Recycling packages 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 interior of the package or coupled with the package in the closed configuration. The package (6014) is configured to be transitionable by a user to an open configuration to expose the interior and allow 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 the surgical procedure to reduce cross-contamination. The return package (6018) is coupled with the package or disposed within the interior at least in the closed configuration.

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 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] 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] Figure 6 depicts a schematic perspective view of a first exemplary surgical kit, wherein an outer package of the surgical kit is in a closed configuration;

[0014] Fig. 7A Depicted Figure 6 A top schematic diagram of a surgical kit of FIG. 1 , but with the outer packaging in a partially opened configuration;

[0015] Figure 7B Depicted include Fig. 7A A top schematic diagram of a return package of a surgical kit of a portion of a surgical instrument;

[0016] Figure 8 depicts a schematic perspective view of a second exemplary surgical kit, wherein an outer package of the surgical kit is in a closed configuration;

[0017] Fig. 9 Depicted Figure 8 A top schematic diagram of a portion of a surgical kit including a sterile package, a return package, and surgical instruments; and

[0018] Fig.10 Describes the use Figure 6 and Figure 8 A diagrammatic view of any exemplary method of a surgical kit.

[0019] 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

[0020] 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.

[0021] 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.

[0022] 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.

[0023] I. Examples of Surgical Systems

[0024] 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.

[0025] Figure 2 An 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).

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] like Figure 2 As 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.

[0032] 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).

[0033] refer to Figure 2 , the surgical instrument (112) is used in a surgical procedure as part of the surgical system (102). The hub (106) is also configured to 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.

[0034] 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).

[0035] 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.

[0036] 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.

[0037] 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.

[0038] The generator (150) of this example is configured to be capable of driving a plurality of surgical instruments (152, 154, 156). An 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 powering the ultrasonic blade (168) and driving the ultrasonic blade or other functions. The toggle buttons (173, 174, 175) can be configured to be capable of powering the ultrasonic transducer (162) with the generator (150).

[0039] 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).

[0040] 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 a switch button (195, 196, 197) for energizing the ultrasonic blade (190) and driving the ultrasonic blade or other functions. The switch button (195, 196, 197) can be configured to be capable of energizing the ultrasonic transducer (162) with the generator (150) and energizing 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.

[0041] 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.

[0042] 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".

[0043] 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.

[0044] 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.

[0045] 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.

[0046] II. Exemplary Surgical Kits and Methods of Processing Medical Devices

[0047] In some cases, it may be desirable to recycle portions of a surgical instrument (e.g., surgical instrument (152, 154, 156) to reduce medical waste, which can reduce environmental impact and associated costs. To increase efficiency, it may be beneficial to separate the various components of the surgical instrument (152, 154, 156). For example, it may be beneficial to process different components in different manners (e.g., send different components to different locations). For components that cannot be recycled, it may be desirable to dispose of the component in an environmentally friendly manner. To assist personnel at a medical facility (e.g., a hospital), it is desirable to make the recycling and disposal processes as simple and straightforward as possible. This can improve the processing workflow within an operating room of a medical facility.

[0048] A. First Exemplary Surgical Kit

[0049] Figures 6 to 7AA first exemplary surgical kit (6010) is shown, which includes a surgical instrument (6012), an outer packaging (6014), a sterile packaging (6016), and a return packaging (6018). Surgical kit (6010) can provide initial sterile delivery of surgical instruments (6012), and also provide packaging for recovery or disposal of surgical instruments (6012). In some versions, sterile packaging (6016) or even outer packaging (6014) can be recovered to minimize contamination during return shipping and processing.

