Surgical system and method for assembling and disassembling surgical instruments
The surgical kit and tool assembly address the challenge of assembling and disassembling surgical instruments by using a torque wrench and removable access ports, enabling efficient retrieval of recyclable components and reducing waste through automated disassembly.
Patent Information
- Application Number
- JP2024577234
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-06-30
- Filing Date
- 2023-06-27
- Publication Date
- 2025-07-30
AI Technical Summary
Existing surgical instruments and systems face challenges in efficiently assembling and disassembling components, particularly those requiring specialized tools and irreversible assembly procedures that complicate reuse, recycling, and component retrieval, especially for high-value components like transducers and sensors.
A surgical kit and tool assembly, including a torque wrench and removable access ports, facilitate the assembly and disassembly of surgical instruments, allowing for easy retrieval of recyclable components using reversible adhesives and standard fasteners, and integrating with robotic systems for automated disassembly.
Facilitates efficient assembly and disassembly of surgical instruments, enabling reuse and recycling of valuable components while minimizing damage and simplifying the process, reducing costs and resource waste.
Smart Images

Figure 2025524542000001_ABST
Abstract
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, entitled “Tissue Pad for Use with an Ultrasonic Surgical Instrument,” published Apr. 13, 2006, now abandoned, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2007 / 0191713, entitled “Ultrasonic Device for Cutting and Coagulating,” published Aug. 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, entitled “Ultrasonic Device for Cutting and Coagulating,” published Aug. 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, entitled “Electrosurgical Instrument and Method of Use,” issued Apr. 8, 2008, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 7,381,209, entitled “Electrosurgical Instrument,” issued Jun. 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 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 grasp 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, washed medical personnel, as well as desired furniture and / or fixtures. Examples of such surgical systems and related mechanisms are disclosed in U.S. Patent Application Publication No. 2019 / 0201046, titled "Method for Controlling Smart Energy Devices," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0201080, titled "Ultrasonic Energy Device Which Varies Pressure Applied by Clamp Arm to Provide Threshold Control Pressure at a Cut Progression Location," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0201091, titled "Radio Frequency Energy Device for Delivering Combined Electrical Signals," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2019 / 0274717, titled "Methods for Controlling Temperature in Ultrasonic Device," published on September 12, 2019, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent Application Publication No. 2019 / 0207857, titled "Surgical Network Determination of Prioritization of Communication, Interaction, or Processing Based on System or Device Needs," published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety.
[0006] Although several surgical instruments and systems have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.
Brief Description of the Drawings
[0007] This specification concludes with claims that 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 in the accompanying drawings, where 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.
Embodiments for Carrying Out 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 understood, the technologies described herein can be implemented in other different and obvious manners without departing from the technology. Therefore, the drawings and description should be regarded as illustrative in nature rather than restrictive.
[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 examples 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, as will be apparent to those skilled in the art in view of the teachings herein, any suitable combination of the mechanisms provided below may be incorporated into an exemplary surgical system such as the surgical system (100) and used in an operating room to perform a desired surgical procedure.
[0013] FIG. 2 shows an example of a surgical system (102) used to perform surgery on a patient lying on an operating table (114) within an operating room (116). A robotic system (110) is used as part of the surgical system 102 in a surgical 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 obtained 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 the image of the surgical site and then display it to the surgeon through the console (118).
[0014] Other types of robotic systems can be readily adapted for use with the surgical system (102). Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, filed Dec. 28, 2017, entitled “Robot Assisted Surgical Platform,” the entire disclosure of which is incorporated herein by reference.
[0015] Various examples of cloud-based analysis methods executed by a cloud (104) and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, filed Dec. 28, 2017, entitled “Cloud-Based Medical Analytics,” the entire disclosure of which is incorporated herein by reference.
[0016] In various aspects, the imaging device (124) includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors. In various aspects, the imaging device (124) is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (stomach cameras), endoscopes, laryngoscopes, nasopharyngo-ureteroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes. Some aspects of spectral and multispectral imaging methods are described in detail in the "Advanced Imaging Acquisition Module" of U.S. Provisional Patent Application No. 62 / 611,341, entitled "Interactive Surgical Platform," filed on December 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0017] During any surgical procedure, strict sterilization of the operating room and surgical instruments is required. The strict hygiene and sterilization conditions required in the "operating room," i.e., the operating or treatment room, require the highest possible sterility of all medical devices and instruments. Part of that sterilization process requires sterilizing anything that comes into contact with the patient or penetrates the sterile field. It will be understood that the sterile field can be considered a specific area that is considered free of microorganisms, such as within a tray or on a sterile towel, or that the sterile field can be considered the area immediately surrounding a patient who is prepared for surgery. The sterile field can include properly attired and scrubbed team members, as well as all equipment and fixtures within that area.
[0018] In addition to the introduction of any mechanism of a surgical system (100), furniture, or fixture into a sterile field that requires sterilization, particularly when such a mechanism has come into contact with, or is presumed to have come into contact with, a patient including any tissue and / or fluid associated with a surgical procedure, additional complications can arise from the removal of these mechanisms from the sterile field. Such contamination of these mechanisms from the patient often requires special consideration during or after the surgical procedure, particularly when processing these mechanisms for disposal, reuse, or remanufacture as needed. In one example, the surgical system (100) and / or healthcare providers associated with the surgical procedure can be particularly 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). Additionally, a visualization tower (111) is positioned outside the sterile field. The visualization tower (111) includes a first non-sterile display (107) and a second non-sterile display (109) facing opposite each other. A visualization system (108) guided by a hub (106) is configured to utilize the displays (107, 109, 119) to coordinate the flow of information to the operators inside and outside the sterile field. For example, the hub (106) can cause the visualization system (108) to display a snapshot of the surgical site recorded by an 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 a 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, titled "Interactive Surgical Platform," filed 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, which 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, titled "Interactive Surgical Platform," filed Dec. 28, 2017, the entire disclosure of which is hereby incorporated by reference.
