Handheld, modular robotic systems, components and methods of assembly and use

Abstract

Handheld medical system, components and methods of assembly and use. The systems may be modular robotic systems and may be image-guided. Medical system may include at least one of a handle, a robotic controller, and a robotically controllable medical tool. Methods of using the medical systems may include performing different medical procedures using at least one reusable component of the system. Methods of using the medical systems may include performing different medical procedures with a medical tool in different preferred orientations relative to at least one other component of the system.

Description

HANDHELD, MODULAR ROBOTIC SYSTEMS, COMPONENTS AND METHODS OF ASSEMBLY AND USECROSS REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY REFERENCE

[0001] This application claims priority to U.S. Provisional Patent Application No.63 / 755,970, filed February 7, 2025, the entire disclosure of which is incorporated by reference herein for all purposes. All publications and patent applications mentioned in this specification are herein incorporated by reference in their entireties for all purposes to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0002] The following references are incorporated by reference herein in their entireties for any and all purposes: WO2021 / 236677, W02023 / 060241, WO / 2023 / 164434, WO / 2023 / 201210, and WO2024215927.BACKGROUND

[0003] In the medical device space in which components are assembled for medical procedures, it may be beneficial for systems to be adapted for use for multiples procedures and / or for individual components to be able to be used with a plurality of different components. Additionally, it may be beneficial for certain components to be re-useable, such as those that are relatively more expensive, such as actuators for robotic control.Additionally, it can be advantageous to be able to use different types of system components in different combinations and / or orientations, providing modularity to the systems. The description herein includes solutions and innovations that address at least one of these benefits and advantages.SUMMARY OF THE DISCLOSURE

[0004] The disclosure herein is related to handheld robotically controlled medical systems, components and methods of assembly and use.

[0005] In some aspects, the disclosure provides for modular systems in which at least one component can be used with more than one other type of component. In some aspects, the disclosure provides for systems in which more than one component can be coupled to different components in different ways depending on the preferred use. In some aspects, the system includes a handle or other controller that is intended to be disposable.- 1 - Docket No.: 14805-706.601

[0006] An exemplary benefit of approaches herein is that modularity provides additional functionality for the system, optionally including using the system for more than one type of medical procedure.

[0007] One aspect of the disclosure is a handheld modular robotic system for medical use.

[0008] In this aspect, the system is optionally image-guided and is optionally adapted for airway access.

[0009] In this aspect, the system optionally includes a handle sized and configured to be held in a hand of an operator, the handle including at least one user control that is responsive to operator interaction.

[0010] In this aspect, the system optionally includes a robotic controller including at least one actuator, the robotic controller optionally sized and configured to be releasably coupled to any of the handles herein.

[0011] In this aspect, the system optionally includes a robotically controllable medical tool (“tool”).

[0012] In this aspect, the tool is optionally an endoscopic tool, and is optionally an endoscope including a camera at a distal end region.

[0013] In this aspect, the tool is optionally sized and configured to be directly or indirectly coupled to any of the robotic controllers herein. The optional tool is optionally sized and configured to be directly or indirectly coupled to a robotic controller in a first orientation relative to the robotic controller and a second orientation relative to the robotic controller. The different orientations may be different rotational orientations, wherein rotation is relative to at least one plane or axis.

[0014] In this aspect, a user control, a robotic controller, and a tool are optionally together adapted and configured to cause robotic control of the tool in response to operator interaction with the at least one user control.

[0015] In this aspect, the handle optionally includes a curved distal portion (for example, a blade) sized and configured to be placed in a subject’s oral cavity. A curved distal portion is optionally adapted to be removed from a handle. In this aspect, a handle is optionally adapted to be coupled to a plurality of different curved distal portions (e.g., blades), each having a different configuration.

[0016] In this aspect, an optional handle optionally does not include a curved distal region sized and configured to be placed in a subject’s oral cavity and is optionally not adapted to be coupled to a curved distal portion.

[0017] In this aspect, a first orientation optionally maintains the tool in a first preferred position for a first medical procedure, and the second orientation optionally maintains the tool - 2 - Docket No.: 14805-706.601in a second preferred position for a second medical procedure. In this aspect, a second orientation is optionally 90 degrees or about 90 degrees relative to the first orientation, rotated in a plane or about an axis.

