Surgical systems and methods of assembling and disassembling surgical instruments

Abstract

A surgical kit and related methods of assembly and disassembly includes a surgical instrument having an end effector, a shaft assembly, and a body assembly. The surgical instrument includes a predetermined access portion configured to be at least partially removable to access an interior of the surgical instrument. The surgical kit also includes an instrument tool assembly having a tool body, a torque wrench connected to the tool body, and a removal portion for obtaining access to the interior of the surgical instrument.

Description

Background Art

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

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

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

[0004] In some scenarios, it may be preferred to have the surgical instrument directly grasped and manipulated by one or more hands of one or more human operators.In addition or as an alternative, it may be preferred to have the surgical instrument controlled via a robotic surgical system. Examples of robotic surgical systems and associated instruments are disclosed in the following documents: U.S. Patent No. 10,624,709, entitled “Robotic Surgical Tool with Manual Release Lever,” issued on May 2, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,314,308, entitled “Robotic Ultrasonic Surgical Device With Articulating End Effector,” issued on April 19, 2016, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,125,662, entitled “Multi-Axis Articulating and Rotating Surgical Tools,” issued on September 8, 2015, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,125,662, entitled “Multi-Axis Articulating and Rotating Surgical Tools,” issued on September 2, 2014, the disclosure of which is incorporated herein by reference in its entirety; No. 8,820,605, entitled “Ultrasonic Surgical Instruments”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2019 / 0201077, entitled “Interruption of Energy Due to Inadvertent Capacitive Coupling”, published on July 4, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2012 / 0292367, entitled “Robotically-Controlled End Effector”, published on November 11, 2012 (now abandoned), the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 16 / 556,661, entitled “Ultrasonic Surgical Instrument with a Multi-Planar Articulating Shaft Assembly”, filed on the same date as this application, the disclosure of which is incorporated herein by reference in its entirety.

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

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

[0007] While this specification results in claims that particularly point out and distinctly claim such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate the same elements, and wherein:

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

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

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

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

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

[0013] Figure 6 Depicted are examples of instrument tool assemblies including and Figure 5 A schematic front view of a surgical kit of surgical instruments;

[0014] Figure 7 Depicted Figure 5 The generator and Figure 6 A schematic side view of an instrument tool assembly;

[0015] Figure 8 Depicted Figure 6 A schematic front view of an instrument tool assembly;

[0016] Fig. 9A depicts a schematic front view of another example of an instrument tool assembly in a first configuration; and

[0017] Fig. 9B Depicted in the second configuration Fig. 9A Schematic front view of an instrument tool assembly.

[0018] 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

[0019] 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.

[0020] 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.

[0021] 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.

[0022] I. Examples of Surgical Systems

[0023] 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, 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.

[0024] 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).

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] like Figure 2 As shown, 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, the snapshot on the non-sterile display (107) or display (109) can allow a non-sterile operator to perform diagnostic steps related to a surgical procedure.

[0031] 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).

[0032] 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.

[0033] 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).

[0034] 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.

[0035] 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, the generator module (140) may be a generator module having integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit (139) that is slidably inserted into the hub modular housing (136). Figure 4 As shown, 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.

[0036] 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.

[0037] 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 power the ultrasonic transducer (162) with the generator (150).

[0038] 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).

[0039] 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.

[0040] 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.

[0041] 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".

[0042] 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.

[0043] 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.

[0044] 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.

[0045] II. Surgical Systems and Methods of Assembling and Disassembling Surgical Instruments

[0046] Manufacturers of medical devices often offer a large number of customized products to meet the individual preferences of surgeons, hospitals, and patients. To meet these preferences, manufacturers may distribute surgical kits consisting of individual components that need to be assembled before use. In many cases, this assembly is performed immediately before use and can be performed by hand without tools. This assembly may include connecting two electrical connectors together, or connecting a vacuum line to a vacuum tank. In other cases, this assembly may require specialized tools, such as a wrench to secure a nut.

