Robotic port placement guide and method of use

Abstract

The present invention is entitled "ROBOTIC PORT PLACEMENT GUIDE AND METHOD OF USE". The present invention discloses a port placement guide which may include a base, a member and at least one tracking element. The base may be configured to be coupled to a surface of a patient at an initial port position of a robotic arm. The member may be coupled to the base and may include a first end and a second end opposite the first end. At least one tracking element may be coupled to the member and may be configured to allow tracking of the member relative to the initial port position.

Description

Technical Field

[0001] The present invention relates generally to the field of robotic surgery, and more particularly to systems and methods for assisting in port placement in robotic surgery. Background Art

[0002] Minimally invasive surgery (MIS) such as laparoscopic surgery involves techniques designed to reduce tissue damage during surgical procedures. For example, laparoscopic surgery typically involves making multiple small incisions in a patient's body (e.g., on the abdomen) and introducing one or more tools and at least one endoscopic camera into the patient's body through the incisions. The surgical procedure is then performed using the introduced tools and the visualization aid provided by the camera.

[0003] Generally speaking, MIS provides a variety of beneficial effects, such as reducing patient scarring, alleviating patient pain, shortening patient recovery periods, and reducing medical expenses associated with patient recovery. However, standard MIS systems have many deficiencies. For example, non-robotic MIS systems place higher demands on surgeons, in part because they require surgeons to manipulate tissues indirectly through tools in an unnatural manner. Conventional robotic MIS systems may involve an operator viewing a display showing an endoscopic camera video feed and operating remotely to manipulate tools based on commands from the operator, which can provide many of the benefits of MIS while reducing the demand on surgeons.

[0004] However, the location of the incision or port within the patient is important to the success of MIS procedures, particularly those involving robotic MIS systems. For example, a less than ideal location of the incision may impair access to the surgical work site, increase the risk of collisions and other interferences between robotic arms, and / or may not be preferred for patient-specific needs, procedure-specific needs, and / or surgeon preferences.

[0005]

[0006] It would therefore be desirable to be able to improve the process for determining effective port locations on a patient during minimally invasive surgical procedures. Summary of the invention

[0006] Described herein are systems and methods for guiding port placement on a patient and steering a robotic arm toward the port location. The systems and methods can be used, for example, in conjunction with a robotic surgical system.

[0007] In general, in some embodiments, an apparatus includes a base, a member, and at least one tracking element. The base can be configured to be coupled to a surface of a patient at an initial port position of a robotic arm (e.g., via suction or an adhesive material). The member can be coupled to the base and can include a first end and a second end opposite the first end. At least one tracking element can be coupled to the member and can be configured to allow tracking of the member relative to the initial port position.

[0008] In some embodiments, the member may be coupled to the base via a flexible joint. For example, the flexible joint may be configured to enable the member to pivot relative to the base. In some variations, the member may be rotationally fixed relative to the base.

[0009] At least one tracking element can be disposed at the second end of the member to track movement of the second end of the member relative to the initial port position. The tracking element can, for example, include infrared reflective material, electromagnetic transmitters, or any suitable tracking marker or other tracking technology. Additionally, in some variations, one or more tracking elements can be arranged on the member in a pattern (e.g., a two-dimensional pattern or a three-dimensional pattern).

[0010] In some embodiments, the device may further include a marking element configured to mark the initial port position on the patient (e.g., to identify the position as a suitable port position for a robotic surgical system). For example, the base and / or member may define an inner cavity so that the marking element can be inserted through the inner cavity. When the base is disposed on the patient, the marking element can be inserted through the inner cavity and placed in contact with the surface of the patient for marking. In some embodiments, the marking element can be engaged with a member that can be transformed between an extended configuration and a compressed configuration. When the base is coupled to the patient, the marking element can be spaced apart from the patient when the member is in the extended configuration, and can contact the patient when the member is in the compressed configuration.

[0011] In general, in some embodiments, a method includes receiving a position of at least one tracking element associated with a port placement guide positioned at an initial port location on a surface of a patient. A workspace around the initial port location can be analyzed based at least in part on the received position of the at least one tracking element. A port location can be associated with the initial port location based at least in part on the analysis of the workspace around the initial port location. A distal end of a robotic arm can be registered to the port location, and the distal end of the robotic arm can be manipulated toward the port location. Manipulating the distal end of the robotic arm toward the port location can, for example, be at least partially performed automatically (e.g., via a trajectory following algorithm) and / or assisted actuation in conjunction with manual manipulation (e.g., via one or more virtual fixtures).

[0012] In some embodiments, analyzing the workspace around the initial port position may, for example, include evaluating the initial port position relative to anatomical features of the patient and / or an entry position associated with an intended procedure (e.g., an entry position based on a template associated with an intended surgical procedure). As another example, analyzing the workspace may include evaluating the position of a second robotic arm, the position of a second initial port position, and / or the position of an actual port position (e.g., a second port position that has been selected for a surgical procedure). In some embodiments, the method may include receiving a second position associated with a port placement guide positioned at a second initial port position on the patient. For example, in these embodiments, the analysis of the workspace may be repeated for different initial port positions of the port placement guide before associating the appropriate initial port position with the actual port position used during the surgical procedure.

[0013] In general, in some embodiments, a method of using a port placement guide may include positioning the port placement guide at an initial port location on a surface of a patient and identifying a port location of a robotic arm based on an analysis of a workspace around the initial port location. In some embodiments, the method may include repositioning the port placement guide to a different initial port location (e.g., to a second initial port location). The identified port location may be marked with a marking element. After identifying the port location of the robotic arm, the port placement guide may be removed from the initial port location, and the robotic arm may be moved toward the port location. In addition, the method may also include forming an incision at the identified port location, inserting a medical device (e.g., a cannula) at least partially through the port location, and coupling the distal end of the robotic arm to the medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 is an overview of an exemplary operating room arrangement with a robotic surgical system.

[0015] Figure 2A is a schematic illustration of an exemplary variation of a robotic arm manipulator with a surgical tool, a tool driver, and a cannula. Figure 2B is a schematic illustration of one exemplary variation of a tool driver and cannula having a surgical tool. Figure 2C is a schematic illustration of an exemplary variation of a cannula and surgical tool and their degrees of freedom of movement.

[0016] Figure 3 is a cross-sectional illustration of a port placement guide according to an embodiment.

[0017] Figure 4 is a perspective illustration of a portion of a member coupled to a tracking element according to an embodiment.

[0018] Figure 5 is a perspective illustration of a portion of a member coupled to a tracking element according to an embodiment.

[0019] Figure 6 is a perspective view illustration of a tracking assembly according to an embodiment.

[0020] Figure 7 is a perspective view illustration of a tracking assembly according to an embodiment.

[0021] Figure 8 is a perspective view illustration of a tracking assembly according to an embodiment.

[0022] Fig.9A is a perspective illustration of a port placement guide in a first configuration relative to a surface of a patient according to an embodiment.

[0023] Fig. 9B is in a second configuration relative to the surface of the patient Fig.9A A perspective view illustration of a port placement guide is shown.

[0024] Fig. 9C is in a third configuration relative to the surface of the patient Fig.9A A perspective view illustration of a port placement guide is shown.

[0025] Fig.10 is a perspective view illustration of a port placement guide according to an embodiment.

[0026] Fig.11A is a cross-sectional illustration of a portion of a port placement guide according to an embodiment.

[0027] Fig. 11B is a cross-sectional illustration of a port placement guide including a marking element according to an embodiment.

[0028] Fig.12 is a cross-sectional illustration of a port placement guide according to an embodiment.

[0029] Fig.13A and Fig. 13B 2 are cross-sectional views of a base and a port placement guide including the base according to an embodiment, respectively.

[0030] Fig.14 is a cross-sectional illustration of a port placement guide according to an embodiment.

[0031] Fig.15 is a cross-sectional illustration of a port placement guide according to an embodiment.

[0032] Fig.16 is a cross-sectional illustration of a port placement guide according to an embodiment.

[0033] FIG. 17A to FIG. 17E A method of using a port placement guide to identify one or more port locations is shown according to an embodiment.

[0034] Fig.18A A robotic arm is shown in a first configuration, detached from a cannula at a port location on a patient, in accordance with an embodiment.

[0035] Fig.18B A robotic arm is shown in a second configuration coupled to a cannula at a port location on a patient in accordance with an embodiment.

[0036] FIG. 19A to FIG. 19C Various ways of delivering a workspace to a user are shown according to various embodiments.

[0037] Fig. 20 Methods in which a predicted workspace can be compared to a pre-operative model are shown, according to an embodiment.

[0038] Fig.21A and Fig. 21B A method of combining data collected by a tracking system with patient positioning information to identify a port location is shown according to an embodiment.

[0039] Fig. 22 is a perspective view illustration of a workspace including potential port placement locations according to an embodiment.

[0040] Fig.23A is an illustration of a workspace including four port placement locations according to an embodiment.

[0041] Fig. 23B is an illustration of four robotic arms arranged relative to a workspace including four port placement locations, according to an embodiment.

[0042] Fig.24 is a flow chart of a method according to an embodiment.

[0043] Fig.25 is a flow chart of a method of using a port placement guide according to an embodiment. DETAILED DESCRIPTION

[0044] Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.

