Patent Description:
Surgical procedures, such as minimally-invasive procedures, may require a surgeon to insert surgical tools inside the body of the patient to a particular depth to reach the target area inside the patient's body. For example, minimally invasive spinal surgical procedures have been used for stabilization of vertebral bones and spinal joints and for relieving of pressure applied to the spinal nerves. Such procedures may utilize relatively small incisions and insertion of tubular retractors and cannulas while minimizing damage to muscles and other surrounding anatomical features. Minimally invasive surgical approaches can be faster, safer and require less recovery time than conventional open surgeries. There is a continuing need for improvement to the safety and speed of surgical procedures, such as minimally-invasive surgical procedures.

<CIT> discloses a cannula seal that can include a base portion that engages with a cannula. The cannula seal further includes a seal portion integrally formed with the base portion that slidably engages with an instrument shaft such that an insertion frictional force between the seal portion and the instrument shaft for insertion of the instrument shaft is symmetrical and substantially equal with a retraction frictional force.

<CIT> discloses a surgical portal apparatus with a seal assembly which enables a surgeon to utilize instruments of varying diameter by providing a seal with an adjustable opening.

According to aspects of the present disclosure, an end effector for a robotic-assisted surgical system and a non-surgical method of controlling the robotic end effector are provided according to the independent claims. Preferred embodiments are recited in the dependent claims.

Other features and advantages of the present invention will be apparent from the following detailed description of the invention, taken in conjunction with the accompanying drawings of which:.

Various embodiments include an end effector for a robotic arm that includes a hollow tube or cannula through which one or more tools, such as an invasive surgical tool, may be inserted. The end effector according to various embodiments may have an adjustable inner diameter to enable tools of different sizes to be accurately guided through the interior of the end effector.

<FIG> illustrates a system <NUM> for performing computer-assisted image-guided surgery that may utilize an end effector <NUM> having an adjustable inner diameter according to various embodiments. The system <NUM> in this embodiment includes an imaging device <NUM>, a motion tracking system <NUM> and a robotic arm <NUM> for performing a robotically-assisted surgical procedure. The robotic arm <NUM> may be fixed to a support structure at one end and may have an adjustable-diameter end effector <NUM> located at the other end of the robotic arm <NUM>. The robotic arm <NUM> may comprise a multi-joint arm that includes a plurality of linkages connected by joints having actuator(s) and optional encoder(s) to enable the linkages to rotate, bend and/or translate relative to one another in response to control signals from a robot control system. The motions of the robotic arm <NUM> may enable the end effector <NUM> to be moved to various positions and/or orientations, such as various positions and/or orientations with respect to a patient (not illustrated) that may be located on a patient support <NUM> (e.g., surgical table).

The imaging device <NUM> may be used to obtain diagnostic images of a patient (not shown in <FIG>), which may be a human or animal patient. In embodiments, the imaging device <NUM> may be an x-ray computed tomography (CT) imaging device. The patient may be positioned within a central bore <NUM> of the imaging device <NUM> and an x-ray source and detector may be rotated around the bore <NUM> to obtain x-ray image data (e.g., raw x-ray projection data) of the patient. The collected image data may be processed using a suitable processor (e.g., computer) to perform a three-dimensional reconstruction of the object. In other embodiments, the imaging device <NUM> may comprise one or more of an x-ray fluoroscopic imaging device, a magnetic resonance (MR) imaging device, a positron emission tomography (PET) imaging device, a single-photon emission computed tomography (SPECT), or an ultrasound imaging device. In embodiments, image data may be obtained pre-operatively (i.e., prior to performing a surgical procedure), intra-operatively (i.e., during a surgical procedure) or post-operatively (i.e., following a surgical procedure) by positioning the patient within the bore <NUM> of the imaging device <NUM>. In the system <NUM> of <FIG>, this may be accomplished by moving the imaging device <NUM> over the patient to perform a scan while the patient may remain stationary.

