 and releasing the inner balloon. This results in an increase in pressure within the smart packaging system (assuming P2 is greater than atmospheric pressure). The inner balloon remains at Pi, and upon breakage of the smart packaging system 10, the pressure will drop to atmospheric pressure, thereby changing the shape of the inner balloon and indicating that sterility has been compromised. These indicators 2011, 2012 can assist in avoiding reuse of the packaging, and can assist in preventing counterfeiting.

[0096] Returning to the supply chain, the smart packaging system 10 can sense when it is in a warehouse and when it is in transit, and it can send information as needed via the display 22 or some other means described herein. This information can include a serial number, lot number, manufacture date, country mode code, mode of transportation, etc. In the warehouse, the information sent can include a UDI, lot number, and other information relevant to warehouse operations. When the smart packaging system 10 determines that it is being loaded for shipment, the information can change to include an address, handling instructions, etc. The smart packaging system 10 can also display shipping identification information. When received by a distributor, the information sent can include an expiration date, bin number, location, count, etc. The smart packaging system 10 can also display information related to the current or future geopolitical location, such as information related to regulatory information for that location. For example, if the smart packaging system 10 contains lithium ion batteries, the smart packaging system 10 can display a warning explaining that lithium ion batteries cannot be shipped on commercial flights. When the smart packaging system 10 is with a supplier, the information sent can include first in first out information, lot number, unique identifier, build aspects, etc. The supplier can be interested in the direction of development of the smart packaging system, the quantity of shipments, where it should be stored, and other information. When the smart packaging system 10 is at customs, the information sent can include the value of the product, destination, origin, common name, hazardous material warnings and descriptions, fragility, perishability, liquids, etc. When the smart packaging system 10 is on the way to a healthcare facility, the information sent can include the address of the facility, invoice, list of items in shipment, purchase order number, handling requirements (e.g., refrigeration, etc.).

[0097] The smart packaging system 10 can sense when it is received at a healthcare facility, for example, upon initial scanning at the HUB 50, upon initial scanning by facility personnel, upon manual or remote activation, upon determining a current geographic location, upon detecting a compatible system that indicates the healthcare facility, or by some other detection means. When the smart packaging system 10 receives the determination indication at the healthcare facility, the smart packaging system 10 can run an internal check to determine its own status, and can take certain actions based on its own status. When the smart packaging system 10 is received at the facility, the information sent can include a storage location and expiration date.

[0098] As explained herein, the smart packaging system 10 can include one or more sensors that measure the environment in which the smart packaging system 10 is located, such as temperature sensors, humidity sensors, etc. Based on the data collected by the sensors, the smart packaging system 10 can sense a situation in which the external environment is potentially harmful to the smart packaging system 10. For example, if the smart packaging system 10 has a maximum temperature threshold of 100 degrees Fahrenheit, but the temperature sensor detects a temperature greater than that threshold, the smart packaging system 10 can assume that it is at risk of adverse damage to itself due to the temperature exceeding a safe threshold. As described, other sensors can be used to determine when the smart packaging system 10 has experienced some environmental condition that can result in damage to the smart packaging system 10, and the particular safety threshold can vary depending on aspects of the smart packaging system 10.

[0099] If the smart packaging system 10 determines that it has experienced an unsafe environment, the smart packaging system 10 can respond in a number of ways. For example, the smart packaging system 10 can display a warning on the display 22, or display a warning via a transmission to a device in electronic communication with the smart packaging system 10. The warning can be a simple message, such as “Do Not Use.” More specific details can then be provided upon request from another system, such as the HUB 50, a scanner, etc., in order to understand why the smart packaging system 10 displayed such a warning. These details can indicate that the packaging experienced, for example, too high of a temperature, which has now potentially compromised the smart packaging system 10.

[0100] In some variations, if the smart packaging system 10 senses an event, such as too high of a temperature, too much humidity, an expiration date is exceeded, the smart packaging system 10 is subjected to too much force, etc., one or more operational capabilities of the smart packaging system 10 can be disabled. This disabling can occur at various stages. For example, if the smart packaging system 10 is in communication with the HUB 50, such as for a status check or other reason, the HUB 50 can run a quick diagnostic test to determine if the smart packaging system 10 has experienced any potentially harmful events. If a harmful event is detected, such as a loss of sterility, a termination switch can be activated within the smart packaging system 10.

[0101] The termination switch can come in various forms, and examples can be seen in Figure 8 , Figure 9 and Figure 10 . Figure 8 A smart packaging system 10 is depicted that includes a surgical instrument 14 electrically coupled to a sensor 2040 and a circuit 2042 equipped with a battery 2044 and a solenoid 2046. Upon detection of a harmful event by the sensor 2040, a termination switch can be triggered in the smart packaging system 10. Figure 9A first variation of the kill switch is depicted, in which a trigger solenoid 2046 is used to open a first portion 2048 of the circuit 2042 that carries power from the battery 2044 to the surgical instrument 14, thereby permanently disabling the smart-pack system 10. Figure 10 A second variation of the kill switch is depicted, except that instead of opening the circuit 2042 to isolate the battery 2044, the solenoid 2046 opens a second portion 2049 of the circuit to isolate the surgical instrument 14, thereby forcing the battery 2044 to deplete at a rate that compromises the integrity of the battery 2044. Other kill switches, not depicted, can include software that interrupts the boot sequence of the affected smart-pack system 10. Upon detecting a harmful event, the software prevents the smart-pack system 10 from starting properly, effectively preventing any use of the smart-pack system 10.

[0102] As explained above, the smart-pack system 10 can sense when it enters a healthcare facility storage device. The smart-pack system 10 can include a readable medium 20 of device information, and a tag of the smart-pack system 10 can be generated by the healthcare facility that explains to the HUB 50 how to parse the device information into a format compatible with the healthcare facility’s record system for automated report writing in post-procedure procedures involving the smart-pack system 10. In practice, when the surgical-pack system 10 is received at a healthcare facility, the surgical-pack system can be scanned and immediately logged within the facility’s inventory. Once in inventory, the smart-pack system 10 can be monitored for events of interest, including recalls, expiration, first-in-first-out usage, etc. Monitoring can even include special use cases, such as when a procedure involving the smart-pack system 10 needs to exert high stress during the procedure. Selection of the smart-pack system 10 can occur based on the need for high stress exertion, where older smart-pack systems 10 can not be selected in preference due to the increased likelihood of operational risks associated with older smart-pack systems 10 performing high stress exertion. Conversely, a more “fresh” smart-pack system 10 can be selected despite a first-in-first-out usage policy.

[0103] The smart-pack system 10 can be provided with an adaptive expiration date, which can be programmed and stored on the smart-pack system 10. While a default expiration date can be provided, the adaptive expiration date can be adjusted based on environmental conditions measured by the smart-pack system 10. For example, if the shipping journey and / or storage room is very hot, the expiration date can come sooner than expected. The adaptive expiration date can be adjusted based on environmental data sensed by sensors of the smart-pack system 10.

[0104] The smart packaging system 10 can indicate its expiration date in a variety of ways, including light indicators (e.g., green and red), non-electric indicators (e.g., time-based markers), scanning and providing the information on the user's device, periodically registering and providing the user with corresponding notifications about expired products by the HUB 50, the HUB 50 checking all smart packaging systems entering and leaving the storage room and notifying the user of any expiration dates, and so on.

[0105] exist Figure 11A and Figure 11B The example smart packaging system 2010 with a dynamic tracker 2050 can be seen in the image. Figure 12A and Figure 12B Tracker 2050 can be seen in more detail below. Smart Packaging System 2010 may be identical to Smart Packaging System 10 in any variant described herein. Smart Packaging System 2010 may include a tray insert 2052 on which the contents of Smart Packaging System 2010 (including surgical instruments 2014) are located in various compartments, wherein surgical instruments 2014 are placed in a first compartment 2052A and tracker 2050 is placed in a second compartment 2052B. A lid 2054 may be used to seal tray insert 2052 to maintain the sterility of Smart Packaging System 2010. To check the sterility of Smart Packaging System 2010, a user may peel off lid 2054 to expose tracker 2050 while keeping Smart Packaging System 2010 sealed.

[0106] The tracker 2050 can interact with multiple components to enhance its operational capabilities. Figure 12A The tracker 2050 and components can be seen in block diagram 2060, which provides illustrative and non-limiting examples. Tracker 2050 components may include sensor 2062, processor 2064, timer 2066, battery 2068, and indicator 2069. Sensor 2062 may be one or more sensors described herein, such as a temperature sensor or other sensors capable of detecting environmental conditions that may affect the sterility and conditions of the smart packaging system 2010. A switch 2070 may also be included, and when switch 2070 is in a first position, such as... Figure 12A As seen in the diagram, the circuitry between sensor 2062, processor 2064, timer 2066, and battery 2068 can be complete. When switch 2070 is in the second position, as... Figure 12B As seen in the image, indicator 2050 can also receive power from battery 2068, and tracker 2050 can show the remaining time before expiration and / or current status of smart packaging system 2010.

[0107] Although not shown, the block diagram 2060 can have components that enable wired or wireless communication with other features of the smart packaging system 2010, the HUB 50, and any other type of device described herein.

[0108] The smart packaging system 10 can be aware of when it is needed for use in a medical procedure. The smart packaging system 10 can be aware of the kinds of procedures it is typically used in, the types of equipment used in those procedures, its operational capabilities and requirements, etc. Accordingly, the smart packaging system 10 can recommend, via the display 22, an electronic notification of a preferred storage location within the healthcare facility, etc., which can include environmental factors, proximity to other compatible products, etc.

[0109] The smart packaging system 10 can include indicia to enable the smart packaging system 10 to customize integration of the smart packaging system 10 into operation of the healthcare facility. The indicia can include a scannable code of the device information and a second indicia generated specifically by the hospital that tells the HUB 50 how to parse the device information into a format used by the facility to feed into records for post-procedure reporting write-up.

[0110] If the smart packaging system 10 becomes aware that it has been requested for use in a particular procedure, the smart packaging system 10 can also know that, generally, certain equipment is used in conjunction with the smart packaging system 10. Some of these other equipment can be smart equipment that is capable of communicating with the smart packaging system 10, the HUB 50, and other devices. When the smart packaging system 10 detects an incompatibility, it can provide an alert or notification of the incompatibility. However, in some cases, a physician can pull an odd-looking combination of devices. The smart packaging system 10 can ask the physician if they would like to register the combination as a new bundle for future reference.

[0111] When a product is pulled for use, the information sent by the smart packaging system 10 can include the cart number, item number, destination, whether a return visit to the storage room is needed, the physician’s name, etc.

[0112] The smart packaging system 10 can be aware of when it enters the operating room. If the smart packaging system 10 is confirmed for use in a procedure, no alarm, warning, or other contraindication is issued. The smart packaging system 10 can display a message indicating that the procedure is ready, such as a specific word like “Ready” or a symbol such as a green checkmark intended to indicate readiness. The various smart packaging systems 10 used in that procedure can also change their displays 22 to reflect the order of use typical for the procedure (e.g., 1 / 5, 2 / 5, etc.).

[0113] If the smart packaging system 10 enters the operating room and issues an alarm or warning, or some other message such as an indication of a preferred alternative, the display 22 or a display of the smart packaging system 10 can provide an indicator such as "Danger not cleared, do not open" or other message, symbol, etc. Such a message can also be displayed on the smart packaging system 10 which should not be opened until a certain time in the procedure, even if the smart packaging system 10 is otherwise cleared of danger.

[0114] For a given procedure, the HUB 50 or other system can display an indicator of readiness. This indicator can reflect the proportion of components needed for the surgical procedure that are ready, and the indicator can be represented as, for example, a loading bar. There can also be an indicator of the entire procedure, such as a timeline that indicates when certain smart packaging systems 10 should be used relative to one another. If certain information is critical to the procedure, that information can be displayed in a conspicuous manner, such as in a conspicuous location, in an appropriate size, and with additional indicators such as a flashing light, a sound alarm, etc. Certain information indicators can also be temporary, such that they disappear if they are ignored for a certain amount of time.

