WO2025207873A1 - Systems and methods for providing a sterility indiciator - Google Patents
Systems and methods for providing a sterility indiciatorInfo
- Publication number
- WO2025207873A1 WO2025207873A1 PCT/US2025/021732 US2025021732W WO2025207873A1 WO 2025207873 A1 WO2025207873 A1 WO 2025207873A1 US 2025021732 W US2025021732 W US 2025021732W WO 2025207873 A1 WO2025207873 A1 WO 2025207873A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sterility
- status
- links
- indication
- computer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
- A61G13/00—Operating tables; Auxiliary appliances therefor
- A61G13/02—Adjustable operating tables; Controls therefor
- A61G13/06—Adjustable operating tables; Controls therefor raising or lowering of the whole table surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
- A61G13/00—Operating tables; Auxiliary appliances therefor
- A61G13/02—Adjustable operating tables; Controls therefor
- A61G13/08—Adjustable operating tables; Controls therefor the table being divided into different adjustable sections
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
- B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
- B25J9/00—Programme-controlled manipulators
- B25J9/16—Programme controls
- B25J9/1674—Programme controls characterised by safety, monitoring, diagnostic
- B25J9/1676—Avoiding collision or forbidden zones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/081—Indication means for contamination or dirt
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/50—Supports for surgical instruments, e.g. articulated arms
- A61B90/57—Accessory clamps
- A61B2090/571—Accessory clamps for clamping a support arm to a bed or other supports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/25—User interfaces for surgical systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/70—Manipulators specially adapted for use in surgery
- A61B34/76—Manipulators having means for providing feel, e.g. force or tactile feedback
Definitions
- Disclosed examples relate to guided robotic control manipulator systems.
- the disclosed examples relate to systems and methods for determining the sterility of various parts of a manipulator system, and further providing indications of the sterility of the parts of the manipulator system.
- manipulator systems may include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments coupled to the manipulators.
- a manipulator generally includes mechanical links connected by joints.
- An instrument is removably (or permanently) coupled to one of the links, typically a distal link of the plural links.
- robotic manipulator systems are draped with a sterile drape.
- the systems are then positioned relative to a sterile field of operation, such as an operating table or bed.
- a sterile field of operation such as an operating table or bed.
- portions of the system may reside in non-sterile zones or regions of the OR such as regions close to the floor, regions below an operating table, etc.
- portions or parts of the manipulator system may move into non-sterile regions, or come into contact with non-sterile objects (including individuals).
- manipulators can include those as configured as part of the medical systems that are part of various da Vinci® Surgical Systems, such as the da Vinci X®, da Vinci Xi®, and da Vinci SP systems, commercialized by Intuitive Surgical, Inc., of Sunnyvale, California.
- the rail assembly 120 is coupled to one of the platform sections 103. In other embodiments, the rail assembly 120 is coupled to the support column 102. Which structure the rail assembly 120 is coupled to can make a difference in embodiments in which the platform assembly 110 as a whole is movable relative to the support column 102, for example by tilting relative to the support column 102. In embodiments in which the rail assembly 120 is coupled to one of the platform sections 103 (e.g., a middle section 103_2), when the platform assembly 110 moves relative to the support column 102, the rail assembly 120 and hence the manipulators 140 coupled thereto move along with the platform assembly 110.
- the platform sections 103 e.g., a middle section 103_2
- the manipulators 140 can allow the manipulators 140 to automatically maintain a set pose and position relative to the platform assembly 110, and thus relative to a patient supported on the platform assembly, regardless of a configuration of the platform assembly 110 and without having to reposition the manipulators 140. Moreover, in some circumstances, collision between the platform assembly 110 and the rail assembly 120 due to motion of the platform assembly 1 10 can be avoided as they both move together.
- the rail assembly 120 is coupled to the support column
- the rail assembly 120 and hence the manipulators 140 coupled thereto remain with the support column 102 and do not move along with the platform assembly 110. This can allow greater motion of the rail assembly 120 and manipulators 140 relative to the platform assembly 110.
- This also can increase the strength and/or relative stiffness of the structure between the manipulators 140 and the support column 102 by reducing the length of the structure between them and reducing the number of connections between them.
- the motion of the manipulators 140 relative to the platform assembly 110 enabled by the rail assembly 120 allows the distal link assemblies of the manipulators 140 to be moved into a nested configuration near one end portion of the platform assembly 110 which can allow the intermediate and distal link assemblies of the manipulators 140 to be moved around an end of the platform assembly 110 to positions adjacent a laterally extending side 109a of the platform assembly 110.
- the nested configuration includes a configuration in which the proximal arms 141 of two adjacent manipulators 140 coupled to the same rail 121 are oriented at angles of 180 degrees or more relative to that rail 121.
- the manipulators 140 are configured to be moved beyond the foot end of the platform assembly 110 in the nested configuration.
- the manipulators 140 can be moved beyond the head end of the platform assembly 110, and in still other embodiments the manipulators 140 can be moved beyond both the head end and beyond the foot end.
- the nested configuration can allow for the manipulators 140 to be stowed in a compact manner under the second end section 103_3.
- an input device can be provided with the same degrees of freedom as the associated instrument that they control, and as the input device is actuated, the instrument, through drive inputs from the manipulator assembly, is controlled to follow or mimic the movement of the input device, which can provide the user a sense of directly controlling the instrument.
- Telepresence input devices can provide the operator with telepresence, meaning the perception that the input devices are integral with the instrument.
- the user input and feedhack system 1004 can also include feedback devices, such as a display device (not shown) to display images (e.g., images of the workspace as captured by one of the instruments 150), haptic feedback devices, audio feedback devices, other graphical user interface forms of feedback, etc.
- the logic of the processing circuitry can include dedicated hardware to perform various operations, software (machine readable and/or processor executable instructions) to perform various operations, or any combination thereof.
- the processing circuitry can include a processor to execute the software instructions and a memory device that stores the software.
- the processor can include one or more processing devices capable of executing machine readable instructions, such as, for example, a processor, a processor core, a central processing unit (CPU), a controller, a microcontroller, a system-on-chip (SoC), a digital signal processor (DSP), a graphics processing unit (GPU), etc.
- the dedicated hardware can include any electronic device that is configured to perform specific operations, such as an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), a Complex Programmable Logic Device (CPLD), discrete logic circuits, a hardware accelerator, a hardware encoder, etc.
- ASIC Application Specific Integrated Circuit
- FPGA Field Programmable Gate Array
- CPLD Complex Programmable Logic Device
- the processing circuitry can also include any combination of dedicated hardware and processor plus software.
- the system 200 includes a table assembly 201, two rail assemblies 220 coupled to the table assembly, and multiple manipulators 240 coupled to the rail assemblies 220.
- Each manipulator 240 is configured to support one or more instruments (not illustrated), which can be removably or permanently mounted thereon.
- the system 200 also can include a control system (not illustrated), a user input and feedback system (not illustrated), and/or an auxiliary system (not illustrated) similar to those described above in relation to the system 100.
- the system 200 is configured as a computer-assisted, teleoperable medical system.
- the system 200 is configured as a teleoperable and/or manually- operable system for use in non-medical contexts.
- auxiliary devices can be coupled to the one or more of the platform sections 203, in addition to or in lieu of one or more of the platform sections 203; for example, leg stirrups can be coupled the middle section 203_3 in lieu of the second end section 203_4 in some embodiments.
- FIG. 2B illustrates the platform assembly 210 in a neutral configuration in which all of the platform sections 203 are parallel to one another and to the ground or other supporting surface upon which the table assembly 201 rests
- FIG. 2A illustrates the platform assembly 210 in articulated configurations in which some of the platform sections 203 are oriented at non-zero angles relative to adjacent platform sections 203 and/or relative to the ground or other supporting surface.
- the middle platform sections 203_2 and 203_3 can share the same cushion portion 203a that extends across both platform sections 203 2 and 203_3.
- the cushion portion 203a shared by the platform sections 203_2 and 203_3 can bend when the platform sections 203 2 and 203 3 are articulated relative to one another, as shown in FIG. 2A.
- the platform assembly 210 also includes a number of accessory rails 204 attached to side surfaces of the support portions 203b of the platform sections 203.
- the accessory rails 204 can be configured to receive accessory devices removably mounted thereon, such as such as leg stirrups, liver retractor, arm boards, and bed extenders.
- the accessory rails 204 are be attached to longitudinally extending side faces of one or more of the platform sections 203.
- the manipulators 240 are deployed and have a distal link assembly positioned in a sterile field (see, for example, Fig. 2A).
- the sterile field is a region in which any exposed surfaces of objects in the region are maintained in a sterile condition (e.g., a condition substantially free from contaminants, such as biological pathogens, dusts, oils, etc.).
- an object may include a non-sterile surface covered by a sterile barrier.
- FIG. 2C further illustrates examples of sterility boundaries, and various regions of space that may be associated with varying sterility and status classifications and/or rankings.
- the sterile field may be defined as a region above a certain height, such as above the rail 221, platform 210, or other chosen reference point.
- the sterile field may be defined as an upper region 290 corresponding to the region of space above the top surface 211 of the platform 210, or any other boundary defined in a sterility protocol implemented by the control system 1006.
- the upper region 290 is bounded by a plane at an upper axis 280 corresponding to the top surface 211 of the platform 210.
- any portions of an object below that height may be considered to be outside of the sterile field, and therefore, not be sterile.
- the upper region 290 may include an upper limit proximate to a ceiling or ventilation equipment within the OR, above which is outside of the sterile field.
- additional sterility boundaries may be defined to allow for a gradient of status ranks or sterility ranks to be provided to a user, which will be described further herein.
- the height defining the sterility field is statically defined throughout the operation.
- the height defining the sterility field may change dynamically throughout the operation. For example, as described above, the platform 210 may translate in the vertical direction. Accordingly, as the platform 210 translates vertically, the height of the platform 210 and/or rail 221 changes. Thus, the sterility field boundary may also change in accordance with the translation of the platform 210.
- the distal link assembly 263 is raised to a height sufficient for the distal link assembly 263 and any instrument supported thereon to remain within the sterile field while deployed.
- the distal link assembly 263 is at or above a height of the proximal arm 241, the rail 221, the platform 210, and/or some other predetermined level.
- the manipulators 240 can be deployed, but do not have a distal link assembly positioned fully in the sterile field.
- the deployed state can include a variety of configurations and positions of the manipulators 240 including but not limited to those shown in FIGs. 2A, 2B, and 2C.
- the sterility protocols implemented by the control system 1006 may define a plurality of sterility boundaries that bound a plurality of respective sterility regions.
- the upper boundary 280 is defined by the upper surface 211 of the platform 210
- an intermediate boundary 285 is defined by a lower surface 212 of the platform 210
- a lower boundary 288 is defined relative to a floor 213.
- the boundaries define various regions of space that the sterility protocol associates with different levels of risk of non-sterility.
- a platform region 282 may be defined as the region of space defined by the upper boundary 280 and the intermediate boundary 285, a lower region 287 may be defined as the region of space between the intermediate boundary 285 and the lower boundary 288, and a floor region 289 may be defined as the region of space between the lower boundary 288 and the floor 213.
- the boundaries that define the various regions and/or gradients may be customizable, for example, via a user interface presented via the user input system 1004.
- different institutions have different standards for sterility for different settings, procedures, equipment, etc.
- an operator of the user input system 1004 may input and/or upload a set of boundary preferences for use with the disclosed techniques.
- Each of the regions of space 290, 282, 287, and 289 may be classified as having different sterility rankings, resulting in a potential gradient of sterility ratings across the regions of space 290, 282, 287, and 289.
- the sterility protocols may assign the regions a rating on a scale from 1 to 4 with 1 being a high-confidence of sterility to 4 being a high confidence of non-sterile.
- the floor region 289 may have a sterility ranking of 4
- the lower region 287 may have a sterility ranking of 3
- the platform region 282 may have a sterility rank of 2
- the upper region 290 may have a ranking of 1.
- FIG. 2C depicts one example set of boundaries defined by a sterility protocol, other sterility protocols may define the gradient of sterility risk and the corresponding boundary regions in any suitable manner.
- a processor or control system may define a continuous, or quasi-continuous, gradient of sterility risk or sterility ratings across any of the regions of space 290, 282, 287, and 289 relative to the various sterility boundaries 280, 285, 288 and the floor 213.
- boundaries may be generally static (e.g., a boundary defined by a floor, wall, or ceiling) while other boundaries may be dynamic such as a boundary defined by one or more portions of the platform 210 that may tilt, raise, lower, etc. during an operation or procedure. Accordingly, the control system 1006 may monitor kinematic data associated with the corresponding portions of the platform 210 to adjust the boundary regions based on the motion.
- the control system 1006 monitors kinematic data associated with manipulators 240 to determine the pose of the positions thereof with respect to the boundaries defined by the sterility protocol. If the control system 1006 determines that a portion of the manipulators 240 crossed one of the sterility boundaries, the control system 1006 may assign that portion a sterility value and/or status associated with the region in which the portion entered. It should be appreciated that the control system 1006 may assign each portion of the manipulators 240 the sterility value and/or status associated with the least sterile region the portion has entered.
- FTGs. 3 and 4 illustrate two embodiments of manipulators 240_l and 240_2, having status indicators 270 respectively.
- the manipulators 240_l and 240_2 are generally similar to one another except that the manipulators 240_l and 240_2 employ status indicators 270 in two different configurations.
- FIG. 3 includes status indicators 270 disposed generally in a strip arrangement along the lengths of the various links and joints of the manipulator 240_l, while the status indicators 270 of the manipulator 240_2 of FIG. 4 are disposed circumferentially around the links and joints at different positions along the lengths of the links and joints.
- the circumferential configuration of FIG. 4 provides status indications about the various links and/or joints to allow a user or operator to see the status from a variety of perspectives of a given link or joint.
