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  Method and apparatus having an elongate guide and controllable portionUSPTO Application #: 20060089531Title: Method and apparatus having an elongate guide and controllable portion Abstract: An endoscope with guiding apparatus is described herein. A steerable endoscope is described having an elongate body with a manually or selectively steerable distal portion, an automatically controlled portion, a flexible and passively manipulated proximal portion, and an externally controlled and manipulatable tracking rod or guide. The tracking rod or guide is positioned within a guide channel within the endoscope and slides relative to the endoscope. When the guide is in a flexible state, it can conform to a curve or path defined by the steerable distal portion and the automatically controlled portion. The guide can then be selectively rigidized to assume that curve or path. Once set, the endoscope can be advanced over the rigidized guide in a monorail or “piggy-back” fashion so that the flexible proximal portion follows the curve held by the guide until the endoscope reaches a next point of curvature within a body lumen. (end of abstract)
Agent: Wilson Sonsini Goodrich & Rosati - Palo Alto, CA, US Inventors: Joseph M. Tartaglia, Amir Belson, Robert Matthew Ohline USPTO Applicaton #: 20060089531 - Class: 600114000 (USPTO) Related Patent Categories: Surgery, Endoscope, With Guide Means For Body Insertion The Patent Description & Claims data below is from USPTO Patent Application 20060089531. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part-of U.S. patent application Ser. No. 10/087,100 entitled "Endoscope with Guiding Apparatus" filed Mar. 1, 2002, which is a continuation-in-part of U.S. patent application Ser. No. 09/969,927 entitled "Steerable Segmented Endoscope and Method of Insertion" filed Oct. 2, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/790,204 entitled "Steerable Endoscope and Improved Method of Insertion" filed Feb. 20, 2001, which claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 60/194,140 entitled the same and filed Apr. 3, 2000, all of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION [0002] The present invention relates generally to endoscopes and endoscopic procedures. More particularly, it relates to a method and apparatus to facilitate insertion of a flexible endoscope along a tortuous path, such as for colonoscopic examination and treatment. BACKGROUND OF THE INVENTION [0003] An endoscope is a medical instrument for visualizing the interior of a patient's body. Endoscopes can be used for a variety of different diagnostic and interventional procedures, including colonoscopy, bronchoscopy, thoracoscopy, laparoscopy and video endoscopy. [0004] Colonoscopy is a medical procedure in which a flexible endoscope, or colonoscope, is inserted into a patient's colon for diagnostic examination and/or surgical treatment of the colon. A standard colonoscope is typically 135-185 cm in length and 12-19 mm in diameter, and includes a fiberoptic imaging bundle or a miniature camera located at the instrument's tip, illumination fibers, one or two instrument channels that may also be used for insufflation or irrigation, air and water channels, and vacuum channels. The colonoscope is inserted via the patient's anus and is advanced through the colon, allowing direct visual examination of the colon, the ileocecal valve and portions of the terminal ileum. [0005] Insertion of the colonoscope is complicated by the fact that the colon represents a tortuous and convoluted path. Considerable manipulation of the colonoscope is often necessary to advance the colonoscope through the colon, making the procedure more difficult and time consuming and adding to the potential for complications, such as intestinal perforation. Steerable colonoscopes have been devised to facilitate selection of the correct path though the curves of the colon. However, as the colonoscope is inserted farther and farther into the colon, it becomes more difficult to advance the colonoscope along the selected path. At each turn, the wall of the colon must maintain the curve in the colonoscope. The colonoscope rubs against the mucosal surface of the colon along the outside of each turn. Friction and slack in the colonoscope build up at each turn, making it more and more difficult to advance, withdraw, and loop the colonoscope. In addition, the force against the wall of the colon increases with the buildup of friction. In cases of extreme tortuosity, it may become impossible to advance the colonoscope all of the way through the colon. [0006] Steerable endoscopes, catheters and insertion devices for medical examination or treatment of internal body structures are described in the following U.S. patents, the disclosures of which are hereby incorporated by reference in their entirety: U.S. Pat. Nos. 4,543,090; 4,753,223; 5,337,732; 5,337,733; 5,383,852; 5,487,757; 5,624,381; 5,662,587; and 5,759,151. SUMMARY OF THE INVENTION [0007] Accordingly, an improved endoscopic apparatus is disclosed herein for the examination of a patient's colon, other internal bodily cavities, and any other spaces within the body with minimal impingement upon bodily cavities or upon the walls of the organs. The disclosed apparatus may also be employed for various surgical treatments of those regions, e.g., insufflation, drug delivery, biopsies, etc. A steerable endoscope having an elongate body with a manually or selectively steerable distal portion, an automatically controlled portion, which may be optionally omitted from the device, a flexible and passively manipulated proximal portion, and an externally controlled and manipulatable tracking rod or guide is described below. The tracking rod or guide may be slidably positioned within a guide channel or lumen within the endoscope or it may be externally positionable such that the guide and the endoscope may slide relative to one another along a rail or channel located along an external surface