[0050] The surgical instrument (6012) may be similar to Figure 5 The surgical instrument (152, 154, 156) shown. For example, the surgical instrument (6012) may be similar to an ultrasonic surgical instrument (152), an RF electrosurgical instrument (154), a combined ultrasonic / RF electrosurgical instrument 156, or a surgical stapler (not shown). The surgical instrument (6012) may be attached to the surgical arm (123) of the robotic system (110), or may be similar to a handheld intelligent surgical instrument (112). The surgical instrument (6012) includes a plurality of parts configured to be separable from each other, which are shown as first, second, and third parts (6020a-c). As used herein, a part may refer to different positions of the same part or completely different parts. Although the first part (6020a) is shown to include an end effector, the second part (6020b) is shown to include a shaft, and the third part is shown to include a handle, these are not exclusive. The first, second, and third parts (6020a-c) may refer to a variety of different parts of the surgical instrument (6012). While first, second, and third portions (6020a-c) are shown, more or fewer portions are contemplated. It is also contemplated that certain portions of surgical instrument (6012) may still be disposed of as medical waste while other portions are recycled for subsequent use in a surgical instrument.

[0051] The first, second, and third parts (6020a-b) can be separated using a variety of different connection structures (e.g., mechanical, electrical, and / or magnetic connection structures). In some versions, the first, second, and third parts (6020a-c) of the surgical instrument (6012) can be destructively disassembled (e.g., using a laser or a breaking tool) after use of the surgical instrument (6012). For example, a breaking tool (not shown) can cause the first and second parts (6020a-b) of the surgical instrument (6012) to break along a predetermined breaking point. As shown, the first, second, or third parts (6020a-c) of the surgical instrument (6012) each include a machine-readable tag (6021a-c). As used herein, a machine-readable tag is intended to cover physical chips (e.g., RFID chips) and optical codes (e.g., QR codes or bar codes). As shown, the surgical instrument (6012) includes a host-readable tag (6023), which can be a machine-readable tag separate from the machine-readable tag (6021a-c). However, one of the machine-readable labels (6021a-c) may be used as the host-readable label (6023). The host-readable label (6023) may include information (e.g., serial number, production date, model number, etc.) about the entire surgical instrument (6012) and / or specific included parts (e.g., first, second, and third parts (6020a-c)).

[0052] The outer package (6014) includes a body (6022) defining an interior (6024) and an exterior (6026) and an optional cover (6027). Figure 6 In the closed configuration, the interior (6024) is completely enclosed. When the outer package (6014) is opened, the outer package (6014) is Figure 6 The closed configuration moves to Fig. 7A In the open configuration, the user can remove the sterile packaging (6016) containing the surgical instrument (6012). In other words, the outer packaging (6014) is opened by the user in the open configuration to expose the interior (6024), thereby allowing access to the surgical instrument (6012) for surgical procedures. The interior (6024) of the outer packaging (6014) is formed by the inner surface (6028) of the body (6022) and the cover (6027).

[0053] like Figure 6 As shown, the inner surface (6028) of the cover (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 the machine-readable label (6021a-c, 6023, 6034) from being read by a code reader (6438, 6440) when the outer package (6014) is in a closed configuration (see Fig.10) to read. The user can simply remove the repositionable label (6030) from the cover (6027) of the outer package (6014) and place the repositionable label (6030) on the return package (6018), which can reduce the time for the user to locate, remove and position the repositionable label (6030). Alternatively, the repositionable label (6030) can be freely set within the interior (6024) of the outer package (6014).

[0054] The sterile package (6016) is configured to enclose a surgical instrument (6012). The sterile package (6016) includes a body (6036) that defines an interior (6038) (see Fig. 7A ) and exterior (6040). The sterile package (6016) is disposed in a closed configuration within the interior (6024) of the outer package (6014). In some versions, the outer package (6014) may be omitted, such that the return package (6018) is coupled to the sterile package (6016) or disposed within the interior (6038) of the sterile package (6016). As shown, the sterile package (6016) includes a recessed portion (6042) that is complementary to the size and / or shape of the component.

