Abstract:
Endoscopic surgical apparatuses and methods are described. An endoscopic apparatus comprises an elongate shaft, an inflatable element, an instrument base, and an imaging source. The elongate shaft comprises a steerable distal tip, locating feature(s) proximal of the steerable distal tip, inflation inlet(s) adjacent the locating feature(s), and a working channel. The inflatable element is slid over the elongate shaft to removably couple to the elongate shaft at the locating feature(s), thereby placing the inflatable element in fluid communication with the inflation inlet(s). The instrument base is coupled to a proximal end of the elongate shaft and can be coupled to a robotic system. The robotic system articulates the steerable distal tip through the instrument base to perform a procedure in an anatomical lumen. The robotic system can also advance and retract the endoscopic apparatus through the anatomical lumen. The imaging source is located at the steerable distal tip.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/134,350, filed Mar. 17, 2015, which application is incorporated herein by reference. 
         [0002]    The present invention relates to endoscopic instruments, tools, and methods that may be incorporated into a robotic system, such as those disclosed in U.S. patent application Ser. No. 14/523,760, filed Oct. 24, 2014, U.S. Provisional Patent Application No. 62/019,816, filed Jul. 1, 2014, U.S. Provisional Patent Application No. 62/037,520, filed Aug. 14, 2014, and U.S. Provisional Patent Application No. 62/057,936, filed Sep. 30, 2014, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The field of the present invention relates to flexible endoscopic tools that may be used in a number of endolumenal procedures. More particularly, the field of the invention pertains to flexible endoscopic tools that incorporate disposable balloon attachments as a means of isolating the region near the distal tip. 
         [0005]    2. Description of the Background Art 
         [0006]    Endoscopic surgery has precipitated the development of novel technologies. In the context of bronchoscopy, there is a growing interest in using endoscopic tools to treat potentially cancerous lesions and tumors within the lungs. Current technologies, however, provide limited vision capabilities, and practitioners are often left guessing their location within the patient&#39;s lungs and aiming at a guesstimate of the lesion. Current technologies are even further limited with respect to bronchioles on the periphery, where the small size of the bronchioli is beyond the resolution of current CT and optical imaging techniques. This presents a serious problem; numerous tumors and lesions develop on the periphery of the lungs and require early diagnosis and treatment in order to prevent the spread of any cancerous cells. 
         [0007]    Additionally, navigation with current endoscopic technologies leave much to be desired. Today&#39;s endoscopic devices are typically handheld devices with numerous levers, dials, and buttons for various functionalities, but offer limited articulation. In order to control the endoscope, physicians must manipulate levers and/or dials in concert with twisting the shaft of the scope. These techniques require the physician to contort their hands and arms while using the device in order to deliver the scope to the desired position. The resulting arm motions and positions are awkward for physicians; maintaining those positions can also be physically taxing. A robotically controlled solution would dramatically improve ergonomics and usability for the physicians. 
         [0008]    Accordingly, there is a need for a robotic endoscopic tool that is capable of providing real-time video feedback of the interior of the bronchioles, especially in the periphery of a patient&#39;s lung. 
       BRIEF SUMMARY OF THE INVENTION 
       [0009]    In general, the present invention provides an endoscopic tool that that incorporates a balloon applicator attachment that enhances video capture and procedural efficiency. In one aspect, the present invention provides for a medical instrument that comprises an elongated, flexible shaft, and an inflation inlet along the length of the shaft, configured to convey fluid in order to inflate an elastic object. In one aspect, the elastic object is a balloon. In one aspect, the present invention further comprises an instrument base that is configured to interface with a robotic system. In one aspect, the shaft is configured to be articulated in response to rotation motion transmitted from the robotic system to the instrument base. 
         [0010]    In yet another aspect, the present invention further comprises locating features that are configured to hold the elastic object around the inflation inlet when the object is inflated. In one aspect, the elastic object comprises of openings that are configured to be held in place by a pair of locating features on the shaft. In one aspect, the elastic object comprises an applicator that is configured to provide a lower friction surface for loading the object on the shaft. In one aspect, the applicator is permeable to water. 