[0018] In this aspect, a tool optionally comprises an endoscope with a camera at a distal end, and when the tool is in a second rotational orientation in a plane or about an axis, the camera is optionally directed in a different direction than when the tool is in the first orientation.

[0019] In this aspect, a tool, when in a first orientation, optionally orients an endoscope in a direction more preferred for a first procedure than a second procedure subsequent to the first procedure, and when in the second orientation, orients the endoscope in a direction more preferred for a second procedure than the first procedure. A first procedure optionally comprises tracheal intubation and a second subsequent procedure optionally comprises bronchoscopy.

[0020] In this aspect, a robotic controller optionally includes a base integrated and non-detachable from a robotic head, the robotic controller including one or more actuators for facilitating robotic control of the tool. The system optionally includes an extension adaptor, the extension adaptor and the robotic controller each optionally adapted and sized and configured to be coupled together, wherein the extension adaptor is sized and configured to be releasably coupled to the tool when the tool is in a second orientation relative to the robotic controller, wherein the extension adaptor is configured to communicate robotic control to the tool when in the second orientation based on operator interaction with the at least one user control.

[0021] Any of the robotic controllers in this aspect optionally comprise a base and robotic head, wherein the robotic head is optionally detachable from the base. A detachable robotic head is optionally sized and configured to be attached directly to the base in first and second rotational orientations. The system optionally further comprises an extension adaptor that is adapted to be releasably coupled to the base, the extension adaptor further configured to be releasably coupled to a detachable robotic head when in a rotational orientation that is different than when the robotic head is coupled directly to the base. An extension adaptor is optionally adapted to facilitate the robotic control of a tool in response to operator interaction with the at least one user control. An extension adaptor is optionally adapted to communicate at least one of electrically, mechanically or magnetically to a detachable robotic head. An extension adaptor is optionally at least one of mechanically, electrically or magnetically coupled to abase.

[0022] In this aspect, at least a portion of a robotic controller is optionally disposed within a channel or lumen of a handle when and if the robotic controller is coupled to the handle.- 3 - Docket No.: 14805-706.601

[0023] One aspect of this disclosure is a method of using a handheld modular robotic system, optionally for airway access, and optionally image-guided.

[0024] In this aspect, the method optionally includes coupling a handle to a robotic controller, wherein coupling the handle and robotic controller creates an operable communication between the handle and the robotic controller. A robotic controller optionally includes at least one robotic control actuator and wherein the handle optionally includes at least one user control responsive to operator interaction.

[0025] In this aspect, the method optionally includes coupling a robotically controllable medical tool (“tool”) to the robotic controller, optionally in a first orientation. The tool is optionally an endoscopic tool, such as an endoscope.

[0026] In this aspect, performing a first medical procedure with a tool in a first orientation optionally includes robotically controlling the tool in response to user interaction with the at least one user control.

[0027] In this aspect, the method optionally includes adjusting a tool to a second orientation relative to a robotic controller or coupling a second robotically controllable medical tool (optionally endoscopic) to the robotic controller in the second orientation.

[0028] In this aspect, the method optionally comprises performing a second medical procedure with a tool in the second orientation or a second tool in the second orientation, the second procedure including robotically controlling the tool or the second tool in response to user interaction with the at least one user control.

[0029] In this aspect, a first medical procedure is optionally a tracheal intubation.

[0030] In this aspect, a second medical procedure is optionally a bronchoscopy.

[0031] Any one or more features of any of the aspects herein may be suitably combined with any other aspect herein unless the disclosure herein indicates to the contrary.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figs. 1A, 1B and 1C illustrate components of an exemplary medical system.

[0033] Fig. 2 illustrates a side view of an exemplary handle.

[0034] Fig. 3 illustrates an exemplary robotic controller.

[0035] Fig. 4 illustrates an exemplary robotically controllable medical tool.

[0036] Fig. 5 shows an exemplary handle coupled to an exemplary robotic controller.

[0037] Fig. 6 shows the system of figure 5 coupled to an exemplary robotically controllable medical tool.

