Recycled Packaging for Surgical Instruments and Related Methods

Abstract

A surgical kit (6010) includes a surgical instrument (6012), a package (6014), and a return package (6018). The package (6014) defines an interior and an exterior in a closed configuration. The surgical instrument (6012) is disposed within the package or coupled to the package in the closed configuration. The package (6014) is configured to transition to an open configuration by a user to expose the interior and enable access to the surgical instrument during a surgical procedure. The return package (6018) is configured to receive at least a portion of the surgical instrument after a surgical procedure to reduce cross-contamination. The return package (6018) is at least one of coupled to the package or disposed within the interior in the closed configuration.

Description

Background Art

[0001] Various ultrasonic surgical instruments include an end effector having a blade element that vibrates at ultrasonic frequencies to cut and / or seal tissue (e.g., by denaturing proteins within the tissue cells). These instruments include one or more piezoelectric elements that convert electrical power into ultrasonic vibrations, which are transmitted along an acoustic waveguide to the blade element. Examples of ultrasonic surgical instruments and related concepts are disclosed in U.S. Patent Application Publication No. 2006 / 0079874, titled "Tissue Pad for Use with an Ultrasonic Surgical Instrument," published on April 13, 2006, now abandoned, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2007 / 0191713, titled "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. Patent Application Publication No. 2008 / 0200940, titled "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 U.S. Patent No. 7,354,440, titled "Electrosurgical Instrument and Method of Use," issued on April 8, 2008, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 7,381,209, titled "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 U.S. Patent No. 9,949,785, entitled "Ultrasonic Surgical Instrument with Electrosurgical Feature," issued 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 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 November 17, 2020, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 11,229,471, entitled "Modular Battery Powered Handheld Surgical Instrument with Selective Application of Energy Based on Tissue Characterization," issued January 25, 2022, the disclosure of which is incorporated herein by reference in its entirety.

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

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

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

Brief Description of the Drawings

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

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

DETAILED DESCRIPTION OF THE INVENTION

[0009] The following description of specific examples of the present technology should not be used for the purpose of limiting its scope. 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 one of the best modes contemplated for practicing the present technology by way of example. As will be understood, the technologies described herein are capable of other different and obvious aspects without departing from the technology. Therefore, the drawings and description are not limiting and should be regarded as illustrative in nature.

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

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

[0012] I. Example of a Surgical System Referring to FIG. 1, a computer-implemented interactive surgical system (100) includes one or more surgical systems (102) and a cloud-based system (e.g., a cloud (104) that may include a remote server (113) coupled to a storage device (105)). Each surgical system (102) in this example may include at least one surgical hub (106) that communicates with a cloud (104) that may include a remote server (113). In one example, as shown in FIG. 1, the surgical system (102) includes a visualization system (108), a robotic system (110), and a handheld intelligent surgical instrument (112), which are configured to communicate with each other and / or with the hub 106. In some 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 mechanisms 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 in view of the teachings herein.

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

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

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

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

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

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

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

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

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

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

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

[0024] Referring to FIGS. 3-4, aspects of the present disclosure are presented regarding a hub module type enclosure (136) that enables modular integration of a generator module (140), a flue gas discharge module (126), and a suction / irrigation module (128). The hub module type enclosure (136) further facilitates interactive communication between the modules (140, 126, 128). As shown in FIG. 4, the generator module (140) may be a generator module including integrated monopole components, bipolar components, and ultrasonic components supported within a single housing unit (139) slidably insertable into the hub module type enclosure (136). As shown in FIG. 4, the generator module (140) can be configured to connect to a monopole device (146), a bipolar device (147), and an ultrasonic device (148). Alternatively, the generator module (140) may include a series of monopole generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact via the hub module type enclosure (136). The hub module type enclosure (136) can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked to the hub module type enclosure (136) such that the multiple generators function as a single generator. <0oo0102><0oo0103><0oo0104> It should be noted that there seems to be a formatting issue with the tags ,

[0025] , in the original text. They are likely meant to be ,

[0025] , respectively, and they are unchanged in the translation as per the requirements. If this is not the case, please clarify the correct form of these tags.FIG. 5 shows one form of a generator (150) and various surgical instruments (152, 154, 156) that can be used therewith. The surgical instrument (152) is an ultrasonic surgical instrument (152), the surgical instrument (154) is an RF electrosurgical instrument (154), and the multifunctional surgical instrument (156) is an ultrasonic / RF combined electrosurgical instrument (156). The generator (150) can be configured to be used with various surgical instruments. According to various forms, the generator (150) can be configured to be used with various surgical instruments of different types, including, for example, an ultrasonic surgical instrument (152), an RF electrosurgical instrument (154), and a multifunctional surgical instrument (156) that integrates RF energy and ultrasonic energy simultaneously delivered from the generator (150). The generator (150) in the present example of FIG. 5 is shown separately from the surgical instruments (152, 154, 156), but the generator (150) may alternatively be formed integrally with any of the surgical instruments (152, 154, 156) to form a single surgical system. The generator (150) includes an input device (158) located on the front panel of the console of the generator (150). The input device (158) can include any suitable device that generates a signal suitable for programming the operation of the generator (150). The generator (150) may be configured for wired or wireless communication.

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

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

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

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

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

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

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

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

[0034] II. Exemplary Surgical Kits and Methods of Processing Medical Devices In some cases, it may be desirable to recover a portion of a surgical instrument (e.g., surgical instruments (152, 154, 156)) in order to reduce medical waste that can reduce environmental impact and associated costs. To increase efficiency, it may be beneficial to separate the various components of the surgical instruments (152, 154, 156). For example, it may be beneficial to process different components differently (e.g., send different components to different locations). For components that cannot be recovered, it may be desirable to dispose of the components in an environmentally friendly manner. To assist the staff of a medical facility (e.g., a hospital), it is desirable to rationalize and simplify the recycling and disposal processes as much as possible. This can improve the process workflow in the operating room of a medical facility.