[0115] When the smart packaging system 10 is located in a healthcare facility, the smart packaging system 10 can be tracked systemically as part of its ability to receive and transmit electronic information. The smart packaging system can be tracked using a management system for "floating" inventory management that is virtual and non-continuous, but allows for instant retrieval of the location, identification, and tracking of all smart packaging systems 10 in a similar situation within a particular healthcare facility. Such a management system can utilize the capabilities of the smart packaging system 10 as described herein in order for the HUB 50 or other similar management tool to plan procedures and flow inventory as needed based on the HUB 50 and smart packaging system 10's situational awareness of the healthcare facility's procedures, staff, and schedules. This can allow the healthcare facility to stock fewer smart packaging systems 10 overall, as a particular smart packaging system 10 with its unique contents can be tracked and located at any time without needing to have excess product on hand.

[0116] The management system and its various applications, including those related to the capabilities of the smart packaging system 10, will be described below.

[0117] The smart packaging system 10 can dynamically be aware of its location and distribution throughout its lifecycle. For a given smart packaging system 10, the contents of the smart packaging system 10 and surgical instruments 14 can be tracked as they are located in a healthcare facility due to the communication capabilities of the smart packaging system 10 and surgical instruments 14 and the HUB 50. This can allow the smart packaging system 10 to be located not only within a particular storage room within a healthcare facility, but also in a lobby, on a cart, at a returns desk, in a misplacement location, etc.

[0118] Accordingly, management of the smart packaging system 10 need not necessarily rely on physical storage rooms, but rather the management system can rely on a virtual storage room, which can take various forms, such as an electronic database of various smart packaging systems 10, their locations, their operational capabilities, etc. The virtual storage room can include preset locations, such as physical storage rooms located within a healthcare facility, and smart packaging is generally stored in these dedicated storage rooms. However, the virtual storage room can serve as an overall management tool that can be updated in real-time to reflect current information of various smart packaging systems 10 in the healthcare facility.

[0119] In an example, if two smart packaging systems 10 are transported to an operating room for a surgeon to select between the smart packaging systems 10, the unwanted smart packaging system 10 can be placed on a cart to be returned to a storage room. If the smart packaging system 10 is needed in another operating room before the cart can return the smart packaging system 10 to the storage room, it can be difficult to track the smart packaging system 10 in a traditionally managed healthcare facility. With a virtual storage room, the smart packaging system 10 can be continuously tracked, and the cart can be transferred to the second operating room so that the smart packaging system 10 can be immediately put into use without first restocking the smart packaging system 10 in a storage room. This can greatly improve efficiency within a healthcare facility.

[0120] With such a management system, unopened smart packaging systems 10 can be transferred to different operating rooms or patients based on any kind of need, priority, timing, etc. Furthermore, when a first choice for a smart packaging system 10 is not available, suitable alternative options can be quickly located and provided. Since such alternative operations exist on the virtual storage room database, these alternative operations can be easily located within a healthcare facility.

[0121] In another aspect, such a management system can provide automated inventory location and circulation. For example, delivery of inventory can be automated, such as by robotic devices. In some healthcare facilities with automated inventory management robots and other kinds of robots, this type of management system can allow for the location of a particular smart packaging system 10 to be provided to such a robot, which can then travel to wherever the smart packaging system 10 is located to retrieve it.

[0122] The need for physical storage rooms located in fixed locations can be reduced or eliminated entirely by the addition of specialized robotic systems, virtual inventory management systems, and / or the like. These new storage rooms can be a series of mobile "cabinets" with a series of smart packaging systems 10. Because of the need for smart packaging systems 10, the "cabinets" (essentially robots with a large amount of storage) can travel to the location where the smart packaging system 10 is needed and the smart packaging system 10 can be automatically delivered. The automated delivery can be stopped for various scenarios (such as for a certain amount of time before a procedure, upon detection of the opening of the smart packaging system 10), so that a replacement or automated delivery, etc., is no longer needed.

[0123] The system can further control the management of smart packaging systems 10 based on a number of factors and prioritize the movement of the smart packaging systems accordingly, such as by keeping frequently used smart packaging systems 10 in more convenient locations to allow for quick delivery, and by provisioning smart packaging systems 10 in a first-in, first-out manner to reduce the likelihood of the smart packaging system 10 expiring. Alternatively, a specific expiration date of the smart packaging system 10 can be tracked so that the expiration is taken into account when providing the smart packaging system 10.

[0124] In some variations, the management system can employ the use of one or more "smart" operating rooms that can be used to catalog the equipment, supplies, and products that go into it. If cataloged items are not consumed for a given procedure, they can be gathered together to leave the operating room to be returned to storage. As the items leave, the management system can add the items back to the virtual inventory database for future use, e.g., via HUB 50.

[0125] As the smart packaging systems 10 move around a healthcare facility during their management, the smart packaging systems 10 can display information related to that management via the smart display 22, display 22, etc. For example, the smart packaging system 10 can display the operating room number that it is scheduled to use.

[0126] To make the management of the smart packaging systems 10 more efficient, the management system can re-route the smart packaging systems 10 so that they do not move in an inefficient manner. For example, if a smart packaging system 10 is initially requested for use in a first location, but then needed in a second location, instead of first transporting the smart packaging system 10 back to a storage room before transporting it to the second location, the smart packaging system 10 can be routed directly to the second location.

[0127] The management system can employ the use of smart carts that can be included in the virtual stockroom. The smart carts can have the ability to determine one or more products on them and can also provide their location and the location where their products are located. As part of being included in the virtual stockroom, the smart carts can have a unique digital ID and can be tracked within the management system. The smart carts can be equipped with their own display device, such as the one found on the smart packaging system 10, and the smart cart can display information related to the products it carries, the cart destination, plans, etc. The smart cart can also be equipped to identify personnel in its vicinity, such as by detecting a smart badge or other device. The smart cart can communicate certain information to the identified personnel to relay messages, issue requests, etc. For example, the smart cart can instruct the personnel to remove certain products from the smart cart to complete a delivery.

[0128] In some variations, the smart carts can be maneuvered by a person as the products are moved to various locations within the healthcare facility, or the smart carts can be drivable or self-driving. The HUB 50 can track the smart carts as they pass by beacons or as they electronically communicate with other networked equipment. Through this tracking, the smart carts can be directed to various locations and personnel at the healthcare facility can be directed to the carts as needed in order to move the products around the healthcare facility. In some aspects, the smart carts can be free-floating and can be moved to critical areas of the healthcare facility as needed.

[0129] Further, the smart carts can be equipped to display instructions for their next destination, such as a particular operating room in the healthcare facility. These instructions can also include a list of products to be delivered to a set location at the time of delivery.

[0130] In some aspects, the smart carts can be specialty dependent, i.e., all products on a given smart cart are related to cardiovascular surgery. The smart cart can be colored or otherwise marked to indicate this particularity in order to inform observers of the general contents of the cart.

[0131] The management system can aggregate the smart packaging systems 10 and the smart packaging systems 10 can coordinate between them in order to determine priorities, status, and location, among other information. This communication between the smart packaging systems 10 can occur at any time that two or more smart packaging systems 10 are within range of electronic communication occurring and specifically, when the smart packaging systems 10 are located on the same smart cart or in the same physical stockroom, operating room, etc.

[0132] If a smart packaging system 10 is accidentally removed from a smart cart, a notification can be sent by any capable system that senses the removal from the smart cart to the HUB 50 to indicate to the HUB 50 that the particular smart packaging system 10 that was removed is not available for use because that particular smart packaging system is in transit. A request can be made to deliver a replacement product or component to the particular smart cart from which the smart packaging system 10 was removed in order to minimize disruption to the planned schedule.

[0133] The management system can employ a priority system or hierarchy among any kind of equipment. More important equipment can be tracked more closely than less important equipment, and if there is a problem with the management or delivery of two pieces of equipment, the equipment deemed more important by the priority system can be prioritized. For a given smart cart, as packaging is removed and delivered, eventually a threshold is reached, or there is a window in the delivery schedule in which the smart cart can be restocked. With the current management system, restocking can be coordinated to be more efficient. For example, assume that two smart carts are loaded with nearly identical products at the beginning of the day, and assume that one cart is missing a certain product and needs to be restocked, and the other cart has an excess of that product, the two smart carts can coordinate their restocking with each other so that the cart with the excess product can restock the product- deficient cart. This can eliminate an additional trip to the storage room.

[0134] The expiration date of a smart packaging system 10 can be tracked, and as the expiration date approaches, the smart packaging system 10 can be given increased priority to minimize waste.

[0135] In the event that a backup inventory or replacement product is needed, the smart cart can guide the user to find a replacement product. This guidance can manifest as pointing the user to another cart with the replacement product, pointing the user to a particular library storage room containing the product, etc.

[0136] While certain items can not traditionally have “smart” capabilities, all packaging can be equipped with RFID tags or equivalent devices to provide a minimum level of “smart” functionality, which can achieve at least a basic level of management.

[0137] In some variations, the smart cart can display an active inventory of items currently located thereon. This information can be found on a display or other user interface, which can also be navigable (such as through a touchscreen, buttons, or other input) in order to provide information to the user in an organized and meaningful way.

[0138] While planning and scheduling can be implemented to direct smart carts when needed based on various information related to surgical procedures, stockpiles, etc., the scheduling can change quickly. When the scheduling changes and thus needs to change, the management system can adjust based on the updated information to re-route the carts to where they are needed. This information can be provided to the smart carts in the form of updates or alerts to communicate the updated path to the handlers, or if the smart carts are autonomous, the carts can receive the updated route information and then respond automatically. This type of response can reduce the confusion associated with schedule changes and updated procedures related product coordination.

[0139] In some variations, the smart cart can be modular and can be aware of common aspects of products in order to optimize handling and delivery. The smart cart can be equipped with attachable and reattachable sub-sections in the form of trays, drawers, etc. that can be packaged with smart packaging systems 10 or specific arranged groups of products, such as for a given procedure, etc. The sub-sections can be attached in a variety of ways, such as by a series of magnets, by latches, or by other means. This can allow for quick replacement and stocking of smart carts with specific kits or related groups of products. The sub-sections can also be grouped by functionality, such as with a suturing sub-section, a cardiac sub-section, etc. The sub-sections themselves can be equipped with smart capabilities and can be able to identify the compatibility of the products stored within them. In some variations, each of these sub-sections can be packaged with all of the smart packaging systems 10 and accessories needed for a given procedure. When the smart cart arrives at the corresponding operating room, the entire sub-section can be removed and brought into the operating room.

[0140] In some variations, the smart cart can help alleviate the issue of incompatibility between smart packaging systems 10 and other components by providing a secondary check. If an incorrect device is attempted to be removed from the smart cart, the smart cart can identify the person taking the item, such as via their smart badge, and inform them that the product they are grabbing is incorrect. For example, if someone grabs a certain smart packaging system 10 that is needed for a procedure, they also grab an accessory that is used with a different smart packaging system 10, the smart cart can inform them that they actually need to grab a different accessory on the cart.

[0141] In order to make these personnel-based determinations, the smart cart needs to know and understand the personnel associated with a given operating room at a given time. For a procedure that is occurring in a given operating room, the identity of the personnel associated with that particular surgery, such as the surgeon, the nurses, etc. can be known for personnel configuration and coordination purposes. If the smart cart is making a round of deliveries and one of the deliveries is to that given operating room, the smart cart can read the smart badge of the person accepting the delivery, associate that person with a particular delivery of one or more smart packaging systems 10, and then instruct that person to remove the corresponding one or more smart packaging systems 10 from the cart.

[0142] Further, the smart cart can also recognize a "level of clearance" of a person in order to determine who can receive or claim a particular smart packaging system 10 from the smart cart. For example, if the smart cart is handling a package containing sensitive information, controlled substances, etc., the smart cart can check the level of clearance of the person claiming the package and react appropriately. In the event of an improper retrieval by an un-cleared person, the reaction can include notifying another person, such as a person with the authority to correct the situation, preventing this person from claiming the device (e.g., by using a smart lock on a subsection of the smart cart), directly disabling or locking the smart packaging system 10, etc. Further, the smart cart can also simply record the identity of the person carrying the smart packaging system 10, and can further track the smart packaging system 10. This information can be provided as needed.

[0143] In some variations, the smart cart can be programmed through dispatch awareness, and can be optimized based on the layout of the healthcare facility, including critical locations such as storage rooms, operating rooms, etc. More specifically, the smart cart can be programmed through a daily schedule, which can take into account scheduled surgeries, procedure times, other smart carts, and other information. Based on this programming information, the smart cart can determine routing, path optimization, re-stocking windows, etc. For example, if the smart cart knows that it will cross paths with another smart cart that is stocked with a certain product at a certain time, and it also knows that it needs that certain product at a later time, the smart cart can grab the product from the other smart cart when the two smart carts cross paths. This routing, which is based not only on the location of storage rooms, but also on the location and routes of other smart carts, can greatly improve inventory management at a healthcare facility.