[0038] Fig. 7 shows the system of figure 6 coupled to an endotracheal tube.- 4 - Docket No.: 14805-706.601

[0039] Fig. 8 illustrates a side view of an exemplary handle.

[0040] Fig. 9 illustrates an exemplary robotic controller.

[0041] Fig. 10 illustrates an exemplary robotic controller with a detachable robotic head.

[0042] Fig. 11 illustrates an exemplary robotic controller with a detachable robotic head rotated to a second orientation in a plane.

[0043] Fig. 12A illustrates uncoupled components of an exemplary medical system, including an extension adaptor.

[0044] Fig. 12B illustrates coupled components of the system in figure 12 A.

[0045] Fig. 12C illustrates an exemplary handle coupled to the system shown in figure 12B.

[0046] Fig. 12D illustrates a medical tool coupled to the system in figure 12C in a second orientation.

[0047] Figs. 13A, 13B, 13C and 13D illustrates exemplary components of a medical system and exemplary methods of assembly.DETAILED DESCRIPTION

[0048] This disclosure is related to the robotic control of medical devices, portions of which may be related to the disclosures in WO2021 / 236677 (the ‘677 application) and WO / 2023 / 201210 (the ‘210 application), both of which are incorporated by reference herein in their entireties for all purposes. For example, WO / 2023 / 201210 (the ‘210 publication) describes a robotically controlled medical device that includes a handle (e.g., in figures 23 and 24 of the ‘210 publication) and a robotic controller (e.g., in figure 25 of the ’210 publication), wherein when the handle and robotic controller are interfaced, (e.g., in figure 26 of the ‘210 publication) the handle and robotic controller are adapted to facilitate robotic motion of a medical device (e.g., a robotically controllable medical tool) in response to user interaction with the handle. The robotically controlled medical device may be a variety of medical devices, such as an endoscope with one or more channels, and which may be used in a variety of procedures (e.g., intubation, endoscopy, bronchoscopy).

[0049] Additionally, for example, WO2021 / 236677 (the ‘677 publication) includes exemplary assemblies with robotically controlled ETT introducers (e.g., in figures 17a-21 of the ‘677 publication), and the handheld modular robotic systems herein may include one or more components of the assemblies in WO2021 / 236677. For example, the modular systems herein may include any of the electronics and / or actuators in WO2021 / 236677 to robotically control movement of an introducer or endoscope (scope) in one or more of x (+x, -x), y (+y, -y), and z (forward / distal, backward / proximal (axial)) directions. For example, the ETT - 5 - Docket No.: 14805-706.601introducers 1770 in the ‘677 publication may be or have any features of any of the introducers or scopes herein. Additionally for example, any of the electronics and / or actuators described in WO2021 / 236677 (for example only: pull-wires, gears, motor(s), electronic connection(s), processors, power sources, memory, software, hardware) may also be included in any of the systems herein to facilitate handheld robotic control of at least one elongate medical tool.

[0050] One aspect of this disclosure is a medical handheld airway access system that is adapted for upper airway access for performing one or more medical procedures. The system includes a handle sized to be held by an operator, a robotic controller that is sized, adapted and configured to be coupled to the handle, and a robotically controllable medical tool (e.g., an endoscopic tool such as an elongate endoscope), such that when the components are attached (directly or indirectly), user interaction with the handle causes the robotic controller to robotically control movement of the medical tool. In an exemplary use, the system can be adapted for tracheal intubation, examples and exemplary details of which are described in the ‘677 and the ‘210 applications. Any of the robotic controllers (including any of the bases and / or robotic heads) herein may include one or more actuators, such as motor(s) and / or other controllers (e.g., circuitry, software) to facilitate and control the robotic movement of the medical tool, additional details of which are described in WO2021 / 236677 and WO / 2023 / 201210. Any of the robotic controllers herein (including any of the bases and / or robotic heads) may include hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. Any of the bases herein may refer to a portion of a robotic controller that may be disposed within a handle.

[0051] Figures 1A, 1B and 1C together show an exemplary handheld robotic airway medical system, uncoupled from one another, including, respectively, handle 10, robotic controller 20, and robotically controllable medical tool 30 (in this example is a robotically controllable endoscopic tool), each shown in more detail in figures 2-4, respectively. Additional details of the handheld robotic airway medical system, including the individual components, are described in the ‘210 application.

