Systems and related methods for determining treatment of surgical instruments

Abstract

A method of determining a treatment policy for a surgical kit includes determining a geographic location at which the surgical kit is being used, generating location data based on the geographic location, and providing the location data set to a resource device. The method also includes receiving the handling policy from the resource device based on the location data set, and then displaying a set of instructions based on the handling policy received from the resource device.

Description

Background Art

[0001] Many 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 in tissue cells). These instruments include one or more piezoelectric elements that convert electrical power into ultrasonic vibrations that are transmitted along an acoustic waveguide to the blade element. Examples of ultrasonic surgical instruments and related concepts are disclosed in the following documents: U.S. Publication No. 2006 / 0079874, entitled “TissuePad for Use with an Ultrasonic Surgical Instrument,” published on April 13, 2006 (now abandoned), the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2007 / 0191713, entitled “Ultrasonic Device for Cutting and Coagulating,” published on August 16, 2007 (now abandoned), the disclosure of which is incorporated herein by reference in its entirety; and U.S. Publication No. 2008 / 0200940, entitled “Ultrasonic Device for Cutting and Coagulating,” published on August 21, 2008 (now abandoned), the disclosure of which is incorporated herein by reference in its entirety.

[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 the following documents: U.S. Patent No. 7,354,440, entitled "Electrosurgical Instrument and Method of Use," issued on April 8, 2008, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 7,381,209, entitled "Electrosurgical Instrument," issued on June 3, 2008, the disclosure of which is incorporated herein by reference in its entirety.

[0003] Some instruments are capable of applying both ultrasonic energy and RF electrosurgical energy to tissue. Examples of such instruments are described in the following documents: 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. 10,835,307, entitled “Modular Battery Powered Handheld Surgical Instrument Containing Elongated Multi-Layered Shaft”, issued on January 25, 2022, the disclosure of which is incorporated herein by reference in its entirety. No. 11,229,471 for "Tissue Characterization", the disclosure of which is incorporated herein by reference in its entirety.

[0004] In some scenarios, it may be preferred to have the surgical instrument directly grasped and manipulated by one or more hands of one or more human operators.In addition or as an alternative, it may be preferred to have the surgical instrument controlled via a robotic surgical system. Examples of robotic surgical systems and associated instruments are disclosed in the following documents: U.S. Patent No. 10,624,709, entitled “Robotic Surgical Tool with Manual Release Lever,” issued on 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 on 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 on September 8, 2015, 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 on September 2, 2014, the disclosure of which is incorporated herein by reference in its entirety; No. 8,820,605, entitled “Ultrasonic Surgical Instruments”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2019 / 0201077, entitled “Interruption of Energy Due to Inadvertent Capacitive Coupling”, published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2012 / 0292367, entitled “Robotically-Controlled End Effector”, published on November 11, 2012 (now abandoned), 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 on the same date as this application, the disclosure of which is incorporated herein by reference in its entirety.

[0005] These instruments and robotic surgical systems may also be incorporated into surgical systems for performing surgery in a surgical environment, such as a surgical operating room or room in a healthcare facility. A sterile field is typically formed around the patient and may include appropriately dressed, scrubbed medical professionals and desired furniture and / or fixtures. Examples of these surgical systems and associated features are disclosed in the following: U.S. Patent Publication No. 2019 / 0201046, entitled “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 Publication No. 2019 / 0201080, entitled “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 Publication No. 2019 / 0201091, entitled “Radio Frequency Energy Device for Delivering Combined Electrical Signals,” published on September 12, 2019, the disclosure of which is incorporated herein by reference in its entirety; Device”, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent Publication No. 2019 / 0207857, published on July 4, 2019, entitled “Surgical Network Determination of Prioritization of Communication, Interaction, or Processing Based on System or Device Needs”, the disclosure of which is incorporated herein by reference in its entirety.

[0006] While 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] While this specification results in claims that particularly point out and distinctly claim such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate the same elements, and wherein:

[0008] Figure 1 depicts a block diagram of an exemplary computer-implemented interactive surgical system;

[0009] Figure 2 A top schematic diagram depicting an example of a surgical system for performing a surgical procedure in an operating room of a health care facility;

[0010] Figure 3 Depicted Figure 2 A schematic side view of an example of a surgical hub for a surgical system;

[0011] Figure 4 Describes the Figure 2 A perspective view of a combined generator module of bipolar, ultrasonic and monopolar contacts of a surgical system;

[0012] Figure 5 Describes the use of Figure 2 Schematic side views of various examples of exemplary generators and surgical instruments for use with surgical systems;

[0013] Fig. 6A depicts a schematic diagram of an operating room with the surgical suite located within the nonsterile entry room;

[0014] Figure 6B Depicted Fig. 6A Schematic diagram of an operating room in which a surgical kit is transported into the sterile area of ​​the operating room;

[0015] Figure 6C Depicted Fig. 6A Schematic diagram of an operating room of the type shown in FIG. 1 , wherein a surgical suite is divided into assembled surgical subcomponents, non-surgical subcomponents, and a plurality of disposal bags;

[0016] Fig.6D Depicted Fig. 6A Schematic diagram of an operating room with surgical and non-surgical subcomponents broken down into organizationally classified postoperative components;

[0017] Fig. 6E Depicted Fig. 6A Schematic diagram of an operating room where postoperative components are organized and placed Fig. 6A in the corresponding disposal bag of the surgical kit;

[0018] Fig. 6F Depicted Fig. 6ASchematic diagram of an operating room in which postoperative components and disposal bags are transported to a non-sterile exit room;

[0019] Figure 7 depicts a schematic diagram of an exemplary surgical instrument and a computing device;

[0020] Figure 8 A flow chart depicting a method for determining a disposition instruction for a powered surgical instrument most recently used in a surgical procedure;

[0021] Fig.9A depicts a schematic diagram of a generator having a longer power cord and a surgical instrument having a shorter power cord, wherein the longer power cord is contained within a storage case of the generator;

[0022] Fig. 9B Depicted Fig.9A A schematic diagram of a generator and a surgical instrument, wherein a longer power cord extends away from a storage box of the generator; and

[0023] Fig. 9C Depicted Fig.9A Schematic diagram of a generator and surgical instrument, wherein a longer power cord and a shorter power cord are connected together.

[0024] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present technology may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the present technology and, together with the description, explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0025] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments and advantages of the present technology will become apparent to those skilled in the art from the following description, which is by way of example, one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0026] It should also be understood that any one or more of the teachings, expressions, implementations, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, implementations, examples, etc. described herein. Therefore, the following teachings, expressions, implementations, examples, etc. should not be considered isolated from each other. According to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0027] For clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to a location of an element that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of a surgical instrument. The term "distal" refers to a location of an element that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of a surgical instrument. In addition, the terms "upper," "lower," "top," "bottom," "above," and "below" are used relative to the embodiments and associated drawings, and are not intended to unnecessarily limit the invention described herein.

[0028] I. Examples of Surgical Systems

[0029] for Figure 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) of this example includes at least one surgical hub (106) in communication with the cloud (104), which may include the remote server (113). In one example, as Figure 1 As shown in , 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 a hub (106). In some aspects, 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, any suitable combination of the features provided below may be incorporated into an exemplary surgical system such as surgical system (100) and used in an operating room to perform a desired surgical procedure, as will be apparent to those skilled in the art based on the teachings herein.

