Patent Application
20220241040
This disclosure relates to localization and robotic procedures in a surgical application and more particularly to systems and methods to perform robotic retraction and robotic distraction.
Localization systems track objects in a three dimensional space. In a surgical procedure context such as an operating room, objects may include surgical tools, and parts of patient anatomy (e.g. bones, etc.) During some surgical procedures, retraction is used to move a portion of patient anatomy. Retraction is typically maintained for a period of time as well. Distraction is a related activity to move a portion of patient anatomy, for example a bone.
Robot manipulators are used in surgery to perform all or portions of a procedure. Robot manipulators are operable to move tools, for example, via a trajectory or path, and to engage with patient anatomy when performing a portion of a procedure.
It is desirable to provide a system and method for robotic retraction and robotic distraction.
There are provided systems and methods to perform robotic retraction and robotic distraction. An example system is a localization system to automatically position a trackable surgical tool (e.g. a retractor or distractor) with respect to a patient comprising a patient tracking element adapted to be associated with a patient to provide patient pose data; and a processing unit configured to: track the poses of the patient via the patient tracking element, and the trackable surgical tool; and command a robotic manipulator to move a tip of the trackable surgical tool coupled to the manipulator from a first position, in engagement with the patient, to a second position while remaining in engagement with the patient.
In an embodiment, there is provided a method to automatically perform robotic retraction or distraction with respect to a patient. In the embodiment, the method comprises, by a processing unit: a) tracking the poses of: i) a patient via a patient tracking element adapted to be associated with a patient to provide patient pose data; and ii) a trackable tool for surgical retraction or distraction; and b) commanding a robotic manipulator to move a tip of the trackable tool coupled to the manipulator from a first position, in engagement with the patient, to a second position while remaining in engagement with the patient.
In an embodiment, there is provided a system to automatically perform robotic retraction or distraction with respect to a patient. In the embodiment, the system comprises: a) a patient tracking element adapted to be associated with a patient to provide patient pose data; and b) a processing unit configured to: (a) track the poses of: i) the patient via the patient tracking element; and ii) a trackable tool for surgical retraction or distraction; and (b) command a robotic manipulator to move a tip of the trackable tool coupled to the manipulator from a first position, in engagement with the patient, to a second position while remaining in engagement with the patient.
Retraction typically denotes an act of drawing back or pulling. Herein retraction includes other acts to move a portion of anatomy, for example, a pushing act. Also described herein are embodiments related to distraction. Distraction may reference a force applied to separate bony fragments or joint surfaces. The separation may be without rupture of binding ligaments and without displacement. Aspects and/or features described in relation to retraction apply to distraction and vice versa unless the context requires otherwise.
Optical sensor 106, in the present embodiment, is configured to couple with the patient 102 such as to a bone. In the present embodiment it is configured to couple to a pelvis (not shown) for performing a total hip arthroplasty (THA) procedure. Tracking element 108A is configured to be coupled to patient 102, for example, to attach to a bone namely a femur (not shown) for performing a total hip arthroplasty (THA) procedure. Tracking elements 108B and 108C are configured to be coupled to a respective tool as described further.
A patient tracking element may be fixed to a patient bone using bone screws or other bone engaging fasteners. A patient tracking element may be associated with a patient in other ways. For example, fiducials may be applied to skin such as using an adhesive or a cuff or sleeve; or a table or other fixed mounted tracker may be used in association with the patient, preferably where the patient (or a material portion thereof to be tracked) is maintained through the procedure to avoid repeated registration.
As is known, the pose of a tracking element is useful to determine a pose of an object to which the tracking element is coupled. A tracking element may be integrally formed with or attached to an object in a position that is known to processing unit 104. A tracking element may be attached in an unknown position that is then taught to processing unit 104.
As is known, a registration step may be performed using known methods to register a patient in 3D space to the processing unit. Registration permits system 100 to determine relative positions of objects with one another such as tools to the patient.