[0052] Figure 2 illustrates handle 10 adapted for use with the handheld robotic systems herein. Handle 10 includes a handle body 19 sized and configured to be held in a hand of an operator. Handle 10 also includes at least one user control (in this case a plurality; user -6- Docket No.: 14805-706.601controls 12 and 13) responsive to user interaction with the user control. Handle 10 includes an exemplary joystick 12 and buttons 13 for causing the robotic control, but other user controls may be implemented, including controls adapted for voice command. Handle 10 also includes optional curved distal portion 17 configured and sized to be placed in a subject's oral cavity and / or for tongue displacement. The curved distal portion does not need to be curved along its entire length. The curved distal portion may be sized and configured for use as a blade.

[0053] Figure 3 illustrates an exemplary robotic controller 20, which is optionally reusable, and includes one or more mechanical and / or electrical actuators (e.g., motors, controllers) for causing robotic control of the medical tool in response to user interaction with the user control(s) of the handle.

[0054] Figure 4 illustrates an exemplary robotically controllable medical tool 30, including robotically controllable endoscope 31. In this example, the scope can be robotically controlled in six degrees of movement, including axially (forward / backward), as shown. Medical tool 30 and robotic controller 20 are configured to be releasably coupled, and in this example medical tool 30 is coupled to coupling region 21 (which may also be referred to as a robotic head) shown in figure 3, the coupling of which is described in more detail in the ‘210 and ‘677 applications. In figure 3, robotic controller 20 optionally includes video baton for providing visualization, which is optionally detachable from the rest of the robotic controller 20.

[0055] Any of the coupling regions herein (e.g., coupling region 21) may be considered any of the robotic heads herein, including integrated with a base and those detachable from a base.

[0056] Figure 5 illustrates robotic controller 20 coupled to handle 10 and in operable communication with handle 10, and in this example a distal region of robotic controller 20 is disposed within a channel or lumen of handle 10, as shown. When coupled, an interface 40 is created that in this example creates an electrical connection between handle 10 and robotic controller 20, which facilitates communication to the robotic controller 20 in response to user actuation with user controls (e.g., user control 12 and user control 13). Medical tool 30 is not yet coupled to coupling region 21 (robotic head) in figure 5 (and optionally does not need to be based on the use of the system). Figure 5 shows distal end 15 and proximal end 14 of handle 10. Figure 5 also shows distal end 22 of robotic controller 20 within handle 10, as well as the optional video baton 27 within a channel of the curved region (optionally a blade) of handle 10.- 7 - Docket No.: 14805-706.601

[0057] Figure 6 is the same as figure 5, except robotically controllable medical tool 30 is shown after being coupled to coupling region 21 of robotic controller 20. The entire right side of endoscope 31 (which forms a loop configuration in this example) is not shown in figure 6. Figure 7 is the same as figure 6, except optional endotracheal tube 50 is shown coupled to medical tool 30, additional details of which are described in the ‘210 and ‘677 applications.

[0058] In this first aspect, the assembled system shown in figure 7 may be used during a tracheal intubation to robotically control the endoscope (which may also be referred to herein as an introducer) into the trachea, details of which are described in the ‘677 and ‘210 applications. In this example, the optional video baton and the endoscope can each provide visualization during the intubation procedure. Alternatively, the system may be used similar to traditional video laryngoscopes (“VL”), in which case a medical tool (e.g., medical tool 30) does not necessarily need to be used with the system. In these alternative uses, the assembled system shown in figure 5 may be used as a VL, without using robotic control functionality.

[0059] Handle 10 (or any other handle here) may be a disposable component (intended for disposal after one use) while robotic controller may be intended for re-use. For example, after an intubation, handle 10 and medical tool 30 may be discarded, while robotic controller 20 may be re-used with a new handle 10 and new medical tool 30 for a subsequent intubation.

