Patent Application
20070112337
1. Field of the Invention
The present invention relates generally to endoscopy, and specifically to a protective sleeve for sheathing an endoscopic tool after its withdrawal from a body passage.
2. Summary of the Invention
The use of a disposable sleeve (also referred to as a sheath) to cover an endoscope is well known in the art. Flexible endoscopes, such as colonoscopes, 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 avoided by covering the endoscope with a single-use sleeve, which is discarded after use.
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, the working channel may be used, inter alia, 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 As the instrument is withdrawn from the body, it spreads the contamination to the interior of the working channel and to the proximal port of the endoscope and to the operator's hands.
Silverstein (U.S. Pat. No. 5,695,491) discloses a containment system for containment of at least a major portion of the shaft of the working tool. However, this containment system is adapted to contain the shaft remote from the endoscope and it is not designed to cover that portion of the shaft, which is between the containment container and the endoscope.
Methods for sheathing an endoscope while providing working channels that protect the endoscope 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 patents attempt to prevent contamination of the endoscope, either by adding disposable working channels external to the endoscope itself (Silverstein—U.S. Pat. No. 4,646,722) or by adding a disposable liner inside a channel of the endoscope (Sidall—U.S. Pat. No. 4,741,326). They do not address the problem, however, of contamination that may be spread to the area around the proximal end of the endoscope and to the operator's hands as the surgical tool is retracted from the proximal port of the working channel.
An attempt to solve this problem is described for example in Aizenfeld (U.S. Pat. No. 6,908,428), which is incorporated herein by reference. This patent discloses methods and devices for use in sheathing an endoscopic tool as it is removed from the patient's body. Such sheathing prevents contaminants that may adhere to the tool inside the body or from the contaminated working channel from contacting the operator's hands, the handle of the endoscope, or other objects outside the patient's body. As a result, the likelihood of cross-contamination between patients is reduced, and the job of cleaning and disinfecting the endoscope and ancillary equipment between uses is simplified.
In embodiments of this solution, a sheathing assembly is provided, which comprises a sleeve dispenser mating with the proximal port of an endoscopic working channel, outside the patient's body. A flexible sleeve is typically fixed by its distal end to the dispenser, with the remainder of the sleeve bunched inside or otherwise held in a vicinity of the dispenser. An elongate endoscopic tool is passed through the dispenser and the working channel, until the distal end of the tool protrudes from the distal end of the endoscope. While the shaft of the tool is advanced through the dispenser and the proximal port of the working channel, the sleeve remains bunched at the dispenser. When the tool is retracted, however, the proximal end of the sleeve engages the shaft of the tool, so that as the tool is withdrawn, the sleeve unfurls from the dispenser to cover the shaft of the tool, up to and including its distal end. All contaminants on the tool thus remain within the sleeve, while the outside of the sleeve remains clean and can be handled freely without spreading contamination.
Unfortunately this solution suffers from the fact that when the tool is being retracted from the working channel, there exists a possibility that the distal end of the sleeve, which is made of non-elastometic material, might be inadvertently torn and detached from the location where it is anchored to the sheathing assembly. Accordingly the tool might become exposed and contaminations adhered to the tool would spread to the environment.
Another disadvantage of the above solution lies in the fact that after the tool has been already retracted from the working channel and is protracted therein again, the sleeve bunches immediate before the sheathing assembly and impedes the doctor's fingers to grasp the tool as close as possible to the proximal port as would be desirable for easy and sure advancement of the tool inside the port.
Moreover, since the tool shaft deflects within the bunched portion, this opposes the advancement of the tool and renders it difficult.
The present invention seeks to eliminate the above-mentioned disadvantages of the known solution.
The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which:
System 20 comprises an endoscope 22, having a working channel 24 passing therethrough. Channel 24 passes through endoscope 22 from a proximal port 32, typically in or near an operating handle 30 of the endoscope, to a distal port 34 at the distal end of the endoscope. An endoscopic tool 26 is inserted through working channel 24 in order to access an area adjacent to the distal end of the endoscope, within the patient's body. Typically, endoscopic tool 26 comprises an elongate shaft 28, with a working element 36 at its distal end and with a working handle 29 at its proximal end, as is known in the art. In the example shown in
A disposable sheath may cover insertion tube of endoscope 22, and channel 24 may likewise be internally sheathed, in order to protect the endoscope from contamination, e.g. as described in Sidall (U.S. Pat. No. 4,741,326). Alternatively or additionally, although channel 24 is shown in the figure as passing inside the endoscope, the endoscopic working channel may comprise a separate tube, typically disposable, which is retained alongside the endoscope, as described, for example, in Silversstein (U.S. Pat. No. 4,646,722). The present invention is suited for use with either of these types of working channels.
Since at least working element 36 of tool 26 comes into contact with tissue and other biological matter inside the patient's body, the tool and the interior of the working channel (or the internal sheath which provides lining for the working channel) necessarily become contaminated during use. In order to prevent the spread of contamination from tool 26 to handle 30, to the operator's hands and to other areas outside the body, a protective sleeve 38 is attached to port 32. Protective sleeve 38 is connected to port 32 in such a manner that a passage through the sleeve is aligned with working channel 24.