[0055] The return package (6018) is configured to receive at least one of the first portion (6020a), the second portion (6020b), or the third portion (6020c) of the surgical instrument (6012) after a surgical procedure. The return package (6018) can be completely disposed within the interior (6024) of the outer package (6014) in a closed configuration. Optionally, the return package (6018) can be coupled to the outer package (6014) in a closed configuration, coupled to the sterile package (6016), and / or disposed within the interior (6038) of the sterile package (6016). The return package (6018) can be connected to a specific location of the surgical instrument (6012) to improve disassembly. Figure 6 As shown, the return package (6018) can be coupled to the outer package (6014) using a frangible portion (6050) that is configured to be severed by a user. In some versions, the frangible portion (6050) can include a string that, when pulled, weakens the frangible portion (6050) and forms a score therein.

[0056] The return package (6018) may be segmented to contain separate portions of the recycled components. The return package (6018) may include multiple separate return packages. Fig. 7A As shown, the plurality of individual return packages include first, second, and third return packages (6044, 6046, 6048). However, more or fewer return packages (6044, 6046, 6048) are also contemplated. The first return package (6044) includes a body (6052) that defines an interior (6054) (see Figure 7B ) and an exterior (6056). The exterior (6056) includes a repositionable label (6058) and a machine-readable label (6060). Similarly, the second return package (6046) includes a body (6062) that defines an interior (6064) (see Figure 7B ) and an exterior (6066). The exterior (6066) includes a repositionable label (6068) and a machine-readable label (6070). The third return package (6048) is shown as a bag having opposed first and second ends (6072, 6074) that are sealed. The third return package (6048) includes a resealable flap (6076) that is configured to allow a user to insert the third portion (6020c) into the interior (6078). The resealable flap (6076) may include a label (6080).

[0057] Each machine-readable tag (6060, 6070, 6092) is coupled to at least one of the surgical instrument (6012), the outer packaging (6014), or the return packaging (6018). Fig.10 ) is configured to be able to read a machine-readable label (6060, 6070, 6092) from a surgical instrument (6012), an outer package (6014), or a return package (6018). For example, the return package (6018) may include a machine-readable label (6060, 6070, 6092) that is configured to be able to identify the surgical instrument (6012) using a code reader (6434, 6436). For example, the first, second, and third return packages (6044, 6046, 6048) may also include a machine-readable label (6060, 6070, 6092) that can be read by a code reader (6438, 6440). The machine-readable label (6060, 6070, 6092) may be used in addition to or in place of the machine-readable labels (6021a-c, 6023, 6034).

[0058] The repositionable tags (6058, 6068) and the tag (6080) may include an optical code, such as a bar code or a QR code, that can be optically read by a code reader (6438, 6440). The repositionable tags (6058, 6068) and the tag (6080) may include indicia (6082, 6084, 6086) to identify 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 indicia (6082, 6084, 6086) may include at least one of a serial number, a model number, and / or an expiration date. Other indicia (6082, 6084, 6086) are also contemplated. For the third return package (6048), the label (6080) may be attached to one end of the resealable flap (6076) and may be closed by coupling the terminal end (6088) of the resealable flap (6076) to the third return package (6048).

[0059] In some versions, first return package (6044) may be initially coupled to second return package (6046). Figure 6 and Fig. 7A As shown, the first and second return packages (6044, 6046) are coupled using a frangible portion (6094). The frangible portion (6094) can be manually cut by a user to maintain sterility. In some versions, the frangible portion (6094) can include a string (6096) that, once pulled, weakens the frangible portion (6094) and forms a score therein. As shown, the third return package (6048) is disposed within the interior (6024) of the outer package (6014) and is not coupled to the first and second return packages (6044, 6046).

[0060] like Figure 7BAs shown, the first return package (6044) is partially configured to receive the first portion (6020a) of the surgical instrument (6012). The first return package (6044) includes a recessed portion (6098) and at least one protrusion (shown as protrusion (6100)). The protrusion (6100) is configured to actively engage the first portion (6020a) of the surgical instrument (6012). Similarly, the second return package (6046) includes a recessed portion (6102) and at least one protrusion (shown as protrusion (6104)). The protrusion (6104) is configured to actively engage the second portion (6020b) of the surgical instrument (6012). The projections (6100, 6104) can be integrally formed with the corresponding return packages (6044, 6046), or the projections (6100, 6104) can be separate components coupled with the corresponding return packages (6044, 6046). The third return package (6048) is configured to receive the third portion (6020c) of the surgical instrument (6012). The recessed portions (6098, 6102) of the return package (6018) can provide multiple functions. For example, the recessed portions (6098, 6102) can provide rigidity to return the package (6018). The shapes and sizes of the recessed portions (6098, 6102) and the projections (6100, 6104) can be set to keep the first and second portions (6020a-b) when the surgical instrument (6012) is disassembled after a surgical operation. The recessed portions (6098, 6102) and the protrusions (6100, 6104) may improve the ability to separate the first and second portions (6020a-b) in a controlled manner.