[0060] While the handheld robotic system shown in figures 1 A-7 may find particular use for upper airway access for intubation procedures, there may be advantages for adding functionality to the system by making one or more aspects of the system modular. Exemplary non- limiting benefits of modular handheld robotic systems is that at least one component may be used for different procedures and / or at least one re-usable component (e.g., a robotic controller) may be couplable to different types of other components. For example only, handle 10 may be sized and configured to be used with robotic controllers that are different in at least one way than robotic controller 20. Additionally, for example only, robotic controller 20 may be sized and configured to be used with handles that are different in at least one way than handle 10. Additionally, for example only, robotic controller 20 may be adapted such that the video baton can be removed and used with either handle 10 or a handle different than handle 10 in at least one way. Additionally, for example only, the system may be adapted such that medical tool 30 can be coupled to the robotic controller in a first configuration or orientation, detached, and coupled to the system in a different configuration or orientation. Examples of modular handheld robotic systems and components are provided below.

[0061] Figure 8 illustrates an exemplary handle 100, which may be the same as handle 10 but does not include a curved distal portion as does handle 10. The entire description related to - 8 - Docket No.: 14805-706.601handle 10 is incorporated by reference into the description of handle 100, including that handle 100 includes a handle body, which may comprise a monolithic body or comprise multiple parts coupled together to form the handle body. Handle 100 may also be the same as handle 10 after the curved portion of handle 10 is removed, if handle 10 includes a removable curved distal portion. Handle 100 can be used with different robotic controllers herein, including robotic controller 20 as well as other robotic controllers herein with different configurations. Additionally, a first medical procedure (e.g., intubation) may use handle 10 and a robotic controller, while a second, subsequent medical procedure may reuse the same robotic controller (or the same controller after a video baton is removed) with handle 100.

[0062] Figure 9 illustrates an exemplary robotic controller 200, which may be the same as robotic controller 200 but without a video baton at its distal end. Robotic controller 200 may also be the same as robotic controller 20 after the video baton is removed, if robotic controller 20 includes a removable video baton. Robotic controller 200 can be used with different handles, including handle 10 as well as other handles herein with different configurations. Additionally, a first medical procedure (e.g., intubation) may use handle 10 and a robotic controller, while a second, subsequent medical procedure may reuse the same robotic controller (or the same controller after a video baton is removed) with handle 100.

[0063] While some robotic controllers herein (e.g., robotic controller 20 and 200) are integrated assemblies not intended or adapted to be easily disassembled during or after use, figure 10 illustrates an alternative robotic controller 220, which may be used with any of the handles and robotically controllable medical tools herein. Robotic controller 220 includes a base 221 and removable robotic head 222 (which may also be considered a coupling region herein), shown uncoupled, but which are each sized, adapted and configured to be releasably coupled together. For example, base 221 and robotic head 222 may be packaged separately but assembled prior to use during a medical procedure. Additionally, robotically controllable medical tools (e.g., medical tool 30) can be adapted and size to be coupled to removable robotic head 222, either before robotic head 222 is coupled to base 221 or after, examples of which are described and shown herein.

[0064] Any of the robotics heads herein may include one or more mechanical and / or electrical couplings that facilitate communication between the robotic head and a robotically controllable medical tool, wherein the ‘677 and the ‘210 application provide additional exemplary details of robotic heads, any of which may be incorporated by reference herein.

[0065] An additional example of modular handheld robotic airway systems herein is a system in which a robotically controllable medical tool (e.g., an endoscope) may be adapted to be coupled to one or more components of the system in a first orientation for a first procedure - 9 - Docket No.: 14805-706.601and may also be adapted to be coupled to one or more components of the system in a second orientation for a second procedure. An exemplary benefit of this type of modular system is that a component can be used for different procedures, where the different orientations maintains the tool in different preferred positions for the different procedures, respectively.

[0066] Figure 11 illustrates an exemplary robotic controller 230 that include a base 231 and removable robotic head 232. Base 231 and robotic head 232 may be the same as base 221 and robotic head 222 shown in figure 10. In figure 11, robotic head 232 is rotated relative to base 231 compared to the orientation in figure 10. In this non-limiting example, it is rotated 90 or about 90 degrees relative to the first orientation in a plane. In alternative systems and uses, however, which may depend on the different procedures, the second orientation may be at angles less than 90 degrees (and less than about 90 degrees) or greater than 90 degrees (and greater than about 90 degrees) relative to the first orientation. When robotic head 232 is coupled to base 231 in the orientation shown in figure 11 (coupled directly or indirectly), robotically controlled medical tool 30 will also be at a different orientation relative to base 231 when medical tool 30 is coupled to robotic head 232. This provides the functionality of the medical tool (e.g., endoscope) being a at different rotational orientation relative to a handle (and base 231), which may be preferred for a different medical procedure (e.g., bronchoscopy). In this way, the same medical tool such as an endoscope can be attached at different preferred orientations depending on the procedure, providing added functionality through a modular design.

