Patent Publication Number: US-2021177242-A1

Title: Endoscope valve assembly

Description:
FIELD 
     This disclosure relates generally to medical instruments, and more particularly to endoscope devices. 
     BACKGROUND 
     Endoscopes are known in the art and are commonly used in medical procedures for examining a body cavity or organ. Typically, endoscopes are inserted into a bodily opening and used to investigate a patient&#39;s symptoms, administer a treatment, or confirm a diagnosis. Such endoscopes may be used to widen a narrow esophagus, perform a biopsy, or cauterize a blood vessel, among other uses. 
     During an endoscopic procedure, it is desirable that the endoscope be able to deliver air and water. Air may be used to insufflate a patient&#39;s organ for more accessible viewing via an integrated camera, and water may be used to rinse the lens of the camera or irrigate a portion of the patient&#39;s organ. To control the flow of both air and water endoscopes may include an air-water valve that may be actuated in different configurations to either permit or inhibit the flow of air and water to the patient. Some endoscopes may include a suction valve to enable suction and inhibit inflow of air, and a biopsy valve to enable access for endoscopic devices while minimizing leakage. 
     After each use, both the endoscope and the components thereof are sterilized to inhibit the spreading of bacteria, germs, and disease. Sterilization of the air-water valve is difficult. As such, it is beneficial to provide a disposable air-water valve for an endoscope that does not require sterilization and that may be discarded after an endoscopic procedure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an exemplary endoscope air-water valve assembly; 
         FIG. 2  is an exploded view of the air-water valve assembly illustrated in  FIG. 1 ; 
         FIG. 3  is a cross-sectional view taken along line  3 - 3  in  FIG. 1 ; 
         FIG. 4  is a perspective view of a hub of the air-water valve assembly shown in  FIG. 1 ; 
         FIG. 5  is a top plan view of the hub illustrated in  FIG. 4 ; 
         FIG. 6  is a cross-sectional view illustrating the snap-fit connection of the air-water valve assembly of  FIG. 1  to a valve receiving portion of an endoscope; 
         FIGS. 7A through 7F  illustrate various steps in forming the air-water valve assembly illustrated in  FIG. 1 ; 
         FIG. 8  is a perspective view of a first alternative embodiment of an endoscope air-water valve assembly; 
         FIG. 9  is an exploded view of the air-water valve assembly illustrated in  FIG. 8 ; 
         FIG. 10  is a cross-sectional view taken along line  10 - 10  in  FIG. 8 ; 
         FIG. 11  is a perspective view of a second alternative embodiment of an endoscope air-water valve; 
         FIG. 12  is an exploded view of the air-water valve assembly illustrated in  FIG. 11 ; 
         FIG. 13  is a cross-sectional view taken along line  13 - 13  in  FIG. 11 ; 
         FIG. 14A  illustrates the air-water valve assembly of  FIG. 1  installed in an endoscope and showing a first configuration thereof where air is permitted to escape through a channel of the tripartite stem; 
         FIG. 14B  illustrates the air-water valve assembly of  FIG. 1  showing a second configuration thereof for insufflation of a patient; 
         FIG. 14C  illustrates the air-water valve assembly of  FIG. 1  showing a third configuration thereof for irrigation; and 
         FIG. 15  shows a kit including the air-water valve of  FIG. 1 , a biopsy valve, and a suction valve. 
     
    
    
     DETAILED DESCRIPTION 
     Generally, an air-water valve assembly is provided for regulating the flow of both air and water through an endoscope. The valve assembly includes a tripartite stem having a plurality of seals disposed thereon and a hub configured to releasably couple the valve assembly to an endoscope for an endoscopic procedure. The stem includes a lower stem member, an upper stem member, and a cap that may be coupled together in a variety of configurations. Each of the lower stem member, upper stem member, and the cap may include a channel or bore extending therethrough to permit fluid communication between a distal opening of the lower member and an aperture of the cap once the stem is assembled. 
