Abstract:
A device includes an elongated shaft configured for insertion through a body lumen to a desired position within an organ, the shaft defining a first shaft lumen extending therethrough. An articulating section is located at a distal end of the shaft and is movable out of longitudinal alignment with the shaft under user control, the articulating section comprising a first articulating section lumen extending therethrough from a proximal end open to the first shaft lumen to a distal opening in a distal face thereof. A data transmission wire extends through the shaft between a distal end connected to a camera mounted on a distal face of the articulating section and a proximal end remaining external to the body for attachment to an external image processing device. A light source at the distal face of the articulating section is aimed to illuminate an area within the camera&#39;s field of view.

Description:
PRIORITY CLAIM 
       [0001]    This application claims the priority to the U.S. Provisional Application Ser. No. 61/291,507, entitled “Disposable Probe for Hydrothermal Ablation with Digital Miniature Camera and Articulating Distal Section” filed on Dec. 31, 2009. The specification of the above-identified application is incorporated herewith by reference. 
     
    
     BACKGROUND 
       [0002]    Devices for the treatment of menorrhagia comprise ablation of the uterine lining using heated fluid supplied to the uterus by a supply lumen and withdrawn therefrom via a return lumen. Such treatments rely heavily on the maintenance of a substantially continuous fluid flow within the uterus to ensure the safety, efficiency and effectiveness of the treatment. Visualization of the target ablation site is vital to ensure that this continuous circulating flow is maintained as well as to monitor the ablation of various locations. Presently available systems employ rigid or semi-rigid hysteroscopes which provide visualization via a series of optical fibers (e.g. located within an endoscope or embedded within a hysteroscope) advanced to a target location in the body. Such scopes generally include a Charge Couple Camera (“CCD”) at a proximal end thereof which remains outside the body. Light from the distal end of the scope is transmitted to the CCD via a group of optical fibers which extend through the scope to the distal end thereof. The optical fibers require significant space, which increase the size of the insertion section of the scope. In addition, the bulk of the camera makes manipulation of the scope more difficult and fatiguing for the user. 
       SUMMARY OF THE INVENTION 
       [0003]    The present invention is directed to a device, comprising an elongated shaft configured for insertion through a body lumen to a desired position within a target body organ, the shaft defining a first shaft lumen extending therethrough and an articulating section located at a distal end of the shaft, the articulating section being movable out of longitudinal alignment with the shaft under user control, the articulating section comprising a first articulating section lumen extending therethrough from a proximal end open to the first shaft lumen to a distal opening in a distal face of the articulating section in combination with a camera mounted on a distal face of the articulating section and a data transmission wire extending through the shaft between a distal end connected to the camera and a proximal end which remains external to the body for attachment to an external image processing device. A light source at the distal face of the articulating section is aimed to illuminate an area within a field of view of the camera. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings: 
           [0005]      FIG. 1  shows a perspective partial zoom view of a system according to a first exemplary embodiment of the present invention; and 
           [0006]      FIG. 2  shows a perspective view of the system of  FIG. 1  in a first operative configuration wherein an instrument channel thereof is deflated. 
       
    
    
     DETAILED DESCRIPTION 
       [0007]    The present invention may be further understood with reference to the following description and the appended drawings. The present invention relates to a system and method facilitating endolumenal procedures within living bodies. More specifically, the present invention relates to a flexible instrument insertable into an internal organ such as the uterus to permit visualization of target locations within the organ while facilitating the insertion of fluids and/or devices for operation within the organ. An instrument according to the present invention includes a distal articulating and telescoping section which may optionally be removable therefrom facilitating visualization and access to a wide range of areas across a plurality of planes. The distal articulating section permits observation of various target areas without moving the entire device as was required with previous rigid and semi-rigid devices, as will be described in greater detail hereinafter. The device according to the invention further comprises a miniature digital camera at a distal end thereof connected to the external portions of the device via electrical leads—not optical fibers—thus leaving more space for operative components of the device and/or for a working channel extending therethrough. Although the exemplary system and method of the present invention are described with respect to devices for ablating the endometrium, those skilled in the art will understand that the present invention, and/or components thereof, may be utilized in conjunction with devices for the treatment of any internal organ. For example, such devices may be employed in prostate treatment (microwave or cryoablation), irrigation systems, with other devices for procedures which infuse heated fluids to the body or for any device requiring the insertion of an endoscopic instrument into a living body. 
