CN112236071A

CN112236071A - Surgical visualization system and related methods

Info

Publication number: CN112236071A
Application number: CN201980027429.0A
Authority: CN
Inventors: W·凯恩; D·汤姆门; J·霍克; V·C·佐尔曼; J·R·霍金斯; T·伽马奇; J·康尼迪; L·B·古菲; E·科尔布
Original assignee: Medos International SARL
Current assignee: Medos International SARL
Priority date: 2018-02-21
Filing date: 2019-02-20
Publication date: 2021-01-15
Also published as: WO2019164893A1; JP7258900B2; EP3755198A1; JP2021514259A; AU2019223983A1; EP3755198A4

Abstract

Surgical visualization systems and related methods, for example, for providing visualization during a surgical procedure are disclosed herein. The systems and methods herein may be used in a wide range of surgical procedures, including spinal surgery, such as minimally invasive fusion or discectomy. The systems and methods herein may include various features for enhancing the end user experience, improving clinical outcomes, or reducing the invasiveness of the surgical procedure. Exemplary features may include portal integration, hands-free operation, active and/or passive lens cleaning, adjustable camera depth, and many others.

Description

Surgical visualization system and related methods

Technical Field

Surgical visualization systems and related methods, for example, for providing visualization during surgery, including minimally invasive spinal surgery, are disclosed herein.

Background

There are many situations in which it may be desirable to provide a surgeon or other user with visualization of a surgical site. While a number of surgical visualization systems have been developed, they are often cumbersome and cumbersome to use, difficult to clean or sterilize, or have characteristics that make them inadequate or impossible to use for many types of procedures. For example, spinal endoscopes are typically used only for limited procedures, such as disc herniation repair and other pathologies that shrink to a predictable very small location. Such devices typically require very small, specialized tools with low output force and tissue handling capability. Such devices may require multiple operators, where an assistant or other user holds and operates the visualization system while the surgeon uses both hands to perform the surgical procedure. Furthermore, such devices may have steep learning curves, as the visualization orientation may be determined by the instrument orientation, and thus may be constantly changing during the procedure.

Disclosure of Invention

In some embodiments, a surgical system may comprise: an access device having a working channel and a visualization channel; and a visualization system disposed at least partially in the visualization channel, the visualization system including a camera module and a housing in which the camera module is mounted.

The camera module may include an image sensor and a lens configured to direct reflected light onto the image sensor, the image sensor and the lens being disposed within the housing. The camera module may include an optical fiber having a distal end disposed within the housing and a proximal end in optical communication with the light source. The lens may be disposed within a lens lumen of the lens barrel, and the optical fiber may be disposed in an illumination lumen of the lens barrel. The illumination lumen may be disposed closer to the center of the working channel of the access device than the lens lumen. The lens barrel may include a distally facing surface angled obliquely relative to a central longitudinal axis of the working channel. The system may include a diffuser mounted in a recess formed in a distal-facing surface of the lens barrel above the optical fiber. The recess may be crescent-shaped and may substantially follow the perimeter of the lens lumen. A central region of the lens may be coated with a hydrophobic coating and a peripheral region of the lens may be coated with a hydrophilic coating.

The housing may include a body and a distal end cap. The body may include a camera lumen in which the camera module is disposed and first and second fluid lumens. The camera lumen may be centrally disposed in the body between the first fluid lumen and the second fluid lumen. The distal-facing surface of the body and the distal-facing surface of the end cap may be obliquely angled relative to a central longitudinal axis of the working channel. The body may have a sidewall with a concave inner surface disposed adjacent the working channel and a convex outer surface disposed opposite the inner surface. The inner surface of the sidewall of the body may define at least a portion of the inner surface of the working channel. The outer surface of the sidewall may include a first planar region and a second planar region connected by a central transition region defining a segment of a cylinder, the transition region following an outer perimeter of the camera lumen of the body. The inner surface may be concavely curved and connected to the outer surface by first and second transition regions defining sections of the respective cylinders, the first and second transition regions following outer peripheries of first and second fluid lumens formed in the body. The housing may be formed from an inner circular tube disposed within and attached to an outer elliptical tube to define a camera lumen and first and second fluid lumens. The housing may be formed from an inner circular tube having opposing first and second shells attached thereto to define a camera lumen and first and second fluid lumens. The end cap may include a cutout that is axially aligned with a lens of the camera module and a cutout that is axially aligned with an illumination system of the camera module. The proximal facing surface of the end cap may define a recess configured to direct fluid across the lens of the camera module out of the first fluid lumen of the housing and into the second fluid lumen of the housing. The recess may include outboard end portions axially aligned with the first and second fluid lumens and an inboard end portion open to the cutout of the end cap.

The system may include a connector assembly extending from the housing, the connector assembly including electrical and optical connections to the camera module and a fluid connection to the housing. The connector assembly may have an external shape that matches an external shape of the housing. The system may include a controller having an electronic display configured to display image data captured by an image sensor of the camera module. The visualization channel may intersect or overlap the working channel. The housing and camera module may be capable of axial translation relative to the access device. The visualization channel may have a central longitudinal axis disposed radially outward from a central longitudinal axis of the working channel.

The access device can include a mating feature configured to selectively retain the visualization system in a desired position relative to the access device. The mating feature may include a locking track configured to receive a portion of the visualization system to limit movement of the visualization system relative to the access device. The locking track may be formed in a proximal extension of the access device. The locking track may snap fit or friction fit receive the visualization system. The mating feature may include an adjustment track configured to receive at least a portion of the visualization system to allow movement of the visualization system relative to the access device. The visualization system may be configured such that the visualization system may be loaded into the locking track by moving it radially outward from the central longitudinal axis of the visualization channel. The locking rail may be curved or angled obliquely away from the central longitudinal axis of the visualization channel. The visualization system may be configured such that the visualization system may be secured to the mating feature at any point along the connector assembly of the visualization system. The mating feature may include a wheel that, when rotated, advances or retracts the visualization system relative to the access device. The mating feature may include a coil spring clamp configured to selectively lock the visualization system in a fixed position relative to the access device. The mating feature may include an O-ring disposed about a portion of the visualization system and a cone movably coupled to the access device, the cone being movable between a first position in which the cone stretches the O-ring to allow movement of the visualization system relative to the access device and a second position in which the O-ring is released to grip onto the visualization system and prevent movement of the visualization system relative to the access device.

The system may include a sleeve insertable through the working channel of the access device, the sleeve having an outer diameter and a bulb-shaped portion movably coupled to the sleeve, the bulb-shaped portion being movable between a first position in which the bulb-shaped portion is disposed entirely within the outer diameter of the sleeve and a second position in which at least a portion of the bulb-shaped portion protrudes from the outer diameter of the sleeve. The bulb-shaped portion in the second position may be configured to fill a void space distal to a visualization channel of an access device within the access device. The bulb-shaped portion may include a distal-facing surface that is curved or sloped to form a gradual transition between a cylindrical dilator inserted through the cannula and an outer surface of the access device. The bulb-shaped portion is movable between a first position and a second position by axially translating the sleeve relative to the access device. The bulb-shaped portion is movable between a first position and a second position by rotating the sleeve relative to the access device. The bulb-shaped portion may be biased toward the second position. The access device can include a transition portion at a distal end thereof, the transition portion being movable between a first position in which the transition portion extends radially inward to provide a gradual transition between a cylindrical dilator inserted through the working channel and an outer surface of the access device, and a second position in which the transition portion is moved radially outward from the first position. The system can include a dilation shaft insertable through the access device to move the transition portion to the second position. The transition portion may include a plurality of flexible and resilient fingers.

In some embodiments, a visualization system may comprise: a camera module having an image sensor and a lens; and a housing in which the camera module is disposed, the housing having a main body, first and second fluid channels, and an end cap configured to direct fluid flow through the channels across a lens of the camera module.

The camera module may include an optical fiber having a distal end disposed within the housing and a proximal end in optical communication with the light source. The lens may be disposed within a lens lumen of the lens barrel, and the optical fiber may be disposed in an illumination lumen of the lens barrel. The system may include a diffuser mounted in a recess formed in a distal-facing surface of the lens barrel above the optical fiber. The recess may be crescent-shaped and may substantially follow the perimeter of the lens lumen. A central region of the lens may be coated with a hydrophobic coating and a peripheral region of the lens may be coated with a hydrophilic coating.

The camera module may be centrally disposed in the body between the first fluid channel and the second fluid channel. The distal-facing surface of the body and the distal-facing surface of the end cap may be obliquely angled relative to a central longitudinal axis of the camera module. The body may have an outer surface comprising a first planar region and a second planar region connected by a central transition region defining a segment of a cylinder, the transition region following an outer perimeter of a camera lumen of the body. The body may have an inner surface that is concavely curved and connected to the outer surface by first and second transition regions that define sections of the respective cylinders, the first and second transition regions following outer peripheries of the first and second fluid passages. The housing may be formed from an inner circular tube disposed within and attached to an outer elliptical tube to define a camera lumen and first and second fluid channels. The housing may be formed from an inner circular tube having opposing first and second shells attached thereto to define a camera lumen and first and second fluid channels. The end cap may include a cutout axially aligned with the lens. The proximal facing surface of the end cap may define a recess configured to direct fluid across the lens out of the first fluid channel of the housing and into the second fluid channel of the housing. The recess may include an outboard end portion axially aligned with the first and second fluid passages and an inboard end portion open to the cutout of the end cap.

The system may include a connector assembly extending from the housing, the connector assembly including electrical and optical connections to the camera module and a fluid connection to the housing. The connector assembly may have an external shape that matches an external shape of the housing. The system may include a controller having an electronic display configured to display image data captured by an image sensor of the camera module.

In some embodiments, a surgical method may comprise: inserting an access device into a patient; mounting an access device to an anchor, the anchor comprising at least one of an anatomy of a patient and an implant implanted within the patient; inserting a camera module into an entry device; adjusting a depth of the camera module relative to the access device; and securing the camera module to a mating feature of the access device to maintain the camera module at the adjusted depth.

The anchor may comprise a bone anchor implanted into a pedicle of the patient. The method may include performing a surgical procedure through the access device without using hands to hold the access device or the camera module. The method may include inserting a fusion cage through an access device and into the intervertebral disc space. Inserting the access device may include positioning a distal end of the access device in proximity to the patient's intervertebral disc space via a TLIF approach. The method may include positioning a camera module in a relatively proximal position relative to an access device, performing a bone resection with the access device, positioning the camera module in a relatively distal position relative to the access device, and removing intervertebral disc tissue with the access device. The method may include directing a cleaning medium through a housing in which the camera module is disposed and across a lens of the camera module. Inserting the access device can include positioning a distal end of the access device in a dry environment of the patient. Inserting the access device can include positioning a distal end of the access device in a sinus cavity of the patient. The method may include performing a laryngoscopy or a bronchoscopy using the camera module.

In some embodiments, a surgical system may comprise: an access device having a working channel and a visualization channel; a visualization system disposed at least partially in the visualization channel, the visualization system including a camera module and a housing in which the camera module is mounted; and a tissue shield extending distally beyond the distal end face of the housing.

The tissue shield may be capable of longitudinal movement relative to the housing. The tissue shield may be slidably disposed within the lumen of the housing. The tissue shield may be slidably disposed within the lumen of the access device. The tissue shield may be slidably disposed along an outer surface of the housing. The tissue shield may include a wiper configured to clear debris from a lens of the camera module as the tissue shield is moved longitudinally relative to the housing. The tissue shield may extend around less than the entire perimeter of the housing. The tissue shield may include a curved inner surface that follows the curve of the lens of the camera module. The tissue shield may have an outer surface with a contour matching a contour of an outer surface of the housing. The tissue shield may have a crescent-shaped cross-section.

In some embodiments, a surgical system may comprise: an access device having a working channel and a visualization channel; a visualization system disposed at least partially in the visualization channel, the visualization system including a camera module and a housing in which the camera module is mounted; and an active lens cleaning device configured to remove debris from a lens of the camera module.

