Trocar with seal assembly for minimally invasive surgical applications - Patent Application 20070122999

The dual-layer seal assembly in trocars allows for efficient, simultaneous insertion of multiple instruments and cameras through a single incision, addressing inefficiencies and infection risks in traditional trocars.

JP2025532993APending Publication Date: 2025-10-03VICARIOUS SURGICAL INC
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Patent Information

Application Number
JP2025518707
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-30
Filing Date
2023-09-29
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

Traditional trocars with single-layer seals fail to maintain insufflation when no instruments are inserted, hinder simultaneous insertion of multiple instruments, and require large incisions for robotic arms and cameras, leading to inefficiency and increased infection risk.

Method used

A trocar design with a dual-layer seal assembly featuring a first and second flexible layer with individual seals, allowing radial translation to accommodate multiple instruments and maintain insufflation, and a seal support structure with channels and corrugations for flexible movement.

Benefits of technology

Enables simultaneous insertion of multiple instruments and cameras through a single incision, maintaining insufflation and reducing healing time and infection risk.

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Abstract

Disclosed herein is a trocar including a cannula and a seal assembly. The seal assembly may include a first layer of flexible material and a second layer of flexible material. The first layer may include a plurality of individual seals of the first layer, and the second layer may include a plurality of individual seals, each aligned with a corresponding one of the individual seals of the first layer. The seal assembly may include a seal support structure at least partially supported by the first layer. The seal support structure at least partially defines a plurality of channels, each corresponding to an individual seal of the first layer and an individual seal of the second layer. The seal assembly may enable sealing and maintaining insufflation before, during, and after insertion of a plurality of different instruments into the trocar.
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Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing date under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63 / 412,359, filed September 30, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Trocars are used in endoscopic surgical procedures to provide an access channel for cameras and tools to enter the surgical site. Most traditional trocars primarily accommodate one surgical instrument per incision. Because multiple tools are required to perform most endoscopic surgical procedures, surgeons must make multiple incisions using multiple different trocars to successfully complete the procedure. This process is time-consuming, resulting in slower healing times and more potential points of infection for the patient.

[0003] Critical to the safety and effectiveness of trocars for endoscopic procedures is the seal. Many conventional trocar systems have a single-layer seal. Trocars with a single-layer seal cannot adequately seal a cannula to maintain insufflation when no instruments are inserted, while allowing easy passage of materials and surgical instruments. Furthermore, conventional single-layer seal trocar designs do not allow for linear insertion of two robotic arms and a camera while maintaining a seal sufficient to maintain insufflation throughout the insertion and extraction process. Rather, large incisions are made to accommodate the insertion of the arms and camera at various angles. This time-consuming process requires a high degree of precision in trocar positioning and requires a relatively large incision.

[0004] Disclosure Overview The present disclosure provides trocars for surgical applications, methods of using trocars, and methods of manufacturing trocars. For example, the present disclosure provides trocars for use in endoscopic surgical procedures using at least one endoscopic instrument or endoscopic camera. In various embodiments, the trocar includes a central insertion shaft and a proximal end defining a proximal opening. The trocar further includes a seal assembly configured to seal the proximal opening of the cannula. The seal assembly includes a seal support structure and at least a first layer and a second layer.

[0005] In various embodiments, the seal support structure at least partially defines a plurality of channels. The first layer covers the proximal opening of the cannula. In various embodiments, the first layer has a central portion and comprises a first flexible material. The seal support structure is attached to or integral with the central portion of the first layer. The first layer further comprises a plurality of first layer individual seals. Each first layer individual seal has an opening for insertion of an endoscopic tool or instrument.

[0006] In various embodiments, the second layer includes a second flexible material and includes a plurality of second-layer individual seals. Each second-layer individual seal has an opening for insertion of an endoscopic tool or instrument. In various embodiments, each first-layer individual seal aligns with both a corresponding second-layer individual seal and a channel of the plurality of channels in the seal support structure. Furthermore, each first-layer individual seal is offset proximally or distally from a corresponding second-layer individual seal.

[0007] In various embodiments, the seal assembly is configured to allow at least a portion of the central portion of the first layer to translate radially relative to the central insertion axis, such that the seal assembly is configured to move the individual seals of the first layer and the corresponding individual seals of the second layer radially adjacent the central insertion axis of the cannula in use to align an endoscopic instrument or tool with the central insertion axis of the cannula.

[0008] In various embodiments, the first layer of the trocar further comprises one or more concentric corrugations or pleats to allow radial translation of a central portion of the first layer.

[0009] In various embodiments, the first layer of the trocar further includes a peripheral portion, and one or more concentric corrugations or pleats are disposed in the peripheral portion of the first layer and surround the central portion.

[0010] In various embodiments, each second layer individual seal comprises a slit formed in the second flexible material.

[0011] In various embodiments, the individual seals of each first layer include universal seals.

[0012] In various embodiments, the individual seals in each first layer comprise cross-slit valves or duckbill valves.

[0013] In various embodiments, the first layer further comprises a first sheet having a first flexible material and a second sheet including the first flexible material, wherein the individual seals of each first layer include a first slit in the first sheet and a second slit in the second sheet, the orientation of the first slit being different from the orientation of the second slit, thereby forming a cross slit valve.

[0014] In various embodiments, the first layer further comprises a sealing sheet made from the first flexible material, hi some embodiments, the peripheral portion of the first layer and the individual seals of each first layer are integral with the sealing sheet.

[0015] In various embodiments, the second layer comprises a second seal sheet made from a second material, hi some embodiments, each second layer individual seal is integral with the second seal sheet.

[0016] In various embodiments, the individual seals of the first layer are separable from the first layer and the individual seals of the second layer are separable from the second layer.

[0017] In various embodiments, the seal support structure includes a brace plate, the brace plate being positioned proximally relative to the central insertion axis relative to the first and second layers. In some embodiments, the brace plate being positioned distally relative to the central insertion axis relative to the first and second layers. In other embodiments, the brace plate is positioned between the first and second layers.

[0018] In various embodiments, the trocar further comprises a brace plate support layer, in which the brace plate is attached to and supported by the brace plate support layer.

[0019] In various embodiments, the brace plate support layer has a central portion and a peripheral portion, and the brace plate support layer includes one or more concentric corrugations or pleats disposed in the peripheral portion and surrounding the central portion.

[0020] In various embodiments, the seal support structure comprises or further comprises one or more multi-lobe plates, hi some embodiments, each lobe defines an opening corresponding to one of the plurality of holes.

[0021] In various embodiments, the seal support structure of the trocar comprises a plurality of plates.

[0022] In various embodiments, the first layer of the trocar is disposed between a first plate of the plurality of plates and a second plate of the plurality of plates.

[0023] In various embodiments, the second layer is disposed between a second plate of the plurality of plates and a third plate of the plurality of plates.

[0024] In various embodiments, the first layer and the second layer are held between a first plate of the plurality of plates and a second plate of the plurality of plates.

[0025] In various embodiments, the seal support structure includes a first plate including a plurality of holes each defining a portion of a corresponding channel in the plurality of channels.

[0026] In various embodiments, the seal support structure further comprises a second plate, the second plate including at least one hole connecting with the plurality of channels.

[0027] In various embodiments, the seal support structure is at least partially supported by the first layer.

[0028] In various embodiments, the second layer covers the proximal opening of the cannula, hi such embodiments, the second layer supports or partially supports the seal support structure.

[0029] In various embodiments, the second layer has a central portion and a peripheral portion, in such embodiments, the second layer includes one or more concentric corrugations or pleats formed in the peripheral portion surrounding the central portion.

[0030] In various embodiments, the second layer is positioned proximally relative to the central insertion axis relative to the first layer.

[0031] In various embodiments, the second layer is positioned distally relative to the central insertion axis relative to the first layer.

[0032] The present disclosure provides another embodiment of a trocar for use in an endoscopic surgical procedure employing at least one endoscopic instrument or endoscopic camera. For example, the present disclosure provides a trocar having a cannula having a central insertion axis and a proximal end defining a proximal opening. The trocar further includes a seal assembly configured to seal the proximal end of the cannula. In various embodiments, a first layer of the seal assembly covers the proximal opening of the cannula. The first layer of the seal assembly has a central portion and includes a first flexible material. The first layer includes a plurality of first-layer individual seals in the central portion. Each first-layer individual seal has an opening for insertion of an endoscopic instrument or endoscopic camera.

[0033] The trocar seal assembly further includes a second layer including a second flexible material. The second layer further includes a plurality of second-layer individual seals. Each second-layer individual seal has an opening for insertion of an endoscopic tool or instrument. Furthermore, each first-layer individual seal is aligned with a corresponding second-layer individual seal. Each first-layer individual seal is offset proximally or distally from a corresponding second-layer individual seal relative to the central insertion axis.

[0034] Additionally, the seal assembly is configured to allow at least a portion of the central portion of the first layer to translate radially relative to the central insertion axis such that the central portion moves the individual seals of the first layer and the corresponding individual seals of the second layer radially adjacent the central insertion axis of the cannula in use to align an endoscopic instrument or tool with the central insertion axis of the cannula.

[0035] In various embodiments, the first layer, the second layer, or both layers of the trocar at least partially define multiple lumens.

[0036] In various embodiments, the trocar further comprises a seal support structure having a central bore, which in some embodiments corresponds to a central portion of the first layer. Furthermore, the seal support structure is affixed, directly or indirectly, to the first layer. Additionally, the seal support structure is also at least partially supported by the first layer.

[0037] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawings]

[0038] The novel features of the present invention are set forth with particularity in the appended claims. These and other features and advantages of the present invention will be more fully understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which like reference characters refer to like elements throughout the various views.

[0039] To assist those skilled in the art in making and using the presently disclosed trocar, reference is made to the accompanying drawings.

[0040] [Figure 1] 1 illustrates a schematic diagram of a surgical robotic system, according to some embodiments. [Figure 2A] FIG. 1 illustrates a perspective view of a patient cart including a robotic support system coupled to a robotic subsystem of a surgical robotic system, according to some embodiments. [Figure 2B] FIG. 1 is a perspective view of an exemplary operator console of the presently disclosed surgical robotic system, according to some embodiments. [Figure 3A] 1A and 1B schematically illustrate a side view of a surgical robotic system for performing a surgical procedure within an internal cavity of a subject, according to some embodiments. [Figure 3B] 3B schematically illustrates a top view of a surgical robotic system for performing a surgical procedure within an internal cavity of the object of FIG. 3A, according to some embodiments. [Figure 4A] FIG. 1 illustrates a perspective view of a single robotic arm subsystem or subassembly, according to some embodiments. [Figure 4B] FIG. 4B is a side perspective view of a single robotic arm of the single robotic arm subsystem of FIG. 4A, according to some embodiments. [Figure 5] FIG. 10 illustrates a front perspective view of a camera assembly and a robotic arm assembly, according to some embodiments. [Figure 6] FIG. 1 is a perspective view of a trocar according to some embodiments of the present disclosure. [Figure 7] 7 is a cross-sectional view of a proximal portion of the trocar of FIG. 6 in accordance with an embodiment of the present disclosure. [Figure 8] 1 shows a cross-sectional view of a trocar according to some embodiments of the present disclosure. [Figure 9] FIG. 9 is a perspective view of the proximal end of the trocar of FIG. 8. [Figure 10] 9 is a perspective view of the proximal end of the trocar of FIG. 8 with the outer cannula cap and mounting adapter omitted for illustrative purposes. [Figure 11A] FIG. 9 is an exploded perspective view of the seal assembly of the trocar of FIG. 8. [Figure 11B] FIG. 10 is an exploded perspective view of a seal assembly of a trocar, according to some embodiments. [Figure 11C] 1 includes an image of a leaflet that can be inserted into a trocar, according to some embodiments. [Figure 12] FIG. 10 is a cross-sectional view of the proximal end of a trocar according to another embodiment. [Figure 13] FIG. 13 is a proximal end view of the mounting bracket and outer cannula cap attached to the trocar of FIG. 12. [Figure 14] 1 includes an image of a separate first layer valve created by cutting slits in each of two flexible sheets, according to one embodiment. [Figure 15] FIG. 10 is a perspective view of a trocar including a brace plate attached to a flexible layer, according to some embodiments. [Figure 16]FIG. 17 is a perspective view of a brace plate attached to the flexible layer of FIG. 16. [Figure 17] FIG. 1 is a perspective view of a trocar including a bellows plate, according to some embodiments. [Figure 18A] FIG. 10 is a perspective view of a trocar cap including a sliding support clip for use with a trocar, according to some embodiments. [Figure 18B] FIG. 18B is a top view of the trocar cap of FIG. 18A. [Figure 18C] 13 is an image of a top view of a prototype trocar cap including a sliding support clip attached to a trocar, according to some embodiments. [Figure 19A] FIG. 10 is a side view of a cannula including a smoke evacuation lumen and a smoke evacuation port or connection, according to some embodiments. [Figure 19B] FIG. 19B is a side cross-sectional view of the cannula of FIG. 19A. [Figure 19C] FIG. 19B is a side cross-sectional view of the proximal portion of the cannula of FIG. 19A. [Figure 20A] FIG. 1 is a perspective view of a trocar including a trocar funnel with a separate seal, according to some embodiments. [Figure 20B] FIG. 20B is an exploded perspective view of the trocar of FIG. 20A. [Figure 20C] FIG. 20B is a perspective view of the cannula body of the trocar of FIG. 20A. [Figure 20D] 20B is a cross-sectional view of the trocar funnel of the trocar of FIG. 20A. [Figure 21A] 1 is an exploded schematic view of a trocar including an integrated flexible seal piece, according to some embodiments. FIG. [Figure 21B] FIG. 21B is a schematic side view of the trocar of FIG. 21A showing the docketing interface. [Figure 21C] 21B is a schematic perspective view of the cannula body of the trocar of FIG. 21A. [Figure 21D] 21B is a schematic perspective view of a sealing piece of the trocar of FIG. 21A. [Figure 21E] 21B is a schematic cross-sectional view of an individual seal of the seal piece of FIG. 21A. [Figure 21F] 21B is a schematic perspective view of the guide cap of the trocar of FIG. 21A. [Figure 22A] 1 is a schematic cross-sectional side view of a rotating seal used to seal against an instrument inserted into a trocar, according to some embodiments. [Figure 22B] 22B is a schematic cross-sectional side view of the rotating seal, instrument, and trocar of FIG. 22A after the instrument has been further inserted and the seal is fully seated within the trocar. [Figure 22C] 1 is a schematic cross-sectional side view of multiple rotating seals and an instrument being inserted into a trocar, according to some embodiments. [Figure 23A] FIG. 12 illustrates a front perspective view of a cork connectable to a camera support tube insertable into a trocar, according to some embodiments. [Figure 23B] FIG. 23B is a side view of the cork of FIG. 23A. [Figure 23C] FIG. 23B is a rear perspective view of the cork of FIG. 23A. [Figure 23D] FIG. 23B is another side view of the cork of FIG. 23A. [Figure 24] FIG. 23B is a perspective view of the cork of FIG. 23A positioned around a support tube, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0041] While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It will be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0042] As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. Furthermore, the use of the term "comprising," as well as other forms such as "include" and "included," is not limiting.