[0047] As with assembly, it may be desirable to disassemble a component after use. Disassembly may be advantageous for reasons such as reusing certain components, analyzing internal wear items, and recycling or refurbishing high-value components. Disassembly may require the use of certain tools and instruments designed specifically to access and remove these components without damaging them.

[0048] 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 in many cases are single-use components and therefore are not reusable. If any of such instruments (152, 154, 156) are reusable, then these instruments (152, 154, 156) may need to be at least partially disassembled and cleaned after use to remove any biological material that may have been attached to the instruments (152, 154, 156). Regardless of whether the instruments (152, 154, 156) are single-use or reusable, the instruments (152, 154, 156) will typically contain high-value components, such as transducers, circuit boards, and sensors, which can be reused or recycled rather than disposed of.

[0049] Accessing and harvesting these high-value parts can often be a laborious task and in many cases cost-prohibitive, so there is little or no design consideration for harvesting the parts after use. For example, when assembling these instruments (152, 154, 156), certain irreversible assembly procedures may be used to prevent them from being disassembled. These irreversible procedures may include overmolding, use of adhesives, welding, use of conformal coatings, disposable accessories, and irreversible fasteners. A surgical kit including instruments (152, 154, 156) may have one or more features configured to facilitate the acquisition of high-value and recyclable parts. In addition, 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 welded joints.

[0050] to this end, Figure 6 A surgical kit (3000) for use in a surgical setting is depicted, the surgical kit having one or more such features configured to facilitate the collection of high-value and recyclable parts. The kit (3000) includes a tray (3016) designed to hold and present parts, and in this example, includes all items needed to perform a particular operation, although alternative examples may have more or fewer parts as needed for all or part of the surgery. Such a surgical kit (3000) can simplify ordering by using a single part number for the entire kit (3000) rather than ordering each part individually, which may result in inadvertently missing a desired part for a surgical procedure. The surgical kit (3000) can be shipped sterile, can be sterilized on site, or can be used non-sterilely if desired. The components of the surgical kit (3000) of this example include an instrument (152), a replacement component (3012) for the instrument (152), a component compartment (3018) built into a tray (3016) for capturing spare or discarded components, and a component container (3020) for capturing spare or discarded components that may require fluid sealing (such as described herein). The invention also includes a surgical kit (3000) and an instrument tool assembly (3022), and instructions for use (not shown). Although surgical kit (3000) incorporates instrument (152) therein, any surgical instrument (such as instruments (154, 156) or other such instruments described herein) may be incorporated into an alternative kit such that the present invention is not intended to be unnecessarily limited to instrument (152).

[0051] More specifically, instrument tool assembly (3022), also referred to herein as tool (3022), is configured to act on instrument (152) to gain access to high-value and recyclable components of instrument (152). In this case, tool (3022) is provided with instrument (152) in kit (3000) to ensure usability for use with instrument (152), such as when instrument (1520) is disassembled.

[0052] Rather than including tool (3022) in kit (3000), Figure 7 Tool (3022) is shown provided or attached to the instrument (152) (see Figure 6 ) is an alternative example of a generator (150) associated with the generator (150). In one example, the generator (150) includes a mounting member (3026) for the tool (3022) located on the generator (150) (such as on a side wall of the generator (150)). The mounting member (3026) of this example is configured to support multiple attachments and detachments of the tool (3022). The mounting member (3026) may also include instructions for use of the tool (3022), a tool part number of the tool (3022), a handpiece part number associated with the tool (3022), and / or a website that an operator can refer to for use of the generator (150) and the tool (3022). More specifically, the tool (3022) also includes a tool operable to connect to a nearby instrument (152) (see Figure 6 ) and / or the electronic device (3045) for communicating with the generator (150) (see Figure 8 ) and tags. The electronics (3045) include a central processing unit (CPU), memory, a communication unit (such as a wireless receiver and transmitter), and / or a feedback system (such as a tactile button or display). The electronics (3045) can operate with the generator (150) and the instrument (152) to transmit usage and function data either wiredly or wirelessly.

