Alignment and attachment systems for medical devices

Abstract

The present invention provides a medical device that may include an alignment mechanism and an attachment mechanism for aligning and attaching the medical device to another device, such as an adapter on an instrument drive mechanism. For example, a medical system may include a medical device having an instrument handle and an elongated body. The system may include an alignment mechanism configured to provide rotational alignment between the medical device and the adapter. The system may also include an attachment mechanism configured to secure the medical device to the adapter. The attachment mechanism may include at least three locking elements positioned circumferentially around an axis.

Description

Technical Field

[0001] The present application relates to alignment and attachment systems and methods for medical devices. In some embodiments, the alignment and attachment systems and methods can be used with robotic medical systems and devices. Background Art

[0002] Medical procedures such as laparoscopic surgery may involve accessing and visualizing the internal area of ​​a patient. In a laparoscopic procedure, a medical instrument may be inserted into the internal area through a laparoscopic access port.

[0003] In certain procedures, a robotically enabled medical system may be used to control the insertion and / or manipulation of a medical instrument. A robotically enabled medical system may include a robotic arm, or other instrument positioning device to which a medical instrument may be attached. Summary of the invention

[0004] Alignment systems and attachment systems for medical devices are described herein. In some embodiments, the alignment system is configured to align the medical device with a corresponding adapter, and the attachment system is configured to attach the medical device to the adapter. The adapter can be positioned on an instrument drive mechanism. The instrument drive mechanism can be positioned on a robotic arm.

[0005] In a first aspect, a medical system may include a medical instrument including an instrument handle and an elongated body, wherein the instrument handle is configured to be attached to an adapter on an instrument drive mechanism. The system may also include an alignment mechanism configured to provide rotational alignment between the medical instrument and the adapter.

[0006] The medical system may include one or more of the following features in any combination: (a) wherein the alignment mechanism extends through the longitudinal axis of the instrument handle; (b) wherein the alignment mechanism includes an alignment structure located on the slender body; (c) wherein the alignment structure includes a helical surface located on the slender body; (d) wherein when the instrument handle is attached to the adapter, a distal surface on the instrument handle is opposite to a proximal surface on the adapter; (e) wherein the instrument drive mechanism is positioned on a robotic arm; (f) wherein the robotic arm extends from a bed or cart; (g) wherein rotational alignment causes at least one locking element to align with and insert into a corresponding recess; (h) wherein the locking element is positioned on the adapter and the recess is positioned on the handle; (i) wherein the locking element includes a ball bearing; and / or (j) wherein the rotational alignment is passive.

[0007] In another aspect, a medical system may include a medical device configured for use during a robotically enabled medical procedure. The medical device may include an elongated body extending between a distal end and a proximal end, the distal end configured to be inserted into a patient during a robotically enabled medical procedure; and an instrument handle including a proximal side and a distal side, wherein the elongated body extends through the proximal side and the distal side. The distal side may be configured to be attached to an adapter on an instrument drive mechanism. The medical system may also include an alignment mechanism configured to provide rotational alignment between the medical device and the adapter. The alignment mechanism may include a first alignment structure located on the medical device and a second alignment structure located on the adapter. When the medical device is attached to the adapter, the first alignment structure may engage the second alignment structure to provide rotational alignment.

[0008] The medical system may include one or more of the following features in any combination: (a) wherein the alignment mechanism extends through the longitudinal axis of the instrument handle when the instrument handle is attached to the adapter; (b) wherein the first alignment structure includes a helical surface located on the slender body and the second attachment structure includes a bearing surface located within the opening of the adapter; (c) wherein the bearing surface includes a ball bearing; (d) wherein the instrument drive mechanism is positioned on a robotic arm; (e) wherein the robotic arm extends from a bed or cart; (f) wherein the rotational alignment causes at least one locking element to be aligned with and inserted into a corresponding recess; (g) wherein the locking element is positioned on the adapter and the recess is positioned on the handle; (h) wherein the locking element is positioned on the handle and the recess is positioned on the adapter; (i) wherein the locking element includes a ball bearing; and / or (j) wherein the rotational alignment is passive.

[0009] In another aspect, a robotic system may include a medical device comprising an instrument handle and an elongated body, wherein the instrument handle is configured to be attached to an adapter on an instrument drive mechanism; and an attachment mechanism configured to secure the instrument handle to the adapter, wherein when the instrument handle is secured to the adapter, the elongated body of the medical device extends through an opening in the adapter.

[0010] The robotic system may include one or more of the following features in any combination: (a) wherein the attachment mechanism includes at least three locking elements positioned circumferentially around the instrument handle; (b) wherein the attachment mechanism includes at least one locking element positioned on the instrument handle, the at least one locking element being configured to extend into a recess on the adapter; (c) wherein the attachment mechanism includes at least one locking element positioned on the adapter, the at least one locking element being configured to extend into a recess on the instrument handle; (d) wherein the locking element includes a protrusion member; (e) wherein the protrusion member includes a ball bearing; (f) wherein the protrusion member includes a hook; (g) wherein the protrusion member engages a spring-loaded surface in the recess; and / or (h) wherein the instrument handle is configured to be top loaded onto the adapter such that the slender body of the instrument extends through an opening in the adapter.

[0011] In another aspect, a medical system may include a medical device configured for use during a robotically enabled medical procedure, the medical device comprising: an elongated body extending between a distal end and a proximal end, the distal end configured to be inserted into a patient during the robotically enabled medical procedure; and an instrument handle comprising a proximal side and a distal side, wherein the elongated body extends through the proximal side and the distal side, and wherein the distal side is configured to attach to an adapter on an instrument drive mechanism. The medical system may also include an attachment mechanism configured to secure the medical device to the adapter, wherein when the instrument handle is secured to the adapter, the elongated body of the medical device extends from the distal side along an axis through an opening in the adapter, wherein the attachment mechanism includes at least three locking elements positioned circumferentially about the axis.

[0012] The medical system may include one or more of the following features in any combination: (a) wherein at least one of the locking elements comprises a protruding member; (b) wherein the protruding member comprises a ball bearing; (c) wherein the protruding member comprises a hook; and / or (d) wherein the protruding member engages a spring-loaded surface in a recess.

[0013] In another aspect, a method includes inserting an elongated body of a medical device through an opening of an adapter attached to a drive mechanism of the device; advancing a handle of the medical device toward the adapter so that an alignment mechanism provides rotational alignment between the medical device and the adapter; and attaching the handle of the medical device to the adapter.

[0014] The medical system may include one or more of the following features in any combination: (a) wherein the medical device includes a helical surface located on the slender body and the adapter includes a bearing surface located in the adapter, and wherein rotational alignment occurs when the bearing surface contacts the helical surface; (b) wherein attaching the handle of the medical device to the adapter includes engaging an attachment mechanism between the handle and the adapter; (c) wherein engaging the attachment mechanism includes receiving a protrusion member of the attachment mechanism in a recess of the attachment mechanism; (d) wherein the protrusion member is located on the handle and the recess is located on the adapter; (e) wherein the protrusion member includes a ball bearing; (f) wherein the protrusion member includes a hook; and / or (g) wherein the protrusion member engages a spring-loaded surface in the recess. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The disclosed aspects will hereinafter be described in conjunction with the accompanying drawings, which are provided to illustrate and not to limit the disclosed aspects, wherein like reference numerals represent like elements.

[0016] Figure 1 An embodiment of a cart-based robotic system arranged for use in diagnostic and / or therapeutic bronchoscopy procedures is shown.

[0017] Figure 2 Depicted Figure 1 Other aspects of the robotic system.

[0018] Figure 3 Shown is a ureteroscopy arrangement. Figure 1 Implementation scheme of a robotic system.

[0019] Figure 4 Shown is a vascular procedure arranged Figure 1 Implementation scheme of a robotic system.

[0020] Figure 5 An embodiment of a table-based robotic system arranged for use in a bronchoscopy procedure is shown.

[0021] Figure 6 Provided Figure 5 Alternative views of the robotic system.

[0022] Figure 7 An exemplary system configured to stow a robotic arm is shown.

[0023] Figure 8 An embodiment of a table-based robotic system configured for use in a ureteroscopy procedure is shown.

[0024] Fig. 9 An embodiment of a table-based robotic system configured for laparoscopic procedures is shown.

[0025] Fig.10 Shows Figures 5 to 9 Embodiment of a stage-based robotic system with pitch or tilt adjustment.

[0026] Fig.11 Provided Figures 5 to 10 Detailed illustration of the interface between the stage and the column of a stage-based robotic system.

[0027] Fig.12 An exemplary instrument driver is shown.

[0028] Fig.13 An exemplary medical instrument having a pair of instrument drivers is shown.

[0029] Fig.14 An alternative design of an instrument drive and an instrument is shown, wherein the axis of the drive unit is parallel to the axis of the elongated shaft of the instrument.

[0030] Fig.15 Depicts a block diagram illustrating an example embodiment of estimating Figures 1 to 10 The position of one or more elements of the robotic system (such as Fig.13 and Fig.14 A positioning system that determines the position of the device.

[0031] Fig.16A An embodiment of a medical device is shown that includes an alignment mechanism and an attachment mechanism for aligning the medical device with an adapter on a drive mechanism of the device and attaching the medical device to the adapter.

[0032] Fig. 16B An embodiment of an instrument drive mechanism positioned on the distal end of a robotic arm extending from a bed is shown.

[0033] FIG. 17A to FIG. 17D Detailed views of embodiments of an alignment mechanism and embodiments of an attachment mechanism for aligning a medical device with an adapter on an instrument drive mechanism and attaching the medical device to the adapter are provided.

[0034] Fig.17A is a perspective view of the adapter on the medical device and drive mechanism in an unattached configuration and showing the alignment mechanism and the attachment mechanism.

[0035] Fig. 17B is a perspective view of the proximal side of the adapter and illustrates an embodiment of a first alignment structure of the alignment mechanism on the adapter and an embodiment of a locking element of the attachment mechanism on the adapter.

[0036] Fig. 17Cis a perspective view of a distal side of a handle of a medical device and illustrates an embodiment of a second alignment feature of an alignment mechanism on the medical device and a recess of an attachment mechanism configured to engage a locking element.

[0037] Fig.17D A view of the distal side of the handle of the medical device is shown.

[0038] 18A to 18C Views of embodiments of attachment mechanisms during various stages of the attachment process are provided.

[0039] Fig.18A The locking element and recess of the attachment mechanism are shown in an unattached configuration.

[0040] Fig.18B The locking element and the dimple are shown in an intermediate orientation between the unattached configuration and the attached configuration.

[0041] Fig.18C The locking element and the recess are shown in an attached configuration.

[0042] FIG. 19A to FIG. 19C Views are provided showing embodiments of locking elements including ball bearings.

[0043] Fig.19A is a partially exploded perspective view of the adapter.

[0044] Fig.19B is a perspective view of the adapter showing the locking element in an assembled configuration.

