Adjustment device for positioning the uterine manipulator

Abstract

The adjustment device for positioning the uterine manipulator includes a support component movable along an arcuate path defined by the adjustment device, and an adjustment unit. The adjustment unit includes a base component fixed to the support component, and a rotation element fixed to the base component and the uterine manipulator such that the rotation element and the uterine manipulator fixed thereto are movable along the arcuate path and rotatable relative to the support component. The positioning system includes the adjustment device and a positioning arm supporting the adjustment device for positioning the uterine manipulator. TIFF2024547189000002.tif93128

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 USC §119 to U.S. Provisional Application No. 63 / 295,981, filed January 03, 2022.

[0002] Technical Field The present disclosure relates to an adjustment device for positioning a uterine manipulator during a surgical procedure. [Background technology]

[0003] background A uterine manipulator is a medical instrument used to manipulate a patient's uterus during surgical procedures such as laparoscopic gynecologic surgery (e.g., total laparoscopic hysterectomy (TLH) surgery). With the distal portion of the uterine manipulator advanced through the vaginal canal and into the uterus, the uterus can be manipulated through surgeon-controlled movement of the proximal portion of the uterine manipulator. The uterine manipulator can be firmly positioned and held in place during the procedure by a uterine positioning system attached to the operating table. During such procedures, the surgeon often needs to slightly adjust the position of the uterus via the uterine manipulator, which requires the surgeon to either leave the workstation and reposition the manipulator or ask an assistant to do so. In either case, the procedure is interrupted. Furthermore, if the surgeon asks the assistant to make the adjustments, the situation is further complicated as the adjustments will be blind and based only on verbal instructions from the surgeon. Summary of the Invention

[0004] overview Generally, the present disclosure relates to an adjustment device for positioning a uterine manipulator during a surgical procedure.

[0005] In one aspect, an adjustment device for positioning a uterine manipulator includes a support component movable along an arcuate path defined by the adjustment device and an adjustment unit, the adjustment unit including a base component secured to the support component and a rotation element secured to the base component and the uterine manipulator such that the rotation element and the uterine manipulator secured thereto are movable along the arcuate path and rotatable relative to the support component.

[0006] Aspects may include one or more of the following features.

[0007] In some embodiments, the adjustment device is configured to be fixedly attached to the positioning arm of the uterine positioning system.

[0008] In some embodiments, the adjustment unit is configured to move back and forth along an arcuate path relative to the positioning arm.

[0009] In some embodiments, the adjustment device further comprises internal electronics configured to provide wireless or wired communication with a remote controller.

[0010] In some embodiments, the coordinating device further includes a remote control unit configured to power and control one or more movement mechanisms of the coordinating device.

[0011] In some embodiments, the adjustment device further includes a support unit providing an elongated receiving portion that receives the support component and defines an arcuate path.

[0012] In some embodiments, the support component includes a connector having an end that is retained within the elongated receiving portion as the adjustment unit moves in an arc along the elongated receiving portion.

[0013] In some embodiments, the adjustment unit is capable of moving back and forth along an arcuate path a total distance of up to about 6 cm to a total distance of up to about 26 cm.

[0014] In some embodiments, the rotational element comprises a dial rotatable about a pin, the angular span of the dial corresponding to a lateral range of about 6 cm to about 36 cm of the tip of the uterine manipulator.

[0015] In some embodiments, the support component defines an arcuate path.

[0016] In some embodiments, the adjustment device further comprises one or more motors that control the arcuate movement of the support component and the rotation of the rotating element.

[0017] In some embodiments, the adjustment device further comprises a translation assembly coupled to and causing linear movement of the support component.

[0018] In some embodiments, the adjustment device is configured to maintain rotation of the shaft of the uterine manipulator about a reference point as the support component moves along an arcuate path.

[0019] In some embodiments, the reference point is located at the patient's cervix.

[0020] In some embodiments, the adjustment device is configured such that rotation of the uterine manipulator by the rotation element is maintained about a reference point.

[0021] In some embodiments, the reference point is located on the patient's cervix and the axis of the adjustment unit intersects the reference point.

[0022] In another aspect, a positioning system includes a positioning arm and an adjustment device supported on the positioning arm for positioning a uterine manipulator. The adjustment device includes a support component movable along an arcuate path defined by the adjustment device and an adjustment unit. The adjustment unit includes a base component secured to the support component and a rotation element secured to the base component and the uterine manipulator such that the rotation element and the uterine manipulator secured thereto are movable along the arcuate path and rotatable relative to the support component.

[0023] Aspects may include one or more of the following features.

[0024] In some embodiments, the positioning arm defines a global position of the adjustment device, and the adjustment device defines a local position of the uterine manipulator.

[0025] In some embodiments, the positioning system further includes a remote controller and a control box in communication with the remote controller.

[0026] In another aspect, an adjustment device for positioning a uterine manipulator includes a rotary support component fixed to the uterine manipulator and rotatable about a rotation axis defined by the adjustment device, the adjustment device further includes a rotary adjustment unit fixed to an articulation control element of the uterine manipulator and to the rotary support component, the adjustment device configured to rotate the uterine manipulator about the rotation axis and to articulate a portion of the uterine manipulator relative to the rotary support component.

[0027] Aspects may include one or more of the following features.

[0028] In some embodiments, the rotary support component is coupled to a linear translation assembly.

[0029] In some embodiments, the linear translation assembly includes a rail and a carriage.

[0030] In some embodiments, the linear translation assembly is configured to be fixedly attached to the positioning arm of the uterine positioning system.

[0031] In some embodiments, the adjustment device further includes one or more mechanical actuation cables configured to selectively rotate the rotatable support components in opposite rotational directions to one another.

[0032] In some embodiments, the adjustment device further comprises a remote motor coupled to and controlling the one or more mechanical actuation cables.

[0033] In some embodiments, the adjustment device further includes one or more mechanical actuation cables configured to selectively rotate the rotatable adjustment units in opposite rotational directions to one another.