- the strip configuration of FIG. 3 provides finer resolution as to the sterility status of the respective portions of the manipulator 240.
- each manipulator 240 includes a proximal link assembly 261 including a proximal arm 241 coupled to the rail assembly 220 via one or more proximal joints 230 and a carriage 226, an intermediate link assembly 262 including an intermediate arm 242 coupled to a distal end portion of the proximal link assembly 261 via one or more intermediate joints 245, and a distal link assembly 263 including a distal arm 243 coupled to the intermediate link assembly 262 via one or more distal joints 246.
- the distal link assembly 263 also includes an instrument holding portion 269 coupled to the distal arm 243 and configured to support an instrument, such as the instrument 150 illustrated in FIG. 1.
- Each of the proximal link assembly 261, intermediate link assembly 262, and distal link assembly 263 include status indicators 270 disposed thereon.
- FIG. 5 is a side view of a manipulator 240_3 according to a similar configuration of that of FIG. 3 with the status indicators 270 disposed in a strip arrangement along one or more sides of one or more links or joints of the manipulator 240_3.
- the status indicators 270 in any of FIGs. 3-5 may be disposed on one or more links, two or more links, and further be disposed on one or more joints, or two or more joints of the manipulators 240.
- Each of the manipulators 240 of FIGs. 3-5 includes two proximal joints 230 and associated joint housings 264 and 265. In some embodiments, the manipulators 240 may have a single proximal joint.
- the manipulators 240 may have respective indication systems including status indicators 270 disposed on two or more links, two or more joints, a link and a joint, or any combination of links and joints as desired or required for a given application.
- Each of the status indicators 270 may provide an indication of sterility status of a respective link or a joint (or portion thereof).
- the indications of a sterility status may inform a user as to whether the link or joint is sterile such the user knows whether manual movement or positioning of the link or joint will breach sterility protocols.
- the status indicators 270 may provide an indication of whether a link or joint (or portion thereof) has come into contact with an object or user, has entered a non-sterile region, has come close to a non-sterile region, is ready to be physically manipulated, and/or other conditions related to sterility.
- the status indicators 270 may include one or more LEDs, haptic output devices (e.g., actuators, motors, gyroscopes, etc.), speakers, or other sensory output devices.
- the status indicators 270 may provide various indications of sterility and other statuses via various means and types of signals.
- the LEDs may provide status indications via a flashing pattern, being turned on or off, via a color (e.g., green representing sterile, red representing non-sterile, etc.), via a brightness level, or by a numerical display that utilizes LEDs.
- a color e.g., green representing sterile, red representing non-sterile, etc.
- each sterility value may correspond to a different LED intensity and/or color. For example, portions associated with a higher risk of non-sterility may be brighter and redder than regions associated with lower risk of non-sterility.
- the status indicators 270 may include speakers and audio output devices configured to output beeps or sound patterns, as well as verbal messages.
- a display unit or user interface such as a display unit or user interface (e.g., monitor, computer, tablet, touch screen, etc.) of the user input and feedback system 1004 of FIG. 1, may be configured to provide the sterility status of a portion or part of a manipulator 240.
- a control system such as the control system 1006 of FIG. 1, may be in communication with the indication systems of the manipulators 240 to cause the status indicators 270 to provide indications of the various statuses described herein.
- the control system may be configured to control the indication systems to cause status indicators 270 to provide an indication of sterility status of a portion of each respective link on a manipulator 240, with each respective link corresponding to one or more LEDs of a plurality of LEDs as status indicators 270.
- the control system may be configured to control the output of one or more status indicators 270 including haptic devices and audio output devices to provide sterility status indications via a haptic output or audio output.
- the control system may further be configured to cause status indicators 270 disposed on, or associate with various joints of a manipulator, to provide a sterility status of one or more joints. Further, the control system 1006 may be in communication with one or more display units or user interfaces of the user input and feedback system 1004 to provide status indications via the one or more display units.
- the indicator system may include instrument holding portion status indicators 300 disposed along the instrument holding portion 269, distal status indicators 302 disposed along the distal arm 243, intermediate status indicators 305 disposed along the intermediate arm 242, and proximal status indicators 308 disposed along the proximal arm 241.
- the manipulators 240 may include status indicators 270 at the various joints 245, 246, and 247 as well.
- the status indicators 270 may provide indications of an entire link such as the distal status indicators 302 may provide an indication of sterility status of the entire distal arm 243, or the status indicators 270 may provide status indications of a portion of a link.
- the intermediate status indicators 305 may provide a first indication of sterility status at a first portion 305a, an indication of a second sterility status in a second portion 205b, and a third indication of a sterility status in a third portion 205c of the intermediate link 242.
- the status indicators may indicate that the first and third portions 205a and 205c are sterile, while the second portion 205b is not sterile.
- the status indicators may provide an indication that the first portion 205a is sterile, the second portion 205b has entered a region near a non-sterile region and is deemed potentially non-sterile, and that the third portion is non-sterile 305c.
- control system 1006 may determine that the readiness status of a portion of the manipulator 240 as “ready” if the sterility status for the corresponding portion of the manipulator 240 is determined to be sterile. On the other hand, the control system 1006 may determine that the readiness status of a portion of the manipulator 240 as “not ready” if the sterility status for the corresponding portion of the manipulator 240 is determined to be not sterile.
- the control system 1006 may change the sterility value of the contacted portion, thereby causing the indication system corresponding to the contact portion to update to the indication mode associated with the new sterility status. For example, if the object has a known sterility value and/or status, the control system 1006 may assign the portion the same sterility value and/or status as the object. If the object has an unknown sterility status, the control system 1006 may assign the portion a sterility status indicative of the uncertainty. If the object is known to be sterile (or have a lower risk of non-sterility than the contacted portion), the control system 1006 may not change the sterility value and/or status of the portion. It should be appreciated that the contact may cause a more distal portion of the manipulator 240 to have a higher risk of non-sterility than a more proximal portion of the manipulator 240.
- the manipulators draw power from a battery or other energy storage device to avoid wired connections in the OR that may interfere with performance of a procedure.
- the control system 1006 may implement one or more power saving techniques to reduce energy usage associated with the indication system and maximize the amount of time the manipulators 240 can be in use during the procedure.
- the control system 1006 may disable the indication systems when the manipulators 240 are not to be manually-operated. Thus, less energy is expended on sterility indication when operators do not need to know the sterility status of the manipulators 240 (and/or portions thereof).
- control system 1006 may disable only the most distal and most proximal portions when the manipulator 240 is not to be manually-operated to ensure the sterility status of the intermediate portions is still indicated to the operators.
- An example system for performing the method 600 may include a repositionable structure such as the manipulators 240, having two or more links, such as the proximal link assembly 261, intermediate link assembly 262, and/or distal link assembly 263, coupled via one or more joints, such as by the proximal joints 230, intermediate joints 245, and/or distal joints 246.
- Each link of the two or more links may include a respective indication system with one or more status indicators 270.
- the system further includes a controller, such as the control system 1006 of Fig.
- repositionable structure operatively coupled to the repositionable structure to control the various links, joints, and status indication systems to control positions and movement of the parts of the repositionable structure, as well as control the indication systems to provide indications of status (e.g., sterility status, non-sterility status, moveable status, etc.) via the status indicators.
- status e.g., sterility status, non-sterility status, moveable status, etc.
- the method 600 includes obtaining kinematic data indicative of a position of the two or more links relative to a sterility boundary.
- the kinematics data may include data indicative of a current position, past position, or planned future position of the two or more links. Additionally, the kinematics data may include data indicative of the positioning or movement of the two or more links into a non-sterile region, or in a sterile region of space. The kinematics data may also be indicative of whether the two or more links or any joints, have contacted an object or a person.
- a processor, or the controller may obtain the kinematics data from one or more sensors, or from a feedback system, such as the user input & feedback system 1004 of Fig.
- the kinematics data may include two-dimensional or three-dimensional spatial data to identify the positions and movements of the various links and joints of the repositionable structure, and specifically, in reference to one or more sterility boundaries, such as the sterility boundaries 280, 285, and 288.
- a sterility boundary may define a region as non-sterile if the region is too close to a vent or ceiling, outside of a sterile three-dimensional space around the platform assembly, near a floor, near other devices, around an individual, etc.
- a sterility boundary may be defined relative to a bed, wall, ceiling, individual, object, or any other structure.
- the controller determines a sterility status associated with the two or more links and/or joints of the repositionable structure, from the kinematics data.
- the controller or another processor, may determine the sterility status for each link and/or join of the repositionable structure. For example, the controller may determine that a distal link has passed through a non- sterile region, while a proximal link of a same repositionable structure, has not passed through or been positioned in a non-sterile region. As, such, the controller determines the status of the distal link as non-sterile, and the status of the proximal link as sterile. Additionally, the controller may determine the sterility status of any links and/or joints based on if the link or joint has come into contact with a non-sterile user, or an object.
- multiple sterility boundaries may define a plurality of sterile, and non-sterile regions of space.
- Each non-sterile region of space may independently have a respective sterility rating. For example, some regions may be determined as sterile, and non-sterile regions may have a non-sterile, or risk, rating.
- a single sterility boundary may define a continuous gradient that associates the non-sterile region with respective sterility ratings based on a distance from the sterility boundary.
- the risk rating may include a numerical rating from 1 to 5 with 5 being the most at risk or most non-sterile, and 1 being a least at risk or least considered non-sterile.
- a non-sterile region may be defined as the region of space below the bed of a platform assembly, with a lower risk rating closer to the bed, and a higher risk non-sterility rating closer to the floor of an operating area.
- the controller may determine the sterility status of one or more links or joints, or portions thereof, based on the sterility rating of each link and/or joint, or portion thereof.
- the controller may then control the indication systems of independent links and/or joints, or portions thereof, to provide an indication of each respective sterility rating.
- the controller controls the status indicators to provide a status indication of the two or more links and/or joints, or portions thereof, of the repositionable structure.
- the controller may cause the indication systems to provide indications of a sterility status or of other types of status such as whether a link and/or joint, or a portion thereof, has come into contact with a user or object, or a positioning readiness status if a link or joint is ready to be manually positioned or repositioned.
- the controller may control LEDs, haptic devices, or audio output devices to provide status indications via a visual flashing pattern, an LED brightness, a color, a numeral or character display, an audible pattern, a vibratory output, etc.
- the controller may control a single status indicator, or a plurality of status indicators, to provide an indication of a link, joint, portion of a link, or portion of a joint.
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- Accommodation For Nursing Or Treatment Tables (AREA)
Abstract
Systems and methods are described for providing sterility status for a computer-assisted guide robotic system. The method may include (i) obtaining kinematic data indicative of a position of the two or more links relative to a sterility boundary; (ii) determining, based on the kinematic data, a sterility status associated with the two or more links; and (iii) configuring the respective indication systems of the two or more links to provide an indication of the sterility status of the two or more links.
Description
SYSTEMS AND METHODS FOR PROVIDING A STERILITY INDICIATOR
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and the benefit of the filing date of provisional U.S. Patent Application No. 63/571,090 entitled “SYSTEMS AND METHODS FOR PROVIDING A STERILITY INDICIATOR,” filed on March 28, 2024. The entire contents of the provisional application are hereby expressly incorporated herein by reference.
FIELD
[0002] Disclosed examples relate to guided robotic control manipulator systems. In particular, the disclosed examples relate to systems and methods for determining the sterility of various parts of a manipulator system, and further providing indications of the sterility of the parts of the manipulator system.
BACKGROUND
[0003] Computer-assisted manipulator systems (“manipulator systems”), sometimes referred to as robotically assisted systems or robotic systems, may include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments coupled to the manipulators. A manipulator generally includes mechanical links connected by joints. An instrument is removably (or permanently) coupled to one of the links, typically a distal link of the plural links.
[0004] In some computer-assisted manipulator systems, the manipulators are attached to a manipulator support structure (e.g., a patient side cart) that is separate from a support structure that supports a patient or workpiece. In other manipulator systems, the manipulators are attached directly to the support structure (herein referred to as a “table assembly”) that supports the patient or workpiece, e.g., to an operating table. Manipulator systems in which the manipulators are mounted to the table assembly can be referred to herein as table-mounted manipulator systems.
[0005] An important aspect of utilizing computer-assisted manipulator systems, particularly when used for medical procedures, is the monitoring of sterility of various parts of the manipulator systems. Typically, during system setup in an environment, such as an operating room (OR), robotic manipulator systems are draped with a sterile drape. The systems are then positioned relative to a sterile field of operation, such as an operating table or bed. Once the system is
positioned in the OR, portions of the system may reside in non-sterile zones or regions of the OR such as regions close to the floor, regions below an operating table, etc. Further, during operation, portions or parts of the manipulator system may move into non-sterile regions, or come into contact with non-sterile objects (including individuals).
[0006] In many procedures, it is the responsibility of an operator or assistant to manually position, or reposition, portions of a manipulator system during operation. As such, it is important for the operator to know which parts of the manipulator system are sterile and safe to be touched, and which parts are non-sterile and are unsafe to touch or grab. Touching and manipulating non- sterile portions of a manipulator system raises the risk of breaching OR sterility protocols, causing delays or other inefficiencies in the performance of the procedure.
[0007] Accordingly, a need exists for improved manipulator systems with indicator systems that facilitate monitoring of sterility status.
SUMMARY
[0008] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.
[0009] In some examples, a computer-assisted system for indicating sterility status is provided. The system may include (i) a repositionable structure configured to support an instrument, (ii) the repositionable structure comprising two or more links coupled via one or more joints, wherein each link of the two or more links includes a respective indication system, and (iii) a control system operably coupled to the repositionable structure. The control system is configured to (1) obtain kinematic data indicative of at least a position of each of the two or more links relative to a sterility boundary, (2) determine, based on the kinematic data, a sterility status associated with the two or more links, (3) configure the respective indication systems of the two or more links to provide an indication of the sterility status of the respective link of the two or more links.
