WO2019227018A1

WO2019227018A1 - Optical entry trocar camera

Info

Publication number: WO2019227018A1
Application number: PCT/US2019/033968
Authority: WO
Inventors: Cornell Wright; Eric C. Close; Kevin H. LIPKIN
Original assignee: Flash Surgical, Inc.
Priority date: 2018-05-25
Filing date: 2019-05-24
Publication date: 2019-11-28

Abstract

An optical trocar having a built-in or separately inserted camera module is used to assist with cannula insertion prior to laparoscopic procedures. The camera module has one or more optical sensors that can deliver real-time images out the front of the optical trocar during insertion either wirelessly or via a wired connection. Three dimensional, near field and far field views are possible. Devices for insertion of the camera module into an optical trocar are also disclosed as are optical trocars with self-cleaning capabilities.

Description

Title: Optical Entry Trocar Camera

Inventors: Cornell Wright, III, Kevin H. Lipkin and Eric C. Close

Cross-Reference to Related Applications

[0001] The present international application claims the benefit of U.S. Provisional Patent Application No. 62/676,887 filed on May 25, 2018 and U.S. Provisional Patent Application No. 62/741,445 filed on October 4, 2018, which are each hereby incorporated by reference in their entireties. In cases where an application incorporated by reference and the present application conflict, the present application controls.

Field of the Invention

[0002] The present invention relates generally to apparatus, methods, and systems to assist with surgical procedures. More specifically, the present invention relates to a single use surgical instrument that will reduce complications associated with the initial entry.

Background of the Invention

[0003] In laparoscopic surgery, surgeons create a small passageway to an operative site within a patient's body, to create a passageway to an operative site. In order to create this passageway, a trocar may be inserted into an opening in a patient's body wall by use of an obturator. When properly positioned, the obturator portion of the trocar is removed while retaining an exterior cannula in place within the body wall to provide access for other surgical instruments to be inserted through the cannula and manipulated inside the body cavity to perform the desired surgical procedures. The initial entry of the trocar into the patient's body, however, is a significant source of unintended injury.

[0004] One currently preferred method of trocar insertion is called optical entry. Using this method, a laparoscope is inserted into the obturator of an optical trocar during insertion. The surgeon usually makes a small incision and inserts the obturator into the incision and begins to twist the obturator while advancing it into the patient's body. The presence of the laparoscope allows for direct visualization of the layers of the abdominal wall that the surgeon must either cut or push through as the trocar is gradually inserted into the patient. In this way, the surgeon can visually observe exactly when the operative area has been reached. This method of gaining access to the surgical site helps to reduce the frequency with which complications such as perforations of the bowel or other organs occur because the surgeon can see inside the patient's body during entry.

[0005] As illustrated in Figs, la and lb, a rigid 0-degree laparoscope 10 having a cable 20, with fiber optics and video capabilities, is inserted into an optical trocar 30, as demonstrated by the arrow in Fig. lb, having an obturator 40 to assist with visibility when the trocar 30 is inserted into the abdomen of the patient. The tip of the obturator 40 is transparent and typically conical or pyramid-like in shape to allow the laparoscope 10 to provide imagery as the trocar is placed.

[0006] As may be appreciated, having the lengthy laparoscope inserted into the trocar makes for an unwieldy device to be used in a delicate procedure. The long and fragile laparoscope inserted into the smaller trocar is awkward for the surgeon to handle while trying not to push too hard or too far into the patient. This problem is magnified in the case of surgeons of smaller stature or who have smaller hands, as well as with patients who are obese. Additional difficulties include distortion of the video images taken through the conical, transparent tip of the obturator, internal reflections from the obturator tip creating glare in the video feed, and the need to clean and sterilize the laparoscopes, which are often only used for the entry procedure. There are also additional steps involved with the insertion, removal and swap out of the scope, which add time and cost to each surgical procedure. Because operating room time is very valuable, removing unnecessary steps, unreliable equipment, equipment with high capital cost, or equipment that takes up unnecessary real estate in a crowded operating room, saves time and money for the hospital or other treatment facility.

[0007] What is needed, then, is a way to retain the benefits of the use of a laparoscope while reducing the additional risk to the patient and additional expense for the procedure that is created by the use of a laparoscope during trocar insertion. Brief Description of the Drawings

[0008] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the invention and together with the written description serve to explain the principles, characteristics, and features of the invention. In the drawings:

[0009] Figure la is an illustration of a prior art optical trocar being used with a laparoscope by a surgeon.

[0010] Figure lb is a prior art trocar.

