System and related method for determining the disposal of surgical instruments

The interactive surgical system with a hub module enclosure and disposal method addresses sterility and disposal challenges by integrating modular components and managing lines, enhancing surgical efficiency and safety.

JP2025524538APending Publication Date: 2025-07-30CILAG GMBH INTERNATIONAL
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Patent Information

Application Number
JP2024577225
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-06-30
Filing Date
2023-06-27
Publication Date
2025-07-30

AI Technical Summary

Technical Problem

Existing surgical instruments and systems face challenges in maintaining sterility during use and proper disposal, particularly when transitioning between sterile and non-sterile environments, which can lead to contamination and complicate the handling of instruments post-procedure.

Method used

A computer-implemented interactive surgical system with a hub that integrates modular components for sterilization, assembly, and disposal, utilizing a hub module enclosure to manage power, data, and fluid lines, and a method for determining disposal instructions based on geographical location and instrument use.

Benefits of technology

Enhances sterility maintenance during surgical procedures by reducing line entanglements and facilitating efficient assembly, disassembly, and safe disposal of surgical instruments, ensuring proper handling and processing of components post-use.

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Abstract

A method for determining a disposal method of a surgical kit includes determining a geographical location where the surgical kit is used, generating location data based on the geographical location, and providing a location data set to a resource device. The method further includes receiving a disposal method from the resource device based on the location data set, and then displaying a set of instructions based on the disposal method received from the resource device.
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Description

Background Art

[0001] Various ultrasonic surgical instruments include an end effector having a blade element that vibrates at ultrasonic frequencies to cut and / or seal tissue (e.g., by denaturing proteins within tissue cells). These instruments include one or more piezoelectric elements that convert electrical power into ultrasonic vibrations, and these vibrations are transmitted along an acoustic waveguide to the blade element. Examples of ultrasonic surgical instruments and related concepts are disclosed in U.S. Patent Application Publication No. 2006 / 0079874, titled "Tissue Pad for Use with an Ultrasonic Surgical Instrument," published on April 13, 2006, now abandoned, the entire disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2007 / 0191713, titled "Ultrasonic Device for Cutting and Coagulating," published on August 16, 2007, now abandoned, the entire disclosure of which is incorporated herein by reference; and U.S. Patent Application Publication No. 2008 / 0200940, titled "Ultrasonic Device for Cutting and Coagulating," published on August 21, 2008, now abandoned, the entire disclosure of which is incorporated herein by reference.

[0002] Some instruments are operable to seal tissue by applying radiofrequency (RF) electrosurgical energy to the tissue. Examples of such devices and related concepts are disclosed in U.S. Patent No. 7,354,440, titled "Electrosurgical Instrument and Method of Use," issued on April 8, 2008, the entire disclosure of which is incorporated herein by reference; and U.S. Patent No. 7,381,209, titled "Electrosurgical Instrument," issued on June 3, 2008, the entire disclosure of which is incorporated herein by reference.

[0003] Some instruments are capable of applying both ultrasonic energy and RF electrosurgical energy to tissue. Examples of such instruments are U.S. Patent No. 9,949,785, entitled "Ultrasonic Surgical Instrument with Electrosurgical Feature," issued on April 24, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,663,220, entitled "Ultrasonic Electrosurgical Instruments," issued on March 4, 2014, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,835,307, entitled "Modular Battery Powered Handheld Surgical Instrument Containing Elongated Multi-Layered Shaft," issued on November 17, 2020, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 11,229,471, entitled "Modular Battery Powered Handheld Surgical Instrument with Selective Application of Energy Based on Tissue Characterization," issued on January 25, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0004] In some scenarios, it may be preferable to directly grip and manipulate a surgical instrument by one or more hands of one or more human operators. Additionally, or alternatively, it may be preferable to have a surgical instrument that is controlled via a robotic surgical system.Examples of robotic surgical systems and related instruments are disclosed in U.S. Patent No. 10,624,709, entitled "Robotic Surgical Tool with Manual Release Lever," published May 2, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,314,308, entitled "Robotic Ultrasonic Surgical Device With Articulating End Effector," issued April 19, 2016, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,125,662, entitled "Multi-Axis Articulating and Rotating Surgical Tools," issued September 8, 2015, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,820,605, entitled "Robotically-Controlled Surgical Instruments," issued September 2, 2014, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0201077, entitled "Interruption of Energy Due to Inadvertent Capacitive Coupling," published July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2012 / 0292367, entitled "Robotically-Controlled End Effector," published November 11, 2012, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 16 / 556,661, entitled "Ultrasonic Surgical Instrument with a Multi-Planar Articulating Shaft Assembly," filed August 30, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0005] Such instruments and robotic surgical systems may further be incorporated into a surgical system for performing procedures in a surgical environment such as an operating room or surgical suite within a medical facility. The sterile field is typically created around the patient and may include appropriately gowned, scrubbed, and washed medical personnel, as well as desired furniture and / or fixtures. Examples of such surgical systems and related mechanisms are disclosed in U.S. Patent Application Publication No. 2019 / 0201046, titled "Method for Controlling Smart Energy Devices," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0201080, titled "Ultrasonic Energy Device Which Varies Pressure Applied by Clamp Arm to Provide Threshold Control Pressure at a Cut Progression Location," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0201091, titled "Radio Frequency Energy Device for Delivering Combined Electrical Signals," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0274717, titled "Methods for Controlling Temperature in Ultrasonic Device," published on September 12, 2019, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent Application Publication No. 2019 / 0207857, titled "Surgical Network Determination of Prioritization of Communication, Interaction, or Processing Based on System or Device Needs," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0006] Although several surgical instruments and systems have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.

Brief Description of the Drawings

[0007] This specification concludes with the claims, which particularly point out and distinctly claim the technology. However, the technology is better understood by reading the following description of certain specific embodiments in conjunction with the accompanying drawings, in which like reference numerals identify like elements.

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[0008] The drawings are not intended to limit in any way, and it is contemplated that various embodiments of the present technology can be implemented in various other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated herein and forming a part of this specification illustrate some aspects of the present technology and, together with the description, explain the principles of the present technology, but it is understood that the present technology is not limited to the exact arrangements shown.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following description of specific embodiments of the present technology should not be used for the purpose of limiting its scope. Other embodiments, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for practicing the present technology by way of example. As will be understood, all the technologies described herein are capable of other different and obvious aspects without departing from the technology. Therefore, the drawings and description should not be regarded as limiting, but should be considered essentially exemplary.

[0010] It should be further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will become readily apparent to those skilled in the art by considering the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0011] For the clarity of the present disclosure, the terms "proximal" and "distal" are defined herein with respect to the operator of a surgical instrument, whether human or robotic. The term "proximal" means the position of an element that is closer to the operator of the surgical instrument, whether human or robotic, and further away from the surgical end effector of the surgical instrument. The term "distal" means the position of an element that is closer to the surgical end effector of the surgical instrument and further away from the operator of the surgical instrument, whether human or robotic. Note that the terms "upper", "lower", "top", "bottom", "upper side", and "lower side" are used with respect to the embodiments and the associated figures and are not intended to unnecessarily limit the invention described herein.

[0012] I. Example of a Surgical System Referring to FIG. 1, a computer-implemented interactive surgical system (100) includes one or more surgical systems (102) and a cloud-based system (e.g., a cloud (104) that may include a remote server (113) coupled to a storage device (105)). Each surgical system (102) in this example may include at least one surgical hub (106) that communicates with a cloud (104) that may include a remote server (113). In one example, as shown in FIG. 1, the surgical system (102) includes a visualization system (108), a robotic system (110), and a handheld intelligent surgical instrument (112), which are configured to communicate with each other and / or with the hub 106. In some embodiments, the surgical system (102) may include M hubs (106), N visualization systems (108), O robotic systems (110), and P handheld intelligent surgical instruments (112), where M, N, O, and P are integers greater than or equal to 1. In any case, as will be apparent to those skilled in the art in view of the teachings herein, any suitable combination of the mechanisms provided below may be incorporated into an exemplary surgical system such as the surgical system (100) and used in an operating room to perform a desired surgical procedure.

