Spatial aware adaptive surgical system

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 prior to breakage of the manufacturer-sealed sterile surgical package. The operations include: receiving, from a remote server, data characterizing a geopolitical location of at least one of the surgical package and the surgical instrument; and sending instructions 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 based on the received data.

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 are handled by various personnel (including shipping operators, warehouse operators, customs officials, hospital staff, surgical teams, etc.) along the supply chain.

[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 disposal protocols for each of the components of the surgical instrument; and providing the disposal protocols 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 hosting a surgical procedure; 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 hosting a surgical procedure; 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 hosting a surgical procedure. 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 in 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 transmitting 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 hosting a surgical procedure; 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 hosting a surgical procedure; 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] Surgical systems can vary in many ways. For example, handling instructions may include information characterizing at least one of historical state, future state, and operational information. In some variations, historical state may include at least one of manufacturing information, material and component information, geographic origin information, and environmental information experienced by the surgical packaging. In other variations, future state may include at least one of intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedure information. In still other variations, operational information may include at least one of product compatibility information, expected lifecycle information, and handling instructions. For example, these operations may include providing at least a portion of the historical record based on on-demand user requests. In some variations, on-demand user requests may be pre-certified. For example, handling instructions may be provided via a display located on the manufacturer-sealed sterile surgical packaging. For example, handling instructions may include a list of one or more surgical items for surgical procedures involving surgical instruments.

[0013] In another embodiment, a method is provided, which may include: updating the historical record of a surgical system based on at least one of the surgical system's current geopolitical location and supply chain progress; and providing processing instructions for the surgical system based on the surgical system's current geopolitical location and supply chain progress. The surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments.

[0014] This method can vary in several ways. For example, the processing instructions may include information characterizing at least one of historical state, future state, and operational information. In some variations, historical state may include at least one of manufacturing information, material and component information, geographic origin information, and environmental information experienced by the surgical packaging. Future state may include at least one of intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedure information. Operational information may include at least one of product compatibility information, expected lifecycle information, and operating instructions. The method may 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 before providing at least a portion of the historical record. In other aspects, the processing instructions may be provided via a display located on the manufacturer-sealed sterile surgical packaging. For example, the processing instructions may include a list of one or more surgical items for surgical procedures involving surgical instruments. In some variations, the method may also include sending at least one message indicating that at least one of the one or more surgical items is absent.

[0015] In another embodiment, a non-transitory computer program product is provided. This non-transitory computer program product may 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 perform operations. These operations may include: updating the historical record of a surgical system based on at least one of the surgical system's current geopolitical location and supply chain progress; and providing processing instructions for the surgical system based on the surgical system's current geopolitical location and supply chain progress. The surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments.

[0016] In another embodiment, a surgical system is provided. The surgical system may include: at least one manufacturer-sealed sterile surgical package containing surgical instruments; and an electronic management system that electronically communicates with the at least one manufacturer-sealed sterile surgical package. The electronic management system may 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 a surgical inventory list for surgical procedures utilizing surgical instruments based on the updated master management list; and provide the surgical inventory list. The surgical inventory list may include surgical equipment required for the surgical procedure.

[0017] The surgical system can vary in several ways. For example, the surgical system may include: receiving initial inventory data characterizing inventory information of the detected surgical system when at least one surgical system is initially detected by the network system; and appending the initial inventory data to a main management list. For example, the inventory information may include the current location of at least one surgical system. In some variations, inventory information may be received periodically. For example, when a first part of a surgical instrument on the surgical inventory list is detected to be in a first location, instructions are provided for transporting the first part to a second location. In some variations, the surgical system may include providing instructions for transporting the second part to a second location when a second part of a surgical instrument on a procedure list is detected to be in a third location. In some variations, the first location may be a first storage room within a hospital, and the second location may be an operating room within a hospital. In other variations, the first location may be a first storage room within a hospital, the second location may be an operating room within a hospital, and the third location may be a second storage room within a hospital.

[0018] In another embodiment, a method is provided, which may 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 surgical inventory list for surgical procedures utilizing surgical instruments based on the updated master management list; and providing the surgical inventory list. The surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments. The surgical inventory list may include surgical equipment required for the surgical procedure.

[0019] This method can vary in several ways. For example, the method may include: receiving initial inventory data characterizing inventory information of the detected surgical system when at least one surgical system is initially detected by the network system; and appending the initial inventory data to a main management list. The inventory information may include the current location of at least one surgical system. In some variations, inventory information may be received periodically. The method may also include providing instructions to transport the first part to a second location when a first part of a surgical instrument on the surgical inventory list is detected to be in a first location. In some variations, the method may include providing instructions to transport the second part to a second location when a second part of a surgical instrument on a procedure list is detected to be in a third location. The first location may be a first storage room within a hospital, and the second location may be an operating room within a hospital. The third location may be a second storage room within a hospital.

[0020] In one embodiment, a non-transitory computer program product is provided. This non-transitory computer program product may 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 perform operations. These operations may 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 surgical inventory list for surgical procedures utilizing surgical instruments based on the updated master management list; and providing the surgical inventory list. The surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments. The surgical inventory list includes surgical equipment required for surgical procedures.

[0021] In another embodiment, a surgical system is provided, which may include: at least one primary surgical system; and an electronic management system that communicates electronically with the primary surgical system. The electronic management system may be configured to update a virtual compatibility list stored on the primary surgical system with compatibility information. The compatibility information may: characterize the compatibility level between the primary surgical system and one or more secondary surgical systems that communicate electronically with the electronic management system; create a first virtual suite for surgical procedures; and provide the first virtual suite. The first virtual suite may include the primary surgical system and at least one of one or more secondary surgical systems selected based on the compatibility list.

[0022] Surgical systems can vary in several ways. For example, a primary surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments. An electronic management server may be configured to attach one or more tertiary systems to a first virtual suite. One or more tertiary systems may be determined based on the preferences of the surgeon performing the surgery. In other aspects, upon receiving a notification characterizing an error related to at least one selected secondary surgical system among one or more secondary surgical systems, the electronic management server may be configured to replace the selected at least one secondary surgical system among one or more secondary surgical systems with another secondary surgical system among one or more secondary surgical systems based on a compatibility list. In some variations, the error may be a lack of available stock of the selected at least one secondary surgical system among one or more secondary surgical systems. For example, the electronic management server may be configured to create a second virtual suite for a second surgical procedure. The second virtual suite may include a primary surgical system and at least one secondary surgical system among one or more secondary surgical systems selected based on a compatibility list. In some variations, the primary and secondary surgical procedures may be different types of surgeries. In other embodiments, the electronic management server may be further configured to order the surgical systems listed in the first virtual suite from a vendor.

[0023] In another embodiment, a method is provided, comprising: updating a virtual compatibility list stored on a primary surgical system that communicates electronically with an administration server using compatibility information; creating a first virtual suite for surgical procedures; and providing the first virtual suite. The compatibility information characterizes the level of compatibility between the primary surgical system and one or more secondary surgical systems that communicate electronically with the administration server. The first virtual suite may include the primary surgical system and at least one of the one or more secondary surgical systems selected based on the compatibility list.

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

[0025] In another embodiment, a non-transitory computer program product is provided. This non-transitory computer program product may 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 perform operations. These operations may include: updating a virtual compatibility list stored on a primary surgical system electronically communicating with a management server with compatibility information; creating a first virtual kit for surgical procedures; and providing the first virtual kit. The compatibility information may characterize the level of compatibility between the primary surgical system and one or more secondary surgical systems electronically communicating with the management server. The first virtual kit may include the primary surgical system and at least one of one or more secondary surgical systems selected based on the compatibility list.

[0026] In another embodiment, a surgical system is provided, which may include: a manufacturer-sealed sterile surgical package containing surgical instruments; at least one data processor; and a memory storing instructions configured to cause the at least one data processor to perform operations prior to the manufacturer-sealed sterile surgical package being breached. These operations may include: receiving data from a remote server characterizing the geopolitical location of at least one of the surgical package and the surgical instruments; and sending instructions to at least one of the surgical package and the surgical instruments based on the received data to alter one or more aspects of the surgical package and / or the surgical instruments.

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

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

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

[0030] In another embodiment, a non-transitory computer program product is provided. This non-transitory computer program product may 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 perform operations. These operations may include: receiving data characterizing the geopolitical location of the surgical system from a remote server; and sending instructions to a surgical package based on the received data to selectively modify one or more aspects of the surgical package. The surgical system may include a manufacturer-sealed sterile surgical package and surgical instruments contained within the manufacturer-sealed sterile surgical package.

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

[0032] Surgical systems can vary in many ways. For example, one or more aspects of a surgical procedure may include one or more surgical instruments, surgical accessories, and surgical techniques. These operations may include sending a notification of incompatibility between the surgical system and one or more aspects when a determined compatibility level is below a compatibility threshold. In some aspects, the notification may be sent via a display located on the surgical system. In others, the notification may be sent electronically to a remote server. In still others, the notification may include a list of one or more aspects of the surgical procedure with which a compatibility level is below a compatibility threshold. In yet another set of aspects, these operations may include disabling one or more features of the surgical system when a determined compatibility level is below a compatibility threshold. For example, this provision may occur before the manufacturer-sealed sterile surgical packaging containing the surgical instruments breaks.

[0033] In another embodiment, a method is provided. This method may include: receiving data from a remote server by a surgical system characterizing one or more aspects of a surgical procedure involving the surgical system; determining a compatibility level between the surgical system and each of the one or more aspects of the surgical procedure; and providing the determined compatibility level.

[0034] This method can vary in several ways. For example, one or more aspects of a surgical procedure may include one or more surgical instruments, surgical accessories, and surgical techniques. The method may also include sending a notification of incompatibility between the surgical system and one or more aspects when a determined compatibility level is below a compatibility threshold. In some aspects, the notification may be sent via a display located on the surgical system. In other aspects, the notification may be sent electronically to a remote server. In yet another aspect, the notification may include a list of one or more aspects of the surgical procedure with which the compatibility level is below a compatibility threshold. In still other aspects, the method may include disabling one or more features of the surgical system when a determined compatibility level is below a compatibility threshold. For example, the surgical system may include a manufacturer-sealed sterile surgical package containing surgical instruments. In some variations, this provision may occur before the manufacturer-sealed sterile surgical package containing the surgical instruments breaks.

[0035] In another embodiment, a non-transitory computer program product is provided. This non-transitory computer program product may 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 perform operations. These operations may include: receiving data from a remote server by a surgical system characterizing one or more aspects of a surgical procedure involving the surgical system; determining a compatibility level between the surgical system and each of the one or more aspects of the surgical procedure; and providing the determined compatibility level.

[0036] In another embodiment, a package is provided. The package may include: a manufacturer-sealed sterile surgical package; surgical instruments 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 sterilely contain one or more components of the surgical instruments after surgical procedures. The at least one secondary use package may include at least one authenticator configured to selectively allow access to the at least one secondary use package.

[0037] This method can vary in several ways. For example, the authenticator can be an invisible watermark, and at least one reusable 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 a manufacturer-sealed sterile surgical package. At least one reusable package can be configured to open upon detection of at least one RFID chip. In another embodiment, the authenticator can be a timer configured to prevent access to at least one reusable package until a predetermined time period has elapsed. In other aspects, the authenticator can be at least one scannable marker. At least one scannable marker can be configured to allow access to at least one reusable package after being scanned. For example, at least one of the manufacturer-sealed sterile surgical package and at least one reusable package may include a biodegradable material. For example, at least one of the manufacturer-sealed sterile surgical package and at least one reusable package may include a UV-sensitive material configured to darken upon exposure to UV light. For example, at least one of the manufacturer-sealed sterile surgical package and at least one reusable package includes at least one self-compacting feature to assist in the decomposition of at least one of the manufacturer-sealed sterile surgical package and at least one reusable package. In some respects, at least one compaction feature may include two or more separable interlocking panels.

[0038] In another embodiment, a method is provided. The method may include: accessing a surgical instrument stored within a manufacturer-sealed surgical package; performing at least one surgical procedure using the accessed surgical instrument; storing at least one component within at least one secondary package contained within the manufacturer-sealed surgical package; and shipping the one or more components held in the at least one secondary package after the at least one surgical procedure. The secondary package may be shaped to hold one or more components of the surgical instrument.

[0039] This method can vary in several ways. For example, the method may include authenticating at least one authenticator located on at least one reusable package to authorize access to its interior. In some aspects, the authenticator may be an invisible watermark, and at least one reusable package may be configured to open upon detection of the watermark. In other aspects, the authenticator may be at least one RFID chip embedded within a manufacturer-sealed sterile surgical package. At least one reusable package may be configured to open upon detection of at least one RFID chip. In yet another aspect, the authenticator may be a timer configured to prevent access to at least one reusable package until a predetermined time period has elapsed. In still other aspects, the authenticator may be at least one scannable marker. At least one scannable marker may be configured to authorize access to at least one reusable package after being scanned. Attached Figure Description

[0040] The present invention is described with reference to the following figures:

[0041] Figure 1 This is a top view of a passive RFID tag according to one implementation scheme;

[0042] Figure 2 This is a side view of an intelligent packaging system containing surgical instruments according to one implementation scheme;

[0043] Figure 3A This is a diagram of an intelligent packaging system that communicates electronically with beacons and hubs in the operating room, according to an implementation plan.

[0044] Figure 3B This is a diagram of an intelligent packaging system that communicates electronically with beacons and hubs in the operating room, according to an implementation plan.

[0045] Figure 4 This is a diagram illustrating the supply chain for a smart packaging system including surgical instruments, according to one implementation scheme, and the types of information exchanged to and from the smart packaging system at various points along the supply chain.

[0046] Figure 5 This is a side view of an intelligent packaging system comprising surgical instruments and two indicators according to one implementation scheme;

[0047] Figure 6 yes Figure 5 A side view of the indicator, which has radiation-sensitive ink before and after exposure to radiation;

[0048] Figure 7 yes Figure 5 A side view of the indicator, which has a balloon exposed before and after the pressure change;

[0049] Figure 8 This is a side view of an intelligent packaging system containing a surgical instrument according to one embodiment, the surgical instrument having a stop switch;

[0050] Figure 9 This is based on the first variant after the stop switch has been activated. Figure 8 A side view of the intelligent packaging system;

[0051] Figure 10 This is based on the second variation after the stop switch has been activated. Figure 8 A side view of the intelligent packaging system;

[0052] Figure 11A This is a perspective view of a smart packaging system including a tracker according to one implementation scheme;

[0053] Figure 11B yes Figure 11A A top view of the intelligent packaging system;

[0054] Figure 12A yes Figure 11A A schematic diagram of the tracker's components, including a switch in a first position;

[0055] Figure 12B It is in the second position. Figure 12A A schematic diagram of the switch;

[0056] Figure 13 This is a perspective view of a nestable smart packaging system based on an implementation plan;

[0057] Figure 14 This is a diagram showing waste bins used to receive different types of waste according to a waste management plan;

[0058] Figure 15 This is a perspective view of a PCB and a pry bar according to some implementation schemes, the pry bar being configured to remove the PCB from the smart packaging system;

[0059] Figure 16 This is a schematic diagram of an intelligent packaging system and its components, marked according to a disposal plan, based on some implementation schemes;

[0060] Figure 17 It is a diagram illustrating the recommended process based on an implementation plan;

[0061] Figure 18 It is a simplified side view of a patient's stomach with scar tissue and markers of previous surgery;

[0062] Figure 19 yes Figure 18 A perspective view of the stomach;

[0063] Figure 20 This is a top view of a smart packaging system including surgical instruments and surgical accessories, according to a first variation of an implementation scheme;

[0064] Figure 21 It is based on Figure 20 A top view of a second variant of an implementation of an intelligent packaging system including surgical instruments and surgical accessories;

[0065] Figure 22 This is a perspective view of an intelligent packaging system comprising surgical instruments and accessories and featuring tiered trays, according to one embodiment.