[0030] Figure 2An example of a surgical system (102) for performing a surgical procedure on a patient lying flat on an operating table (114) in a surgical operating room (116) is depicted. A robotic system (110) is used as part of the surgical system (102) during a surgical procedure. 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 observes the surgical site through the console (118), the patient side cart (120) can manipulate at least one removably coupled surgical tool (117) through a minimally invasive incision in the patient's body using any of a plurality of surgical arms (123). An image of the surgical site can be obtained through a medical imaging device (124), which can be manipulated by the patient side cart (120) to orient the imaging device (124). The robotic hub (122) can be used to process the image of the surgical site for subsequent display to the surgeon through the console (118).

[0031] Other types of robotic systems may 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 Serial No. 62 / 611,339, entitled “RobotAssisted Surgical Platform,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0032] Various examples of cloud-based analytics performed by the cloud (104) and suitable for use with the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled “Cloud-Based Medical Analytics,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0033] 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 surgery. Examples of imaging devices suitable for the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroendoscopes. Some aspects of spectral and multispectral imaging are described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “Interactive Surgical Platform,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0034] During any surgical operation, operating room and surgical equipment need to be strictly sterilized. The strict sanitation and sterilization conditions required in "surgical room" (i.e., operating room or treatment room) require the highest possible sterility of all medical devices and equipment. A part of this sterilization process is the need to sterilize anything that contacts the patient or penetrates the sterile field. It should be understood that the sterile field can be considered to be a designated area that is considered to be free of microorganisms, such as in a tray or in a sterile towel, or the sterile field can be considered to be the area around the patient prepared for surgical operation. The sterile field can include the team members who are scrubbed and appropriately dressed, as well as all equipment and fixtures in the area.

[0035] In addition to introducing any features of the surgical system (100), furniture, or fixtures into the sterile field that requires sterilization, removing these features from the sterile field may cause additional difficulties, particularly when these features may have contacted or are presumed to have contacted the patient, including any tissue and / or fluid associated with the surgical procedure. Such contamination of these features from the patient generally requires special consideration during or after the surgical procedure, particularly when handling these features for disposal, reuse, or remanufacturing as needed. In one example, the surgical system (100) and / or the health care professionals associated with the surgical procedure may be prepared to address such handling, as discussed in more detail below.

[0036] like Figure 2As shown in , a main display (119) is positioned in the sterile field to be visible to an operator at an 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) that are separated from each other. A visualization system (108) guided by a hub (106) is configured to be able to coordinate information flow to operators inside and outside the sterile field using displays (107, 109, 119). For example, the hub (106) can enable the visualization system (108) to display a snapshot of a surgical site recorded by an imaging device (124) on a non-sterile display (107) or (109) while maintaining a real-time feed of the surgical site on the main display (119). For example, a snapshot on a non-sterile display (107) or display (109) can allow a non-sterile operator to perform diagnostic steps related to a surgical procedure.

[0037] In one aspect, the hub (106) is also configured to be able to route diagnostic input or feedback entered by a non-sterile operator at the visualization tower (111) to a primary display (119) within the sterile field, where the diagnostic input or feedback can be viewed by a sterile operator at the operating table. In one example, the input can be a modified form of a snapshot displayed on a non-sterile display (107) or display (109), which can be routed to the primary display (119) via the hub (106).

[0038] refer to Figure 2 , the surgical instrument (112) is used in a surgical procedure as part of the surgical system (102). The hub (106) can also coordinate information flowing to a display of the surgical instrument (112), such as described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "Interactive Surgical Platform," filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower (111) can be routed by the hub (106) to a surgical instrument display (115) within the sterile field, where the operator of the surgical instrument (112) can view the diagnostic input or feedback. Exemplary surgical instruments suitable for use with surgical system (102) are described, for example, under the title “Surgical Instrument Hardware” in U.S. provisional patent application serial number 62 / 611,341, entitled “Interactive Surgical Platform,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0039] Reference now Figure 3, the hub (106) is depicted as communicating with a visualization system (108), a robotic system (110), and a handheld intelligent surgical instrument (112). The hub (106) includes a hub display (135), an imaging module (138), a generator module (140), a communication module (130), a processor module (132), and a storage array (134). In certain aspects, as Figure 3 As shown, the hub (106) also includes a smoke evacuation module (126), a suction / irrigation module (128) and / or an operating room mapping module (133).

[0040] During surgery, energy application to tissue for sealing and / or cutting is often associated with smoke evacuation, suction of excess fluid, and / or flushing of tissue. Fluid lines, power lines, and / or data lines from different sources often become tangled during surgery. Solving this problem during surgery can waste valuable time. Disconnecting a line may require disconnecting the line from its corresponding module, which may require resetting the module. The hub modular housing (136) provides a unified environment for managing power lines, data lines, and fluid lines, which reduces the frequency of tangles between such lines.

[0041] See also Figure 3 to Figure 4 , aspects of the present disclosure are presented as a hub modular housing (136) that allows modular integration of generator modules (140), smoke exhaust modules (126), and suction / irrigation modules (128). The hub modular housing (136) also facilitates interactive communication between the modules (140, 126, 128). Figure 4 As shown in , the generator module (140) may be a generator module having integrated monopolar components, bipolar components, and ultrasonic components supported in a single housing unit (139) that is slidably inserted into the hub modular housing (136). Figure 4 As shown in , the generator module (140) can be configured to be connected to a monopolar device (146), a bipolar device (147), and an ultrasonic device (148). Alternatively, the generator module (140) can include a series of monopolar generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact through the hub modular housing (136). The hub modular housing (136) can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular housing (136) so that the generators will act as a single generator.

[0042] Figure 5One form of a generator (150) and various surgical instruments (152, 154, 156) that can be used therewith is shown, wherein 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 a combined ultrasonic / RF electrosurgical instrument (156). The generator (150) may be configurable for use with a variety of surgical instruments. According to various forms, the generator (150) may be configurable for use with different 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 delivered simultaneously from the generator (150). Although Figure 5 The generator 150 of the present example is shown as being separate from the surgical instruments (152, 154, 156), but the generator (150) may alternatively be integrally formed with any of the surgical instruments (152, 154, 156) to form an integrated surgical system. The generator (150) includes an input device (158) located on a front panel of the generator (150) console. The input device (158) may include any suitable device that generates signals suitable for programming the operation of the generator (150). The generator (150) may be configured for wired or wireless communication.

[0043] The generator (150) of this example is configured to be able to drive multiple surgical instruments (152, 154, 156). One example of these surgical instruments is an ultrasonic surgical instrument (152), and includes a handpiece (160), an ultrasonic transducer (162), an axis assembly (164), and an end effector (166). The end effector (166) includes an ultrasonic blade (168) and a clamping arm (170) acoustically coupled to the ultrasonic transducer (162). The handpiece (160) includes a trigger (172) for operating the clamping arm (170) and a combination of toggle buttons (173, 174, 175) for energizing the ultrasonic blade (168) and driving the ultrasonic blade or other functions. The toggle buttons (173, 174, 175) can be configured to be able to energize the ultrasonic transducer (162) with the generator (150).