The lens cleaning device may include a source of positive pressure gas directed through the lumen of the housing toward the lens. The gas may comprise air or carbon dioxide. The lens cleaning device may include a fluid lumen having a nozzle opening through which fluid may be directed toward the lens, the nozzle opening being obliquely angled relative to a central longitudinal axis of the housing. The nozzle opening may be formed in a tube extending from a distal end face of the tip of the housing. The lens cleaning device may include a fluid lumen having a nozzle opening through which fluid may be directed toward the lens, the nozzle opening extending perpendicular to a central longitudinal axis of the housing. The lens cleaning device may comprise an ultrasonic agitator. The lens cleaning device may include a membrane movable relative to the lens. The membrane may comprise a continuous ring of material configured to be carried on at least one of a wiper, a brush, a fluid jet, and a vacuum port to clean the membrane. The film may be wound onto a spool. The membrane may extend through the first lumen of the housing, across the lens, and through the second lumen of the housing. The lens cleaning device may include a wiper disposed at least partially in the working channel of the access device. The wiper may include an offset portion that contacts a protrusion formed in the working channel to force the tip of the wiper laterally across the lens as the shaft of the wiper moves longitudinally within the working channel. The wiper may be biased toward the visualization channel such that the wiper wipes over the lens of the camera module as the camera module is advanced distally into the visualization channel.

In some embodiments, a surgical method may comprise: inserting an access device into a patient; inserting a housing having a camera module therein into an access device, the camera module having a lens; and actuating the lens cleaning device to clean a visualization path leading to a lens of the camera module when the access device and the camera module are inserted into the patient.

Actuating the lens cleaning device may include a tissue shield projecting longitudinally from a distal end of the housing relative to the housing to cause a wiper to be carried on the lens. Actuating the lens cleaning device may include directing positive pressure air through a lumen of the housing and toward the lens. The actuating lens cleaning device may include a vibrating lens. Actuating the lens cleaning device may include moving the membrane relative to the lens. Moving the membrane may include rotating a continuous ring of membrane material to move a dirty portion of the membrane away from the lens and to position a clean portion of the membrane over the lens. Actuating the lens cleaning device may include advancing the camera module through the access device to drag a wiper tab biased toward the visualization channel across the lens. Actuating the lens cleaning device may include moving the wiper longitudinally within the working channel, thereby causing the offset portion of the wiper to contact a protrusion disposed in the working channel to force the tip of the wiper laterally across the lens.

In some embodiments, a visualization system may comprise: a camera module having an image sensor and a lens; and a housing in which the camera module is disposed, the housing having a body, one or more fluid channels, and an end cap configured to direct a fluid flow across a lens of the camera module through the one or more fluid channels.

In some embodiments, a surgical system may comprise: an access device having a working channel and a visualization channel; and a visualization system disposed at least partially in the visualization channel, the visualization system comprising a camera module; wherein the visualization system is axially translatable relative to the access device to position the visualization system such that the camera module protrudes from the distal end of the access device.

In some embodiments, a surgical method may comprise: inserting an access device into a patient; inserting a camera module into an entry device; and adjusting a depth of the camera module relative to the access device; wherein adjusting the depth of the camera module includes positioning the camera module such that the camera module protrudes from the distal end of the access device.

Drawings

FIG. 1 is a perspective view of a surgical visualization system and an access device;

FIG. 2A is a perspective view of a camera module of the system of FIG. 1;

FIG. 2B is a cross-sectional side view of the camera module of FIG. 2A;

FIG. 2C is a cutaway perspective view of the camera module of FIG. 2A;

FIG. 3A is a perspective view of a housing of the system of FIG. 1, wherein the housing is shown as transparent, and wherein the camera module of FIG. 2A is disposed in the housing;

FIG. 3B is a perspective view of the housing and the distal end of the camera module of FIG. 3A;

FIG. 3C is a perspective view of the housing of FIG. 3A;

FIG. 3D is a side view of the housing of FIG. 3A;

FIG. 3E is a cutaway perspective view of the housing and camera module of FIG. 3A adjacent its distal end;

FIG. 3F is a perspective view of the housing and the distal end of the camera module of FIG. 3A;

FIG. 3G is a partially exploded perspective view of the housing and camera module of FIG. 3A;

FIG. 3H is a perspective view of the housing and camera module of FIG. 3A, with the end caps of the housing shown as transparent and schematically illustrating fluid flow through the housing;

FIG. 3I is a cross-sectional side view of the housing and camera module of FIG. 3A;

FIG. 3J is a cutaway perspective view of the housing and camera module of FIG. 3A;

FIG. 4A is a perspective view of a connector assembly of the system of FIG. 1;

FIG. 4B is a cutaway perspective view of the connector assembly of FIG. 4A adjacent its distal end;

FIG. 5A is a perspective view of a controller of the system of FIG. 1;

FIG. 5B is a schematic block diagram of the controller of FIG. 5A;

FIG. 6A is a perspective view of the system of FIG. 1 disposed in an access device, wherein the access device is shown as transparent;

FIG. 6B is a side view of the system and access device of FIG. 6A, with the access device shown as transparent;

FIG. 6C is a perspective view of the system and access device of FIG. 6A, with the system disposed in a locking track of the access device;

FIG. 6D is a perspective view of the system and access device of FIG. 6A, with the system disposed in an adjustment track of the access device;

FIG. 6E is a cross-sectional side view of the system and access device of FIG. 6A;

FIG. 6F is a cross-sectional side view of the distal end of the system and access device of FIG. 6A;

FIG. 6G is a top view of the system and access device of FIG. 6A;

FIG. 6H is a cutaway top view of the system and access device of FIG. 6A;

FIG. 7 is a perspective view of a surgical system for performing a surgical procedure on a spine of a patient, the surgical system including the visualization system of FIG. 1;

FIG. 8 is a cross-sectional side view of the camera module of FIG. 2A, schematically illustrating viewing characteristics of the camera module;

FIG. 9 is a perspective view of a distal end of another exemplary housing;

FIG. 10A is a cross-sectional top view of another exemplary housing;

FIG. 10B is a cross-sectional top view of another exemplary housing;

FIG. 11A is a cutaway perspective view of another exemplary housing;

FIG. 11B is a perspective view of the housing of FIG. 11A;

FIG. 11C is a cross-sectional perspective view of the housing of FIG. 11A;

FIG. 11D is a cutaway perspective view of the housing of FIG. 11A;

FIG. 12A is a cross-sectional top view of another exemplary housing;

FIG. 12B is an exploded and assembled view of another exemplary housing;

FIG. 13 is a side view of a mating feature that may be included in the access devices herein;

FIG. 14 is a perspective view of another mating feature that may be included in the access devices herein;

figure 15A is a cross-sectional side view of another mating feature that may be included in the access devices herein, shown in a locked state;

FIG. 15B is a cross-sectional side view of the mating feature of FIG. 15A shown in an unlocked state;

figure 16A is a perspective view of another mating feature that may be included in the access devices herein;

FIG. 16B is a cross-sectional side view of the mating feature of FIG. 16A;

FIG. 16C is a perspective view of the mating feature of FIG. 16A;

FIG. 17 is a perspective view of another mating feature that may be included in the access devices herein;

FIG. 18 is a perspective view of another mating feature that may be included in the access devices herein;

FIG. 19 is a perspective view of another mating feature that may be included in the access devices herein;

FIG. 20 is a perspective view of the system of FIG. 1 showing a user control;

FIG. 21A is a cutaway perspective view of an access device and a standard dilator;

FIG. 21B is a perspective view of the access device and dilation system;

FIG. 21C is a cutaway perspective view of the access device and dilation system of FIG. 21B;

FIG. 21D is a perspective view of a cannula of the dilation system of FIG. 21B;

FIG. 22A is a proximal-facing end view of the access device and dilation system in a first configuration;

FIG. 22B is a proximal-facing end view of the access device and dilation system of FIG. 22A in a second configuration;

figure 23A is a perspective view of the access device;

figure 23B is a cutaway perspective view of the access device of figure 23A;

FIG. 23C is a bottom view of the access device of FIG. 23A;

FIG. 23D is a top view of the access device of FIG. 23A;

fig. 23E is a perspective view of an expansion shaft configured for use with the access device of fig. 23A;

fig. 23F is a cutaway perspective view of the dilating shaft of fig. 23E inserted into the access device of fig. 23A;

fig. 23G is a perspective view of the expansion shaft of fig. 23E inserted into the access device of fig. 23A;

FIG. 24A is a perspective view of a visualization system;

FIG. 24B is a perspective view of the housing, camera module, and mating features of the visualization system of FIG. 24A;

FIG. 24C is a perspective view of a mating feature of the visualization system of FIG. 24A;

FIG. 25A is a perspective view of the distal end of the housing having an angled nozzle opening;

FIG. 25B is a side view of the distal end of the housing of FIG. 25A;

FIG. 25C is a perspective view of the distal end of the housing with a wiper deployable from the nozzle opening of the housing;

FIG. 26A is a perspective view of the distal end of the housing with the tissue shield;

fig. 26B is a detailed perspective view of the distal end of the housing of fig. 26A;

FIG. 26C is a perspective view of the distal end of the housing with the moveable tissue shield;

FIG. 26D is a perspective view of the distal end of the housing with the moveable tissue shield having an integrated wiper;

FIG. 27A is a cross-sectional side view of a camera module having an ultrasonic agitator;

FIG. 27B is a cutaway perspective view of another camera module having an ultrasonic agitator;

FIG. 28A is a cross-sectional side view of a housing with a movable membrane;

FIG. 28B is a cross-sectional side view of another housing with a movable membrane;

FIG. 29A is a bottom view of an access device with mechanical wipers, where the wipers are shown in a first lateral position;

FIG. 29B is a bottom view of the access device and mechanical wipe of FIG. 29A, with the wipe shown in a second lateral position;

FIG. 29C is a cross-sectional side view of the access device and mechanical wipe of FIG. 29A, with the wipe shown in a first lateral position;

FIG. 29D is a cross-sectional side view of the access device and mechanical wipe of FIG. 29A, with the wipe shown in a second lateral position;

FIG. 30A is a cross-sectional side view of an access device with a mechanical wiper, with the wiper shown in a first position; and is

Fig. 30B is a cross-sectional side view of the access device and mechanical wipe of fig. 30A, with the wipe shown in a second position.

Detailed Description

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments.

In some embodiments, the surgical visualization systems disclosed herein can enable hands-free visualization. For example, the camera module may be mounted in the access device in a manner that does not require a surgeon, assistant, or other user to manually hold the camera in place. As another example, the access device can be secured to a support, such as an operating table, anatomical anchor, and the like, thereby eliminating the need for a user to manually hold the access port or hold a camera module disposed therein. Thus, the user's hand is free to perform other steps of the surgical procedure.

The camera module may be separate and independent from the surgical instrument used to perform the procedure. Thus, instruments that may be used with the visualization system are not limited, and the system may be used with any of a variety of custom or off-the-shelf instruments. Such instruments may include instruments with increased size, strength, output force, and/or tissue processing capabilities. Furthermore, the visual trajectory of the camera may be independent of instrument positioning. This may allow the camera and/or the access device on which the camera is disposed to remain relatively stationary while the instrument is manipulated and while the procedure is performed. Thus, the field of view of the camera may remain substantially fixed during the procedure, providing a user with a good spatial orientation and a simplified learning curve compared to other visualization systems.

Conventional spinal microscopes can protrude far from the patient, take up a lot of space above the surgical incision, and must maintain a clear space around the proximal end of the probe to allow the user to see through the probe. This may limit the extent to which other instruments may be manipulated during a surgical procedure, for example, limiting the possible angle of entry of the instrument. This may also limit the size and type of instruments that may be used, the placement of the user's hands during various steps of the surgical procedure, and so forth. Visualization systems of the type described herein may be integrated with an access device, may have a thin design, and/or may display captured images on an external monitor, thereby reducing or eliminating these potential problems.

In some embodiments, the surgical visualization systems disclosed herein are capable of adjusting the depth of the camera within the access device. In some implementations, the camera depth can be adjusted quickly and easily. In some implementations, the camera depth can be adjusted toollessly with one hand. The ability to easily adjust the camera depth may allow for the visualization to be optimized for each stage of the surgical procedure in a seamless manner that does not interfere with or interrupt the surgical procedure. For example, in spinal surgery, the camera may be retracted proximally when performing gross bone removal and other steps that are relatively low risk but may result in the camera lens being obscured by debris. Later, when manipulating nerves or performing other tasks requiring greater precision, the camera may be advanced distally within the access device. In some cases, the camera may be advanced to protrude from the distal end of the access device, e.g., to position the camera within the intervertebral disc space.

In some embodiments, the surgical visualization systems disclosed herein can provide improved visualization in harsh or challenging operating environments. In many spinal procedures, for example, the operating environment is dry (as compared to fluid-filled cavities found in other surgical procedures using visualization systems), and a large amount of smoke and swarf may be generated during the surgical procedure. The surgical visualization systems disclosed herein may include active and/or passive features for clearing such debris from the camera lens, or for preventing such debris from blocking or adhering to the lens in the first position. In some embodiments, the surgical visualization systems disclosed herein can provide high resolution visualization in minimally invasive spinal procedures, such as endoscopic Transforaminal Lumbar Interbody Fusion (TLIF) procedures.