[0010] In further examples, a method for providing sterility status for a computer-assisted system for indicating sterility status is provided. The computer-assisted system may include (i) a repositionable structure having two or more links coupled via one or more joints, and wherein each link of the two or more links includes a respective indication system, and (ii) a control system operably coupled to the repositionable structure. The method includes (1) obtaining kinematic data
indicative of a position of the two or more links relative to a sterility boundary, (2) determining, based on the kinematic data, a sterility status associated with the two or more links, and (3) configuring the respective indication systems of the two or more links to provide an indication of the sterility status of the two or more links.
[0011] In still further examples, a non-transitory computer- readable medium storing instructions thereon is provided. The instructions, when executed by one or more processors, cause the one or more processors to (i) obtain kinematic data indicative of at least a position of each of the two or more links relative to a sterility boundary, (ii) determine, based on the kinematic data, a sterility status associated with the two or more links, and (iii) configure the respective indication systems of the two or more links to provide an indication of the sterility status of the respective link of the two or more links.
[0012] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regal’d, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0013] FIG. 1 is a schematic diagram for a robotically-assisted manipulator system for providing sterility status according to some examples.
[0014] FIG. 2A is a perspective view of a table mounted robotically-assisted manipulator system for providing sterility status according to some examples.
[0015] FIG. 2B is an alternative perspective view of the manipulator system for providing sterility status of FIG. 2A according to some examples.
[0016] FIG. 2C is a side view of the manipulator system for providing sterility status of FIG. 2A with indications of sterility boundaries according to some examples.
[0017] FIG. 3 is a perspective view an embodiment of a manipulator of the manipulator system of FIG. 2A with a strip configuration of status indicators.
[0018] FIG. 4 is a perspective view an embodiment of a manipulator of the manipulator system of FIG. 2A with a circumferential configuration of status indicators
[0019] FIG. 5 is a side view of a manipulator according with status indicators disposed in a strip arrangement along one or more sides of one or more links.
[0020] FIG. 6 is an example flow diagram of an example method for , according to some examples.
[0021] Examples of the present disclosure and their advantages are best understood by referring to 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, wherein showings therein are for purposes of illustrating examples of the present disclosure and not for purposes of limiting the same.
DETAILED DESCRIPTION
[0022] In the following description, specific details are set forth describing some examples consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the examples. It will be apparent, however, to one skilled in the art that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one example may be incorporated into other examples unless specifically described otherwise or if the one or more features would make an example nonfunctional. 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 examples.
[0023] This disclosure describes various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses,
positions, and/or orientations measured along an object. As used herein, the term “distal” refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.
[0024] This disclosure occasionally refers to the disclosed techniques being applied to “patients” undergoing a “medical procedure.” It should be appreciated that these references are not intended to limit the application of the disclosed techniques to applied medicine contexts. For example, the described techniques can be applied to facilitate physician training, equipment testing and/or calibration, and/or other contexts. Accordingly, any reference to the term “patient” is done for ease of explanation and also envisions the application of the described techniques to a generic “subject.”
[0025] The disclosure refers to “sterility” to describe various objects, regions, and statuses of a device. Other terms such as sanitary, clean, disinfected, etc. may be used interchangeably to describe an object, region, or status of a device or tool for performing an operation.
[0026] Aspects of this disclosure herein can be part of a computer-assisted manipulator system, sometimes referred to as a robotically-assisted manipulator system or a robotic system. The manipulator system can include one or more manipulators that can be operated manually and/or with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments when coupled to the manipulators. Embodiments where a manipulator system is electronically controlled, at least in part, may be referred to as a teleoperational manipulator system.
[0027] FIG. 1 illustrates an embodiment of a table-mounted manipulator system 100 (“system 100”) for performing monitoring of sterility status, and providing indications of sterility status of various portions of the manipulator system. The system 100 includes a table assembly 101, at least one rail assembly 120 coupled to the table assembly, and one or more manipulators 140, also referred to as repositionable structures, coupled to each rail assembly 120. Each manipulator 140 can carry one or more instruments 150, which can be removably or permanently mounted thereon. As shown in FIG. 1, the system 100 also can include a control system 1006, a user input and feedback system 1004, and/or an auxiliary system 1008. In some embodiments, the system 100 is
configured as a computer-assisted, teleoperable medical system, in which case table assembly 101 can be configured to support a patient (not shown) and the instruments 150 can be medical instruments. The system 100 in this configuration can be usable, for example, to perform any of a variety of medical procedures, such as surgical procedures, diagnostic procedures, imaging procedures, therapeutic procedures, etc. Moreover, the system 100 when configured as a teleoperable medical system need not necessarily be used on a living human patient. For example, a non-human animal, a cadaver, tissue-like materials used for training purposes, and so on, can be supported on the table assembly 101 and worked on by system 100. In other embodiments, the system 100 is configured as a computer-assisted teleoperable system for use in non-medical contexts, in which case the table assembly 101 can be configured to support an inanimate workpiece (something being manufactured, repaired, tested, etc.) and the instruments 150 can be non-medical instruments, such as industrial instruments.
[0028] As shown in FIG. 1, the table assembly 101 includes a platform assembly 110 configured to support the patient or inanimate workpiece, a support column 102 coupled to and supporting the platform assembly 110, and a base 105 coupled to the support column 102. The base can be configured to contact the ground or other surface upon which the table assembly 101 rests to provide stability for the table assembly 101. In some embodiments, the base 105 is omitted. In some embodiments, the base 105 includes mobility features, such as wheels, tracks, or other such features (not shown), to allow movement of the table assembly 101 along the ground or other surface. In FIG. 1, the support column 102 is illustrated as a single vertical columnar pail to simplify the discussion, but the support column 102 could take any desired shape and could include any number of parts. For example, the support column 102 can include horizontal support structures (not illustrated) such as beams, rails, etc. to couple the platform assembly 110 to a vertical portion of the support column 102. Moreover, in various embodiments, the support column 102 can be telescoping and configured to extend and contract in height.
[0029] The platform assembly 110 includes one or more platform sections 103 to support the patient or workpiece. The platform sections 103 each have a support surface configured to contact and support the patient or workpiece. In some embodiments multiple platform sections 103 are used and the platform sections 103 are arranged in series to support different portions of the patient or workpiece. For example, in the embodiment illustrated in FIG. 1, the platform assembly 110 includes a first end section 103_l, one or more middle sections 103_2, and a second end section
103_3, with the one or more middle sections 103_2 being arranged between the two end sections 103 1 and 103 3. In some embodiments, the first end section 103 1 can be configured to support a head of the patient, the second end section 103_3 can be configured to support the feet and/or legs of the patient, and the one or more middle sections 103_2 can be configured to support a torso and/or other portions of the patient. For convenience, the side of the platform assembly 110 that is near the first end section 103_l (e.g., a left side in the orientation shown in FIG. 1) will be referred to herein as a “head” of the platform assembly 110 (or “head side” or “head end”) and the side of the platform assembly 110 that is near the second end section 103_3 (e.g., a right side in the orientation shown in FIG. 1) will be referred to herein as a “foot” of the platform assembly 110 (or “foot side” or “foot end”), but this is merely an arbitrary convention chosen herein for convenience of description and is not intended to limit the configuration or usage of the table assembly 101 (e.g., a head of a patient could be positioned at the “foot” side of the platform assembly 110 if desired, and vice versa). The relative positions of two components or of two portions of a single component can also be described using “head” and “foot” (e.g., a “head end” and a “foot end” of a rail 121) with “head” referring to the component or portion that is relatively closer to the head end of the table assembly 101 and “foot” referring to the component or portion that is relative closer to the foot end of the table assembly 101. In other embodiments, different numbers and arrangements of platform sections 103 are used, including one, two, four, or more platform sections 103. In some embodiments, one or more of the platform sections 103 can be movable relative to other platform sections 103 and/or relative to the support column 102. For example, in some embodiments, some or all of the platform sections 103 are coupled to adjacent platform sections 103 and/or to the support column 102 by rotatable joints such that at least some of the platform sections 103 can tilt relative to one another and/or relative to the support column 102. The platform assembly 110 can also be movable as a whole relative to the support column 102, as described in greater detail below.
[0030] The platform assembly 110 has a longitudinal dimension 198 (e.g., parallel to the x-axis in FIG. 1), a lateral dimension orthogonal to the longitudinal dimension (e.g., parallel to the y-axis in FIG. 1), and a thickness or height dimension orthogonal to both the longitudinal dimension 198 and lateral dimension (e.g., parallel to the z-axis in FIG. 1). As used herein, the longitudinal dimension 198 refers to a dimension of greatest extent of the platform assembly 110 when all of the platform sections 103 of the platform assembly are fully extended and all are oriented with
their support surfaces roughly aligned in a same plane with one another (or when as close to this state as possible) so as to collectively form a combined support surface that is substantially planar with potentially small gaps between adjacent platform sections 103. In general, the longitudinal and lateral dimensions of the platform assembly 110 and the support surfaces of the platform sections 103 are oriented roughly parallel to the ground or other surface on which the table assembly 101 is supported when the platform assembly 110 is in a neutral configuration. However, one of ordinary skill in the art would understand that the platform assembly 110 as a whole and/or individual platform sections 103 thereof do not necessarily have to be parallel to the ground, and that one or both of the longitudinal and/or lateral dimensions can be tilted relative to the ground in various configurations through which the platform assembly 110 and/or platform section 103 can be movable, including in a neutral configuration in some cases. The platform assembly 110 and the various platform sections 103 thereof have various sides or faces that extend along the longitudinal dimension 198 or lateral dimension, and these can be referred to herein as longitudinally extending sides (or faces) and laterally extending sides (or faces), respectively. Specifically, a longitudinally extending side (or face) is a side (or face) of the platform assembly 110 or of a platform section 103 that extends along the longitudinal dimension 198 of the platform assembly 110 (i.e., along an x-direction in FIG. 1). For example, one longitudinally extending side 109b of the platform assembly 1110 is indicated in FIG. 1. Similarly, a laterally extending side (or face) is a side (or face) of the platform assembly 110 or of a platform section 103 that extends along the lateral dimension of the platform assembly 110 (i.e., along a y-direction in FIG. 1). For example, two laterally extending sides 109a of the platform assembly 110 are indicated in FIG. l.At least one of the platform sections 103 is directly coupled to and supported by the support column 102. The remaining platform sections 103 can be coupled directly to the support column
102 or they can be coupled indirectly to the support column 102 via a chain of one or more intervening platform sections 103. For example, in some embodiments a main platform section
103 (e.g., a middle section 103_2) is coupled to and directly supported by the support column 102 and the others of the platform sections 103 (e.g., end sections 103_l and 103_3) are coupled to the main platform section 103 or to another platform section 103. As another example, in some embodiments multiple platform sections 103 (all in some embodiments) are coupled directly to the support column 102 and not to another platform section 103.
[0031] In some embodiments, some (or, in some cases, all) of the above-described parts of the table assembly 101 can be movable relative to one another. For example, in some embodiments the platform assembly 110 as a whole can be moved relative to the support column 102, such as by tilting around a horizontal axis, swiveling around a vertical axis, translating vertically along the support column 102, translating horizontally relative to the support column 102, and so on. In some embodiments, such movement of the platform assembly 110 as a whole can be provided by one or more joints that couple a main platform section 103 (e.g., a middle section 103_2) to the support column 102. Furthermore, as already noted above, individual platform sections 103 can be movable relative to one another and relative to the support column 102 as well, which can be facilitated by joints coupling the platform sections 103 to the support column 102 or to adjacent platform sections 103.
[0032] In some embodiments, the platform assembly 110 also includes one or more accessory rails 104. The accessory rails 104 can be configured to receive accessory devices removably mounted thereon, such as such as leg stirrups, liver retractor, arm boards, and bed extenders. In some embodiments, the accessory rails 104 adhere to industry standard specifications familiar to those of ordinary skill in the art to allow compatibility with accessory devices compliant with the standard. The accessory rails 104 can be attached to longitudinally extending side faces of one or more of the platform sections 103. One or more openings can be defined between an accessory rail 104 and the side face of the platform section 103 to which the accessory rail 104 is attached and portions of accessories mounted to the accessory rail 104 can be inserted through the openings.
[0033] As noted above, the manipulator system 100 also includes one or more manipulators 140. While FIG. 1 illustrates two manipulators 140, any number of manipulators 140 can be included (such as, for example, one, two, three, or more manipulators mounted to each rail assembly 120, as described in further detail below). A manipulator 140 can include a kinematic structure of links coupled together by one or more joints. Specifically, the manipulators 140 each include a proximal link assembly including a proximal arm 141 movably coupled to the rail assembly 120 via one or more proximal joints 130, an intermediate link assembly including an intermediate arm 142 movably coupled to the proximal link assembly via one or more intermediate joints 145, and a distal link assembly including a distal arm 143 movably coupled to the intermediate link assembly by one or more distal joints 146. The distal link assembly can also
include an instrument holding portion 169 coupled to the distal arm 143 and configured to carry the instrument 150.
[0034] Each manipulator 140 further includes status indicators 170 disposed along the various links and joints of the manipulator 140. For example, the status indicators 170 may be disposed along the proximal arm 141, proximal joints 130, intermediate arm 142, intermediate joints 145, distal arm 143, distal joints, and/or the instrument holding portion 169. Generally, the status indicators 170 may be disposed along any portion of the manipulator 140 to provide indications of various statuses of the portion or region of the manipulator 140. For example, respective status indicators 170 may provide an indication of a respective sterility status of the proximal, intermediate, and arms 141 , 142, and 143, or joints 130, 145, and 146. The status indicators 170 may additionally provide an indication of whether a portion or part of the manipulator 140 is ready to be manually repositioned, has come into contact with an object or person, has entered a non- sterile region of space, has come into proximity of a non-sterile region or object, etc. The status indicators 170 may include one or more light emitting diodes (LEDs), audio speakers, or haptic devices. Accordingly, the status indicators 170 may provide the indications of various statuses of the respective portions of the manipulator 140 via visual, audio, or haptic output. The status indicators 170 will be described with more detail herein in reference to FIGs. 2A-5.