[0045] Fig.19C is a cross-sectional view of the adapter showing the locking element in an assembled configuration.

[0046] Fig. 20 Another embodiment of an attachment mechanism including a spring loaded clamping lever is shown.

[0047] Fig.21 Another embodiment of an attachment mechanism comprising a cantilever hook is shown.

[0048] Fig. 22 is a perspective view of a proximal side of an embodiment of an adapter and illustrates that an adapter release mechanism may be positioned on the proximal side. DETAILED DESCRIPTION

[0049] 1. Overview .

[0050] Aspects of the present disclosure may be integrated into a robotically enabled medical system that is capable of performing a variety of medical procedures, including both minimally invasive procedures such as laparoscopy, and non-invasive procedures such as endoscopy. In endoscopy procedures, the system may be able to perform bronchoscopy, ureteroscopy, gastroscopy, etc.

[0051] In addition to performing a wide range of procedures, the system may provide additional benefits such as enhanced imaging and guidance to assist the physician. Additionally, the system may provide the physician with the ability to perform procedures from an ergonomic position without the need for awkward arm motions and positions. Additionally, the system may provide the physician with the ability to perform procedures with improved ease of use, such that one or more of the system's instruments may be controlled by a single user.

[0052] For illustrative purposes, various embodiments will be described below in conjunction with the accompanying drawings. It should be understood that many other specific implementations of the disclosed concepts are possible, and various advantages can be achieved using the disclosed specific implementations. Titles are included herein for reference and to help locate the various sections. These titles are not intended to limit the scope of the concepts described therein. Such concepts may have applicability throughout the specification.

[0053] A. Robotic System – Cart .

[0054] Robot-enabled medical systems can be configured in a variety of ways, depending on the specific procedure. Figure 1 An embodiment of a cart-based, robotically enabled system 10 arranged for use in a diagnostic and / or therapeutic bronchoscopy procedure is shown. During a bronchoscopy procedure, the system 10 may include a cart 11 having one or more robotic arms 12 to deliver a medical instrument such as a steerable endoscope 13 (which may be a bronchoscope specific to a procedure used for bronchoscopy) to a natural orifice entry point (i.e., the mouth of a patient positioned on a table in this example) to deliver the diagnostic and / or therapeutic tool. As shown, the cart 11 may be positioned proximate to the patient's upper torso to provide access to the entry point. Similarly, the robotic arms 12 may be actuated to position the bronchoscope relative to the entry point. The robotic arms 12 may also be utilized when performing gastrointestinal (GI) procedures with a gastroscope (a specialized endoscope used for GI procedures). Figure 1 The arrangement in . Figure 2 An exemplary embodiment of a cart is depicted in greater detail.

[0055] Continue to refer Figure 1, once the cart 11 is properly positioned, the robotic arm 12 can insert the steerable endoscope 13 into the patient's body robotically, manually, or in combination. As shown, the steerable endoscope 13 may include at least two telescopic parts, such as an inner guide portion and an outer sheath portion, each of which is coupled to a separate instrument driver from a set of instrument drivers 28, each of which is coupled to the distal end of a separate robotic arm. This linear arrangement of the instrument drivers 28 that facilitates coaxial alignment of the guide portion with the sheath portion produces a "virtual track" 29, which can be repositioned in space by manipulating one or more robotic arms 12 to different angles and / or orientations. The virtual tracks described herein are depicted using dashed lines in the accompanying drawings, and therefore the dashed lines do not depict any physical structure of the system. The translation of the instrument driver 28 along the virtual track 29 causes the inner guide portion to telescope relative to the outer sheath portion, or to advance or retract the endoscope 13 from the patient. The angle of the virtual track 29 can be adjusted, translated, and pivoted based on clinical applications or physician preferences. For example, in bronchoscopy, the angle and orientation of the virtual track 29 as shown represents a compromise between providing the physician with access to the endoscope 13 while minimizing the friction caused by bending the endoscope 13 into the patient's mouth.

[0056] After insertion, the endoscope 13 can be guided down the patient's trachea and lungs using precise commands from the robotic system until the target destination or surgical site is reached. To enhance navigation through the patient's pulmonary network and / or to reach the desired target, the endoscope 13 can be manipulated to telescopically extend the inner guide portion from the outer sheath portion to obtain enhanced articulation and a larger bending radius. The use of a separate instrument driver 28 also allows the guide portion and the sheath portion to be driven independently of each other.

[0057] For example, the endoscope 13 can be guided to deliver a biopsy needle to a target, such as a lesion or nodule in a patient's lung. The needle can be deployed downward along a working channel that extends the length of the endoscope to obtain a tissue sample to be analyzed by a pathologist. Depending on the pathological results, additional tools can be deployed downward along the working channel of the endoscope for additional biopsies. After identifying that the nodule is malignant, the endoscope 13 can deliver tools through the endoscope to remove potential cancerous tissue. In some cases, diagnostic and therapeutic treatments may need to be delivered in separate procedures. In these cases, the endoscope 13 can also be used to deliver a benchmark to "mark" the location of the target nodule. In other cases, diagnostic and therapeutic treatments can be delivered during the same procedure.

[0058] The system 10 may also include a movable tower 30 that may be connected to the cart 11 via a support cable to provide control, electronic, fluid, optical, sensor and / or power support to the cart 11. Placing such functionality in the tower 30 allows for a smaller form factor cart 11 that can be more easily adjusted and / or repositioned by the operating physician and his / her staff. Additionally, dividing functionality between the cart / table and the support tower 30 reduces operating room clutter and facilitates improved clinical workflow. While the cart 11 may be positioned close to the patient, the tower 30 may be stowed at a remote location to be out of the way during the procedure.

[0059] To support the robotic system described above, the tower 30 may include components of a computer-based control system that stores computer program instructions, for example, in a non-transitory computer-readable storage medium such as a permanent magnetic storage drive, a solid-state drive, or the like. Whether the execution occurs in the tower 30 or in the cart 11, the execution of these instructions can control the entire system or its subsystems. For example, when executed by a processor of a computer system, the instructions can cause the components of the robotic system to actuate the associated brackets and arm mounts, actuate the robotic arm, and control the medical device. For example, in response to receiving a control signal, a motor in a joint of the robotic arm can position the arm into a specific posture.

[0060] The tower 30 may also include pumps, flow meters, valve controllers, and / or fluid pathways to provide controlled irrigation and aspiration capabilities to systems that may be deployed through the endoscope 13. These components may also be controlled using the computer system of the tower 30. In some embodiments, irrigation and aspiration capabilities may be delivered directly to the endoscope 13 via separate cables.

[0061] The tower 30 may include voltage and surge protectors designed to provide filtered and protected power to the cart 11, thereby avoiding the need to place power transformers and other auxiliary power components in the cart 11, resulting in a smaller, more mobile cart 11.

[0062] The tower 30 may also include support equipment for sensors deployed throughout the robotic system 10. For example, the tower 30 may include optoelectronic equipment for detecting, receiving, and processing data received from optical sensors or cameras throughout the robotic system 10. In conjunction with the control system, such optoelectronic equipment may be used to generate real-time images for display in any number of consoles deployed throughout the system (including display in the tower 30). Similarly, the tower 30 may also include electronic subsystems for receiving and processing signals received from deployed electromagnetic (EM) sensors. The tower 30 may also be used to house and position EM field generators for detection by EM sensors in or on medical devices.

[0063] The tower 30 may also include a console 31 in addition to other consoles available in the rest of the system (e.g., a console mounted on top of a cart). The console 31 may include a user interface and display screen, such as a touch screen, for a physician operator. The console in the system 10 is typically designed to provide both preoperative information and real-time information for robotic control and procedures, such as navigation and positioning information for the endoscope 13. When the console 31 is not the only console available to the physician, it may be used by a second operator (such as a nurse) to monitor the health or vital signs of the patient and the operation of the system, as well as to provide procedure-specific data, such as navigation and positioning information. In other embodiments, the console 30 is housed in a body separate from the tower 30.

[0064] The tower 30 may be coupled to the cart 11 and the endoscope 13 via one or more cables or connections (not shown). In some embodiments, support functions from the tower 30 may be provided to the cart 11 via a single cable, thereby simplifying and eliminating clutter in the operating room. In other embodiments, specific functions may be coupled in separate wiring and connections. For example, while power may be provided to the cart via a single cable, support for control, optics, fluidics, and / or navigation may also be provided via separate cables.

[0065] Figure 2 Provided by Figure 1 Detailed illustration of an embodiment of a cart for a cart-based robotic enabling system is shown. The cart 11 generally includes an elongated support structure 14 (commonly referred to as a "column"), a cart base 15, and a console 16 at the top of the column 14. The column 14 may include one or more brackets, such as for supporting one or more robotic arms 12 ( Figure 2 The bracket 17 (alternatively "arm support") may include a separately configurable arm mount that rotates along a vertical axis to adjust the base of the robotic arm 12 to better position it relative to the patient. The bracket 17 also includes a bracket interface 19 that allows the bracket 17 to translate vertically along the column 14.

[0066] The bracket interface 19 is connected to the column 14 through slots, such as slot 20, which are positioned on opposite sides of the column 14 to guide the vertical translation of the bracket 17. The slot 20 contains a vertical translation interface to position and maintain the bracket at various vertical heights relative to the cart base 15. The vertical translation of the bracket 17 allows the cart 11 to adjust the reach of the robotic arm 12 to meet various table heights, patient sizes, and physician preferences. Similarly, the separately configurable arm mounts on the bracket 17 allow the robotic arm base 21 of the robotic arm 12 to be angled in a variety of configurations.

[0067] In some embodiments, the slot 20 may be supplemented with a slot cover that is flush and parallel to the slot surface to prevent dust and fluid from entering the internal cavity of the column 14 and the vertical translation interface when the carriage 17 is vertically translated. The slot cover can be deployed by a pair of spring reels positioned near the vertical top and bottom of the slot 20. The cover is coiled within the reel until it is deployed to extend and retract from the coiled state of the cover when the carriage 17 is vertically translated up and down. When the carriage 17 is translated toward the reel, the spring loading of the reel provides a force to retract the cover into the reel while also maintaining a tight seal when the carriage 17 is translated away from the reel. The cover can be connected to the carriage 17 using, for example, a bracket in the carriage interface 19 to ensure proper extension and retraction of the cover when the carriage 17 is translated.

[0068] Column 14 may internally include mechanisms such as gears and motors designed to mechanized translate carriage 17 using a vertically aligned lead screw in response to control signals generated in response to user input (eg, input from console 16 ).

[0069] The robotic arm 12 may generally include a robotic arm base 21 and an end effector 22 separated by a series of links 23, the series of links being connected by a series of joints 24, each joint including an independent actuator, each actuator including an independently controllable motor. Each independently controllable joint represents an independent degree of freedom available to the robotic arm. Each of the arms 12 has seven joints and therefore provides seven degrees of freedom. Multiple joints result in multiple degrees of freedom, thereby allowing "redundant" degrees of freedom. The redundant degrees of freedom allow the robotic arm 12 to position its corresponding end effector 22 at a specific position, orientation, and trajectory in space using different link positions and joint angles. This allows the system to position and guide the medical device from a desired point in space, while allowing the physician to move the arm joint to a clinically advantageous position away from the patient to create greater access while avoiding arm collisions.