     The stem includes one or more seats or seat portions for disposing seals thereon. For example, the lower stem member and the upper stem member may each include one or more seal seats such that the tripartite stem includes a plurality of seal seats positioned at intervals therealong once assembled. Once the valve assembly is installed in the valve seat of an endoscope, the seals define chambers therebetween or barriers to either permit or inhibit the flow of air and water through the endoscope as the valve assembly is differentially actuated. In addition, a resilient member such as a spring may be disposed between the cap and a retaining shelf of the hub such that the valve assembly is biased into a first or resting configuration. 
     In operation, a user may apply an axial force to the cap to depress same and cause axial movement of the stem and seals disposed thereon to control the flow of air and water through the endoscope during an endoscopic procedure. For example, in the first or resting configuration the seals are positioned to inhibit both air and water flow through the endoscope, and a flow of air is configured to escape through a channel formed between a distal opening of the lower stem member and an aperture of the cap. In a second configuration, a user may cover the aperture of the cap (e.g., with a fingertip) to cause a collapsible seal to collapse and allow the air provided to insufflate the organ or body cavity being examined via the endoscope. In a third configuration, the user may apply an axial force to the cap to depress same and cause the stem and seals disposed thereon to move in an axial direction to permit fluidic communication between a water source and a water outlet for irrigation purposes. 
     The air-water valve assembly provided herein is preferably disposable such that it may be detached from the endoscope and discarded after an endoscopic procedure. As described above, the hub may be configured to releasably couple the air-water valve assembly to an endoscope such that it may be selectively attached and removed by the user. In some forms, the hub includes a distal resilient portion with a retaining boss such that the hub may be press fit or snap fit over a tubular valve receiving portion of the endoscope to secure the air-water valve assembly thereto. 
     The present disclosure likewise provides a kit including an air-water valve assembly as provided herein, in addition to a suction valve assembly and biopsy valve assembly known in the art. Each of the air-water valve assembly, suction valve assembly, and biopsy valve assembly may be disposable, single-use devices. In operation, a user may releasably couple each valve assembly to an endoscope for an endoscopic procedure and discard each of the valves thereafter such that no cleaning or sterilization of those valves is required. 
     One method of forming an air-water valve assembly for an endoscope includes providing a lower stem member having a proximal region and disposing a seal over the proximal region such that it abuts a shoulder thereof. The upper stem member may then be slidably received over the proximal region of the lower stem member such that the seal is positioned and secured therebetween. A hub having a retaining shelf may then be positioned surrounding at least a portion of the upper stem member, and a resilient member may be disposed on a proximal surface of the retaining shelf thereof. The cap may then be coupled to one of the upper stem member or the lower stem member to secure the resilient member between the cap and the proximal surface of the retaining shelf. One or more seals may then be disposed in seal seats of the upper stem member and lower stem member via, for example, overmolding. 
     Referring now to  FIG. 1 , exemplary air-water valve assembly  100  includes a tripartite stem  102  formed of a lower stem member  104 , an upper stem member  106 , and a cap  108 . As illustrated, a hub  110  is positioned adjacent the cap  108  and surrounds at least a portion of the upper stem member  106 . Seals are disposed in seat portions or seal seats (shown in  FIG. 2 ) and discussed further below located along the stem  102 . including a first seal  112 , a second seal  114 , a third seal  116 , and a fourth seal  118 . The seals may be formed of pliable materials such as rubber, plastic, silicon, or other polymeric materials. 
     In addition, lower stem member  104  and upper stem member  106  may each include one or more ridges extending radially outward therefrom that are configured to stabilize and inhibit lateral displacement of the valve assembly  100  after installation into a tubular valve receiving portion of an endoscope. For example, the lower stem member  104  may include a lower stabilizing ridge  113  and the upper stem member may include an upper stabilizing ridge  115  that are sized to correspond with internal surfaces of the valve receiving portion of an endoscope such that the valve assembly is closely held therein. So configured, the valve assembly  100  is inhibited from laterally shifting within the valve receiving seat  170 . 
