Patent Description:
Computer-assisted devices often include one or more movable manipulators operable to manipulate instruments for performing a task at a work site. The computer-assisted devices may include at least one movable manipulator for supporting a medical instrument, such as an image capturing device that captures images of the work site or a surgical instrument that may be used to manipulate or treat tissue at the surgical work site. A movable manipulator can include interconnected links that are coupled together by one or more actively controlled joints. The manipulator can include one or more passive joints that are not actively controlled and comply with movement of an actively controlled joint.

The computer-assisted devices can include industrial and recreational systems, and also medical robotic systems used in procedures for diagnosis, cosmetics, therapeutics, nonsurgical treatment, surgical treatment, etc. As a specific example, computer-assisted devices include minimally invasive, computer-assisted, teleoperated surgical systems ("telesurgical systems") that allow a surgeon to operate on a patient from bedside or a remote location. Telesurgery is a general term for surgical systems in which the surgeon, rather than directly holding and moving all parts of the instruments by hand, uses some form of indirect or remote control, e.g., a servomechanism, or the like, to manipulate surgical instrument movements with at least partial computer assistance. The surgical instruments for such surgical systems can be inserted through minimally invasive surgical apertures or natural orifices to treat tissues at sites within the patient, often reducing the trauma generally associated with accessing a surgical worksite by open surgery techniques.

Computer-assisted devices may be sterilized prior to use in surgical procedures. Improved systems and methods are needed to sterilize one or more computer-assisted devices, store the sterile computer-assisted devices, and introduce the sterilized computer-assisted devices into a surgical environment, such as an operating room, in a sterile condition. Further, improved systems and methods are needed to determine whether the sterile computer-assisted devices are functioning properly or to gather other information from the sterile computer-assisted devices while maintaining sterility of the computer-assisted devices. <CIT> discloses an endoscopic camera for a robotic surgical system where the optical and electro-optic components of the camera module are hermetically sealed within a first housing. The camera module may be sterilized by an autoclave. <CIT> discloses a surgical robot system including a support structure for positioning relative to a patient. The support structure includes a plurality of mounting structures. It also discusses one or more robotic tool cassettes that are configured to interchangeably connect with any of the mounting structures. Each tool cassette including a concentric tube manipulator and a transmission for operating the concentric tube manipulator. <CIT> discloses a container for sterilizing and storing surgical materials and preserving surgical materials in a sterilized condition. The container includes a lid, liner, and in many examples a frame. The lid and liner can be disposable and recyclable after a single use whist the frame is reusable many times. <CIT> discloses a sterile container system for the sterile transport and storage of medical, in particular surgical instruments and/or implants during a sterilization process, including a closable sterile container which is formed by a lid, a trough, at least one sieve cage, at least one fastening device which acts on one of the medical instruments which can be inserted into the sieve cage. <CIT> discloses a sterilization container that holds instruments during a sterilization process. It has an enclosure with an opening into the enclosure and an adapter at the opening. Various inserts such as semi-permeable filters and blocking plated may be placed into the adapter. <CIT> discloses surgical instrumentation and drivetrain assembly for a surgical instrument in particular a robot controlled instrument and surgical instrument.

The present disclosure containing several embodiments assists better understanding of the invention.

Consistent with some embodiments, a system is provided. The system includes a reclosable storage container comprising an interior sterile environment. The system further includes a sterile teleoperated component of a teleoperated surgical manipulator assembly in the interior sterile environment.

Consistent with other embodiments, a method includes performing a cleaning operation on a teleoperated component of a teleoperated surgical manipulator assembly used during a surgical procedure on a first patient, to produce a cleaned teleoperated component. The method further includes placing the cleaned teleoperated component into a storage container. The method further includes sterilizing the cleaned teleoperated component in the storage container and the storage container together to produce a sterilized teleoperated component in a sterile interior environment of the storage container.

Consistent with other embodiments, a method of evaluating a sterilized teleoperated component positioned within a sterile storage container is provided. The method includes establishing a communication through a wall of the sterile storage container to the sterilized teleoperated component. The method further includes, responsive to the communication, moving a mechanism of the sterilized teleoperated component.

Other embodiments include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

Embodiments of the present disclosure and their advantages are described in the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures for purposes of illustrating but not limiting embodiments of the present disclosure.

In the following description, specific details describe some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent to one skilled in the art, however, that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described, are within the scope and the of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

Further, specific words chosen to describe one or more embodiments and optional elements or features are not intended to limit the present disclosure. For example, spatially relative terms-such as "beneath", "over", "proximal", "distal", and the like-may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., translational placements) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as "beneath" other elements or features would then be "over" the other elements or features. Thus, the example term "beneath" can encompass both positions and orientations of over and beneath. A device may be otherwise oriented (e.g., rotated <NUM> degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along (translation) and around (rotation) various axes include various special device positions and orientations. The combination of a body's position and orientation define the body's pose.

In addition, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context indicates otherwise. And the terms "comprises," "comprising," "includes," "has," and the like specify the presence of stated features, steps, operations, elements, and/or components but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups. Components described as coupled may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. The auxiliary verb "may" likewise implies that a feature, step, operation, element, or component is optional.

Elements described in detail with reference to one embodiment, implementation, or application optionally may be included, whenever practical, in other embodiments, implementations, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Thus, to avoid unnecessary repetition in the following description, one or more elements shown and described in association with one embodiment, implementation, or application may be incorporated into other embodiments, implementations, or aspects unless specifically described otherwise, unless the one or more elements would make an embodiment or implementation non-functional, or unless two or more of the elements provide conflicting functions.

A computer is a machine that follows programmed instructions to perform mathematical or logical functions on input information to produce processed output information. A computer includes a logic unit that performs the mathematical or logical functions, and memory that stores the programmed instructions, the input information, and the output information. The term "computer" and similar terms, such as "processor" or "controller" or "control system", are analogous.

Although some of the examples described herein refer to surgical procedures or instruments, or medical procedures and medical instruments, the techniques disclosed apply to non-medical procedures and non-medical instruments. For example, the instruments, systems, and methods described herein may be used for non-medical purposes including industrial uses, general robotic uses, and sensing or manipulating non-tissue work pieces. Other example applications involve cosmetic improvements, imaging of human or animal anatomy, gathering data from human or animal anatomy, and training medical or non-medical personnel. Additional example applications include use for procedures on tissue removed from human or animal anatomies (without return to a human or animal anatomy), and performing procedures on human or animal cadavers. Further, these techniques can also be used for surgical and nonsurgical medical treatment or diagnosis procedures.

Further, although some of the examples presented in this disclosure discuss teleoperational robotic systems or remotely operable systems, the techniques disclosed are also applicable to computer-assisted systems that are directly and manually moved by operators, in part or in whole.

<FIG> is a simplified diagram of a computer-assisted, teleoperated system <NUM>. In some embodiments, system <NUM> may be suitable for use in, for example, surgical, teleoperated surgical, diagnostic, therapeutic, or biopsy procedures. While some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, nonsurgical diagnosis, as well as for industrial systems and general robotic, general teleoperational, or robotic medical systems.

As shown in <FIG>, system <NUM> generally includes a plurality of manipulator assemblies <NUM>. Although three manipulator assemblies <NUM> are illustrated in the embodiment of <FIG>, in other embodiments, more or fewer manipulator assemblies may be used. The exact number of manipulator assemblies will depend on the medical procedure and the space constraints within the operating room, among other factors. Multiple user control systems may be collocated or they may be positioned in separate locations. Multiple user control systems allow more than one operator to control one or more teleoperated manipulator assemblies in various combinations.

The manipulator assembly <NUM> is used to operate a medical instrument <NUM> (e.g., a surgical instrument or an image capturing device) in performing various procedures on a patient P. The medical instrument <NUM> is sterile prior to being used in the various procedures. The manipulator assembly <NUM> may be teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly with select degrees of freedom of motion that may be motorized and/or teleoperated and select degrees of freedom of motion that may be non-motorized and/or non-teleoperated. In some embodiments, the manipulator assembly <NUM> may be mounted to or near an operating or surgical table T. In such embodiments, the manipulator assembly <NUM> may be mounted directly to the table T or to a rail coupled to the table T. In various other embodiments, the manipulator assembly <NUM> may be mounted to a manipulating system (e.g., a patient-side cart). The manipulating system may be separate from and spaced from the table T in the operating room. In such embodiments, the manipulating system may be independently movable relative to the table T. In other examples, the manipulator assembly <NUM> may be mounted to a ceiling of the operating room. In some additional examples, the manipulator assembly <NUM> may be mounted to one or more of a floor of the operating room or a wall of the operating room. In embodiments in which a plurality of manipulator assemblies <NUM> are employed, one or more of the manipulator assemblies <NUM> may support surgical instruments, and another of the manipulator assemblies may support an image capturing device such as a monoscopic or stereoscopic endoscope. In such embodiments, one or more of the manipulator assemblies <NUM> may be mounted to any structure or in any manner as described above. For example, one manipulator assembly <NUM> may be mounted to the table T and another manipulator assembly <NUM> may be mounted to a manipulating system. In other examples, an additional manipulator assembly <NUM> may be mounted to the ceiling of the operating room.