[0044] 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 located in clamping arms (181, 182) and returned through an electrical conductor portion of the shaft assembly (178). The electrodes are coupled to and powered by a bipolar energy source within the generator (150). The handpiece (176) includes a trigger (183) for operating the clamping arms (181, 182) and an energy button (184) for actuating an energy switch to power the electrodes in the end effector (180).

[0045] The generator (150) is also configured to be capable of driving a multifunctional surgical instrument (156). The multifunctional surgical instrument (156) includes a handpiece (185), an axis assembly (186), and an end effector (188). The end effector (188) has an ultrasonic blade (190) and a clamping arm (192). The ultrasonic blade (190) is acoustically coupled to the ultrasonic transducer (162). The handpiece (185) includes a trigger (194) for operating the clamping arm (192) and a combination of switching buttons (195, 196, 197) for powering the ultrasonic blade (190) and driving the ultrasonic blade or other functions. The switching buttons (195, 196, 197) can be configured to be capable of powering the ultrasonic transducer (162) with the generator (150) and powering the ultrasonic blade (190) with a bipolar energy source also contained in the generator (150). It should be understood that handpieces (160, 176, 185) may be replaced with robotically controlled instruments for incorporating one or more aspects of surgical instruments (152, 154, 156). Thus, the term "handpiece" should not be limited to this context and handheld use.

[0046] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through a non-solid medium using modulated electromagnetic radiation. The term does not mean that the associated devices do not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and its Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0047] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually a memory or some other data stream). The term is used herein to refer to a central processing unit (Central Processing Unit) in a system or computer system (especially a System on a Chip (SoC)) that combines multiple specialized "processors".

[0048] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It may include digital, analog, mixed signal, and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), a Wi-Fi module, or a coprocessor. A SoC may or may not include built-in memory.

[0049] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; an SoC may include a microcontroller as one of its components. A microcontroller may include one or more core processing units (CPUs) as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, as well as a small amount of RAM, is also often included on the chip. Compared to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used for embedded applications.

[0050] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between two components of a computer or a controller on an external device that manages the operation of (and connections to) the device. Modular devices include modules that can be received within a surgical hub (e.g., such as a combination of Figure 3 The invention relates to a surgical device or instrument that can be connected to various modules so as to be connected or paired with a corresponding surgical hub. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithm can be executed on the modular device itself, on a surgical hub paired with a specific modular device, 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 in, on, or connected to the modular device). The data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which the knife is advanced, the motor current, or the energy level). For example, the control algorithm of a surgical suturing and cutting instrument can control the rate at which the motor of the instrument drives its knife through the tissue according to the resistance encountered by the knife as it advances.

[0051] II. Exemplary Introduction, Assembly, Use, and Disposal of a Surgical Kit in a Surgical Operating Room

[0052] As described above, objects used to penetrate the sterile field of a surgical operating room during a surgical procedure need to be properly sterilized; and objects that leave the sterile field after a surgical procedure generally require special consideration when handling for disposal, reuse, or remanufacturing. In some cases, surgical instruments / tools (112, 117, 152, 154, 156) may need to be assembled to at least a certain degree in a surgical operating room prior to exemplary use as described herein; and then require a certain degree of disassembly after exemplary use so that selective components can be disposed of, reused, and / or remanufactured. For example, prior to exemplary use of the instrument (152), the ultrasonic scalpel (168) may need to be properly coupled to the ultrasonic transducer (162) and / or the shaft assembly (164) may need to be properly coupled to the handpiece (160) in the operating room. In addition, after exemplary use, the ultrasonic scalpel (168) may need to be disconnected from the ultrasonic transducer (162) for appropriate handling as described herein.

[0053] Thus, in some cases, surgical instruments / tools (112, 117, 152, 154, 156) may be introduced into a sterile field as a surgical kit, wherein the subcomponents require at least some degree of assembly prior to exemplary use. In addition to the subcomponents used to form the surgical instruments / tools (112, 117, 152, 154, 156), such surgical kits may also include the tools necessary for assembly, disassembly, and proper processing for disposal, reuse, or remanufacturing of the instruments / tools (112, 117, 152, 154, 156) and their subcomponents. 6A to 6F Exemplary introduction, assembly, use, disassembly, and disposal of surgical kit (5020) is shown.

[0054] Initially, as Fig. 6A As shown in , prior to a surgical procedure, a surgical kit (5020) can be contained within the sealed and sterile interior of a storage bag (5025). The storage bag (5025) can have a non-sterile exterior so that non-sterile personnel can grasp the exterior of the storage bag (5025) in order to transport the surgical kit (5020) to a non-sterile room (5012) to prepare for a surgical procedure, as will be apparent to one of skill in the art based on the teachings herein. Additionally, the sealed and sterile nature of the interior of the storage bag (5025) can help ensure that the surgical kit (5020) remains properly sterile while being transported within the storage bag (5025).

[0055] In preparation for a surgical procedure, the surgical kit (5020) may be transferred from the non-sterile entry room (5012) of the operating room (5000) to the sterile field (5006), such as Figure 6B As shown. The surgical kit (5020) can be transferred into the sterile area (5006) via an appropriate portal (5008), as will be apparent to those skilled in the art in light of the teachings herein. During such a transfer, a person within the non-sterile portal room (5012) can place the kit (5020) and bag (5025) into the portal (5008) and provide appropriate access to the interior of the bag while maintaining the sterile nature of the bag (5025). Next, sterile personnel within the sterile area (5006) can appropriately access the sterile interior of the storage bag (5025) and remove the surgical kit (5020) from the storage bag (5025) so that the kit (5020) is appropriately transferred into both the sterile room (5002) and the sterile area (5006), as shown. Figure 6B Thus, after being transferred from the non-sterile entry room (5012) into the operating room (5000), the kit (5020) may remain properly sterilized.

[0056] Sterile room (5002) can be substantially similar to surgical operating room (116) described above. Sterile room (5002) includes a surgical environment (5004), which can be substantially similar to operating table (114) described above. Additionally, sterile room (5002) also includes an assembly station (5005), which can include a sterile table and / or any other suitable structure, as will be apparent to those of skill in the art based on the teachings herein.

[0057] Go to Figure 6C Once the surgical kit (5020) is properly transferred into the sterile room (5002), the contents of the surgical kit (5020) can be accessed and placed on the assembly station (5005). In the current example, the surgical kit (5020) includes a surgical subcomponent (5022), a non-surgical subcomponent (5024), and a plurality of disposal bags (5026, 5028, 5030). The surgical subcomponents (5022) are intended to be assembled to form a surgical instrument substantially similar to the instruments / tools (112, 117, 152, 154, 156) described above. The non-surgical subcomponents (5024) may include portions of the surgical kit (5020) that are not intended to be used directly in a surgical procedure but are used for auxiliary purposes of a surgical procedure. For example, the non-surgical subcomponent (5024) may include tools for assembling and disassembling the surgical subcomponent (5022), a tray that can organize the other components (5022, 5024, 5026, 5028, 5030), or other features desired according to the exemplary uses described herein. As will be described in more detail below, the disposal bags (5026, 5028, 5030) are configured to store the corresponding post-operative components (5032, 5034, 5036) (see Fig.6D ) so that the post-operative components (5032, 5034, 5036) can be removed from the sterile chamber (5002) while being appropriately sealed to prevent exposure to the non-sterile environment (5012, 5014).

