Method and apparatus 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 - 71 . (canceled) 
     
     
         72 . A self-contained, hand-held, low-cost endometrial endoscope having a single-use, disposable cannula releasably connected by hand to a multiple-use handle that contains an image display and detachable by hand from the handle, including:
 a distal portion of the cannula configured and dimensioned for insertion into the patient's uterus and having one or more distal openings configured to provide fluid outflow, an imaging system configured to image the uterus and generate video signals in electronic format, and an illumination system configured to illuminate the uterus;   a proximal portion of the cannula provided with one or more ports configured to provide passage of fluid into the cannula, and a connector;   an electrical cable extending within the cannula from the imaging system to the proximal portion and configured to carry video and control signals;   a handle configured for multiple endoscopic examinations of patients and shaped and dimensioned to be grasped by a user's hand to manipulate the endoscope while examining a patient's uterus, the handle including an integral image display and an interior containing electronic components;   a coupling formed of portions of the handle and the connector and configured to releasably, by hand, attach to and detach from the handle, by mating an extension of one of the handle and the connector with a recess in the other one of the handle and the connector, and to releasably establish an electrical connection between the cable and the handle;   wherein the connector includes an outer shell and a barrier fitted inside the outer shell and including a first seal configured to keep fluid in the cannula from reaching the electronic components in the handle but to allow passage of the electrical cable and one or more additional seals between the first seal and the electronic components, also configured to keep fluid in the cannula from reaching the electronic components, including a seal formed by an inner portion of the barrier tightly enveloping a radial extend of the cable;   wherein the electronic components are configured to receive user commands entered by user operations of one or more of the handle and the display, the imaging system is configured to provide an image of the uterus, and the display is configured to display the image for viewing by the user while the cannula is inserted in the patient's uterus.   
     
     
         73 . The endoscope of  claim 72 , further including plural user-operated control elements in at least one of the handle and the display configured to receive the commands entered by user operation to selectively energize the illumination and imaging systems to image the patient's uterus and to display images at said display. 
     
     
         74 . The endoscope of  claim 72 , further including a tissue sampling element at the distal portion of the cannula configured to sample endometrial tissue and deliver samples into the cannula. 
     
     
         75 . The endoscope of  claim 74 , in which the tissue sampling element includes a side opening with a proximally facing edge configured to scrape endometrial tissue from the uterus. 
     
     
         76 . The endoscope of  claim 72 , in which the illumination system includes one or more LED devices at the distal portion of the cannula. 
     
     
         77 . The endoscope of  claim 72 , in which the imaging system comprises an electronic imaging device generating a standard video format image for display. 
     
     
         78 . The endoscope of  claim 72 , in which the cannula includes plural enclosed channels extending between the distal and proximal portions. 
     
     
         79 . The endoscope of  claim 78 , in which one of the plural channels is configured for endometrial tissue sampling. 
     
     
         80 . A self-contained endoscope for examining a patient's uterus, including:
 a cannula configured for insertion into the patient's uterus to distend and image the uterus, and a handle including an integral image display and configured and dimensioned for a user to hold and manipulate the endoscope;   wherein a distal end of the cannula has one or more openings configured to provide fluid outflow, an imaging system configured to image the uterus and provide electronic video images to the display, and an illumination system configured to illuminate the uterus;   a coupling between at least one of (i) the cannula and the handle and (ii) the handle and the display, which coupling forms a boundary between a single-use portion of the endoscope that includes at least the cannula and a multiple use portion that includes at least the display;   wherein the coupling has an attached state in which the single-use portion and the multiple-use portion joined by a hand operation into a single, self-contained endoscope that the user manipulates in space through the handle, and the imaging system and display are physically and electrically integrated, and a released state in which the single-use portion and the multiple-use portion of the instrument are physically and electrically separated by a hand operation;   one or more ports in a proximal, side surface of the cannula;   computer circuits and control elements in at least one of the handle and the display that are responsive to operator manipulation of the control elements to selectively energize the illumination and imaging systems to image the patient's uterus and to display images at the display when the coupling is in its attached state;   a fluid barrier configured to keep fluid in the cannula from entering interior portions of the multiple-use portion scope;   wherein the endoscope is configured for a medical procedure in which the cannula is inserted into the patient's uterus to selectively provide, under operator control including through the control elements, each of (a) uterus distention by introducing fluid under positive pressure into one or more of the ports, which fluid passes through the cannula and enters the uterus through one or more of the openings at the distal end, (b) uterus illumination with the illumination system; (c) images of the illuminated uterus taken said imaging system; and (d) display of the images at the display; and   wherein the coupling is hand-changed from the attached state to the released state to thereby uncouple the single-use portion so that a new single-use portion can be coupled by a hand operation with the same multiple-use portion for use for another uterus examination; and   whereby the multiple-use portion is kept from being contaminated with fluid from the single-use portion and need not be sterilized between patient but can be simply disinfected.   
     