[0022] Referring now to FIG. 3, a hub (106) is shown that communicates with a visualization system (108), a robotic system (110), and a hand-held intelligent surgical instrument (112). The hub (106) includes a hub display (135), an imaging module (138), a 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 evacuation module (126), a suction / irrigation module (128), and / or an operating room mapping module (133).
[0023] During surgery, 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 surgery. Valuable time can be lost in dealing with this problem during surgery. To untangle the lines, it may be necessary to disconnect the lines from their corresponding modules, which may require resetting the modules. The hub module enclosure (136) provides an integrated environment for managing power lines, data lines, and fluid lines, reducing the frequency of such line entanglements.
[0024] Referring to FIGS. 3-4, aspects of the present disclosure are presented regarding a hub module type enclosure (136) that enables modular integration of a generator module (140), a 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 that includes integrated monopole components, bipolar components, and ultrasonic components supported within a single housing unit (139) that is slidably insertable into the hub module type enclosure (136). As shown in FIG. 4, the generator module (140) can be configured to connect to a monopole device (146), a bipolar device (147), and an ultrasonic device (148). Alternatively, the generator module (140) may include a series of monopole generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact via the hub module type enclosure (136). The hub module type enclosure (136) can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked to the hub module type enclosure (136) such that the multiple generators function as a single generator.
[0025] FIG. 5 shows one form of a generator (150) and various surgical instruments (152, 154, 156) that can be used therewith. The surgical instrument (152) is an ultrasonic surgical instrument (152), the surgical instrument (154) is an RF electrosurgical instrument (154), and the multifunctional surgical instrument (156) is an ultrasonic / RF combined electrosurgical instrument (156). The generator (150) 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) of this example is configured to drive a plurality of surgical instruments (152, 154, 156). An example of such a surgical instrument is an ultrasonic surgical instrument (152), which includes a handpiece (160), an ultrasonic transducer 162, a shaft assembly (164), and an end effector (166). The end effector (166) includes an ultrasonic blade (168) and a clamp arm (170) acoustically coupled to the ultrasonic transducer (162). The handpiece (160) includes a trigger (172) for operating the clamp arm (170) and a combination of toggle buttons (173, 174, 175) for supplying and driving energy to the ultrasonic blade (168) or other functions. The toggle buttons (173, 174, 175) can be configured to supply energy to the ultrasonic transducer (162) using the generator (150).
[0027] The generator (150) is also configured to drive another example of a surgical instrument (154). The RF electrosurgical instrument (154) includes a handpiece (176), a shaft assembly (178), and an end effector (180). The end effector (180) includes electrodes within the clamp arms (181, 182) and returns through the electrical conductor portion of the shaft assembly (178). The electrodes are coupled to a bipolar energy source within the generator (150) and are energized by the bipolar energy source. The handpiece (176) includes a trigger (183) for operating the clamp arms (181, 182) and an energy button (184) for actuating an energy switch for supplying energy to the electrodes within the end effector (180).
[0028] The generator (150) is also configured to drive a multi-functional surgical instrument (156). The multi-functional surgical instrument (156) includes a handpiece (185), a shaft assembly (186), and an end effector (188). The end effector (188) includes an ultrasonic blade (190) and a clamp arm (192). The ultrasonic blade (190) is acoustically coupled to 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 energy to and driving the ultrasonic blade (190) or other functions. The toggle buttons (195, 196, 197) can be configured to supply energy to the ultrasonic transducer (162) using the generator (150) and, similarly, to supply energy to the ultrasonic blade (190) using a bipolar energy source housed within the generator (150). It will be appreciated that the handpieces (160, 176, 185) may be replaced with robotically 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, techniques, communication channels, etc. that can communicate data through the use of modulated electromagnetic radiation via a non-solid medium. This term is not meant to imply that the associated devices do not include any wired components, although in some aspects 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 beyond. The computing module may include multiple communication modules. For example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a 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, the term is used to refer to the central processor (central processing unit) within a system or computer system (especially a system on a chip (SoC)) that combines many specialized "processors".
[0031] As used herein, a system-on-chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. This can include digital, analog, mixed-signal, and in many cases high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with state-of-the-art peripherals such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. An SoC may or may not include on-chip memory.
[0032] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU of a microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller may house memory and programmable input / output peripherals along with one or more core processing units (CPUs). Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM and a small amount of RAM are also often included on the chip. A microcontroller can be used for embedded applications, as opposed to microprocessors used for general-purpose applications such as personal computers or other general-purpose applications composed of various individual chips.
[0033] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may also be the connection 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, suction / 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 may be related to the modular device itself (e.g., the speed of a advancing knife, motor current, or energy level). For example, the control algorithm of a surgical stapling instrument and a cutting instrument can control the speed at which the motor of the instrument drives the knife through the tissue according to the resistance generated by the knife as it advances.
