Patent Publication Number: US-2020288951-A1

Title: Endscope port stopper

Description:
TECHNICAL FIELD 
     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. 
     BACKGROUND 
     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&#39;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. 
     SUMMARY 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side perspective view of a first embodiment of a stopper of the present disclosure. 
         FIG. 2  is a side elevational view of the embodiment of  FIG. 1 . 
         FIG. 3  is a side sectional view of the embodiment of  FIG. 1 . 
         FIG. 4  is a detail of a portion of the side sectional view of the embodiment of  FIG. 1 . 
         FIG. 5  shows an endoscope control body having ports of different dimensions that may be releasably sealed by the stopper of  FIG. 1 . 
         FIG. 6  is a plan view of a second embodiment of a stopper of the present disclosure. 
         FIG. 7  is a plan view of a third embodiment of a stopper of the present disclosure. 
         FIG. 8  is a plan view of an embodiment of a plug of the present disclosure. 
         FIG. 9  is a plan view of an embodiment of a plug of the present disclosure. 
         FIG. 10  is a plan view of an embodiment of a plug of the present disclosure. 
         FIG. 11  is a plan view of an embodiment of a plug of the present disclosure. 
         FIG. 12  is a side elevational view of a fourth embodiment of a stopper of the present disclosure. 
         FIG. 13  is a side sectional view of the first embodiment of a stopper of  FIG. 1  with a cavity in an end of a plug. 
     
    
    
     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. 
     DETAILED DESCRIPTION 
     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. 
     
       
         
           
               
             
               
                 TABLE 1 
               
             
            
               
                   
               
               
                 Port Dimensions for Endoscopes from Different Manufacturers 
               
            
           
           
               
               
               
               
            
               
                 Port 
                 OLYMPUS 
                 FUJI (SVO is stepped) 
                 PENTAX 
               
            
           
           
               
               
               
               
               
               
               
               
               
            
               
                 Dimensions (mm) 
                 Diameter 
                 Depth 
                 Diameter 1 
                 Depth 1 
                 Diameter 2 
                 Depth 2 
                 Diameter 
                 Depth 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
            
               
                 Suction valve 
                 5.6 
                 22.6 
                 9.5 
                 4.9 
                 6.2 
                 20.8 
                 8.3 
                 27 
               
               
                 opening 
               
               
                 (“SVO”) 
               
               
                 Instrument 
                 5.9 
                 46.2 
                 5.9 
                 53.8 
                 — 
                 — 
                 4.1 
                 54.6 
               
               
                 or biopsy 
               
               
                 channel 
               
               
                   
               
            
           
         
       
     