Processing unit 104 may be configured to receive 3D data 109 (e.g. image data, for example a segmented computerized tomography (CT) scan) representing a portion of the patient for storing to storage device 110 and for display on display device 111. Such 3D data 109 may be generated using various imaging modalities and be defined using applicable standards and/or techniques. The 3D data 109 may be registered to processing unit 104 such as using known methods to relate the 3D data 109 to the patient in 3D space and/or to the tools in 3D space. As is known, as an object is tracked, its location relative to the 3D data may be displayed (e.g via an overlay or other manner).
Processing unit 104 can be coupled to a keyboard 112 to receive user input. The keyboard and other input devices may be coupled via wired or wireless means. Input devices may include buttons, foot pedal(s), microphone, etc.
Processing unit 104 is configured to track tools for the THA procedure using tracking elements 108B and 108C. Tracking element 108B is configured to couple with a scalpel 116 and tracking element 108C is configured to couple to a surgical tool operated by a robot manipulator 120. Scalpel 116 is an example of a soft tissue cutting tool.
Robot manipulator 120 comprises articulating arms 122, 124, which are configured to move one or more tools at the distal end thereof, such as a trackable surgical retractor 126 having a retractor tip 128. Tracking element 108C is configured to couple to trackable surgical retractor 126. It will be understood that the couplings for the tracking elements may enable removing of the tracking elements and replacement at a same location. Couplings may be kinematic couples that enforce a particular coupling location or position.
In accordance with the embodiment, robot manipulator 120 comprises a tool sensor 130 (or retractor sensor) to provide tool sensor data (e.g. retractor sensor data) to processing unit 104.
In an embodiment, robot manipulator 120 comprises a processing unit 132 for operating the articulating arms 122, 124 and one or more tools at the distal end thereof such as retractor 126. Retractor sensor data may be communicated via processing unit 132 to processing unit 104 or may be communicated directly (e.g. not via processing unit 132).
In accordance with the embodiment, processing unit 104 is configured to (e.g. via software) track the poses of: the patient via the patient tracking element, and the trackable surgical retractor; and command a robotic manipulator to move a retractor tip of the trackable surgical retractor coupled to the manipulator from a first position, in engagement with the patient, to a second position while remaining in engagement with the patient. As described further, in accordance with an embodiment, the first position may be determined relative to an incision location.
In accordance with the embodiment, scalpel 106 is an incision indicating tool, when tracked during cutting or at another time (e.g. before or after cutting), the location of an incision 140 is indicated to processing unit 104. In an embodiment, processing unit 104 is configured to provide workflow to guide a surgical procedure. A portion of such workflow may relate to registration steps, retractions steps, tracking element coupling steps, etc. In an example, workflow is provided to instruct a user to operate the system 100 to capture the location of the incision (e.g. which location may be related to the patient and/or patient 3D data). A button or key, etc. may be invoked to signal the processing unit to track the incision indicating tool (e.g. its tip) as it makes the incision or traces its location.
In an example, a probe tip of a trackable probe tool (not shown) rather than a scalpel or cutting tool, is tracked and indicates the incision location 140. The trackable probe tool may trace along the incision location or indicate two or more points there along to processing unit 104 for processing to define the incision location. The trackable probe tool can indicate the incision location 140 after the incision is made, or can indicate the intended location of incision 140 before the incision is made.
In an example, the incision indicating tool may indicate a location that is less than the whole length of the actual (or proposed) incision and only indicate a portion where it is desired to have the retractor tip engage with the patient.
Accordingly, the incision indicating tool can be one of: i) a soft tissue cutting tool and the incision location is determined in response to the soft tissue cutting tool making an incision or tracing an incision; and ii) a probe and the incision location is determined in response to the probe indicating the incision location.