[0058] Likewise Figure 6CAs shown in , after being appropriately assembled (pre-assembled, manually assembled in a sterile room (5002), and / or utilizing tools from a non-surgical subcomponent (5024)), the surgical subcomponent (5022) can be used in a surgical environment (5004) to perform a suitable surgical procedure on a patient, as would be apparent to one of skill in the art based on the teachings herein. The surgical subcomponent (5022) can form any suitable instrument / tool ​​(112, 117, 152, 154, 156) described herein. Thus, the surgical subcomponent (5022) can be configured as a component of a computer-implemented interactive surgical system (100). For example, where the surgical subcomponent (5022) forms a removably coupled surgical tool (117) intended for use with a patient-side cart (120), the surgical subcomponent (5022) can be used in conjunction with a robotic system (110). As another example, where the surgical subcomponent (5022) forms a handheld intelligent surgical instrument (112), the surgical subcomponent (5022) may be manipulated by a surgeon and appropriately coupled to the hub (106) during exemplary use as described herein.

[0059] Go to Fig.6D , after proper use, surgical subcomponent (5022) may have been exposed to a patient, such that subcomponent (5022) requires special consideration. Thus, surgical subcomponent (5022) and non-surgical subcomponent (5024) may be disassembled and divided into post-operative components (5032, 5034, 5036). Any suitable manner of disassembling subcomponents (5022, 5024) may be utilized as would be apparent to one of skill in the art in light of the teachings herein. Post-operative components (5032, 5034, 5036) may be categorized based on the type of post-operative treatment contemplated for each category. For example, disassembled subcomponents (5022, 5024) that are expected to be reused or remanufactured may be classified into a first category of post-operative components (5032); when the disassembled subcomponents (5022, 5024) include electrical components that are expected to be disposed of, they may be classified into a second category of post-operative components (5034); and disassembled subcomponents (5022, 5024) that are expected to be disposed of but do not include electrical components may be classified into a third type of post-operative components (5036). Fig.6D At the moment shown in , certain disposable components may be further processed to prepare for proper disposal. For example, an internal power source (e.g., a battery) used as a surgical subcomponent (5022) may need to be fully discharged at this time.

[0060] Next, if Fig. 6EAs shown, while still in sterile room (5002), the sorted post-operative components (5032, 5034, 5036) can then be placed within respective disposal bags (5026, 5028, 5030). The disposal bags (5026, 5028, 5030) can then be sealed such that the post-operative components (5032, 5034, 5036) are isolated from the external environment outside the respective bags (5026, 5028, 5030). The disposal bags (5026, 5028, 5030) can utilize any suitable sealing means, as will be apparent to those of skill in the art in light of the teachings herein.

[0061] Next, if Fig.6D As shown, postoperative components (5032, 5034, 5036) and corresponding disposal bags (5026, 5028, 5030) can be transported from the chamber (5002) and the sterile area (5006) to the non-sterile chamber (5014) via the outlet (5010). Thus, the postoperative components (5032, 5034, 5036) can then be transported to a suitable location for disposal, reprocessing and / or remanufacturing while remaining sealed from the external environment. In the event that the components (5032, 5034, 5036) may have contacted the patient during the surgical procedure, these components (5032, 5034, 5036) will be prevented from being undesirably exposed to the non-sterile chamber (5012, 5014).

[0062] Although in the current example, non-sterile inlet chamber (5012) and non-sterile outlet chamber (5014) are used in combination with inlet (5008) and outlet (5010), this is merely optional. In some cases, surgical kit (5020) and postoperative components (5032, 5034, 5036) are transported from / to the same non-sterile room (5012, 5014) and utilize the same inlet and outlet (5008, 5010).

[0063] Although disposal bags (5026, 5028, 5030) are used in the current example, an appropriate disposal structure configured to properly support the corresponding components (5032, 5034, 5036) while isolating the components (5032, 5034, 5036) from the external environment during transportation may be used, as will be apparent to those skilled in the art based on the teachings herein.

[0064] III. Exemplary Apparatus and Methods for Determining and Extracting Disposal Instructions for Used Powered Surgical Instruments

[0065] As described above, after appropriate use of surgical subcomponents (5022), surgical subcomponents (5022) (e.g., portions of surgical kits (5020) used to form powered surgical instruments / tools (112, 117, 152, 154, 156)) may be broken down into post-operative components (5032, 5034, 5036) for disposal, reprocessing, and / or remanufacturing purposes. As an example, such post-operative components (5032, 5034, 5036) may be categorized into components (5032) intended for reuse / remanufacturing, electrical components (5034) intended for disposal, and non-electrical components (5036) intended for disposal.

[0066] In some cases, there may be various criteria for classifying which used surgical subcomponents (5022) may be reusable / manufacturable and which surgical subcomponents (5022) are disposable. Additionally, there may be various criteria for appropriately handling / disposing of such reusable, manufacturable, and disposable surgical subcomponents; whether within a sterile environment when the surgical subcomponents (5022) are initially disassembled, or outside of a sterile environment when the surgical subcomponents (5022) are appropriately reprocessed, remanufactured, and / or disposed of, as will be apparent to one skilled in the art based on the teachings herein. The criteria and / or recommended guidelines for classifying subcomponents (5022) as reusable or disposable may vary from jurisdiction to jurisdiction. Additionally, the reprocessing, remanufacturing, and / or disposal criteria and / or recommended guidelines may also vary from jurisdiction to jurisdiction. Such criteria / guidelines for classifying, reprocessing, remanufacturing, disposing of, etc., used surgical subcomponents (5022) may be referred to as a disposal strategy.

[0067] For example, in a first jurisdiction, an energized component (e.g., an electrode, a transducer, an ultrasonic scalpel, a battery, etc.) may be certified only for a first number of surgical uses (such as one surgical procedure); 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). For another example, in a first jurisdiction, an electrical component may need to be fully discharged before being transferred to a corresponding disposal bag (5026, 5028, 5030); while in a second jurisdiction, the same electrical component may not need to be fully discharged before being transferred to a corresponding disposal bag (5026, 5028, 5030).

[0068] Thus, it may be desirable to retrieve a set of disposal instructions for processing the components of surgical kit (5020) following an exemplary surgical procedure described herein. Furthermore, it may be desirable to retrieve a particular set of disposal instructions for surgical kit (5020) based on any number of suitable variables, as would be apparent to one of ordinary skill in the art in light of the teachings herein. For example, such variables may include, but are not limited to, the geographic location of the surgical procedure, the use of other surgical products in conjunction with surgical kit (5020), and / or performance data of surgical subcomponents (5022).

[0069] Figure 7 An exemplary surgical instrument (5040) and an exemplary treatment aid (5050) are shown, which may be used to Figure 8 It should be understood that although the exemplary surgical instrument (5040) and the treatment aid (5050) are used in the current example to perform the treatment instructions shown in the determination procedure (5060). Figure 8 The treatment instruction determination procedure (5060) is shown, however, any suitable surgical instrument may be used alone or in combination with any suitable treatment aid, as will be apparent to those skilled in the art in view of the teachings herein.