[0067] In some examples, robotic head 232 may be adapted and configured such that it may be attached to base 231 directly in the orientation shown in figure 11. For example, base 231 and head 232 may each have at least one of mechanical, electrical, and / or magnetic coupling that facilitate coupling and electrical communication. Base 231 and head 232 may each have at least one of mechanical, electrical, and / or magnetic coupling that facilitate coupling and electrical communication in the relative orientations shown in figure 10 as well.

[0068] Alternatively, as shown in figure 12A, a modular handheld airway system may include a base and a robotically controlled medical tool that, when rotated relative to base, is coupled to an extension adaptor, wherein the extension adaptor is coupled to the base. Figure 12A shows a merely exemplary implementation of this, and robotic head 242 and base 241 may be the same as those shown in figure 11. In figure 12, the system further includes extension adaptor 250, which acts as an intermediary between base 241 and robotic head 242, and which facilitates stability between the two (e.g., mechanical and / or magnetic) as well as electrical communication. The extension adaptor 250 may be mechanically or magnetically coupled to one or both of base 241 and robotic head 242 in any number of known manners,- 10 - Docket No.: 14805-706.601such as clips, male / female coupling, etc. The extension adaptor 250 may include internal components that allow the robotic head 242 to “talk” to base 241 in the different orientation, as compared to figure 11 in which the base and robotic are each adapted to talk to each other in the different relative orientations. The extension adaptor 250 and / or the base 241 may include one or more actuators that facilitates robotic control of the endoscope (endoscope not shown in figure 12), which examples of actuators are included in the ‘677 and ‘210 applications. The extension adaptor in this example has an optional L-shape / configuration, although it may have any other suitable configuration.

[0069] Figure 12A shows the system components uncoupled. Figure 12B shows the components of the system from Figure 12A coupled (handle and endoscope not shown). Figure 12C shows an example handle 100 coupled to base 241 (part of base 241 is within handle 100 as in figure 5), creating relative stability and putting handle 100 and base 241 in operable communication.

[0070] Figure 12D shows the system after a robotically controlled medical tool 30 is coupled to the removable robotic head 242 (head 242 is behind the housing of the medical tool 30). In this exemplary orientation, the endoscope may be robotically controlled for a procedure different than a tracheal intubation, such as a bronchoscopy.

[0071] The system shown in figures 12A-12D may be intended to be used solely for bronchoscopy, or it may be adapted for use for both intubation as well as bronchoscopy (and other procedures) if desired. For example, in some uses an exemplary advantage is that the base can be used with a video baton such as shown in figure 3 (e.g., if used for video laryngoscopy) or without a video baton. Additionally, the base can be used with a video baton for intubation, and the video baton may then be removed if the same base is subsequently used in a bronchoscopy.

[0072] In alternatives implementations to figures 12A - 12D, the robotic head is not detachable from the base, but an extension adaptor (e.g., extension adaptor 250) is at least one of mechanically or magnetically couplable to the robotic controller. In this implementation, the robotically controlled medical tool (e.g., tool 30) is optionally sized and configured to be coupled to the extension adaptor rather than the robotic controller. In these alternative designs, the extension adaptor 250 is adapted to “talk” directly to the medical tool 30 and facilitate robotic control of the medical tool. In this implementation, the robotic head does not need to be detachable from the base if that is preferred.

[0073] Any of the extension adaptors herein may have a variety of sizes and configurations based on the other component(s) of the system to which it is coupled. Any of the extension- 11 - Docket No.: 14805-706.601adaptors herein may be adapted to communicate electrical signals and / or mechanical forces between first and second components.