In some embodiments, the surgical visualization systems disclosed herein can be disposable, can be easily cleaned or sterilized, can have a low profile, can be lightweight, can be low cost, can have high resolution, and/or can be used in minimally invasive surgery, such as spinal surgery.

Fig. 1 illustrates an exemplary surgical visualization system 100. The system 100 may include a camera module 102 disposed within a housing 104. The housing 104 may be configured for positioning at or adjacent a surgical site. The system 100 may include a controller or display 106 for controlling the camera module 102, for displaying images captured by the camera module, and the like. The camera module 102 and/or the housing 104 may be coupled to the controller 106 by a connector or connector assembly 108. The connector assembly 108 may include electrical and/or optical connections to the camera module 102. The connector assembly 108 may include a fluid connection to the housing 104. The fluid connection may be used to deliver material to the housing 104, withdraw material from the housing, or both, e.g., for cleaning a lens of the camera module 102. The system 100 may be selectively mountable to an access device 110 or other support, may be used independently, may be selectively mountable to a surgical robot or connector arm, may be insertable through a surgical instrument, or may be used in various other ways to facilitate a surgical procedure.

The camera module 102 is shown in more detail in fig. 2A-2C. The camera module 102 may include an image sensor 112 for capturing an image of a field of view (e.g., an image of a surgical site) disposed within a field of view of the image sensor. The image sensor 112 may be configured to convert light directed onto the image sensor into an electronic signal. The image sensor 112 may be configured to capture full-color still images and video images. The image sensor 112 may be configured to capture 1080p high definition video. The image sensor 112 may be a full frame image sensor. The image sensor 112 may be a charge-coupled device (CCD) image sensor, a complementary metal-oxide semiconductor (CMOS) image sensor, an N-type metal-oxide semiconductor (NMOS) image sensor, a video chip, a chip-on-tip camera, and/or may use various other image sensing technologies. Image sensor 112 may be a monochrome sensor having a pixel array and supporting circuitry that is sensitive to electromagnetic radiation of any wavelength. Exemplary image sensors 112 and other features that may be included in or incorporated into the camera module 102 are disclosed in the following documents: U.S. patent application 13/952,518 entitled "CONTINUOUS VIDEO IN A LIGHT DEFICIENT environnment"; U.S. patent application 14/214,412 entitled "IMAGE ROTATION USING SOFTWARE FOR implementation APPLICATIONS"; U.S. Pat. No. 8,648,932 entitled "SYSTEM, APPARATUS AND METHOD FOR PROVIDING A SINGLE USE IMAGING DEVICE FOR STERILE ENVIRONMENTS"; U.S. Pat. No. 8,952,312 entitled "IMAGE SENSOR FOR ENDOSCOPIC USE"; U.S. Pat. No. 3, 8,972,714 entitled "SYSTEM AND METHOD FOR PROVIDING glass USE IMAGING DEVICE FOR MEDICAL APPLICATIONS"; U.S. Pat. No. 9,123,602 entitled "PIXEL ARRAY AREA OPTIMIZATION USE STACKING SCHEME FOR HYBRID IMAGE SENSOR WITH MINIMAL VERTICAL INTERCONNECTICTS"; U.S. patent 9,153,609 entitled "IMAGE SENSOR WITH telephone optioning interconnecting"; U.S. patent 9,462,234 entitled "CAMERA SYSTEM WITH MINIMAL AREA MONOLITHIC CMOS IMAGE SENSOR"; U.S. patent 9,509,917 entitled "WIDE DYNAMIC RANGE use MONOCHROMATIC SENSOR"; and U.S. Pat. No. 9,622,650 entitled "SYSTEM AND METHOD FOR SUB-COLUMN sample diagnostic FOR HYBRID STACKED IMAGE SENSOR use converting interconnected, each of which is incorporated herein by reference.

The camera module 102 may include a lens or optical element 114 configured to direct light onto the image sensor 112. The lens 114 may be a static lens. The lens 114 may be a single piece of optically transparent material. The lens 114 may be polymeric. The lens 114 may have a fixed focal length or may have an adjustable focal length. The lens 114 may include a mechanical shutter. Lens 114 may include a plurality of optical elements that are movable relative to one another. The lens 114 may include one or more motors, actuators, gears, etc. for adjusting the lens' focal length, aperture size, shutter speed, and other parameters. The camera module 102 may include a modular lens receiver so that a user may attach any of a variety of lenses to the camera module. Exemplary lenses 114 may include fixed focus lenses, standard lenses, wide angle lenses, fisheye lenses, telephoto lenses, zoom lenses, anamorphic lenses, catadioptric lenses, variable focal length or variable focal range lenses, and so forth. The lens 114 may include high speed autofocus. The lens 114 may include an adjustable aperture and an adjustable shutter speed.

The camera module 102 may include an illumination system for illuminating the field of view of the image sensor 112. The illumination system may comprise digital or analog light sources. The light source may comprise one or more laser emitters or light emitting diodes, incandescent bulbs, or the like. The light source may emit light in any dithered, diffused or collimated emission manner, and may be controlled digitally or by analog methods or systems. The light source may be pulsed to illuminate the surgical scene. The light source may generate pulses in one or more regions, where each region is a predetermined range of wavelengths of the electromagnetic spectrum that is less than the entire electromagnetic spectrum. The pixel array of image sensor 112 may be electronically paired with the light sources such that they are synchronized during operation for receiving the emission of reflected electromagnetic radiation and adjustments made within the system. The light source may be tuned to emit electromagnetic radiation. The light source may be pulsed at intervals corresponding to the operation and function of the pixel array. The light source may pulse light in multiple electromagnetic bins such that the pixel array receives reflected electromagnetic energy and generates a data set corresponding (in time) to each particular electromagnetic bin. For example, the light source may emit green, blue, and red electromagnetic bins in any desired order, which may be combined to form a color image. Any combination of colors or any electromagnetic segmentation may be used instead of the red, green and blue segments, such as cyan, magenta, yellow, ultraviolet, infrared or any other combination, including all visible and invisible wavelengths. Exemplary illumination systems and other features that may be included or incorporated in the camera module 102 are disclosed in the following documents: U.S. Pat. No. 9,516,239 entitled "YCBCR PULSED ILLUMINATION SCHEME IN A LIGHT DEFICIENT ENVIRONMENT"; AND U.S. Pat. No. 9,641,815 entitled "SUPPER RESOLUTION AND COLOR MOTION ARTIFACT CORRECTION IN APPULSED COLOR IMAGING SYSTEM," each of which is incorporated herein by reference.

The light source may be disposed within the housing 104 or may be disposed remotely from the housing. For example, the illumination system may include an optical fiber 116 having a distal end disposed within or proximate to the housing 104 and a proximal end in optical communication with a light source disposed distal to the housing. The optical fiber 116 may direct light emitted from the light source into the field of view of the image sensor 112. The illumination system may include an optical element 118 for adjusting various illumination characteristics. Exemplary optical elements 118 may include diffusers, filters, and the like. In the illustrated embodiment, the camera module 102 includes an optical element 118, shown as a diffuser, disposed over the distal end of the optical fiber 116.

The camera module 102 may include a Printed Circuit Board Assembly (PCBA) 120. The image sensor 112 may be mounted directly to the PCBA 120, or may be operably coupled thereto, for example, using a connector 122. The PCBA 120 may include power conditioning circuitry, hardware logic, a clock, and/or other components for operating the image sensor 112 and communicating image data generated by the image sensor to the controller 106.

One or more of the components of the camera module 102 described above may be mounted on a frame or lens barrel 124. The lens barrel 124 may include an outer sidewall having one or more channels or lumens formed therein. For example, as shown, the lens barrel 124 may include a lens lumen 126 and an illumination lumen 128.

Lens lumen 126 may include proximal and

distal ends

126p, 126d and a central longitudinal axis a 1. Lens lumen 126 may have a circular cross-section. Lens 114 may be disposed within a distal end of lens lumen 126. Image sensor 112 may be positioned at or on the proximal end of lens lumen 126. The lens lumen 126 may be open at its proximal and distal ends and closed along its sides, as shown, or a portion or all of the lens lumen may be open to the outer sidewall of the lens barrel 124.

The illumination lumen 128 may include proximal and

distal ends

128p, 128d and a central longitudinal axis a 2. The illumination lumen 128 may have a circular cross-section. The optical fiber 116 may be disposed within the illumination lumen 128. The illumination lumen 128 may be open at its proximal and distal ends and closed along its sides, or, as shown, a portion or all of the illumination lumen may be open to the outer sidewall of the lens barrel 124. This may facilitate insertion of the optical fiber 116 into the lens barrel 124 during assembly, for example, by allowing the optical fiber to be side-loaded or inserted into the illumination lumen 128. The distal end of the illumination lumen 128 may be curved or angled, for example, such that it extends in a direction that is not parallel to the axis a 2. This arrangement may allow the flat distal end of the straight cut optical fiber 116 to be oriented parallel to the angularly cut distal end of the lens barrel 124, as shown. In other arrangements, the optical fiber 116 may be cut at an angle to match the distal end of the lens barrel 124.

The

lumens

126, 128 may or may not be coaxial with each other. For example, the

lumens

126, 128 may be laterally offset from one another. The

lumens

126, 128 may be formed such that they extend parallel to each other, for example such that their respective central longitudinal axes a1, a2 are parallel. As described further below, when integrated with the access device 110, the illumination lumen 128 can be disposed radially inward from the lens lumen 126, e.g., such that the illumination lumen is disposed closer to the center of the working channel of the access device than the lens lumen. This may provide a more uniform light distribution within the working channel of the entry device 110.

The proximal end of the lens barrel 124 may include a depression or dimple 130. The image sensor 112 may be disposed within the recess 130. At least a portion of the image sensor connector 122 and/or the PCBA 120 can be disposed within the recess 130. The lens barrel 124 may include an internal baffle 132 disposed between the lens 114 and the image sensor 112. The baffle 132 may include an aperture through which light passing through the lens 114 may be transmitted to the image sensor 112. The aperture may have a fixed size or may be mechanically adjustable.

The lens barrel 124 may include a distal-facing surface at its distal end. The

lumens

126, 128 of the lens barrel 124 may be open to the facing distal surface. The distal facing surface may be obliquely angled. For example, the distal-facing surface may lie substantially on a plane that is obliquely angled relative to the central axis a1 of the lens lumen 126, obliquely angled relative to the central axis a2 of the illumination lumen 128, and/or obliquely angled relative to the central longitudinal axis of the working channel or access device in which the camera module 102 is disposed. The lens 114 may be flush with the distal-facing surface as shown, or may be recessed or protruding from the distal-facing surface. The distally facing surface may comprise a recess 134 in which a diffuser or other optical element 118 of the illumination system may be disposed. The recess 134 may be formed around the perimeter of the illumination lumen 128. The recess 134 and the optical element 118 disposed therein may have a curved or crescent shape as shown. Recess 134 may include an inner edge that follows or substantially follows the perimeter of lens lumen 126.

As described further below, when integrated with the access device 110, the distally facing surface of the lens barrel 124 may be angled in a distal-to-proximal direction toward the center of the access device or working channel thereof in which the camera module 102 is disposed. This may provide a better view of the surgical site for the image sensor 112 and/or a more uniform light distribution within the surgical site. The lens barrel 124 may have an oval, rectangular, circular, elliptical, square, rectangular, etc. cross-section.

As shown in fig. 3A-3J, the camera module 102 may be mounted in a housing 104. The housing 104 may include a body 136 and a distal end cap 138. As described further below, the end cap 138 may be configured to direct fluid across the lens 114 and/or illumination system of the camera module 102, for example, to clear obstructions therefrom. The housing 104 may be rigid or flexible. The housing 104 may be made as short as possible to facilitate positioning of the housing within the access device 110. The housing 104 may have a length of less than about 60 mm. For example, the housing 104 may have a length of about 45mm or less than about 45 mm.

The body 136 of the housing 104 may include a proximal-facing surface 136p, a distal-facing surface 136d, and a sidewall 136s connecting the proximal-facing and distal-facing surfaces. One or more channels or lumens may be formed on the body 136. Body 136 may be formed by extruding a multi-lumen shaft. The body 136 may be formed by welding or otherwise attaching multiple longitudinal members to one another.

The body 136 may include a camera lumen 140 in which the camera module 102 may be selectively mounted. At least a portion of the camera lumen 140 may be lined with or otherwise include a metal tube, which may provide electromagnetic shielding for components of the camera module 102.