[0035] The manipulators 140 are movable through various degrees of freedom of motion provided by various joints, including the proximal, intermediate, and distal joints 130, 145, and 146, thus allowing an instrument 150 mounted thereon to be moved relative to the worksite. Some of the joints can provide for rotation of links relative to one another, other joints can provide for translation of links relative to one another, and some can provide for both rotation and translation. In particular, in some embodiments, the proximal arm 141 is rotatably coupled to the rail 121 via a first proximal joint 130a, which provides for rotation of the proximal arm 141 relative to the rail 121 around a first axis 136 that is perpendicular to a longitudinal dimension 197 of the rail 121 (e.g., perpendicular to the x-direction in FIG. 1). In a neutral state of the proximal arm 141, the first axis 136 is also perpendicular to a lateral dimension of the rail 121 (e.g., perpendicular to the y-direction in FIG. 1), and thus in this state the first axis 136 is oriented vertically (i.e., perpendicular to the aforementioned horizontal plane, or in other words oriented in the z-direction in FIG. 1). In addition, in a neutral state of the table assembly 101, in which the platform 110 is parallel to the ground and the rail 121 (i.e., an x-direction in the orientation of FIG. 1), the first
axis 136 is also perpendicular to the longitudinal axis 198 of the platform 110, but this is not necessarily the case in other states (e.g., states in in which the platform 110 is tilted relative to the rail 121, which can be possible in some embodiments).
[0036] In some embodiments, the proximal link assembly of certain manipulators 140 is configured to allow for rotation of the proximal link 141 about a second axis 137, in addition to allowing for rotation about the first axis 136, with the second axis 137 being orthogonal to the first axis 136. In some embodiments, the rotation about the second axis 137 can be provided by a second proximal joint 130b included in the proximal link assembly. In particular, in some embodiments the proximal link assembly of certain of the manipulators 140 further includes a second proximal joint 130b, and the first and second proximal joints 130a and 130b together couple the proximal arm 141 to the rail 121 , with the second proximal j oint 130b providing for rotation of the proximal arm 141 relative to the rail 121 around a second axis 137 orthogonal to the first axis 136 and parallel to a longitudinal dimension 197 of the rail 121 (e.g., x-direction in FIG. 1). In some embodiments, the second proximal joint 130b is coupled between the rail 121 and the first proximal joint 130a, while in other embodiments the second proximal joint 130b is coupled between the first proximal joint 130a and the proximal 141 (not shown in FIG. 1). In still other embodiments, the rotation about the second axis 137 is provided by the first proximal joint 130a without the addition of a second proximal joint (e.g., the first proximal joint 130a is configured to provide rotation about multiple axes, such as a ball-and-socket joint). The longitudinal dimension 197, and hence the second axis 137, is parallel to the ground in some embodiments. In the neutral state of the table assembly 101, the second axis 137 is also parallel to the longitudinal axis 198 of the platform 110, but this is not necessarily the case in other states (e.g., states in in which the platform 110 is tilted relative to the rail 121, which can be possible in some embodiments). Rotation of the proximal arm 141 around this second axis 137 (e.g., via the second proximal joint 130b) causes the proximal arm 141 to incline or decline relative to the horizontal plane, thus raising or lowering a distal end of the proximal arm 141 relative to the rail 121. In addition, as the proximal arm 141 inclines relative to the horizontal plane, movement of the proximal arm 141 can cause more distal portions of the manipulator 140 to correspondingly both raise and extend further across the table (as opposed to vertical movement alone). In some embodiments, the rotation about the second axis 137 (e.g., via second proximal joint 130b) allows the proximal arm 141 to be moved between orientations ranging at least between a horizontal orientation and a vertical inclined orientation
(e.g., at least 90 degrees of rotation). In some embodiments, rotation about the second axis 137 (c.g., via the second proximal joint 130b) can also allow for rotation of the proximal arm 141 to orientations that are declined relative to a horizonal orientation. In some embodiments, certain manipulators 140 are provided with the ability to rotate about the second axis 137 (e.g., via the second proximal joint 130b) while others are not. For example, in some embodiments a first manipulator 140 whose proximal arm 141 is positionable under a second manipulator 140 in a nested configuration (described further below) can be provided with the second proximal joint 130b (e.g., because the lower positioning of the proximal arm 141 makes room for the proximal joint 130b), while a second proximal joint 130b can be omitted in the second manipulator 140 (e.g., because the higher positioning of the proximal arm 141 of the second manipulator 140 does not leave sufficient room for the second joint). In other embodiments (not illustrated), coupled to a same rail 121 all of the manipulators 140 (or all manipulators 140 in the system 100, in some embodiments) are provided with the ability to rotate about the second axis 137 (e.g., via second proximal joints 130b). In still other embodiments (not illustrated), none of the manipulators 140 coupled to a given rail 121 (or none of the manipulators 140 in the entire system 100, in some embodiments) are provided with the ability to rotate about the second axis 137.
[0037] In addition, in some embodiments, the proximal ami 141 is extendable and retractable. For example, the proximal arm 141 can include two or more links that are translatable relative to one another in a telescoping fashion to extend or retract the proximal arm 141. In other words, these two or more links are coupled together by, or they themselves form, a prismatic joint. For example, in some embodiments the proximal arm 141 includes an outer link that has a bore (for example an axial bore extending along a longitudinal axis of the proximal arm 141) and an inner link that is nested within the outer link in the bore thereof.
[0038] In addition, in some embodiments, the proximal arm 141 has an asymmetrical shape, meaning that in extending from a proximal end portion of the proximal arm 141 to a distal end portion of the proximal arm 141, the proximal arm 141 follows a non-straight path, i.e., a path that deviates from a hypothetical straight line extending between (i.e., connecting) the two end portions. More specifically, the proximal arm 141 can extend between the proximal joint 130 coupled to the proximal end portion of the proximal arm 141 and an intermediate joint 145 (described below) coupling the distal end portion of the proximal arm 141 to intermediate arm 142, with a centerline of the proximal arm 141 extending between these joints 130 and 145
deviating from a straight line between respective axes of the joints 130 and 145. For example, in some embodiments the proximal arm 141 has a smoothly curved shape (c.g., a centerline of the proximal arm follows a smoothly curved path), while in other embodiments the proximal arm 141 has a segmented shape including multiple straight and/or curved segments joined together at angles (e.g., an L- shape).
[0039] In some embodiments, the intermediate arm 142 can be rotatably coupled to the distal end portion of the proximal arm 141 via one or more intermediate rotary joints 145. For example, the intermediate joints 145 can provide for rotation of the intermediate arm 142 relative to the proximal arm 141 about a third axis (not illustrated) perpendicular to the intermediate arm 142 and the proximal arm 141. In addition, in some embodiments, the intermediate joints 145 can provide for rotation of a distal end of the intermediate arm 142 relative to the proximal arm 141 about an axis that is parallel to a longitudinal dimension of the intermediate arm 142. In some embodiments, the intermediate arm 142 is also extendable and retractable. For example, the intermediate arm 142 can include two or more links that are translatable relative to one another in a telescoping fashion to extend or retract the intermediate arm 142, in a manner similar to that described above in relation to proximal arm 141. In some embodiments, the links of the intermediate arm 142 are both translatable relative to one another along a longitudinal dimension of the intermediate arm 142 and also rotatable relative to one another about an axis parallel to the longitudinal dimension of the intermediate arm 142, thus providing for the above-described rotation of the distal end of the intermediate arm 142 relative to the proximal anti 141 about the axis that is parallel to a longitudinal dimension of the intermediate arm 142.
[0040] Moreover, in some embodiments, the distal arm 143 is movably coupled to the instrument holding portion 169 via a wrist 147, which includes joints for moving the instrument holding portion 169 relative to the distal arm 143. The joints of the wrist 147 can be referred to herein as wrist joints. In some embodiments, the wrist 147 provides multiple rotational degrees of freedom motion. For example, in some embodiments the wrist 147 has three rotational degrees of freedom of motion for the instrument holding portion 169 relative to the distal arm 143. For example, the wrist 147 can be rotatably coupled to the distal arm 143 to provide a roll degree of freedom of motion including rotation of the wrist 147 as a whole about an axis parallel to the distal arm 143, and the wrist 147 can further include two joints for providing yaw and pitch degrees of freedom of motion including rotation around pitch and yaw axes which are perpendicular to one
another. One of the pitch and yaw axes is also perpendicular to the roll axis (the other of the pitch and yaw axes can also be perpendicular to the roll axis in a neutral state of the wrist 147, but not necessarily in other states). In some embodiments, the joints providing some of the degrees of freedom of motion of the wrist 147 (e.g., yaw and pitch, in some embodiments) are driven by actuators disposed remotely from the wrist 147, such as in a more proximal portion of the manipulator 140 with actuation elements (such as cables, filaments, belts, bands, linkages, etc.) extending from the actuators to the wrist 147 to drive the motion of the wrist. For example, in some embodiments, the wrist includes two wrist joints disposed in the wrist that provide rotation about the yaw and pitch axes, and these two wrist joints can be coupled to actuation elements (e.g., cables) that drive the rotation. In some embodiments, the actuators that drive the wrist 147 are positioned in the distal arm 143. Disposing the actuators remotely from the wrist 147 allows the wrist 147 to be more compact. Wrists that are compact, such as the wrists 147, can be positioned more closely to portions of other manipulators 140, in some circumstances, which can allow for greater flexibility in the positioning and posing of the manipulators 140. Moreover, placing the actuators in a more proximal portion of the manipulators 140, such as in the distal arm 143, moves the weight of the actuators closer to a proximal end of the kinematic chain that makes up the manipulator 140, thus reducing the moment arm (leverage) created by the weight of the actuators.
[0041] Some or all of the joints of the system 100 described above (as well as other joints that might be present in the system) can be powered joints, meaning a powered drive element can control movement of the joint through the supply of motive power. Such powered drive elements can include, for example, electric motors, pneumatic or hydraulic actuators, and other types of powered drive elements those having ordinary skill in the art would be familiar with. In some embodiments, the joints of the wrist 147 are powered joints. Additionally, in some embodiments some of the joints of the system 100 can be manually articulable (e.g., unpowered) joints, which can be articulated manually for example by manually moving the links coupled thereto. Joints referred to herein as unpowered can lack powered drive elements to drive articulation of the joint but still can include other powered aspects or devices, such as electronically (or hydraulically/pneumatically, etc.) controlled brakes, sensors (e.g., position, velocity, force, torque sensors), or other powered devices. Additionally, in some embodiments some of the joints of the system 100 can be partially powered and partially manually articulable — for example powered elements such as motors can assist manipulation, such as by compensating for gravity loads, but
some manual force input can also be used to cause the articulation. Additionally, some joints (whether powered or not) can also be passively counterbalanced (e.g., via masses or springs). Certain joints can be actively controllable during performance of a procedure, for example, under the control of a control system 1006 in response to inputs recited at a user input and feedback system 1004. Other joints, sometimes referred to as setup joints, can be articulated during a setup phase in preparation for performance of the procedure but can generally remain more-or-less stationary during performance of the procedure. Setup joints can be powered, manually articulable, or partially powered. For example, in some embodiments, the proximal joints 130 and the prismatic joint that provides extension of the proximal arm 141 are setup joints.
[0042] As noted above, the instrument holding portion 169 is configured to support an instrument 150, and in some embodiments the instrument holding portion 169 includes a drive interface to removably couple the instrument and to provide driving inputs (e.g., mechanical forces, electrical inputs, etc.) to drive an instrument coupled thereto. For example, the drive interface can include output couplers (not illustrated) to engage (directly or indirectly via an intermediary) with input couplers (not illustrated) of the instrument 150 to provide driving forces or other inputs to the mounted instrument 150 to control various degree of freedom movement and/or other functionality of the instrument 150, such as moving an end-effector of the instrument, opening/closing jaws, driving translation and/or rotation of a variety of components of the instrument, delivery of substances and/or energy from the instrument, and various other functions those of ordinary skill in the art are familiar with. The output couplers can be driven by actuators (e.g., electrical servo-motors, hydraulic actuators, pneumatic actuators) with which those of ordinary skill in the art have familiarity. An instrument sterile adaptor (ISA) can be disposed between the instrument 150 and the instrument manipulator mount interface to maintain sterile separation between the instrument 150 and the manipulator 140. The instrument manipulator mount can also include other interfaces (not illustrated), such as electrical interfaces to provide and/or receive electrical signals to/from the instrument 150. The instruments 150 can include any tool or instrument, including for example industrial instruments and medical instruments (e.g., surgical instruments, imaging instruments, diagnostic instruments, therapeutic instruments, etc.). In some embodiments, the system 100 can include flux delivery transmission capability as well, such as, for example, to supply electricity, fluid, vacuum pressure, light, electromagnetic radiation, etc. to the end effector. In other embodiments, such flux delivery transmission can be provided to
an instrument through another auxiliary system 1008, described further below and as those of ordinary skill in the art would be familiar with in the context of computer-assisted, tclcopcratcd medical systems.