[0043] In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of "or" means "and / or" unless specifically stated otherwise. Furthermore, as used herein, the terms "or" and "and / or" include any and all combinations of one or more of the associated listed items.

[0044] The terms "endoscopic camera" and "camera," as used herein with respect to insertion into and through a trocar or cannula, should be interpreted to include a camera unit, camera assembly, camera body, camera module, or other structure, device, or system including at least one imaging device configured to be inserted completely into an internal cavity of a body via a trocar or cannula, or portions of the foregoing configured to be inserted completely into an internal cavity of a body via a trocar or cannula. As used herein with respect to insertion into and through a trocar or cannula, an endoscopic camera or camera may include multiple imaging devices, which may include, but are not limited to, imaging devices for light in the visible spectrum, light in the invisible spectrum, or both.

[0045] As used herein with respect to insertion into a trocar or cannula, the term support shaft or support tube refers to a structure that extends through the trocar or cannula and supports a tool, instrument, robotic arm, or camera that is inserted completely into an internal body cavity. The disclosure herein regarding support tubes should be understood to be applicable to support shafts.

[0046] As used herein, "endoscopic instrument" and its plural "endoscopic instruments" may refer to any of a variety of instruments and tools used by a surgeon during endoscopic surgery that are inserted into a surgical site or internal body cavity through a trocar. For example, "endoscopic instrument" may include, but is not limited to, endoscopic cameras, needles, needle holders, needle drivers, graspers, hooks, blades, forceps, loops, shears, scissors, injection tools, suction devices, wound closure devices, staples, ligation devices, electrodes, and electrocautery tools.

[0047] As used herein, "proximal" refers to being relatively closer to the surgeon and farther from the patient's internal cavity in use, and "distal" refers to being relatively farther from the surgeon and adjacent to or within the patient's internal cavity in use.

[0048] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0049] Unless specifically stated or apparent from the context, the term "about" as used herein is understood to mean within normal tolerances in the art, for example, within two standard deviations of the mean. "About" may be understood to mean within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise apparent from the context, all numerical values ​​provided herein are modified by the term "about."

[0050] When an amount, concentration, or other value or parameter is given as either a range, a preferred range, or a list of upper and lower preferred values, this should be understood to specifically disclose all ranges formed from any pair of any upper or preferred value and any lower or preferred value, regardless of whether the ranges are separately disclosed. When a range of numerical values ​​is recited herein, unless otherwise specified, it is intended that the range include its endpoints, and all integers and fractions within the range. The scope of the present invention is not intended to be limited to the specific values ​​recited when defining the range.

[0051] Although exemplary embodiments are described herein or in documents incorporated by reference as employing multiple units to perform exemplary processes, it is understood that exemplary processes may also be performed by one or more modules. Furthermore, the term controller / control unit is understood to refer to a hardware device, including a memory and a processor, specifically programmed to perform processes according to some embodiments described herein. In some embodiments, the memory is configured to store modules, and the processor is specifically configured to execute the modules to perform one or more processes described further below. In some embodiments, multiple different controllers or control units, or multiple different types of controllers or control units, may be employed to perform one or more processes. In some embodiments, different controllers or control units may be implemented in different portions of a surgical robotic system.

[0052] While exemplary embodiments of trocars are described herein, those skilled in the art will recognize that the embodiments are not limited to the exemplary embodiments. Those skilled in the art will further recognize that the presently disclosed trocars can be used as surgical adjuncts for a variety of indications, patients, and procedures. Additionally, the components of the exemplary trocars and methods of using the trocars are not limited to the exemplary embodiments described below.

[0053] Embodiments of the present disclosure provide trocars for surgical applications (e.g., endoscopic surgical applications) and methods of using the trocars. In some embodiments, the trocars are configured for use in an endoscopic surgical procedure in which at least one endoscopic instrument or an endoscopic camera is inserted through the trocar. In some embodiments, the trocars are configured for use in an endoscopic surgical procedure in which at least two endoscopic instruments are inserted through the trocar. In some embodiments, the trocars are configured for use in an endoscopic surgical procedure in which at least one endoscopic instrument and an endoscopic camera are inserted through the trocar. In some embodiments, the trocars are configured for use with a surgical robotic system including at least one robotic arm and at least one camera operating through the same trocar. In some embodiments, the trocars are configured for use with a surgical robotic system including at least two robotic arms and at least one camera operating through the same trocar.

[0054] Before providing specific descriptions of trocar, cannula, and seal embodiments with respect to Figures 6-22C, surgical robotic systems with which trocar embodiments may be used or may be used within are described below with respect to Figures 1-5. Those skilled in the art considering this disclosure will understand that the embodiments described herein are not limited to use with the surgical robotic systems described with respect to Figures 1-5, but may be used with other surgical robotic systems and in surgical procedures that do not use a surgical robotic system or that use only some of the robotic components.

[0055] 1.Surgical Robot System Some embodiments may be used with a surgical robotic system. A system for robotic surgery may include a robotic subsystem. A robotic subsystem, as used herein, includes at least a portion that can be inserted into a patient via a trocar through a single incision point or site. The portion inserted into the patient via the trocar is small enough to be deployed in vivo at a surgical site and is sufficiently maneuverable when inserted into the body to be able to move within the body to perform various surgical procedures at multiple different points or sites. The portion inserted into the body that performs a functional task may be referred to as a surgical robot module or a surgical robot unit. A surgical robot module or a surgical robot unit may include multiple different sub-modules, sub-units, or portions that can be separately inserted into a trocar. A surgical robot module may include multiple separate robotic arms that can be deployed into the patient along different or separate axes. Furthermore, a surgical camera assembly may also be deployed along a separate axis. Thus, a surgical robotic module employs multiple different components, such as a pair of robotic arms and a surgical or robotic camera assembly, each of which can be deployed along a different axis and is separately operable, steerable, and movable. A robotic arm and camera assembly that are disposable along separate steerable axes are referred to herein as a split-arm (SA) architecture. The SA architecture is designed to simplify and increase the efficiency of insertion of robotic surgical instruments through a single trocar at a single insertion site, while also assisting in the deployment of the surgical instruments to a surgical-ready state and their subsequent removal through the trocar. As an example, surgical instruments can be inserted through the trocar to access a patient's abdominal cavity and perform surgery in vivo. In some embodiments, a variety of surgical instruments can be used or employed, including, but not limited to, robotic surgical instruments and other surgical instruments known in the art.

[0056] The systems, devices, and methods disclosed herein may be incorporated into and utilized in conjunction with, for example, the robotic surgical devices and related systems disclosed in U.S. Patent No. 10,285,765 and PCT Patent Application No. PCT / US2020 / 39203, and / or the camera assemblies and systems disclosed in U.S. Patent Publication No. 2019 / 0076199, and / or the systems and methods for exchanging surgical tools in an implantable surgical robotic system disclosed in PCT Patent Application No. PCT / US2021 / 058820, the entire contents and teachings of which are incorporated herein by reference. The surgical robot module may be part of a robotic subsystem of a surgical robotic system. The surgical robotic system may include a surgeon workstation or operator console including appropriate sensors and displays, and in some embodiments, a robotic support system (RSS) for interacting with and supporting the robotic subsystem. The robotic subsystem, in some embodiments, includes a motor module and a surgical robot module, including one or more robotic arms and one or more camera assemblies. The robotic arms and camera assemblies may form part of a single-axis robotic system, a split-arm (SA) architecture robotic system, or other arrangements. The robotic support system can provide multiple degrees of freedom so that the surgical robot module can be maneuvered to a single position or multiple different positions within a patient. In one embodiment, the robotic support system can be attached directly to the operating table or to the floor or ceiling in the operating room. In another embodiment, attachment is achieved by various fastening means, including, but not limited to, clamps, screws, or combinations thereof. In other embodiments, the structure may be upright. The robotic support system can attach a motor assembly coupled to the surgical robot module, including the robotic arms and camera assemblies. The motor assembly can include gears, motors, drivetrains, electronics, etc. for powering the components of the surgical robot unit.

[0057] The robotic arm and camera assembly are capable of multiple degrees of freedom of movement. According to some embodiments, when the robotic arm and camera assembly are inserted into a patient through a trocar, they are capable of movement in at least axial, yaw, pitch, and roll directions. The robotic arm is designed to incorporate and utilize a multi-degree of freedom of movement robotic arm having an end effector attached to its distal end that corresponds to a user's wrist region or joint. In other embodiments, the working end (e.g., end effector end) of the robotic arm is designed to incorporate, use, or employ other robotic surgical instruments, such as, for example, the surgical instruments described in U.S. Publication No. 2018 / 0221102, the entire contents of which are incorporated herein by reference.

[0058] 1 is a schematic diagram of a surgical robotic system 10 in which aspects of the present disclosure may be employed according to some embodiments. The surgical robotic system 10 includes an operator console 11 and a robotic subsystem 20 according to some embodiments.

[0059] The operator console 11 includes a display device or unit 12, an image computing unit 14 (which may be a three-dimensional (3D) computing unit), a hand controller 17 having a sensing and tracking unit 16, and a computing unit 18. Additionally, the operator console 11 may include a foot pedal array 19.

[0060] The display unit 12 may be any selected type of display for displaying information, images, or video generated by the image computation unit 14, the computation unit 18, and / or the robotic subsystem 20. The display unit 12 may include or form part of, for example, a head-mounted display (HMD), an augmented reality (AR) display (e.g., an AR display, or AR glasses combined with a screen or display), a screen or display, a two-dimensional (2D) screen or display, a three-dimensional (3D) screen or display, or the like. The display unit 12 may also include an optional sensing and tracking unit 16A. In some embodiments, the display unit 12 may include an image display for outputting images from a camera assembly 44 (see FIG. 1 ) of the robotic subsystem 20.

[0061] In some embodiments, if the display unit 12 includes an HMD device, an AR device that senses head position, or another device with an associated sensing and tracking unit 16A, the HMD device or head tracking device generates tracking and position data 34A that is received and processed by the image computation unit 14. In some embodiments, the HMD, AR device, or other head tracking device can provide an operator (e.g., a surgeon, nurse, or other suitable medical professional) with a display at least partially coupled to or attached to the operator's head, a lens that enables a focused view of the display, and a sensing and tracking unit 16A for providing position and orientation tracking of the operator's head. The sensing and tracking unit 16A can include, for example, an accelerometer, a gyroscope, a magnetometer, a motion processor, infrared tracking, eye tracking, computer vision, emitting and sensing an alternating magnetic field, and any other method of tracking at least one of position and orientation, or any combination thereof. In some embodiments, the HMD or AR device can provide image data from a camera assembly 44 to the operator's right and left eyes. In some embodiments, to maintain the operator's virtual reality experience, the sensing and tracking unit 16A may track the position and orientation of the operator's head and generate tracking and position data 34A, which may then be relayed to the image calculation unit 14 and / or the calculation unit 18 directly or via the image calculation unit 14.

