Surgical visualization systems and related methods
By designing a visualization system with an access device and a camera module for a working channel and a visualization channel, the problems of the existing surgical visualization system being bulky and difficult to clean are solved, and efficient visualization support in a variety of surgical operations is achieved.
Patent Information
- Application Number
- CN201980027429.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-02-21
- Filing Date
- 2019-02-20
- Publication Date
- 2025-01-21
- Estimated Expiration
- 2039-02-20
AI Technical Summary
Existing surgical visualization systems are bulky, difficult to clean or disinfect, and are often only used for limited procedures, making them difficult to meet the needs of many types of surgical procedures.
A surgical visualization system is designed. The system includes an access device and a visualization system. The access device has a working channel and a visualization channel. The visualization system includes a camera module and a housing. The camera module has an image sensor and a lens. The housing is provided with a fluid channel. For lens cleaning.
The system can provide visual support in a variety of surgical procedures, including spine surgery, improving the surgeon's convenience and surgical effectiveness while reducing the invasiveness of the surgery.
Smart Images

Figure CN112236071B_ABST
Abstract
Description
Technical Field
[0001] Disclosed herein are surgical visualization systems and related methods, for example, for providing visualization during surgical procedures, including minimally invasive spinal procedures. Background Art
[0002] There are many situations where it may be desirable to provide visualization of the surgical site to a surgeon or other user. Although multiple surgical visualization systems have been developed, they are often bulky and cumbersome to use, difficult to clean or sterilize, or have characteristics that make them inadequate or impossible to use for many types of surgeries. For example, spinal endoscopes are typically used only for limited surgeries, such as herniated disc repair and other pathologies that are narrowed to a predictable, very small location. Such devices typically require very small, specialized tools with low output force and tissue handling capabilities. Such devices may require multiple operators, with an assistant or other user holding and operating the visualization system while the surgeon uses two hands to perform the surgical procedure. In addition, such devices may have a steep learning curve because the visualization orientation may be determined by the instrument orientation and may therefore be constantly changing during the operation. Summary of the invention
[0003] Surgical visualization systems and related methods are disclosed herein, for example, for providing visualization during surgical procedures. The systems and methods herein can be used in a wide range of surgical procedures, including spinal surgeries, such as minimally invasive fusions or discectomies. The systems and methods herein can include various features for enhancing the end-user experience, improving clinical outcomes, or reducing the invasiveness of surgical procedures. Exemplary features can include portal integration, hands-free operation, active and / or passive lens cleaning, adjustable camera depth, and many other features.
[0004] In some embodiments, a surgical system may include an access device having a working channel and a visualization channel, and a visualization system at least partially disposed in the visualization channel, the visualization system including a camera module and a housing in which the camera module is mounted.
[0005] 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 a housing. The camera module may include an optical fiber having a distal end disposed within the housing and a proximal end optically connected to a light source. The lens may be disposed within a lens lumen of a 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 an access device working channel than the lens lumen. The lens barrel may include a distally facing surface obliquely angled relative to a central longitudinal axis of the working channel. The system may include a diffuser mounted in a recessed portion in a distally facing surface of the lens barrel formed above the optical fiber. The recessed portion may be crescent-shaped and may substantially follow the periphery 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.
[0006] The housing may include a body and a distal end cap. The body may include a camera lumen and a first fluid lumen and a second fluid lumen, the camera module being disposed in the camera lumen. The camera lumen may be centrally disposed in the body, between the first fluid lumen and the second fluid lumen. The distally facing surface of the body and the distally 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 having a concave inner surface disposed adjacent to 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 of a segment defining a cylinder, the transition region following the outer periphery 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 of segments defining respective cylinders, the first and second transition regions following the outer peripheries of the first and second fluid lumens formed in the body. The housing may be formed by an inner circular tube disposed within and attached to an outer oval tube to define a camera lumen and a first fluid lumen and a second fluid lumen. The housing may be formed by an inner circular tube having a first shell and a second shell attached thereto to define a camera lumen and a first fluid lumen and a second fluid lumen. The end cap may include a cutout axially aligned with a lens of the camera module and a cutout axially aligned with an illumination system of the camera module. The proximal-facing surface of the end cap may define a recessed portion configured to direct fluid to flow out of the first fluid lumen of the housing across the lens of the camera module and into the second fluid lumen of the housing. The recessed portion may include an outer end portion axially aligned with the first fluid lumen and the second fluid lumen and an inner end portion open to the cutout of the end cap.
[0007] The system may include a connector assembly extending from the housing, the connector assembly including an electrical connection and an optical connection to the camera module and a fluid connection to the housing. The connector assembly may have an external shape that matches the 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 with the working channel. The housing and the 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.
[0008] The access device may include a mating feature structure configured to selectively maintain the visualization system in a desired position relative to the access device. The mating feature structure may include a locking track configured to receive a portion of the visualization system to limit the 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 receive the visualization system with a snap fit or a friction fit. The mating feature structure may include an adjustment track configured to receive at least a portion of the visualization system to allow the visualization system to move relative to the access device. The visualization system may be configured so that the visualization system can be loaded into the locking track by moving it radially outward from the central longitudinal axis of the visualization channel. The locking track may be angled curved or obliquely away from the central longitudinal axis of the visualization channel. The visualization system may be configured so that the visualization system can be fixed to the mating feature structure at any point along the connector assembly of the visualization system. The mating feature structure may include a wheel that advances or retracts the visualization system relative to the access device when rotated. The mating feature structure 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 structure may include an O-ring disposed around a portion of the visualization system and a cone movably connected to the access device, the cone being movable between a first position and a second position, wherein the O-ring is extended to allow the visualization system to move relative to the access device and the O-ring is released to clamp onto the visualization system and prevent the visualization system from moving relative to the access device.
[0009] The system may include a cannula insertable through a working channel of an access device, the cannula having an outer diameter and a bulb-shaped portion movably coupled to the cannula, the bulb-shaped portion being movable between a first position and a second position, wherein the bulb-shaped portion is completely disposed within the outer diameter of the cannula and wherein at least a portion of the bulb-shaped portion protrudes from the outer diameter of the cannula. The bulb-shaped portion in the second position may be configured to fill a void space within the access device distal to a visualization channel of the access device. The bulb-shaped portion may include a distally facing surface that is curved or angled 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 may be movable between the first position and the second position by axially translating the cannula relative to the access device. The bulb-shaped portion may be movable between the first position and the second position by rotating the cannula relative to the access device. The bulb-shaped portion may be biased toward the second position. The access device may include a transition portion at a distal end thereof, the transition portion 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 moves radially outward from the first position. The system may include an expansion 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.
[0010] In some embodiments, a visualization system may include: 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, a first fluid channel and a second fluid channel, and an end cap configured to direct a fluid flow through the channel across the lens of the camera module.
[0011] The camera module may include an optical fiber having a distal end disposed within the housing and a proximal end in optical communication with a light source. The lens may be disposed within a lens lumen of a 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 distally facing surface of the lens barrel above the optical fiber. The recess may be crescent-shaped and may substantially follow the periphery 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.
[0012] The camera module may be centrally disposed in the body, between the first and second fluid channels. The distally facing surface of the body and the distally facing surface of the end cap may be obliquely angled relative to the central longitudinal axis of the camera module. The body may have an outer surface including 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 the outer periphery of the camera lumen of the body. The body may have an inner surface that is concavely curved and connected to the outer surface by a first transition region and a second transition region defining a segment of a corresponding cylinder, the first transition region and the second transition region following the outer periphery of the first and second fluid channels. The housing may be formed by an inner circular tube disposed within and attached to an outer oval tube to define the camera lumen and the first and second fluid channels. The housing may be formed by an inner circular tube having first and second opposing shells attached thereto to define the camera lumen and the first and second fluid channels. The end cap may include a cutout aligned axially with the lens. The proximal-facing surface of the end cap may define a recessed portion configured to direct fluid flow across the lens out of the first fluid channel of the housing and into the second fluid channel of the housing. The recessed portion may include an outer end portion axially aligned with the first fluid channel and the second fluid channel and an inner end portion open to the cutout of the end cap.
[0013] 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 outer shape that matches an outer 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.
[0014] In some embodiments, a surgical method may include: inserting an access device into a patient; mounting the access device to an anchor comprising at least one of an anatomical structure of the patient and an implant implanted in the patient; inserting a camera module into the access device; adjusting a depth of the camera module relative to the access device; and securing the camera module to a mating feature structure of the access device to maintain the camera module at the adjusted depth.
[0015] The anchor may include a bone anchor implanted in a pedicle of the patient. The method may include performing a surgical procedure through an access device without using a hand to hold the access device or the camera module. The method may include inserting a fusion cage through the access device and inserting into the intervertebral disc space. Inserting the access device may include positioning the distal end of the access device near the intervertebral disc space of the patient via a TLIF method. The method may include positioning the camera module in a relatively proximal position relative to the access device, performing bone resection through the access device, positioning the camera module in a relatively distal position relative to the access device, and removing intervertebral disc tissue through the access device. The method may include guiding 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 may include positioning the distal end of the access device in a dry environment of the patient. Inserting the access device may include positioning the 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.
[0016] In some embodiments, a surgical system may include: an access device having a working channel and a visualization channel; a visualization system at least partially disposed in the visualization channel, the visualization system including a camera module and a shell in which the camera module is mounted; and a tissue shield extending distally beyond a distal end surface of the shell.
[0017] The tissue shield may be capable of longitudinal movement relative to the housing. The tissue shield may be slidably disposed within a lumen of the housing. The tissue shield may be slidably disposed within a 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 the lens of the camera module when the tissue shield is longitudinally moved relative to the housing. The tissue shield may extend around less than the entire periphery 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 having a contour that matches the contour of the outer surface of the housing. The tissue shield may have a crescent-shaped cross-section.
[0018] In some embodiments, a surgical system may include: an access device having a working channel and a visualization channel; a visualization system at least partially disposed in the visualization channel, the visualization system comprising 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.
[0019] The lens cleaning device may include a positive pressure gas source directed to the lens through a lumen of the housing. The gas may include air or carbon dioxide. The lens cleaning device may include a fluid lumen having a nozzle opening through which a fluid may be directed to the lens, the nozzle opening being obliquely angled relative to the central longitudinal axis of the housing. The nozzle opening may be formed in a tube extending from the distal end face of the housing. The lens cleaning device may include a fluid lumen having a nozzle opening through which a fluid may be directed to the lens, the nozzle opening extending perpendicular to the central longitudinal axis of the housing. The lens cleaning device may include an ultrasonic agitator. The lens cleaning device may include a membrane movable relative to the lens. The membrane may include 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 membrane may be wound onto a reel. The membrane may extend through a first lumen of the housing, across the lens, and through a second lumen of the housing. The lens cleaning device may include a wiper at least partially disposed in a 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 wiper shaft moves longitudinally within the working channel. The wiper may be biased toward the visualization channel so that the wiper wipes over the lens of the camera module as the camera module is advanced distally into the visualization channel.