[0034] In some embodiments, the adjustment device further comprises a remote motor coupled to and controlling the one or more mechanical actuation cables.

[0035] In some embodiments, the articulation control element comprises a handle and said portion comprises a distal tip.

[0036] In some embodiments, the axis of rotation intersects with the patient's cervix.

[0037] In another aspect, a positioning system includes a positioning arm and an adjustment device supported on the positioning arm for positioning a uterine manipulator. The adjustment device includes a rotary support component fixed to the uterine manipulator and rotatable about an axis of rotation defined by the adjustment device. The adjustment device further includes a rotary adjustment unit fixed to the articulation control element of the uterine manipulator and to the rotary support component, the adjustment device configured to rotate the uterine manipulator about the axis of rotation and to articulate a portion of the uterine manipulator relative to the rotary support component.

[0038] In one aspect, an adjustment device for positioning a uterine manipulator includes a base, an adjustment unit, and an adapter. The base includes an elongated receiving portion, and the adjustment unit is movable in an arc along the elongated receiving portion. The adapter is fixed to the rotation element of the adjustment unit and the uterine manipulator such that the arcuate movement of the adjustment unit and the rotational movement of the rotation element respectively result in the arcuate movement and the rotational movement of the uterine manipulator.

[0039] Aspects may include one or more of the following features.

[0040] In some embodiments, the base is fixedly mountable to a positioning arm of a positioning system.

[0041] In some embodiments, the elongated receiver has a curved profile.

[0042] In some embodiments, the arcuate movement of the adjustment unit includes a horizontal component.

[0043] In some embodiments, the adjustment unit is configured to move back and forth along the elongated receiving portion.

[0044] In some embodiments, the adjustment unit can move back and forth a total distance of up to about 6 cm to a total distance of up to about 26 cm.

[0045] In some embodiments, the adjustment unit includes a connector having an end that is retained within the elongated receiving portion of the base as the adjustment unit moves in an arc along the elongated receiving portion.

[0046] In some embodiments, the rotating element comprises a dial rotatable about an internal pin.

[0047] In some embodiments, the dial can be rotated through an angle of up to about 90 degrees to a maximum of about 270 degrees.

[0048] In some embodiments, the angular span of the dial corresponds to a lateral range of about 6 cm to about 36 cm of the tip of the uterine manipulator.

[0049] In some embodiments, the adjusting device further includes internal electronics housed within one or both of the base and the adjusting unit.

[0050] In some embodiments, the internal electronics facilitate wireless communication with a remote control.

[0051] In some embodiments, the internal electronics facilitate wired communication with a remote control.

[0052] In another aspect, a positioning system includes a positioning arm and an adjustment device supported on the positioning arm for positioning a uterine manipulator. The adjustment device includes a base, an adjustment unit, and an adapter. The base includes an elongated receiving portion and the adjustment unit is movable in an arc along the elongated receiving portion. The adapter is fixed to the rotation element of the adjustment unit and the uterine manipulator such that the arcuate movement of the adjustment unit and the rotational movement of the rotation element respectively result in the arcuate movement and the rotational movement of the uterine manipulator.

[0053] Aspects may include one or more of the following features.

[0054] In some embodiments, the positioning arm defines a global position of the adjustment device.

[0055] In some embodiments, the positioning system further comprises a remote controller.

[0056] In some embodiments, the adjustment device further comprises internal electronics that provide wireless communication with a remote controller.

[0057] In some embodiments, the internal electronics and the signal cable together provide wired communication with a remote control.

[0058] In some embodiments, the adjustment unit is configured to move back and forth along the elongated receiving portion.

[0059] In some embodiments, the rotating element comprises a dial rotatable about an internal pin.

[0060] Aspects may provide one or more of the following advantages.

[0061] In some embodiments, remote control of the robotic movement of the adjustment device allows the surgeon to desirably position the patient's uterus for optimal access for incision and removal without leaving the robotic surgery workstation operating the remote controller. Thus, the surgeon can continue to visualize the patient's pelvic region on the display screen at the workstation while the adjustment device is being remotely operated and without interruption. Thus, such remote control of the adjustment device has the advantage of resulting in a streamlined procedure with increased efficacy, increased precision, and reduced procedure time.

[0062] Other aspects, features, and advantages will become apparent from the description, drawings, and claims of the present specification. [Brief description of the drawings]

[0063] [Figure 1] FIG. 1 is a perspective view of a positioning system supporting the uterine manipulator. [Diagram 2] FIG. 2 is a perspective view of an adjustment device of the positioning system of FIG. [Diagram 3] FIG. 3 is a side view of the adjustment device of FIG. 2. [Figure 4] 3 is a side view of the adjustment device of FIG. 2, with the adjustment unit shown in three different arcuate positions. [Diagram 5] 3 is a perspective view of the adjustment device of FIG. 2, in which the rotating element is illustrated in three different angular positions. [Figure 6] FIG. 2 is a perspective view of an alternative uterine manipulator that can be supported by the positioning system of FIG. 1. [Figure 7] FIG. 13 is a side view of the adjustment device in the reference linear configuration. [Figure 8] FIG. 8 is a side view of the adjustment device of FIG. 7 in an extended linear configuration. [Figure 9] FIG. 8 is a side view of the adjustment device of FIG. 7 in a nominal arcuate configuration. [Figure 10] FIG. 8 is a side view of the adjustment device of FIG. 7 in an adjusted arcuate configuration. [Figure 11] FIG. 8 is a perspective view of the adjustment device of FIG. 7 in a first angle configuration. [Figure 12] FIG. 8 is a side view of the adjustment device of FIG. 7 in a second, opposite angular configuration. [Figure 13] FIG. 13 is a side view of the adjustment device in the reference linear configuration. [Figure 14] FIG. 14 is a side view of the adjustment device of FIG. 13 in an extended linear configuration. [Figure 15] FIG. 14 is a side view of the adjustment device of FIG. 13 in a first rotational configuration. [Figure 16] 14 is a side view of the adjustment device of FIG. 13 in a second rotational configuration opposite to the first rotational configuration. [Figure 17] FIG. 14 is a side view of the adjustment device of FIG. 13 in a third rotational configuration. [Figure 18] 14 is a side view of the adjustment device of FIG. 13 in an opposite fourth rotational configuration; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] Detailed Description 1 illustrates a positioning system 100 designed to position a surgical tool to perform a surgical procedure. In some embodiments, the surgical procedure is laparoscopic or robotic pelvic surgery to perform a Total Laparoscopic Hysterectomy (TLH), and the surgical tool is a uterine manipulator 101 used to perform the TLH. The positioning system 100 is designed to be mounted on a surgical table 103 and therefore includes a mounting / powering unit 102. The positioning system 100 further includes a positioning arm 104 extending from the mounting / powering unit 102, an adjustment device 110 attached to an upper end 106 of the positioning arm 104, a remote control 108 for controlling certain components of the adjustment device 110, and a foot pedal 112 for locking and unlocking the configuration of the positioning arm 104.