[0144] The smart cart can be subdivided into at least two categories, which can include fixed and mobile floating carts. The mobile floating cart can have a set path based on the time of day, delivery location, etc., and can update the routing of the mobile floating cart based on procedure times. The fixed floating cart can be placed or moved to critical locations, and can be used as a pick-up point for various smart packaging systems 10 and accessories.

[0145] Based on timing, scheduling, and other variables, such as current inventory located on the smart cart, the smart cart can shuffle its inventory into a particular order. The smart cart can be equipped with a system for moving its components, such as a drive mechanism equipped with a device that operates like a vending machine or another device that operates like a conveyor belt.

[0146] As part of the management of the smart packaging system 10, the virtual storage room can create digital kits in whole within the virtual storage room or supply chain. These digital kits can tag each smart packaging system 10 with a digital indicator that marks that each smart packaging system as part of a package or bundle of smart packaging systems 10 associated with a given procedure. For example, if a routine procedure requires five specific kinds of smart packaging systems 10, the smart packaging systems 10 of those kinds can be marked with an identifier that connects them to the routine procedure as part of a kit for that routine procedure. The kinds of smart packaging systems 10 for that routine procedure can be permanently associated with the kit of that kind for that routine procedure and the smart packaging system 10.

[0147] To assist in management, smart packaging systems 10 including surgical instruments 14, accessories, etc. can be identified and marked as commonly used together, such as for a given procedure or as a result of some functionality in one of the surgical instruments 14. With this knowledge, adjustments can be made organizationally to co-locate commonly pulled smart packaging systems 10 in storage to minimize effort during retrieval of commonly pulled smart packaging systems 10. For example, if a surgical instrument 14 is always used in conjunction with a particular type of suture, the two items can be organized together so that when the procedure requires them, the items are physically located close to each other to minimize the effort to track them down.

[0148] To further assist in tracking smart packaging systems 10 in a kit, the smart packaging systems 10 can emit an indicator. The indicator can be an audible indicator and / or a visual indicator. When certain devices in a kit are placed close together, the audible indicator can be in the form of a tone, whereby the source of the tone indicates that they are correct. Different tones can be used to indicate a mismatch or incorrect pairing. The respective tones can be happy or sad to further indicate the purpose of the tone. The audible tone can be used to assist in the general location of a certain smart packaging system 10. The visual indicator can be in the form of a color coded marking or other special marker to indicate that the smart packaging system belongs to a certain kit, or in the form of a flash light to assist in the location of the smart packaging system 10. This type of indicator can be based on user preference and can be adjusted as needed.

[0149] In certain variations, a smart packaging system 10 supporting augmented reality can be used. In these variations, locations can be indicated via augmented reality (AR) and displayed on a tablet, wearable device such as glasses or a watch, phone, or other system. Certain combinations can be displayed as different colors in the AR environment and can provide an indicator in the AR environment showing compatibility and / or incompatibility with other systems. The AR environment can cross-check with other systems described herein to confirm any necessary information, as well as supplement when any given system fails to meet a request.

[0150] When smart packaging systems 10 are grouped together as kits, additional features can be employed. For example, coupled products can be automatically bulk ordered according to their kits. Kits also provide a convenient list of items for the HUB 50, which can be used as a checklist in other contexts. Kits can also describe alternatives for any of their members, which can be quickly referenced if a particular item in the kit is not available. Further, as smart packaging systems 10 continue to pull together with other smart packaging systems 10, the smart packaging systems 10 can begin to recognize patterns formed, including their association with other smart packaging systems 10. This can be done in various ways, such as machine learning or pattern recognition programs, among others. When certain patterns are recognized, the smart packaging systems 10 can make suggestions for updates or create virtual kits based on the recognized patterns.

[0151] Additionally, users such as healthcare personnel can create their own custom kits, which can be based on a variety of factors, including preferences, availability, cost, and the like. Based on these customizations and other recommendations, kits can be offered to healthcare facilities by manufacturers, such that the institution can purchase kits in bulk and / or at a discounted rate, while ensuring that the members of the kits are compatible. Other benefits can also be provided.

[0152] One such benefit includes the ability to pair smart packaging systems 10 belonging to the suite, which provides the ability to transmit data to optimize algorithms used in the operation of one or more smart packaging systems within the smart packaging system 10. For example, if a harmonic blade is used first in a procedure, the procedure can identify the tissue type / integrity and relay information about which staple delivery method is best suited for the tissue type to the suturer (which is part of the same suite). The harmonic blade can also suggest which suture compartment to use. In cases where the suturer is used first in surgery, the suturer can provide certain information to the harmonic blade. Additionally, functional adjustments can be sent between devices based on information collected from one device. This information can be communicated and coordinated via HUB 50, and can be displayed to users or other personnel, such as via a display screen in the operating room. This functionality can be disabled unless the device is properly identified as belonging to the suite to encourage the use of such virtual suites. In some variations, devices belonging to the suite, or those that can be made to join the suite, can prompt the pairing process when a nearby device belonging to the same suite is detected.

[0153] The packaging 12 of the smart packaging system 10 may include features and design elements that make various smart packaging systems 10 more physically compatible. Bundled packaging 12 reduces the chance of selecting the wrong or incompatible equipment or running out of inventory for a particular piece of equipment. For example, packaging 12 may be designed to nest within other packaging and thus occupy less space; for instance, this can be achieved by... Figure 13 As seen in the image, the package 12 is shown as including an extension 2080 and a corresponding recess 2082 (shown in dashed lines), which can be locked together, for example, via a snap-fit ​​engagement. This design allows the packages 12 to be stacked. Furthermore, the contact points can be electrical contact points 2083, which electronically connect the smart packaging systems 10 together to enable communication between the engaged smart packaging systems 10. Although only one extension 2080 and one recess 2082 are shown, multiple extensions 2080 and recesses 2082 may be included, and they may be located at various positions on the package 12, including the top / bottom and / or sides. Furthermore, the extensions 2080 and recesses 2082 may have various sizes, shapes, and patterns, including regular, irregular, and / or unusual shapes, such as logos.

[0154] The smart packaging system 10 can further be connected to a smart pallet or other smart carrier device, such as the smart cart described above. The pallet or equivalent can be reusable and include an on-board power source and memory, as well as a means of connecting to the smart packaging system 10 such as via the electrical contact points described above, the wireless communication described herein, or any other known method. The smart pallet can also be capable of communicating with the HUB 50 and receiving data related to the smart packaging systems of the healthcare facility to which it was originally transported. The smart pallet can then be returned and the data can be collected as needed. As described herein, disposal protocols for smart packaging systems can be complex and varied, and such protocols can be integrated with the smart pallet for recycling processes.

[0155] In the variant where the smart packaging system 10 is connectable, the unique identification features of each individual smart packaging system 10 can be placed so that they are individually readable even when packaged and connected to one another.

[0156] In some embodiments, the smart packaging system 10 is aware of waste management protocols in order to provide the user with approved disposal and recycling instructions related to the contents of the smart packaging system 10. The smart packaging system 10 can include packaging aspects that provide interactive waste stream guidance that enables the contents of the smart packaging system 10 to be stored, repurposed, and broken down for disposal, and the packaging aspects can endow the smart packaging system 10 with the ability to determine the correct waste stream guidance.

[0157] The smart packaging system 10 can provide disposal methods, disposal recommendations, and general disposal management information to the user. These can include: instructions or steps for disassembly and disposal; documentation of use, product operability, and aspects related to device utilization; and tracking of the disposal process.

[0158] The smart packaging system 10 can provide instructions for disassembling and disposing of the components of the smart packaging system 10, which can vary based on a number of factors. For example, the instructions can follow standard guidelines for waste management, where healthcare waste segregation involves separating various wastes into different colored bins according to waste classification. These standard guidelines can be found, for example, in the World Health Organization’s Guidelines on Health Care Waste Management, which can be found at https: / / apps.who.int / iris / bitstream / handle / 10665 / 259 1 10 / 9789241548455_eng.pdf?ua=l&ua=l. Figure 14The containers, 2100, are categorized by color and are labeled as follows: Red 2100A for anatomical waste (e.g., blood and organs); Orange 2100B for clinical / infectious waste; Yellow 2100C for clinical / highly infectious waste; Blue 2100D for pharmaceuticals (e.g., unused drugs); Purple 2100E for cytotoxic and / or cell-inhibiting products (e.g., chemotherapy drugs); Black 2100F for municipal waste (i.e., non-clinical or medical waste); and White 2100G for dental waste. Ideally, healthcare waste should be segregated at the first possible opportunity to prevent hazardous waste from mixing with general waste. Clear procedures and instructions for proper disposal and management can reduce potential contamination risks.

[0159] Standard guidelines can be presented to users in several ways. In some variations, each label on each package of the smart packaging system 10 can have some markings indicating the correct disposal method. For example, if surgical instrument 14 contains cobalt (a regulated substance whose regulations vary based on local regulatory schemes), the labeling of surgical instrument 14 can indicate the correct waste management guidelines according to the relevant local regulatory scheme, since it relates to cobalt. The labeling can also provide instructions to users to act according to the correct guidelines. In some variations, the packaging can be based on general disposal guidelines (such as those mentioned above regarding...). Figure 14 The described types of packaging systems feature color coding. In some variations, LEDs or equivalents on the smart packaging system 10 or any of its components can indicate which bin the component is placed in (e.g., a red LED indicates the component is placed in red bin 2100A). The LEDs can change based on whether the packaging has been opened or the equipment has been used. If the equipment has been used and is contaminated, the LEDs can indicate the relevant bin. If unused, the LEDs can indicate a different color corresponding to the bin for components that were not used during the procedure. To encourage proper component disposal, disposal guidelines can be incorporated into contracts with healthcare providers (i.e., a discount will be offered if a certain percentage of waste is recycled). Guidelines for recycling procedures can be provided to healthcare providers to assist in achieving compliance.

[0160] In some embodiments, the smart packaging system 10, surgical instrument 14, and / or packaging can read product information contained in the surrounding equipment in the disposal bin. This can be accomplished in a variety of ways, including utilizing RFID tags to detect other tags in close proximity. For example, if a certain device or component is disconnected from the HUB 50 (indicating disposal), and that device or component then detects that it is in the vicinity of a component that should belong to a separate disposal location, this can indicate that one or more devices or components were improperly disposed. If a certain component is detected and no other components belonging to a separate container are detected, this can indicate that the proper disposal procedure was followed. In another example, if a battery or battery-carrying component is detected in the vicinity after disposal, then improper disposal can have occurred. If such a scenario of improper disposal is detected, the detection component can send this information to the user or HUB 50 after reconnection and notify the user of the error. If repeated errors are detected, or a pattern is detected that indicates improper procedure, the supplier can be notified through any appropriate communication channel.

[0161] If the disposal options of the healthcare provider are limited, the smart packaging system 10 can adjust the instructions provided based on the available options. This can be accomplished in a variety of ways, and can involve, for example, setting a hierarchy between disposal options, such that if one option is not available, the smart packaging system 10 will select the next option, continuing down the list until an option is available. If no options are available, the smart packaging system 10 can inform the user to follow its standard procedure for that unavailable aspect.

[0162] During disassembly of the contents of the smart packaging system 10, the complexity of disassembly can be an issue. Thus, it can be beneficial to simplify the procedure in order to reduce the likelihood of errors that can result in injury. In some variations, the smart packaging system 10 can include a numbered protocol for disassembly to provide an order in which disassembly should occur (e.g., remove the battery first, then isolate the blade, etc.). The smart packaging system 10 can include one or more indicators (e.g., LEDs) that activate after each step in the protocol is completed in order to provide a visual indication of progress. In some variations, a dynamic label such as the smart display 22 (e.g., electronic ink label) or the display 22 can provide step-by-step instructions for disassembly. When a disassembled component has been properly disposed of, the smart packaging system 10 can update the display 22 or notify the user to activate the next step. As explained herein, the smart packaging system 10 and the HUB 50 can communicate with each other to monitor progress and update the displayed disassembly instructions. In some variations, the smart packaging system 10 can include specific surgical instrument 14 instruction data for a particular geopolitical location. For example, based on the current geopolitical location of the smart packaging system 10, the instructions can vary to accommodate relevant local regulations. In some variations, a compliance assurance service can be used to track equipment disassembly and disposal to confirm that specific components, like batteries, are properly disposed of.