[0013] FIG. 2 shows an example of a surgical system (102) used to perform surgery on a patient lying on an operating table (114) within an operating room (116). A robotic system (110) is used as part of the surgical system 102 in a surgical operation. The robotic system (110) includes a surgeon's console (118), a patient-side cart (120) (surgical robot), and a surgical robot hub (122). While the surgeon views the surgical site through the console (118), the patient-side cart (120) can manipulate a surgical tool (117) removably coupled to any of a plurality of surgical arms (123) through a minimally invasive incision in the patient's body. An image of the surgical site can be acquired by a medical imaging device (124) that can be manipulated by the patient-side cart (120) to change the orientation of the imaging device (124). The robot hub (122) can be used to process an image of the surgical site and then display it to the surgeon through the console (118).

[0014] Other types of robotic systems can be readily adapted for use with the surgical system (102). Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, filed Dec. 28, 2017, entitled “Robot Assisted Surgical Platform,” the entire disclosure of which is incorporated herein by reference.

[0015] Various examples of cloud-based analysis methods executed by the cloud (104) and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, filed Dec. 28, 2017, entitled “Cloud-Based Medical Analytics,” the entire disclosure of which is incorporated herein by reference.

[0016] In various aspects, the imaging device (124) includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors. In various aspects, the imaging device (124) is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (stomach cameras), endoscopes, laryngoscopes, nasopharyngo-ureteroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes. Some aspects of spectral and multispectral imaging methods are described in detail in the "Advanced Imaging Acquisition Module" of U.S. Provisional Patent Application No. 62 / 611,341, entitled "Interactive Surgical Platform," filed on December 28, 2017, the entire disclosure of which is incorporated herein by reference.

[0017] During any surgical procedure, strict sterilization of the operating room and surgical instruments is required. The strict hygiene and sterilization conditions required in the "operating room," i.e., the operating room or procedure room, require the highest possible sterility of all medical devices and instruments. Part of that sterilization process requires sterilizing anything that comes into contact with the patient or penetrates the sterile field. It will be understood that the sterile field can be considered a specific area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or that the sterile field can be considered the area immediately surrounding a patient who is prepared for surgery. The sterile field can include properly attired and scrubbed team members, as well as all equipment and fixtures within that area.

[0018] In addition to the introduction of any mechanism of a surgical system (100), furniture, or fixture into a sterile field that requires sterilization, particularly when such a mechanism comes into contact with, or is presumed to come into contact with, a patient including any tissue and / or fluid associated with a surgical procedure, additional complications can arise from the removal of these mechanisms from the sterile field. Such contamination of these mechanisms from the patient often requires special consideration during or after the surgical procedure, particularly when processing these mechanisms for disposal, reuse, or remanufacture as necessary. In one example, the surgical system (100) and / or healthcare providers associated with the surgical procedure can be specifically equipped to handle such processing, as described in more detail below.

[0019] As shown in FIG. 2, the primary display (119) is positioned within the sterile field so as to be visible to the operator of the operating table (114). In addition, a visualization tower (111) is positioned outside the sterile field. The visualization tower (111) includes a first non-sterile display (107) and a second non-sterile display (109) facing opposite each other. A visualization system (108) guided by a hub (106) is configured to utilize the displays (107, 109, 119) to coordinate the flow of information to the operators inside and outside the sterile field. For example, the hub (106) can cause the visualization system (108) to display a snapshot of the surgical site recorded by the imaging device (124) on the non-sterile display (107) or (109) while maintaining a live video of the surgical site on the primary display (119). The snapshot on the non-sterile display (107) or display (109) can, for example, permit a non-sterile operator to perform diagnostic steps associated with the surgical procedure.

[0020] In one aspect, the hub (106) is also configured to send diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower (111) to a primary display (119) within the sterile field, such that it can be viewed by a sterile operator at the operating table. In one example, the input can be in the form of a modification to a snapshot displayed on a non-sterile display (107) or display (109) that can be sent by the hub (106) to the primary display (119).

[0021] Referring to FIG. 2, the surgical instrument (112) is used as part of a surgical system (102) in a surgical procedure. The hub (106) is also configured to regulate the flow of information to a display of the surgical instrument (112), such as, for example, as described in U.S. Provisional Patent Application No. 62 / 611,341, entitled "Interactive Surgical Platform," filed on Dec. 28, 2017, the disclosure of which is hereby incorporated by reference in its entirety. Diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower (111) can be sent by the hub (106) to a surgical instrument display (115) within the sterile field, such that it can be viewed by an operator of the surgical instrument (112). Exemplary surgical instruments suitable for use with the surgical system (102) are described, for example, in the "Surgical Instrument Hardware" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "Interactive Surgical Platform," filed on Dec. 28, 2017, the entire disclosure of which is hereby incorporated by reference.

[0022] Referring now to FIG. 3, a hub (106) is shown that communicates with a visualization system (108), a robotic system (110), and a hand-held intelligent surgical instrument (112). The hub (106) includes a hub display (135), an imaging module (138), a power generator module (140), a communication module (130), a processor module (132), and a storage array (134). In certain embodiments, as shown in FIG. 3, the hub (106) further includes a smoke exhaust module (126), a suction / irrigation module (128), and / or an operating room mapping module (133).

[0023] During a surgical procedure, applying energy to tissue for sealing and / or cutting is generally associated with smoke evacuation, suction of excess fluid, and / or irrigation of tissue. Fluid lines, power lines, and / or data lines from different sources often become entangled during a surgical procedure. Valuable time may be lost in addressing this problem during a surgical procedure. To untangle the lines, it may be necessary to disconnect the lines from their corresponding modules, which may require resetting the modules. The hub module enclosure (136) provides an integrated environment for managing power lines, data lines, and fluid lines, reducing the frequency of such line entanglements.

[0024] Referring to FIGS. 3-4, aspects of the present disclosure are presented regarding a hub module type enclosure (136) that enables modular integration of a generator module (140), a smoke exhaust module (126), and a suction / irrigation module (128). The hub module type enclosure (136) further facilitates interactive communication between the modules (140, 126, 128). As shown in FIG. 4, the generator module (140) may be a generator module including integrated monopole components, bipolar components, and ultrasonic components, supported within a single housing unit (139) slidably insertable into the hub module type enclosure (136). As shown in FIG. 4, the generator module (140) can be configured to connect to a monopole device (146), a bipolar device (147), and an ultrasonic device (148). Alternatively, the generator module (140) may include a series of monopole generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact via the hub module type enclosure (136). The hub module type enclosure (136) can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked to the hub module type enclosure (136) such that the multiple generators function as a single generator.

[0025] FIG. 5 shows one form of a generator (150) and various surgical instruments (152, 154, 156) that can be used therewith. The surgical instrument (152) is an ultrasonic surgical instrument (152), the surgical instrument (154) is an RF electrosurgical instrument (154), and the multifunctional surgical instrument (156) is an ultrasonic / RF combined electrosurgical instrument (156). The generator (150) is configurable to be used with various surgical instruments. According to various forms, the generator (150) can be configured to be used with various surgical instruments of different types, including, for example, an ultrasonic surgical instrument (152), an RF electrosurgical instrument (154), and a multifunctional surgical instrument (156) that integrates RF energy and ultrasonic energy simultaneously delivered from the generator (150). The generator (150) in this example of FIG. 5 is shown separately from the surgical instruments (152, 154, 156), but the generator (150) may alternatively be formed integrally with any of the surgical instruments (152, 154, 156) to form a single surgical system. The generator (150) includes an input device (158) located on the front panel of the console of the generator (150). The input device (158) can include any suitable device that generates a signal suitable for programming the operation of the generator (150). The generator (150) may be configured for wired or wireless communication.

[0026] The generator (150) of this example is configured to drive a plurality of surgical instruments (152, 154, 156). An example of such a surgical instrument is an ultrasonic surgical instrument (152), which includes a handpiece (160), an ultrasonic transducer (162), a shaft assembly (164), and an end effector (166). The end effector (166) includes an ultrasonic blade (168) and a clamp arm (170) acoustically coupled to the ultrasonic transducer (162). The handpiece (160) includes a trigger (172) for operating the clamp arm (170) and a combination of toggle buttons (173, 174, 175) for supplying and driving energy to the ultrasonic blade (168) or other functions. The toggle buttons (173, 174, 175) can be configured to supply energy to the ultrasonic transducer (162) using the generator (150).