[0020] In some embodiments, a surgical method may include inserting an access device into a patient; inserting a housing having a camera module therein into the access device, the camera module having a lens; and actuating a lens cleaning device to clean a visualization path to the lens of the camera module while the access device and the camera module are inserted into the patient.
[0021] Actuating the lens cleaning device may include a tissue shield protruding longitudinally from the distal end of the housing relative to the housing so that the wiper is carried on the lens. Actuating the lens cleaning device may include directing positive pressure air through the lumen of the housing and toward the lens. Actuating the lens cleaning device may include vibrating the lens. Actuating the lens cleaning device may include moving a membrane relative to the lens. The moving membrane may include a continuous ring of rotating membrane material to move a dirty portion of the membrane away from the lens and position a clean portion of the membrane above the lens. Actuating the lens cleaning device may include advancing the camera module through the entry device to drag a wiper wing 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 an offset portion of the wiper to contact a protrusion disposed in the working channel to force the end of the wiper to laterally cross the lens.
[0022] In some embodiments, a visualization system may include: 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 the lens of the camera module through the one or more fluid channels.
[0023] In some embodiments, a surgical system may include: an access device having a working channel and a visualization channel; and a visualization system at least partially disposed in the visualization channel, the visualization system including a camera module; wherein the visualization system is axially translatable relative to the access device to position the visualization system so that the camera module protrudes from a distal end of the access device.
[0024] In some embodiments, a surgical method may include: inserting an access device into a patient; inserting a camera module into the access 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 so that the camera module protrudes from a distal end of the access device. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Figure 1 is a perspective view of a surgical visualization system and access device;
[0026] Figure 2A yes Figure 1 A perspective view of a camera module of a system;
[0027] Figure 2B yes Figure 2A A cross-sectional side view of a camera module;
[0028] Figure 2C yes Figure 2A A cross-sectional perspective view of a camera module;
[0029] Figure 3A yes Figure 1 A perspective view of a housing of the system, wherein the housing is shown as transparent, and wherein Figure 2A The camera module is arranged in the housing;
[0030] Figure 3B yes Figure 3A A perspective view of a distal end of a housing and a camera module;
[0031] Figure 3C yes Figure 3A A perspective view of a housing;
[0032] Figure 3D yes Figure 3A A side view of a housing;
[0033] Figure 3EThe housing and the distal end thereof are adjacent Figure 3A A cross-sectional perspective view of a camera module;
[0034] Figure 3F yes Figure 3A A perspective view of a distal end of a housing and a camera module;
[0035] Figure 3G yes Figure 3A A partially exploded perspective view of a housing and a camera module;
[0036] Figure 3H yes Figure 3A A perspective view of a housing and camera module of FIG. 1 , wherein an end cap of the housing is shown as transparent and schematically illustrating a fluid flow through the housing;
[0037] Fig. 3I yes Figure 3A A cross-sectional side view of a housing and a camera module;
[0038] Figure 3J yes Figure 3A A cross-sectional perspective view of a housing and a camera module;
[0039] Figure 4A yes Figure 1 A perspective view of a connector assembly of a system;
[0040] Figure 4B is adjacent to its distal end Figure 4A a cutaway perspective view of a connector assembly;
[0041] Figure 5A yes Figure 1 A perspective view of a controller of a system;
[0042] Figure 5B yes Figure 5A A schematic block diagram of a controller;
[0043] Fig. 6A It is set in the entry device Figure 1 A perspective view of a system of FIG. 1 , wherein the entry device is shown as transparent;
[0044] Figure 6B yes Fig. 6A a side view of a system and an access device, wherein the access device is shown as transparent;
[0045] Figure 6C yes Fig. 6A A perspective view of a system and an entry device, wherein the system is disposed in a locking track of the entry device;
[0046] Fig.6D yes Fig. 6AA perspective view of a system and an access device, wherein the system is disposed in an adjustment track of the access device;
[0047] Fig. 6E yes Fig. 6A A sectional side view of the system and access device;
[0048] Fig. 6F yes Fig. 6A a cross-sectional side view of a system and a distal end of an access device;
[0049] Figure 6G yes Fig. 6A Top view of the system and access device;
[0050] Figure 6H yes Fig. 6A A cross-sectional top view of the system and access device;
[0051] Figure 7 is a perspective view of a surgical system for performing a surgical procedure on a patient's spine, the surgical system comprising Figure 1 Visualization system;
[0052] Figure 8 yes Figure 2A A cross-sectional side view of a camera module schematically illustrating viewing characteristics of the camera module;
[0053] Fig. 9 is a perspective view of a distal end of another exemplary housing;
[0054] Fig. 10A is a cross-sectional top view of another exemplary housing;
[0055] Fig. 10B is a cross-sectional top view of another exemplary housing;
[0056] Fig.11A is a cutaway perspective view of another exemplary housing;
[0057] Fig. 11B yes Fig.11A A perspective view of a housing;
[0058] Fig. 11C yes Fig.11A A sectional perspective view of a shell;
[0059] Fig.11D yes Fig.11A A sectional perspective view of a shell;
[0060] Fig. 12A is a cross-sectional top view of another exemplary housing;
[0061] Fig. 12Bis an exploded and assembled view of another exemplary housing;
[0062] Fig.13 is a side view of a mating feature that may be included in an access device herein;
[0063] Fig.14 is a perspective view of another mating feature that may be included in the access devices herein;
[0064] Fig.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;
[0065] Fig. 15B It is shown in unlocked state Fig.15A A cross-sectional side view of a matching feature structure;
[0066] Fig.16A is a perspective view of another mating feature that may be included in the access devices herein;
[0067] Fig. 16B yes Fig.16A A cross-sectional side view of a matching feature structure;
[0068] Fig. 16C yes Fig.16A A perspective view of the mating feature structure;
[0069] Fig.17 is a perspective view of another mating feature that may be included in the access devices herein;
[0070] Fig.18 is a perspective view of another mating feature that may be included in the access devices herein;
[0071] Fig.19 is a perspective view of another mating feature that may be included in the access devices herein;
[0072] Fig. 20 yes Figure 1 A perspective view of a system showing a user controller;
[0073] Fig.21A is a cutaway perspective view of an access device and a standard dilator;
[0074] Fig. 21B is a perspective view of the access device and dilation system;
[0075] Fig. 21C yes Fig. 21B A cross-sectional perspective view of an access device and a dilation system;
[0076] Fig.21D yes Fig. 21B A perspective view of a cannula of a dilation system;
[0077] Fig.22A is a proximally facing end view of the access device and the expansion system in a first configuration;
[0078] Fig. 22B yes Fig.22A a proximally facing end view of the access device and expansion system in a second configuration;
[0079] Fig.23A It is a perspective view of entering the device;
[0080] Fig. 23B yes Fig.23A A sectional perspective view of an access device;
[0081] Fig.23C yes Fig.23A A bottom view of an entry device;
[0082] Fig.23D yes Fig.23A A top view of the entry device;
[0083] Fig.23E is constructed with Fig.23A A perspective view of a dilation shaft for use with an access device;
[0084] Fig.23F Yes Insert Fig.23A of the entry device Fig.23E A cross-sectional perspective view of the expansion axis;
[0085] Figure 23G Yes Insert Fig.23A of the entry device Fig.23E A perspective view of the expansion axis;
[0086] Fig.24A It is a perspective view of the visualization system;
[0087] Fig. 24B yes Fig.24A A perspective view of the housing, camera module, and mating features of the visualization system;
[0088] Fig.24C yes Fig.24A A perspective view of the coordination feature structure of the visualization system;
[0089] Fig.25A is a perspective view of a distal end of a housing having an angled nozzle opening;
[0090] Fig.25B yes Fig.25A a side view of a distal end of the housing;
[0091] Fig.25C is a perspective view of a distal end of a housing having a wiper deployable from a nozzle opening of the housing;
[0092] Fig.26A is a perspective view of a distal end of the housing having a tissue shield;
[0093] Fig.26B yes Fig.26A A detailed perspective view of the distal end of the housing;
[0094] Fig.26C is a perspective view of a distal end of the housing having a movable tissue shield;
[0095] Fig.26D is a perspective view of a distal end of a housing having a removable tissue shield with an integrated wiper;
[0096] Fig.27A is a cross-sectional side view of a camera module having an ultrasonic agitator;
[0097] Fig.27B is a cutaway perspective view of another camera module having an ultrasonic agitator;
[0098] Fig.28A is a cross-sectional side view of a housing having a movable membrane;
[0099] Fig.28B is a cross-sectional side view of another housing having a movable membrane;
[0100] Fig.29A is a bottom view of an access device having a mechanical wiper, wherein the wiper is shown in a first lateral position;
[0101] Fig.29B yes Fig.29A a bottom view of an access device and a mechanical wiper, wherein the wiper is shown in a second lateral position;
[0102] Fig.29C yes Fig.29A A cross-sectional side view of an access device and a mechanical wiper, wherein the wiper is shown in a first lateral position;
[0103] Fig.29D yes Fig.29A A cross-sectional side view of an access device and a mechanical wiper, wherein the wiper is shown in a second lateral position;
[0104] Fig. 30A is a cross-sectional side view of an access device having a mechanical wiper, wherein the wiper is shown in a first position; and
[0105] Fig. 30Byes Fig. 30A A cross-sectional side view of an access device and a mechanical wiper, wherein the wiper is shown in a second position. DETAILED DESCRIPTION
[0106] Surgical visualization systems and related methods are disclosed herein, for example, for providing visualization during surgical procedures. The systems and methods herein can be used in a wide range of surgical procedures, including spinal surgeries, such as minimally invasive fusions or discectomies. The systems and methods herein can include various features for enhancing the end-user experience, improving clinical outcomes, or reducing the invasiveness of surgical procedures. Exemplary features can include portal integration, hands-free operation, active and / or passive lens cleaning, adjustable camera depth, and many other features.
[0107] Certain exemplary embodiments will now be described to provide a comprehensive 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 shown in the accompanying drawings. It should be understood by those skilled in the art that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments. The feature structures shown or described in conjunction with an exemplary embodiment may be combined with the feature structures of other embodiments.