[0066] Figure 23A It is a side view of the packaging of a smart packaging system in a nested configuration, based on some variations of the implementation scheme;

[0067] Figure 23B It is in a collapsed configuration. Figure 23A Side view of the packaging;

[0068] Figure 24A It is a side view of the packaging of a smart packaging system based on some implementation schemes;

[0069] Figure 24B It is in a nested configuration Figure 24A A top view of the packaging;

[0070] Figure 25 It is a top view of a package having multiple nested positions according to an embodiment; and

[0071] Figure 26 It is a diagram depicting the watermark authentication process according to an implementation plan. Detailed Implementation

[0072] Certain exemplary embodiments will now be described to provide an overall understanding of the structure, function, manufacture, and principles of use of the apparatuses, 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 apparatuses, systems, and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features illustrated or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention.

[0073] Furthermore, in this disclosure, components with similar names in various embodiments often have similar features, and therefore, in specific embodiments, not every feature of every component with a similar name is necessarily fully described. Additionally, the extent to which linear or circular dimensions are used in the description of the disclosed systems, apparatuses, and methods is not intended to limit the types of shapes that can be used in conjunction with such systems, apparatuses, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. Those skilled in the art will also understand that dimensions may not be precise values, but are considered to be approximately such values ​​due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The dimensions and shapes of systems and apparatuses and their components can depend at least on the dimensions and shapes of the components to be used with the systems and apparatuses.

[0074] Intelligent surgical devices, systems, and methods are provided. The use of intelligent devices, systems, and methods typically enables the storage, sharing, and utilization of information throughout the supply chain, as well as aiding in the management of various systems, procedures, and aspects of healthcare facilities in which they are used. Information regarding various aspects of the supply chain and healthcare facilities can be recorded, monitored, and reviewed at any time to allow for real-time adjustments to these aspects. Furthermore, the analysis of compiled information can be used to minimize or avoid defects and problems associated with the supply chain and / or products flowing through it, as well as defects and problems associated with the coordination of surgical procedures and related equipment at the healthcare facility. Overall, intelligent devices, systems, and methods can improve the efficiency of the supply chain by managing information associated with products flowing through it, and they can improve the efficiency of healthcare facilities in which they are deployed for surgical procedures. While the specific types of intelligent devices, systems, and methods can vary, in some aspects, the packaging of the product itself can be used to consistently track, monitor, and record information associated with the product. Additionally, tracking devices (e.g., scanners, beacons, etc.) and / or centralized computer management systems can be used as part of intelligent systems and devices.

[0075] 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.

[0076] 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.

[0077] 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 passive RFID tag 2, there is an IC 4 electrically coupled to an antenna 6. The IC 4 and the antenna 6 are mounted on a substrate 8.

[0078] 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.

[0079] In some variations, the outer packaging may include additional memory storage devices and / or one or more additional processors to electronically communicate with one or more RFID tags in order to enhance the capabilities of the RFID tags. The smart packaging system may also include one or more of a display (such as an e-ink display, LCD display, touchscreen, or equivalent) and / or readable media (such as barcodes, QR codes, or equivalents). In some variations, the smart packaging system may include a data port, such as a USB port. Utilizing some or all of these features, the smart packaging system can typically acquire data from external sources (such as computers, computer networks) and data received from one or more of its sensors, and the smart packaging system can typically transmit data and / or present information to computers, computer networks, users, scanning devices, RFID readers, and any devices capable of receiving data from the features of the smart packaging system.

[0080] Surgical instruments and / or components contained within the outer packaging can vary in both form and function. In some variations, the entire surgical instrument can be a “smart” device, where the state and operation of the surgical instrument can be monitored, recorded, and altered at any time. For example, if the surgical instrument is an endoscopic cutter configured to cut into and suture tissue, the amount of torque applied by the instrument’s jaws can be monitored throughout the surgical procedure. If the hub determines that the surgeon has applied too much torque, a maximum torque limit can be wirelessly applied to the instrument in real time to prevent accidents. Furthermore, with such surgical instruments, if an accident does occur during operation involving the instrument, details surrounding the accident can be recorded and stored in the packaging’s memory or virtually stored on the hub. This information can then be used to determine the source of the accident and, for example, whether a recall should be issued for similarly positioned surgical instruments.

[0081] In other variations, a sub-section of the surgical instrument may be "intelligent," while other parts of the instrument may be electrically isolated from the "intelligent" sub-section, making it impossible for the state and operation of the surgical instrument to be monitored, recorded, or altered under any circumstances. For example, in the same endoscopic cutter described above, the jaw actuator subsystem may be "intelligent," but the articulated subsystem involving the axis of the endoscopic cutter may not be "intelligent." Even if the axis may be electronically articulated, it may not communicate electronically with the hub and / or outer packaging, and therefore it may be "hidden" and unmonitorable. These examples are merely illustrative, and more specific examples and variations are described below.

[0082] An example of the intelligent packaging system 10 is in Figure 2The illustrated smart packaging system 10 includes a package 12 containing a surgical instrument 14. The surgical instrument 14 can be any surgical instrument or surgical material, such as an endoscopic cutter as shown. The smart packaging system 10 may include a controller 13 configured to perform the functions of the smart packaging system 10. The controller 13 typically includes a control unit 13A, a logic unit 13B, and a memory 13C to implement the functionality of the controller 13. The smart packaging system 10 may also include an internal power source 15 (such as a battery) capable of providing power to the various components of the smart packaging system 10, including the controller 13 described herein. The package 12 may also include an RFID tag 16 configured to transmit and receive information from external sources. A serial number 18, which may or may not have encrypted data, may be located on the package 12, making it readable by a processor or computer system. The package 12 may also include a scannable or readable medium 20 (such as a QR code or barcode) and a display 22 (such as the previously mentioned type, e.g., an electronic ink display). Although not shown, the smart packaging system 10 may include additional surgical attachments, components, and elements that can be disposed in a separate compartment from the surgical instrument 14. The surgical attachments, components, and elements may be used in conjunction with or separately from the surgical instrument 14. These items may generally be referred to collectively as the contents of the smart packaging system 10. For example, the surgical instrument 14 may be a surgical suture device, and the contents of the smart packaging system 10 may include a staple cartridge compatible with the surgical suture device, which may be packaged separately from the surgical suture device within the smart packaging system 10, such as in a sub-compartment of the package 12. Reference will be made to the smart packaging system 10 and its components for illustrative purposes only.

[0083] The intelligent packaging system 10 can receive and present information relevant to individuals who interact with it throughout the lifecycle of the contained surgical instrument 14, as well as other surgical instruments and products that interface with the contained surgical instrument 14. The type of individuals and the relevance of the information will vary depending on the location of the surgical instrument 14 and the intelligent packaging system 10 within their lifecycle. After manufacturing in the factory, the surgical instrument 14 will be packaged and ready for delivery to ultimately end up at a healthcare facility, such as a hospital or surgical center, for use in surgery. To reach the hospital or surgical center, the intelligent packaging system 10 will interact with a range of individuals, including factory personnel, warehouse personnel, transportation personnel, customs personnel, and hospital personnel. At each stage of its journey, the intelligent packaging system 10 can receive and send relevant information to individuals. Although the intelligent packaging system 10 can store a variety of information, it can selectively provide only relevant information based on context.

[0084] Additionally, during its journey, the smart packaging system 10 can communicate with a central network, also known as a HUB 50, which monitors and coordinates information including and about the smart packaging system 10. The HUB 50 may exist along the smart packaging supply chain in the form of beacons 102 placed in critical locations such as hospital operating rooms (ORs). When the beacon 102 or other aspects of the HUB 50 detect the close proximity of the smart packaging system 10, information can be exchanged between the smart packaging system 10 and the HUB 50, and information can also be exchanged between the HUB 50 and various external networks.

[0085] Each beacon 102 may include a transceiver, a power supply, a processor, and local memory. The beacon 102 typically operates as an RFID reader that communicates electronically with a central network HUB 50. The beacon 102 can communicate via wired or wireless means, such as infrared communication, radio communication, Wi-Fi communication, Bluetooth, etc. The RFID reader can be a passive reader capable of receiving signals transmitted by active RFID tags, or an active reader capable of sending interrogator signals and receiving responses (such as authentication responses) from RFID tags. During operation, the beacon 102 may receive transmitted data from the smart packaging system 10, which characterizes information recorded by the smart packaging system 10 related to its history since manufacturing. The beacon 102 may then transmit the received data to the HUB 50, where the data can be stored, analyzed, and / or manipulated. The beacon 102 may also transmit information from the HUB 50 to nearby smart packaging systems 10.

[0086] Figure 3A and Figure 3B The diagram illustrates a non-limiting example of information exchange between beacon 102 (or typically HUB 50) and smart packaging system 10. Figure 3A The diagram depicts a general hierarchical structure between a HUB 50, beacons 102 (represented individually as beacons 102A-102D), and one or more smart packaging systems 10 (represented individually as smart packaging systems 10A-10L). The HUB 50 can communicate with beacons 102, which in turn 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 send information to and receive information directly from the HUB 50. Figure 3BThe diagram illustrates an exemplary supply chain 100 and the different contexts in which a smart packaging system 10 can communicate with a hub 50 via one or more beacons 102. The interaction between the smart packaging system 10 and the hub 50 via beacons 102 can be significant depending on the context in which the smart packaging system 10 is situated. This context can change as the smart packaging system 10 moves through the supply chain from manufacturing to transportation to use.

[0087] Figure 3B and Figure 4 The supply chain 100 shown is a simplified version having key stages along the supply chain of a surgical device or system, such that the depiction of supply chain 100 is illustrative and exemplary, not mandatory or necessary. In reality, actual supply chains may include these stages in a different order, or they may include additional stages, replicate certain stages, or omit stages entirely.

[0088] The first depicted stage in the supply chain 100 is the assembly stage 120, which may include a beacon 102A to facilitate communication with the HUB 50. Assembly stage 120 represents the manufacture of the surgical instrument 14. Information exchanged at assembly stage 120 may include assembly information 112 relating to the surgical instrument 14 itself, including its performance metrics, manufacturing specifications, tolerances, safety, and usage information. Assembly information 112 may also include, for example, sub-assembly information relating to one or more sub-components compatible with the surgical instrument. Additionally, assembly information 112 may include the work-in-process (WIP) stage of the surgical instrument and the assembly date.

[0089] The second depicted stage in supply chain 100 is warehouse stage 110, which may include beacon 102B. Warehouse stage 110 represents the storage of the smart packaging system 10 prior to shipment. Information exchanged at warehouse stage 110 may include warehouse information 122, such as batch number, inventory number and count, FIFO date and shelf location, enabling the smart packaging system 10 to be tracked and located within the warehouse itself.

[0090] The third depicted stage in supply chain 100 is transportation stage 130, which may include beacon 102C. Transportation stage 130 represents the transportation of the smart packaging system 10 from the warehouse to its final destination at the distribution center. Information exchanged at transportation stage 130 may include transportation information 132, such as sender address, truck ID, recipient address, processing instructions, and customs data.

[0091] Following the third delineation phase and before ending at the distribution center, the smart packaging system 10 may optionally be shipped across geopolitical boundaries, including to international locations. The fourth delineation phase is the customs phase 140, which may include beacons 102D and indicates those events when the smart packaging system 10 must cross geopolitical boundaries. Information exchanged during the customs phase may include customs information 142, such as declared value, contents, and documentation.

[0092] If the smart packaging system 10 is not an international shipment, it can proceed directly from the transport stage 130 to the distribution stage 150. If the smart packaging system 10 is an international shipment, it can proceed to the distribution stage 150 after the customs stage 140. The distribution stage 150 represents a warehouse or distribution center, which may include a beacon 102E that receives the smart packaging system before delivering it to its final destination, such as a hospital. Information exchanged at the distribution stage 150 may include distribution information 152, such as shelf location, quantity of a specific stock-holding unit (SKU) in inventory, model number, FIFO date, delivery time, and due date.

[0093] The sixth depicted stage in supply chain 100 is local transportation stage 160, which may include beacon 102F. Local transportation stage 160 represents the transportation required to get the smart packaging system 10 to its final destination. Information exchanged at local transportation stage 160 may include local transportation information 162, such as the location of the hospital or surgical center, truck number, delivery time, processing instructions, and invoice number. During local transportation, if any aspect of the smart packaging system has been recalled, the information exchanged may include, for example, a return address, and the smart packaging system 10 may be recalled and returned for evaluation and / or disposal.

[0094] The seventh depicted stage in supply chain 100 is the hospital stage 170, which may include one or more beacons 102G. Hospital stage 170 represents a hospital or surgical center where surgical instruments 14 will be used during surgical procedures. If local transport is able to deliver the smart packaging system 10, it will deliver the smart packaging system 10 to the hospital, where it can be stored until needed. Information exchanged at the hospital stage may include hospital information 172A, such as operating room (OR) number, storage location, and item count. If local transport is unable to deliver the smart packaging system 10, such as for recall purposes, the smart packaging system 10 may exchange recall information 172B, such as the return address of the smart packaging system, and a warning with information related to the recall.

[0095] The eighth depiction stage in the supply chain 100 is OR stage 180, which may include beacon 102H. OR stage 180 indicates the operating room where surgical instruments 14, which are part of the smart packaging system 10, will be used. The information exchanged at OR stage 180 may include OR information 182, such as OR room number, surgical kit details, device number in the total equipment required for the operation, surgeon information, and patient information.

[0096] The information described at each stage of the supply chain 100 is merely exemplary and does not represent an exhaustive list of information that can be exchanged at the beginning of a given stage.

[0097] Typically, the smart packaging system 10 can provide users (e.g., transport workers, customs officers, surgeons, warehouse personnel, etc.) with information about themselves. This information can be delivered by the smart packaging system 10 in various ways, as described below, and the delivered information can depend on a variety of factors, including: composition, contents, current location, destination, user identity, authorization level, functional capabilities, external stimuli, etc.

[0098] In some implementations, the smart packaging system 10 is configured to store its intended destination (e.g., a specific hospital) and to record and store its historical data as it moves toward that destination. Additionally, the smart packaging system 10 may be configured to determine its position along the path to its intended destination.

[0099] The intelligent packaging system 10 can locate and monitor its various aspects and components, such as surgical instruments 14, surgical accessories and their contained contents, as well as other elements within the operating room. This information can be broadcast or otherwise provided as needed. For example, when items enter the operating room containing the intelligent packaging system 10, these items can be added in real time to a database containing a list of components present in the operating room. This list can be stored on the intelligent packaging system 10 or on a device that communicates electronically with the intelligent packaging system 10, HUB 50, or another similar system. If the intelligent packaging system 10 enters an operating room containing items, these items can be added to the list upon the first detection. When items on the list leave the operating room or are disposed of, these items can be removed from the list.

[0100] Items can be added to the list manually, by scanning (e.g., via barcodes or QR codes, or by remote scanning using electronic systems such as the HUB 50), or by any combination of the methods described herein. When items are added to the list manually, healthcare professionals can enter information characterizing the items present in the operating room. Items can be manually removed from the list when they are disposed of or otherwise removed from the operating room. When scanning is the input method, various methods can be used. These methods may include manual scanning, active wireless transmission via capable devices, direct detection, geofencing, BLE beacons, and surgical procedures.

[0101] Manual scanning can also involve healthcare personnel, but instead of manually entering the attributes of items upon entering the operating room, they can use any described method to scan the items, and the attributes of the scanned items can be automatically populated into a list. For example, by scanning the barcode of the smart packaging system 10, 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, the operability of the contents, etc.) can be obtained from the barcode and added to a list.