[0045] Described herein are systems and methods for guiding port placement on a patient and manipulating a robotic arm toward a port location. The systems and methods may be used, for example, in conjunction with a robotic surgical system. In some embodiments, an apparatus includes a base, a member, and at least one tracking element. The base may be configured to be coupled to a patient (e.g., a surface of a patient) at an initial port location of the robotic arm. The member may be coupled to the base and may include a first end and a second end opposite the first end. At least one tracking element may be coupled to the member and may be configured to allow tracking of the member relative to the initial port location.

[0046] In some embodiments, a method includes receiving a position of at least one tracking element associated with a port placement guide positioned at an initial port location on a surface of a patient. A workspace around the initial port location can be analyzed based at least in part on the received position of the at least one tracking element. A port location can be associated with the initial port location based at least in part on the analysis of the workspace around the initial port location. A distal end of a robotic arm can be registered to the port location. The distal end of the robotic arm can be manipulated toward the port location.

[0047] In some embodiments, a method of using a port placement guide includes positioning the port placement guide at an initial port location on a surface of a patient. The port placement guide may, for example, include a base, a member, and at least one tracking element. A port location of a robotic arm may be identified based at least in part on an analysis of a workspace surrounding the initial port location. The port placement guide may be removed from the initial port location. The robotic arm may be moved toward the port location.

[0048] Overview of surgical procedures

[0049] Figure 1 is a diagram of an exemplary operating room environment having a robotic surgical system 100. Figure 1 As shown, the robotic surgical system 100 includes a user console 120, a control tower 130, and one or more robotic arms 112 located at a robotic platform 110 (e.g., a table, a bed, etc.), wherein surgical instruments (e.g., having end effectors) are attached to the distal ends of the robotic arms 112 to perform surgical procedures. The robotic arms 112 are shown as a table-mounted system, but in other configurations, the robotic arms may be mounted to a cart, ceiling or side wall, or other suitable support surface.

[0050] Generally, a user, such as a surgeon or other operator, can use the user console 120 to remotely manipulate the robotic arm 112 and / or surgical instruments (e.g., in teleoperation). The user console 120 can be located in the same operating room as the robotic system 100, such as in FIG. Figure 1As shown. In other environments, the user console 120 can be located in an adjacent or nearby room, or can be remotely operated from a remote location in a different building, city, or country, etc. The user console 120 may include a seat 122, foot-operated controls 124, one or more handheld user interface devices 126, and at least one user display 128, the at least one user display being configured to display, for example, a view of a surgical site within a patient's body (e.g., captured with an endoscopic camera). As shown in the exemplary user console 120, a user in the seat 122 and viewing the user display 128 can manipulate the foot-operated controls 124 and / or the handheld user interface device 126 to remotely control the robotic arm 112 and / or surgical instruments mounted to the distal end of the arm.

[0051] In some variations, a user may operate the surgical robotic system 100 in an "over the bed" (OTB) mode, wherein the user is on one side of the patient and simultaneously manipulates the attached robotically driven instruments / end effectors (e.g., holding the handheld user interface device 126 with one hand) and manual laparoscopic tools. For example, the user's left hand may manipulate the handheld user interface device 126 to control the robotic surgical components, while the user's right hand may manipulate the manual laparoscopic tools. Thus, in these variations, the user may perform both robotic-assisted MIS and manual laparoscopic surgery on a patient.

[0052] During an exemplary operation or surgical procedure, the patient may be prepared and covered with a drape in a sterile manner, and anesthesia may be administered. Initial entry to the surgical site may be performed manually using the robotic system 100 in a stowed configuration or a withdrawn configuration to facilitate entry into the surgical site. Once entry is completed, initial positioning and / or preparation of the robotic system may be performed. During surgery, the surgeon in the user console 120 may manipulate various end effectors and / or imaging systems using foot-operated controls 124, user interface devices 126, and / or other suitable controls to perform surgical procedures. Manual assistance may be provided by other personnel on the operating table, who may perform tasks including, but not limited to, retracting tissue, or performing manual repositioning or tool changes involving one or more robotic arms 112. Other personnel may be present to assist the user at the user console 120. When a procedure or surgical intervention is completed, the robotic system 100 and / or the user console 120 may be configured or set to a state to facilitate one or more post-operative procedures, including, but not limited to, cleaning and / or sterilization of the robotic system 100, and / or health care record entry or printout (whether electronic or hard copy), such as via the user console 120.

[0053] In some variations, communication between the robotic platform 110 and the user console 120 may be performed via a control tower 130, which may translate user commands from the user console 120 into control commands for the robot and transmit them to the robotic platform 110. The control tower 130 may transmit status and feedback from the robotic platform 110 back to the user console 120. The connection between the robotic platform 110, the user console 120, and the control tower 130 may be performed via wired and / or wireless connections, and may be proprietary and / or may be performed using any of a variety of data communication protocols. Any wired connection may be built into the floor and / or wall or ceiling of the operating room. The robotic surgical system 100 may provide video output to one or more displays, including displays in the operating room and remote displays accessible via the Internet or other networks. The video output or supply may be encrypted to ensure privacy, and all or one or more portions of the video output may be saved to a server, an electronic health record system, or other suitable storage medium.

[0054] Robotic Arms and Surgical Tools Overview

[0055] Generally speaking, a robot or robot-assisted surgical system (e.g., for performing minimally invasive surgery) may include one or more robotic arms for manipulating surgical tools, such as during minimally invasive surgery. Figure 2A As shown in the exemplary schematic diagram of , the robotic assembly 200 may include a robotic arm 210 and a tool driver 220 generally attached to the distal end of the robotic arm 210. A cannula 230 coupled to the end of the tool driver 220 may receive and guide a surgical tool 250. In addition, the robotic arm 210 may include a plurality of actuated connections to position and orient the tool driver 220.

[0056] For use in a surgical procedure, at least one robotic arm 210 may be mounted to an operating table on which a patient lies (or may be mounted to a cart, ceiling, side wall, etc., near the patient). To create a port for introducing surgical tools into the patient, a cannula assembly (e.g., cannula 230 and obturator) may be at least partially inserted into the patient through an incision or entry point in the patient (e.g., in the abdominal wall). Cannula 230 may be coupled to a distal end (e.g., a tool driver 220) during placement of such a cannula in the patient (or, in some variations, after placement). Figure 2A ). After the cannula is placed, the obturator may be removed and a connection in the robotic arm 210 may be controlled to manipulate the tool driver 220.

[0057] The proximal portion of the surgical tool 250 can be coupled to the tool driver 220 so that Figure 2BAs shown, at least a portion (e.g., a tool shaft) passes through the cannula and into the patient P. For example, a proximal portion of the surgical tool 250 may be coupled to a carriage 224 movable along a platform 222 , and the platform 222 may be coupled to a distal end of the robotic arm 210 for positioning the tool driver 220 .

[0058] When the surgical tool 250 is coupled to the tool driver 220, actuation of the robotic arm 210 and / or the tool driver 220 may provide one or more different degrees of freedom of the tool, such as Figure 2C As shown, including but not limited to movement in the yaw direction or spherical rolling (arrow A), movement of the cannula in the pitch direction (arrow B), axial rotation of the tool in the cannula (arrow C) and / or translation of the tool in the cannula (arrow D). For example, the movement in the yaw direction and / or the pitch direction can be controlled by actuating at least a portion of the robot arm 210. In some variations, the movement of the tool in the yaw direction and / or the pitch direction can be limited to movement around the spherical rotation center or the mechanical remote motion center (RCM). In addition, the axial rotation of the tool in the cannula 230 can be controlled by one or more tool driver actuators in the bracket 224 connected to the surgical tool 250 (directly or indirectly through a sterile barrier, etc.), and the translation of the tool in the cannula 230 can be controlled by one or more tool driver actuators, which cause the bracket 224 to translate along the platform 222.

[0059] The distal portion of the surgical tool 250 may include an end effector, and the actuator in the bracket 224 may be further controlled to actuate the tool 250 to perform various tasks (e.g., cutting, grasping, etc.) during the surgical procedure depending on the particular type of end effector. In addition, the tool 250 may be retracted from the aperture and separated from the tool driver 220 to be exchanged with another tool (such as another tool having an end effector with different functionality).

[0060] Port Placement Guide

[0061] As further described below, in some embodiments, a port placement guide can be used to help a user (e.g., a surgical staff or surgeon) identify a suitable or preferred port placement on the surface of a patient. Selecting a suitable or preferred port placement can, for example, be based at least in part on increasing access to the surgical site, positioning the RCM of the cannula relative to the port location, thereby reducing the risk of injury to the patient, reducing the risk of leakage at the interface between the cannula and the patient, and avoiding collisions between objects such as robotic arms. In addition, in some embodiments, a port placement guide can provide information about the port location to assist in docking the robotic arm at the port location (e.g., moving the robotic arm toward the cannula or other device at the port location). The port placement guide can, for example, reduce the surgical procedure setup time by accelerating the port location selection process, thereby reducing the risk of problems such as arm collisions or failed cannula docking attempts. In addition, in some embodiments, a port placement guide can help train users to perform robotic surgery, can help improve the consistency of port placement between different surgical procedures, and the like.

[0062] Typically, in some variations, such as Figure 3 As shown, the port placement guide 300 may include: a base 350 configured to be coupled to a surface of a patient at an initial port position of a robotic arm; a member 360 coupled to the base; and at least one tracking element 370 coupled to the member. A first end 361 of the member 360 may be coupled to the base 350 via a flexible joint 362. A second end 363 of the member 360 may be coupled to the tracking element 370. The port placement guide 300 may be coupled to a surface (e.g., skin) of a patient at a location where a user intends to place or is considering placing a port on the surface (e.g., a robotic port or a laparoscopic port).