[0070] Surgical instrument (5040) may be assembled from surgical kit (5020) such that surgical instrument (5040) is substantially similar to surgical subcomponents (5022) described above. Thus, surgical instrument (5040) may be assembled within operating room (5000) prior to use in a surgical procedure and then disassembled and sorted into various post-operative components (5032, 5034, 5036). In some cases, such disassembly may occur within operating room (500) after use in a surgical procedure.

[0071] The surgical instrument (5040) may be substantially similar to any of the surgical instruments / tools described herein, including the surgical instruments / tools (112, 117, 152, 154, 156) described above. Thus, the surgical instrument (5040) is configured to be used in conjunction with the computer-implemented interactive surgical system (100) by coupling with appropriate components of the hub (106), such as the generator module (140), the communication module (130), the storage array (134), etc. In some cases, the surgical instrument (5040) may be handheld; however, in other cases, the surgical instrument (5040) may be configured to be appropriately coupled to the robotic system (110). In some cases, the surgical instrument (5040) may be used without being connected to the hub (1060), such that the surgical instrument (5040) includes its own power source, or such that the surgical instrument (5040) is coupled to a generator other than the generator associated with the hub (1060).

[0072] The surgical instrument (5040) includes a memory unit (5042) and a processing unit (5044); these two units can be used together as a control unit of the surgical instrument (5040). The memory unit (5042) is operable to store various information related to the performance of the surgical instrument (5040) during an exemplary surgical procedure described herein. The memory unit (5042) can also store data related to various components used to form the surgical instrument (5040). For example, the memory unit (5042) of the surgical instrument (5040) can store data related to what geographic location the instrument (5040) is sold and sent to. The memory unit (5042) can include data including a serial number that identifies the particular instrument (5040). The surgical instrument (5040) can include a QR code (5048). The QR code (5048) can include appropriate data required to identify the particular instrument (5040), as well as various appropriate information related to the particular instrument (5040), such as the geographic location where the instrument (5040) is sold and / or sent.

[0073] The apparatus (5040) further includes a communication module (5046) in communication with the processor (5044). The communication module (5046) is configured to establish communication with a corresponding communication module (5056) of the treatment aid (5050) so that data can be shared between the apparatus (5040) and the treatment aid (5050). The communication module (5046) can include any suitable communication means, as will be apparent to those skilled in the art based on the teachings herein. For example, the communication module (5046) is configured to communicate via Bluetooth technology, near field communication "NCF", radio frequency identification "RFID", etc.

[0074] The handling aid (5050) may take any suitable form, such as a smartphone, tablet computer, etc. The handling aid (5050) may be used within the sterile field (5006) during disassembly of the surgical subcomponent (5022), as described herein. Additionally or alternatively, the handling aid (5050) may be used outside of the sterile field (5006) during reprocessing, remanufacturing, and / or disposal of the surgical subcomponent (5022), as described herein.

[0075] The disposal aid (5050) includes a memory unit (5052) and a processing unit (5054); these two units can be used together as a control unit of the disposal aid (5050). The memory unit (5052) may include a suitable application (e.g., a software product) that includes download and upload capabilities that can be used to access the cleaning and sterilization protocols described herein. The disposal aid (5050) includes a corresponding communication module (5056) configured to be able to communicate with the above-mentioned communication module (5046). The communication module (5056) may include any suitable communication method, as will be apparent to those skilled in the art based on the teachings of this article. For example, the communication module (5056) is configured to be able to communicate via Bluetooth technology, near field communication "NCF", radio frequency identification "RFID", etc.

[0076] The treatment assisting device (5050) also includes a display (5055) in communication with the processing unit (5054). The processing unit (5054) may instruct the display (5055) to display appropriate information to the user, such as information provided by running a suitable application described herein. The display (5055) may take any suitable form, as will be apparent to those skilled in the art based on the teachings herein. For example, the display (5055) may be a touch screen. The treatment assisting device (5050) also includes a camera (5058) in communication with the processing unit (5054). The camera (5058) may be used to capture images and transmit the images to the processing unit (5054) so ​​that a suitable application can utilize the images according to the description herein. The camera (5058) may include any suitable components, as will be apparent to those skilled in the art based on the teachings herein.

[0077] In some cases, a treatment assistance device (5050) running an application may be configured to be connected to a hub (106) for use in conjunction with an instrument (5040) during a surgical procedure. Such an application may have limited permissions to the hub (106) such that a person utilizing the treatment assistance device (5050) and the corresponding application does not have access to any portion of the hub (106) other than relevant treatment instructions, cleaning, and / or sterilization information. Such a connection between the hub (106) and the application of the device (5050) may allow the device (5050) to communicate with interconnected hospital systems for operating room systems / inventory tracking, etc. Thus, once an instrument (5040) or other suitable instrument / component is used in a surgical procedure and scanned by the device (5050), the hub (106) may update the hospital system's inventory to identify the use of the instrument (5040) and / or other components. It should be understood that being "scanned" by device (5050) may include device (5050) utilizing camera (5056) to scan QR code (5048); establishing a connection between communication modules (5046, 5056); or any other suitable form of device (5050) obtaining data from instrument (5040), as would be apparent to one of ordinary skill in the art based on the teachings herein.

[0078] In the event that the handling aid (5050) is used within an operating room (5000), the application used by the handling aid (5050) may communicate with a sterilization team located outside of the operating room (5000). Thus, when the handling aid (5050) scans the instrument (5040) and / or various subcomponents of the instrument (5040) to obtain appropriate reprocessing / handling instructions as described herein, the application running on the device (5050) may inform the sterilization team that the appropriate portion of the instrument (5040) intended for sterilization is to be transported to the sterilization team.

[0079] Similarly, the application utilized by the treatment assistance device (5050) can communicate with the maintenance team to notify the maintenance team when the equipment is ready for service. Thus, when the treatment assistance device (5050) scans the instrument (5040) and / or the various subcomponents of the instrument (5040) to obtain appropriate reprocessing / treatment instructions as described herein, the application running on the device (5050) can notify the maintenance team that the appropriate portion of the instrument (5040) intended for maintenance is ready for service.

[0080] In the event that the treatment aid (5050) communicates with the hub (106), the treatment aid (5050) and the hub (106) may be configured to be able to identify any lost or missing devices, such as instruments (5040), used during the procedure. For example, the hub (106) may be configured to be able to track what instruments (5040) or other devices were used during the procedure. During the treatment process, the treatment aid (5050) may be used to scan or otherwise process the instruments (5040) used in the procedure. The communication between the device (5050) and the hub (106) may allow the treatment aid (5050) and / or the hub (106) to compare which instruments (5040) were used during the procedure and which instruments (5040) were scanned for appropriate reprocessing / disposal. This comparison allows the device (5050) and / or the hub (106) to ensure that all devices have been accounted for. In the case of using an intelligent treatment system, the treatment assistance device (5050) can confirm appropriate treatment via communication with the intelligent treatment system.