[0070] The cart base 15 balances the weight of the column 14, bracket 17, and arm 12 on the floor. Thus, the cart base 15 houses heavier components such as electronics, motors, power supplies, and components that enable the cart to be moved and / or fixed. For example, the cart base 15 includes rollable wheel-shaped casters 25 that allow the cart to be easily moved around the room before a procedure. After reaching the proper orientation, the casters 25 can be secured using wheel locks to keep the cart 11 in the proper orientation during the procedure.

[0071] The console 16 positioned at the vertical end of the column 14 allows both a user interface and a display screen (or a dual-purpose device, such as a touch screen 26) for receiving user input to provide both preoperative and intraoperative data to the physician user. Potential preoperative data on the touch screen 26 may include preoperative planning, navigation and mapping data derived from a preoperative computerized tomography (CT) scan and / or a record from a preoperative patient interview. The intraoperative data on the display may include optical information provided from tools, sensors and coordinate information from sensors and important patient statistics, such as respiration, heart rate and / or pulse. The console 16 may be positioned and tilted to allow the physician to approach the console from the side of the column 14 opposite to the bracket 17. From this position, the physician can observe the console 16, the robot arm 12 and the patient while operating the console 16 from behind the cart 11. As shown, the console 16 also includes a handle 27 to help manipulate and stabilize the cart 11.

[0072] Figure 3 An embodiment of a robotic-enabled system 10 arranged for ureteroscopy is shown. In a ureteroscopy procedure, a cart 11 can be positioned to deliver a ureteroscope 32 (a protocol-specific endoscope designed to traverse a patient's urethra and ureters) to the patient's lower abdominal region. In a ureteroscopy, it may be desirable to align the ureteroscope 32 directly with the patient's urethra to reduce friction and forces on sensitive anatomical structures in this area. As shown, the cart 11 can be aligned at the foot of the table to allow the robotic arm 12 to position the ureteroscope 32 for direct linear access to the patient's urethra. The robotic arm 12 can insert the ureteroscope 32 directly into the patient's lower abdomen along a virtual guide 33 from the foot of the operating table through the urethra.

[0073] After insertion into the urethra, the ureteroscope 32 can be navigated into the bladder, ureters, and / or kidneys for diagnostic and / or therapeutic applications using similar control techniques as in bronchoscopy. For example, the ureteroscope 32 can be guided into the ureters and kidneys to break up accumulated kidney stones using a laser or ultrasonic lithotripsy device deployed down the working channel of the ureteroscope 32. After lithotripsy is complete, the resulting stone fragments can be removed using a basket deployed down the ureteroscope 32.

[0074] Figure 4An embodiment of a robotically enabled system similarly arranged for vascular procedures is shown. In a vascular procedure, the system 10 can be configured so that the cart 11 can deliver a medical device 34 (such as a steerable catheter) to an access point in the femoral artery of the patient's leg. The femoral artery presents both a larger diameter for navigation and a relatively less circuitous and tortuous path to the patient's heart, which simplifies navigation. As in a ureteroscopy procedure, the cart 11 can be positioned toward the patient's legs and lower abdomen to allow the robotic arm 12 to provide a virtual track 35 for direct linear access to the femoral artery access point in the patient's thigh / hip region. After insertion into the artery, the medical device 34 can be guided and inserted by translating the instrument drive 28. Alternatively, the cart can be positioned around the patient's upper abdomen to reach alternative vascular access points, such as the carotid and brachial arteries near the shoulder and wrist.

[0075] B. Robotic system – unit .

[0076] Embodiments of the robotic-enabled medical system may also incorporate a patient table. Incorporating a table reduces the amount of capital equipment in the operating room by removing a cart, which allows for greater access to the patient. Figure 5 An embodiment of such a robotically enabled system is shown arranged for use in a bronchoscopy procedure. System 36 includes a support structure or column 37 for supporting a platform 38 (shown as a "table" or "bed") on a floor. Much like a cart-based system, the end effector of a robotic arm 39 of system 36 includes an instrument drive 42 designed to manipulate an elongated medical instrument, such as a slender medical instrument, through or along a virtual track 41 formed by the linear alignment of the instrument drive 42. Figure 5 In practice, a C-arm for providing fluoroscopic imaging can be positioned over the upper abdominal region of the patient by placing the emitter and detector around the table 38.

[0077] Figure 6An alternative view of the system 36 without the patient and medical device for discussion purposes is provided. As shown, the column 37 may include one or more brackets 43 shown as annular in the system 36, on which one or more robotic arms 39 may be based. The bracket 43 may translate along a vertical column interface 44 extending along the length of the column 37 to provide different vantage points from which the robotic arm 39 may be positioned to reach the patient. The bracket 43 may rotate around the column 37 using a mechanical motor positioned within the column 37 to allow the robotic arm 39 to access multiple sides of the table 38, such as both sides of the patient. In an embodiment with multiple brackets, the brackets may be positioned individually on the column and may translate and / or rotate independently of the other brackets. Although the bracket 43 need not be around the column 37 or even circular, the annular shape as shown facilitates the rotation of the bracket 43 around the column 37 while maintaining structural balance. The rotation and translation of the bracket 43 allows the system to align medical devices such as endoscopes and laparoscopes to different entry points on the patient. In other embodiments (not shown), the system 36 may include a patient table or bed with an adjustable arm support in the form of a rod or rail extending therealong. One or more robotic arms 39 may be attached to the adjustable arm support (e.g., via a shoulder with an elbow joint) that may be vertically adjustable. By providing vertical adjustment, the robotic arms 39 advantageously can be compactly stowed beneath the table or bed and subsequently raised during a procedure.

[0078] The arm 39 may be mounted on the carriage via a set of arm mounts 45 including a series of joints that may be individually rotated and / or telescopically extended to provide additional configurability to the robotic arm 39. Additionally, the arm mount 45 may be positioned on the carriage 43 such that when the carriage 43 is appropriately rotated, the arm mount 45 may be positioned on the same side of the table 38 (e.g., Figure 6 As shown), on the opposite side of the platform 38 (as shown Fig. 9 shown) or on an adjacent side of stage 38 (not shown).

[0079] The column 37 provides structural support for the stage 38 and provides a path for the vertical translation of the carriage. Internally, the column 37 can be equipped with a lead screw for guiding the vertical translation of the carriage, and a motor for mechanizing the translation of the carriage based on the lead screw. The column 37 can also transmit power and control signals to the carriage 43 and the robotic arm 39 mounted thereon.

[0080] The base 46 has Figure 2The cart base 15 in the illustrated cart 11 functions similarly, accommodating heavier components to balance the table / bed 38, column 37, bracket 43, and robotic arm 39. The table base 46 may also incorporate rigid casters to provide stability during the procedure. Casters deployed from the bottom of the table base 46 may extend in opposite directions on both sides of the base 46 and retract when the system 36 needs to be moved.

[0081] continue Figure 6 , the system 36 may also include a tower (not shown) that divides the functions of the system 36 between the table and the tower to reduce the form factor and volume of the table. As in the previously disclosed embodiments, the tower can provide various support functions to the table, such as processing, computing and control capabilities, power, fluid and / or optical and sensor processing. The tower can also be movable to be positioned away from the patient, thereby improving the physician's access and eliminating clutter in the operating room. In addition, placing the components in the tower allows more storage space in the table base for potential folding of the robotic arm. The tower may also include a main controller or console that provides a user interface such as a keyboard and / or a pendant for user input, and a display screen (or touch screen) for preoperative and intraoperative information such as real-time imaging, navigation and tracking information. In some embodiments, the tower may also include a holder for a gas tank used for insufflation.

[0082] In some embodiments, the table base can fold up and store the robotic arm when not in use. Figure 7 A system 47 for stowing the robotic arm in an embodiment of a table-based system is shown. In the system 47, a carriage 48 can be translated vertically into a base 49 to stow a robotic arm 50, an arm mount 51, and the carriage 48 within the base 49. A base cover 52 can be translated and retracted open to deploy the carriage 48, the arm mount 51, and the arm 50 around a column 53, and closed to stow the carriage 48, the arm mount 51, and the arm 50 to protect them when not in use. The base cover 52 can be sealed along the edges of its opening with a membrane 54 to prevent dust and fluids from entering when closed.

[0083] Figure 8An embodiment of a robotically enabled table-based system configured for a ureteroscopy procedure is shown. During ureteroscopy, the table 38 may include a rotating portion 55 for positioning the patient at an angle to the column 37 and the table base 46. The rotating portion 55 may rotate or pivot about a pivot point (e.g., located below the patient's head) so as to position the bottom portion of the rotating portion 55 away from the column 37. For example, the pivoting of the rotating portion 55 allows a C-arm (not shown) to be positioned above the patient's lower abdomen without competing for space with the column (not shown) below the table 38. By rotating the bracket 35 (not shown) about the column 37, the robotic arm 39 can insert the ureteroscope 56 directly into the patient's groin area along a virtual track 57 to reach the urethra. During ureteroscopy, stirrups 58 may also be fixed to the rotating portion 55 of the table 38 to support the orientation of the patient's legs during the procedure and allow full access to the patient's groin area.

[0084] In a laparoscopic procedure, minimally invasive instruments can be inserted into the patient's anatomical structure through a small incision in the patient's abdominal wall. In some embodiments, the minimally invasive instrument includes an elongated rigid member, such as a shaft, for entering the patient's anatomical structure. After the patient's abdominal cavity is insufflated, the instrument can be guided to perform surgical or medical tasks, such as grasping, cutting, ablation, suturing, etc. In some embodiments, the instrument may include a probe, such as a laparoscope. Fig. 9 An embodiment of a robotically enabled operating table-based system configured for laparoscopic procedures is shown. Fig. 9 As shown, carriage 43 of system 36 can be rotated and vertically adjusted to position a pair of robotic arms 39 on opposite sides of operating table 38 so that instruments 59 can be positioned using arm mounts 45 to pass through minimal incisions on both sides of a patient to reach his / her abdominal cavity.

[0085] To accommodate laparoscopic procedures, the robotic-enabled table system can also tilt the platform to a desired angle. Fig.10 An embodiment of a robotic-enabled medical system with pitch or tilt adjustment is shown. Fig.10 As shown, system 36 can accommodate the tilt of table 38 to position one portion of the table at a greater distance from the ground than another portion. Additionally, arm mount 45 can be rotated to match the tilt so that arm 39 maintains the same planar relationship with table 38. To accommodate steeper angles, column 37 can also include telescoping portion 60 that allows vertical extension of column 37 to prevent table 38 from contacting the floor or colliding with base 46.