In
The major portions of the first protective sleeve portion and the elastomeric sleeve portion have approximately the same diameter, while their diameter along the bridging region is less. The first protective sleeve portion is made of a thin polymeric material, e.g. Nylone, and has a thickness of about 10-30 micron. In practice it is advantageous if the first protective sleeve portion is made of a transparent material. The material of the first protective sleeve portion is selected such, that upon pulling its one end, it unfurls without however being stretched.
In order to bring it in the initial bunched state the first protective sleeve portion should be forcibly pushed in the distal direction. The second sleeve portion, or elastomeric sleeve portion, has a thickness of 0.1-0.5 mm. In contrast to the first protective sleeve portion the elasytomeric sleeve portion is made of a polymeric material, which is elastically stretchable upon pulling one of the sleeve ends. Therefore it is capable of returning by itself to the initial bunched state upon release. An example of suitable materials for the elastomeric sleeve portion are Silicone, Polyurethane, etc.
It will be explained further with reference to
Now with reference to
The guide member is made of a rigid plastic material, e.g. ABS, PVC, etc. The guide member extends longitudinally along the sleeve and has a distal end 60, a proximal end 62 and an intermediate tubular portion. The elastomeric sleeve portion is deployed close to distal end 60 of the guide member, while the first covering sleeve portion is deployed close to proximal end 62 of the guide member. An adapter bushing 64 is provided, which is put over the intermediate portion of the guide member with possibility for relative longitudinal displacement therebetween. The respective ends of both sleeve portions overlap at the bridging region 44 and are anchored to the adapter bushing by a suitable means, e.g. by an elastic ring or by gluing.
A snap ring 66 is provided for attaching non-bunched proximal extremity 50 of the first protective sleeve portion to an outside periphery of proximal end 62 of the guide member. Proximal end 62 of the guide member has an entry opening for receiving a hollow securing nut 68, which is screwable into the opening. Situated within proximal end 62 and located before the entry opening an expansion bushing 70 is provided. This bushing is made of resilient material and therefore is transversally expandable upon screwing the nut. By virtue of this provision it is possible to secure proximal end of the endoscopic tool at the proximal end of the guide member when the tool is being inserted into the sleeve through a flared end 69 of the nut and further through the nut and the bore of the guide member. It should be borne in mind, however, that alternative methods for securing the proximal end of the tool shaft can be used, e.g. it can be a plug, which is made of elastic material and contains an aperture that fits snugly around the shaft and enables advancement thereof through the plug only in the distal direction.
Releasable attached to the distal end of the guide member, a distal fitting 71 is provided, having a nipple portion 72 for connecting to proximal port 32 of the endoscope.
In practice releasable attachment can be achieved by a snap connection, which would comprise annular protrusion 74 made on the distal end of the guide member and correspondingly mating annular groove made on an inside periphery of the distal fitting. By virtue of this provision the guide member can be easily detached from the fitting.
A snap ring 76 is provided for anchoring distal extremity 54 of the elastomeric sleeve portion to an outside periphery of the distal fitting. Optionally the elastomeric sleeve portion could be connected to the fitting by gluing.
Attention is called now to
In
Referring to
At the same time the first protective sleeve portion 40, which has one end secured on the bushing 64 and the opposite end secured to the proximal end of the guide member, continues to unfold and cover the tool shaft.
Eventually the tool shaft is fully retracted from the port and upon detachment of the fitting from the port, the biopsy sample can be transferred into a dedicated sample container.
For further protracting or retracting of the tool one should grasp the tool shaft through the elastomeric sleeve portion by fingers in an initial position close to the port 32, as shown in
In the prior art endoscopes, which do not employ protecting sleeves, the doctors are accustomed to protracting the tool in the port and retracting it from the port by the same way and therefore they should not change their habit while using the protective sleeve of the present invention.
It can be readily appreciated that, when the doctor's fingers advance the tool shaft forward to protract it in the port, the elastomeric sleeve portion slightly bunches between the initial position and the fitting. This situation is depicted in
At the same time when the shaft is displaced backward, i.e. is retracted from the port, as seen in
Furthermore, since the elastically stretchable elastomeric sleeve portion would act as a spring, the probability for its detachment from fitting 71 is much less.
In practice the covering sleeve of the invention is used as follows. First, the preparation step is carried out, during which the tool shaft is entered into the proximal end of the guiding member and then pushed forwards until the working element 36 of the tool slightly protrudes from the fitting. After that, connection fitting is attached to proximal port 32 of the endoscope and the tool is protracted thereinto until the tool's operating handle is in vicinity to the proximal end of the guiding member as shown in
After completing the preparation step the tool shaft can be either retracted from proximal port 32 or protracted thereinto by virtue of the above described “milking” movement applied to the elastomeric sleeve portion.
Up to now an embodiment of the protective sleeve has been described, in which the cover constitutes a sole item, which is independent from the endoscopic tool. This item can be supplied separately from the tool and for its use during the endoscopic procedure one should complete the above described preparation step.
However, one can contemplate also a situation, in which the cover and the tool are supplied as a unitary item, i.e. as a protective cover assembly in which the tool has been already inserted in the guiding member, its shaft is secured at the proximal end of the guiding member and the working tool is ready for protracting into the colonoscope upon connection of the fitting 71 with proximal port 32.
It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
| Number | Date | Country | |
|---|---|---|---|
| 60738001 | Nov 2005 | US |