A user control system <NUM> allows an operator (e.g., a surgeon or other clinician, as illustrated in <FIG>) to view the interventional site and to control manipulator assembly <NUM>. In some examples, the user control system <NUM> is a surgeon console, which is usually located in the same room as the operating or surgical table T, such as at the side of a table on which patient P is located. However, it is to be understood that operator O can be located in a different room or a completely different building from patient P. User control system <NUM> generally includes one or more input devices for controlling manipulator assembly <NUM>. The input devices may include any number of a variety of devices, such as joysticks, trackballs, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, body motion or presence sensors, and/or the like. To provide operator O a strong sense of directly controlling medical instrument <NUM>, the input devices may be provided with the same degrees of freedom as the associated medical instrument <NUM>. In this manner, the input devices provide operator O with telepresence or the perception that the input devices are integral with medical instrument <NUM>.

In some embodiments, the input devices may have more or fewer degrees of freedom than the associated medical instrument <NUM> and still provide operator O with telepresence. In some embodiments, the input devices may optionally be manual input devices which move with six degrees of freedom, and which may also include an actuatable handle for actuating instruments (for example, for closing grasping jaws, applying an electrical potential to an electrode, delivering a medicinal treatment, and/or the like).

Manipulator assembly <NUM> supports medical instrument <NUM> and may include a kinematic structure of one or more non-servo controlled links (e.g., one or more links that may be manually positioned and locked in place, generally referred to as a set-up structure), and/or one or more servo controlled links (e.g., one or more links that may be controlled in response to commands from a control system), and a manipulator. Manipulator assembly <NUM> may optionally include a plurality of actuators or motors that drive inputs on medical instrument <NUM> in response to commands from the control system (e.g., a control system <NUM>). The actuators may optionally include drive systems that when coupled to medical instrument <NUM> may advance medical instrument <NUM> into a naturally or surgically created anatomic orifice. Other drive systems may move the distal end of medical instrument <NUM> in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). Additionally, the actuators can be used to actuate an articulable end effector of medical instrument <NUM> for grasping tissue in the jaws of a biopsy device and/or the like. Actuator position sensors such as resolvers, encoders, potentiometers, and other mechanisms may provide sensor data to system <NUM> describing the rotation and orientation of the motor shafts. This position sensor data may be used to determine motion of the objects manipulated by the actuators. The manipulator assembly <NUM> may position its held instrument <NUM> so that a pivot point occurs at the instrument's entry aperture into the patient. The manipulator assembly <NUM> may then manipulate its held instrument so that the instrument may be pivoted about the pivot point, inserted into and retracted out of the entry aperture, and rotated about its shaft axis.

System <NUM> also includes a display system <NUM> for displaying an image or representation of the surgical site and medical instrument <NUM>. Display system <NUM> and user control system <NUM> may be oriented so operator O can control medical instrument <NUM> and user control system <NUM> with the perception of telepresence. In some embodiments, medical instrument <NUM> may include a visualization system, which may include a viewing scope assembly that records a concurrent or real-time image of a surgical site and provides the image to the operator O and/or other operators or personnel through one or more displays of system <NUM>, such as one or more displays of display system <NUM>. The concurrent image may be, for example, a two or three dimensional image captured by an endoscope positioned within the surgical site. The visualization system may be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system <NUM>.

In some examples, display system <NUM> may present images of a surgical site recorded pre-operatively or intra-operatively using image data from imaging technology such as, computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like. The pre-operative or intra-operative image data may be presented as two-dimensional, three-dimensional, or four-dimensional (including, e.g., time-based or velocity-based information) images and/or as images from models created from the pre-operative or intra-operative image data sets.

System <NUM> may also include control system <NUM>. Control system <NUM> includes at least one memory and at least one computer processor (not shown) for effecting control between medical instrument <NUM>, user control system <NUM>, and display system <NUM>. Control system <NUM> also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all the methods described in accordance with aspects disclosed herein, including instructions for providing information to display system <NUM>. While control system <NUM> is shown as a single block in the simplified schematic of <FIG>, the system may include two or more data processing circuits with one portion of the processing optionally being performed on or adjacent to manipulator assembly <NUM>, another portion of the processing being performed at user control system <NUM>, and/or the like. The processors of control system <NUM> may execute instructions comprising instruction corresponding to processes disclosed herein and described in more detail below. Any of a wide variety of centralized or distributed data processing architectures may be employed. Similarly, the programmed instructions may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the robotic medical systems described herein. In one embodiment, control system <NUM> supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE <NUM>, DECT, and Wireless Telemetry.

In some embodiments, a communication is sent from the control system <NUM> to the manipulator assembly <NUM>. Additionally, status information regarding testing of the manipulator assembly <NUM> may be sent from a sterile storage container (see <NUM> in <FIG>) to the control system <NUM>. This status information is used to optimize the performance of the system <NUM> by indicating an operational status of one or more components of the manipulator assembly <NUM>. The status information may additionally be received by the operator O, a surgeon, and/or any other suitable personnel. The status information may also be received by a hospital information system, a patient information portal, a surgical information database, and/or any other suitable information system or database. In some embodiments, the status information is sent to a manufacturer of the manipulator assembly <NUM> to indicate whether the manipulator assembly <NUM> or any other component of the system requires maintenance. Communications between components of the manipulator assembly <NUM>, the sterile storage container, and the control system <NUM> will be discussed in more detail below with respect to <FIG> and <FIG>.

Movement of a manipulator assembly <NUM> may be controlled by the control system <NUM> so that a shaft or intermediate portion of instruments mounted to the manipulator assemblies <NUM> are constrained to safe motions through minimally invasive surgical access sites or other apertures. Such motion may include, for example, axial insertion of a shaft through an aperture site, rotation of the shaft about its axis, and pivotal motion of the shaft about a pivot point adjacent the access site. In some cases, excessive lateral motion of the shaft that might otherwise tear the tissues adjacent the aperture or enlarge the access site inadvertently is inhibited. Some or all of such constraint on the motions of the manipulator assemblies <NUM> at the access sites may be imposed using mechanical manipulator joint linkages that inhibit improper motions, or may in part or in full be imposed using data processing and control techniques. In some embodiments, control system <NUM> may receive force and/or torque feedback from medical instrument <NUM>. Responsive to the feedback, control system <NUM> may transmit signals to user control system <NUM>. In some examples, control system <NUM> may transmit signals instructing one or more actuators of manipulator assembly <NUM> to move medical instrument <NUM>.

<FIG> is a perspective view of a patient coordinate space <NUM> including teleoperated surgical manipulator assemblies <NUM>, <NUM> mounted on a side of a surgical table T according to some embodiments. In some embodiments, the manipulator assemblies <NUM>, <NUM> may be used as manipulator assembly <NUM> in a medical procedure performed with system <NUM> and controlled by the control system <NUM>. In some examples, the manipulator assemblies <NUM>, <NUM> may be used in procedures involving traditional manually operated minimally invasive surgical instruments, such as manual laparascopy. While only two manipulator assemblies <NUM>, <NUM> are depicted, it is to be understood that more than two (e.g., three, four, five, six, and more than six) or fewer than two (e.g., one) manipulator assemblies can be included in some configurations.

In some embodiments, an equipment rail <NUM> is attached to the table T. The teleoperated surgical manipulator assemblies <NUM>, <NUM> are coupled to the equipment rail <NUM> during the surgery. The manipulator assemblies <NUM>, <NUM> may be coupled to the equipment rail <NUM> after being fully assembled, or the manipulator assemblies <NUM>, <NUM> may be coupled to the equipment rail <NUM> before being fully assembled. In alternative embodiments, the equipment rail <NUM> may be attached to a manipulating system (e.g., a patient-side cart or a side table).

The manipulator assembly <NUM> may be operated to move an instrument <NUM> within the space <NUM>, and the manipulator assembly <NUM> may be operated to move an instrument <NUM> within the space <NUM>. The instruments <NUM>, <NUM> are sterilized prior to use in a medical procedure.