Examples of x-ray CT imaging devices that may be used according to various embodiments are described in, for example, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>. In the embodiment shown in <FIG>, the patient support <NUM> (e.g., surgical table) upon which the patient may be located is secured to the imaging device <NUM>, such as via a column <NUM> which is mounted to a base <NUM> of the imaging device <NUM>. A portion of the imaging device <NUM> (e.g., an O-shaped imaging gantry <NUM>) which includes at least one imaging component may translate along the length of the base <NUM> on rails <NUM> to perform an imaging scan of the patient, and may translate away from the patient to an out-of-the-way positon for performing a surgical procedure on the patient. It will be understood that other imaging devices may be utilized, including other mobile or fixed x-ray CT devices or a C-arm x-ray fluoroscopy device.

Further, although the imaging device <NUM> shown in <FIG> is located close to the patient within the surgical theater, the imaging device <NUM> may be located remote from the surgical theater, such as in another room or building (e.g., in a hospital radiology department).

The motion tracking system <NUM> shown in <FIG> includes a plurality of marker devices <NUM>, <NUM> and an optical sensor device <NUM>. Various systems and technologies exist for tracking the position (including location and/or orientation) of objects as they move within a three-dimensional space. Such systems may include a plurality of active or passive markers fixed to the object(s) to be tracked and a sensing device that detects radiation emitted by or reflected from the markers. A 3D model of the space may be constructed in software based on the signals detected by the sensing device.

The motion tracking system <NUM> in the embodiment of <FIG> includes a plurality of marker devices <NUM>, <NUM> and a stereoscopic optical sensor device <NUM> that includes two or more cameras <NUM> (e.g., IR cameras). The optical sensor device <NUM> may include one or more radiation sources (e.g., diode ring(s)) that direct radiation (e.g., IR radiation) into the surgical field, where the radiation may be reflected by the marker devices <NUM>, <NUM> and received by the cameras. The marker devices <NUM>, <NUM> may each include three or more (e.g., four) reflecting spheres, which the motion tracking system <NUM> may use to construct a coordinate system for each of the marker devices <NUM>, <NUM>. A computer <NUM> may be coupled to the sensor device <NUM> and may determine the transformations between each of the marker devices <NUM>, <NUM> and the cameras using, for example, triangulation techniques. A 3D model of the surgical space in a common coordinate system may be generated and continually updated using motion tracking software implemented by the computer <NUM>. In embodiments, the computer <NUM> may also receive image data from the imaging device <NUM> and may register the image data to the common coordinate system as the motion tracking system <NUM> using image registration techniques as are known in the art. In embodiments, at least one reference marker device <NUM> may be attached to the patient <NUM>, as shown in FIGS. The reference marker device <NUM> may be rigidly attached to a landmark in the anatomical region of interest (e.g., clamped or otherwise attached to a bony portion of the patient's anatomy) to enable the anatomical region of interest to be continually tracked by the motion tracking system <NUM>. Additional marker devices <NUM> may be attached to surgical tools or instruments <NUM> to enable the tools/instruments <NUM> to be tracked within the common coordinate system. Another marker device <NUM> may be rigidly attached to the robotic arm <NUM>, such as on the end effector <NUM> of the robotic arm <NUM>, to enable the position of robotic arm <NUM> and end effector <NUM> to be tracked using the motion tracking system <NUM>. The computer <NUM> may also include software configured to perform a transform between the joint coordinates of the robotic arm <NUM> and the common coordinate system of the motion tracking system <NUM>, which may enable the position and orientation of the end effector <NUM> of the robotic arm <NUM> to be controlled with respect to the patient <NUM>.

In addition to passive marker devices described above, the motion tracking system <NUM> may alternately utilize active marker devices that may include radiation emitters (e.g., LEDs) that may emit radiation that is detected by an optical sensor device <NUM>. Each active marker device or sets of active marker devices attached to a particular object may emit radiation in a pre-determined strobe pattern (e.g., with modulated pulse width, pulse rate, time slot and/or amplitude) and/or wavelength which may enable different objects to be uniquely identified and tracked by the motion tracking system <NUM>. One or more active marker devices may be fixed relative to the patient, such as secured to the patient's skin via an adhesive membrane or mask. Additional active marker devices may be fixed to surgical tools <NUM> and/or to the end effector <NUM> of the robotic arm <NUM> to allow these objects to be tracked relative to the patient.