[0074] Figures 13A-13D illustrate a merely exemplary method of assembly of a handheld modular airway system, including using two different types of robotically controllable medical tools with the same base. Figure 13A illustrates an exemplary robotic controller 300 and robotically controllable endoscopic tool 310 each adapted to be coupled (such as in figure 6). A handle, while not shown in figure 13 A, is coupled to the robotic base (such as in figure 5). The handle may be handle 10, or handle 100, for example. For example, handle 10 may be preferred if performing an initial tracheal intubation. In this example, the robotically controllable endoscopic tool 310 (or introducer) is not adapted for robotic axial motion but can be steered in the “x” and “y” directions by the operator through interaction with the handle. By way of example only, it may be necessary to perform a second medical procedure, such as a bronchoscopy, in which it is desired to change the rotational orientation of the robotic head relative to the handle (and base). As shown in figure 13B, the robotic controller may include a robotic head 302 that is adapted to be removed from base 301 (as in figures 10 and 11). Additionally, it may be desired to provide robotic axial control of the endoscope, and thus a different medical tool 360 may be used (which may be the same in all ways as medical tool 30, or a different type of medical tool than tool 30). After removing robotic head 302, an extension adaptor 350 (shown in figure 13C) can be coupled to base 301, and after rotating the robotic head 302 (optionally but not limited to 90 degrees), robotic head 302 is attached to extension adaptor 350 (as in figure 12B). Figure 13D shows exemplary robotically controllable medical tool 360 then attached to robotic head (specifically the rotated robotic head). Figure 13D also shows handle 340 (which may be handle 10, handle 100, or any other handle) coupled to the base, and with the modular system assembled, user interaction with handle 340 can create and cause handheld robotic control of the endoscopic tool 360 for a bronchoscopy (or other procedure). Figures 13 A and 13D are examples of a robotically controllable endoscope camera directed in, or facing, different directions.

[0075] Alternatively, the robotically controlled tool in figure 13A may be the same as in figure 13D, and vice versa.

[0076] Any of the handles and robotic controllers herein may be sized and configured to be releasably coupled in a wide variety of ways, including mechanical and / or magnetic coupling, which may facilitate electrical communication therebetween. For example only, they may each have corresponding magnetic and / or mating mechanical elements that when coupled provide positional stability between the two.- 12 - Docket No.: 14805-706.601

[0077] Any of the robotic controllers and robotically controllable tools herein may be sized and configured to be releasably coupled in a wide variety of ways, including mechanical and / or magnetic coupling, which may facilitate electrical and / or mechanical communication therebetween. For example only, they may each have corresponding magnetic and / or mating mechanical elements that when coupled provide positional stability between the two components.

[0078] Any of the robotic controllers and extension adaptors herein may be sized and configured to be releasably coupled in a wide variety of ways, including mechanical and / or magnetic coupling, which may facilitate electrical and / or mechanical communication therebetween. For example only, they may each have corresponding magnetic and / or mating mechanical elements that when coupled provide positional stability between the two components.

[0079] Any of the extension adaptors and robotic heads herein may be sized and configured to be releasably coupled in a wide variety of ways, including mechanical and / or magnetic coupling, which may facilitate electrical and / or mechanical communication therebetween. For example only, they may each have corresponding magnetic and / or mating mechanical elements that when coupled provide positional stability between the two components.

[0080] Any of the extension adaptors and robotically controllable medical tools herein may be sized and configured to be releasably coupled in a wide variety of ways, including mechanical and / or magnetic coupling, which may facilitate electrical and / or mechanical communication therebetween. For example only, they may each have corresponding magnetic and / or mating mechanical elements that when coupled provide positional stability between the two components.

[0081] It is understood that examples in the figures are non-limiting, and modularity concepts described herein may be applied to other devices, systems, and procedures.- 13 - Docket No.: 14805-706.601

Claims

CLAIMS1. A handheld image-guided modular robotic system for airway access, the system comprising:a handle sized and configured to be held in a hand of an operator, the handle including at least one user control that is responsive to operator interaction; a robotic controller including at least one actuator, the robotic controller and the handle sized and configured to be releasably coupled; anda robotically controllable endoscopic tool (“tool”) sized and configured to be directly or indirectly coupled to the robotic controller in a first orientation relative to the robotic controller and a second rotational orientation relative to the robotic controller,the user control, the robotic controller, and the tool together adapted and configured to cause robotic control of the tool in response to operator interaction with the at least one user control.