         [0011]    In yet another aspect, the present invention provides for a method that comprises inserting an elongated medical instrument into an anatomical lumen, wherein the elongated instrument comprises of a distal tip and an elastic object surrounding an inflation inlet located on the length of the instrument; positioning the distal tip at an operative site; inflating the object by conveying fluid through the inflation inlet, such that the inflated object blocks the anatomical lumen; irrigating the operative site; performing an operative procedure at the operative site; and deflating the object. In one aspect, the irrigation of the operative site is performed by an irrigation lumen that is located at the distal tip of the elongated instrument. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The invention will be described, by way of example, and with reference to the accompanying diagrammatic drawings, in which: 
           [0013]      FIG. 1A  illustrates a robotically-driven endoscopic instrument that incorporates an inflation inlet, in accordance with an embodiment of the present invention; 
           [0014]      FIG. 1B  illustrates the distal end  104  of the endoscopic instrument  101  from  FIG. 1A , in accordance with an embodiment of the present invention; 
           [0015]      FIG. 1C  illustrates the endoscopic instrument  101  with a disposable balloon disposed around the inflation inlet  109 , in accordance with an embodiment of the present invention; 
           [0016]      FIG. 1D  illustrates the endoscopic instrument  101  from  FIGS. 1A, 1B  with uninflated balloon  107  disposed around the inflation inlet  108 , in accordance with an embodiment of the present invention; 
           [0017]      FIG. 1E  illustrates the endoscopic instrument  101  from  FIGS. 1A, 1B, 1D  with inflated balloon  111  disposed around the inflation inlet  108 , in accordance with an embodiment of the present invention; 
           [0018]      FIG. 2  illustrates a protocol for using the endoscopic device with a balloon attachment, such as endoscopic device  101  and balloon  111  from  FIG. 1A-1E , within an anatomical lumen, to prevent unwanted fluid in non-operative regions in accordance with an embodiment of the invention; and 
           [0019]      FIG. 3  illustrates use of an endoscopic device with a balloon attachment within an anatomical lumen. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. 
         [0021]    In clinical applications, the use of a distally-located camera at the tip of the endoscope often provides significant visual feedback to the user, allowing the physician to successfully navigate, operate, and treat pre-determined operative regions within a patient. In the context of certain clinical procedures, however, vision may be impeded for a number of reasons, including the presence of mucus. In bronchoscopy, for example, vision may be obscured when mucus clings to the lens of the distally-located camera, obscuring large portions of the lung from the physician. Additionally, mucus may also obscure light sources, greatly reducing the visibility within the bronchioli. 
         [0022]    Among other reasons, vision may be improved by filling the anatomical lumen (a peripheral bronchiole in the context of bronchoscopy) with fluid, such as water or saline, which distends small airways, prevents debris from obscuring the camera, and improves optical performance. Unchecked use of fluid, however, is however undesirable. For example, in bronchoscopy, when flooding bronchioles in the lung&#39;s periphery during a clinical procedure, fluid in the lung periphery often flows out of the area of interest, requiring that a constant stream of fluid to keep the area flooded. As a result, the patient&#39;s lungs often get irrigated with more fluid than initially intended for the operative region. Relatedly, filling a patient&#39;s lungs with too much fluid can be dangerous. 
         [0023]    Accordingly, the present invention provides an efficient, disposable design for an endoscopic tool that isolates the irrigation of a target operative region. 
         [0024]      FIG. 1A  illustrates a robotically-driven endoscopic instrument that incorporates an inflation inlet, in accordance with an embodiment of the present invention. As shown in view  100  from  FIG. 1 , endoscopic instrument  101  principally incorporates a flexible, elongated shaft  102  and an instrument base  103 . In some embodiments, the endoscopic instrument  101  as a whole is reposable, i.e., usable for several procedures after sterilization. The endoscopic instrument  101  may be configured to be used within a larger robotic system, such as those disclosed in the aforementioned patent applications. In some embodiments, the instrument base  103  of the endoscopic instrument  101  may be configured to interface to the robotic instrument drive mechanism through a sterilizable interface that may incorporate a disposable drape. 
         [0025]    The elongated shaft  102 , or “catheter”, may generally be constructed by any of the manufacturing techniques disclosed in the aforementioned patent applications. Like the embodiments discussed in the aforementioned patent applications, pull wires may be run the length of the elongated shaft  102  and be fixedly coupled to the distal end such that tension on those pull wires results in articulation of the elongated shaft  102 . 