[0053] Figure 8 The apparatus (152) for assembling or disassembling is shown in more detail (see Figure 6). The tool (3022) may include a body (3023), a torque limiting aspect attached to the body (3023), such as a torque wrench coupler (3028). The coupler (3028) may be more quickly mated to conventional hex head, flat head, cross head screws, or any other proprietary or non-proprietary accessories. In one example, the tool (3022) includes a predefined torque limit associated with the coupler (3028), which is set and calibrated when the tool (3022) is produced and cannot be adjusted by the user. In another example, the tool (3022) includes an adjustable torque limit associated with the coupler (3028), allowing the user to set the torque limit from a plurality of available torque limits to change the torque that the user desires to apply. A torque limit indicator (3030) is presented on the body (3023) of this example to indicate the torque limit to which the tool (3022) has been adjusted. Adjusting the torque limit can be performed by twisting the handle (3044) to the indicated torque limit, such as a click-type torque wrench; twisting the rotating shaft, such as a T-shaped handle torque wrench; pressing a button, such as an electronic torque wrench; or manipulating a portion of the tool (3022) according to a predetermined amount. When in use, the tool (3022) uses an audible noise, a tactile indication, and / or a visual indication to indicate that the desired torque has been reached. The tool (3022) is also capable of indicating the current torque being applied without limiting the torque, such as a beam torque wrench. Aspects of torque limitation, such as those associated with the connector (3028), can be selectable to allow torque limitation or prohibit torque limitation, thereby using the tool (3022) as a wrench or ratchet. All torque limiting and torque indication features can be used for clockwise and / or counterclockwise rotation and can be presented electronically and / or mechanically.

[0054] The tool (3022) also includes a prying portion (3034), which is more specifically shown as a wedge (3034) in this example, and is intended to separate and pry apart two parts of the instrument (152) by wedging the prying portion (3034) at a predetermined approach (3035) between two parts (such as two parts of the housing). The separation of the two parts at the predetermined approach (3035) can be achieved by using the prying portion (3034) as a lever once the prying portion (3034) has been wedged between the two parts, or it can also be achieved by wedging the prying portion (3034) more deeply between the two parts and thus forcing them to separate. The prying portion (3034) can be located at any position on the tool (3022) that can appropriately manipulate the tool (3022) to achieve the desired separation of the two parts. The prying portion (3034) can be used to separate parts that have been coupled together, such as by a clip or press pin, an adhesive, a magnet, a break region, or by any other fixing means. Prying portion (3034) also functions as a scraper to remove biomaterial or adhesive from instrument (152) or generator (150).

[0055] The tool (3022) of this example also includes a key (3032) intended to unlock portions of the instrument (152) and / or the generator (150). The key (3032) may be device-specific, or may be universal so as to be applicable to a number of devices. The key (3032) may be operable to disassemble the instrument (152) for component collection, or may be operable to unlock or access otherwise unavailable features of the instrument (152). For example, the key is configured to be received within a lock assembly (not shown) of a hatch (3033) that is configured to be able to transition from a locked state to an unlocked state. In the locked state, the hatch (3033) is fixed to prevent access to the interior (3036) of the instrument (152) through it. In the unlocked state, the hatch (3033) is configured to be able to selectively move to allow access to the interior (3036) and to remove and / or replace components, such as an ultrasonic transducer, from the interior (3036).

[0056] The tool (3022) of this example also includes a cleaning tube (3037) configured to scrub and clean the instrument (152). More specifically, the tool (3022) has a lumen cleaner configured to clean a lumen (not shown) on the instrument (152). The cleaning tube (3037) and lumen cleaner may include bristles and contact surfaces configured to clean a surface.

