The present invention relates generally to the field of endoscopy and specifically to flexible endoscopes used for medical examination of an intestinal system during which an insertion tube provided with an optical head is put through the mouth and down the esophagus. An example of possible implementation of the present invention could be a gastroscope for viewing the stomach or duodenum and for removing tissues from these organs. It should be kept in mind, however that the present invention is not limited to gastroscopes and can be implemented in any other endoscopes employed for medical examination of the intestinal system, e.g. in duodenoscopes, sigmoidoscopes, etc.
The main components of a modern gastroscopic apparatus comprise a flexible insertion tube fitted at its distal end with an optical head, an operating handle for manipulating the insertion tube during its advancement within the body organ and a system control unit provided with a source of compressed air, water and vacuum to be supplied to the body organ during the gastroscopic procedure. The insertion tube is introduced within a patient's mouth through a dedicated mouthpiece held by the patient's teeth. The mouthpiece guides the insertion tube during the gastroscopic procedure.
Flexible endoscopes in general and gastroscopes in particular are notoriously difficult to clean and disinfect thoroughly, leading to problems of cross-contamination between patients and between patients and staff. These problems can be partially avoided by covering the endoscope with a single-use sleeve, which is discarded after use. The use of a disposable sleeve (also referred to as a sheath) to cover an endoscope is well known in the art.
Endoscopes commonly have working channels, running from a proximal port outside the body to a distal port at the distal end of the endoscope. When the distal end of the endoscope is inserted into the body organ, the working channel may be used to pass a surgical instrument through to the distal end of the endoscope in order to perform a surgical procedure, such as a biopsy.
Instruments that are used in this manner become contaminated with biological matter from inside the patient's body. As the instrument is withdrawn from the body, it spreads the contamination to the interior of the working channel and to the proximal port of the endoscope and eventually to the operator's hands.
Therefore it would be very beneficial to prevent spread of contamination originating from the endoscope itself or from the surgical instrument
Ouchi (US Publication 2003/0097043) describes a cover for preventing contamination of an operating portion of an endoscope. The cover is formed in a bag-like shape for enveloping a total of the operating portion. The cover can prevent exposure to contamination during the endoscopic procedure when the insertion tube is inside the patient. However, during the procedure and in the end of the procedure, the insertion tube is withdrawn from the patient and, since it remains uncovered, the spread of contamination originating from the insertion tube would not be prevented.
Chinese patent CN 1,486,666 describes an endoscope system fitted with a disposable sheath, which at least at its distal end is made of transparent material. The sheath seals all the inserted portion of the endoscope. Various hard-to-clean, open-ended channels of the endoscope, including working channel for surgical instrument, are arranged outside the insertion tube and are disposed of together with the sheath after single use.
Still further methods for sheathing an endoscope for protecting it from contamination are described, for example, in Silverstein (U.S. Pat. No. 4,646,722) and Sidall (U.S. Pat. No. 4,741,326), whose disclosures are incorporated herein by reference. These methods attempt to prevent contamination of the endoscope, either by adding disposable working channels external to the endoscope itself (Silverstein) or by adding a disposable liner inside a working channel of the endoscope (Sidall).
Voloshin (U.S. Pat. No. 6,485,409), whose disclosure is incorporated herein by reference, describes an endoscope, which comprises an endoscopic probe, a bending section for directing the probe within the colon (steering unit), an insertion tube and a flexible covering sleeve or a sheath, which is coupled proximally to the probe. The sleeve is attached to the endoscope in such a manner that its folded section is retained between a cap and an internal spindle located between the insertion tube and the probe head. When inflated, the folded section unfolds over a flange of the internal spindle and an inner portion of the sleeve is pulled in a distal direction. The sleeve at the same time covers the insertion tube and prevents its contamination during the endoscopic procedure.