[0063] The base is used to connect the port placement guide to the patient. The base 350 may include a fixing element 352 so that the base 350 can be attached to the surface of the patient via the fixing element 352. The fixing element 352 may include an adhesive material (e.g., a temporary glue or adhesive) so that the base 350 can be attached to the surface of the patient via the adhesive material. In some embodiments, the fixing element 352 may include a double-sided bonding tape or foam. In some embodiments, the fixing element 352 may include and / or be formed into a disc-shaped (e.g., donut-shaped) pad. The pad may include any suitable material, such as rubber, plastic, and / or metal. The pad may also include an adhesive material or be coated with an adhesive material so that the pad can be attached to the surface of the patient.

[0064] In some embodiments, although not shown, the fixing element 352 may be formed as or include one or more suction cups. The base 350 may be adhered to the surface of the patient by pressure applied to the one or more suction cups by the base 350. The one or more suction cups may be formed of any suitable material, such as, for example, rubber. In some embodiments, a medium such as saline or gel may be applied to the patient-facing surface of the one or more suction cups and / or to the patient's surface to help seal the one or more suction cups to the patient's surface. In some embodiments, an adhesive material may be disposed on the patient-facing surface of the one or more suction cups to increase the firmness of the base 350 to the patient's surface.

[0065] After attachment, the fixation element 352 can be removed from the surface of the patient. In some embodiments, the fixation element 352 can be reattached to the patient so that the guide 300 can be moved between the first position and the second position on the patient. In some embodiments, the fixation element 352 can be attached to the patient-facing side 351 of the base 350 before the guide 300 is coupled to the surface of the patient. In some embodiments, the fixation element 352 can be coupled to the surface of the patient before the base 350 of the guide 300 is attached to the fixation element 352.

[0066] In some embodiments, member 360 may be approximately centered on base 350. For example, Figure 3 As shown, member 360 can be coaxially aligned with the central axis of base 350, such that member 360 extends substantially perpendicular to base 350 when not affected by any external forces (i.e., not pivoted relative to base 350 by a user). Alternatively, member 360 can extend from base 350 at any suitable angle. Furthermore, in some embodiments, member 360 can be offset from the center relative to base 350 (e.g., a first end of member 360 can be laterally offset from the central axis of base 350). Although member 360 is shown as being elongated, member 360 can be formed into any suitable shape.

[0067] The flexible joint 362 may allow the member 360 (or a portion of the member 360) to pivot relative to the base 350. In other words, in some embodiments, the member 360 may rotate relative to the base 350 in any direction relative to a plane including the patient-facing side 351 of the base 350. For example, the flexible joint 362 may allow the member 360 to pivot relative to the surface of the patient so that when the guide 300 is coupled to the surface of the patient, the member 360 may move similarly to a medical device (e.g., a cannula) in a port at the location of the guide 300 mounted on the surface of the patient. In some embodiments, the flexible joint 362 may be disposed at the interface between the member 360 and the base 350. In some embodiments, the flexible joint 362 may be disposed along the member 360 so that an upper portion of the member 360 (e.g., a portion on a first side of the flexible joint 362) may pivot relative to a lower portion of the member 360 (e.g., a portion on a second side of the flexible joint 362).

[0068] In some embodiments, the base 350, the flexible joint 362, and the member 360 may be formed as an integral unitary structure. The base 350 and the member 360 may be formed of a more rigid material than the flexible joint 362, which may be relatively more elastic. Alternatively, in some embodiments, the flexible joint 362 may be formed as a different structure and may be coupled between the base 350 and the member 360 during assembly. For example, the flexible joint 362 may include a flexible bellows or a ball and socket coupling so that the member 360 may pivot relative to the base.

[0069] The tracking element 370 can be any suitable type of tracking element and can be formed into any suitable shape so that the position and / or orientation of the tracking element 370 in three-dimensional space can be detected and observed. For example, in some embodiments, the tracking element 370 can include an infrared reflective material so that the position of the tracking element 370 can be detected by an external optical infrared tracking system (not shown). In some embodiments, the tracking element 370 can include an electromagnetic sensor and / or an electromagnetic transmitter so that the position (e.g., X, Y, and / or Z coordinates in space) and orientation (e.g., yaw, pitch, and / or roll) of the tracking element 370 can be monitored by an electromagnetic-based tracking system (not shown). For example, the tracking element 370 can include a transmitter that emits an electromagnetic dipole field, which can be evaluated to determine the position and / or orientation of the tracking element 370. In some embodiments, the guide 300 can include multiple tracking elements, rather than a single tracking element. Figure 3 The illustrated embodiment includes a single tracking element 370. For example, the guide 300 may include two, three, four, or more than four tracking elements. Figures 4 to 8 Various tracking elements that may be included in guide 300 are shown and described in greater detail.

[0070] As described above, guide 300 can be connected to the surface of the patient. Then, member 360 can be pivoted in any suitable range relative to base 350 and patient in any suitable direction (for example, through the range of motion of flexible joint 362). Tracking system (not shown) can be used to detect the position and / or orientation of tracking element 370, and determine the position of guide 300 on the surface of the patient. For example, the tracking system can use the position of tracking element 370 at various pivot angles relative to base 350 to identify the position of guide 300. Then, the tracking system can associate guide 300 with potential port position. In some embodiments, as member 360 moves tracking element 370 within the range of motion of flexible joint 362 in all directions, a point cloud can be generated. Then the point cloud can be used to infer the position of flexible joint 362 and / or base 350. Then the guide 300 can be removed from the surface of the patient, and an incision can be made at the potential port position on the surface of the patient to form a port.

[0071] Although guide 300 is shown as including flexible joint 362, and member 360 is described as being able to pivot relative to base 350, in some embodiments, member 360 can be rotationally fixed relative to base 350. In other words, member 360 can be substantially fixed relative to base 350 (e.g., the interface between member 360 and base 350 can be substantially rigid). In such embodiments, the position and / or orientation of tracking element 370 can be detected so that the tracking system can use the position and / or orientation to identify the position of guide 300 relative to the patient.

[0072] In some embodiments, the base 350, member 360 and / or other suitable portions of the guide 300 can be configured to serve as an artificial body wall and / or provide additional structural support during a surgical procedure. For example, during some procedures, the surgical site (e.g., procedures involving natural orifices or procedures in which large incisions have been made, etc.) may not have enough body wall or patient surface, making it difficult to place a cannula at the surgical site and / or obtain a proper seal between the cannula and the patient's tissue. In some embodiments, the shape and / or size of the port placement guide can be designed to complement the surgical site. For example, the base, member and / or other suitable portions of the guide 300 (e.g., in height and / or diameter) can be large enough to receive the cannula when the guide 300 is connected to the patient's surface. In addition, in some embodiments, similar to the patient's body wall, the guide 300 can sealably engage the cannula during a surgical procedure. Figures 4 to 8 Examples of various tracking elements and tracking assemblies that may be included in a port placement guide, such as guide 300 or any of the other guides described herein, are shown. Figure 4 4 is an illustration of a portion of member 460 coupled to a tracking element 470. Member 460 can be the same or similar in structure and / or function to any of the members described herein, such as member 360. As shown, tracking element 470 can be shaped as a flat disk. Tracking element 470 can be formed of or include an infrared reflective material, for example, so that the position of tracking element 470 can be detected by an optical infrared tracking system (not shown). Figure 5 5 is an illustration of a portion of member 560 coupled to a tracking element 570. Member 560 can be the same or similar in structure and / or function to any of the members described herein, such as member 360. Tracking element 570 can be formed in a hemispherical shape or so that tracking element 570 has a rounded upper surface. Similar to tracking element 470, tracking element 570 can be formed of or include an infrared reflective material so that the position of tracking element 570 can be detected by an optical infrared tracking system (not shown). However, tracking element 570 can have any suitable shape.

[0073] although Figure 4 and Figure 5 Only one tracking element coupled to the member is shown, but in some embodiments, an array of multiple tracking elements may be provided on or near the second end of a member (such as member 360 or any of the members described herein). The array of tracking elements may be used to provide position and / or orientation information to a tracking system. For example, Figure 6 672. Tracking assembly 672 may include a plate 674 having a two-dimensional surface. Alternatively, in some variations, plate 674 may include a three-dimensional surface (e.g., a contoured surface). Plate 674 may be coupled to a second end of a member (such as any of the members described herein) via an extension member 676. In some embodiments, plate 674 may be coupled directly to the second end of the member, rather than being attached to the second end of the member via extension member 676. Figure 6 As shown, an array of tracking elements 671A-671C is disposed on a two-dimensional surface of plate 674. Each of tracking elements 671A-671C may be formed of or include an infrared reflective material such that the position of each of tracking elements 671A-671C may be detected by an optical infrared tracking system. Although three tracking elements are shown on plate 674, any suitable number of tracking elements may be disposed on plate 674.