[0027] The generator (150) is also configured to drive another example of a surgical instrument (154). The RF electrosurgical instrument (154) includes a handpiece (176), a shaft assembly (178), and an end effector (180). The end effector (180) includes electrodes within the clamp arms (181, 182) and returns through the electrical conductor portion of the shaft assembly (178). The electrodes are coupled to a bipolar energy source within the generator (150) and are energized by the bipolar energy source. The handpiece (176) includes a trigger (183) for operating the clamp arms (181, 182) and an energy button (184) for actuating an energy switch for supplying energy to the electrodes within the end effector (180).

[0028] The generator (150) is also configured to drive a multi-functional surgical instrument (156). The multi-functional surgical instrument (156) includes a handpiece (185), a shaft assembly (186), and an end effector (188). The end effector (188) includes an ultrasonic blade (190) and a clamp arm (192). The ultrasonic blade (190) is acoustically coupled to the ultrasonic transducer (162). The handpiece (185) includes a trigger (194) for operating the clamp arm (192) and a combination of toggle buttons (195, 196, 197) for supplying energy to and driving the ultrasonic blade (190) or other functions. The toggle buttons (195, 196, 197) can be configured to supply energy to the ultrasonic transducer (162) using the generator (150) and, similarly, to supply energy to the ultrasonic blade (190) using a bipolar energy source housed within the generator (150). It will be appreciated that the handpieces (160, 176, 185) may be replaced with robotic-controlled instruments for incorporating one or more aspects of the surgical instruments (152, 154, 156). Thus, the term "handpiece" should not be limited to this context and handheld use.

[0029] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, technologies, communication channels, etc. that can communicate data through the use of modulated electromagnetic radiation via a non-solid medium. This term does not mean that the associated devices do not include any wired connections, but in some embodiments, they may not be present. The communication module may implement any of several wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE802.11 family), WMAX (IEEE802.16 family), IEEE802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, their Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G, and later. The computing module may include a plurality of communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0030] As used in this specification, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually memory) or some other data stream. In this specification, this term is used to refer to the central processor (central processing unit) within a system or computer system (especially a system on a chip (SoC)) that combines many specialized "processors".

[0031] As used herein, a system-on-chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. This can include digital, analog, mixed-signal, and in many cases high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with state-of-the-art peripherals such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. An SoC may or may not include on-chip memory.

[0032] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU of a microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller may house memory and programmable input / output peripherals along with one or more core processing units (CPUs). Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM and a small amount of RAM are also often included on the chip. A microcontroller can be used for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications composed of various discrete chips.

[0033] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may also be the linkage between two parts of a computer or controller on an external device that manages the operation of the device (and the connection to the device). A modular device includes a module that can be received within a surgical hub (e.g., as described in connection with FIG. 3), and a surgical device or instrument that can be connected to various modules to connect or pair with a corresponding surgical hub. Examples of modular devices include, for example, intelligent surgical instruments, medical imaging devices, aspiration / irrigation devices, smoke evacuators, energy generators, ventilators, inhalers, and displays. The modular devices described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). This data may be related to the patient during surgery (e.g., tissue characteristics or insufflation pressure), or may be related to the modular device itself (e.g., the speed of a advancing knife, motor current, or energy level). For example, the control algorithms of surgical stapling and cutting instruments can control the speed at which the motor of the instrument drives the knife through tissue according to the resistance generated by the knife as it advances.

[0034] II. Exemplary Introduction, Assembly, Use, and Disposal of a Surgical Kit in the Operating Room As described above, objects intended to penetrate the sterile field in the operating room during surgery need to be properly sterilized, while objects emerging from the sterile field after surgery often require special considerations when being disposed of, reused, or remanufactured. In some cases, surgical instruments / tools (112, 117, 152, 154, 156) may require at least some degree of assembly in the operating room before the exemplary use according to the description herein, and then may require some degree of disassembly after the exemplary use so that select components can be disposed of, reused, and / or remanufactured. For example, before the exemplary use of an instrument (152), it may be necessary to suitably couple an ultrasonic blade (168) to an ultrasonic transducer (162) in the operating room and / or to suitably couple a shaft assembly (164) to a handpiece (160). Additionally, after the exemplary use, the ultrasonic blade (168) may need to be detached from the ultrasonic transducer (162) for suitable processing according to the description herein.

[0035] Accordingly, in some cases, the surgical instruments / tools (112, 117, 152, 154, 156) may be introduced into the sterile field as a surgical kit having sub-components that require at least some degree of assembly before the exemplary use. In addition to the sub-components used to form the surgical instruments / tools (112, 117, 152, 154, 156), such a surgical kit may include tools necessary for the assembly, disassembly, and suitable processing for disposal, reuse, or remanufacture of the instruments / tools (112, 117, 152, 154, 156) and their sub-components. FIGS. 6A - 6F illustrate the exemplary introduction, assembly, use, disassembly, and disposal of a surgical kit (5020).

[0036] First, as shown in FIG. 6A, prior to surgery, the surgical kit (5020) can be housed within the sealed and sterilized interior of a storage bag (5025). As will be apparent to those skilled in the art in view of the teachings herein, the storage bag (5025) may have a non-sterile exterior so that a non-sterile person can grasp the exterior of the storage bag (5025) for transporting the surgical kit (5020) into the non-sterile room (5012) in preparation for surgery. Additionally, the sealed and sterilized nature of the interior of the storage bag (5025) can help ensure that the surgical kit (5020) remains properly sterilized while being transported within the storage bag (5025).

[0037] In preparation for surgery, the surgical kit (5020) may be transferred from the non-sterile entrance (5012) to the sterile field (5006) of the operating room (5000), as shown in FIG. 6B. The surgical kit (5020) can be transferred into the sterile field (5006) via a suitable entrance portal (5008), as will be apparent to those skilled in the art in view of the teachings herein. During such transfer, a person within the non-sterile entrance (5012) may place the kit (5020) and the bag (5025) within the entrance portal (5008) and provide suitable access to its interior while maintaining the sterility of the interior of the bag (5025). Next, a sterilized person within the sterile field (5006) can suitably access the sterilized interior of the storage bag (5025) so that the kit (5020) is properly transferred to both the sterile room (5002) and the sterile field (5006), and can remove the surgical kit (5020) from the storage bag (5025). Thus, the kit (5020) can remain properly sterilized even after being transferred from the non-sterile entrance (5012) into the operating room (5000).

[0038] The aseptic chamber (5002) may be substantially similar to the above-described operating room (116). The aseptic chamber (5002) includes a surgical setting (5004) that may be substantially similar to the above-described operating table (114). Additionally, the aseptic chamber (5002) also includes an assembly station (5005), which may include an aseptic table and / or any other suitable structure as will be apparent to those skilled in the art in view of the teachings herein.

[0039] Referring to FIG. 6C, when the surgical kit (5020) is properly transferred into the aseptic chamber (5002), the contents of the surgical kit (5020) can be accessed and placed on the assembly station (5005). In this example, the surgical kit (5020) includes surgical sub-components (5022), non-surgical sub-components (5024), and a plurality of waste bags (5026, 5028, 5030). The surgical sub-components (5022) are intended to be assembled to form surgical instruments substantially similar to the above-described instruments / tools (112, 117, 152, 154, 156). The non-surgical sub-components (5024) are not intended to be directly used in a surgical operation and may include a part of the surgical kit (5020) for auxiliary purposes for the surgical operation. For example, the non-surgical sub-components (5024) may include tools (in some cases multiple) for assembling and disassembling the surgical sub-components (5022), a tray that can organize the other components (5022, 5024, 5026, 5028, 5030), or other features desired for exemplary use according to the description herein. As will be described in more detail below, the waste bags (5026, 5028, 5030) are configured to store the respective post-operative components (5032, 5034, 5036) (see FIG. 6D) such that the post-operative components (5032, 5034, 5036) can be removed from the aseptic chamber (5002) while being properly sealed from exposure to the non-sterile environments (5012, 5014).