[0065] The positioning arm 104 stably supports and firmly positions the uterine manipulator 101 in place during the surgical procedure. The positioning arm 104 is embodied as a "gooseneck" structure including a rigid elbow section 114 and an adjustable section 116 to which the adjustment device 110 is attached. The adjustable section 116 includes multiple collars 118 (e.g., metal links) that are movable relative to one another to provide the adjustable section 116 with a full range of motion. The positioning arm 104 also includes an internal tension cable (e.g., a braided mechanical cable) that extends from the upper end 106 of the positioning arm to the mounting / powering unit 102.

[0066] The foot pedal 112 may be depressed to unlock the positioning arm 104. That is, depressing the foot pedal 112 releases tension from the internal tensioning cable (e.g., deactivates the internal tensioning cable) to allow manual manipulation of the adjustable section 116 when desired. Conversely, the foot pedal 112 may be released from the depressed position to tension the internal tensioning cable (e.g., activates the internal tensioning cable) to lock the configuration of the adjustable section 116. In the locked configuration, the collar 118 is fixed in position such that the positioning arm 104 is rigid and immovable during the surgical procedure. Thus, in the locked configuration, the positioning arm 104 establishes a global position of the adjustment device 110 fixed to the upper end 106. To lock and unlock the positioning arm 104, the mounting / powering unit 102 includes a servo motor operable to pull and release the internal tensioning cable within the positioning arm 104. The mounting / powering unit 102 is powered via a wired connection to a wall plug.

[0067] 2 and 3, the adjusting device 110 is a robotic head that can further position (e.g., locally position) the uterine manipulator 101 relative to the global position of the adjusting device 110. For example, once the positioning arm 104 is locked in a desired configuration to establish the global position of the adjusting device 110, the adjusting device 110 can be operated by a remote control 108 to fine-tune the position of the uterine manipulator 101 supported on the adjusting device 110. The adjusting device 110 includes a lower base 122 (e.g., a support unit) that is fixedly attached to the upper end 106 of the positioning arm 104, an upper adjusting unit 124 that is movable relative to the base 122, and an adapter 126 that securely couples the adjusting unit 124 to the uterine manipulator 101.

[0068] The base 122 includes a housing 128, internal electronics 130, a rechargeable battery 132 that may be enclosed within the housing 128 to power the adjusting device 110, and a power indicator light. In addition, the base 122 may be directly connected to the remote control 108 by a signal cable. The internal electronics 130 may provide wireless communication with the remote control 108 and / or the adjusting unit 124, as well as wired communication with the remote control 108. The housing 128 includes a power selector 134 (e.g., a button or switch) for turning on and off power to the adjusting device 110. The base 122 further includes an elongated receiving portion 136 having a curved (e.g., arc-shaped) profile (e.g., a rail or slot, shown diagrammatically by dashed lines, corresponding to an arc-shaped path) to allow the adjusting unit 124 to perform an arc-shaped (e.g., curvilinear) movement in the xy plane along the elongated receiving portion 136.

[0069] Adjustment unit 124 includes a housing 138 (e.g., a base component), internal electronics 140, a connector 142 (e.g., a support component) that moves along an elongated receptacle of base 122, and a rotational element 144 (e.g., a pivotable element) that effectively allows adapter 126 and attached uterine manipulator 101 to tilt left and right. Internal electronics 140 may provide wireless communication with remote control 108 and / or base 122. In some embodiments, internal electronics 140 may also provide wired communication with remote control 108.

[0070] 2 and 3, the connector 142 is an elongated component (e.g., a rod, peg, or extension piece) that extends from the underside of the housing 138. The lower end of the connector 142 is shaped to be held within the elongated receiver 136 of the base 122. The elongated receiver 136 is formed substantially parallel to the curved profile of the housing 128 in the xy plane. The curved shape of the elongated receiver 136 allows for forward and backward movement of the adjustment unit 124 about the horizontal x-axis, and up and down movement of the adjustment unit 124 about the vertical y-axis. The forward / backward and up / down components of movement together provide an arcuate motion (arc-like movement) of the adjustment unit 124. With reference to FIG. 4, in some embodiments, the adjustment unit 124 can move forward (e.g., along the x-axis) a total distance l of up to about 6 cm to up to about 26 cm from a rearmost position 146 (e.g., defined at the connector 142) to a forward-most position 148. In some embodiments, the adjustment unit 124 can move vertically (eg, along the y-axis) a total distance h of up to about 5 cm to a maximum of about 10 cm.

[0071] 2 and 5, the rotation element 144 includes a dial 150 and an adapter mount. The adapter mount extends from the dial 150 and fits securely into a corresponding receptacle of the adapter 126. The dial 150 can rotate about an internal pin through an angle β of up to about 90 degrees to up to about 270 degrees, thereby adjusting the orientation of the adapter 126 and, accordingly, the uterine manipulator 101 secured to the adapter 126. In some embodiments, such an angular span corresponds to a lateral range d of the tip 105 of the uterine manipulator 101 of about 6 cm to about 36 cm.