[0074] Figure 7is an illustration of a tracking assembly 772. The tracking assembly 772 may include an array of tracking elements 771 (e.g., tracking element 771A and tracking element 771B) coupled to each other via support members 778 (e.g., support member 778A and support member 778B). The tracking assembly 772 may also include an extension member 776 such that the support member 778 may be coupled to a second end of a member of a guide (such as member 360 of the guide described above) via the extension member 776. Although the tracking assembly 772 shows an array of four tracking elements coupled to each other via four support members 778, the tracking assembly 772 may include any suitable number of tracking elements 771. Each support member 778 and tracking element 771 may be arranged at any suitable angle relative to the extension member 776 such that the tracking elements 771 are arranged in a three-dimensional array. Each of the tracking elements 771 may be formed of or include an infrared reflective material such that the position of each of the tracking elements 771 may be detected by an optical infrared tracking system.

[0075] Figure 8 872. The tracking assembly 872 may include an electromagnetic component 873. The electromagnetic component 873 may be coupled to a second end of a member of the guide (such as any of the members described herein) via an extension member 876. In some embodiments, the electromagnetic component 873 may be directly coupled to the second member of the guide, rather than including the extension member 876. The electromagnetic component 873 may include an electromagnetic sensor and / or an electromagnetic transmitter so that the position (e.g., X, Y, and / or Z coordinates in space) and / or orientation (e.g., yaw, pitch, and / or roll) of the tracking element 370 may be monitored by an electromagnetic-based tracking system (not shown). For example, the electromagnetic component 873 may include a transmitter that transmits an electromagnetic dipole field, which may be evaluated to determine the position and orientation of the electromagnetic component 873.

[0076] In some embodiments, the port placement guide can include a marking element so that the port placement location on the patient's surface can be marked (e.g., with ink or an incision) and identified (e.g., after removal of the port placement guide). 9A to 9C As shown, the port placement guide 900 may include a marking element 980. The port placement guide 900 may include any of the port placement guides described herein (such as those described above with reference to Figure 3Port placement guide 900 may include the same or similar structural and / or functional aspects as described above with respect to the port placement guide 300). For example, port placement guide 900 includes base 950, member 960 and flexible joint 962, which is arranged so that member 960 can pivot relative to base 950. Port placement guide 900 may define an inner cavity (not shown) extending from an open proximal end or second end 963 of member 960 through base 950. In other words, base 950, member 960 and flexible joint 962 may together define an inner cavity through which marking element 980 may translate. Marking element 980 may be formed and / or shaped as, for example, a pen or marker, and may include a marking tip on the distal end of marking element 980. In some embodiments, marking element 980 may be coupled to member 960 so that marking element 980 is fixed to member 960. Marking element 980 may translate relative to base 950 within member 960 and / or with the member toward and away from the surface of the patient. In some embodiments, the marking element 980 may include an adhesive element (e.g., an adhesive pad or other suitable marker) configured to be coupled to a surface of the patient to mark the port placement location. Additionally or alternatively, the marking element 980 may include a scalpel or other tool to make a small incision at the port placement location.

[0077] In use, for example, Fig.9A As shown, the guide 900 can be placed on the patient's surface S at the desired port placement location. The marking element 980 can then be translated toward the patient's surface S in the direction of arrow EE. Fig. 9B As shown, when the marking element 980 has been translated or pushed in the direction of arrow EE so that the marking tip of the marking element 980 is in marking contact with the surface S, the marking element 980 can be partially disposed within the member 960. After marking the surface S, the entire guide 900 can be moved along Fig. 9B The guide 900 can be moved in the direction of the arrow FF in the figure so that it can be removed from the surface S of the patient, leaving a mark M on the surface, as shown in FIG. Fig. 9C As shown. Fig. 9C As shown, the marking element 980 can be extended relative to the base 950 so that the flexible joint 562 stretches or extends, thereby protecting the marking tip of the marking element 980 within the member 960. An incision can then be made at the location of the marking M so that a port for inserting a medical device (e.g., a cannula and / or a trocar) is formed.

[0078] In some embodiments, the marking element can be separate from the guide and can be inserted through the guide, rather than being fixedly attached to a member or other portion of the port placement guide. Fig.10As shown, the port placement guide 1000 may include a marking element 1080 that is separable from the rest of the guide 1000. The port placement guide 1000 may include the same or similar structural and / or functional aspects as any of the port placement guides described herein. For example, the guide 1000 may include a base 1050 and a member 1060. The guide 1000 may also include a flexible joint 1062 such that a portion of the member 1060 above the flexible joint 1062 may pivot relative to the base 1050. The port placement guide 1000 may define an inner cavity 1064 extending from an open proximal end or second end 1063 of the member 1060 through the base 1050. In other words, the base 1050, the member 1060, and the flexible joint 1062 may collectively define an inner cavity through which the marking element 1080 may be inserted.

[0079] The marking element 1080 can be the same or similar in structure and / or function to the marking element 980 described above with reference to FIG. 9. For example, similar to the marking element 980 described above with reference to FIG. 9A to 9C As described, the marking element 1080 can be formed and / or shaped as, for example, a pen or a marker (or include an adhesive marker). The marking element 1080 can include a marking tip 1082 on a distal end. Additionally, the tracking element 1070 can be disposed on a proximal end of the marking element 1080. The tracking element 1070 can include or be, for example, a tracking element as described herein, such as with reference to Figures 5 to 8 Tracking element as shown and described. The shape and size of the marking element 1080 can be designed so that the marking element 1080 can be disposed within the lumen 1064 defined by the guide 1000 and translated so that the marking tip 1082 makes marking contact with the surface of the patient.

[0080] More specifically, in some embodiments, the marking element 1080 can be inserted through the lumen 1064 of the guide 1000 and moved relative to the member 1060 toward the surface of the patient, so that the marking element 1080 can mark the surface of the patient. In some embodiments, the member 1060 and / or the flexible joint 1062 can be axially compressible, so that the marking element 1080 can be inserted to engage with the member 1060 and can axially compress the guide 1000 toward the surface of the patient. Specifically, the marking element 1080 can be engaged with the member 1060, and the marking element 1080 and the member 1060 can be pressed together toward the surface of the patient, so that the member 1060 and / or the flexible joint 1062 are compressed toward the surface of the patient, and the marking tip 1082 can contact and mark the surface of the patient. The guide 1000 (or at least the marking element 1080) can then be removed from the surface of the patient, and an incision can be made at a potential port location on the surface of the patient to form a port. In some embodiments, the guide 1000 can be removed, and a port can be formed at a marked location on the surface of the patient. In some embodiments, the marking element 1080 can be retracted from the lumen 1064 of the guide 1000, thereby coupling the guide 1000 to the surface of the patient. One or more medical devices can then be inserted into the guide 1000 and contacted with the surface of the patient to form a port (e.g., make an incision) and / or perform a medical procedure through the guide 1000.

[0081] In some embodiments, when the marking element 1080 is inserted into the lumen 1064 of the guide 1000, the marking element 1080 can then be pivoted by the user in various directions relative to the base 1050 so that the tracking system can detect the position of the tracking element 1070. The tracking system can then use the position information to determine the position of the guide 1000, and therefore the location of the potential port.

[0082] In some embodiments, although not shown, the marking element 1080 may have a non-marking distal end instead of a marking tip. The marking element 1080 may then be inserted through the lumen 1064 and pivoted so that the tracking system can identify the various positions of the tracking element 1070. The tracking system may then use the position information to identify the expected position of the port. In some embodiments, after being used for tracking, the marking element 1080 may be replaced within the guide 1000 with an instrument intended to mark and / or cut into the surface of the skin. In some embodiments, as an alternative or supplement to the marking element 1080, the guide 1000 may include or receive a scalpel that may be inserted through the lumen 1064 to form a small incision at a potential port location, thereby forming a port or a portion of a port. In some embodiments, as an alternative or supplement to the marking element 1080, the guide 1000 may include a cannula that may be inserted through the lumen 1064 and through the surface of the patient, thereby forming a port in the surface of the patient at the location of the guide 1000. In some embodiments, guide 1000 can be removed from the patient's surface to allow the cannula to be positioned in the port.

[0083] In some embodiments, the marker element and the member can be configured to engage with each other so that the marker element and at least a portion of the member move in tandem toward the surface of the patient. For example, in some embodiments, the marker element can include an engagement feature to axially engage the marker element with the member so that movement of the marker element toward the surface of the patient also compresses the member toward the surface of the patient. For example, Fig.11A and Fig. 11B As shown, the port placement guide 1100 may include a marking element 1180 having an engagement feature 1184 . Fig.11A and Fig. 11B 1180 and 119. The port placement guide 1100 may include structural and / or functional aspects that are the same or similar to any of the port placement guides described herein. For example, the guide 1100 may include a base 1150, a member 1160, and a flexible joint 1162. The base 1150, the member 1160, and the flexible joint 1162 may be the same and / or similar in structure and / or function to the base 1050, the member 1060, and the flexible joint 1062, respectively. In addition, the base 1150 includes a fixing element 1152, which may be the same and / or similar in structure and / or function to any of the fixing elements described herein (such as those described above with reference to Figure 3 The guide 1100 may define a central lumen 1164 and may include a proximal end 1163 .

[0084] like Fig. 11B As shown, the marking element 1180 may include a marking tip 1182 and a tracking element 1170. The marking element 1180 may be structurally and / or functionally similar to any of the marking elements described herein (such as those described with reference to Fig.10 The marking element 1180 may be the same or similar to the marking element 1080 described above. As described above, the marking element 1180 may also include an engagement feature 1184. The engagement feature 1184 may be in the form of a protrusion, flange, ring or other suitable stopper extending from the outer surface of the marking element 1180.