Eizenfeld (WO 2004/016299; PCT/IL03/000661), whose disclosure is incorporated herein by reference, discloses an endoscope which employs a flexible inflatable sleeve assisting propulsion of the insertion tube within the body organ. The sleeve is retained in folded condition within a dedicated dispenser. The insertion tube is inserted into a dispenser and is advanced within the body organ. The insertion tube engages the sleeve, which covers the insertion tube and protects it from contamination.
Bar-Or (WO 2005/110185; PCT/IL05/000426), whose disclosure is incorporated herein by reference, discloses a disposable set which comprises a dispenser for retaining a folded disposable sleeve, which upon inflation unfolds and protects the insertion tube from contamination.
The above-mentioned references teach how the principle of a disposable covering sleeve can be realized essentially in a colonoscopic apparatus, however they do not disclose how to implement this approach for preventing contamination in a gastroscopic apparatus as well.
The object of the present invention is to provide a new and improved gastroscopic apparatus, which minimizes the risk of cross contamination to both patient and staff during the gastroscopic procedure.
Still a further object of the invention is to provide a new and improved gastroscopic apparatus, wherein an insertion tube can be advanced along the esophagus while being protected by a disposable covering sleeve.
Still a further object of the invention is to provide a new and improved gastroscopic apparatus fitted with a simple arrangement for deployment of a covering sleeve around the insertion tube when it is being inserted in the esophagus and displaced along the esophagus.
Various embodiments of the present invention can be implemented as a gastroscopic apparatus and as a method for propelling a gastroscope in the esophagus.
For a better understanding of the present invention as well of its benefits and advantages, reference will now be made to the following description of its embodiments, taken in combination with the accompanying drawings.
With reference to
The operation handle includes an angulation control knob or wheel 11, suction and air/water buttons 12, 14 for admitting fluid medium into the esophagus and a Y-connector 16 provided with an inlet port 18 and a channel for connecting to respective sources of fluid medium (usually air, water and vacuum). These sources are available at the SCU.
The operation handle is operatively connected to a proximal end of an insertion tube 20, through which a guide channel 22 extends. In a preferred embodiment of the invention the guide channel is designed as an integral conduit suitable for receiving a disposable tube with separate lumens for supplying air, water and vacuum. This tube will be referred-to further as multilumen tubing. An example of such multilumen tubing and its description can be found in Bar-Or (WO 2005/110200; PCT/IL05/000428), whose disclosure is incorporated herein by reference. The operation handle is connected also to a system control unit (SCU, shown in
It is not shown in detail, but one should keep in mind that within the insertion tube are provided various devices, which are necessary for proper functioning of the endoscope. These devices and their arrangement within the insertion tube are known in the art. Among such devices one can mention vertebrae and strings, which can be manipulated by the angulation knob provided at the operation handle.
Referring now to
One should also keep in mind that adjacent the distal section of the insertion tube a bending section is provided. This section enables maneuvering of the distal end of the insertion tube during the endoscopic procedure. The bending section comprises a plurality of vertebrae connected to the strings, which are pullable upon rotation of the angulation knob. By virtue of this provision it is possible to change the vertebrae's position and thus to control the curvature of the distal end and to navigate the insertion tube during its advancement within the patient.
Deployed within the dispenser a fixation bushing 44 is provided. This bushing has a flaring entrance opening 46 to pass the insertion tube there through and a conical outside surface 48, which snugly fits with a mating inwardly facing conical surface 50 at the rear end of the dispenser. The remainder of the bushing is configured as a thin cylindrical tube, which is put on the insertion tube with possibility for relative displacement there between.
An annular space is defined between intermediate portion 36 of the dispenser and the bushing and a flexible protection sleeve or sheath 52 is deployed in this space. The sleeve is folded within the dispenser as shown in
Now with reference to
During the gastroscopic procedure the mouthpiece is held within the patient's mouth by her or his teeth and the insertion tube is advanced along the esophagus through the mouthpiece, while the dispenser is arrested within the mouthpiece.