         [0008]      FIGS. 1-2  depict an exemplary device  100  according to the present invention. The device  100  includes an insertion section configured to be advanced to a target position within a living body (e.g., via a body lumen accessed via a naturally occurring body orifice). In this embodiment, the device  100  is an ablation probe for hydrothermal ablation (“HTA”) comprising a handle  102  and an elongated cannula  104  extending distally therefrom. The cannula  104  includes a lumen  106  extending therethrough from a proximal opening  108  to a distal opening  110  configured for engagement with a reduced diameter channel  112  extending distally therefrom. Specifically, the channel  112  may be attached to a distal end of the cannula  104  or, in another embodiment, may extend through the cannula  104 . A distal end of the channel  112  is configured to receive an articulating section  116  having a lumen  134  extending therethrough in alignment with and open to the lumen  114 . The distal end of the channel  112  includes a seal  118  including a plurality of flexible fins extending radially outward from the channel  112  to a diameter selected so that, when the articulating section  116  is located in a desired position within the uterus, the fins of the seal  118  engage the wall of the cervix and/or the cervical of to seal the uterus so that heated fluids supplied thereto via the articulating section do not leak into the cervix. Those skilled in the art will understand that the flexibility of the seal  118  allows the fins to flex proximally as the device  100  is inserted distally through the cervix facilitating passage of the device  100  therethrough. When the articulating section  116  enters the uterus, the bias of the material returns the fins of the seal  118  to their original position (e.g., with each fin extending in a plane substantially perpendicular to a longitudinal axis of the articulating section  116 ). The user then draws the device  100  proximally until the seal  118  is seated in the cervical of with the fins of the seal  118  pressing against the tissue of the of under the bias of the material of which they are formed to seal the cervix and prevent fluids from leaking from the uterus into the cervix. The seal  118  may be formed of silicone and the articulating section  116  may be formed of one of a plastic (e.g., polypropylene, polyethylene, nylon, etc.) and a metal (e.g., stainless steel). Engagement of the seal  118  with the channel  112  and the articulating section  116  may be facilitated by one of a threaded engagement, a friction fit, bonding or another temporary attachment means known in the art. 
         [0009]    The articulating section  116  is formed as a series of substantially cylindrical links  126  attached to one another to define a channel  130  extending therethrough. Specifically, each of the links  126  tapers down in diameter toward a distal end thereof, with the decrease in diameter permitting insertion of the distal end of each link  126  into a proximal opening of an adjacent one of the links  126 . A proximal end of each of the links in this embodiment includes a circumferential tab (not shown) configured to engage a corresponding circumferential groove (not shown) formed in a distal end of an adjacent link  126  wherein a diameter of the circumferential groove (not shown) is larger than a diameter of the proximal end of the adjacent link to permit the movement of adjacent links relative to one another. Specifically, in an exemplary embodiment, adjacent links may be movable out of longitudinal alignment with one another to permit the articulating section  116  to exhibit an overall curvature conforming to, for example, a body conduit into which the articulating section  116  is inserted. In an exemplary embodiment, each link  126  is configured to be deflectable by up to 15° from an adjacent link  126 . In the embodiment of  FIGS. 1-2 , the articulating section  116  comprises six links  126  and may therefore deflect by up to ±90° from a longitudinal axis of the channel  112 . The desired deflection angle may therefore be changed by adding or reducing the number of links  126  in the articulating section  116 . This engagement permits each of the links  126  to be at least partially receivable within an adjacent link  126 . Thus, the articulating section  116  may have at least two degrees of freedom, permitting a curvature thereof in any direction along a single plane or, in another embodiment, in any direction with respect to a longitudinal axis of the articulating section  116 . The articulating section  116  may be formed substantially similarly to the device described in U.S. application Ser. No. 12/121,345 entitled “Articulating Torqueable Hollow Device” filed on May 15, 2008 to Ostrovsky et al., the contents of which are incorporated herein by reference. 