In further embodiments, the marker devices may be passive maker devices that include moiré patterns that may enable their position and orientation to be tracked in three-dimensional space using a single camera using Moiré Phase Tracking (MPT) technology. Other tracking technologies, such as computer vision systems and/or magnetic-based tracking systems, may also be utilized.

As shown in <FIG>, the optical sensor device <NUM> may include a plurality of cameras <NUM> mounted to an arm <NUM> extending above the patient surgical area. The arm <NUM> may be mounted to or above the imaging device <NUM>. The arm <NUM> may enable the sensor device <NUM> to pivot with respect to the arm <NUM> and/or the imaging device <NUM> (e.g., via one or more ball joints <NUM>). The arm <NUM> may enable a user to adjust the position and/or orientation of the sensor device <NUM> to provide the cameras <NUM> with a clear view into the surgical field while avoiding obstructions. The arm <NUM> may enable the position and/or orientation of the sensor device <NUM> to be adjusted and then locked in place during an imaging scan or surgical procedure.

The system <NUM> may also include at least one display device <NUM> as illustrated in <FIG>. The display device <NUM> may display image data of the patient's anatomy obtained by the imaging device <NUM>. In the case of CT image data, for example, the display device <NUM> may display a three-dimensional volume rendering of a portion of the patient's anatomy and/or may display two-dimensional slices (e.g., axial, sagittal and/or coronal slices) through the 3D CT reconstruction dataset. The display device <NUM> may facilitate planning for a surgical procedure, such as by enabling a surgeon to define one or more target positions in the patient's body and/or a path or trajectory into the patient's body for inserting surgical tool(s) to reach a target position while minimizing damage to other tissue or organs of the patient. The position and/or orientation of one or more objects tracked by the motion tracking system <NUM> may be shown on the display <NUM>, and may be shown overlaying the image data. The use of tracked surgical instruments or tools in combination with pre-operative or intraoperative images of the patient's anatomy in order to guide a surgical procedure may be referred to as "image-guided surgery.

In embodiments, the display device <NUM> may be a handheld computing device, such as a tablet device. One or more handheld display devices <NUM> may be mounted to an arm <NUM> extending above the patient surgical area, as shown in <FIG>. The arm <NUM> may also support the optical sensing device <NUM> for the motion tracking system <NUM>, as described above. In other embodiments, a handheld display device <NUM> may be mounted to the patient support <NUM> or column <NUM> or to any portion of the imaging system <NUM>, or to any of the wall, ceiling or floor in the operating room, or to a separate cart. Alternately or in addition, the at least one display device <NUM> may be a monitor display that may be located on a mobile cart or mounted to another structure (e.g., a wall) within the surgical theater. In further embodiments, a display device <NUM> may be a head-mounted display that may be worn by a surgeon or other clinician.

As shown in <FIG>, the robotic arm <NUM> may be fixed to the imaging device <NUM>, such as on a support element <NUM> (e.g., a curved rail) that may extend concentrically over the outer surface of the O-shaped gantry <NUM> of the imaging device <NUM>. In embodiments, an arm <NUM> to which the optical sensing device <NUM> is mounted may be mounted to the same or a similar support element <NUM> (e.g., curved rail) as the robotic arm <NUM>. The position of the robotic arm <NUM> and/or the arm <NUM> may be adjustable along the length of the support element <NUM>. In other embodiments, the robotic arm <NUM> may be secured to any other portion of the imaging device <NUM>, such as directly mounted to the gantry <NUM>. Alternatively, the robotic arm <NUM> may be mounted to the patient support <NUM> or column <NUM>, to any of the wall, ceiling or floor in the operating room, or to a separate cart. Although a single robotic arm <NUM> is shown in <FIG>, it will be understood that two or more robotic arms <NUM> may be utilized. Each robotic arm <NUM> may include an end effector <NUM> with an adjustable internal diameter opening, as described in further detail below.