     The tripartite stem  102  and hub  110  may be formed of a suitable material such as a polymeric or metal material. The stem  102  may be formed of carbon fiber, glass fiber, ceramics, rubber, polycarbonate, polypropylene, or other suitable materials. 
     As seen in  FIGS. 2 and 3 , the lower stem member  104  includes an axially oriented proximal opening  120  along a proximal region  122  thereof. As shown, the lower stem member  104  further includes a distal opening  126  that is oriented generally transverse the proximal opening  120  such that a channel  128  (shown in  FIG. 3 ) is defined to provide fluidic communication therebetween. As illustrated, the lower stem member  104  includes grooves and/or ridges forming one or more seat portions (or seal seats) for receiving seals therein. For example, the illustrated lower stem member  104  includes a distal extension  130  having a proximal seal seat  132  and a distal seal seat  134  that are configured to receive the third seal  116  and the fourth seal  118  respectively. In some embodiments, the proximal region  122  of the lower stem member  104  may be coupled directly to the cap  108 . As shown, the proximal region  122  includes a threaded portion  136  corresponding to, and configured to mate with, an aperture  135  of the cap  108  having an internal thread  138 . A glue or other bonding agent may be utilized instead of or in addition to coupling of the threaded portion  136  and the internal thread  138  to increase the strength of the coupling. 
     The lower stem member  104  includes a shoulder  140  extending radially outward thereabout for seating the second seal  114  thereagainst. As illustrated, the second seal  114  may be generally annular and includes an aperture  141  therethrough such that the second seal  114  may be slidably received over the proximal region  122  of the lower stem member  104  until it abuts the shoulder  140 . So configured, the second seal  114  is positioned superior the distal opening  126  of the lower stem member  104  when positioned abutting the shoulder  140 . As described in more detail with respect to  FIGS. 14A-14B , the second seal  114  may be collapsible such that the seal  114  may at least partially collapse upon an increase in air pressure within the endoscope. 
     The upper stem member  106  includes an axial bore  142  extending therethrough and includes an upper stem shoulder  144  extending radially outward thereabout and a proximal edge  145 . In the illustrated form, the axial bore  142  is sized having a diameter such that it may be slidably received over the proximal region  122  of the lower stem member  104  until it abuts a secondary shoulder  146  thereof. In this regard, the second seal  114  may either be slidably received over the proximal region  122  of the lower stem member  104  as noted above, or alternatively may be overmolded thereon once the upper stem member  106  has been slidably received over the lower stem member  104  and is abutting the secondary shoulder  146 . 
     The upper stem member  106  is wholly received over the proximal region  122  of the lower stem member  104  such that the threaded portion  136  extends superior the proximal edge  145  of the upper stem member  106 . The upper stem member  106  includes various ridges and grooves forming one or more seat portions (or seal seats) for receiving seals therein. For example, the first seal  112  may be disposed in seal seat  147 . 
     As shown in  FIG. 3 , the hub  110  of the valve assembly  100  is positioned to concentrically surround at least a portion of the upper and lower stem members  104 ,  106  when the valve assembly  100  is assembled. The hub includes a retaining shelf  111  extending radially inward and forming an opening  150  (shown in  FIG. 5 ). Upon assembly, a distal surface  152  of the retaining shelf  111  is configured to abut the upper stem shoulder  144  of the upper stem member  106 , and a proximal surface  154  of the retaining shelf  111  is configured to receive a resilient member  156  that may be positioned between the retaining shelf  111  and the cap  108  to bias the valve assembly  100  into a resting configuration. As illustrated, the resilient member  156  disposed between the retaining shelf  111  and the cap  108  is in the form of a spring and the stem  102  extends through a center of the spring. In other forms, the resilient member  156  may be formed of a rubber or other elastic material and its position may be different within the device  100 . Once the resilient member  156  has been placed on the retaining shelf  111  of the hub  110 , the cap  108  including the aperture  135  may be coupled to the threaded portion  136  of the lower stem member  104  such that the retaining shelf  111  of the hub  110  abuts and is biased against the upper stem shoulder  144 . 