[0163] When the instructions vary according to geopolitical location and / or specific healthcare provider regulations, the location, including the location of a specific healthcare provider, can be determined based on a product code or some other identification (i.e., the product code is known to have been shipped to a specific location, so the instructions will correspond to that location). This determination can also be made through communication with the HUB 50.

[0164] Alternative disposal methods and options can also be provided. As explained above, a hierarchy of options can be used such that if one option is not available, the next option in the hierarchy is selected. If an error is detected during use of the surgical instrument 14, for example, an alternative disposal procedure can be implemented. The procedure can be conducted by inquiring whether a battery is included in the surgical instrument 14, and if so, receiving an indication from the system or user whether the battery is problematic. If the battery is problematic, the surgical instrument 14 can be recycled without the battery, and instructions can be provided to implement the recycling. If the battery is not problematic, the surgical instrument 14 can be recycled with the battery, and instructions can be provided to implement the recycling. The inquiry can be conducted by moving to the next possible component, and the recycling procedure can be adjusted based on user indication of the faulty component. In some variations, a message can be sent and / or displayed by the smart packaging system 10 and / or the HUB 50 to inform the user to return the smart packaging system 10 according to the packaging instructions. Upon detection of an error, data around the error can be logged and reported to the supplier or relevant party for evaluation of the error, such as for correction purposes.

[0165] If a component of the smart packaging system 10 is determined to be unavailable, either by detection by the smart packaging system 10 itself, the HUB 50, or by indication by the user, alternative procedures can be provided. Knowing when a component is considered unavailable can also assist in evaluation of the failure. For example, if the error occurred during shipping, the healthcare provider would not be at fault. In some variations, alternative procedures can be triggered based on the context of use. For example, if problematic use occurred during a clinical trial, the recycling procedure can be varied so as to recycle more components, receiving as much information as possible from the clinical trial, including information related to operational errors.

[0166] As explained above, the smart packaging system 10 can memorialize aspects of use, operability, and device utilization. In some variations, the HUB 50 can write permanent information related to the information memorialized above to the smart packaging system 10.

[0167] As explained above, the smart packaging system 10 can assist in tracking the disposal process. Also as explained above, the smart packaging system 10 can store a list of all of its contents, including components and subcomponents of the contents. The smart packaging system 10 can create a list of all products that enter the operating room. When the disposal process begins, the smart packaging system 10 can create a certificate of destruction (COD) for all supplies that are consumed during the procedure. After the procedure has occurred, the HUB 50 can record and cross-check the expected disposal instructions for each product with the products that were actually disposed of. If a deviation is detected, a notification can be sent to the user. If the HUB 50 identifies that a package was not used during surgery, but it was placed into the disposal area, the package can signal to the HUB that it was not opened, and the healthcare staff can be notified to return the unused package to the stockroom. If the HUB 50 determines that a battery was not disposed of properly, or for example, that the battery was not properly packaged for return, the smart packaging system 10 and / or the HUB 50 can alert the user and require the user to confirm before additional actions are taken.

[0168] In some variations, the HUB 50 or the smart packaging system 10 can provide the user with indicia or digital metadata related to the disposal of the package that provides destination instructions, method of destruction, special handling instructions, and other relevant information. This information can be provided in a variety of ways, such as via the dynamic display 22, which can be made removable and reattachable to return the package. The RFID tag 16 or similar device can detect the change in the package and update the indicia to display the information.

[0169] In some embodiments, the smart packaging system 10 can track the waste stream and disposal progress in order to determine whether the disposal procedures are being adhered to. To assist in determining compliance, the smart packaging system 10 can determine whether the components to be disposed of are eligible as regulated medical waste according to the relevant local regulatory scheme or larger regulatory scheme (e.g., the Medical Waste Tracking Act (MWTA) and the Resource Conservation and Recovery Act (RCRA) in the United States). The smart packaging system 10 can further determine the site-specific regulations, including regulations related to the current geopolitical location of the smart packaging system 10. For example, in the United States, it can not be enough to know that the smart packaging system 10 is in a facility in the United States, as regulations can vary by state. Knowing the specific state can be necessary to determine the appropriate disposal procedures. Relevant regulated medical waste can include pathological waste, human blood / blood products, microbiological waste, contaminated sharps, isolation waste (e.g., from highly infectious diseases), animal waste, etc.

[0170] In some variations, the smart packaging system 10 can determine whether a component to be disposed of qualifies as a battery, electronic device, heavy metal, or other similar material. If it is determined and receives confirmation that the component does qualify, a protocol can be provided, including returning the device to the supplier for proper disposal if no other options are available.

[0171] In some variations, the HUB 50 can record disposal data for the smart packaging system 10. This data can be used to satisfy contractual provisions made with healthcare providers regarding disposal protocols, which can result in penalties or incentives for the healthcare providers.

[0172] In some variations, the HUB 50 can flag specific components of the smart packaging system 10 and inform the user when the correct disposal bin is not available.

[0173] In some variations, the smart packaging system 10 can provide information to the HUB 50 about any components or materials within the smart packaging system 10 that have been flagged, enabling the HUB 50 to return the facility, region, or waste management company any relevant disposal requirements. The smart packaging system 10 can update the listed disposal instructions to reflect current information and / or best practices. For example, special handling locations for electronic circuit boards, batteries, local adjustments, REACH materials, and device / packaging disposal can often require certain specialized waste management instructions.

[0174] In some variations, the smart packaging system 10 can track recycling values and provide this information to the user. For example, a metric can be that certain components must be properly recycled if used. To encourage proper disposal, the smart packaging system 10 can display or provide a metric of recycling financial savings, an indication of progress toward a larger recycling goal (e.g., 15% of the first quarter recycling goal), and the HUB 50 can also inform the user of the contribution of recycling a certain component toward achieving a larger recycling goal. The smart packaging system 10 can also employ a recycling credit system. For example, a user can be shown or provided a tracking or progress of recycling, and certain rewards can be tied to recycling (e.g., recycle 10 devices and get a certain number of credits). The rewards can be exponential to encourage recycling. Credits can be awarded upon receipt of a recycled device. In some aspects, the display 22 can be removable so that the tag remains in the recycled device so that the data recorded by the tag is also recycled.

[0175] The smart packaging system 10 can include features to assist with the reusability, disassembly, and / or return of the contents of the smart packaging system 10 after use.

[0176] These features can include aspects of the smart packaging system 10 that facilitate the temporary storage of components and contents of the smart packaging system 10, and that facilitate the repackaging of components and contents of the smart packaging system 10. In some cases, it is desirable to recover components of the smart packaging system 10, such as for performance evaluation, error handling, recall, etc. To assist in the recovery of components, the smart packaging system 10 can include a return package. This return package can be a reusable package that, after use, is reassigned to dispose of or return contents of the smart packaging system 10, as well as to serve as a system through which products can enter a sterile field during a surgical procedure involving the smart packaging system 10.

[0177] For example, the package 12 can open into a form such that it can rest on top of a disposal bin. Once the surgical instrument 14 has been fully used and is ready for disposal, the surgical instrument 14 can be resealed into the package 12 and immediately dropped into the waste bin. In some variations, the package 12 can be positioned in more than one orientation (e.g., on the bottom and one or more sides), while still providing access to its contents. In this way, the package 12 can occupy a smaller footprint. To assist in the repackaging process, the package 12 can come with a resealing device, such as an adhesive strip located on a selective flap of the package 12 that is covered by a seal. When repackaging is desired, the seal can be removed to expose the adhesive and allow the flap to be closed by adhering the flap to the package 12 via the exposed adhesive.

[0178] To assist in disposal, the smart packaging system 10 can include features that interface with disposal receptacles that can be located in the operating room where the procedure involving the smart packaging system 10 is being performed, or they can be located on-site at the healthcare facility. Items placed in the disposal receptacles can be properly disposed of according to their contents. In some variations, the disposal receptacles can come in various forms, including as a resealable package for contamination control in disposal. In some variations, the disposal receptacles can be waste stream receptacles that are specifically designed for the kind of waste stream that will be processed through it, for example, as described above with respect to Figure 14 For example, if the waste stream receptacle is intended for disposal of organic waste, the waste stream receptacle can be made of a non-reactive, non-porous material, such as various plastics, in order to properly divert the organic waste to its final disposal location (e.g., an incinerator). The disposal receptacles can be provided by the original equipment manufacturer (OEM) according to the contents of the smart packaging system 10. However, in appropriate cases, the disposal receptacles can also be used to store non-OEM waste. If non-OEM equipment is used in a procedure along with OEM equipment, the instructions and procedures for disposal and / or recovery as explained herein can indicate to the user that the non-OEM equipment can have unknown waste management requirements.

[0179] In some variations, the disposal container can be provided with a lid for the packaging 12 to provide temporary storage. When the procedure is complete, the lid can be quickly used to dispose of the stored contents. In some variations, the packaging 12 can be magnetically attached to a side of the disposal container for temporary storage.

[0180] Prior to the disposal and / or recycling process can occur, the contents of the smart packaging system 10, such as the surgical instrument 14, can need to be disassembled or separated into components and subcomponents, depending on the nature of the components and subcomponents (e.g., non-recyclable components versus recyclable components), as their nature can result in different disposal and / or recycling processes, as explained herein. In some variations, the smart packaging system 10 can include one or more specialized jigs, such as certain proprietary screws, and associated tools to assist in recycling certain components. For example, certain components to be recycled can be fastened to the surgical instrument 14, and associated tools can be used to easily remove the components for disassembly. Figure 15 An example can be seen in FIG. 21, which is provided with a simple crowbar 2110 to allow removal of a circuit board 2112. The crowbar 2110 can be inserted into a specially designed slot and pried to disengage the circuit board 2112 from surrounding components. In some variations, the packaging itself can be disassembled into a tool like the crowbar 2110. The packaging 12 can be provided with ribs that can support the strength of the packaging during shipping and handling, and during disassembly, the ribs can double as the crowbar 2110.

[0181] In some variations, the packaging 12 can include tools that emerge after a component is removed from the packaging or a compartment of the packaging is opened. For example, certain tools can be revealed when a seam is pulled, a surgical tool is removed from its location, or a tab is pulled. In other variations, the packaging included within the smart packaging system 10 can be used to package components of the smart packaging system 10 that include one or more components to be recycled, and the packaging 12 and components can be transported to an ancillary site that is specially equipped to disassemble and recycle the components, thereby placing the task at the ancillary site.

[0182] The smart packaging system 10 can also measure or assess portions of the surgical instrument 14 to determine the ability of the portions to be recycled, and determine an associated disposal path based on various factors. For example, based on a determined geopolitical location, availability of waste management regulations, components of the smart packaging system 10, the smart packaging system can determine whether a certain component can be recycled. This indication can be provided to a user using any of the methods described herein.

[0183] Disposal and recycling procedures can involve hazardous materials, including electrical components and biohazardous materials. Procedures for electrical components can involve including materials and features in the smart packaging system 10 to minimize potential hazards involved. These can include insulating surfaces for containing materials, as well as electrical tape for joining and securing components as needed. Procedures for biohazardous components can involve containing these components and preventing cross-contamination during various post-procedure procedures. For example, storage bags and / or rags soaked in bleach can be included in the smart packaging system 10 for containing components as well as for wiping surfaces. In some variations, storage bags can be made of materials with antimicrobial properties to prevent the spread of certain materials. The bags can also contain absorbent materials to capture fluids placed within them. In some variations, the smart packaging system 10 can include blade covers and sharps covers to prevent breakage of containers of biohazardous materials, as well as to prevent accidental injury from blades or sharps. To contain biohazardous materials, contaminated components can be broken down and contained within a sterile field.

[0184] Disposal and recycling procedures can occur in an operating room without supervision of the HUB 50 or similar system. In these cases, and in known cases, the smart packaging system 10 can include features that help track the various components being disposed and recycled. For example, the packaging 12 for disposal can include an incremental serial number to easily coordinate several disposal smart packaging systems 10 at once. In another example, components to be disposed or to be recycled can include removable markers, like stickers, that can be removed and moved elsewhere, such as on a tracking board, to monitor the status of disposal or recycling of a given component.

[0185] The smart packaging system 10 can provide selective and separate disposal paths for components of the smart packaging system 10 and subcomponents of the components. This can include identifying these components and subcomponents and then providing methods for separating the smart packaging system 10 as needed to introduce the components and subcomponents into their correct waste stream for proper waste management.