         [0026]      FIG. 1B  illustrates the components located at the distal tip  104  of elongated shaft  102 , in accordance with an embodiment of the present invention. As shown in view  105  from  FIG. 1B , the distal tip  104  of elongated shaft  102  may comprise a visual sensing means, such as a digital camera  106 . The distally-located camera  106  may be helpful for visual feedback and to assist the physician with navigation within the patient&#39;s anatomical lumens. The camera  106  may necessitate the incorporation of wires down the length of the elongated shaft  102  to convey visual data from the distal end  104  to the instrument base  103  and ultimately to the robotics platform that drives the instrument base  103 . Accompanying the camera  106  at the distal tip  104  may be one or more light emitting means, such as light-emitting diodes  107 , that are configured to assist the camera with visualizing the interior of the anatomical lumens. Additionally, there may be one or more channels that may be used to accommodate irrigation from the distal tip  104 , such as irrigation ports  108 . In this embodiment, aspiration of the irrigated fluid may be managed through aspiration from the working channel  109 . Working channel  109  may also be configured to be used with tools, end effectors, and other payloads. 
         [0027]    In some embodiments, the ports  108  may lead to combination aspiration/irrigation channels. However, the dual-purpose aspiration/irrigation channels may suffer from latency issues in comparison to dedicated aspiration channels and dedicated irrigation channels. For example, when changing functionality from irrigation to aspiration, the entire channel may need to aspirated prior to aspirating any external fluid. Similarly, when changing from aspiration to irrigation, fluid will only irrigate from the port after first flooding the entire channel first. 
         [0028]    Among other reasons, the tapered shape of the distal tip  104 , where the camera protrudes from the tip  104  as it tapers downwards towards the working channel  109 , improves cannulation within anatomical lumens. Additionally, the reduced surface area around the lens of camera  106  reduces the amount of undesirable debris that may cling to the camera  106  and thus obscure its vision. Polishing the tip or applying a surface finish may be employed to further enhance these properties. The distal tip  104  is also designed to reach small anatomical spaces-the components at the distal tip  104  may be manufactured to a 3.3 mm outside diameter or less using 3/16″ steel material. The distal tip  104  may also be composed of other materials used in catheter construction, such as polyether ether ketone (PEEK). 
         [0029]    Returning to  FIG. 1A , the elongated shaft  102  may also comprise an inflation inlet  110  and a pair of balloon locating features  111 . The inflation inlet  110  may be various shapes and sizes that may be appropriate for conveying fluid out of the elongated shaft  102 . The inflation inlet may be fed by an inflation lumen (now shown) that may be embedded within the length of the elongated shaft  102 . The inflation inlet  110  may be configured to convey fluid from the robotic system. In some embodiments, the inflation inlet  110  may run to the instrument base  103 , where a fluid access port in the base  103  may interface with the robotically-provided fluid source. In some embodiments, the fluid source may be external to the robotic system. In some embodiments, the fluid source may be manually-driven and controlled. 
         [0030]      FIG. 1C  illustrates the endoscopic instrument  101  with a disposable balloon disposed around the inflation inlet  110 , in accordance with an embodiment of the present invention. As shown in view  112 , a disposable balloon  113  may be slidingly disposed over the distal end of the endoscopic instrument  101  and positioned over the inflation inlet  110 . Balloon  113  may have two ends, each with an elastic opening  114  to provide a tight fit over the elongated shaft  102 . The balloon  113  may be loaded onto the endoscopic device  101  by sliding the balloon  113  over the elongated shaft  102  from the distal tip  104 . To facilitate loading, balloon  113  may further comprise an interior applicator tube  114  that may be positioned over the inflation inlet  110 . The applicator tube  114  may provide a lower friction surface for easier loading of the balloon  113  onto the elongated shaft  102 . Applicator tube  114  may also be fluid permeable to allow fluid from the inflation inlet  110  to fill the balloon  113 . 
         [0031]      FIG. 1D  illustrates the endoscopic instrument  101  from  FIGS. 1A-1C  with uninflated balloon  113  disposed around the inflation inlet  110 , in accordance with an embodiment of the present invention. As shown in view  115 , after positioning the balloon  113  over the inflation inlet  110 , the ends of the balloon  113  may be unwrapped or stretched such that the elastic openings  116  of the balloon couple with the balloon locating features  111  that flank the inflation inlet  110 . The balloon locating features  111  are configured to anchor the ends of (disposable) balloon  113  that may be wrapped around the inflation inlet  110 . When positioning the balloon  113 , the balloon locating features  111  may be helpful to ensure that the balloon  113  is correctly aligned over the inflation inlet  110 . The balloon locating features  111  are configured to tightly couple with the elastic openings  116  of the balloon  113  such that they maintain their grip and hold the balloon  113  in place even under pressure and/or if the balloon  113  is inflated. The balloon locating features may be in a variety of forms configured to anchor the ends of the disposable balloon  113 , including ridges or indentations, which may be cornered, sharp, or smooth. 