[0062] The hand controller 17 is configured to sense the movement of the operator's hand and / or arm to operate the surgical robotic system 10. The hand controller 17 may include a sensing and tracking unit 16, circuitry, and / or other hardware. The sensing and tracking unit 16 may include one or more sensors or detectors that sense the movement of the operator's hand. In some embodiments, the one or more sensors or detectors that sense the movement of the operator's hand are disposed within a pair of hand controllers that are held by or engaged with the operator's hands. In some embodiments, the one or more sensors or detectors that sense the movement of the operator's hand are coupled to the operator's hand and / or arm. For example, sensors of the sensing and tracking unit 16 may be coupled to regions of the hand and / or arm, such as the fingers, wrist region, elbow region, and / or shoulder region. If an HMD is not used, in some embodiments, additional sensors may also be coupled to the operator's head and / or neck region. If the operator uses an HMD, eye, head, and / or neck sensors and associated tracking technology may be incorporated into or used within the HMD device and, as described above, may therefore form part of optional sensor and tracking unit 16A. In some embodiments, sensing and tracking unit 16A may be external and coupled to hand controller 17 via electrical components and / or mounted hardware. In some embodiments, optional sensor and tracking unit 16A may sense and track movement of one or more of the operator's head, the operator's eyes, or at least a portion of the operator's neck based at least in part on imaging of the operator, in addition to, or instead of, sensors attached to the operator's body.

[0063] In some embodiments, the sensing and tracking unit 16 may use sensors coupled to the operator's torso or any other body part. In some embodiments, the sensing and tracking unit 16 may use, in addition to sensors, an inertial momentum unit (IMU) having, for example, an accelerometer, a gyroscope, a magnetometer, and a motion processor. The addition of a magnetometer may reduce sensor drift around the vertical axis. In some embodiments, the sensing and tracking unit 16 also includes sensors placed within surgical materials such as gloves, surgical scrubs, or a surgical gown. The sensors may be reusable or disposable. In some embodiments, the sensors may be disposed external to the operator, such as in a fixed location in a room such as an operating room. The external sensors 37 may generate external data 36 that may be processed by the computing unit 18 and thus used by the surgical robotic system 10.

[0064] The sensors generate position and / or orientation data indicative of the position and / or orientation of the operator's hands and / or arms. The sensing and tracking units 16 and / or 16A may be utilized to control the movement (e.g., change in position and / or orientation) of the camera assembly 44 and the robotic arm 42 of the robotic subsystem 20. The tracking and position data 34 generated by the sensing and tracking units 16 may be communicated to the computing unit 18 for processing by at least one processor 22.

[0065] The computing unit 18 may determine or calculate the position and / or orientation of the operator's hands or arms, and in some embodiments, the operator's head, from the tracking and position data 34 and 34A and communicate the tracking and position data 34 and 34A to the robotic subsystem 20. The tracking and position data 34, 34A may be processed by the processor 22 and stored, for example, in the storage unit 24. The tracking and position data 34 and 34A may also be used by the control unit 26, which may responsively generate control signals to control the movement of the robotic arm 42 and / or the camera assembly 44. For example, the control unit 26 may change the position and / or orientation of at least a portion of the camera assembly 44, at least a portion of the robotic arm 42, or both. In some embodiments, the control unit 26 may also adjust the pan and tilt of the camera assembly 44 to follow the movement of the operator's head.

[0066] The robotic subsystem 20 may include a robotic support system (RSS) 46 having a motor unit 40 and a trocar 50 or trocar mount, a robotic arm 42, and a camera assembly 44. The robotic arm 42 and camera assembly may collectively be referred to as a surgical robot module or a surgical robot unit. The robotic arm 42 and camera assembly 44 may form part of a single support axis robotic unit such as that disclosed and described in U.S. Pat. No. 10,285,765, or may form part of a split-arm (SA) architecture robotic system such as that disclosed and described in PCT Patent Application No. PCT / US2020 / 039203, both of which are incorporated herein by reference in their entireties.

[0067] The robotic subsystem 20 may employ multiple distinct robotic arms deployable along different or separate axes. In some embodiments, a camera assembly 44, which may employ multiple distinct camera elements, may also be deployed along a common, separate axis. Thus, the surgical robot system 10 may employ multiple distinct components, such as a pair of distinct robotic arms and camera assemblies 44 deployable along different axes. In some embodiments, the robotic arm 42 and camera assembly 44 are independently operable, steerable, and movable. The robotic subsystem 20, including the robotic arm 42 and camera assembly 44, is disposable along separate operable axes and is referred to herein as an SA architecture. The SA architecture is designed to simplify and increase the efficiency of insertion of robotic surgical instruments through a single trocar at a single insertion point or site, while also assisting in the deployment of the surgical instruments into a surgical-ready state and subsequent removal of the surgical instruments through the trocar 50, as further described below.

[0068] The RSS 46 may include a motor unit 40 and a trocar 50 or trocar mount. The RSS 46 may further include a support member coupled to its distal end to support the motor unit 40. The motor unit 40 may in turn be coupled to each of the camera assembly 44 and the robotic arm 42. The support member may be configured and controlled to move one or more components of the robotic subsystem 20 linearly or in any other selected direction or orientation. In some embodiments, the RSS 46 may be upright. In some embodiments, the RSS 46 may include a motor unit 40 coupled at one end to the robotic subsystem 20 and at an opposite end to an adjustable support member or element.

[0069] The motor unit 40 may receive control signals generated by the control unit 26. The motor unit 40 may include gears, one or more motors, a drive train, electronics, etc. for powering and driving the robotic arm 42 and the camera assembly 44, individually or together. The motor unit 40 may also provide mechanical power, electrical power, mechanical communications, and electrical communications to the robotic arm 42, the camera assembly 44, and / or the RSS 46 and other components of the robotic subsystem 20. The motor unit 40 may be controlled by the computing unit 18. Thus, the motor unit 40 may generate signals to control one or more motors, which in turn can control and drive not only the camera assembly 44 but also the robotic arm 42, including, for example, the position and orientation of each articulating joint of each robotic arm. The motor unit 40 may further provide translational or linear degrees of freedom primarily utilized to insert and remove each component of the robotic subsystem 20 through the trocar 50. The motor unit 40 may also be used to adjust the insertion depth of each robotic arm 42 and camera assembly 44 as they are inserted into the patient 100 through the trocar 50 .

[0070] The trocar 50 is a medical device that, in some embodiments, may consist of an obturator (which may have a sharp or non-bladed tip of metal or plastic), a cannula (essentially a hollow tube), and a seal. The trocar may be used to place at least a portion of the robotic subsystem 20 within an internal cavity of a subject (e.g., a patient) to insert and / or withdraw gases and / or fluids from the body cavity. The robotic subsystem 20 may be inserted through the trocar to access the patient's body cavity and perform surgery in vivo. In some embodiments, the robotic subsystem 20 of the present invention may be supported, at least in part, by a trocar 50 or trocar mount with multiple degrees of freedom so that the robotic arm 42 and camera assembly 44 may be maneuvered to a single position or multiple different positions within the patient. In some embodiments, the robotic arm 42 and camera assembly 44 may be supported by a trocar 50 or trocar mount with multiple degrees of freedom so that the robotic arm 42 and camera assembly 44 may be maneuvered to a single position or multiple different positions within the patient.

[0071] In some embodiments, the RSS 46 may further include an optional controller for processing input data from one or more of the system components (e.g., the display 12, the sensing and tracking unit 16, the robotic arm 42, the camera assembly 44, etc.) and for generating control signals in response thereto. The motor unit 40 may also, in some embodiments, include a memory element for storing data.

[0072] In some embodiments, and in some modes of operation, the robotic arm 42 may be controlled to follow scaled-down movements or motions of an operator's arm and / or hand as sensed by associated sensors. The robotic arm 42 includes a first robotic arm including a first end effector having an instrument tip disposed at the distal end of the first robotic arm, and a second robotic arm including a second end effector having an instrument tip disposed at the distal end of the second robotic arm. In some embodiments, the robotic arm 42 may have portions or regions associated with shoulder, elbow, and wrist joints, as well as movements associated with the operator's fingers. For example, a robotic elbow joint may track the position and orientation of a human elbow, and a robotic wrist joint may track the position and orientation of a human wrist. The robotic arm 42 may also have a terminal region associated with it, which in some embodiments may terminate in an end effector that tracks the movement of one or more of the operator's fingers, such as the index finger, when the user pinches the index finger and thumb together. In some embodiments, in some control modes, the robot arm 42 may follow the movement of the operator's arm, while in some control modes, the robot's shoulder may be fixed in place. In some embodiments, the position and orientation of the operator's torso is subtracted from the position and orientation of the operator's arm and / or hand. This subtraction allows the operator to move their torso without the robot arm moving. Further disclosure of control of movement of individual arms of a robot arm assembly is provided in International Patent Application Publication Nos. 2022 / 094000 A1 and 2021 / 231402 A1, each of which is incorporated herein by reference in its entirety.

[0073] The camera assembly 44 is configured to provide the operator with image data 48, such as a live video feed of the procedure or surgical site, as well as to allow the operator to operate and control the cameras forming part of the camera assembly 44. In some embodiments, the camera assembly 44 may include one or more cameras (e.g., a pair of cameras) whose optical axes are axially spaced a selected distance apart, known as the inter-camera distance, to provide a stereoscopic view or image of the surgical site. In some embodiments, the operator can control camera movement through hand movement, via a sensor coupled to the operator's hand or via a hand controller grasped or held by the operator's hand, thus allowing the operator to obtain a desired view of the surgical site in an intuitive and natural manner. In some embodiments, the operator can additionally control camera movement through movement of the operator's head. The camera assembly 44 is movable in multiple directions, including, for example, yaw, pitch, and roll, relative to the direction of view. In some embodiments, the stereoscopic camera components may be configured to provide a natural and comfortable user experience. In some embodiments, the axial distance between the cameras can be modified to adjust the depth of the surgical site as perceived by the operator.

[0074] Image or video data 48 generated by camera assembly 44 may be displayed on display unit 12. In embodiments, if display unit 12 includes an HMD, the display may include an embedded sensing and tracking unit 16A that acquires raw orientation data in the yaw, pitch, and roll directions of the HMD, as well as position data in Cartesian space (x, y, z) of the HMD. In some embodiments, position and orientation data for the operator's head may be provided via a separate head tracking unit. In some embodiments, sensing and tracking unit 16A may be used to provide supplemental position and orientation tracking data for the display instead of, or in addition to, the HMD's embedded tracking system. In some embodiments, operator head tracking is not used or employed. In some embodiments, an image of the operator may be used by sensing and tracking unit 16A to track at least a portion of the operator's head.

[0075] 2A shows an exemplary robot assembly 20 (also referred to herein as a robotic subsystem) of a surgical robotic system 10 integrated into or mounted on a mobile patient cart, according to some embodiments. In some embodiments, the robotic assembly 20 includes an RSS 46, which in turn includes a motor unit 40, a robotic arm 42 having an end effector 45, a camera assembly 44 having one or more cameras 47, and may also include a trocar 50 or a trocar mount.

[0076] 2B shows an example of an operator console 11 of the presently disclosed surgical robotic system 10, according to some embodiments. The operator console 11 includes a display unit 12, a hand controller 17, and one or more additional controllers, such as a foot pedal array 19, for controlling the robotic arm 42, the camera assembly 44, and other aspects of the system.

[0077] FIG. 3A schematically illustrates a side view of the surgical robotic system 10 performing surgery within an internal cavity 104 of an object 100, according to some embodiments and for some surgical procedures. FIG. 3B schematically illustrates a perspective top view of the surgical robotic system 10 performing surgery within an internal cavity 104 of an object 100. The object 100 (e.g., a patient) is positioned on a surgical table 102 (e.g., surgical table 102). In some embodiments and for some surgical procedures, an incision is made in the patient 100 to gain access to the internal cavity 104. A trocar 50 is then inserted into the patient 100 at a selected location to provide access to the internal cavity 104 or surgical site. The RSS 46 can then be manipulated into position on the patient 100 and the trocar 50. In some embodiments, the RSS 46 includes a trocar mount that couples to the trocar 50. The robot assembly 20 may be coupled to the motor unit 40, and at least a portion of the robot assembly may be inserted into the trocar 50 and, therefore, into the internal cavity 104 of the patient 100. For example, the camera assembly 44 and the robotic arm assembly 42 may be inserted individually and sequentially into the patient 100 through the trocar 50. While the camera assembly and the robotic arm assembly may include some portions that remain outside the subject's body during use, references to inserting the robotic arm assembly 42 and / or the camera assembly 44 into the internal cavity of the subject and disposing the robotic arm assembly 42 and / or the camera assembly 44 within the internal cavity of the subject refer to the portions of the robotic arm assembly 42 and the camera assembly 44 that are intended to be within the internal cavity of the subject during use. The sequential insertion method has the advantage of supporting smaller trocars, and therefore allowing for smaller incisions to be made in the patient 100, thereby reducing trauma experienced by the patient 100. In some embodiments, the camera assembly 44 and the robotic arm assembly 42 may be inserted in any order or in a specific order. In some embodiments, the camera assembly 44 may be followed by a first robotic arm of the robotic arm assembly 42, followed by a second robotic arm of the robotic arm assembly 42, all of which may be inserted into the trocar 50 and thus into the internal cavity 104.Once inserted into the patient 100 , the RSS 46 can move the robotic arm assembly 42 and camera assembly 44 to the surgical site, controlled manually or automatically by the operator console 11 .

[0078] Disclosures regarding management of movement of individual arms of a robotic arm assembly are provided in International Patent Application Publication Nos. 2022 / 094000A1 and 2021 / 231402A1, each of which is incorporated herein by reference in its entirety.