[0072] The adapter 126 includes a body 156 that defines a corresponding receptacle and mounting feature (e.g., a slot, receptacle, or another mounting feature) into which the shaft 107 of the uterine manipulator 101 can be securely fitted. The adapter 126 also includes a rear connection feature at which the body 156 can be attached to the handle 109 of the uterine manipulator 101. That is, the shaft 107 of the uterine manipulator 101 may be detached from the handle 109 of the uterine manipulator 101 to allow for both components to be attached to the adapter 126. In some embodiments, the handle 109 of the uterine manipulator 101 may be discarded, in lieu of the handle 109 being provided pre-assembled with the body 156 of the adapter 126.

[0073] Once the uterine manipulator 101 is assembled to the adapter 126, the adapter 126 is secured to the adjustment unit 124, and the positioning arm 104 is locked in a desired configuration, a remote control 108 (e.g., a joystick) may be operated at a remote user workstation to robotically manipulate the adjustment unit 124 of the adjustment device 110. For example, as described above, the adjustment unit 124 may be moved forward and downward along the elongated receiving portion 136, the downward movement resulting in an upward movement of the tip 105 of the uterine manipulator 101 due to the curved shape of the shaft 107. In addition, the dial 150 may be rotated to change the orientation of the adapter 126 and correspondingly change the orientation of the uterine manipulator 101 (e.g., to tilt the uterine manipulator 101 left or right).

[0074] Although adjusting device 110 has been described and illustrated with respect to particular dimensions, sizes, shapes, arrangements, configurations, materials, and methods, in some embodiments, adjusting devices that are otherwise substantially similar in construction and function to adjusting device 110 may include one or more different dimensions, sizes, shapes, arrangements, configurations, and materials, or may be utilized according to different methods.

[0075] For example, although adjusting device 110 has been described and illustrated as including an adapter 126 designed to mate with uterine manipulator 101, in some embodiments an adjusting device that is otherwise substantially similar in construction and function to adjusting device 110 may alternatively include a different adapter designed to mate with a different uterine manipulator, such as uterine manipulator 111 shown in FIG. 6.

[0076] Although adjustment device 110 has been described and illustrated with respect to particular numerical ranges for parameters l, h, β, and d, in some embodiments, an adjustment device that is otherwise substantially similar in construction and function to adjustment device 110 may alternatively be designed to operate based on different numerical ranges for one or more of parameters l, h, β, and d.

[0077] Although the adjusting device 110 has been described and illustrated as including a rechargeable battery 132 in the lower base 122, in some embodiments, an adjusting device that is otherwise substantially similar in construction and function to the adjusting device 110 may alternatively include a rechargeable battery in the upper adjusting unit instead of in the lower base.

[0078] 7 and 8, in some embodiments, an adjustment device 210 may be used as an alternative to the adjustment device 110 to locally position the uterine manipulator 101 of the positioning system 200. The positioning system 200 is substantially similar in construction and function to the positioning system 100, except that it includes the adjustment device 210 instead of the adjustment device 110. Thus, the positioning system 200 further includes the mounting / powering unit 102, the positioning arm 104, the remote control 108, and the foot pedal 112 of the positioning system 100, all of which are shown in FIG. 1. The adjustment device 210 includes a device connector 250, by which the adjustment device 210 is fixedly attached to the positioning arm 104.

[0079] Once the positioning arm 104 of the positioning system 200 is locked in a desired configuration to establish a global position of the adjustment device 210, the adjustment device 210 can be operated by the remote control 108 to fine-tune the position of the uterine manipulator 101 supported on the adjustment device 210. The adjustment device 210 also includes a lower motor assembly 222 (e.g., a translation assembly) fixedly attached to the upper end 106 of the positioning arm 104, a middle motor assembly 224 fixedly attached to the lower motor assembly 222, and an upper motor assembly 226 (e.g., an adjustment unit) fixedly attached to the middle motor assembly 224.

[0080] The lower motor assembly 222 is operable to provide linear motion of the uterine manipulator 101 along the x-axis (e.g., in both positive and negative horizontal x-axis directions). The motor assembly 222 includes a housing 228, a motor 232 located within the housing 228, and a translation mechanism 230 located on the upper side of the housing 228. The motor 232 drives the linear motion of the translation mechanism 230. In some embodiments, the motor 232 is a brushless DC motor with a built-in planetary gear transmission. In some embodiments, one or more components of the regulating device 210 are coupled to a separate control box 234 that provides power to the motor 232 (e.g., via a signal cable), wirelessly communicates control signals to the motor 232, and provides wired or wireless communication with the remote controller 108 (shown in FIG. 1). In some embodiments, the regulating device 210 alternatively includes an on-board power source (e.g., a battery) and an on-board controller that powers and controls the motor 232, and communicates with the remote controller 108.

[0081] The translation mechanism 230 includes a linear track 238 (e.g., an elongated, substantially straight track) and a linear linkage member 240 that is slidable and translatable within the linear track 238. For example, the linear linkage member 240 includes a lower rail 242 that is formed complementarily to an interior profile 244 (e.g., represented by dashed line 244) of the linear track 238 such that the rail 242 is linearly slidable and translatable along the interior profile 244. The rail 242 is connected or otherwise coupled to the motor 232 such that linear motion of the rail 242 along the x-direction is driven by action of the motor 232.

[0082] In some embodiments, the motor assembly 222 optionally includes a position stop 246 that limits the extent to which the linear linkage 240 can translate in the +x direction. In some embodiments, the rail 242 is movable along the +x direction a distance D of up to about 10 cm relative to the linear track 238. The linear linkage 240 includes an upper platform 248 from which the lower rail 242 extends and through which the position stop 246 extends. The middle motor assembly 224 is mounted to the platform 248 (e.g., along a substantially flat surface 252) such that operation of the lower motor assembly 222 causes the middle motor assembly 224 to move linearly. In this manner, the lower motor assembly 222 provides the adjustment device 210 with a linear degree of freedom along the x-axis.