[0186] Certain components of the smart packaging system 10 can require separate disposal. These components can include batteries, electronic components, heavy metals, dissected waste-contaminated labeled-for-disposal surgical instruments 14 components, and dissected waste-contaminated labeled-for- return surgical instruments 14 components. For example, for dissected waste-contaminated labeled-for-return surgical instruments 14 components, a specific additional contamination procedure can be required to sterilize the surgical instruments 14 components.

[0187] The smart packaging system 10 can be used to easily identify key aspects needed for selective disposal and / or recycling components in order to properly separate these components. In an example, a barcode can indicate which surgical instrument 14 needs to be recycled and returned. The barcode can be located on the packaging of the smart packaging system 10. In another example, the HUB 50 and / or visual identification system can be used to identify recyclable components and the location of these components. In another example, the smart packaging system 10 can contain components in a modular form. One sub-area of the smart packaging system 10 can contain a motor, another sub-area can contain a battery, etc. The staff in the operating room can use the modular components to assemble the surgical instrument 14, use the surgical instrument 14, and then disassemble the surgical instrument 14 back into the modular components. The modular components to be recycled can be individually re-sealed in separate packaging 12. In another example, the surgical instrument 14 and / or packaging can include a color coordination with the associated waste stream path. Separate patterns can be used for the equipment or its components to be recycled.

[0188] The separation of components can occur in a variety of ways and can depend on the identity of the component identified, such as whether the component is a battery, a circuit board, etc.

[0189] The protocol for the battery can vary depending on a number of factors. For example, if the battery is provided in packaging separate from the surgical instrument 14, that same packaging can be used to separate and store the battery after disassembly. The same is true for other components, where the packaging in which they are provided can double as a separation package after the surgical procedure. In some cases, special protocols can need to be followed in order to dispose of the battery. The battery disposal bin can not be universal, in which case a sub-disposal instruction can be needed. For example, if the battery is primarily lithium, it can be sent to the correct recycling facility or disposal site. If the battery is rechargeable, a separate disposal protocol can be needed. The proper separation of batteries can prevent them from being incinerated or improperly disposed of, possibly in violation of local regulations.

[0190] The protocol for the circuit board can also vary depending on many factors. The shroud can be removable to access the circuit board for disposal or for recycling. Certain design choices can be made to the equipment and components of the smart packaging system 10 to make it easier to access and / or disassemble the circuit board into components. For example, the circuit board can be on a separate piece of plastic that is accessible through the battery cavity. The circuit board can be torn open by a simple pull tab to enable access to the circuit board. The wires can also be accessible to allow for easy severing to remove sensitive components. The smart packaging system 10 can include a bin or area that is included for storing and containing loose components. If the circuit board includes detached attachments or components, the circuit board can be designed such that these attachments or components are attached to the circuit board via a mechanical decoupler, such as via a snap fit or equivalent, to aid in disassembly. Flexible circuits can be severed or made easy to sever near the middle circuit close to the farthest end attachment and away from certain components that can include heavy or precious metals. In cases where multiple circuit boards are used, the circuit boards can be interconnected with several flexible circuits to allow for easy severability. The packaging 12 can also include instructions to show the location of the circuit board, the location of the decoupling points, which components should not be decoupled due to their certain contents, and the like.

[0191] In another example, once the battery is inserted into place, the circuit board can be designed to lock to the battery. To remove the battery, the lock causes the circuit board to have to be removed as well. Once both are removed, a simple switch or lever or equivalent that was hidden prior to removal can be switched to decouple the battery and the circuit board.

[0192] At each step of disassembly, the user can be provided with instructions in any form to guide them on the details of the disassembly based on the components to be disassembled within the smart packaging system 10 and based on the relevant waste management protocols. In addition, a passive guide can also be provided, for example, a slot or container of the appropriate shape for each component to be disassembled. If there is a certain slot or container, the user can be passively informed that it must be filled with some of the components to be disassembled during the disassembly protocol.

[0193] In some variations, the user can not need to disassemble the components, but can instead return the entire product, packaging, sub-components, etc. as is. Portions of the smart packaging system 10, such as certain packaging 12, can be reused to return components of the smart packaging system 10. This packaging 12 can include a plastic bag or the like for biologically contaminated products. In addition, while the packaging can include separate sub-areas that house the necessary components of the smart packaging system 10 (i.e., there is a first space molded to fit the surgical instrument 14, there is a second and third space molded to fit the accessories), the packaging 12 can be made separable to remove the sub-areas, thereby turning the packaging 12 into a single box or container. The user can then place the recycled components into the single box or container without having to think about organization.

[0194] Once the components are separated, they can follow their designated path for disposal or recycling. For example, certain components can be marked for incineration, and they can be transferred to an incinerator. Other components can be marked for a landfill, and they can be transferred to a landfill. For components marked for recycling, the protocol can vary based on the component. Metal and plastic components can be ground and melted at certain temperatures to separate out individual components, such as precious metals. If certain expensive plastics are to be recycled, or if aggregate is to be recycled, making the grinding / melting protocol ineffective, there can be some visual indicator on the component (or included in the instructions) for the user that notifies the user of the appropriate specific recycling path for these special materials. This can involve simply shipping the special materials to a place that specializes in the relevant recycling.

[0195] There can also be standard protocols for handling more traditional waste, such as sharps. For example, according to certain medical protocols, needles used with sutures and knives can be separated out and then placed in the correct bin.

[0196] HUB 50 and / or smart packaging system 10 can provide notifications related to waste management protocols. HUB 50 can sense that the correct waste management protocol is being followed, and that certain parts of the correct waste management protocol are not being performed correctly, and HUB 50 can notify the user using any of the methods described herein. For example, a notification to the user can indicate that components related to smart packaging system 10, as well as any other components that HUB 50 normally senses, are incorrectly exiting the sterile field.

[0197] Figure 16An example of the identification and coordination of components and subcomponents of a surgical instrument 2214, which is part of an example smart packaging system 2210, is depicted. The smart packaging system 2210 can be substantially equivalent to any variation of the smart packaging systems described herein, including the smart packaging system 10, and the surgical instrument 2214 can have the same meaning with respect to any surgical instrument described herein, including the surgical instrument 14. The surgical instrument 2214 can be subdivided into regions of interest, including the identification of a motor 2222, a battery 2224, a circuit board 2226, and a magnet 2228. Members of each identified region of interest can be associated with a certain disposal path. While some members can have the same processing path, each member can have a separate processing path. For example, in a first region of interest associated with the motor 2222, magnets, copper coils, rare earth metals, etc. located within the motor 2222 can be harvested for recycling and / or can be selected for disposal according to certain local regulations. In a second region of interest associated with the battery 2224, the battery 2224 can need to be discharged, isolated if it contains certain valuable or toxic materials, and cannot be shipped via certain modes of transportation, such as airplanes. These requirements can affect the disposal path of these materials. For example, European regulations can prohibit disposal of batteries containing certain hazardous substances, and they can also establish related programs for the collection and recycling of batteries. In a third region of interest associated with the circuit board 2226, the contents of the circuit board 2226, such as silicon, heavy metals, potentially precious metals, etc. can require a separate disposal path, depending on the relevant local geopolitical regulations. In a fourth region of interest associated with the magnet 2228, disposal and disassembly can vary according to the relevant local geopolitical regulations.

[0198] The procedures associated with Figure 16 are exemplary and can vary according to a number of variables, including the relevant local geopolitical regulations, components of the surgical system 2214, available procedures, etc., as discussed herein.

[0199] The smart packaging system 10 can selectively change, enable, and disable functions of the smart packaging system 10 based on the current geopolitical location of the smart packaging system in order to comply with the relevant local regulatory programs.

[0200] The smart packaging system 10 can determine whether its components and capabilities are suitable for a given geopolitical location based on the regulatory scheme for that location. The smart packaging system 10 can provide information to the user regarding the feasibility of its location for the user to evaluate, or the smart packaging system 10 can compare its current location to known "availability zones" for given aspects of itself. For example, the European Union requires smoke evacuators to be equipped with HEPA filters to prevent cancer cell aerosolization into the air breathed by healthcare providers, but not all jurisdictions require this. A smart packaging system 10 that contains a smoke evacuator and knows that it contains a smoke evacuator can compare that known information and information about its current geopolitical location to a list or database of regulatory information in order to make a determination. The smart packaging system 10 can provide a message to the user informing them of this regulatory requirement. In another example, the smart packaging system 10 can inform the user whether a certain medication has been approved for treatment or use within a geopolitical location.

[0201] In some variations, individual facility rules can be important to the operation of the smart packaging system 10. If the circumstances of a certain facility are known in advance, the instructions and specific regulations associated with individual facilities can be pre-loaded into the smart packaging system 10.

[0202] In some variations, the smart packaging system 10 can collect and store data. Based on the current geopolitical location of the smart packaging system 10, the data collection capabilities of the smart packaging device and / or the data being collected change to comply with local regulations.

[0203] In some cases, certain components and / or capabilities of the smart packaging system 10 can be completely prohibited from entering a certain geopolitical location. If it is determined that the smart packaging system 10 has reached such a location or is about to enter such a location, the display 22 can display a warning indicating the prohibition (e.g., "Product is banned in China"). In another example, the surgical instrument 14 can contain a battery that is designed to deploy a compound that can not be acceptable within a jurisdiction (e.g., bovine pericardium). The display 22 can be configured to change to include a message such as "Contains bovine pericardium." The message can specify the offending component or content of the smart packaging system. In another example, in 1985, China banned the import of blood and / or plasma-derived products. If the smart packaging system 10 contains such products, the display 22 can provide a message similar to the messages described above that explains that the smart packaging system 10 contains a banned substance. The determination can be based on FDA, CE, UL, or other approval.

[0204] In general, the smart packaging system 10 can determine its suitability for shipping to a given geopolitical region and then provide that information as needed.

[0205] In assessing situations that result in determining that one or more operational capabilities of the smart packaging system do not comply with the local set of regulations of the jurisdiction, the smart packaging system 10 can change and / or disable the non-compliant operational capabilities, or receive a set of instructions from an external system to change and / or disable the non-compliant operational capabilities, so that the smart packaging system 10 complies with the local set of regulations. For example, the smart packaging system 10 can be configured to collect data during its shipping and use, at various locations such as warehouses, hospitals, and operating rooms. Due to local privacy laws, such as HIPAA, GDPR, etc., aspects of this data collection can not be allowed in the jurisdiction. In such jurisdictions, the ability of the smart packaging system 10 to collect disallowed data can be disabled so that the device operates in accordance with the local privacy laws of the jurisdiction. In some cases, operational capabilities can be limited or reduced due to mismatches between accompanying systems, such as when a certain component has not yet been approved for use in a given geopolitical location.

[0206] In some embodiments, the controller 13 of the smart packaging system 10, or any equivalent storage device of the smart packaging system 10, can have certain decision-making capabilities integrated therein.

[0207] In some embodiments, the decision-making capabilities can include the integration of multiple levels of decision-making, generally within the smart packaging system 10, and in the packaging display 22 using hierarchical organization techniques. These techniques can include the selection of components driven by physician preferences, and / or the selection of components driven by component availability.

[0208] When one or more smart packaging systems 10, still in their packaging 12, enter the OR, the HUB 50 can communicate with the smart packaging systems 10 and create a list of the smart packaging systems 10, their contents, their characteristics, additional known information, etc., and the HUB 50 can also receive information related to the procedure to be performed within the OR, such as specific patient biometrics, procedure type, surgeon identity, surgeon preferences related to the smart packaging systems, OR capabilities, etc. Based on this information, the HUB 50 can assess information related to the interactions that can occur between the various systems in the OR and the procedure to be performed.

[0209] In an example, the HUB 50 can run scenarios on how a scheduled procedure can be performed using the systems detected within the OR based on stored data related to surgical procedures. The HUB 50 can inform OR staff whether unnecessary systems are included in the OR, and whether systems should be added to the OR for a given procedure are missing. If systems should be added to the OR for a given procedure are missing, the HUB 50 can provide a list of possible alternatives in order of hierarchical preference, with or without receiving a prompt from a user. In a variation of receiving a prompt from a user, the prompt can inform the HUB 50 of a desired system deficiency, prompting the HUB 50 to provide a list of alternatives.

[0210] In another example, the HUB 50 can identify that an intelligent packaging system 10 is included in the OR that is incompatible with one or more other systems in the OR. The HUB 50 can inform OR staff of this incompatibility.