[0043] Additional details relating to the manipulators are described below with reference to FIGs. 2-5, which illustrate various embodiments of manipulators 240 that can be used as the manipulators 140. Moreover, in some embodiments, aspects of the manipulators 140 can be similar to the manipulators described in US Provisional Patent Application No. 63/336,773, entitled “RAIL ASSEMBLY FOR TABLE MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” inventor Ryan Abbott, in US Provisional Patent Application No. 63/336,778, entitled “NESTING PROXIMAL LINKS FOR TABLE MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” first named inventor Bram Lambrecht, both filed April 29, 2022, or those described in, for example, U.S. Patent No. 9,358,074 (filed May 31, 2013) to Schena et al., entitled “Multi-Port Surgical Robotic System Architecture,” U.S. Patent No. 9,295,524 (filed May 31, 2013) to Schena et al., entitled “Redundant Axis and Degree of Freedom for Hardware-Constrained Remote Center Robotic Manipulator,” and U.S. Patent No. 8,852,208 (filed Augustl2, 2010) to Gomez et al., entitled “Surgical System Instrument Mounting,” WO International Publication Number 2023/212344 Al (filed April 28, 2023) entitled “TABLE-MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” first named inventor Steven Manuel, the contents of each of which are incorporated herein by reference in their entirety. Various other embodiments of manipulators can include those as configured as part of the medical systems that are part of various da Vinci® Surgical Systems, such as the da Vinci X®, da Vinci Xi®, and da Vinci SP systems, commercialized by Intuitive Surgical, Inc., of Sunnyvale, California.
[0044] The number, locations, and types of links, joints, and status indicators of the manipulators, as well as the various degrees of freedom of motion thereof, are not limited to those described above. In some embodiments, manipulators include additional links, joints, status indicators and/or degrees of freedom beyond those described above. In other embodiments, manipulators can omit certain of the links, joints, status indicators, and/or degrees of freedom described above. Embodiments contemplated herein include embodiments including various
combinations of one or more of the links, joints, and degrees of freedom of motion described above.
[0045] As shown in FIG. 1, the manipulators 140 are coupled to the table assembly 101 via the at least one rail assembly 120. The table assembly 101 includes a platform assembly 110 on top of which a body or patient may be supported. In some embodiments, multiple similar rail assemblies 120 are provided, for example one for each longitudinally extending side of the platform assembly 110. For example, in some embodiments, a first rail assembly 120 can be provided at a first longitudinally extending side of the platform assembly 110 and a second rail assembly 120 can be provided at a second longitudinally extending side of the platform assembly 110. In such embodiments with multiple rail assemblies 120, manipulators 140 can be coupled to the rail assemblies 120 in any number or combination, and because the rail assemblies 120 can be positioned along different sides of the platform assembly 110, the manipulators 140 too can be positioned along different sides of the platform assembly 110. The description below will describe one rail assembly 120 to simplify the description, but the other rail assemblies 120 (if present) can be configured similarly. The rail assembly 120 includes a rail 121 and a number of carriages 126 (also “first carriages 126”) coupled to the rail 121 and to the manipulators 140 to allow motion of the manipulators 140 along the rail 121. More specifically, the first carriage 126 can be coupled to (or can be a part of) the proximal link assembly of a corresponding manipulator 140. Each carriage 126 is moveable along a longitudinal dimension 197 of the rail 121 and couples a respectively corresponding one of the manipulators 140 to the rail 121 such that the manipulators 140 can translate relative to the rail 121 along the longitudinal dimension 197 of the rail 121. In some embodiments, the longitudinal dimension 197 of the rail 121 is parallel to the longitudinal dimension 198 of the platform assembly 110 (e.g., parallel to the x-axis) in a neutral configuration of the platform assembly 110, as shown in FIG. 1.
[0046] The movable rail 121 includes a first set of engagement features 122 configured to engage with complementary engagement features of the first carnages 126. For example, the first set of engagement features 122 of the rail 121 can include a track including flanges extending along the longitudinal dimension 197, and the complementary engagement features of the first carriages 126 are configured to engage and ride along the flanges of the first set of engagement features 122. The first set of engagement features 122 can also include a track including grooves in which the complementary engagement feature is received. Any other type of complementary
engagement features that when engaged allow for relative translation can be used as the complementary engagement features, and those having ordinary skill in the art arc familiar with various complementary engagement features that are used in rail and carriage systems. In some embodiments, the first set of engagement features 122 and/or the complementary engagement features can include bearing devices configured to reduce friction to facilitate easier translation, such as wheels, balls, plain bearing surfaces coated or otherwise provided with a low friction material, and other friction reducing mechanisms. In FIG. 1, one first carriage 126 is shown per manipulator 140, but multiple first carriages 126 could be provided to operably couple to and support a given manipulator 140.
[0047] In some embodiments, in addition to the manipulators 140 being movable along the rail 121, the rail 121 can also be movable relative to the table assembly 101. In such embodiments, the rail assembly 120 also includes one or more carriages 127 (also referred to as “second carriages 127”) coupled to the rail 121 and to the table assembly 101 to allow motion of the rail 121. More specifically, the carriages 127 couple the rail 121 to the table assembly 101 such that the rail 121 can translate relative to the table assembly 101 along a direction of the longitudinal dimension 197 of the rail 121. In particular, in these embodiments the rail 121 includes a second set of engagement features 123 (e.g., tracks or other engagement features) that engage with complementary engagement features of the second carriage 127 to couple the raill21 to the second carriage 127 while allowing translation between the rail 121 and second carriage 127.
[0048] In some embodiments, the translation between the rail 121 and the table assembly 101 is provided by relative motion between the second carriages 127 and the rail 121. For example, in some embodiments the second carriages 127 are fixed relative to (e.g., are a part of) the table assembly 101 and the rail 121 and second carriages 127 are movably coupled together such that the rail 121 translates relative to the second carriages 127 along the direction of the longitudinal dimension 197 of the rail 121. One second carriage 127 is shown in FIG. 1 for ease of description, but any number could be used, including none in some embodiments.
[0049] In some embodiments, the translation of the rail 121 and the table assembly 101 is provided by relative motion between the second carriages 127 and the table assembly 101. For example, in some embodiments the second carriages 127 are fixed relative to (e.g., are a part of) the rail 121 and movably coupled to the table assembly 101 such that translation of the second
carriages 127 relative to the table assembly 101 along the longitudinal dimension 197 causes the rail 121 to also translate relative to the table assembly 101.
[0050] In some embodiments, the translation between the rail 121 and the table assembly 101 is provided by a combination of relative motion between the second carriages 127 and the rail 121 and relative motion of the second carriages 127 and the table assembly 101.
[0051] In some embodiments in which the second carriages 127 are movably coupled to the table assembly 101, the rail assembly 120 further includes a second rail 124, which can be coupled between the second carriages 127 and the table assembly 101. In other embodiments the second carriages 127 can be coupled directly to the table assembly 101.
[0052] The movability of the rail 121 relative to the table assembly 101 can allow for a greater range of motion of the manipulators 140 and/or for a shortening of the rail 121, as compared to a configuration in which the rail 121 is fixed relative to the table assembly 101. This can also enable the rail assembly 120 and/or manipulators 140 to more easily be moved out of the way of the platform assembly 110 to avoid interference therewith as the platform assembly 110 and/or individual platform sections 103 thereof are moved through various configurations. However, in some embodiments the rail 121 is fixed relative to the table assembly 101 and the manipulators 140 are positioned relative to the platform assembly 110 solely through motion of the manipulators 140 along the rail 121.
[0053] In some embodiments, the rail assembly 120 is coupled to one of the platform sections 103. In other embodiments, the rail assembly 120 is coupled to the support column 102. Which structure the rail assembly 120 is coupled to can make a difference in embodiments in which the platform assembly 110 as a whole is movable relative to the support column 102, for example by tilting relative to the support column 102. In embodiments in which the rail assembly 120 is coupled to one of the platform sections 103 (e.g., a middle section 103_2), when the platform assembly 110 moves relative to the support column 102, the rail assembly 120 and hence the manipulators 140 coupled thereto move along with the platform assembly 110. This can allow the manipulators 140 to automatically maintain a set pose and position relative to the platform assembly 110, and thus relative to a patient supported on the platform assembly, regardless of a configuration of the platform assembly 110 and without having to reposition the manipulators 140. Moreover, in some circumstances, collision between the platform assembly 110 and the rail
assembly 120 due to motion of the platform assembly 1 10 can be avoided as they both move together. In embodiments in which the rail assembly 120 is coupled to the support column, when the platform assembly 110 moves relative to the support column 102, the rail assembly 120 and hence the manipulators 140 coupled thereto remain with the support column 102 and do not move along with the platform assembly 110. This can allow greater motion of the rail assembly 120 and manipulators 140 relative to the platform assembly 110. This also can increase the strength and/or relative stiffness of the structure between the manipulators 140 and the support column 102 by reducing the length of the structure between them and reducing the number of connections between them.
[0054] In some embodiments, motors or other actuation devices (not illustrated) are provided to drive the relative translation between the rail 121 and the first carriages 126. Similarly, in embodiments in which the second carriages 127 are present, motors or other actuation devices (not illustrated) can be provided to drive the relative translation between the rail 121 and the second carriages 127 and/or between the second carriages 127 and the table assembly 101. In some embodiments, motors/actuators are housed within the rail 121. In some embodiments, motors/actuators are housed within the first and/or second carriages 126 and 127. In some embodiments, motors/actuators are housed within the table assembly 101.
[0055] In some embodiments, the motion of the manipulators 140 relative to the platform assembly 110 enabled by the rail assembly 120 allows the distal link assemblies of the manipulators 140 to be moved into a nested configuration near one end portion of the platform assembly 110 which can allow the intermediate and distal link assemblies of the manipulators 140 to be moved around an end of the platform assembly 110 to positions adjacent a laterally extending side 109a of the platform assembly 110. In particular, in some embodiments the nested configuration includes a configuration in which the proximal arms 141 of two adjacent manipulators 140 coupled to the same rail 121 are oriented at angles of 180 degrees or more relative to that rail 121. In other words, the nested configuration includes a configuration in which each of the proximal arms 141 is oriented parallel with, or beyond parallel with, the longitudinal dimension 197 of the rail 121 and/or the longitudinal dimension 199 of the platform 110. Moreover, in the nested configuration, the proximal arms 141 of the two manipulators 140 are positioned adjacent to one another near an end portion of the platform assembly 110 (e.g., near a foot end in some embodiments) with the proximal arms 141 overlapping one another in the vertical
direction (e.g., z-axis direction). This allows the manipulators to be out of the way for tasks that need clearance along longitudinally extending sides 109b of the platform assembly 110. In the embodiments of FIG. 1 the manipulators 140 are configured to be moved beyond the foot end of the platform assembly 110 in the nested configuration. In other embodiments, the manipulators 140 can be moved beyond the head end of the platform assembly 110, and in still other embodiments the manipulators 140 can be moved beyond both the head end and beyond the foot end. In addition, the nested configuration can allow for the manipulators 140 to be stowed in a compact manner under the second end section 103_3.
[0056] In some embodiments, the rail assembly 120 can be similar to the rail assemblies described in US Provisional Patent Application No. 63/336,773, entitled “RAIL ASSEMBLY FOR TABLE MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” in US Provisional Patent Application No. 63/336,778, entitled “NESTING PROXIMAL LINKS FOR TABLE MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” and in WO International Publication Number 2023/212344 Al (filed April 28, 2023) entitled “TABLE-MOUNTED MANIPULATOR SYSTEM, AND RELATED DEVICES, SYSTEMS AND METHODS,” first named inventor Steven Manuel, each incorporated by reference above.
[0057] The user input and feedback system 1004, control system 1006, and auxiliary system 1008 will be further described. Some or all of these components can be provided at a location remote from the table assembly 101. The user input and feedback system 1004 is operably coupled to the control system 1006 and includes one or more input devices to receive input control commands to control operations of the manipulators 140, status indicators 170, instruments 150, rails assembly 120, and/or table assembly 101. Such input devices can include but are not limited to, for example, telepresence input devices, triggers, grip input devices, buttons, switches, pedals, joysticks, trackballs, data gloves, trigger-guns, gaze detection devices, voice recognition devices, body motion or presence sensors, touchscreen technology, or any other type of device for registering user input. In some cases, an input device can be provided with the same degrees of freedom as the associated instrument that they control, and as the input device is actuated, the instrument, through drive inputs from the manipulator assembly, is controlled to follow or mimic the movement of the input device, which can provide the user a sense of directly controlling the instrument. Telepresence input devices can provide the operator with telepresence, meaning the
perception that the input devices are integral with the instrument. The user input and feedhack system 1004 can also include feedback devices, such as a display device (not shown) to display images (e.g., images of the workspace as captured by one of the instruments 150), haptic feedback devices, audio feedback devices, other graphical user interface forms of feedback, etc.
[0058] The control system 1006 can control operations of the system 100. In particular, the control system 1006 can send control signals (e.g., electrical signals) to the table assembly 101, rail assembly 120, manipulators 140, status indicators 170, and/or instruments 150 to control movements, provide status indications, and/or perform other operations of the various parts. In some embodiments, the control system 1006 can also control some or all operations of the user input and feedback system 1004, the auxiliary system 1008, or other parts of the system 100. The control system 1006 can include an electronic controller to control and/or assist a user in controlling operations of the manipulators 140, and other components of the system 100. The electronic controller includes processing circuitry configured with logic for performing the various operations. The logic of the processing circuitry can include dedicated hardware to perform various operations, software (machine readable and/or processor executable instructions) to perform various operations, or any combination thereof. In examples in which the logic includes software, the processing circuitry can include a processor to execute the software instructions and a memory device that stores the software. The processor can include one or more processing devices capable of executing machine readable instructions, such as, for example, a processor, a processor core, a central processing unit (CPU), a controller, a microcontroller, a system-on-chip (SoC), a digital signal processor (DSP), a graphics processing unit (GPU), etc. In cases in which the processing circuitry includes dedicated hardware, in addition to or in lieu of the processor, the dedicated hardware can include any electronic device that is configured to perform specific operations, such as an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), a Complex Programmable Logic Device (CPLD), discrete logic circuits, a hardware accelerator, a hardware encoder, etc. The processing circuitry can also include any combination of dedicated hardware and processor plus software.