The manipulator assembly <NUM> includes a manipulator <NUM>, a link <NUM>, and a drive unit <NUM>. The manipulator assembly <NUM> includes a manipulator <NUM>, a link <NUM>, and a drive unit <NUM>. The instrument <NUM> is coupled to the drive unit <NUM>, and the instrument <NUM> is coupled to the drive unit <NUM>. In some embodiments, the drive unit <NUM> is, for example, a standalone unit including a system of drive mechanisms (not shown, e.g., motors). The drive unit <NUM> may be operated to control motion of the instrument <NUM> in multiple degrees of freedom (DOFs) when the instrument <NUM> is mounted to the drive unit <NUM>. The drive unit <NUM> is similarly configured for operation of the instrument <NUM>. The drive unit <NUM> is coupled to the manipulator <NUM>, and the drive unit <NUM> is coupled to the manipulator <NUM>. The manipulator <NUM> is movably coupled to the link <NUM>, and the manipulator <NUM> is movably coupled to the link <NUM>. Any one or more of the components of the manipulator <NUM>, the manipulator <NUM>, the drive unit <NUM>, and/or the drive unit <NUM> may be teleoperated. Thus, at least the manipulator <NUM>, the manipulator <NUM>, the drive unit <NUM>, and/or the drive unit <NUM> are teleoperated components. The instruments <NUM>, <NUM>; the drive units <NUM>, <NUM>; the manipulators <NUM>, <NUM>; and the links <NUM>, <NUM> are sterilized prior to use in a medical procedure. Additionally, one or more of the input devices (e.g., joysticks, trackballs, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, body motion or presence sensors, and/or the like), which may be used for controlling manipulator assembly <NUM>, may be sterilized prior to use in a medical procedure.

In some embodiments where the manipulator assembly <NUM> is mounted to a surgical table T, the manipulator assembly <NUM> is coupled to the table T by a coupling member <NUM> and a clamp <NUM>. In some embodiments, the coupling member <NUM> is a joint (e.g., a ball joint, a spherical ball joint, a prismatic joint, a gimbal, and the like). The manipulator assembly <NUM> is coupled to the table T by a coupling member <NUM> and a clamp <NUM>. Housing <NUM> is coupled to the coupling member <NUM>, and housing <NUM> is coupled to the coupling member <NUM>. In some examples, the manipulator assembly <NUM> includes the coupling member <NUM>, the clamp <NUM>, and the housing <NUM>. In some examples, the manipulator assembly <NUM> includes the coupling member <NUM>, the clamp <NUM>, and the housing <NUM>.

In some embodiments, the manipulator assembly <NUM> is coupled to the rail <NUM> of the operating table T by the clamp <NUM>. The clamp <NUM> (which may be a support component and/or a support structure) kinematically supports the manipulator <NUM> and, therefore, the manipulator assembly <NUM> before, during, and/or after a surgical procedure. The clamp <NUM> may translate along the rail <NUM> to allow the position of the manipulator assembly <NUM> to be moved relative to the table T and the patient P.

As described in further detail below, one or more of the component parts of the input devices, the manipulator assembly <NUM>, the coupling member <NUM>, the clamp <NUM>, and the housing <NUM> may be placed within an interior environment <NUM> of a storage container <NUM>, <NUM> (see <FIG>) and sterilized together with the storage container <NUM>, <NUM>. In some embodiments, when removed from the interior environment <NUM>, the clamp <NUM> is coupled to the table T via the rail <NUM>. Alternatively, the clamp <NUM> may be coupled directly to the table T. The coupling member <NUM> is attached to the clamp <NUM>. Accordingly, the clamp kinematically supports the manipulator <NUM> and, therefore, the manipulator assembly <NUM> before, during, and/or after a surgical procedure. In alternative embodiments, the clamp <NUM> may be coupled directly to the housing <NUM> or the link <NUM>.

<FIG> is a perspective view of a reclosable storage container <NUM> according to some embodiments. The storage container <NUM> includes an outer surface <NUM> defining an exterior of the storage container <NUM>, a front wall <NUM>, a back wall (not shown), a top <NUM>, a bottom (not shown), and side walls <NUM>. The storage container <NUM> also includes a communication interface <NUM> within the front wall <NUM>, a viewing window <NUM> within the front wall <NUM>, a vent <NUM> within the top <NUM>, and a handle <NUM> attached to the front wall <NUM>. In other examples, the communication interface <NUM> may be positioned within a back wall (not shown), the top <NUM>, a bottom (not shown), and/or either one or both of the side walls <NUM>. Similarly, the viewing window <NUM> may be positioned within the back wall (not shown), the top <NUM>, the bottom (not shown), and/or either one or both of the side walls <NUM>. Further, the vent <NUM> may be positioned within the back wall (not shown), the front wall <NUM>, the bottom (not shown), and/or either one of the side walls <NUM>. Additionally, the storage container <NUM> may include more than one vent <NUM>. In various embodiments, the communication interface <NUM>, the viewing window <NUM>, and/or the handle <NUM> may be omitted.

In some embodiments, the manipulator assembly <NUM> is disassembled into component parts and one or more of the component parts are placed within an interior <NUM> (see <FIG>) of the storage container <NUM> such that one or more of the component parts of the manipulator assembly <NUM> are located within the storage container <NUM>. For example, the component parts placed in the interior <NUM> of the storage container <NUM> may include the manipulator <NUM>, the link <NUM>, the coupling member <NUM>, the housing <NUM>, the drive unit <NUM>, the clamp <NUM>, input devices, and any other related components (e.g., a communication link or a kinematic arm). In alternative embodiments, one or only some of the component parts of the manipulator assembly <NUM> and/or input devices are placed within the interior <NUM> of the storage container <NUM>. After the component parts are placed within the interior <NUM> of the storage container <NUM>, the storage container <NUM> may be closed. The storage container <NUM> and the stored component parts may then be sterilized together. When the storage container <NUM> is closed, the storage container <NUM> may prevent microbes and other large molecules from entering the interior <NUM> while permitting sterilization of the interior <NUM> (e.g., via vent <NUM>), as described in further detail below. The storage container <NUM>, including the components of the manipulator assembly <NUM> in the interior <NUM> of the storage container <NUM>, is sterilized using various methods. For example, an autoclave may be used. The autoclave sterilizes the storage container <NUM> and the components of the manipulator assembly <NUM> using a combination of steam, low and high pressure, and high temperature. After the sterilization process is complete, an operator (e.g., a sterilization technician) opens the autoclave and retrieves the storage container <NUM>. The interior <NUM> of the storage container <NUM> and the components of the manipulator assembly <NUM> are now sterile and will remain sterile until the sterile interior <NUM> and the sterile components of the manipulator assembly <NUM> contact a non-sterile object or a non-sterile environment. In some embodiments, the storage container <NUM> is opened in a sterile environment. In such embodiments, the interior <NUM> of the storage container <NUM> and the components of the manipulator assembly <NUM> remain sterile even after the storage container <NUM> is opened. As other examples, the storage container <NUM>, including the components of the manipulator assembly <NUM> in the interior <NUM> of the storage container <NUM>, may be sterilized using a hydrogen peroxide sterilization method, a liquid chemical sterilization method, a low temperature, hydrogen peroxide gas plasma sterilization method, an ethylene oxide sterilization method, or any other suitable sterilization method.

In some embodiments, the outer surface <NUM>, an inner surface <NUM> (see <FIG>), the front wall <NUM>, the side walls <NUM>, the back wall (not shown), the top <NUM>, and the bottom (not shown)) of the storage container <NUM> are made of a material that can withstand a specific sterilization process (e.g., an autoclave sterilization process). For example, the walls and surfaces may be made of a material that can be sterilized under high pressure and high temperature. In other examples, the walls and surfaces may be made of a material that can be sterilized using chemicals, such as hydrogen peroxide or ethylene oxide, for example.

The walls and surfaces may also be made of a material that, in addition to being sterilizable under high pressure and high temperature, for example, allows for wireless signals to pass through the walls and surfaces. For example, a wireless signal may connect one or more components outside of the storage container <NUM> (e.g., the control system <NUM>) to one or more components within the interior <NUM> of the storage container <NUM> (e.g., the manipulator <NUM>). In such examples, the walls and surfaces may be made of plastic (such as polypropylene, polycarbonate, polysulfone, PEEK, polyphenylsulfone, polyetherimide, polyoxymethylene), ceramic, glass, or any other suitable material.