[0011] Figure 2 is a schematic illustration of a camera module consistent with embodiments of the present invention disclosed herein.

[0012] Figure 3 is an isolated partial perspective view of an obturator tip consistent with an embodiment of the present invention.

[0013] Figure 4 is a mocked-up illustration of a camera module with a sizing sleeve consistent with an embodiment of the present invention.

[0014] Figure 5 is a plan illustration of the interior component of an embodiment of a camera module.

[0015] Figure 6 is a partial plan illustration of a camera module with two cameras.

[0016] Figure 7 is a partial plan illustration of an optical trocar tip.

[0017] Figures 8a-c are a graphical illustration of a process of calibrating a camera module.

[0018] Figure 9 is an illustration of a calibration and glint removal process.

[0019] Figure 10 is an illustration of an insertion device for a camera module.

[0020] Figure 11 is an illustration of a method of rotating the camera module inside the obturator.

[0021] Figure 12 is an illustration of a breakable insertion device for enforcing single use. [0022] Figure 13a is a perspective view of a camera module with channels to allow gas escape.

[0023] Figure 13b is a cross sectional view of a camera module along plane A-A with channels to allow gas to escape.

[0024] Figure 14 is an illustration of an imaging obturator consistent with an embodiment of the invention.

[0025] Figure 15 is an illustration of an imaging obturator with a side-facing camera.

[0026] Figures 16a-c are illustrations of a distal end of a trocar demonstrating a tip-cleaning wiper.

[0027] Figures 17a-b are illustrations of trocar with an optical tip cleaner installed.

[0028] Figures 18a-b are illustrations of an irrigated cleaning system for an optical tip.

[0029] Figures 19a-b are illustrations of an obturator that splits open to allow a trocar camera to extend through the tip.

Detailed Description of the Invention

[0030] In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of example embodiments. It will be evident to one skilled in the art, however, that embodiments can be practiced without these specific details.

[0031] This document features various embodiments of a camera module that can be employed in a number of ways to assist a surgeon with the installation of a trocar into a patient in advance of a laparoscopic procedure. By way of non-limiting example, the camera module of the present invention can be shaped to be inserted into an optical trocar by surgical staff at or near the time of use, or it can be pre-installed in an optical trocar at the time of manufacture. Either way, there are many features and related aspects disclosed herein, of which one or a plurality, or all features and related aspects may be used in any particular implementation. [0032] Notwithstanding that there are a variety of implementations, with reference to FIGS. 2 and 3, a first particular embodiment of a camera module 100 for use in an optical trocar 30 is illustrated. In this embodiment, the camera module 100 is cylindrical in shape and is sized to match the inside diameter of an obturator 35 of an optical trocar 30. Traditionally, this inside cavity was shaped to receive a distal portion of a laparoscope to enable visualization of internal tissues and the present invention takes advantage of this form factor to provide a camera module 100 that takes the laparoscope's place.

[0033] Certain embodiments of the camera module 100 may be between 5 and 10 millimeters in diameter and may have a length of approximately 50 mm; however, the length may vary widely depending on the intended use. Traditional laparoscopic surgery employed trocars having obturators with internal diameters of five and ten millimeters; whereas some newer technologies, such as some robotically assisted procedures, are using obturators with internal diameters as small as three and as large as eight and one half millimeters. All of these diameters are intended to be within the ambit of the present disclosure.

[0034] In certain embodiments, such as in Fig. 4, a small diameter camera module 100 may be used in a larger diameter obturator space by employing a sleeve 105. Other non-limiting examples include the use of an inflatable balloon to fill any space around a camera module 100 that is smaller in diameter than the internal cavity diameter. Another embodiment employs compliant spring-loaded legs extending from the outside of module 100 and wedging it in place upon insertion. The diameter of the camera module 100 may also be tapered so that it can fit multiple obturators, but at different insertion depths. The trocar insertion module 100 may also be installed with a gap-filling adhesive like an epoxy.

[0035] With reference to Fig. 5, a non-limiting example of the components of a camera module 100 is illustrated and includes a power source 110, a camera 120 placed at or near the distal end 160, lighting elements 140, also generally located near the distal end 160, and support circuitry 130. While this example includes a power supply, other embodiments may instead include a port for connecting to an external AC or DC power supply. Further, while this example does not include user controls on the proximal end 150, it is certainly within the scope of the present invention to include controls for manipulating power status, light status, and features related to the camera, such as calibration, zoom or focus that will be discussed in further detail.