The body 136 may include one or more fluid lumens 142. For example, in the exemplified embodiment, the body 136 includes a first fluid lumen 142A that can be used to convey material from the proximal end of the housing 104 to the distal end of the housing and a second fluid lumen 142B that can be used to convey material from the distal end of the housing to the proximal end of the housing. Although first and second fluid lumens 142 are shown, the housing 104 may include any number of fluid lumens. The first and second lumens 142 may form part of a lens cleaning system in which cleaning fluid or media is delivered through one lumen to deliver cleaning fluid to the distal end of the camera module 102 and suction or vacuum is applied to the other lumen to draw cleaning fluid, tissue, debris, or other material away from the camera module. In some embodiments, a fluid such as air or other gas may be directed at the lens under positive pressure. The positive pressure fluid may be delivered through one or more of the lumens 142. Each of the lumens 142 may include a fluid connector or coupling 144 at a proximal end thereof for establishing fluid communication between the lumen and the connector assembly 108. The fluid connector 144 may be a male barb fitting extending proximally from the proximal facing surface 136p of the body 136 as shown, or may be any other type of fluid fitting or connection, such as a luer connection, a female fitting, or the like. Multiple different types of cleaning media may be delivered through the same lumen or through separate lumens. The multiple types of cleaning media may be delivered simultaneously, sequentially, intermittently, or otherwise. In one example, a spray of saline or other liquid may be directed through the lumen to the lens and may be expelled through the same lumen by a puff of carbon dioxide or other gas. In another example, the liquid and gas may be delivered through separate lumens. In some embodiments, the housing may include only a single fluid lumen.

Lumens

140, 142 of housing 104 may be coaxial, non-coaxial, or some lumens may be coaxial while others are non-coaxial. The camera lumen 140 may be centrally disposed between the first and second fluid lumens 142, as shown. The

lumens

140, 142 of the housing 104 may be parallel to each other. The

lumens

140, 142 may have various shapes. The

lumens

140, 142 may have an oval, oblong, circular, elliptical, square, rectangular, etc. inner cross-section. The camera lumen 140 may have an internal shape that matches the external shape of the camera module 102 or its lens barrel 124.

The distal-facing surface 136d of the body 136 may be obliquely angled. For example, the distal-facing surface 136d may lie substantially on a plane that is obliquely angled relative to the central longitudinal axis a3 of the housing 104 and/or obliquely angled relative to the central longitudinal axis of the working channel or access device in which the housing is disposed. The distal facing surface 136d of the body 136 may be angled in the same manner as the distal facing surface of the camera module 102 or lens barrel 124. The distal-facing surface of the camera module 102 may be flush with the distal-facing surface 136d of the body 136, or may be recessed or protruding relative to the distal-facing surface.

The side wall 136s of the housing 136 may have any of a variety of shapes. The sidewalls 136s may have an inner cross-section that is substantially triangular, crescent-shaped, circular, square, or rectangular. The sidewall 136s may be cylindrical. The sidewalls 136s may be curved. The sidewalls 136s can be shaped to facilitate integration of the housing 104 with the access device 110, e.g., to reduce or eliminate the degree to which the housing interferes with the working channel of the access device. Sidewall 136s may include an interior portion 136i that is concave. The inner portion 136i may be curved. The inner portion 136i may form a segment of a working channel, such as a cylindrical or oval working channel, of the access device 110. The sidewall 136s may include an outer portion 136o that is convex. The outer portion 136o may be curved. As shown, for example, in fig. 3E, the sidewall 136s can include an outer portion 136o having a first planar area and a second planar area connected by a central transition area defining a segment of a cylinder. The transition region may follow the outer perimeter of the camera lumen 140. As also shown, for example, in fig. 3E, the sidewall 136s can include an inner portion 136i that is concavely curved and connected to an outer portion 136o by first and second transition regions that define segments of respective cylinders. The first transition region and the second transition region may follow an outer perimeter of the fluid lumen 142.

An end cap 138 of the housing 104 may be coupled to the distal end of the body 136. The exterior sidewall of the end cap 138 may have a shape that matches the shape of the sidewall of the body 136. The end cap 138 may include one or more cutouts 146 formed therein. The endcap 138 may include a first cutout 146A aligned with the lens 114 of the camera module 102 to allow light to pass through the endcap and into the lens. The endcap 138 can include a second cutout 146B aligned with the illumination system of the camera module 102 to allow light to pass through the endcap and into the surgical site. The first and second cuts 146 may be separate cuts or may be contiguous, as shown. The first and second cutouts 146 may be circular, may have a shape that matches the shape of the lens 114 or illumination system, or may be otherwise shaped to perform the functions described above. The proximal facing surface of the end cap 138 may include one or more recesses, grooves, or channels 148 for directing fluid flow. Alternatively, the proximal-facing surface of the end cap 138 may be a flat planar surface, and a recess, groove, or channel 148 may be formed in the distal-facing surface of the body 136. The lateral end portion of the recess 148 may be axially aligned with the fluid lumen 142 of the main body 136. An inboard end portion of the recess 148 may open to the cutout 146 and/or to the distally facing surfaces of the lens 114 and the illumination system. In use, as shown in fig. 3H, fluid exiting the first lumen 142A of the body 136 may be directed by the end cap 138 across the lens 114 and illumination system (e.g., diffuser or optical element 118 of the illumination system) and toward the distal inlet of the second fluid lumen 142B, e.g., along the path of the arrows shown. It will be appreciated that the fluid may alternatively be directed in the opposite direction. The recess 148 may include baffles, nozzles, diverters, or other structures for customizing the fluid flow across the lens 114 and/or the illumination system. In some embodiments, the fluid flow may be substantially contained within the interior of the end cap, e.g., without flushing the surgical site or working channel of the access device in which the housing 104 is installed. The inclusion of fluid flow in this manner may be particularly useful in "dry environment" procedures, such as lumbar TLIF procedures. The inclusion of a fluid flow may help limit bleeding and possible tissue damage. In other embodiments, the fluid is not contained in the end cap and may be used to irrigate the surgical site and/or working channel.

The housing 104 and/or the camera module 102 may be coupled to the controller 106 via a connector or connector assembly 108. An exemplary connector assembly 108 is shown in fig. 4A-4B. The connector assembly 108 may include one or more conductors therein. The connector assembly 108 may include fluid conductors for delivering fluids to or from the housing 104. The connector assembly 108 may include optical conductors for delivering light to or from the camera module 102. The connector assembly 108 may include electrical conductors for communicating image data, control signals, or other information between the controller 106 and the camera module 102. The conductors may be partially or completely disposed within the outer jacket 150 of the connector assembly 108.

The connector assembly 108 may include a distal segment 108d and a proximal segment 108 p. In the distal section 108d, all conductors of the connector assembly 108 may be disposed within the outer sheath 150. In the proximal segment 108p, one or more of the conductors may exit the outer sheath 150 and may extend separately therefrom. For example, in the exemplified embodiment, the distal section 108d of the connector assembly 108 comprises an electrical conductor 152A, one or more optical fibers 152B, and first and second fluid lumens 152C that each extend through a common outer sheath 150. Also in the exemplified embodiment, the proximal section 108p of the connector assembly 108 is configured such that the electrical conductors 152A and the one or more optical fibers 152B continue through the common outer sheath 150 while the first and second fluid lumens 152C exit the outer sheath as separate fluid tubes 154. The outer sheath 150 may include a mechanical connector 156 at its proximal end for making optical and/or electrical connections with the controller 106. Fluid line 154 may include a corresponding fluid fitting or connector for fluidly connecting with, for example, a fluid reservoir and/or a vacuum or positive pressure source of controller 106 or fluidly connecting separately from the controller.

The distal segment 108d of the connector assembly 108 may have an external shape that matches the external shape of the housing 104, for example, as shown in fig. 4B. The distal segment 108d of the connector assembly 108 may cooperate with the shell 104 to define a seamless external transition. At least a portion of the connector assembly 108 may be flexible or bendable. As described further below, the distal section 108d of the connector assembly 108 can be flexible to facilitate integration of the system 100 with the access device 110.

An exemplary controller 106 is shown in fig. 5A-5B. Although an exemplary controller 106 is depicted and described herein, it should be understood that this is for generality and convenience. In other embodiments, the architecture and operation of the controller 106 may differ from that shown and described herein. The controller 106 may be a tablet computer, mobile device, smartphone, laptop computer, desktop computer, cloud-based computer, server computer, or the like. The controller 106 includes a processor 156 for controlling the operation of the controller 106, such as by executing embedded software, an operating system, device drivers, application programs, and the like. Processor 156 may be or include one or more microprocessors, microcontrollers, ASICs, FPGAs, PICs, processors that read and interpret program instructions from internal or external memory or registers, and the like. The control 106 may include a memory 158 that provides temporary or permanent storage for code to be executed by the processor 156 or data processed by the processor. The memory 158 may include Read Only Memory (ROM), flash memory, one or more Random Access Memories (RAM), and/or a combination of memory technologies. The various components of the controller 106 may be interconnected via any one or more separate traces, physical buses, communication lines, etc.

The controller 106 may include an interface 160, such as a communication interface or an I/O interface. The communication interface may enable the controller 106 to communicate with remote devices (e.g., other computer systems) over a network or a communication bus (e.g., a universal serial bus). The I/O interface may facilitate communication between one or more input devices, one or more output devices, and various other components of the controller 106. Exemplary input devices include touch screens, mechanical buttons, keyboards, and pointing devices. The controller 106 may include a storage device 162, which may include any conventional media for storing data in a non-volatile and/or non-transitory manner. Storage 162 may include one or more hard disk drives, flash drives, USB drives, optical disk drives, various media disks or cards, and/or any combination thereof. The controller 106 may include a display 164 and may generate images to be displayed thereon. The display 164 may be an electronic display, a Vacuum Fluorescent Display (VFD), an Organic Light Emitting Diode (OLED) display, or a Liquid Crystal Display (LCD). The controller 106 may include a power source 166 and appropriate modulation and conditioning circuitry. Exemplary power sources include batteries, such as polymer lithium ion batteries, or adapters (e.g., USB adapters or wall adapters) for coupling the controller 106 to a DC or AC power source.

The controller 106 may include a fluid source 168 that may be in fluid communication with the fluid lumen 152C of the connector assembly 108 when the connector assembly is attached to the controller 106. The fluid source 168 may include a reservoir of cleaning media. The cleaning medium may be a flowable gas or liquid. The cleaning medium may include one or more of carbon dioxide, brine, oxygen, air, water, and the like. The fluid source may comprise a source of positive pressure air or other gas. The fluid source 168 may include a pump or other mechanism for forcing cleaning media through the connector assembly 108 and the housing 104. The pump may be controlled by the processor 156 to perform a cleaning cycle. The cleaning cycle may be performed automatically, or in response to user instructions. For example, the processor 156 may detect user actuation of a button, foot pedal, or other interface element, and initiate a cleaning cycle in response thereto.

The controller 106 may include a light source 170 that may be optically coupled to the optical fiber 152B of the connector assembly 108 when the connector assembly is attached to the controller. Exemplary light sources include Light Emitting Diodes (LEDs), incandescent or fluorescent bulbs, and the like.

The controller 106 may include a vacuum or suction source 172 that may be in fluid communication with the fluid lumen 152C of the connector assembly 108 when the connector assembly is attached to the controller. The controller 106 may include an on-board vacuum pump for generating suction, or may be configured to attach to a standard hospital or operating room vacuum source. The suction source 172 may include a valve, regulator, or other means for adjusting the degree of suction applied to the housing 104 and/or for turning suction on or off. The suction source 172 may be controlled by the processor 156, for example, to perform a cleaning cycle. The cleaning cycle may be performed automatically, or in response to user instructions. For example, as described above, the processor 156 may detect user actuation of a button, foot pedal, or other interface element, and initiate a cleaning cycle in response thereto.

The controller 106 may include one or more connectors 174 for mating with the connector 156 and/or the fluid coupling 154 of the connector assembly 108. When mated, the connectors may establish an electrical, optical, and/or fluid connection between the controller 106 and the connector assembly 108. It should be understood that any one or more of the above-described components may be disposed outside of the housing of the controller 106 and/or may be completely separate or isolated from the controller. For example, any one or more of the fluid source 168, the light source 170, and the suction source 172 may be external to and/or separate from the controller 106.

The controller 106 may receive image data from the image sensor 112. The image data may be transmitted via a wired or wireless connection. The image data may include still image data and/or video image data. The controller 106 may display the image data on an on-board display 164 of the controller or on one or more external monitors or displays operatively coupled to the controller. The image data may be displayed to a surgeon or other user to facilitate the surgical procedure. The controller 106 may display patient data, user interface controls for manipulating system settings, controls for capturing screenshots of displayed images, and the like.

