Method and apparatus for hysteroscopy and endometrial biopsy

A low-cost medical instrument for examining a patient's uterus, which instrument includes a single-use portion that in a single insertion distends, images and biopsies a patient's uterus, said instrument comprising:

• a single-use, elongated conduit having a distal portion configured and dimensioned for insertion into the patient's uterus, and a proximal portion, said conduit comprising:
• a fluid hub formed at the proximal portion of the conduit;
• one or more proximal ports at the fluid hub, configured to provide passage of fluid into the conduit and out of the conduit;
• one or more distal openings at the distal portion of the conduit configured to provide fluid outflow from the conduit and inflow of fluid and biopsy samples into the conduit;
• one or more biopsy implements at the distal end of the conduit, configured and shaped to take biopsy samples from the uterus and transfer them into the conduit;
• an imaging system at the distal portion of the conduit configured to image the uterus and provide video signals;
• an illumination system at the distal portion of the conduit configured to illuminate the uterus at an illumination field viewed by said imaging system;
• and
• an electrical cable extending from a proximal end of the hub to the imaging and illumination systems and configured to carry video signals and control signals;
• a multiple-use handle that includes electronic and electrical components and is configured and dimensioned to be grasped by a user's hand and manipulated by the user;
• a coupling formed of portions of the handle and the fluid hub and configured to directly and releasably couple the fluid hub to the handle and thus mount the conduit to the handle;
• said coupling comprising (i) an extension of one of the handle and the hub and (ii) a channel in the other one of the handle and the hub, wherein the extension releasably fits in the channel;
• said hub comprising an outer shell having a distal portion and a proximal portion;
• a barrier fitted inside the outer shell of the fluid hub and comprising a first seal configured to keep fluid in the conduit from entering the hub in the proximal direction but allowing passage of the electrical cable from the proximal portion of the hub to the distal portion of the conduit;
• said first seal being spaced in the proximal direction from said one or more proximal ports in the hub;
• at least one additional seal disposed between the first seal and the handle and configured to keep fluid and tissue samples flowing in the conduit from reaching the handle, including a seal formed by an inner portion of said barrier tightly enveloping a radial extend of a proximal portion of the said cable;
• whereby the handle interior is kept from contamination with fluid and tissue samples in use of the instrument to examine a patient's uterus and therefore need not be sterilized but can be simply wiped for cleaning and disinfection after the conduit is detached from the handle and disposed;
• said handle comprising an integral image display and including a control system that is electrically coupled with said imaging system, the illumination system and the image display when the conduit is coupled to and mounted to the handle and is configured to selectively cause, in response to user commands entered through the handle, the illumination system to illuminate the uterus, the imaging system to provide an image of the uterus, and the display system to display the image for viewing by the user when the conduit is inserted in the patient's uterus;
• wherein:
• said conduit is configured to be uncoupled by hand from the handle after a single use in a patient and disposed;
• and
• the instrument is configured for a medical procedure in which said distal portion is inserted only once into the patient's uterus to provide each of (a) uterus distention by introducing fluid under positive pressure into one or more of said one or more proximal ports of the fluid hub, which fluid passes through said conduit and enters the uterus through one or more of said one or more distal openings, (b) an image of the uterus by illuminating the uterus with said illumination system and imaging the illuminated uterus with said imaging system, and (c) taking biopsy samples from the uterus by engaging the uterus with said biopsy implements and drawing fluid and biopsy samples from the uterus into the conduit through one or more of said one or more distal openings by applying negative pressure to one or more of said one or more proximal ports of the fluid hub.