[0040] Also, as shown in FIG. 6C, after being properly assembled (either pre-assembled, assembled by hand within the sterile chamber (5002), and / or using tools from the non-surgical sub-components (5024)), the surgical sub-component (5022) can be utilized in a surgical setting (5004) to perform an appropriate surgical procedure on a patient, as would be apparent to one of ordinary skill in the art considering the teachings herein. The surgical sub-component (5022) can form any suitable instrument / tool (112, 117, 152, 154, 156) described herein. Thus, the surgical sub-component (5022) may be configured as a component of the computer-implemented interactive surgical system (100). For example, if the surgical sub-component (5022) forms a removably coupled surgical tool (117) intended to be used in conjunction with the patient-side cart (120), the surgical sub-component (5022) may be used in conjunction with the robotic system (110). As another example, if the surgical sub-component (5022) forms a hand-held intelligent surgical instrument (112), the surgical sub-component (5022) can be handled by a surgeon and suitably coupled to the hub (106) during exemplary use in accordance with the description herein.

[0041] Referring to FIG. 6D, after suitable use, the surgical sub-component (5022) may be exposed to the patient such that the sub-component (5022) requires special consideration. Thus, the surgical sub-component (5022) and the non-surgical sub-component (5024) may be disassembled and compartmentalized into post-operative components (5032, 5034, 5036). Any suitable means for disassembling the sub-components (5022, 5024) may be utilized, as will be apparent to those skilled in the art in view of the teachings herein. The post-operative components (5032, 5034, 5036) may be classified based on the type of post-operative treatment intended for each category. For example, disassembled sub-components (5022, 5024) intended to be reused or remanufactured may be sorted into a first category of post-operative components (5032), while disassembled sub-components (5022, 5024) containing electrical components intended to be disposed of may be sorted into a second category of post-operative components (5034), and disassembled sub-components (5022, 5024) intended to be disposed of but not containing electrical components may be sorted into a third category of post-operative components (5036). At the point shown in FIG. 6D, certain disposable components may be further processed as being ready for proper disposal. For example, an internal power source (e.g., a battery) utilized as the surgical sub-component (5022) may need to be fully discharged at this point.

[0042] Next, as shown in FIG. 6E, while still within the sterile chamber (5002), the classified post-operative components (5032, 5034, 5036) may then be placed within their respective waste bags (5026, 5028, 5030). The waste bags (5026, 5028, 5030) can then be sealed such that the post-operative components (5032, 5034, 5036) are sealed from the external environment outside of their respective bags (5026, 5028, 5030). The waste bags (5026, 5028, 5030) can utilize any suitable sealing means, as will be apparent to those skilled in the art in view of the teachings herein.

[0043] Next, as shown in FIG. 6D, the post-surgical components (5032, 5034, 5036) and their respective waste bags (5026, 5028, 5030) may be transported from the room (5002) and the sterile field (5006) into the non-sterile chamber (5014) via the exit portal (5010). Thus, the post-surgical components (5032, 5034, 5036) may then be transported, while remaining sealed from the external environment, to a suitable location for disposal, reprocessing, and / or remanufacture. If the components (5032, 5034, 5036) may have come into contact with a patient during the surgical procedure, such components (5032, 5034, 5036) are prevented from unwanted exposure within the non-sterile chambers (5012, 5014).

[0044] In this example, the non-sterile inlet (5012) and the non-sterile outlet (5014) are used in conjunction with the inlet portal (5008) and the exit portal (5010), but this is merely optional. In some cases, the surgical kit (5020) and the post-surgical components (5032, 5034, 5036) are transported from / to the same non-sterile chambers (5012, 5014) using the same portals (5008, 5010).

[0045] In this example, waste bags (5026, 5028, 5030) are used, but as will be apparent to those skilled in the art in view of the teachings herein, an appropriate disposal structure configured to properly support such components (5032, 5034, 5036) while sealing them from the external environment during transport of each component (5032, 5034, 5036) can be used.

[0046] III. Exemplary Devices and Methods for Determining and Extracting Disposal Instructions for Used Energized Surgical Instruments As described above, after suitable use of the surgical sub-component (5022), the surgical sub-component (5022) (e.g., part of a surgical kit (5020) used to form an energized surgical instrument / tool (112, 117, 152, 154, 156)) can be disassembled into post-operative components (5032, 5034, 5036) for purposes of disposal, reprocessing, and / or remanufacturing. As an example, such post-operative components (5032, 5034, 5036) can be classified as components (5032) intended for reuse / remanufacturing, electrical components (5034) intended for disposal, and non-electrical components (5036) intended for disposal.

[0047] In some cases, there may be various criteria for classifying which used surgical sub-components (5022) may be reusable / manufacturable and which surgical sub-components (5022) are disposable. Additionally, there may be various criteria for suitably processing / disposing of such reusable, manufacturable, and disposable surgical sub-components, which will be apparent to those skilled in the art in view of the teachings herein, whether the surgical sub-component (5022) is in a sterile environment when first disassembled or outside a sterile environment while the surgical sub-component (5022) is being appropriately reprocessed, remanufactured, and / or disposed of. The criteria and / or proposed guidelines for classifying sub-components (5022) as either reusable or disposable may vary between jurisdictions. Additionally, the reprocessing, remanufacturing, and / or disposal criteria and / or proposed guidelines may also vary between jurisdictions. Such criteria / guidelines for the classification, reprocessing, remanufacturing, disposal, etc. of used surgical sub-components (5022) may be referred to as disposal methods.

[0048] For example, in a first jurisdiction, an energized component (e.g., an electrode, a transducer, an ultrasonic blade, a battery, etc.) may be certified only for a first number of surgical uses (such as a single surgical procedure), and while in a second jurisdiction, the same energized component may be certified for reprocessing and / or remanufacturing for a different number of surgical uses (such as multiple surgical procedures). As another example, in a first jurisdiction, an electrical component may need to be fully discharged before being transferred to respective waste bags (5026, 5028, 5030), while in a second jurisdiction, the same electrical component may not need to be fully discharged before being transferred to respective waste bags (5026, 5028, 5030).

[0049] Accordingly, it may be desirable to retrieve a set of disposal instructions for processing components of a surgical kit (5020) after an exemplary surgical procedure in accordance with the description herein. Further, it may be desirable to retrieve a particular set of disposal instructions for a surgical kit (5020) based on any number of suitable variables that will be apparent to those skilled in the art in view of the teachings herein. Such variables may include, for example, but are not limited to, the geographical location of the surgical procedure, the use of other surgical products in conjunction with the surgical kit (5020), and / or the performance data of the surgical sub-components (5022).

[0050] FIG. 7 shows an exemplary surgical instrument (5040) and an exemplary disposal support device (5050) that may be utilized in a determination procedure (5060) for disposal instructions shown in FIG. 8. In this example, the exemplary surgical instrument (5040) and the disposal support device (5050) are utilized to perform a determination procedure (5060) for disposal instructions as shown in FIG. 8, it being understood that any suitable surgical instrument may be utilized alone or in conjunction with any suitable disposal support device, as will be apparent to those skilled in the art in view of the teachings herein.

[0051] The surgical instrument (5040) may be assembled from the surgical kit (5020) such that the surgical instrument (5040) is substantially similar to the above-described surgical sub-component (5022). Thus, the surgical instrument (5040) may be assembled within the operating room (5000) before being used in a surgical procedure and may then be disassembled and classified into various post-operative components (5032, 5034, 5036). In some cases, such disassembly may occur within the operating room (500) after being used in a surgical procedure.

[0052] The surgical instrument (5040) may be substantially similar to any surgical instrument / tool described herein, including the above-described surgical instruments / tools (112, 117, 152, 154, 156). Thus, the surgical instrument (5040) is configured to be used in conjunction with the computer-implemented interactive surgical system (100) by coupling to suitable components of a hub (106) such as a generator module (140), a communication module (130), a storage array (134), etc. In some cases, the surgical instrument (5040) may be handheld, while in other examples, the surgical instrument (5040) may be configured to be suitably coupled to a robotic system (110). In some cases, the surgical instrument (5040) may be utilized without being connected to a hub (1060) such that the surgical instrument (5040) includes its own power source or is coupled to a generator other than the generator associated with the hub (1060).