[0086] Fig.11A detailed illustration of the interface between the table 38 and the column 37 is provided. The pitch rotation mechanism 61 can be configured to change the pitch angle of the table 38 relative to the column 37 in multiple degrees of freedom. The pitch rotation mechanism 61 can be implemented by positioning orthogonal axes 1, 2 at the column-table interface, each axis being actuated by a separate motor 3, 4 in response to an electrical pitch angle command. Rotation along one screw 5 will enable tilt adjustment in one axis 1, while rotation along another screw 6 will enable tilt adjustment along another axis 2. In some embodiments, a ball joint can be used to change the pitch angle of the operating table 38 relative to the column 37 in multiple degrees of freedom.

[0087] For example, pitch adjustment is particularly useful when attempting to position the table in the Trendelenburg position (i.e., positioning the patient's lower abdomen at a higher orientation than the patient's lower abdomen from the floor) for lower abdominal surgery. The Trendelenburg position allows the patient's internal organs to slide toward his / her upper abdomen by gravity, thereby clearing the abdominal cavity for minimally invasive tool access and performance of lower abdominal surgical or medical procedures, such as laparoscopic prostatectomy.

[0088] C. Device Drivers and Interfaces .

[0089] The end effector of the system's robotic arm includes (i) an instrument driver (alternatively referred to as an "instrument drive mechanism" or "instrument device manipulator") that incorporates an electromechanical device for actuating a medical device, and (ii) a removable or detachable medical device that may not contain any electromechanical components, such as a motor. This dichotomy may be driven by the need to sterilize medical instruments used in medical procedures and the inability to adequately sterilize expensive capital equipment due to its complex mechanical assemblies and sensitive electronics. Therefore, the medical device may be designed to be disassembled, removed, and interchanged from the instrument driver (and therefore from the system) for separate sterilization or disposal by a physician or physician's staff. In contrast, the instrument driver does not need to be changed or sterilized and can be covered for protection.

[0090] Fig.12An exemplary instrument driver is shown. The instrument driver 62, positioned at the distal end of the robotic arm, includes one or more drive units 63 arranged in parallel axes to provide controlled torque to a medical device via a drive shaft 64. Each drive unit 63 includes a separate drive shaft 64 for interacting with the instrument, a gear head 65 for converting motor shaft rotation into a desired torque, a motor 66 for generating the drive torque, an encoder 67 for measuring the speed of the motor shaft and providing feedback to the control circuit, and a control circuit 68 for receiving control signals and actuating the drive unit. Each drive unit 63 is independently controlled and motorized, and the instrument driver 62 can provide multiple (e.g., Fig.12 In operation, the control circuit 68 will receive the control signal, transmit the motor signal to the motor 66, compare the resulting motor speed measured by the encoder 67 with the desired speed, and modulate the motor signal to generate the desired torque.

[0091] For the procedures requiring a sterile environment, the robotic system can be combined with a drive interface, such as a sterile adapter connected to a sterile cover, which is located between the instrument driver and the medical device. The main purpose of the sterile adapter is to transfer angular motion from the drive shaft of the instrument driver to the drive input of the instrument, while maintaining the physical separation between the drive shaft and the drive input and thus maintaining sterility. Therefore, an exemplary sterile adapter may include a series of rotational inputs and outputs intended to cooperate with the drive shaft of the instrument driver and the drive input on the instrument. The sterile cover composed of a thin flexible material (such as transparent or translucent plastic) connected to the sterile adapter is designed to cover capital equipment, such as instrument drivers, robot arms and carts (in cart-based systems) or tables (in tables-based systems). The use of the cover will allow capital equipment to be positioned near the patient while still being located in an area that does not require sterilization (i.e., non-sterile area). On the other side of the sterile cover, medical devices can dock with patients in areas that require sterilization (i.e., sterile areas).

[0092] D.Medical devices .

[0093] Fig.13An exemplary medical device with a paired instrument driver is shown. Similar to other instruments designed for use with a robotic system, the medical device 70 includes an elongated shaft 71 (or elongated body) and an instrument base 72. The instrument base 72, also referred to as an "instrument handle" due to its intended design for manual interaction by a physician, can typically include a rotatable drive input 73 (e.g., a socket, pulley, or reel) that is designed to mate with a drive output 74 of a drive interface on an instrument driver 75 extending through a distal end of a robotic arm 76. When physically connected, latched, and / or coupled, the mating drive input 73 of the instrument base 72 can share an axis of rotation with the drive output 74 in the instrument driver 75 to allow torque to be transferred from the drive output 74 to the drive input 73. In some embodiments, the drive output 74 can include a spline that is designed to mate with a socket on the drive input 73.

[0094] The elongated shaft 71 is designed to be delivered through an anatomical opening or lumen (e.g., as in endoscopy) or through a minimally invasive incision (e.g., as in laparoscopy). The elongated shaft 71 can be flexible (e.g., having properties similar to an endoscope) or rigid (e.g., having properties similar to a laparoscope), or a customized combination of both flexible and rigid portions. When designed for laparoscopy, the distal end of the rigid elongated shaft can be connected to an end effector extending from a connected wrist member formed by a connecting fork having at least one degree of freedom and a surgical tool or medical device such as a grasper or scissors, which can be actuated based on the force from the tendon when the drive input rotates in response to the torque received from the drive output 74 of the instrument driver 75. When designed for endoscopy, the distal end of the flexible elongated shaft can include a steerable or controllable curved segment that articulates and bends based on the torque received from the drive output 74 of the instrument driver 75.

[0095] The torque from the instrument driver 75 is transmitted to the elongated shaft 71 downward along the shaft 71 using a tendon. These individual tendons (e.g., pull wires) can be individually anchored to individual drive inputs 73 within the instrument handle 72. The tendons guide one or more pulling lumens downward from the handle 72 along the elongated shaft 71 and are anchored at the distal portion of the elongated shaft 71, or in the wrist at the distal portion of the elongated shaft. During surgical procedures, such as laparoscopic, endoscopic, or hybrid procedures, these tendons can be connected to a distally mounted end effector, such as a wrist component, a grasper, or scissors. In such an arrangement, the torque applied to the drive input 73 transmits tension to the tendons, causing the end effector to actuate in some manner. In some embodiments, during surgical procedures, the tendons can cause the joint to rotate around the axis, causing the end effector to move in one direction or another. Alternatively, the tendons can be connected to one or more jaws of a grasper at the distal end of the elongated shaft 71, wherein the tension from the tendons causes the grasper to close.

[0096] In endoscopy, the tendon can be coupled to a curved or articulated segment located along the elongated shaft 71 (e.g., at the distal end) via an adhesive, a control ring, or other mechanical fastener. When fixedly attached to the distal end of the curved segment, the torque applied to the drive input 73 will be transmitted downward along the tendon, causing the softer curved segment (sometimes referred to as an articulated segment or region) to bend or articulate. Along the uncurved segment, it may be advantageous to spiral or swirl a separate traction cavity that guides a separate tendon along the wall (or inside) of the endoscope shaft to balance the radial forces caused by the tension in the traction wire. For specific purposes, the angle of the spiral and / or the spacing therebetween can be changed or designed, wherein a tighter spiral presents less axial compression under load force, while a lower spiral amount causes greater axial compression under load force, but also presents limited bending. In another case, the traction cavity can be guided parallel to the longitudinal axis of the elongated shaft 71 to allow controlled articulation in the desired curved or articulated segment.

[0097] In endoscopy, the elongated shaft 71 accommodates multiple components to assist in robotic procedures. The shaft may include a working channel for deploying surgical tools (or medical devices), irrigation pieces, and / or suction pieces to the operating area at the distal end of the shaft 71. The shaft 71 may also accommodate wires and / or optical fibers to transmit signals to / from an optical assembly at the distal end, which may include an optical camera. The shaft 71 may also accommodate an optical fiber to carry light from a proximally located light source (e.g., a light emitting diode) to the distal end of the shaft.

[0098] At the distal end of the instrument 70, the distal tip may also include an opening for a working channel for delivering tools for diagnosis and / or treatment, flushing and suctioning the surgical site. The distal tip may also include a port for a camera (such as a fiberscope or a digital camera) to capture images of the internal anatomical space. Relatedly, the distal tip may also include a port for a light source, which is used to illuminate the anatomical space when the camera is used.

[0099] exist Fig.13 In the example of , the drive shaft axis, and therefore the drive input axis, is orthogonal to the axis of the elongated shaft. However, this arrangement complicates the ability of the elongated shaft 71 to roll. Rolling the elongated shaft 71 along its axis while holding the drive input 73 stationary causes the tendons to undesirably tangle as the tendons extend away from the drive input 73 and into the pulling lumen within the elongated shaft 71. The resulting tangle of such tendons can disrupt any control algorithm designed to predict the motion of the flexible elongated shaft during an endoscopic procedure.

[0100] Fig.14 An alternative design of an instrument driver and an instrument is shown, wherein the axis of the drive unit is parallel to the axis of the elongated shaft of the instrument. As shown, a circular instrument driver 80 includes four drive units, and its drive output 81 is aligned in parallel at the end of a robot arm 82. The drive units and their respective drive outputs 81 are contained in a rotating assembly 83 of an instrument driver 80 driven by a drive unit in the drive unit in the assembly 83. In response to the torque provided by the rotating drive unit, the rotating assembly 83 rotates along a circular bearing, which connects the rotating assembly 83 to the non-rotating portion 84 of the instrument driver. Electric power and control signals can be transmitted to the rotating assembly 83 from the non-rotating portion 84 of the instrument driver 80 by electrical contact, and the electrical contact can be maintained by the rotation of the brush slip ring connection (not shown). In other embodiments, the rotating assembly 83 can be responsive to a separate drive unit integrated into the non-rotating portion 84, and is therefore not parallel to other drive units. The rotating mechanism 83 allows the instrument driver 80 to allow the drive unit and its corresponding drive output 81 to rotate around the instrument driver axis 85 as a single unit.

[0101] Similar to previously disclosed embodiments, the instrument 86 may include an elongated shaft portion 88 and an instrument base 87 (shown with a transparent outer skin for discussion purposes) that includes a plurality of drive inputs 89 (such as sockets, pulleys, and spools) configured to receive drive outputs 81 in the instrument driver 80. Unlike previously disclosed embodiments, the instrument shaft 88 extends from the center of the instrument base 87, with the axis of the instrument base being substantially parallel to the axis of the drive inputs 89, rather than being substantially parallel to the axis of the drive outputs 81 as in the embodiment of the present invention. Fig.13 as orthogonal in the design.

[0102] When coupled to the rotation assembly 83 of the instrument driver 80, the medical device 86 including the instrument base 87 and the instrument shaft 88 rotates in combination with the rotation assembly 83 about the instrument driver axis 85. Since the instrument shaft 88 is located at the center of the instrument base 87, the instrument shaft 88 is coaxial with the instrument driver axis 85 when attached. Therefore, the rotation of the rotation assembly 83 causes the instrument shaft 88 to rotate about its own longitudinal axis. In addition, when the instrument base 87 rotates with the instrument shaft 88, any tendons connected to the drive input 89 in the instrument base 87 do not tangle during rotation. Therefore, the parallelism of the axes of the drive output 81, the drive input 89, and the instrument shaft 88 allows the shaft to rotate without tangling any control tendons.