The vent <NUM> is a grouping of holes, which may be arranged in consecutive lines, in a symmetrical pattern, in a random order, etc. While the vent <NUM> is depicted within the top <NUM> of the storage container <NUM>, it is to be understood that the vent <NUM> may be located within any other wall of the storage container <NUM>, such as the front wall <NUM>, one or more of the side walls <NUM>, the back wall (not shown), or the bottom (not shown). In some embodiments, autoclave filter paper is placed behind the vent <NUM> and secured in place (i.e., such that the autoclave filter paper is positioned between the vent <NUM> and the interior environment <NUM> of the storage container <NUM>). The autoclave filter paper may be secured in place with brackets, clasps, clips, or any other suitable connection method. The vent <NUM> and the autoclave filter paper behind it allow for steam to enter and/or exit the interior <NUM> of the storage container <NUM> during the sterilization process, such as the sterilization process in the autoclave. During the sterilization process, heat, pressure, and the steam extinguish any microbes within the interior <NUM> of the storage container <NUM>. After the sterilization process is completed, the autoclave filter paper behind the vent <NUM> prevents microbes from entering the interior <NUM> of the storage container <NUM>. In this way, the vent <NUM> and the filter paper prevent desterilization of the components within the interior <NUM> of the storage container <NUM>. In alternative embodiments, the vent <NUM> may be a platform that is raised from the top <NUM>, for example, of the storage container <NUM>. In such embodiments, steam may enter and/or exit the interior <NUM> of the storage container <NUM> through a filtered gap between the vent <NUM> and the top <NUM> of the storage container <NUM>. In further alternative embodiments, a sterilization wrap (which may be autoclave filter paper) is placed around the outside of the vent <NUM>. For example, the entire storage container <NUM> may be wrapped (e.g., single wrapped, doubled wrapped, or wrapped any other suitable number of times) with sterilization wrap to create a sterile barrier between the interior <NUM> of the storage container <NUM> and the environment outside of the storage container <NUM>.

The optional communication interface <NUM> connects one or more components outside of the storage container <NUM> (e.g., the control system <NUM>) with one or more components in the interior <NUM> of the storage container <NUM> (e.g., the manipulator <NUM>). The communication interface <NUM> may connect components by hardware or by non-contact based communication connections. In some examples, the one or more outside components and interior components may be connected through a mechanical connection, an optical connection, an electrical connection, an electromechanical connection, a wired connection, a wireless connection, an RFID connection, an inductive path connection, etc..

The optional viewing window <NUM> is used to view the components in the interior <NUM> of the storage container <NUM>. An operator can look through the viewing window <NUM> and view the components in the interior <NUM> of the storage container <NUM>. For example, the operator can look through the viewing window <NUM> to determine whether the manipulator <NUM> is responding to a communicated command, without opening the storage container <NUM> to view the manipulator <NUM>. Thus, the operator can determine whether the manipulator <NUM> is functioning properly while maintaining sterility of the interior environment <NUM> and the manipulator <NUM>.

The optional handle <NUM> may be used in combination with a similar optional handle on the opposite side of the storage container <NUM>, such as the back wall (not shown). An operator uses the handle(s) <NUM> to pick up and hold the storage container <NUM>. The handle(s) <NUM> may be used to hold the storage container <NUM> substantially level as the storage container <NUM> is carried from place to place. In some embodiments, the handle(s) <NUM> is connected to and swings on hinges <NUM> that are fixedly coupled to the front wall <NUM> of the storage container <NUM>. In alternative embodiments, the handle(s) <NUM> may be connected to the front wall <NUM> of the storage container <NUM> by a screw connection, an adhesive connection, a welded connection, or any other suitable connection. In another aspect, one or more handles may be integrally formed on or in the outer surface <NUM> of the storage container <NUM>.

In the embodiment of <FIG>, the handle(s) <NUM> is connected to two hinges <NUM>. In alternative embodiments, the handle(s) <NUM> may be connected to more than two hinges (e.g., three hinges, four hinges, or more than four hinges) or to less than two hinges (e.g., one hinge). While <FIG> shows the handle <NUM> attached to the front wall <NUM> of the storage container <NUM>, it is to be understood that the handle <NUM> may be attached to any other wall of the storage container <NUM>, such as the top <NUM>, either one or both of the side walls <NUM>, the back wall (not shown), or the bottom (not shown).

<FIG> is a top view of the interior <NUM> of a storage container <NUM> including a manipulator <NUM> according to some embodiments. The storage container <NUM> is substantially similar to the storage container <NUM>. The manipulator <NUM> is substantially similar to the manipulator <NUM>. A link <NUM> is substantially similar to the link <NUM>. The coupling member <NUM> is substantially similar to the coupling member <NUM>, and the housing <NUM> is substantially similar to the housing <NUM>.

The manipulator <NUM>, the housing <NUM>, the link <NUM>, and the coupling member <NUM> are placed in the interior <NUM> of the storage container <NUM> before the storage container <NUM> is inserted into the autoclave. The storage container <NUM> is then closed and sterilized by undergoing a sterilization process in the autoclave. In this way, the storage container <NUM>, the interior environment <NUM>, and the components in the interior environment <NUM> are all sterilized together. After the sterilization process is completed, the interior contents are sterile, and the interior environment <NUM> is a sterile environment. The sterile interior environment <NUM> remains sterile until the sterile interior environment <NUM> contacts a non-sterile object or a non-sterile environment (e.g., the interior <NUM> remains sterile while the container <NUM> remains closed). The sterile interior environment <NUM> allows the sterile components inside the storage container <NUM> to remain sterile as they are stored for use and transported to an operating room for use during surgery.

<FIG> is a top view of the interior <NUM> of the storage container <NUM> including a drive unit <NUM> according to some embodiments. The drive unit <NUM> is substantially similar to the drive unit <NUM>. <FIG> is a top view of the interior <NUM> of the storage container <NUM> including a clamp <NUM> according to some embodiments. The clamp <NUM> is substantially similar to the clamp <NUM>. <FIG> is a top view of the interior <NUM> of the storage container <NUM> including a kinematic arm <NUM> according to some embodiments. As discussed above with respect to <FIG>, the storage container <NUM> is sterilized by undergoing a sterilization process in an autoclave. The drive unit <NUM>, the clamp <NUM>, and the kinematic arm <NUM> are placed in the interior <NUM> of the storage container <NUM> before the storage container <NUM> is inserted into the autoclave. Accordingly, the drive unit <NUM>, the clamp <NUM>, and the kinematic arm <NUM> are sterilized with the storage container <NUM>, the interior environment <NUM>, and the other components in the interior environment <NUM>.

In some embodiments, the components in the interior environment <NUM> may be arranged in the interior environment <NUM> in the same configuration every time the components are placed in the storage container <NUM>. For example, fixtures, holders, or other structures may provide dedicated locations within the interior environment <NUM> for each component. In alternative embodiments, there is no set configuration in which the components are arranged when they are placed in the storage container <NUM>.

In some embodiments, when removed from the interior environment <NUM>, the kinematic arm <NUM> may be coupled at an end <NUM> to the table T. The coupling to the table T may be direct or indirect (e.g., via the rail <NUM>, via the clamp <NUM>, or via another type of suitable connection). The kinematic arm <NUM> is coupled at an end <NUM> to the coupling member <NUM>. In some embodiments, the kinematic arm <NUM> (which may be a support component) and the clamp <NUM> are coupled together to kinematically support the manipulator <NUM> and, therefore, the manipulator assembly <NUM> before, during, and/or after a surgical procedure. In alternative embodiments, the end <NUM> of the kinematic arm <NUM> may be coupled directly to the housing <NUM> or to the link <NUM>.

In some embodiments, the kinematic arm <NUM> may be manually manipulated to adjust the position of the manipulator assembly <NUM>. In other embodiments, the kinematic arm <NUM> may be remotely manipulated by teleoperational control. For example, movement of the kinematic arm <NUM> may be controlled by the control system <NUM> (see <FIG>). The operator O may manipulate the user control system <NUM> (see <FIG>), which then manipulates the kinematic arm <NUM> via the control system <NUM>. The kinematic arm <NUM> may move the manipulator assembly <NUM> in any manner that is required for the surgical procedure. For example, the kinematic arm <NUM> may ascend, descend, translate laterally, rotate, and/or move the manipulator assembly <NUM> in any other direction.

<FIG> is a top view of the interior <NUM> of the storage container <NUM> including a communication interface <NUM> according to some embodiments. The communication interface <NUM> is substantially similar to the communication interface <NUM>, and the outer surface <NUM> is substantially similar to the outer surface <NUM>. In some embodiments, the communication interface <NUM> is located within the front wall <NUM> of the storage container <NUM> (e.g., between the outer surface <NUM> and the inner surface <NUM>). An operator may access the communication interface <NUM> from the exterior (e.g., the outer surface <NUM>) of the storage container <NUM>. In alternative embodiments, the communication interface <NUM> may be partially within the front wall <NUM> and partially within the interior environment <NUM> of the storage container <NUM>. In various other embodiments, the communication interface <NUM> may be partially within the front wall <NUM> and partially outside of the storage container <NUM>. In some embodiments, the communication interface <NUM> may be partially within the front wall <NUM>, partially within the interior environment <NUM>, and partially outside of the storage container <NUM>. An optional cap may be placed over the communication interface <NUM> before the storage container <NUM> is placed in the autoclave to be sterilized. The cap protects the communication interface <NUM> during the sterilization process and helps prevent the communication interface <NUM> from being damaged.