[0079] 4A is a perspective view of the robotic arm subassembly 21, according to some embodiments. The robotic arm subassembly 21 includes a robotic arm 42A, an end effector 45 having an instrument tip 120 (e.g., monopolar scissors, a needle driver / holder, a bipolar grasper, or any other suitable tool), and a shaft 122 that supports the robotic arm 42A. A distal end of the shaft 122 is coupled to the robotic arm 42A, and a proximal end of the shaft 122 is coupled to the housing 124 of the motor unit 40 (as shown in FIG. 2A). At least a portion of the shaft 122 can be external to the internal cavity 104 (as shown in FIGS. 3A and 3B). At least a portion of the shaft 122 can be inserted into the internal cavity 104 (as shown in FIGS. 3A and 3B).

[0080] 4B is a side view of the robotic arm assembly 42, which in some implementations includes a virtual shoulder 126, a virtual elbow 128 with a capacitive proximity sensor 132, a virtual wrist 130, and an end effector 45. In some embodiments, the virtual shoulder 126, virtual elbow 128, and virtual wrist 130 can include a series of hinges and revolute joints to provide seven positionable degrees of freedom for each arm, along with an additional grasping degree of freedom for the end effector 45.

[0081] 5 shows a perspective front view of a portion of a robotic subsystem 20 configured for insertion into a patient's internal body cavity, which may be referred to herein as a surgical robot module. The robotic assembly 20 includes a first robotic arm 42A and a second robotic arm 42B. The two robotic arms 42A and 42B may, in some embodiments, define a virtual chest 140 of the robotic arm 20. In some embodiments, the virtual chest 140 (shown as a dotted triangle) may be defined by a chest plane extending between a first pivot point 142A of the most proximal joint of the first robotic arm 42A (e.g., shoulder joint 126), a second pivot point 142B of the most proximal joint of the second robotic arm 42B, and a camera imaging center point 144 of the camera 47. A pivot center 146 of the virtual chest 140 is at the center of the virtual chest.

[0082] In some embodiments, sensors on one or both of the first robotic arm 42A and the second robotic arm 42B may be used by the system to determine a change in position in three-dimensional space of at least a portion of the robotic arms. In some embodiments, sensors on one or both of the first robotic arm and the second robotic arm may be used by the system to determine a position in three-dimensional space of at least a portion of one robotic arm relative to a position in three-dimensional space of at least a portion of the other robotic arm.

[0083] In some embodiments, the camera assembly 44 is configured to acquire images that enable the system to determine relative positions in three-dimensional space. For example, the camera assembly may include multiple cameras, at least two of which are laterally offset from one another relative to an imaging axis, and the system may be configured to determine distances to features within an internal body cavity. Further disclosure regarding surgical robotic systems including camera assemblies and associated systems for determining distances to features may be found in International Patent Application Publication No. WO 2021 / 159409, entitled "System and Method for Determining Depth Perception In Vivo in a Surgical Robotic System," published August 12, 2021, and incorporated herein by reference in its entirety. Information regarding distances to features and information regarding optical properties of the cameras may be used by the system to determine relative positions in three-dimensional space. 2.

[0084] 3. Trocar Various embodiments of the presently disclosed trocars are described below with reference to FIGS. 6-22C. Some embodiments provide trocars with independent split seals that allow a surgeon to perform endoscopic surgery using multiple instruments or tools from a single small incision. Some embodiments provide multi-lumen trocars with independent split seals. In some embodiments, the trocar includes multiple seals per endoscopic instrument or tool access point for maintaining the trocar seal before, during, and after insertion of surgical materials, tools, instruments, and components. In some embodiments, the trocar configuration allows at least one seal for each lumen, or each endoscopic tool, to translate laterally and concentrically with the cannula (e.g., translate radially toward the central insertion axis of the cannula) during insertion. In some embodiments, after insertion, a portion of the endoscopic tool in the lumen and the corresponding at least one seal translate radially away from the central insertion axis of the cannula after insertion or when fully inserted.

[0085] In some embodiments, trocars can be configured to seal around a number of very different diameters and cross-sections (e.g., circular vs. oval). Typically, flexible seals (e.g., silicone seals) function optimally for the narrow range of diameters for which they are sized. Some surgical robotic systems include one or more robotic arms and cameras with larger instrument / tool ​​diameters and smaller support tube / shaft diameters. In use, the support shaft or support tube is positioned within the trocar or cannula when and where the tool, instrument, robotic arm, or camera with the wider insertion diameter is fully inserted into the internal body cavity. Alternatively, some surgical systems as taught herein include a camera assembly with a diameter larger than the diameter of the robotic arm, and the camera assembly can be inserted into a seal with the larger diameter.

[0086] Some embodiments described herein incorporate two layers of individual seals, one layer configured to seal when inserted within the trocar or around a larger diameter (e.g., for a robotic instrument arm or camera) and one layer configured to seal around a smaller diameter (e.g., a support tube / shaft diameter for a robotic instrument tool or camera, or a laparoscopic tool shaft). The shape and geometry of the individual seals can be any suitable geometry and need not be the same between layers or between individual seals within the same layer. In some embodiments, during insertion and extraction, an instrument may need to push one or more support tubes / shafts of a camera or another instrument laterally out of the way to fit the larger "working portion" diameter of the instrument through the trocar. In some embodiments, the individual seals are surrounded by one or more bellows, such as accordion folds, to accommodate such radial or lateral movement of the camera / instrument toward or away from the trocar's central insertion axis (also referred to herein as the primary insertion axis). In some embodiments, the individual seals of one layer and the bellows are all integrated into one molded flexible component, while in other embodiments the bellows is a separate component from the seals.

[0087] In some embodiments, the trocar can have a leakage of less than 0.3 L / min with no instruments or cameras inserted and less than 1 L / min with all instruments or cameras inserted, using an insufflation pressure in the range of 8-15 mmHg or 5-20 mmHg and an insufflation flow rate of less than about 20 L / min or less than about 40 L / min. In some embodiments, the trocar can have a leakage of 0 L / min to 0.3 L / min with no instruments or cameras inserted and a leakage of 0.3 L / min to 1 L / min with all instruments or cameras inserted, using an insufflation pressure in the range of 8-15 mmHg or 5-20 mmHg and an insufflation flow rate of less than about 20 L / min or less than about 40 L / min. In some embodiments, the trocar may have a leakage of less than 0.3 L / min with all instruments or cameras inserted, using an insufflation pressure in the range of 8-15 mmHg or 5-20 mmHg and an insufflation flow rate of less than about 20 L / min or less than about 40 L / min.

[0088] FIG. 6 provides a perspective view of a trocar 200 according to some embodiments of the present disclosure. Trocar 200 includes a cannula 210 and a seal assembly 230. Cannula 210 has a proximal end 212a, a distal end 212b, and a central insertion axis 216. Proximal end 212a defines a proximal opening 214 (shown in FIG. 7), which is covered by seal assembly 230 in FIG. 6. Cannula 210 also includes central insertion axis 216, which is also the central or main insertion axis of the trocar. Seal assembly 230 is configured to seal cannula proximal opening 214. In some embodiments, cannula 210 includes a tubular portion 218 that includes cannula distal end 212b and a widened, conical, or flared portion 220 that includes cannula proximal end 212a. Tubular portion 218 defines a central lumen 222 of cannula 210, which is the main lumen of trocar 200. Typically, during an endoscopic procedure, a patient is prepared for surgery and an incision is made at the surgical site. The distal end 212b of the cannula is inserted through the incision, and cannula 210 is advanced into the patient until the surgeon reaches the desired location within the patient.

[0089] Trocar embodiments, according to some embodiments, can have a variety of configurations and sizes to suit various surgical applications and needs. For example, some trocar embodiments are suitable for adult patients, while others are suitable for pediatric patients. Trocar embodiments can be sized and configured for different types of procedures, such as, but not limited to, thoracic, renal, gastrointestinal, pharyngeal, nasal, or brain surgery.

[0090] To accommodate a variety of patients and procedures, the trocar and its components may have a variety of shapes and sizes, according to some embodiments. For example, in some embodiments, the length of the cannula tubular portion 218 may range from about 30 mm to about 170 mm, from about 60 mm to about 160 mm, or from about 70 mm to about 150 mm.

[0091] In various embodiments, the cannula of the trocar can have a variety of different widths. For example, in some embodiments, the inner width (e.g., diameter) of the tubular portion 218 of the cannula, which may be referred to as the central lumen diameter or central lumen width, can be in the range of about 5 mm to about 25 mm, about 5 mm to about 20 mm, about 7 mm to about 20 mm, or about 10 mm to about 19 mm. In some embodiments, the central lumen diameter is about 26 mm, about 20 mm, about 19 mm, about 18 mm, about 17 mm, about 16 mm, about 15 mm, about 14 mm, about 13 mm, about 12.5 mm, about 12 mm, about 11 mm, about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, about 5.5 mm, or about 5 mm. In some embodiments, the median lumen diameter or width is less than about 26 mm, about 20 mm, about 19 mm, about 18 mm, about 17 mm, about 16 mm, about 15 mm, about 14 mm, about 13 mm, about 12 mm, about 11 mm, about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, or about 5.5 mm. If the cannula has a circular cross-section, the inner width is the median lumen diameter. Generally, the median lumen diameter or width of the cannula 210 allows for the insertion of multiple endoscopic instruments appropriate for a particular application and surgical procedure type.

[0092] Although cannula 210 is shown with a circular cross-section, in other embodiments, at least some portions of the cannula (eg, the tubular portion, the wide portion, or both) may have a non-circular cross-section.

[0093] In some embodiments, the outer surface 217 of the tubular portion 218 of the cannula may have one or more protrusions to aid in cannula retention. For example, the cannula 210 includes a cannula retention feature in the form of ribs 223 on the outer surface 217 of the tubular portion 218 to aid in retention.

[0094] In some embodiments, the cannula 210 includes a port or connection 224 for receiving gas for insufflation. For example, the cannula may include a luer lock connector or connection for an air line.

[0095] As described above, seal assembly 230 is configured to seal proximal end 212a of cannula 210 during use. Seal assembly 230 is configured to maintain a seal before, during, and after insertion of multiple endoscopic tools (e.g., one or more endoscopic instruments and an endoscopic camera) into a surgical site or internal body cavity, according to some embodiments. Seal assembly 230 is also configured to maintain a seal before, during, and after removal of multiple endoscopic tools (e.g., one or more endoscopic instruments and an endoscopic camera) from a surgical site, according to some embodiments.

[0096] 6 and 7, seal assembly 230, according to some embodiments, includes a seal support structure 240 that at least partially defines a plurality of channels 242. The plurality of channels may be described herein as a plurality of mini-lumens. In some embodiments, seal support structure 240 includes a plurality of plates 244a, 244b, 244c, 244d. In some embodiments, at least some or all of plates 244a-244d each include a plurality of holes, each defining a portion of a corresponding channel 242 within the plurality of channels. In some embodiments, each plate 244a-244d may have a shape corresponding to a docking ring, as shown.

[0097] Seal assembly 230 includes a first layer 260 that covers proximal opening 214 of cannula 210. In some embodiments, first layer 260 includes a first flexible material and has a central portion 262. In some embodiments, first flexible material may be or may include silicone. In some embodiments, first flexible material may be or may include silicone, rubber, or another suitable material. In some embodiments, seal support structure 240 is attached to central portion 262 of first layer 260. In some embodiments, seal support structure is integral with central portion 262 of first layer 260 of seal assembly 230.

[0098] In some embodiments, first layer 260 of seal assembly 230 includes a plurality of first layer individual seals 264. Each first layer individual seal 264 has an opening 266 for insertion of an endoscopic tool or instrument. In some embodiments, each first layer individual seal 264 corresponds to a channel 242 in the plurality of channels. In some embodiments, each first layer individual seal 264 seals the end of a corresponding channel 242.

[0099] In some embodiments, the seal assembly 230 also includes a second layer 280, which itself includes a second flexible material and a plurality of second-layer individual seals 282. Each second-layer individual seal 282 has an opening 284 for insertion of an endoscopic tool or instrument. Each first-layer individual seal 264 is aligned with a corresponding second-layer individual seal 282 and a channel 242 of the plurality of channels, according to some embodiments. Each first-layer individual seal 264 is offset proximally or distally from a corresponding second-layer individual seal 282 (see FIG. 7 ), according to some embodiments. For example, the trocar 200 of FIGS. 6 and 7 is configured such that each first-layer individual seal 264 is offset distally from a corresponding second-layer individual seal 282. In some embodiments, each channel creates a mini-lumen for a different camera or instrument.

[0100] In some embodiments, seal assembly 220 is configured to allow at least a portion of central portion 262 of first layer 260 to translate radially or laterally relative to central insertion axis 216. In some embodiments, this radial or lateral translation moves individual seals 264 of the first layer and corresponding individual seals 282 of the second layer proximate central insertion axis 216 of cannula 210 during use to align an endoscopic instrument or tool with central insertion axis 216 of cannula 210.

[0101] In some embodiments, first layer 260 of seal assembly 230 also includes one or more concentric corrugations or pleats 268, which may also be referred to herein as bellows 268. Bellows 268 allow for radial and lateral translation of central portion 262 of first layer 260. In some embodiments, first layer 260 also includes a peripheral portion 263. In some embodiments, bellows 268 is disposed in peripheral portion 263 of first layer 260. In some embodiments, bellows 268 surrounds central portion 262 of first layer 260.