[0103] E. Navigation and Control .

[0104] Conventional endoscopy may involve the use of fluoroscopy (e.g., as may be delivered by a C-arm) and other forms of radiation-based imaging modalities to provide intracavitary guidance to the operating physician. In contrast, the robotic system contemplated by the present disclosure may provide non-radiation-based navigation and positioning devices to reduce physician exposure to radiation and reduce the amount of equipment in the operating room. As used herein, the term "positioning" may refer to determining and / or monitoring the orientation of an object in a reference coordinate system. Technologies such as preoperative mapping, computer vision, real-time EM tracking, and robotic command data may be used alone or in combination to achieve a radiation-free operating environment. In other cases where radiation-based imaging modalities are still used, preoperative mapping, computer vision, real-time EM tracking, and robotic command data may be used alone or in combination to improve the information obtained only by radiation-based imaging modalities.

[0105] Fig.15 is a block diagram illustrating a positioning system 90 for estimating the position of one or more elements of a robotic system, such as the position of an instrument, according to an example embodiment. The positioning system 90 may be a set of one or more computer devices configured to execute one or more instructions. The computer device may be embodied by a processor (or multiple processors) and a computer readable memory in one or more of the components discussed above. By way of example and not limitation, the computer device may be located at Figure 1 The tower 30 shown, Figures 1 to 4 The cart shown, Figures 5 to 10 The bed shown, etc.

[0106] like Fig.15As shown, the positioning system 90 may include a positioning module 95 that processes the input data 91-94 to generate position data 96 for the distal tip of the medical device. The position data 96 may be data or logic that represents the position and / or orientation of the distal end of the device relative to a reference frame. The reference frame may be a reference frame relative to the patient's anatomy or a known object such as an EM field generator (see below for a discussion of EM field generators).

[0107] The various input data 91-94 are now described in more detail. Preoperative mapping can be accomplished using a collection of low-dose CT scans. The preoperative CT scans are reconstructed into three-dimensional images that are visualized, for example, as "slices" of cross-sectional views of the patient's internal anatomical structures. When analyzed as a whole, an image-based model of the anatomical cavities, spaces, and structures of the patient's anatomical structures (such as the patient's lung network) can be generated. Techniques such as centerline geometry can be determined and approximated from CT images to form a three-dimensional volume of the patient's anatomical structure, referred to as model data 91 (also referred to as "preoperative model data" when generated using only preoperative CT scans). The use of centerline geometry is discussed in U.S. Patent Application No. 14 / 523,760, the contents of which are incorporated herein in their entirety. Network topology models can also be derived from CT images and are particularly suitable for bronchoscopy.

[0108] In some embodiments, the instrument can be equipped with a camera to provide visual data 92. The positioning module 95 can process the visual data to implement one or more vision-based position tracking. For example, preoperative model data can be used in conjunction with the visual data 92 to implement computer vision-based tracking of a medical instrument (e.g., an endoscope or an instrument advanced through a working channel of an endoscope). For example, using the preoperative model data 91, the robotic system can generate a library of expected endoscopic images from the model based on the expected path of travel of the endoscope, each image linked to a location within the model. In operation, the robotic system can reference the library to compare real-time images captured at a video camera (e.g., a camera at the distal end of an endoscope) with those in the image library to assist in positioning.

[0109] Other computer vision based tracking techniques use feature tracking to determine the motion of the camera, and therefore the motion of the endoscope. Some features of the localization module 95 may identify circular geometric shapes corresponding to anatomical lumens in the preoperative model data 91, and track changes in these geometric shapes to determine which anatomical lumen is selected, as well as the relative rotational and / or translational motion of the camera. The use of topological maps may further enhance vision based algorithms or techniques.

[0110] Optical flow (another computer vision-based technique) can analyze the displacement and translation of image pixels in a video sequence in the visual data 92 to infer camera movement. Examples of optical flow techniques may include motion detection, object segmentation calculations, brightness, motion compensated coding, stereo disparity measurements, etc. Through multiple iterations of multi-frame comparisons, the movement and position of the camera (and therefore the endoscope) can be determined.

[0111] The positioning module 95 can use real-time EM tracking to generate the real-time position of the endoscope in a global coordinate system that can be aligned to the patient's anatomical structure represented by the preoperative model. In EM tracking, an EM sensor (or tracker) comprising one or more sensor coils in one or more positions and orientations embedded in a medical device (e.g., an endoscopic tool) measures changes in the EM field generated by one or more static EM field generators positioned at known locations. The position information detected by the EM sensor is stored as EM data 93. The EM field generator (or transmitter) can be placed close to the patient to generate a low-intensity magnetic field that can be detected by the embedded sensor. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. These distances and orientations can be "aligned" to the patient's anatomical structure (e.g., a preoperative model) during surgery to determine a geometric transformation that aligns a single position in the coordinate system with an orientation in the preoperative model of the patient's anatomical structure. Once registered, an embedded EM tracker in one or more locations of a medical device (eg, the distal tip of an endoscope) can provide a real-time indication of the progress of the medical device through the patient's anatomy.

[0112] The robotic commands and kinematic data 94 may also be used by a positioning module 95 to provide orientation data 96 for the robotic system. The pitch and yaw of the device derived from the joint motion commands may be determined during preoperative calibration. In surgery, these calibration measurements may be used in conjunction with known insertion depth information to estimate the orientation of the instrument. Alternatively, these calculations may be analyzed in conjunction with EM, vision, and / or topological modeling to estimate the orientation of the medical device within the network.

[0113] like Fig.15 As shown, the positioning module 95 can use a variety of other input data. For example, although Fig.15 Not shown, but an instrument utilizing shape sensing fibers may provide shape data that positioning module 95 may use to determine the position and shape of the instrument.

[0114] The localization module 95 may use the input data 91-94 in combination. In some cases, such a combination may use a probabilistic approach, where the localization module 95 assigns a confidence weight to a position determined from each of the input data 91-94. Thus, in situations where the EM data may be unreliable (such as where EM interference may be present), the confidence in the position determined by the EM data 93 may be reduced, and the localization module 95 may rely more heavily on the visual data 92 and / or the robot command and kinematics data 94.

[0115] As discussed above, the robotic systems discussed herein may be designed to incorporate a combination of one or more of the above techniques. A computer-based control system for a robotic system located in a tower, bed, and / or cart may store computer program instructions, for example, in a non-transitory computer-readable storage medium (such as a permanent magnetic storage drive, a solid-state drive, etc.) that, when executed, causes the system to receive and analyze sensor data and user commands, generate control signals for the entire system, and display navigation and positioning data, such as the position of an instrument in a global coordinate system, an anatomical map, etc.

[0116] 2. Alignment and attachment mechanisms for medical devices

[0117] Medical devices such as those described above may include alignment mechanisms and attachment mechanisms as described in this section. In some embodiments, the alignment mechanisms and attachment mechanisms provide for aligning the device (see, e.g., Fig.16A ) and a robotic arm (see e.g. Fig. 16B ) alignment and attachment. In some embodiments, the instrument can be directly attached to the instrument drive mechanism of the robotic arm, while in other embodiments, the instrument handle can be attached to an adapter that serves as an interface between the instrument drive mechanism and the instrument. In some embodiments, the adapter helps maintain sterility during sterile procedures.

[0118] The alignment mechanism can be configured to facilitate the correct orientation of the medical device to the component to which the medical device is to be attached. For example, the alignment mechanism can provide appropriate rotational alignment between the medical device and the device drive mechanism and / or the adapter. In some embodiments, the alignment mechanism also provides appropriate translational alignment. Proper alignment between the device and the device drive mechanism and / or the adapter can facilitate the connection of the attachment mechanism. For example, proper alignment can facilitate appropriate engagement between the locking features of the attachment mechanism on the device and the corresponding locking features of the attachment mechanism on the device drive mechanism and / or the adapter.

[0119] The attachment mechanism can be configured to provide a firm and stable connection between the medical device and the instrument drive mechanism and / or the adapter. As will be described in more detail below with reference to certain exemplary embodiments shown in the accompanying drawings, the attachment mechanism can provide a circumferential locking with multiple connection points. For example, in some embodiments, the attachment mechanism includes two, three, four, five or more locking features that can be positioned circumferentially around the axis of the instrument, instrument drive mechanism and / or adapter. In some embodiments, the instrument includes an instrument that runs through the loading, and the instrument that runs through the loading includes an elongated body, which extends along the axis of the passage, hole or other opening through the loading in the instrument drive mechanism and / or adapter. The attachment mechanism may include a locking feature positioned circumferentially on the handle of the instrument around the axis of the elongated body. The attachment mechanism may also include a corresponding locking feature positioned circumferentially on the instrument drive mechanism and / or adapter around the passage, hole or other opening.

[0120] It will become more apparent from the following description that, in some embodiments, the advantages of the alignment mechanisms and attachment mechanisms described herein are that the mechanisms provide improved or increased attachment strength for the instrument. In some embodiments, the mechanisms described herein allow the instrument to be very firmly attached and the attachment is stable and / or rigid. In addition, in some embodiments, the mechanisms are configured to provide this stable attachment using a limited number or a minimum number of machined parts and metal parts. This can reduce manufacturing costs and simplify the manufacturing process.

[0121] Furthermore, in some embodiments, the alignment mechanisms and attachment mechanisms described herein can advantageously require relatively low forces to attach and / or release an instrument from an instrument drive mechanism or adapter when desired. For example, in some embodiments, an instrument can advantageously be removed or attached with one hand. In some embodiments, an instrument can advantageously be removed or attached when the robotic arm is in any position or orientation. Thus, attachment and removal of an instrument can be performed in a controlled and / or ergonomic manner.

[0122] In many of the examples described herein, the alignment mechanisms and attachment mechanisms are described as providing alignment and attachment between a medical device and an adapter. However, in some embodiments, the adapter may be omitted, and the alignment mechanisms and attachment mechanisms may directly provide alignment and attachment between a medical device and an instrument drive mechanism, for example, without an intermediate adapter. Additionally, in some embodiments, the alignment mechanisms and attachment mechanisms may be configured to provide alignment and attachment between a medical device (or even other non-medical devices) and any other component to which the device may be attached. Therefore, the embodiments shown and described should be understood to provide only certain non-limiting examples.

[0123] Fig.16AAn embodiment of a medical device 100 is shown. Fig. 16B An embodiment of a medical system 120 is shown that includes a robotic arm 122 having an instrument drive mechanism 124 and an adapter 126 positioned thereon. Fig.16A and Fig. 16B As shown, the medical device 100 and the medical system 120 include an alignment mechanism 140 and an attachment mechanism 160. The alignment mechanism 140 is configured to provide proper orientation between the medical device 100 and the instrument drive mechanism 124 and the adapter 126, and the attachment mechanism 160 is configured to provide a secure connection between the medical device 100 and the instrument drive mechanism 124 and the adapter 126.