[0083] 9 and 10, the midsection motor assembly 224 is operable to effect an arcuate motion (e.g., curvilinear motion with both x-axis and y-axis components) of the uterine manipulator 101 about a reference point 254. The reference point 254 is fixed relative to the linear linkage 240 and corresponds to the location of the cervix of the patient's uterus (e.g., an average depth uterus of about 8 cm). The motor assembly 224 includes a housing 256 fixed to the platform 248 of the translation mechanism 230, a motor 260 located within the housing 256, and an arcuate movement mechanism 258 coupled to the housing 256. The motor 260 drives the arcuate movement of the mechanism 258. In some embodiments, the motor 260 is a brushless DC motor with a built-in planetary gear transmission. In some embodiments, the control box 234 (shown in FIG. 7) provides power to the motor 260 (e.g., via a signal cable), wirelessly communicates control signals to the motor 260, and provides wired or wireless communication with the remote control 108 (shown in FIG. 1). In alternative embodiments, an on-board power source (e.g., a battery) and on-board controller of the regulating device 210 are provided to power and control the motor 260 and to communicate with the remote control 108.

[0084] The arcuate movement mechanism 258 includes an arcuate coupling member 266 (e.g., a support component) that defines an arcuate track 268 (e.g., a curved recess, channel, or slot). The arcuate movement mechanism 258 also includes a gear 270 that is positioned within the housing 256 along the arcuate track 268 and that is coupled to and driven by the motor 260. The gear 270 is coupled to the arcuate track 268 such that movement (e.g., rotation) of the gear 270 relative to the arcuate track 268 moves the arcuate coupling member 266 up and down through the housing 256 along the arcuate path 201 constrained and defined by the arcuate track 268. The motor assembly 224 further includes a coupling member 272 that secures the arcuate coupling member 266 to the housing 256.

[0085] Movement of the arcuate coupling member 266 relative to (e.g., through) the housing 256 along the arcuate path 201 causes the uterine manipulator 101 to perform a corresponding arcuate motion (that keeps the shaft 107 of the uterine manipulator 101 always about the reference point 254). Constraining the movement of the shaft 107 in this manner ensures that (e.g., for a given x-axis position of the housing 256) the tip 105 of the uterine manipulator 101 is properly positioned (e.g., at a desired vertical position) within the patient's uterus. In some embodiments, movement of the arcuate coupling member 266 from a first vertical position 274 shown in FIG. 9 to a second vertical position 276 shown in FIG. 10 results in a vertical movement of the tip 105 a distance of about 3 cm. As the arcuate connecting member 266 moves within the housing 256 along the arcuate path 201, a desired position (e.g., an operable position) of the tip 105 can be selected by moving the arcuate connecting member 266 to any desired vertical position between the first and second vertical positions 274, 276.

[0086] The upper motor assembly 226 is attached (e.g., at an opening) to the support base 278 of the arcuate linkage 266 such that operation of the middle motor assembly 224 causes the upper motor assembly 226 to move in an arc (as shown in FIGS. 11 and 12 ). In this manner, the middle motor assembly 224 provides an arcuate motion, thereby providing degrees of freedom to the adjustment device 210 along both the x-axis and the y-axis.

[0087] 11 and 12, the upper motor assembly 226 is operable to provide rotational movement of the uterine manipulator 101 about the reference point 254. The motor assembly 226 includes a housing 282 (e.g., a base component) attached to the support base 278 of the arcuate coupling member 266. For example, a connecting rod 284 of the motor assembly 226 extends from the housing 282 through an opening in the support base 278 to a device coupling member 286 of the motor assembly 226 that is coupled to the uterine manipulator 101. The device coupling member 286 and the connecting rod 284 together provide a rotation mechanism 288. The motor assembly 226 further includes a motor 290 located within the housing 282. The motor 290 drives the rotational movement of the mechanism 288. In some embodiments, the motor 290 is a brushless DC motor with a built-in planetary gear transmission. In some embodiments, a control box 234 (shown in FIG. 7) provides power to the motor 290 (e.g., via a signal cable), wirelessly communicates control signals to the motor 290, and provides wired or wireless communication with the remote control 108 (shown in FIG. 1). In alternative embodiments, an on-board power source (e.g., a battery) and on-board controller of the adjusting device 210 are provided to power and control the motor 290 and to communicate with the remote control 108.

[0088] The connecting rod 284 of the rotation mechanism 288 is rotationally driven by a motor 290. The device coupling member 286 is fixedly attached to and surrounds the connecting rod 284 such that rotation of the connecting rod 284 causes rotation of the device coupling member 286. The device coupling member 286 includes a substantially cylindrical portion 296 that surrounds the connecting rod 284 and a support arm 298 (e.g., a rotation element) that extends upwardly from the cylindrical portion 296. In some embodiments, the device coupling member 286 optionally includes a stop element 202 that extends downwardly from the cylindrical portion 296. An adapter 206 attached to the uterine manipulator 101 is attached to the support arm 298. The support arm 298 is also disposed at an acute angle γ (see FIG. 7 ) with respect to the central axis 204 of the motor 290, thereby partially intersecting the shaft 107 of the uterine manipulator 101 with the reference point 254.

[0089] By virtue of the cylindrical portion 296 being attached to the connecting rod 284, rotation of the connecting rod 284 correspondingly rotates the support arm 298 left or right relative to the reference point 254. In some embodiments, the support base 278 of the arcuate coupling member 266 optionally includes two position stops 208 (only one visible in FIGS. 11 and 12 ) located on opposite sides of the central axis 204. The stop elements 202 abut the position stops 208 when the device coupling member 286 reaches a particular degree of rotation such that the stop elements 202 limit the range of rotation of the device coupling member 286. In some embodiments, the device coupling member 286 is permitted to rotate up to about 30 degrees on each side of the housing 282 relative to the central axis 204 of the housing 282.

