This disclosure relates in general to the field of evaluation of lumened devices and more particularly to an assembly and method for assessing the cleanliness and/or disinfection of an endoscope.
Millions of gastrointestinal endoscopy procedures are performed on an annual basis around the world. These endoscopy procedures are typically performed using complex, flexible instruments that, when inserted into a patient's body, may become contaminated with biomaterial and microorganisms, including potential pathogens. Thus, careful and thorough cleaning of endoscopes between patients is critical to reducing the risk of cross-contamination and the possible transmission of pathogens during an endoscopy procedure.
The cleaning of endoscope channels, i.e., lumens, can be particularly demanding, as they may be convoluted and too narrow to accommodate a scrub brush. As a result, pathogens may adhere to the interior surfaces of the endoscope even after a thorough cleaning Because endoscope channels do not lend themselves to visual inspection and harsh sterilization procedures may be unsuitable for some endoscopes, it is therefore advantageous to be able to monitor the cleanliness and/or disinfection of an endoscope with a procedure that is simple, accurate, and reduces the risk of cross-contamination of medical instruments.
In one aspect, provided is an endoscope flushing assembly 100 comprising an adapter 200, where the adapter 200 is configured to support a distal portion of an endoscope and receive a sample fluid from the distal portion of the endoscope. In some embodiments, the adapter 200 comprises a fluid guide 250. In some embodiments, the flushing assembly 100 further comprises a stand 300 configured to support the adapter 200. In some embodiments, the stand 300 comprises a notch 350 configured to secure the adapter 200. In some embodiments, the endoscope flushing assembly 100 further comprising a stopper 400. In some embodiments, the stopper 400 comprises a first port plug 420 and a second port plug 440. In some embodiments, the endoscope flushing assembly 100 further comprises a tube 500, wherein the tube 500 is configured to releasably connect to a fluid inlet of the endoscope. In some embodiments, the tube 500 comprises a silicone rubber. In some embodiments, the endoscope flushing assembly 100 further comprises a fluid receptacle 600. method comprising sealing an open endoscope port with a stopper 400, securing an adapter 200 to a stand 300, inserting the distal end of the endoscope into the adapter 200, connecting a first end of a tube 500 to a fluid inlet of the endoscope and a second end of the tube 500 to a fluid source comprising a sample fluid, flushing the endoscope interior with the sample fluid, collecting the sample fluid at an outlet 220 of the adapter 200, and analyzing the sample fluid for the presence of a contaminant.
Features and advantages of the present disclosure will be further understood upon consideration of the detailed description as well as the appended claims.
engagement of the adapter and fluid receptacle with an embodiment of a stand of the present disclosure.
Repeated use of reference characters in the specification and drawings is intended to represent the same or analogous features or elements of the disclosure. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of the principles of the disclosure. The figures may not be drawn to scale.
Flushing a lumened device, such as, for example, an endoscope with sample fluid, e.g., sterile water, saline, special recovery fluids, such as broth, and collection of the fluid sample as it exits the endoscope can provide the endoscope operator with the opportunity to test the fluid sample for residual contaminants e.g., ATP, protein, microbial contamination, that may remain in the endoscope interior after reprocessing, such as cleaning and/or disinfection, thus providing a measure for cleanliness and/or disinfection and efficacy of endoscope reprocessing methods and operations.
Before any embodiments of the present disclosure are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the term “coupled” and variations thereof are used broadly and encompass both direct and indirect couplings. It is to be understood that other embodiments may be utilized, and structural or logical changes may be made without departing from the scope of the present disclosure. Furthermore, terms such as “front,” “rear,” “top,” “bottom,” and the like are only used to describe elements as they relate to one another, but are in no way meant to recite specific orientations of the apparatus, to indicate or imply necessary or required orientations of the apparatus, or to specify how the invention described herein will be used, mounted, displayed, or positioned in use.
Provided in the present disclosure is an assembly for flushing a lumened device, such as an endoscope, with a sample fluid.