         [0010]    Movement of the articulating section  116  is facilitated by a control wheel  146  located on a proximal portion of the handle  102 , the control wheel being connected to a knob  148  which may be actuated by a user of the device  100 . Specifically, the control wheel  146  is connected to two pull wires (not shown) extending through specially formed channels extending through the handle, lumen  114  and each link of the articulating section  116 . As shown in  FIG. 3 , manual actuation of a lateral side of the knob  148  rotates the control wheel  146  which in turn places a pressure on the control wires (not shown) causing lateral movement of the articulating section  116 . Specifically,  FIG. 3  depicts actuation of a left lateral wall  150  of the knob  148  causing the control wheel to turn clockwise shortening a length of the control wire on the right lateral portion of the device  100 . This shortening causes the articulating section  116  to extend outward toward the right lateral portion of the device  100 . 
         [0011]    Each of the channel  112  and the articulating section  116  defines two lumens extending therethrough—e.g., one for the introduction of fluids into the target organ and one for the withdrawal of fluids therefrom. Specifically, as shown in  FIG. 1 , the device  100  comprises an introduction lumen  132  located within and surrounded by a withdrawal lumen  134 . In this embodiment, the introduction lumen  132  is substantially concentric with the withdrawal lumen  134 . A proximal end of the introduction lumen  132  is connected to a fluid input port  140  of the handle  102  and a proximal end of the withdrawal lumen  134  is connected to the lumen  114  of the channel  112  which extends to a fluid withdrawal port  142  at a proximal end thereof 
         [0012]    A distal end of the articulating section  116  according to this embodiment has an increased outer diameter end link  128  while a diameter of the withdrawal lumen  134  extending through the articulating section  116  remains substantially constant. A miniature camera  136  is mounted on a distal face of an outer wall of the end link  128 . In a preferred embodiment, the digital camera is approximately 1 mm×1 mm in size although other sizes may be employed without deviating from the scope of the present invention. The digital camera  136  is preferably a Complimentary Metal-Oxide Semiconductor (“CMOS”) camera. Fiber optic light conductors  138  also extend through the device  100  from the handle  102  where they are connected to a source of light (not shown) to the distal face of the end link  128  to provide illumination to an area visualized by the camera  136 . The CMOS digital camera  136  according to the present invention transmits recorded data to a processor such as a computer via a signal cable  144 , wherein the processor may be a computer or other electronic device. It is noted that although the present invention has been described with a fiber optic light source, any other light source may be employed without deviating from the spirit and scope of the present invention including, but not limited to light emitting diodes (LEDs). 
         [0013]    The exemplary articulating section  116  of the present invention bypasses the need for optical conductors and a conventional CCD camera, thus allowing a reduction of a diameter of the distal end of the device  100  as compared to conventional devices employing imaging systems using a bundle of optical fibers to collect an image at the distal end and to transmit this image to a camera which remains external to the body. By employing a CMOS camera  136 , the device of the present invention permits a miniaturization of the device not possible with presently available endoscopic devices. Furthermore, since the CMOS camera  136  is less expensive than conventional endoscopic cameras, the exemplary articulating section  116  of the present invention may be configured to be disposable and therefore eliminates a need for sterilization, repair, etc. As a result, the device  100  of the present invention is both smaller and lighter than conventional imaging devices. Specifically, the articulating section  116  according to the present invention permits the use of a smaller outer diameter of the end link  128  while still providing at least as large as inner diameter as is used with presently available device. In an alternate diameter, the outer diameter of the articulating section  116  may be the same as conventional devices but may provide a larger inner diameter of the lumen  134  extending therethrough to permit the insertion of larger tools therethrough or to increase a volume of fluid flow therethrough. In a preferred embodiment, an outer diameter of the articulating section  116  is approximately 6 mm whereas conventional devices have an outer diameter of approximately 8 mm. The articulating section  116  of the present invention has the added advantage of being disposable and inexpensive in comparison to conventional imaging devices which also must be sterilized for reuse. 
         [0014]    Those skilled in the art will understand that the described exemplary embodiments of the present invention may be altered without departing from the spirit or scope of the invention. Thus, it is to be understood that these embodiments have been described in an exemplary manner and are not intended to limit the scope of the invention which is intended to cover all modifications and variations of this invention that come within the scope of the appended claims and their equivalents.