[0035] A. First Exemplary Surgical Kit Figures 6 - 7A show a first exemplary surgical kit (6010) that includes a surgical instrument (6012), an outer package (6014), a sterilization package (6016), and a return package (6018). The surgical kit (6010) may also provide for the initial sterilized delivery of the surgical instrument (6012) and packaging for the recycling or disposal of the surgical instrument (6012). In some versions, the sterilization package (6016), or even the outer package (6014), may be recovered to minimize contamination during return and handling.

[0036] The surgical instrument (6012) may be similar to the surgical instruments (152, 154, 156) shown in FIG. 5. For example, the surgical instrument (6012) may be similar to an ultrasonic surgical instrument (152), an RF electrosurgical instrument (154), an ultrasonic / RF combined electrosurgical instrument (156), or a surgical stapler (not shown). The surgical instrument (6012) may be attachable to the surgical arm (123) of the robotic system (110), or may be similar to a hand-held intelligent surgical instrument (112). The surgical instrument (6012) includes a plurality of parts shown as a first part, a second part, and a third part (6020a-c) configured to separate from each other. As used herein, a part may refer to different locations of the same component or completely different components. The first part (6020a) is shown as including an end effector, the second part (6020b) is shown as including a shaft, and the third part is shown as including a handle, but these are not exclusive. The first part, the second part, and the third part (6020a-c) may refer to various different parts of the surgical instrument (6012). Although the first part, the second part, and the third part (6020a-c) are shown, more or fewer parts are envisioned. Certain parts of the surgical instrument (6012) may still be disposed of as medical waste, while other parts are also envisioned to be recovered for subsequent use in the surgical instrument.

[0037] The first portion, the second portion, and the third portion (6020a - b) can be separated using various different connection structures (e.g., mechanical, electrical, and / or magnetic connection structures). In some versions, the first portion, the second portion, and the third portion (6020a - c) of the surgical instrument (6012) may be destructively disassembled after use of the surgical instrument (6012) (e.g., using a laser or a destructive tool). For example, a breaking tool (not shown) may break the first portion and the second portion (6020a - b) of the surgical instrument (6012) along a predetermined breaking point. As shown, the first portion, the second portion, or the third portion (6020a - c) of the surgical instrument (6012) each includes a machine-readable tag (6021a - c). As used herein, machine-readable tags are intended to include physical chips (e.g., RFID chips) as well as optical codes (e.g., QR codes or barcodes). As shown, the surgical instrument (6012) includes a master machine-readable tag (6023) which may be a machine-readable tag separate from the machine-readable tags (6021a - c). However, one of the machine-readable tags (6021a - c) may function as the master machine-readable tag (6023). The master machine-readable tag (6023) may contain information (e.g., serial number, manufacturing date, model number, etc.) regarding the entirety of the surgical instrument (6012) and / or specific included portions (e.g., the first portion, the second portion, and the third portion (6020a - c)).

[0038] The outer package (6014) includes a body (6022) and an optional lid (6027) that define an interior (6024) and an exterior (6026). In the closed configuration of FIG. 6, the interior (6024) is completely enclosed. The outer package (6014) moves from the closed configuration of FIG. 6 to the open configuration of FIG. 7A when the outer package (6014) is opened. In the open configuration, the user may remove the sterile package (6016) containing the surgical instrument (6012). In other words, the outer package (6014) is opened by the user so as to expose the interior (6024) in the open configuration, enabling access to the surgical instrument (6012) for use in a surgical procedure. The interior (6024) of the outer package (6014) is collectively formed from the inner surfaces (6028) of the body (6022) and the lid (6027).

[0039] As shown in FIG. 6, the inner surface (6028) of the lid (6027) includes a repositionable label (6030) configured to couple with the return package (6018). The outer package (6014) may include a signal blocking feature layer to prevent machine-readable tags (6021a-c, 6023, 6034) from being read by a code reader (6438, 6440) (see FIG. 10) when the outer package (6014) is in the closed configuration. The user may simply remove the repositionable label (6030) from the lid (6027) of the outer package (6014) and place the repositionable label (6030) on the return package (6018), which may reduce the time for the user to position, remove, and position the repositionable label (6030). Alternatively, the repositionable label (6030) may be freely disposed within the interior (6024) of the outer package (6014).

[0040] The sterilization package (6016) is configured to surround the surgical instrument (6012). The sterilization package (6016) includes a body (6036) that defines an interior (6038) (see FIG. 7A) and an exterior (6040). The sterilization package (6016) is disposed within the interior (6024) of the outer package (6014) in a closed configuration. In some versions, the outer package (6014) may be omitted such that the return package (6018) is coupled to the sterilization package (6016) or disposed within the interior (6038) of the sterilization package (6016). As shown, the sterilization package (6016) includes a recess (6042) that complements the size and / or shape of the component.

[0041] The return package (6018) is configured to receive at least one of a first portion (6020a), a second portion (6020b), or a third portion (6020c) of the surgical instrument (6012) after surgery. The return package (6018) may be fully disposed within the interior (6024) of the outer package (6014) in a closed configuration. Optionally, the return package (6018) may be coupled to the outer package (6014), may be coupled to the sterilization package (6016), and / or may be disposed within the interior (6038) of the sterilization package (6016) in a closed configuration. The return package (6018) may be connected to a particular location on the surgical instrument (6012) to facilitate disassembling. As shown in FIG. 6, the return package (6018) may be coupled to the outer package (6014) using a frangible portion (6050) that is configured to be cut by the user. In some versions, the frangible portion (6050) may include a single string that weakens and scores the frangible portion (6050) when pulled.