[0061] B. Second Exemplary Surgical Kit

[0062] Figure 8 A second exemplary surgical kit (6210) is shown, which includes a surgical instrument (6212), an outer packaging (6214), a sterile packaging (6216), and a return packaging (6218). Surgical kit (6210) is similar to the surgical kit described above with reference to Figures 6 to 7B The surgical kit (6010) is different from the sterile package (6016) described in detail below. Unlike the sterile package (6016), a portion of the return package (6218) is coupled to the sterile package (6216), and a portion of the return package (6218) is disposed inside (6238) of the sterile package (6216) (see Fig. 9 ). In some versions, outer packaging (6214) may be omitted.

[0063] Surgical instrument (6212) is similar to surgical instrument (6012). Surgical instrument (6212) includes a plurality of portions configured to be separable from one another along a frangible portion (6219), namely, first, second, and third portions (6220a-c). In some versions, at least one of the first, second, or third portions (6220a-c) of surgical instrument (6212) includes a machine-readable label (6221a-c). Surgical instrument (6212) includes a host-readable label (6223) similar to host-readable label (6023).

[0064] Outer package (6214) is similar to outer package (6014). Outer package (6214) includes a body (6222) defining an interior (6224) and an exterior (6226). Figure 8 In the closed configuration, the interior (6224) is completely enclosed. When the outer package (6214) is opened, the outer package (6214) is Figure 8 The closed configuration moves to (similar to Fig. 7A The interior (6224) of the outer package (6214) is formed by the inner surface (6228) of the body (6222).

[0065] The sterile package (6216) is similar to the sterile package (6016). The sterile package (6216) is configured to be able 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 arranged in a closed configuration within the interior (6224) of the outer package (6214). As shown, the sterile package (6216) may include a recessed portion (6242) complementary to the size and / or shape of the component. Repositionable labels (6230, 6232) can be used to cover and mark the first and second parts (6220a-b) for transportation. Although not shown, a computer readable code may also be included for tracking. A portion of the surgical instrument (6212) may be returned to the sterile package (6216) after use.

[0066] 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 a surgical procedure. The return package (6218) may be segmented to contain separate portions of the returned or recycled components. The return package (6218) may include a plurality of separate return packages. Figure 8As shown, the plurality of individual return packages include first, second, and third return packages (6244, 6246, 6248). However, more or fewer return packages are contemplated. The first return package (6244) includes a body (6252) defining an interior (not shown) and an exterior (6256). Similarly, the second return package (6246) includes a body (6262) defining an interior (not shown) and an exterior (6266). Fig. 9 A repositionable label (6230) is shown attached to the exterior (6266) and a new repositionable label (6268) is shown attached to the exterior (6256). The repositionable labels (6230, 6232) may include markings (6282, 6284) similar to markings (6082, 6084) that function as machine-readable labels as described above. Although not shown, the exterior (6256, 6266) may include additional machine-readable labels.

[0067] The third return package (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) containing a mark (6286). The return package (6218) includes a fluid-tight seal (6274) that is configured to prevent fluid from passing therethrough. The fluid-tight seal (6274) is configured to be able to transform from an open configuration for receiving the surgical instrument (6212) after a surgical procedure to a closed configuration that prevents fluid from leaving the return package (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 by the surgical robot hub (122) or recorded by the surgical robot hub (122) to indicate use, time of use, location of use, etc.