[0085] like Fig.11A As shown, guide 1100 can be disposed on a surface, such as a surface of a patient. Fig. 11B As shown, the marking element 1180 can be inserted into the inner cavity 1164 of the guide 1100 so that the engagement feature 1184 can engage with the proximal end 1163 of the guide 1100. Then, the marking element 1180 can be moved from the inner cavity 1164 of the guide 1100 in the direction of arrow GG. Fig. 11B The retracted position shown moves to a surface contact position represented by dashed line 1180' so that the marking tip 1182 can contact and mark the surface of the patient. Due to the engagement between the engagement feature 1184 and the proximal end 1163 of the member 1160, as the marking element 1180 approaches the surface of the patient, the translation of the marking element 1180 in the direction of arrow GG can compress the member 1160 and / or the flexible joint 1162. After marking the surface of the patient, the marking element 1180 can be removed and the guide 1100 can remain on the surface of the skin. One or more medical devices can then be inserted into the guide 1100 and contact the surface of the patient to form a port (e.g., make an incision) and / or perform a medical procedure through the guide 1100. Alternatively, the guide 1100 can be removed before forming a port, which can be formed in the surface at the location of the mark formed by the marking element 1180.

[0086] Fig.12 Another example of a marking element and at least a portion of a member moving in tandem is shown. Fig.121 is a cross-sectional illustration of a port placement guide 1200. Aspects of the port placement guide 1200 can be identical or similar in structure and / or function to any of the port placement guides described herein. For example, the guide 1200 can include a marking element 1280. The guide 1200 can include a base 1250 and a member 1260. The base 1250 can include a fixing element 1252, which can be identical or similar to any of the fixing elements described herein (such as the fixing element 352). The member 1260 can include a first end 1261 and a second end 1263, the second end 1263 defining an opening 1266 leading to an inner cavity 1264. The marking element 1280 can be identical or similar in structure and / or function to any of the marking elements described herein. For example, the marking element 1280 can include a marking tip 1282. The opening 1266 of the second end 1263 of the member 1260 may have a diameter that is large enough to receive the marking tip 1282 of the marking element 1280 , but is smaller than the diameter of the body 1286 of the marking element 1280 .

[0087] like Fig.12 As shown, the member 1260 may have an inverted proximal end or may be manipulated so that the second end 1263 is inverted, so that the second end 1263 of the member 1260 is folded into the inner cavity 1264. The marking element 1280 can engage the second end 1263 of the member 1260, so that movement of the marking element 1280 toward the surface of the patient causes the member 1260 to fold toward the surface of the patient. The marking element 1280 can then be moved distally to make marking contact with the surface of the patient, so that as the marking element 1280 moves toward the base 1250 and ultimately to the surface of the patient, the second end 1263 of the member 1260 translates toward the first end 1261 of the member.

[0088] Fig.13A and Fig. 13B 13 and 14. The base 1350 of the port placement guide and the cross-sectional illustration of the port placement guide 1300 including the base 1350 are shown, respectively. The guide 1300 can be attached to the surface of the patient using, for example, suction. The base 1350 can have a first end 1353 and a second end 1354, and can define an inner cavity extending from the first end 1353 through the base 1350 to the second end 1354. Fig. 13B As shown, the guide 1300 may include a member 1360. The member 1360 may have a first end 1361 and a second end 1363. The member 1360 may include an engagement feature 1368 protruding from the first end 1361. The shape and size of the engagement feature 1368 may be designed so that the engagement feature 1368 can be coupled to (e.g., sealingly engaged with) the second end 1354 of the base 1350.

[0089] In use, the base 1350 can be placed on the surface of a patient. The member 1360 can be engaged with the base 1350 to define an interior cavity 1355 by engaging the engagement feature 1368 of the first end 1361 of the member 1360 with the second end 1354 of the base 1350. The member 1360 can then be pressed toward the surface of the patient so that a gaseous fluid (e.g., air) is pushed out of the interior cavity 1355 and a seal is formed between the base 1350, the member 1360, and the surface of the patient due to the suction of the base 1350 and the member 1360 on the surface of the patient.

[0090] Fig.14 14 is a cross-sectional illustration of a port placement guide 1400. The guide 1400 includes a base 1450 and a member 1460. The base 1450 includes an engagement feature 1456 and a patient-facing surface 1457. Fig.14 As can be seen in FIG. 1 , the patient-facing surface 1457 can be shaped so that the base 1450 can be coupled to the surface of the patient via suction. For example, the base 1450 can be placed at a desired location on the surface of the patient and pressed toward the surface to form a seal between the surface and the base 1450. The member 1460 having an engagement recess 1469 complementary to the engagement feature 1456 of the base 1450 can be translated in the direction of arrow HH and engaged with the base 1450.

[0091] Fig.15 is a cross-sectional illustration of a port placement guide 1500. Guide 1500 includes a base 1550. Base 1550 can be identical or similar in structure and / or function to any of the bases described herein. For example, base 1550 can include a fixing element 1552, which can be identical or similar to any of the fixing elements described herein (such as fixing element 352). Base 1550 may also include an engagement feature 1558. Engagement feature 1558 can be any suitable shape, such as a flange or a plurality of prongs. In some embodiments, base engagement feature 1558 can provide a seal around a medical tool or instrument inserted through base 1550 to prevent fluid from leaking from port P.

[0092] Base 1550 may be disposed on the patient's surface S at a location where port P is intended to be formed. In some embodiments, a marking element (not shown) including a tracking element may be engaged with base 1550 to assist a tracking system in identifying the location of the port prior to forming an incision. Fig.15As shown, once port P is formed in surface S, instrument 1540 (e.g., cannula) can be inserted through base 1550 and through port P. Instrument 1540 can define a recess 1542 corresponding to engagement feature 1558 of base 1550, so that the insertion depth of instrument 1540 is limited. For example, instrument 1540 can slide through base 1550, and engagement feature 1558 can apply pressure to the outer surface of instrument 1540. When recess 1542 of instrument 1540 reaches engagement feature 1558, engagement feature 1558 can engage recess 1542, thereby preventing instrument 1540 from moving distally into port P.

[0093] Fig.16 is a cross-sectional illustration of a port placement guide 1600. Guide 1600 includes a base 1650. Base 1650 can be the same or similar in structure and / or function to any of the bases described herein (such as base 1550). For example, base 1650 can include a fixing element 1652, which can be the same or similar to any of the fixing elements described herein (such as fixing element 352). Base 1650 can provide stress relief assistance for a medical tool or instrument inserted through base 1650 into port P. In some embodiments, base 1650 can seal around a medical tool or instrument inserted through base 1650, thereby preventing fluid from leaking from port P.

[0094] The base 1650 may define a lumen 1659 through which a medical device, such as a cannula 1640, may be inserted. The base 1650 may be disposed on the surface S of the patient at a location where the port P is intended to be formed. In some embodiments, a marking element (not shown) including a tracking element may be engaged with the base 1650 to assist the tracking system in identifying the location of the port P prior to forming the incision. Fig.16 As shown, once port P is formed in surface S, an instrument such as cannula 1640 may be inserted through base 1650 and through port P. Cannula 1640 may remain within lumen 1659 and port P and provide access to the patient for other medical instruments.

[0095] Method using port placement guide

[0096] In some embodiments, a port placement guide (such as any of the port placement guides described herein) can be used to help a user (e.g., a surgical staff or surgeon) identify a suitable or preferred port placement on a patient's surface. Suitable or preferred port placement can be based on a variety of factors, including the location of other existing or anticipated ports and the need to access other portions of the patient's surface during a procedure. Suitable or preferred port placement can also be identified to avoid collisions and interferences between robotic arms and between robotic arms and other instruments. For example, the identification can be based at least in part on the size, shape, and location of the robotic arm to be associated with the port and / or the size, shape, and location of the robotic arm that has been or is planned to be associated with other existing or anticipated ports. In some embodiments, suitable or preferred port placement can also take into account the path or trajectory that the distal end of the robotic arm (e.g., an end effector) can travel to reach the port location and / or the space occupied by each portion of the robotic arm when the distal end is manipulated to the port location. In some embodiments, suitable or preferred port placement can take into account the path or trajectory that the distal end (e.g., end effector) of each robotic arm for a procedure can travel to reach the port location and / or the space occupied by each portion of each robotic arm when the distal end is manipulated to the port location. In some embodiments, suitable or preferred port placement can also take into account patient-specific anatomical features and / or fiducials, procedure-specific needs, and personal user preferences.

[0097] In some embodiments, the computing device may be configured to determine suitable or preferred port placement on the surface of the patient and identify the port placement location for the user and / or the robotic surgical system. For example, the computing device may be a personal computer (PC), laptop computer, workstation, etc., located at a central location or distributed at multiple locations. In some embodiments, the computing device may be embodied, for example, as Figure 1The control tower 130 and / or user console 120 shown. The computing device may include at least a processor and a memory. In some embodiments, the computing device may also include a display, a graphical user interface, etc. The memory may be, for example, a random access memory (RAM), a storage buffer, a hard drive, a database, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), a solid-state drive (SSD), etc. The processor may be any suitable processor configured to run and / or execute, for example, an instruction set stored in the memory. For example, the processor may be a general-purpose processor, a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a digital signal processor (DSP), a central processing unit (CPU), an accelerated processing unit (APU), a front-end processor, a graphics processing unit (GPU), etc. In some embodiments, the memory may store instructions and / or codes to cause the processor to execute modules, processes, and / or functions, which are associated with determining a suitable or preferred port placement position, defining a digital representation of a workspace including a potential port placement position, and / or displaying a digital representation of a workspace including an existing or suggested port placement position. In some embodiments, the memory may store instructions and / or codes to cause the processor to execute modules, processes, and / or functions associated with determining and displaying appropriate or preferred robotic arm and port pairings and robotic arm trajectories and geometries. In some embodiments, the memory may store instructions and / or codes to cause the processor to execute modules, processes, and / or functions associated with aligning a port placement location with a particular robotic arm and / or manipulating the distal end of a robotic arm toward a port placement location and / or engaging it with an instrument disposed at the port placement location.