[0034] II. Surgical System and Methods of Assembling and Disassembling Surgical Instruments Medical device manufacturers often offer a wide variety of products tailored to the individual preferences of surgeons, hospitals, and patients. To address these preferences, manufacturers may distribute surgical kits of individual components that require assembly before use. In many cases, this assembly is performed immediately before use and can be done by hand without tools. Such assembly may include connecting two electrical connections together or connecting a vacuum line to a vacuum canister. In other cases, this assembly may require special tools such as a wrench to secure nuts.
[0035] Similar to assembly, it may be desirable to disassemble components after use. Disassembly can be advantageous for reasons such as reuse of specific components, analysis of internal wear items, and recycling or refurbishment of expensive components. Disassembly may require the use of specific tools and instruments specialized to access these components and remove them without damage.
[0036] Surgical instruments such as instruments (152, 154, 156) and other instruments shown and described herein are often the most valuable components of a surgical kit, but are often disposable components and thus not reusable. If any of such instruments (152, 154, 156) are reusable, these instruments (152, 154, 156) may require at least partial disassembly and cleaning after use to remove any biological substances that may have been attached to the instruments (152, 154, 156). Whether the instruments (152, 154, 156) are single-use or reusable, the instruments (152, 154, 156) often include expensive components such as transducers, circuit boards, and sensors that can be reused or recycled rather than disposed of.
[0037] Accessing and retrieving these expensive components is often a cumbersome task and, in many scenarios, very costly because there is little or no design consideration for retrieving components after use. For example, in the assembly of such instruments (152, 154, 156), certain irreversible assembly procedures may be used to prevent them from being disassembled. These irreversible procedures can include overmolding, use of adhesives, soldering, use of conformal coatings, one-time joints, and irreversible fasteners. A surgical kit including instruments (152, 154, 156) may have one or more mechanisms configured to facilitate retrieval of expensive and recyclable components. Further, the instruments (152, 154, 156) may include the use of assembly practices such as reversible adhesives, standard fasteners, special access ports, and electrical connectors instead of soldering.
[0038] To this end, FIG. 6 illustrates a surgical kit 3000 for use in a surgical setting that has one or more such features configured to facilitate collection of high-value, recyclable components. The kit 3000 includes a tray 3016 designed to hold and present the components, and while in this example includes all of the items needed to perform a particular operation, alternative examples may have more or fewer components as desired for all or part of the procedure. Such a surgical kit 3000 can simplify ordering by using a single part number for the entire kit 3000 rather than ordering each component separately, which could result in inadvertently omitting a component desired for a surgical procedure. The surgical kit 3000 may be shipped sterile, sterilized on-site, or used non-sterile as needed. The components in surgical kit 3000 in this example include instrument 152, a replacement part 3012 for instrument 152, a parts compartment 3018 incorporated into tray 3016 for capturing spare or discarded parts, a parts container 3020, such as a TYVEK® bag as described herein, for capturing spare or discarded parts that may need to be fluid-tight, an instrument tool assembly 3022, and instructions for use (not shown). While surgical kit 3000 incorporates instrument 152 therein, any surgical instrument, such as instrument 152, 156, or other such instruments described herein, may be incorporated into alternative kits, such that the invention is not intended to be unnecessarily limited to instrument 154.
[0039] More specifically, instrument tool assembly 3022, which may also be referred to herein as tool 3022, is configured to act on instrument 152 to gain access to high-value, recyclable components of instrument 152. In this case, tool 3022 is provided in kit 3000 along with instrument 1520 to ensure availability for use with instrument 152, such as upon disassembly of instrument 152.
[0040] Rather than including the tool (3022) in the kit (3000), FIG. 7 shows an alternative example where the tool (3022) is provided or attached to a generator (150) associated with the instrument (152) (see FIG. 6). In one example, the generator (150) includes a mount (3026) for the tool (3022) on the generator (150), such as on a sidewall of the generator (150). The mount (3026) in this example is configured to support multiple attachment and detachment of the tool (3022). The mount (3026) may also include instructions for using the tool (3022), the tool part number of the tool (3022), the handpiece part number associated with the tool (3022), and / or a website that an operator can refer to for the use of the generator (150) and the tool (3022). The tool (3022) more specifically also includes a label operable to communicate with an electronic device (3045) (see FIG. 8), a nearby instrument (152) (see FIG. 6), and / or the generator (150). The electronic device (3045) includes a communication unit such as a central processing unit (CPU), a memory, a wireless receiver and a wireless transmitter, and / or a feedback system such as a tactile button or a display. The electronic device (3045) is operable with the generator (150) and the instrument (152) and communicates usage and functional data, either wired or wirelessly.