[0081] In some cases, an application running on the treatment assistance device (5050) may connect to a remote server (113) and / or 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 remote services (113) may coordinate with an appropriate application on the device (5050) to provide cleaning, sterilization, and / or treatment protocols and provide step-by-step instructions in accordance with the teachings herein. In examples where an application connects to a remote server (113) and / or cloud (104), such an application may automatically connect the treatment assistance device (5050) to an appropriate manufacturer call center for assistance.

[0082] In some cases, an application running on the device (5050) may utilize location information to determine the country and / or region in which the device (5050) is being used. For example, an application running on the device (5050) may have an application location service that determines the location of use by utilizing any suitable means, as will be apparent to one of skill in the art based on the teachings herein. In some cases, an application running on the device (5050) may request that the user enter a location of use when establishing an application account on the device (5050).

[0083] In some cases, the instrument (5040) may not be connected to the hub (106) during the surgical procedure, such that the hub (106) does not collect performance data of the surgical instrument (5040) during the exemplary use. As described above, the memory (5042) of the instrument (5040) is operable to store various information related to the performance of the surgical instrument (5040) during the exemplary surgical procedure described herein. For example, such information may include device motor data, sensor data, faults experienced by the instrument (5040) during use, error codes, etc. In some cases, the application running on the device (5050) may be configured to be able to extract the performance data stored on the memory (5042) of the instrument (5040) via the communication module (5046, 5056). The application running on the device (5050) may then be configured to be able to upload the extracted performance data to the hub (106), the cloud (104), the remote server (113), etc. Without the use of hub (106), performance data may be extracted using a gateway to device (5050). Such extraction and uploading of data may be invisible to an operator utilizing device (5050) and may occur automatically once device (5050) establishes communication with instrument (5040) via communication modules (5046, 5056).

[0084] Figure 8 A determination program (5060) is shown that is configured to allow an instrument (5040), a generator module (140), and / or a hub (106) to identify relevant factors used by the instrument (5040), and then access or determine an appropriate treatment strategy based on the identified relevant factors. The determination program (5060) can be used with any suitable device, as will be apparent to those skilled in the art based on the teachings herein. For example, the determination program (5060) can be used in conjunction with the above-mentioned instrument (5040) and / or treatment auxiliary device (5050). For another example, the determination program (5060) can be used in conjunction with the instrument (5040) and the hub (106). For another example, the determination program (5060) can be used in conjunction with the instrument (5040) hub (106) and the treatment auxiliary device (5050). Although the determination program (5060) is shown and described in a particular order of steps, it should be understood that some steps may be completely optional. However, it should be understood that the order in which the steps are performed can be in any suitable order, as would be apparent to one of ordinary skill in the art based on the teachings herein.

[0085] As described above, the criteria and / or guidelines of the treatment strategy may be deviated depending on the location where the instrument (5040) is being used. Thus, a step (5062) in the determination procedure (5060) may include determining the location of the operating room (5000) where the surgery is being performed. The location of the operating room (5000) may be determined using any suitable means or methods, as will be apparent to one of ordinary skill in the art based on the teachings herein. For example, an application running on the treatment aid (5050) may be configured to be able to determine the country and / or region in which the device (5050) is being used; this may then be used to infer the location of the operating room (5000).

[0086] As another example, the instrument (5040) and / or the generator module (140) may have a device code and / or serial number that contains or provides access to a designated location to which the instrument (5040) is to be shipped for intended use as described herein. Where the device code and / or serial number is associated with the instrument (5040), when the instrument (5040) is coupled to the generator module (140) / hub (106) / cloud (104), the generator module (140) / hub (106) / cloud (104) may read the device code provided by the instrument (5040) to determine the intended location of use. In some cases, the generator (140) may be pre-programmed by the manufacturer with the intended location to which the generator (140) is to be shipped; such as using a program EEPROM code. In such a case, the generator (140) may determine the location of use by referencing this pre-programmed information during exemplary use. Additionally, when the generator (140) is activated, the generator (140) may perform an initialization check to identify the location of use. Such location of use may be stored in the field service settings.

[0087] As another example, in addition to the device code and / or serial number, the generator module (140) and / or the instrument (5040) may include another identifier, such as an RFID chip, that would enable tracking of the sale of the product to determine its intended location of use. In some cases, the intended location of use determined by the manufacturer may be cross-checked with a suitable means of identifying actual use (some examples of identifying actual use are provided below). In the event that the intended location of use does not match the identified actual location of use, the hub (106) and / or cloud (104) may be notified to allow for special handling by the manufacturer device tracking.

[0088] As another example, a GPS device may be associated with an instrument (5040), a device (5050), a hub (106), a generator module (140), or any other suitable device, as will be apparent to one skilled in the art from the teachings herein. Once activated, the GPS device may determine the location of use and transmit that information to any suitable component, such as a hub (106), a generator module (140), a device (5050), and / or an instrument (5040). As another example, a hub (106) and / or a device (5050) may analyze the network to which they are connected in order to determine the location of use. As another example, a generator, a hub (106), and / or a device (5050) may have a hospital identifier that may determine the location of use. As another example, a hub (106) and / or a device (5050) may determine the location of use by connecting to a remote server (113) and / or a 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 manufacturer-generated region code that specifies a 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 a user to select its region of use. As another example, the hub (106) and / or the device (5050) may determine the location of use using its associated IP address. As another example, the hub (106) and / or the device (5050) may determine the location of use using its software license.

[0089] After appropriately determining the use location (5062), the instrument (5040), hub (106) and / or device (5050) may then provide the location information (5064) to an appropriate application or device for determining and / or accessing an appropriate treatment strategy. The provided location information (5064) may be utilized by the treatment assistance device (5050), remote server (113), cloud (104) and / or hub (106). It should be understood that providing the location information (5064) may occur at any suitable time in the determination procedure (5060), as will be apparent to those skilled in the art based on 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) scans the instrument (5040) or communicates with the instrument (5040) via the communication module (5046, 5056).

[0090] During a surgical procedure according to the description herein, the instrument (5040) and / or the hub (106) may track whether any other products are used in combination with the instrument (5040). For example, the instrument (5040) and / or the hub (106) may track whether there are any drugs, controlled substances, adjuvants, or any other suitable medical products, as will be apparent to those skilled in the art based on the teachings herein. The use of such medical products may affect the standards and / or criteria for the disposal strategy used to treat the instrument (5040) after the exemplary use. Therefore, a step (5066) in the determination procedure (5060) may include providing information about various related medical products used in combination with the instrument (5040). The instrument (5040), the hub (106), and / or the device (5050) may then provide such medical product information (5066) to an appropriate application or device for determining and / or obtaining an appropriate disposal strategy. For example, the provided medical product information (5066) can be utilized by the treatment aid (5050), the remote server (113), the cloud (104), and / or the hub (106). The information can be provided automatically or in response to a specific action; for example, the device (5050) scans the instrument (5040) or communicates with the instrument (5040) via the communication module (5046, 5056).

[0091] Although in the current example, the location information (5064) and the related medical product information (5066) are provided to help determine the criteria and / or criteria for the treatment strategy, in some cases, only the location information (5064) or only the medical product information (5066) may be used to help determine the criteria and / or criteria for the treatment strategy. In addition, any other suitable information may also be provided in combination with other parameters or alone. For example, performance data accumulated during use of the surgical instrument (5040) accessed (5070) and uploaded (5072) as described herein may be provided to an appropriate application or device for determining and / or accessing an appropriate treatment strategy.