[0042] The return packaging (6018) may be divided to include separate parts of the recovered components. The return packaging (6018) can include a plurality of individual return packagings. As shown in FIG. 7A, the plurality of individual return packagings include a first return packaging, a second return packaging, and a third return packaging (6044, 6046, 6048). However, more or fewer return packagings (6044, 6046, 6048) are also envisioned. The first return packaging (6044) includes a body (6052) that defines an interior (6054) (see FIG. 7B) and an exterior (6056). The exterior (6056) includes a repositionable label (6058) and a machine-readable tag (6060). Similarly, the second return packaging (6046) includes a body (6062) that defines an interior (6064) (see FIG. 7B) and an exterior (6066). The exterior (6066) includes a repositionable label (6068) and a machine-readable tag (6070). The third return packaging (6048) is shown as a bag with opposed first and second ends (6072, 6074) sealed. The third return packaging (6048) includes a resealable flap (6076) configured to allow a user to insert a third portion (6020c) into the interior (6078). The resealable flap (6076) may include a label (6080).

[0043] Each machine-readable tag (6060, 6070, 6092) is coupled to at least one of the surgical instrument (6012), the outer package (6014), or the return package (6018). Code readers (6434, 6436) (see FIG. 10) are configured to read the machine-readable tags (6060, 6070, 6092) from the surgical instrument (6012), the outer package (6014), or the return package (6018). For example, the return package (6018) may include machine-readable tags (6060, 6070, 6092) configured to identify the surgical instrument (6012) using the code readers (6434, 6436). For example, the first return package, the second return package, and the third return package (6044, 6046, 6048) may also include machine-readable tags (6060, 6070, 6092) readable by code readers (6438, 6440). In addition to, or instead of, the machine-readable tags (6021a-c, 6023, 6034), the machine-readable tags (6060, 6070, 6092) can be used.

[0044] The repositionable labels (6058, 6068) and the label (6080) may include an optical code such as a barcode or a QR code that is optically readable by code readers (6438, 6440). The repositionable labels (6058, 6068) and the label (6080) may include markings (6082, 6084, 6086) for identifying the surgical instrument (6012) or the first portion (6020a), the second portion (6020b), or the third portion (6020c) of the surgical instrument (6012). For example, the markings (6082, 6084, 6086) may include at least one of a serial number, a model number, and / or an expiration date. Other markings (6082, 6084, 6086) are also contemplated. With respect to the third return package (6048), the label (6080) may be attached to one end of the resealable flap (6076) and may be closable by coupling the end (6088) of the resealable flap (6076) to the third return package (6048).

[0045] In some versions, the first return wrapper (6044) may first be combined with the second return wrapper (6046). As shown in FIGS. 6 and 7A, the first return wrapper and the second return wrapper (6044, 6046) are combined using a frangible portion (6094). The frangible portion (6094) may be manually cut by the user to maintain sterility. In some versions, the frangible portion (6094) may include a piece of string (6096) that, when pulled, weakens the frangible portion (6094) and makes a cut along a break line. As shown, the third return wrapper (6048) is disposed within the interior (6024) of the outer wrapper (6014) and is not combined with the first return wrapper and the second return wrapper (6044, 6046).

[0046] As shown in FIG. 7B, the first return package (6044) portion is configured to receive the first portion (6020a) of the surgical instrument (6012). The first return package (6044) includes a recess (6098) and at least one protrusion shown as a protrusion (6100). The protrusion (6100) is configured to securely engage the first portion (6020a) of the surgical instrument (6012). Similarly, the second return package (6046) includes a recess (6102) and at least one protrusion shown as a protrusion (6104). The protrusion (6104) is configured to securely engage the second portion (6020b) of the surgical instrument (6012). The protrusions (6100, 6104) may be integrally formed with their respective return packages (6044, 6046), or the protrusions (6100, 6104) may be separate components coupled to their respective return packages (6044, 6046). The third return package (6048) is configured to receive the third portion (6020c) of the surgical instrument (6012). The recesses (6098, 6102) of the return package (6018) can perform various functions. For example, the recesses (6098, 6102) may provide rigidity to the return package (6018). The recesses (6098, 6102) and the protrusions (6100, 6104) may be shaped and sized to hold the first and second portions (6020a - b) of the surgical instrument (6012) during disassembly after surgery. The recesses (6098, 6102) and the protrusions (6100, 6104) may improve the ability to separate the first and second portions (6020a - b) in a controlled manner.

[0047] B. Second Exemplary Surgical Kit FIG. 8 shows a second exemplary surgical kit (6210) including a surgical instrument (6212), an outer package (6214), a sterilization package (6216), and a return package (6218). The surgical kit (6210) is similar to the surgical kit (6010) described above with reference to FIGS. 6-7B, and differences will be described in detail below. Unlike the sterilization package (6016), a portion of the return package (6218) is coupled to the sterilization package (6216), and a portion of the return package (6218) is disposed within the interior (6238) (see FIG. 9) of the sterilization package (6216). In some versions, the outer package (6214) may be omitted.

[0048] The surgical instrument (6212) is similar to the surgical instrument (6012). The surgical instrument (6212) includes a plurality of parts including a first part, a second part, and a third part (6220a-c) configured to separate from each other along a fragile portion (6219). In some versions, at least one of the first part, the second part, or the third part (6220a-c) of the surgical instrument (6212) includes a machine-readable tag (6221a-c). The surgical instrument (6212) includes a master machine-readable tag (6223) similar to the master machine-readable tag (6023).