[0041] FIG. 8 shows in more detail an example of a tool (3022) for assembling or disassembling an instrument (152) (see FIG. 6). The tool (3022) may include a body (3023) and a torque limiting aspect such as a torque wrench coupler (3028) attached to the body (3023). The coupler (3028) may fit a conventional hex head fastener, flat head screw, Phillips head screw, or any other dedicated or non-dedicated joint. In one example, the tool (3022) includes a predetermined torque limit associated with the coupler (3028) that is set and calibrated when the tool (3022) is manufactured and is not adjustable by the user. In another example, the tool (3022) includes an adjustable torque limit associated with the coupler (3028), whereby the user can set the torque limit from a plurality of available torque limits and change the applied torque according to the user's desire. A torque limit indicator (3030) is presented on the body (3023) of this example and indicates the adjusted torque limit of the tool (3022). Adjusting the torque limit may be done by turning a handle (3044) such as a click-type torque wrench to the indicated torque limit, turning a rotating shaft such as a T-handle torque wrench, pressing a button such as an electronic torque wrench, or operating a portion of the tool (3022) according to a predetermined amount. In use, the tool (3022) indicates reaching the desired torque by an audible noise, a tactile indication, and / or a visual indication. The tool (3022) can also indicate the current torque being applied without limiting the torque, such as a beam-type torque wrench. Torque limiting aspects such as those associated with the coupler (3028) may be selectable to either enable or disable the torque limit, thereby using the tool (3022) as a wrench or a ratchet. All torque limit and torque display mechanisms may be used with clockwise and / or counterclockwise rotation and may be presented electronically and / or mechanically.
[0042] The tool (3022) further includes a lever portion (3034), which is more specifically shown as a wedge (3034) in this example, and is intended to separate two components of the instrument (152) by pushing the lever portion (3034) into a predetermined access portion (3035) between two components, such as two portions of the housing, and pulling them apart with the lever. The separation of the two components at the predetermined access portion (3035) may be achieved by using the lever portion (3034) as a lever when the lever portion (3034) is pushed between the two components, or may be completed by pushing the lever portion (3034) deeper between the two components and thus forcing them apart. The lever portion (3034) may be located anywhere on the tool (3022) where the tool (3022) can be properly operated to achieve the desired separation of the two components. The lever portion (3034) may be used to separate components joined to each other using a clip or press pin, adhesive, magnet, frangible area, or any other fixture, etc. The lever portion (3034) also functions as a scraper for removing biological material or adhesive on the instrument (152) or generator (150).
[0043] The tool (3022) of this example also includes a key (3032) intended to unlock parts of the appliance (152) and / or the generator (150). The key (3032) may be device-specific or general-purpose so as to be applicable to several devices. The key (3032) may be operable to disassemble the appliance (152) for component removal, or alternatively, may be operable to unlock or access mechanisms of the appliance (152) that would otherwise not be accessible. By way of example, the key is configured to be received within a lock assembly (not shown) of a hatch (3033) configured to transition from a locked state to an unlocked state. In the locked state, the hatch (3033) is secured to prevent access to the interior (3036) of the appliance (152). In the unlocked state, the hatch (3033) enables access to the interior (3036) and is configured to allow removal and / or replacement of components such as ultrasonic transducers from the interior (3036).
[0044] The tool (3022) of this example also includes a cleaning tube (3037) configured to scrub the appliance (152). More specifically, the tool (3022) has a lumen cleaner configured to clean lumens (not shown) on the appliance (152). The cleaning tube (3037) and the lumen cleaner may include bristles and contact surfaces configured to clean the surface.
[0045] As a further example, the tool (3022) has a plier (3040) and a spreader (3038). The plier (3040) and the spreader (3038) may be separate components or may be included as a single component hinged to the body (3023) of the tool (3022). The plier (3040) and the spreader (3038) have handles configured to clamp and expand arms (3042) respectively with respect to the body of the tool (3022) as shown in this example. The plier (3040) and the spreader (3038) may also be a single handle with a plurality of arms (not shown) as a mechanism, where one arm is configured to clamp with respect to the body (3023) of the tool (3022) and the other arm is configured to expand with respect to the body (3023) of the tool (3022). The plier (3040) may be configured to compress components together, such as assembling a plurality of components of the instrument (152), or may be used to crush the components of the instrument (152), thereby gaining access to parts of the instrument (152). In contrast, the spreader (3038) is configured to separate the components of the instrument (152), thereby gaining access to parts of the instrument (152) through, for example, a predetermined access portion (3035).
[0046] In one example, the tool (3022) may be incorporated into a robotic surgical system. In addition to the following teachings, the tool (3022) may be constructed and operable in accordance with at least a portion of the teachings of U.S. Patent No. 9,125,662, the disclosure of which is incorporated herein by reference in its entirety, and / or various other references cited herein. As a further example, the tool (3022) is configured to couple with complementary components of the robotic arm (123) at the robotic joint (3046) (see Figure 2). While the tool (3022) is coupled to the robotic arm (123), the robotic arm (123) can use the tool (3022) to disassemble, assemble, and / or clean the instrument (152) and the generator (152). The robotic arm (123) can use the tool (123) on the instrument (152), and the instrument (152) can be within the tray (3016), mounted on the generator (150), freely movable on a table, etc., or coupled to a complementary robotic arm (123). The robotic arm (123) can use all of the aforementioned functions of the tool (3022), such as changing torque limits and using torque limit modes, using the key (3032), using the lever portion (3034), and using the pliers (3040) and spreader (3038). When the robotic arm (123) is in proximity to the tool (3022), the robotic arm (123) can communicate with the electronics (3045) to learn how the tool (3022) was previously used and can disable the tool (3022) from future use. Communication between the robotic arm (123) and the tool (3022) can be accomplished wirelessly or via a wired link at the robotic joint (3046).