of the endoscope. [0008] In operation, the steerable distal portion of the endoscope may be first advanced into a patient's rectum via the anus. The endoscope may be simply advanced, either manually or automatically by a motor, until the first curvature is reached. At this point, the steerable distal portion may be actively controlled by the physician or surgeon to attain an optimal curvature or shape for advancement of the endoscope. The optimal curvature or shape is considered to be the path which presents the least amount of contact or interference from the walls of the colon. In one variation, once the desired curvature has been determined, the endoscope may be advanced further into the colon such that the automatically controlled segments of controllable portion follow the distal portion while transmitting the optimal curvature or shape proximally down the remaining segments of the controllable portion. The operation of the controllable segments will be described in further detail below. [0009] In one variation, the guide is shorter than the full length of the endoscope, e.g., approximately the length of the controllable portion, and this shortened guide can be preloaded through the proximal end of the endoscope or through the handle of the endoscope. Once the guide is inserted, it may be advanced distally through the endoscope to the distal tip of the endoscope. As the user advances the endoscope distally, the automatically controlled segments of the proximal controllable portion propagate the selected curves down the endoscope, and the guide, in its flexible state, passively conforms to the shape of the desired pathway. Once the endoscope has advanced to a desired position, e.g. to a depth less than the length of the controllable portion of the endoscope, the user can rigidize the guide and maintain it at that depth (or axial position). The endoscope can then be further advanced relative to the rigidized guide, sliding over the rigid guide and along the selected pathway. Thus, the surgeon or physician only needs to lock the guide in position once. If the controllable region of the endoscope and the guide are each at least half of the length of the endoscope, the entire endoscope can conform to a selected pathway in this manner. It is also possible to reposition the guide easily by relaxing and/or unlocking it from its rigidized axial position and then moving the guide into its new position. [0010] In an alternative variation, once the steerable distal portion has been steered or positioned for advancement, the guide may be advanced distally in its flexible state along or within the endoscope until it reaches a distal position, i.e., preferably some point distal of the flexible proximal portion. Regardless whether the optional controllable portion is omitted or not from the device, the guide may be advanced near or to the end of the distal portion. Once the guide has been advanced, it may directly attain and conform to the curvature or shape defined by the steerable distal portion. [0011] Preferably, the guide is advanced to the distal end of steerable distal portion or, if the controllable portion is included in the device, the guide may be advanced to the distal end of the controllable portion, or to some point between the two portions. The guide may be advanced to any distal position as long as a portion of guide attains and conforms to the optimal curvature or shape. Prior to advancing the endoscope over the guide, the guide may be left in its flexible state or it may be optionally rigidized, as discussed further below. If left in its flexible state, the guide may possibly provide desirable column strength to the endoscope as it is advanced through the colon over the guide. It is preferable, however, that the guide is rigidized once it has attained and conformed to the curvature. This allows the flexible proximal portion, i.e., the passive portion, to remain flexible and lightweight in structure. As the position of the guide is preferably rigidized and maintained, the endoscope may then be advanced over the guide in a monorail or "piggy-back" fashion so that the flexible proximal portion follows the curve held by the guide until the endoscope reaches the next point of curvature. [0012] In some variations, the process of alternately advancing the guide and the endoscope may be repeated to advance the entire endoscope through the colon while the guide may be alternatively rigidized and relaxed while being advanced distally. While the endoscope is advanced through the colon, the physician or surgeon may stop the advancement to examine various areas along the colon wall using, e.g., an imaging bundle located at the distal end of the endoscope. During such examinations, the guide may be temporarily withdrawn from the endoscope to allow for the insertion of other tools through the guide channel if there is no separate channel defined within the endoscope for the guide. The guide may also be withdrawn through the instrument to any location within the body of the endoscope. In other words, the guide may be withdrawn partially or removed entirely from the endoscope at any time, if desired, because there are no constraints which may limit the travel of the guide through the body of the endoscope. After a procedure has been completed on the colon wall, the tool may be withdrawn from the guide channel and the guide may be reintroduced into the endoscope so that the endoscope may optionally be advanced once again into the colon. [0013] A further variation on advancing the endoscope may use multiple guides which are alternately rigidized while being advanced distally along a path. Although multiple guides may be used, two guides are preferably utilized. As the endoscopic device approaches a curvature, a first guide may be advanced in a relaxed and flexible state towards the steerable distal end of the device. While being advanced, the first guide preferably conforms to the shape defined by the distal end and the first guide may be subsequently