[0049] The outer package (6214) is similar to the outer package (6014). The outer package (6214) includes a body (6222) defining an interior (6224) and an exterior (6226). In the closed configuration of FIG. 8, the interior (6224) is completely enclosed. The outer package (6214) moves from the closed configuration of FIG. 8 to an open configuration (similar to FIG. 7A) when the outer package (6214) is opened. The interior (6224) of the outer package (6214) is formed from the inner surface (6228) of the body (6222).

[0050] The sterile package (6216) is similar to the sterile package (6016). The sterile package (6216) is configured to surround the surgical instrument (6212). The sterile package (6216) includes a body (6236) that defines an interior (6238) and an exterior (6240). The sterile package (6216) is disposed within the interior (6224) of the outer package (6214) in a closed configuration. As shown, the sterile package (6216) may include recesses (6242) that complement the size and / or shape of the components. Re-positionable labels (6230, 6232) can be used to cover and label the first and second portions (6220a - b) for transportation. Although not shown, a computer-readable code can also be included for tracking. A portion of the surgical instrument (6212) may be returned into the sterile package (6216) after use.

[0051] The return package (6218) is configured to receive at least one of the first portion (6220a), the second portion (6220b), or the third portion (6220c) of the surgical instrument (6212) after surgery. The return package (6218) may be segmented to accommodate separate portions of the returned or recovered components. The return package (6218) includes a plurality of individual return packages. As shown in FIG. 8, the plurality of individual return packages includes a first return package, a second return package, and a third return package (6244, 6246, 6248). However, more or fewer return packages are envisioned. The first return package (6244) includes a body (6252) that defines an interior (not shown) and an exterior (6256). Similarly, the second return package (6246) includes a body (6262) that defines an interior (not shown) and an exterior (6266). FIG. 9 shows a re-positionable label (6230) affixed to the exterior (6256) and a re-positionable label (6268) affixed to the exterior (6266). The re-positionable labels (6230, 6232) may include marks (6282, 6284) similar to the marks (6082, 6084) that function as machine-readable tags as described above. Although not shown, the exteriors (6256, 6266) may include additional machine-readable tags.

[0052] The third return wrapper (6248) includes a flexible bag (6272). The flexible bag (6272) is configured to allow a user to insert the third portion (6220c) into the interior (6278) of the flexible bag (6272). As shown, the flexible bag (6272) includes a label (6280) including a mark (6286). The return wrapper (6218) includes a fluid prevention seal (6274) configured to prevent fluid from passing therethrough. The fluid prevention seal (6274) is configured to transition from an open configuration for receiving the surgical instrument (6212) after surgery to a closed configuration for preventing fluid from exiting the return wrapper (6218). The mark (6286) may include one or more of a serial number, expiration date data, and / or a unique identifier that can be marked or recorded by the surgical robot hub (122) to indicate use, usage time, location of use, etc.

[0053] As shown in FIG. 9, the first return wrapper (6244) is configured to receive the first portion (6220a) of the surgical instrument (6212). The first return wrapper (6244) includes a recess (6298) and at least one protrusion shown as a protrusion (6300). The protrusion (6300) is configured to securely engage the first portion (6220a) of the surgical instrument (6212). Similarly, the second return wrapper (6246) includes a recess (6302) and at least one protrusion shown as a protrusion (6304). The protrusion (6300) is configured to securely engage the second portion (6220b) of the surgical instrument (6212). The recesses (6298, 6302) hold the first and second portions (6220a-b) during disassembly of the surgical instrument (6212). The third return wrapper (6248) portion is configured to receive the third portion (6220c) of the surgical instrument (6212) such that the third portion (6220c) can be handled while minimizing user contamination.

[0054] C. Exemplary Method A method (6410) for processing a medical device (e.g., a surgical instrument (6012, 6212)) is shown and described with reference to FIG. 10. As shown, the method (6410) includes steps (6412, 6414, 6416, 6418, 6420, 6422, 6424, 6426, 6428, 6430, 6432). However, more or fewer steps are envisioned.

[0055] In step (6412), the method (6410) includes applying at least one machine-readable tag (6021a-c, 6221a-c) to components (e.g., first, second, and third parts (6020a-c, 6220a-c)) of a surgical instrument (6012, 6212) using a marking device (6430). In some versions, the marking device (6430) may apply the machine-readable tag (6021a-c, 6221a-c) using a pressing process or a laser etching process. The machine-readable tags (6021a-c, 6221a-c) are described as being applied before the surgical instrument (6012, 6212) is assembled, but in some cases, the machine-readable tags (6021a-c, 6221a-c) may be applied after the surgical instrument (6012, 6212) is assembled. For example, a master machine-readable tag (6023, 6223) may be applied after the surgical instrument (6012, 6212) is assembled.

[0056] In step (6414), method (6410) includes sorting and assembling components for surgical instruments (6012, 6212). For example, the sorting may be performed using a sorting system (6436). By matching reusable components, the performance and lifespan of the surgical instruments (6012, 6212) can be optimized. The sorting system (6436) can include a vision system that can read machine-readable tags (6021a-c, 6221a-c) during this sorting step. A display regarding the usability status of the components may be provided. The display may be an alert in the form of an audible tone or a visual display. For example, the visual display may include one or more colored lights on the assembly equipment. The machine-readable tags (6021a-c, 6221a-c) indicate that specific components (e.g., the first part, the second part, and the third part (6020a-c, 6220a-c)) are incorporated into the surgical instruments (6012, 6212). Specific internal components have an electronic chip that identifies specific components that can be read by a master machine-readable tag (6023). The master machine-readable tags (6023, 6223) recognize the components associated with the installation and use of the surgical instruments (6012, 6212). For example, the master machine-readable tag (6023) may recognize the machine-readable tags (6021a-c, 6221a-c) and recognize the proximity of the manufacturing facility where there is a camera that groups the components into the surgical instruments (6012, 6212) or each station.