[0090] 7, 11, and 12, the central axis 204 of the motor 290 intersects with a reference point 254 (e.g., corresponding to the cervix), thus ensuring that rotation of the uterine manipulator 101 occurs relative to the cervix. To maximize the range of rotation of the distal tip 105 of the uterine manipulator 101, the acute angle θ between the central axis 204 and a line 212 that is tangent to the shaft 107 of the uterine manipulator 101 and intersects with the reference point 254 is maximized. In some embodiments, the angle θ is between about 30 degrees and about 50 degrees. Because the rotational motor assembly 226 is directly connected to the uterine manipulator 101 (e.g., via the adapter 206), the angle θ may remain fixed. Mounting the motor assembly 226 in a different configuration (e.g., between the lower motor assembly 222 and the middle motor assembly 224) can cause undesirable changes in the angle between the tangent 212 and the central axis 204 as the arcuate motion of the uterine manipulator 101 (discussed in relation to Figures 9 and 10) changes, which is unacceptable during a surgical procedure.

[0091] The upper motor assembly 224 provides the coordination device 210 with a rotational degree of freedom about a reference point 254. In some embodiments, a control box 234 (shown in FIG. 7 ) provides power to the motor 290, wirelessly communicates control signals to the motor 290, and provides wired or wireless communication with the remote control 108 (shown in FIG. 1 ). In alternative embodiments, an on-board power source (e.g., a battery) and on-board controller of the coordination device 210 are provided to power and control the motor 290 and to communicate with the remote control 108.

[0092] In some embodiments, the adjusting device 210 may be powered on and off by operation of the control box 234, and still the adjusting device 210 may optionally include a power selector (e.g., a button or switch) located on the housing 228 or on another component of the adjusting device 210. In alternative embodiments in which the adjusting device 210 includes an on-board power source (e.g., a battery) and an on-board controller, the adjusting device 210 includes a power selector located on the housing 228 or on another component of the adjusting device 210. In some embodiments, the adjusting device 210 weighs from about 2 kg to about 4 kg. Examples of materials from which the housings 228, 256, 282 and components of the mechanisms 230, 258, 288 may be made include steel and aluminum.

[0093] Although adjusting device 210 has been described and illustrated with respect to particular dimensions, sizes, shapes, arrangements, configurations, materials, and methods, in some embodiments, adjusting devices that are otherwise substantially similar in construction and function to adjusting device 210 may include one or more different dimensions, sizes, shapes, arrangements, configurations, and materials, or may be utilized according to different methods.

[0094] 13 and 14, in some embodiments, an adjustment device 310 may be used to locally position the uterine manipulator 111 of the positioning system 300. The positioning system 300 is substantially similar in construction and function to the positioning system 100, except that the positioning system 300 includes the adjustment device 310 instead of the adjustment device 110, and the uterine manipulator 111 instead of the uterine manipulator 101. Thus, the positioning system 300 further includes the mounting / powering unit 102, the positioning arm 104, the remote control 108, and the foot pedal 112 of the positioning system 100, all of which are shown in FIG.

[0095] Once the positioning arm 104 of the positioning system 300 is locked in a desired configuration to establish a global position of the adjustment device 310, the adjustment device 310 can be operated by the remote control 108 to fine-tune the position of the uterine manipulator 111 supported on the adjustment device 310. Thus, the adjustment device 310 includes a device connector 350 by which the adjustment device 310 is fixedly attached to the positioning arm 104. The adjustment device 310 also includes a translation assembly 322 fixedly attached to the upper end 106 of the positioning arm 104, a rotation assembly 324 fixedly attached to the translation assembly 322, and a rotatable receiver 326 (e.g., a rotary adjustment unit) fixedly attached to the rotation assembly 324.

[0096] The translation assembly 322 is operable to provide linear movement of the uterine manipulator 111 along the x-axis (e.g., in both positive and negative horizontal x-axis directions). The translation assembly 322 includes a rail 328 secured to the device connector 350, a back wall 338 secured to an end of the rail 328, and a horizontal support structure 330 (e.g., a carriage) that is linearly slidable along the rail 328. Thus, the rail 328 has a substantially rectangular shape, and the horizontal support structure 330 defines a slot 332 with a complementary shape to enable linear movement of the horizontal support structure 330 along the rail 328.

[0097] The translation assembly 322 further includes two flexible mechanical actuation cables (e.g., Bowden cables) that allow the horizontal support structure 330 to be moved in the +x direction (e.g., pushed forward) by one cable 334 (represented by dashed line 334) and moved in the -x direction (e.g., pulled backward) by the other cable 336 (represented by dashed line 336). Each cable 334, 336 is connected at one end to the horizontal support structure 330 and connected at the opposite end through a rear wall 338 to a remote motor 372. Manipulation of the remote control 108 controls the remote motor 372 by associated electronics 374 to actuate the cables 334, 336 to linearly move the horizontal support structure 330. In some embodiments, the remote motor 372 is a linear actuator. In some embodiments, the horizontal support structure 330 is movable relative to the rail 328 along the +x direction a distance of up to about 10 cm. In this manner, the translation assembly 322 provides the adjustment device 310 with a linear degree of freedom along the x-axis.

[0098] 15 and 16, rotation assembly 324 is operable to effect rotational movement of uterine manipulator 111 about a rotation axis 340 that is parallel to the x-axis and extends through the patient's cervix. Rotation assembly 324 includes a vertical support structure 342 and a platform 344 (e.g., a rotatable support component) coupled to vertical support structure 342. Platform 344 includes a base 346 that is fixed to uterine manipulator 111 at a distal portion 370, and a connecting wall 348. To enable platform 344 to rotate (e.g., pivot) relative to translation assembly 322, rotation assembly 324 includes a pin 352 that connects connecting wall 348 of platform 344 to vertical support structure 342 of translation assembly 322.

[0099] The rotation assembly 324 further includes two flexible mechanical actuation cables 354, 356 (e.g., Bowden cables) that enable the platform 344 to rotate left and right relative to the rotation axis 340. The flexible cable 354 (represented by dashed line 354 in FIG. 14 ) is connected to one side of the platform 344 and can be pulled to move the platform 344 in a first rotational direction 358. The flexible cable 356 (represented by dashed line 356 in FIG. 13 ) is connected to the opposite side of the platform 344 and can be pulled to move the platform 344 in an opposite second rotational direction 360.