As shown in
One end of the central body portion of the mouthpiece terminates by a flange portion 68, while the opposite end terminates by a distal, bite portion 70. The flange portion is directed essentially perpendicularly to the central body portion and has an overall dimension D. The inside diameter of the opening 66 is less than the outside diameter of the rear end 32 of the dispenser. By virtue of this provision when the dispenser is fully inserted within the mouthpiece, the flange portion 68 of the mouthpiece abuts the rear end 32 of the dispenser to limit its axial displacement within the mouthpiece as seen in
The bite portion is configured with a rim, which slightly widens laterally to ensure reliable holding of the bite portion by the patient's teeth when the mouthpiece is in the patient's mouth.
Attention is now called again to
In practice the dispenser, the sleeve and the mouthpiece are cheap disposable items, which are discarded at the end of the endoscopic procedure after evacuating the insertion tube from the esophagus. The dispenser and the mouthpiece could be made from a rigid or semi rigid plastic material, e.g. polypropylene, polyethylene, ABS, etc.
The sleeve could be typically made from a flexible biocompatible plastic, such as polyamide, having a thickness of about several tens of microns.
In
Still further stage of the gastroscopic procedure is depicted in
It is seen that proximal portion 96 of the insertion tube still has not been advanced in the dispenser. This portion would be available if it is required to advance the insertion tube along the esophagus still further, through the stomach 94 within a duodenum 98.
At the end of gastroscopic procedure the insertion tube and the sleeve are withdrawn from the patient.
According to one embodiment of the invention the dispenser remains arrested within the mouthpiece during the withdrawal. When the insertion tube is being withdrawn, the sleeve bunches and remains in the patient's mouth outside the dispenser. At the end of withdrawal the compactly bunched sleeve is located in the mouth adjacent the bite portion. Now the dispenser is disengaged from the mouthpiece and the insertion tube together with the bunched sleeve is taken out. Thereafter the insertion tube is separated from the sleeve and the sleeve along with the dispenser is disposed of. The mouthpiece is removed from the patient's mouth and is disposed of too.
According to an alternative embodiment the dispenser is disengaged from the mouthpiece before the withdrawal and the insertion tube is evacuated from the esophagus together with the sleeve being extended and deployed there along. The insertion tube is removed from the mouthpiece together with the dispenser and with the covering sleeve. Thereafter the insertion tube is separated from the sleeve and the sleeve along with the dispenser is disposed of. The mouthpiece is removed from the patient's mouth and is disposed of too.
It can be readily appreciated that by virtue of the present invention it is possible to minimize the risk of cross contaminations to both patients and staff during the gastroscopic procedure and to make the gastroscopic procedure cleaner and safer.
Furthermore, the present invention eliminates the need for reprocessing equipment and helps the facility to save on capital expenses (purchase of additional scopes), labor costs and costs of disinfectants, cleaning tools and scope maintenance.
The present invention allows for increased patient throughput as a result of faster procedures with shorter down time for the scope. This, in its turn, allows to schedule more procedures and therefore to increase revenues for both physician and facility.
The gastroscopic apparatus of the present invention has very simple construction, which is reliable and at the same time remains very similar to a standard apparatus, thus enabling an extremely short learning time to the physician to achieve optimal performance.
It should be appreciated that the present invention is not limited to the above-described embodiments and that one ordinarily skilled in the art can make modifications without deviation from the scope of the invention, as will be defined in the appended claims.
For example, more that two openings could be made in the dispenser and more than one tooth could be made in the mouthpiece.
The openings could be made in the mouthpiece instead of the dispenser and the teeth can be arranged in the dispenser instead of the mouthpiece.
Other types of detachable connections between the mouthpiece and the dispenser could be employed instead of a snap connection.
When used in the following claims, the meaning of terms “comprise”, “include”, “have” and their conjugates is “including but not limited to”.
It should also be appreciated that the features disclosed in the foregoing description, and/or in the following claims, and/or in the accompanying drawings may, both separately and in any combination thereof, be material for realizing the present invention in diverse forms thereof.
Number | Date | Country | |
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60658564 | Mar 2005 | US |