[0098] In some embodiments, the digital representation of the workspace can be a graphical representation of the surface of the patient with the marked positions, which can be presented on a display of the computing device. In some embodiments, the digital representation of the workspace can be an instruction, digital and / or machine code representation of the surface of the patient, the actual port position and / or the expected or recommended (e.g., suitable and / or preferred) port placement position. In addition, the memory can be configured to store data (e.g., in a database), such as port placement data, patient data, procedure data and / or data associated with the recommended change port placement position, as described in further detail herein.

[0099] The computing device can receive tracking data representing the position of the tracking element, can determine the position of a potential port placement location based on the position of the tracking element, can determine and / or calculate whether the potential port placement location is suitable or preferred, and if the potential port placement location is determined and / or calculated to be inappropriate or not preferred, then an alternative port placement location can be recommended. In addition, the computing device can be configured to align the port placement location and / or a path or trajectory to the port placement location with the robotic arm. In some embodiments, the computing device can be configured to manipulate the distal end of the robotic arm toward the port placement location. In some embodiments, the computing device can be configured to manipulate the distal end of the robotic arm along a specific path or trajectory. In some embodiments, the computing device can be configured to control or guide the robotic arm relative to certain areas in space (e.g., by using a virtual fixture, as further described below).

[0100] For example, in some embodiments, a user (e.g., a surgical staff or surgeon) may use a computing device to indicate an expected procedure to be performed on a patient. The computing device may include a graphical user interface so that the procedure may be indicated, for example, by selecting a procedure and / or inputting relevant information using a graphical user interface. The computing device may suggest one or more potential port locations to the user. For example, the computing device may suggest one or more potential port locations by displaying potential port placement positions via a graphical user interface on a monitor display, a graphical user interface on an augmented or virtual reality headset, an image projected onto a patient, or using any other suitable display device or method. In some embodiments, the potential port placement positions suggested may represent preferred port placements or optional port placement positions based on any suitable factors, such as, for example, the needs of a particular procedure, the port placement layout of a previous procedure, and / or the surgeon's preferences. In some embodiments, the potential port placement positions suggested in relation to the patient's anatomical landmarks may be presented to the user. In some embodiments, the user may additionally or alternatively estimate the potential port placement positions based on, for example, user knowledge and / or experience.

[0101] A user may obtain a port placement guide (such as any of the port placement guides described herein). For example, a user may remove a port placement guide and / or assemble a port placement guide from an associated package. A user may connect a port placement guide to a patient (e.g., a surface of a patient) at a potential port placement position. A computing device may be communicatively connected to a tracking system or include a tracking system so that the position of a tracking element of a port placement guide may be observed and / or determined. In some embodiments, a user may pivot a portion of a guide having a tracking element (such as a member of a guide) relative to a base of the guide so that the tracking system may receive additional position and / or orientation data for analysis by the computing device. The computing device may then use the position of the tracking element to identify the position of the port placement guide on the surface of the patient. The computing device may then analyze whether the position of the port placement guide is suitable or preferred, as further described below. If the position is suitable or preferred, the computing device may indicate to the user (e.g., using a graphical user interface) that the port placement guide is in a suitable or preferred position.

[0102] If the computing device determines that the port placement guide is not in a suitable or preferred position for the port to be formed, the computing device may suggest to the user that the port placement guide be moved to an alternative position. In some embodiments, the computing device may suggest an alternative position. The user may adjust the position of the port placement guide based on feedback received from the computing device. For example, if the computing device indicates that a first port placement position may not be suitable for the procedure, the user may move the guide to a second port placement position. The computing device may then analyze whether the second port placement position is suitable or preferred based on, for example, data received indicating the position of the tracking element. The steps of moving the port placement guide and analyzing the suitability of the position may be repeated until the computing device confirms that the position of the port placement guide on the surface of the patient (and therefore the port position) is suitable.

[0103] Any suitable number of port placement guides may be used to identify any number of port locations. In some embodiments, the same guide may be used to determine each of the port placement locations for a procedure, rather than using additional guides. For example, after determining that a particular port location is appropriate, the guide or user may mark the surface of the patient at that particular port location. The guide may then be moved to a second potential port placement location to determine the suitability of the second potential port placement location.

[0104] After determining two or more port placement locations using the computing device, the computing device can compare the suitability of all confirmed and / or remaining unconfirmed port placement locations relative to each other, relative to the operating table, and / or relative to the position of the patient on the operating table. The computing device can then recommend repositioning one or more guides or port placement locations so that, for example, the workspace is transformed into a preferred arrangement and / or potential collisions between surgical personnel and / or robotic arms are minimized or avoided during the procedure.

[0105] One or more port placement positions can be finalized and recorded by a computing device (e.g., recorded in software associated with a graphical user interface). A model (e.g., a digital representation) of a workspace can be generated and / or finalized, including the expected robotic arm and port pairing assignments. Each port placement position can be registered with a robotic arm so that the robotic arm can be manipulated toward a specific port placement position, as described below. In some embodiments, at least one specific path or trajectory for each robotic arm toward a port placement position can be generated so that, for example, the workspace is transformed into a preferred arrangement and the risk of collision between surgical arms is reduced. The computing device can provide instructions to the user to dock a specific robotic arm to a specific port. The instructions can be based on a preoperative plan and / or a generated model.

[0106] An incision can be made at the final port location to form the port, and a cannula can be inserted into the port. In some embodiments, the cannula can include a cannula docking feature (e.g., a clamp, snap or other suitable mounting member or docking feature). The distal end of the robotic arm aligned to the port can be manipulated (e.g., manually by a user and / or automatically and / or assisted by a control system as described below) and connected to the cannula at the port via the cannula docking feature. Alternatively, the distal end of the robotic arm can be connected to the cannula, and then the arm and cannula assembly can be manipulated together toward the port (e.g., manually, automatically and / or assisted as described below), after which the cannula can be inserted into the port.

[0107] In some embodiments, a port placement guide (such as any of the guides described herein) can be configured to couple to a portion of a robotic arm (e.g., to serve as a simulated intubation). For example, a port placement guide can include a guide docking feature (e.g., a clamp, snap, or other suitable mount or docking feature) configured to couple to a distal end of a robotic arm. The guide docking feature can be disposed on a member, a marking element, a base, or any suitable portion of the port placement guide. Thus, if a robotic arm is attached to a cannula positioned in a port where the guide is placed (e.g., an initial port position), the robotic arm can move the guide to, for example, simulate the behavior of the robotic arm and / or the cannula. In some embodiments, a port placement guide having a guide docking feature can be used, for example, to train users and / or plan procedures.

[0108] In some embodiments, the distal end of the robotic arm can be manually moved to the cannula docking feature by a user. Fig.18A and Fig.18B As further described, the control system may guide the distal end of the robotic arm to manually move toward the port, for example, by adjusting various torques of the robotic arm according to one or more virtual fixtures. In some embodiments, the control system may additionally or alternatively control the robotic arm to automatically follow a predetermined generated path or trajectory toward the port. It should be understood that in some embodiments, the robotic arm may be manipulated in any suitable combination (e.g., completely manually, automatically by the control system, assisted by the control system, etc.) during different parts of its movement toward the port. In some embodiments, when the robotic arm reaches the final position, the robotic arm may automatically prevent any further movement and may maintain the final position. The user may then engage the distal end of the robotic arm (e.g., the arm docking feature at the distal end) with the docking feature of the cannula by, for example, moving the cannula to the distal end of the robotic arm. In some embodiments, after docking the robotic arm to the cannula, the user may reposition the robotic arm as needed, for example, to transform the position or posture of the robotic arm to a preferred position or posture relative to the workspace and / or other robotic arms.

[0109] FIG. 17A to FIG. 17E Exemplary methods of using a port placement guide, such as any of the port placement guides described herein, are shown. Fig.17A As shown, a user may identify a desired port placement location L on a surface S of a patient (e.g., a body wall such as skin). Fig. 17BAs shown, the user can then obtain the port placement guide 1700. The port placement guide 1700 can be the same or similar to any port placement guide described herein. For example, the port placement guide 1700 can include a base 1750, a member 1760, a flexible joint 1762, and a marking element 1780. The marking element 1780 may include a tracking component 1772. As shown in 1700', the user can connect the port placement guide 1700 to the surface S at the desired port placement position L. The tracking device 1790 can be arranged so that the tracking device 1790 can detect the position of the tracking component 1772.