Retraction (and distraction) relate to moving a portion of the patient's anatomy. In the present embodiment of
In an example, retractor tip 128 engages the patient at a portion of the incision and moves to a second position while remaining engaged. The retractor 126 and its tip 128 are moved by the robot manipulator 120 as commanded. The movement is tracked (e.g. by a localization system including the processing unit 104 and tracking elements (e.g. 108A, 108C). In an example, retractor sensor data is provided to processing unit 104 for processing as further described. Via one or a series of movements between positions, the retractor tip 128 reaches the retraction point 208. In an example, the movements follow a trajectory or path (e.g in one or more segments). Movements may be in up to 6 degrees of freedom. In an example, retractor tip 128 may be positioned at an edge of a bone (e.g. the retraction point 208) and rotated against the bone as a point of leverage to further retract (and maintain retraction) of soft tissue.
At
At
In an example, during the retraction step, processing unit 104 may process tool sensor data received from tool sensor 130. Tool sensor data may provide any of: force, torque and other information regarding the retractor 126 and retractor tip 128. Tool sensor data may be evaluated (processed) to determine a measure of engagement of the retractor 126, particularly retractor tip 128, with patient 102. For example, a sudden drop (a change in value) in the level of engagement may indicate a slippage or other unintended movement of a retracted portion of patient 102 and/or retractor 126. In response, in an embodiment, processing unit 104 is configured to signal a patient engagement message, for example, an error message, in response to the patient engagement measure.
In response, in an embodiment, processing unit 104 is configured to signal or initiate a repositioning sub-step (e.g. via display 111 and or by other output device (speaker, bell, etc.) coupled to the processing unit 104 responsive to a detection of retractor slippage or other unintended movement. A threshold or safety limit to the value of the measure of engagement may be configured for use to compare with the engagement measure. The limit may be configured to vary (e.g. be dynamic) during the retraction step. For example, during a retraction step requiring less force or torque, the threshold or safety limit value may be different from a value for a retraction step requiring greater force or torque. The threshold or safety limit may be a percentage change in value, as an example, indicating a sudden drop of force. In an embodiment, the processing unit is configured to signal any of retractor movement or patient movement responsive to tracking.
Tool sensor data from sensor 130 may be a useful indicator during retractor movement. Retraction sensor data may be a useful indicator when the retractor is not moving but is maintaining a retraction. As noted, retraction point 208 indicates a surface of the bone 206. The retraction point 208 may be used to define a second position where the retractor is directed to move from a first position. In an embodiment, the processing unit may be configured to: i) define a soft tissue retraction parameter relative to the retractor sensor data; and ii) command the robotic manipulator to retract soft tissues at the retraction point in accordance with the soft tissue parameter to maintain the retraction.
In an embodiment, the soft tissue retraction parameter is defined according to more or more of:
In an embodiment, the second trackable retractor 136 is coupled (not shown) for movement by the robotic manipulator 120. In an embodiment, the second trackable retractor 136 is coupled (not shown) for movement by another robotic manipulator (not shown) in communication with processing unit 104. In an embodiment, the processing unit is configured to track each of the trackable retractors and command each of the trackable retractors for movement in engagement with the patient and between respective first and second positions.
In
In an embodiment, the retractor (or distractor) may be (initially) positioned in a manual manner through the port 504C.
As noted, processing unit 104, in an embodiment, is configured to i) receive 3D data representing a portion of the patient related to the retraction; and ii) register an association between the 3D data and the patient to determine a position of the retractor relative to the 3D data. The processing unit may be configured to receive second position data representing a location of the second position in the 3D data for the patient. That is the 3D data is associated with position data relative to a 3D position therein (a virtual position). This second position data may be used by the processing unit to command movement of the retractor in the real world 3D space of the operating room, relative to the patient. In an embodiment, the processing unit tracks the position of the retractor relative to the patient to determine an arrival of the retractor tip at the second position.
In an embodiment, the processing unit 104 is configured to display via a display device (e.g. 111) the position of the retractor 126 relative to the 3D data. For example, the position may be displayed as an overlay on 3D data of the patient.