     As shown in  FIG. 4 , the hub  110  is of a generally annular shape and includes a tubular proximal portion  160  and one or more distal resilient portions  162  flared radially outward and having notches  164  extending therebetween. The tubular proximal portion  160  has a diameter D ( FIG. 5 ) and in some forms may be sized to at least partially receive a portion of the cap  108  therein. Inner surfaces  166  of the distal resilient portions  162  may include a retaining boss  168  (shown in  FIG. 6 ) such that the valve assembly  100  may be releasably coupled to an endoscope. For example, the endoscope may include a tubular valve receiving seat  170  (shown in  FIG. 6 ) including a rim  172  such that the retaining bosses  168  of the distal resilient portions  162  may be snap-fit thereover. Distal resilient portions  162  may be axially advanced over the rim  172  of the valve receiving seat  170  such that the retaining bosses  168  are deflected and may rebound once advanced past the rim  172  to releasably secure the valve assembly  100  to the endoscope. Other forms, such as through a threaded connection are also possible. In addition, the hub  110  includes one or more ribs  174  extending along an outer surface  176  thereof along the axial direction to provide a tactile gripping point for the user and to increase rigidity of the hub  110 . As illustrated in  FIG. 6 , the upper stabilizing ridge  115  has an outside diameter that is slightly smaller than the inside diameter of the tubular valve receiving seat  170  to inhibit lateral movement of the valve assembly  100  within the valve receiving portion. 
     As seen in  FIG. 5 , retaining shelf  111  extends radially inward from the inner surface  166  of the hub  110  and is sized to receive at least a portion of the stem  102  therethrough while still allowing the resilient member  156  to be secured thereagainst. 
       FIGS. 7A-7F  illustrate various steps in forming the exemplary air-water valve assembly  100  shown in  FIGS. 1-6 . In  FIG. 7A , the lower stem member  104  having proximal region  122  and distal extension  130  are provided, and in  FIG. 7B  the second seal  114  is slidably received over the proximal region  122  until it is seated against the lower stem shoulder  140 . In alternative forms, the second seal  114  is overmolded onto the lower stem member  104  after the tripartite stem  102  has been assembled (e.g., as shown in  FIG. 7E ). As shown in  FIG. 7C , the upper stem member  106  may be slidably received over the proximal region  122  of the lower stem member  104  in a similar manner until it abuts and rests against either the secondary shoulder  146  of the proximal region  122  or the second seal  114 . In the illustrated form, the threaded portion  136  of the proximal region  122  extends superior a proximal edge  145  of the upper stem member  106  once the upper stem member  106  has been wholly received over the proximal region  122 . So configured, the threaded portion  136  may be coupled to the threaded portion  138  of the cap  108  such that the upper stem member  106  is positioned and secured between the second seal  114  and the cap  108 . 
     In  FIG. 7D , the hub  110  is shown positioned around the upper and lower stem members  104 ,  106  and the threaded portion  136  extends superior the hub  110  in the axial direction. In this step, the distal surface  152  of the retaining shelf  111  is resting on and abutting the upper stem shoulder  144  (shown in  FIG. 3 ). In  FIG. 7E , the resilient member  156  is disposed at least partially in the hub  110  against the proximal surface  154  of the retaining shelf  111 . The cap  108  may then be advanced over the threaded portion  136  and screwed thereon to secure the resilient member  156  between the cap  108  and the retaining shelf  111 . In a final step illustrated in  FIG. 7F , the first seal  112 , third seal  116 , and fourth seal  118  may be disposed in seal seats  147 ,  132 , and  134  respectively. In alternative forms as described above, the second seal  114  may be disposed on the lower stem member  104  in this step instead of being slidably received thereon as shown in  FIG. 7B . In some embodiments the seals may be overmolded onto the tripartite stem  102 , and in other forms, the seals may be expanded and pushed over the ridges of the stem  102  until seated in the respective seal seats. 