[0110] like Fig. 17C As shown, member 1760 of guide 1700 can pivot relative to base 1750 (and therefore relative to position L) and within any suitable range in any suitable direction (e.g., through the range of motion of flexible joint 1762). For example, member 1760 can pivot so that guide 1700 is in a second position represented by dashed line 1700' and a third position represented by dashed line 1700". Tracking device 1790 can detect the position and / or orientation of tracking element 1772 at each of these positions. In some embodiments, a processor (not shown) associated with tracking device 1790 can process position and / or orientation data (e.g., tracking data) collected by tracking device 1790 and determine position L of guide 1700 on surface S. For example, the processor can fit the tracking data to a spherical surface 1792 disposed on surface S, as shown. Fig.17D The center of the sphere having the spherical surface 1792 can be identified (eg, by a processor) as a location L, which can also be identified as an entry point for a potential port P.

[0111] Additionally, in some embodiments, a three-dimensional working space for a tool can be calculated. For example, if a particular catheter is intended to be inserted through port P, a three-dimensional working space can be calculated for the catheter, including the predicted area of ​​movement of the catheter above surface S during use of the catheter. The three-dimensional working space calculated for a particular tool can be incorporated into the suitability analysis of the port placement position by, for example, any of the devices or methods described herein.

[0112] Reference FIG. 17A to FIG. 17D The method shown and described may be performed multiple times to identify multiple port locations. For example, after identifying the location of potential port P, guide 1700 may be moved to a second desired port placement location and pivoted so that tracking device 1790 may collect tracking data associated with the second desired port placement location. A second potential port P2 may then be identified, such as Fig.17EThese steps can be repeated multiple times so that the third potential port P3 and the fourth potential port P4 are also identified on the surface S of the patient. Fig.17E Four potential port locations are depicted as being identified, but it should be understood that the method may be used to identify fewer (eg, one, two, or three) or more (eg, five, six, or more) ports.

[0113] When a potential port location has been identified as a suitable or preferred port location, the port location can be registered to one or more robotic arms (e.g., so that one or more robotic arms can be directed toward the port location). For example, in some embodiments, the coordinates of a potential port P on a surface S can be converted (e.g., by a processor) into a data format associated with a robotic arm so that the coordinates can be registered to the robotic arm for use in directing the robotic arm toward the potential port P. In some embodiments, the distal end of the robotic arm can be moved toward the port location registered to the robotic arm. In some embodiments, the distal end of the robotic arm can be coupled to a medical device (e.g., a cannula or trocar), and the robotic arm can be manipulated so that the medical device is, for example, moved to engage with the surface of a patient at the location of the potential port location or moved into a cannula or port placement guide previously located at the port location.

[0114] As a specific example, Fig.18A and Fig.18B The cannula 1840 and the robotic arm 1804 are shown in a first uncoupled configuration and a second coupled configuration, respectively. The cannula 1840 can be disposed in a port P that has been registered to the robotic arm 1804. In some embodiments, the robotic arm 1804 can be guided to the cannula 1840 along a path or trajectory T, such as Fig.18A As shown. In some embodiments, the robotic arm 1804 can be automatically driven to the cannula 1840 or port P along at least a portion of a predetermined trajectory T using a suitable control algorithm. In some embodiments, the robotic arm 1804 can be manually moved toward the cannula 1840 or port P by a user. Such manual movement can be assisted by an appropriate control system to, for example, provide gravity compensation and / or friction compensation to assist the manual movement of the robotic arm 1804. Suitable exemplary gravity compensation and friction compensation algorithms are further described in detail in U.S. Application No. 15 / 838,094, filed on December 11, 2017, entitled "ACTIVE BACK DRIVING FOR ROBOTIC ARM", which is incorporated herein by reference in its entirety.

[0115] As another example, the control system can help guide the movement of the robotic arm via one or more virtual fixtures, which can substantially prevent the arm from moving into one or more defined areas or restrict the arm to one or more defined areas (e.g., between the starting position of the robotic arm 1804 and the cannula 1840 or port P). For example, one or more virtual fixtures can be defined to represent one or more areas in which the robotic arm 1804 does not interfere with access to any other ports or the robotic arm path to these ports. In some variations, the robotic arm 1804 can be guided to the position of port P via guidance with one or more virtual fixtures that constrain the movement of the robotic arm 1804 (e.g., a task space virtual fixture applied to the arm, a joint space virtual fixture applied at the inter-joint level of the arm, etc.). Such virtual fixtures can include, for example, guiding virtual fixtures or prohibited area virtual fixtures.

[0116] In some variations, as described herein, a virtual fixture may be defined as a set of one or more boundaries of a robotic arm 1804 such that movement of the robotic arm 1804 (or a selected point thereon) is substantially constrained relative to the boundaries. For example, a user may manually manipulate and position the robotic arm 1804 (e.g., with the assistance of actuation provided by a gravity compensation and / or friction compensation control mode). In a guided virtual fixture, a control system (e.g., any control system or suitable computing device described herein) may generally allow such user-manipulated movement of the robotic arm 1804 within the boundaries of the virtual fixture while substantially preventing or blocking movement outside the boundaries. For example, movement outside the boundaries may be resisted by delivering a set of one or more resisting joint torques that are opposite to one or more force components perpendicular to a reference plane (any force component that tends to cause a portion of the robotic arm 1804 to move outside the reference plane). The control system may drive one or more joints in the robotic arm 1804 to deliver resisting joint torques according to the virtual fixture. In a forbidden region virtual fixture, the system may generally allow user-manipulated movement of the robotic arm 1804 outside a set of boundaries of the virtual fixture while substantially preventing or blocking movement within the boundaries.

[0117] In other variations, the movement of at least a portion of the robot arm 1804 can be directed to the position of port P in a trajectory following mode. In the trajectory following mode, the robot arm 1804 can move to follow one or more trajectory (e.g., Cartesian trajectory) command sequences. The trajectory command may include, for example, a velocity command (constructed according to linear and / or angular movement) or a target posture command (constructed according to the final target position and orientation of the connector and joint module). If the command is a target posture that requires a large number of connectors to move to transition from the current posture to the target posture, the control system can generate a trajectory that defines the necessary connector movement. If the command involves a target posture that is the same as the current posture, the control system can effectively generate a trajectory command, resulting in a "hold" position that complies with the command. For example, the trajectory can be based on inputs including: a velocity or posture that complies with the command (e.g., a transformation matrix, a rotation matrix, a 3D vector, a 6D vector, etc.); an arm connector to be controlled; measured joint parameters (angles, velocities, accelerations, etc.); tool parameters (type, weight, size, etc.); and environmental parameters (e.g., a predefined area where the arm connector is blocked or prohibited from entering, etc.). The control system may then use one or more algorithms to generate outputs of commanded joint parameters (position, velocity, acceleration, etc.) for the firmware and / or commanded motor currents as current feedforwards for the firmware. Suitable algorithms for determining these output commands include those based on forward kinematics, inverse kinematics, inverse dynamics, and / or collision avoidance (e.g., collisions between arm links, collisions between different instances of the robot arm, collisions between the arm and the environment, etc.).

[0118] like Fig.18B As shown, the posture or geometry of the robotic arm 1804 in the second configuration can be modeled and / or transformed to a preferred posture or geometry. For example, the posture or geometry of the robotic arm 1804 can be selected so that parts of the robotic arm 1804 (e.g., connectors and / or joints) do not obstruct access to other ports on the surface of the patient. Fig.18B As shown, after the robotic arm 1804 reaches the cannula 1840, for example, a posture 1804' can be identified for the robotic arm 1804. The robotic arm 1804 can then transition to the posture 1804' for the remainder of the procedure.

[0119] In some embodiments, the distal end of the robotic arm 1804 can be coupled to a medical device (e.g., a cannula 1840 or a trocar), and the robotic arm can be manipulated so that the medical device is, for example, moved to engage with the surface of the patient at the location of a potential port location or into a cannula or port placement guide previously located at the port location. For example, a port placement guide (such as any of the guides described herein) can be positioned on the surface of the patient. The robotic arm 1804 can engage with a docking feature of the medical instrument. The robotic arm 1804 can then be manipulated so that the medical device is manipulated to engage with or pass through the lumen of a guide positioned on the surface of the patient and contact the surface of the patient and / or enter the port.

[0120] As shown FIG. 19A to FIG. 19C As shown, the three-dimensional workspace for the intended medical device and / or robotic arm can be displayed or transmitted to the user through various graphic rendering devices. Fig.19A As shown, workspace W1 may be communicated to a user via a computer monitor 1911. Workspace W1 may include, for example, any of the port placement guides described herein.

[0121] like Fig.19B As shown, in some embodiments, the workspace W2 can be transmitted to the user U via the headset 1913. The headset 1913 can be an augmented reality or virtual reality headset. A port placement guide (such as any of the port placement guides described herein) can be positioned on the surface of the patient. The position of the port placement guide can be detected by any of the methods described herein. The user U can use the headset 1913 to visualize the workspace W2 associated with the position of the port placement guide.

[0122] like Fig.19C As shown, in some embodiments, the workspace W3 can be transmitted to the user U via light or laser projected to form a pattern or indicator directly on the surface of the patient. The light or laser can be projected from a light source LS. For example, the light or laser can be projected onto the surface to identify an area D. The area D can be associated with a procedure or action to be taken by the user U. For example, the area D can represent a suggested alternative location for placing a port placement guide (such as any of the guides described herein).