rigidized to maintain this shape. The device may then be advanced further distally along the pathway while riding over the rigidized first guide. [0014] After the device has been advanced to its new position, a second guide may also be advanced distally in its relaxed state through the device up to the distal end while the first guide is maintained in its rigidized state. The second guide may then conform to the new shape defined by the distal end of the device and become rigidized to maintain this new shape. At this point, the first guide is also preferably maintained in its rigid state until the distal end of the device has been advanced further distally. The first guide may then be relaxed and advanced while the rigidity of the second guide provides the strength for advancing the guide. This procedure may be repeated as necessary for negotiating the pathway. [0015] To withdraw the endoscope from within the colon, the procedure above may be reversed such that the withdrawal minimally contacts the walls of the colon. Alternatively, the guide may simply be removed from the endoscope while leaving the endoscope within the colon. Alternatively, the guide may be left inside the endoscope in the relaxed mode. The endoscope may then be simply withdrawn by pulling the proximal portion to remove the device. This method may rub or contact the endoscope upon the walls of the colon, but any impingement would be minimal. [0016] The selectively steerable distal portion can be selectively steered or bent up to a full 180.degree. bend in any direction. A fiberoptic imaging bundle and one or more illumination fibers may extend through the body from the proximal portion to the distal portion. The illumination fibers are preferably in communication with a light source, i.e., conventional light sources, which may be positioned at some external location, or other sources such as LEDs. Alternatively, the endoscope may be configured as a video endoscope with a miniaturized video camera, such as a CCD camera, positioned at the distal portion of the endoscope body. The video camera may be used in combination with the illumination fibers. Optionally, the body of the endoscope may also include one or two access lumens that may optionally be used for insufflation or irrigation, air and water channels, and vacuum channels, etc. Generally, the body of the endoscope is highly flexible so that it is able to bend around small diameter curves without buckling or kinking while maintaining the various channels intact. The endoscope can be made in a variety of other sizes and configurations for other medical and industrial applications. [0017] In some variations the endoscope may optionally include a suction device that can withdraw air or other gases, e.g. gases used for insufflating the interior of a colon. In the example of insufflating a colon, the insufflated gas may be trapped within regions of the colon due to the sacculation and movement of the colon walls. To facilitate removal of these gases, the suction device may be utilized to withdraw these trapped gases as the endoscope is advanced or withdrawn through the colon. [0018] The suction device may comprise a suction tube positioned within the endoscope and connected to a suction port defined along the endoscope outer surface at a location proximal of the distal tip. The suction port can apply suction at some distance from the tip of the endoscope so that the suction does not interfere with insufflation or other activities at the distal end of the endoscope. In one variation, the suction port is located in the distal half of the endoscope, approximately one-quarter down the length of the insertable portion of the endoscope, e.g., 40 to 50 cm from the steerable tip. Some variations may apply suction continuously, while others allow the user to selectively control application of the suction. [0019] The optional controllable portion is composed of at least one segment and preferably several segments which may be controllable via a computer and/or controller located at a distance from the endoscope. In one variation, approximately half of the length of the endoscope is comprised of controllable segments. Each of the segments preferably have an actuator mechanically connecting adjacent segments to allow for the controlled motion of the segments in space. The actuators driving the segments may include a variety of different types of mechanisms, e.g., pneumatic, vacuum, hydraulic, electromechanical motors, drive shafts, etc. If a mechanism such as a flexible drive shaft were utilized, the power for actuating the segments would preferably be developed by a generator located at a distance from the segments, i.e., outside of a patient during use, and in electrical and mechanical communication with the drive shaft. Alternatively, segments could be actuated by push-pull wires or tendons, e.g. Bowden cables, that bend segments by distributing force across a segment, as described in "Tendon-Driven Endoscope and Methods of Insertion" filed Aug. 27, 2002 (attorney docket number 514812000125), which is incorporated in its entirety by reference. [0020] A proximal portion comprises the rest of the endoscope and preferably a majority of the overall length of the device. The proximal portion is preferably a flexible tubing member that may conform to an infinite variety of shapes. It may also be covered by a polymeric covering optionally extendable over the controllable portion and the steerable distal portion as well to provide a smooth transition between the controllable segments and the flexible tubing of the proximal portion. The controllable portion may be optionally omitted from the endoscope. A more detailed description on the construction and operation of the segments may be found in U.S. patent application Ser. No. 09/969,927 entitled "Steerable Segmented Endoscope and Method of Insertion" filed Oct. 2, 2001, which has been incorporated by reference in its entirety. Continue reading... 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