[0057] As another example, tool (3022) has pliers (3040) and dilator (3038). Pliers (3040) and dilator (3038) may be separate components, or may be included as one component hinged against the body (3023) of tool (3022). Pliers (3040) and dilator (3038) have handles that are configured to clamp arms (3042) against the body of tool (3022) and dilate the arms, respectively, as shown in this example. Pliers (3040) and dilator (3038) may also feature a single handle with multiple arms (not shown), one of which is configured to clamp against the body (3023) of tool (3022), and another of which is configured to dilate against the body (3023) of tool (3022). Forceps (3040) are configured to compress components together, such as to assemble multiple components of instrument (152), or may be used to squeeze components of instrument (152) to gain access to portions of instrument (152). In contrast, dilator (3038) is configured to separate components of instrument (152) to gain access to portions of instrument (152), such as through a predetermined access portion (3035).

[0058] In one example, tool (3022) may be incorporated into a robotic surgical system. In addition to the teachings below, tool (3022) may be constructed and operated in accordance with at least some of the teachings of: U.S. Pat. No. 9,125,662, the disclosure of which is incorporated herein by reference in its entirety; and / or various other references cited herein. As another example, tool (3022) is configured to be capable of coupling with robotic arm (123) (see FIG. 1 ) at robotic coupling (3046). Figure 2) is coupled to a complementary component of the robot arm (123). When the tool (3022) is coupled to the robot arm (123), the robot arm (123) can use the tool (3022) to disassemble, assemble and / or clean the instrument (152) and the generator (152). The robot arm (123) can use the tool (123) on the instrument (152) when the instrument (152) is located in the tray (3016), mounted on the generator (150), freely movable (such as on a table), or coupled to a complementary robot arm (123). The robot arm (123) can use all of the aforementioned functions of the tool (3022), such as changing the torque limit and using the torque limiting aspects, using the key (3032), using the prying portion (3034), and using the forceps (3040) and the dilator (3038). When the robotic arm (123) approaches the tool (3022), the robotic arm (123) can communicate with the electronics (3045) to learn how the tool (3022) was previously used and to disable the tool (3022) from future use. The communication between the robotic arm (123) and the tool (3022) can be done wirelessly or through a wired link at the robotic linkage (3046).

[0059] As described above, in one example, the tool (3022) includes electrical features and / or conductive mechanical features. Such features may induce a risk of power or signals unexpectedly crossing from one electrical feature to another electrical feature and / or from one electrical feature to a conductive mechanical feature. In addition, the tool (3022) may include electrical features and / or conductive mechanical features that may induce a risk of generating a potential between adjacent components or forming a capacitive coupling between the electrical features and / or between the electrical features and the conductive mechanical features. In the context of the tool (3022), such a risk may occur for components connected to the tool (3022). Other components of the tool (3022) that may be subject to the above-mentioned risks will be apparent to those skilled in the art in view of the teachings herein.

[0060] refer to Fig. 9A and Fig. 9B , shows another example of a tool (3122) that is similar to tool (3022) (see Figure 8 ), unless otherwise discussed below. Fig. 9A Tool (3122) is shown in a first configuration (3152) such that tool (3122) may be used in a particular manner with first feature (3048) enabled. First feature (3148) may include tool (3022) as described above (see Figure 8), such as a torque wrench coupling (3028), a key (3032), a prying portion (3034), a cleaning tube (3037), a dilator (3038), a forceps (3040), a handle (3044), a link to an electronic device (3045), and a robotic coupling (3046) (see Figure 8 ). The tool (3122) is configured such that once the first feature (3148) is used for its intended purpose, the second feature (3150) of the tool (3122) becomes operable after use of the first feature (3148), and in one example, becomes operable only after use of the first feature (3148). Similarly, the second feature (3150) may include any of the above-mentioned features of the tool (3022), such as a torque wrench coupling (3028), a key (3032), a prying portion (3034), a cleaning tube (3037), a dilator (3038), a pliers (3040), a handle (3044), a link to an electronic device (3045), and a robotic coupling (3046) (see Figure 8 ). Although tools (3022) (see Figure 8 ) may be incorporated into the tool (3122), but in this example, the first feature (3148) includes the torque wrench coupler (3028) and the second feature (3150) includes the prying portion (3034), but the present invention is not intended to be unnecessarily limited to this particular combination of this example. In this example, once the torque wrench coupler (3028) has reached a predefined torque, the tool (3122) is able to automatically transition from the first feature (3148) to the second feature (3150). The transition of the tool (3122) from the first feature (3148) to the second feature (3150) can change the way a user holds and operates the tool (3122).

