Method and apparatus for hysteroscopy and combined hysteroscopy and endometrial biopsy

• US 9,468,367 B2
• Filed: 05/14/2013
• Issued: 10/18/2016
• Est. Priority Date: 05/14/2012
• Status: Active Grant

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: EndoSee Corporation (The Cooper Cos., Inc.)
• Inventors: Ouyang, Xiaolong, Indman, Paul D., Deckman, Robert K., Wang, Shih-Ping
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): CHOU, WILLIAM B
• Application Number:
  US14/400,986
• Publication Number:
  US 20150164313A1
• Time in Patent Office: 1,253 Days
• Field of Search: 600/103, 600/104, 600/109, 600/117, 600/118, 600/127, 600/129, 600/131, 600/132, 600/135, 600/153, 600/155, 600/156, 600/157, 600/158, 600/159, 600/160, 600/179, 348/77
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00006 of control signals
• CPC Class Codes: A61B 1/00034 rechargeable
• CPC Class Codes: A61B 1/00052 positioned at proximal end of the endoscope body
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/00071 Insertion part of the endoscope body A61B1/0055 takes precedence
• CPC Class Codes: A61B 1/00094 Suction openings
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/00114 Electrical cables in or with an endoscope
• CPC Class Codes: A61B 1/00124 electrical, e.g. electrical plug-and-socket connection
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/126 provided with means for cleaning in-use
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes

Abstract

Instruments and methods are described for performing hysteroscopy and/or combined hysteroscopy and endometrial biopsy. According to some embodiments, the handle, electronics and integrated display screen form a re-usable portion of the instrument while the fluid hub and cannula which includes a CMOS imaging module and LED lighting, form a single use portion of the instrument. The cannula is semi-flexible such that the operator can easily grasp the cannula at some intermediate point along the shaft (e.g. 5 inches from the distal tip) to bend and/or steer the cannula during use. According to some embodiments, the distal tip has a larger diameter than the shaft which has been found to improve fluid management during use in some applications.

Claims

1. An integrated endoscopic instrument for examining a uterus of a patient, the integrated endoscopic instrument comprising:

an elongate member having a proximal end, a distal end, and a shaft extending from the distal end to the proximal end,

wherein the shaft defines a fluid channel and houses a plurality of electrical conductors,

wherein the shaft has a first outer diameter of less than 5 mm, and the distal end has a second outer diameter that is greater than the first outer diameter, such that the elongate member can be advanced distally to position the distal end inside of the uterus and to position the shaft within a cervix of the patient for allowing fluid to leak from the uterus around the shaft and into the cervix, and such that the elongate member can be withdrawn proximally to position the distal end within the cervix for blocking leakage of fluid from the uterus to the cervix; and

wherein the plurality of electrical conductors are configured to carry video signals and control signals;

an imaging system at the distal end of the elongate member configured to image the uterus and to provide the video signals;

an illumination system at the distal end of the elongate member configured to illuminate the uterus at an illumination field viewed by the imaging system;

a distal facing fluid opening at the distal end of the elongate member and in fluid communication with the fluid channel, wherein the distal facing fluid opening is positioned to improve a visual inspection using the imaging system by delivering fluid to flow in a distal direction thereby clearing debris close to the imaging system;

a handle that is configured and dimensioned to be grasped and manipulated by a user; and

an integral image display that is electrically coupled to the imaging system by at least some of the plurality of electrical conductors, wherein the integral image display is configured to display images provided by the imaging system for viewing by the user.

2. An integrated endoscopic instrument according to claim 1, wherein the first outer diameter is less than 3.8 mm.

3. An integrated endoscopic instrument according to claim 2, wherein the second outer diameter is at least 0.4 mm greater than the first outer diameter.

4. An integrated endoscopic instrument according to claim 1, wherein the second outer diameter is greater than 3.5 mm.

5. An integrated endoscopic instrument according to claim 4, wherein the second outer diameter is at least 0.4 mm greater than the first outer diameter.

6. An integrated endoscopic instrument according to claim 1, wherein the distal end is an integral distal end.

7. An integrated endoscopic instrument according to claim 1, wherein the handle comprises control buttons and system electronics that actuate the imaging system and the illumination system.

8. An integrated endoscopic instrument according to claim 1, wherein the integral image display is mounted to the handle.

9. An integrated endoscopic instrument according to claim 1, wherein the elongate member, the handle, and the integral image display are positioned along a longitudinal axis defined by the shaft of the elongate member.

10. An integrated endoscopic instrument according to claim 1, wherein the elongate member, the handle, and the integral image display are coupled to one another such that the elongate member, the handle, and the integral image display move together when the handle is moved.

11. An integrated endoscopic instrument according to claim 1, wherein the integral image display is tiltable with respect to the handle.