[0102] Active wireless transmission is a type of technology used for object monitoring. Active wireless transmission can operate between capable devices to send information between them. Polling devices (such as HUB 50 or Smart Packaging System 10) can send wireless polls or inventory checks. Capable devices within range of the wireless polling or inventory check can respond by sending their own signals toward the polling device. Based on the signals sent by the polling device, both the direction and distance to each detected device can be determined. Using this information, the polling device can further determine whether one or more detected devices are in the operating room or within the area of ​​interest. Devices identified as being in the operating room can be added to a list.

[0103] This method can even be used to detect devices that are not currently in the area of ​​interest (such as an operating room) but should be within it. For example, if a polling device sends a signal and detects a device within range but outside the operating room, and the polling device knows that the detected device should be in the operating room, it can provide a notification to the user. Additionally, the user can be provided with the direction and distance to one or more detected devices, allowing the user to locate the detected devices. This information can be provided on the display 22 of the smart packaging system 10, on the display of the polling device, or on a monitor (such as a monitor located in the operating room) that is electronically communicating with the sending device. Furthermore, location can be achieved by requesting secondary local feedback from one or more detected devices via transmission; that is, the detected devices transmit their own signals to receive information about their current location, nearby devices, etc., and then this information can be provided to the initial polling device. If possible, the detected devices can also play audio signals.

[0104] Direct detection of devices or components is another type of technique used for object monitoring. If the device being searched has certain physical properties, detection can utilize these properties to locate the device. For example, if the device being searched is known to be metal, the metal can be detected via impedance or capacitance field monitoring to locate the device within the scanned area.

[0105] Active global geofencing is another class of technology for object detection. Active global geofencing can be assigned to specific geophysical locations and can track all objects passing through that geofence. Combinations of systems can be assembled to monitor objects passing through the geofence, allowing the combination of systems to detect objects within the combined device or as individual elements. This monitoring can function in various ways, such as relying on specific visual indicators present on the object to continuously track it. For example, the packaging of surgical needles may include a specific yellow and black stripe pattern. Cameras included in the system can be used to visually monitor the area of ​​that specific yellow and black stripe pattern, even from multiple angles. When the pattern is detected, the object can be added to a list of items known to exist within the geofence. An example of detectable objects includes surgical sponges, which may have integrated RF transmitters. Surgeons or other personnel can use corresponding devices (such as sticks) to determine whether sponges have been left after surgery. One advantage offered by geofencing would be the automatic tracking and detection of such sponges to ensure their removal without active detection by surgeons or other personnel.

[0106] Bluetooth Low Energy (“BLE”) beacons can be employed for another class of technologies used for object monitoring. BLE beacons can repeatedly transmit signals detectable by other devices, such as via radio signals. Signals may include encoded alphanumeric messages transmitted over short intervals, which can be used for specific transmissions and to encode specific messages and data. BLE beacons can be used to register products currently located in the operating room, and they can also be used to communicate changes in the status of detected objects and products. Once an object enters the operating room, the initial detection by the BLE beacon can add the object to a database list. Furthermore, if a status change occurs, this information can be communicated to other networks. For example, if the smart packaging system 10 is opened, the beacon can change its message to indicate that a given product is currently in use in the operating room. A signal can be sent to the HUB 50 to mark the opened smart packaging system 10 from the inventory count across the healthcare facility, indicating that the opened smart packaging system 10 is no longer in stock. In another example, if an object leaves the operating room, the BLE beacon can send a message to indicate whether the object is being returned to central storage or whether the object has been consumed and is now entering the waste stream.

[0107] Tracking objects via surgical steps is another class of techniques for object monitoring. Tracking objects via surgical steps may require reliance on previously described techniques (such as geofencing) to provide additional information for object monitoring. For example, geofencing can be used to designate sub-regions within an operating room (e.g., surgical fields of view). Objects known to be necessary for surgery but not yet detected entering a geofenced surgical field of view can provide an indication that a step in the surgery has not yet occurred.

[0108] Multiple communication devices in an operating room environment can be disruptive and cause interference between signals transmitted by these devices. Various techniques can be employed to minimize disruption. For example, the smart packaging system 10 may include one or more methods for varying the bandwidth of its transmissions, as well as multiple communication methods. Some communication methods may rely on the internal power supply 15 of the smart packaging system 10. Some methods may obtain power from external sources, such as external electromagnetic fields, such as using near-field communication (NFC), or using external wired connections, such as via a USB cable.

[0109] The smart packaging system 10 can rely on RFID tags to communicate with other devices, but if RFID becomes unavailable, the smart packaging system can rely on auxiliary communication methods. For example, NFC and RFID can be combined, allowing power to be obtained from an external field using RFID and broadcasting only when the system is prompted. Using NFC, an antenna can be used, and other systems (such as Wi-Fi and battery systems) can be deactivated to save power when activated.

[0110] Other techniques for minimizing interference can vary. For example, a surgical cart (described herein) can be intelligent, and when a smart device is placed on the cart, the smart device can detect the cart and relinquish communication capabilities to it; that is, the cart can maintain a list of devices placed on it and handle all location requests sent to devices on the list. For example, location-related communication can be disabled if the smart packaging system 10 is opened. For example, location-related communication can be disabled based on the current location of the smart device. If the smart device is being shipped, location-related request capabilities can be disabled to save power. For example, the smart device can broadcast a limited number of times for a given event. If a device is programmed to broadcast changes in its location during movement, then at least in some scenarios, the device can alternatively be limited to providing less frequent broadcasts. For example, the smart device can operate in a hierarchical system such that all transmissions from the smart device are routed to a central point (such as HUB 50), and HUB 50 routes the transmissions to their correct receivers while prioritizing and coordinating the transmissions to minimize interference.

[0111] In some implementations, the smart packaging system 10 may record information related to its assembly and manufacturing aspects, and the smart packaging system 10 may store this information and provide it to various personnel interacting with the smart packaging system 10, and make certain decisions in part based on the stored information. The stored information may vary and may include information related to aspects that ultimately affect the use of the smart packaging system 10 and its contents, including surgical equipment (e.g., surgical instruments 14) contained therein. For example, the stored information may include: information related to the calibration and specific settings of the smart packaging system 10, which may adjust the operation of the smart packaging system 10 based on a combination of settings and equipment interactions; information related to the manufacturing process and materials of the smart packaging system 10; and information related to special instructions for use of the smart packaging system 10 and operational limitations (such as adverse reactions with other equipment).

[0112] When information pertains to the calibration and specific settings of the smart packaging system 10, this information may specifically include information relating to the calibration of the smart packaging system 10 and its contents, which is based on other devices paired with or used with the contents to adjust the operation of the contents (e.g., surgical instruments 14). This can be achieved by locating or identifying key aspects of the smart packaging system 10 and its contents that relate to various combinations of accessories and equipment that are combined or grouped with or associated with the smart packaging system 10 and its contents. For example, surgical instruments 14 may operate with a variety of surgical needles, each of which may be tagged with an RFID tag (e.g., similar to RFID tag 16) or an equivalent. When a surgical instrument is paired with a tagged surgical needle, the calibration of the surgical instrument can be adjusted based on that pairing. The information required for the adjustment may be coordinated via HUB 50, or surgical instruments 14 may be programmed to recognize the result of pairing with that particular type of tagged surgical needle.

[0113] Locating or identifying key aspects of the smart packaging system 10 and its contents associated with various combinations can improve the traceability of the components constituting the smart packaging system 10. This traceability can benefit sustainable work, safe work, and more. The smart packaging system 10 can store a log or inventory of its components, such as various needles, blades, batteries, sensors, housings, etc. Separable components can be identified as special elements that must be considered after surgery or other procedures. Furthermore, the manufacturing origin 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 described in more detail below.

[0114] When the information pertains to manufacturing processes and materials, it may specifically include information related to the manufacturing processes and composition of the components of the smart packaging system 10.

[0115] Manufacturing tracking information may include information related to the procedures that components of the smart packaging system 10 undergo from assembly to shipment. For example, once a component is assembled, the tracking information may record when the component was incorporated into the smart packaging system 10. The smart packaging system 10 may be tagged with a basic serial number and any other necessary special identification information. The smart packaging system 10 may also be tagged with one or more additional serial numbers associated with a specific component contained therein, as well as additional data to assist post-assembly procedures, such as information that helps evaluate the smart packaging system 10 after a potential recall. The smart packaging system 10 may also be tagged with information related to manufacturing data and location.

[0116] Manufacturing tracking information may also include sterilization counts and procedures, as well as related sterilization information, including sterilization data.

[0117] Manufacturing tracking information may also include information related to entries made by the smart packaging system 10 in the bulk packaging / shipping procedures. For example, in a variant of the smart packaging system 10 that relies on the smart display 22, the smart display 22 may 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 determine the current status, the display 22 may default to displaying the last known location. The display 22 may also be configured to display information related to the manufacturer's contact information.

[0118] Component composition information may include information relating to the composition of a given component of the smart packaging system 10. This information may include any notable materials of the component, or, where two alternative compositions are possible, a specific composition of the component to avoid ambiguity. For example, the smart packaging system 10 may include a surgical instrument 14 in the form of an endoscopic cutter. Some endoscopic cutters may include a channel retainer, which may be made of plastic or aluminum, which may affect the cleanup process of the endoscopic cutter and its disposal procedures. Component composition information may specifically include an indication of whether the channel retainer is plastic or aluminum to clarify any ambiguity surrounding the cleanup procedures for the endoscopic cutter.

[0119] In another example, component composition information can convey whether a radioactive needle is included in the smart packaging system 10. Such inclusions may affect the labeling requirements and travel restrictions of the smart packaging system 10 when applied in certain jurisdictions. Component composition information may also include information relating to other regulated components that may face restrictions during international transport. For example, cobalt is restricted by certain regulations in Europe, and this information would be noteworthy in the context of European regulations.

[0120] Typically, the smart packaging system 10 can understand its historical and future status and its intended use throughout its entire lifecycle. Essentially, the smart packaging system 10 can have self-awareness during its lifecycle. This awareness allows the smart packaging system to know: 1) its location within the facility supply chain; 2) when it is received at a medical facility; 3) when it enters a storage room or storage area at the medical facility; 4) when it is requested for use in a medical procedure; and 5) when it enters the operating room for the requested medical procedure. Each of these aspects of awareness will be described further.

[0121] Locations that trigger different markers or information transmissions may include: warehouses, storage facilities, in transit, sterilization areas, supplier distribution centers, transportation modes, customs, regional distribution centers, local delivery, healthcare facility receiving areas, storage rooms, operating rooms, repackaging areas within operating rooms, healthcare facility cleaning / sorting areas, disposal areas, reuse areas, return shipment areas, etc.

[0122] The intelligent packaging system 10 can sense its position within the facility supply chain. Specifically, as described herein, the intelligent packaging system 10 can sense virtual kits. The intelligent packaging system 10 can also identify connectivity components to enable interfacing with various facility equipment, procedures, etc. The intelligent packaging system 10 can also identify missing capital equipment within the operating room. For example, if software is outdated, it can be flagged by the intelligent packaging system 10, such as through notifications on display 22 or by sending messages via the intelligent packaging system 10 to devices communicating electronically with it. The intelligent packaging system 10 can identify attempts to communicate with incompatible systems. The intelligent packaging system 10 can relay information to other devices that identify incompatible systems to prevent the identified system from attempting to communicate with these other devices. This information can also be relayed to a hub 50, which can inform the correct user.

[0123] Intelligent packaging systems may include at least two separate aseptic visual indicators, such as... Figure 5 What I saw in the middle Figure 5 A smart packaging system 10 according to another variation is depicted. The smart packaging system 10 may include a first indicator 2011 and a second indicator 2012. Indicators 2011 and 2012 may convey changes in sterility, such as loss of sterility within the smart packaging system 10. Each indicator 2011 and 2012 may be an element of appearance change, such as changing color or changing from invisible to visible. The first indicator 2011 may indicate whether the smart packaging system 10 has been adequately sterilized. The second indicator 2012 may indicate whether sterility has been lost. Each indicator 2011 and 2012 may initially be triggered by a sterilization event, but the second indicator 2012 may be triggered in the event of loss of sterility, while the first indicator 2011 remains unchanged.

[0124] Also there Figure 6 The first indicator 2011 seen in the image may include a portion of a code 2020 on the smart packaging system 10, such as a QR code or barcode. The code 2020 may be printed in the first portion 2022 with standard ink to form an incomplete code. A second type of ink may be used for the second portion 2024 of the code 2020. The ink may darken upon exposure to gamma radiation, which is a preferred sterilization method for the smart packaging system 10, thereby completing the code 2020 and facilitating its scanning. Unless the smart packaging system 10 is sterilized via gamma radiation 2026, the second portion 2024 of the code 2020 will never darken and the code 2020 cannot be scanned, thereby indicating that the smart packaging system 10 has not been properly sterilized and should not be used.

[0125] For the second indicator 2012 (in) Figure 7As seen in [the diagram], for example, the packaging process may include the step of trapping an inert gas or vacuum within a balloon 2030 or similar device stored in the smart packaging system 10 at a pressure (P1) different from 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 breaks, causing P2 to now equal to P1 at atmospheric pressure, the size of the balloon 2030 or similar device will change, thereby indicating a breach in the smart packaging system and a loss of sterility.

[0126] An alternative second indicator (not shown) may involve a double-walled balloon located within the smart packaging system 10. The inner balloon contains a volume under a first pressure P1, and the outer balloon contains the inner balloon and is held between the outer and inner balloons at a second pressure P2. The outer balloon is made of a thin material and ruptures during sterilization, thereby releasing its contents into the smart packaging system 10 and releasing the inner balloon. This causes an increase in pressure within the smart packaging system (assuming P2 is greater than atmospheric pressure). The inner balloon remains at P1, and when the smart packaging system 10 ruptures, the pressure drops to atmospheric pressure, thereby changing the shape of the inner balloon and indicating a breach in sterility. These indicators 2011, 2012 can help prevent the reuse of packaging and can help prevent counterfeiting.

[0127] 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 display 22 or some other devices described herein. This information may include serial numbers, batch numbers, manufacturing dates, country code, mode of transport, etc. In the warehouse, the information sent may include UDI, batch number, and other information related to warehouse operations. When the smart packaging system 10 determines that it is being loaded for transport, the information may change to include address, handling instructions, etc. The smart packaging system 10 can also display shipping identification information. When received by a distributor, the information sent may include expiry date, box number, location, count, etc. The smart packaging system 10 may also display information related to 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, it may display a warning explaining that lithium-ion batteries cannot be transported on commercial flights. When the smart packaging system 10 is with a supplier, the information sent may include first-in, first-out (FIFO) information, batch number, unique identifier, construction details, etc. Suppliers may be interested in the development direction of the smart packaging system, the shipment quantity, the storage location, and other information. When the smart packaging system 10 is at customs, the information transmitted may include the product's value, destination, origin, generic name, warnings and descriptions of hazardous materials, fragility, perishability, liquids, etc. When the smart packaging system 10 is en route to a medical facility, the information transmitted may include the facility's address, invoice, list of items in shipment, purchase order number, and handling requirements (e.g., refrigeration, etc.).

[0128] The smart packaging system 10 can sense when it is received at a healthcare facility, for example, during the initial scan of the HUB 50, during the initial scan by facility personnel, during manual or remote activation, when determining the current geographic location, when a compatible system instructing the healthcare facility is detected, or through some other detection means. When the smart packaging system 10 receives this instruction at the healthcare facility, it can run internal checks to determine its own status and can take certain actions based on its status. Information sent when the smart packaging system 10 is received at the facility may include the storage location and expiration date.

[0129] As explained herein, the smart packaging system 10 may include one or more sensors, such as temperature sensors, humidity sensors, etc., that measure the environment in which the smart packaging system 10 is located. Based on the data collected by the sensors, the smart packaging system 10 can sense situations where the external environment may cause potential damage 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 may assume that it has suffered adverse damage to itself due to the temperature exceeding a safety threshold. As described, other sensors may be used to determine when the smart packaging system 10 has experienced some environmental conditions that may have caused damage to the smart packaging system 10, and specific safety thresholds may vary depending on various aspects of the smart packaging system 10.