[0036] As used herein, it is intended that the term "camera," such as camera 120, refers to any of a variety of imaging sensors such as charge-coupled device (CCD) sensors, CMOS pixel sensors, or hybrid devices. Lighting elements 140 at the distal end 160 of the camera module 100 include low power usage, low heat generating light sources such as LED lights for example. In certain embodiments, a proximal light source may supply illumination to the distal end of the camera module 100 by way of a fiber optic light guide. Support circuitry 130 is intended to include connective wires or printed electrical pathways that connect the power source 110 to the camera 120 and lighting elements 140.

[0037] In embodiments, support circuitry 130 may be in the form of a printed circuit board (PCB) and may also include a wireless radio for sending real-time video from the camera to an external monitor. Alternatively, it is also within the scope of the invention to have an adapter that can be included at the proximal end 150 for wired connection electronically connecting the support circuitry 130 to an external monitor or image processing module. In some

embodiments, image fiber may enable transmission of an image to a camera in the case of a bundled fiber lens, or from a camera to a processor or external monitor. In yet another embodiment, rod lenses can be employed in a similar manner as is used in many laparoscopes, to transmit an image from the camera or lens to an eyepiece at the proximal end 150 or to an eyepiece adjacent to the obturator in use where it may be viewable by the user via a surgical camera head.

[0038] In addition to a traditional display of images or a video feed, additional embodiments include status information overlaid on the display, a three-dimensional image is presented, multiple displays are used, the image is resampled to provide multiple available resolutions for the display, or the display from the camera module 100 can be sent to a conventional vision cart. In still other embodiments, the display device may be integrated into the obturator or trocar or a consumer display such as a tablet device may be configured to receive the display output. In embodiments, AR or VR goggles may be used to present the display to the surgeon.

In another non-limiting example, especially related to robotic surgery, the device may be integrated with other devices in the OR, for example, displaying the image from the camera module 100 on said other devices, instead of or in addition to other displays discussed herein.

[0039] Fig. 6 illustrates a cut-away view of another alternative embodiment of a distal end 160 of a camera module 100 that is consistent with the teachings of the present invention. In this embodiment, two offset cameras 120 are used, which can create a three-dimensional image that can be used by the surgical team to ensure proper placement of a trocar.

Alternatively, two cameras can be used wherein the first camera is a traditional narrow angle lens, similar to what might be provided by a traditional laparoscope and the second camera could be a wide-angle lens. The user would then have the option of narrow or wide-angle views, depending on the application. In embodiments, of course, the cameras can also employ optical zoom, such as a consumer point and shoot camera does, or a digital zoom that employs software to stretch or crop an image. Software can also be used to crop a portion of the full field, if desired.

[0040] In certain embodiments, software can also be used to correct an image, such as in de warping an image collected through a curved optical trocar tip, Fig. 7 is a non-limiting example of a camera 120 that must collect images through an obturator tip 170 having a transparent, curved surface.

[0041] Fig. 8 illustrates a calibration process for use with the camera module 100 of the present invention. In certain embodiments, handshake targets 200 contain a machine readable optical code (such as a barcode or QR code) to allow the camera module 100 (in wireless embodiments) to establish communication with a monitor 238 or computer system 240 and for event capture as well as event referencing. In wired embodiments, calibration still occurs, but establishing a communication link occurs in a standard way that is known to those of skill in the art. Once communication is established, the camera module 100 can be focused on a calibration target 210 in order to ensure the camera 140 is properly calibrated. As may be expected, certain embodiments of the computer system will include additional processing components for purposes of communicating either in wired or wireless mode, de-encrypting the wireless video, manipulating signals received from the camera module 100 and displaying the images received for the surgical team to use in ensuring appropriate insertion of a trocar. [0042] In certain other embodiments, when the camera module 100 is installed in the obturator 40 and pointed at a calibration card 205 containing a calibration pattern 210, software is employed that calibrates and corrects the images that are captured through the optical tip 40 of the obturator 35. In certain non-limiting examples, a calibration target 220, in this case a checkerboard design, is used. The user points the camera 140 in the camera module 100 through the optical tip 40 of the obturator 35 at the calibration target 220 and, upon activation of a calibration software routine housed in memory of the computer system 240, correction parameters are determined that will remove any distortion from the image or feed. Other methods of calibration of cameras using calibration cards are known to those of skill in the art.

[0043] The acquired digital images or video feed may be enhanced or modified for ease of viewing or interpretation, such as through the use of specialized software as is known in the art. Typical types of modification include automatically de-warping the images or video feed to correct any distortion that is created by the optical tip. While some amount of warping is acceptable for optical entry because the layers of tissue are still readily visible as the obturator passes by them, the warping and glare on the resulting image makes it impossible to visualize any structures once the tip enters the abdominal cavity. The present invention allows for both the near field visualization of the tissue passing the obturator tip as well as the far field visualization of abdominal structure and direct visualization of placement of the working trocars. Glare is reduced by controlling illumination.