[0053] The surgical instrument (5040) includes a memory unit (5042) and a processing unit (5044), which may function together as a control unit for the surgical instrument (5040). The memory unit (5042) may be operable to store various information regarding the performance of the surgical instrument (5040) during an exemplary surgical procedure as described herein. The memory unit (5042) may also store data related to the various components used to form the surgical instrument (5040). For example, the memory unit (5042) of the surgical instrument (5040) may store data regarding to which geographical locations the instrument (5040) has been sold and shipped. The memory unit (5042) can include data including a serial number that identifies a particular instrument (5040). The surgical instrument (5040) may also include a QR code (5048). The QR code (5048) may include suitable data necessary to identify a particular instrument (5040), along with various suitable information regarding the particular instrument (5040) (such as the geographical location where the instrument (5040) has been sold and / or shipped).

[0054] The instrument (5040) also includes a communication module (5046) that communicates with a processor (5044). The communication module (5046) is configured to establish communication with a corresponding communication module (5056) of a treatment support device (5050) such that data can be shared between the instrument (5040) and the treatment support device (5050). The communication module (5046) can include any suitable communication means that will be apparent to those skilled in the art in view of the teachings herein. For example, the communication module (5046) can be configured to communicate via Bluetooth technology, Near Field Communication "NCF", Radio Frequency Identification "RFID", and the like.

[0055] The treatment support device (5050) can take any suitable form, such as a smartphone or a tablet. The treatment support device (5050) may be used within the sterile field (5006) during the disassembly of the surgical sub-component (5022) in accordance with the description herein. Additionally or alternatively, the treatment support device (5050) may be used outside the sterile field (5006) during the reprocessing, remanufacturing, and / or disposal of the surgical sub-component (5022) in accordance with the description herein.

[0056] The treatment support device (5050) includes a memory unit (5052) and a processing unit (5054), which may function together as a control unit for the treatment support device (5050). The memory unit (5052) may include a suitable application (e.g., a software product) that includes download and upload functions that can be used to access cleaning and sterilization protocols in accordance with the description herein. The treatment support device (5050) includes a corresponding communication module (5056) configured to communicate with the communication module (5046) described above. The communication module (5056) can include any suitable communication means that will be apparent to those skilled in the art in view of the teachings herein. For example, the communication module (5056) may be configured to communicate via Bluetooth technology, Near Field Communication "NCF", Radio Frequency Identification "RFID", etc.

[0057] The process support device (5050) also includes a display (5055) that communicates with the processing unit (5054). The processing unit (5054) may instruct the display (5055) to show the user suitable information, such as information provided by executing suitable applications described herein. The display (5055) can take any suitable form that would be apparent to one of ordinary skill in the art in view of the teachings herein. For example, the display (5055) may be a touch screen. The process support device (5050) also includes a camera (5058) that communicates with the processing unit (5054). The camera (5058) may be used to capture an image and communicate it to the processing unit (5054) so that a suitable application can utilize the image in accordance with the description herein. The camera (5058) can include any suitable components that would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0058] In some cases, the application that executes the treatment support device (5050) may be configured to connect to a hub (106) used in conjunction with an instrument (5040) during a surgical procedure. Such an application may have limited permissions with the hub (106) such that the staff using the treatment support device (5050) and the corresponding application cannot access any part of the hub (106) except for relevant disposal instructions, cleaning, and / or sterilization information. Such a connection between the hub (106) and the application of the device (5050) may enable the device (5050) to communicate with an interconnected hospital system for purposes such as operating room systems / inventory tracking. Thus, when an instrument (5040) or other suitable instrument / component is used in a surgery and scanned by the device (5050), the hub (106) may update the hospital system's inventory and recognize the use of the instrument (5040) and / or other components. It should be understood that being "scanned" by the device (5050) may include the device (5050) using a camera (5056) to scan a QR code (5048), establishing a connection between communication modules (5046, 5056), or any other suitable form of the device (5050) obtaining data from the instrument (5040) that would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0059] When the treatment support device (5050) is utilized within the operating room (5000), the application utilized by the treatment support device (5050) may communicate with a sterilization group located outside the operating room (5000). Thus, when the treatment support device (5050) scans an instrument (5040) and / or various sub-components of the instrument (5040) to obtain appropriate reprocessing / disposal instructions in accordance with the description herein, the application executed on the device (5050) may notify the sterilization group that the appropriate parts of the instrument (5040) intended for sterilization are being transported to the sterilization group.

[0060] Similarly, the application utilized by the disposal support device (5050) can communicate with the maintenance group and notify the maintenance group when the device is ready for service. Thus, when the disposal support device (5050) scans the appliance (5040) and / or various sub-components of the appliance (5040) to obtain appropriate reprocessing / disposal instructions in accordance with the description herein, the application running on the device (5050) can notify the maintenance group that the appropriate part of the appliance (5040) intended for maintenance is ready for service.

[0061] When the disposal support device (5050) is communicating with the hub (106), the disposal support device (5050) and the hub (106) may be configured to identify any lost or missing devices, such as the appliance (5040) used during the procedure. For example, the hub (106) may be configured to track which appliance (5040) or other device is used during the procedure. During the disposal process, the appliance (5040) used in the procedure can be scanned using the disposal support device (5050) or otherwise processed. Communication between the device (5050) and the hub (106) can enable the disposal support device (5050) and / or the hub (106) to compare which appliance (5040) was used during the procedure and which appliance (5040) was scanned for appropriate reprocessing / disposal. This comparison can enable the device (5050) and / or the hub (106) to ensure that all devices have been accounted for. When a smart disposal system is used, the disposal support device (5050) can verify appropriate disposal via communication with the smart disposal system.

[0062] In some cases, the application executed on the disposal support device (5050) may be connected to either the remote server (113) and / or the cloud (104) instead of the hub (106). As an example, some hospital systems may not have access to the hub (106). In such cases, the cloud (104) and / or the remote service (113) may cooperate with a suitable application on the device (5050) to provide cleaning, sterilization, and / or disposal protocols and may provide step-by-step instructions in accordance with the teachings herein. In an example where the application is connected to either the remote server (113) and / or the cloud (104), such an application may automatically connect the disposal support device (5050) to an appropriate manufacturer call center for help.

[0063] In some cases, the application executed on the device (5050) may use location information to determine the country and / or region where the device (5050) is being used. For example, the application executed on the device (5050) may have an application location service that determines the location of use by utilizing any suitable means, as would be apparent to one of ordinary skill in the art considering the teachings herein. In some cases, the application executed on the device (5050) may request the user to input the location of use when setting up an application account on the device (5050).

[0064] In some cases, the instrument (5040) may not be connected to the hub (106) during a surgical procedure so that the hub (106) does not collect performance data of the surgical instrument (5040) during exemplary use. As described above, the memory (5042) of the instrument (5040) may be operable to store various information regarding the performance of the surgical instrument (5040) during an exemplary surgical procedure according to the description herein. For example, such information may include device motor data, sensor data, malfunctions that the instrument (5040) experiences during use, error codes, and the like. In some cases, an application executed on the device (5050) may be configured to extract performance data stored on the memory (5042) of the instrument (5040) via the communication modules (5046, 5056). The application executed on the device (5050) may then be configured to upload the extracted performance data to the hub (106), the cloud (104), the remote server (113), or the like. When the hub (106) is not used, a gateway to the device (5050) may be utilized to extract the performance data. The extraction and upload of this data can be made invisible to the operator using the device (5050) and can be performed automatically when the device (5050) establishes communication with the instrument (5040) via the communication modules (5046, 5056).

[0065] FIG. 8 shows a determination procedure (5060) configured to enable an instrument (5040), a generator module (140), and / or a hub (106) to identify relevant factors associated with the use of the instrument (5040) and then access or determine a suitable disposal method based on the identified relevant factors. The determination procedure (5060) can be utilized with any suitable device that would be apparent to one of ordinary skill in the art in view of the teachings herein. For example, the determination procedure (5060) may be utilized in conjunction with the aforementioned instrument (5040) and / or a disposal support device (5050). As another example, the determination procedure (5060) may be utilized in conjunction with the instrument (5040) and the hub (106). As yet another example, the determination procedure (5060) may be utilized in conjunction with the instrument (5040), the hub (106), and the disposal support device (5050). It should be understood that although the determination procedure (5060) is shown and described in terms of steps in a particular order, some of the steps may be entirely optional. Further, it should be understood that the order in which the steps are performed may have any suitable order that would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0066] As described above, the criteria and / or guidelines for the disposal method may vary depending on the location where the instrument (5040) is used. Accordingly, one step (5062) in the determination procedure (5060) may include determining the location of the operating room (5000) where the procedure is being performed. As would be apparent to one of ordinary skill in the art in view of the teachings herein, any suitable component or means can be utilized to determine the location of the operating room (5000). For example, an application executed on the disposal support device (5050) may be configured to determine the country and / or region in which the device (5050) is being used, which can then be used to infer the location of the operating room (5000).