[0211] In another example, the HUB 50 can cross-check equipment recorded within the OR against the capabilities of the OR and determine whether there are compatibility issues. If a newly added device to the OR requires the use of additional equipment not currently in the OR, such as a large machine that is not easily moved into the OR, the HUB 50 can inform OR staff of the missing machine and recommend another OR that has the necessary machine.

[0212] As introduced above, patient data can be used to determine compatibility with intelligent packaging systems 10. When an intelligent packaging system 10 enters an OR space, the capabilities, contents, and other details of the intelligent packaging system 10 can be analyzed against relevant patient biometrics / data to provide information related to optimal equipment selection and use.

[0213] More specifically, device compatibility can be determined. If a patient has undergone a previous surgical procedure, this information can be used in the current surgical procedure to determine on-the-job compatibility. For example, if the patient's body contains metal from a previous surgical procedure and the current surgical procedure plan involves an RF device, a notification of incompatible use can be provided, which can be due to a short circuit or other malfunction caused by the interaction between the RF device and the metal. Depending on the surgical instrument 14 being used, more local effects can also be considered. If the surgical instrument 14 is a harmonic tool, a metal detector on its tip can sound an audible alarm to the user if there is metal nearby. The tissue impedance can be affected by the metal, potentially causing harm to the patient and / or the surgical instrument 14, and such a scenario should be flagged. If the surgical instrument 14 is a stapler, detection of the end of a segment used for stapling can cause the stapler to be prevented from further stapling in the undesired area. In some aspects, the surgical instrument 14 can adapt to the detected adverse event. For example, the surgical instrument 14 can employ an adaptive case algorithm that adjusts the power delivered to the surgical instrument 14 to drive the staple or cut the tissue when a proximate impacting material is detected (i.e., there is metal nearby, so the smart device shortens the drive stroke to avoid hitting the metal).

[0214] Further, patient-specific tissue can change device behavior and compatibility. Irradiated tissue can be more tenacious than other tissue, and can also be handled differently by the device feedback. Thresholds in the surgical instrument 14 can be changed to account for the tenacious tissue, such as increasing the power after the drive stroke to make a specific cut that normal tissue would typically require less power. The surgical instrument 1414 whose behavior can be changed can also be configured to receive input from an external system, such as the HUB 50, or to receive an annotation from the operator that specifies changes made in response to the patient tissue. Such changes can affect the life cycle of the surgical instrument 14, especially if the surgical instrument 14 is required to have greater demands due to the changes.

[0215] In another example, certain ablation systems can only be used for tumors of a certain size (e.g., 10 cm) or smaller. If a tumor is detected that exceeds this threshold, the surgical instrument 14 can alert the user and allow the user to choose to ignore the alert. The size of the tumor can be communicated to the smart packaging system 10 by the HUB 50 as a result of the scan. The display 22 and / or the display 22 can even update before the smart packaging system 10 is opened to reflect possible compatibility issues.

[0216] In another example, if a certain task in the surgical procedure requires a much lower power output than the capabilities of the surgical instrument 14, a warning can be displayed on the display 22 or the display 22 of the smart packaging system 10, notifying the user of the possible danger associated with using the surgical instrument 14 at its normal power level.

[0217] Alternatives for surgical instruments 14 can be provided based on cost, inventory, or healthcare facility guidelines. For a given procedure, once all of the smart packaging systems 10 have entered the operating room, their capabilities can be compared by the HUB 50 against the requirements of the procedure itself. Based on the comparison, the HUB 50 can provide a recommendation for a more effective and / or optical device that can be used in place of the one currently found in the operating room. For example, the HUB 50 identifies that an energy device was pulled for the procedure and also identifies that based on the planned procedure, a monopolar or bipolar energy device is traditionally used. The HUB 50 checks the energy device that was pulled, determines that the pulled device is inadequate, and then checks other devices for potential alternatives. After determining that there are no alternatives, the HUB 50 can search the inventory at the healthcare facility and request a capable alternative. The user can be notified of the request and the capable device can be delivered to the operating room.

[0218] In some variations, the HUB 50 can determine that the selection of products pulled for a procedure exceeds the reimbursement limit. Based on the total cost as presented in a fiat currency, operating room time, number of staff, or another metric, the HUB 50 can make a substitution recommendation. Additionally, the smart packaging systems 10 can display their own unit cost to the user or provide this information directly to the HUB 50 without the need for the HUB 50 to take inventory. Alternatives can be ranked based on cost, historical operational data, and any other desired metric.

[0219] To assist the smart packaging systems 10 in making decisions, metadata can be included in the smart packaging systems 10 to provide context for irregular use. This context can come with conformational and interrogative markers.

[0220] With conformational markers, the smart packaging systems 10, the HUB 50, or another device that appears to be front correct but looks strange in context can receive irregular data. A notification can be provided to the user of the receiving system that does not require user confirmation for further action. For example, if a physician selects a surgical instrument 14 that is not typically used for the procedure, once this is intentional, a confirmation can be received and then in the future each time the system would have potentially flagged some aspect of the surgical instrument 14, an override can be triggered that identifies that the surgical instrument 14 selection was intentional and the surgical instrument 14 otherwise behaves normally. This override can also function in the case of a substitute surgical instrument 14 being selected due to a stock shortage of a preferred surgical instrument 14.

[0221] With interrogating indicia, a user input can be requested to make further decisions when receiving irregular data. For example, when an incorrect surgical instrument 14 type is detected, a user confirmation can be required before allowing the procedure to continue. The smart packaging system 10 can generate an alert indicating the incorrect surgical instrument 14 type and can request confirmation from the user. In another application, when a surgical instrument 14 with an incorrect device length is selected for a procedure, an override scenario can be implemented based on historical data related to the procedure. For example, if the operations that occur in a surgical procedure depend on a particular surgical instrument 14 size, these operations can be adjusted according to the new surgical instrument 14 size.

[0222] In some scenarios, multiple device options can be delivered to the operating room for user selection based on historical data. Regardless of which surgical instrument 14 is selected, the inventory of surgical instruments 14 to be returned is notified to minimize user interaction.

[0223] When an insufficient smart packaging system 10 has been pulled, the HUB 50 and / or the smart packaging system 10 itself can react accordingly. For example, if one aspect of a surgical procedure or patient has flagged that additional surgical instruments 14 can be needed to complete the surgical procedure given that aspect, a user’s interrogation can confirm that the flag is correct and that additional surgical instruments 14 are actually needed. The interrogation can be processed via any means of communication with the user to confirm that additional surgical instruments 14 are indeed needed and can be requested from a stockroom. In another example, the HUB 50 can identify that for a given procedure, six staple cartridges are typically pulled. However, based on the patient’s biometrics, additional staple cartridges need to be pulled for a typical patient of this size. The HUB 50 can issue a request for additional cartridges and can notify the user. Similarly, if six staple cartridges are pulled for a surgical procedure, but the HUB 50 detects based on historical data of similar surgical procedures that patients of this size typically only need four staple cartridges, the user can be notified of the potential excess.

[0224] Responses to various inputs received from the user can be recorded to inform future recommendations of the smart packaging system 10 and the HUB 50. These recommendations can include making incremental changes by suggesting similar products, based on surgeon or facility exceptions, and based on answers to repeat confirmations of specific responses (e.g., the HUB 50 flags a surgical instrument 14 three times, each time the user denies; the HUB 50 can adjust the fourth time and not flag the surgical instrument 14.

[0225] In some embodiments, the smart packaging system 10 and / or the HUB 50 can determine compatibility between its own capacity and other devices, including other smart packaging systems 10. The smart packaging system 10 can provide notification of possible interactions (both acceptable and adverse) between itself and other devices, and between other devices. This information can be especially beneficial in the context of a surgical procedure.

[0226] In some variations, the smart packaging system 10 can provide notification of potential interactions with other equipment that can be dangerous and / or harmful to the patient, personnel, and equipment.

[0227] As explained herein, both the HUB 50 and the smart packaging system 10 have the ability to receive and transmit information with other systems. Based on this transmission of information, the HUB 50 and the smart packaging system 10 can assess potential interactions between systems and devices. When an incompatible combination is observed, the user can be notified, such as via the display 22 or other notification. Further, the system that detected the incompatibility can transmit information to the HUB 50 (unless the HUB 50 is the detection system), which can then transmit instructions to the affected smart packaging system 10 and devices to change or stop operational capabilities, thereby preventing an adverse interaction from occurring.

[0228] For example, certain surgical staples can include a magnesium-based coating. Exposure to high heat can damage the coating and compromise the integrity of the staple. In another example, if a CT device, such as a C-arm, is being used to scan a patient that possesses a pacemaker, the HUB 50 can notify the user of the possible adverse reaction and / or instruct the C-arm to change operation so as to not interfere with the operational function of the pacemaker.

[0229] In some variations, a risk-based assessment of the combination can be performed, and a corresponding notification can be provided. If the interaction is deemed potentially catastrophic, the HUB 50 can communicate this risk to other equipment to prevent the equipment from activating and causing possible harm. For events that are less catastrophic, the user can be notified of the potential adverse interaction and can be required to confirm before enabling normal operational functions. For secondary interactions, a non-actionable warning can be displayed for communication to the user, informing them of the interaction.

[0230] In an example, a new generation of loading cartridges for surgical staplers can be designed with backwards compatibility in mind, but this is not always the case. In some cases, a new generation of loading cartridges can be incompatible with certain surgical staplers, and attempting to combine the loading cartridge with an invalid surgical stapler can result in damage to one or both components. Indicating to the user prior to the interaction can resolve the potentially dangerous situation.

[0231] In some embodiments, due to specific limitations of a surgical procedure, such as replacement of surgical instruments 14, patient needs, etc., the smart packaging system 10 and / or HUB 50 can assist in the adaptation of the procedure. Details of the surgical procedure can be imported into the HUB 50, and the HUB 50 can flag interactions between surgical instruments 14, accessories, and equipment that should be avoided, as well as combinations that should be used together.

[0232] When the HUB 50 flags an interaction that should be avoided, the user can ignore the flag and proceed anyway, as explained above. When this happens, certain data can be inaccurate or can be corrupted by the flagged interaction. To avoid presenting inaccurate data, data cannot be provided in these scenarios. For example, if an electrocautery device is used on a patient who is receiving EKG monitoring, the electrocautery device can interfere with the readings of the EKG. This adverse interaction between the electrocautery device and the EKG can be flagged by the HUB 50, but in the event that the user proceeds anyway, the display of readings from the EKG can be prevented to avoid presenting misleading readings while the electrocautery device is in use. This adverse interaction, and adverse interactions related to electrical interference with devices in particular, can result in completely false data.

[0233] In some variations, where possible, the impact of an interaction on data collection can be measured, and the user can be provided with a notification of the impact and the degree of impact. This can be done by measuring the same data source in the absence of an interfering device and comparing it to the data in the presence of the interfering device. Based on historical trends, past data measurements, machine learning, secondary sources, etc., the user can be provided with a measured impact of the interfering device. Additionally, error rates and / or cyclic redundancy check (CRC) error detection codes can be used to determine the impact of the interference. In some aspects, suggestions for changes to reduce or minimize the impact of the device can be provided by the HUB 50, such as adjusting settings of the device, repositioning the device, etc.

[0234] When the HUB 50 flags interactions that should be facilitated, these interactions can be provided to the user to assist in performing the surgical procedure. In an example, during a colorectal surgical procedure, in the case of circular stapler anastomosis through a prior linear staple line, the HUB 50 can recommend certain device combinations. These combinations can include recommending which stapler to use (e.g., powered stapler vs. mechanical stapler) based on the anastomosis plan to best complete the procedure. A powered stapler (an example of a possible smart surgical instrument 14) can suggest staple alignment by sensing staple position (e.g., through impedance, etc.) and suggesting re-orientation. For example, if an unsatisfactory re-alignment occurs after the recommendation, a new recommendation can be provided by the powered stapler. If the procedure continues, future aspects of the procedure can be adjusted based on the unsatisfactory re-alignment. In another example involving a circular stapler, the preferred performance of the circular stapler can require that the trocar used with the stapler be pushed through the center of the prior linear transection stapler line. When aligned, the staple height should be adjusted based on the thickness or other attributes of the tissue in the relevant location. If the user does not properly align the circular stapler or adjust the staple height, subsequent steps in the procedure involving the surgery can be adapted (e.g., firing rate, waiting period between firings, etc.) in order to compensate for the user’s failure to perform the alignment and / or adjustment. These adjustments can even cascade to subsequent procedure steps, such as pressure testing of the formed anastomosis, mobilization, etc., all of which can be managed by the HUB 50.