The various functions performed by the controller 106 may be described logically as being performed by one or more modules. It should be understood that such modules may be implemented in hardware, software, or a combination thereof. It will be further appreciated that when implemented in software, the modules may be part of a single program or one or more separate programs, and may be implemented in a variety of contexts (e.g., as part of an embedded software package, an operating system, a device driver, a stand-alone application, and/or combinations thereof). Further, software embodying one or more modules may be stored as executable programs on one or more non-transitory computer-readable storage media.

The system 100 may be configured to be integrated with or used with an access device. Exemplary access devices can include cannulas, retractors, tubes, and other structures for providing a working channel in surgical applications. The access device may define a working channel extending from a surgical site (e.g., an intervertebral disc space or a region of the spine proximal thereto) to a location outside of the patient's body. The access device may include a visualization channel for receiving the housing 104 and the camera module 102 of the visualization system 100. The visualization channel may also receive at least a portion of the connector assembly 108. The visualization channel may be the same as the working channel, may be independent of the working channel, or may overlap or intersect the working channel. At least a portion of the side wall of the working channel may be defined by an outer surface of the housing 104. The housing 104 and/or the camera module 102 may be disposed off-center within the access device. The housing 104 and/or the camera module 102 may be slidably and/or rotatably coupled to the access device.

The housing 104 and/or the camera module 102 may be axially translated within the access device, for example, in a proximal-distal direction, to adjust a depth of the camera module relative to the access device. For example, the housing 104 may be advanced distally relative to the access device to move the lens 114 and image sensor 112 closer to the surgical site. By way of another example, the housing 104 may be retracted proximally relative to the access device to move the lens 114 and image sensor 112 away from the surgical site. The ability to reposition the camera module 102 within the access device may facilitate various surgical procedures. For example, in an exemplary TLIF procedure, the camera module 102 may be positioned relatively shallow within the access device when cutting through the Kambin triangle, and then may be advanced deeper within the access device when performing a subsequent discectomy. In some cases, the camera module 102 may be advanced distally into the intervertebral space. The camera module 102 may be advanced distally so that the camera module protrudes or extends from the distal end of the access device when the access device is inserted into a patient. For example, the camera module 102 may be advanced such that the lens 114 and/or the image sensor 112 are disposed outside and distal of the distal end of the tip of the access device. The camera module 102 may be advanced or retracted relative to the access device to any of an infinite number of relative longitudinal positions. The ability to reposition the camera module 102 may also allow the camera module to be a modular component that may be used interchangeably with many different types or sizes of access devices or with adjustable length access devices.

An exemplary access device 110 is shown in fig. 6A through 6H. The access device 110 can include an elongated body having a proximal end and a distal end.

The access device 110 can define a working channel 174 extending between the proximal and distal ends and having a central longitudinal axis a 4. The working channel 174 may be cylindrical. Working channel 174 may have a dovetail-shaped cross-section. The working channel 174 may have a diameter in the range of about 3mm to about 30mm, in the range of about 10mm to about 20mm, and/or in the range of about 12mm to about 15 mm. The working channel 174 may have a diameter of about 15 mm. Although a single working channel 174 is shown, the access device 110 may include any number of working channels. In use, instruments and/or implants may be disposed in, passed through, and/or inserted into working channel 174 to perform a surgical procedure. In some embodiments, the access device 110 can be used to access an intervertebral disc space. A cutting instrument may be inserted through working channel 174 to cut tissue, such as bone or intervertebral disc tissue. A suction instrument may be inserted through working channel 174 to suction material, including resected bone or disc tissue, from the intervertebral space. The cutting instrument and the suction instrument may be a single tool. Implants such as fusion cages, fusion cages having expandable heights and/or widths, intervertebral disc prostheses, and the like may be inserted into the intervertebral space through working channel 174.

The access device 110 may define a visualization channel 176. Visualization channel 176 may extend between the proximal and distal ends of access device 110, or may extend along less than the entire length of the access device. Visualization channel 176 may include a central longitudinal axis a 5. The central axis a5 of the visualization channel 176 may be disposed radially outward from the central axis a4 of the working channel 174. Working channel 174 may have a larger cross-sectional area than visualization channel 176. Visualization channel 176 may be open to working channel 174 along its length or may intersect the working channel. Visualization channel 176 may be isolated or separate from working channel 174.

Visualization channel 176 may have an interior cross-section that matches or substantially matches an exterior cross-section of housing 104. When disposed within visualization channel 176, the outer surface of housing 104 may define at least a portion of the inner sidewall of working channel 174. The working channel 174 may be cylindrical about a central axis a4, and the surface of the housing 104 facing the working channel may form a segment of a cylinder centered on the axis a 4. The inner sidewalls of the working channel 174 and the outer surface of the housing 104 may define a substantially smooth and continuous surface.

The access device 110 can include, for example, an attachment feature 180 for attaching the access device to a support or other object. An attachment feature 180 may be formed at the proximal end of the access device 110. For example, the access device 110 may include an annular circumferential groove 180 formed in an outer surface thereof.

The access device 110 can include mating features 178 for stabilizing, retaining, and/or attaching the visualization system 100 to the access device. The mating feature 178 may be a proximal extension of the access device 110, as shown. The mating features 178 may define one or more tracks 182 configured to receive the connector assembly 108 therein. The track 182 may be open to one side such that the connector assembly 108 may be side loaded into the track, for example, by moving the connector assembly away from the central axis a5 of the visualization channel 176. Alternatively or additionally, the connector assembly may be loaded into the mating feature by translating the connector assembly 108 proximally or distally relative to the mating feature 178.

One or more of the rails 182 may define a connector path that is curved or obliquely angled away from the central axis a5 of the visualization channel 176. The track 182 may have an interior cross-section that matches or substantially matches an exterior cross-section of the connector assembly 108. The track 182 may extend around the outer periphery of the connector assembly 108. The track 182 may extend around the connector assembly 108 to a sufficient extent that the free edge of the track slightly interferes with the side loading of the connector assembly into the track. Accordingly, slight deformation or deflection of the connector assembly 108 and/or the mating features 178 may be required to load the connector assembly into the track 182. This may allow the connector assembly 108 to be securely retained by the mating features 178, such as by "snapping" the connector assembly into the track 182.

The mating feature 178 may include an inner rail 182A and an outer rail 182B, for example, as shown in fig. 6C, 6D, and 6G. The track 182 may include an interference edge of the type described above to limit movement of the connector assembly 108 into and out of the track, but to allow such movement when sufficient force is applied, such as when a user specifically desires to perform such movement. The inner rail 182A may be axially aligned with the visualization channel 176 or aligned to a greater extent than the outer rail 182B. The outer rail 182B may be curved, angled obliquely, or otherwise axially offset from the visualization channel 176. When disposed in the inner track 182A, as shown in fig. 6D, the connector assembly 108 may be retained to the access device 110 while still being able to translate proximally or distally relative to the access device with relatively little friction. When disposed in the outer track 182B, as shown in fig. 6C, proximal-distal translation of the connector assembly 108 relative to the access device 110 may be limited or prevented, for example, due to bending of the connector assembly and/or due to increased friction between the connector assembly and the access device. In use, the connector assembly 108 can be positioned in the inner track 182A to adjust the height of the camera module 102 relative to the access device 110, and can be positioned in the outer track 182B to securely hold the camera module in place at a fixed height relative to the access device.

Connector assembly 108 may be secured to mating feature 178 at any point along its length (e.g., at any point along distal segment 108d of the connector assembly). Thus, the visualization system 100 may lock to the access device 110 at any insertion depth of the camera module 102. Further, the visualization system 100 may be locked with the camera module 102 at a desired depth regardless of the length of the access device 110, the location of the mating features 178 along the access device, and the like. This may allow visualization system 100 to be used interchangeably with any of a number of different types or sizes of access devices 110.

The ability to lock the system 100 to the mating feature 178 may allow the camera module 102 to be used in a hands-free manner. In other words, the surgeon or other user does not need to manually grasp and/or hold the camera module 102 in place during use. The mating features 178 may provide for simple, quick, and/or one-handed depth adjustment of the camera module 102, resulting in minimal delay and disruption to the procedure.

The access device 110 can have a circular outer cross-section, for example, as shown in fig. 6G. The access device 110 may have an oval or egg-shaped outer cross-section, for example, as shown in fig. 6H. The access device 110 can include any of a variety of other external cross-sectional shapes. The access device 110 may have an outer diameter or dimension in the range of about 5mm to about 30mm, in the range of about 10mm to about 25mm, and/or in the range of about 15mm to about 22 mm. The access device 110 may have an outer diameter or dimension of about 17 mm. The outer surface of the access device 110 may be rough, ribbed, ground, or coated or formed from a material having a high coefficient of friction, which may advantageously improve grip and stability with the surrounding tissue when the access device is inserted into a patient.

As described above and shown in fig. 6F, when disposed in the access device 110, the lens 114 of the camera module 102 may be aimed at the central axis a4 of the working channel 174. Similarly, when so positioned, the illumination system of the camera module 102 (e.g., the optical fibers 116 and/or the optical elements 118) may be aimed at the central axis a4 of the working channel 174. The illumination system may be disposed radially outward from the central axis a4 of the working channel 174, and the lens 114 may be disposed radially outward from the illumination system.

Fig. 7 illustrates an exemplary surgical system 10 that may use the devices and methods described herein, but it should be understood that such devices and methods may alternatively or additionally be used in various other applications. Further details regarding the system of fig. 7 can be found in U.S. application 15/437,792 filed on 21/2/2017, which is hereby incorporated by reference. The system 10 may be used in a variety of surgical procedures, including spinal surgery, such as microsurgical osteotomies, spinal decompressions, spinal fusions, and the like. In general, the system 10 may include any one or more of an access device 110, a tissue retractor 12, a pedicle post or other anchor 14, a connector 16, and a camera or visualization system 100. The access device 110 may be any of the access devices described herein. The visualization system 100 may be any of the visualization systems described herein.

An exemplary method of using the system 10 of fig. 7 may include any one or more of the following steps, performed in any of a variety of orders: a) forming an incision in the skin of a patient; b) percutaneously inserting through an incision an access device 110 having a substantially tubular shape, such as a tube or multi-slot retractor, having a length suitable for extending from the incision to a boundary between sensitive and insensitive tissue in a spine of a patient (e.g., an upper articular process (SAP) or a lamina); c) stabilizing the access device to the anchor 14 (e.g., pedicle anchor) using the connector 16; d) inserting an optical visualization system 100 integrated with an access device, such as a visualization system of the type described herein; e) resecting a portion of the superior articular process, and/or performing a microsurgical reduced pressure procedure; f) inserting or deploying the tissue retractor 12 through or from an access device such that a distal end portion of the tissue retractor extends to an intervertebral disc, the retractor having an outer surface; g) contacting an outer surface of the retractor with a nerve root to shield the nerve root; h) microsurgical decompression of any tissue believed to cause nerve entrapment; i) extracting intervertebral disc material, including removing cartilage material from vertebral endplates; j) inserting an interbody device; and k) deploying a stabilization mechanism to stabilize the intervertebral segment.

Exemplary characteristics of the camera module 102 and its lens 114 are shown in fig. 8. The camera module 102 may have a field of view (FOV), a direction of view (DOV), and a depth of field (DOF). The FOV may be in the range of about 60 degrees to about 70 degrees. The DOV may be in the range of about 15 degrees to about 30 degrees. The DOV may be in the range of about 20 degrees to about 25 degrees. The DOV may be about 22.5 degrees. The DOF is in the range of about 7mm to about 40mm degrees.

The system 100 may include active cleaning features. Active cleaning features may include applying active forces to the lens 114, illumination system, or other components of the camera module 102. The primary force may be or include a fluid jet, fluid suction, mechanical or acoustic vibration, mechanical wiper, or the like. The primary force may be or may include positive air pressure or other gas directed toward, onto, and/or across a lens or other component of the camera module.

The system 100 may include passive cleaning features. Passive cleaning features may be used independently or may enhance or improve the performance of active cleaning features. As one example, lens 114 may have a coating applied thereto to resist or prevent debris from adhering to the lens. The coating may be hydrophilic. The coating may be oleophilic. The coating may be hydrophobic. The coating may be oleophobic. The coating may be an antifouling coating. The coating may be a gradient coating, such as a coating in which a central region of the lens has a hydrophobic coating and a peripheral region of the lens has a hydrophilic coating. The gradient lens coating may effectively "walk" or direct fluid away from the image sensor 112 from the center of the lens toward the outer perimeter of the lens.