[0067] As another example, the appliance (5040) and / or the generator module (140) may have a device code and / or serial number that includes or provides access to the particular location where the appliance (5040) was shipped for the intended use according to the description herein. If the device code and / or serial number is associated with the appliance (5040), when the appliance (5040) is coupled to the generator module (140) / hub (106) / cloud (104), the generator module (140) / hub (106) / cloud (104) can read the device code provided by the appliance (5040) to determine the intended location of use. In some cases, the generator (140) may be pre-programmed by the manufacturer at the intended location where the generator (140) is to be shipped, for example, using program EEPROM code. In such a case, the generator (140) may determine the location of use by referring to this pre-programmed information during exemplary use. Further, when the generator (140) is activated, the generator (140) may perform an initialization check to identify the location of use. Such a location of use may be stored within the field service settings.

[0068] As another example, instead of a device code and / or serial number, the generator module (140) and / or the appliance (5040) may include another identifier, such as an RFID chip, that can track the sale of the product and determine its intended location of use. In some cases, the intended location of use as determined by the manufacturer may be cross-checked using suitable means to identify actual use (some examples of identifying actual use are provided below). If the intended location of use does not match the identified actual location of use, the hub (106) and / or the cloud (104) may be notified to enable special processing of device tracking by the manufacturer.

[0069] As another example, the GPS device may be associated with an instrument (5040), a device (5050), a hub (106), a generator module (140), or any other suitable device that would be apparent to one of ordinary skill in the art in view of the teachings herein. When activated, the GPS device may determine the location of use and communicate that information to any suitable component such as the hub (106), the generator module (140), the device (5050), and / or the instrument (5040). As another example, the hub (106) and / or the device (5050) may analyze the network to which they are connected to determine the location of use. As another example, the generator, the hub (106) and / or the device (5050) may have a hospital identifier that can determine the location of use. As another example, the hub (106) and / or the device (5050) may determine the location of use by connecting to a remote server (113) and / or the cloud (104). After connecting to the remote server (113) and / or the cloud (104), the hub (106) and / or the device (5050) may access a region code generated by the manufacturer that specifies the location of use. As another example, the hub (106), the device (5050), and / or any other suitable component of the surgical system (100) may provide an interface that allows the user to select their region of use. As another example, the hub (106) and / or the device (5050) may be able to determine the location of use using their associated IP address. As another example, the hub (106) and / or the device (5050) may be able to determine the location of use using their software license.

[0070] After appropriately determining the usage location (5062), the appliance (5040), hub (106), and / or device (5050) can provide location information (5064) to an appropriate application or device used in determining and / or accessing an appropriate disposal method. The provided location information (5064) can be utilized by the disposal support device (5050), remote server (113), cloud (104), and / or hub (106). It should be understood that the provision of the location information (5064) can occur at any appropriate time during the determination procedure (5060), as will be apparent to those skilled in the art in view of the teachings herein. For example, providing the location information (5064) may occur simultaneously with other steps in the determination procedure (5060). The information may be provided automatically or in response to a specific action. For example, the device (5050) may scan the appliance (5040) or communicate with the appliance (5040) via the communication modules (5046, 5056).

[0071] During surgery as described herein, the instrument (5040) and / or the hub (106) may track whether any other product was used in combination with the instrument (5040). For example, the instrument (5040) and / or the hub (106) may track whether there is any drug, regulated substance, adjuvant, or any other suitable medical product, as would be apparent to one of ordinary skill in the art considering the teachings herein. The use of such medical products may affect the criteria and / or guidelines for the disposal method used to process the instrument (5040) after an exemplary use. Thus, one step (5066) in the determination procedure (5060) may include providing information regarding the various related medical products used in combination with the instrument (5040). The instrument (5040), the hub (106), and / or the device (5050) can then provide such medical product information (5066) to an appropriate application or device used to determine and / or access the appropriate disposal method. For example, the provided medical product information (5066) can be utilized by a disposal support device (5050), a remote server (113), the cloud (104), and / or the hub (106). The information may be provided automatically or in response to a particular action. For example, the device (5050) may scan the instrument (5040) or communicate with the instrument (5040) via communication modules (5046, 5056).

[0072] In the current example, location information (5064) and related medical product information (5066) are provided to assist in determining the criteria and / or guidelines for the disposal method. However, in some cases, only the location information (5064) or only the medical product information (5066) can be used to assist in determining the criteria and / or guidelines for the disposal method. Additionally, any other suitable information may be provided similarly, in combination with other parameters or alone. For example, performance data accumulated during the use of the surgical instrument (5040) accessed (5070) and uploaded (5072) in accordance with the description herein can be provided to an appropriate application or device used to determine and / or access the appropriate disposal method.

[0073] The hub (106) and / or the disposal support device (5050) can access a selective look-up table (5068) including various local disposal methods. Using the provided appropriate information (5064, 5066, 5070, 5072), the hub (106) and / or the disposal support device (5050) selects an appropriate local disposal method from the various methods provided on the selective look-up table. Various criteria and / or guidelines for the local disposal method can be stored in any appropriate device as will be apparent to those skilled in the art in view of the teachings herein. For example, the look-up table may be stored in the cloud (104), a remote server (113), the hub (106), the disposal support device (5050), etc. Access to the selective look-up table (5068) may be performed automatically or in response to a specific operation. For example, the device (5050) may scan the instrument (5040) or communicate with the instrument (5040) via the communication modules (5046, 5056).

[0074] As described above, the instrument (5040) may store performance data on the memory (5042). In some examples, also as described above, when the instrument (5040) is scanned by the disposal support device (5050) or communication between the instrument (5040) and the device (5050) is established via the communication modules (5046, 5056), such information can be accessed (5070) and uploaded to the cloud (104) (5072). The cloud (104) can store the uploaded performance data for various purposes. In some cases, uploading performance data to the cloud (104) via communication between the instrument (5040) and the device (5050) may be beneficial when the hub (106) is not utilized during a surgical procedure.

[0075] When appropriate criteria and / or guidelines for the local disposal method are accessed, the determination procedure (5060) can then display (5074) the local disposal procedure to the staff responsible for performing the disposal method. The disposal procedure can include displaying the time-series instructions of the disposal method. Such instructions can include how to disassemble the appliance (5040), which components of the appliance (5040) are reusable, which components of the appliance (5040) are disposable, how to properly prepare such components for disposal or reuse, how to properly store such components for disposal or reuse, etc., and such display (5074) may be shown on a suitable component of the device (5050) or the hub (106). The display (5074) can enable the user to scroll through the time-series instructions of the disposal method and indicate when each instruction has been completed.

[0076] While the staff executes the disposal method according to the displayed criteria and / or the displayed guidelines, the hub (106) and / or the device (5050) can notify the sterilization team that a device (5078) expected to be transported to the sterilization team is incoming, in light of the displayed disposal method. It should be understood that such notification (5078) can be omitted if the sterilization staff is using the determination procedure (5060).

[0077] IV. Exemplary Generator Storage Bin with Reusable Code and Sterilization Means In some cases, the surgical kit (5020) described above is accompanied by a power cord configured to electrically couple a surgical sub-component (5022) to the generator module (140), and the generator module (140) can supply power to the surgical sub-component (5022) during exemplary use as described herein. The cord may also be capable of communicating data between the surgical sub-component (5022) and the hub (106). In some cases, it may be desirable for at least a portion of the cord to be reusable with the generator module (140) rather than being associated with the surgical kit (5020). Thus, as will be apparent to those skilled in the art in view of the teachings herein, after the procedure, a portion of the cord associated with the generator module (140) may remain associated with the generator module (140), and a portion of the cord associated with the surgical kit (5020) may be classified as post-operative components (5032, 5034, 5036) for reuse or disposal.