         [0032]      FIG. 1E  illustrates the endoscopic instrument  101  from  FIGS. 1A-1D  with inflated balloon  113  disposed around the inflation inlet  110 , in accordance with an embodiment of the present invention. In view  117 , the balloon  113  is inflated by providing fluid through the inflation lumen and out through the inflation inlet  110  (not visible in view  117 ). The balloon locating features  111  are configured to hold the balloon even when inflated. To deflate the balloon, the fluid may be aspirated out of the inflation lumen. Post-procedure, the potentially cheaply-produced balloon  113  may be discarded, while the more expensive endoscopic device  101  may be sterilized and re-used. After a predetermined number of uses, the endoscopic device  101  may be disposed as well. 
         [0033]      FIG. 2  illustrates a protocol for using the endoscopic device with a balloon attachment, such as endoscopic device  101  and balloon  113  from  FIG. 1A-1E , within an anatomical lumen, to prevent unwanted fluid in non-operative regions in accordance with an embodiment of the invention. As shown in process  200 , there are a series of steps to appropriately use a balloon attachment within a patient&#39;s body. However, prior to engaging in process  200 , the distal end of the endoscopic device must first be positioned near the operative site in the correct anatomical lumen. Localization of the distal end  104  of the device  101  may be achieved using visual cues through the distally-mounted camera  106 , fluoroscopy, electromagnetic imaging, or any other of a number of techniques. 
         [0034]    Having located the distal end  104  of the endoscopic device  101  within the desired anatomical lumen (e.g., bronchiole), and having positioned the distal end  104  near the operative site, in step  201 , the balloon  113  may be inflated by conveying fluid down the inflation lumen and through the inflation inlet  104 . The balloon  113  may be inflated to the extent necessary to isolate the operative site and block the bronchiole. Confirmation of proper inflation may be confirmed using a variety of techniques, including fluoroscopy. Using fluoroscopy, the inflation fluid used in the balloon may be a combination of saline and contrast (e.g., 50/50 mixture) to enhance visibility. 
         [0035]      FIG. 3  illustrates use of an endoscopic device with a balloon attachment within an anatomical lumen. Specifically, internal view  300  from  FIG. 3  illustrates how endoscopic tool  101  may be used within an anatomical lumen, such as a secondary bronchiole  302  off from the central airways  301 . As shown in view  300 , endoscopic device  101  may be positioned such that the distal tip  104  may be near the operative region  304 , close to a lesion  303 . As shown in view  300 , inflating balloon  113  isolates the operative region  304  by blocking bronchiole  302 . 
         [0036]    Having properly inflated the balloon  113 , and thus isolated the operative site  304  by blocking the anatomical lumen ( 302 ), in step  202 , the operative region may be safely irrigated using irrigation ports  108  to improve the efficacy and efficiency of the subsequent clinical operation. As shown in view  300  from  FIG. 3 , when properly inflated, balloon  113  should prevent irrigated fluid  305  from endoscopic tool  101  from unintentionally entering the central airways  301 . With the operative region  304  flooded, endoscopic tool  101  may then perform the desired procedure in step  203  from  FIG. 2 . 
         [0037]    Steps  204  and  205  from  FIG. 2  generally represent clean up after the procedure is completed in step  203 . With the procedure complete, the irrigated fluid ( 305  in  FIG. 3 ) may be aspirated by endoscopic tool  101  using any number of distally-mounted ports, such as working channel  109 . After aspirating the fluid, the balloon  113  may be deflated by aspirating the fluid back through the inflation inlet  110  or by relieving fluid pressure in the inflation lumen. Having aspirated the irrigated fluid  305  and deflated the balloon  113 , endoscopic device  101  and its distal tip  104  may be repositioned for either the next operative site or evacuated from the patient&#39;s body. 
         [0038]    Beyond bronchoscopy, the present invention may be applied to a variety of other procedures, such as gastrointestinal and urology. For example, in gastrointestinal procedures, the anatomical lumens are much larger-using a balloon may assist stabilizing the flexible endoscopic device near the operative area. 
         [0039]    For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein. 
         [0040]    Elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. The invention is not limited, however, to the particular forms or methods disclosed, but to the contrary, covers all modifications, equivalents and alternatives thereof.