While <FIG> depicts the communication interface <NUM> in the front wall <NUM> of the storage container <NUM>, it is to be understood that the communication interface <NUM> can be located in any other wall of the storage container <NUM> (e.g., a top (not shown), a bottom (not shown), the side walls <NUM>, and/or the back wall <NUM>). That is, the communication interface <NUM> establishes a way that a one- or two-way communication can be established between a device outside the storage container <NUM> and a sterile device inside the storage container <NUM> without opening the storage container <NUM> and without exposing the interior sterile environment <NUM> of the storage container <NUM> to the environment located outside of the storage container <NUM>. As described in further detail below, in some embodiments, the communication interface <NUM> may provide electrical energy (e.g., power) to the storage container from an external source (e.g., a wall outlet, a battery, etc.). In some embodiments, there may be multiple communication interfaces placed within the walls of the storage container <NUM>. Having multiple communication interfaces allows the operator to have easier access, via one or more communication links (e.g., communication links <NUM>, <NUM>), to the particular component the operator is testing within the interior environment <NUM> of the storage container <NUM>. If the communication interface <NUM> requires a hardware connection to a device inside the storage container <NUM>, then this connection is made prior to closing the storage container <NUM> and performing the sterilization process on the storage container <NUM> and its contents. If the communication interface <NUM> facilitates a wireless connection to a device inside the storage container <NUM>, then the device inside the storage container <NUM> is positioned inside the storage container <NUM> so that the wireless connection can be established through the communication interface <NUM> once the storage container <NUM> is closed and the sterilization process is complete.

In some embodiments, communication links <NUM>, <NUM> are coupled to the communication interface <NUM>. The communication links <NUM>, <NUM> may be hardware communication links providing material contact between the connected components or non-contact based communication links (e.g., electromagnetic communication links). The communication link <NUM> connects the manipulator <NUM> to the communication interface <NUM>. Similarly, the communication link <NUM> connects the drive unit <NUM> to the communication interface <NUM>. While <FIG> only depicts two communication links <NUM>, <NUM>, it is to be understood that more or less than two communication links may be connected to the components in the interior environment <NUM>. For example, one communication link, three communication links, four communication links, or more than four communication links may be connected to the components in the interior environment <NUM>. In some embodiments, a separate communication link may connect to each teleoperated component (e.g., the manipulator <NUM> and the drive unit <NUM>) in the interior environment <NUM>. In other embodiments, one communication link may simultaneously connect to each teleoperated component in the interior environment <NUM>.

The communication links <NUM>, <NUM> are used to test the components in the interior environment <NUM> to determine whether the components are functioning properly without opening the storage container <NUM> and without exposing the interior sterile environment <NUM> of the storage container <NUM> to the environment located outside of the storage container <NUM>. In some embodiments, the communication links <NUM>, <NUM> may be used to transmit communications from outside the storage container <NUM> via the communication interface <NUM> to the components in the interior environment <NUM>. The interior components (e.g., the manipulator <NUM> and the drive unit <NUM>) may be electrically powered, mechanically powered, electromechanically powered, hydraulically powered, and/or pneumatically powered. In some embodiments, the functionality of the components may be determined while maintaining sterility of the components. In some embodiments, the communication links <NUM>, <NUM> are wired connections. In other embodiments, the communication links <NUM>, <NUM> are wireless connections. Accordingly, the components in the interior environment <NUM> (e.g., the manipulator <NUM> and the drive unit <NUM>) may be connected to the communication interface <NUM> via a wired and/or a wireless connection. In alternative embodiments, the communication links <NUM>, <NUM> may be used to calibrate and/or actuate the components in the interior environment <NUM>. In some embodiments, the communication links <NUM>, <NUM> may supply power to the components in the interior environment <NUM>. In other embodiments, the communication links <NUM>, <NUM> may gather data from the components in the interior environment <NUM>.

Regarding supplying power to the components in the interior environment <NUM>, in some embodiments, electrical energy (e.g., power) may be provided to the storage container <NUM> through the communication interface <NUM> from an external source (e.g., a wall outlet, a battery, etc.) located external to the storage container <NUM>. In some embodiments, the storage container <NUM> may contain an onboard power supply (e.g., one or more sterilizable batteries) for supplying power to the storage container <NUM> and the components in the interior environment <NUM>. The onboard power supply may be located in the interior environment <NUM> and may undergo sterilization together with the storage container <NUM> and the components in the interior environment <NUM>, for example during an autoclave sterilization process as described above. The onboard power supply may be in communication with the communication interface <NUM> and the components in the interior environment <NUM> via the communication links <NUM>, <NUM>. In some embodiments, the storage container <NUM> may receive power from an external source over the communication interface <NUM>, from an onboard power supply, or from both an external source and the onboard power supply. The power may then be supplied to the components in the interior environment <NUM> via one or more of the communication links <NUM>, <NUM>. In some examples, the power supplied to the components stored in the container <NUM> may be used to power one or more active elements of the components (e.g., motors, actuators, etc.). For example, the manipulator assembly <NUM> may include one or more motors and/or actuators. The power supplied through the communication interface <NUM> may be supplied to the manipulator assembly <NUM> and, more specifically, may be supplied to the one or more motors and/or actuators of the manipulator assembly <NUM>. The motor(s) and/or actuator(s) may then be tested while the manipulator assembly <NUM> is stored within the interior sterile environment <NUM>. Because the power may be supplied through the communication interface <NUM> and the communication links <NUM>, <NUM>, the active components of the manipulator assembly <NUM> may be tested without the need to open the storage container <NUM> and without exposing the interior sterile environment <NUM> of the storage container <NUM> to the environment located outside of the storage container <NUM>. Therefore, the active components of the manipulator assembly <NUM> may be tested within the interior sterile environment <NUM> while the interior sterile environment <NUM> remains sterile. In some embodiments, the storage container <NUM> may receive power from an external source over the communication interface <NUM> to charge an onboard power supply in the storage container <NUM>.

In some embodiments, the communication interface <NUM> is a teleoperation interface used to connect with the teleoperated components (e.g., the manipulator <NUM>, a movable component of the manipulator <NUM>, the drive unit <NUM>, a movable component of the drive unit <NUM>, the kinematic arm <NUM>, or any other teleoperated component) in the interior environment <NUM>. In some examples, the manipulator <NUM> includes at least one movable component (e.g., an arm portion <NUM>) that is actuated in response to the communication sent from the control system <NUM>. Similarly, the drive unit <NUM> includes at least one movable component (e.g., a motor) that is actuated in response to the communication sent from the control system <NUM>. Alternatively, the manipulator <NUM> may be a movable component that is actuated in response to the communication sent from the control system <NUM>, and the drive unit <NUM> may also be a movable component that is actuated in response to the communication sent from the control system <NUM>.

A communication may be sent from the control system <NUM> (see <FIG>) to the manipulator <NUM>, for example, via the communication link <NUM>. In other embodiments, the communication interface <NUM> is a self-test interface used to instruct the manipulator <NUM> to perform a self-test. The manipulator <NUM> may then perform an internal system check to determine whether the manipulator <NUM> is operational. In other examples, the communication interface <NUM> is a component status interface used to determine an operation status of the manipulator <NUM>. The manipulator <NUM> may send a communication via the communication link <NUM> and via the communication interface <NUM> indicating an operational status of the manipulator <NUM>. In various other embodiments, the communication interface <NUM> may include an indicator light <NUM> that indicates whether the teleoperated component being tested (e.g., the manipulator <NUM>) is functioning properly. The indicator light <NUM> may turn on to indicate that the manipulator <NUM> is functioning properly. If the manipulator <NUM> is not functioning properly, the indicator light <NUM> may remain off. In some embodiments, the indicator light <NUM> may change color (e.g., from red to green) to indicate that the manipulator <NUM> is functioning properly, and may not change color (e.g., by remaining red) to indicate that the manipulator <NUM> is not functioning properly. In other embodiments, the indicator light <NUM> may turn on as a red color to indicate that the manipulator <NUM> is not functioning properly.