     The alternative assembly  200  shown in  FIG. 8  includes a tripartite stem  202  formed of the lower stem member  204 , the upper stem member  206 , and the cap  208 . As illustrated, the cap  208  includes a distally extending tubular portion  209  and an aperture  235  extending therethrough in the axial direction. The lower stem member  204  is coupled to the upper stem member  206  via a first threaded connection, and the upper stem member  206  is coupled to the cap  208  via a second threaded connection to form the tripartite stem  202 . The lower stem member  204  includes a proximal threaded portion  236  corresponding to, and configured to mate with, a distal internally threaded portion  237  (shown in  FIG. 10 ) of the upper stem member  206 . Additionally, the upper stem member  206  includes a proximal threaded portion  239  corresponding to, and configured to mate with, a distal internally threaded portion  241  (shown in  FIG. 10 ) tubular portion  209  of the cap  208 . Additionally, as described above, a glue or other bonding agent may be applied to either of the first and second threaded connections to increase the strength of the coupling. 
     Similarly, a hub  210  may be positioned adjacent the cap  208  such that it surrounds at least a portion of the upper stem member  206 , and a resilient member  256  may be positioned between the cap  208  and a retaining shelf  211  of the hub  210 . The valve assembly  200  additionally includes one or more seals, such as a first seal  212 , a second seal  214 , a third seal  216 , and a fourth seal  218 . 
     With reference to the second alternative embodiment of an air-water valve assembly  300  shown in  FIGS. 11-13 , the valve assembly  300  includes a tripartite stem  302  formed of the lower stem member  304 , the upper stem member  306 , and the cap  308  that are snap-fit together. The lower stem member  304  includes a rim  380  extending radially outward from a proximal region  322  thereof. As illustrated, the proximal region  322  also includes one or more notches  382  configured to permit portions of the rim  380  to flex inward to be received in an internal groove  384  (shown in  FIG. 13 ) of the upper stem member  306 . In a similar manner, the upper stem member  306  may include a rim  386  extending radially outward adjacent a proximal edge  345  thereof, and may further include one or more notches  388 , such that the rim  386  may be flexed inward to be received in an internal groove  390  of tubular portion  309  of the cap  308 . So configured, the rim  380  of the lower stem member  304  may be snap-fit within the internal groove  384  of the upper stem member  306  via a similar arrangement, and the rim  386  of the upper stem member  306  may be snap-fit within the internal groove  390  of the tubular portion  309  stem  302 . In alternative forms, the positioning of the rims and grooves may be reversed. For example, the tubular portion  309  of the cap may include a rim to be snap fit within a groove of the upper stem member  306 . 
       FIGS. 14A-14C  illustrate exemplary operation of the air-water valve assembly  100  provided herein once installed in an endoscope for use in an endoscopic procedure. Operation of the air-water valve assembly will be described with respect to the air-water valve assembly  100  but the same general operation is applicable to each other embodiment provided herein. Referring to  FIG. 14A , the air-water valve assembly  100  is shown installed in a valve receiving seat  170  of an endoscope in a first configuration (or resting state) where air is permitted to escape through the channel  128  of the tripartite stem  102 . The hub  110  is shown in phantom for ease of illustration. As shown, the endoscope includes an air inlet  400 , an air outlet  402  (for insufflation of a patient), a water reservoir  404 , a water inlet  406 , and a water outlet  408  (for irrigation of the patient). In the first configuration, air may flow into the endoscope through the air inlet  400  into a chamber  410  defined between the second seal  114  and the third seal  116 . The air may then flow into the distal opening  126  of the lower stem member  104 , and upward through the channel  128  such that the air may escape from the proximal opening  120 . The air may likewise flow into the water reservoir  404  as illustrated, however, the fourth seal  118  positioned on the distal extension  130  of the lower stem member  104  operates as a barrier to prevent any fluid communication between the water reservoir  404  and the water outlet  408  in this configuration. In this form, neither air nor water are delivered to the patient via the endoscope. As shown, both the lower stabilizing ridge  113  and the upper stabilizing ridge  115  are sized to correspond with, and are closely received within, the valve receiving seat  170  to inhibit lateral movement along the lateral direction L. 