As shown in fig. 9, the fluid lumens 142 of the housing 104 may each include a respective nozzle 184 disposed at a distal end thereof. In such an arrangement, the end cap 138 of the housing 104 may be omitted. The nozzle 184 may be configured to aim or direct the fluid stream and/or suction toward the lens 114 or illumination system of the camera module 102.

Fig. 10A shows another exemplary cross-section of the housing 104. As shown, the fluid lumen 142 may be enlarged and may be non-circular. The fluid lumen 142 may be ear-shaped. The fluid lumen 142 may be asymmetric.

Fig. 10B illustrates another exemplary cross-section of the housing 104. As shown, the fluid lumen 142 may be crescent-shaped or banana-shaped. The fluid lumen 142 may have a convex inner sidewall that follows the outer perimeter of the camera lumen 140.

Fig. 11A-11D illustrate the distal end of an alternative housing 104 having a crescent-shaped fluid lumen 142, an elliptical or rectangular outer cross-section, and an end cap 138 having an elliptical or rectangular central opening 146.

As described above, the body 136 of the housing 104 may be formed by welding or otherwise attaching a plurality of longitudinal members to one another. For example, as shown in fig. 12A, an inner circular tube 136A can be inserted into an outer elliptical tube 136B to define a main body 136 having a central camera lumen 140 and first and second lateral fluid lumens 142. The inner tube 136A may be welded, adhered, or otherwise attached and/or sealed to the outer tube 136B. By way of another example, as shown in fig. 12B, opposing outer shells 136C may be welded or otherwise attached to the inner tube 136A to define a main body 136 having a central camera lumen 140 and first and second lateral fluid lumens 142. Outer housing 136C may include respective proximal fluid couplings 144 and internal channels that connect the fluid couplings to void spaces 142 formed between the outer housing and inner tube 136A when the components are mated to one another. The arrangement shown in fig. 12B may advantageously allow complex shell cross-sections to be formed within one or more simple welds of the two outer shells 136C to the inner tube 136A and/or to each other.

Fig. 13 illustrates an exemplary mating feature 178A for attaching the visualization system 100 to the access device 110. The mating feature 178A may comprise a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. An actuator wheel or gear 186 may be rotatably mounted on the track 182. The wheel 186 may be engaged with the connector assembly 108 such that rotation of the wheel advances or retracts the connector assembly relative to the access device 110. The wheels 186 may allow for stepless and precise depth adjustment of the camera module 102. The wheel 186 may include teeth, protrusions, or other surface features for enhancing a user's grip and/or friction between the wheel and the connector assembly 108. The connector assembly 108 may include teeth or ridges that may engage with the teeth of the wheel 186. The wheel 186 may be spring biased into engagement with the connector assembly 108. The gap between the wheels 186 and the track 182 may be open to one side, for example, to allow the connector assembly 108 to be side loaded into the gap. The user may thus perform a coarse depth adjustment of the camera module 102 in a hands-free manner, then insert the connector assembly 108 into the gap and use the wheel 186 to achieve a fine depth adjustment.

Fig. 14 illustrates an exemplary mating feature 178B for attaching the visualization system 100 to the access device 110. The mating feature 178B may comprise a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. The mating feature 178B may include a clip 188 that may be actuated by a user to selectively grasp or selectively release the connector assembly 108. Any of a variety of types of clips may be used, but in the illustrated embodiment, the mating feature 178B includes a coil spring 188 defining a central passage through which the connector assembly 108 may be inserted. The spring 188 may include a handle stem that, when squeezed together, relaxes the tension of the spring and stretches the diameter of the central passage to allow the connector assembly 108 to move relative to the access device 110. When the lever is released, the tension in the spring 188 may increase to contract the diameter of the central passage and clamp onto the connector assembly 108, thereby holding it in a fixed position relative to the access device 110.

Fig. 15A-15B illustrate an exemplary mating feature 178C for attaching the visualization system 100 to the access device 110. The mating feature 178C may comprise a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. The mating feature 178C may include an O-ring 190 defining a central passage through which the connector assembly 108 may be inserted. The O-ring 190 may be held in a fixed position relative to the extension 178C such that when the O-ring is clamped down onto the connector assembly 108 inserted therethrough, the connector assembly may be held in a fixed position relative to the extension. The extension 178C may include a movable button 192 having a tapered or angled bearing surface. Pressing the button 192 into the extension 178C (to the left in the figure) effectively wedges the cone of the button into the O-ring 190, thereby expanding the diameter of the O-ring and allowing the connector assembly 108 to move relative to the extension, as shown in fig. 15B. As shown in FIG. 15A, when the button 192 is released, the spring 194 may push the button outward (to the right in the drawing), withdrawing the taper from the O-ring 190 to allow the O-ring to contract in diameter and clamp onto the connector assembly 108, thereby holding the connector set in a fixed position relative to the access device 110.

Fig. 16A-16C illustrate an exemplary mating feature 178D for attaching the visualization system 100 to the access device 110. The mating feature 178D may comprise a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. Mating feature 178D may be an angled snap-in fastening system of the type described above. The mating feature 178D may be optimized for use with a connector assembly 108 having a circular outer cross-section. The mating feature 178D may include a longitudinally oriented adjustment track 182A and an obliquely or laterally oriented locking track 182B.

Fig. 17 illustrates an exemplary mating feature 178E for attaching the visualization system 100 to the access device 110. The mating feature 178E may comprise a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. Mating feature 178E may be an angled snap-in fastening system of the type described above. The mating feature 178E may include a longitudinally oriented adjustment track 182A and an obliquely or laterally oriented locking track 182B. The locking track 182B may be spaced a distance from and radially outward of the body of the access device 110 by a post or beam 196. The mating feature 178E may be configured to contact the connector assembly 108 only at the locking track 182B. The mating feature 178E may be easy to manufacture and may accommodate the gradual bend radius of the connector assembly 108.

Fig. 18 illustrates an exemplary mating feature 178F for attaching the visualization system 100 to the access device 110. The mating feature 178F may include a cutout 198 formed on a proximal edge of the access device 110. The mating feature 178F may be a snap-in fastening system of the type described above. The connector assembly 108 may be positioned within the longitudinally oriented adjustment track 182A of the mating feature 178F to allow for depth adjustment of the camera module 102. The connector assembly 108 may be pushed out of the adjustment track 182A and into the cutout 198 to apply sufficient friction to the connector assembly to limit or prevent depth adjustment of the camera module 102. The cutout 198 may be U-shaped. The cutout 198 may be V-shaped. The mating features 178F may allow the path of the connector assembly 108 to be at a greater angle and closer to the skin surface of the patient away from the access device 110, thereby reducing the overall profile of the system 100 and keeping the connector assembly out of the way of the surgeon or other user.

Fig. 19 illustrates an exemplary mating feature 178G for attaching the visualization system 100 to the access device 110. The mating feature 178G may include a proximal extension of the access device 110 having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. The mating feature 178G may include a lid or closure 101 pivotably coupled thereto, for example, via a living hinge of the extension or a flexible material property. The cover 101 may be positioned in a closed state in which it clamps the connector assembly 108 to the extension to limit or prevent depth adjustment of the camera module 102. The cover 101 may be positioned in an open state in which the cover does not engage the connector assembly 108, or engages the connector assembly to a lesser extent, such that the connector assembly may be moved relative to the extension to adjust the depth of the camera module 102. The lid 101 may be held in a closed state, for example, via a snap lock, or other locking structure. The closure 101 may include a lever 103 to facilitate release of the closure from the closed state.

As shown in fig. 20, visualization system 100 also includes user controls 105. The user controls 105 may be disposed at any of a number of locations along the visualization system 100, such as along a distal portion of the connector assembly 108, as shown. In use, user controls 105 may be positioned within a sterile field. This may allow a surgeon or other user to directly actuate control 105 without having to leave the sterile field or rely on an assistant outside the sterile field. The controls 105 may be operably coupled to the camera module 102, the controller 106, the fluid source 168, the light source 170, and/or the suction source 172. Actuation of the control 105 may be effective to initiate a cleaning operation, stop a cleaning operation, capture an image, rotate the display of an image captured by the camera module 102, adjust the white balance of a displayed image, adjust the brightness of a displayed image, play or stop recorded video, zoom in or out (optically and/or digitally) a displayed image, and so forth. Controls 105 may include one or more push buttons. Controls 105 may include one or more footswitches. The controls 105 may include a manual pump or syringe for directing the cleaning media toward the camera module 102. The controller 105 may include a remote control integrated into the connector assembly 108. Controller 105 may include a remote control coupled to controller 106 via a wired or wireless connection.

The access devices disclosed herein may be inserted into a patient using a variety of dilation techniques. In an exemplary method, a guidewire or needle may be inserted through a percutaneous incision in a patient. The guidewire may be placed using fluoroscopic guidance, surgical navigation systems, hands-free, or other means. The incision can be sequentially or continuously dilated, for example, by inserting one or more dilators over the guidewire, each dilator having a progressively increasing outer diameter. Once sufficiently dilated, the access device can be inserted by placing the outermost dilator into the working channel of the access device and sliding the access device distally along the dilator and into the patient. One or more dilators may then be removed from the patient, leaving an open working channel through the access device through which surgery may be performed.

There may be instances where it may be necessary or desirable to enhance standard cylindrical dilation techniques. For example, as shown in fig. 21A, the access device 110 can include a cylindrical working channel 174 and an offset visualization channel 176. The access device 110 may have a non-cylindrical outer dimension. Visualization channel 176 can terminate at a distance from the distal end of access device 110, leaving void space 107 within the access device distal to the visualization channel. As shown, when a standard cylindrical dilator 109 is inserted through the working channel 174, there is a sharp transition or step 111 at the distal end of the access device 110 between the outer surface of the dilator and the outer surface of the access device adjacent the visualization channel 176. In this example and/or other examples, a dilation system may be used to facilitate insertion of the access device 110 and dilation of tissue disposed in the path of the visualization channel 176.

Fig. 21B-21D illustrate exemplary dilation systems. As shown, the system may include a sleeve 113 having a bulb-shaped portion 115 movably coupled thereto. When the cannula 113 is disposed in the working channel 174 of the access device 110, the bulb 115 may occupy the void space 107 in the access device and provide a smooth transition 117 between the outer surface of the dilator 109 and the outer surface of the access device adjacent the visualization channel 176. Accordingly, the bulb-shaped portion 115 may minimize or eliminate the step 111 described above.

The sleeve 113 may be substantially cylindrical. The cannula 113 may be hollow to define a passage 119 through which a standard cylindrical dilator 109 may be inserted. The sleeve 113 may define an outer diameter D. The bulb 115 may be movable relative to the sleeve 113 between a first position in which the bulb is disposed entirely within the outer diameter D of the sleeve and a second position in which at least a portion of the bulb protrudes from the outer diameter D of the sleeve. The bulb-shaped portion 115 may be biased toward the second position. The bulb-shaped portion 115 may be attached to or integrally formed with the sleeve 113. The bulb 115 may be attached to the sleeve by a spring. For example, the bulb-shaped portion 115 may be mounted at the distal end of a longitudinal leaf spring or flat spring 121 of the sleeve 113. The spring 121 may be an integral extension of the sleeve 113 defined between opposing longitudinal slits formed in the sleeve. The bulb 115 may include a distal facing surface 115d that is sloped, curved, tapered, or otherwise configured to provide a smooth lead-in between the outer diameter of the dilator 109 disposed in the cannula 113 and the outer diameter of the access device 110. The bulb 115 may include a proximally facing surface 115p that is sloped, curved, tapered, or otherwise configured to urge the bulb radially inward toward the first position as the sleeve 113 is withdrawn proximally from the access device 110.

In use, the incisions may be sequentially dilated using standard cylindrical dilators (including the outermost dilator 109). The sleeve 113 may be loaded into the access device 110 with the bulb 115 disposed in a first radially inward position. The sleeve 113 may be advanced distally relative to the access device 110 until the bulb 115 is at the depth of the void space 107, at which point the bulb may move radially outward to a second position under the bias of the spring 121. The bulb 115 may also be pushed radially outward and held in this position by inserting the expander 109 through the sleeve 113. The access device 110 with the inserted cannula 113 can then be advanced distally over the outermost dilator 109. As the access device 110 is advanced distally, the distally facing surface 115d of the bulb 115 may gently push tissue out of the path of the access device. Once the access device 110 is positioned as desired, the dilator 109 may be removed from the cannula by proximally withdrawing the dilator from the cannula 113. The cannula 113 may also be removed from the access device by withdrawing the cannula proximally from the access device 110. As the sleeve 113 is withdrawn proximally relative to the access device 110, the bulb 115 may be urged radially inward, such as by a proximally facing surface 115p of the bulb 115 abutting a distal end of the visualization channel 176, thereby moving the bulb to a first radially inward position to allow removal of the sleeve from the access device. The cannula 113 can form a dilator having a profile at its distal end that differs from a profile at its proximal end.