[0057] In step (6416), method (6410) includes scanning the machine-readable tags (6021a-c, 6023, 6221a-c) before the surgical kits (6010, 6210) are shipped from the manufacturer. In step (6418), method (6410) includes shipping the surgical kits (6010, 6210) to a medical facility for subsequent use.

[0058] In step (6420), method (6410) includes opening the outer packaging (6014, 6214) and / or the sterilization packaging (6016, 6216) to deform the surgical kit (6010, 6210) from a closed configuration to an open configuration. For example, a user in a healthcare facility may manually open the outer packaging (6014, 6214) and / or the sterilization packaging (6016, 6216). The sterilization packaging (6216) may be removed from the outer packaging (6214) in preparation for storage, or the sterilization packaging (6216) may be removed from the outer packaging (6214) before being used for a medical procedure. The surgical system (102) may recognize when the packaging has been opened. For example, after the outer packaging (6014, 6214) is opened and the surgical instruments (6012, 6212) are removed from the outer packaging (6014, 6214), signals from the machine-readable tags (6021a-c, 6023, 6034, 6221a-c, 6223) are no longer blocked by the outer packaging (6014, 6214). The signal is blocked or otherwise contained until the lid (6027) is removed. When the lid (6027) of the outer packaging (6014) is removed, signals from the machine-readable tags (6021a-c, 6023, 6034, 6221a-c, 6223) may reach the surgical robot hub (122).

[0059] In step (6422), method (6410) includes using a code reader (6440) to scan the machine-readable tags (6021a-c, 6023, 6221a-c, 6223). Another part of the surgical robot hub (122) or the surgical system (102) may include the code reader (6440). The code reader (6440) may determine information regarding the surgical instrument (6012, 6212) in its entirety or its components. This scan may be performed manually by the user or automatically by the surgical robot hub (122). The machine-readable tags (6021a-c, 6221a-c) may be scanned when the surgical instrument (6012, 6212) is incorporated into the robotic system (110).

[0060] In step (6424), method (6410) includes determining the states of various components. The states can include the coupling state (e.g., whether the surgical instruments (6012, 6212) are coupled to the robotic system (110)), the states of the components of the surgical instruments (6012, 6212), and their availability for use. A controller (6442) that may be located within the surgical robot hub (122) can use the scan from step (6422) to determine usage information for the first, second, and third portions (6020a - c, 6220a - c). The controller (6442) can record this usage information for later retrieval in at least one of the cloud (104), the surgical robot hub (122), the controller (6442), or the machine - readable tags (6021a - c, 6023, 6034, 6221a - c, 6223). This usage data can be transmitted to the central system of the manufacturer of the surgical instruments (6012, 6212) and / or the database of the return facility.

[0061] In step (6426), method (6410) includes providing the user with a display regarding the coupling state of the surgical instruments (6012, 6212). The surgical system (102) can recognize when the first, second, and third portions (6020a - c, 6220a - c) were used. The surgical system (102) may also recognize whether the manufacture of the components of a particular surgical instrument (6012, 6212) is acceptable or unacceptable, and in the case of unacceptability, may prevent installation. The display may be an alert in the form of an audible tone or a visual display.

[0062] In step (6428), method (6410) includes inserting components into return packages (6018, 6218). In some versions, to assist in filling the first return package, the second return package, and the third return package (6044, 6046, 6048, 6244, 6246, 6248), and / or to prevent the outflow of contents (e.g., the first portion, the second portion, and the third portion (6020a-c, 6220a-c)) disposed within the first return package, the second return package, and the third return package (6044, 6046, 6048, 6244, 6246, 6248), a packaging tray (which may be formed from a part of the sterilization package (6216) or a separate tray) may be used. The packaging tray can improve organization and shorten the overall time for subsequent shipping of the first return package, the second return package, and the third return package (6044, 6046, 6048, 6244, 6246, 6248) in step (6430).

[0063] In step (6432), method (6410) includes evaluating the returned portion of the surgical instrument (6012, 6212). Evaluating the returned components (e.g., the first part, the second part, and the third part (6020a-c, 6220a-c)) improves the process flow so that the components can be evaluated and possibly reused. For example, the recycling system (6444) may mark the surgical instrument (6012, 6212) to track usage. Tracking may enable a more direct sorting of the components (e.g., the first part, the second part, and the third part (6020a-c, 6220a-c)) at the return location (e.g., the manufacturing facility or other return facility). The return location can scan the machine-readable tags (6021a-c, 6221a-c) and sort the components (e.g., the first part, the second part, and the third part (6020a-c, 6220a-c)) according to various criteria including the number of uses. The recycling system (6444) can read usage information from the surgical instrument (6012, 6212). This usage data may be on a memory (e.g., EEPROM). The recycling system (6444) can determine whether the surgical instrument (6012, 6212) has been used. The memory can store recording data regarding the use of the surgical instrument (6012, 6212) and can record the serial numbers of the components. In some versions, the surgical instrument (6012, 6212) may be physically marked as described in step (6412).

[0064] III. Exemplary Combinations The following examples relate to various non-exhaustive ways in which the teachings of this specification can be combined or applied. It should be understood that the following examples are not intended to limit any claims that may be presented at any point in this application or in subsequent applications of this application. No waiver of any rights is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this specification can be configured and applied in many other ways. Also, in some variations, it is also contemplated that specific features mentioned in the following examples may be omitted. Accordingly, none of the aspects or features mentioned below should be considered important unless so expressly indicated later by the inventors or their successors in interest. If the claims presented in this application or in subsequent applications related to this application include additional features other than those mentioned below, those additional features should not be considered to have been added for any reason related to patentability.