[0100] Each cable 354, 356 is connected at one end to the platform 346 and at the opposite end to a remote motor 376. Manipulation of the remote control 108 controls the remote motor 376 through associated electronics 378 to actuate the cables 354, 356 to rotate the platform 346 about the pin 352. In some embodiments, the remote motor 376 is a linear actuator. In some embodiments, the platform 344 can rotate up to about 90 degrees on either side of the axis of rotation 340. The rotatable receiver 326 is rotatably coupled to the platform 344. In this manner, the rotation assembly 324 provides the adjustment device 310 with a degree of rotational freedom about the axis of rotation 340 that extends parallel to the x-axis.

[0101] 17 and 18, the rotatable receiver 326 is operable to provide rotational movement of the distal tip 115 of the uterine manipulator 111 about a transverse axis 123 that extends perpendicular (e.g., along the z-axis) to the central axis 117 of the uterine manipulator 111. The distal tip 115 can be articulated (e.g., pivoted) approximately 90 degrees upwardly (as shown in FIG. 18) and approximately 50 degrees downwardly (as shown in FIG. 17) about the transverse axis 123 by rotating the handle 119 (e.g., articulation control element) of the uterine manipulator 111 side to side relative to the central axis 117 at the pin mechanism 121.

[0102] The rotatable receiver 326 provides a seat (e.g., a holding or support component) on which the handle 119 is securely attached for rotating the handle 119. The receiver 326 includes two flexible mechanical actuation cables 362, 364 (e.g., Bowden cables) that allow the receiver 326, with the handle 119 resting thereon, to rotate left and right relative to the central axis 117. The flexible cable 362 (represented by dashed line 362 in FIG. 17 ) is connected to one side of the receiver 326 and can be pulled to rotate the receiver in a first rotational direction 366. The flexible cable 364 (represented by dashed line 364 in FIG. 18 ) is connected to an opposite side of the receiver 326 and can be pulled to rotate the receiver 326 in an opposite second rotational direction 368.

[0103] Each flexible cable 362, 364 is connected at one end to the receiver 326 and at the opposite end to a remote motor 380. Activation of the remote control 108 controls the remote motor 380 by associated electronics 382 to operate the cables 362, 364 to rotate the receiver 326 about the pin mechanism 121. In some embodiments, the remote motor 380 is a linear actuator. In this manner, the rotatable receiver 326 provides the adjustment device 310 with a rotational degree of freedom about the central axis 117 and the transverse axis 123 that extends perpendicular to the x-axis.

[0104] In contrast to uterine manipulator 101, uterine manipulator 111 includes different distal tips 115 that can be selected for use with uteruses at different depths. As a result, the cervix remains in the same position relative to handle 119, and adjustment device 310, by way of rotation assembly 324 and rotatable receiver 326, can adjust distal tip 115 at the cervix regardless of the depth of the uterus.

[0105] The remote location of the motors 372, 376, 380 of the adjusting device 310 has the advantage of reducing the weight of the adjusting device 310. In some embodiments, the adjusting device 310 weighs between about 0.5 kg and about 3 kg. Examples of materials from which the translating assembly 322, the rotating assembly 324, and the rotatable receiver 326 can be made include aluminum and steel.

[0106] Although adjusting device 310 has been described and illustrated with respect to particular dimensions, sizes, shapes, arrangements, configurations, materials, and methods, in some embodiments, adjusting devices that are otherwise substantially similar in construction and function to adjusting device 310 may include one or more different dimensions, sizes, shapes, arrangements, configurations, and materials, or may be utilized according to different methods.

[0107] For example, although the adjusting device 310 has been described and illustrated as including a rotatable receiver 326 designed to seat the handle 119 of the uterine manipulator 111, in some embodiments, an adjusting device that is otherwise substantially similar in construction and function to the adjusting device 310 may alternatively include a rotatable receiver 326 designed to seat a different rotatable component (e.g., a fitting) of the uterine manipulator 111 that replaces the handle 119.

[0108] Although adjustment device 310 has been described and illustrated as including remote motors 372, 376, 380 that provide actuation via mechanical actuation cables 334, 336, 354, 356, 362, 364, in some embodiments, adjustment devices that are otherwise substantially similar in construction and function to adjustment device 310 may alternatively include remote motors that provide actuation via hydraulic mechanisms.

[0109] Although the adjustment device 310 has been described and illustrated as including remote motors 372, 376, 380 that provide actuation via mechanical actuation cables 334, 336, 354, 356, 362, 364, in some embodiments, an adjustment device that is otherwise substantially similar in construction and function to the adjustment device 310 may alternatively include one or more local motors directly connected to the local components and receivers 326 of the assemblies 322, 324.

[0110] The adjustment device 310 has been described and illustrated as including three sets of two mechanical actuation cables 334, 336; 354, 356; 362, 364, with each cable in each set effecting opposing movement of the mechanisms 322, 324, 326, respectively. However, in some embodiments, an adjustment device that is otherwise substantially similar in construction and function to the adjustment device 310 may alternatively include a single flexible mechanical actuation cable for each movement mechanism 322, 324, 326 that can selectively effect one of two opposing movements. In some embodiments, any cable in the set of two mechanical actuation cables 334, 336; 354, 356; or 362, 364 may be configured to effect one of two alternative opposing movements.

[0111] Remotely controlling the robotic movement of the adjustment devices 110, 210, 310 allows the surgeon to desirably position the patient's uterus (e.g., seated on the uterine manipulators 101, 111 secured to the adjustment devices 110, 210, 310) for optimal access for incision and removal without leaving the workstation where the surgeon operates the remote controller 108. Thus, the surgeon can continue to visualize the patient's pelvic region on a display screen at the robotic surgery workstation without interruption while the adjustment devices 110, 210, 310 are being remotely operated. Thus, such remote control of the adjustment devices 110, 210, 310 has the advantage of resulting in streamlined procedures with increased efficacy, increased precision, and reduced procedure time.