[0108] In some embodiments, the surgical visualization system disclosed herein can achieve hands-free visualization. For example, the camera module can be mounted in the access device in a manner that does not require the surgeon, assistant, or other user to manually hold the camera in place. As another example, the access device can be fixed to a support, such as an operating table, an anatomical anchor, etc., so that the user does not need to manually hold the access port or hold the camera module disposed therein. Therefore, the user's hands are free to perform other steps of the surgical procedure.
[0109] The camera module may be separate and independent from the surgical instrument used to perform the procedure. Thus, the 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. In addition, the visual trajectory of the camera may be independent of the positioning of the instrument. This may allow the camera and / or the access device on which the camera is disposed to remain relatively stationary while the instrument is being manipulated and while the procedure is being performed. Thus, the field of view of the camera may remain substantially fixed during surgery, thereby providing the user with good spatial orientation and a simplified learning curve compared to other visualization systems.
[0110] Conventional spinal microscopes may protrude significantly from the patient, occupy a significant amount of space above the surgical incision, and clear space must be maintained 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 the surgical procedure, such as limiting the possible angles of entry for the instruments. 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 the like. A visualization system of the type described herein may be integrated with an access device, may have a low profile design, and / or may display captured images on an external monitor, thereby reducing or eliminating these potential problems.
[0111] In some embodiments, the surgical visualization system disclosed herein is capable of adjusting the depth of the camera within the access device. In some embodiments, the camera depth can be adjusted quickly and easily. In some embodiments, the camera depth can be adjusted with one hand in a tool-free manner. The ability to easily adjust the camera depth can allow for visualization to be optimized for each stage of the surgical procedure in a seamless manner that does not interfere with or interrupt the surgical process. For example, in spinal surgery, the camera can be retracted proximally when performing rough bone removal and other steps that are relatively low risk but may cause the camera lens to be blocked by debris. Later, when manipulating nerves or performing other tasks that require greater precision, the camera can be advanced distally within the access device. In some cases, the camera can be advanced to protrude from the distal end of the access device, for example, to position the camera within the intervertebral disc space.
[0112] In some embodiments, the surgical visualization system disclosed herein can provide improved visualization in harsh or challenging operating environments. In many spinal surgeries, for example, the operating environment is dry (compared to the fluid-filled cavities present in other surgical procedures using visualization systems), and a large amount of smoke and cuttings may be generated during the surgical procedure. The surgical visualization system 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 system disclosed herein can provide high-resolution visualization in minimally invasive spinal surgeries such as endoscopic transforaminal lumbar interbody fusion (TLIF) surgery.
[0113] In some embodiments, the surgical visualization systems disclosed herein may be disposable, may be easily cleaned or sterilized, may have a thin profile, may be lightweight, may be low-cost, may have high resolution, and / or may be used in minimally invasive surgical procedures, such as spinal surgery.
[0114] Figure 1An exemplary surgical visualization system 100 is shown. System 100 may include a camera module 102 disposed within a housing 104. Housing 104 may be configured for positioning at or adjacent to a surgical site. System 100 may include a controller or display 106 for controlling camera module 102, for displaying images captured by the camera module, and the like. Camera module 102 and / or housing 104 may be coupled to controller 106 via a connector or connector assembly 108. Connector assembly 108 may include an electrical connection and / or an optical connection to camera module 102. Connector assembly 108 may include a fluid connection to housing 104. The fluid connection may be used to deliver material to housing 104, to extract material from the housing, or to both deliver and extract material from the housing, for example, for cleaning a lens of camera module 102. System 100 may be selectively mountable to 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 a variety of other ways to facilitate a surgical procedure.
[0115] The camera module 102 is shown in more detail in FIG. 2A to FIG. 2CThe 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 the 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-chip camera on a cutting edge, and / or may use a variety of other image sensing technologies. The image sensor 112 may be a monochrome sensor having a pixel array and supporting circuitry that is sensitive to electromagnetic radiation of any wavelength.An exemplary image sensor 112 and other features that may be included or incorporated in the camera module 102 are disclosed in the following references: U.S. patent application Ser. No. 13 / 952,518, entitled “CONTINUOUS VIDEOIN A LIGHT DEFICIENT ENVIRONMENT”; U.S. patent application Ser. No. 14 / 214,412, entitled “IMAGEROTATION USING SOFTWARE FOR ENDOSCOPIC APPLICATIONS”; U.S. Patent No. 8,648,932, entitled “SYSTEM, APPARATUS AND METHODS FOR PROVIDING A SINGLE USE IMAGING DEVICE FOR STERILE ENVIRONMENTS”; U.S. Patent No. 8,952,312, entitled “IMAGE SENSOR FOR ENDOSCOPIC USE”; U.S. Patent No. 8,952,312, entitled “SYSTEM AND METHOD FOR PROVIDING A SINGLE USE IMAGING DEVICE FOR MEDICAL APPLICATIONS” U.S. Patents 8,972,714, entitled “PIXEL ARRAY AREA OPTIMIZATION USING STACKING SCHEME FOR HYBRID IMAGE SENSOR WITH MINIMAL VERTICAL INTERCONNECTS”; U.S. Patents 9,123,602, entitled “IMAGE SENSOR WITH TOLERANCE OPTIMIZING INTERCONNECTS”; U.S. Patents 9,462,234, entitled “CAMERA SYSTEM WITH MINIMAL AREA MONOLITHIC CMOS IMAGE SENSOR”; U.S. Patents 9,509,917, entitled “WIDE DYNAMIC RANGE USING MONOCHROMATIC SENSOR”; and U.S. Patents 9,153,609, entitled “SYSTEM AND METHOD FOR SUB-COLUMN PARALLEL DIGITIZERS FOR HYBRID STACKED IMAGE SENSOR USING VERTICAL INTERCONNECTS"; each of which is incorporated herein by reference.
[0116] 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. The lens 114 may include a plurality of optical elements that may be moved relative to each other. The lens 114 may include one or more motors, actuators, gears, etc., for adjusting the focal length, aperture size, shutter speed, and other parameters of the lens. 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 length range lenses, etc. The lens 114 may include high-speed autofocus. The lens 114 may include an adjustable aperture and an adjustable shutter speed.
[0117] The camera module 102 may include an illumination system for illuminating the field of view of the image sensor 112. The illumination system may include a digital or analog light source. The light source may include one or more laser emitters or light emitting diodes, incandescent bulbs, etc. The light source may emit light in any dithered, diffuse or collimated emission mode and may be controlled digitally or by an analog method or system. The light source may be pulsed to illuminate the surgical scene. The light source may generate pulses in one or more partitions, each of which is a predetermined wavelength range of the electromagnetic spectrum that is less than the entire electromagnetic spectrum. The pixel array of the image sensor 112 may be electronically paired with the light source so that during operation they are synchronized 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 generate pulses at intervals corresponding to the operation and function of the pixel array. The light source may pulse light in multiple electromagnetic partitions so that the pixel array receives reflected electromagnetic energy and generates a data set corresponding to each specific electromagnetic partition (in time). For example, the light source may emit a green electromagnetic partition, a blue electromagnetic partition, and a red electromagnetic partition in any desired order, which may be combined to form a color image. Any color combination or any electromagnetic partitioning may be used in place of the red, green, and blue partitioning, 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 into the camera module 102 are disclosed in the following documents: U.S. Patent No. 9,516,239, entitled "YCBCR PULSED ILLUMINATION SCHEME IN A LIGHT DEFICIENT ENVIRONMENT"; and U.S. Patent No. 9,641,815, entitled "SUPERRESOLUTION AND COLOR MOTION ARTIFACT CORRECTION IN APULSED COLOR IMAGING SYSTEM", each of which is incorporated herein by reference.
[0118] 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 proximal to the housing 104 and a proximal end optically connected to a light source disposed remotely from 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, which is shown as a diffuser disposed above the distal end of the optical fiber 116.
[0119] 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 regulation circuitry, hardware logic, clocks, and / or other components for operating the image sensor 112 and communicating image data generated by the image sensor to the controller 106.
[0120] 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.
[0121] The lens lumen 126 may include a proximal end 126p and a distal end 126d and a central longitudinal axis A1. The lens lumen 126 may have a circular cross-section. The lens 114 may be disposed within the distal end of the lens lumen 126. The image sensor 112 may be positioned at or on the proximal end of the 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.
[0122] The illumination lumen 128 may include a proximal end 128p and a distal end 128d and a central longitudinal axis A2. The illumination lumen 128 may have a circular cross-section. The optical fiber 116 may be disposed in 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 side wall of the lens barrel 124. This may facilitate the insertion of the optical fiber 116 into the lens barrel 124 during assembly, for example, by allowing the optical fiber to be loaded sideways or inserted sideways into the illumination lumen 128. The distal end of the illumination lumen 128 may be curved or angled, for example, so that it extends in a direction that is not parallel to the axis A2. This arrangement may allow the flat distal end of the straight-cut optical fiber 116 to be oriented parallel to the angled distal end of the lens barrel 124, as shown. In other arrangements, the optical fiber 116 may be angled to match the distal end of the lens barrel 124.
[0123] The lumens 126, 128 may be coaxial with each other or may be non-coaxial. For example, the lumens 126, 128 may be laterally offset from each other. The lumens 126, 128 may be formed so that they extend parallel to each other, for example so that their respective central longitudinal axes A1, A2 are parallel. As further described below, when integrated with the access device 110, the illumination lumen 128 may be disposed radially inward from the lens lumen 126, for example so that the illumination lumen is disposed closer to the center of the access device working channel than the lens lumen. This may provide a more uniform light distribution within the working channel of the access device 110.
[0124] The proximal end of the lens barrel 124 may include a recess or depression 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 may 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.
[0125] The lens barrel 124 may include a distally facing surface at its distal end. The lumens 126, 128 of the lens barrel 124 may be open to the distally facing surface. The distally facing surface may be obliquely angled. For example, the distally facing surface may be substantially located on a plane 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 distally facing surface as shown, or may be recessed or protruding from the distally facing surface. The distally facing surface may include 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 periphery of the illumination lumen 128. The recess 134 and the optical element 118 disposed therein may have a curved or crescent shape as shown. The recess 134 may include an inner edge that follows or substantially follows the perimeter of the lens lumen 126 .
[0126] As further described below, when integrated with the access device 110, the distal-facing surface of the lens barrel 124 can be angled in the distal-to-proximal direction toward the center of the access device or its working channel in which the camera module 102 is disposed. This can provide the image sensor 112 with a better view of the surgical site and / or provide a more uniform light distribution within the surgical site. The lens barrel 124 can have an oval, rectangular, circular, elliptical, square, rectangular, etc. cross-section.