Example

[0065] A surgical kit comprising: (a) a surgical instrument; (b) a package defining an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within the interior of the package or coupled to the package in the closed configuration, and the package is configured to transition to an open configuration by a user to expose the interior and enable access to the surgical instrument during a surgical procedure; and (c) a return package configured to receive at least a portion of the surgical instrument after a surgical procedure to reduce cross-contamination, the return package being at least one of coupled to the package in the closed configuration or disposed within the interior.

Example

[0066] The surgical kit according to Example 1, wherein the package includes an outer package and the return package is disposed within the interior of the outer package in the closed configuration.

Example

[0067] The return packaging includes a machine-readable code configured to identify the surgical instrument using a code reader, and the outer packaging includes a signal blocking feature configured to prevent the machine-readable code from being read using the code reader in a closed configuration, the surgical kit according to Example 2.

Example

[0068] The return packaging includes an interior and an exterior, the interior of the outer packaging is formed from a plurality of inner surfaces, and one of the plurality of surfaces includes a repositionable label configured to be coupled to the exterior of the return packaging, the surgical kit according to any one of Examples 2 to 4.

Example

[0069] The packaging includes a sterile packaging configured to surround the surgical instrument, and the sterile packaging is disposed within the interior of the outer packaging in a closed configuration, the surgical kit according to any one of Examples 2 to 4.

Example

[0070] The return packaging is coupled to the sterile packaging or disposed within the sterile packaging, the surgical kit according to Example 5.

Example

[0071] The return packaging includes at least one protrusion configured to securely engage a portion of the surgical instrument, the surgical kit according to any one of Examples 1 to 6.

Example

[0072] The return packaging includes a mark configured to identify the surgical instrument, the surgical kit according to any one of Examples 1 to 7.

Example

[0073] The return packaging includes a repositionable label, and the repositionable label includes a mark, the surgical kit according to Example 8.

Example

[0074] The return package includes a fluid prevention seal configured to transition from an open configuration for receiving surgical instruments after surgery to a closed configuration for preventing fluid from exiting the return package, the surgical kit according to any one of Examples 1 to 9.

Example

[0075] The return package is coupled to the package using a frangible portion configured to be cut by a user, the surgical kit according to any one of Examples 1 to 10.

Example

[0076] The surgical instrument includes a first portion and a second portion configured to separate from each other, the return package includes a first return package and a second return package, the first return package is configured to receive the first portion of the surgical instrument, and the second return package is configured to receive the second portion of the surgical instrument, the surgical kit according to any one of Examples 1 to 11.

Example

[0077] The first return package is configured to securely engage the first portion of the surgical instrument, and the second return package is configured to securely engage the second portion of the surgical instrument, the surgical kit according to Example 12.

Example

[0078] The first return package is coupled to the second return package, the surgical kit according to Example 12.

Example

[0079] The surgical kit further includes a robotic surgical system, the robotic surgical system including an arm configured to couple to the surgical instrument, the surgical kit according to any one of Examples 1 to 14.

Example

[0080] A robotic surgical system comprising: (a) a surgical instrument; (b) a package defining an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within or coupled to the package in the closed configuration, and the outer package is configured to be opened by a user to expose the interior in an open configuration to enable access to the surgical instrument during a surgical procedure; (c) a return package configured to receive the surgical instrument after a surgical procedure to reduce cross-contamination; (d) a machine-readable code coupled to at least one of the surgical instrument, the outer package, or the return package; and (e) a code reader configured to read the machine-readable code.

Example

[0081] The robotic surgical system according to Example 16, wherein the package includes an outer package, and the return package is disposed inside the outer package in a closed configuration.

Example

[0082] The robotic surgical system according to Example 16 or 17, wherein the outer package includes a signal blocking feature configured to prevent the machine-readable code from being read by the code reader in a closed configuration.

Example

[0083] A method for retrieving a surgical instrument, comprising: (a) opening a packaging material to expose the surgical instrument and a return package contained within the packaging material; (b) determining that a portion of the surgical instrument is reusable; (c) inserting a portion of the surgical instrument into the return package; and (d) enclosing the return package.

Example

[0084] The method according to Example 19, further comprising attaching a repositionable label to the return package.

[0085] IV. Others The variations of the above-described devices are applicable not only to conventional medical procedures and surgeries performed by medical professionals, but also to robot-assisted medical procedures and robot-assisted surgeries.

[0086] It should be understood that any of the variations of the instruments described herein may include, in addition to or instead of those described above, various other features. By way of example only, any of the instruments described herein may further include one or more of the various features disclosed in any of the various references incorporated herein by reference. The teachings herein may be readily applied to any of the instruments described in any of the other references cited herein, and thus it should also be understood that the teachings herein may be readily combined in many ways with the teachings of any of the references cited herein. Other types of instruments into which the teachings herein may be incorporated will be apparent to those skilled in the art.

[0087] In addition to the above, the teachings herein may be readily combined with the teachings of the U.S. patent application entitled "Method of Reclaiming Portions of Surgical Instruments for Remanufacturing and Sustainability" [Attorney Docket No. END9447USNP1.0754992], filed on the same date as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein may be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9447USNP1.0754992] will be apparent to those skilled in the art in view of the teachings herein.