[0068] like Fig. 9As shown, the first return package (6244) is configured to receive the first portion (6220a) of the surgical instrument (6212). The first return package (6244) includes a recessed portion (6298) and at least one protrusion (shown as protrusion (6300)). The protrusion (6300) is configured to actively engage the first portion (6220a) of the surgical instrument (6212). Similarly, the second return package (6246) includes a recessed portion (6302) and at least one protrusion (shown as protrusion (6304)). The protrusion (6300) is configured to actively engage the second portion (6220b) of the surgical instrument (6212). When the surgical instrument (6212) is disassembled, the recessed portions (6298, 6302) retain the first and second portions (6220a-b). The third return package (6248) portion is configured to receive a third portion (6220c) of the surgical instrument (6212) such that the third portion (6220c) may be processed while minimizing user contamination.

[0069] C. Exemplary Methods

[0070] refer to Fig.10 A method (6410) of treating a medical device (e.g., a surgical instrument (6012, 6212)) is shown and described. As shown, the method (6410) includes steps (6412, 6414, 6416, 6418, 6420, 6422, 6424, 6426, 6428, 6430, 6432). However, more or fewer steps are also contemplated.

[0071] At step (6412), the method (6410) includes applying at least one machine-readable label (6021a-c, 6221a-c) to a component (e.g., first, second, and third portions (6020a-c, 6220a-c)) of the surgical instrument (6012, 6212) using a marking device (6430). In some versions, the marking device (6430) may apply the machine-readable label (6021a-c, 6221a-c) using an indentation process or a laser etching process. Although the machine-readable label (6021a-c, 6221a-c) is described as being applied prior to assembly of the surgical instrument (6012, 6212), in some cases, the machine-readable label (6021a-c, 6221a-c) may be applied after assembly of the surgical instrument (6012, 6212). For example, the host-readable label (6023, 6223) may be applied after the surgical instrument (6012, 6212) is assembled.

[0072] At step (6414), the method (6410) includes sorting and assembling the components of the surgical instrument (6012, 6212). For example, the sorting may be performed using a sorting system (6436). Matched reusable components may optimize the performance and life of the surgical instrument (6012, 6212). The sorting system (6436) may include a visual system that can read machine-readable labels (6021a-c, 6221a-c) during the sorting step. An indication of the availability status of the component may be provided. The indication may be an alarm in the form of an audible tone or a visual indication. For example, the visual indication may include one or more colored lights on the assembly device. The machine-readable label (6021a-c, 6221a-c) indicates that a particular component (e.g., the first, second, and third parts (6020a-c, 6220a-c)) has been assembled into the surgical instrument (6012, 6212). Certain internal components have electronic chips that identify the specific components that can be read by a host readable tag (6023). The host readable tag (6023, 6223) identifies the component associated with the installation and use of the surgical instrument (6012, 6212). For example, the host readable tag (6023) can identify the presence of a camera nearby or at each station in the manufacturing facility that recognizes the machine readable tags (6021a-c, 6221a-c) and groups the components into surgical instruments (6012, 6212).

[0073] At step (6416), the method (6410) includes scanning the machine-readable label (6021a-c, 6023, 6221a-c) before the surgical kit (6010, 6210) leaves the manufacturer. At step (6418), the method (6410) includes shipping the surgical kit (6010, 6210) to a medical facility for subsequent use.

[0074] At step (6420), method (6410) includes opening the outer packaging (6014, 6214) and / or the sterile packaging (6016, 6216) to transform the surgical kit (6010, 6210) from a closed configuration to an open configuration. For example, a user at a medical facility may manually open the outer packaging (6014, 6214) and / or the sterile packaging (6016, 6216). The sterile packaging (6216) may be removed from the outer packaging (6214) in preparation for storage, or the sterile packaging (6216) may be removed from the outer packaging (6214) prior to use in a medical procedure. The surgical system (102) may identify when the packaging has been opened. For example, after the outer packaging (6014, 6214) is opened and the surgical instrument (6012, 6212) is removed from the outer packaging (6014, 6214), the signal from the machine-readable tag (6021a-c, 6023, 6034, 6221a-c, 6223) is no longer blocked by the outer packaging (6014, 6214). Before the cover (6027) is removed, the signal is blocked or otherwise contained. Once the cover (6027) of the outer packaging (6014) is removed, the signal from the machine-readable tag (6021a-c, 6023, 6034, 6221a-c, 6223) can reach the surgical robot hub (122).