[0047] As described above, a tool (3022) in one example includes an electrical mechanism and / or a conductive mechanical mechanism. Such mechanisms can introduce the risk that power or signals cross undesirably from one electrical mechanism to another electrical mechanism and / or from one electrical mechanism to a conductive mechanical mechanism. Note that the tool (3022) may include electrical mechanisms and / or conductive mechanical mechanisms that introduce the risk of generating a potential between adjacent components or of creating a capacitive coupling between electrical mechanisms and / or between an electrical mechanism and a conductive mechanical mechanism. In the context of the tool (3022), such risks can occur with respect to the components to which the tool (3022) is coupled. Other components of the tool (3022) that can present the above risks will be apparent to those skilled in the art in view of the teachings herein.
[0048] Referring to FIGS. 9A and 9B, another example of a tool (3122) similar to the tool (3022) (see FIG. 8) is shown, except as described separately below. FIG. 9A shows the tool (3122) in a first configuration (3152) such that the tool (3122) can be used in a particular manner with the first mechanism (3048) activated. The first mechanism (3148) can include any of the mechanisms of the above-described tool (3022) (see FIG. 8), such as a torque wrench coupler (3028), a key (3032), a lever portion (3034), a cleaning tube (3037), a spreader (3038), a plier (3040), a handle (3044), a link to an electronic device (3045), and a robot coupling (3046) (see FIG. 8). When the first mechanism (3148) is utilized for its intended purpose, the second mechanism (3150) of the tool (3122) becomes operable after the use of the first mechanism (3148) and, in one example, is configured to become operable only after the use of the first mechanism (3148). Here too, the second mechanism (3150) may include any of the above-described mechanisms of the tool (3022), such as a torque wrench coupler (3028), a key (3032), a lever portion (3034), a cleaning tube (3037), a spreader (3038), a plier (3040), a handle (3044), a link to an electronic device (3045), and a robot coupling (3046) (see FIG. 8). Any combination of the mechanisms of the tool (3022) (see FIG. 8) may be incorporated into the tool (3122), but in this example, the first mechanism (3148) includes the torque wrench coupler (3028) and the second mechanism (3150) includes the lever portion (3034), although the present invention is not intended to be unnecessarily limited to this particular combination of this example. In this example, the tool (3122) can automatically shift from the first mechanism (3148) to the second mechanism (3150) when the torque wrench coupler (3028) reaches a predetermined torque. By shifting the tool (3122) from the first mechanism (3148) to the second mechanism (3150), the user can change the way of holding and operating the tool (3122).
[0049] To enable the second mechanism (3150), the tool (3122) transitions from the first configuration (3152) to the second configuration (3154), as shown in Figure 9B. The tool (3122) also includes a mechanism blocker (3156), such as a cap. For this purpose, when in the first configuration (3152), the mechanism blocker (3156) is configured to prevent access to and / or the function of the second mechanism (3150) prior to the use of the first mechanism (3148). The mechanism blocker (3156) may further include a warning indication thereon, such as an instruction that the first mechanism (3148) should be used before the second mechanism (3150) becomes accessible and / or is used, or an indication that the tool (3122) should transition to the second configuration (3154). The tool (3122) may require the removal or destruction of the mechanism blocker (3156) to make the second mechanism (3150) operable or accessible. When in the second configuration (3154), the tool (3022) is configured to disable the first mechanism (3148) such that the first mechanism (3148) is no longer accessible and / or operable. For example, the mechanism blocker (3156) as a cap may be arranged to cover and / or hide the first mechanism (3148) such that the first mechanism (3148) is no longer accessible and / or visible. The tool (3122) in one example needs to be reset to make the first mechanism (3148) further operable by resetting the tool (3122) to the first configuration (3152). In one example, when in the second configuration (3154), both the first mechanism (3048) and the second mechanism (3050) of the tool (3022) are operable. In this regard, the present invention is not intended to be unnecessarily limited to the sequential operation and access of the first and second mechanisms (3148, 3150) as shown in this example.
[0050] 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 contemplated that certain features mentioned in the following examples can be omitted. Accordingly, none of the aspects or features mentioned below should be considered important unless explicitly so indicated later by the inventors or their successors in right. 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
[0051] A surgical kit comprising: (a) a surgical instrument comprising: (i) an end effector, (ii) a shaft assembly configured to extend proximally from the end effector, and (iii) a body assembly configured to extend proximally from the shaft assembly, wherein at least one of the end effector, the shaft assembly, or the end effector has a predetermined access portion configured to be at least partially removed therefrom for accessing the interior thereof; and (b) an instrument tool assembly comprising: (i) a tool body, (ii) a torque wrench operably connected to the tool body, and (iii) a removal portion operably connected to the tool body and configured to selectively engage a predetermined access portion of the surgical instrument and thereby at least partially remove the predetermined access portion for accessing the interior of the surgical instrument.
Example
[0052] The body assembly includes a body housing, the body housing including an interior and a predetermined access portion for at least partially removing the predetermined access portion of the body housing from the remainder of the body housing, the body housing with the predetermined access portion removed defining a body opening, the surgical kit according to Example 1.
Example
[0053] The body assembly further includes an internal component that is located inside and configured to be removed through an opening, the surgical kit according to Example 2.
Example
[0054] The internal component includes an ultrasonic transducer, the surgical kit according to Example 3.
Example
[0055] The removable portion includes a lever configured to pull the predetermined access portion away from the remainder of the surgical instrument, the surgical kit according to Example 1.
Example
[0056] The predetermined access portion includes a hatch configured to transition from a locked state to an unlocked state, the locked hatch being fixed to prevent access to the interior and the unlocked hatch being configured to selectively move to allow access to the interior, the surgical kit according to Example 1.