[0102] In some embodiments, at least a portion of the seal support structure (e.g., plate 244a) is disposed proximally relative to the first layer 260 and the second layer 280. In some embodiments, at least a portion of the seal support structure 240 (e.g., plate 244d) is disposed distally relative to the first layer 260 and the second layer 280. In some embodiments, at least a portion of the seal support structure 240 (e.g., plate 240b) is disposed between the first layer 260 and the second layer 280.

[0103] The material or materials of the seal support structure, in some embodiments, are stiffer than the first material of the first layer and the second material of that layer. For example, in some embodiments, the seal support structure comprises one or more of high density polyethylene (HDPE), polyoxymethylene (POM), acetal homopolymer POM (e.g., DELRIN from DuPont), acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PET), nylon, polycarbonate, or another suitable material.

[0104] In some embodiments, each first layer's individual seal 264 is or includes a universal seal. A universal seal typically includes two or more layers of overlapping leaflets. In some embodiments, each first layer's individual seal includes a cross-slit valve or a duckbill valve. In some embodiments, each first layer's individual seal is or includes a septum seal, wiper seal, hourglass or cone seal, or the like.

[0105] In some embodiments, the first layer 260 comprises a sealing sheet comprising a first flexible material, and the peripheral portion 263 of the first layer and the individual seals 264 of each first layer are integral with the sealing sheet.

[0106] Referring again to second layer 280, in some embodiments, each second layer's individual seal 282 comprises a slit formed in the second flexible material. The slit forms at least a portion of opening 284 through which an endoscopic instrument may pass during surgery. In some embodiments, each second layer's individual seal is or includes a cross-slit valve or a duckbill valve. In some embodiments, each second layer's individual seal is or includes a septum seal, wiper seal, hourglass or cone seal, or the like.

[0107] In trocar 200, second layer individual seals 282, according to some embodiments, maintain air insufflation when a smaller diameter element (e.g., support tube / shaft) is inserted through the respective channel. First layer individual seals 264, according to some embodiments, maintain air insufflation when no instrument, tool, or camera is inserted through the respective channel, or each seal around a larger diameter instrument tool or camera when inserted through the respective channel.

[0108] In a trocar with multiple lumens (e.g., channels 242), each individual seal (e.g., individual seal 264 in the first layer, individual seal 282 in the second layer) must be separated from the other seals in the same layer so that if one individual seal is compromised, the other will remain closed. The seal assembly 230 of trocar 200 separates each of the lumens (e.g., channels 242) to create an acceptable seal when one, two, or three surgical tools are inserted into trocar 200. In addition to separating the individual seals (e.g., individual seal 264 in the first layer, individual seal 282 in the second layer), trocar 200 employs a dual layer of individual seals (e.g., individual seal 264 in the first layer and individual seal 282 in the second layer) to ensure an acceptable seal before, during, and after insertion of surgical materials, tools, and / or robotic components.

[0109] In some embodiments, the dual layer of individual seals allows the trocar to maintain an acceptable seal before, during, and after insertion of a tool through the trocar. Additionally, in some embodiments, the use of a bellows of flexible material (e.g., a rubber or silicone sinusoidal bellows) allows the seal support structure or seal plate to translate radially or laterally to be concentric with the cannula and incision during insertion, and then return to its original position upon full insertion.

[0110] In some embodiments, some or all of the seal may include a plastic reinforcing leaflet to protect against puncture. In some embodiments, a lubricant may be used with or included in or on at least a portion of the seal to facilitate insertion / removal.

[0111] Figure 8 shows a cross-sectional view of another trocar 300, according to some embodiments. Figure 9 shows a perspective view of the proximal end of trocar 300, and Figure 10 shows a perspective view of the proximal end of trocar 300 with outer cannula cap 390 and docking adapter 392 removed for illustrative purposes. Figure 11A shows an exploded view of seal assembly 330 of trocar 300.

[0112] As shown in FIGS. 8-10 , trocar 300 includes a cannula 310 having a proximal end 312a and a distal end 312b. A seal assembly 330 seals a proximal opening 314 of the cannula. Seal assembly 330 includes a seal support structure 340 that at least partially defines a plurality of lumens 342. Seal assembly 330 also includes a first layer 360 covering cannula proximal opening 314. First layer 360 includes a first flexible material and a plurality of first layer individual seals 364a, 364b, 364c. In some embodiments, first layer individual seals 364a, 364b, 364c each have an asymmetrical conical or funnel-shaped valve shape with a central opening, as shown. In some embodiments, the individual seals 364a, 364b, 364c of the first layer may have some other shape, for example, seal 364a may be an hourglass seal configured to seal around an inserted instrument, such as a support tube of a camera assembly.

[0113] First layer 360 has a central portion 362 and a peripheral portion 363, and seal support structure 340 is attached to or integral with central portion 362 of first layer 360. Seal assembly 330 also includes second layer 380, which itself includes a second flexible material and a plurality of second layer individual seals 382 a, 382 b, 382 c. In some embodiments, each second layer individual seal 382 a, 382 b, 382 c is a molded cross-slit seal.

[0114] Some surgical systems as taught herein include a camera assembly having a diameter larger than the diameter of the robotic arm, and the camera assembly can be inserted into a seal having a larger diameter. For example, Figure 10 shows two seals 382a and 382b that are smaller in diameter than seal 382c. In such an embodiment, the camera assembly having a larger diameter is inserted into seal 382c, and the robotic arm, having a smaller diameter, is inserted into seals 382a and 382b.

[0115] In some embodiments, the first layer peripheral portion 363 is integral with each first layer individual seal 364 a, 364 b, 364 c. For example, in seal assembly 330, first layer 360 includes a single molded piece that forms peripheral portion 363 and each first layer individual seal 364 a, 364 b, 364 c.

[0116] In some embodiments, each second layer individual seal 382 a , 382 b , 382 c is part of the same unitary second layer 380 .

[0117] In some embodiments, the individual seals 364a, 364b, and 364c of the first layer are separate from the first layer 360 (e.g., bellows) and not integral with the first layer 360 (i.e., formed as a single sheet or layer or assembly), and the individual seals 382a, 382b, 382c of the second layer are not integral with the second layer 380 (i.e., formed as a single sheet or layer or assembly). In such embodiments, the proximal seal 364' can be located between the cap 390' and the plate 344b'. The distal seal 382' can be located between the plate 344b' and the plate 344c'.

[0118] In embodiments where the seals are not integral with their respective layers (i.e., formed as a single sheet, layer, or assembly), the seals and plates can be coupled with a first layer 360′ to form a seal assembly, as shown in FIG. 11B. In some embodiments, there are three plates 344′ in the seal assembly. Distal plate 344c′ and middle plate 344b′ are pressed together using press pins 348, which compress first layer 360′ and distal seal 382′. Middle plate 344b′ and top plate (shown as components of cap 390′) are also pressed together with press pins 348, which compress proximal seal 364′ onto first layer 360′. Finally, first layer 360′ is placed between the cannula body and cap 390′, which snap together and compress first layer 360′. All seals are compressed between rigid components to create an airtight seal.

[0119] As shown in FIG. 11B, proximal seal 364' can include two seals 364a' and 364b', which can be duckbill seals (i.e., shaped like a duckbill), and one seal 364c', which can be empty. Seals 364a' and 364b' can be configured to maintain a seal when no instrument or tool is inserted through seals 364a' and 364b'. Seal 364c' can be configured to receive a cork or plug, as described in more detail below with respect to FIGS. 23A-23D.

[0120] Distal seal 382' may include seal 382c' configured as a duckbill seal and two seals 382a' and 382b' configured as hourglass seals (i.e., seals having a shape resembling at least a portion of an hourglass). Seal 382c' can maintain a seal when no instrument or tool is inserted within seal 382c' and may be configured to receive a camera assembly. Seals 382a' and 382b' may be configured to seal around an inserted instrument, for example, a support tube of a robotic arm.

[0121] In some embodiments, leaflets 365 may be added to the proximal seals 364a' and 364b' to help prevent tearing of the distal seal. The leaflets 365 are further shown in FIG. 11C. The leaflets 365 may include one or more slits at the distal end of the leaflets 365 to form one or more straps 365a. The straps 365a may be configured to allow the leaflets 365 to more easily conform to the shape of the seal. In some embodiments, the leaflets 365 are formed from a polymeric material, such as polyethylene or polypropylene. Some tools have sharp edges that can cut and damage the distal seals 382b' and 382c'. The leaflets 365 may line the inner surfaces of the seals 382a' and 382b', where rips often occur. The leaflets 365 provide a layer of plastic that prevents sharp tools from coming into contact with the seals 382a' and 382b', which in turn prevents ripping. Leaflets 365 may be lubricated or inherently lubricious to add a lubricious surface that reduces the force required to insert a tool through seals 364a' and 364b'. Leaflets 365 may be incorporated into any of the trocar embodiments discussed herein.

[0122] In some embodiments, all of the individual seals in the first layer have the same width or diameter. In some embodiments, at least some of the individual seals in the first layer have a width or diameter that is different from the width or diameter of another individual seal in the first layer. For example, individual seals 364a and 364b in the first layer have a diameter that is smaller than the diameter of individual seal 364c in the first layer (see FIG. 11A).

[0123] In some embodiments, all of the individual seals in the second layer have the same width or diameter. In some embodiments, at least some of the individual seals in the second layer have a width or diameter that is different from the width or diameter of another individual seal in the second layer. For example, individual seals 382a and 382b in the second layer have a diameter that is smaller than the diameter of individual seal 382c in the second layer (see FIGS. 10 and 11A).

[0124] In some embodiments, seal support structure 340 includes multiple plates 344a, 344b, and 344c. As shown in Figures 8 and 11A, seal support structure plate 342a includes multiple holes or openings 345a, 345b, 345c, with each hole or opening corresponding to a channel 342, according to some embodiments. In contrast, seal support plate 344c includes one large hole or opening 346 through which all channels 342 pass, according to some embodiments. Seal support plate 344 includes a multi-lobe opening, with each lobe corresponding to a channel 342, according to some embodiments.

[0125] In some embodiments, each hole in the support plate has the same width or diameter. In some embodiments, at least some holes in the support plate have a width or diameter that is different from the width or diameter of another hole. For example, holes 345a and 345b have a diameter that is smaller than the diameter of hole 345c.

[0126] In some embodiments, one or more of the individual seals and one or more of the channels in a layer may have a diameter that is different from the diameter of another individual seal or another channel in the same layer. For example, one of the channels may be configured for insertion of an instrument, tool, or component having a first maximum insertion diameter, and another one of the channels may be configured for insertion of an instrument, tool, or component having a second maximum insertion diameter that is larger than the first maximum insertion diameter.

[0127] Peripheral portion 363 of first layer 360 includes corrugations or pleats in the form of concentric bellows 368 that surround central portion 362. Bellows 368 and the first flexible material of first layer 360 allow central portion 362 of first layer, seal support structure 340, individual seals 364a, 364b, 364c of the first layer, and individual seals 382a, 382b, 382c of the second layer to shift radially or laterally relative to central insertion axis 316 to better align channels 342 with central insertion axis 316 for inserting or withdrawing instruments, tools, or cameras therethrough. In some embodiments, trocar 300 is configured to allow each of the channels to shift radially or laterally to align with central insertion axis 316. In some embodiments, none of the channels are aligned with the central insertion axis when no external force is applied to the first layer.

[0128] In some embodiments, seal support structure plate 344a is proximal relative to first layer 360 and second layer 380, seal support structure plate 344c is distal relative to first layer 360 and second layer 380, or both. In some embodiments, seal support structure plate 344b is within first layer 360 (see FIG. 8 ). For example, in trocar 300, plate 344b may be used to form at least a portion of, and be primarily encapsulated by, first layer 360.

[0129] In some embodiments, the first layer, second layer, and at least some of the components of the seal support structure are configured to be mechanically affixed to one another. For example, first layer 360, second layer 380, and plates 342a, 342b, and 342c all include holes or channels 361, 381, 343a, 343b, and 343c, respectively, to allow them to be fastened to one another (e.g., via screws or bolts). In some embodiments, at least some of the components of the trocar may be chemically bonded. In some embodiments, at least some of the components of the trocar may be ultrasonically welded together. In some embodiments, at least some of the components of the trocar may be adhesively bonded to one another.

[0130] In some embodiments, the cannula 310 also includes one or more suture tie structures (e.g., suture tie loops 325) for retention and / or port site closure. In some embodiments, the outer surface of the cannula 310 includes a cannula retention mechanism, such as one or more protrusions (e.g., ribs 323) for retention. In some embodiments, the cannula also includes a port or connection 324 (e.g., a luer lock connection) for receiving gas for insufflation. In some embodiments, the trocar or cannula also includes a second port or connection (e.g., a second luer lock connection) for smoke evacuation.

[0131] In some embodiments, trocar 300 also includes an outer cannula cap 390 and a docking mount or docking adapter 392 attached to or integral with outer cannula cap 392. Docking mount or docking adapter 392 allows a surgical robotic system to engage trocar 300. In some embodiments, the surgical robotic system may connect with the outer cannula cap, the seal assembly, or the cannula.