[0044] In certain embodiments, the camera is integrated into the obturator, thus allowing for full control of the optical stack. This, in turn, allows for control over image warping and for calibration and software/FPGA-based dewarping of the image, for example by visualizing a checkerboard target and applying a software transformation known to those skilled in the art such that the image rendered on the display is a true checkerboard with minimal warping. From this, the physician is able to visualize abdominal structure and placement of the working trocars without having to remove the obturator from the cannula or insert a traditional laparoscope.

[0045] In still other embodiments, software may enable glint removal. Fig. 9 illustrates a dark or all black calibration target 250. The user turns on the camera module 100 and provides illumination through the optical tip 40. Software may then be used to identify areas of the raw image 42 having internal reflection or "glint" and correcting for those areas to provide an improved image 44. The brightness of these areas may be lowered and/or these areas may not be taken into account in automatically setting image brightness to prevent the image from "blowing out/' i.e. the brightness getting set unnecessarily low to accommodate the bright areas caused by internal reflection. In certain other embodiments, the image improvement software may include white balance by adjusting the intensity of the rendered colors so that neutral colors will be presented correctly.

[0046] In another embodiment, the images and collected and modified such that the near field focus is closer than the typical working range when performing an optical entry procedure and the far field focus is farther than the maximum typical distance when not performing optical entry. In certain other embodiments, a pinhole lens is employed to bring everything into focus. This provides an infinite depth of field. With focus-free optics, everything within the patient's abdominal cavity is in focus.

[0047] For de-warping the images collected through the curved optical trocar tip 40, a checkerboard calibration target 251 can be used. The raw warped image 46 can be improved or corrected through the use of software so that a non-warped image 48 is presented to the user.

[0048] The camera module 100 embodiments discussed thus far are intended to be inserted into a separately provided obturator; however, this presents challenges with respect to, among other things, ensuring proper position and orientation. As illustrated in Figure 10, a non-limiting example of an applicator device 300 for installation of the camera module 100 into an obturator 35 is provided. The applicator device 300 contains a camera module 100 and a plunger 320 sequentially and slidably disposed within a plunger tube 310, the camera module 100 distal to the plunger 320. One or more fixed exterior flanges 330 extend from the plunger tube 310.

[0049] Optical tipped obturators are designed with a cylindrical cavity so that they may receive a laparoscope in surgical procedures performed prior to the present invention. Thus, in operation, the plunger tube 310 is inserted into the cylindrical cavity inside the obturator 35 until the camera module 100 is in its intended place, at which time, the plunger 320 is pressed against the camera module 100 using the leverage created by the surgeon's fingers against the flanges 330 to keeping the camera module 100 in place while the plunger tube 310 is removed from the obturator 35.

[0050] In another non-limiting example, the camera module is inserted into the obturator using a simple push rod. In embodiments, the push rod is fixably or removably attached to the proximal end of the camera module and the user simply pushes the camera module 100 into place. Where removable, the push rod can be removed by unscrewing it from the camera module where the distal end has been prepared with a threaded void for such purpose. In yet another non-limiting example, the camera module contains a telescoping rod that, when extended, can be locked to enable it to be used to push the camera module 100 into the obturator 35.

[0051] In some embodiments, the applicator may contain mechanical features to handle various obturator lengths and diameters. These features include making the applicator longer than all compatible obturator lengths and narrower than all compatible obturator inner diameters so that it fits every possible third party obturator. In other embodiments, certain applicators may only be compatible with a certain group of obturators and the user will have to match the proper applicator with desired obturator. In still other embodiments, the applicator may be more like tweezers or pliers to hold/manipulate the camera module 100 during insertion.