     
         81 . The self-contained endoscope of  claim 80 , in which the multiple-use portion includes the handle and the display. 
     
     
         82 . The self-contained endoscope of  claim 80 , in which the control elements include buttons on the handle. 
     
     
         83 . The self-contained endoscope of  claim 80 , in which at least some of the computer circuits are in the handle. 
     
     
         84 . The self-contained endoscope of  claim 80 , further including another fluid barrier configured to keep fluid flowing in the cannula from moving in the proximal direction into interior portions of the handle. 
     
     
         85 . The self-contained endoscope of  claim 80 , further including a sampling opening at a side surface of the distal end of the cannula configured to collect tissue samples from the patient's uterus. 
     
     
         86 . The self-contained endoscope of  claim 85 , in which the sampling opening includes an edge facing in a proximal direction and configured to scrape tissue from the patient's uterus wall and direct the scraped tissue into the cannula. 
     
     
         87 . The self-contained endoscope of  claim 80 , in which the illumination system includes at least one LED device at the distal end of the cannula. 
     
     
         88 . The self-contained endoscope of  claim 80 , in which the imaging system includes an integrated circuit at the distal end of the cannula that generated and transmits to the display a standard video format image. 
     
     
         89 . A method of examining a patient's uterus with a hand-held, self-contained endoscope, said method including:
 releasably attaching by hand a sterile, single-use portion of the endoscope to a multiple-use portion of the endoscope;   introducing a distal end of the single-use portion into the patient's uterus;   distending the patient's uterus by introducing fluid into one or more channels in the single-use portion and causing the fluid to flow into the patient's uterus through one or more openings at the distal end;   illuminating the patient's uterus with an illumination system emitting light at the distal end;   imaging the uterus while illuminated with an imaging system at the distal end;   sending images of the uterus from the illumination system through a cable in the single-use portion;   selectively displaying the images at a display that is connected to the cable and is physically and electrically integrated with, and moves with, the single-use portion of the instrument during the patient's examination;   controlling the illumination and imaging systems with operator-manipulated control elements on at least one of the single-use and multiple-use portions;   keeping fluid in the single-use portion from contaminating interior portions of the multiple-use portion through the use of one or more fluid barriers in the endoscope;   releasing by hand and removing the single-use portion from the multiple-use portions;   disinfecting the multiple-use portion without requiring sterilization; and   attaching by hand a new, sterile single-use portion to the multiple-use portion to prepare the endoscope for another examination of a uterus.   
     
     
         90 . The method of  claim 89 , in which the controlling comprises manipulating by hand control elements in a handle that is a part of the multiple-use portion of the endoscope and that the user grasps to manipulate the endoscope while examining the patient's uterus. 
     
     
         91 . The method of  claim 89 , including sampling endometrial tissue by scraping the patient's uterus with a sampling opening that is on a side surface of the distal end of the single-use portion and has an edge facing in a proximal direction, and extracting scraped tissue through at least one said channels.