[0130] If the smart packaging system 10 determines that it has experienced an unsafe environment, it can respond in several ways. For example, the smart packaging system 10 may display a warning on display 22 or by sending a warning to a device that communicates electronically with the smart packaging system 10. The warning may be a simple message such as "Do not use". More specific details may then be provided upon request from another system (such as HUB 50, scanner, etc.) to understand why the smart packaging system 10 displayed such a warning. These details may indicate that the packaging has experienced, for example, excessively high temperatures, which have now potentially jeopardized the smart packaging system 10.

[0131] In some variations, if the smart packaging system 10 senses an event such as excessive temperature, excessive humidity, exceeding the expiration date, or being subjected to excessive force, 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 communicates with the HUB 50, such as for a status check or other reason, the HUB 50 can run a rapid diagnostic test to determine if the smart packaging system 10 has experienced any potentially harmful events. If a harmful event, such as loss of sterility, is detected, a stop switch can be activated within the smart packaging system 10.

[0132] A stop switch can appear in various forms, and examples are available. Figure 8 , Figure 9 and Figure 10 I saw it in the middle. Figure 8 A smart packaging system 10 is depicted, comprising a surgical instrument 14 electrically coupled to a sensor 2040 and a circuit 2042 equipped with a battery 2044 and a solenoid 2046. A stop switch can be triggered in the smart packaging system 10 when the sensor 2040 detects a harmful event. Figure 9A first variation of the stop switch is depicted, wherein a trigger solenoid 2046 is used to disconnect a first portion 2048 of the circuit 2042 that delivers power from the battery 2044 to the surgical instrument 14, thereby permanently disabling the smart packaging system 10. Figure 10 A second variation of the kill switch is depicted, in which instead of disconnecting circuit 2042 to isolate battery 2044, solenoid 2046 disconnects a second portion 2049 of the circuit to isolate surgical instrument 14, thereby forcing battery 2044 to deplete at a rate that compromises its integrity. Other kill switches not depicted may include software that interrupts the boot sequence of the affected smart packaging system 10. Upon detecting a harmful event, this software prevents the smart packaging system 10 from properly starting, thereby effectively preventing any use of the smart packaging system 10.

[0133] As explained above, the smart packaging system 10 can sense when it enters the healthcare facility's storage device. The smart packaging system 10 may include a readable medium 20 containing device information, and a tag for the smart packaging system 10 may be generated by the healthcare facility. This tag explains to the HUB 50 how to parse the device information into a format compatible with the healthcare facility's recording system for automated report writing in postoperative procedures involving the smart packaging system 10. In practice, when the surgical packaging system 10 is received at a healthcare facility, it can be scanned and immediately recorded in the facility's inventory. Once in inventory, the smart packaging system 10 can be monitored for events of interest, including recalls, expiration dates, first-in-first-out (FIFO) use, etc. Monitoring may even include specific use cases, such as when procedures involving the smart packaging system 10 require the application of high stress during the procedure. The selection of the smart packaging system 10 may occur based on the need for high stress application, where older smart packaging systems 10 received by the hospital may not be preferred due to the increased operational risks associated with performing high stress application with older smart packaging systems 10. Conversely, despite the existence of a first-in-first-out (FIFO) usage strategy, a more "fresh" smart packaging system can be selected.

[0134] The smart packaging system 10 may have an adaptive expiration date, which can be programmed and stored on the smart packaging system 10. While a default expiration date is available, the adaptive expiration date can be adjusted based on environmental conditions measured by the smart packaging system 10. For example, if it is very hot during transport and / or in the storage room, the expiration date may arrive sooner than expected. The adaptive expiration date can be adjusted based on environmental data sensed by sensors of the smart packaging system 10.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] Although not shown, block diagram 2060 may include components that enable wired or wireless communication with other features of the smart packaging system 2010, HUB 50, and any other type of device described herein.

[0139] The intelligent packaging system 10 can sense when it needs to be used in medical procedures. The intelligent packaging system 10 can sense the types of procedures it typically uses, the types of equipment used in these procedures, their operational capabilities, and requirements. Therefore, the intelligent packaging system 10 can provide electronic notifications via display 22 recommending preferred storage locations within the healthcare facility, including environmental factors, proximity to other compatible products, etc.

[0140] The smart packaging system 10 may include tags to enable the smart packaging system 10 to be customized for integration into the operation of a healthcare facility. The tags may include a scannable code containing device information and a second tag specifically generated by the hospital, which tells the HUB 50 how to parse the device information into a format used by the facility for feeding into records for post-procedure report writing.

[0141] If the smart packaging system 10 becomes aware that it has been requested for a specific procedure, it can also know that, typically, certain devices are used in conjunction with it. Some of these other devices may be smart devices capable of communicating with the smart packaging system 10, HUB 50, and other devices. When the smart packaging system 10 detects incompatibility, it can provide an incompatibility alert or notification. However, in some cases, a physician may pull out seemingly unusual combinations of devices. The smart packaging system 10 can ask the physician if they wish to register the combination as a new bundle for future reference.

[0142] When a product is retrieved and used, the information sent by the smart packaging system 10 may include the cart number, item number, destination, whether the storage room needs to be accessed again, doctor's name, etc.

[0143] The intelligent packaging system 10 can sense when it enters the operating room. If the intelligent packaging system 10 is confirmed to be used in the procedure, no alarms, warnings, or other prohibitions will be issued. The intelligent packaging system 10 can display messages indicating that the procedure is ready, such as specific words like "ready" or symbols such as green checkmarks designed to indicate readiness. Various intelligent packaging systems 10 used in the procedure can also change their displays 22 to reflect the typical usage sequence for the operation (e.g., 1 / 5, 2 / 5, etc.).

[0144] If the intelligent packaging system 10 enters the operating room and issues an alarm or warning, or some other message (such as an instruction on a preferred alternative), the display 22 or the display of the intelligent packaging system 10 may provide an indicator such as "Danger not eliminated, do not open," or other messages, symbols, etc. Such a message may also be displayed on the intelligent packaging system 10, which should not be opened before a specific time according to the procedure, even if the intelligent packaging system 10 has otherwise eliminated the danger.

[0145] For a given procedure, the HUB 50 or other systems may display a readiness indicator. This indicator may reflect the proportion of ready components required for the surgical procedure, and the indicator may be represented, for example, as a loading bar. Indicators may also be present throughout the procedure, such as timelines indicating when a particular smart packaging system 10 should be used relative to each other. If certain information is critical to the procedure, it may be displayed in a prominent manner, such as in a visible location, at an appropriate size, or using additional indicators such as flashlights, audible alarms, etc. Some information indicators may also be temporary, disappearing if they are ignored for a certain amount of time.

[0146] When the smart packaging system 10 is located within a healthcare facility, it can be systematically tracked as part of its ability to receive and transmit electronic information. A management system for “floating” inventory management can be used to track the smart packaging system; this system is virtual and discontinuous, but allows for the immediate retrieval of the location, identification, and tracking of all smart packaging systems 10 in a similar situation within a specific healthcare facility. This management system can leverage the capabilities of the smart packaging system 10 as described herein, so that HUB 50 or other similar management tools can plan procedures and circulating inventory as needed based on the situational awareness of the healthcare facility's procedures, staff, and schedules provided by HUB 50 and the smart packaging system 10. This allows healthcare facilities to maintain a smaller overall inventory of smart packaging systems 10, as specific smart packaging systems 10 with their unique contents can be tracked and located at any time, without the need for excessive on-site product storage.

[0147] The following section describes the management system and its various applications, including those related to the capabilities of the intelligent packaging system 10.

[0148] The intelligent packaging system 10 can dynamically sense its location and distribution throughout its entire lifecycle. For a given intelligent packaging system 10, due to the communication capabilities of the intelligent packaging system 10, surgical instruments 14, and HUB 50, the contents of the surgical instruments 14 and the intelligent packaging system 10 can be tracked within the healthcare facility. This allows the intelligent packaging system 10 to be located not only in a specific storage room within the healthcare facility, but also in the lobby, on a trolley, on a return table, in misplaced locations, etc.

[0149] Therefore, the management of the smart packaging system 10 does not necessarily rely on a physical storage room. Instead, the management system can rely on a virtual storage room, which can take various forms, such as an electronic database of the various smart packaging systems 10, their locations, and their operational capabilities. This virtual storage room can include pre-set locations, such as physical storage rooms within healthcare facilities, where smart packaging can typically be stored. However, the virtual storage room can serve as a comprehensive management tool that can be updated in real time to reflect the current information of the various smart packaging systems 10 within the healthcare facility.

[0150] In the example, if two smart packaging systems 10 are transported to an operating room for a surgeon to choose between, the unnecessary smart packaging system 10 can be placed on a trolley and returned to the storage room. In a traditionally managed healthcare facility, tracking a smart packaging system 10 might be difficult if it is needed in another operating room before the trolley can be returned to the storage room. Using a virtual storage room, the smart packaging system 10 can be continuously tracked, and the trolley can be moved to a second operating room, making the smart packaging system 10 immediately usable without first needing to restock it in the storage room. This significantly improves efficiency within the healthcare facility.

[0151] Using this 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 the first option for smart packaging systems 10 is unavailable, suitable alternatives can be quickly located and provided. Because such alternative operations exist in a virtual storage database, these alternative operations can be easily located within the healthcare facility.

[0152] On the other hand, such a management system can provide automated inventory location and circulation. For example, the delivery of inventory can be automated, such as through robotic equipment. In some healthcare facilities with automated inventory management robots and other types of robots, this type of management system can allow the location of a specific smart packaging system 10 to be provided to such a robot, which can then travel to any location where the smart packaging system 10 is located to retrieve it.

[0153] By adding dedicated robotic systems, virtual inventory management systems, and / or similar systems, the need for physical storage rooms located in fixed locations can be reduced or completely eliminated. These new storage rooms can be a series of mobile “cabinets” equipped with a series of intelligent packaging systems 10. Since the intelligent packaging systems 10 are needed, the “cabinets” (essentially robots with large storage capacities) can travel to the location where the intelligent packaging systems 10 are needed, and the intelligent packaging systems 10 can deliver automatically. This automated delivery can be stopped for various scenarios (such as a certain amount of time before a procedure, or when the opening of the intelligent packaging system 10 is detected), thus eliminating the need for alternatives or automated delivery.

[0154] The system can further control the management of the smart packaging system 10 based on multiple factors, and accordingly prioritize the movement of the smart packaging system, such as keeping frequently used smart packaging systems 10 in more convenient locations to allow for rapid delivery, and supplying smart packaging systems 10 in a first-in, first-out manner to reduce the likelihood of the smart packaging system 10 becoming expired. Alternatively, specific expiration dates of the smart packaging system 10 can be tracked so that expiration is taken into account when supplying the smart packaging system 10.

[0155] In some variations, the management system may employ one or more "smart" operating rooms for cataloging equipment, supplies, and products entering them. If, for a given procedure, the cataloged items are not consumed, they can be aggregated to leave the operating room and be returned to storage. When items leave, the management system may, for example, add them back to a virtual inventory database via HUB 50 for future use.

[0156] When the smart packaging system 10 moves around a healthcare facility during its management, it can display management-related information via smart displays 22, monitors 22, etc. For example, the smart packaging system 10 can display the operating room number that has been scheduled for use.

[0157] To make the management of the smart packaging system 10 more efficient, the management system can reroute the smart packaging system 10 so that it does not move in an inefficient manner. For example, if the smart packaging system 10 is initially requested to be used at a first location, but is subsequently needed at a second location, instead of sending the smart packaging system 10 back to the storage room before sending it to the second location, the smart packaging system 10 can be directly routed to the second location.

[0158] The management system may employ the use of smart carts, which can be incorporated into a virtual storage area. Each smart cart may have the ability to identify one or more products on it and provide their location. As part of its inclusion in the virtual storage area, the smart cart may have a unique digital ID and can be tracked within the management system. The smart cart may be equipped with its own display device, such as the one found on the smart packaging system 10, and may display information related to the products it carries, its destination, and its schedule. The smart cart may also be configured to identify nearby personnel, such as by detecting smart badges or other devices. The smart cart may inform the identified personnel of certain information, such as relaying messages or making requests. For example, the smart cart may instruct personnel to remove certain products from the cart to complete the delivery.

[0159] In some variations, the smart cart can be manually operated, or it can be drivable or self-driving, as it moves the product to various locations within the healthcare facility. The HUB 50 can track the smart cart as it passes a beacon or when it communicates electronically with other networked equipment. This tracking allows the smart cart to be guided to various locations, and personnel within the healthcare facility can be guided to the cart as needed to move the product around the facility. In some aspects, the smart cart can be free-floating and can be moved to key areas of the healthcare facility as needed.

[0160] In addition, smart carts can be equipped to display instructions for their next destination, such as a specific operating room in a healthcare facility. These instructions may also include a list of products to be delivered to the designated location upon delivery.

[0161] In some respects, smart carts may rely on specialization, meaning that all the products on a given smart cart are related to cardiovascular surgery. Smart carts may be colored or otherwise labeled to indicate this specificity, in order to inform the observer of the cart's general contents.

[0162] The management system can aggregate the smart packaging systems 10, and the smart packaging systems 10 can coordinate among them to determine priorities, status, location, and other information. Such communication between the smart packaging systems 10 can occur at any time when two or more smart packaging systems 10 are within the range of electronic communication, and specifically, when the smart packaging systems 10 are located on the same smart cart or in the same physical storage room, operating room, etc.

[0163] If the smart packaging system 10 is accidentally removed from the smart cart, any capable system that senses the removal can send a notification to the HUB 50, informing the HUB 50 that the specific smart packaging system 10 removed is unusable because it is being moved. A request can be made to deliver a replacement product or component to the specific smart cart from which the smart packaging system 10 was removed, in order to minimize disruption to planned procedures.

[0164] The management system can employ a prioritization system or hierarchy among any type of equipment. More important equipment can be tracked more closely than less important equipment, and if there are problems with the management or delivery of two devices, the equipment deemed more important by the prioritization system can be given priority. For a given smart cart, as packages are removed and delivered, a certain threshold is eventually reached, or a window in the delivery schedule becomes available for restocking the smart cart. Using the current management system, restocking can be coordinated to make it more efficient. For example, suppose two smart carts are loaded with almost identical products at the start of the day, and suppose one cart is short of a certain product and needs restocking, while 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 resupply the cart with the shortage. This eliminates the additional trip to the storage room.

[0165] The expiration date of the 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.

[0166] When backup stock or alternative products are needed, smart carts can guide users to the alternatives. This guidance can manifest as directing users to another cart with the alternative product, or directing users to a specific storage room containing the product, etc.

[0167] While some items may not traditionally be “smart”, all packaging can be equipped with RFID tags or equivalent devices to provide a minimum level of “smart” functionality, which at least enables a basic level of management.

[0168] In some variations, the smart cart can display the active inventory of items currently on it. This information can be found on a display or other user interface, which can also be navigable (such as via touchscreen, buttons, or other inputs) to provide information to the user in an organized and meaningful way.

[0169] While planning and scheduling can be implemented based on various information related to surgery, reserves, etc., to guide smart carts as needed, scheduling can change rapidly. When scheduling changes and therefore needs to be changed, the management system can adjust based on updated information to reroute 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 routes to handlers, or, if the smart cart is autonomous, the cart can receive updated route information and then respond automatically. This type of response reduces confusion associated with coordinating related products with schedule changes and updated procedures.