In an embodiment, processing unit 104 is configured to command movement of the trackable retractor to position the retractor tip at the first position in engagement with the patient 102. In an embodiment, the first position is coincident with (at least a portion of) the incision location 140. The processing unit 104 is configured to command the manipulator 120 to move the retractor tip 128 to the first position.
In an embodiment, initially the processing unit 104 does not command movement to the first position. Instead the processing unit 104 commands the robotic manipulator 120 to move to engage with the retractor 126 that is manually pre-positioned with the tip 128 at the first position. The first position may be coincident with (at least a portion of) an incision location 140. Thus, prior to commanding the robotic manipulator 120 to move the retractor tip 128 (e.g. from the first position to the second position), the retractor 128 is not coupled to the manipulator 120. The processing unit 104 is configured to command the manipulator 120 to move to couple with the retractor 128 when the retractor tip 128 is pre-positioned at the first position.
In an embodiment, the processing unit 104 is configured to command movement of the retractor to an insertion depth at the first position.
In an embodiment, insertion depth is determined using tool sensor data for sensor 130 for example. Responsive to the tool sensor data, the retractor tip is positioned within the insertion at the first position until a threshold measure of engagement is achieved. For example, the threshold is responsive to a data value that indicates contact with a bone. In an embodiment, the retractor tip 128 is then moved away (e.g. backed away) from the bone, reducing the insertion depth. Thereafter the processing unit commands movement from the first position to the second position.
In an embodiment, for example as shown in
In an embodiment, insertion depth is determined using 3D data for the patient. In accordance with the registration of the patient and the 3D data and the tracking of the retractor in the patient space, in an example, the relative position of the bone and the retractor tip are determined by the processing unit 104. Movement of the retractor tip to an insertion depth (e.g. which may be a defined distance relative to the bone location, as an example) is commanded. In an embodiment, the movement (and commands therefor) is guided using the relative position.
In an embodiment, the processing unit 104 is configured to monitor sensor data, for example, retractor sensor data, during movement of the retractor. A “spike” in values of the sensor data may indicate contact with a non-soft tissue object such as a bone or a surgical tool (e.g. a femur platform (not shown) of a trackable element (e.g. 108A)). Movement of the retractor may be commanded accordingly (e.g. stop and back away, reposition, etc.).
In an embodiment, retractor sensor data comprises conductive detection or magnetometer data to detect contact or proximity with surgical tools. A responsive signal may be output. Movement of the retractor may be commanded accordingly (e.g. stop and back away, reposition, etc.).
In an embodiment, the processing unit is configured to signal any of retractor movement or patient movement responsive to tracking. For example, during movement, the display screen may change color or output a sound to indicate the retractor is moving. If a patient movement is detected, the display may be updated (e.g. with an informational warning) or a sound may be outputted or both. If the patient movement is material, the processing unit may be configured to stop a procedure step, for example, stopping a movement of the retractor, stopping a workflow, etc.
In an embodiment, the processing unit is configured to command the robot retractor to move the reactor tip along a trajectory or path to the second position.
In respective embodiments, the path is defined according to any one of: i) a path traced by a trackable tool (e.g. a probe) for receiving via the processing unit 104; ii) a path received by the processing unit 104 from a planning system (not shown); iii) one or both of a distance value and direction value relative to the first position e.g. X cm from the first position at an angle or an anatomical direction; iv) one or both of a force and/or torque value and a direction value relative to the first position (e.g. 5 N, etc.); and v) a path defined relative to standard anatomical structures (e.g. muscles) that are expected to be adjacent to the retractor tip 128.
At
Distractor 602 position (e.g. its tip 610) may be tracked as previously described in relation to retraction and the position (e.g. location or relative position) displayed. The position, for example, may be displayed relative to 3D data of the patient such as via an overlay.