     Referring now to  FIG. 14B , the air-water valve assembly  100  is shown in a second configuration where air is permitted to escape through the air outlet  402  for insufflation of the patient. In this form, the clinician covers the aperture  135  of the cap  108  including the proximal opening  120  (e.g., using a fingertip as shown) to inhibit the air from escaping therefrom. Air pressure within the chamber  410  defined between the second and third seals  114 ,  116  may then cause the second, collapsible seal  114  to collapse such that air may flow into a chamber  412  defined between the first and third seals  112 ,  116  and out through the air outlet  402 . If the user were to remove his or her fingertip from the cap  108 , the second seal  114  may return to its uncollapsed state such that the air-water valve assembly  100  is returned to the resting configuration. Again, seal  118  prevents water from escaping the valve assembly. 
     If irrigation is desired for rinsing a lens of the endoscope or delivering water to the patient, the user may axially depress the air-water valve assembly  100  in a third configuration as illustrated in  FIG. 14C . In this configuration, the user applies an axial force to the cap  108  in axial direction A which causes corresponding axial movement of the entire tripartite stem  102  and compression of the resilient member  156  positioned between the cap  108  and the hub  110 . The hub  110  is stationary with respect to the valve seat of the endoscope such that the stem  102  moves axially with respect thereto. The chamber  414  defined between the third and fourth seals  116 ,  118  is now axially displaced such that fluidic communication is permitted between the water inlet  406  and the water outlet  408  of the endoscope. Water reservoir  404  is pressurized via the air inlet to cause water to flow through the valve into the water outlet  408 . In addition, the second, collapsible seal  114  is configured to abut a chamfered or angled edge  416  of the endoscope to inhibit further delivery of air via the air outlet  402  of the endoscope. Pressured air causes the water to flow through water inlet  406  and into the chamber  414  defined between the third and fourth seals  116 ,  118  and out of the water outlet  408 . Once a desired amount of water has been delivered, the user may then remove his or her fingertip from the cap  108  and the resilient member  156  will bias the tripartite stem  102  back to the resting configuration shown in  FIG. 14A . 
       FIG. 15  provides a kit  500  including the exemplary air-water valve  100 , a suction valve  502 , and a biopsy valve  504 . In some forms, the kit  500  may be provided for use in a single endoscopic procedure and each of the air-water valve assembly  100 , suction valve  502 , and biopsy valve  504  may be disposed thereafter. In operation, a user may releasably couple each valve to an endoscope for an endoscopic procedure and discard each of the valves thereafter such that no subsequent cleaning or sterilization of the valves is required. The kit  500  may additionally or alternatively include additional or alternative air-water valve assemblies (e.g., valve assembly  200 , valve assembly  300 ), or other components for use in an endoscopic procedure. In some forms, the valve assemblies or portions thereof may be color coded to indicate the type of valve assembly for faster recognition by a user. 
     It is thus seen that an endoscopic valve is provided by the foregoing teachings. 
     Uses of singular terms such as “a,” “an,” are intended to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms. Any description of certain embodiments as “preferred” embodiments, and other recitation of embodiments, features, or ranges as being preferred, or suggestion that such are preferred, is not deemed to be limiting. The invention is deemed to encompass embodiments that are presently deemed to be less preferred and that may be described herein as such. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended to illuminate the invention and does not pose a limitation on the scope of the invention. Any statement herein as to the nature or benefits of the invention or of the preferred embodiments is not intended to be limiting. This invention includes all modifications and equivalents of the subject matter recited herein as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. No unclaimed language should be deemed to limit the invention in scope. Any statements or suggestions herein that certain features constitute a component of the claimed invention are not intended to be limiting unless reflected in the appended claims. Neither the marking of the patent number on any product nor the identification of the patent number in connection with any service should be deemed a representation that all embodiments described herein are incorporated into such product or service.