[0170] In some variations, the smart cart can be modular and aware of common aspects of the products to optimize handling and delivery. The smart cart can be equipped with attachable and reattachable sub-sections in the form of trays, drawers, etc., which can be packaged using the smart packaging system 10 or specific product groups, such as those for a given procedure. Sub-sections can be attached in various ways, such as via a series of magnets, latches, or other means. This allows for the rapid replacement and storage of smart carts with specific kits or related product groups. Sub-sections can also be functionally grouped, such as having suture sub-sections, cardiac sub-sections, etc. The sub-sections themselves can be equipped with intelligent capabilities and may be able to identify the compatibility of the products stored within them. In some variations, each of these sub-sections can be packaged together with all the smart packaging system 10 and accessories required for a given procedure. When the smart cart arrives at the corresponding operating room, the entire sub-section can be removed and carried into the operating room.

[0171] In some variations, the smart cart can help mitigate incompatibility issues between the smart packaging system 10 and other components by providing a secondary check. If someone attempts to remove the wrong device from the smart cart, it can identify the person picking up the item, for example, via its smart badge, and inform them that they have grabbed the wrong product. For instance, if someone grabs a smart packaging system 10 required by the procedure, and also grabs an accessory that is used with a different smart packaging system 10, the smart cart can inform them that they actually need to grab the different accessory from the cart.

[0172] 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 procedures occurring in a given operating room, the identities of the personnel associated with that specific surgery (such as surgeons, nurses, etc.) are typically known for staffing and coordination purposes. If the smart cart is conducting a round of deliveries and one delivery is made to that given operating room, the smart cart can read the smart badge of the person receiving the delivery, associate that person with a specific 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.

[0173] Furthermore, the smart cart can identify a person's "permission level" to determine who can receive or claim a specific smart packaging system 10 from the cart. For example, if the smart cart is handling packaging containing sensitive information, controlled substances, etc., it can check the permission level of the person claiming the packaging and react appropriately. In the event of an unauthorized person making an incorrect retrieval, the reaction may include notifying another person (such as someone authorized to correct the situation), preventing that person from claiming the device (e.g., by using a smart lock on a sub-section of the smart cart), directly disabling or locking the smart packaging system 10, etc. Additionally, the smart cart can 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.

[0174] In some variations, smart carts can be programmed with scheduling awareness and optimized based on the layout of healthcare facilities, including key locations such as storage rooms and operating rooms. More specifically, smart carts can be programmed with daily schedules that may take into account planned surgeries, procedure times, other smart carts, and other information. Based on this programmed information, smart carts can determine route planning, path optimization, and restocking windows. For example, if a smart cart knows it will cross paths with another smart cart holding a particular product at a certain time, and it also knows it will need that product at a later time, then when the two smart carts cross paths, the smart cart can retrieve the product from the other smart cart. This routing based not only on the location of storage rooms but also on the location and routes of other smart carts can significantly improve inventory management at healthcare facilities.

[0175] Smart trolleys can be subdivided into at least two categories, which may include fixed floating trolleys and mobile floating trolleys. Mobile floating trolleys may have a set path based on the time of day, delivery location, etc., and the route arrangement of mobile floating trolleys can be updated based on scheduled times. Fixed floating trolleys can be placed or moved to key locations and can be used as pick-up points for various smart packaging systems 10 and accessories.

[0176] Based on timing, scheduling, and other variables (such as the current inventory on the smart cart), the smart cart can shuffle its inventory into a specific order. The smart cart may be equipped with a system for moving its components, such as a drive mechanism that operates a device similar to a vending machine or another device similar to a conveyor belt.

[0177] As part of the management of the smart packaging system 10, a virtual storage room can be used to create digital suites throughout the virtual storage room or supply chain. These digital suites can be tagged with digital indicators that identify each smart packaging system 10 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 types of smart packaging systems 10, these types of smart packaging systems 10 can be tagged with identifiers that link them to the routine procedure as part of a suite used for that routine procedure. The type of smart packaging system 10 used for that routine procedure can be permanently associated with that type of suite used for that routine procedure and with the smart packaging system 10 itself.

[0178] To assist in management, the intelligent packaging system 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 functional result of one of the surgical instruments 14. Using this knowledge, organizational adjustments can be made to co-locate the co-retrieval intelligent packaging system 10 in storage, minimizing the workload during retrieval. For example, if the surgical instruments 14 are consistently used in conjunction with a specific type of suture, these two items can be organized together such that they are physically located close to each other when the procedure requires them, minimizing the effort required to track them.

[0179] To further assist in tracking the smart packaging system 10 within a kit, the smart packaging system 10 may emit indicators. These indicators can be audible and / or visual. When certain devices within the kit are placed close together, audible indicators may take the form of tones, thereby indicating their correct origin. Different tones can be used to indicate mismatches or incorrect pairings. Corresponding tones can be cheerful or somber to further indicate the purpose of the tone. Audible tones can assist in the approximate location of a smart packaging system 10. Visual indicators may take the form of color-coded markers or other special markings to indicate that the smart packaging system belongs to a kit, or the form of flashlights to assist in the location of the smart packaging system 10. This type of indicator can be based on user preferences and can be adjusted as needed.

[0180] In some variations, an augmented reality-enabled smart packaging system 10 may be used. In these variations, location can be indicated and displayed via augmented reality (AR) on a tablet, wearable device (such as glasses or a watch), phone, or other system. Certain combinations may be displayed as different colors in the AR environment, and indicators showing compatibility and / or incompatibility with other systems may be provided within the AR environment. The AR environment may be cross-checked with other systems described herein to confirm any necessary information, and to supplement any requests that fail to be met by any given system.

[0181] When the smart packaging systems 10 are grouped together into kits, additional features can be employed. For example, coupled products can be automatically bulk-ordered according to their kits. Kits also provide the HUB 50 with a convenient list of items that can be used as a checklist in other contexts. Kits can also describe alternatives to any of their members, allowing for quick reference if a specific item in the kit is unavailable. Furthermore, as the smart packaging systems 10 continue to pull with other smart packaging systems 10, they can begin to recognize the resulting patterns, including their associations with other smart packaging systems 10. This can be accomplished in various ways, such as machine learning or pattern recognition programs. When certain patterns are recognized, the smart packaging systems 10 can suggest updates or the creation of virtual kits based on the recognized patterns.

[0182] Additionally, users (such as healthcare professionals) can create their own customized kits based on various factors, including preferences, availability, and cost. Based on these customizations and other recommendations, manufacturers can then supply the kits to healthcare facilities, allowing the institution to purchase them in bulk and / or at a discount, while ensuring compatibility among the kit members. Other benefits may also be provided.

[0183] 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.

[0184] 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 to the package 12, for example, via a snap-fit ​​engagement. This design allows the packages 12 to be stacked together. 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.

[0185] The smart packaging system 10 can be further connected to a smart pallet or other smart carrier device, such as the smart cart described above. The pallet or equivalent may be reusable and includes onboard power and memory, as well as means of connection to the smart packaging system 10, such as via electrical contacts described above, wireless communication as described herein, or any other known method. The smart pallet may also be able to communicate with the HUB 50 and receive data related to the smart packaging system of the healthcare facility initially transmitted thereto. The smart pallet can then be returned, and data can be collected as needed. As described herein, disposal procedures for the smart packaging system can be complex and variable, and such procedures can be integrated with the smart pallet for recycling processes.

[0186] In the connectable variant of the smart packaging system 10, the unique identification features of each individual smart packaging system 10 can be arranged such that they are individually readable even when packaged and connected to each other.

[0187] In some implementations, the smart packaging system 10 senses waste management procedures to provide users with approved disposal and recycling instructions related to the contents of the smart packaging system 10. The smart packaging system 10 may include a packaging aspect that provides interactive waste flow guidance, enabling the contents of the smart packaging system 10 to be stored, reused, and decomposed for disposal, and the packaging aspect may give the smart packaging system 10 the ability to determine the correct waste flow guidance.

[0188] The intelligent packaging system 10 can provide users with disposal methods, disposal recommendations, and general disposal management information. These may include: instructions or procedures for disassembly and disposal; documentation of aspects related to use, product operability, and equipment utilization; and tracking of the disposal process.

[0189] The smart packaging system 10 may provide instructions for disassembling and disposing of its components, and these instructions may vary based on a number of factors. For example, these instructions may follow standard guidelines for waste management, where healthcare waste segregation involves separating various types of waste into different colored bins according to waste classification. These standard guidelines may be available in, for example... 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.

[0190] 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.

[0191] In some implementations, the smart packaging system 10, surgical instruments 14, and / or packaging can read product information from surrounding devices contained in the disposal container. This can be done in several ways, including using RFID tags to detect other adjacent tags. For example, if a device or component is disconnected from the HUB 50 (indicating disposal), and that device or component is then detected near a component that should belong to a separate disposal location, this may indicate that one or more devices or components have been improperly disposed of. If a component is detected and no other components belonging to a separate container are detected, this may indicate that the correct disposal procedure was followed. In another example, if a battery or battery-carrying component is detected nearby after disposal, improper disposal may have occurred. If such an improper disposal scenario is detected, the detection component can send this information to the user or HUB 50 after reconnection and inform the user of the error. If a repeated error is detected, or a pattern indicating improper procedure appears, the supplier can be notified through any appropriate communication channel.

[0192] If the healthcare provider has limited treatment options, the smart packaging system 10 can adjust the provided instructions based on the available options. This can be done in several ways and may involve, for example, setting a hierarchy among treatment options so that if one option is unavailable, the smart packaging system 10 will select the next option, continuing along the list until an option becomes available. If no option is available, the smart packaging system 10 can inform the user to follow its standard procedures for that unavailability.

[0193] The complexity of disassembly during the removal of the contents of the smart packaging system 10 can be a problem. Therefore, simplifying the procedure to reduce the likelihood of errors that could cause injury may be beneficial. In some variations, the smart packaging system 10 may include a numbering scheme for disassembly to provide the order in which disassembly should occur (e.g., removing the battery first, then isolating the blade, etc.). The smart packaging system 10 may include one or more indicators (e.g., LEDs) that activate after each step in the scheme is completed to provide visual indication of progress. In some variations, dynamic markings (such as smart display 22 (e.g., e-ink markings) or displays 22) may provide step-by-step instructions for disassembly. When a disassembled component has been properly disposed of, the smart packaging system 10 may update displays 22 or notify the user to activate the next step. As explained herein, the smart packaging system 10 and the HUB 50 may communicate with each other to monitor progress and update the displayed disassembly instructions. In some variations, the smart packaging system 10 may 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 may be varied to accommodate applicable local regulations. In some variants, compliance assurance services can be used to track equipment removal and disposal to confirm that specific components (such as batteries) are disposed of correctly.

[0194] When instructions vary based on geopolitical location and / or specific healthcare provider regulations, the location may be determined based on the product code or some other identifier, including the location of a specific healthcare provider (i.e., the product code is known to be shipped to a specific location, so these instructions will correspond to that location). This determination can also be made through communication with HUB 50.

[0195] Alternative disposal methods and options can also be provided. As explained above, a hierarchical structure of options can be used, such that if one option is unavailable, the next option in the hierarchy is selected. If an error is detected during the use of surgical instrument 14, an alternative disposal procedure can be implemented, for example. This procedure can be performed by querying whether a battery is included in surgical instrument 14, and if so, by receiving an indication from the system or user that the battery is faulty. If the battery is faulty, surgical instrument 14 can be recycled without the battery, and instructions can be provided to achieve this recycling. If the battery is not faulty, surgical instrument 14 can be recycled with the battery, and instructions can be provided to achieve this recycling. Queries can be performed by moving to the next possible component, and the recycling procedure can be adjusted based on the user's indication of the faulty component. In some variations, messages can be sent and / or displayed by smart packaging system 10 and / or HUB 50 to inform the user to return the smart packaging system 10 according to the packaging instructions. When an error is detected, data surrounding the error can be recorded and reported to the supplier or relevant party for error assessment, such as for corrective purposes.

[0196] If a component of the smart packaging system 10 is determined to be unavailable by the smart packaging system 10 itself, by detection of the HUB 50, or by user instructions, an alternative procedure can be provided. Knowing when a component is considered unavailable can also assist in assessing the failure. For example, if the error occurs during transportation, the healthcare provider will not be at fault. In some variations, alternative procedures can be triggered based on the context of use. For example, if problematic use occurs during a clinical trial, the recall procedure can be modified to recall more components, thereby obtaining as much information as possible from the clinical trial, including information related to operational errors.

[0197] As explained above, the intelligent packaging system 10 can record various aspects of its use, operability, and equipment utilization. In some variations, the HUB 50 can write permanent information related to the information described above into the intelligent packaging system 10.

[0198] As explained above, the intelligent packaging system 10 assists in tracking the disposal process. Also as explained above, the intelligent packaging system 10 can store a list of all its contents, including components and sub-components. The intelligent packaging system 10 can create a list of all products entering the operating room. When the disposal process begins, the intelligent packaging system 10 can create a Certificate of Disposal (COD) for all supplies consumed during the procedure. After the procedure occurs, the HUB 50 can record and cross-check the intended disposal instructions for each product with the products actually disposed of. If a discrepancy is detected, a notification can be sent to the user. If the HUB 50 identifies that a package was not used during the procedure but was placed in the disposal area, the package can signal to the HUB that it was not opened and can notify healthcare personnel to return the unused package to the storage room. If the HUB 50 determines that a battery was not disposed of correctly, or for example, was not properly packaged for return, the intelligent packaging system 10 and / or the HUB 50 can warn the user and require confirmation before further action.

[0199] In some variations, the HUB 50 or the smart packaging system 10 can provide users with tags or digital metadata related to the disposal of the packaging. These tags or metadata provide destination information, disposal methods, special handling instructions, and other relevant information. This information can be provided in various ways (such as via a dynamic display 22), which can be made removable and reattached to return the packaging. RFID tags 16 or similar devices can detect changes to the packaging and update the tags to display the information.

[0200] In some implementations, the smart packaging system 10 can track waste flow and disposal progress to determine whether disposal procedures are in compliance. To assist in determining compliance, the smart packaging system 10 can determine whether the components to be disposed of qualify as regulated medical waste based on relevant local regulatory schemes or broader regulatory schemes (e.g., the U.S. Medical Waste Tracking Act (MWTA) and Resource Conservation and Recovery Act (RCRA)). The smart packaging system 10 can further determine site-specific regulations, including those relevant to the current geopolitical location of the smart packaging system 10. For example, in the United States, knowing that the smart packaging system 10 is in a U.S. facility may not be sufficient, as regulations may vary by state. Knowing the specific status may be necessary to determine appropriate disposal procedures. Relevant regulations for medical waste may include pathological waste, human blood / blood products, microbiological waste, contaminated sharps, quarantine waste (e.g., from highly infectious diseases), animal waste, etc.

[0201] In some variations, the intelligent packaging system 10 can determine whether a component to be disposed of is eligible as a battery, electronic device, heavy metal, or other similar material. If confirmation that the component is indeed qualified is received, procedures can be provided, including returning the equipment to the supplier for proper disposal if no other options are available.

[0202] In some variants, the HUB 50 can record disposal data from the smart packaging system 10. This data can be used to meet contractual requirements with healthcare providers regarding disposal procedures, which may result in penalties or incentives for the healthcare providers.

[0203] In some variants, the HUB 50 can tag specific components of the smart packaging system 10 and inform the user when the correct disposal box is unavailable.

[0204] In some variations, the smart packaging system 10 can provide the HUB 50 with information about any tagged components or materials within the smart packaging system 10, enabling the HUB 50 to return any relevant disposal requests from the facility, district, or waste management company. The smart packaging system 10 can update the listed disposal instructions to reflect current information and / or best practices. For example, specific waste management instructions may be required for the special handling locations of electronic circuit boards, batteries, local adjustments, REACH materials, and equipment / packaging disposal.