It will be understood that a series of retraction or distraction sub steps may be performed to complete a retraction or distraction step. The series of sub steps may comprise respective first positions and second positions. The second position of one sub step may serve as the first position of a subsequent sub step. In the distraction example of
In accordance with an embodiment, system 100 (e.g. processing unit) is configurable to present workflow such as via display device 111 and/or other output devices and to receive input via keyboard 112 or other input devices for performing one or more steps of a surgical procedure. The workflow is configured to perform any of:
It will be understood that the trackable surgical retractors herein (e.g. 126, 136,) and the trackable surgical distractor (e.g. 506C and 602) are examples of a trackable surgical tool for retraction or distraction as is applicable and such a tool has a tool tip (e.g. 128, 138, 610). It will be understood that a distractor may be associated with a distractor sensor (not shown) like retractor sensor 130 providing distraction data (e.g. force or torque or other data). Such sensors are examples of tool sensors providing tool sensor data.
In the embodiment, at 726, operations initiate a trackable tool repositioning responsive to a detection of any of i) a tool slippage or other unintended tool movement; and ii) contact with or proximity with a bone or other surgical tool that impedes further movement. Though not shown in the flowcharts, operations of the processing unit, for example, can signal any of trackable tool movement or patient movement responsive to tracking.
At 750, operations track the position of the trackable tool relative to the patient to determine an arrival of the tool tip at the second position. Though not shown, operations can be configured to display via a display device the position of the trackable tool relative to the 3D data.
In an embodiment, the first position (e.g. in operations 700) can be coincident with at least a portion of an incision location. Though not shown in the flowcharts, operations can command the manipulator to move the tool tip to the first position.
In an embodiment, the first position (e.g. in operations 700) can be coincident with at least a portion of an incision location. Prior to commanding the robotic manipulator to move the tool tip, the trackable tool can be uncoupled to the manipulator. Though not shown in the flowcharts, operations can command the manipulator to move to couple with the trackable tool when the tip is pre-positioned at the first position.
In an embodiment, though not shown, operations can use bone contact and/or bone proximity as indicated by measured engagement using tool sensor data to guide commands for movement of the trackable tool. In an embodiment, though not shown, operations can determine insertion depth using 3D data for the patient to determine a relative position of a bone and the tool tip and commands movement of the trackable tool using the relative position.
In an embodiment, the trackable tool is a first trackable retractor of a plurality of trackable retractors for movement by the robotic manipulator or another robotic manipulator. Though not shown, operations associated with operations 700 can command each of the trackable retractors for movement in engagement with the patient and between respective first and second positions.
In an embodiment, though not shown, operations associated with operations 700 can present workflow to perform a patient procedure. The workflow can be as previously described herein.
In addition to computing device aspects, a person of ordinary skill will understand that computer program product aspects are disclosed, where instructions are stored in a non-transient storage device (e.g. a memory, CD-ROM, DVD-ROM, disc, etc.) to configure a computing device to perform any of the method aspects stored herein. A processing unit herein can include any form of programmable processor, including a programmable processor. A processing unit can include any one or more of a CPU (central processing unit), GPU (graphics processing unit), microprocessor, FPGA (field programmable gate array), ASIC (application specific integrated circuit) or other processor or unit.
Practical implementation may include any or all of the features described herein. These and other aspects, features and various combinations may be expressed as methods, apparatus, systems, means for performing functions, program products, and in other ways, combining the features described herein. A number of embodiments have been described. Nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the processes and techniques described herein. In addition, other steps can be provided, or steps can be eliminated, from the described process, and other components can be added to, or removed from, the described systems. Accordingly, other embodiments are within the scope of the following claims.
Throughout the description and claims of this specification, the word “comprise” and “contain” and variations of them mean “including but not limited to” and they are not intended to (and do not) exclude other components, integers or steps. Throughout this specification, the singular encompasses the plural unless the context requires otherwise. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.
Features, integers characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example unless incompatible therewith. All of the features disclosed herein (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing examples or embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings) or to any novel one, or any novel combination, of the steps of any method or process disclosed.
This application claims the benefit of U.S. Provisional Application No. 63/144,635, filed Feb. 2, 2021, the entire contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63144635 | Feb 2021 | US |