[0059] Differing degrees of user control versus autonomous control can be utilized in the system 100, and embodiments disclosed herein can encompass fully user-controlled systems, fully autonomously-controlled systems, and systems having any combination of user and autonomous control. For operations that are user-controlled, the control system 1006 generates control signals
in response to receiving a corresponding user input command via the user input and feedback system 1004. For operations that arc autonomously controlled, the control system 1006 can execute pre-programmed logic (e.g., a software program) and can determine and send control commands based on the programming (e.g., in response to a detected state or stimulus specified in the programming). In some systems, some operations can be user controlled and others autonomously controlled. Moreover, some operations can be partially user controlled and partially autonomously controlled — for example, a user input command can initiate performance of a sequence of events, and then the control system 1006 can perform various operations associated with that sequence without needing further user input.
[0060] Additionally, the control system 1006 may analyze kinematic data associated with the manipulator system 100 and/or the components thereof to determine a pose of the various components with respect to one or more sterility boundaries. For example, in some embodiments, the control system 1006 may register the manipulators 140 and/or the portions thereof with respect to a coordinate system (such as those described elsewhere herein). The control system 1006 may define the one or more sterility boundaries based on coordinates of the registered coordinate system. As one example, the control system 1006 may define a horizontal plane at a height of a z- value corresponding to a top surface of the platform assembly 110. Accordingly, by comparing the kinematic data of the manipulators 140 to the sterility boundary using the same coordinate system, the control system 1006 can identify precisely which portions of the manipulators 140 have breached sterility protocols.
[0061] It should be appreciated that, according to certain aspects, different users may define different sterility protocols and, as such, utilize different sterility boundaries. Accordingly, the control system 1006 may be configured to present one or more graphical user interfaces that enable a user to define the sterility protocol for a procedure. Said another way, the control system 1006 may enable the user to define the one or more sterility boundaries the pose of the manipulators 140 are compared against. In some embodiments, the definitions are provided with respect to a reference component registered with the control system 1006 (e.g., a top surface of the platform assembly 110). In other embodiments, the definitions may be defined by the user interacting with a virtual model of the manipulator system 100. In still other embodiments, the definitions may be stored in a sterility protocol file that the user provides to the control system 1006.
[0062] Turning now to FIGs. 2-5, another embodiment of a table-mounted manipulator system
200 (“system 200”) is described below. The system 200 can be used as the system 100, and some components of the system 200 can be used as components of the system 100 described above. In particular, the system 200 includes manipulators 240 (e.g., manipulators 240_l, 240_2: that can be used as the manipulators 140 of the system 100, as described in greater detail below. Thus, the descriptions of the components of the system 100 above are applicable to the related components of the system 200, and duplicative descriptions of these components are omitted below. The related components of the systems 100 and 200 are given reference numbers having the same right-most two digits — for example, 140 and 240. Although the system 200 is one embodiment of the system 100, the system 100 is not limited to the system 200.
[0063] As shown in FIGs. 2A, 2B, and 2C the system 200 includes a table assembly 201, two rail assemblies 220 coupled to the table assembly, and multiple manipulators 240 coupled to the rail assemblies 220. Each manipulator 240 is configured to support one or more instruments (not illustrated), which can be removably or permanently mounted thereon. The system 200 also can include a control system (not illustrated), a user input and feedback system (not illustrated), and/or an auxiliary system (not illustrated) similar to those described above in relation to the system 100. In some embodiments, the system 200 is configured as a computer-assisted, teleoperable medical system. In other embodiments, the system 200 is configured as a teleoperable and/or manually- operable system for use in non-medical contexts.
[0064] As shown in FIGs. 2A and 2B, the table assembly 201 includes a platform assembly 210 configured to support the patient or inanimate workpiece, a support column 202 coupled to and supporting the platform assembly 210, and a base 205 coupled to the support column 202. The base 205 can be configured to contact the ground or other surface upon which the table assembly
201 rests, and in some embodiments the base 205 includes wheels 206 to allow movement of the system 200 along the ground or other surface. In some embodiments the support column 202 includes a telescoping support column that can raise or lower the platform assembly 210.
[0065] The platform assembly 210 includes multiple platform sections 203 configured to support the patient or workpiece. In particular, in the embodiment illustrated in FIGs. 2-5, the platform assembly 210 includes first end section 203_l (“head section 203_l”), middle sections 203_2 and 203_3, and second end section 203_4 (“foot section 203_4”), which are arranged in series and movably
coupled together via joints 207. In some embodiments, the first end section 203_l can be configured to support a head of the patient, the second end section 203_4 can be configured to support the feet and/or legs of the patient, and the more middle sections 203_2 and 203_3 can be configured to support a torso and/or other portions of the patient. The joints 207 allow adjacent platform sections 203 to pivot relative to one another about rotation axes parallel to a lateral dimension 299 of the platform assembly 210 (e.g., parallel to a y-axis in the Figures). In some embodiments, one or more of the platform sections 203 can be removable, for example when it is not needed based on the size of the patient or based on the procedure to be performed. In some embodiments, additional platform sections 203 can be added to the platform assembly 210. In some embodiments, auxiliary devices can be coupled to the one or more of the platform sections 203, in addition to or in lieu of one or more of the platform sections 203; for example, leg stirrups can be coupled the middle section 203_3 in lieu of the second end section 203_4 in some embodiments. FIG. 2B illustrates the platform assembly 210 in a neutral configuration in which all of the platform sections 203 are parallel to one another and to the ground or other supporting surface upon which the table assembly 201 rests, and FIG. 2A illustrates the platform assembly 210 in articulated configurations in which some of the platform sections 203 are oriented at non-zero angles relative to adjacent platform sections 203 and/or relative to the ground or other supporting surface. In some embodiments, some of the joints 207 can also allow for other motion between adjacent platform sections 203, such as relative translation along the longitudinal dimension 298 or relative rotation around a vertical axis parallel to a height dimension (i.e., the z-axis in the Figures), which is perpendicular to the lateral and longitudinal dimensions 299 and 298. In some embodiments, the platform sections 203 include relatively rigid support portions 203b and softer cushion portions 203a attached to the support portions 203b, with a surface of the cushion portions 203a (i.e., the top surface in the orientation illustrated in FIG. 2A) forming a support surface that contacts the patient or workpiece. In some embodiments, multiple platform sections 203 can share some components. For example, as illustrated in FIG. 2A, the middle platform sections 203_2 and 203_3 can share the same cushion portion 203a that extends across both platform sections 203 2 and 203_3. The cushion portion 203a shared by the platform sections 203_2 and 203_3 can bend when the platform sections 203 2 and 203 3 are articulated relative to one another, as shown in FIG. 2A.
[0066] In addition to moving individual platform section 203 relative to adjoining platform sections 203, the platform assembly 210 as a whole is movable relative to the support column 202. In some embodiments, the middle section 203_3 is coupled to the support column 202 by one or more joints (not illustrated), providing for motion between the middle section 203_3 and the column 202. The
other platform sections 203_l, 203_2, and 203_4 are coupled (directly or indirectly) to the middle section 203_3, and thus as the middle section 203_3 moves relative to the support column 202 the platform assembly 210 as a whole moves relative to the support column 202. In some embodiments, the motion of the middle section 203_3 (and hence platform assembly 210 as a whole) relative to the support column 202 includes pivoting (tilting) about a horizontal axis parallel to the lateral dimension 299 (e.g., a pitch degree of freedom of motion), as shown in FIG. 2A. In some embodiments, other degrees of freedom of motion are provided between the middle section 203_3 and the support column 202, including pivoting (tilting) about a horizontal axis parallel to the longitudinal dimension 298 (e.g., a roll degree of freedom of motion), rotating about a vertical axis (e.g., a yaw degree of freedom of motion), and/or translation along the longitudinal and/or lateral dimensions 299 or 298. As shown in FIG. 2B, in the neutral configuration of the platform assembly 210, the platform assembly 210 is parallel to the ground or other supporting surface.
[0067] As shown in FIG. 2A, the platform assembly 210 also includes a number of accessory rails 204 attached to side surfaces of the support portions 203b of the platform sections 203. The accessory rails 204 can be configured to receive accessory devices removably mounted thereon, such as such as leg stirrups, liver retractor, arm boards, and bed extenders. The accessory rails 204 are be attached to longitudinally extending side faces of one or more of the platform sections 203.
[0068] As noted above, the system 200 includes multiple manipulators 240. In the embodiment illustrated in FIGs. 2-5 four manipulators 240 are present, with two manipulator 240 on each longitudinally extending side 209b of the platform assembly 210 (i.e., two manipulators 240 are mounted to a first longitudinally extending side 209b of the platform assembly 210 and two manipulators 240 are mounted to a second longitudinally extending side 209b of the platform assembly 210). In other embodiments, more or fewer manipulators 240 can be used, such as one, two, three, or more manipulators per longitudinally extending side 209b. In FIGs. 2A, 2B, and 2C one or more manipulators 240 are shown in a stowed state under end section 203_4 while remaining coupled to the rail 221.
[0069] FIGs. 2A, 2B, and 2C show some or all of the manipulators 240 in various deployed states (not all of the manipulators 240 are visible in each of FIGs. 2A, 2B, and 2C). The deployed states include states in which one or more of the manipulators 240 are not stowed, which in some embodiments means at least that the one or more manipulators 240 are at least partially unfolded/uncompacted while remaining coupled to the rail 221 , and removed from a stowed location, e.g., removed out from under the platform assembly 110. The manipulators 240 can be positioned in
a variety of deployed states. In some deployed states, the manipulators 240 are deployed and have a distal link assembly positioned in a sterile field (see, for example, Fig. 2A). The sterile field is a region in which any exposed surfaces of objects in the region are maintained in a sterile condition (e.g., a condition substantially free from contaminants, such as biological pathogens, dusts, oils, etc.). In some embodiments, an object may include a non-sterile surface covered by a sterile barrier.
[0070] FIG. 2C further illustrates examples of sterility boundaries, and various regions of space that may be associated with varying sterility and status classifications and/or rankings. The sterile field may be defined as a region above a certain height, such as above the rail 221, platform 210, or other chosen reference point. For example, as shown in FIG. 2C, the sterile field may be defined as an upper region 290 corresponding to the region of space above the top surface 211 of the platform 210, or any other boundary defined in a sterility protocol implemented by the control system 1006. In the illustrated embodiment of FIG. 2C, the upper region 290 is bounded by a plane at an upper axis 280 corresponding to the top surface 211 of the platform 210. In this embodiment, any portions of an object below that height may be considered to be outside of the sterile field, and therefore, not be sterile. Additionally, in some alternate embodiments, the upper region 290 may include an upper limit proximate to a ceiling or ventilation equipment within the OR, above which is outside of the sterile field.
[0071] In some examples, additional sterility boundaries may be defined to allow for a gradient of status ranks or sterility ranks to be provided to a user, which will be described further herein. In some embodiments, the height defining the sterility field is statically defined throughout the operation. In other embodiments, the height defining the sterility field may change dynamically throughout the operation. For example, as described above, the platform 210 may translate in the vertical direction. Accordingly, as the platform 210 translates vertically, the height of the platform 210 and/or rail 221 changes. Thus, the sterility field boundary may also change in accordance with the translation of the platform 210.
[0072] In some deployed states the distal link assembly 263 is raised to a height sufficient for the distal link assembly 263 and any instrument supported thereon to remain within the sterile field while deployed. Thus, in some embodiments in the deployed state, the distal link assembly 263 is at or above a height of the proximal arm 241, the rail 221, the platform 210, and/or some other predetermined level. In other deployed states, the manipulators 240 can be deployed, but do not have a distal link assembly positioned fully in the sterile field. The deployed state can include a variety of
configurations and positions of the manipulators 240 including but not limited to those shown in FIGs. 2A, 2B, and 2C.
[0073] As shown in FIG. 2C, the sterility protocols implemented by the control system 1006 may define a plurality of sterility boundaries that bound a plurality of respective sterility regions. In the example of FIG. 2C, the upper boundary 280 is defined by the upper surface 211 of the platform 210, an intermediate boundary 285 is defined by a lower surface 212 of the platform 210, and a lower boundary 288 is defined relative to a floor 213. The boundaries define various regions of space that the sterility protocol associates with different levels of risk of non-sterility. For example, a platform region 282 may be defined as the region of space defined by the upper boundary 280 and the intermediate boundary 285, a lower region 287 may be defined as the region of space between the intermediate boundary 285 and the lower boundary 288, and a floor region 289 may be defined as the region of space between the lower boundary 288 and the floor 213.
[0074] In other embodiments, the gradient of sterility risk may be defied with respect to a single boundary. For example, the gradient may be associated with an equation that increases the risk of non-sterility based on distance from the boundary along a given axis (e.g., the vertical axis). Depending on the equation, the risk of non-sterility may increase linearly, quadratically, exponentially, etc. In some embodiments, the equation is normalized to a scale (e.g., 0 at the boundary and 100 at a maximum, such as a floor surface or a virtual plane above the floor surface).
[0075] In some embodiments, the boundaries that define the various regions and/or gradients may be customizable, for example, via a user interface presented via the user input system 1004. To this end, different institutions have different standards for sterility for different settings, procedures, equipment, etc. Accordingly, an operator of the user input system 1004 may input and/or upload a set of boundary preferences for use with the disclosed techniques.
[0076] Each of the regions of space 290, 282, 287, and 289 may be classified as having different sterility rankings, resulting in a potential gradient of sterility ratings across the regions of space 290, 282, 287, and 289. As one example, the sterility protocols may assign the regions a rating on a scale from 1 to 4 with 1 being a high-confidence of sterility to 4 being a high confidence of non-sterile. In the illustrated scenario, the floor region 289 may have a sterility ranking of 4, the lower region 287 may have a sterility ranking of 3, the platform region 282 may have a sterility rank of 2, and the upper region 290 may have a ranking of 1. While FIG. 2C depicts one example set of boundaries
defined by a sterility protocol, other sterility protocols may define the gradient of sterility risk and the corresponding boundary regions in any suitable manner.