[0205] In some variations, the smart packaging system 10 can track recycling values ​​and provide this information to the user. For example, a metric could be that if certain components are used, they must be properly recycled. To encourage proper disposal, the smart packaging system 10 can display or provide metrics of recycling financial savings, indications of progress toward larger recycling targets (e.g., 15% of the first quarter recycling target), and the HUB 50 can also inform the user of the contribution of recycling a particular component to achieving the larger recycling target. The smart packaging system 10 can also employ a recycling credit system. For example, recycling tracking or progress can be displayed or provided to the user, and certain rewards can be linked to recycling (e.g., recycling 10 devices and receiving a certain number of credits). The rewards may be exponential to encourage recycling. Credits can be awarded upon receiving recycled equipment. In some aspects, the display 22 can be removable, allowing tags to remain in the recycled equipment so that data recorded by the tags is also recycled.

[0206] The smart packaging system 10 may include features for assisting the reusability, disassembly, and / or return of the contents of the smart packaging system 10 after use.

[0207] These features may include aspects of the smart packaging system 10 that facilitate the temporary storage of components and contents of the smart packaging system 10 and facilitate the repackaging of components and contents of the smart packaging system 10. In some cases, it is desirable to recycle components of the smart packaging system 10, such as for performance evaluation, error handling, recall, etc. To assist in component recycling, the smart packaging system 10 may include return packaging. This return packaging may be reusable packaging that is reassigned after use to dispose of or return the contents of the smart packaging system 10, and may also serve as a system for allowing products to enter a sterile area during surgical procedures involving the smart packaging system 10.

[0208] For example, package 12 can be opened to a position that allows it to rest on top of a disposal bin. Once the surgical instrument 14 has been fully used and is ready for disposal, it can be resealed into package 12 and immediately dropped into the waste bin. In some variations, 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, package 12 can occupy a smaller footprint. To assist the repackaging process, package 12 may include a resealing device, such as adhesive tape located on a selective flap covered by a seal on package 12. When repackaging is required, the seal can be removed to expose the adhesive, allowing the flap to be closed by adhering it to package 12 via the exposed adhesive.

[0209] To assist in disposal, the smart packaging system 10 may include features that interface with disposal containers, which may be located in an operating room hosting procedures involving the smart packaging system 10, or they may be located on-site at a healthcare facility. Items placed in the disposal containers can be properly disposed of according to their contents. In some variations, the disposal containers may take various forms, including as resealable packaging for contamination control during disposal. In some variations, the disposal containers may be waste stream containers specifically designed for the type of waste stream that will be processed through them, for example, as described above regarding... Figure 14 As described herein. For example, if the waste flow container is intended for the disposal of organic waste, it may be made of a non-reactive, non-porous material, such as various plastics, to properly transfer the organic waste to its final disposal location (e.g., an incinerator). Depending on the contents of the smart packaging system 10, the disposal container may be supplied by the original equipment manufacturer (OEM). However, where appropriate, the disposal container may also be used to store non-OEM waste. If non-OEM equipment is used in conjunction with OEM equipment in a procedure, the instructions and procedures for disposal and / or recycling, as explained herein, may indicate to the user that the non-OEM equipment may have unknown waste management requirements.

[0210] In some variations, the disposal container may have a lid for temporary storage provided by the packaging 12. When the procedure is complete, the lid can be quickly used to dispose of the stored contents. In some variations, the packaging 12 may be magnetically attached to one side of the disposal container for temporary storage.

[0211] Prior to the possible disposal and / or recycling process, the contents of the smart packaging system 10 (such as surgical instruments 14) may need to be disassembled or separated into components and sub-components, depending on the nature of these components and sub-components (e.g., non-recyclable components versus recyclable components), as their nature may lead to different disposal and / or recycling processes, as explained herein. In some variations, the smart packaging system 10 may include one or more specialized clamps (such as certain proprietary screws) and associated tools to aid in the recycling of specific components. For example, certain components to be recycled may be secured to surgical instruments 14, and associated tools may be used to easily remove the components for separation. Figure 15 An example can be seen, which features a simple pry bar 2110 to allow the removal of circuit board 2112. The pry bar 2110 can be inserted into a specially designed slot and pried to detach circuit board 2112 from surrounding components. In some variations, the packaging itself can be disassembled into a tool similar to pry bar 2110. Packaging 12 may have ribs that support the strength of the packaging during transport and handling, and these ribs can also function as pry bar 2110 during disassembly.

[0212] In some variations, the package 12 may include tools that emerge after a component is removed from the package or a compartment of the package is opened. For example, a tool may be exposed when a seam is pulled, a surgical instrument is removed from its location, or a tab is pulled. In other variations, a package included within the smart packaging system 10 may be used to package components of the smart packaging system 10 that include one or more components to be recycled, and the package 12 and components may be transported to an auxiliary location specifically for disassembling and recycling the components, thereby placing the task at the auxiliary location.

[0213] The intelligent packaging system 10 can also measure or evaluate the parts of the surgical instrument 14 to determine their recyclability and to determine associated disposal pathways based on various factors. For example, based on the determined geopolitical location, the availability of waste management protocols, and the components of the intelligent packaging system 10, the intelligent packaging system can determine whether a particular component is recyclable. This indication can be provided to the user using any of the methods described herein.

[0214] Disposal and recycling procedures may involve hazardous materials, including electrical components and biohazardous materials. Procedures for electrical components may involve including materials and features in the smart packaging system 10 to minimize potential hazards. These may include insulating surfaces for containing the material and electrical straps for attaching and securing components as needed. Procedures for biohazardous components may involve containing these components and preventing cross-contamination during various postoperative procedures. For example, storage bags and / or bleach-soaked rags may be included in the smart packaging system 10 for containing components and for wiping surfaces. In some variations, the storage bags may be made of materials with antimicrobial properties to prevent the spread of certain materials. The bags may also contain absorbent material to trap fluids placed therein. In some variations, the smart packaging system 10 may include blade caps and sharps caps to prevent container breakage of biohazardous materials and to prevent accidental injury from blades or sharps. To contain biohazardous materials, contaminated components may be decomposed and contained in a sterile area.

[0215] Disposal and recycling procedures can occur in an operating room without the need for supervision of the HUB 50 or similar systems. In these cases, and where known, the smart packaging system 10 may include features that facilitate tracking of various components being disposed of and recycled. For example, the packaging 12 for disposal may include incremental serial numbers to easily coordinate several disposal smart packaging systems 10 at once. In another example, the component to be disposed of or recycled may include a removable marker (such as a sticker) that can be removed and moved to another location, such as on a tracking board, to monitor the status of disposal or recycling of a given component.

[0216] The smart packaging system 10 can provide selective and separate disposal paths for its components and sub-components. This may include identifying these components and sub-components and then providing methods for separating the smart packaging system 10 as needed to direct the components and sub-components into their proper waste streams for proper waste management.

[0217] Certain components of the smart packaging system 10 may require separate disposal. These components may include batteries, electronic components, heavy metals, surgical instrument 14 components marked for disposal that have been contaminated with anatomical waste, and surgical instrument 14 components marked for return that have been contaminated with anatomical waste. For example, specific additional contamination procedures may be required to sterilize surgical instrument 14 components marked for return that have been contaminated with anatomical waste.

[0218] The intelligent packaging system 10 can be used to easily identify key aspects required for selective disposal and / or recycling of components in order to properly separate these components. In one 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 intelligent packaging system 10. In another example, a HUB 50 and / or a visual identification system can be used to identify recyclable components and their locations. In another example, the intelligent packaging system 10 can contain components in modular form. One sub-area of ​​the intelligent packaging system 10 can contain a motor, another sub-area can contain a battery, etc. Operating room staff 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. Modular components to be recycled can be individually resealed in separate packages 12. In another example, the surgical instrument 14 and / or packaging can include colors coordinated with the associated waste flow path. Separate patterns can be used for the equipment or its components to be recycled.

[0219] Component separation can occur in a variety of ways and can depend on the identity of the identified component, such as whether the component is a battery, circuit board, etc.

[0220] Battery disposal procedures can vary depending on many factors. For example, if the battery is packaged separately from the surgical instruments 14, that same packaging can be used for separation and storage after disassembly. The same applies to other components, where the packaging that provides them can also serve as separation packaging after surgery. In some cases, special procedures may need to be followed for battery disposal. Battery disposal boxes may not be universal, in which case sub-disposal instructions may be required. For example, if the battery is primarily lithium, it can be transferred to the appropriate recycling facility or disposal site. If the battery is rechargeable, a separate disposal procedure may be required. Proper separation of batteries prevents them from being incinerated or improperly disposed of, which may violate local regulations.

[0221] The specifications of the circuit board can also vary depending on many factors. A removable cover allows access to the circuit board to be disposed of or recycled. Certain design choices can be made to the equipment and components of the smart packaging system 10 to facilitate easier access to and / or disassembly of the circuit board into components. For example, the circuit board may be located on a separate plastic piece accessible through the battery compartment. Access to the circuit board can be achieved by tearing it open with a simple pull tab. Wires can also be accessible to allow easy cutting to remove sensitive components. The smart packaging system 10 may include a box or area for storing and containing loose components. If the circuit board includes separable attachments or components, the circuit board may be designed such that these attachments or components are attached to the circuit board via mechanical disconnectors (such as via snap-fit ​​or equivalent) to aid in disassembly. Flexible circuitry may be cut or made easily cut in intermediate circuitry near the furthest attachments and away from certain components that may include heavy or precious metals. In the case of using multiple circuit boards, the circuit boards may be interconnected with several flexible circuits to allow for easy cutability. Package 12 may also include indicators to show the location of the circuit board, the location of the break point, and which components should not be disconnected due to some of their contents.

[0222] In another example, the circuit board can be designed to lock to the battery once it is inserted. To remove the battery, the lock necessitates the removal of the circuit board as well. Once both are removed, a simple switch, lever, or equivalent that was hidden before removal can be toggled to separate the battery and circuit board.

[0223] At each separation step, instructions can be provided to the user in any form to guide them through the separation details based on the components to be separated within the smart packaging system 10 and relevant waste management procedures. Additionally, passive guidance can be provided, such as specifying appropriately shaped slots or containers for each component to be separated. If a slot or container exists, the user can be passively notified that it must be filled with some components to be separated during the separation process.

[0224] In some variations, users may not need to separate components and can instead return the entire product, packaging, sub-components, etc., as is. Parts of the smart packaging system 10 (such as certain packages 12) can be reused for the return of components of the smart packaging system 10. The package 12 may include, for example, plastic bags for biocontaminated products. Furthermore, while the packaging may include separate sub-areas housing the necessary components of the smart packaging system 10 (i.e., a first space molded to fit surgical instruments 14, and second and third spaces molded to fit accessories), the package 12 can be made detachable to remove the sub-areas, thus turning the package 12 into a single box or container. The user can then place the recycled components into the single box or container without considering tissue.

[0225] Once the components are separated, they can be disposed of or recycled following their designated paths. For example, some components may be tagged for incineration and can be transported to an incinerator. Other components may be tagged for landfills and can be transported to landfills. For components tagged for recycling, the procedures may vary based on the component. Metal and plastic components, such as precious metals, may be ground and melted at certain temperatures to separate the individual parts. If certain expensive plastics or aggregates need to be recycled, rendering the grinding / melting procedure ineffective, a visual indicator may be present on the component (or included in the instructions) for the user, informing them of the appropriate specific recycling path for these particular materials. This may involve simply shipping the special material to a facility specializing in the relevant recycling.

[0226] Standard procedures may also exist for handling more traditional waste, such as sharp objects. For example, needles used with sutures and scalpels may be separated and placed in the correct bins according to specific medical procedures.

[0227] HUB 50 and / or the intelligent packaging system 10 can provide notifications related to waste management procedures. HUB 50 can sense that a correct waste management procedure is being followed, and if it senses that certain parts of the correct waste management procedure are not being followed correctly, HUB 50 can notify the user using any of the methods described herein. For example, a notification to the user could indicate that components associated with the intelligent packaging system 10, as well as any other components that HUB 50 typically senses, are not leaving the sterile area correctly.

[0228] Figure 16Examples of the identification and coordination of components and sub-components of surgical instrument 2214, which is part of an exemplary smart packaging system 2210, are depicted herein. Smart packaging system 2210 may be substantially equivalent to any variation of the smart packaging system described herein (including smart packaging system 10), and surgical instrument 2214 may have the same meaning relative to any surgical instrument described herein (including surgical instrument 14). Surgical instrument 2214 may be subdivided by regions of interest, including identifying motor 2222, battery 2224, circuit board 2226, and magnet 2228. Members of each identified region of interest may be associated with a disposal path. While some members may have the same disposal path, each member may have a separate disposal path. For example, in a first region of interest associated with motor 2222, magnets, copper coils, rare earth metals, etc., located within motor 2222 may be harvested for recycling and / or may be disposed of according to certain local regulations. In the second area of ​​interest associated with battery 2224, battery 2224 may require discharge, isolation if it contains certain valuable or toxic materials, and may not be transportable via certain modes of transport, such as air. These requirements may affect the disposal pathway for these materials. For example, European regulations may prohibit the disposal of batteries containing certain hazardous substances, and they may also establish protocols for the collection and recycling of batteries. In the third area of ​​interest associated with circuit board 2226, the contents of circuit board 2226 (such as silicon, heavy metals, potentially precious metals, etc.) may require a separate disposal pathway, depending on applicable local geopolitical regulations. In the fourth area of ​​interest associated with magnet 2228, disposal and removal may vary according to applicable local geopolitical regulations.

[0229] and Figure 16 The associated procedures are exemplary and can vary depending on many variables, including relevant local geopolitical regulations, components of the surgical system 2214, available procedures, etc., as discussed herein.

[0230] The intelligent packaging system 10 can selectively change, enable, and disable its functions based on its current geopolitical location in order to comply with relevant local regulatory schemes.

[0231] The smart packaging system 10 can determine whether its components and capabilities are suitable for a given geopolitical location based on regulatory provisions. The smart packaging system 10 can provide users with information related to the feasibility of its location for evaluation, or it can compare its current location with known “areas of availability” for a given aspect of itself. For example, the EU requires exhaust fans to be equipped with HEPA filters to prevent cancer cells from aerosolizing into the air breathed by healthcare providers, but not all jurisdictions require this. A smart packaging system 10 that contains an exhaust fan and knows it contains one can compare this known information and information about its current geopolitical location with a list or database of regulatory information to make a determination. The smart packaging system 10 can then provide a message to users informing them of this regulatory requirement. In another example, the smart packaging system 10 can inform users whether a certain drug has been approved for treatment or use within a geopolitical location.

[0232] In some variations, the rules for each facility may be important for the operation of the smart packaging system 10. If the conditions of a particular facility are known in advance, the descriptions and specific regulations related to each facility can be preloaded into the smart packaging system 10.

[0233] In some variations, the intelligent packaging system 10 can collect and store data. Based on the current geopolitical location of the intelligent packaging system 10, the data collection capabilities of the intelligent packaging equipment and / or the data being collected may change to comply with local regulations.

[0234] In some cases, certain components and / or capabilities of the smart packaging system 10 may be completely prohibited from entering a geopolitical location. If it is determined that the smart packaging system 10 has arrived at or is about to enter such a location, the display 22 may show a warning indicating the prohibition. In another example, the surgical instrument 14 may contain a battery designed to be deployed with a compound that may be unacceptable within the jurisdiction (e.g., bovine pericardium). The display 22 may be configured to change to include a message such as "Contains bovine pericardium." This message may specify the prohibited component or content of the smart packaging system. If the smart packaging system 10 contains such a product, the display 22 may provide a message similar to the one described above, explaining that the smart packaging system 10 contains a prohibited substance. This determination may be based on FDA, CE, UL, or other approvals.

[0235] Typically, the smart packaging system 10 can determine the appropriateness of its delivery to a given geopolitical region and then provide that information as needed.