[0078] Figures 9A - 9C show an exemplary power coupling assembly (5080) and a generator storage bin (5090) that can be easily incorporated into the surgical kit (5020) and the generator module (140). The power coupling assembly (5080) includes a short cord (5082) and a long cord (5086). The short cord (5082) can be associated with an instrument (5040) formed by the surgical kit (5020) such that the short cord (5082) is packaged with the surgical kit (5020). The short cord (5082) includes a coupling member (5084) configured to selectively establish communication with the long cord (5086) and the generator module (140) via a coupling member of the long cord (5088). When the short cord (5082) is coupled to the long cord (5086), the generator module (140) can actively supply power to the instrument (5040) in accordance with the description herein.

[0079] The long cord (5086) is attached to the generator module (140) and wound around and stored inside the generator storage bin (5090) of the generator module (140) via a coupling post (5094). The long cord (5086) remains associated with the generator module (140) and is configured to couple with the short cord (5082), so the long cord (5086) can reduce the amount of dispensed material from the surgical kit (5020). In some cases, there is no short cord (5082) such that the long cord (5086) is directly coupled to the instrument (5040). In some cases, the device includes a removable and reusable power cord having a connection joint positioned at the end of the handpiece. The connection can be severed using a physical unique key that may require multiple operations. Alternatively, this connection can be severed by an electronically actuated release mechanism initiated via the user or the generator module (140).

[0080] The storage bin (5090) may include a pop top having bins for cord storage and multi-tool storage. Instead of the post (5094), the storage bin (5090) may have a hook and the cord (5086) may be wound around the hook.

[0081] The storage bin (5090) includes UV light (5092). The UV light (5092) can be utilized to sterilize the long cord (5086) while the long cord (5086) is stored within the storage bin (5090) after exemplary use. FIGS. 9A-9C show exemplary couplings of the cords (5082, 5086). First, as shown in FIG. 9A, the long cord (5086) and the coupling member (5088) are within the storage bin (5090). Next, the coupling member (5088) may be removed from the storage bin (5090) as shown in FIG. 9B. Finally, the coupling members (5084, 5088) may be coupled to the power instrument (5040) as shown in FIG. 9C.

[0082] V. Exemplary Combinations The following examples relate to various non-exhaustive ways in which the teachings of this specification can be combined or applied. It should be understood that the following examples are not intended to limit any claims that may be presented at any time in this application or in a subsequent application of this application. It is not intended that any waiver of rights occur. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this specification can be configured and applied in many other ways. Also, in some variations, it is contemplated that certain features referred to in the following examples may be omitted. Accordingly, none of the aspects or features referred to below should be considered important unless so explicitly indicated later by the inventors or their successors in right. If the claims presented in this application or in a subsequent application related to this application include additional features other than those referred to below, those additional features should not be considered to have been added for any reason related to patentability.

Example

[0083] A method for determining a disposal method of a surgical kit, comprising: (a) determining a geographical location where the surgical kit is being used; (b) generating a location dataset based on the geographical location where the surgical kit is being used; (c) providing the location dataset to a resource device; (d) receiving a disposal method from the resource device based on the location dataset; and (e) displaying a set of instructions based on the disposal method received from the resource device.

Example

[0084] The method according to Example 1, wherein the resource device includes a cloud storage system.

Example

[0085] The method according to any one of Example 1 or 2, wherein the cloud storage system includes a plurality of disposal methods each targeting a different geographical location.

Example

[0086] The method according to any one or more of Examples 1 to 3, further comprising determining a list of medical products to be used in conjunction with a surgical kit.

Example

[0087] The method according to any one or more of Examples 1 to 4, further comprising generating a medical product dataset based on a list of medical products to be used in conjunction with a surgical kit.

Example

[0088] The method according to any one or more of Examples 1 to 5, further comprising providing the medical product dataset to a resource device.

Example

[0089] The method according to any one or more of Examples 1 to 6, further comprising receiving a disposal method from the resource device based on the medical product dataset.

Example

[0090] The method according to any one or more of Examples 1 to 7, further comprising displaying a set of instructions on a disposal support device.

Example

[0091] The method according to any one or more of Examples 1 to 8, further comprising displaying a set of instructions on a display screen of a surgical hub configured to be used in conjunction with a surgical kit.

Example

[0092] The method according to any one or more of Examples 1 to 9, wherein determining a geographical location further comprises using a serial code on the surgical kit.

Example

[0093] The method according to any one or more of Examples 1 to 10, wherein determining the geographical location further includes reading pre-programmed code on the generator module.

Example

[0094] The method according to any one or more of Examples 1 to 11, wherein determining the geographical location further includes receiving usage input.

Example

[0095] The method according to any one or more of Examples 1 to 12, wherein determining the geographical location further includes utilizing a network address.

Example

[0096] The surgical kit includes a handheld device, according to any one or more of Examples 1 to 13.

Example

[0097] The surgical kit includes a battery, according to any one or more of Examples 1 to 14.

Example

[0098] The surgical kit includes an ultrasonic transducer, according to any one or more of Examples 1 to 15.

Example

[0099] The surgical kit includes a power cord, according to any one or more of Examples 1 to 16.

Example

[0100] A method for determining a disposal method of a surgical kit, the method comprising: (a) identifying a geographical location of use of the surgical kit; (b) providing the geographical location of use to a resource device that stores a plurality of disposal method bases; (c) receiving a specific disposal method from the resource device based at least in part on the geographical location provided to the resource device; and (d) displaying a set of instructions based on the specific disposal method received from the resource device.

Example

[0101] The method according to any one or more of Examples 1 to 18, wherein the set of instructions is arranged in chronological order.

Example

[0102] A surgical system comprising: (a) a generator; (b) a surgical kit configured to be assembled into a surgical instrument, the surgical instrument being configured to be disassembled into a first set of used components and a second set of used components; (c) an identification mechanism associated with any of the generators of the surgical kit; and (d) a disassembly assistance device configured to display a set of instructions on how to disassemble the surgical instrument into the first set of used components and the second set of used components, the set of instructions being dependent on data obtained from the identification mechanism.

Example

[0103] A method for determining a disposal method of a surgical kit, the method comprising: (a) identifying a geographical location of use of the surgical kit; (b) extracting a set of disposal instructions from a lookup table based on the identified geographical location of use of the surgical kit; and (c) displaying the disposal instructions.

[0104] VI. Others The variations of the above-described device can be applied not only to conventional medical treatments and surgeries performed by medical professionals, but also to robot-assisted medical treatments and robot-assisted surgeries.

[0105] It should be understood that any of the variations of the devices described herein may include, in addition to or instead of those described above, various other features. By way of example only, any of the devices described herein may further include one or more of the various features disclosed in any of the various references incorporated herein by reference. The teachings herein may be readily applied to any of the devices described in any of the other references cited herein, and thus it should also be understood that the teachings herein may be readily combined in many ways with the teachings of any of the references cited herein. Other types of devices into which the teachings herein may be incorporated will be apparent to those skilled in the art.

[0106] In addition to the above, the teachings herein can be readily combined with the teachings of the U.S. patent application entitled "Method of Reclaiming Portions of Surgical Instruments for Remanufacturing and Sustainability" [Attorney Docket No. END9447USNP1.0754992], filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9447USNP1.0754992] will be apparent to those skilled in the art in view of the teachings herein.

[0107] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP1.0754994], entitled "Surgical Instrument with Predetermined Separation Features for Waste Stream Utilization and Related Methods," filed on the same day as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP1.0754994] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0108] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP2.0754977], entitled "Surgical Instrument with Removable Cable and Associated Couplings," filed on the same day as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP2.0754977] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0109] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application [Docket No. END9448USNP3.0754979], entitled "Surgical System and Methods of Assembly and Disassembly of Surgical Instrument," filed on the same day as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP3.0754979] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0110] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. Patent Application entitled "Robotic Surgical System with Removable Portion and Method of Disassembling Same" [Attorney Docket No. END9449USNP1.0754981] filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9449USNP1.0754981] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0111] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. Patent Application entitled "Reclamation Packaging for Surgical Instrument and Related Methods" [Attorney Docket No. END9450USNP2.0754999] filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9450USNP2.0754999] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0112] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9450USNP3.0755001] entitled "Surgical Instrument with Various Alignment Features and Methods for Improved Disassembly and Assembly" filed on the same day as this specification. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9450USNP3.0755001] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0113] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "Surgical System and Methods for Instrument Assessment and Cleaning" [Attorney Docket No. END9450USNP4.0755006] filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9450USNP4.0755006] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0114] It should also be understood that any range of values referred to herein is to be read as including the upper and lower limits of such range. For example, a range expressed as "about 1.0 inch to about 1.5 inches" is to be read as including about 1.0 inch and about 1.5 inches in addition to the values between those upper and lower limits.