[0127] like FIG. 3A to FIG. 3JAs shown, the camera module 102 can be mounted in the housing 104. The housing 104 can include a body 136 and a distal end cap 138. As further described below, the end cap 138 can be configured to direct fluid across the lens 114 and / or the lighting system of the camera module 102, for example to clear an obstruction therefrom. The housing 104 can be rigid or flexible. The housing 104 can be made as short as possible to facilitate positioning the housing within the access device 110. The housing 104 can have a length of less than about 60 mm. For example, the housing 104 can have a length of about 45 mm or less.
[0128] 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 surface and the distal-facing surface. One or more channels or lumens may be formed on the body 136. The body 136 may be formed by extruding a multi-lumen shaft. The body 136 may be formed by welding or otherwise attaching multiple longitudinal components to each other.
[0129] 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 may otherwise include a metal tube that may provide electromagnetic shielding for components of the camera module 102.
[0130] The body 136 may include one or more fluid lumens 142. For example, in the illustrated embodiment, the body 136 includes a first fluid lumen 142A and a second fluid lumen 142B, the first fluid lumen being useful for conveying material from the proximal end of the housing 104 to the distal end of the housing, and the second fluid lumen being useful for conveying material from the distal end of the housing to the proximal end of the housing. Although the first fluid lumen and the second fluid lumen 142 are shown, the housing 104 may include any number of fluid lumens. The first lumen and the second lumen 142 may form part of a lens cleaning system in which a cleaning fluid or medium is delivered through one lumen to deliver the cleaning fluid to the distal end of the camera module 102, and suction or vacuum is applied to another lumen to draw the 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 to the lens under positive pressure. Positive pressure fluid may be conveyed through one or more of the lumens 142. Each lumen in lumen 142 may include a fluid connector or coupling 144 at its proximal end for establishing fluid communication between lumen and connector assembly 108. Fluid connector 144 may be a convex barb fitting extending proximally from the proximal-facing surface 136p of body 136 as shown, or may be any other type of fluid fitting or connection, such as a Luer connection, a concave fitting, etc. A variety of different types of cleaning media may be delivered by the same lumen or by a separate lumen. A variety of 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 to the lens by the lumen, and may be expelled by a burst of carbon dioxide or other gases through the same lumen. In another example, liquid and gas may be delivered by a separate lumen. In some embodiments, the housing may include only a single fluid lumen.
[0131] The lumens 140, 142 of the 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 fluid lumen and the second fluid lumen 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 inner cross-section that is oval, rectangular, circular, elliptical, square, rectangular, etc. The camera lumen 140 may have an inner shape that matches the outer shape of the camera module 102 or its lens barrel 124.
[0132] The distally facing surface 136d of the body 136 may be obliquely angled. For example, the distally 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 distally facing surface 136d of the body 136 may be angled in the same manner as the distally facing surface of the camera module 102 or the lens barrel 124. The distally facing surface of the camera module 102 may be flush with the distally facing surface 136d of the body 136, or may be recessed or protruding relative to the distally facing surface.
[0133] The sidewall 136s of the housing 136 may have any of a variety of shapes. The sidewall 136s may have an inner cross-section that is substantially triangular, crescent-shaped, circular, square, or rectangular. The sidewall 136s may be cylindrical. The sidewall 136s may be curved. The sidewall 136s may be shaped to facilitate integration of the housing 104 with the access device 110, for example to reduce or eliminate the extent to which the housing interferes with the working channel of the access device. The sidewall 136s may include an inner portion 136i that is concave. The inner portion 136i may be curved. The inner portion 136i may form a segment of the working channel of the access device 110, such as a cylindrical or elliptical working channel. The sidewall 136s may include an outer portion 136o that is convex. The outer portion 136o may be curved. For example Figure 3E As shown, the side wall 136s may 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 area may follow the outer periphery of the camera lumen 140. Also as shown, for example Figure 3E As shown, the sidewall 136s may include an inner portion 136i that is concavely curved and connected to the outer portion 136o by first and second transition regions that define segments of respective cylinders. The first and second transition regions may follow the outer perimeter of the fluid lumen 142.
[0134] The end cap 138 of the housing 104 may be coupled to the distal end of the body 136. The outer 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 end cap 138 may include a first cutout 146A aligned with the lens 114 of the camera module 102 to allow light to pass through the end cap and into the lens. The end cap 138 may include a second cutout 146B aligned with the lighting system of the camera module 102 to allow light to pass through the end cap and into the surgical site. The first cutout and the second cutout 146 may be separate cutouts or may be adjacent, as shown. The first cutout and the second cutout 146 may be circular, may have a shape that matches the shape of the lens 114 or the lighting system, or may be otherwise shaped to achieve 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 proximally facing surface of the end cap 138 may be a flat planar surface, and the recess, groove or channel 148 may be formed in the distally 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 body 136. The medial end portion of the recess 148 may be open to the cutout 146 and / or the distally facing surface leading to the lens 114 and the illumination system. In use, as shown in FIG. Figure 3H As shown, the fluid exiting the first lumen 142A of the body 136 can be directed by the end cap 138 across the lens 114 and the illumination system (e.g., the diffuser or optical element 118 of the illumination system) and toward the distal entrance of the second fluid lumen 142B, such as along the path of the arrow shown. It should be understood that the fluid can alternatively be directed in the opposite direction. The recess 148 may include a baffle, a nozzle, a diverter, or other structure 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, for example, without flushing the surgical site or the working channel of the access device in which the housing 104 is installed. Containing the fluid flow in this manner may be particularly suitable for "dry environment" surgery, such as lumbar TLIF surgery. Containing the fluid flow can help limit bleeding and possible tissue damage. In other embodiments, the fluid is not contained in the end cap and can be used to flush the surgical site and / or the working channel.
[0135] The housing 104 and / or the camera module 102 may be coupled to the controller 106 via a connector or connector assembly 108. Example Connector Assembly 108 Figures 4A to 4B106 and 108. The connector assembly 108 may include one or more conductors therein. The connector assembly 108 may include a fluid conductor for delivering fluid to or from the housing 104. The connector assembly 108 may include an optical conductor for delivering light to or from the camera module 102. The connector assembly 108 may include electrical conductors for transmitting 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 an outer sheath 150 of the connector assembly 108.
[0136] The connector assembly 108 may include a distal segment 108d and a proximal segment 108p. In the distal segment 108d, all conductors of the connector assembly 108 may be disposed within an outer sheath 150. In the proximal segment 108p, one or more of the conductors may leave the outer sheath 150 and may extend separately therefrom. For example, in the illustrated embodiment, the distal segment 108d of the connector assembly 108 includes an electrical conductor 152A, one or more optical fibers 152B, and a first fluid lumen and a second fluid lumen 152C that both extend through a common outer sheath 150. Also in the illustrated embodiment, the proximal segment 108p of the connector assembly 108 is configured such that the electrical conductor 152A and the one or more optical fibers 152B continue to pass through the common outer sheath 150, while the first fluid lumen and the second fluid lumen 152C leave the outer sheath as separate fluid tubes 154. The outer sheath 150 may include a mechanical connector 156 at its proximal end for optical and / or electrical connection with the controller 106. The fluid tube 154 may include corresponding fluid fittings or connectors for fluid connection with, for example, a fluid reservoir and / or a vacuum or positive pressure source of the controller 106 or separate from the controller.
[0137] The distal segment 108d of the connector assembly 108 may have an outer shape that matches the outer shape of the housing 104, for example, Figure 4B As shown. The distal segment 108d of the connector assembly 108 can cooperate with the housing 104 to define a seamless external transition. At least a portion of the connector assembly 108 can be flexible or bendable. As further described below, the distal segment 108d of the connector assembly 108 can be flexible to facilitate integration of the system 100 with the access device 110.
[0138] The exemplary controller 106 is Figures 5A to 5B. Although an exemplary controller 106 is depicted and described herein, it should be understood that this is for reasons of generality and convenience. In other embodiments, the architecture and operation of the controller 106 may be different from those shown and described herein. The controller 106 may be a tablet computer, a mobile device, a smart phone, a laptop computer, a desktop computer, a cloud-based computer, a server computer, etc. The controller 106 includes a processor 156 for controlling the operation of the controller 106, such as by executing embedded software, an operating system, a device driver, an application, etc. The processor 156 may be or may include one or more microprocessors, microcontrollers, ASICs, FPGAs, PICs, processors that read and interpret program instructions from internal or external memory or registers, etc. The control 106 may include a memory 158 that provides temporary or permanent storage for the code to be executed by the processor 156 or the data processed by the processor. The memory 158 may include a read-only memory (ROM), a 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.
[0139] 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 a remote device (e.g., other computer systems) via 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-transient manner. The storage device 162 may include one or more hard drives, flash drives, USB drives, optical drives, various media disks or cards, and / or any combination thereof. The controller 106 may include a display 164, and an image to be displayed thereon may be generated. 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 regulation circuits. Exemplary power sources include batteries, such as polymer lithium-ion batteries, or an adapter (eg, a USB adapter or a wall adapter) for coupling the controller 106 to a DC or AC power source.
[0140] Controller 106 may include a fluid source 168, and when the connector assembly is attached to controller 106, the fluid source may be in fluid communication with the fluid lumen 152C of the connector assembly 108. Fluid source 168 may include a reservoir of a cleaning medium. The cleaning medium may be a flowable gas or liquid. The cleaning medium may include one or more of carbon dioxide, saline, oxygen, air, water, etc. The fluid source may include a source of positive pressure air or other gases. Fluid source 168 may include a pump or other mechanisms for causing the cleaning medium to pass through the connector assembly 108 and housing 104. The pump may be controlled by processor 156 to perform a cleaning cycle. The cleaning cycle may be automatically executed, or executed in response to a user instruction. For example, processor 156 may detect a user actuation of a button, a foot pedal, or other interface element, and start a cleaning cycle in response thereto.
[0141] 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.
[0142] The controller 106 may include a vacuum or suction source 172, which 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 onboard vacuum pump for generating suction, or may be configured to be attached to a standard hospital or operating room vacuum source. The suction source 172 may include a valve, a regulator, or other components for adjusting the degree of suction applied to the housing 104 and / or for opening or closing suction. 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 a user instruction. For example, as described above, the processor 156 may detect a user actuation of a button, a foot pedal, or other interface element, and in response thereto, start a cleaning cycle.