[0052] In certain embodiments, an applicator is delivered with a device to assist the surgical team with identifying the taper in diameter at or near the distal tip 40 of the cylindrical cavity inside the obturator. In embodiments, the camera module 100 may have a distal protrusion, outer cylindrical ring or partial ring, contact sensor, or outer diameter specifically chosen such that it limits the distance the camera module 100 may be inserted into the obturator 35 due to the taper present at the tip 40. In other embodiments, a rod that can be permanent, removable or folding, extends from the distal end of the camera module 100 to contact the distal tip 40 of the obturator 35 and provide certainty as to the exact distance the camera module 100 is from the distal tip 40, such as via a scale observable to the user using a mechanical linkage. [0053] The applicator may still further, in certain embodiments, be provided with a scale having an indicator that shows the distance the camera module 100 is from the distal tip 40. In embodiments, a device may protrude from the proximal end 102 of the camera module 100 that has markings that can be lined up with the proximal end of the obturator 35 to indicate the exact distance of the camera from the distal tip of the obturator. Some embodiments may have a string disposed on the proximal end of the camera module. Prior to insertion, the user may cut this string to match the desired insertion depth by placing the camera module 100 and string next to the obturator it is to be installed in. The camera module 100 can then be inserted into the obturator until the remaining string lines up with the proximal end of the obturator.

[0054] Still additional non-limiting examples of insertion methods and devices include disposing distance-measuring sensors on the distal end of the camera module or an encoder on the proximal end of the obturator to determine when insertion is complete. Sensors may take measurements by various means, including mechanically or optically. The camera built into the camera module can also be used. A calibration target could be programmed to identify the correct insertion if placed a certain distance away from the tip of the obturator during calibration.

[0055] In addition to installing the camera module the correct distance, it is also important to know or determine the orientation of the camera - which way is "up" in any given image or video feed. In embodiments, then, the applicator contains a mark to indicate the clocking angle of the camera to the user (for example by indicating which direction is "up" in the video). The user would then install the camera module with the obturator at the desired clocking angle. In certain embodiments, an indicator (LED or mechanical) located at the proximal end of the camera module indicates "up" for the video.

[0056] In embodiments, the clocking angle can be modified after the camera module 100 has been installed. Fig. 11 demonstrates the rotation of a camera module 100 through the use of a screwdriver 400. In this embodiment, the proximal end 150 of the camera module must have either a Philips head or flat head indentation so that the entire module 100 can be rotated.

[0057] In certain other embodiments, the clocking angle can be modified. The user can rotate the video on a monitor in some cases. In other embodiments, video can be autorotated depending on feedback from gravity sensors or compass readings, both or either of which may be disposed on the camera module 100. Software may also be used to correct for mis alignment of a camera module 100 within an obturator, such as may occur when the module 100 is a smaller diameter than the internal cavity of the obturator.

[0058] Once the camera module 100 is at the correct depth and orientation for the obturator 35 with which it is being used, it is important to make sure it is securely placed. In certain embodiments, the camera module 100 is secured with adhesive that may be optically, by exposure to light, or anaerobically cured, or may be glue, tape or springs. Air pressure may also be used to create a vacuum or, at least, negative pressure at the distal tip of the obturator. Likewise, positive pressure may be used to ensure proper seating of the camera module 100 in the obturator 35. In embodiments, the module 100 may also be secured by maintaining a high coefficient of friction between the module 100 and the interior walls of the cavity within the obturator 35, through, among other things, appropriate material selection. In another embodiment, thermal expansion may be used whereby the camera module 100 is kept refrigerated until it is inserted into the obturator, at which point, it expands and pushes against the walls of the internal cavity. A further embodiment provides for screw threads or ribs protruding from the exterior wall of the camera module 100 that secure it in place.

[0059] In certain embodiments, the camera module 100 is intended to be single-use or disposable so that it is not possible to accidentally or improperly re-use a contaminated camera module 100. In a non-limiting example illustrated by Fig. 12, a method is disclosed whereby removing the camera module 100 from an obturator prevents reuse. Batteries 510 and 520 are held in place and electrically contacted by a plate 505 connected to eyebolt 500. The plate 505 is held in place by tabs 507 which are strong enough to put pressure on the batteries and make good electrical contact but weak enough such that they bend or potentially break off when forcibly removing the camera module 100 from the obturator 35 using the eyebolt 500, creating a space between the plate 505 and the batteries 510, 520 and electrically

disconnecting them, causing the camera module 100 to power off and remain off without chance of re-use. The presence of the bendable or breakable tabs 507 prevents the camera module 100 from being re-used. [0060] In another embodiment, it may be possible to limit multiple uses by only allowing the camera module 100 to turn on and not off. In other words, installing the camera module 100 into an obturator 35 may cause the device to turn on and remain on until the battery dies. Another non-limiting example of a way to ensure the camera module 100 is not improperly reused is to require that the camera module 100 be damaged in order for it to be removed. Further, to the extent that the camera module 100 is secured with threads or ribs, they may be tapered or barbed to only permit one-way motion. In another non-limiting example, the batteries supplied with the camera module 100 can be non-replaceable and contain only enough energy for a single use plus some safety factor. Additional non-limiting examples include a time delay fuse to enforce single use or a software time limit.