[0077] In examples, a single sterility boundary may define a gradient of sterility risk. For example, a region of space may be defined relative to a sterility boundary, such as the upper region 290 relative to the upper boundary 280. The upper region 290 may have a gradient of sterility rating with a lower sterility rating lower from the upper boundary 280, and a high sterility rating closer to the upper boundary. In such an example, the lower sterility rating may be a value such as a 0, with 0 indicating non-sterile, while a value of 1 may be assign away from the upper boundary 280 indicating a sterile region, with the gradient of sterility rating ranging between 0 and 1 from the upper boundary 280 away from the upper boundary. In such a way, a processor or control system may define a continuous, or quasi-continuous, gradient of sterility risk or sterility ratings across any of the regions of space 290, 282, 287, and 289 relative to the various sterility boundaries 280, 285, 288 and the floor 213.
[0078] It should be understood that some boundaries may be generally static (e.g., a boundary defined by a floor, wall, or ceiling) while other boundaries may be dynamic such as a boundary defined by one or more portions of the platform 210 that may tilt, raise, lower, etc. during an operation or procedure. Accordingly, the control system 1006 may monitor kinematic data associated with the corresponding portions of the platform 210 to adjust the boundary regions based on the motion.
[0079] During operation, the control system 1006 monitors kinematic data associated with manipulators 240 to determine the pose of the positions thereof with respect to the boundaries defined by the sterility protocol. If the control system 1006 determines that a portion of the manipulators 240 crossed one of the sterility boundaries, the control system 1006 may assign that portion a sterility value and/or status associated with the region in which the portion entered. It should be appreciated that the control system 1006 may assign each portion of the manipulators 240 the sterility value and/or status associated with the least sterile region the portion has entered. Returning to the prior example, if a portion crossed the boundary from region 282 into region 287 during performance of the procedure, if the portion crosses back into the region 282, the control system 1006 may continue to associate the portion with the sterility value and/or status associated with the region 287.
[0080] FTGs. 3 and 4 illustrate two embodiments of manipulators 240_l and 240_2, having status indicators 270 respectively. The manipulators 240_l and 240_2 are generally similar to one another except that the manipulators 240_l and 240_2 employ status indicators 270 in two different configurations. The manipulator 240_l of FIG. 3 includes status indicators 270 disposed generally in a strip arrangement along the lengths of the various links and joints of the manipulator 240_l, while the status indicators 270 of the manipulator 240_2 of FIG. 4 are disposed circumferentially around the links and joints at different positions along the lengths of the links and joints. The circumferential configuration of FIG. 4 provides status indications about the various links and/or joints to allow a user or operator to see the status from a variety of perspectives of a given link or joint. The strip configuration of FIG. 3 provides finer resolution as to the sterility status of the respective portions of the manipulator 240.
[0081] As shown in FIGs. 3 and 4, each manipulator 240 includes a proximal link assembly 261 including a proximal arm 241 coupled to the rail assembly 220 via one or more proximal joints 230 and a carriage 226, an intermediate link assembly 262 including an intermediate arm 242 coupled to a distal end portion of the proximal link assembly 261 via one or more intermediate joints 245, and a distal link assembly 263 including a distal arm 243 coupled to the intermediate link assembly 262 via one or more distal joints 246. The distal link assembly 263 also includes an instrument holding portion 269 coupled to the distal arm 243 and configured to support an instrument, such as the instrument 150 illustrated in FIG. 1. Each of the proximal link assembly 261, intermediate link assembly 262, and distal link assembly 263 include status indicators 270 disposed thereon.
[0082] FIG. 5 is a side view of a manipulator 240_3 according to a similar configuration of that of FIG. 3 with the status indicators 270 disposed in a strip arrangement along one or more sides of one or more links or joints of the manipulator 240_3. The status indicators 270 in any of FIGs. 3-5 may be disposed on one or more links, two or more links, and further be disposed on one or more joints, or two or more joints of the manipulators 240. Each of the manipulators 240 of FIGs. 3-5 includes two proximal joints 230 and associated joint housings 264 and 265. In some embodiments, the manipulators 240 may have a single proximal joint.
[0083] In examples, the manipulators 240 may have respective indication systems including status indicators 270 disposed on two or more links, two or more joints, a link and a joint, or any combination of links and joints as desired or required for a given application. Each of the status indicators 270 may provide an indication of sterility status of a respective link or a joint (or portion
thereof). The indications of a sterility status may inform a user as to whether the link or joint is sterile such the user knows whether manual movement or positioning of the link or joint will breach sterility protocols.
[0084] The status indicators 270 may provide an indication of whether a link or joint (or portion thereof) has come into contact with an object or user, has entered a non-sterile region, has come close to a non-sterile region, is ready to be physically manipulated, and/or other conditions related to sterility. The status indicators 270 may include one or more LEDs, haptic output devices (e.g., actuators, motors, gyroscopes, etc.), speakers, or other sensory output devices. The status indicators 270 may provide various indications of sterility and other statuses via various means and types of signals. In embodiments where the status indicators 270 include LEDs, the LEDs may provide status indications via a flashing pattern, being turned on or off, via a color (e.g., green representing sterile, red representing non-sterile, etc.), via a brightness level, or by a numerical display that utilizes LEDs. In embodiments where the sterility protocol defines a gradient of sterility risks, each sterility value may correspond to a different LED intensity and/or color. For example, portions associated with a higher risk of non-sterility may be brighter and redder than regions associated with lower risk of non-sterility.
[0085] Additionally, in some embodiments, the status indicators 270 may include speakers and audio output devices configured to output beeps or sound patterns, as well as verbal messages. As another example, a display unit or user interface, such as a display unit or user interface (e.g., monitor, computer, tablet, touch screen, etc.) of the user input and feedback system 1004 of FIG. 1, may be configured to provide the sterility status of a portion or part of a manipulator 240.
[0086] A control system, such as the control system 1006 of FIG. 1, may be in communication with the indication systems of the manipulators 240 to cause the status indicators 270 to provide indications of the various statuses described herein. The control system may be configured to control the indication systems to cause status indicators 270 to provide an indication of sterility status of a portion of each respective link on a manipulator 240, with each respective link corresponding to one or more LEDs of a plurality of LEDs as status indicators 270. Additionally, as previously described, the control system may be configured to control the output of one or more status indicators 270 including haptic devices and audio output devices to provide sterility status indications via a haptic output or audio output. The control system may further be configured to
cause status indicators 270 disposed on, or associate with various joints of a manipulator, to provide a sterility status of one or more joints. Further, the control system 1006 may be in communication with one or more display units or user interfaces of the user input and feedback system 1004 to provide status indications via the one or more display units.
[0087] As illustrated in FIG. 5, the indicator system may include instrument holding portion status indicators 300 disposed along the instrument holding portion 269, distal status indicators 302 disposed along the distal arm 243, intermediate status indicators 305 disposed along the intermediate arm 242, and proximal status indicators 308 disposed along the proximal arm 241. In embodiments, the manipulators 240 may include status indicators 270 at the various joints 245, 246, and 247 as well. The status indicators 270 may provide indications of an entire link such as the distal status indicators 302 may provide an indication of sterility status of the entire distal arm 243, or the status indicators 270 may provide status indications of a portion of a link. For example, the intermediate status indicators 305 may provide a first indication of sterility status at a first portion 305a, an indication of a second sterility status in a second portion 205b, and a third indication of a sterility status in a third portion 205c of the intermediate link 242. As such, the status indicators may indicate that the first and third portions 205a and 205c are sterile, while the second portion 205b is not sterile. Or, in another example, the status indicators may provide an indication that the first portion 205a is sterile, the second portion 205b has entered a region near a non-sterile region and is deemed potentially non-sterile, and that the third portion is non-sterile 305c. Further, the status indicators 270 of the second portion 305b may indicate that the second portion 305b has bumped or come into contact with an object or user, while the status indicators 270 of the first and third portions 305a and 305c may indicate that the first and third portions 305a and 3205c did not contact any object or user. Additionally, the various status indicators 270 disposed on the distal arm 243, intermediate arm 242, and/or proximal arm 241, or portions of an arm thereof, may indicate whether an arm, link, joint, or portion of an arm is ready to be manually positioned or repositioned by a user, operator, or clinician.
[0088] To determine whether a manipulator 240 or a portion thereof is ready to be manually positioned or repositioned, the control system 1006 may determine the readiness of the arms and or portions of arms based on a sterility status. For example, the control system 1006 may determine a readiness status of an arm, joint, link, or portion of the manipulator 240, based on the sterility status of two or more links. Status indicators 270 of the portion of the repositionable structure (e.g.,
arms, links, joints, etc.) may then provide an indication of whether the respective corresponding part or portion of the manipulator 240 is ready to be manually positioned based on the determined readiness status. For example, the control system 1006 may determine that the readiness status of a portion of the manipulator 240 as “ready” if the sterility status for the corresponding portion of the manipulator 240 is determined to be sterile. On the other hand, the control system 1006 may determine that the readiness status of a portion of the manipulator 240 as “not ready” if the sterility status for the corresponding portion of the manipulator 240 is determined to be not sterile.
[0089] In some embodiments, the control system 1006 may monitor data of the objects within the OR to detect contact between an object and the manipulators 240. The control system 1006 may detect the contact by monitoring kinematic data, image data, contact sensor data, proximity sensor data, and/or other types of data indicative of a contact between a manipulator 240 and an object (such as a person, an instrument, another manipulator 240, etc.).
[0090] In response to detecting the contact, the control system 1006 may attempt to determine a sterility status of the contacting object. For objects tracked by the control system 1006 (e.g., other manipulators 240), the control system 1006 may determine status as the sterility status assigned to the object when implementing the instant techniques. For other objects, the sterility status may be more difficult to determine. Accordingly, the sterility status of the contacted portion of the manipulator 240 may also be unknown.
[0091] Based on the assessment of object sterility, the control system 1006 may change the sterility value of the contacted portion, thereby causing the indication system corresponding to the contact portion to update to the indication mode associated with the new sterility status. For example, if the object has a known sterility value and/or status, the control system 1006 may assign the portion the same sterility value and/or status as the object. If the object has an unknown sterility status, the control system 1006 may assign the portion a sterility status indicative of the uncertainty. If the object is known to be sterile (or have a lower risk of non-sterility than the contacted portion), the control system 1006 may not change the sterility value and/or status of the portion. It should be appreciated that the contact may cause a more distal portion of the manipulator 240 to have a higher risk of non-sterility than a more proximal portion of the manipulator 240.
[0092] It should be appreciated that in some manipulator systems 200, the manipulators draw power from a battery or other energy storage device to avoid wired connections in the OR that may
interfere with performance of a procedure. Accordingly, in some embodiments, the control system 1006 may implement one or more power saving techniques to reduce energy usage associated with the indication system and maximize the amount of time the manipulators 240 can be in use during the procedure. As one example, the control system 1006 may disable the indication systems when the manipulators 240 are not to be manually-operated. Thus, less energy is expended on sterility indication when operators do not need to know the sterility status of the manipulators 240 (and/or portions thereof). Alternatively, because in many scenarios, the most proximal portion may be assumed to be non-sterile and the most distal may be assumed to be sterile, the control system 1006 may disable only the most distal and most proximal portions when the manipulator 240 is not to be manually-operated to ensure the sterility status of the intermediate portions is still indicated to the operators.
[0093] FIG. 6 is an example flow diagram of an example method 600 for providing sterility status for a computer-assisted manipulator system, such as, for example, performed by a system with manipulators according to any of FIGs. 1-5. The method 600 may be used to provide sterility status of one or more elements of a manipulator, such as the manipulators 140 or 240, or computer- assisted system for performing treatment to a patient, or for performing medical procedures, according to some examples. An example system for performing the method 600 may include a repositionable structure such as the manipulators 240, having two or more links, such as the proximal link assembly 261, intermediate link assembly 262, and/or distal link assembly 263, coupled via one or more joints, such as by the proximal joints 230, intermediate joints 245, and/or distal joints 246. Each link of the two or more links may include a respective indication system with one or more status indicators 270. The system further includes a controller, such as the control system 1006 of Fig. 1, operatively coupled to the repositionable structure to control the various links, joints, and status indication systems to control positions and movement of the parts of the repositionable structure, as well as control the indication systems to provide indications of status (e.g., sterility status, non-sterility status, moveable status, etc.) via the status indicators.
[0094] The method 600, at block 602, includes obtaining kinematic data indicative of a position of the two or more links relative to a sterility boundary. The kinematics data may include data indicative of a current position, past position, or planned future position of the two or more links. Additionally, the kinematics data may include data indicative of the positioning or movement of the two or more links into a non-sterile region, or in a sterile region of space. The kinematics data
may also be indicative of whether the two or more links or any joints, have contacted an object or a person. A processor, or the controller, may obtain the kinematics data from one or more sensors, or from a feedback system, such as the user input & feedback system 1004 of Fig. 1, in communication with various components of the links and joints of the repositionable structure. The kinematics data may include two-dimensional or three-dimensional spatial data to identify the positions and movements of the various links and joints of the repositionable structure, and specifically, in reference to one or more sterility boundaries, such as the sterility boundaries 280, 285, and 288.