[0061] To enable the second feature (3150), the tool (3122) is transformed from the first configuration (3152) to the second configuration (3154), such as Fig. 9BAs shown. The tool (3122) also includes a feature inhibitor (3156), such as a cap. To this end, when in the first configuration (3152), the feature inhibitor (3156) is configured to prevent access to the second feature (3150) and / or inhibit the function of the second feature before the use of the first feature (3148). The feature inhibitor (3156) may also include a warning mark, such as an instruction that the first feature (3148) will be used or that the tool (3122) will be transformed to the second configuration (3154) before the second feature (3150) becomes accessible and / or used. The tool (3122) may need to remove or destroy the feature inhibitor (3156) to make the second feature (3150) operable or accessible. When in the second configuration (3154), the tool (3022) is configured to disable the first feature (3148) so that the first feature (3148) is no longer accessible and / or operable. For example, the feature inhibitor (3156) as a cap can be placed to cover and / or hide the first feature (3148) so that the first feature (3148) is no longer accessible and / or visible. In one example, it is necessary to reset the tool (3122) to further make the first feature (3148) operable by resetting the tool (3122) to the first configuration (3152). In one example, when in the second configuration (3154), both the first feature (3048) and the second feature (3050) of the tool (3022) are operable. In this regard, the present invention is not intended to be unnecessarily limited to the continuous operation and access of the first and second features (3148, 3150) as shown in this example.

[0062] III. Exemplary Combinations

[0063] 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.

[0064] Example 1

[0065] A surgical kit comprises: (a) a surgical instrument, the surgical instrument comprising: (i) an end effector; (ii) a shaft assembly, the shaft assembly being configured to extend proximally from the end effector, and (iii) a body assembly, the body assembly being configured to extend proximally from the shaft assembly; wherein the end effector, at least one of the shaft assembly or the end effector has a predetermined access portion, the predetermined access portion being configured to be at least partially removed to access the interior of the surgical instrument; and (b) an instrument tool assembly, the instrument tool assembly comprising: (i) a tool body, (ii) a torque wrench, the torque wrench being operably connected to the tool body and (iii) a removal portion, the removal portion being operably connected to the tool body and being configured to selectively engage the predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument.

[0066] Example 2

[0067] A surgical kit according to Example 1, wherein the main body assembly includes a main body shell, and wherein the main body shell includes the interior and the predetermined access portion for at least partially removing the predetermined access portion of the main body shell from the remainder of the main body shell, wherein the main body shell from which the predetermined access portion is removed defines a main opening.

[0068] Example 3

[0069] A surgical kit according to Example 2, wherein the main body assembly further includes an internal component, the internal component being located in the interior and being configured to be removable through the opening.

[0070] Example 4

[0071] A surgical kit according to Example 3, wherein the internal component includes an ultrasonic transducer.

[0072] Example 5

[0073] A surgical kit according to Example 1, wherein the removal portion includes a lever configured to pry the predetermined access portion from the remainder of the surgical instrument.

[0074] Example 6

[0075] A surgical kit according to Example 1, wherein the predetermined access portion includes a hatch, which is configured to be able to transition from a locked state to an unlocked state, wherein the hatch in the locked state is fixed to prevent access to the interior through the hatch, and wherein the hatch in the unlocked state is configured to be able to be selectively moved to allow access to the interior.

[0076] Example 7

[0077] A surgical kit according to Example 6, wherein the instrument tool assembly includes a key, and the key is configured to selectively guide the hatch from the locked state to the unlocked state.