[0061] Where it is desirable to re-use an obturator 40 or where the camera module 100 is not designed for re-use, it needs to be safely removed from the obturator 40. In embodiments, this can require a specialized unlocking tool that allows the user to grasp the camera module 100 and pull it out of the obturator only with use of the tool. A pull string or other graspable appendage can also be used to remove the module. In wired embodiments, the data cable may be reinforced to facilitate its use as a removal option.

[0062] After the camera module 100 has been properly inserted and calibrated, the obturator is ready to be inserted into the body. Some obturators have a hole or gap in the optical tip to facilitate insertion into the abdomen as the abdominal cavity is normally under negative pressure. Insertion then allows air to flow into the abdominal cavity creating space during the insertion and reducing potential for injury. If a camera module in accordance with the present disclosure has been placed in the internal cavity of the obturator, it needs to enable that gas to escape. Fig. 13a illustrates a perspective illustration of a camera module 100 having two channels 600 for allowing gas to either enter or exit the patient's abdomen, depending on the situation. Fig. 13b illustrates a cross-sectional view of a camera module 100 having an embodiment of the channels 600.

[0063] It is important to control temperature within the optical tip 40 of the obturator 35 given that lights are being used to illuminate the tissue as the obturator is being introduced. Overheating and fogging can create problems with equipment and make it difficult to see the tissue. Moreover, overheating can also create a tissue damage issue due to potential for burning. Therefore, embodiments of the camera module 100 include a heater to prevent fogging of the optical tip 40, LED intensity control to control corresponding heat, PWM frequency variation or signal driver waveform shape, and use of a temperature sensor that may optionally be tied to LED intensity for automatic temperature control. In another non-limiting example, an additional element constructed of a material having a high specific heat may be added to act as a heat sink.

[0064] To assist the surgical team, the camera module 100, in embodiments, is configured to report its status. By way of non-limiting example, the module 100 may report improper installation, error status such as temperature abnormalities or low battery, type of obturator into which the module 100 has been installed, or illumination requirements to avoid

overheating. While status may be reported on the display of the video feed, other

embodiments of the method of status reporting include one or more of blinking the

illumination LED's or separate error reporting LED's, sounds, and vibrations. In embodiments, notifications can be configured to occur in different colors, patterns, intensities, or vibrations, all in accordance with a defined message paradigm. In robotic system embodiments where the camera module 100 integrates with other systems, the reporting mechanisms of the other systems may be co-opted and used by the module 100.

[0065] In certain embodiments, the camera module 100 can receive user input through input devices located physically on the exterior module or on a separate interface unit. These physical interface mechanisms include one or more of buttons, switches, knobs, joysticks, and trackpads. Other embodiments include receiving user input via hand gestures, voice

commands, or movement of the module 100 in a predetermined way.

[0066] Some embodiments of the camera module 100 include a separate interface unit 240 to connect the camera module 100 to one or more displays in the operating room. By way of non limiting example, the interface unit may include an interface with the module 100 via a wired or wireless connection to receive video, control the module 100, or provide user input

functionality. In certain embodiments, the interface unit 240 connects to a hospital network to send data or video, generate video overlays, record video, images or other data, perform computation or calibration procedures, display images, video or data, provided status indications or store user preferences or user logs. In a particular embodiment, the interface unit 240 may be configured to show layers of abdominal wall that have been passed with either actual images or cartoon-like illustration. It may also interface with existing vision carts or other devices in the operating room, such as robotic surgery systems, in particular, via wired or wireless connections.

[0067] As those of skill in the art will appreciate, through the use of appropriate material and equipment selection, certain embodiments of the camera module 100 can be manufactured to be disposable, reusable (durable), or a combination of both. By way of non-limiting example, the reusable portion may display video and the disposable portion may be the camera module. In a wired embodiment, the wire could be durable, potentially with a disposable sterile drape.

In other wired embodiments, the wire may be disposable.

[0068] The foregoing notwithstanding, in certain embodiments, a camera module 650 is integrated with the obturator 900 during manufacture or assembled as a separate procedure after manufacture and delivered to the surgeon as finished package as seen in Fig. 14. As part of manufacturing of the obturator 900 for a particular embodiment, it could be modified to contain elements to prevent internal reflections and light leakage from the lighting elements into the camera by the addition of opaque elements between the obturator tip through which illumination passes in an outward direction and the area of the obturator tip through which the image is captured. As will be appreciated by those of skill in the art, any item or feature previously discussed in relation to the construction of the camera module 100 can be incorporated into the preinstalled obturator discussed here 900.