[0143] 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 connection, an optical connection, and / or a fluid connection between the controller 106 and the connector assembly 108. It should be understood that any one or more of the above components may be disposed outside the housing of the controller 106 and / or may be completely separated 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 the controller 106 and / or separate from the controller.
[0144] 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 onboard display 164 of the controller, or on one or more external monitors or displays operably coupled to the controller. The image data may be displayed to a surgeon or other user to facilitate a 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.
[0145] The various functions performed by the controller 106 may be logically described as being performed by one or more modules. It will be appreciated that such modules may be implemented in hardware, software, or a combination thereof. It will be further appreciated that when implemented in software, a module 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 a combination thereof). In addition, the software embodying one or more modules may be stored as an executable program on one or more non-transitory computer-readable storage media.
[0146] The system 100 can be configured to be integrated with or used with an access device. Exemplary access devices may 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., a spinal region proximal to a disc space or the like) to a location outside the patient's body. The access device may include a visualization channel for receiving a housing 104 and a camera module 102 of the visualization system 100. The visualization channel may also receive at least a portion of a 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 with the working channel. At least a portion of the sidewall 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.
[0147] 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 the 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 the image sensor 112 closer to the surgical site. In another example, the housing 104 may be retracted proximally relative to the access device to move the lens 114 and the image sensor 112 away from the surgical site. The ability to reposition the camera module 102 within the access device may be beneficial to various surgical procedures. For example, in an exemplary TLIF procedure, the camera module 102 may be positioned relatively shallowly 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 the patient. For example, the camera module 102 can be advanced so that the lens 114 and / or the image sensor 112 are disposed externally and distally of the distal end of the access device. The camera module 102 can be advanced or retracted to any of an infinite number of relative longitudinal positions relative to the access device. The ability to reposition the camera module 102 can also allow the camera module to be a modular component that can be used interchangeably with many different types or sizes of access devices or with adjustable length access devices.
[0148] Exemplary Entry Device 110 Figures 6A to 6H The access device 110 may include an elongated body having a proximal end and a distal end.
[0149] The access device 110 may define a working channel 174 extending between the proximal end and the distal end and having a central longitudinal axis A4. The working channel 174 may be cylindrical. The working channel 174 may have a dovetail cross section. The working channel 174 may have a diameter in the range of about 3 mm to about 30 mm, in the range of about 10 mm to about 20 mm, and / or in the range of about 12 mm 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, through, and / or inserted into the working channel 174 to perform a surgical procedure. In some embodiments, the access device 110 may be used to enter the intervertebral disc space. A cutting instrument may be inserted through the working channel 174 to cut tissue, such as bone or intervertebral disc tissue. A suction instrument may be inserted through the working channel 174 to aspirate material from the intervertebral space, including excised bone or intervertebral disc tissue. The cutting instrument and the suction instrument may be a single tool. Implants such as fusion cages, fusion cages with expandable height and / or width, intervertebral disc prostheses, etc. may be inserted into the intervertebral space through the working channel 174 .
[0150] The access device 110 can define a visualization channel 176. The visualization channel 176 can extend between the proximal end and the distal end of the access device 110, or can extend along less than the entire length of the access device. The visualization channel 176 can include a central longitudinal axis A5. The central axis A5 of the visualization channel 176 can be disposed radially outward from the central axis A4 of the working channel 174. The working channel 174 can have a larger cross-sectional area than the visualization channel 176. The visualization channel 176 can be open to the working channel 174 along its length or can intersect with the working channel. The visualization channel 176 can be isolated or separated from the working channel 174.
[0151] The visualization channel 176 may have an internal cross-section that matches or substantially matches the external cross-section of the housing 104. When disposed within the visualization channel 176, the outer surface of the housing 104 may define at least a portion of the inner sidewall of the working channel 174. The working channel 174 may be cylindrical about the central axis A4, and the surface of the housing 104 facing the working channel may form a segment of a cylinder centered about the axis A4. The inner sidewall of the working channel 174 and the outer surface of the housing 104 may define a substantially smooth and continuous surface.
[0152] Access device 110 can include, for example, attachment features 180 for attaching the access device to a support or other object. Attachment features 180 can be formed at a proximal end of access device 110. For example, access device 110 can include an annular circumferential groove 180 formed in an outer surface thereof.
[0153] The access device 110 may include a mating feature 178 for stabilizing, maintaining 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 feature 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 so that the connector assembly 108 may be loaded laterally into the track, for example, by moving the connector assembly away from the central axis A5 of the visualization channel 176. Alternatively or in addition, 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.
[0154] One or more of the tracks 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 internal cross-section that matches or substantially matches the external 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 lateral loading of the connector assembly into the track. Therefore, slight deformation or deflection of the connector assembly 108 and / or the mating feature structure 178 may be required to load the connector assembly into the track 182. This allows the connector assembly 108 to be securely held by the mating feature structure 178, such as by "snapping" the connector assembly into the track 182.
[0155] The mating feature 178 may include an inner track 182A and an outer track 182B, for example, Figure 6C , Fig.6D and Figure 6G 176 . The track 182 may include interference edges of the type described above to limit movement of the connector assembly 108 into and out of the track, but permit such movement when sufficient force is applied, such as when a user specifically desires to perform such movement. The inner track 182A may be axially aligned with the visualization channel 176, or aligned therewith to a greater degree than the outer track 182B. The outer track 182B may be curved, obliquely angled, or otherwise axially offset from the visualization channel 176. When disposed within the inner track 182A, as Fig.6D As shown, the connector assembly 108 can 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. Figure 6CAs shown, proximal-distal translation of the connector assembly 108 relative to the access device 110 can be limited or prevented, for example, due to flexure 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.
[0156] The connector assembly 108 can be secured to the mating feature 178 at any point along its length (e.g., at any point along the distal section 108d of the connector assembly). Thus, the visualization system 100 can be locked to the access device 110 at any insertion depth of the camera module 102. Furthermore, the visualization system 100 can 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 feature 178 along the access device, etc. This can allow the visualization system 100 to be used interchangeably with any of a variety of different types or sizes of access devices 110.
[0157] The ability to lock the system 100 to the mating feature 178 can 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 feature 178 can provide for easy, quick, and / or one-handed depth adjustment of the camera module 102, resulting in minimal delay and disruption to the procedure.
[0158] The access device 110 may have a circular outer cross-section, for example, Figure 6G The access device 110 may have an elliptical or egg-shaped outer cross-section, for example, Figure 6H As shown. Access device 110 may include any of a variety of other external cross-sectional shapes. Access device 110 may have an outer diameter or size in the range of about 5 mm to about 30 mm, in the range of about 10 mm to about 25 mm, and / or in the range of about 15 mm to about 22 mm. Access device 110 may have an outer diameter or size of about 17 mm. The outer surface of access device 110 may be rough, ribbed, ground, or coated with or formed of a material having a high coefficient of friction, which may advantageously improve grip and stability with surrounding tissue when the access device is inserted into a patient's body.
[0159] As mentioned above and as Fig. 6FAs shown, when disposed in the access device 110, the lens 114 of the camera module 102 can be aimed at the central axis A4 of the working channel 174. Similarly, when so positioned, the illumination system (e.g., the optical fiber 116 and / or the optical element 118) of the camera module 102 can be aimed at the central axis A4 of the working channel 174. The illumination system can be disposed radially outward from the central axis A4 of the working channel 174, and the lens 114 can be disposed radially outward from the illumination system.
[0160] Figure 7 An exemplary surgical system 10 is shown 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 a variety of other applications. Figure 7 Further details of the system can be found in U.S. Application 15 / 437,792 filed on February 21, 2017, which is hereby incorporated by reference herein. The system 10 can be used in various surgical procedures, including spinal surgery, such as microsurgical bone resection, spinal decompression, spinal fusion, etc. In general, the system 10 can 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 can be any of the access devices described herein. The visualization system 100 can be any of the visualization systems described herein.
[0161] use Figure 7 An exemplary method of system 10 may include any one or more of the following steps performed in any of a variety of orders: a) forming an incision in the patient's skin; b) percutaneously inserting an access device 110 having a substantially tubular shape (such as a tube or a multi-groove retractor) through the incision, the access device having a length suitable for extending from the incision to a boundary between sensitive tissue and insensitive tissue in the patient's spine (e.g., a superior articular process (SAP) or a lamina); c) stabilizing the access device to an anchor 14 (e.g., a pedicle anchor) using a connector 16; d) inserting an optical visualization system integrated with the access device 100, such as a visualization system of the type described herein; e) resecting a portion of the superior articular process and / or performing a microsurgical decompression procedure; f) inserting a tissue retractor 12 through the access device or deploying a tissue retractor from the access device so that a distal end portion of the tissue retractor extends into the intervertebral disc, the retractor having an outer surface; g) contacting the outer surface of the retractor with a nerve root to shield the nerve root; h) microsurgically decompressing any tissue believed to be causing nerve entrapment; i) removing intervertebral disc material, including removing cartilage material from the vertebral endplates; j) inserting an intervertebral body device; and k) deploying a stabilization mechanism to stabilize the intervertebral segment.
[0162] Exemplary characteristics of the camera module 102 and its lens 114 are shown in Figure 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 may be in the range of about 7 mm to about 40 mm degrees.
[0163] The system 100 may include active cleaning features. The active cleaning features may include applying an active force to the lens 114, lighting system, or other components of the camera module 102. The active force may be or may include a fluid jet, fluid suction, mechanical or acoustic vibration, a mechanical wiper, etc. The active force may be or may include positive pressure air or other gas directed toward, onto, and / or across the lens or other components of the camera module.
[0164] 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 an 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 anti-fouling coating. The coating may be a gradient coating, such as one 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 image sensor 112 from the center of the lens toward the outer periphery of the lens.
[0165] like Fig. 9 As shown, the fluid lumens 142 of the housing 104 can each include a corresponding nozzle 184 disposed at its distal end. In such an arrangement, the end cap 138 of the housing 104 can be omitted. The nozzle 184 can be configured to aim or direct the fluid flow and / or suction force toward the lens 114 or the lighting system of the camera module 102.
[0166] Fig. 10A Another exemplary cross section of the housing 104 is shown. As shown, the fluid lumen 142 can be enlarged and can be non-circular. The fluid lumen 142 can be ear-shaped. The fluid lumen 142 can be asymmetric.
[0167] Fig. 10B Another exemplary cross section of the housing 104 is shown. As shown, the fluid lumen 142 can be crescent-shaped or banana-shaped. The fluid lumen 142 can have a convex inner sidewall that follows the outer perimeter of the camera lumen 140.