[0078] Example 8

[0079] A surgical kit according to Example 1, wherein the torque wrench has a limiting state and a non-limiting state, wherein the torque wrench in the limiting state is configured to limit the torque applied by the torque wrench, and wherein the torque wrench in the non-limiting state is configured to not limit the torque applied by the torque wrench.

[0080] Example 9

[0081] The surgical kit according to Example 1 also includes a bag configured to receive and fluid-seal a portion of the surgical instrument therein for storage after use.

[0082] Example 10

[0083] A surgical kit according to Example 1, wherein the instrument tool assembly further comprises a robotic interface, wherein the robotic interface is configured to be connectable to a robot for use in disassembling the surgical instrument using the robot.

[0084] Embodiment 11

[0085] A surgical kit according to Example 1, wherein the removal portion includes: (i) a removal tool, which is operably connected to the tool body and is configured to selectively engage the predetermined access portion of the surgical instrument, and (ii) a tool shield, which is configured to cover at least a portion of the removal tool, thereby rendering the removal tool unusable, wherein the tool shield is further configured to be selectively movable relative to the removal tool, thereby exposing at least a portion of the removal tool and rendering the removal tool usable.

[0086] Example 12

[0087] The surgical kit according to Example 1 further includes a package, which includes: (i) a support body, which is configured to receive at least one of the surgical instrument or the instrument tool for storage, and (ii) a removal tool, which is formed separately and integrally with the support body, wherein the removal tool is configured to selectively engage the predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

[0088] Embodiment 13

[0089] A surgical kit according to Example 1, wherein the removal portion includes a removal tool, which is operably connected to the tool body and is configured to selectively engage the predetermined access portion of the surgical instrument, wherein the removal tool is configured to be unusable prior to using the torque wrench.

[0090] Embodiment 14

[0091] A surgical kit according to Example 13, wherein the torque wrench is configured to be unusable once the torque wrench has been used.

[0092] Embodiment 15

[0093] A surgical kit according to Example 1, wherein the instrument tool includes a communication unit, which is configured to communicate with at least one of the surgical instrument or the generator to instruct the operator on use.

[0094] Example 16

[0095] A surgical system comprises: (a) an instrument tool assembly, the instrument tool assembly comprising: (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 removal portion having a removal tool, the removal portion operably connected to the tool body and configured to selectively engage a predetermined access portion of a surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument, wherein the removal tool is configured to be unusable before the torque portion transitions from the first state to the second state.

[0096] Embodiment 17

[0097] The surgical system according to Example 16 also includes a surgical device having a tool mount, wherein the instrument tool is configured to be releasably secured to the tool mount.

[0098] Embodiment 18

[0099] The surgical system according to Example 16 further includes a package, which includes: (i) a support body, which is configured to receive at least one of the surgical instrument or the instrument tool for storage, and (ii) a removal tool, which is formed separately and integrally with the support body, wherein the removal tool is configured to selectively engage the predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

[0100] Embodiment 19

[0101] According to Example 18, the surgical system also includes a bag configured to receive and fluid-seal a portion of the surgical instrument therein for storage after use.

[0102] Embodiment 20

[0103] A method for accessing the interior of a surgical instrument using an instrument tool, the instrument tool 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, the method comprising: (a) selectively engaging the predetermined access portion of the surgical instrument, thereby at least partially removing the predetermined access portion to access the interior of the surgical instrument.

[0104] IV. Miscellaneous

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] In addition to the foregoing, the teachings of this article can be easily combined with the teachings of the following: U.S. Patent Application [Agent Docket No. END9450USNP2.0754999], entitled "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. END9450USNP2.0754999] will be apparent to those of ordinary skill in the art based on the teachings of this article.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] By way of example only, the versions 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 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 can 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.