[0124] Fig.16A A side view of the instrument 100 is shown. In the illustrated embodiment, the instrument 100 includes an elongated body 102 and a handle 104. The elongated body 102 extends between a distal end 103 and a proximal end 105. As used herein, the term distal refers to a position or orientation located toward the end of an instrument that is inserted into a patient or otherwise interacts with a patient during a procedure, and the term proximal refers to a position or orientation located in the opposite direction away from the end of an instrument that is inserted into a patient.

[0125] As shown, the end effector 108 (which is configured as a grasper in the illustrated embodiment) can be positioned at the distal end 103 of the elongated body 102. In other embodiments, the instrument may include other types of end effectors, such as scissors, forceps, ligation tools, cauterization tools, basket tools, etc. In some embodiments, for example, as shown, the end effector 108 is connected to the distal end of the elongated body 102 by a wrist 106. The wrist 106 can be configured to allow one or more degrees of freedom of the instrument 100. For example, the wrist 106 can be a dual-degree-of-freedom wrist. For example, the dual-degree-of-freedom wrist can allow the end effector 108 to pivot or rotate around the pitch axis and the yaw axis. In some embodiments, the wrist 106 can be fixed to provide zero degrees of freedom. In some embodiments, the wrist 106 can allow one, two, three or more degrees of freedom.

[0126] like Fig.16A As shown, the instrument 100 includes a handle 104. The handle 104 can be configured to be connected to Fig. 16B The instrument drive mechanism 124 or adapter 126 is shown. As previously mentioned, the instrument 100 may include one or more tendons, cables, or pull wires extending along the elongated body 102 between the end effector 108 and the handle 104 (e.g., through the elongated body or extending on the elongated body). The handle 104 may include one or more drive inputs that are configured to engage the instrument drive mechanism (see Fig.14) on the robotic arm 122 to allow the instrument drive mechanism to actuate (e.g., tension or pull) the pull wire. Actuating the pull wire can cause movement of the end effector 108 to allow remote manipulation and control of the end effector 108. For example, in some embodiments, actuation of the pull wire can be configured to cause the jaws of the end effector 108 to open and close and / or allow the end effector 108 to rotate about a pitch axis or a yaw axis. As described above, the instrument drive mechanism can be positioned on the robotic arm 122 (see Fig. 16B ). In some embodiments, the robotic arm 122 can be controlled to position, roll, advance, and / or retract the instrument 100.

[0127] The elongated body 102 may extend through the handle 104, such as Fig.16A In some such embodiments, the elongated body 102 may be configured to be advanced or retracted relative to the handle 104, but this is not always the case. In some embodiments, the instrument drive mechanism 124 is configured to cause the elongated body 102 to be advanced or retracted relative to the handle 104. This may allow, for example, the handle 104 to remain stationary while the elongated body 102 and the end effector 108 are advanced into the patient during a procedure. In some embodiments, the proximal end of the elongated body 102 is attached to the handle 104 so that the elongated body 102 extends only between the end effector 108 and the handle 104.

[0128] like Fig.16A As shown, the handle 104 may include a distal surface 109. In some embodiments, the alignment mechanism 140 includes components extending from the distal surface 109. These components can interact or engage with corresponding components of the alignment mechanism 140 on the adapter 126 to provide alignment between the instrument 100 and the adapter 126 when the instrument 100 is attached to the adapter 126. In some embodiments, the attachment mechanism 160 includes components positioned on the distal surface 109 of the handle 104. These components can interact or engage with corresponding components of the attachment mechanism 160 on the adapter 126 to provide a connection between the instrument 100 and the adapter 126. FIG. 17A to FIG. 17D The alignment mechanism 140 and the attachment mechanism 160 are shown in greater detail in the illustrated embodiment and will be described in greater detail below.

[0129] As mentioned above, Fig. 16B A view of an embodiment of a medical system 120 is shown. In the illustrated embodiment, the medical system 120 includes a plurality of robotic arms 122. Each of the robotic arms 122 includes an instrument drive mechanism 124 positioned on a distal end. As shown, the instrument drive mechanism 124 includes a distal side 128 and a proximal side 130. Again, the term distal is used to refer to a direction or orientation toward a patient, and the term proximal is used to refer to a direction or orientation away from a patient.

[0130] In some embodiments, the instrument 100 is configured to be through-loaded onto the instrument drive mechanism 124. For example, the instrument drive mechanism 124 may include a channel, hole, or other opening (not visible) extending from the proximal side 130 through the instrument drive mechanism 124 to the distal side 128, and the instrument may be through-loaded (or top-loaded) onto the instrument drive mechanism by inserting the distal end 103 of the elongated body 102 through the proximal side 130, through the channel, and out through the distal side 128. The instrument 100 may then be moved distally until the distal side 109 of the handle 104 contacts and engages the proximal side 130 of the instrument drive mechanism 124. In some embodiments, the system 120 includes an adapter 126 positioned on the proximal side 130 of the instrument drive mechanism 124. In such embodiments, the distal side 109 of the handle 104 may contact and engage the adapter 126. As previously described, the adapter 126 may be a sterile adapter configured to maintain a sterile state between the instrument 100 and the instrument drive mechanism 124. Through-loading or top-loading the instrument 100 in this manner advantageously allows the instrument 100 to be separated from the instrument drive mechanism 124 in a proximal direction by pulling the instrument 100 away from the patient. This can advantageously improve patient safety because the instrument 100 can be removed in a direction away from the patient.

[0131] In addition, as described below, when the instrument is loaded onto the instrument drive mechanism 124, the alignment mechanism 140 on the instrument 100 and the adapter 126 and / or the instrument drive mechanism 124 can provide alignment. For example, when the instrument 100 is lowered distally by the instrument drive mechanism 124, the alignment features on the instrument 100 engage with the alignment features on the adapter 126 or the instrument drive mechanism 124. These features can automatically rotate the instrument 100 into proper rotational alignment with the adapter 126 or the instrument drive mechanism 124. In some embodiments, the alignment occurs automatically. In some embodiments, the alignment occurs passively. Passive alignment can include alignment that occurs naturally when the instrument 100 and the adapter 126 or the instrument drive mechanism 124 are put together. In some embodiments, the alignment mechanism 140 also provides translational alignment between the instrument 100 and the adapter 126 or the instrument drive mechanism 124. For example, the alignment mechanism 140 can coaxially align the axis of the instrument 100 with the axis of the adapter 126 or the instrument drive mechanism 124.

[0132] The alignment provided by the alignment mechanism 140 can facilitate proper orientation of the attachment mechanism 160. For example, the alignment can ensure that the locking features of the attachment mechanism 160 on the distal side 109 of the instrument 100 are aligned with corresponding locking features of the attachment mechanism 160 on the proximal side 130 of the adapter 126 or the instrument drive mechanism 124 so that these features can engage when the distal side 109 contacts the proximal side 130. In some embodiments, the engagement of these features can occur automatically or passively. As described above, the following will refer to FIG. 17A to FIG. 17D More detailed examples of the alignment mechanism 140 and the attachment mechanism 160 are described in more detail.

[0133] exist Fig. 16B In the illustrated embodiment, the system 120 includes a patient platform 132 or bed supported from below by a column 134 or other support and a base 136. As shown, in some embodiments, the robotic arm 122 can be attached to the column 134 or base 136 at a position below the patient platform 132. In some embodiments, the robotic arm 122 can be attached to an adjustable arm support 138, and the adjustable arm support 138 can be attached to the column 134 or base 136 at a position below the patient platform 132. This configuration allows the robotic arm 122 to be deployed from a position below the patient platform 132. In some embodiments, the alignment mechanism 140 and attachment mechanism 160 described herein are particularly advantageous in these types of systems (e.g., as Fig. 16B For example, in some embodiments of the system 120, the instrument drive mechanism 124 allows the attached instrument 100 to have an infinite roller via a motor in the instrument drive mechanism 124, which should be accommodated by the attachment mechanism 160. In addition, the instrument 100 should be able to be quickly attached and detached from the robotic arm 122.

[0134] FIG. 17A to FIG. 17D Detailed views of an embodiment of the alignment mechanism 140 and an embodiment of the attachment mechanism 160 are provided. Fig.17A is a perspective view of the medical device 100 and the adapter 126 on the drive mechanism 124 in an unattached configuration. Fig. 17B is a perspective view of the proximal side 130 of the adapter 126 . Fig. 17C is a perspective view of the distal side 109 of the handle 104 of the medical device 100 . Fig.17D A view of the distal side 109 of the handle 104 of the medical device 100 is shown. Exemplary alignment mechanisms 140 and attachment mechanisms 160 will be described in the following sections with reference to these figures.

[0135] B. Exemplary Alignment Mechanisms

[0136] like FIG. 17A to FIG. 17DAs shown, the instrument handle 104 and the adapter 126 include an alignment mechanism 140. For example, as shown, the alignment mechanism 140 may include a first alignment structure 142 located on the instrument 100 (see Fig.17A and Fig. 17C ) and a second alignment structure 144 located on the adapter 126 (see Fig. 17B As described below, the first alignment structure 142 can be configured to engage or contact the second alignment structure 144 when the instrument 100 is through-loaded onto the instrument drive mechanism 124.

[0137] like Fig.17A and Fig. 17C As best shown, in the illustrated embodiment, the first alignment structure 142 includes a shaft 146 extending from the distal surface 109 of the handle 104. The elongated body 102 of the instrument 100 can extend through the shaft 146 ( Fig. 17C The shaft 146 may have a length extending from the distal side 109 a distance that allows the shaft 146 to extend into the channel 148 of the adapter 126 (and / or the instrument drive mechanism 124), such as Fig.17A In some embodiments, the shaft 146 is long enough so that it extends completely through the instrument drive mechanism 124. In some embodiments, the shaft 146 extends partially through the instrument drive mechanism 124.

[0138] The first alignment structure 142 also includes an alignment surface 149 formed on the outer surface of the shaft 146. As described below, when the instrument 100 is loaded onto the instrument drive mechanism 124 to provide alignment, the alignment surface 149 engages and contacts the second alignment structure 144. In some embodiments, the alignment surface 149 is configured as an angled surface. The angled surface can be formed as a surface located in a plane that is not orthogonal to the longitudinal axis of the shaft 146. In some embodiments, the alignment surface 149 is configured as a helical surface. The helical surface can be spiraled around the longitudinal axis of the shaft 146 in a spiral or helical manner.