[0095] The kinematics data may include data indicative of the relative positions and movements of the links and or arms of the repositionable structure relative to a sterility boundary. The sterility boundary provides a boundary between regions of space considered sterile, and regions of space not considered sterile. For example, the sterility boundary may be such that a region of space above the height of a table or bed, such as illustrated in the platform assembly of FIG. 2A and region 290 illustrated in FIG. 2C, is classified as sterile, while any region below the height of the bed, such as the regions 282, 287, and 289, is classified as a non-sterile region, with the sterility boundary being the boundary between the sterile and non-sterile regions, as illustrated as boundaries 280, 285, and 288 in FIG. 2C. Additionally, a sterility boundary may define a region as non-sterile if the region is too close to a vent or ceiling, outside of a sterile three-dimensional space around the platform assembly, near a floor, near other devices, around an individual, etc. A sterility boundary may be defined relative to a bed, wall, ceiling, individual, object, or any other structure. In examples, the sterility region may be defined by a user and may be provided via an interface of the user input & feedback system 1004 of FIG. 1. A sterility boundary may be a dynamic boundary that changes based on the movement of people and/or objects during a procedure or operation. For example, a sterility boundary may be defined relative to the height of a bed or table of a platform assembly, and the bed may raise and lower during an operation, therefore the sterility boundary may then dynamically raise and lower according to the changing height of the bed or table.
[0096] At block 604, the controller determines a sterility status associated with the two or more links and/or joints of the repositionable structure, from the kinematics data. The controller, or another processor, may determine the sterility status for each link and/or join of the repositionable structure. For example, the controller may determine that a distal link has passed through a non- sterile region, while a proximal link of a same repositionable structure, has not passed through or
been positioned in a non-sterile region. As, such, the controller determines the status of the distal link as non-sterile, and the status of the proximal link as sterile. Additionally, the controller may determine the sterility status of any links and/or joints based on if the link or joint has come into contact with a non-sterile user, or an object.
[0097] In implementations, multiple sterility boundaries may define a plurality of sterile, and non-sterile regions of space. Each non-sterile region of space may independently have a respective sterility rating. For example, some regions may be determined as sterile, and non-sterile regions may have a non-sterile, or risk, rating. In other examples, a single sterility boundary may define a continuous gradient that associates the non-sterile region with respective sterility ratings based on a distance from the sterility boundary. In either case, the risk rating may include a numerical rating from 1 to 5 with 5 being the most at risk or most non-sterile, and 1 being a least at risk or least considered non-sterile. For one example, a non-sterile region may be defined as the region of space below the bed of a platform assembly, with a lower risk rating closer to the bed, and a higher risk non-sterility rating closer to the floor of an operating area. The controller may determine the sterility status of one or more links or joints, or portions thereof, based on the sterility rating of each link and/or joint, or portion thereof. The controller may then control the indication systems of independent links and/or joints, or portions thereof, to provide an indication of each respective sterility rating.
[0098] At block 606, the controller controls the status indicators to provide a status indication of the two or more links and/or joints, or portions thereof, of the repositionable structure. As described above the controller may cause the indication systems to provide indications of a sterility status or of other types of status such as whether a link and/or joint, or a portion thereof, has come into contact with a user or object, or a positioning readiness status if a link or joint is ready to be manually positioned or repositioned. The controller may control LEDs, haptic devices, or audio output devices to provide status indications via a visual flashing pattern, an LED brightness, a color, a numeral or character display, an audible pattern, a vibratory output, etc. The controller may control a single status indicator, or a plurality of status indicators, to provide an indication of a link, joint, portion of a link, or portion of a joint.
[0099] One or more components of the embodiments discussed in this disclosure, such as control system 1006, may be implemented in software for execution on one or more processors of a computer system. The software may include code that when executed by the one or more
processors, configures the one or more processors to perform various functionalities as discussed herein. The code may be stored in a non-transitory computer readable storage medium (c.g., a memory, magnetic storage, optical storage, solid-state storage, etc.). The computer readable storage medium may be part of a computer readable storage device, such as 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 may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium. The code may be executed by any of a wide variety of centralized or distributed data processing architectures. The programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. The components of the computing systems discussed herein may be connected using wired and/or wireless connections. In some examples, the wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).
[0100] Various general-purpose computer systems may be used to perform one or more processes, methods, or functionalities described herein. Additionally or alternatively, various specialized computer systems may be used to perform one or more processes, methods, or functionalities described herein. In addition, a variety of programming languages may be used to implement one or more of the processes, methods, or functionalities described herein.
[0101] While certain embodiments and examples have been described above and shown in the accompanying drawings, it is to be understood that such embodiments and examples are merely illustrative and are not limited to the specific constructions and arrangements shown and described, since various other alternatives, modifications, and equivalents will be appreciated by those with ordinary skill in the art.
Claims
1. A computer-assisted system for indicating sterility status, the system comprising: a repositionable structure configured to support an instrument, the repositionable structure comprising two or more links coupled via one or more joints, wherein each link of the two or more links includes a respective indication system; and a control system operably coupled to the repositionable structure, the control system is configured to: obtain kinematic data indicative of at least a position of each of the two or more links relative to a sterility boundary; determine, based on the kinematic data, a sterility status associated with the two or more links; and configure the respective indication systems of the two or more links to provide an indication of the sterility status of the respective link of the two or more links.
2. The computer-assisted system of claim 1, wherein the sterility boundary is at least partially defined by a height of a table.
3. The computer-assisted system of claim 2, wherein the sterility boundary is a dynamic boundary that adjusts in response to a change in height of the table.
4. The computer-assisted system of claim 1, wherein the sterility boundary defines a gradient of sterility risk corresponding to different sterility ratings.
5. The computer-assisted system of claim 4, wherein to define the gradient of sterility risk, the control system is configured to: define a plurality of sterility boundaries each defining a sterility region having a different sterility rating.
6. The computer-assisted system of claim 4, wherein to define the gradient of sterility risk, the control system is configured to: define a continuous gradient of sterility ratings across a region of space relative to the sterility boundary.
7. The computer-assisted system of claim 4, wherein to determine the sterility status the control system is further configured to: determine a sterility status based on the different sterility ratings, wherein the respective indication systems are configured to provide an indication of respective sterility ratings.
8. The computer-assisted system of claim 1, wherein the sterility boundary is a user-defined boundary.
9. The computer-assisted system of claim 1, wherein to determine the sterility status, the control system is configured to: determine whether one or more portions of the repositionable structure have come into contact with an object or a user.
10. The computer-assisted system of claim 9, wherein to provide the indication of the sterility status, the controller is configured to: detect that the one or more portions of the repositionable structure have come into contact with the object or the user; and configure the respective indication systems to provide indications that the one or more portions have come into contact with the object or the user.
11. The computer-assisted system of any one of claims 1 to 10, wherein to determine the sterility status, the control system is configured to: determine whether one or more portions of the repositionable structure are (i) sterile or
(ii) non- sterile.
12. The computer-assisted system of any one of claims 1 to 10, wherein the respective indication systems comprise: a plurality of light emitting diodes (LEDs) disposed along a length of the two or more links, the LEDs configured to provide the indication of sterility status of one or more portions of the respective links of the two or more links.
13. The computer-assisted system of claim 12, wherein the plurality of LEDs are configured to indicate sterility status via a color indication, a flashing on/off pattern, a brightness, or a numeral display.
14. The computer-assisted system of claim 12, wherein the plurality of LEDs are configured to provide an indication of whether a portion of the repositionable structure is ready to be manually positioned or repositioned.
15. The computer-assisted system of claim 14, wherein to provide the indication of whether the portion of the repositionable structure is ready to be manually positioned, the control system is further configured to: determine, based on the sterility status of the two or more links, a readiness status of the portion of the repositionable structure, and the indication of whether the portion of the repositionable structure is ready to be manually positioned is based on the readiness status.
16. The computer-assisted system of claim 15, wherein: the readiness status is determined as ready to be manually positioned or repositioned if a sterility status of the portion of the repositionable structure is determined to be sterile, and the readiness status is determined as not ready to be manually positioned or repositioned if a sterility status of the portion of the repositionable structure is determined to be not sterile.
17. The computer-assisted system of claim 12 wherein the plurality of LEDs are disposed in a strip arrangement along the length of the two or more links, or circumferentially disposed at differing lengths along the length of the two or more links.
18. The computer-assisted system of claim 12, wherein: the one or more portions of the respective links of the two or more links correspond to an LED of the plurality of LEDs; and to configure the respective indication systems of the two or more links to provide the indication of the sterility status of the respective link of the two or more links, the control system is configured to: control the respective indication systems to provide the indication of the sterility status for the one or more portions of the respective links by controlling the corresponding LED of the plurality of LEDs.
19. The computer-assisted system of any one of claims 1 to 10, wherein the indication systems provide an indication of sterility status via a haptic output, or an audio output.
20. The computer-assisted system of any one of claims 1 to 10, further comprising: a display unit having a user interface, and wherein the control system is configured to provide the sterility status via the user interface.
21. The computer-assisted system of any one of claims 1 to 10, wherein the respective indication systems are configured to provide a sterility status of one or more of the joints.
22. The computer-assisted system of any one of claims 1 to 10, further comprising a table assembly comprising: a platform configured to support a body; and a rail couplable to the table assembly, wherein the repositionable structure is physically coupled to the table assembly via the rail.
23. The computer-assisted system of any one of claims 1 to 10, further comprising a repositionable cart including a support body and a mount, wherein the repositionable structure is physically coupled to the repositionable cart via the mount.
24. A method for providing sterility status for a computer-assisted system for indicating sterility status comprising a rcpositionablc structure having two or more links coupled via one or more joints, and wherein each link of the two or more links includes a respective indication system, and a control system operably coupled to the repositionable structure, the method comprising: obtaining kinematic data indicative of a position of the two or more links relative to a sterility boundary; determining, based on the kinematic data, a sterility status associated with the two or more links; and configuring the respective indication systems of the two or more links to provide an indication of the sterility status of the two or more links.
25. The method of claim 24, wherein the sterility boundary is at least partially defined by a height of a table.
26. The method of claim 25, wherein the sterility boundary is a dynamic boundary that adjusts in response to a change in height of the table.
27. The method of claim 24, wherein the sterility boundary defines a gradient of sterility risk corresponding to different sterility ratings.
28. The method of claim 27, wherein the method further comprises: defining the gradient of sterility risk by defining a plurality of sterility boundaries each defining a sterility region having a different sterility rating.
29. The method of claim 27, wherein to define the gradient of sterility risk, the method further comprises: defining, by the control system, a continuous gradient of sterility ratings across a region of space relative to the sterility boundary.
30. The method of claim 27, wherein to determine the sterility status the method further comprises: determining, by the control system, a sterility status based on the different sterility ratings, and providing, by the respective indication systems, an indication of respective sterility ratings.
31. The method of claim 24, wherein the sterility boundary is a user-defined boundary.
32. The method of claim 24, wherein determining the sterility status comprises: determining, by the control system, whether one or more portions of the repositionable structure have come into contact with an object or a user.
33. The method of claim 32, further comprising: detecting that the one or more portions of the repositionable structure have come into contact with the object or user; and providing, by the indication systems, indications that the one or more portions have come into contact with the object or the user.
34. The method of any one of claims 24 to 33, wherein determining the sterility status comprises: determining, by the control system, whether one or more portions of the repositionable structure are (i) sterile or (ii) non-sterile.
35. The method of any one of claims 24 to 33, wherein the respective indication systems comprise: a plurality of light emitting diodes (LEDs) disposed along a length of the two or more links, the LEDs configured to provide the indication of sterility status of one or more portions of the respective links of the two or more links.
36. The method of claim 35, further comprising providing, by the plurality of LEDs, an indication of a sterility status via a color indication, a flashing on/off pattern, a brightness, or a numeral display.
37. The method of claim 35, further comprising providing, by the plurality of LEDs, an indication of whether a portion of the repositionable structure is ready to be manually positioned or repositioned.
38. The method of claim 37, wherein providing the indication of whether the portion of the repositionable structure is ready to be manually positioned includes determining, by the control system and based on the sterility status of the two or more links, a readiness status of the portion of the repositionable structure, and wherein the indication of whether the portion of the repositionable structure is ready to be manually positioned is based on the readiness status.
39. The method of claim 38, wherein: the readiness status is determined as ready to be manually positioned or repositioned if a sterility status of the portion of the repositionable structure is determined to be sterile, and the readiness status is determined as not ready to be manually positioned or repositioned if a sterility status of the portion of the repositionable structure is determined to be not sterile.
40. The method of claim 35, wherein the plurality of LEDS are disposed in a strip arrangement along the length of the two or more links, or circumferentially disposed at differing lengths along the length of the two or more links.
41. The method of claim 35, wherein: the one or more portions of the respective links of the two or more links correspond to an LED of the plurality of LEDs; and configuring the respective indication systems of the two or more links to provide the indication of the sterility status of the respective link of the two or more links comprises:
controlling, by the control system, the respective indication systems to provide the indication of sterility status for the one or more portions of the respective links by controlling the corresponding LED of the plurality of LEDs.
42. The method of any one of claims 24 to 33, further comprising: providing, by the indication systems, an indication of sterility status via a haptic output, or an audio output.
43. The method of any one of claims 24 to 33, further comprising: providing, via a display unit having a user interface operatively coupled to the control system, the sterility status via the user interface.
44. The method of any one of claims 24 to 33, further comprising providing, by the respective indication systems, a sterility status of one or more of the joints.
45. The method of any one of claims 24 to 33, wherein the computer-assisted system further includes a table assembly comprising: a platform configured to support a body; and a rail couplable to the table assembly, wherein the repositionable structure is physically coupled to the table assembly via the rail.
46. The method of any one of claims 24 to 33, wherein the computer-assisted system further includes a repositionable cart including a support body and a mount, wherein the repositionable structure is physically coupled to the repositionable cart via the mount.
47. A computer-readable media storing instructions that, when executed by a processor, cause a system to perform the method of any of claims 24-46.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202463571090P | 2024-03-28 | 2024-03-28 | |
| US63/571,090 | 2024-03-28 |
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| Publication Number | Publication Date |
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| WO2025207873A1 true WO2025207873A1 (en) | 2025-10-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/021732 Pending WO2025207873A1 (en) | 2024-03-28 | 2025-03-27 | Systems and methods for providing a sterility indiciator |
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| WO (1) | WO2025207873A1 (en) |
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