[0119] 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) A surgical instrument, comprising: (i) 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 to access an interior of the surgical instrument; and (b) an instrument tool assembly, the instrument tool assembly comprising: (i) the 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 the predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

2. The surgical kit of claim 1, wherein: The body assembly includes a body shell, and wherein the body shell includes the interior and the predetermined access portion for at least partially removing the predetermined access portion of the body shell from the remainder of the body shell, wherein the body shell from which the predetermined access portion is removed defines a body opening.

3. The surgical kit of claim 2, wherein: The body assembly also includes an interior component located within the interior and configured to be removable through the opening.

4. The surgical kit of claim 3, wherein: The internal components include an ultrasonic transducer.

5. A surgical kit according to any preceding claim, wherein: The removal portion includes a lever configured to pry the predetermined access portion from the remainder of the surgical instrument.

6. A surgical kit according to any preceding claim, wherein: The predetermined access portion includes a hatch that is configured to transition from a locked state to an unlocked state, wherein the hatch in the locked state is secured to prevent access to the interior through the hatch, and wherein the hatch in the unlocked state is configured to be selectively movable to allow access to the interior.

7. The surgical kit of claim 6, wherein: The instrument tool assembly includes a key configured to selectively direct the hatch from the locked state to the unlocked state.

8. A surgical kit according to any preceding claim, wherein: The torque wrench has a restricted state and a non-restricted state, wherein the torque wrench in the restricted state is configured to limit a torque applied by the torque wrench, and wherein the torque wrench in the non-restricted state is configured to not limit the torque applied by the torque wrench.

9. The surgical kit of any preceding claim, further comprising a bag configured to receive and fluidly seal a portion of the surgical instrument therein for storage after use.

10. A surgical kit according to any preceding claim, wherein: The instrument tool assembly also includes a robotic interface configured to be connectable to a robot for robotic disassembly of the surgical instrument.

11. A surgical kit according to any preceding claim, wherein: The removed portion includes: (i) a removal tool operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument, and (ii) a tool shield configured to cover at least a portion of the removal tool, thereby rendering the removal tool unusable, wherein the tool shield is further configured to be selectively movable relative to the removal tool, thereby exposing at least a portion of the removal tool and rendering the removal tool unusable.

12. The surgical kit of any preceding claim, further comprising packaging comprising: (i) a support body configured to receive at least one of the surgical instrument or the instrument tool for storage, and (ii) a removal tool formed separately and integrally with the support body, wherein the removal tool is configured to selectively engage the predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

13. A surgical kit according to any preceding claim, wherein: The removal portion includes a removal tool operably connected to the tool body and configured to selectively engage the predetermined access portion of the surgical instrument, wherein the removal tool is configured to be unusable prior to use of the torque wrench.

14. The surgical kit of claim 13, wherein: The torque wrench is configured to be unusable once the torque wrench has been used.

15. A surgical kit according to any preceding claim, 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 comprising: (a) an instrument tool assembly, the instrument tool assembly comprising: (i) the 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 removal portion having a removal tool, the removal portion being operably connected to the tool body and being configured to selectively engage a predetermined access portion of a surgical instrument to at least partially remove the predetermined access portion to access an interior of the surgical instrument, Wherein the removal tool is configured to be unusable before the torque portion is transitioned from the first state to the second state.

17. The surgical system of claim 16, further comprising a surgical device having a tool mount, wherein: The instrument tool is configured to be releasably secured to the tool mount.

18. The surgical system of claim 16 or claim 17, further comprising packaging, the packaging comprising: (i) a support body configured to receive at least one of the surgical instrument or the instrument tool for storage, and (ii) a removal tool formed separately and integrally with the support body, wherein the removal tool is configured to selectively engage the predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

19. The surgical system of claim 18, further comprising a bag configured to receive and fluidly seal a portion of a surgical instrument therein for storage after use.

20. A method of accessing an interior of a surgical instrument with an instrument tool, the instrument tool 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, the method comprising: (a) selectively engaging a predetermined access portion of the surgical instrument to at least partially remove the predetermined access portion to access the interior of the surgical instrument.

Images