[0132] In some embodiments, the individual seals of the first layer (e.g., individual seals 364a, 364b, 364c of the first layer of seal assembly 330 and individual seal 264 of the first layer of seal assembly 230) are distal relative to the individual seals of the second layer (e.g., individual seals 382a, 382b, 382c of the second layer of seal assembly 330 and individual seal 282 of the second layer of seal assembly 230) (see FIGS. 7 and 8). In such embodiments, the individual seals 364a, 364b, 364c, or 264 of the first layer may be referred to as distal seals, and the individual seals 382a, 382b, 382c, or 282 of the second layer may be referred to as proximal seals.

[0133] In trocar 300, individual seals 364a, 364b, 364d in the first layer each maintain air insufflation when a smaller diameter element (e.g., a support tube / shaft) is inserted through its respective channel, according to some embodiments. Individual seals 382a, 382b, 382c in the second layer each maintain air insufflation when no instrument, tool, or camera is inserted through its respective channel, according to some embodiments, or each seal around a larger diameter instrument tool or camera when inserted through its respective channel.

[0134] In some embodiments, due to instruments, tools, or cameras having different insertion diameters in different portions of the instrument, tool, or camera during insertion, the seal assembly of the trocar is configured to seal around a range of diameters or widths for each channel. For example, in some embodiments, the seal assembly of the trocar is configured to seal around a range of insertion widths including about 4 mm to about 19 mm for an instrument, tool, or camera inserted into a first channel, and is configured to seal around a range of insertion widths including about 4 mm to about 16 mm for an instrument, tool, or camera inserted into a second channel.

[0135] In some embodiments, the second layer of the seal assembly can be distal to the first layer of the seal assembly, and the individual seals of the second layer can be distal to the individual seals of the first layer. For example, FIG. 12 shows a trocar 400 including a seal assembly 430, which itself includes a first layer 460 and a second layer 480, where the second layer 480 is distal to the first layer 460, according to some embodiments. The first layer 460 includes a first flexible material and includes a plurality of first layer individual seals 464. The second layer 480 includes a second flexible material and a plurality of second layer individual seals 482 that are distal to the plurality of first layer individual seals 464. In the trocar 400, the first layer individual seals 464 are proximal seals, and the second layer individual seals 482 are distal seals. The trocar 400 also includes a seal support structure including a proximal plate 444a and a distal plate 444b that together support the individual seals 482 of the first and second layers 464 and 482, respectively. The seal support structure (e.g., collectively the proximal plate 444a and the distal plate 444b) at least partially defines a plurality of channels 442, which may be referred to herein as multiple lumens or multiple mini-lumens.

[0136] In some embodiments, the first layer of the seal assembly can include multiple sub-layers. For example, first layer 460 includes proximal sub-layer 461 a and distal sub-layer 461 b, which are held between proximal plate 444 a and distal plate 444 b (see FIG. 12 ).

[0137] In some embodiments, at least a portion of the proximal sub-layer 461a, the distal sub-layer 461b, the second layer 480, the proximal plate 444a, and the distal plate 444b may be affixed to one another using an adhesive (e.g., glue), bonded to one another, welded to one another, or joined or affixed to one another using any other suitable method or mechanism.

[0138] 13 is a top view of trocar 400 with outer cannula cap 490 and docking mount or adapter 492 attached on the proximal end of the cannula. When no force is applied to the first layer, all of the individual seals 464 and corresponding channels in the first layer are offset from central insertion axis 464.

[0139] As described above, in some embodiments, the first layer of the seal assembly can include multiple sublayers or multiple sheets. In some embodiments, the first layer includes a first sheet including a first flexible material and a second sheet including a first flexible material. In some embodiments, the individual seals of each first layer include a first slit in the first sheet and a second slit in the second sheet, with the orientation of the first slit being different from the orientation of the second slit that forms the universal seal. In some embodiments, forming the universal seal from two components (e.g., a first sheet and a second sheet) and then cutting slits 447 therein creates an improved molding and assembly process over some other methods for forming a universal seal. FIG. 14 includes an image of an individual universal seal formed from a first sheet and a second sheet of flexible material guided by proximal plate 444.

[0140] FIG. 15 shows a trocar 500 including a brace plate 545 attached to a flexible layer 546, and FIG. 16 shows a similar brace plate 546' attached to a similar flexible layer 548', where the shape of the brace plate 546' and the shape of the flexible layer 568 in FIG. 16 are slightly different from the shape of the brace plate 546 and the shape of the flexible layer 568 in FIG. 15. The brace plates 545, 545' are rigid plates that include cutouts for the camera / instrument to pass through. In some embodiments, the brace plates 545, 545' are supported on the flexible layers 546, 546' in addition to the first and second layers. The flexible layers 568, 568' include holes 547, 547' for the camera / instrument to pass through. In some embodiments, the flexible layer 546, 546′ supporting the brace plate 545, 545′ includes bellows 568, 568′ in the form of one or more concentric corrugations or pleats surrounding the brace plate 545, 545′ and the holes 547, 547′. In some embodiments, the brace plate 545, 546′ provides mechanical support to the instrument or camera support (e.g., support tube / shaft) while it is subjected to forces that push it radially outward toward the wall of the trocar cannula lumen. The bellows 568, 568′ allow the brace plate 545, 545′ to move radially or laterally to accommodate instrument movement toward or away from the trocar insertion axis during insertion / removal. The outer sealing layer has been omitted from FIG. 15 for illustrative purposes.

[0141] Brace plates as described above may be combined with any of the above embodiments. For example, the brace plates may be layered with individual seal layers in any order according to some embodiments.

[0142] In some embodiments, the seal support structure may require more support than that provided by the first layer. In such embodiments, the second layer may also include a peripheral portion having a concentric bellows and may also be used to support the seal support structure. In some embodiments, additional support for the seal support structure may be provided by using an additional flexible layer including holes and a peripheral portion having a concentric bellows to attach the seal support structure to the additional flexible layer.

[0143] FIG. 17 shows a trocar 600 including a first flexible layer 660 and a rigid bellows plate 645. In FIG. 17, the second flexible layer is omitted for illustrative purposes. The first flexible layer 660 includes a plurality of first layer individual seals 664 and a concentric bellows 668 that surrounds the first layer individual seals 664 as a group. Instead of a rigid seal support structure at least partially defining multiple channels, the trocar 600 includes a bellows plate 646 attached to the flexible first layer 600, which surrounds or encircles the individual seals 664 as a group. The bellows plate 646 prevents deformation of the other seals when an instrument (e.g., a robotic arm or camera assembly) passes through one seal and moves toward the central / main insertion axis of the trocar.

[0144] In some embodiments, the trocar seal assembly includes a first layer of individual seals, a peripheral bellows, and a second layer of individual seals surrounded by the peripheral bellows without a rigid seal support structure (e.g., a seal support plate or bellows plate).

[0145] In some embodiments, after a first camera, instrument, or tool is inserted through the trocar and its support tube or shaft (first support tube / shaft) remains extending through the trocar, there must be sufficient space in the primary cannula to insert a second, first camera, instrument, or tool through the trocar, even if the first support tube / shaft is still present within the primary cannula lumen. Furthermore, after a second camera, instrument, or tool is inserted through the trocar and its support tube or shaft (second support tube / shaft) and the first support tube / shaft remains extending through the trocar, there must be sufficient space in the primary cannula lumen to insert a third camera, instrument, or tool, even if the first and second support tubes / shafts are still present within the primary cannula lumen. In some embodiments, cameras, instruments, or tools used with some trocars described herein may use relatively small diameter support tubes / shafts to increase the available space in the primary camera lumen for the insertion of subsequent cameras, instruments, or tools. Reducing the diameter or width of the support tube / shaft may reduce the bending stiffness of the support tube / shaft and increase its deflection. When a tool, instrument, or robotic arm exerts a force during a procedure (e.g., pulling tissue or suturing a puncture defect closed), a less stiff support tube / shaft may deflect from its nominal / desired position, causing undesirable effects such as hitting the abdominal wall or abdominal contents or hitting another instrument. Some embodiments include features or components that provide mechanical support or damping to support the tube / shaft to reduce passive and force-induced deflection. Some embodiments that provide mechanical support or damping to support the tube / shaft may allow an associated instrument to exert a greater force.

[0146] Some embodiments provide one or more slide clips that can be positioned within the trocar cap proximal to the individual seals. Figures 18A-18C show a trocar cap 670, which may also be referred to as an outer cannula cap, that includes a slide clip 610 attached to a trocar 300 similar to that shown in Figures 9-11. In some embodiments, a slide clip 610 can be used for each instrument support tube / shaft. In some embodiments, a slide clip can be used for only a portion of the support tube / shaft. For example, in some embodiments, a slide clip can be used for the support tube / shaft for the robotic arm but not for the support tube / shaft for the camera assembly.

[0147] Each slide clip 610 includes a clip portion 612 at an end of the slide clip that extends toward the central axis 316 of the trocar 300 and trocar cap, according to some embodiments. Each slide clip may also include an outer portion, such as a finger tab portion 614, at an opposite end of the slide clip that extends away from the central axis of the trocar cap 316 and beyond the side wall 674 of the trocar cap, according to some embodiments. For each slide clip 610, the clip portion 612 is connected to the outer portion (e.g., finger tab portion 614) by an intermediate portion 613. In some embodiments, the intermediate portion 613 extends through the side wall 674 of the trocar cap 674. Each slide clip 612 is configured to be displaced radially toward or away from the central axis 316 by applying force to the outer portion (e.g., pulling or pushing on the finger tab portion 614). Arrows 620 indicate the direction of displacement but do not correspond to the magnitude of displacement. FIG. 18C is an image of a trocar cap 674 with sliding clips 610, one of which is offset away from the central axis.

[0148] The slide clip 610 can be slid radially by pulling on the finger tab 614 to allow insertion of instruments and surgical material. When the clip 610 is slid out, it is housed within the trocar cap 674 so as not to block the individual seal 382b, allowing the instrument (or laparoscopic tool with surgical material) to pass through the individual seal 382b.

[0149] Once an instrument is fully inserted through trocar 300, clip portion 612 can be attached to the support tube / shaft (not shown) and sliding clip 610 can be locked into place within trocar cap 674 to secure the support tube / shaft (not shown) in a desired position. In the illustrated embodiment, the locking mechanism includes a cantilever snap fit. In other embodiments, another or different type of locking feature can be used.

[0150] An example of an instrument insertion and extraction workflow is provided below.

[0151] To insert and secure the device: 1. Starting position - clip is retracted into trocar cap 2. Insert the instrument through the trocar 3. The user slides the clip and clips it onto the support tube.

[0152] To remove the device: 1. The user removes the support tube from the clip. 2. The user slides the clip outward to store it inside the cap. 3. Remove the instrument through the trocar 4.

[0153] Some embodiments provide a cannula that allows for smoke evacuation and insufflation in a single cannula. Figures 19A-19C show a trocar 700 having a cannula 710 that includes a first port / connector for connecting to a source for insufflation gas delivery and also includes a second port, connector, or connection 726 for smoke evacuation. The second port / connector 726 for smoke evacuation connects to a smoke evacuation lumen 728 of the cannula that extends to the distal tip 712b of the cannula.

[0154] The cannula 710 of the trocar 700 uses a smoke evacuation lumen 728 for a smoke evacuation port / connector 726 (e.g., a Luer lock connector) that is separate from the cannula 710. The smoke evacuation lumen 728 extends from the evacuation port connector 726 to the distal tip 712b of the cannula 712b. The smoke evacuation lumen 728 and second port / connector 726 enable the use of both an insufflation device and a smoke evacuation machine or system with a single trocar. By having a separate lumen for smoke evacuation, a single trocar can be connected to both an insufflation device and a smoke evacuation machine and can efficiently remove smoke generated during some procedures (e.g., those employing electrocautery). Traditionally, a separate secondary trocar and associated port are used to connect to a smoke evacuation machine. Trocar 700 reduces the number of trocars and associated incisions in a patient during procedures where insufflation and smoke evacuation are required, which may reduce complication rates and infection risk, and can shorten procedure time by eliminating the time associated with positioning a separate smoke evacuation trocar. Additionally, any trocar system that claims to be a single port and supports an electrocautery device, tool, or instrument requires the ability to use an insufflation and smoke evacuation system or device with only one trocar.

[0155] The smoke evacuation lumen 728 creates a passageway for air or gas to flow from an internal body cavity (e.g., the abdominal cavity) to a smoke evacuation machine, allowing smoke to be removed from the internal body cavity. By extending the smoke evacuation lumen 728 to the distal tip 712b of the cannula, the smoke evacuation lumen opening / inlet 729 at the distal tip 712b of the cannula draws more air / gas / smoke from the internal body cavity than it draws clean air supplied via the first insufflation port / connector 724 at the proximal portion of the cannula. The smoke evacuation lumen 728 is useful for effective smoke evacuation because if the inlet opening 729 of the smoke evacuation lumen 728 is not routed all the way to the cannula distal tip 712b but instead is closer to the proximal end of the cannula 712a, the inlet opening 729 will primarily draw clean air coming from the insufflation port / connector 724 and smoke will not be efficiently removed from the internal body cavity.

[0156] In some embodiments, cannula 710 includes one or more cannula retention features, such as ribs 723, on the outer surface of tubular body 718. Cannula 710 may also include any of the features described herein with respect to other embodiments.