[0112] In some embodiments, any of the adjustment devices 110, 210, 310 may be provided as modular devices that can be retrofitted or otherwise assembled to the positioning arm 104 of the positioning system 100, 200, 300 at the point of care. In other embodiments, the adjustment devices 110, 210, 310 may be pre-assembled with the positioning arm 104 of the positioning system 100, 200, 300.

[0113] Although adjustment devices 110, 210, 310 have been described and illustrated as allowing particular degrees of freedom, in some embodiments, adjustment devices that are otherwise substantially similar in construction and function to any of adjustment devices 110, 210, 310 may be designed to allow additional or alternative movements and / or degrees of freedom.

[0114] Accordingly, other embodiments are within the scope of the following claims.

Claims

1. 1. An adjustment device for positioning a uterine manipulator, comprising: a support component movable along an arcuate path defined by the adjustment device; An adjustment unit, a base component secured to the support component; and a rotating element secured to the base component and the uterine manipulator such that the rotating element and the uterine manipulator secured thereto are movable along the arcuate path and rotatable relative to the support component; An adjustment unit comprising: An adjusting device comprising:

2. 13. The adjustment device of claim 1, configured to be fixedly attached to a positioning arm of a uterine positioning system.

3. The adjustment device of claim 2 , wherein the adjustment unit is configured to move back and forth along the arcuate path relative to the positioning arm.

4. 10. The adjusting device of claim 1, further comprising internal electronics configured to provide wireless or wired communication with a remote control.

5. The coordinating device of claim 1 , further comprising a remote control unit configured to power and control one or more movement mechanisms of the coordinating device.

6. The adjustment device of claim 1 , further comprising a support unit providing an elongated receiving portion, the elongated receiving portion receiving the support component and defining the arcuate path.

7. 7. The adjustment device of claim 6, wherein the support component includes a connector having an end that is retained within the elongated receiving portion as the adjustment unit moves in an arc along the elongated receiving portion.

8. 10. The adjustment device of claim 1, wherein the adjustment unit is movable back and forth along the arcuate path a total distance of up to about 6 cm to a total distance of up to about 26 cm.

9. 2. The adjustment device of claim 1, wherein the rotating element comprises a dial rotatable about a pin, and the angular span of the dial corresponds to a lateral range of about 6 cm to about 36 cm of the tip of the uterine manipulator.

10. The adjustment device of claim 1 , wherein the support component defines the arcuate path.

11. The adjustment device of claim 1 , further comprising one or more motors that control the arcuate movement of the support component and the rotation of the rotating element.

12. The adjustment device of claim 1 , further comprising a translation assembly coupled to the support component and causing linear movement thereof.

13. 10. The adjustment device of claim 1, configured to maintain rotation of the shaft of the uterine manipulator about a reference point as the support component moves along the arcuate path.

14. The adjustment device of claim 13, wherein the reference point is located on the patient's cervix.

15. The adjustment device of claim 1 , configured such that rotation of the uterine manipulator by the rotational element is maintained about a reference point.

16. 16. The adjustment device of claim 15, wherein the reference point is located on the patient's cervix and the axis of the adjustment unit intersects the reference point.

17. A positioning arm; and an adjustment device supported on said positioning arm for positioning a uterine manipulator; a support component movable along an arcuate path defined by the adjustment device; An adjustment unit, a base component secured to the support component; and a rotating element secured to the base component and the uterine manipulator such that the rotating element and the uterine manipulator secured thereto are movable along the arcuate path and rotatable relative to the support component; An adjustment unit comprising: An adjustment device comprising: A positioning system comprising:

18. 20. The positioning system of claim 17, wherein the positioning arm defines a global position of the adjustment device, and the adjustment device defines a local position of the uterine manipulator.

19. A remote control; and a control box in communication with the remote control; 20. The positioning system of claim 17, further comprising:

20. An adjustment device for positioning a uterine manipulator, a rotatable support component fixed to the uterine manipulator and rotatable about an axis of rotation defined by the adjustment device; a rotary adjustment unit secured to an articulation control element of the uterine manipulator and secured to the rotary support component such that the adjustment device is configured to rotate the uterine manipulator about the axis of rotation and to articulate a portion of the uterine manipulator relative to the rotary support component; An adjusting device comprising:

21. The adjustment device of claim 20 , wherein the rotary support component is coupled to a linear translation assembly.

22. The adjustment device of claim 21 , wherein the linear translation assembly comprises a rail and a carriage.

23. 21. The adjustment device of claim 20, wherein the linear translation assembly is configured to be fixedly attached to a positioning arm of a uterine positioning system.

24. 21. The adjustment device of claim 20, further comprising one or more mechanical actuation cables configured to selectively rotate the rotatable support component in opposite rotational directions.

25. 25. The adjusting device of claim 24, further comprising a remote motor coupled to and controlling the one or more mechanical actuation cables.

26. 21. The adjustment device of claim 20, further comprising one or more mechanical actuation cables configured to selectively rotate the rotatable adjustment unit in opposite rotational directions.

27. 27. The adjusting device of claim 26, further comprising a remote motor coupled to and controlling the one or more mechanical actuation cables.

28. The adjustment device of claim 20 , wherein the articulation control element comprises a handle and the portion comprises a distal tip.

29. 21. The adjustment device of claim 20, wherein the axis of rotation intersects the patient's cervix.

30. A positioning arm; and an adjustment device supported on the positioning arm for positioning the uterine manipulator, a rotatable support component fixed to the uterine manipulator and rotatable about an axis of rotation defined by the adjustment device; a rotary adjustment unit secured to an articulation control element of the uterine manipulator and to the rotary support component such that the adjustment device is configured to rotate the uterine manipulator about the axis of rotation and to articulate a portion of the uterine manipulator relative to the rotary support component; An adjustment device comprising: A positioning system comprising:

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