The at least one robotic arm <NUM> may aid in the performance of a surgical procedure, such as a minimally-invasive spinal surgical procedure or various other types of orthopedic, neurological, cardiothoracic and general surgical procedures. In embodiments, the motion tracking system <NUM> may track the position of the robotic arm <NUM> (e.g., via marker device <NUM> on end effector <NUM> as shown in <FIG>) within the patient coordinate system. A control loop may continuously read the tracking data and the current parameters (e.g., joint parameters) of the robotic arm <NUM> and may send instructions to a robotic controller to cause the robotic arm <NUM> to move to a desired position and orientation within the patient coordinate system.

In embodiments, a surgeon may use an image-guided surgery system as a planning tool for a surgical procedure, such as by setting trajectories within the patient for inserting surgical tools, as well as by selecting one or more target locations for a surgical intervention within the patient's body. The trajectories and/or target locations set by the surgeon may be saved (e.g., in a memory of a computer device, such as computer device <NUM> shown in <FIG>) for later use during surgery. In embodiments, the surgeon may be able to select stored trajectories and/or target locations using an image guided surgery system, and the robotic arm <NUM> may be controlled to perform a particular movement based on the selected trajectory and/or target location. For example, the robotic arm <NUM> may be moved to position the end effector <NUM> of the robotic arm <NUM> into alignment with the pre-defined trajectory and/or over the pre-determined target location. The hollow tube or cannula extending through the end effector <NUM> may be used to guide an instrument <NUM> into the patient's body along the pre-defined trajectory and/or to the pre-defined target location.

In addition to a robotic arm <NUM> as described above, an end effector <NUM> of the present embodiments may be attached to a moveable arm or boom, which may be motor-driven or manually moved. The arm may be moved to position the end effector <NUM> at a desired location with respect to the patient and the arm may be configured to hold its pose during a surgical intervention.

An embodiment of an end effector <NUM> having an adjustable-diameter internal cannula is illustrated in <FIG>. The end effector <NUM> may be utilized in a system <NUM> such as shown in <FIG>. The end effector <NUM> in this embodiment includes an elongated main body <NUM> having a central opening <NUM> extending through the main body <NUM>. The main body <NUM> may have a generally cylindrical outer shape. In some embodiments, such as shown in <FIG>, the main body <NUM> may have a stepped or tapered outer width (e.g., diameter) along its length, and may be wider at a first end <NUM> than at a second end <NUM>. Alternately, the outer width of the main body <NUM> may be substantially constant along its length.

A connecting member <NUM> (see <FIG>) may extend from a side of the main body <NUM> and may be used to secure the end effector <NUM> to the end of a robotic arm <NUM>. In embodiments, the main body <NUM> and the connecting member <NUM> may be permanently connected (e.g., integrally-formed components and/or connected by an adhesive or mechanical fasteners). In other embodiments, the main body <NUM> and the connecting member <NUM> may be separate components that may be joined to form an end effector <NUM> as shown in <FIG>. For example, the connecting member <NUM> may have an opening (e.g., a cylindrical-shaped opening) extending through the connector that is sized and shaped to receive the main body <NUM> within the opening. Alternately or in addition, the connecting member <NUM> and the main body <NUM> may have mating features that enable the main body <NUM> to snap onto or otherwise attach to the connecting member <NUM>. In some embodiments, the connecting member <NUM> may not be utilized, and the main body <NUM> of the end effector <NUM> may directly attach to the robotic arm <NUM>.

The end effector <NUM> may be a sterile or sterilizable component that may not need to be draped during surgery. In some embodiments, the end effector <NUM> may be attached to a robotic arm <NUM> over a surgical drape that covers the arm <NUM>. The end effector <NUM> may be a single-use disposable component, or a multi-use component that may be re-sterilized (e.g., autoclavable). The end effector <NUM> may have a marker device <NUM> (e.g., an array of reflective spheres mounted to a rigid frame) attached to the end effector <NUM> to enable the end effector <NUM> to be tracked by a motion tracking system <NUM>, such as shown in <FIG>.