     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. 
       FIGS. 1-3  illustrate an endoscope port stopper  100  according to one embodiment of the present disclosure. As shown in  FIGS. 1-3 , the port stopper  100  has a first plug  200  comprising a first central axis  201  and a second plug  300  comprising a second central axis  301 , where the first plug  200  is configured to releasably seal a first endoscope port, the first endoscope port having a first set of dimensions, such as, for example, a 4.1 mm diameter and a 54.6 mm depth, and the second plug  300  is configured to releasably seal a second endoscope port, either on the same endoscope or on a different endoscope, having a second set of dimensions, such as, for example, an 8.3 mm diameter and a 27 mm depth. 
     In  FIGS. 1-3 , the first central axis  201  and the second central axis  301  have an angle θ between them of about 180°. As shown in  FIGS. 6 and 7 , other values of angle θ are contemplated for different stopper  110 ,  120  embodiments. For a single stopper, angle θ can be equal between each plug or can be different between each plug. Referring to  FIG. 6 , in some embodiments, a stopper  110  may include a first plug  650  comprising a first central axis  651 , a second plug  660  comprising a second central axis  661 , and a third plug  670  comprising a third central axis  671 , where the angle θ between the central axes is about 120°. Referring to  FIG. 7 , in some embodiments, a stopper  120  may include a first plug  750  comprising a first central axis  751 , a second plug  760  comprising a second central axis  761 , a third plug  770  comprising a third central axis  771 , and a fourth plug  780  having a fourth central axis  781 , where the angle θ between the central axes is about 90°. Generally, angle θ may have values from 45° to 225° in embodiments of the present disclosure. 
     As shown in  FIGS. 1-3 , the first plug  200  can have a first plug first sealing region  210  having a generally frustoconical shape, and a first plug second sealing region  220  also having a generally frustoconical shape. In some embodiments, the smallest cross-sectional diameter of the first plug first sealing region  210  is greater than the largest cross-sectional diameter of the first plug second sealing region  220 . In one embodiment, the first plug first sealing region  210  has a smallest cross-sectional diameter of 9.3 mm, a largest cross-sectional diameter of 10.4 mm, and a height of 5.7 mm and the first plug second sealing region  220  has a smallest cross-sectional diameter of 3.65 mm, a largest cross-sectional diameter of 4.84 mm, and a height of 5.7 mm. 
     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  FIGS. 1-3 , the smallest cross-sectional diameter of the second plug  300  may be greater than the smallest cross-sectional diameter of the first plug  200 . In some embodiments, and as shown in  FIGS. 1-3 , the largest cross-sectional diameter of the first plug  200  may be greater than the largest cross-sectional diameter of the second plug  300 . 
     In some embodiments, a plug may include only one sealing region. As shown in  FIG. 6 , an embodiment of a stopper  110  includes plug  650  and plug  660  having only one sealing region, and in  FIG. 7 , a stopper  120  includes plug  750 , plug  760 , and plug  770  having only one sealing region. As shown in  FIGS. 6-8 , in some embodiments, a plug may have more than one sealing region. Referring to  FIG. 6 , a second embodiment of a stopper of the present disclosure, stopper  110  includes a plug  670  having two sealing regions  675 ,  676 . Referring to  FIG. 7 , a third embodiment of a stopper of the present disclosure, stopper  120  includes a plug  780  having two sealing regions  785 ,  786 . In some embodiments, all plugs on a stopper may include only one sealing region. In some embodiments, all plugs on a stopper may include two or more sealing regions. As shown in  FIG. 8 , a plug  800  may include two sealing regions  810 ,  820  having the same or similar shape. As shown in  FIG. 9  and in some embodiments, a plug  900  may include more than two sealing regions  910 ,  920 ,  930 ,  940  having similar and/or different shapes. In some embodiments, the sealing region  1000  shape can be other than generally frustoconical, as shown in  FIGS. 10-12 . 
     In some embodiments, and as shown in  FIGS. 1-4 , the stopper  100  may include a rim  400  positioned between, i.e., separating, the first plug  200  and the second plug  300 , such that the rim  400  has a cross-sectional diameter greater than the greatest cross-sectional diameter of the first plug  200  and the second plug  300 . In some conditions, the rim  400  can act to prevent the plug  200  or  300  from extending further into a port hole than desired by the operator and can also act to cover irregularities in the endoscope port opening, e.g., a groove in the circumference of the port that enlarges the port diameter at the location of the groove, to provide a water-tight seal of the port. In some embodiments, the rim  400  may have a cross-sectional diameter that is at least 0.8 mm, at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, or at least 10 mm greater than the greatest cross-sectional diameter of the first plug  200  and the second plug  300 . In some embodiments, the rim  400  may have a cross-sectional diameter that is no more than 20 mm, no more than 15 mm, no more than 10 mm greater than the greatest cross-sectional diameter of the first plug  200  and the second plug  300 . In some embodiments, the cross-sectional diameter of the rim  400  may be 0.8 mm to 20 mm, 0.8 mm to 15 mm, 0.8 mm to 10 mm, 1 mm to 9 mm, 1 mm to 8 mm, 1 mm to 7 mm, 1 mm to 6 mm, 1 mm to 5 mm, 1 mm to 4 mm, 1 mm to 3 mm, or 1.5 mm to 2.5 mm, e.g., 1.9 mm, greater than the greatest cross sectional diameter of the first plug  200  and the second plug  300 . 
     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  FIGS. 1-3 , other geometries for the rim  400 , e.g., rectangular, square, trapezoidal, triangular, and irregular are possible. Moreover, and as shown in  FIGS. 6 and 7 , the rim  400  may be positioned between more than a first plug and a second plug.  FIG. 6  shows an embodiment of stopper  110  having a first plug  650 , a second plug  660 , and a third plug  670  with the rim  400  separating each of the plugs  650 ,  660 ,  670 .  FIG. 7  shows an embodiment of stopper  120  having a first plug  750 , a second plug  760 , a third plug  770 , and a fourth plug  780 , with the rim  400  separating each of the plugs  750 ,  760 ,  770 ,  780 . 
     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  FIG. 13 , any or all plugs of a stopper may comprise a cavity  800  in the plug. In  FIG. 13 , which is a side sectional view of an embodiment of  FIG. 1 , a cavity  800  is within the plug  300 . The cavity  800  is a portion of the material of the plug removed to allow for flexibility of the sealing region of the plug. In  FIG. 13 , the cavity  800  is within the second plug sealing region  320 . The cavity  800  is removed from the perimeter of the second plug sealing region  320  so that the perimeter of the second plug sealing region  320  remains intact. In one embodiment, a cavity  800  could extend entirely into any additional sealing regions of a plug. For example, in the embodiment shown in  FIG. 13 , the cavity  800  could extend in the first and second plug sealing region  310 ,  320 . Any of the plugs in the embodiments disclosed could include a cavity in the sealing region. 
     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  FIG. 5 , but could also be used to seal a port having appropriate dimensions on a different kind of device entirely. 
     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.