[0075] At step (6422), the method (6410) includes scanning the machine-readable tag (6021a-c, 6023, 6221a-c, 6223) using a code reader (6440). The surgical robot hub (122) or another portion of the surgical system (102) may include the code reader (6440). The code reader (6440) may determine information about the entire surgical instrument (6012, 6212) or its components. Such scanning may be performed manually by a user or automatically by the surgical robot hub (122). Once the surgical instrument (6012, 6212) is assembled into the robotic system (110), the machine-readable tag (6021a-c, 6221a-c) may be scanned.

[0076] At step (6424), the method (6410) includes determining the status of various components. The status may include a coupling status (e.g., whether the surgical instrument (6012, 6212) is coupled to the robotic system (110)), a condition of the components of the surgical instrument (6012, 6212), and their availability for use. A controller (6442), which may be located in the surgical robot hub (122), may use the scan of step (6422) to determine usage information of the first, second, and third portions (6020a-c, 6220a-c). The controller (6442) may record the usage information on at least one of the cloud (104), the surgical robot hub (122), the controller (6442), or the machine-readable tag (6021a-c, 6023, 6034, 6221a-c, 6223) for later retrieval. This usage data may be sent to a central system of the manufacturer of the surgical instrument (6012, 6212) and / or to a database at the return facility for enhanced tracking.

[0077] At step (6426), the method (6410) includes providing an indication to the user regarding the coupling status of the surgical instrument (6012, 6212). The surgical system (102) can identify when the first, second, and third portions (6020a-c, 6220a-c) have been used. The surgical system (102) can identify whether the component makeup of a particular surgical instrument (6012, 6212) is acceptable or unacceptable, and can prevent installation if unacceptable. The indication can be an alarm in the form of an audible tone or a visual indication.

[0078] At step (6428), the method (6410) includes inserting the components into the return package (6018, 6218). In some versions, a packaging tray (which may be formed from a portion of the sterile package (6216) or a separate tray) may be used to help fill the first, second, and third return packages (6044, 6046, 6048, 6244, 6246, 6248) and / or prevent the contents (e.g., first, second, and third portions (6020a-c, 6220a-c)) placed within the first, second, and third return packages (6044, 6046, 6048, 6244, 6246, 6248) from spilling. At step (6430), the packaging tray may improve organization and reduce the overall time to prepare the first, second, and third return packages (6044, 6046, 6048, 6244, 6246, 6248) for subsequent shipment.

[0079] At step (6432), the method (6410) includes evaluating the returned portions of the surgical instrument (6012, 6212). Evaluating the returned portions (e.g., the first, second, and third portions (6020a-c, 6220a-c)) improves the process flow so that the portions can be evaluated and potentially reused. For example, the recycling system (6444) may tag the surgical instrument (6012, 6212) to track usage. Tracking may allow for more straightforward sorting of the portions (e.g., the first, second, and third portions (6020a-c, 6220a-c)) at a return location (e.g., a manufacturing facility or other return facility). The return location may scan the machine-readable label (6021a-c, 6221a-c) and sort the portions (e.g., the first, second, and third portions (6020a-c, 6220a-c)) according to a variety of criteria, including number of uses. Retrieval system (6444) may read usage information from surgical instrument (6012, 6212). The usage data may be on a memory (e.g., an EEPROM). Retrieval system (6444) may determine whether surgical instrument (6012, 6212) has been used. The memory may store record data regarding the use of surgical instrument (6012, 6212) and record component serial numbers. In some versions, surgical instrument (6012, 6212) may be physically tagged as described in step (6412).