[0115] It should be understood that all or part of any patent, publication, or other disclosure referred to herein as being incorporated by reference is incorporated herein only to the extent that the incorporated content does not conflict with the existing definitions, opinions, or other disclosure set forth in this disclosure. In itself and to the extent necessary, the disclosure expressly set forth in this specification shall supersede any conflicting description incorporated herein by reference. Any content, or portion thereof, that is referred to as being incorporated by reference but conflicts with the current definitions, opinions, or other disclosure set forth in this specification shall be incorporated only to the extent that there is no conflict between the incorporated content and the current disclosure.

[0116] The above-described variants may be designed to be discarded after single use, or they may be designed for multiple uses. In either or both cases, the variants may be reconditioned for reuse after at least one use. Reconditioning may include any combination of a device disassembly process, followed by a cleaning or replacement process of specific parts, and subsequent reassembly. Specifically, some variants of the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. During the cleaning and / or replacement of specific parts, some variants of the device may be reassembled for subsequent use either in a reconditioning facility or by an operator immediately prior to the procedure. One skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized in the reconditioning of the device. The use of such techniques and the resulting reconditioned device are all within the scope of this application.

[0117] Merely by way of example, the variants described herein may be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a sealed container such as a plastic or TYVEK bag and the container is sealed. Next, the container and device may be placed in a radiation field such as gamma rays, X-rays, or high-energy electron beams that can penetrate the container. The radiation can kill bacteria on the device and within the container. Next, the sterilized device may be stored within the sterilized container for later use. The device may also be sterilized using any other technique well known in the art, including but not limited to beta or gamma rays, ethylene oxide, or steam.

[0118] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by those skilled in the art with appropriate modifications without departing from the scope of the present invention. Some of such possible modifications have been described, but other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, ratios, processes, etc. discussed above are illustrative and not essential. Therefore, the scope of the present invention should be considered with respect to the following claims, and it is understood that it is not limited to the details of the structures and operations shown and described in this specification and the drawings.

[0119] 〔Embodiment〕 (1) A method for determining a disposal method of a surgical kit, comprising: (a) determining the geographical location where the surgical kit is being used; (b) generating a location dataset based on the geographical location where the surgical kit is being used; (c) providing the location dataset to a resource device; (d) receiving the disposal method from the resource device based on the location dataset; (e) displaying a set of instructions based on the disposal method received from the resource device. (2) The method according to embodiment 1, wherein the resource device includes a cloud storage system. (3) The method according to embodiment 2, wherein the cloud storage system includes a plurality of disposal methods each targeting a different geographical location. (4) The method according to any one of embodiments 1 to 3, further comprising determining a list of medical products used in conjunction with the surgical kit. (5) The method according to embodiment 4, further comprising generating a medical product dataset based on the list of medical products used in conjunction with the surgical kit.

[0120] (6) The method of embodiment 5, further comprising providing the medical product dataset to the resource device. (7) The method of embodiment 6, further comprising receiving the disposition method from the resource device based on the medical product dataset. (8) A method according to any one of claims 1 to 7, further comprising displaying the set of instructions on a disposal assistance device. (9) The method of any one of claims 1 to 8, further comprising displaying the set of instructions on a display screen of a surgical hub configured for use in conjunction with the surgical kit. (10) The method of any one of claims 1 to 9, wherein determining the geographic location further comprises using a serial code on the surgical kit.

[0121] (11) A method according to any one of claims 1 to 10, wherein determining the geographic location further comprises reading a pre-programmed code on a generator module. (12) A method according to any one of the preceding claims, wherein determining the geographic location further comprises receiving a usage input. (13) The method of any one of embodiments 1 to 12, wherein determining the geographic location further comprises using a network address. (14) The method of any one of embodiments 1 to 13, wherein the surgical kit comprises a handheld device. (15) The method of any one of claims 1 to 14, wherein the surgical kit includes a battery.

[0122] (16) The method of any one of claims 1 to 15, wherein the surgical kit includes an ultrasound transducer. (17) The method of any one of claims 1 to 16, wherein the surgical kit includes a power cord. (18) A method for determining how to dispose of a surgical kit, comprising: (a) identifying a geographic location of use of said surgical kit; (b) providing the geographical location to a resource device that stores a plurality of disposal method bases; (c) receiving, from the resource device, a specific disposal method based at least in part on the geographical location provided to the resource device; (d) displaying a set of instructions based on the specific disposal method received from the resource device. A method comprising: (19) The method according to embodiment 18, wherein the set of instructions is arranged in chronological order. (20) A surgical system, comprising: (a) a generator; (b) a surgical kit configured to be assembled into a surgical instrument, the surgical instrument being configured to be disassembled into a first set of used components and a second set of used components; (c) an identification mechanism associated with any of the generators of the surgical kit; (d) a disassembly assistance device configured to display a set of instructions regarding a method of disassembling the surgical instrument into the first set of used components and the second set of used components, the set of instructions being dependent on data obtained from the identification mechanism. A surgical system comprising:

Claims

1. A method for determining a disposal method for a surgical kit, comprising: (a) determining the geographical location where the surgical kit is used; (b) generating a location dataset based on the geographical location where the surgical kit is used; (c) providing the location dataset to a resource device; (d) receiving the disposal method from the resource device based on the location dataset; and (e) displaying a set of instructions based on the disposal method received from the resource device.

2. The method according to claim 1, wherein the resource device includes a cloud storage system.

3. The method according to claim 2, wherein the cloud storage system includes a plurality of disposal methods each targeting a different geographical location.

4. The method according to any one of claims 1 to 3, further comprising determining a list of medical products used in conjunction with the surgical kit.

5. The method according to claim 4, further comprising generating a medical product dataset based on the list of medical products used in conjunction with the surgical kit.

6. The method according to claim 5, further comprising providing the medical product dataset to the resource device.

7. The method according to claim 6, further comprising receiving the disposal method from the resource device based on the medical product dataset.

8. The method according to claim 1, further comprising displaying the set of instructions on a disposal support device.

9. The method according to claim 1, further comprising displaying the set of instructions on a display screen of a surgical hub configured to be used in conjunction with the surgical kit.

10. The method according to claim 1, wherein determining the geographical location further comprises using a serial code on the surgical kit.

11. The method according to claim 1, wherein determining the geographical location further comprises reading a pre-programmed code on a generator module.

12. The method according to claim 1, wherein determining the geographical location further comprises receiving a usage input.

13. The method according to claim 1, wherein determining the geographical location further comprises utilizing a network address.

14. The method according to claim 1, wherein the surgical kit includes a hand-held device.

15. The method according to claim 1, wherein the surgical kit includes a battery.

16. The method according to claim 1, wherein the surgical kit includes an ultrasonic transducer.

17. The method according to claim 1, wherein the surgical kit includes a power cord.

18. A method for determining a method of disposing of a surgical kit, comprising: (a) identifying a geographical location of use of the surgical kit; (b) providing the geographical location of use to a resource device that stores a plurality of disposal method bases; (c) receiving a specific disposal method from the resource device based at least in part on the geographical location provided to the resource device; (d) displaying a set of instructions based on the specific disposal method received from the resource device.

19. The method according to claim 18, wherein the set of instructions is arranged in chronological order.

20. A surgical system, comprising: (a) a generator; (b) a surgical kit configured to be assembled into a surgical instrument, the surgical instrument being configured to be disassembled into a first set of used components and a second set of used components; (c) an identification mechanism associated with either the generator or the surgical kit; (d) a disassembly assistance device configured to display a set of instructions regarding a method of disassembling the surgical instrument into the first set of used components and the second set of used components, the set of instructions being dependent on data obtained from the identification mechanism.