Example
[0057] The instrument tool assembly includes a key configured to selectively guide the hatch from a locked state to an unlocked state, the surgical kit according to Example 6.
Example
[0058] The surgical kit according to Example 1, wherein the torque wrench has a restricted state and an unrestricted state, and the torque wrench in the restricted state is configured to limit the torque applied thereby, and the torque wrench in the unrestricted state is configured not to limit the torque applied thereby.
Example
[0059] The surgical kit according to Example 1, further comprising a bag configured to receive and fluidly seal a part of the surgical instrument for storage after use.
Example
[0060] The surgical kit according to Example 1, further comprising a robot interface configured to connect to a robot for robotic disassembly of the surgical instrument.
Example
[0061] The removable portion includes (i) a removal tool operably connected to the tool body and configured to selectively engage a predetermined access portion of the surgical instrument, and (ii) a tool shield covering at least a portion of the removal tool and configured to render the removal tool inoperable. The tool shield is further configured to be selectively moved relative to the removal tool to expose at least a portion of the removal tool and render the removal tool operable. The surgical kit according to Example 1.
Example
[0062] The surgical kit according to Example 1, further comprising a package, the package including (i) a support configured to receive at least one of the surgical instrument or the instrument tool for storage, and (ii) a removal tool integrally formed with the support alone. The removal tool is configured to selectively engage a predetermined access portion of the surgical instrument and thereby at least partially remove the predetermined access portion to access the interior of the surgical instrument.
Example
[0063] The removable tool kit according to Example 1, wherein the removable portion includes a removable tool configured to be operably connected to the tool body and selectively engage a predetermined access portion of the surgical instrument, and the removable tool is configured to be inoperable until a torque wrench is used.
Example
[0064] The surgical tool kit according to Example 13, wherein the torque wrench is configured to become inoperable when the torque wrench is used.
Example
[0065] The surgical tool kit according to Example 1, wherein the instrument tool includes a communication unit configured to communicate with at least one of a surgical instrument or a generator to indicate use to an operator.
Example
[0066] A surgical system comprising: (a) an instrument tool assembly including: (i) a tool body; (ii) a torque wrench operably connected to the tool body and having a torque portion configured to transition from a first state to a second state; and (iii) a removable portion operably connected to the tool body and having a removable tool configured to selectively engage a predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument, wherein the removable tool is configured to be inoperable until the torque portion transitions from the first state to the second state.
Example
[0067] The surgical system according to Example 16, further comprising a surgical device having a tool mount, wherein the instrument tool is configured to be releasably fixed to the tool mount.
Example
[0068] Further including a package, the package includes (i) a support configured to receive at least one of a surgical instrument or an instrument tool for storage, and (ii) a removal tool integrally formed with the support alone, the removal tool selectively engages a predetermined access portion of the surgical instrument, thereby being configured to at least partially remove the predetermined access portion to access the interior of the surgical instrument, the surgical system according to Example 16.
Example
[0069] Further including a bag configured to receive a part of a surgical instrument and fluidly seal it for storage after use, the surgical system according to Example 18.
Example
[0070] A method of accessing the interior of a surgical instrument using an instrument tool, the instrument tool includes (i) a tool body, (ii) a torque wrench operably connected to the tool body, and (iii) a removal portion operably connected to the tool body, the method includes (a) selectively engaging a predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument.
[0071] IV. Others The above-described variations of the device 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.
[0072] It should be understood that any variations of the devices described herein may include various other features in addition to, or instead of, those described above. By way of example only, any of the devices described herein may further include one or more of the various features disclosed in any of the various references incorporated herein by reference. The teachings herein may be readily applied to any of the devices described in any of the other references cited herein, and thus it should also be understood that the teachings herein may be readily combined in many ways with the teachings of any of the references cited herein. Other types of devices into which the teachings herein may be incorporated will be apparent to those skilled in the art.
[0073] 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 upon consideration of the teachings herein.
[0074] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9448USNP1.0754994], entitled "Surgical Instrument with Predetermined Separation Features for Waste Stream Utilization and Related Methods", filed on the same date as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9448USNP1.0754994] will be apparent to those skilled in the art in view of the teachings of this specification.
[0075] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9448USNP2.0754977], entitled "Surgical Instrument with Removable Cable and Associated Couplings", filed on the same date as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9448USNP2.0754977] will be apparent to those skilled in the art in view of the teachings of this specification.
[0076] In addition to the above, the teachings of this specification can be readily combined with the teachings of U.S. Patent Application [Attorney Docket No. END9449USNP1.0754981], entitled "Robotic Surgical System with Removable Portion and Method of Disassembling Same", filed on the same date as this specification and incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. Patent Application No. [Attorney Docket No. END9449USNP1.0754981] will be apparent to those skilled in the art in view of the teachings of this specification.
[0077] 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.
[0078] In addition to the above, the teachings of this specification can be readily combined with the teachings of the U.S. patent application entitled "Reclamation Packaging for Surgical Instrument and Related Methods" [Attorney Docket No. END9450USNP2.0754999], filed on the same day as this specification, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings of this specification can be combined with the teachings of U.S. patent application Ser. No. [Attorney Docket No. END9450USNP2.0754999] will be apparent to those skilled in the art upon consideration of the teachings of this specification.
[0079] 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.
[0080] 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" filed on the same day as this specification and incorporated herein by reference [Attorney Docket No. END9450USNP4.0755006]. 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.