[0088] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP1.0754994] entitled "Surgical Instrument with Predetermined Separation Features for Waste Stream Utilization and Related Methods", filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP1.0754994] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0089] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP2.0754977] entitled "Surgical Instrument with Removable Cable and Associated Couplings", filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP2.0754977] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0090] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application [Docket No. END9448USNP3.0754979] entitled "Surgical System and Methods of Assembly and Disassembly of Surgical Instrument", filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Docket No. END9448USNP3.0754979] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0091] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "Robotic Surgical System with Removable Portion and Method of Disassembling Same" [Attorney Docket No. END9449USNP1.0754981], filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9449USNP1.0754981] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0092] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "System for Determining Disposal of Surgical Instrument and Related Methods" [Attorney Docket No. END9450USNP1.0754983], filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9450USNP1.0754983] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0093] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "Surgical Instrument with Various Alignment Features and Methods for Improved Disassembly and Assembly" Ser. No. [Attorney Docket No. END9450USNP3.0755001], filed on the same day as this specification. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9450USNP3.0755001] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0094] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "Surgical System and Methods for Instrument Assessment and Cleaning" [Attorney Docket No. END9450USNP4.0755006] filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9450USNP4.0755006] will be apparent to those skilled in the art upon consideration of the teachings of this specification.

[0095] It should also be understood that any range of values recited herein is to be read as including the upper and lower limits of such range. For example, a range expressed as "about 1.0 inch to about 1.5 inches" is to be read as including about 1.0 inch and about 1.5 inches, in addition to the values between those upper and lower limits.

[0096] It should be understood that any patent, publication, or other disclosure that is referred to as being incorporated herein by reference is incorporated herein only to the extent that the incorporated content does not conflict with the existing definitions, opinions, or other disclosure set forth in this disclosure. As such, and to the extent necessary, the disclosure expressly set forth herein shall supersede any conflicting disclosure incorporated herein by reference. Any content, or portions thereof, that is referred to as being incorporated herein by reference but that conflicts with the current definitions, opinions, or other disclosure set forth in this specification shall be incorporated only to the extent that no conflict arises between the incorporated content and the current disclosure.

[0097] The above-described variants may be designed to be discarded after single use, or they may be designed for multiple uses. In either or both cases, the variants may be reconditioned for reuse after at least one use. Reconditioning may include any combination of a device disassembly process, a subsequent cleaning or replacement process of specific parts, and a subsequent reassembly process. Specifically, some variants of the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some variants of the device may be reassembled for subsequent use either in a reconditioning facility or by an operator immediately prior to the procedure. One skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized in reconditioning the device. The use of such techniques and the resulting reconditioned device are all within the scope of this application.

[0098] Merely by way of example, the variants described herein may be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a sealed container such as a plastic or TYVEK bag and the container is sealed. Next, the container and the device may be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electron beams. The radiation can kill bacteria on the device and within the container. Next, the sterilized device may be stored in the sterilized container for later use. The device may also be sterilized using any other technique well known in the art, including but not limited to beta or gamma rays, ethylene oxide, or steam.

[0099] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be realized by those skilled in the art with appropriate modifications without departing from the scope of the present invention. Some of such possible modifications have been described, but other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, ratios, processes, etc. discussed above are illustrative and not essential. Accordingly, the scope of the present invention should be considered with respect to the following claims and it is understood that it is not limited to the details of the structures and operations shown and described in this specification and the drawings.

[0100] 〔Embodiment〕 (1) A surgical kit, comprising: (a) a surgical instrument; (b) a package that defines an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within the interior of the package or coupled to the package in the closed configuration, and the package is configured to transition to an open configuration by a user to expose the interior and enable access to the surgical instrument during a surgical procedure; (c) a return package configured to receive at least a portion of the surgical instrument after the surgical procedure to reduce cross-contamination, the return package being at least one of coupled to the package or disposed within the interior in the closed configuration. (2) The surgical kit according to embodiment 1, wherein the package includes an outer package, and the return package is disposed within the interior of the outer package in the closed configuration. (3) The surgical kit according to embodiment 2, wherein the return package includes a machine-readable code configured to identify the surgical instrument using a code reader, and the outer package includes a signal blocking feature configured to prevent the machine-readable code from being read using the code reader in the closed configuration. (4) The return package includes an interior and an exterior, the interior of the outer package is formed from a plurality of inner surfaces, and one of the plurality of surfaces, the inner surface, includes a repositionable label configured to be coupled to the exterior of the return package, the surgical kit according to embodiment 2 or embodiment 3. (5) The package includes a sterilization package configured to surround the surgical instrument, and the sterilization package is disposed within the interior of the outer package in the closed configuration, the surgical kit according to any one of embodiments 2 to 4.

[0101] (6) The return package is coupled to the sterilization package or disposed within the sterilization package, the surgical kit according to embodiment 5. (7) The return package includes at least one protrusion configured to securely engage a portion of the surgical instrument, the surgical kit according to any one of embodiments 1 to 6. (8) The return package includes a mark configured to identify the surgical instrument, the surgical kit according to any one of embodiments 1 to 7. (9) The return package includes a repositionable label, and the repositionable label includes the mark, the surgical kit according to embodiment 8. (10) The return package includes a fluid prevention seal configured to transition from an open configuration for receiving the surgical instrument after the surgery to a closed configuration for preventing fluid from exiting the return package, the surgical kit according to any one of embodiments 1 to 9.

[0102] (11) The return package is coupled to the package using a frangible portion configured to be cut by a user, the surgical kit according to any one of embodiments 1 to 10. (12) The surgical instrument includes a first part and a second part configured to be separated from each other, the return package includes a first return package and a second return package, the first return package is configured to receive the first part of the surgical instrument, and the second return package is configured to receive the second part of the surgical instrument. The surgical kit according to any one of Embodiments 1 to 11. (13) The first return package is configured to securely engage with the first part of the surgical instrument, and the second return package is configured to securely engage with the second part of the surgical instrument. The surgical kit according to Embodiment 12. (14) The first return package is combined with the second return package. The surgical kit according to Embodiment 12. (15) Further comprising a robotic surgical system, the robotic surgical system including an arm configured to be coupled to the surgical instrument. The surgical kit according to any one of Embodiments 1 to 14.

