METHOD AND APPARTUS FOR HYSTEROSCOPY AND ENDOMETRIAL BIOPSY

• US 20140276207A1
• Filed: 04/23/2012
• Published: 09/18/2014
• Est. Priority Date: 10/25/2010
• Status: Abandoned Application

• 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
• Application Number:
  US14/115,318
• Publication Number:
  US 20140276207A1
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/00034 rechargeable
• CPC Class Codes: A61B 1/00042 for mechanical operation
• CPC Class Codes: A61B 1/0005 combining images e.g. side-by-side, superimposed or tiled
• 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 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00091 Nozzles
• CPC Class Codes: A61B 1/00094 Suction openings
• CPC Class Codes: A61B 1/00101 the distal tip features being detachable
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/00108 characterised by self-sufficient functionality for stand-alone use
• CPC Class Codes: A61B 1/00124 electrical, e.g. electrical plug-and-socket connection
• CPC Class Codes: A61B 1/00128 mechanical, e.g. for tubes or pipes
• CPC Class Codes: A61B 1/00179 for off-axis viewing
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/045 Control thereof
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/053 : being detachable
• CPC Class Codes: A61B 1/0607 : for annular illumination
• 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 10/0275 : with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0291 : for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 10/04 : Endoscopic instruments
• CPC Class Codes: A61B 2017/00221 : with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2090/309 : using white LEDs
• CPC Class Codes: A61B 2090/372 : Details of monitor hardware
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 2210/1433 : Uterus

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.

Claims

1-49. -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.

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.

59-67. -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.