In some embodiments, a communication sent from the control system <NUM> to the teleoperated components in the interior <NUM> of the storage container <NUM> via the communication interface <NUM> and the communication links <NUM>, <NUM> commands movement of one or more of the teleoperated components in order to demonstrate the operability of the teleoperated components. The inner surface <NUM> of the storage container <NUM> may include one or more tactile interfaces (e.g., tactile interface <NUM>). The tactile interface <NUM> may be a pressure pad, a switch, a button, and the like, that may be physically contacted by the manipulator <NUM>. The tactile interface <NUM> may be positioned such that the manipulator <NUM> may physically contact the tactile interface <NUM>. The operator may determine that the manipulator <NUM> is functioning properly if, after the communication is sent instructing the manipulator <NUM> to move, the manipulator <NUM> physically contacts the tactile interface <NUM>. After the manipulator <NUM> physically contacts the tactile interface <NUM>, a communication may be sent by the tactile interface <NUM> to the control system <NUM> via the communication interface <NUM> indicating that the manipulator <NUM> contacted the tactile interface <NUM>.

In alternative embodiments, the tactile interface <NUM> may be positioned such that the drive unit <NUM> may physically contact the tactile interface <NUM>. The operator may determine that the drive unit <NUM> is functioning properly if, after the communication is sent instructing the drive unit <NUM> to move, the drive unit <NUM> physically contacts the tactile interface <NUM>. After the drive unit <NUM> physically contacts the tactile interface <NUM>, a communication may be sent by the tactile interface <NUM> to the control system <NUM> via the communication interface <NUM> indicating that the drive unit <NUM> contacted the tactile interface <NUM>.

In still other examples, the drive unit <NUM> may be coupled to the manipulator <NUM> while both components are in the interior environment <NUM>. In such examples, a communication may be sent instructing the drive unit <NUM> to actuate the manipulator <NUM>. Alternatively, a communication may be sent instructing the manipulator <NUM> to actuate the drive unit <NUM>. The operator may determine that the drive unit <NUM> is functioning properly if, after the communication is sent, the manipulator <NUM> and/or the drive unit <NUM> physically contacts the tactile interface <NUM>.

In some embodiments, testing of the components in the interior environment <NUM> may include electronic integrity testing, brake testing, and/or drive train integrity testing. In some cases where electronic integrity testing, brake testing, and drive train integrity testing are each performed, the testing may be performed in a specific order such that electronic integrity testing is performed before brake testing and brake testing is performed before drive train integrity testing. In other embodiments, electronic integrity testing, brake testing, and drive train testing may be performed simultaneously or in any other order.

The electronic integrity testing is used to test that the electronic boards (e.g., nodes) and sensors localized in the components in the interior environment <NUM> and their communication channels are functioning properly. Each of the nodes may be connected via an interconnected network through which each node may communicate with each other node. The electronic integrity testing may include a test of global communications, whereby the nodes send messages throughout the interconnected network to make sure all of the nodes are present and communicating. The global communication may be determined to be functioning properly if messages are being sent and received by each of the nodes. In some embodiments, the messages for the global communications test may include the nodes sending/receiving unique IDs, ping-echo queries, and the like. Additionally or alternatively, the electronic integrity testing may include a local test, whereby one or more nodes run a local diagnostic test to make sure all of the sensors connected to the one or more nodes are within a nominal range for each particular sensor. The local diagnostic test for a node may be determined to be functioning properly if all of the sensors connected to the node are reading nominal values within a predetermined range for each particular sensor. In some embodiments, the components in the interior environment <NUM> may include redundant sensors that may be used to check whether primary sensors in the components are functioning. The local diagnostic test described above may also test the redundant sensors connected to the node to determine whether the redundant sensor readings match the primary sensor readings within a specified error tolerance. For example, the local diagnostic test may determine that a redundant sensor is functioning properly if a reading from the redundant sensor matches a reading from the corresponding primary sensor within the specified error tolerance. Sensor status information from the local diagnostic test for a node may be part of the messages exchanged during the global communications test.

The brake testing is used to ensure that the brakes of the motorized joints of the components in the interior environment <NUM> are functioning properly. In more detail, a manipulator assembly (e.g., the manipulator assembly <NUM>) may include a brake system to allow motorized joints to be locked into place. Each motorized joint may include a brake, and the brakes may be applied to hold the manipulator assembly in place. In some embodiments, when a manipulator assembly is in use, the brakes may be applied when the manipulator assembly is not being actuated, for example, or when the manipulator assembly is in a fault condition. When the brakes are applied, the joint actuators can be turned off. The brakes may have a holding requirement with an upper force limit and a lower force limit. The brake holding limits may be set such that the brakes are strong enough to hold the manipulator assembly when the joint actuators are off (e.g., to prevent the manipulator assembly from inadvertently moving), while also permitting a human operator to overpower the brake holding force (e.g., to move a faulted manipulator assembly away from an area to allow for human intervention). The brake test may test a brake of a motorized joint by leaving the brake of the joint applied while commanding a joint actuator of the motorized joint to move with a prescribed amount of force. The range of motion in which the joint may need to move for the brake test may be small. For example, the range of motion may be a few degrees in cases when the brakes of a rotary joint are being tested. During the brake test, joint friction is measured to make sure the brake holding force is between the upper force limit and the lower force limit. If it is determined that the joint moves too much, then the brake may be determined to not be sufficiently holding the joint (e.g., the brake holding force is below the lower force limit). Conversely, if it is determined that the joint moves too little, then the brake may be determined to be holding the joint with too much force (e.g., the brake holding force is above the upper force limit). A joint may be determined to pass the brake test when the joint friction is within a specified range. For example, a joint may be determined to pass the brake test when the brake holding force is between the lower force limit and the upper force limit.

In some embodiments, once the brakes have been tested, the brakes can be released and the joints can be held in place by the joint actuators. In some embodiments, the joints are driven by motors using gear heads and include two position sensors (e.g., encoders). The position sensors may be located at a motor shaft and at the joint itself (i.e., the position sensors are located before and after the gear head). During drive train testing, the manipulator assembly may be commanded to make a short motion, and the signals from the two position sensors may then be compared. The drive train testing may be used to measure gear head backlash as well as gear head friction. The drive train testing may be determined to be satisfied (i.e., it may be determined that the manipulator assembly passes the drive train testing) when the gear head backlash and the gear head friction are within a predetermined specification or tolerance and when the position sensors are functioning and their motion measurements are in agreement. The motion of the drive train integrity test may be larger than that of the brake test. For example, the range of motion may be several degrees (e.g., <NUM>-<NUM> degrees) in cases when the brakes of a rotary joint are being tested. The range of motion is provided for exemplary purposes only. In other embodiments, the range of motion may be less than <NUM> degrees (e.g., <NUM>-<NUM> degrees) or greater than <NUM> degrees (e.g., <NUM>-<NUM> degrees).

The manipulator <NUM>, the drive unit <NUM>, or any other teleoperated component in the interior <NUM> of the storage container <NUM> may be tested immediately after the storage container <NUM> is sterilized. The manipulator <NUM>, for example, may additionally be tested while the storage container <NUM> is in storage. The manipulator <NUM> may further be tested in the operating room immediately before the surgical procedure is to be performed. The manipulator <NUM> may be tested at any other time after the sterilization process and before the surgical procedure. Because the storage container <NUM> is not opened during the testing, the manipulator <NUM> remains sterile before, during, and after the testing is performed.

<FIG> is a top view of the interior <NUM> of the storage container <NUM> including a viewing window <NUM> according to some embodiments. The viewing window <NUM> is substantially similar to the viewing window <NUM>. The viewing window <NUM> may be transparent. In alternative embodiments, the viewing window <NUM> is semi-transparent. The viewing window <NUM> is used to view at least a portion of one or more of the components in the interior <NUM> of the storage container <NUM>. For example, an operator can look through the viewing window <NUM> and view the components in the interior <NUM> of the storage container <NUM>. In some embodiments, the operator can look through the viewing window <NUM> to determine whether the manipulator <NUM>, for example, is functioning properly without opening the storage container <NUM>. Thus, the operator can determine whether the manipulator <NUM> is functioning properly while maintaining sterility of the interior environment <NUM> of the storage container <NUM>.

In some examples, the communication interface <NUM> and the viewing window <NUM> may be combined as one component. In such examples, an optical or infrared (IR) signal can be directed into or received from the interior <NUM> of the storage container <NUM> through the combined communication interface <NUM>/viewing window <NUM>. The optical or IR signal may be used to determine whether the manipulator <NUM>, for example, is functioning properly without opening the storage container <NUM>. The optical or IR signal may additionally or alternatively be used to determine whether the drive unit <NUM>, for example, is functioning properly without opening the storage container <NUM>.