[0139] In the illustrated embodiment, the first alignment structure 142 also includes an alignment groove 150. The alignment groove 150 is also configured to contact and engage with the second alignment structure 144 to provide alignment between the instrument 100 and the adapter 126 or the instrument drive mechanism 124. The alignment groove 150 can extend along the outer surface of the shaft 146 and be formed into the outer surface. In some embodiments, the alignment groove 150 can extend along the shaft 146 toward the handle 104 starting from the farthest point of the alignment surface 149 (i.e., the point along the alignment surface 149 closest to the handle 104). For example, in some embodiments, the alignment surface 149 is angled relative to the longitudinal axis of the shaft 146 so that a first portion of the alignment surface 149 is positioned proximally relative to a second portion of the alignment surface 149 that is positioned distally. The groove 150 can extend from the second portion of the alignment surface 149 toward the handle 104.

[0140] like Fig. 17B As shown, the adapter 126 includes a second alignment structure 144. The second alignment structure 144 may include a protrusion 152 extending from the inner wall of the channel 148. In some embodiments, the protrusion 152 may be integrally formed with the inner wall of the channel 148. In some embodiments, the protrusion 152 may be formed as a separate piece attached to or extending through the inner wall of the channel 148. In some embodiments, the protrusion 152 includes a portion of a ball bearing extending through the inner wall of the channel 148. When the instrument 100 is through-loaded onto the adapter 126 to provide alignment between the instrument 100 and the adapter 126, the protrusion 152 contacts and interacts with the alignment surface 149 and the alignment groove 150.

[0141] For example, the adapter 126 may be attached to the proximal side of the instrument drive mechanism 124. The distal end 103 of the elongated body 102 of the instrument 100 may be inserted into the channel 148 through the proximal side 130 in the adapter. The instrument 100 is moved in the distal direction so that the distal side 109 of the handle 104 faces the proximal side 130 of the adapter 126. Eventually, the shaft 146 of the first alignment structure 142 enters the channel 148. Inserting the shaft 146 of the first alignment structure 142 into the channel 148 may provide translational alignment between the instrument 100 and the adapter 126; however, at this stage, the instrument 100 may not be properly rotationally aligned with the adapter 126. When the instrument 100 is further moved in the distal direction, the protrusion 152 of the second alignment structure 144 contacts the alignment surface 149 of the first alignment structure 142. The protrusion 152 travels along the alignment surface 149, causing the instrument 100 to rotate to the correct orientation. In some embodiments, passive, automatic, or natural alignment is caused. The protrusion 152 eventually reaches the distal lowest point of the alignment surface 149. At this point, the instrument 100 is in the correct rotational alignment orientation. This allows the protrusion 152 to enter the alignment groove 150. The alignment groove 150 is narrow enough that further rotation of the instrument 100 is limited or inhibited. The instrument 100 can then be moved in the distal direction until the distal side 109 of the handle 104 contacts the proximal side 130 of the adapter.

[0142] In the aligned orientation, various features of the instrument handle 104 are aligned with corresponding features of the adapter 126 (and / or the instrument drive mechanism 124). These features may include, for example, corresponding locking features of the attachment mechanism 160 described in more detail below. The aligned features may also include, for example, a drive output 156 on the adapter 126 or the instrument drive mechanism 124 (see Fig.17A and Fig. 17B ), the drive output member is configured to be coupled to a corresponding drive input member 158 on the instrument handle 104 (see Fig. 17C and Fig.17D ) engagement. The drive output 156 may engage the drive input to control the instrument 100, as described above with reference to Figure 13 to Figure 14 In some embodiments, the drive output 156 and the drive input 158 ​​are configured to have shapes that include some draft (e.g., a tapered shape) to facilitate alignment and engagement. 17A to 17C In the illustrated embodiment, the instrument handle 104 and adapter 126 include five drive outputs 156 and five corresponding drive inputs 158 . Fig.17D The illustrated embodiment includes six drive inputs 158 .

[0143] The alignment feature may also include, for example, a computer readable tag on the instrument 100, such as an RFID tag 161 (see Fig.17D) and a corresponding reader 162 on the adapter 126 or the instrument drive mechanism 124 (see Fig.17A ). In some embodiments, an RFID tag 161 is included on the instrument handle 104 within the channel, recess, or pit. The RFID tag 161 can be configured to provide wireless identification of the instrument 100 to the system 120. It can provide parameters to the system 120 and can allow authentication and tracking of the instrument 100. The reader 162 can be configured to protrude into the channel to access and read the RFID tag 161. In addition, the alignment mechanism 140 can include one or more sensors 164 ( Fig. 17C ). The sensor 164 can be configured to detect the alignment of the elongated body 102 and properly align it using the infinite rollers of the instrument 100.

[0144] In some embodiments, the first alignment structure 142 and the second alignment structure 144 may be reversed. For example, the alignment surface 149 and the alignment groove 150 may be included in the channel 148 on the adapter 126, and the protrusion 152 may be included on the shaft 146 of the instrument handle 104. Other suitable alignment structures are also possible. For example, other suitable alignment sensors may include a key tab that may or may not be passive, but will only engage when properly aligned.

[0145] As described herein, the instrument handle 104 may include an alignment mechanism 140 to enable the instrument handle 104 to be quickly attached to the adapter 126, thereby aligning the attachment mechanism 160 and other components. The alignment mechanism 140 may be in the form of a spiral alignment formed on the instrument shaft. In some embodiments, the alignment mechanism 140 is in the form of a double spiral. The alignment mechanism 140 can quickly align the instrument handle 104 with the adapter 126, thereby providing a quick connection feature that allows the instrument 100 to be easily replaced on the robotic arm 122.

[0146] B. Exemplary Attachment Mechanisms

[0147] like FIG. 17A to FIG. 17D As shown, the instrument handle 104 and the adapter 126 include an attachment mechanism 160. For example, as shown, the attachment mechanism 160 may include a locking element 166 located on the adapter 126 or the instrument drive mechanism 124 (see Fig.17A and Fig. 17C ) and a corresponding recess 168 located on the device 100 (see Fig. 17C and Fig.17D ). As described below, locking element 166 is configured to be received within and engage with recess 168 to attach instrument handle 104 to adapter 126. As described above, alignment mechanism 140 is configured to facilitate alignment of these features.

[0148] like Fig.17A As shown, the adapter 126 (or the instrument drive mechanism 124) can include a plurality of locking elements 166. In the illustrated embodiment, the adapter 126 includes three locking elements 166, but other numbers of locking elements 166 can be used in other embodiments. For example, the adapter 126 can include two, three, four, five, six, or more locking elements 166. The locking elements 166 can extend or protrude outwardly from the proximal side 130 of the adapter 126.

[0149] Advantageously, the locking elements 166 can be positioned circumferentially around the longitudinal axis of the adapter 126. For example, the locking elements 166 can be positioned circumferentially around the passage 148. When arranged circumferentially, the locking elements 166 can provide a lock around the periphery of the adapter 126. This can provide a connection with improved stability compared to embodiments that include only a single locking element or a locking element that is only located on a single side of the device. In some embodiments, the circumferentially positioned locking elements 166 can be evenly spaced. In some embodiments, the spacing does not need to be uniform.

[0150] In some embodiments, the locking element 166 of the adapter 126 comprises a radial locking element. For example, the locking element 166 may protrude outwardly from the proximal surface of the adapter and may be configured to engage a spring-loaded surface before being received in the recess 168. The engagement between the locking element 166 and the recess may include a radial force that maintains the connection.

[0151] exist FIG. 17A to FIG. 17D In the illustrated embodiment, the locking element 166 comprises a ball bearing. These embodiments are shown in more detail in FIG. 18A to FIG. 19C However, the locking element 166 can be any type of radial locking element that forms an interlocking device. In some embodiments, the locking element can be in the form of a spring tab. Such an embodiment is shown in the following description. Fig. 20 In some embodiments, the locking element 166 can be in the form of a cantilever hook. Such an embodiment is shown in the following description Fig.21 middle.

[0152] like Fig. 17C and Fig.17D As shown, the distal side 109 of the instrument handle 104 includes a recess 168 configured to receive and engage the locking element 166. In the illustrated embodiment, the instrument handle 104 includes three recesses 168 to engage with the locking element. Fig.17A Three locking elements 166 are shown engaged. Of course, other embodiments may include other numbers of dimples 168 to correspond to the number of locking elements used on the adapter 126.

[0153] In some embodiments, the attachment mechanism 160 allows not only a quick connection between the instrument handle 104 and the adapter 126, but also allows for easy detachment or removal simply by pulling the instrument handle 104 away from the adapter 126. As described above, the handle 104 is pulled away from the adapter 126 in a proximal direction (away from the patient), which may be advantageous because there is little or no chance of the patient being accidentally stabbed by a sharp instrument.

[0154] While the above embodiments show the adapter 126 having a locking element 166 protruding therefrom and a dimple 168 formed on the instrument handle 104, in other embodiments, these features may be reversed. For example, the instrument handle 104 may include a protruding locking element 166, and the adapter 126 may include a dimple. In some embodiments, each of the instrument handle 104 and the adapter 126 includes both a locking element 166 and a dimple 168.

[0155] 18A to 18C Provided FIG. 17A to FIG. 17D Additional detailed views of the locking element 166 and recess 168 of the attachment mechanism 160 are shown. In this embodiment, the locking element 166 includes a ball bearing 172 that is retained within a flange 170 extending from the adapter 126. FIG. 19A to FIG. 19C It is shown how an embodiment with a ball bearing 172 retained within a flange 170 may be manufactured.

[0156] like 18A to 18C As shown, the recess 168 may include a retaining surface 174. The retaining surface 174 may be configured to be radially (along 18A to 18C The retaining surface 174 may have a profile configured to correspond to the shape of the ball bearing 172. The retaining surface 174 may be biased in a radially outward (e.g., downward relative to the orientation of the drawing) direction. The biasing may be achieved, for example, by using a spring (not shown).

[0157] The well 168 may further include a collar 176. The collar 176 may include a ramped or inclined surface 178, as shown. The collar 176 may be movable in the proximal and distal directions (e.g., to the right and to the left relative to the orientation of the drawing). The collar 176 may be biased in the distal direction (e.g., toward the right in the drawing), for example, by a spring (not shown). The interaction of the ball bearing 172, the retaining surface 174, and the collar 176 may allow the locking element 166 to be connected and disconnected from the well 168.

[0158] Exemplary attachments will refer to 18A to 18C Give a description. Fig.18A The locking element 166 and the dimple 168 of the attachment mechanism 160 are shown in an unattached configuration. Fig.18B The locking element 166 and the dimple 168 are shown in an intermediate orientation between the unattached configuration and the attached configuration. And, Fig.18C The locking element 166 and the recess 168 are shown in an attached configuration. As shown, when the instrument handle 104 is inserted onto the adapter 126, the spring-loaded inner liner 176 is pushed proximally into the housing or shell of the instrument handle 104 ( Fig.19B When the ball bearing 172 of the locking element 166 is aligned with the cup feature on the retaining surface 174, the ball bearing 172 moves into the cup and the collar 176 slides downward ( Fig.19C ). In this position ( Fig.18C ), the locking element 166 is fixed in the recess 168.