[0157] The smoke evacuation port / connector 726 and smoke evacuation lumen 728 may be incorporated into any of the trocars described or disclosed herein, according to some embodiments. Some embodiments provide a cannula including a smoke evacuation port / connector and a smoke evacuation lumen as described herein, but without a seal assembly. Some embodiments provide a trocar including a cannula including a smoke evacuation port / connector and a smoke evacuation lumen as described herein, but without a seal assembly. Some embodiments provide a trocar including a seal assembly and a cannula including a smoke evacuation port / connector and a smoke evacuation lumen.

[0158] Some embodiments employ a rigid triple-seal funnel trocar 800, as shown in FIGS. 20A-20D. Trocar 800 includes a cannula with a distal seal, cannula body seal 864a, and a trocar funnel containing a set of individual proximal seals. In contrast to trocars 200, 300, 400, 500, and 600, the individual proximal seals of trocar 800 are not radially or laterally offset toward the central insertion axis of the trocar, according to some embodiments. Trocar 800 can accommodate three instruments / tools, such as two instruments (e.g., two robotic arms) and a camera assembly. Each instrument / tool / arm first passes through its own separate proximal seal in the trocar funnel and then through a larger distal seal at the proximal end of the cannula portion of the trocar, whose function is to maintain a seal when not inserted.

[0159] In addition to the cannula body 810 and the trocar funnel 894, the trocar 800 may include an interface for docking the trocar 800 to a surgical robotic system. In some embodiments, the trocar funnel 894 is separable from the cannula body 810, allowing for the removal of material (e.g., tissue) through the main cannula lumen that would be too large to extract through one of the lumens of the trocar funnel 894.

[0160] In some embodiments, the cannula body 810 has one large lumen, also referred to as the main lumen, through which instruments / tools (e.g., the camera assembly, then both instruments) can pass, and into which all three support tubes / shafts are placed. This main lumen has its own seal 864a at the proximal end of the cannula, which may be referred to as the distal seal because it is distal to the individual seals on the trocar funnel 894. The distal seal 864a on the cannula body 810 maintains insufflation when nothing is inserted into the trocar and when the trocar funnel 894 is separated from the cannula body 810. In some embodiments, the cannula body 810 also includes a luer lock connection for an air insufflation tube that opens into the main lumen.

[0161] The trocar funnel 894 incorporates a separate set of lumens 842 and proximal seals 864b for each camera / instrument inserted into the trocar funnel 894. Each set of lumens 842 and proximal seals 864b can be sized to accommodate a specific size tool or instrument. For example, some surgical systems as taught herein include a camera assembly with a diameter larger than that of a robotic arm; the camera assembly can be inserted into a seal with the larger diameter, and the arm can be inserted into a seal with the smaller diameter. Each set of lumens 842 and proximal seals 864b can funnel down together toward the cannula body lumen. A seal around each instrument / camera solves the problem of sealing a gap in the middle of the three seals. In the illustrated embodiment, for each instrument / camera lumen, each set of lumens 842 and proximal seals 864b follows the same trajectory toward the cannula body, meaning the seals 864b seat at an angle. At the outer proximal end of the trocar funnel 894, the rear partition wall functions as a funnel to guide the camera / instrument into its respective lumen during insertion.

[0162] The need for trocar funnel 894 to direct the arms into a single large lumen is that if each camera / instrument had its own lumen for the entire length of the cannula, the trocar diameter would be much larger than desired.

[0163] In some embodiments, the separate instrument / camera seal within the trocar funnel 894 may be constructed from multiple layers of seal to maintain insufflation for both the maximum and minimum diameters of the instrument / camera as its diameter varies along the length of the instrument / camera. Additionally, the trocar funnel seal may incorporate a plastic leaflet on top of the seal as reinforcement.

[0164] In some embodiments, the lumen / seal trajectories within the trocar funnel 894 may be different for each set of lumens 842, and the proximal seals 864b may follow different trajectories, for example, be oriented at an angle relative to each other (e.g., where the seals are not perpendicular to the central axis of their respective lumens). This includes the seals being seated "flat" or perpendicular to the central insertion axis of the cannula body 810, but not perpendicular to the central axis of their respective lumens.

[0165] Some embodiments provide a trocar 900 with a flexible, integrated seal, as shown in FIGS. 21A-21E. The trocar 900 includes a cannula body 910, a seal piece 965, and a guide cap 966. The seal piece 965 includes a triple seal including three individual seals 964b, referred to herein as the proximal seal. The cannula body 910 includes a larger central seal 964a, which may be referred to as the distal seal. In some embodiments, the cannula body 910 also includes an interface 995 for docking the trocar with a robotic surgical system (e.g., a patient cart). The seal piece 965 and guide cap 966 form a separable subassembly from the cannula body 910, allowing for removal of material (e.g., tissue) through the main cannula lumen and the larger central seal 964a that would otherwise be too large to extract through one of the individual proximal seals 964b in the seal piece.

[0166] The cannula body 910 has one large lumen through which instruments / cameras (e.g., the camera, then both instruments) can pass, and within which all three support tubes reside after insertion. This lumen has its own central seal 964a toward the proximal end of the lumen. The large central seal 964a maintains insufflation when nothing is inserted into the trocar and the seal piece guide cap subassembly is separated from the cannula body 910. In some embodiments, the cannula body 910 includes a luer lock connection 926 for an air insufflation tube that opens into the main lumen.

[0167] In some embodiments, the seal piece 965 comprises a rigid plastic outer ring over which a flexible, integrated triple seal (e.g., a silicone stretch lid) is stretched. The flexible, integrated triple seal comprises three individual seals 964b. A seal around each instrument / camera solves the problem of sealing the gap in the middle of the three.

[0168] During insertion and extraction, instruments must push the support tubes / shafts of cameras and other instruments out of the way to accommodate the larger "working section" diameter of the instrument through the trocar. To maintain insufflation, it is beneficial for the seal to be able to translate radially or laterally and / or pivot to accommodate this. In some embodiments, a flexible integrated triple seal is constructed from a single piece of flexible material (e.g., silicone) with all three seals contained in the same part, and each individual seal is surrounded by an accordion-like "bellows" 968 that allows each seal to move and pivot independently.

[0169] Guide cap 966 features a dividing wall 975, which may or may not be connected in the middle, that helps funnel the camera and instruments into their respective seals during insertion.

[0170] In addition to the lumen for the instrument / camera arm, the cannula body 910 may also include a smaller lumen for insufflation, a smaller lumen for smoke evacuation, or both.

[0171] In some embodiments, there may be two stacked seal pieces 965 with different integral seals (i.e., different seal diameters / shapes) to maintain a seal around both the maximum and minimum diameters of the arm (the diameter varies along the arm).

[0172] In some embodiments described above with respect to trocars 200, 300, 400, 500, 600, 800, and 900, any or all of the seal assemblies, individual seals, or central seals may incorporate plastic leaflets that act as reinforcements for the top of one or more of the seals.

[0173] In some embodiments, a biocompatible lubricant may be used in one or more of the seals.

[0174] Some embodiments described above with respect to trocars 200, 300, 400, 500, 600, 800, and 900 allow for smaller nominal trocar diameters than those provided by conventional multi-lumen trocar designs that use separate lumens for each camera / instrument along the entire length of the trocar tubular portion for insertion of instruments / cameras of the same diameter. In some embodiments, the trocar inner diameter can be less than about 25 mm, less than about 19 mm, within the range of about 13 mm to about 25 mm, within the range of about 15 mm to about 22 mm, or within the range of about 15 mm to 20 mm.

[0175] Unlike some trocars that use a balloon seal, the above-described embodiment does not require a separate gas source from the insufflation gas source to maintain the seal.

[0176] Some embodiments include fewer components and require fewer steps during use than conventional gel-based trocars (eg, AMT GelPOINT®).

[0177] In some embodiments, a rotatable inflatable seal for single-port laparoscopy is provided, as shown schematically in FIGS. 22A and 22C . The inflatable seal 1000 prevents gas exchange between a patient's internal body cavity (e.g., the abdominal cavity) and the operating room during laparoscopic surgery. In single-port surgery, where there is a single incision for all tools entering the abdomen, sealing around all tools is a complex challenge. In some embodiments, multiple rotatable inflatable seals may be used per trocar, with each one fitting around an inserted tool. The inflatable seal 1000 has the shape of an elongated torus along a central axis and has a single, continuous outer surface 1002 with a portion forming an inward-facing surface and a portion forming an outward-facing surface. The portion of the outer surface that forms the inward-facing surface and the portion that forms the outward-facing surface change as the outer surface 1002 of the inflatable seal 1000 rotates. The inflatable seal 1000 forms an airtight seal around the exterior of one of the laparoscopic tools 1020, creating a uniform, compressible outer surface. For example, point A on the leading edge of the outer surface 1002 as the tool 1020 enters the lumen 1012 in Figure 22A rolls to the trailing edge in Figure 22B as the tool 1020 advances into the lumen 1012. Similarly, point B, which is on the trailing edge of the outer surface 1002 as the tool 1020 enters the lumen in Figure 22A, is at the leading edge of the outer surface 1002 as the tool advances into the lumen 1012 in Figure 22B. When multiple rotating inflatable seals are used, each tool is sealed independently, and compression of all the seals for each tool and the lumen 1012 seals the internal body cavity (e.g., abdominal cavity) from the operating room (see Figure 22C).

[0178] Some conventional inflatable air seals large enough for use with multiple tools within a single trocar require high flow rates, specialized trocars, and specialized insufflation equipment that can be noisy. Rotating inflatable seals for trocars can be configured so that they do not require specialized trocars, require less space around the trocar than a standard trocar, are compatible with any number of given tools, are silent or quiet during operation, and do not require specialized tools according to some embodiments.

[0179] While conventional inflatable seals for trocars exist, in which the seal is housed within the trocar itself, they suffer from the drawback of experiencing relative movement between the seal surface and the instrument passing through it. On irregular tool surfaces, this can lead to tears and rips, resulting in loss of air insufflation. With an inflatable rotating seal, initially there is no sliding action between the seal and the trocar or instrument. At some point during the insertion process, this changes, and the tool slides against the rotating seal, but this can be adjusted to occur on a uniform, smooth area of ​​the tool past the break point. The sliding over rotation action also reduces the force required to insert the tool. With an all-tool seal, this also provides greater redundancy, since a single seal failure does not require complete removal of the trocar and replacement of the entire seal assembly. Rotating inflatable seals use pressure against the instrument and the interior of the trocar to form a bilateral seal. The seal, a pressurizable and / or compressible tube, is placed around the tip of an instrument, such as a laparoscopic needle driver. The inner diameter of the seal is designed to match the outer diameter of the tool (e.g., perhaps larger, the same, or smaller), and the outer diameter is sized to interfere with the rest of the seal in a way that prevents gas exchange.

[0180] As a tool 1020, such as a needle driver 1020, is inserted into the trocar 1010, the inflatable seal 1000 contacts the edge of the trocar 1010, and additional pressure begins to build up within the inflatable seal 1000 due to compression from the trocar 1010. As the needle driver 1020 is further inserted, the distal end of the inflatable seal 1000 remains relatively stationary relative to the trocar (see point B), causing the seal 1000 to invert or rotate along with the needle driver. Once the needle driver 1020 is fully inserted, the inflatable seal 1000 is fully inverted (see comparison of the position of point B in FIG. 22B with the position of point B in FIG. 22A), and further distal movement along the insertion axis is a sliding movement, while extraction is again a rotational movement.

[0181] If a second tool, a fenestrated grasper, is prepared and inserted in the same manner, the seal on the fenestrated grasper will interfere with the seal on the needle driver, increasing pressure at both seals. Once the grasper is inserted, it rotates through the second seal in the same manner as the needle driver until fully inserted. At that point, both seals are within the trocar and press against the outer diameter of the tool and the inner diameter of the trocar cannula. Applying sufficient pressure can prevent gas exchange between the abdomen and the operating room.

[0182] In some embodiments, the trocar may include a plug or cork 1100, as shown in Figures 23A-23D. The plug or cork 1100 may be slidably connected to a camera assembly support tube 1150. The plug or cork 1100 may include one or more ridges 1123 configured to provide rigidity to a stem 1140 of the cork 1100 to prevent bending during use. In some embodiments, the stem 1140 is tapered to reduce the surface area in contact with the camera assembly support tube 1150, thereby reducing the force required to move the cork 1100 along the support tube 1150.

[0183] The trocar may include a distal seal 382, ​​which may be structured as a duckbill, for insertion of the camera assembly, and a proximal seal 364, which is empty. The cork 1100 may include a hole 1120 through which the camera assembly passes. The support tube 1150 is seated as shown in FIG. 24 . The cork 1100 is configured to slide along the support tube 1150. For example, the support tube 1150 seats within the hole 1120 in the cork 1100 and extends through a support 1130 located at the opposite end of the hole 1120. The distal seal 382c′ may provide a perfect seal when the camera assembly is not present. Once the camera assembly is inserted, the distal seal 382c′ no longer provides an adequate seal. The user may then slide the cork 1100 on the support tube 1150 into the empty proximal seal 364c′. The cork 1100 may include structure 1110 that snaps into the void proximal seal 364c' to form a snap fit, filling the void and sealing properly around the camera assembly.