2. The system of Claim 1, wherein the handle includes a curved distal portion sized and configured to be placed in a subject’s oral cavity.

3. The system of Claim 2, wherein the curved distal portion is adapted to be removed from the handle.

4. The system of Claim 3, wherein the handle is adapted to be coupled to a plurality of different curved distal portions, each having a different configuration.

5. The system of Claim 1, wherein the handle does not include a curved distal region sized and configured to be placed in a subject’s oral cavity and is not adapted to be coupled to a curved distal portion.

6. The system of Claim 1, wherein the first orientation maintains the tool in a first preferred position for a first medical procedure, and the second orientation maintains the tool in a second preferred position for a second medical procedure.

7. The system of Claim 1, wherein the second orientation is 90 degrees or about 90 degrees relative to the first orientation rotated in a plane.- 14- Docket No.: 14805-706.6018. The system of Claim 7, wherein the tool comprises an endoscope with a camera at a distal end, and when the tool is in the second rotational orientation, the camera is directed in a different direction than when the tool is in the first orientation.

9. The system of Claim 1, wherein the tool, when in the first orientation, orients an endoscope in a direction more preferred for a first procedure than a second procedure subsequent to the first procedure, and when in the second orientation, orients the endoscope in a direction more preferred for a second procedure than the first procedure.

10. The system of the Claim 9, wherein the first procedure comprises tracheal intubation and the second procedure comprises bronchoscopy.

11. The system of Claim 1, wherein the robotic controller includes a base integrated and non-detachable from a robotic head, the robotic controller including one or more actuators for facilitating robotic control of the tool.

12. The system of Claim 11, further comprising an extension adaptor, the extension adaptor and the robotic controller each adapted and sized and configured to be coupled together, wherein the extension adaptor is sized and configured to be releasably coupled to the tool when the tool is in a second orientation relative to the robotic controller, the extension adaptor configured to communicate robotic control to the tool when in the second orientation based on operator interaction with the at least one user control.

13. The system of Claim 1, wherein the robotic controller comprises a base and robotic head, the robotic head detachable from the base.

14. The system of Claim 13, wherein the detachable robotic head is sized and configured to be attached directly to the base in first and second rotational orientations.

15. The system of Claim 13, further comprising an extension adaptor that is adapted to be releasably coupled to the base, the extension adaptor further configured to be- 15 - Docket No.: 14805-706.601releasably coupled to the detachable robotic head when in a rotational orientation that is different than when the robotic head is coupled directly to the base.

16. The system of Claim 15, wherein the extension adaptor is adapted to facilitate the robotic control of the tool in response to operator interaction with the at least one user control.

17. The system of Claim 15, wherein the extension adaptor is adapted to communicate at least one of electrically, mechanically or magnetically to the detachable robotic head.

18. The system of Claim 15, wherein the extension adaptor is at least one of mechanically, electrically or magnetically coupled to the base.

19. The system of Claim 1, wherein at least a portion of the robotic controller is disposed within a channel or lumen of the handle when the robotic controller is coupled to the handle.

20. A method of using a handheld image-guided modular robotic system for airway access, comprising:coupling a handle to a robotic controller, wherein coupling the handle and robotic controller creates an operable communication between the handle and the robotic controller,wherein the robotic controller includes at least one robotic control actuator and wherein the handle includes at least one user control responsive to operator interaction;coupling a robotically controllable endoscopic tool (“tool”) to the robotic controller in a first orientation;performing a first medical procedure with the tool in the first orientation that includes robotically controlling the tool in response to user interaction with the at least one user control;adjusting the tool to a second orientation relative to the robotic controller, or coupling a second robotically controllable endoscopic tool to the robotic controller in the second orientation; andperforming a second medical procedure with the tool in the second orientation or the second tool in the second orientation, the second procedure including - 16 - Docket No.: 14805-706.601robotically controlling the tool or the second tool in response to user interaction with the at least one user control.

21. The method of Claim 20, wherein the first medical procedure is a tracheal intubation.

22. The method of Claim 21, wherein the second medical procedure is a bronchoscopy.- 17 - Docket No.: 14805-706.601

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