Patent Application
20200288951
This disclosure relates in general to the field of medical instrument port stoppers and more particularly to an apparatus for stoppering an endoscope port to create a seal between the interior of the endoscope and the outside environment.
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 flexible endoscopes between patients is critical to reducing the risk of cross-contamination and the possible transmission of pathogens during an endoscopy procedure.
In the process of cleaning or evaluating the cleanliness of an endoscope, it may be desirable to flush the interior of the endoscope with one or more fluids, e.g., water, air. But, to control how a fluid enters and exits an endoscope, selective stoppering of one or more ports of the endoscope may be required.
In one aspect, provided is an endoscope port stopper comprising a first plug including a first central axis, and a second plug comprising a second central axis, where the first plug is configured to releasably seal a first endoscope port and the second plug is configured to releasably seal a second endoscope port.
In another aspect, provided is an endoscope port stopper comprising a first plug including a first central axis, a second plug comprising a second central axis, and a third plug comprising a third central axis, where the first plug is configured to releasably seal a first endoscope port, the second plug is configured to releasably seal a second endoscope port, and the third plug is configured to releasably seal a third endoscope port.
In another aspect, provided is an endoscope port stopper comprising a first plug including a first central axis, a second plug comprising a second central axis, a third plug comprising a third central axis, and a fourth plug comprising a fourth central axis, where the first plug is configured to releasably seal a first endoscope port, the second plug is configured to releasably seal a second endoscope port, the third plug is configured to releasably seal a third endoscope port, and the fourth plug is configured to releasably seal a fourth endoscope port.
Features and advantages of the present disclosure will be further understood upon consideration of the detailed description as well as the appended claims.
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 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 efficacy of endoscope reprocessing methods and operations.
Because an endoscope may include ports along its length that allow for fluids, e.g., water, air, to both enter and exit the interior of the device, it may be desirable to close at least some of these ports e.g., a suction valve opening (“SVO”), an instrument or biopsy channel port, an air/water valve opening, prior to flushing the endoscope with a chosen fluid to prevent the fluid from leaking from the device at the location of such ports. To prevent the undesired fluid leakage, endoscope ports may be reversibly sealed, for example, with an appropriate stopper. However, as shown by the data in Table 1, because endoscope port dimensions, e.g., diameter of the opening on the outside of the endoscope, depth of the port, diameter of the opening on the interior of the endoscope where the port intersects a channel, may vary according to their location on the device and by manufacturer, more than one stopper configuration may be required to seal different ports on the same endoscope.
Furthermore, if a stopper extends too far into the interior of the endoscope when sealing the port, for example, greater than 20.8 mm on the FUJI SVO, greater than 22.6 mm on the OLYMPUS SVO, or greater than 27 mm on the PENTAX SVO, the flow of fluid through the endoscope channel may be restricted or entirely prevented. Therefore, it would be beneficial to provide the endoscope operator with a single endoscope port stopper that is both easy to insert and remove, and capable of sealing a variety of openings, while not restricting the flow of fluid through the endoscope interior when the opening is stoppered.
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 endoscope port stopper including a first plug comprising a first central axis and a second plug comprising a second central axis, wherein the first plug is configured to releasably seal a first endoscope port and the second plug is configured to releasably seal a second endoscope port.
In
As shown in
The second plug 300 can have a second plug first sealing region 310 having a generally frustoconical shape, and a second plug second sealing region 320 also having a generally frustoconical shape, where the smallest cross-sectional diameter of the second plug first sealing region 310 is greater than or equal to the largest cross-sectional diameter of the first plug second sealing region 320. In one embodiment, the second plug first sealing region 310 has a smallest cross-sectional diameter of 9.6 mm, a largest cross-sectional diameter of 10.1 mm, and a height of 3 mm and the second plug second sealing region 320 has a smallest cross-sectional diameter of 6.4 mm, a largest cross-sectional diameter of 9.6 mm, and a height of 8.6 mm.
The second plug 300 can, as shown, further have a third sealing region, 330, also with a generally frustoconical shape, where the smallest cross-sectional diameter of the second plug second sealing region 320 is greater than or equal to the largest cross-sectional diameter of the second plug third sealing region 330. In one embodiment, the second plug second sealing region 320 has a smallest cross-sectional diameter of 6.4 mm, a largest cross-sectional diameter of 9.6 mm, and a height of 8.6 mm and the second plug third sealing region 330 has a smallest cross-sectional diameter of 4.4 mm, a largest cross-sectional diameter of 6.4 mm, and a height of 1.6 mm.
In some embodiments, and as shown in
In some embodiments, a plug may include only one sealing region. As shown in
In some embodiments, and as shown in
In some embodiments, the rim 400 may have a thickness, i.e., height of at least 1 mm, at least 1.5 mm at least 2 mm, or at least 2.5 mm. In some embodiments, the rim 400 may have a thickness of no more than 5 mm, no more than 4.5 mm, no more than 4 mm, or no more than 3.5 mm. In some embodiments, the rim 400 may have a thickness of 1 mm to 5 mm, 1.5 mm to 4.5 mm, 2 mm to 4 mm, or 2.5 mm to 3.5 mm, e.g., 3 mm.
Though shown as circular in
A stopper of the present disclosure may be made of any suitably durable and conformable material. Suitable materials can include, for example, a silicone rubber, a neoprene rubber, a gum rubber, an ethylene propylene diene monomer (“EPDM”) rubber, a polyethylene rubber, a polypropylene rubber, a polyurethane foam rubber, a natural latex foam rubber, a polyethylene foam rubber, a polypropylene foam rubber, and combinations thereof. In some embodiments, the stopper 100 comprises a silicone rubber. Generally, the stopper may comprise a material that is stable when subjected to an ethylene oxide sterilization process.
A stopper of the present disclosure should be sufficiently conformable such that when it is inserted into an endoscope port, it fills at least a portion of the port, creating a water-tight seal, but also should be durable enough that it may be readily removed without breaking by an operator wishing to reopen the port. In some embodiments, the stopper may comprise a material having a Shore (A) hardness of 20-70, 25-60, 30-50, or 35-45, e.g., 40.
A rim, if included, may be formed of the same material as stopper or may be a different material. For example, the rim may be a harder or less conformable material as the plug portions of the stopper to further prevent the plug from extending further into a port hole than desired by the operator and can also act to cover irregularities in the endoscope port opening.
In some embodiments, and as shown in
Methods of making endoscope port stoppers of the present disclosure are well known to those of ordinary skill in the relevant arts, and may include, for example, conventional molding of a rubber or foam rubber to the desired specifications or three-dimensional printing techniques. In some embodiments, a stopper may be made of a unitary piece of material. In other embodiments, a stopper may be formed from two or more elements joined together, where the elements may be made from the same material or from different materials.
A stopper of the present disclosure may be used to releasably seal an endoscope port 50, as shown in
To releasably seal an endoscope port with a stopper of the present disclosure, the operator may grasp the stopper by a first plug and insert a second plug into the endoscope port while pressing toward the body of the endoscope. In some embodiments, it may be desirable to press the second plug into the port while rotating the first plug, i.e., with a “screwing” motion. The stopper may be removed from the port when desired by grasping the first plug and pulling away from the body of the endoscope. Stoppers of the present disclosure may be useful for more than one port sealing, and it may therefore be desirable to clean and/or disinfect the stopper between uses, e.g., using an ethylene oxide sterilization process.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2018/051476 | 9/18/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62567522 | Oct 2017 | US |