Referring again to <FIG>, a collar <NUM> may be located proximate to the first end <NUM> of the main body <NUM>. The collar <NUM> may include a first portion <NUM> that extends over a portion of the outer surface of the main body <NUM> and an end portion <NUM> that is located over the first end <NUM> of the main body <NUM>. The end portion <NUM> may include an opening <NUM> that is aligned with the central opening <NUM> extending through the main body <NUM> of the end effector <NUM>. The first portion <NUM> of the collar <NUM> may also include a ridged/fluted outer surface to enable the collar <NUM> to be easily gripped and manipulated.

The collar <NUM> may be rotatable with respect to the main body <NUM> of the end effector <NUM>. The rotation of the collar <NUM> on the main body <NUM> may cause a variation in the internal diameter of the central opening <NUM>. For example, the rotation of the collar <NUM> may drive the extension and retraction of one or more members (e.g., flutes <NUM>) towards or away from the interior side wall of the main body <NUM> to increase or decrease a size of a void space within the main body <NUM> through which a surgical instrument or other tool may pass.

An example of a mechanism for adjusting the internal diameter of an end effector <NUM> is shown in <FIG>. <FIG> is a partial cross-section view of the end effector <NUM> taken along line A-A in <FIG>. As shown in <FIG>, the main body <NUM> of the end effector <NUM> includes a flange <NUM> extending from the interior sidewall of the main body <NUM>. A gear <NUM> is located on a first side of the flange <NUM> and is coupled to a flute <NUM> located on the opposite side of the flange <NUM>. The rotation of the gear <NUM> causes the flute <NUM> to pivot towards and away from the interior sidewall of the main body <NUM>. The teeth of the gear <NUM> engage with corresponding teeth extending on an interior surface <NUM> of the collar <NUM>. Thus, as the collar <NUM> is turned, the flute <NUM> is pivoted outwards and inwards with respect to the interior sidewall of the main body <NUM>.

The end effector <NUM> may have a plurality of flutes <NUM> coupled to corresponding gears <NUM> that may similarly pivot out and back with respect to the main body <NUM> as the collar <NUM> is turned to adjust the internal diameter of the central opening <NUM>. For example, three flutes <NUM> may be equally spaced around the periphery of the main body <NUM>. The flutes <NUM> may be pivotable between a first configuration shown in <FIG>, in which the flutes <NUM> are positioned against the sidewall of the main body <NUM> to provide a maximum amount of clearance through the central opening <NUM>, and a second configuration shown in <FIG> in which the flutes <NUM> are pivoted out to their maximum extent such that their tip ends contact one another and the clearance through the center of the central opening <NUM> is at its minimal extent. The flutes <NUM> may also be moved to an intermediate configuration between the configurations of <FIG>. For example, <FIG> illustrates the flutes <NUM> pivoted out such that the tip ends of the flutes <NUM> define a central opening <NUM> (i.e., a working channel) having a diameter, d. A tool having a cross-sectional dimension (e.g., diameter) that is approximately equal to diameter d may be inserted through the central opening <NUM>. The tool may slide past the flutes <NUM> along the length of the main body <NUM> and out through the second end <NUM> of the main body <NUM> (e.g., into the body of a patient). The flutes <NUM> may guide the advancement of the tool along a fixed trajectory (e.g., along the central axis of the main body <NUM>) and may prevent radial motion of the tool within the main body <NUM>. In some embodiments, the flutes <NUM> may be further tightened against a tool located within the main body <NUM> by rotating the collar <NUM> so as to fix the longitudinal position of the tool within the main body <NUM>.

Although the embodiment shown in <FIG> includes three flutes <NUM>, it will be understood that other embodiments may include a different number (e.g., <NUM>, <NUM>, <NUM>, etc.) of flutes <NUM> that may extend and retract within the main body <NUM> to adjust the interior diameter of the opening <NUM> through which a tool/instrument may be inserted. The plurality of flutes <NUM> may be moveable within the main body <NUM> using a suitable mechanism, and may be self-centering, as in the embodiment shown in <FIG>.

The end effector <NUM> may also include a locking mechanism that may be engaged to hold the position of the flutes <NUM> within the main body <NUM>. In the embodiment shown in <FIG>, the locking mechanism may be a second collar <NUM> (a locking collar) located on the main body <NUM> adjacent to collar <NUM>. The second collar <NUM> may be engaged to prevent collar <NUM> from rotating on the main body <NUM> and may be disengaged to allow the collar <NUM> to rotate on the main body <NUM>.

