Surgery – Endoscope – With protective sheath
Reexamination Certificate
2000-07-31
2002-09-10
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With protective sheath
C600S114000, C600S109000, C600S129000, C600S156000, C600S159000
Reexamination Certificate
active
06447444
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical probes, and specifically to endoscopes.
BACKGROUND OF THE INVENTION
Various types of endoscopes are known in the art for visual inspection and diagnosis of the rectum and sigmoid of the large intestine. Rigid rectoscopes and sigmoidoscopes are most commonly used for this purpose, since they are durable, easy to use and relatively inexpensive.
To perform an examination using the rigid rectoscope (or sigmoidoscope), the physician first inserts a speculum through the anus. An obturator, having a blunt, rounded distal end, is fitted inside the speculum and protrudes distally therefrom to ease the insertion. Once the speculum is in place, the physician withdraws the obturator and closes the proximal end of the speculum with a plug. A special telescope is fitted into the plug, which enables the physician to view the inside of the rectum and sigmoid at the distal end of the speculum, either by direct vision or using a video camera coupled proximally to the telescope. In order to illuminate the area under view, a light source in an external console is coupled proximally to the speculum by fiberoptics. Typically, the plug also includes one or more working channels, which are used for irrigation, insufflation or insertion of surgical tools through the speculum.
Various rectoscopes and sigmoidoscopes of this type are available commercially. For example, Karl Storz GmbH, of Tuttlingen, Germany, offers the model 24911S rectoscope, which may be used with a rod lens telescope (for example, model 24946B) to view the rectum either under direct view or using a Karl Storz Endovision video camera. The rectoscope and accessories are made from stainless steel to allow disinfection and autoclaving between uses.
Rectoscopes and sigmoidoscopes having a disposable speculum and obturator are also available, such as the KleenSpec disposable sigmoidoscope produced by Welch Allyn Inc., of Skaneateles Falls, N.Y. The speculum and obturator are made of plastic. The speculum clips or screws onto a multi-use handle, to which a light source, telescope, video camera and instruments may be attached.
Flexible sigmoidoscopes and colonoscopes are also known in the art. Most such scopes include a fiberoptic bundle for conveying images from their distal end, within the intestine, to an eyepiece or video camera fixed to the proximal end. Some such scopes, such as the Pentax ES3801 PVE Video Sigmoidoscope, made by Asahi Optical Company of Tokyo, have a CCD detector with an objective lens at its distal end. By comparison with rigid rectoscopes and sigmoidoscopes, however, flexible scopes are costly, fragile and difficult to clean.
SUMMARY OF THE INVENTION
It is an object of some aspects of the present invention to provide an improved endoscope, and particularly an improved rectoscope.
It is an object of some aspects of the present invention to provide a video rectoscope that gives improved visibility of anatomical features within the rectum.
It is another object of some aspects of the present invention to provide a rectoscope that is easy and convenient for medical personnel to use.
It is a further object of some aspects of the present invention to provide a rectoscope including an easily-replaceable disposable portion, thus minimizing or eliminating the need for disinfection and sterilization between uses.
It is yet another object of some aspects of the present invention to provide methods and apparatus that facilitate insertion of an endoscope, particularly a rectoscope or sigmoidoscope, into a body cavity.
It is still another object of some aspects of the present invention to provide an improved steering mechanism for an endoscope.
In preferred embodiments of the present invention, a rectoscope comprises an elongate, generally rigid insertion member having a video camera head at its distal end. The insertion member and camera head are covered by a disposable sheath, which includes a transparent distal portion, preferably including an optical window, covering the camera head. The camera head includes an image detector array, preferably a CCD array, as is known in the art, along with a light source for illuminating an area of the intestine viewed by the camera head and an objective lens, which focuses an image of the area onto the array. The sheath, which is preferably made of a biocompatible plastic material, is removed and discarded after use. The rectoscope is used to examine and treat areas of the colon of a patient, specifically the rectal and sigmoid portions of the colon.
By comparison with rigid rectoscopes and sigmoidoscopes known in the art, the present invention can provide substantially improved image quality, because the video camera head is placed at the distal end of the rectoscope, near the area under view. The distal positioning of the camera head enables the present rectoscope to achieve both higher magnification and a wider field of view than video rectoscopes and sigmoidoscopes known in the art, in which the camera head views the intestine through a telescope from the proximal end of the scope.
In preferred embodiments of the present invention, the sheath comprises a narrowed, generally bluntly pointed tip, to ease insertion of the rectoscope through the anus. The narrowed tip thus performs the function of the obturator used in insertion of rectoscopes and sigmoidoscopes known in the art. Elimination of the obturator relieves a physician using the rectoscope of unpleasant odors and possible exposure to infection that are commonly associated with removal of the obturator.
In some preferred embodiments of the present invention, the optical axis of the camera head is angled relative to the longitudinal axis of the insertion member, and the distal end of the sheath is likewise angled, thus defining the narrowed tip. Preferably, the sheath has a bulbous protrusion at the tip, which further eases insertion of the rectoscope through the anus.
In one such preferred embodiment, a mirror is fixed to the bulbous protrusion, which is shaped so that the mirror is positioned within the field of view of the camera head and is oriented obliquely relative to the optical axis thereof An image of the inner wall of the rectum or sigmoid is reflected from the mirror and captured by the camera head. The mirror thus enables the physician to see an image from an alternative view angle, which may be useful particularly in observing and controlling the movement of tools that the physician inserts into the rectum using the rectoscope, as described below.
In other preferred embodiments of the present invention, the narrowed tip of the sheath is formed by a plurality of leaves, formed of a resilient material, which butt together tightly in a closed configuration to cover the transparent portion of the sheath and the camera head. During insertion through the anus, the closed leaves protect the transparent portion from fouling by fecal matter, lubricants or other substances. After the rectoscope has been inserted, the leaves are drawn apart, preferably by pulling the sheath back proximally, so as to expose the transparent portion of the sheath and allow the camera head to receive images of the area of the intestine under view.
In some preferred embodiments of the present invention, the sheath includes one or more worldling channels, which may be used for suction, irrigation, insulation, passage of surgical tools or other functions known in the art. The rectoscope includes a handle, to which the sheath is attached, preferably by a quick connect/disconnect fitting. Preferably, the handle includes user controls for regulating such functions as suction, irrigation and insufflation through the working channels. Further preferably, one or more of the working channels include a one-way valve, to prevent back-flow of fluid (gas or liquid) used in irrigation or insufflation through the channels.
Although rectoscopes in accordance with the present invention are described herein as being generally rigid, in some preferred embodiments the insertion member may include a
Avni Arie
Levin Victor
Oz Dan
Leubecker John P.
Sightline Technologies Ltd.
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