Method and appartus for hysteroscopy and endometrial biopsy

Abstract

Methods and devices are described for performing a combined hysteroscopy and endometrial sampling. Techniques for improving visual images include forward facing fluid ports for clearing tissue debris and LED positioning and design. Manufacturability is improved through separately formed tip and shaft pieces. User interface features are described including user-friendly handle-mounted buttons as well the use of an interactive integrated touch screen display. The handle and display can be mated to a docking station for storage and recharging batteries.

1 - 49 . (canceled) 
     
     
         50 . A user-friendly integrated endoscopic apparatus for examining uterine tissues comprising:
 an elongate member having a proximal end, a distal end, and being dimensioned and configured to facilitate insertion of the distal end through a patient's cervix and into the uterus;   a light delivery system configured to illuminate the uterine tissues being examined;   an electronic imaging module positioned at the distal end of the elongate member;   wherein the improvement comprises,   a handle having a low overall off-axis profile so as to facilitate easy rotation and tilting in use, the handle including:   a plurality of user-operated electrical controls to control a plurality of features of the apparatus; and   an integrated electronic display monitor being in electrical communication with the electronic imaging module;   wherein the elongate member is configured to be attached by hand to the handle for a patient examination and to be detached by hand from the handle for disposal after the examination whereas the handle is configured for use in multiple examinations.   
     
     
         51 . An apparatus according to  claim 50  wherein the integrated electronic display monitory is touch-sensitive. 
     
     
         52 . An apparatus according to  claim 50  wherein the plurality of user-operated electrical controls includes a brightness control with which a user can make a selection from at least three different illumination levels from the light delivery 
     
     
         53 . An apparatus according to  claim 50  wherein the plurality of user-operated electrical controls buttons includes a single capture button with which a user can select either capturing a still image or capturing video images which are stored in a storage device within the apparatus. 
     
     
         54 . An apparatus according to  claim 50  further comprising a lighted battery status indicator indicating battery status information to a user using two or more colors. 
     
     
         55 . An apparatus according to  claim 50  wherein the integrated electronic display monitory is touch-sensitive and a plurality of display screens can be displayed on the integrated touch-sensitive display monitor including a basic menu screen from which a plurality of other screens can he accessed; and one of the plurality of user-operated electrical controls can be used by a user to jump directly to the basic menu screen. 
     
     
         56 . An apparatus according to  claim 50  wherein the handle mates with a base station. 
     
     
         57 . An apparatus according to  claim 56  wherein the base station recharges a rechargeable battery in the handle when mated with the handle. 
     
     
         58 . An apparatus according to  claim 50  wherein the elongate member is designed to be disposable after a single use and the handle and display monitor are designed to be re-used many times. 
     
     
         59 - 67 . (canceled) 
     
     
         68 . A method of using an integrated endoscopic apparatus for examining uterine tissues comprising:
 opening a sealed package containing an unused elongate member, the elongate member having a proximal end and a distal end, and including a light delivery system at the distal end configured to illuminate the uterine tissues being examined and an electronic imaging module positioned at the distal end;   attaching the proximal end of the unused elongate ember to a previously-used handle and display unit,   wherein the improvement comprises,   including in the handle and display unit user-operated control features to control operation of the apparatus, and an integrated electronic display monitor;   inserting the distal end of the elongate member through a patient's cervix and into the patient's uterus;   examining uterine tissues by viewing images displayed on the integrated display monitor captured by the electronic imaging module and controlling operation of the apparatus with said control features; and   thereafter removing the elongate member from the handle and display unit for disposal.   
     
     
         69 . A method according to  claim 68  wherein the elongate member further includes one or more distal-facing fluid openings positioned at the distal end of the elongate member, and the method further comprising flowing fluid in a distal direction through the one or more distal facing fluid openings thereby urging debris away from the imaging module thereby improving visual inspection of the uterine tissues. 
     
     
         70 . A method according to  claim 68  wherein the handle has a low overall off-axis profile so as to facilitate easy rotation and tilting in use and the user-operated controls include two or more buttons included in the handle to control a plurality of features of the apparatus. 
     
     
         71 . A method according to  claim 68  wherein the display monitor, handle and attached elongate member are mounted in a fixed relationship so as to rotate about a longitudinal axis of the elongate member in alignment. 
     
     
         72 . A method according to  claim 68  wherein the integrated electronic display monitor is touch-sensitive. 
     
     
         73 . A method according to  claim 68  wherein the elongate member further includes a side-facing sampling opening, and the method further comprising collecting endometrial tissues through the sampling opening. 
     
     
         74 . A method according to  claim 68  wherein the elongate member includes a fluid hub and a sliding connector at the proximal end, the connector configured to mate with a distal end of the handle thereby establishing electrical connection between light delivery system and electronic imaging module with the handle and display unit. 
     
     
         75 . An apparatus according to  claim 50  wherein the elongate member includes:
 a side-facing sampling opening located and dimensioned and configured to facilitate in collection of endometrial tissues; and 
 a first distal-facing fluid opening positioned at the distal end of the elongate member to improve visual inspection of uterine tissue using the electronic imaging module by delivering fluid to flow in a distal direction thereby urging debris away from the imaging module. 
 
     
     
         76 . An apparatus according to  claim 75  wherein the sampling opening includes a cutting edge facing in the proximal direction. 
     
     
         77 . An apparatus according to  claim 75  wherein the elongate member includes separated fluid paths for the side-facing opening and the distal-facing opening. 
     
     
         78 . An apparatus according to  claim 75  including a second distal-facing fluid opening positioned on the distal end of the elongate member so as to improve visual inspection using the electronic imaging module by allowing fluid to flow in a distal direction thereby reducing debris close to the imaging module. 
     
     
         79 . An apparatus according to  claim 50  wherein the electronic imaging module includes a solid-state CMOS sensor. 
     
     
         80 . An apparatus according to  claim 50  wherein the electronic imaging module includes integrated video processing circuitry adapted and programmed to output standard video signals, the video processing circuitry being positioned on substantially the same plane as the CMOS sensor. 
     
     
         81 . An apparatus according to  claim 50  wherein the light delivery system includes LEDs positioned to surround a first distal-facing fluid opening positioned at the distal end of the elongate member.