In embodiments, the second collar <NUM> may be engaged to lock the rotation of collar <NUM> by moving the second collar <NUM> into contact with collar <NUM>. The second collar <NUM> may be disengaged by moving the second collar <NUM> out of contact with collar <NUM>. In one embodiment, the second collar <NUM> may be moved into contact with collar <NUM> to provide an interference fit between the two collars <NUM>, <NUM> that prevents collar <NUM> from rotating on the main body <NUM>. Alternately or in addition, the two collars <NUM>, <NUM> may include mating features that engage with one another to prevent collar <NUM> from rotating. In embodiments, the second collar <NUM> may be threaded onto the outer surface of the main body <NUM>, and may be tightened against the collar <NUM> to prevent the collar <NUM> from rotating, and may be backed away from the collar <NUM> to allow the collar <NUM> to rotate. In an alternative embodiment, the second collar <NUM> may be spring-biased against collar <NUM> to prevent the collar <NUM> from rotating, and may be pushed away from the collar <NUM> to allow the collar <NUM> to rotate. It will be understood that other mechanisms for locking and unlocking the collar <NUM> may also be utilized.

The adjustable-diameter end effector <NUM> may also include an indicator, such as a dial indicator <NUM>, that provides an indication of the internal diameter of the central opening <NUM> through which a tool may be inserted. As shown in <FIG> and <FIG>, the dial indicator <NUM> may include a reference indicator <NUM> that may be fixed to the main body <NUM>, such as via a cantilevered arm <NUM> that extends from the side of the main body <NUM> over the end portion <NUM> of the collar <NUM>. Graduated markings <NUM> may be located on the end portion <NUM> of the collar <NUM>. The markings <NUM> may be calibrated to indicate the internal diameter of the opening <NUM> as the collar <NUM> is turned on the main body <NUM>. Rotating the collar <NUM> in a first direction (e.g., counterclockwise) may increase the diameter of the opening <NUM> and rotating the collar <NUM> in a second dimension (e.g., clockwise) may decrease the diameter of the opening <NUM>.

In various embodiments, the end effector <NUM> may be easily adjusted to accommodate various-sized surgical instruments/tools that may be inserted through the end effector <NUM> while maintaining a desired trajectory into a patient. Examples of such tools/instruments include, without limitation, a needle, a cannula, an awl, a drill, a screw driver, a screw, and implant, a tool for gripping or cutting, an electrode, a radiation source, and an endoscope.

The foregoing method descriptions are provided merely as illustrative examples and are not intended to require or imply that the steps of the various embodiments must be performed in the order presented. Words such as "thereafter," "then," "next," etc. are not necessarily intended to limit the order of the steps; these words may be used to guide the reader through the description of the methods.

Claim 1:
An end effector (<NUM>) with an adjustable inner diameter for a robotic-assisted surgical system (<NUM>), comprising:
a main body (<NUM>) having an opening (<NUM>) extending through the main body;
one or more members located within the main body that extend into and retract from the opening to vary a diameter of the opening through which a tool may be inserted, wherein the one or more members comprise a plurality of flutes (<NUM>) that are pivotable towards and away from an interior sidewall of the main body to vary the diameter of the opening; and
an adjustment mechanism on the end effector and coupled to the one or more members for varying the diameter of the opening, wherein the adjustment mechanism comprises a collar (<NUM>) located over the main body and coupled to the plurality of flutes such that a rotation of the collar in a first direction relative to the main body causes the plurality of flutes to pivot away from the interior sidewall of the main body to reduce the diameter of the opening, and a rotation of the collar in a second direction relative to the main body causes the plurality of flutes to pivot towards the interior sidewall of the main body to increase the diameter of the opening,
wherein the plurality of flutes (<NUM>) are adapted to guide advancement of a tool along a fixed trajectory, and to be further tightened against the tool when located within the main body (<NUM>) by rotating the collar so as to fix the longitudinal position of the tool within the main body (<NUM>).