[0092] The hub (106) and / or the treatment aid (5050) may access a selective lookup table (5068) that includes various local treatment strategies. Using the appropriate information (5064, 5066, 5070, 5072) provided, the hub (106) and / or the treatment aid (5050) selects an appropriate local treatment strategy from a plurality of methods provided on the selective lookup table. Various standards and / or criteria for local treatment strategies may be stored on any suitable device, as will be apparent to one skilled in the art based on the teachings herein. For example, the lookup table may be stored on the cloud (104), a remote server (113), a hub (106), a treatment aid (5050), etc. Accessing the selective lookup table (5068) may occur automatically or in response to a specific action; for example, the device (5050) scanning the instrument (5040) or communicating with the instrument (5040) via the communication module (5046, 5056).

[0093] As described above, the instrument (5040) can store performance data on the memory (5042). In some examples, also as described above, when the instrument (5040) is scanned by the treatment aid (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 (5072) to the cloud (104). The cloud (104) can store the uploaded performance data for various purposes. In some cases, when the hub (106) is not used during a surgical procedure, it may be beneficial to upload the performance data to the cloud (104) via communication between the instrument (5040) and the device (5050).

[0094] Having accessed the appropriate standards and / or guidelines for the local disposal strategy, the determination program (5060) may then display (5074) the local disposal procedure to the person responsible for executing the disposal strategy. The disposal procedure may include chronological instructions showing the disposal strategy. Such instructions may include how to disassemble the instrument (5040); which parts of the instrument (5040) are reusable and which parts of the instrument (5040) are disposable; how to properly prepare such parts for disposal or reuse; how to properly store such parts for disposal or reuse; and the like. Such a display (5074) may be displayed on the appropriate part of the device (5050) or the hub (106). The display (5074) may allow the user to scroll through the chronological instructions of the disposal strategy and indicate when each instruction is completed.

[0095] When personnel execute the treatment strategy according to the displayed criteria and / or displayed guidelines, the hub (106) and / or device (5050) can notify the sterilization team of the incoming devices (5078) expected to be delivered to the sterilization team according to the displayed treatment strategy. It should be understood that such notification (5078) can be omitted in the event that the sterilization personnel utilizes the determination procedure (5060).

[0096] IV. Exemplary Generator Storage Box with Reusable Power Cord and Sterilization Device

[0097] In some cases, the surgical kit (5020) described above has a power cord that is configured to electrically couple the surgical subcomponent (5022) to the generator module (140) so that the generator module (140) can power the surgical subcomponent (5022) during exemplary use according to the description herein. The power cord can also enable data to be communicated between the surgical subcomponent (5022) and the hub (106). In some cases, it may be desirable to make at least a portion of the power cord reusable with the generator module (140) rather than associated with the surgical kit (5020). Thus, after surgery, the portion of the power cord associated with the generator module (140) can remain associated with the generator module (140), and the portion of the power cord associated with the surgical kit (5020) can be classified as a postoperative component (5032, 5034, 5036) for reuse or disposal, as will be apparent to those skilled in the art based on the teachings herein.

[0098] 9A to 9C An exemplary power connection assembly (5080) and a generator storage box (5090) that can be easily incorporated into a surgical kit (5020) and a generator module (140) are shown. The power connection assembly (5080) includes a short power cord (5082) and a long power cord (5086). The short power cord (5086) can be associated with an instrument (5040) formed by the surgical kit (5020) so that the short power cord (5082) is packaged with the surgical kit (5020). The short power cord (5082) includes a coupling member (5084) that is configured to selectively establish communication with the long power cord (5088) and the generator module (140) via the coupling member of the long power cord (5086). When the short power cord (5082) is coupled to the long power cord (5086), the generator module (140) can actively power the instrument (5040) according to the description herein.

[0099] The long power cord (5086) is attached to the generator module (140) and is wound and stored internally within the generator storage box (5090) of the generator module (140) via a coupling post (5094). Since the long power cord (5086) remains associated with the generator module (140) and is configured to be coupled to the short power cord (5082), the long power cord (5086) can reduce the amount of disposal from the surgical kit (5020). In some cases, there is no short power cord (5082), so that the long power cord (5086) is directly coupled to the instrument (5040). In some cases, the device includes a detachable, reusable power cord having a connection connector positioned at the end of the handpiece. A physically unique key that may require multiple actions can be used to cut the connection. The connection can alternatively be cut by an electronically activated release mechanism, which can be activated by the user or the generator module (140).

[0100] The storage box (5090) may include a pop-up top with a box for power cord storage and multi-tool storage. The storage box (5090) may have a hook instead of a post (5094) around which the power cord (5086) is wrapped.

[0101] Storage box (5090) includes UV light (5092). After exemplary use and while long power cord (5086) is stored within storage box (5090), UV light (5092) can be used to sterilize long power cord (5086). 9A to 9C An exemplary connection of power lines (5082, 5086) is shown. First, as Fig.9A As shown, the long power cord (5086) and the connecting member (5088) are located in the storage box (5090). Fig. 9B As shown, coupling member (5088) can be removed from storage box (5090). Finally, coupling members (5084, 5088) can be coupled to electric device (5040), as shown. Fig. 9C shown.

[0102] V. Exemplary Combinations

[0103] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise explicitly indicated by the inventor or the successor with an interest in the inventor at a later date. If any claim proposed in this patent application or in the subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.

[0104] Example 1

[0105] A method for determining a treatment strategy for a surgical kit, the method comprising: (a) determining a geographic location where the surgical kit is being used; (b) generating a location data set based on the geographic location where the surgical kit is being used; (c) providing the location data set to a resource device; (d) receiving the treatment strategy from the resource device based on the location data set; and (e) displaying a set of instructions based on the treatment strategy received from the resource device.

[0106] Example 2

[0107] The method according to any one or more of the preceding embodiments, wherein the resource device comprises a cloud storage system.

[0108] Example 3

[0109] The method according to any one or more of the aforementioned embodiments, wherein the cloud storage system includes multiple handling strategies, each handling strategy involves a different geographical location.

[0110] Example 4

[0111] The method according to any one or more of the foregoing embodiments further includes determining a list of medical products for use in conjunction with the surgical kit.

[0112] Example 5

[0113] The method according to any one or more of the aforementioned embodiments further includes generating a medical product dataset based on the list of medical products used in conjunction with the surgical kit.

[0114] Example 6

[0115] The method according to any one or more of the preceding embodiments further comprises providing the medical product dataset to the resource device.

[0116] Example 7

[0117] The method according to any one or more of the preceding embodiments further comprises receiving the treatment strategy from the resource device based on the medical product data set.

[0118] Example 8

[0119] The method according to any one or more of the preceding embodiments, further comprising displaying the set of instructions on a treatment aid.

[0120] Example 9

[0121] The method described in any one or more of the foregoing embodiments also includes displaying the set of instructions on a display screen of a surgical hub configured for use in conjunction with the surgical kit.