[0236] In cases where an assessment determines that one or more operational capabilities of the smart packaging system do not comply with the local rule set of a jurisdiction, the smart packaging system 10 may modify and / or disable the non-compliant operational capabilities, or receive a set of instructions from an external system to modify and / or disable the non-compliant operational capabilities so that the smart packaging system 10 complies with the local rule set. For example, the smart packaging system 10 may be configured to collect data at various locations such as warehouses, hospitals, and operating rooms during its delivery and use. Due to local privacy laws (such as HIPAA, GDPR, etc.), aspects of such data collection may not be permitted in that jurisdiction. In such jurisdictions, the ability of the smart packaging system 10 to collect disallowed data may be disabled so that the device operates in accordance with the local privacy laws of that jurisdiction. In some cases, operational capabilities may be limited or reduced due to mismatches between accompanying systems, such as when a component has not yet been approved for use in a given geopolitical location.

[0237] In some implementations, the controller 13 of the smart packaging system 10 or any equivalent storage device of the smart packaging system 10 may have some decision-making capabilities integrated therein.

[0238] In some implementations, decision-making capabilities may include the integration of multi-level decision-making, typically within the smart packaging system 10 and in the packaging display 22 using hierarchical organization technology. These technologies may include component selection driven by physician preferences and / or component selection driven by component availability.

[0239] When one or more smart packaging systems 10, still within their packaging 12, enter the OR, the HUB 50 can communicate with the smart packaging system 10 and create a list of the smart packaging system 10, its contents, its characteristics, additional known information, etc. The HUB 50 can also receive information related to procedures to be performed within the OR, such as specific patient biometrics, procedure type, surgeon identity, surgeon preferences associated with the smart packaging system, OR capabilities, etc. Based on this information, the HUB 50 can assess potential interactions between various systems within the OR and information related to the procedures to be performed.

[0240] In the example, HUB 50 can run scenarios based on stored data related to surgical procedures, exploring how systems detected within the OR can be used to execute scheduled procedures. HUB 50 can inform OR staff whether unnecessary systems are included in the OR and whether any systems are missing that should be added to the OR for a given procedure. If a system is missing, HUB 50 can provide a list of possible alternatives, in hierarchical preference order, with or without a prompt from the user. In a variant where a prompt from the user is received, the prompt may inform HUB 50 of the expected system lack of availability, prompting HUB 50 to provide a list of alternatives.

[0241] In another example, HUB 50 can identify a smart packaging system 10 within the OR that is incompatible with one or more other systems within the OR. HUB 50 can notify OR staff of this incompatibility.

[0242] In another example, HUB 50 can cross-check the equipment recorded within an OR against the capabilities of the OR and determine if there are any compatibility issues. If new equipment added to an OR requires additional equipment not currently available in the OR (such as large machinery that is not easily moved to the OR), HUB 50 can notify the OR staff of the missing machinery and recommend another OR that possesses the necessary machinery.

[0243] As described above, patient data can be used to determine compatibility with the smart packaging system 10. When the smart packaging system 10 enters the OR space, its capabilities, contents, and other details can be analyzed against relevant patient biometrics / data to provide information related to optimal device selection and use.

[0244] More specifically, device compatibility can be determined. If the patient has undergone a previous surgery, this information can be used in the current surgery to determine compatibility. For example, if the patient's body contains metal from a previous surgery and the current surgical plan involves an RF device, notification of incompatible use can be provided, possibly due to a short circuit or other malfunction caused by the interaction between the RF device and the metal. Further local influences can also be considered depending on the surgical instrument 14 being used. If the surgical instrument 14 is a harmonic tool, a metal detector on its tip can issue an audible alarm to the user when metal is nearby. Tissue impedance can be affected by metal, potentially causing injury to the patient and / or the surgical instrument 14, and such scenarios should be flagged. If the surgical instrument 14 is a suture device, detecting the end of the segment used for suturing can prevent the suture device from further suturing undesirable areas. In some respects, the surgical instrument 14 can adapt to detected adverse events. For example, the surgical instrument 14 can employ an adaptive situational algorithm that adjusts the power delivered to the surgical instrument 14 to drive the staple or cut tissue when impact material is detected nearby (i.e., metal is nearby, so the smart device shortens its drive stroke to avoid impacting the metal).

[0245] Furthermore, patient-specific tissue can alter device behavior and compatibility. Irradiated tissue may be tougher than other tissues and may respond differently to device feedback. Thresholds in surgical instrument 14 can be modified to account for toughened tissue, such as increasing the power behind the drive stroke to create a specific incision that would typically require less power for normal tissue. Surgical instrument 14, whose behavior can be modified, can also be configured to receive input from an external system, such as HUB 50, or annotations from the operator describing changes made in response to patient tissue. Such changes can affect the lifespan of surgical instrument 14, especially if the changes require greater performance from the surgical instrument 14.

[0246] In another example, certain ablation systems are only applicable to tumors of a specific size (e.g., 10 cm) or smaller. If a tumor exceeding this threshold is detected, the surgical instrument 14 can warn the user and allow the user to choose to ignore the warning. 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 monitor 22 can even be updated before the smart packaging system 10 is opened to reflect any potential incompatibility issues.

[0247] In another example, if a task in a surgical procedure requires a power output much lower than that of the surgical instrument 14, a warning can be displayed on the display 22 or the display 22 of the smart packaging system 10 to inform the user of the potential dangers associated with using the surgical instrument 14 at its normal power level.

[0248] Alternatives to surgical instruments 14 can be provided based on cost, inventory, or healthcare facility guidelines. For a given procedure, once all smart packaging systems 10 have entered the operating room, the HUB 50 can compare their capabilities against the requirements of the procedure itself. Based on this comparison, the HUB 50 can provide recommendations for more effective and / or optical devices that can be used to replace those currently found in the operating room. For example, the HUB 50 identifies energy devices being pulled for a procedure and also identifies procedures based on the plan that traditionally use monopolar or bipolar energy devices. The HUB 50 examines the pulled energy devices, determines that the pulled devices are insufficient, and then examines other devices for potential alternatives. After determining that no alternatives exist, 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.

[0249] In some variations, HUB 50 may determine that the selection of products pulled by the procedure exceeds reimbursement limits. Based on total cost in fiat currency, operating room time, number of staff, or another metric, HUB 50 can make alternative recommendations. Furthermore, the intelligent packaging system 10 can display its own unit cost to the user or provide this information directly to HUB 50 without requiring inventory checks. Alternatives can be ranked based on cost, historical operating data, and any other desired metrics.

[0250] To assist the smart packaging system 10 in making decisions, metadata can be included in the smart packaging system 10 to provide context for irregular use. This context may appear alongside conformational tags and query tags.

[0251] Using conformational marking, the intelligent packaging system 10, HUB 50, or another device that appears correct on the surface but strange in context can receive irregular data. A notification can be provided to the user of the receiving system without requiring user confirmation for further action. For example, if a physician selects surgical instrument 14, which is not typically used in the procedure, confirmation can be received once this is an intentional selection. Then, in the future, each time the system potentially marks some aspect of surgical instrument 14, an omission can be triggered that recognizes the selection of surgical instrument 14 as intentional and that surgical instrument 14 otherwise performs correctly. This omission can also be effective in cases where an alternative surgical instrument 14 is selected due to a shortage of the preferred surgical instrument 14 in stock.

[0252] Using query tags, user input can be requested to make further decisions when irregular data is received. For example, when an incorrect type of surgical instrument 14 is detected, user confirmation may be required before allowing the operation to continue. The smart packaging system 10 can generate an alert indicating an incorrect type of surgical instrument 14 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, scenarios can be ignored based on historical data related to the procedure. For example, if operations during surgery depend on a specific size of surgical instrument 14, these operations can be adjusted according to the new size of surgical instrument 14.

[0253] In some scenarios, multiple device options can be sent to the operating room for the user to choose from based on historical data. Regardless of which surgical instrument 14 is selected, the inventory of surgical instruments 14 to be returned will be notified to minimize user interaction.

[0254] When the smart packaging system 10 has been insufficiently retrieving, the HUB 50 and / or the smart packaging system 10 itself can react accordingly. For example, if a surgical procedure or a patient's aspect has been marked as potentially requiring additional surgical instruments 14 to complete the procedure, a user inquiry can confirm that the marking is correct and that additional surgical instruments 14 are indeed needed. The inquiry can be processed via any device communicating with the user to confirm that additional surgical instruments 14 are indeed needed and that additional surgical instruments can be requested from the storage compartment. In another example, the HUB 50 may identify that for a given procedure, six staple cartridges are typically retrieving. However, based on the patient's biometrics, additional staple cartridges need to be retrieving for a typical patient of this body type. The HUB 50 can issue a request for additional cartridges and can notify the user. Similarly, if six staple cartridges are retrieving for a surgical procedure, but the HUB 50 detects based on historical data from similar surgeries that patients of this body type typically only require four staple cartridges, it can notify the user of the possibility of an overdose.

[0255] The system can record responses to various inputs received from the user to inform future recommendations for the smart packaging system 10 and the HUB 50. These recommendations may include incremental changes by suggesting similar products, exceptions based on surgeons or facilities, and repeated confirmation of specific responses based on the answers (e.g., the HUB 50 marks the surgical instrument 14 three times, and the user refuses each time; the HUB 50 may adjust a fourth time and not mark the surgical instrument 14).

[0256] In some implementations, the smart packaging system 10 and / or HUB 50 can determine its own capacity and compatibility with other devices, including other smart packaging systems 10. The smart packaging system 10 can provide notification of possible interactions (acceptable and unfavorable) between itself and other devices, as well as between other devices. This information can be particularly useful in the context of surgery.

[0257] In some variations, the smart packaging system 10 can provide notification of potential interactions with other equipment that may be dangerous and / or harmful to patients, personnel, and equipment.

[0258] As explained herein, both HUB 50 and Smart Packaging System 10 have the ability to receive and send information to other systems. Based on this information transmission, HUB 50 and Smart Packaging System 10 can assess potential interactions between systems and devices. When an incompatible combination is observed, the user can be notified, for example, via display 22 or other notifications. Furthermore, a system that detects incompatibility can send information to HUB 50 (unless HUB 50 is the detection system), which can then send instructions to the affected Smart Packaging System 10 and devices to change or cease operational capabilities, thereby preventing adverse interactions.

[0259] For example, some surgical staples may include a magnesium-based coating. Exposure to high heat may damage the coating and compromise the staple's integrity. In another example, if a CT scanner (such as a C-arm) is being used to scan a patient with a pacemaker, the HUB 50 may notify the user of potential adverse reactions and / or instruct the C-arm to change its operation to avoid interfering with the pacemaker's function.

[0260] In some variants, a risk-based assessment of the combination can be performed, and corresponding notifications can be provided. If an interaction is deemed potentially catastrophic, the HUB 50 can communicate this risk to other equipment to prevent its activation and potential harm. For less catastrophic events, the user can be notified of the potentially adverse interaction, and confirmation from the user may be required before normal operation can be enabled. For minor interactions, an inactive warning can be displayed to inform the user of the interaction.

[0261] In the example, the next-generation loading chamber for the surgical suture device was designed with backward compatibility in mind, but this is not always the case. In some situations, the next-generation loader may be incompatible with certain surgical suture devices, and attempting to combine the loader with an incompatible surgical suture device may result in damage to one or both components. Providing the user with instructions before interaction can address potentially hazardous situations.

[0262] In some implementations, due to specific limitations of the surgical procedure, such as alternative surgical instruments 14, patient needs, etc., the smart packaging system 10 and / or HUB 50 may help adapt the procedure. Details of the surgical procedure can be imported into HUB 50, and HUB 50 can mark interactions that should be avoided between surgical instruments 14, accessories, and devices, as well as combinations that should be used together.

[0263] When the HUB 50 flags an interaction to be avoided, the user can ignore the flag and continue anyway, as explained above. When this occurs, some data may be inaccurate or potentially 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 undergoing EKG monitoring, the device may interfere with EKG readings. This undesirable interaction between the electrocautery device and the EKG can be flagged by the HUB 50, but if the user continues anyway, readings from the EKG can be prevented from being displayed to avoid misleading readings when using the electrocautery device. Such undesirable interactions, especially those related to electrical interference with the device, can lead to completely erroneous data.

[0264] In some variants, where possible, the impact of the interaction on data collection can be measured, and users can be notified of the impact and its extent. This can be done by measuring the same data source in the absence of interfering devices and comparing it with data in the presence of interfering devices. The measured impact of interfering devices can be provided to users based on historical trends, past data measurements, machine learning, secondary sources, etc. Furthermore, the impact of interference can be determined using bit error rate and / or cyclic redundancy check (CRC) error detection codes. In some aspects, the HUB 50 can provide suggested changes to reduce or minimize the impact of devices, such as adjusting device settings, repositioning devices, etc.

[0265] When the HUB 50 identifies interactions that should be facilitated, these interactions can be provided to the user to assist in surgical procedures. In an example, during colorectal surgery, in the case of a circular stapler anastomosis via a previous linear staple suture, the HUB 50 may recommend certain combinations of devices. These combinations may include recommending which stapler (e.g., an electric stapler versus a mechanical stapler) to best complete the procedure based on the anastomosis plan. An electric stapler (an example of a possible smart surgical instrument 14) may suggest staple alignment by sensing staple position (e.g., by impedance, etc.) and suggesting reorientation. For example, if an unsatisfactory reorientation occurs after a recommendation, a new recommendation may be provided by the electric stapler. If the procedure continues, future aspects of the procedure may be adjusted based on the unsatisfactory reorientation. In another example involving a circular stapler, optimal performance of the circular stapler may require pushing a cannula used with the stapler through the center of the previous linear transverse stapler suture line. When aligned, the staple height should be adjusted based on the thickness or other properties of the tissue in the relevant location. If the user fails to properly align the circular stapler or adjust the staple height, subsequent steps in the surgical procedure (e.g., firing rate, waiting time between firings, etc.) can be adapted to compensate for the user's failure to align and / or adjust. These adjustments can even be cascaded to subsequent procedural steps, such as pressure testing and activation of the resulting anastomosis, all of which can be managed by the HUB 50.

[0266] In some variations, the HUB 50 and / or the intelligent packaging system 10 can identify whether a device is not optimal for a given surgical procedure, in which case the HUB 50 and / or the intelligent packaging system 10 can recommend alternative devices. For example, if an older device is detected lacking certain features beneficial to the surgical procedure. If not using an alternative device and incompatibility may affect the procedure outcome, the user can be notified. If the procedure continues to use the older device, the HUB 50 and / or the intelligent packaging system 10 can inform the user of certain procedure steps that may be affected by incompatibility and can provide adjustments to compensate for the incompatibility at the affected procedure steps. For example, adjusting the current setpoint of the harmonic device to deliver less power, or changing the frequency range of the bipolar energy device to reduce potential adverse interactions with other devices.

[0267] In some implementations, the smart packaging system 10 and / or HUB 50 may suggest free products or preferred alternatives based on the products currently selected for the surgery. For example, a recommendation may include a newer model of the selected surgical instrument 14, which may lead to greater efficiency during the surgery. Recommendations may be provided before, during, or after the surgery, and may influence future surgeries. Recommendations provided before surgery may rely on past data and recommendations to flag alternatives before the surgery begins. For example, if a previous recommendation was used in a previous procedure, the same recommendation may be made before a similar procedure begins. Recommendations provided during the procedure may be provided in real-time by HUB 50 based on the procedure status. During the procedure in which the recommendation is made, the recommendation may also include an estimated timeframe for collecting the recommended alternatives, and HUB 50 may request the user to input whether they want the recommendation flagged for future surgeries, making it the default option for those future surgeries. Recommendations provided after the procedure may be based on observed trends and data collected from past procedures. Recommendations may typically take into account specific procedures and usage data from a healthcare facility.