[0103] (16) A robotic surgical system, wherein the robotic surgical system (a) a surgical instrument, (b) a package defining an interior and an exterior in a closed configuration, the surgical instrument being disposed within the interior of the package or coupled to the package in the closed configuration, and the outer package being configured to be opened by a user to expose the interior in an open configuration to enable access to the surgical instrument during a surgical procedure, (c) a return package configured to receive the surgical instrument after the surgical procedure to reduce cross-contamination, (d) a machine-readable code coupled to at least one of the surgical instrument, the outer package, or the return package, (e) a code reader configured to read the machine-readable code. A robotic surgical system comprising. (17) The robot surgical system according to embodiment 16, wherein the wrapper includes an outer wrapper, and the return wrapper is disposed within the interior of the outer wrapper in the closed configuration. (18) The robot surgical system according to embodiment 16 or 17, wherein the outer wrapper includes a signal blocking feature configured to prevent the machine-readable code from being read by the code reader in the closed configuration. (19) A method of retrieving a surgical instrument, the method comprising: (a) opening a packaging material to expose a surgical instrument and a return wrapper contained within the packaging material; (b) determining that a portion of the surgical instrument is reusable; (c) inserting the portion of the surgical instrument into the return wrapper; (d) enclosing the return wrapper. (20) The method according to embodiment 19, further comprising attaching a repositionable label to the return wrapper.

Claims

**Claim 1** A surgical kit comprising: (a) a surgical instrument; (b) a package defining an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within the interior of the package or coupled to the package in the closed configuration, and the package is configured to transition to an open configuration by a user to expose the interior and enable access to the surgical instrument during a surgical procedure; and (c) a return package configured to receive at least a portion of the surgical instrument after the surgical procedure to reduce cross-contamination, the return package being at least one of coupled to the package or disposed within the interior in the closed configuration. **Claim 2** The surgical kit of claim 1, wherein the package includes an outer package, and the return package is disposed within the interior of the outer package in the closed configuration. **Claim 3** The surgical kit of claim 2, wherein the return package includes a machine-readable code configured to identify the surgical instrument using a code reader, and the outer package includes a signal-blocking feature configured to prevent the machine-readable code from being read using the code reader in the closed configuration. **Claim 4** The surgical kit of claim 2 or claim 3, wherein the return package includes an interior and an exterior, the interior of the outer package is formed from a plurality of inner surfaces, and one of the plurality of surfaces includes a repositionable label configured to be coupled to the exterior of the return package. **Claim 5** The surgical kit of claim 1, wherein the package includes a sterile package configured to surround the surgical instrument, and the sterile package is disposed within the interior of the outer package in the closed configuration. **Claim 6** The surgical kit of claim 5, wherein the return package is coupled to the sterile package or disposed within the interior of the sterile package. **Claim 7** The surgical kit of claim 1, wherein the return package includes at least one protrusion configured to securely engage the portion of the surgical instrument. **Claim 8** The surgical kit of claim 1, wherein the return package includes a mark configured to identify the surgical instrument. **Claim 9** The surgical kit according to claim 8, wherein the return package includes a repositionable label, and the repositionable label includes the mark.

10. The surgical kit according to claim 1, wherein the return package includes a fluid prevention seal configured to transition from an open configuration for receiving the surgical instrument after the surgery to a closed configuration for preventing fluid from exiting the return package.

11. The surgical kit according to claim 1, wherein the return package is coupled to the package using a frangible portion configured to be cut by a user.

12. The surgical instrument includes a first portion and a second portion configured to separate from each other, the return package includes a first return package and a second return package, the first return package is configured to receive the first portion of the surgical instrument, and the second return package is configured to receive the second portion of the surgical instrument. The surgical kit according to claim 1.

13. The surgical kit according to claim 12, wherein the first return package is configured to securely engage the first portion of the surgical instrument, and the second return package is configured to securely engage the second portion of the surgical instrument.

14. The surgical kit according to claim 12, wherein the first return package is coupled to the second return package.

15. The surgical kit according to claim 1, further comprising a robotic surgical system, the robotic surgical system including an arm configured to couple to the surgical instrument.

16. A robotic surgical system, wherein the robotic surgical system includes (a) a surgical instrument, (b) a package defining an interior and an exterior in a closed configuration, the surgical instrument being disposed within the interior of the package or coupled to the package in the closed configuration, and the outer package being configured to be opened by a user to expose the interior in an open configuration to enable access to the surgical instrument during surgery, (c) a return package configured to receive the surgical instrument after the surgery to reduce cross-contamination, (d) a machine-readable code coupled to at least one of the surgical instrument, the outer package, or the return package A robotic surgical system comprising: (e) a code reader configured to read the machine-readable code. **Claim 17** The robotic surgical system according to claim 16, wherein the package includes an outer package, and the return package is disposed within the interior of the outer package in the closed configuration. **Claim 18** The robotic surgical system according to claim 16 or 17, wherein the outer package includes a signal blocking feature configured to prevent the machine-readable code from being read by the code reader in the closed configuration. **Claim 19** A method of retrieving a surgical instrument, the method comprising: (a) opening a packaging material to expose a surgical instrument and a return package contained within the packaging material; (b) determining that a portion of the surgical instrument is reusable; (c) inserting the portion of the surgical instrument into the return package; and (d) enclosing the return package. **Claim 20** The method according to claim 19, further comprising attaching a repositionable label to the return package.

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