[0235] In some variations, the HUB 50 and / or the smart packaging system 10 is able to identify whether a device is not optimal for a given surgical procedure, in which case the HUB 50 and / or the smart packaging system 10 can recommend an alternative device. For example, if an older device is detected that lacks certain features that are beneficial to the surgical procedure. If the alternative device is not used and the incompatibility can affect the procedure outcome, the user can be notified. If the procedure continues with the older device, the HUB 50 and / or the smart packaging system 10 can notify the user of certain procedure steps that can be affected by the incompatibility, and can provide adjustments to compensate for the incompatibility at the affected procedure steps. For example, adjust the current setpoint of a harmonic device to deliver less power, or change the frequency range of a bipolar energy device to reduce potential adverse interaction with other devices.

[0236] In some embodiments, the smart packaging system 10 and / or HUB 50 can suggest a free product or a preferred alternative based on a product currently selected for a surgical procedure. For example, the recommendation can include a newer model of the selected surgical instrument 14 that can result in higher efficiency in the surgical procedure. The suggestion can be provided before, during, or after the surgical procedure, and the suggestion can impact future surgical procedures. Suggestions provided before the surgical procedure can rely on past data and suggestions to flag alternatives before the surgical procedure begins. For example, if a previous recommendation was used for a previous procedure, the same recommendation can be made before a similar procedure begins. Suggestions provided during the procedure can be provided by the HUB 50 in real-time based on the procedure status. During the procedure in which the recommendation is made, the recommendation can also include collecting an estimated time for the recommended alternative, and the HUB 50 can request user input as to whether they would like to flag the recommendation for future surgical procedures so that it becomes the default option for those future surgical procedures. Suggestions provided after the procedure can be based on observed trends and data collected from past procedures. The recommendations can generally take into account the specific procedure and usage data of the healthcare facility.

[0237] As seen in Figure 17 A general process 2230 for making recommendations is depicted, which details the manner in which a particular smart packaging system can be selected for a procedure. As explained herein, one or more smart packaging systems 2232A, 2232B,..., 2232N can be recorded by the HUB 50 with additional information 2234A from other sources, such as information about the facility in which the system is recorded, information about the equipment itself, including interaction information, updated procedures, recall notices, etc. When a recommendation is needed, a subset of the recorded systems 2236 can be provided, which can be informed by additional information 2234B. This additional information 2234B can include information such as availability, location of the system within the facility, patient information, procedure requirements, etc. Once the subset 2236 is provided, a final result or selection 2238 can be made according to final information 2234C. This final information can include such information as surgeon preference, information of negative interaction with other selected equipment for a given procedure, and other information that can disqualify a potentially viable selection.

[0238] In one example, the use of a harmonic footplate can be an optional accessory for a surgical procedure. A recommendation can be made to the surgeon to use a harmonic footplate, and the recommendation can be based on a number of factors, including: past preferences of the surgeon, ease of use with other equipment pulled for the surgical procedure, prevalence of use in the healthcare facility, and the nature of the particular procedure.

[0239] In some aspects, the OR configuration can be adjusted based on the devices pulled for a surgical procedure. For example, based on the length of the pulled devices, HUB 50 can recommend a particular surgical cart, a specially sized surgical table, additional accessories, etc. In another example, if multiple energy devices are pulled for a surgical procedure, HUB 50 can recommend that two generators be used in the OR to compensate for the pulled devices. In another example, if an older insufflator is available in the OR, a newer trocar can be suggested to optimize the seal integrity between the systems. In another example, if an older smoke evacuator is present in the OR, a recommendation can be made for a newer device that produces less smoke, or a more efficient newer pump can be recommended so that the older smoke evacuator remains effective.

[0240] In another example, multiple monopolar tips can be used with surgical instrument 14, and a recommendation can be made for a given surgical procedure for a particular monopolar tip that will be more effective. The recommendation can take into account an alternative monopolar tip that will be more effective only in certain situations, and pulling the alternative monopolar tip will not be needed at all for the surgical procedure.

[0241] In another example, for a given surgical procedure, HUB 50 can detect an incomplete set of smart-packaged systems 10 and other devices and components, and HUB 50 can locate the missing elements. This assessment and detection by HUB 50 can occur prior to the surgical procedure, as explained above, and it can also occur after the surgical procedure to prevent components and objects from being left behind in the patient, a known problem. Left-behind objects (objects inadvertently left behind in the patient after surgery) can cause dangerous complications, such as perforations, infections, and blockages.

[0242] In some variations, compatibility between two surgical instruments 14, components, accessories, etc. can be determined based on geometric aspects of one of the items. For example, if a surgical stapler is compatible with a 45 mm staple cartridge, but not with a 60 mm staple cartridge, if a 60 mm staple cartridge is pulled for a surgical procedure, a notification can be provided to the user.

[0243] In some variations, as explained above, the smart packaging system 10 can include a readable medium 20. The readable medium 20 can be connected to a central database of manufacturing information and / or device information for the surgical instrument 14, typically to support recommendations based on cross-references to other devices and possible alternatives. For example, a smart packaging system 10 containing an endocutter can be scanned prior to opening the smart packaging system 10. The HUB 50 can receive information obtained from the scan, which can connect the HUB to a database containing manufacturing parameters for the endocutter, including firing force, cut length, articulation angle range, etc. The HUB 50 can provide a notification indicating that the endocutter is best suited for a certain tissue thickness at a certain location on the patient, as well as other information based on the manufacturing parameters of the endocutter. In a similar example with a harmonic device, the manufacturing parameters can include blade length and offset (related to heat diffusion potential).

[0244] In Figure 18 a simplified view of a patient's stomach 2260 is depicted. The stomach 2260 includes staples 2262 from a previous procedure as well as scar tissue 2264. Both the staples 2262 and the scar tissue 2264 can limit the kinds of surgical devices that can be used in a subsequent procedure, and can limit the procedures that can be successfully performed by future devices. This information can be included in the patient data perceived by the HUB 50 and / or the smart packaging system. In a future procedure, if a smart packaging system 2270 containing a surgical instrument 2272 capable of delivering bipolar energy for arterial dissection is brought to the operating room in preparation for a procedure involving the patient's stomach 2260, an attempt to use the bipolar capabilities of the surgical instrument 2272 can poorly interact with the staples 2262 and can harm the patient. The smart packaging system 2270 can determine that such a risk exists prior to opening and provide a message to the surgical staff warning them of the risk and / or incompatibility. The message can be provided in various ways, including via a display 2274 (e.g., a smart label or an e-ink label).

[0245] In a gastric sleeve revision, a patient's stomach can self-remodel, causing the stomach tissue to thicken and harden. As a result of the remodeling, it can be challenging to re-staple or re-loop a line over the top of a previous sleeve staple line. Some staplers are better than others at handling this challenge. For example, certain powered surgical staplers (e.g., carrying the Echelon ® name) have an I-beam, and will be more capable than non-I-beam staplers at accomplishing this task. In Figure 19The image depicts a stomach 2260 with remodeled tissue 2264, including various structures surrounding the stomach 2260. The stomach 2260 can be displayed on a screen or GUI located in the operating room prior to surgery, along with surrounding information about relevant patients that may influence the current protocol. Typically, this prior gastric protocol can be perceived by the intelligent packaging system 10 and / or the HUB 50, and notification can be provided if a better option for the protocol exists, if a non-I-beam suturer was selected.

[0246] In some embodiments, the smart packaging system may include features that help maximize the storage and containment efficiency of the smart packaging system itself and the accessories, devices, and equipment contained within it. Smart packaging system 2310 may include packaging 2312 containing surgical instruments 2314. Generally, smart packaging system 2310 may be similar to smart packaging system 10, and features of smart packaging system 10 may be applicable to smart packaging system 2310. Packaging 2312 of smart packaging system 2310 may include physical characteristics that facilitate transport from the manufacturing site to the place of use, in addition to the functions required for transport. These physical characteristics may include features that allow surgical instruments 2314 (or components thereof) to be stored and returned to the manufacturer after use of surgical instruments 14, and to be protected during such storage and return processes.

[0247] The packaging 2312 of the intelligent packaging system 2310 may include one or more physical aspects that assist in the control and / or storage of components and / or auxiliary parts of the surgical instrument 2314 within the operating room during the use of the surgical instrument 2314 in a surgical procedure. In this way, the packaging 2312 can function during the shipment and handling of the surgical instrument 2314, rather than simply protecting the surgical instrument 2314. Instead, the packaging can continue to function after the initial shipping period.

[0248] In some respects, packaging 2312 can be used for product management in the operating room during surgical procedures. For example, one aspect of packaging 2312 can assist in wire management.

[0249] In other respects, packaging 2312 may include selectively openable packaging that can be opened at key points during surgery when the contents of the selectively openable packaging are needed. Instead of storing all its contents in a single location within packaging 2312, the components may be divided based on the procedures discussed. Selectively openable packaging can be made selectively openable in a variety of ways.

[0250] In some variations, the package 2312 can have a main section 2312A (as explained above) for holding the surgical instrument 2314 and at least one sub-section 2312B for holding additional components such as accessories 2314A that can be used with the surgical instrument 2314. Based on the size of the surgical instrument 2314, the smart package system 2310 can have packages 2312 with different layouts including main sections 2312A of different sizes and at least one sub-section 2312B of different sizes. In Figure 20 and Figure 21 Examples can be seen in which the packages 2312 and 2312' have similar sizes, respectively. Figure 20 The package 2312 in Figure 21 includes a smaller surgical instrument 2314 compared to the surgical instrument 2314' shown. Thus, the main section 2312A is smaller than the main section 2312A'. The smaller main section 2312A leaves room for a larger at least one sub-section 2312B that can contain a larger size or a larger number of accessories 2314A compared to the smaller at least one sub-section 2312B', or for more than one at least one sub-section 2312B.

[0251] In one variation, where the timing of sub-procedures in a surgical procedure is known, a timer or timing device can be used to prevent access to a given selectively openable package until a predetermined amount of time has passed after the procedure begins. In another variation, the selectively openable package can include one or more scannable indicia for each individual compartment of the selectively openable package. The scannable indicia can take various forms, such as a bar code or a QR code. Upon scanning the scannable indicia, a signal can be transmitted to the container associated with the scannable indicia that causes the container to open and provide access to the contents stored therein. In another variation, the containers can include one or more safety interlocks that are linked together. Each of the containers within the selectively openable package can be ranked according to priority and / or order of use during a surgical procedure. In such an arrangement, a certain container will not open if a container of higher priority or that occurs earlier in the order of use has not yet been opened. For example, if the surgical instrument 14 is a device that includes a harmonic blade, the contents of the containers within the selectively openable package can include a blade cleaning solution that is recommended for use when the harmonic blade becomes too dirty. When the harmonic blade device is removed from the package 12, a secondary lid having a pull tab can prevent the blade cleaning solution from falling out of the package prematurely. In order to access the blade cleaning solution, the harmonic blade device must be removed from the package 12 and the pull tab attached to the secondary lid must be pulled to expose the cleaning solution. In this arrangement, the harmonic blade device has a higher priority than the blade cleaning solution, which is reflected within the structure of the outer package.

[0252] In one embodiment, a smart packaging system 2410 is provided, which may possess the same quality as any smart packaging system described herein. The smart packaging system 2410 can be shipped together with sub-packages 2413 arranged in layers or tiers. Figure 22 The illustration shows an example arrangement of an intelligent packaging system 2410, characterized in that the intelligent packaging system 2410 includes a main package 2412 placed on top of a base layer 2412A, and sub-packages 2413 placed on top of secondary layers 2412B and tertiary layers 2412C. The main package 2412 may contain surgical instruments (not shown). Secondary layers 2412B and tertiary layers 2412C only accommodate sub-packages 2413, which may contain accessories for surgical instruments 2414. For example, if the surgical instrument is a suture device, the accessory may be a staple cartridge that can be used with the suture device. The sub-package 2413 on tertiary layer 2412C may intentionally include surgical accessories before the accessories contained in the sub-package 2413 on secondary layer 2412B, making previously used accessories easier to access.

[0253] In some variations, packaging 12 may include reusable packaging 12. Reusable packaging 12 may be an aspect or component of packaging 12 that is held within packaging 12, or a physical characteristic of packaging 12 itself, to assist in the control or storage of one or more components of the smart packaging system 10 after use. For example, this aspect may promote sustainability.