[0268] like Figure 17 As seen herein, a general process 2230 for recommendation is depicted, which details the manner in which a specific smart packaging system can be selected for use in a procedure. As explained herein, one or more smart packaging systems 2232A, 2232B, ..., 2232N may be recorded by HUB 50 along with supplementary information 2234A from other sources, such as information about the facility recording the system, information about the device itself, including interaction information, updated procedures, recall notices, etc. When a recommendation is required, a subset of the recorded systems 2236 may be provided, which may be notified by supplementary information 2234B. This supplementary information 2234B may include information such as availability, the 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 based on final information 2234C. This final information may include information such as surgeon preferences, negative interactions with other selected devices for a given procedure, and other information that may disqualify potentially viable options.

[0269] In one example, the use of a harmonic foot flap could be an optional accessory for surgical procedures. A recommendation to use a harmonic foot flap can be made to the surgeon, and this recommendation can be based on many factors, including: the surgeon's past preference, ease of use with other devices pulled for surgical procedures, prevalence of use in healthcare facilities, and the nature of the specific procedure.

[0270] In some respects, the OR configuration can be tailored based on the equipment being pulled for surgical procedures. For example, based on the length of the pulled equipment, HUB 50 can recommend specific surgical trolleys, specially sized operating tables, additional accessories, etc. In another example, if multiple energy devices are being pulled for surgery, HUB 50 can recommend using two generators in the OR to compensate for the pulled equipment. In yet another example, if an older blower is available in the OR, a newer cannula can be recommended to optimize the seal integrity between systems. In yet another example, if an older fumigator exists in the OR, a newer device that produces less smoke can be recommended, or a more efficient newer pump can be recommended to keep the older fumigator effective.

[0271] In another example, multiple monopolar ends can be used with surgical instrument 14, and a recommendation for a specific monopolar end can be made for a given surgical procedure, where that specific monopolar end will be more effective. This recommendation may take into account alternative monopolar ends that will be more effective only in specific situations, and for which there will be no need to retrieve an alternative monopolar end at all for that surgical procedure.

[0272] In another example, for a given surgical procedure, HUB 50 can detect an incomplete set of smart packaging systems 10, along with other devices and components, and HUB 50 can locate missing elements. This assessment and detection by HUB 50 can occur before surgery, as explained above, and it can also occur after surgery to prevent components and objects from being retained in the patient's body, a known problem. Retained objects (objects unintentionally left in the patient's body after surgery) can lead to dangerous complications such as perforation, infection, and obstruction.

[0273] In some variations, compatibility between two surgical instruments 14, components, accessories, etc., can be determined based on the geometry of one of these items. For example, if a surgical stapler is compatible with a 45mm staple cartridge but not with a 60mm staple cartridge, the user can be notified if the 60mm staple cartridge is pulled out for surgical procedures.

[0274] In some variations, as explained above, the smart packaging system 10 may include a readable medium 20. The readable medium 20 may be connected to a central database of manufacturing 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, the smart packaging system 10, including the endoscopic cutter, may be scanned before it is opened. A hub 50 may receive information from the scan that connects the hub to a database containing manufacturing parameters of the endoscopic cutter, including firing force, cutting line length, range of joint motion angles, etc. The hub 50 may provide notifications indicating the optimal tissue thickness at a specific location on the patient for the endoscopic cutter, as well as other information based on the manufacturing parameters of the endoscopic cutter. In a similar example with a harmonic device, manufacturing parameters may include blade length and offset (related to thermal diffusion potential).

[0275] exist Figure 18 The image depicts a simplified view of a patient's stomach 2260. The stomach 2260 includes staples 2262 from previous procedures and scar tissue 2264. Both staples 2262 and scar tissue 2264 can limit the types of surgical devices that can be used in subsequent procedures and can limit the surgeries that can be successfully performed by future devices. This information can be included in patient data sensed by the HUB 50 and / or the smart packaging system. In a future procedure, if the smart packaging system 2270, containing surgical instruments 2272 capable of delivering bipolar energy for arterial anatomy, is brought to the operating room in preparation for a procedure involving the patient's stomach 2260, attempting to use the bipolar capabilities of the surgical instruments 2272 may adversely interact with the staples 2262 and potentially harm the patient. The smart packaging system 2270 can identify this risk before opening and provide a message to surgical personnel 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 tag or e-ink tag).

[0276] In gastric sleeve revision surgery, the patient's stomach undergoes remodeling, resulting in thickened and hardened gastric tissue. Due to this remodeling, re-stitching or re-looping sutures over the previous cuff sutures can be challenging. Some suture devices are better suited to handling this challenge than others. For example, certain motorized surgical suture devices (e.g., those bearing the Echelon® name) have an I-beam and are more capable of accomplishing this task than non-I-beam suture devices. 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.

[0277] 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.

[0278] 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.

[0279] 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.

[0280] In other respects, packaging 2312 may include selectively openable packaging, which 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.

[0281] In some variations, the package 2312 may include a main section 2312A for holding the surgical instrument 2314 (as explained above) and at least one subsection 2312B for holding additional components, such as an accessory 2314A that can be used with the surgical instrument 2314. Depending on the size of the surgical instrument 2314, the intelligent packaging system 2310 may have packages 2312 with different layouts, including main sections 2312A of different sizes and at least one subsection 2312B of different sizes. Figure 20 and Figure 21 Examples can be seen in the images, which are packaged in similar sizes, 2312 and 2312ʹ. Figure 20 Packaging 2312 and Figure 21 The surgical instrument 2314' shown includes a smaller surgical instrument 2314. Therefore, the main section 2312A is smaller than the main section 2312A'. The smaller main section 2312A makes room for at least one larger subsection 2312B (which may contain a larger size or a greater number of accessories 2314A compared to the smaller at least one subsection 2312B'), or for at least one more subsection 2312B.

[0282] In one variation, where the timing of sub-procedures during surgery is known, a timer or timing device can be used to prevent access to a given selectively openable package before a predetermined amount of time has elapsed since the start of the procedure. In another variation, the selectively openable package may include one or more scannable markers for each individual compartment of the selectively openable package. The scannable markers may take various forms, such as barcodes or QR codes. Upon scanning a scannable marker, a signal may be transmitted to the container associated with the scannable marker, causing the container to open and providing access to its contents. In another variation, the containers may include one or more safety interlocking devices linked together. Each container within the selectively openable package may be ranked according to priority and / or order of use during surgery. In this arrangement, a container may not be opened if a higher-priority or earlier-appearing container in the order of use has not yet been opened. For example, if surgical instrument 14 is a device including a harmonic blade, the contents of the containers within the selectively openable package may include a blade cleaning solution recommended when the harmonic blade becomes too dirty. When the harmonic blade device is removed from packaging 12, a secondary cover with a pull tab prevents the blade cleaning solution from prematurely falling out of the packaging. To access the blade cleaning solution, the harmonic blade device must be removed from packaging 12, and the pull tab attached to the secondary cover 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 in the structure of the outer packaging.

[0283] 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.

[0284] 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.

[0285] 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.

[0286] 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.

[0287] 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.

[0288] 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.

[0289] 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.

[0290] exist Figure 25In another variation of the smart packaging system 10 depicted, a smart packaging system 2710 is described, which includes a plurality of nesting locations 2711 defined therein. These nesting locations 2711 may be located outside the sterile portion of the smart packaging system 2710 and may consist substantially of a series of spaces for receiving sub-packages placed in predetermined locations within the smart packaging system 2710. Sub-packages 2713 may include attachments, supplements, materials, etc., which can be used with the rest of the smart packaging system 2710. For example, if the smart packaging system 2710 is for packaging a suture device, then the smart packaging system 2710 may include a suture device 2714 and a stapler 2716 disposed within the nesting locations 2711, as well as supplementary materials. Each nested position 2711 may include a dynamic marker 2722, such as the one described herein, such that when the staple loader 2716 is removed from one of the nested positions 2711, the corresponding dynamic marker 2722 can display information related to the pulled-out loader 2716, including size, type, condition, and other information about the loader 2716 itself, as well as information about the larger procedure involving the loader 2716, including the order of use, purpose, etc. In this way, healthcare providers (such as surgical teams) can use this information to understand whether all components of the procedure are present and taken into account, and whether they are in good condition within the procedure.

[0291] The reusable packaging 12 may include aspects that help control the overall shape or configuration of the packaging 12. For example, the packaging 12 may be made to self-wind into a cylindrical or pyramidal shape to occupy less space. The packaging 12 may also include various notches or features that allow other items to be stacked on it in a secure manner.

[0292] The smart packaging system 10 may include improved packaging protection behaviors and features. These may include active packaging features that respond to various external stimuli. In one example, temperature recording by the smart packaging system 10 ensures that the smart packaging system 10 and its contents are not exposed to temperatures that could potentially degrade its materials. The smart packaging system 10 may be equipped with packaging made of materials that respond to certain hot or cold temperatures to protect its contents.

[0293] In another example, the smart packaging system 10 may have shock-responsive cushioning. For example, if the packaging is dropped or subjected to forces that could potentially damage its contents, the corrugated design in the packaging can act as an absorption mechanism. In yet another example, the packaging may be made of 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 types of plastics.

[0294] Various aspects of the packaging can enhance the certification process for components of the Smart Packaging System 10. The certification process can occur before or during surgery using or about to use one or more components of the Smart Packaging System 10 to act as an additional safety measure. Such a certification process can prevent the use of fraudulent, recalled, unsafe, or other problematic products during surgery, thereby preventing harm to patients and / or staff. To perform the certification process, the outer packaging of the Smart Packaging System 10 may include one or more verification marks that can be detected by the HUB 50 or another system. Upon detection of one or more verification marks, the authenticity of the Smart Packaging System in question can be determined.

[0295] One or more verification marks may take many forms and may include marks that are disguised and / or completely hidden from human detection (e.g., marks made of ultraviolet ink), hidden watermarks, or specific shape patterns contained within a larger, seemingly random pattern. For example, an array of dots may be present on the packaging, and the presence of a specific subset of dots (e.g., a subset of dots comprising specific patterns of color, shape, arrangement, etc.) may be detected and used to complete the authentication process.

[0296] HUB 50 or another system may include vision processing components or optical detectors, such as a camera that can be used prior to surgical examination to check one or more verification marks on the packaging. These marks indicate the authenticity of the product and can be disguised as invisible or blurred to the naked eye. For example, infrared ink, unique patterns, etc., can all be computer-readable, yet humans would find it difficult or impossible to distinguish the marks. Furthermore, these marks can be designed so that they become visible only when the smart packaging system 10 has been properly sterilized or resterilized. Additionally, individual systems may have compatible marks that provide visual feedback on operational compatibility between the individual systems.

[0297] Figure 26 The document describes a sample verification procedure 2800 for watermark 2802. Figure 26In the process, an unlabeled female image 2804 can be provided. At 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 unlabeled image 2804 using key 2810, making the image now labeled 2805. The labeled image 2805 can be downgraded or attacked at degradation step 2806, resulting in a downgraded labeled image 2806A. This downgrade ensures the product is not compromised. During verification step 2808, key 2810 can be provided to extract watermark 2802A from the downgraded image 2806A at extraction step 2809, and robustness check step 2812 can be used to compare the extracted watermark 2802A with the original watermark 2802. If there is sufficient similarity between watermarks 2802 and 2802A, verification procedure 2800 is completed and authentication 2814 is achieved at robustness check step 2812.

[0298] Certain exemplary embodiments have been described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these embodiments have been illustrated in the accompanying drawings. Those skilled in the art will understand that the systems, devices, and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Features illustrated or described in one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention. Furthermore, in this disclosure, components with similar names in the embodiments generally have similar features, and therefore, in a particular embodiment, not every feature of every component with a similar name is necessarily fully described.

[0299] As used herein and throughout the specification and claims, approximate language may be applied to modify any quantitative representation that may be permitted to change without altering its associated essential function. Therefore, values ​​modified by one or more terms (such as “about,” “approximate,” and “substantially”) are not limited to the specified precise values. In at least some cases, approximate language may correspond to the precision of the instrument used to measure that value. Scope limitations may be combined and / or interchanged herein and throughout the specification and claims, and such scopes are identified and include all subscopes contained herein unless otherwise indicated by context or language.

[0300] Based on the specific embodiments described above, those skilled in the art will understand further features and advantages of the present invention. Therefore, this application should not be limited to the specific illustrations and descriptions except as indicated in the appended claims. All publications and references cited herein are expressly incorporated by way of reference in their entirety.

Claims

1. A surgical system, the 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; and A memory, disposed within the surgical packaging, stores instructions configured to cause the at least one data processor to perform operations including the following, prior to the breach of the manufacturer-sealed sterile surgical packaging: Receive data from a remote server characterizing the geopolitical location of at least one of the surgical packaging and the surgical instruments, and Based on the received data, instructions are sent to at least one of the surgical packaging and the surgical instruments to modify one or more aspects of the surgical packaging and / or the surgical instruments.

2. The surgical system according to claim 1, wherein, The manufacturer-sealed sterile surgical packaging includes a display configured to present visual information.

3. The surgical system according to claim 2, wherein, The display is configured to present one or more messages indicating non-compliance with one or more regulations of the geopolitical location.

4. The surgical system according to claim 3, wherein, The language of one or more presented messages is based on the geopolitical location.

5. The surgical system according to any of the preceding claims, wherein, One or more of these aspects include the capacity to collect medical data and surgical-related data.

6. The surgical system according to any of the preceding claims, wherein, The instructions are configured to disable one or more functions of the manufacturer-sealed sterile surgical packaging that do not comply with one or more regulations of the geopolitical location.

7. The surgical system according to any of the preceding claims, wherein, The one or more aspects include one or more operations of the surgical instruments that can be used during surgical procedures.

8. The surgical system according to any of the preceding claims, wherein, The geographical and political location mentioned is a customs checkpoint.

9. The surgical system according to any of the preceding claims, wherein, One or more aspects include the capacity to deliver one or more controlled substances, wherein the one or more controlled substances are prohibited or controlled in the geopolitical location.

10. A method comprising: The surgical system receives data from a remote server characterizing the geopolitical location of the surgical system, which includes a manufacturer-sealed sterile surgical package and surgical instruments contained within the manufacturer-sealed sterile surgical package. as well as Instructions are sent to the surgical package based on the received data to selectively alter one or more aspects of the surgical package.

11. The surgical system of claim 10, wherein, The manufacturer-sealed sterile surgical packaging includes a display configured to present visual information.

12. The surgical system of claim 11, wherein, The display is configured to present one or more messages indicating non-compliance with one or more regulations of the geopolitical location.

13. The surgical system according to claim 12, wherein, The language of the one or more presented messages is based on the geopolitical location.

14. The surgical system according to any one of claims 10 to 13, wherein, One or more of these aspects include the capacity to collect medical data and surgical-related data.

15. The method according to any one of claims 10 to 14, wherein, The instruction disables one or more functions of the surgical package that do not comply with one or more regulations of the geopolitical location.

16. The surgical system according to any one of claims 10 to 15, wherein, The one or more aspects include one or more operations of the surgical instruments that can be used during surgical procedures.

17. The surgical system according to any one of claims 10 to 16, wherein, One or more aspects include the capacity to deliver one or more controlled substances, wherein the one or more controlled substances are prohibited or controlled in the geopolitical location.

18. The surgical system according to any one of claims 10 to 17, wherein, The geographical and political location mentioned is a customs checkpoint.

19. The surgical system of claim 17, wherein, The instruction is sent before crossing the geopolitical boundary into the geopolitical location.

20. 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 characterizing the geopolitical location of the surgical system from a remote server. The surgical system includes a manufacturer-sealed sterile surgical package and surgical instruments contained within the manufacturer-sealed sterile surgical package; and Instructions are sent to the surgical package based on the received data to selectively alter one or more aspects of the surgical package.

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