22A-22B illustrate another exemplary dilation system wherein the cannula 113A is configured to rotate relative to the access device 110 about a central longitudinal axis A4 of the working channel 174. The sleeve 113A may have a longitudinal slit or other feature that allows the sleeve to radially expand and contract. The sleeve 113A may be radially collapsed upon insertion into the access device 110 to bias the bulb-shaped portion 115A radially outward. The sleeve 113A is rotatable about the axis a4 between a first position shown in fig. 22A, in which the bulb 115 is rotationally offset from the void space 107 and is thus deflected radially inward by the inner side wall of the working channel 174, and a second position shown in fig. 22B, in which the bulb is rotationally aligned with the void space such that the bulb springs radially outward to fill the void space. In the first position, the bulb-shaped portion 115A may be positioned such that it does not interfere with insertion or removal of the sleeve 113A from the access device 110. In the second position, the bulb-shaped portion 115A may fill the void space 107 to provide a smooth transition between the dilator and the access device 110, e.g., as described above. The cannula 113A can form a dilator having a profile at its distal end that differs from a profile at its proximal end.

Fig. 23A-23G illustrate another exemplary dilation system. As shown, the distal end of the access device 110A can include a sloped, curved, or tapered transition portion 123 that provides a smooth transition between a cylindrical dilator inserted through the working channel 174 of the access device and the outer surface of the access device adjacent the visualization channel 176. The transition portion 123 may be flexible or bendable. The transition portion 123 may be movable between a first position in which the transition portion extends radially inward to provide a smooth distally facing flared surface 123d and a second position in which the transition portion moves radially outward from the first position so as not to obstruct the field of view of a camera module mounted in the access device 110A. The transition portion 123 may include one or more movable fingers 125. The fingers 125 may be defined by a plurality of longitudinal slits formed in the outer wall of the access device 110A. The fingers 125 may have resilient material properties such that they are biased inwardly toward the first position.

The transition portion 123 is movable between a first position and a second position by a dilating shaft 127 insertable through the access device 110A. The dilation shaft 127 can include a distal shield 129 configured to contact and abut the transition portion 123 as the dilation shaft is advanced distally within the access device 110A to urge the transition portion radially outward. The cover 129 may form a segment of a cylinder as shown. At least a portion of visualization channel 176 can be formed in dilating shaft 127. When the camera module 102 is disposed in the access device and as the surgical procedure is performed, the distraction shaft 127 can remain in place within the access device 110.

Fig. 24A to 24C show the auxiliary visualization system 100A. The system 100A may be used independently or may be used with the visualization system 100 described above. The system 100A may include a camera module 102A, a housing 104A, and a connector assembly 108A, each of which may include any of the features of the corresponding components of the system 100. The system 100A may be used as a hands-free stylus or rod camera. The system 100A may be inserted through the working channel of the access device, while the system 100 is inserted through the visualization channel of the access device. Both

cameras

100, 100A may be coupled to the same controller or display, or each may be coupled to a separate controller or display. A plurality of auxiliary cameras 100A may be used simultaneously. In the case of spinal surgery, the secondary camera 100A may extend into the intervertebral space, and the primary camera 100 may remain within the access device. The auxiliary camera 100A may be attached to the access device using mating features 131. The mating feature 131 may be configured to hold or support the auxiliary camera 100A relative to the access device. The mating features 131 may allow hands-free operation of the auxiliary camera 100A. As shown in fig. 24C, the mating feature 131 may include a C-clip or other mechanism 133 for attachment to a housing or connector assembly of the auxiliary camera 100A. The mating features 131 may include any of the features described above with respect to the mating features for attaching the visualization system 100 to an access device. The mating feature 131 may include a distal clip or resilient strip 135 for attaching the mating feature to the proximal rim of the access device.

Fig. 25A-25B illustrate an exemplary housing 104B that may be used with the camera modules and/or access devices described herein. The housing 104B may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104B may include one or more fluid lumens 142B. The fluid lumen 142B may include a nozzle 184B disposed at a distal end thereof. The nozzle 184B may be configured to aim or direct the fluid stream and/or suction force toward the lens 114 of the camera module 102. The nozzle 184B may be defined by a slot or cut-out 137 formed in a sidewall of a length of tubing that projects distally from the distal end of the housing 104B. The slot 137 may allow fluid to flow between the interior of the lumen 142B and the region adjacent the distal end of the visualization channel or the lens 114 or other component of the camera module 102 disposed therein. The slots 137 may be obliquely angled. For example, the long axis of the slot 137 may extend at an oblique angle relative to the central longitudinal axis of the fluid lumen 142B, the central longitudinal axis of the housing 104B, and/or the central longitudinal axis of the access device or visualization channel of the access device. In some embodiments, the slots 137 may extend at an angle B relative to a transverse plane perpendicular to the central longitudinal axis of the housing 104B. Angle B may range from about 5 degrees to about 85 degrees. Angle B may range from about 10 degrees to about 60 degrees. Angle B may range from about 15 degrees to about 30 degrees. Angle B may be about 22.5 degrees. The angle of the slot 137 may be equal or substantially equal to the corresponding angle of the angled distal end of the housing 104B and/or the angled distal end of the lens 114. The slots 137 may be angled non-obliquely. For example, the long axis of the slot 137 may extend perpendicular to the central longitudinal axis of the fluid lumen 142B, the central longitudinal axis of the housing 104B, and/or the central longitudinal axis of the access device or visualization channel of the access device. In such an arrangement, the distal end of the housing 104B and/or the distal end of the lens 114 can likewise extend perpendicular to the central longitudinal axis of the fluid lumen 142B, the central longitudinal axis of the housing 104B, and/or the central longitudinal axis of the access device or visualization channel of the access device. The slot 137 may have an angle that matches the angle of the lens surface.

The housing may include wipers, brushes, fins or other features for cleaning debris from the lens. The wiper may be disposed within, inserted through, and/or deployable from the lumen of the housing. For example, the wiper may be selectively deployed through a nozzle opening of a fluid lumen of the housing. The wiper may be deployed from the opening before, during, or after fluid is directed through the lumen and toward the lens to wipe debris from the lens. Fig. 25C illustrates an exemplary housing 104H that may be used with the camera modules and/or access devices described herein. The housing 104H may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104H may include one or more fluid lumens 142H. The fluid lumen 142H may include a nozzle 184H disposed at a distal end thereof. The nozzle 184H may be configured to aim or direct the fluid stream and/or suction force toward the lens 114 of the camera module 102. The nozzle 184H may be defined by a slot or cutout 137H formed in a sidewall of a length of tubing that projects distally from the distal end of the housing 104H. The slot 137H may allow fluid to flow between the interior of the lumen 142H and the region adjacent the distal end of the visualization channel or the lens 114 or other component of the camera module 102 disposed therein. A wiper, brush, fin, or other feature 177 for removing debris from the lens may be disposed within the lumen 142H. The wiper 177 may include a proximal shaft 179 and a distal wiper tip 181. Wiper tip 181 is selectively deployable through nozzle slot 137H to wipe debris from lens 114. For example, shaft 179 can be advanced distally within lumen 142H to push wiper tip 181 out of slot 137H and toward lens 114. Wiper tip 181 may be formed of a resilient material, a shape memory material, or may be otherwise biased toward lens 114 to facilitate such deployment. The wiper tip 181 may be flexible. Once the wiper tip 181 is deployed through the slot 137H, the shaft 179 can be axially rotated relative to the housing 104H to draw the wiper tip 181 across the lens surface, thereby clearing debris therefrom. Shaft 179 can be withdrawn proximally relative to housing 104H to retract wiper tip 181 into lumen 142H.

The housing may include various features for retracting, shielding, or manipulating tissue adjacent to the camera lens. For example, fig. 26A-26B illustrate an exemplary housing 104C that may be used with the camera modules and/or access devices described herein. The housing 104C may include any of the features of the other housings (e.g., housing 104) described herein. The housing 104C may include a shield 139 extending or protruding distally from a distal end face of the housing. The shield 139 may include an outer surface 139o and an inner surface 139 i. When the housing 104C is inserted into the patient, the outer surface 139o of the shield 139 can abut adjacent tissue to restrain the tissue and prevent the tissue from expanding into the field of view of the camera lens 114. Alternatively or in addition, as the housing 104C is advanced distally into the patient, the distal tip of the shield 139 can gently push tissue apart, or can act as a standoff to prevent accidental contact between the lens 114 and the tissue, which could lead to undesirable fouling of the lens. The shield 139 can also facilitate the flow of cleaning fluid or reagent as it is ejected across the lens surface, such as by concentrating, diverting, or targeting the fluid toward the lens 114. The shield 139 may extend around the entire perimeter of the housing 104C or, as shown, may extend around only a portion of the perimeter of the housing. The outer surface 139o of the shield 139 may have a contour that matches the contour of the outer surface 136o of the shell 104C, such that the shell and shield define a continuous smooth outer surface. The shield 139 may have a convex outer surface and a concave inner surface. The shield 139 may have a crescent-shaped cross-section. The shield 139 may include a fillet or chamfer 141 at its lateral edges to provide a smooth transition to the distal facing surface of the housing 104C. The inner surface of the shield 139 may have a radius of curvature that follows the radius of curvature of the lens 114. The shield 139 can protrude distally a distance D from the distal end face of the housing 104C. The distance D may be in the range of about 2mm to about 30 mm. The distance D may be in the range of about 4mm to about 12 mm. The distance D may be about 8 mm.

The shield may be movable relative to the housing. For example, the shield may be retractable, e.g., longitudinally retractable, relative to the housing. In some embodiments, the shield may be slidably disposed within a lumen formed in the housing. The shield may be configured to longitudinally translate in a proximal-distal direction within the lumen. This may allow the shield to be selectively deployed or retracted as desired by the user, or may allow the degree to which the shield protrudes to be adjusted during surgery. Movement of the shield relative to the housing may be controlled in various ways, such as by a user manually grasping the proximal end of the shield and sliding it relative to the housing. Fig. 26C illustrates an exemplary housing 104D that may be used with the camera modules and/or access devices described herein. The housing 104D may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104D may include a lumen 143 in which the shield 139 is slidably mounted, thereby facilitating longitudinal adjustment of the shield relative to the housing 104D.

The shield may include wipers, brushes, fins, fluid jets, vacuum ports, or other features, for example, for cleaning debris from the lens as the shield moves relative to the housing. Fig. 26D illustrates an exemplary housing 104E that may be used with the camera modules and/or access devices described herein. The housing 104E may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104E may include a lumen 143 in which the shield 139 is slidably mounted, thereby facilitating longitudinal adjustment of the shield relative to the housing 104E. The shield 139 may include a wiper tab 145 mounted to an inner surface 139i of the shield. As the shield 139 is withdrawn proximally relative to the housing 104E, the tabs 145 may contact the distal end of the housing, causing the tabs to splay outward and wipe across the face of the lens 114. Continued proximal movement of the shield 139 may cause the flap 145 to fold over onto itself and slide up into the lumen 143. When the shield 139 is advanced distally relative to the housing 104E, the tabs 145 may lay flat against the inner side walls 139i of the shield so as not to obstruct the field of view of the camera lens 114. The flap 145 may be formed from a flexible and/or resilient material such as an elastomer, silicone, or the like.

The tissue shield may be disposed within the lumen of the housing as described above, or may be otherwise incorporated into the system. For example, the tissue shield may be integrally formed with the housing, may be integrally formed with the access device, and/or may be integrally formed with the camera module. As another example, the tissue shield can be slidably disposed within a lumen of the housing, a lumen of the access device, and/or a lumen of the camera module. As another example, the tissue shield can slide along an exterior surface of the housing, the access device, and/or the camera module.

The system may comprise an active mechanical and/or acoustic system for maintaining a clear visualization of the camera. For example, the system may include an ultrasonic agitator that may be actuated to clear debris from the lens or to first prevent debris from clogging the lens. Fig. 27A illustrates an exemplary camera module 102B that may be used with the housings and/or access devices described herein. Camera module 102B may include any of the features of other camera modules described herein (e.g., camera module 102). As shown, the camera module 102B may include an ultrasound transducer 147. The transducer 147 may be mounted to the lens barrel 124 as shown, or to any other component of the camera module, such as the lens 114, the image sensor 112, the illumination lumen 128, the PCBA 120, and so forth. Although the transducer 147 is shown mounted to the camera module 102B, it should be understood that the transducer may be mounted to any component of the visualization system, including the housing or the access device. The transducer may also be provided in or on a separate component, such as an outer sheath or collar provided around the camera module or portal. The transducer may be operatively connected to the controller 106 via wires disposed in the connector 108. In use, an electrical potential may be applied to the transducer to generate mechanical vibrations that may shake debris away from or off the lens.