[0069] Referring to Fig. 15, certain embodiments have a side-looking image sensor 800 which may be integrated with the side of the obturator (for example through a flat window in the side of the obturator) to provide an undistorted view in a direction normal to a long axis of the imaging obturator 900 or camera module 100. Images collected from this additional side looking image sensor 800 can be stitched together with images taken from the forward-facing camera or cameras 140 to provide the surgeon with an even large field of view in real time. [0070] During manufacture of the imaging obturator 900, in embodiments where it is either integrated into the obturator when the obturator is manufactured or assembled after manufacturing of the obturator, calibration for image white balance, image distortion due to the obturator tip or to remove/lessen the effect of internal reflections due to illumination from the lighting elements reflecting from the obturator tip, and other calibrations of the software and or imaging mechanisms described above may be performed at the factory or in a location off-site and prior to delivering the imaging obturator 900 to the user.

[0071] In still other embodiments, such as in the case where the camera module 100 is not fully integrated into an imaging obturator 900 prior to delivery to the surgeon, installation may consist of placing some or all of a camera 120, illumination devices 140 such as LED's, supporting electronics 130 such as power supplies or converters, image processors, and LED drivers, the wireless transceiver and one or more batteries 110, in the case of wireless embodiments, inside a provided obturator 900 prior to use. In certain additional embodiments, user controls 910 are located on the proximal portion 905 of the provided obturator 900, along with a data and/or power wire 925, in the case of wired embodiments, to connect to a monitor or video interface box (not shown).

[0072] Figs. 16 through 19b illustrate several embodiments of trocars having a mechanism for cleaning the optical tip of the obturator. Fig. 16a illustrates a trocar 1000 having a cannula 1005 and an obturator 1035. In certain embodiments, a cannula inner surface 1010 contains a wiper 1020 for cleaning the optical tip 1040 of the obturator when it gets smudged with tissue or other debris. As demonstrated by Fig. 16b, to clean the tip 1040 using the wiper 1020, the user retracts the obturator 1035 into the cannula 1005 past the wiper that is biased to extend away from the cannula inner surface 1010. Next, as illustrated by Fig. 16c, the user re-extends the obturator 1035, causing the wiper 1020 to clean the tip 1040.

[0073] In certain embodiments, the wiper 1020 comprises a wiping arm that is actuated by a user via the use of a lever or actuated through the use of a motor. This wiper 1020 does not interfere with conventional laparoscopic too use because it is similar in structure to a prior art trocar seal in construction. Figs. 17a-b demonstrate an alternative embodiment of a wiper 1020 wherein the wiper 1020 is located at the distal end of the cannula 1005. [0074] As illustrated in Figs 18a-b, another embodiment of an obturator tip cleaner employs one or more irrigation tubes 1100 to carry fluid, which may be saline or some other sterile liquid, to the tip 1040 during use. The liquid can be sprayed on the tip and used in conjunction with or without a wiper 1020. In certain embodiments, such as Fig. 18b, a plurality of irrigation jets 1105 are situated on or in the obturator 1035 so that they are positioned to spray the tip 1040 with liquid. The tubes 1100 can, in embodiments, be connected to a syringe 1110 containing liquid and a pressure-inducing device, such as a plunger 1115 or a motor or other electromechanical actuator, to advance the liquid onto the tip 1040 for cleaning. In an alternative embodiment, the obturator 1035 contains a reservoir that holds the liquid. In still another embodiment, the liquid reservoir is positively pressurized so that opening a valve is sufficient to cause the liquid to be expelled when needed.

[0075] Figs 19a-b illustrate a fold-open obturator tip 1240 for use when tip 1240 gets dirty on entry. In certain embodiments, the tip is opened as shown in Fig 19b if something smudges or otherwise obscures the optical tip for the camera 1200. In this way, the smudges are removed from view and the camera 1200 is exposed for direct visualization of the surgical site, such as for assistance with the installation of additional ports, for example. If the camera 1200 subsequently becomes dirty, however, it must be withdrawn from the surgical site and cleaned.

[0076] In certain embodiments, a continuous sheath of clear plastic film wraps over the optical trocar tip 1040 so that it can be advanced when it gets dirty. Eventually, the film that is dirty will circulate back around, but enough film should be on the roll so that clean film can be advanced onto the tip several times without the need for removal of the obturator from the surgical site.

[0077] While various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which these teachings pertain.