[0168] Figures 11A to 11DThe distal end of an alternative housing 104 is shown having a crescent-shaped fluid lumen 142 , an oval or rectangular exterior cross-section, and an end cap 138 having an oval or rectangular central opening 146 .
[0169] 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. Fig. 12A As shown, the inner circular tube 136A can be inserted into the outer oval tube 136B to define a body 136 having a central camera lumen 140 and a first lateral fluid lumen and a second lateral fluid lumen 142. The inner tube 136A can be welded, adhered or otherwise attached and / or sealed to the outer tube 136B. In another example, as Fig. 12B As shown, an opposing outer shell 136C may be welded or otherwise attached to the inner tube 136A to define a body 136 having a central camera lumen 140 and first and second lateral fluid lumens 142. The outer shell 136C may include a corresponding proximal fluid coupling 144 and an internal passageway that connects the fluid coupling to the void space 142 formed between the outer shell and the inner tube 136A when the components are mated to one another. Fig. 12B The arrangement shown may advantageously allow complex shell cross-sections to be formed within one or more simple welds between the two outer shells 136C to the inner tube 136A and / or to each other.
[0170] Fig.13 An exemplary mating feature 178A for attaching the visualization system 100 to the access device 110 is shown. The mating feature 178A may include a proximal extension of the access device 110 having a track 182 for guiding or holding the connector assembly 108 of the visualization system 100. An actuating wheel or gear 186 may be rotatably mounted on the track 182. The wheel 186 may engage with the connector assembly 108 such that rotation of the wheel advances or retracts the connector assembly relative to the access device 110. The wheel 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 teeth of the wheel 186. The wheel 186 may be spring biased into engagement with the connector assembly 108. The gap between the wheel 186 and the track 182 can be open to one side, for example to allow the connector assembly 108 to be loaded sideways into the gap. The user can thus perform a rough 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.
[0171] Fig.14An exemplary mating feature 178B for attaching the visualization system 100 to the access device 110 is shown. The mating feature 178B 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 178B may include a clamp 188 that can be actuated by a user to selectively grasp or selectively release the connector assembly 108. Any of a variety of types of clamps may be used, but in the illustrated embodiment, the mating feature 178B includes a coil spring 188 that defines a central passage through which the connector assembly 108 can be inserted. The spring 188 may include a handle rod that, when squeezed together, relaxes the tension of the spring and expands the diameter of the central passage to allow the connector assembly 108 to move relative to the access device 110. When the rod is released, the tension in the spring 188 may increase to shrink the diameter of the central passage and clamp on the connector assembly 108, thereby holding it in a fixed position relative to the access device 110.
[0172] FIG. 15A to FIG. 15B An exemplary mating feature structure 178C is shown for attaching the visualization system 100 to the access device 110. The mating feature structure 178C may include a proximal extension of the access device 110, the proximal extension having a track 182 for guiding or retaining the connector assembly 108 of the visualization system 100. The mating feature structure 178C may include an O-ring 190 defining a central passage through which the connector assembly 108 can be inserted. The O-ring 190 can be maintained in a fixed position relative to the extension 178C, so that when the O-ring is clamped down on the connector assembly 108 inserted therethrough, the connector assembly can be maintained in a fixed position relative to the extension. The extension 178C may include a movable button 192 having a tapered or inclined bearing surface. As shown in FIG. Fig. 15B As shown, pressing the button 192 into the extension 178C (to the left in the figure) can effectively wedge 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. Fig.15A As shown, when button 192 is released, spring 194 can push the button outward (to the right in the figure), withdrawing the cone from O-ring 190 to allow the O-ring to shrink in diameter and clamp onto connector assembly 108, thereby holding the connector group in a fixed position relative to access device 110.
[0173] FIG. 16A to FIG. 16CAn exemplary mating feature 178D for attaching the visualization system 100 to the access device 110 is shown. The mating feature 178D may include a proximal extension of the access device 110 having a track 182 of the connector assembly 108 for guiding or retaining the visualization system 100. The mating feature 178D may be an angled snap-on 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 oblique or laterally oriented locking track 182B.
[0174] Fig.17 An exemplary mating feature 178E for attaching the visualization system 100 to the access device 110 is shown. The mating feature 178E 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 178E may be an angled snap-on fastening system of the type described above. The mating feature 178E may include a longitudinally oriented adjustment track 182A and an oblique or laterally oriented locking track 182B. The locking track 182B may be spaced a distance from the body of the access device 110 and radially outward by a strut 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 a gradual bend radius of the connector assembly 108.
[0175] Fig.18 An exemplary mating feature 178F for attaching the visualization system 100 to the access device 110 is shown. The mating feature 178F may include a cutout 198 formed on the proximal edge of the access device 110. The mating feature 178F may be a snap-on 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 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 feature 178F may allow the routing of the connector assembly 108 away from the access device 110 at a greater angle and closer to the patient's skin surface, thereby reducing the overall profile of the system 100 and keeping the connector assembly out of the way of the surgeon or other user.
[0176] Fig.19An exemplary mating feature 178G for attaching the visualization system 100 to the access device 110 is shown. 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 cover or closure cap 101 pivotally coupled thereto, for example, via a living hinge or flexible material property of the extension. 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 cover 101 may be retained in a closed state, for example, via a snap lock, a bayonet lock, or other locking structure. The closure 101 may include a lever 103 to facilitate release of the closure from a closed state.
[0177] like Fig. 20 As shown, the visualization system 100 also includes a user control 105. The user control 105 can be set at any position in a plurality of positions along the visualization system 100, such as along the distal portion of the connector assembly 108, as shown. In use, the user control 105 can be positioned in the sterile field. This can allow a surgeon or other user to directly actuate the control 105 without having to leave the sterile field or rely on an assistant outside the sterile field. The control 105 can be operably connected 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 can effectively start a cleaning operation, stop a cleaning operation, capture an image, rotate the display of the image captured by the camera module 102, adjust the white balance of the displayed image, adjust the brightness of the displayed image, play or stop the recorded video, zoom in or out (optically and / or digitally) the displayed image, etc. The control 105 may include one or more push buttons. The control 105 may include one or more foot switches. Controls 105 may include a manual pump or syringe for directing cleaning media toward camera module 102. Controller 105 may include a remote control integrated into connector assembly 108. Controller 105 may include a remote control coupled to controller 106 via a wired or wireless connection.
[0178] Various expansion techniques can be used to insert the access device disclosed herein into the patient's body. In an exemplary method, a guide wire or needle can be inserted through a percutaneous incision in the patient. The guide wire can be placed using fluoroscopic guidance, a surgical navigation system, hands-free or other means. The incision can be expanded sequentially or continuously, for example, by inserting one or more dilators over the guide wire, each dilator having a gradually increasing outer diameter. Once fully expanded, 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's body. One or more dilators can then be removed from the patient's body, leaving an open working channel through the access device, through which a surgical procedure can be performed.
[0179] There may be situations where it may be necessary or desirable to enhance the standard cylindrical expansion technique. Fig.21A As shown, the access device 110 may include a cylindrical working channel 174 and an offset visualization channel 176. The access device 110 may have a non-cylindrical outer dimension. The visualization channel 176 may terminate at a distance from the distal end of the access device 110, thereby leaving a 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, at the distal end of the access device 110, there is a sharp transition or step 111 between the outer surface of the dilator and the outer surface of the adjacent visualization channel 176 of the access device. In this example and / or other examples, an expansion system can be used to facilitate the insertion of the access device 110 and the expansion of tissue disposed in the path of the visualization channel 176.
[0180] FIG. 21B to FIG. 21D An exemplary dilation system is shown. As shown, the system may include a cannula 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-shaped portion 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 adjacent visualization channel 176 of the access device. Thus, the bulb-shaped portion 115 may minimize or eliminate the above-described step 111.
[0181] The sleeve 113 may be substantially cylindrical. The sleeve 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-shaped portion 115 may be movable relative to the sleeve 113 between a first position in which the bulb-shaped portion is completely disposed within the outer diameter D of the sleeve and a second position in which at least a portion of the bulb-shaped portion 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 the sleeve 113 or formed integrally with the sleeve. The bulb-shaped portion 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. Bulb 115 may include a distally facing surface 115d that is beveled, curved, tapered, or otherwise configured to provide a smooth introduction end between the outer diameter of dilator 109 disposed in cannula 113 and the outer diameter of access device 110. Bulb 115 may include a proximally facing surface 115p that is beveled, curved, tapered, or otherwise configured to urge the bulb radially inward toward the first position as cannula 113 is proximally withdrawn from access device 110.
[0182] In use, the incision can be sequentially expanded using standard cylindrical dilators (including the outermost dilator 109). The sleeve 113 can be loaded into the access device 110, wherein the bulb-shaped portion 115 is disposed in a first radially inward position. The sleeve 113 can be advanced distally relative to the access device 110 until the bulb-shaped portion 115 is at the depth of the void space 107, at which point the bulb-shaped portion can be moved radially outward to a second position under the bias of the spring 121. The bulb-shaped portion 115 can also be pushed radially outward and held in this position by inserting the dilator 109 through the sleeve 113. The access device 110 with the inserted sleeve 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-shaped portion 115 can gently push the tissue out of the path of the access device. Once the access device 110 is positioned as desired, the dilator 109 can be removed from the sleeve by withdrawing the dilator proximally from the sleeve 113. The cannula can also be removed from the access device by withdrawing the cannula 113 proximally from the access device 110. As the cannula 113 is withdrawn proximally relative to the access device 110, the bulb 115 can be urged radially inward, such as by abutting a proximally facing surface 115p of the bulb 115 at the distal end of the visualization channel 176, thereby moving the bulb to a first radially inward position to allow the cannula to be removed from the access device. The cannula 113 can form a dilator having a profile at its distal end that is different from a profile at its proximal end.
[0183] FIG. 22A to FIG. 22B Another exemplary dilation system is shown in which a sleeve 113A is configured to rotate relative to the access device 110 about the central longitudinal axis A4 of the working channel 174. The sleeve 113A may have a longitudinal slit or other feature structure that allows the sleeve to radially expand and contract. The sleeve 113A may radially contract when inserted into the access device 110 to bias the bulb-shaped portion 115A radially outward. The sleeve 113A may be rotated about the axis A4. Fig.22A The first position shown is Fig. 22B 107 and 110. The bulb-shaped portion 115A can be rotated between the first position, in which the bulb-shaped portion 115 is rotationally offset from the void space 107 and is thus deflected radially inward by the inner sidewall of the working channel 174, and the second position, in which the bulb-shaped portion is rotationally aligned with the void space so that the bulb-shaped portion springs radially outward to fill the void space. In the first position, the bulb-shaped portion 115A can be positioned so that it does not interfere with the insertion or removal of the sleeve 113A from the access device 110. In the second position, the bulb-shaped portion 115A can fill the void space 107 to provide a smooth transition between the dilator and the access device 110, for example, as described above. The sleeve 113A can form a dilator having a profile at its distal end that is different from the profile at its proximal end.