[0123] In some embodiments, such as Fig. 20As shown, the predicted workspace can be compared to the preoperative model. For example, a computing device such as any of the computing devices described herein can generate a preoperative model of a patient's surface S including potential port placement locations. After a user has placed one or more port placement guides 2002 (e.g., any of the guides described herein) on the patient's surface S, the computing device can generate a predicted workspace (shown on display 2015) based at least in part on data received from tracking elements from the one or more port placement guides. The computing device can then compare the predicted workspace to the preoperative model and can identify any differences between the predicted workspace and the preoperative model. The user and / or the computing device can then determine whether to modify the final workspace layout based on the preoperative model or to accept the predicted workspace. For example, the computing device can identify a recommended alternative port placement location AL on the surface S.

[0124] In some embodiments, pre-procedure data, in-procedure data, and / or post-procedure data can be used to generate a preoperative model or recommend adjustments to port placement or predicted workspace. For example, in-procedure data or post-procedure data collected based on a previous procedure for the same patient or a previous procedure for a different procedure can be incorporated into the analysis. This data can be used to refine algorithms for predicting, analyzing, and confirming port placement.

[0125] In some embodiments, data collected by the tracking system may be combined with patient positioning information. Fig.21A and 21B A user U is shown using a system including a display 2115 and a plurality of port placement guides (2102A and 2102B). The port placement guides may be the same and / or similar in structure and / or function to any of the guides described herein. Fig. 21B As shown, the user can position the port placement guide 2102A on the surface S of the patient P. Fig.21AAs shown, the user can be via the position of the guide 2102A represented as an indicator I on the patient's representation 2117. The patient's representation 2117 can be generated based on, for example, patient positioning information. In some embodiments, the tracking data associated with the guide 2102A can be combined by using a graphical user interface on the display 2115, so that the user can enter data including patient positioning information. For example, the user can move, scale and / or orient the patient's graphical representation relative to the graphical representation of the port on the screen. The user can also identify the patient's benchmark, such as indicating the position of the head, feet, arms and other anatomical parts and their positions relative to the port placement guide. In addition, the user can use one or more port placement guides or use three-dimensional scanning to draw the patient's surface. Then the patient model can be automatically defined based on the input data. The patient model can be confirmed or modified by the user. Additional port placement guides (such as guide 2102B) can be placed relative to other guides (for example, guide 2102A).

[0126] In some embodiments, such as Fig. 22 As shown, multiple port placements can be compared to a preoperative plan or a protocol guide. Suggestions for improving port placement can be provided to the user based on any suitable factors, such as any of the various factors described herein. Fig. 22 As shown, four potential port placement positions P1-P4 can be identified using, for example, a port placement guide (such as any of the port placement guides described herein). A suggestion can then be provided to the user to move one of the potential port placement positions (e.g., P4) to a different position L.

[0127] In some embodiments, such as Fig.23A and 23B As shown, an arm position can be generated for each identified port position. For example, Fig.23A Four port placement positions P1-P4 are shown. A model of the final robotic arm positions relative to the port placement positions within the workspace can be generated. The generated model can, for example, include preferred pairing assignments between robotic arms and port placement positions, preferred robotic arm positions, and preferred paths or trajectories to the port placement positions. Preferred pairing assignments, robotic arm positions, and / or robotic arm paths or trajectories can be identified for any suitable goal (e.g., to minimize collisions, maximize user access to specific areas of the patient) and / or based on results / data from previous surgical procedures. The pairing assignments can then be communicated to the user. As Fig. 23BAs shown, each of the robotic arms 2304A-2304D can then be manipulated toward a corresponding port placement location (e.g., one of the port placement locations P1-P4) on the patient's surface S. In some embodiments, the model can also provide a recommended sequence of events so that the robotic arms move toward each port placement location in sequence.

[0128] Fig.24 is a flow chart of method 2400 according to an embodiment. Method 2400 may include receiving, at 2402, a position of at least one tracking element associated with a port placement guide positioned at an initial port position on a surface of a patient. At 2404, a workspace around the initial port position may be analyzed based at least in part on the received position of the at least one tracking element. In some embodiments, the analysis may include evaluating the initial port position relative to at least one of an anatomical feature of the patient and an entry position associated with an intended procedure. In some embodiments, the analysis may include evaluating at least one of a position of a second robotic arm, a position of a second initial port position, and a position of a second port position. At 2406, the port position may be associated with the initial port position based at least in part on the analysis of the workspace around the initial port position. At 2408, a distal end of the robotic arm may be registered to the port position. At 2410, the distal end of the robotic arm may be manipulated toward the port position. In some embodiments, manipulating the distal end of the robotic arm may include automatically controlling the robotic arm via a trajectory following algorithm. In some embodiments, manipulating the distal end of the robotic arm may include assisted control of the robotic arm via one or more virtual fixtures. In some embodiments, a second position associated with a port placement guide positioned at a second initial port location on the surface of the patient can be received.

[0129] Fig.252500 is a flow chart of a method 2500 for using a port placement guide according to an embodiment. Method 2500 may include positioning a port placement guide at an initial port position of a patient at 2502. The port placement guide may be identical or similar in structure and / or function to any of the port placement guides described herein. For example, the port placement guide may include a base configured to be coupled to the patient and a member coupled to the base. At 2504, the port position of the robotic arm may be identified based on an analysis of the workspace around the initial port position. At 2506, the port placement guide may be removed from the initial port position. At 2508, the robotic arm may move toward the port position. In some embodiments, the port placement guide may be repositioned at a second initial port position, and the second initial port position may be identified as the port position. In some embodiments, an incision may be formed at the port position. A medical device (e.g., a cannula) may be at least partially inserted through the port position. The distal end of the robotic arm may be coupled to the medical device. In some embodiments, the patient surface at the port location can be marked via axial movement of a translating marking element through a lumen defined by a port placement guide.

[0130] Although various embodiments have been described above, it should be understood that they are presented by way of example only and not by way of limitation. Where the above method indicates that certain events occur in a certain order, the ordering of certain events may be modified. In addition, if possible, some of the events may be executed simultaneously in a parallel process, as well as sequentially as described above.

[0131] In some embodiments, the systems described herein (or any of their components) may include a non-transitory computer-readable medium (also referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. In a sense, a computer-readable medium (or processor-readable medium) is non-transitory when it does not itself include a transient propagating signal (e.g., an electromagnetic wave carrying information propagating over a transmission medium such as space or a cable). The media and computer code (also referred to as code) may be those designed and constructed for one or more specific purposes. Examples of non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as compact disks / digital video disks (CD / DVD), compact disk read-only memories (CD-ROMs), and holographic devices; magneto-optical storage media such as compact disks; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as application specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memories (ROMs), and random access memory (RAM) devices.

[0132] Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, code for generating web services, and files containing higher-level instructions executed by a computer using an interpreter. For example, embodiments may be implemented using an imperative programming language (e.g., C, Fortran, etc.), a functional programming language (Haskell, Erlang, etc.), a logical programming language (e.g., Prolog), an object-oriented programming language (e.g., Java, C++, etc.), or other suitable programming languages ​​and / or development tools. Other examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0133] Although various embodiments have been described as having particular features and / or component combinations, other embodiments are possible having any combination of features and / or components from any of the embodiments, where appropriate.

[0134] For ease of explanation, the above description uses specific nomenclature to provide a thorough understanding of the present invention. However, it is obvious to those skilled in the art that specific details are not required to implement the present invention. Therefore, the above description of specific embodiments of the present invention is provided for the purpose of illustration and description. They are not intended to be exhaustive or limit the present invention to the precise form disclosed; obviously, in view of the above teachings, many modifications and variations are possible. The embodiments are selected and described in order to best explain the principles of the present invention and its practical application, so that other technical personnel in the field can best utilize the present invention and various embodiments with various modifications suitable for the intended specific use. It is expected that the following claims and their equivalents define the scope of the present invention.

Claims

1. A device for assisting port placement in robotic surgery, the device comprising: a base configured to couple to a patient at an initial port location of the robotic arm; a member coupled to the base via a flexible joint, the flexible joint being configured to enable the member to pivot relative to the base, the member comprising a first end and a second end opposite the first end, wherein the member is transitionable between an extended configuration and a compressed configuration; at least one tracking element coupled to the member, wherein the at least one tracking element is configured to allow tracking of the member relative to the initial port position; and A marking element engaged with the member such that when the base is coupled to the patient, the marking element is spaced apart from the patient when the member is in the extended configuration and is in contact with the patient when the member is in the compressed configuration, wherein the marking element is configured to mark the initial port location on the patient.

2. The apparatus of claim 1, wherein the base is configured to be coupled to the patient via at least one of suction or an adhesive material.

3. The device according to claim 1, wherein the marking element is a pen or a marker.

4. The apparatus of claim 1, wherein the member is rotationally fixed relative to the base.

5. The apparatus of claim 1, wherein the at least one tracking element is disposed on the second end of the member, and the first end of the member is coupled to the base via the flexible joint.

6. The device of claim 1, wherein the at least one tracking element comprises an infrared reflective material.

7. The device of claim 1, wherein the at least one tracking element comprises an electromagnetic component.

8. The apparatus of claim 1, wherein the at least one tracking element comprises a plurality of tracking elements arranged in a pattern.

9. The apparatus of claim 1, wherein the base and the member together define a lumen such that when the base is disposed on the patient, a marking element can be inserted through the lumen to contact the patient.

10. The device of claim 7, wherein the electromagnetic component comprises an electromagnetic sensor or an electromagnetic transmitter.

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