Claims

We claim:

1. A camera module adapted to be inserted into an internal recess of an obturator portion of an optical trocar to permit safe advancement of the trocar into an abdomen of a patient during a laparoscopic procedure, the module comprising: a substantially cylindrical body having a distal end, a proximal end, and an exterior surface between the ends, the entire body shaped to fit within the internal recess; an imaging sensor and one or more lighting elements disposed at the distal end; the imaging sensor and lighting elements oriented to illuminate and collect imagery axially beyond the distal end; control circuitry inside the body in communication with the imaging sensor for delivering the imagery to a display.

2. The camera module of claim 1 wherein the module is shaped to fittingly conform to the internal recess within the obturator.

3. The camera module of claim 1, wherein the imagery is delivered to the display in real time.

4. The camera module of claim 1, wherein the control circuitry further comprises a

wireless radio for delivering the imagery to the display.

5. The camera module of claim 1, further comprising one or more of the following: a

power source within the body and a port for receiving a power cord.

6. The camera module of claim 1, further comprising an additional imaging sensor

disposed at the distal end for one or more of three-dimensional imaging and wide-angle imaging.

7. The camera module of claim 1, further comprising one or more additional imaging sensors oriented radially and disposed on the body in an area adjacent the distal end for providing a wider view to the display.

8. The camera module of claim 1, further comprising an external sizing mechanism

comprising one or more of: an annular spacer, an inflatable bladder, compliant spring- loaded legs extending outward from the body, for providing a secure fit in obturators having recesses with larger diameters.

9. The camera module of claim 1, wherein the exterior surface forms one or more

channels for equilibrating gas pressure.

10. The camera module of claim 1, wherein the substantially cylindrical body has a diameter that increases from the distal end to the proximal end, whereby the module is secured by friction upon insertion.

11. The camera module of claim 1, further comprising user controls at the proximal end, the user controls in communication with the control circuitry inside the body.

12. The camera module of claim 11, wherein the user controls control at least one of

lighting intensity, imaging sensor calibration, focus and zoom, and power.

13. The camera module of claim 1, further comprising a distance indicator for determining the location of the camera module within the obturator portion.

14. The camera module of claim 13, wherein the distance indicator is one or more of

protrusion, external ring or partial ring, electronic sensor, encoder, mechanical linkage, graded scale and a pre-measured string or tape.

15. The camera module of claim 1, further comprising one or more of anti-fogging devices, heaters, illumination intensity and frequency control mechanisms, and heat sinks in order to control temperature within the obturator.

16. A optical trocar comprising an obturator having an internal recess and a cannula, the obturator sleevingly disposed within the cannula; and a camera module securely installed within the obturator.

17. The optical trocar of claim 16, wherein the camera module further comprises: a substantially cylindrical body having a distal end, a proximal end, and an exterior surface between the ends, the entire body shaped to fit within the internal recess; an imaging sensor and one or more lighting elements disposed at the distal end; the imaging sensor and lighting elements oriented to illuminate and collect imagery axially beyond the distal end; control circuitry inside the body in communication with the imaging sensor for delivering the imagery to a display.

18. A disposable optical trocar comprising an obturator and a cannula, the obturator sleevingly disposed within the cannula; a camera module securely installed within the obturator, wherein the attempted removal of the camera module from the obturator disables the module.

19. An applicator device for installing a camera module into an optical trocar having an obturator, the applicator device comprising a tube sized to fit into the obturator, the tuber further configured to releasably hold the module until it is in a desired location.

20. An applicator device for installing a camera module into an optical trocar employing an obturator comprising a plunger tube having a proximal end, a distal end, and an extended hollow body; an outwardly extending flange disposed on the proximal end and the body extending toward the distal end having an outside diameter sized to fit inside the obturator; a plunger having a handle end and a pusher end slidably disposed within a portion of the plunger tube, the pusher end in series contact with the camera module inside the plunger tube; whereby actuation of the plunger into the plunger tube causes the camera module to be installed.

21. The applicator device of claim 20 further comprising a releasable connector mechanism at the pusher end of the plunger whereby the plunger is rotatably affixed to the camera module to enable rotational adjustment of the module within the obturator prior to removal of the applicator device from the trocar.

22. The applicator device of claim 21, further comprising a clocking angle indicator to enable insertion of the camera module and a pre-selected orientation relative to the trocar.

23. An optical trocar with a self-cleaning obturator tip comprising: a cannula having an interior surface; an obturator having a clear tip for seeing layers of tissue during installation of the trocar, the obturator slidably movable within the cannula; a wiping assembly attached to and extending inward from the interior surface; whereby withdrawal of the obturator tip into the cannula causes the wiping assembly to clean the tip.