The viewing window <NUM> is located within the front wall <NUM> of the storage container <NUM> (e.g., between the outer surface <NUM> and the inner surface <NUM>). While <FIG> depicts the viewing window <NUM> in the front wall <NUM> of the storage container <NUM>, it is to be understood that the viewing window <NUM> can be located in any other wall of the storage container <NUM> (e.g., a top (not shown), a bottom (not shown), the side walls <NUM>, and/or the back wall <NUM>). In some embodiments, there may be multiple viewing windows placed within the walls of the storage container <NUM>. Having multiple viewing windows may provide the operator with a better line of sight to the particular component the operator is testing within the interior environment <NUM>.

In some embodiments, a communication sent from the control system <NUM> to the teleoperated components in the interior environment <NUM> via the communication interface <NUM> and the communication links <NUM>, <NUM> commands movement of one or more of the teleoperated components in order to demonstrate the operability of the teleoperated component(s). For example, the manipulator <NUM> may be actuated by the communication sent from the control system <NUM>. In some embodiments, the operator may determine that the manipulator <NUM> is functioning properly if, after the communication is sent instructing the manipulator <NUM> to move, the operator views the manipulator <NUM> in motion by looking through the viewing window <NUM>.

While the embodiments above are discussed in the context of medical or surgical procedures, it is to be understood that the systems, instruments, and methods may also be used for non-medical purposes. For example, the systems, instruments, and methods may be used for nonsurgical diagnosis, industrial systems, general robotic systems, and general teleoperational systems.

<FIG> is a perspective view of multiple storage containers <NUM>, <NUM>, <NUM> stacked on top of one another according to some embodiments. The storage containers <NUM>, <NUM>, <NUM> are each substantially similar to the storage container <NUM>. The storage containers <NUM>, <NUM>, <NUM> may be stacked on top of each other in the operating room, in a storage room, or in any other suitable location. The storage containers <NUM>, <NUM>, <NUM> are stored after being sterilized (e.g., in an autoclave). Thus, the interiors of storage containers <NUM>, <NUM>, <NUM> and the components within the storage containers <NUM>, <NUM>, <NUM> remain sterile during non-sterile handling and while in storage in a non-sterile environment. The storage containers <NUM>, <NUM>, <NUM> may be stored in rows and/or on shelves in a storage room. The storage containers <NUM>, <NUM>, <NUM> are stacked in a manner to ensure that a front wall <NUM>, <NUM>, <NUM> of each storage container <NUM>, <NUM>, <NUM>, respectively, may all be viewed by an operator at the same time. In such embodiments, communication interfaces <NUM>, <NUM>, <NUM>, which are each substantially similar to the communication interface <NUM>, may all be viewed by an operator at the same time. Similarly, the viewing windows <NUM>, <NUM>, <NUM>, which are each substantially similar to the viewing window <NUM>, may all be viewed by the operator at the same time. Such a storage configuration allows an operator to quickly and easily test and/or view the components within each storage container <NUM>, <NUM>, <NUM> without needing to unstack or move the stored storage containers <NUM>, <NUM>, <NUM>.

In some embodiments, a surgical procedure may require the use of more than one teleoperated surgical manipulator assembly. In some embodiments, each of the storage containers <NUM>, <NUM>, <NUM> includes all components of a teleoperated surgical manipulator assembly (e.g., the manipulator assembly <NUM>). In alternative embodiments, each of the storage containers <NUM>, <NUM>, <NUM> includes one type of component of a teleoperated surgical manipulator assembly. For example, the storage container <NUM> may only include manipulators (e.g., manipulator <NUM>); the storage container <NUM> may only include drive units (e.g., drive unit <NUM>); and the storage container <NUM> may only include clamps (e.g., clamp <NUM>).

In some examples, one or more of the containers <NUM>, <NUM>, <NUM> may be connected (e.g., electrically connected) such that electrical energy (e.g., power) and/or data may be transferred between the containers <NUM>, <NUM>, <NUM>. Thus, the containers <NUM>, <NUM>, <NUM> may form a local power network and/or a local data network. The connection between the containers <NUM>, <NUM>, <NUM> may be a result of the containers being stacked on top of one another. Additionally or alternatively, the connection between the containers <NUM>, <NUM>, <NUM> may be a result of the containers being in close proximity to one another. In some examples, the power and/or the data may be transferred between the containers <NUM>, <NUM>, <NUM> when only one of the containers <NUM>, <NUM>, <NUM> is connected to an external power source and/or an external data source (e.g., a data communication device). For example, the container <NUM> may be connected wirelessly and/or with a wired connection to an external power source (e.g., a wall outlet, a battery, etc.). The container <NUM> may receive power from the external power source. In this example, because the container <NUM> is electrically connected to one or more of the containers <NUM>, <NUM>, the power received from the external power source may be transferred from the container <NUM> to one or more of the containers <NUM>, <NUM>. For example, the container <NUM> may be in communication with an external data communication device to exchange data (e.g., send and receive data) between the data communication device and the containers <NUM>, <NUM>, <NUM>. In embodiments when the container <NUM> receives data from an external data source, the data may be transferred from the container <NUM> to one or more of the containers <NUM>, <NUM>. In some embodiments, power and/or data may be transferred between any number of containers that are stacked on top of one another or are within close proximity to one another. In some embodiments, one container may be connected to an external power source (e.g., container <NUM>) and a different container may be connected to an external data communication device (e.g., container <NUM> and/or container <NUM>). In some embodiments where one or more of the containers <NUM>, <NUM>, <NUM> have an onboard power supply (e.g., sterilizable batteries), the local power network may be used to charge the onboard power supplies of one or more of the containers <NUM>, <NUM>, <NUM>. For example, one container may be connected to an external power source (e.g., container <NUM>), which may be used to charge onboard power supplies located in one or more of the containers <NUM>, <NUM>, <NUM> via the local power network.

<FIG> illustrates a method <NUM> for sterilizing a storage container according to some embodiments. The method <NUM> is illustrated as a set of operations or processes <NUM> through <NUM> and is described with continuing reference to <FIG>. Not all of the illustrated processes <NUM> through <NUM> may be performed in all embodiments of method <NUM>. Additionally, one or more processes that are not expressly illustrated in <FIG> may be included before, after, in between, or as part of the processes <NUM> through <NUM>. In some embodiments, one or more of the processes <NUM> through <NUM> may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a control system) may cause the one or more processors to perform one or more of the processes.

At a process <NUM>, a cleaning operation is performed on a teleoperated component (e.g., manipulator <NUM>) of a teleoperated surgical manipulator assembly (e.g., manipulator assembly <NUM>) used during a surgical procedure on a first patient to produce a cleaned teleoperated component. The cleaning operation may be performed after the surgical procedure in a decontamination area. The cleaning operation may be performed immediately after the surgical procedure is completed. In alternative embodiments, the cleaning operation may be performed during the surgical procedure but after the teleoperated component has been used and will no longer be needed during the surgical procedure.

At a process <NUM>, the cleaned teleoperated component is placed into a storage container (e.g., storage container <NUM>). In some embodiments, the teleoperated component may then be connected to a communication interface (e.g., communication interface <NUM>) via a communication link (e.g., communication link <NUM>).

In some embodiments a filter is placed adjacent to the vent <NUM>. In some embodiments, the filter is autoclave filter paper. The filter may be placed beneath the vent <NUM>. For example, the filter may be placed on the side of the vent <NUM> that is adjacent to the interior <NUM> of the storage container <NUM>. The storage container <NUM> may then be closed except that air and steam may pass into and out of the storage container <NUM> via the vent <NUM> and the filter.

At a process <NUM>, the cleaned teleoperated component in the storage container <NUM> and the storage container <NUM> are sterilized together to produce a sterilized teleoperated component in a sterile interior environment of the storage container <NUM>. In some embodiments, the teleoperated component and the storage container <NUM> are sterilized in an autoclave by inserting the storage container <NUM>, with the teleoperated component inside an interior environment (e.g., interior environment <NUM>), into the autoclave and performing a sterilization process. In embodiments in which autoclave filter paper covers the vent <NUM>, steam may pass into the storage container <NUM> through the filter paper under pressure. The steam and heat destroy any microbes inside the storage container <NUM>. The filter paper prevents microbes or other large molecules from entering through the vent <NUM>, thus allowing the interior of the storage container <NUM> to remain sterilized after the sterilization process.