[0184] FIG. 23A to FIG. 23GAnother exemplary expansion system is shown. As shown, the distal end of the access device 110A may include an inclined, 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 adjacent visualization channel 176 of the access device. The transition portion 123 may be flexible or bendable. The transition portion 123 may be capable of moving between a first position and a second position, in which the transition portion extends radially inward to provide a smooth distally facing expansion surface 123d, and in which the transition portion moves radially outward from the first position so as not to block the field of view of a camera module installed 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 elastic material properties such that they are biased inwardly toward the first position.
[0185] Transition portion 123 can be moved between a first position and a second position by an expansion shaft 127 that can be inserted through access device 110A. Expansion shaft 127 can include a distal shroud 129 that is configured to contact and abut transition portion 123 as expansion shaft 129 is advanced distally within access device 110A to push transition portion radially outward. Shroud 129 can form a segment of a cylinder as shown. At least a portion of visualization channel 176 can be formed in expansion shaft 127. Expansion shaft 127 can remain in place within access device 110 when camera module 102 is disposed within the access device and as a surgical procedure is performed.
[0186] FIG. 24A to FIG. 24C An auxiliary visualization system 100A is shown. The system 100A can be used independently or can be used with the visualization system 100 described above. The system 100A can include a camera module 102A, a housing 104A, and a connector assembly 108A, each of which can include any of the feature structures of the corresponding components of the system 100. The system 100A can be used as a hands-free stylus or rod camera. The system 100A can be inserted through the working channel of the access device, and the system 100 is inserted through the visualization channel of the access device. Both cameras 100, 100A can be connected to the same controller or display, or each can be connected to a separate controller or display. Multiple auxiliary cameras 100A can be used simultaneously. In the case of spinal surgery, the auxiliary camera 100A can extend into the intervertebral space, and the main camera 100 can be maintained in the access device. The auxiliary camera 100A can be attached to the access device using a mating feature structure 131. The mating feature structure 131 can be configured to hold or support the auxiliary camera 100A relative to the access device. The mating feature 131 may allow for hands-free operation of the auxiliary camera 100A. Fig.24CAs shown, the mating feature 131 may include a C-shaped clamp or other mechanism 133 for attaching to the housing or connector assembly of the auxiliary camera 100A. The mating feature 131 may include any of the features described above with respect to the mating features for attaching the visualization system 100 to the access device. The mating feature 131 may include a distal clamp or elastic strip 135 for attaching the mating feature to the proximal edge of the access device.
[0187] FIG. 25A to FIG. 25B An exemplary housing 104B that can be used with the camera module and / or access device described herein is shown. The housing 104B may include any of the feature structures of 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 its distal end. The nozzle 184B may be configured to aim or direct a 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 cutout 137 formed on the sidewall of a length of tubing that protrudes 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 area of the distal end of the adjacent visualization channel or the lens 114 or other components of the camera module 102 disposed therein. The slot 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 the visualization channel of the access device. In some embodiments, the slot 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 be in the range of about 5 degrees to about 85 degrees. Angle B may be in the range of about 10 degrees to about 60 degrees. Angle B may be in the range of about 15 degrees to about 30 degrees. Angle B may be about 22.5 degrees. The angle of the slot 137 may be equal to or substantially equal to the corresponding angle of the inclined distal end of the housing 104B and / or the inclined distal end of the lens 114. The slot 137 may be non-obliquely angled. 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 the 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 also 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 the visualization channel of the access device. The slot 137 can have an angle that matches the angle of the lens surface.
[0188] The housing may include a wiper, brush, fin, or other feature for clearing debris from the lens. The wiper may be disposed within, inserted through, and / or deployable from a lumen of the housing. For example, the wiper may be selectively deployable through a nozzle opening of a fluid lumen of the housing. The wiper may be deployed from the opening to wipe debris from the lens before, during, or after fluid is directed through the lumen and toward the lens. Fig.25C An exemplary housing 104H that can be used with the camera module and / or access device described herein is shown. The housing 104H may include any of the features of other housings described herein (e.g., housing 104). As shown, the housing 104H may include one or more fluid lumens 142H. The fluid lumen 142H may include a nozzle 184H disposed at its distal end. The nozzle 184H may be configured to aim or direct a fluid flow 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 on the sidewall of a length of tubing that protrudes 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 area adjacent to the distal end of the visualization channel or the lens 114 or other components of the camera module 102 disposed therein. A wiper, brush, wing, 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. The wiper tip 181 may be selectively deployed through the nozzle slot 137H to wipe debris from the lens 114. For example, the shaft 179 may be advanced distally within the lumen 142H to push the wiper tip 181 out of the slot 137H and toward the lens 114. The wiper tip 181 may be formed of an elastic material, a shape memory material, or may be otherwise biased toward the 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 may be axially rotated relative to the housing 104H to drag the wiper tip 181 across the lens surface, thereby removing debris from it. The shaft 179 may be withdrawn proximally relative to the housing 104H to retract the wiper tip 181 into the lumen 142H.
[0189] The housing may include various features for retracting, shielding, or manipulating tissue adjacent to the camera lens. For example, FIG. 26A to FIG. 26BAn exemplary housing 104C is shown that can be used with the camera modules and / or access devices described herein. The housing 104C may include any of the features of other housings described herein (e.g., housing 104). The housing 104C may include a shield 139 extending or protruding distally from the distal end face of the housing. The shield 139 may include an outer surface 139o and an inner surface 139i. When the housing 104C is inserted into the patient, the outer surface 139o of the shield 139 may abut against 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 may gently push the tissue away, or may serve as a standoff to prevent accidental contact between the lens 114 and the tissue, which may cause undesirable fouling of the lens. The shield 139 may also facilitate the flow of the cleaning fluid or reagent as it is sprayed across the lens surface, for example 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 profile that matches the profile of the outer surface 136o of the housing 104C, so that the housing and the 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 an inner fillet or chamfer 141 at its lateral edges to provide a smooth transition to the distally 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 may protrude distally from the distal end surface of the housing 104C by a distance D. The distance D may be in the range of about 2 mm to about 30 mm. The distance D may be in the range of about 4 mm to about 12 mm. The distance D may be about 8 mm.
[0190] The shield may be capable of moving relative to the housing. For example, the shield may be retracted relative to the housing, such as longitudinally. In some embodiments, the shield may be slidably disposed within a lumen formed in the housing. The shield may be configured to translate longitudinally 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 of protrusion of the shield to be adjusted during a surgical procedure. Movement of the shield relative to the housing may be controlled in a variety of ways, such as by the user manually grasping the proximal end of the shield and sliding it relative to the housing. Fig.26CAn exemplary housing 104D that can be used with the camera modules and / or access devices described herein is shown. The housing 104D can include any of the features of other housings described herein, such as housing 104. As shown, the housing 104D can include a lumen 143 in which the shield 139 can be slidably mounted, thereby facilitating longitudinal adjustment of the shield relative to the housing 104D.
[0191] The shield may include wipers, brushes, wings, fluid jets, vacuum ports, or other features for clearing debris from the lens, for example, as the shield moves relative to the housing. Fig.26D An exemplary housing 104E that can be used with the camera module and / or access device described herein is shown. The housing 104E may include any of the features of other housings described herein (e.g., housing 104). 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 fin 145 mounted to the inner surface 139i of the shield. As the shield 139 is withdrawn proximally relative to the housing 104E, the fin 145 may contact the distal end of the housing, causing the fin to splay outward and wipe the face of the lens 114. Continued proximal movement of the shield 139 may cause the fin 145 to fold over itself and slide upward into the lumen 143. When the shield 139 is advanced distally relative to the housing 104E, the tabs 145 can lie flat against the inner sidewalls 139i of the shield so as not to obstruct the field of view of the camera lens 114. The tabs 145 can be formed of a flexible and / or resilient material such as an elastomer, silicone, or the like.
[0192] 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 may be slidably disposed within the lumen of the housing, the lumen of the access device, and / or the lumen of the camera module. As another example, the tissue shield may slide along an outer surface of the housing, the access device, and / or the camera module.
[0193] The system may include active mechanical and / or acoustic systems for maintaining clear visualization of the camera. For example, the system may include an ultrasonic agitator that can be actuated to clear debris from the lens or prevent debris from clogging the lens in the first place. Fig.27AAn exemplary camera module 102B that can be used with the housing and / or access device described herein is shown. The camera module 102B can include any of the features of other camera modules described herein (e.g., camera module 102). As shown, the camera module 102B can include an ultrasonic transducer 147. The transducer 147 can 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, etc. Although the transducer 147 is shown as being mounted to the camera module 102B, it should be understood that the transducer can be mounted to any component of the visualization system, including the housing or the access device. The transducer can also be disposed in or on a separate component, such as an outer sheath or collar disposed around the camera module or the access port. The transducer can be operably connected to the controller 106 via a wire disposed in the connector 108. In use, an electrical potential can be applied to the transducer to generate mechanical vibrations that can shake debris away from or away from the lens.
[0194] The transducer may be a piezoelectric transducer. The transducer may emit ultrasonic waves, for example, having a frequency in the range of about 20 kHz to about 40 kHz. The transducer may be a ring transducer, a plate transducer, or any other suitable transducer type.
[0195] Fig.27B An exemplary camera module 102C that can be used with the housing and / or access device described herein is shown. The camera module 102C may include any of the feature structures of other camera modules described herein (e.g., camera module 102). As shown, the camera module 102C may include an ultrasonic transducer 147. The transducer 147 may be in the form of an annular or ring-shaped element axially disposed between the distal end of the lens barrel 124 and a transparent top cover 149. The cover 149 may form the outermost distal range of the camera module 102C, and thus may limit the surface exposed to the 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 electric potential is applied to the transducer. This can effectively vibrate the top cover 149 and cause droplets or debris 151 to leave the top cover surface. The annular shape of the transducer 147 may advantageously provide a clear line of sight through the transducer to the lens 114 or image sensor 112 while applying substantially uniform vibrations around the entire circumference of the top cover 149 .