[0081] It should also be understood that any range of values referred to herein should be read to include the upper and lower limits of such range. For example, a range expressed as "about 1.0 inch to about 1.5 inches" should be read to include about 1.0 inch and about 1.5 inches in addition to the values between their upper and lower limits.
[0082] It should be understood that all or part of any patent, publication, or other disclosure referred to herein as being incorporated by reference is incorporated herein only to the extent that the incorporated content does not conflict with the existing definitions, opinions, or other disclosure set forth in this disclosure. In and of itself, 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 by reference but conflicts with the current definitions, opinions, or other disclosure set forth in this specification shall be incorporated only to the extent that there is no conflict between the incorporated content and the current disclosure.
[0083] The above-described variants may be designed to be discarded after single use, or they may be designed for multiple uses. The variants may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of a device disassembly step, followed by a cleaning or replacement step of specific parts, and a subsequent reassembly step. 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.
[0084] 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 and a sealed container such as a plastic or TYVEK® bag. 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.
[0085] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by those skilled in the art with appropriate modifications without departing from the scope of the present invention. Some of such possible modifications have been described, but other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, ratios, processes, etc. discussed above are illustrative and not essential. Therefore, the scope of the present invention should be considered with respect to the following claims, and it is understood that the present invention is not limited to the details of the structures and operations shown and described in this specification and the drawings.
[0086] 〔Embodiment〕 (1) A surgical kit, comprising: (a) A surgical instrument, comprising: (i) An end effector; (ii) A shaft assembly configured to extend proximally from the end effector; (iii) A body assembly configured to extend proximally from the shaft assembly, wherein at least one of the end effector, the shaft assembly, or the end effector has a predetermined access portion configured to be at least partially removed therefrom for accessing the interior thereof; and a surgical instrument; (b) An instrument tool assembly, comprising: (i) A tool body; (ii) A torque wrench operably connected to the tool body; (iii) A removal portion operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion for accessing the interior of the surgical instrument; and an instrument tool assembly, (2) The surgical kit according to embodiment 1, wherein the body assembly includes a body housing, the body housing includes the interior and a predetermined access portion for at least partially removing the predetermined access portion of the body housing from the rest of the body housing, and the body housing with the predetermined access portion removed defines a body opening. (3) The surgical kit according to embodiment 2, wherein the body assembly further includes an internal component that is disposed inside and configured to be removed through the opening. (4) The surgical kit according to embodiment 3, wherein the internal component includes an ultrasonic transducer. (5) The surgical kit according to any one of embodiments 1 to 4, wherein the removable portion includes a lever configured to separate the predetermined access portion from the rest of the surgical instrument.
[0087] (6) The surgical kit according to any one of embodiments 1 to 5, wherein the predetermined access portion includes a hatch configured to transition from a locked state to an unlocked state, the hatch in the locked state is fixed to prevent access to the interior through the hatch, and the hatch in the unlocked state is configured to selectively move to allow access to the interior. (7) The surgical kit according to embodiment 6, wherein the instrument tool assembly includes a key configured to selectively guide the hatch from the locked state to the unlocked state. (8) The surgical kit according to any one of embodiments 1 to 7, wherein the torque wrench has a restricted state and an unrestricted state, the torque wrench in the restricted state is configured to limit the torque applied thereby, and the torque wrench in the unrestricted state is configured not to limit the torque applied thereby. (9) The surgical kit according to any one of embodiments 1 to 8, further including a bag configured to receive and fluidly seal a part of the surgical instrument for storage after use. (10) The surgical kit according to any one of embodiments 1 to 9, wherein the instrument tool assembly further includes a robot interface configured to be connected to a robot for robotic disassembly of the surgical instrument.
[0088] (11) The removable portion (i) a removal tool operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument; (ii) a tool shield covering at least a portion of the removal tool, thereby rendering the removal tool inoperable, the tool shield being selectively movable relative to the removal tool to thereby expose at least a portion of the removal tool and further configured to render the removal tool operable. The surgical kit according to any one of embodiments 1 to 10. (12) Further comprising a package, the package (i) a support configured to receive at least one of the surgical instrument or the instrument tool for storage; (ii) a removal tool integrally formed with the support alone, the removal tool being selectively engaged with the predetermined access portion of the surgical instrument to thereby at least partially remove the predetermined access portion for accessing the interior of the surgical instrument. The surgical kit according to any one of embodiments 1 to 11. (13) The removable portion includes a removal tool operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument, the removal tool being configured to be inoperable until the torque wrench is used. The surgical kit according to any one of embodiments 1 to 12. (14) The torque wrench is configured to be rendered inoperable when the torque wrench is used. The surgical kit according to embodiment 13. (15) The surgical kit according to any one of embodiments 1 to 14, wherein the instrument tool includes a communication unit configured to communicate with at least one of the surgical instrument or the generator to indicate use to an operator.