[0080] III. Exemplary Combinations

[0081] 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.

[0082] Example 1

[0083] 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 or coupled to the interior of the package in the closed configuration, wherein the package is configured to be transitioned by a user to an open configuration to expose the interior and allow access to the surgical instrument during the 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, wherein the return package is coupled to or disposed within the interior of the package in at least the closed configuration.

[0084] Example 2

[0085] A surgical kit according to Example 1, wherein the packaging includes an outer package, and wherein the return package is disposed in the closed configuration within the interior of the outer package.

[0086] Example 3

[0087] A surgical kit according to Example 2, wherein the return packaging includes a machine-readable code, the machine-readable code is configured to enable the use of a code reader to identify the surgical instrument, and wherein the outer packaging includes a signal blocking feature, the signal blocking feature is configured to prevent the machine-readable code from being read using the code reader in the closed configuration.

[0088] Example 4

[0089] A surgical kit according to any one of Examples 2 to 4, wherein the return package includes an interior and an exterior, wherein the interior of the exterior package is formed by a plurality of interior surfaces, wherein one of the plurality of surfaces includes a repositionable label configured to be coupled to the exterior of the return package.

[0090] Example 5

[0091] A surgical kit according to any one of embodiments 2 to 4, wherein the packaging includes a sterile package, which is configured to surround the surgical instrument, and wherein the sterile package is disposed in the closed configuration within the interior of the outer package.

[0092] Example 6

[0093] A surgical kit according to Example 5, wherein the return package is coupled to the sterile package or is disposed within the interior of the sterile package.

[0094] Example 7

[0095] A surgical kit according to any one of embodiments 1 to 6, wherein the return package includes at least one protrusion, and the at least one protrusion is configured to actively engage the portion of the surgical instrument.

[0096] Example 8

[0097] A surgical kit according to any one of embodiments 1 to 7, wherein the return packaging includes markings configured to identify the surgical instrument.

[0098] Example 9

[0099] The surgical kit of Example 8, wherein the return packaging includes a repositionable label, wherein the repositionable label includes the marking.

[0100] Example 10

[0101] A surgical kit according to any one of embodiments 1 to 9, wherein the return package includes a fluid-tight seal, and the fluid-tight seal is configured to be able to transition from an open configuration for receiving the surgical instrument after the surgical procedure to a closed configuration for preventing fluid from leaving the return package.

[0102] Embodiment 11

[0103] A surgical kit according to any one of embodiments 1 to 10, wherein the return package is coupled to the package using a frangible portion that is configured to be severed by a user.

[0104] Example 12

[0105] A surgical kit according to any one of embodiments 1 to 11, wherein the surgical instrument includes a first part and a second part that are configured to be separated from each other, wherein the return package includes a first return package and a second return package, wherein the first return package is configured to receive the first part of the surgical instrument, and wherein the second return package is configured to receive the second part of the surgical instrument.

[0106] Example 13

[0107]

[00136] The surgical kit of Example 12, wherein the first return package is configured to positively engage the first portion of the surgical instrument, and wherein the second return package is configured to positively engage the second portion of the surgical instrument.

[0108] Embodiment 14

[0109] A surgical kit according to Example 12, wherein the first return package is coupled to the second return package.

[0110] Embodiment 15

[0111] According to any one of embodiments 1 to 14, the surgical kit also includes a robotic surgical system, wherein the robotic surgical system includes an arm configured to be coupled to the surgical instrument.

[0112] Example 16

[0113] A robotic surgical system comprises: (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 interior of the package in the closed configuration, wherein the outer package is configured to be opened by a user to expose the interior in an open configuration to allow 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; and (e) a code reader configured to read the machine-readable code.

[0114] Embodiment 17

[0115]

[00136] The robotic surgical system of Example 16, wherein the packaging comprises an outer packaging, wherein the return packaging is disposed within the interior of the outer packaging in the closed configuration.

[0116] Embodiment 18

[0117] A robotic surgical system according to any one of embodiments 16 to 17, wherein the outer packaging includes a signal blocking feature, and the signal blocking feature is configured to prevent the machine-readable code from being read by the code reader in the closed configuration.