As shown in
The housing 210 may include a grip area 218 proximal to the first end 214. The grip area 218 may include ribbbing 219 as shown in
Referring to
In some embodiments, and as shown in
An adapter 200 of the present disclosure may be fabricated according to methods known to those of ordinary skill in the relevant arts such as, for example, molding, pressing, casting, additive manufacturing (e.g., three-dimensional printing, generic manufacturing), subtractive manufacturing (e.g., machining, turning, milling, drilling), and combinations thereof. In some embodiments, the adapter 200 may be fabricated as one, unitary piece. In some embodiments, components of the adapter 200, such as, for example, the housing 210 and the fluid guide 250, may be fabricated separately and then joined together by a suitable means such as, for example, heating, gluing, soldering, welding, press fitting, cone fitting, snap fitting, sealing, and combinations thereof. Suitable materials for the adapter 200 can include, but are not limited to, a glass, a metal, (e.g., foil), a polymer (e.g., polypropylene, polycarbonate, polyphenylene, polythyene, polystyrene, polyester (e.g., polyethylene terephthalate), polymethyl methacrylate (PMMA or acrylic), acrylonitrile butadiene styrene, cyclo olefin polymer, cyclo olefin copolymer, polysulfone, polyethersulfone, polyetherimide, polybutyleneterephthalate), a ceramic, a porcelain, or combinations thereof In some embodiments, the adapter 200 is transparent or translucent. In some embodiments, the adapter comprises polypropylene.
The stand 300 is shown in
As shown in
As shown in
The fluid receptacle holder 330, as shown in
A stand 300 of the present disclosure may be fabricated according to methods know to those of ordinary skill in the relevant arts such as, for example, molding, pressing, casting, additive manufacturing (e.g., three-dimensional printing, generic manufacturing), subtractive manufacturing (e.g., machining, turning, milling, drilling), and combinations thereof. In some embodiments, the stand 300 may be fabricated as one, unitary piece. In some embodiments, components of the stand 300, such as, for example, the support plate 310, the base 320, and the fluid receptacle holder 330, may be fabricated separately and then joined together by a suitable means such as, for example, heating, gluing, soldering, welding, press fitting, cone fitting, snap fitting, sealing, and combinations thereof. Suitable materials for the stand 300 can include, but are not limited to, a glass, a metal, (e.g., aluminum), a polymer (e.g., polypropylene, polyethylene, polycarbonate, and other resins inert to sample fluid) a ceramic, a porcelain, and combinations thereof.
The stand 300 may have a weight sufficient to hold the adapter 200 in place after it has been coupled to an endoscope and during the flushing procedure. In some embodiments, the stand 300 has a weight of at least about 0.5 kg, at least about 1.0 kg, at least about 1.5 kg, or at least about 2.0 kg. In some embodiments, it may be desirable to secure the stand to a surface with, for example, a magnetic mount, a suction cup, a clamp, a bolt and/or screw through the base, a bayonet, a hook and loop fastener, adhesive tape, and combinations thereof.
A second embodiment of an adapter 2000 and a stand 3000 is shown in
Referring to
A fourth embodiment of an adapter 2020 and a stand 3020 is shown in
A stopper 400 suitable for use in an assembly 100 of the present disclosure is shown in
A sample fluid tube 500 suitable for use in an assembly 100 of the present disclosure is shown in
A fluid receptacle 600 suitable for use in an assembly 100 of the present disclosure is shown in
Components of an endoscope flushing assembly 100 of the present disclosure may be provided in the form of a kit. In some embodiments, the kit may include an adapter 200 and a stand 300. In some embodiments, the kit may further comprise a stopper 400. In some embodiments, the kit may further comprise a sample fluid tube 500. In some embodiments, the kit may further comprise a fluid receptacle 600. In some embodiments, the kit may further comprise a fluid source, e.g., a syringe. The kit may be provided in a suitable container such as, for example, a box (e.g., metal, paper, plastic), a bag (e.g., paper, plastic), and combinations thereof.
An endoscope flushing assembly 100 of the present disclosure may be used for flushing a lumened device, such as an endoscope, with a sample fluid to evaluate the cleanliness and/or disinfection of an endoscope. The first steps of this process, which may be executed in any convenient order, include: sealing an open endoscope port with a stopper 400, securing an adapter 200 to a stand 300 by, for example, sliding the adapter 200 into the notch 312 in the support plate 310 from the back to the front of the stand 300, as shown in
Filing Document | Filing Date | Country | Kind |
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PCT/IB2018/057653 | 10/2/2018 | WO | 00 |
Number | Date | Country | |
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62567565 | Oct 2017 | US |