The transducer may be a piezoelectric transducer. The transducer may emit ultrasonic waves, for example, having a frequency in the range of about 20kHz to about 40 kHz. The transducers may be ring transducers, plate transducers, or any other suitable transducer type.

Fig. 27B illustrates an exemplary camera module 102C that may be used with the housings and/or access devices described herein. Camera module 102C may include any of the features of other camera modules described herein (e.g., camera module 102). As shown, the camera module 102C may include an ultrasound transducer 147. The transducer 147 may be in the form of an annular or ring-shaped element disposed axially between the distal end of the lens barrel 124 and the transparent cap 149. The cover 149 may form the outermost distal extent of the camera module 102C and, thus, may define a surface exposed to a surgical environment where debris may accumulate. The transducer 147 may be a piezoelectric element that oscillates in the direction of the arrow shown when an electrical potential is applied to the transducer. This can effectively vibrate the cap 149 and urge droplets or debris 151 away from the cap surface. The annular shape of the transducer 147 may advantageously provide a clear line of site through the transducer to the lens 114 or image sensor 112 while imparting substantially uniform vibration around the entire circumference of the cap 149.

While an ultrasonic agitator is described above, it should be understood that any means for applying vibration or agitation to the system may be used instead or in addition. In some embodiments, vibration may be applied to the system using an electric motor with an eccentrically mounted mass. The motor may be mounted within the camera module, the housing, or the access device. In some embodiments, the system may include an actuator, such as a solenoid or linear actuator, configured to strike the camera module when an electrical potential is applied to the camera module. In use, an electrical current may be selectively applied to the actuator to cause the actuator to strike the camera module, thereby removing or clearing debris from the lens. The actuator may be mounted within the camera module, the housing, or the access device. In some embodiments, debris may be removed from the lens using a generator operating below an ultrasonic frequency range (e.g., in the infrasonic or acoustic range).

The system may include a membrane that is movable over the lens to maintain visibility through the lens. The film may be transparent. The membrane may be pulled through the lens to change the portion of the membrane that is aligned with the lens, such as moving a dirty section of the membrane away from the lens and replacing the dirty section with a clean section of the membrane. The membrane may be a continuous ring of material that is pulled through the lens and moved past a wiper, brush, fin, fluid jet, vacuum port, or other cleaning element that removes debris from the membrane. Thus, a dirty section of the membrane may be moved away from the lens and replaced by a clean section of the membrane, which is eventually moved across a brush or wiper to clean the section before it is again aligned with the lens. The film may be wound on one or more reels, for example, where a dirty section of the film is wound on one reel after use, as a clean section unwinds from the other reel to align with the lens. The movement of the membrane may be continuous or intermittent. The movement of the membrane may be controlled by an electric motor, a hand crank or handle, or various other mechanisms. Movement of the membrane may occur automatically, for example, in response to a controller detecting debris or lack of clarity in an image captured from the camera, or manually, for example, in response to a user actuating a button, wheel, or other input mechanism.

Fig. 28A illustrates an exemplary housing 104F that may be used with the camera modules and/or access devices described herein. The housing 104F may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104F may include a movable membrane 153. The first end of the membrane 153 may be wound around a first "clean" spool 155A disposed at or near the proximal end of the housing 104F. The membrane 153 may extend through a first longitudinal lumen 157A of the housing 104F, across the exposed face of the lens 114, and back through a second longitudinal lumen 157B of the housing. A second end of the membrane 153 may be wound around a second "dirty" spool 155B disposed at or near the proximal end of the housing 104F. In use, one or both of the spools 155 may be rotated to move the membrane 153 in the direction of the illustrated arrow, thereby moving a dirty section of the membrane away from the lens 114 and, in turn, aligning a clean section of the membrane with the lens. One or both of the spools 155 may be driven by a motor or manual input device.

Fig. 28B illustrates an exemplary housing 104G that may be used with the camera modules and/or access devices described herein. The housing 104G may include any of the features of the other housings (e.g., housing 104) described herein. As shown, the housing 104G may include a movable membrane 153. The membrane 153 may be a continuous loop of material that follows a path through the housing 104G that causes the membrane to span across the exposed face of the lens 114 and across a wiper, brush, fin, fluid jet, vacuum port, or other cleaning element 159. The film 153 may be wrapped on a series of rollers 161, one or more of which may be coupled to a motor or manual input device to effect movement of the film. In use, one or more of the rollers 161 may be rotated to move the membrane 153 in the direction of the illustrated arrow, thereby moving a dirty section of the membrane away from the lens 114 and, in turn, aligning a clean section of the membrane with the lens. As the membrane 153 moves, a dirty section of the membrane may be carried on the cleaning element 159 to clean the section of the membrane before it is realigned with the lens 114.

The system may include a mechanical wiper that is movable across the lens to clear debris from the lens. Fig. 29A-29D illustrate an exemplary wiper 163. The wiper 163 may be inserted or disposed within a working channel of any of the access devices described herein (e.g., working channel 174B of access device 110B as shown). The wiper 163 may be moved in a proximal-distal direction, such as by applying a manual input force to a proximal end of the wiper, to move the wiper in a lateral direction across the camera lens 114 to clear debris therefrom. As shown, the wiper 163 can include an elongated wiper shaft 165 and a wiper tip 167. The tip 167 may be formed of a relatively soft material such as silicone, rubber, elastomer, or the like. The shaft 165 may include an offset or relief 169 that interacts with a protrusion 171 formed in the working channel of the access device to convert longitudinal movement of the shaft into lateral movement of the wiper tip 167. Specifically, as shown in fig. 29A and 29C, when the wiper shaft 165 moves proximally within the working channel, the protrusion 171 contacts the offset 169 in the wiper shaft to urge the wiper tip 167 laterally (to the right in the illustrated example). The protrusion 171 and/or the offset 169 may define a sloped or tapered surface to facilitate such lateral movement. The lateral movement of the wiper tip 167 across the lens 114 is effective to clear debris from the lens surface. As seen in fig. 29B and 29D, when the wiper shaft 165 is subsequently moved distally, the offset 169 on the wiper shaft may move longitudinally past the protrusion 171, allowing the wiper shaft to move in the opposite lateral direction, bringing the wiper tip 167 back into the lens 114 in the opposite direction (to the left in the illustrated example). The wiping shaft 165 may be biased toward the side wall of the working channel (to the left in the example shown) to facilitate such lateral movement. The return lateral movement of the wiper tip 167 across the lens 114 is effective to further clear debris from the lens.

Fig. 30A-30B illustrate another exemplary wipe 173. The wiper 173 may be inserted or disposed within the working channel of any of the access devices described herein. The wiper 173 can include a flexible and/or resilient material tab 175 biased toward a visualization lumen 176 of the access device 110. As camera module 102 and/or housing 104 move longitudinally past fins 175, the fins may wipe across the exposed surface of lens 114 to remove debris therefrom. Specifically, as shown in fig. 30A, as the housing 104 and camera module 102 are withdrawn proximally, the bias of the wiper 173 may cause the tab 175 to move into the visualization channel 176 of the access device 110. As shown in fig. 30B, as the housing 104 and camera module 102 are subsequently advanced distally, the tab 175 may wipe across the exposed surface of the lens 114 as the housing and camera module push the wipe 173 out of the path. Wiper 173 may enable automatic cleaning of lens 114 each time camera module 102 moves past wiper tab 175. The camera module 102 may be repeatedly moved up and down within the access device 110 as many times as necessary or desired to clean the lens 114. The wipe tab 175 may be formed of a relatively soft material such as silicone, rubber, elastomer, or the like.

The various lens cleaning mechanisms described herein may be used alone or in combination. For example, the visualization system may include a mechanical wiper, an ultrasonic agitator, a movable membrane, and a fluid cleaning system. As another example, a visualization system may include an ultrasonic agitator and a fluid cleaning system. As another example, a visualization system can include a movable membrane and a fluid cleaning system. Any other combination or sub-combination may also be used.

The visualization systems and/or access devices disclosed herein may be used in any of a variety of surgical procedures. For example, such systems and devices may be used for ear, nose, and throat (ENT) surgery, sinus surgery, Gastrointestinal (GI) surgery, abdominal surgery, endovascular surgery, cardiothoracic surgery, joint surgery, and the like. In some embodiments, the visualization system may be a self-cleaning endoscope for sinus surgery with or without an access device. The active and/or passive cleaning features of the system may reduce or eliminate the need to repeatedly withdraw the scope from the patient to clean the lens. In some embodiments, the visualization system may be used as a self-cleaning endoscope for airway surgery (e.g., laryngoscopy, bronchoscopy, etc.) with or without an access device. In some embodiments, the visualization system may be used as a self-cleaning upper GI mirror and/or lower GI mirror with or without an access device. The visualization system may form a rigid endoscope with self-cleaning capabilities.

The various housings and camera modules disclosed herein may be used with an access device or may be used independently without any access device. Any of the systems described herein may include a housing that is separate and distinct from the camera module, or may include an integral camera module and housing, such as a system in which the outer covering of the camera module defines the housing.

It should be noted that any order of method steps expressed or implied in the above description or figures should not be construed as limiting the disclosed method to performing the steps in that order. Rather, the various steps of each method disclosed herein may be performed in any of a variety of orders. Moreover, since the methods described are merely exemplary embodiments, various other methods including more steps or including fewer steps are also encompassed within the scope of the present disclosure.

The devices disclosed herein may be constructed from any of a variety of known materials. Exemplary materials include materials suitable for use in surgical applications including metals (such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof), polymers (such as PEEK, ceramics, carbon fiber), and the like. The various components of the devices disclosed herein can be rigid or flexible. One or more components or portions of the device may be formed of radiopaque materials to facilitate visualization under fluoroscopy and other imaging techniques, or radiolucent materials to not interfere with visualization of other structures. Exemplary radiolucent materials include carbon fibers and high strength polymers.

The devices and methods disclosed herein may be used in minimally invasive surgery and/or open surgery. While the devices and methods disclosed herein are generally described in the context of spinal surgery on a human patient, it should be understood that the methods and devices disclosed herein may be used in any type of surgery on a human or animal subject, on an inanimate object (in a non-surgical application), and so forth.

While specific embodiments have been described above, it should be understood that numerous changes could be made within the spirit and scope of the described concepts.

Claims

1. A surgical system, comprising:

an access device having a working channel and a visualization channel; and

a visualization system disposed at least partially in the visualization channel, the visualization system including a camera module and a housing in which the camera module is mounted.

2. The system of claim 1, wherein the camera module comprises an image sensor and a lens configured to direct reflected light onto the image sensor, the image sensor and the lens disposed within the housing.

3. The system of claim 2, wherein the camera module comprises an optical fiber having a distal end disposed within the housing and a proximal end in optical communication with a light source.

4. The system of claim 3, wherein the lens is disposed within a lens lumen of a lens barrel, and wherein the optical fiber is disposed in an illumination lumen of the lens barrel.

5. The system of claim 4, wherein the illumination lumen is disposed closer to a center of the access device working channel than the lens lumen.

6. The system of claim 4, wherein the lens barrel includes a distally facing surface angled obliquely relative to a central longitudinal axis of the working channel.

7. The system of claim 6, further comprising a diffuser mounted in a recess formed in the distal-facing surface of the lens barrel above the optical fiber.

8. The system of claim 7, wherein the recess is crescent-shaped and substantially follows a perimeter of the lens lumen.

9. The system of claim 2, wherein a central region of the lens is coated with a hydrophobic coating and a peripheral region of the lens is coated with a hydrophilic coating.

10. The system of claim 1, wherein the housing comprises a body and a distal end cap.

11. The system of claim 10, wherein the body comprises a camera lumen and first and second fluid lumens, the camera module disposed in the camera lumen.

12. The system of claim 11, wherein the camera lumen is centrally disposed in the body between the first fluid lumen and the second fluid lumen.

13. The system of claim 10, wherein the distal-facing surface of the body and the distal-facing surface of the end cap are obliquely angled relative to a central longitudinal axis of the working channel.

14. The system of claim 10, wherein the body has a sidewall with a concave inner surface disposed adjacent the working channel and a convex outer surface disposed opposite the inner surface.

15. The system of claim 14, wherein the inner surface of the sidewall of the body defines at least a portion of an inner surface of the working channel.