[0118] Embodiment 19

[0119] A method for recycling a surgical instrument, the method comprising: (a) opening 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 can be reused; (c) inserting the portion of the surgical instrument into the return package; and (d) closing the return package.

[0120] Embodiment 20

[0121] The method of Embodiment 19, further comprising attaching a repositionable label to the return package.

[0122] IV. Miscellaneous

[0123] 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.

[0124] 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.

[0125] 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 "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. END9447USNP1.0754992] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0126] 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 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. END9448USNP1.0754994] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0127] 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 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. END9448USNP2.0754977] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0128] 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 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. END9448USNP3.0754979] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0129] 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 "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. END9449USNP1.0754981] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0130] 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. END9450USNP1.0754983], 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 the U.S. Patent Application [Agent Docket No. END9450USNP1.0754983] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0131] 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 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 the 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.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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 surgical kit comprising: (a) surgical instruments; (b) a package defining an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within or coupled to the interior of the package in the closed configuration, wherein the package is configured to be transitioned by a user to an open configuration to expose the interior and allow access to the surgical instrument during the 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, wherein the return package is coupled to the package or disposed within the interior in at least the closed configuration.

2. The surgical kit of claim 1, wherein: The packaging includes an outer packaging, wherein the return packaging is disposed within the interior of the outer packaging in the closed configuration.

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, wherein 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. A surgical kit according to claim 2 or claim 3, wherein: The return package includes an interior and an exterior, wherein the interior of the outer package is formed by a plurality of interior surfaces, wherein one of the plurality of surfaces includes a repositionable label configured to couple with the exterior of the return package.

5. The surgical kit according to any one of claims 2 to 4, wherein: The packaging includes a sterile package configured to surround the surgical instrument, wherein the sterile package is disposed within the interior of the outer package in the closed configuration.

6. The surgical kit of claim 5, wherein: The return package is coupled to the sterile package or disposed within an interior of the sterile package.

7. A surgical kit according to any preceding claim, wherein: The return package includes at least one protrusion configured to positively engage the portion of the surgical instrument.

8. A surgical kit according to any preceding claim, wherein: The return package includes indicia configured to identify the surgical instrument.

9. The surgical kit of claim 8, wherein: The return package includes a repositionable label, wherein the repositionable label includes the indicia.

10. A surgical kit according to any preceding claim, wherein: The return package includes a fluid-tight seal configured to transition from an open configuration for receiving the surgical instrument following the surgical procedure to a closed configuration for preventing fluid from exiting the return package.

11. A surgical kit according to any preceding claim, wherein: The return package is coupled to the package using a frangible portion configured to be severed by a user.

12. A surgical kit according to any preceding claim, wherein: The surgical instrument includes a first part and a second part that are configured to be separated from each other, wherein the return package includes a first return package and a second return package, wherein the first return package is configured to receive the first part of the surgical instrument, and wherein the second return package is configured to receive the second part of the surgical instrument.

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

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

15. The surgical kit of any preceding claim, further comprising a robotic surgical system, wherein: The robotic surgical system includes an arm configured to be coupled to the surgical instrument.

16. A robotic surgical system comprising: (a) surgical instruments; (b) a package defining an interior and an exterior in a closed configuration, wherein the surgical instrument is disposed within or coupled to the interior of the package in the closed configuration, and wherein the outer package is configured to be openable by a user to expose the interior in an open configuration to allow 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 packaging, or the return packaging; and (e) A code reader configured to read the machine-readable code.

17. The robotic surgical system of claim 16, wherein: The packaging includes an outer packaging, wherein the return packaging is disposed within the interior of the outer packaging in the closed configuration.

18. A robotic surgical system according to claim 16 or claim 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.

19. A method of recovering a surgical instrument, the method comprising: (a) opening the 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 the portion of the surgical instrument into the return package; as well as (d) closing the return package.

20. The method of claim 19, further comprising attaching a repositionable label to the return package.

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