[0254] In one variation, aspects of the outer packaging can facilitate the minimization of the physical footprint of package 12. This minimization can be achieved in various ways, including through self-compacting and / or user-initiated compaction. User-initiated compaction may include the use of an outer packaging comprising a non-rigid inner packaging and a rigid outer layer, allowing for easy separation of the outer and inner packaging after use and simple disposal. The non-rigid inner packaging may be an impermeable cover, such as one made of plastic, polymer, etc., and the rigid outer layer may comprise a rigid outer skeleton made of plastic, polymer, metal, or a combination thereof. The rigid outer skeleton may be further folded or detached into sub-components to further allow for easier disposal of package 12.

[0255] In addition to the inner packaging 12, minimization can be achieved through the interlocking of the sub-packagings of packaging 12. For example, packaging 12 may consist of multiple interlocking panels that together form a complete outer packaging. Once the contents of packaging 12 have been used, the panels can be separated from each other and allowed to lie flat. In another example, packaging 12 may be made of a material (such as corrugated cardboard) that includes one or more foldable sections. When compression is required, packaging 12 can be folded along predetermined points or folds and laid flat. Figure 23A and Figure 23BThe examples shown depict variations of package 2512 that can be used with the various smart packaging systems described herein. After using the smart packaging system, the various packages 2512A to 2512C included in the smart packaging system are foldable, and their sizes are set so that packages 2512 can be nested together to save space, such as... Figure 23B As depicted in the text.

[0256] In addition to the fact that packages from the same smart packaging system are nestable, several smart packaging systems may also include packages designed to be nested together. Figure 24A and Figure 24B Examples can be seen in the document, which include several smart packaging systems 2610A to 2610D and their corresponding packages 2612A to 2612D. Packages 2612A to 2612D are... Figure 24B It is depicted as being in a normal state, and then... Figure 24B It is described as being in a nested state.

[0257] In another variation, the outer packaging can be designed to remain intact after opening. Typically, the outer packaging can be disassembled or stacked within other similar packaging for waste management. If packaging 12 is designed for compact handling without disassembly, it can be reused to remove surgical instruments 14 from the surgical space. In such cases, marking 22 can be used to track the usage cycle of the contained surgical instruments 14. This information may be beneficial when retrievable surgical instruments 14 are included. Using a retrievable system, the manufacturer can retrieve the surgical instruments 14 or components thereof after each use, and the retrieved instruments can be resterilized and resold. The packaging 14 used for retrieving the surgical instruments 14 can be reused, and the number of times the surgical instruments 14 have been reused or handled throughout their lifespan can be tracked.

[0258] In another variation, one or more components of the packaging 12 may be made in a way that is recyclable, such as biodegradable, reusable, and / or recyclable. Additionally, components that are intentionally more environmentally friendly can be selected. To improve reusability, the packaging 12 of the smart packaging system 10 can be made more durable, and components of the smart packaging system 10 can be selected based on their durability. To improve recyclability, excess packaging material in the smart packaging system 10 can be removed, and easily recyclable materials, such as multiple interlocking cardboard pieces, can be selected instead of various plastics. The smart packaging system 10 may also have separable electronics to allow for increased disassembly between components placed in separate waste streams or fully recycled. This makes the decomposition process more efficient, allowing as many components as possible to be recycled.

[0259] exist Figure 25In another variation of the depicted smart packaging system 10, a smart packaging system 2710 is depicted that includes a plurality of nesting locations 2711 defined therein. These nesting locations 2711 can be located outside of the sterile portion of the smart packaging system 2710 and can essentially consist of a series of spaces to receive a sub-packaging that is shelved in a predetermined location within the smart packaging system 2710. The sub-packaging 2713 can include attachments, add-ons, materials, etc. that can be used with the rest of the smart packaging system 2710. For example, if the smart packaging system 2710 is a packaging for a stapler, the smart packaging system 2710 can include a stapler 2714 and a staple loader 2716 disposed within the nesting locations 2711 and additional materials. Each nesting location 2711 can include a dynamic marker 2722, as described herein, such that when a staple loader 2716 is removed from one of the nesting locations 2711, the corresponding dynamic marker 2722 can display information related to the pulled loader 2716, including size, type, condition, and other information about the loader 2716 itself, as well as information about the larger procedure that the loader 2716 is involved in, including order of use, purpose, etc. In this way, a healthcare provider, such as a surgical team, can use this information to understand whether all components of a procedure are present and accounted for, and whether they are in good standing for the procedure.

[0260] The secondary use packaging 12 can include aspects that help control the overall shape or configuration of the packaging 12. For example, the packaging 12 can be made to self- wind into a cylindrical or pyramidal shape to occupy less footprint space. The packaging 12 can also include various notches or features that enable other items to be stacked on top of it in a safe manner.

[0261] The smart packaging system 10 can include improved packaging protection behaviors and features. These can include active packaging features that react to various external stimuli. In one example, temperature logging by the smart packaging system 10 can ensure that the smart packaging system 10 and its contents are not exposed to temperatures that can potentially degrade its materials. The smart packaging system 10 can be equipped with packaging made from materials that react to certain hot or cold temperatures to protect its contents.

[0262] In another example, the smart packaging system 10 can be equipped with impact reactive cushioning. For example, if the packaging is dropped or subjected to forces that can potentially damage its contents, the corrugated design in the packaging can act as an absorption mechanism. In another example, the packaging can be made from a reactive material that darkens in the presence of UV light to protect the contents of the smart packaging system 10 from exposure to UV light, which is known to degrade many plastics.

[0263] Aspects of the packaging can enhance the authentication process for components of the smart packaging system 10. The authentication process can occur before or during a surgical procedure in which one or more components of the smart packaging system 10 are used or are to be used in order to act as an additional safety measure. Such an authentication process can prevent the use of fraudulent, recalled, unsafe, or otherwise problematic products during a surgical procedure, thereby preventing harm to patients and / or staff. To perform the authentication process, the outer packaging of the smart packaging system 10 can include one or more verification markers that can be detected by the HUB 50 or another system. Upon detection of the one or more verification markers, the authenticity of the smart packaging system in question can be determined.

[0264] The one or more verification markers can take a variety of forms and can include markers that are camouflaged and / or completely hidden from detection by the human eye (e.g., markers made in ultraviolet ink), hidden watermarks, or specific shape patterns contained within a larger seemingly random pattern. For example, there can be an array of dots on the packaging, and the presence of a specific subset of the dots (e.g., the subset of dots includes a specific pattern of color, form, arrangement, etc.) can be detected and used to complete the authentication procedure using those dots.

[0265] The HUB 50 or another system can include a vision processing component or optical detector, such as a camera that can inspect one or more verification markers on the packaging before use in a surgical procedure. These markers can indicate the authenticity of the product and can be camouflaged to be invisible or obscured to the naked eye. For example, infrared ink, unique patterns, etc. can all be computer readable, yet humans can find it difficult or impossible to discern the markers. Furthermore, these markers can be designed such that they only become visible when the smart packaging system 10 is properly sterilized or re-sterilized. Furthermore, separate systems can possess compatible markers that can provide visual feedback of the operable compatibility between separate systems.

[0266] Figure 26 An example verification procedure 2800 for a watermark 2802 is depicted in FIG. 28. In Figure 26At embedding step 2803, a watermark 2802 including a depiction of a logo with the number "2009" and a circle with lines can be embedded within the unmarked image 2804 using a key 2810 so that the image is now marked 2805. The marked image 2805 can be degraded or attacked at degradation step 2806, resulting in a degraded marked image 2806A. Such degradation can ensure that the product is not compromised. During verification step 2808, the key 2810 can be provided to extract the watermark 2802A from the degraded image 2806A at extraction step 2809, and a robustness check step 2812 can be used to compare the extracted watermark 2802A to the original watermark 2802. If there is sufficient similarity between the watermarks 2802, 2802A, then at robustness check step 2812, the verification procedure 2800 is completed and authentication 2814 is achieved.

[0267] Certain illustrative implementations have been described in order to provide a thorough understanding of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these implementations have been presented in the drawings. Those skilled in the art will understand that the systems, devices, and methods described herein with their components are non-limiting example implementations and that the scope of the disclosure is not limited to the described implementations. Features illustrated with respect to one example implementation can be combined with features illustrated or described with respect to other implementations. Such modifications and variations are considered within the scope of the present disclosure. Further, in the disclosure, like-named components of the implementations generally have similar features, and thus one of skill in the art will recognize that each feature need not be re-described in detail. Additionally, in the disclosure, the term "exemplary" is used to mean "an example of."

[0268] As used herein in the specification and claims, including the paragraphs above, approximate language can be applied to quantify any quantitative representation that can be tolerably varied without changing the basic function to which it relates. Thus, a value modified by one or more terms such as "about," "approximately," and "substantially" is not limited to the exact value stated following such term(s). In at least some instances, the approximate language can correspond to the precision of the instrument used to measure the value. Ranges can be combined and / or interchanged, such ranges being identified and include all the sub-ranges contained therein unless context or language indicates otherwise. Herein and throughout the specification and claims, the use of "including" and "comprising" will be understood to be open-ended, and will be followed by applications without limitation. The use of "including" and "comprising" does not therefore limit those terms in the examples to the specific examples recited.

[0269] Based on the implementations described above, those skilled in the art will appreciate additional features and advantages of the present disclosure. Accordingly, the application should not be limited, except as by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. A surgical system comprising: Manufacturer-sealed sterile surgical packaging containing surgical instruments; At least one data processor, wherein the at least one data processor is disposed in the surgical package; as well as A memory disposed within the surgical packaging and storing instructions configured to cause the at least one data processor to perform operations including: Receive data from a remote server characterizing one or more aspects of a surgical procedure involving the surgical instruments; Determine the level of compatibility between the surgical instrument and each of the one or more aspects of the surgical procedure; as well as Provide the determined level of compatibility.

2. The surgical system according to claim 1, wherein, The surgical procedure includes one or more surgical instruments, surgical accessories, and surgical techniques.

3. The surgical system of claim 1 or 2 further includes sending a notification of incompatibility between the surgical system and the one or more aspects when the determined compatibility level is below a compatibility threshold.

4. The surgical system according to claim 3, wherein, The notification is sent via a display located on the surgical system.

5. The surgical system according to claim 3 or 4, wherein, The notification was sent electronically to a remote server.

6. The surgical system according to claim 3, 4 or 5, wherein, The notification includes a list of one or more aspects of the surgical procedure whose compatibility level is below the compatibility threshold.

7. The surgical system according to any one of claims 3 to 6, further comprising disabling one or more features of the surgical system when the determined compatibility level is below a compatibility threshold.

8. The surgical system according to any one of claims 1 to 7, wherein, The delivery occurs before the sterile surgical packaging, sealed by the manufacturer and containing the surgical instruments, is damaged.

9. A method comprising: The surgical system receives data from a remote server that characterizes one or more aspects of a surgical procedure involving the surgical system. Determine the level of compatibility between the surgical system and each of the one or more aspects of the surgical procedure; as well as Provide the determined level of compatibility.

10. The method according to claim 9, wherein, The surgical procedure includes one or more surgical instruments, surgical accessories, and surgical techniques.

11. The method of claim 9 or 10, further comprising sending a notification of incompatibility between the surgical system and the one or more aspects when the determined compatibility level is below a compatibility threshold.

12. The method according to claim 11, wherein, The notification is sent via a display located on the surgical system.

13. The method according to claim 11 or 12, wherein, The notification is sent electronically to the remote server.

14. The method according to claim 11, 12 or 13, wherein, The notification includes a list of one or more aspects of the surgical procedure whose compatibility level is below the compatibility threshold.

15. The method according to any one of claims 11 to 14, further comprising disabling one or more features of the surgical system when the determined compatibility level is below a compatibility threshold.

16. The method according to any one of claims 9 to 15, wherein, The surgical system includes a manufacturer-sealed sterile surgical package containing surgical instruments.

17. The method according to claim 16, wherein, The delivery occurs before the sterile surgical packaging, sealed by the manufacturer and containing the surgical instruments, is damaged.

18. A non-transitory computer program product containing stored instructions, said instructions, when executed by at least one data processor forming part of at least one computing system, causing said at least one data processor to perform operations including: The surgical system receives data from a remote server that characterizes one or more aspects of a surgical procedure involving the surgical system. Determine the level of compatibility between the surgical system and each of the one or more aspects of the surgical procedure; as well as Provide the determined level of compatibility.

Images