[0184] While embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It will be understood that various alternatives to the embodiments of the invention described herein may be employed. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. 1. A trocar for use in an endoscopic surgical procedure employing at least one endoscopic instrument or endoscopic camera, said trocar comprising: a cannula having a central insertion axis and a proximal end defining a proximal opening; A seal assembly configured to seal the proximal opening of the cannula, the seal assembly comprising: a seal support structure at least partially defining a plurality of channels; a first layer covering the proximal opening of the cannula, the first layer having a central portion and comprising a first flexible material, the seal support structure being attached to or integral with the central portion of the first layer, the first layer comprising a plurality of first layer individual seals each having an opening for insertion of an endoscopic tool or instrument; a second layer comprising a second flexible material and including a plurality of second-layer individual seals, each having an opening for insertion of an endoscopic tool or instrument, each first-layer individual seal aligned with a corresponding second-layer individual seal and one of the plurality of channels and offset proximally or distally from the corresponding second-layer individual seal; The seal assembly is configured such that, in use, at least a portion of the central portion of the first layer translates radially relative to the central insertion axis of the cannula to move individual seals of the first layer and corresponding individual seals of the second layer radially closer to the central insertion axis of the cannula to align an endoscopic instrument or tool with the central insertion axis of the cannula.

2. The trocar of claim 1 , wherein the first layer further comprises one or more concentric corrugations or pleats to allow radial translation of the central portion of the first layer.

3. The trocar of claim 2 , wherein the first layer also has a peripheral portion, and the one or more concentric corrugations or pleats are disposed on the peripheral portion of the first layer and surround the central portion.

4. The trocar of any one of claims 1 to 3, wherein each second layer individual seal comprises a slit formed in the second flexible material.

5. The trocar of any one of claims 1 to 4, wherein the individual seals of each first layer comprise a universal seal.

6. The trocar of any one of claims 1 to 5, wherein each first layer individual seal comprises a cross-slit valve or a duckbill valve.

7. 7. The trocar of claim 1, wherein the first layer comprises a first sheet comprising the first flexible material and a second sheet comprising the first flexible material, and wherein each individual seal of the first layer comprises a first slit in the first sheet and a second slit in the second sheet, and an orientation of the first slit is different from an orientation of the second slit, forming a cross-slit valve.

8. A trocar according to any one of claims 1 to 7, wherein the first layer comprises a sealing sheet comprising the first flexible material, and the peripheral portion of the first layer and the individual seals of each first layer are integral with the sealing sheet.

9. The trocar of claim 8 , wherein the second layer comprises a second sealing sheet comprising the second material, and each second layer individual seal is integral with the second sealing sheet.

10. The trocar of any one of claims 1 to 7, wherein the individual seals of the first layer are separable from the first layer and the individual seals of the second layer are separable from the second layer.

11. the seal support structure comprises a brace plate, the brace plate being positioned proximally relative to the central insertion axis relative to the first layer and the second layer; or is located distally relative to the central insertion axis relative to the first and second layers; or The trocar according to any one of claims 1 to 10, disposed between the first layer and the second layer.

12. The trocar of claim 11 , further comprising a brace plate support layer, the brace plate being attached to and supported by the brace plate support layer.

13. the brace plate support layer having a central portion and a peripheral portion; The trocar of claim 12 , wherein the brace plate support layer includes one or more concentric corrugations or pleats disposed in the peripheral portion and surrounding the central portion.

14. 14. The trocar of any one of claims 1 to 13, wherein the seal support structure comprises or further comprises one or more multi-lobe plates, each lobe defining an opening corresponding to one of the plurality of holes.

15. The trocar of any one of claims 1 to 13, wherein the seal support structure comprises a plurality of plates.

16. The trocar of claim 15, wherein the first layer is disposed between a first plate of the plurality of plates and a second plate of the plurality of plates.

17. The trocar of claim 16, wherein the second layer is disposed between the second plate of the plurality of plates and a third plate of the plurality of plates.

18. The trocar of claim 15, wherein the first layer and the second layer are held between the first plate of the plurality of plates and the second plate of the plurality of plates.

19. The trocar of any one of claims 1 to 13, wherein the seal support structure comprises a first plate, the first plate including a plurality of holes each defining a portion of a corresponding channel within the plurality of channels.

20. The trocar of claim 19, wherein the seal support structure further comprises a second plate, the second plate including at least one hole connecting with the plurality of channels.

21. The trocar of any one of claims 1 to 20, wherein the seal support structure is at least partially supported by the first layer.

22. The trocar of any one of claims 1 to 21, wherein the second layer covers the proximal opening of the cannula, and the second layer supports or partially supports the seal support structure.

23. 23. The trocar of claim 22, wherein the second layer has a central portion and a peripheral portion, the second layer including one or more concentric corrugations or pleats formed in the peripheral portion surrounding the central portion.

24. The trocar of any one of claims 1 to 23, wherein the second layer is positioned proximally relative to the central insertion axis compared to the first layer.

25. The trocar of any one of claims 1 to 23, wherein the second layer is positioned distally relative to the central insertion axis compared to the first layer.

26. 1. A trocar for use in an endoscopic surgical procedure employing at least one endoscopic instrument or endoscopic camera, said trocar comprising: a cannula having a central insertion axis and a proximal end defining a proximal opening; A seal assembly configured to seal the proximal end of the cannula, the seal assembly comprising: a first layer covering the proximal opening of the cannula, the first layer having a central portion and comprising a first flexible material, the first layer including a plurality of first layer individual seals in the central portion, each first layer individual seal having an opening for insertion of an endoscopic instrument or an endoscopic camera; a second layer comprising a second flexible material and including a plurality of second-layer individual seals, each second-layer individual seal having an opening for insertion of an endoscopic tool or instrument, each first-layer individual seal aligned with and offset proximally or distally from a corresponding second-layer individual seal relative to a central insertion axis; The seal assembly is configured such that, in use, at least a portion of the central portion of the first layer translates radially relative to the central insertion axis of the cannula to move individual seals of the first layer and corresponding individual seals of the second layer radially closer to the central insertion axis of the cannula to align an endoscopic instrument or tool with the central insertion axis of the cannula.

27. 27. The trocar of claim 26, wherein the first layer, the second layer, or both at least partially define a plurality of lumens.

28. 29. The trocar of claim 27 or claim 28, further comprising a seal support structure having a central hole corresponding to the central portion of the first layer, the seal support structure being affixed, directly or indirectly, to the first layer and at least partially supported by the first layer.

29. 29. The trocar of claim 1, wherein, for each set of individual seals of a first layer and corresponding individual seals of a second layer, the central portion of the first layer is configured to allow radial translation of at least a portion of the central portion of the first layer relative to the central insertion axis to enable movement of the individual seals of the first layer and the corresponding individual seals of the second layer in radial alignment with the central insertion axis of the cannula.

30. 30. The trocar of any one of claims 1 to 29, wherein the seal assembly is configured, in use, to maintain a gas and liquid seal between the ambient atmosphere and the interior of the trocar before and during insertion of an endoscopic instrument or an endoscopic camera into the trocar.

31. The trocar of any one of claims 1 to 30, wherein the seal assembly is configured, in use, to maintain a gas and liquid seal between the ambient atmosphere and the interior of the trocar during and after withdrawal of an endoscopic tool or endoscopic camera from the trocar.

32. A trocar according to any one of claims 1 to 31, wherein each of the individual seals of the first layer is radially offset from the central insertion axis of the cannula when an endoscopic instrument or endoscopic camera is not inserted within the trocar.

33. The trocar of any one of claims 1 to 32, wherein the trocar is configured for use with a surgical robotic system comprising a robotic arm having an instrument and a camera assembly including a camera.

34. the plurality of first layer individual seals include a first layer camera seal and a first layer robot arm seal, and the plurality of second layer individual seals include a second layer camera seal and a second layer robot arm seal; the trocar is configured to maintain a seal when a robotic arm instrument or a camera assembly is not inserted within the trocar; the trocar is configured to maintain a seal during insertion of the camera assembly into the trocar via the first layer camera seal and the second layer camera seal; 34. The trocar of claim 33, wherein the trocar is configured to maintain a seal during insertion of the first robotic arm into the trocar via the first layer robotic arm seal and the second layer robotic arm seal.

35. 35. The trocar of any one of claims 1 to 34, wherein the trocar is configured for use with a surgical robotic system comprising a first robotic arm having a first instrument, a second robotic arm having a second instrument, and a camera assembly including a camera.

36. 36. The trocar of claim 35, wherein the plurality of first layer individual seals includes a first layer camera assembly seal and a pair of first layer robot arm seals, and the plurality of second layer individual seals includes a second layer camera assembly seal and a pair of second layer robot arm seals.

37. the trocar is configured to maintain a seal when a robotic arm or a camera assembly is not inserted within the trocar; the trocar is configured to maintain a seal during insertion of the camera assembly into the trocar via the first layer camera assembly seal and the corresponding second layer camera assembly seal; the trocar is configured to maintain a seal during insertion of the first robotic arm into the trocar via a first robotic arm seal of the pair of first layer robotic arm seals and a corresponding first robotic arm seal of the pair of second layer robotic arm seals; 37. The trocar of claim 36, wherein the trocar is configured to maintain a seal during insertion of the second robotic arm into the trocar via a second robotic arm seal of the pair of first layer robotic arm seals and a corresponding second robotic arm seal of the pair of second layer robotic arm seals.

38. the trocar is configured to maintain a seal when a robotic arm or a camera assembly is not inserted within the trocar; the trocar is configured to maintain a seal when the camera assembly extends through the trocar via the first layer camera assembly seal and the corresponding second layer camera seal, the first robotic arm does not extend into or through the trocar, and the second robotic arm does not extend into or through the trocar; the trocar is configured to maintain a seal when the camera assembly extends through the trocar via the first layer camera assembly seal and the corresponding second layer camera seal, the first robotic arm extends through the trocar via a first robotic arm seal of the pair of first layer robot arm seals and a corresponding first robotic arm seal of the pair of second layer robot arm seals, and the second robotic arm is not extending into or through the trocar; 38. The trocar of claim 36 or claim 37, wherein the trocar is configured to maintain a seal when the camera assembly extends through the trocar via the first layer camera assembly seal and the corresponding second layer camera seal, the first robotic arm extends through the trocar via the first robotic arm seal of the pair of first layer robot arm seals and the corresponding first robotic arm seal of the pair of second layer robot arm seals, and the second robotic arm extends through the trocar via the second robotic arm seal of the pair of first layer robot arm seals and the corresponding second robotic arm seal of the pair of second layer robot arm seals.

39. the first layer camera assembly seal and the corresponding second layer camera seal are configured for insertion of the camera assembly having a first maximum insertion diameter; a first robot arm seal of the pair of first layer robot arm seals and a corresponding first robot arm seal of the pair of second layer robot arm seals are configured for insertion of the first robot arm having a second maximum insertion diameter that is smaller than the first maximum insertion diameter; A trocar according to any one of claims 36 to 38, wherein a second robotic arm seal of the pair of first layer robotic arm seals and a corresponding second robotic arm seal of the pair of second layer robotic arm seals are configured for insertion of the second robotic arm having a third maximum insertion diameter smaller than the first maximum insertion diameter.

40. a first seal of the first layer of individual seals and a corresponding first seal of the second layer of individual seals configured for insertion of an endoscopic instrument or an endoscopic camera having a first maximum insertion diameter; a second seal of the first layer of individual seals and a corresponding second seal of the second layer of individual seals configured for insertion of an endoscopic instrument or an endoscopic camera having a second maximum insertion diameter that is smaller than the first maximum insertion diameter; A trocar according to any one of claims 1 to 34, wherein a third seal of the individual seals of the first layer and a corresponding third seal of the individual seals of the second layer are configured for insertion of an endoscopic instrument or an endoscopic camera having a third maximum insertion diameter smaller than the first maximum insertion diameter.

41. The trocar of any one of claims 1 to 40, wherein at least a portion of the proximal portion of the cannula comprises a funnel or flared shape.

42. The trocar of any one of claims 1 to 41, wherein at least a portion of the individual seals in the first layer, at least a portion of the individual seals in the second layer, or both, comprise leaflets.

43. 43. The trocar of claim 42, wherein the leaflets comprise a third material.

44. 44. The trocar of claim 43, wherein the third material has a stiffness greater than the stiffness of the first material and the stiffness of the second material.

45. The trocar of any one of claims 1 to 44, wherein the seal support structure is a rigid seal support structure.

46. The trocar of any one of claims 1 to 45, wherein the proximal end of the cannula includes at least one mating structure configured to secure the seal assembly to the proximal end of the cannula.

47. 47. The trocar of claim 46, wherein the seal assembly includes at least one complementary mating structure for securing the seal assembly to the proximal end of the cannula.

48. The trocar of any one of claims 1 to 47, wherein the cannula further comprises a retention structure on at least a portion of an outer surface of the cannula configured to engage tissue of a patient during use.

49. The trocar of any one of claims 1 to 48, wherein the cannula further comprises at least one port.

50. 50. The trocar of claim 49, wherein the at least one port is configured to receive gas for insufflation.

51. The trocar of any one of claims 1 to 50, wherein the cannula further comprises a smoke evacuation port and a smoke evacuation lumen in a proximal portion of the cannula.

52. 52. The trocar of claim 51, wherein the smoke evacuation lumen extends from the distal end of the cannula to the smoke evacuation port.

53. 52. The trocar of claim 51, wherein the smoke evacuation lumen extends from a distal opening of the cannula to the smoke evacuation port.