[0159] To disengage, collar 176 and instrument handle 104 are simultaneously pulled proximally. When collar 176 is retracted far enough so that the angled or ramped surface 178 of collar 176 allows ball bearing 172 to escape from the cup feature of retaining surface 174, locking element 166 disengages from dimple 168, allowing instrument 100 to be smoothly disconnected.

[0160] FIG. 19A to FIG. 19C Various views of exemplary components of locking element 166 are provided, but other embodiments are possible. FIG. 19A to FIG. 19C An exemplary assembly of includes a locking element 166 located on the adapter 126, which includes a ball bearing 172 and a flange 170. In this embodiment, the ball bearing 172 is captured between two layers or stacked plate components of the adapter 126 within the flange 170. Fig.19A is a partially exploded perspective view of the adapter 126 . Fig.19B is a perspective view of the adapter 126 showing the locking element 166 in an assembled configuration. Fig.19C is a cross-sectional view of the adapter 126 showing the locking element 166 in an assembled configuration.

[0161] like Fig.19A As shown, the adapter 126 may include a stacked plate configuration including a proximal plate 191 and a distal plate 192. The flange 170 may extend from the proximal plate 191. The flange 170 includes a hole or aperture extending therethrough to receive the ball bearing 172. In the illustrated embodiment, the ball bearing 172 may be inserted into the flange 170 from the radially outer side of the flange 170. The protrusion 195 prevents the ball bearing 172 from being pushed all the way through the flange. Fig.19C As shown in the cross-sectional view of , the protrusion 195 narrows the diameter of the hole passing through the flange 170 so that the ball bearing 172 cannot pass through the radial inner side of the flange.

[0162] The distal plate 192 may include a stop 193 formed as a protrusion extending from the distal plate 192. When assembled, as shown Fig.19B As shown, the backstop 193 extends through a corresponding opening 194 in the proximal plate 191 (eg, Fig.19A In this orientation, the stop 193 can retain the ball bearing 172 within the flange 170.

[0163] Fig. 20 Another embodiment of the attachment mechanism 160 is shown. In this embodiment, the instrument handle 104 includes a clamping rod 180. The clamping rod 180 can be attached to the instrument handle 104 by a hinge 182 about which the clamping rod can pivot. A spring element 185 can be positioned to bias the clamping rod to a radially outward orientation in which a hooked end 184 of the clamping rod 180 engages a cantilevered hook 186 extending from the adapter 126.

[0164] To engage the attachment mechanism 160, the instrument handle is moved toward the adapter 126. The outer surface of the cantilever hook 186 deflects the clamping rod 180 inwardly, allowing the hooked end 184 to pass through and engage the cantilever hook 186. To disengage, the clamping rod 180 can be pressed inwardly, causing the hooked end 184 to move away from the cantilever hook 186.

[0165] Fig.21 Another embodiment of an attachment mechanism 160 is shown that includes a stamped metal element 188 that is securely attached to the adapter 126. The instrument handle 104 includes a cantilever hook 187 that engages an opening in the stamped metal element 188. The stamped metal element may be configured to be pried in or out by the cantilever hook to allow attachment.

[0166] Fig. 22 1 is a perspective view of the proximal side 130 of an embodiment of the adapter 126, and illustrates that in some embodiments, an adapter release mechanism 190 can be positioned on the proximal side 130. The adapter release mechanism 190 can be configured to actuate to release the adapter 126 from the instrument drive mechanism 124. The adapter release mechanism 190 can be, for example, a button or a sliding latch. Including the adapter release mechanism 190 on the proximal side 130 can prevent accidental removal of the adapter 126 because the adapter release mechanism 190 is not accessible when the instrument 100 is attached to the adapter 126. In other embodiments, the adapter release mechanism 190 can be included on other portions of the adapter 126, including portions that are accessible when the instrument 100 is attached to the adapter.

[0167] 3. Implement systems and terminology .

[0168] Implementations disclosed herein provide systems, methods, and apparatus for robotically enabled medical systems. Various implementations described herein include robotically enabled medical systems with high-force instruments.

[0169] It should be noted that as used herein, the terms "couple", "coupling", "coupled" or other variations of the word coupled may indicate an indirect connection or a direct connection. For example, if a first component is "coupled" to a second component, the first component may be indirectly connected to the second component via another component or directly connected to the second component.

[0170] The orientation estimation and robot motion actuation functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or processor. By way of example and not limitation, such a medium may include a random access memory (RAM), a read-only memory (ROM), an electrically erasable programmable read-only memory (EEPROM), a flash memory, a compact disk read-only memory (CD-ROM) or other optical disk storage device, a magnetic disk storage device or other magnetic storage device, or any other medium that can be used to store the desired program code in the form of an instruction or data structure and can be accessed by a computer. It should be noted that a computer-readable medium may be tangible and non-transient. As used herein, the term "code" may refer to software, instructions, code or data that can be executed by a computing device or processor.

[0171] The method disclosed herein includes one or more steps or actions for implementing the method. The method steps and / or actions may be interchangeable with each other without departing from the scope of the claims. In other words, unless the correct operation of the method being described requires a specific order of steps or actions, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0172] As used herein, the term "plurality" means two or more. For example, a plurality of components indicates two or more components. The term "determine" encompasses a variety of actions, and thus, "determine" may include calculating, computing, processing, deriving, investigating, searching (e.g., searching in a table, a database, or another data structure), ascertaining, etc. Additionally, "determine" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc. Additionally, "determine" may include parsing, selecting, choosing, establishing, etc.

[0173] Unless explicitly stated otherwise, the phrase “based on” does not mean “based only on.” In other words, the phrase “based on” describes both “based only on” and “based at least on.”

[0174] As used herein, the term "about" or "approximately" refers to a measurement range of a length, thickness, amount, time period, or other measurable value. Such measurement ranges encompass variations of + / -10% or less, preferably + / -5% or less, more preferably + / -1% or less, and still more preferably + / -0.1% or less of the specified value, as long as such variations are appropriate in order to function in the disclosed devices, systems, and techniques.

[0175] The foregoing specific embodiments of the disclosed specific implementations are provided to enable any person skilled in the art to make or use the present invention. Various modifications to these specific implementations will be apparent to those skilled in the art, and the general principles defined herein may be applied to other specific implementations without departing from the scope of the present invention. For example, it should be understood that one of ordinary skill in the art will be able to adopt a plurality of corresponding alternatives and equivalent structural details, such as equivalent ways of fastening, mounting, coupling or engaging tool parts, equivalent mechanisms for producing specific actuating motions, and equivalent mechanisms for delivering electrical energy. Therefore, the present invention is not intended to be limited to the specific implementations shown herein, but is given the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A medical system comprising: a medical device comprising an instrument handle and an elongated body, wherein the instrument handle is configured to be attached to an adapter on an instrument drive mechanism such that a plurality of drive inputs on the instrument handle engage a corresponding plurality of drive outputs of the adapter; as well as an alignment mechanism including an alignment surface on the elongated body configured to provide rotational alignment between the medical device and the adapter such that the plurality of drive inputs are aligned with the plurality of drive outputs, wherein the rotational alignment causes at least one locking element to be aligned with and inserted into a corresponding recess, Wherein the locking element comprises a ball bearing. 2 . The system of claim 1 , wherein the alignment mechanism extends along a longitudinal axis of the instrument handle.

3. The system of claim 1, wherein the alignment surface comprises a helical surface on the elongated body.

4. The system of claim 1, wherein a distal surface on the instrument handle is opposite a proximal surface on the adapter when the instrument handle is attached to the adapter.

5. The system of claim 1, wherein the instrument drive mechanism is positioned on a robotic arm.

6. The system of claim 5, wherein the robotic arm extends from a bed or a cart.

7. The system of claim 1, wherein the locking element is positioned on the adapter and the dimple is positioned on the handle.

8. The system of claim 1, wherein the rotational alignment is passive.

9. A medical system comprising: A medical device configured for use during a robotically enabled medical procedure, the medical device comprising: an elongated body extending between a distal end and a proximal end, the distal end being configured to be inserted into a patient during a robotically enabled medical procedure, and an instrument handle comprising a proximal side and a distal side, wherein the elongated body extends through the proximal side and the distal side, wherein the instrument handle comprises a plurality of drive inputs, wherein the distal side is configured as an adapter attached to an instrument drive mechanism, and wherein the instrument drive mechanism comprises a plurality of drive outputs configured to engage the plurality of drive inputs; and an alignment mechanism configured to provide rotational alignment between the medical device and the adapter, the alignment mechanism comprising: a first alignment structure located on the medical device, wherein the first alignment structure comprises an alignment surface located on the elongated body, and a second alignment structure, the second alignment structure being located on the adapter, wherein when the medical device is attached to the adapter, the first alignment structure engages the second alignment structure to provide the rotational alignment so that the plurality of drive inputs on the device handle engage the plurality of drive outputs of the adapter, Wherein the rotational alignment causes at least one locking element to be aligned with and inserted into a corresponding recess, wherein the locking element comprises a ball bearing.

10. The system of claim 9, wherein the alignment mechanism extends along a longitudinal axis of the instrument handle when the instrument handle is attached to the adapter.

11. The system of claim 9, wherein the alignment surface comprises a helical surface on the elongated body and the second attachment structure comprises a bearing surface within the opening of the adapter.

12. The system of claim 11, wherein the bearing surface comprises a ball bearing.

13. The system of claim 9, wherein the instrument drive mechanism is positioned on a robotic arm.

14. The system of claim 13, wherein the robotic arm extends from a bed or a cart.

15. The system of claim 9, wherein the locking element is positioned on the adapter and the dimple is positioned on the handle.

16. The system of claim 9, wherein the locking element is positioned on the handle and the dimple is positioned on the adapter.

17. The system of claim 9, wherein the rotational alignment is passive.

18. A method comprising: inserting an elongated body of a medical device through an opening of an adapter attached to a drive mechanism of the device; advancing a handle of the medical device toward the adapter such that an alignment mechanism provides rotational alignment between the medical device and the adapter and a plurality of drive inputs on the handle of the medical device engage a plurality of drive outputs of the adapter, wherein the alignment mechanism includes an alignment surface on the elongated body; as well as attaching the handle of the medical device to the adapter, wherein attaching the handle of the medical device to the adapter comprises engaging an attachment mechanism between the handle and the adapter, wherein engaging the attachment mechanism comprises receiving a protruding member of the attachment mechanism in a recess of the attachment mechanism, Wherein the protruding member comprises a ball bearing.

19. The method of claim 18, wherein the alignment surface comprises a helical surface on the elongated body, and the adapter comprises a bearing surface in the adapter, and wherein the rotational alignment occurs when the bearing surface contacts the helical surface.

20. The method of claim 18, wherein the protruding member is located on the handle and the recess is located on the adapter.

21. The method of claim 18, wherein the protruding member engages a spring loaded surface in the recess.

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