[0196] Although an ultrasonic agitator is described above, it should be understood that any device for applying vibration or agitation to the system may be used alternatively or in addition thereto. In some embodiments, an electric motor with an eccentrically mounted mass may be used to apply vibration to the system. The motor may be mounted in a camera module, a housing, or an access device. In some embodiments, the system may include an actuator, such as a solenoid or a linear actuator, configured to strike the camera module when an electric potential is applied to the camera module. In use, an electric current may be selectively applied to the actuator so that the actuator strikes the camera module, thereby removing or clearing debris from the lens. The actuator may be mounted in a camera module, a housing, or an access device. In some embodiments, a generator operating below the ultrasonic frequency range (e.g., in the infrasound or acoustic range) may be used to clear debris from the lens.
[0197] The system may include a film that can be moved over the lens to maintain visibility through the lens. The film may be transparent. The film may be pulled over the lens to change the portion of the film that is aligned with the lens, such as moving a dirty segment of the film away from the lens and replacing the dirty segment with a clean segment of the film. The film may be a continuous loop of material that is pulled over the lens and moved through a wiper, brush, wing, fluid jet, vacuum port, or other cleaning element that removes debris from the film. Thus, the dirty segment of the film may be moved away from the lens and replaced by a clean segment of the film, which eventually moves across a brush or wiper to clean the segment before it is aligned with the lens again. The film may be wound on one or more reels, such as where a dirty segment of the film is wound on one reel after use because a clean segment is unwound from another reel to align with the lens. The movement of the film may be continuous or intermittent. The movement of the film may be controlled by an electric motor, a manual crank or handle, or various other mechanisms. Movement of the membrane may occur automatically, such as in response to a controller detecting debris or blur in an image captured by a camera, or manually, such as in response to a user actuating a button, wheel, or other input mechanism.
[0198] Fig.28AAn exemplary housing 104F that can be used with the camera module and / or access device described herein is shown. The housing 104F may include any of the features of other housings described herein (e.g., housing 104). 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" reel 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 return through a second longitudinal lumen 157B of the housing. The second end of the membrane 153 may be wound around a second "dirty" reel 155B disposed at or near the proximal end of the housing 104F. In use, one or both reels 155 may be rotated to move the membrane 153 in the direction of the arrow shown, thereby moving the dirty segment of the membrane away from the lens 114, and in turn aligning the clean segment of the membrane with the lens. One or both of the reels 155 may be driven by a motor or manual input device.
[0199] Fig.28B An exemplary housing 104G that can be used with the camera module and / or access device described herein is shown. Housing 104G may include any of the feature structures of other housings (e.g., housing 104) described herein. As shown, housing 104G may include a movable membrane 153. Membrane 153 may be a continuous ring of material that follows a path through housing 104G that allows the membrane to cross the exposed surface of lens 114 and across a wiper, brush, wing, fluid jet, vacuum port or other cleaning element 159. Membrane 153 may be wrapped around a series of rollers 161, one or more of which may be coupled to a motor or manual input device to enable movement of the membrane. In use, one or more of rollers 161 may be rotated to move membrane 153 in the direction of the arrow shown, thereby moving a dirty segment of the membrane away from lens 114, and in turn aligning a clean segment of the membrane with the lens. As the membrane 153 moves, a dirty segment of the membrane may be carried on the cleaning element 159 to clean the segment of the membrane before it is realigned with the lens 114 .
[0200] The system may include a mechanical wipe that can be moved across the lens to clear debris from the lens. FIG. 29A to FIG. 29DAn exemplary wiper 163 is shown. The wiper 163 may be inserted through or disposed within the 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, for example by applying a manual input force to the 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 may 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 convex-concave portion 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 Fig.29A and Fig.29C As shown, when the wiper shaft 165 moves proximally within the working channel, the protrusion 171 contacts the offset 169 in the wiper shaft to push the wiper tip 167 laterally (to the right in the illustrated example). The protrusion 171 and / or the offset 169 may define an inclined or tapered surface to facilitate such lateral movement. The lateral movement of the wiper tip 167 across the lens 114 can effectively remove debris from the lens surface. Fig.29B and Fig.29D As shown, when the wiper shaft 165 is subsequently moved distally, the offset 169 on the wiper shaft can move longitudinally past the protrusion 171, so that the wiper shaft is allowed to move in the opposite lateral direction, thereby bringing the wiper tip 167 back to the lens 114 in the opposite direction (leftward in the illustrated example). The wiper shaft 165 can be biased toward the side wall of the working channel (leftward in the illustrated example) to promote such lateral movement. The return lateral movement of the wiper tip 167 across the lens 114 can effectively further clear debris from the lens.
[0201] FIG. 30A to FIG. 30B Another exemplary wiper 173 is shown. The wiper 173 may be inserted through or disposed within a working channel of any of the access devices described herein. The wiper 173 may include a flexible and / or resilient material flap 175 biased toward a visualization lumen 176 of the access device 110. As the camera module 102 and / or housing 104 moves longitudinally past the flap 175, the flap may wipe across the exposed surface of the lens 114 to clear debris therefrom. Specifically, as shown in FIG. Fig. 30A As shown, when the housing 104 and camera module 102 are withdrawn proximally, the bias of the wiper 173 can cause the flap 175 to move into the visualization channel 176 of the access device 110. Fig. 30BAs shown, as the housing 104 and camera module 102 are subsequently advanced distally, the fin 175 can wipe across the exposed surface of the lens 114 as the housing and camera module push the wiper 173 out of the way. Each time the camera module 102 moves past the wiper fin 175, the wiper 173 can achieve automatic cleaning of the lens 114. The camera module 102 can be repeatedly moved up and down within the access device 110 as many times as needed or desired to clean the lens 114. The wiper fin 175 can be formed of a relatively soft material such as silicone, rubber, elastomer, etc.
[0202] The various lens cleaning mechanisms described herein may be used alone or in combination. For example, a visualization system may include a mechanical wiper, an ultrasonic agitator, a removable membrane, and a fluid cleaning system. For another example, a visualization system may include an ultrasonic agitator and a fluid cleaning system. For another example, a visualization system may include a removable membrane and a fluid cleaning system. Any other combination or sub-combination may also be used.
[0203] The visualization systems and / or access devices disclosed herein can be used for any of a variety of surgical procedures. For example, such systems and devices can be used for ear, nose and throat (ENT) surgery, sinus surgery, gastrointestinal (GI) surgery, abdominal surgery, endovascular surgery, cardiothoracic surgery, joint surgery, etc. In some embodiments, the visualization system can be used as a self-cleaning endoscope for sinus surgery with or without an access device. The active and / or passive cleaning features of the system can reduce or eliminate the need to repeatedly withdraw the scope from the patient to clean the lens. In some embodiments, the visualization system can 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 can be used as a self-cleaning upper GI scope and / or lower GI scope with or without an access device. The visualization system can form a rigid endoscope with self-cleaning capabilities.
[0204] 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 system 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 envelope of the camera module defines the housing.
[0205] It should be noted that any order of method steps expressed or implied in the above description or in the accompanying drawings should not be understood as limiting the disclosed method to perform the steps in that order. On the contrary, the various steps of each method disclosed herein can be performed in any number of orders. In addition, since the described methods are only exemplary embodiments, various other methods including more steps or including fewer steps are also included in the scope of the present disclosure.
[0206] The devices disclosed herein can be constructed of any of a variety of known materials. Exemplary materials include materials suitable for surgical applications, including metals (such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof), polymers (such as PEEK, ceramics, carbon fibers), etc. The various components of the devices disclosed herein can be rigid or flexible. One or more components or portions of the device can be formed of radiopaque materials to facilitate visualization under fluoroscopy and other imaging techniques, or formed of radiolucent materials so as not to interfere with the visualization of other structures. Exemplary radiolucent materials include carbon fibers and high-strength polymers.
[0207] The devices and methods disclosed herein can be used in minimally invasive surgery and / or open surgery. Although the devices and methods disclosed herein are generally described in the context of spinal surgery on human patients, it should be understood that the methods and devices disclosed herein can be used in any type of surgery on human or animal subjects, on inanimate objects (in non-surgical applications), etc.
[0208] While specific embodiments are described above, it will be appreciated that numerous changes could be made within the spirit and scope of the concepts described.
Claims
1. A surgical system comprising: an access device having a working channel and a visualization channel; as well as a visualization system disposed at least partially in the visualization channel, the visualization system comprising a camera module and a housing in which the camera module is mounted, the housing comprising a sidewall having a concave inner surface disposed adjacent to the working channel and a convex outer surface disposed opposite the concave inner surface, wherein the concave inner surface is connected to the outer surface by first and second transition regions defining segments of respective cylinders, a distally facing end surface in which a camera lumen of the camera module is disposed, a first fluid lumen and a second fluid lumen, wherein the first and second transition regions follow outer peripheries of the first and second fluid lumens, and a shield extending from the distally facing end surface of the housing; as well as an active lens cleaning device configured to remove debris from a lens of the camera module, the active lens cleaning device comprising a nozzle extending from the distal-facing end surface of the housing, the nozzle comprising an opening configured to direct fluid from at least one of the first fluid lumen and the second fluid lumen across the distal-facing end surface toward the lens and away from the nozzle; wherein the opening is configured to direct fluid toward the lens at an oblique angle relative to a central longitudinal axis of the housing; wherein a distal-most end of the shield extends beyond the nozzle relative to the central longitudinal axis; and The shielding element is movable relative to the housing. 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 being disposed within the housing.
3. 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.
4. The system of claim 1, wherein the inner surface of the side wall of the housing defines at least a portion of an inner surface of the working channel.
5. The system of claim 1, wherein the active lens cleaning device comprises a source of positive pressure gas directed toward the lens through a lumen of the housing.
6. The system of claim 5, wherein the gas comprises air or carbon dioxide.
7. The system of claim 1, wherein the shield extends around less than an entire perimeter of the housing. The system of claim 7 , wherein the shield defines a curved inner surface.
9. The system of claim 8, wherein the shield defines an outer surface having a contour matching a contour of an outer surface of the housing.
10. The system of claim 9, wherein the shield has a crescent-shaped cross-section.
11. The system of claim 8, wherein the curved inner surface is configured to facilitate delivery of fluid to the lens.
12. The system of claim 1, wherein the opening is located between opposing lateral ends of the shield.
13. The system of claim 1, wherein a lateral edge of the shield defines a chamfer that provides a smooth transition to a distally facing end surface of the housing.
14. The system of claim 1, wherein the shield comprises the nozzle.
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