In alternative embodiments, e.g., when autoclave filter paper does not cover the vent <NUM>, the storage container <NUM> may be closed after the cleaning process and wrapped with a sterilization wrap. The sterilization wrap may be wrapped around the exterior of the vent <NUM> and the storage container <NUM>. Steam passes into the storage container <NUM> through the sterilization wrap under pressure. The steam and heat destroy any microbes inside the storage container <NUM>. The sterilization wrap prevents microbes or other large molecules from entering through the vent <NUM>, thus allowing the interior of the storage container <NUM> to remain sterilized after the sterilization process. The sterilization wrap may be wrapped one time, two times, or any other suitable number of times around the exterior of the vent <NUM> and the storage container <NUM>.

The storage container <NUM> is kept closed to define a sterile interior environment (e.g., interior environment <NUM>) of the storage container <NUM> that contains the sterilized teleoperated component. The sterile interior environment <NUM> is defined by an inner surface (e.g., inner surface <NUM>) of the storage container <NUM>. The sterile interior environment <NUM> remains sterile until the sterile interior environment <NUM> contacts a non-sterile object or a non-sterile environment.

In some embodiments, the method <NUM> may further include the process of moving the storage container <NUM> that contains the sterilized teleoperated component to an operating room. In some embodiments, the storage container <NUM> that contains the sterilized teleoperated component is moved to an operating room shortly after the sterilization process is completed. In other embodiments, the storage container <NUM> that contains the sterilized teleoperated component is moved to a storage room after the sterilization process is completed and is then moved from the storage room to the operating room.

The sterilized teleoperated component may be removed from the storage container <NUM> in the operating room. The sterilized teleoperated component may be removed prior to or during a surgical procedure on the second patient. In some embodiments, the sterile teleoperated component is assembled into a teleoperated surgical manipulator assembly (e.g., manipulator assembly <NUM>) for use in a surgical procedure on the second patient.

In some embodiments, the method <NUM> may further include the process of establishing a communication through the storage container <NUM> that defines an interior sterile environment <NUM> to a sterilized teleoperated component of a teleoperated surgical manipulator assembly within the interior sterile environment <NUM>. The communication may be established using communication links <NUM>, <NUM>. The communication is used to test the sterilized teleoperated component while maintaining sterility of the sterilized teleoperated component in the storage container <NUM>. This allows an operator to determine whether the sterilized teleoperated component is functioning properly prior to removing the sterilized teleoperated component from the storage container <NUM>, which maintains sterility of the sterilized teleoperated component. Thus, the operator can determine whether the sterilized teleoperated component is functioning properly well before the time of the surgical operation. This can allow for a replacement sterilized teleoperated component to be obtained, if needed, without delaying the surgical operation.

In some embodiments, the communication may include a teleoperation communication, and the component of the sterilized teleoperated component moves in response to the teleoperation communication. In some embodiments, the communication may provide a command to move a teleoperated component of the manipulator assembly <NUM>. In other embodiments, the communication may include a self-test communication to allow for a self-test of the sterilized teleoperated component. In further embodiments, the communication may include a component status communication for the sterilized teleoperated component, a hardware communication, and/or a wireless communication.

In some embodiments, the processes <NUM> through <NUM> may be performed for a manipulator support component (e.g., kinematic arm <NUM>, coupling member <NUM>, and/or clamp <NUM>) of the teleoperated surgical manipulator assembly. For example, a cleaning operation may be performed on a manipulator support component of the teleoperated surgical manipulator assembly used during the surgical procedure on the first patient to produce a cleaned manipulator support component. Additionally, the cleaned manipulator support component may be placed into the storage container <NUM>, wherein the storage container <NUM> includes the vent <NUM>. The filter may then be placed adjacent to the vent <NUM>. The storage container <NUM> may then be closed. The cleaned manipulator support component in the storage container <NUM> and the storage container <NUM> may then be sterilized together to produce a sterilized manipulator support component. Further, the storage container <NUM> may be kept closed to define a sterile interior environment <NUM> of the storage container <NUM> that contains the sterilized manipulator support component. Then, the storage container <NUM> that contains the sterilized manipulator support component and the sterilized teleoperated component is moved to the operating room. The sterilized manipulator support component and the sterilized teleoperated component are removed from the storage container <NUM> at the operating room. Further, the sterile manipulator support component and the sterile teleoperated component may be assembled into the teleoperated surgical manipulator assembly for use in the surgical procedure on the second patient.

<FIG> illustrates a method <NUM> for communicating with components in an interior of a storage container according to some embodiments. The method <NUM> is illustrated as a set of operations or processes <NUM> through <NUM> and is described with continuing reference to <FIG>. Not all of the illustrated processes <NUM> through <NUM> may be performed in all embodiments of method <NUM>. Additionally, one or more processes that are not expressly illustrated in <FIG> may be included before, after, in between, or as part of the processes <NUM> through <NUM>. In some embodiments, one or more of the processes <NUM> through <NUM> may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a control system) may cause the one or more processors to perform one or more of the processes. In one or more embodiments, the processes <NUM> through <NUM> may be performed by the control system <NUM>.

At a process <NUM>, a sterile storage container (e.g., storage container <NUM>) comprising a sterilized teleoperated component (e.g., manipulator <NUM>) that includes a mechanism is provided. In some embodiments, the mechanism is a teleoperated arm portion (e.g., arm portion <NUM>), a teleoperated motor, or any other suitable teleoperated mechanism. In alternative examples, the sterilized teleoperated component is the drive unit <NUM>. In such examples, the mechanism may be one motor of a plurality of motors that manipulates a component of the instrument (e.g., the instrument <NUM>), rather than manipulating the entire instrument.

At a process <NUM>, a communication may be established through an exterior wall (e.g. front wall <NUM>) of the sterile storage container <NUM> to the sterilized teleoperated component. The communication is established using the communication links <NUM>, <NUM>. In some embodiments, the communication includes a teleoperation communication that provides a command to move the mechanism of the sterilized teleoperated component. In some embodiments, the communication may provide a command to move a teleoperated component of the manipulator assembly <NUM>. In other embodiments, the communication may include a self-test communication to allow for a self-test of the sterilized teleoperated component. In further embodiments, the communication may include a component status communication for the sterilized teleoperated component, a hardware communication, and/or a wireless communication.

At a process <NUM>, the mechanism of the sterilized teleoperated component may optionally be moved in response to the communication. This allows an operator to determine whether the sterilized teleoperated component is functioning properly prior to removing the sterilized teleoperated component from the storage container <NUM>, which maintains sterility of the sterilized teleoperated component. Thus, the operator can determine whether the sterilized teleoperated component is functioning properly well before the time of the surgical operation. This can allow for a replacement sterilized teleoperated component to be obtained, if needed, without delaying the surgical operation. Likewise, an electronic component may be tested to determine if the electronic component is functioning properly. The electronic component test result may generate a signal transmitted from the electronic component to a device outside the storage container <NUM>, or it may generate a visible indication that can be seen through the viewing window <NUM> (e.g., a red or green light).

Optionally, a status of the sterilized teleoperated component may be analyzed. The component status may be used to ensure proper performance of the system (e.g., system <NUM>) by indicating a correct operational status of the sterilized teleoperated component. This feature prevents a poorly functioning component from being assembled into a telesurgical system.

Optionally, the status may be communicated to at least one of medical personnel and a control system (e.g., control system <NUM>). The status information may be received by the operator O, a surgeon, and/or any other suitable medical personnel. The status may additionally be received by a hospital information system, a patient information portal, a surgical information database, and/or any other suitable system or database. In some embodiments, the status may additionally be communicated to a manufacturer of the sterilized teleoperated component to indicate whether the sterilized teleoperated component requires maintenance.

One or more elements in embodiments of this disclosure may be implemented in software to execute on a processor of a computer system such as a control processing system. When implemented in software, the elements of the embodiments of the present disclosure are essentially the code segments to perform the necessary tasks. The program or code segments can be stored in a processor readable storage medium or device that may have been downloaded by way of a computer data signal embodied in a carrier wave over a transmission medium or a communication link. The processor readable storage device may include any medium that can store information including an optical medium, semiconductor medium, and magnetic medium. Processor readable storage device examples include an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code segments may be downloaded via computer networks such as the Internet, Intranet, etc..

Note that the processes and displays presented may not inherently be related to any particular computer or other apparatus, and various systems may be used with programs in accordance with the teachings herein. In addition, the embodiments of the present disclosure are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the present disclosure as described herein.

Claim 1:
A system comprising:
a reclosable portable storage container (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising an interior sterile environment (<NUM>);
a sterile teleoperated component of a teleoperated surgical manipulator assembly (<NUM>, <NUM>, <NUM>) in the interior sterile environment;
wherein the sterile teleoperated component is teleoperably movable in the interior sterile environment; and
a control system (<NUM>) configured to carry out kinetic testing of the sterile teleoperated component whilst in the interior sterile environment (<NUM>).