[0122] Example 10

[0123] A method according to any one or more of the preceding embodiments, wherein determining the geographic location further comprises using a serial code on the surgical kit.

[0124] Embodiment 11

[0125] The method according to any one or more of the preceding embodiments, wherein determining the geographic location further comprises reading a pre-programmed code on a generator module.

[0126] Example 12

[0127] The method according to any one or more of the preceding embodiments, wherein determining the geographic location further comprises receiving a usage input.

[0128] Embodiment 13

[0129] The method according to any one or more of the preceding embodiments, wherein determining the geographic location further comprises utilizing a network address.

[0130] Embodiment 14

[0131] A method according to any one or more of the preceding embodiments, wherein the surgical kit comprises a handheld device.

[0132] Embodiment 15

[0133] A method according to any one or more of the preceding embodiments, wherein the surgical kit comprises a battery.

[0134] Example 16

[0135] A method according to any one or more of the preceding embodiments, wherein the surgical kit comprises an ultrasonic transducer.

[0136] Embodiment 17

[0137] A method according to any one or more of the preceding embodiments, wherein the surgical kit comprises a power cord.

[0138] Embodiment 18

[0139] A method for determining a treatment strategy for a surgical kit, the method comprising: (a) identifying a geographic location of use of the surgical kit; (b) providing the geographic location of use to a resource device storing treatment strategies based on a plurality of treatment strategies; (c) receiving a specific treatment strategy from the resource device based at least in part on the geographic location provided to the resource device; and (d) displaying a set of instructions based on the specific treatment strategy received from the resource device.

[0140] Embodiment 19

[0141] A method according to any one or more of the preceding embodiments, wherein the set of instructions are arranged in chronological order.

[0142] Embodiment 20

[0143] A surgical system comprises: (a) a generator; (b) a surgical kit configured to be assembled into a surgical instrument, wherein the surgical instrument is configured to be disassembled into a first set of used components and a second set of used components; (c) an identification feature associated with the generator of the surgical kit; and (d) a disassembly aid 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, wherein the set of instructions depends on data obtained from the identification feature.

[0144] Embodiment 21

[0145] A method for determining a treatment strategy for a surgical kit, the method comprising: (a) identifying a geographic location of use of the surgical kit; (b) extracting a set of treatment instructions from a lookup table based on the identified geographic location of use of the surgical kit; and (c) displaying the treatment instructions.

[0146] VI. Miscellaneous

[0147] Versions of the above-described devices may find application in traditional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries.

[0148] It should be understood that any type of apparatus described herein may also include various other features in addition to or as an alternative to those described above. By way of example only, any of the apparatus described herein may also include one or more of the various feature structures disclosed in any of the various references incorporated herein by reference. It should also be understood that the teachings herein may be readily applied to any apparatus described in any other reference cited herein, such that the teachings herein may be readily combined with the teachings in any reference cited herein in a variety of ways. Other types of apparatus that may incorporate the teachings herein will be apparent to those of ordinary skill in the art.

[0149] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9447USNP1.0754992], entitled "Method of Reclaiming Portions of Surgical Instruments for Remanufacturing and Sustainability", filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of the U.S. Patent Application [Agent Docket No. END9447USNP1.0754992] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0150] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent 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 application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of the U.S. Patent Application [Agent Docket No. END9448USNP1.0754994] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0151] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9448USNP2.0754977], entitled "Surgical Instrument with Removable Cable and Associated Couplings", filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9448USNP2.0754977] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0152] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9448USNP3.0754979], entitled "Surgical System and Methods of Assembly and Disassembly of Surgical Instrument" filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9448USNP3.0754979] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0153] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9449USNP1.0754981], entitled "Robotic Surgical System with Removable Portion and Method of Disassembling Same" filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9449USNP1.0754981] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0154] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9450USNP2.0754999], entitled "Reclamation Packaging for Surgical Instrument and Related Methods", filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9450USNP2.0754999] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0155] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent 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 application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9450USNP3.0755001] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0156] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9450USNP4.0755006], entitled "Surgical System and Methods for Instrument Assessment and Cleaning" filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this article can be combined with the teachings of U.S. Patent Application [Agent Docket No. END9450USNP4.0755006] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0157] It should also be understood that any range of values ​​referenced herein should be understood to include the upper and lower limits of such ranges. For example, a range expressed as "between about 1.0 inches and about 1.5 inches" should be understood to include about 1.0 inches and about 1.5 inches, in addition to including values ​​between these upper and lower limits.

[0158] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials listed in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.

[0159] The patterns described above can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case or both, these patterns can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some patterns of the device can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some patterns of the device can be reassembled at a repair facility or reassembled by the operator before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.

[0160] By way of example only, the types described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0161] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A method for determining a treatment strategy for a surgical kit, the method comprising: (a) determining the geographic location where the surgical kit is being used; (b) generating a location dataset based on the geographic location where the surgical kit is being used; (c) providing the location data set to a resource device; (d) receiving the handling strategy from the resource device based on the location data set; as well as (e) displaying a set of instructions based on the handling policy 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 handling strategies, each handling strategy relates to a different geographical location.

4. The method of any preceding claim, further comprising determining a list of medical products for use in conjunction with the surgical kit.

5. The method of claim 4, further comprising generating a medical product data set based on a list of medical products used in conjunction with the surgical kit. The method of claim 5 , further comprising providing the medical product data set to the resource device. 7 . The method of claim 6 , further comprising receiving the treatment strategy from the resource device based on the medical product data set.

8. The method of any preceding claim, further comprising displaying the set of instructions on a treatment aid.

9. The method according to any preceding claim further includes displaying the set of instructions on a display screen of a surgical hub configured for use in conjunction with the surgical kit.

10. A method according to any preceding claim, wherein: Determining the geographic location also includes using a serial code on the surgical kit.

11. A method according to any preceding claim, wherein: Determining the geographic location also includes reading a preprogrammed code on the generator module.

12. A method according to any preceding claim, wherein: Determining the geographic location also includes receiving a usage input.

13. A method according to any preceding claim, wherein: Determining the geographic location also includes utilizing a network address.

14. A method according to any preceding claim, wherein: The surgical kit includes a handheld device.

15. A method according to any preceding claim, wherein: The surgical kit includes a battery.

16. A method according to any preceding claim, wherein: The surgical kit includes an ultrasonic transducer.

17. A method according to any preceding claim, wherein: The surgical kit includes a power cord.

18. A method of determining a disposal strategy for a surgical kit, the method comprising: (a) identifying the geographic location where the surgical kit is to be used; (b) providing the geographical location of use to a resource device storing a plurality of disposal strategies; (c) receiving a particular treatment policy from the resource device based at least in part on the geographic location provided to the resource device; as well as (d) displaying a set of instructions based on the particular handling policy 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) Generator; (b) a surgical kit configured to be assembled into a surgical instrument, wherein the surgical instrument is configured to be disassembled into a first set of used components and a second set of used components; (c) an identification feature associated with the generator of the surgical kit; and (d) a disassembly aid configured to display a set of instructions on how to disassemble the surgical instrument into the first set of used parts and the second set of used parts, wherein the set of instructions depends on data obtained from the identification feature.

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