[0089] (16) A surgical system, (a) An instrument tool assembly, (i) A tool body, (ii) A torque wrench having a torque portion operably connected to the tool body and configured to transition from a first state to a second state, (iii) A removal tool operably connected to the tool body, the removal tool selectively engaging a predetermined access portion of a surgical instrument and thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument, the instrument tool assembly including a removal portion configured as such. The surgical system, wherein the removal tool is configured to be unusable until the torque portion transitions from the first state to the second state. (17) The surgical system according to embodiment 16, further including a surgical device having a tool mount, wherein the instrument tool is configured to be releasably fixed to the tool mount. (18) The surgical system according to embodiment 16 or 17, further including a package, the package including: (i) A support configured to receive at least one of the surgical instrument or the instrument tool for storage, (ii) A removal tool integrally formed with the support alone, the removal tool selectively engaging the predetermined access portion of the surgical instrument and thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument. (19) The surgical system according to embodiment 18, further including a bag configured to receive a part of the surgical instrument and fluidly seal it for storage after use. (20) A method of accessing the interior of a surgical instrument using an instrument tool, the instrument tool including (i) a tool body, (ii) a torque wrench operably connected to the tool body, and (iii) a removable portion operably connected to the tool body, the method comprising (a) selectively engaging a predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument.
Claims
**Claim 1** A surgical kit comprising: (a) A surgical instrument comprising: (i) An end effector; (ii) A shaft assembly configured to extend proximally from the end effector; (iii) A body assembly configured to extend proximally from the shaft assembly, wherein at least one of the end effector, the shaft assembly, or the end effector has a predetermined access portion configured to be at least partially removed therefrom to provide access to the interior thereof; A surgical instrument; and (b) An instrument tool assembly comprising: (i) A tool body; (ii) A torque wrench operably connected to the tool body; (iii) A removal portion operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument to thereby at least partially remove the predetermined access portion to provide access to the interior of the surgical instrument. **Claim 2** The surgical kit of claim 1, wherein the body assembly includes a body housing, the body housing including the interior and the predetermined access portion for at least partially removing the predetermined access portion of the body housing from the remainder of the body housing, and the body housing with the predetermined access portion removed defines a body opening. **Claim 3** The surgical kit of claim 2, wherein the body assembly further includes an internal component located within the interior and configured to be removed through the opening. **Claim 4** The surgical kit of claim 3, wherein the internal component includes an ultrasonic transducer. **Claim 5** The surgical kit according to any one of claims 1 to 4, wherein the removal portion includes a lever configured to pull the predetermined access portion away from the remainder of the surgical instrument. **Claim 6** The surgical kit of claim 1, wherein the predetermined access portion includes a hatch configured to transition from a locked state to an unlocked state, the hatch in the locked state being fixed to prevent access to the interior through the hatch, and the hatch in the unlocked state being configured to selectively move to permit access to the interior. **Claim 7** The surgical kit according to claim 6, wherein the instrument tool assembly includes a key configured to selectively guide the hatch from the locked state to the unlocked state.
8. The torque wrench has a restricted state and a non-restricted state, the torque wrench in the restricted state is configured to limit the torque applied thereby, and the torque wrench in the non-restricted state is configured not to limit the torque applied thereby. The surgical kit according to claim 1.
9. The surgical kit according to claim 1, further comprising a bag configured to receive and fluidly seal a part of the surgical instrument for storage after use.
10. The surgical kit according to claim 1, wherein the instrument tool assembly further includes a robot interface configured to connect to a robot for robotic disassembly of the surgical instrument.
11. The removable portion is (i) a removal tool operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument; (ii) a tool shield covering at least a portion of the removal tool and configured to render the removal tool inoperable, the tool shield being selectively movable relative to the removal tool to thereby expose at least a portion of the removal tool and further configured to enable the removal tool to be usable. The surgical kit according to claim 1.
12. Further comprising a package, the package comprising (i) a support configured to receive at least one of the surgical instrument or the instrument tool for storage; (ii) a removal tool integrally formed separately from the support, the removal tool being selectively engageable with the predetermined access portion of the surgical instrument and configured to at least partially remove the predetermined access portion to access the interior of the surgical instrument. The surgical kit according to claim 1.
13. The surgical kit according to claim 1, wherein the removable portion includes a removal tool configured to be operably connected to the tool body and selectively engage the predetermined access portion of the surgical instrument, and the removal tool is configured to be unusable until the torque wrench is used.
14. The surgical kit according to claim 13, wherein the torque wrench is configured to become unusable when the torque wrench is used.
15. The surgical kit according to claim 1, wherein the instrument tool includes a communication unit configured to communicate with at least one of the surgical instrument or the generator to indicate use to an operator.
16. A surgical system, (a) An instrument tool assembly, (i) A tool body, (ii) A torque wrench having a torque portion operably connected to the tool body and configured to transition from a first state to a second state, (iii) A removal portion having a removal tool operably connected to the tool body, selectively engaging a predetermined access portion of a surgical instrument, and thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument, the surgical system including an instrument tool assembly, The surgical system, wherein the removal tool is configured to be unusable until the torque portion transitions from the first state to the second state.
17. The surgical system according to claim 16, further including a surgical device having a tool mount, wherein the instrument tool is configured to be releasably fixed to the tool mount.
18. Further including a package, the package including (i) A support configured to receive at least one of the surgical instrument or the instrument tool for storage, (ii) A removal tool integrally formed with the support alone, the removal tool selectively engaging the predetermined access portion of the surgical instrument and thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument, the surgical system according to claim 16 or 17.
19. The surgical system of claim 18, further comprising a bag configured to receive a portion of a surgical instrument and fluidly seal it for storage after use. **Claim 20** A method of accessing the interior of a surgical instrument using an instrument tool, the instrument tool including: (i) a tool body; (ii) a torque wrench operably connected to the tool body; and (iii) a removable portion operably connected to the tool body, the method comprising: (a) selectively engaging a predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument.