Urethral catheter device

Abstract

The urinary catheter (100) is generally configured for self-deployment. The catheter includes a lubricant (108) disposed within the catheter lumen. The catheter further includes a sheath (125) covering the catheter tube, the sheath lumen also containing a lubricant. The catheter includes an engagement member at the proximal end that is selectively transitionable between a closed state and an open state. Various embodiments of a cap (160) defining the engagement member are disclosed. The cap may also be retained in an open position so as to be positioned away from urine exiting the catheter lumen during use.

Description

[Technical Field]

[0001] The present disclosure relates to urinary catheter devices. [Background technology]

[0002] Urinary incontinence causes a person to lose control of their bladder, resulting in the loss of large or small amounts of urine. This can be caused by several reasons. Paraplegic or quadriplegic users lose control of their bladder and need to empty their bladder using a urinary catheter. These can be indwelling (where the catheter is placed inside the bladder for a longer period of time and attached to a urine bag to collect urine) or intermittent (where the catheter is inserted periodically into the bladder and urine drains from the bladder directly into an appropriate drainage area or into the urine bag). Intermittent catheters are preferred when the user can insert the catheter themselves or when they prefer not to be seen with a urine bag. Intermittent catheters allow the user freedom of movement. Summary of the Invention [Problem to be solved by the invention]

[0003] Catheters may be pre-lubricated. In some cases, the lubricant may spill when the package is opened, soiling or staining the user's clothing. Similarly, residual urine in the catheter lumen may exit the catheter lumen and soil or stain the user's clothing. In some cases, urinary catheters may include packaging that is not suitable for a person to carry, such as in a clothing pocket.

[0004] Disclosed herein are urinary catheters and catheter insertion methods that address the above-mentioned concerns. [Means for solving the problem]

[0005] Briefly summarized, disclosed herein is a urinary catheter according to some embodiments, the urinary catheter including: (i) a catheter tube defining a catheter lumen extending between a distal end and a proximal end, the catheter tube configured for insertion into a patient's bladder; (ii) a sheath defining a sheath lumen extending along the catheter tube, the catheter tube being disposed within the sheath lumen; and (iii) an outlet hub coupled to the catheter tube at its proximal end. The outlet hub includes a hub body defining a hub chamber, the hub chamber defining the catheter lumen extending therethrough. The catheter further includes an engagement member coupled to the outlet hub, the engagement member being selectively transitionable between (i) a closed state at the proximal end that prevents fluid from exiting the catheter lumen and (ii) an open state at the proximal end that allows fluid to exit the catheter lumen.

[0006] In some embodiments, the catheter further comprises a lubricant disposed within the catheter lumen. In some embodiments, a lubricant is further disposed within the sheath lumen along the exterior of the catheter tube. In some embodiments, the fluid comprises a lubricant.

[0007] In some embodiments, the engagement member includes a lid coupled to the outlet hub via a hinge, the lid being rotatable between a closed position defining a closed state and an open position defining an open state, wherein in the closed position the lid extends over the proximal end of the outlet hub and in the open position the lid is rotated away from the proximal end of the outlet hub.

[0008] In some embodiments, when the lid is in the open position, the lid is rotated at least 90 degrees away from the closed position. In some embodiments, when the lid is in the open position, the lid is rotated at least 180 degrees away from the closed position. In some embodiments, the lid is rotatably biased toward the open position by a hinge.

[0009] In some embodiments, the lid includes a first protrusion extending away from the periphery of the lid and the outlet hub includes a corresponding second protrusion extending away from the sidewall of the outlet hub, the corresponding second protrusion positioned adjacent the hinge, and interference between the corresponding second protrusion and the first protrusion defines a detent for maintaining the lid in the open position.

[0010] In some embodiments, the outlet hub includes a protrusion extending away from the sidewall of the outlet hub, and the lid includes a protrusion receiving member disposed on an upper side of the lid, the receiving member configured to prevent separation of the protrusion from the protrusion receiving member in the absence of a separation force, and the protrusion is inserted into the protrusion receiving member to maintain the lid in an open position.

[0011] In some embodiments, the lid includes a plug disposed on an underside of the lid, at least a portion of the plug being disposed within the hub chamber when the lid is in the closed position, hi some embodiments, the plug is formed from an elastomeric material.

[0012] In some embodiments, the engagement member includes a lid coupled to the outlet hub via a tether. The lid is positionable between a closed position defining a closed state and an open position defining an open state, where in the closed position the lid extends over the proximal end of the outlet hub and in the open position the lid is positioned away from the proximal end of the outlet hub. The tether biases the lid toward the open position, away from the closed position.

[0013] In some embodiments, the engagement member includes a plug cap disposed within the hub chamber, the plug cap including a fluid passage extending therethrough between an underside of the plug cap and one or more side ports located along a cylindrical side wall of the plug cap, the plug cap being positionable between a closed position defining a closed state and an open position defining an open state, the one or more side ports being disposed within the hub chamber such that the side wall of the outlet hub sealably covers the one or more side ports when the plug cap is in the closed position, and the one or more side ports being disposed proximally beyond the side wall of the outlet hub when the plug cap is in the open position.

[0014] In some embodiments, the plug cap is coupled to the outlet hub such that it is tiltable relative to the outlet hub about an axis of rotation extending laterally through the plug cap and the outlet hub, and the plug cap is tilted such that a proximal end face of the plug cap is oriented perpendicular to the longitudinal axis of the outlet hub when the plug cap is in the closed position and is rotated away from the perpendicular orientation when the plug cap is in the open position.

[0015] In some embodiments, the plug cap is longitudinally positionable between a closed position and an open position. In some embodiments, the outlet hub includes a ring extending circumferentially around the outside of the hub body, the ring being operably coupled between the plug cap and the hub body such that (i) rotation of the ring in one direction relative to the hub body displaces the plug cap proximally from the closed position to the open position, and (ii) rotation of the ring in the opposite direction relative to the hub body displaces the plug cap distally from the open position to the closed position.

[0016] In some embodiments, the outlet hub includes a latch mechanism operably coupled between the plug cap and the hub body, the latch mechanism configured to position the plug cap in the open position when a distally directed force is (i) manually applied to and (ii) released from the plug cap when the plug cap is in the closed position, and the latch mechanism configured to position the plug cap in the closed position when a distally directed force is (i) manually applied to and (ii) released from the plug cap when the plug cap is in the open position.

[0017] Also disclosed herein is a method for draining urine from a patient's bladder. According to some embodiments, the method includes providing a catheter having a catheter tube configured for insertion into the patient's bladder, the catheter tube defining a catheter lumen. The method further includes transitioning an engagement member of the catheter from a closed state to an open state, the engagement member being configured, in the closed state, to prevent fluid from exiting a proximal end of the catheter lumen through an outlet hub coupled to the catheter tube at the proximal end. The method further includes (i) draining lubricant from the catheter lumen, (ii) inserting the catheter tube into the patient's bladder to establish urine flow through the catheter lumen, and (iii) transitioning the engagement member from the open state to the closed state.

[0018] In some embodiments of the method, the catheter further includes a sheath extending along the catheter tube, the catheter tube being disposed within the lumen of the sheath, and a portion of the lubricant being disposed within the lumen of the sheath, the portion of the lubricant contacting an outer surface of the catheter tube.

[0019] In some embodiments of the method, the engagement member includes a lid coupled to the outlet hub via a hinge. The lid is rotatable between a closed position defining a closed state and an open position defining an open state, where in the closed position the lid extends over a proximal end of the outlet hub and in the open position the lid is rotated away from the proximal end of the outlet hub. Transitioning the engagement member from the closed state to the open state includes rotating the lid at least 90 degrees away from the closed position.

[0020] In some embodiments, the lid includes a first protrusion extending away from the periphery of the lid, and the outlet hub includes a corresponding second protrusion extending away from the sidewall of the outlet hub, the corresponding second protrusion positioned adjacent the hinge, and interference between the corresponding second protrusion and the first protrusion defines a rotational detent for the lid. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes rotating the lid past the detent to secure the lid in the open state.

[0021] In some embodiments of the method, the outlet hub includes a protrusion extending away from the sidewall of the outlet hub, and the lid includes a protrusion receiving member disposed on an upper side of the lid, the protrusion receiving member configured to prevent separation of the protrusion from the protrusion receiving member in the absence of a separation force. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes rotating the lid to cause the protrusion to enter the receiving member to restrain the lid in the open position.

[0022] In some embodiments of the method, the engagement member includes a lid coupled to the outlet hub via a tether. The lid is positionable between a closed position defining a closed state and an open position defining an open state, where in the closed position the lid extends over a proximal end of the outlet hub and in the open position the lid is positioned away from the proximal end of the outlet hub. The tether biases the lid toward the open position, away from the closed position, and in such embodiments of the method, transitioning the engagement member from the closed state to the open state includes (i) displacing the lid away from the closed position and (ii) allowing the tether to displace the lid toward the open position.

[0023] In some embodiments of the method, the engagement member includes a plug cap disposed within a chamber of the outlet hub, the plug cap including a fluid passage extending therethrough between an underside of the plug cap and one or more side ports located along a cylindrical sidewall of the plug cap. The plug cap is positionable between a closed position defining a closed state and an open position defining an open state, the one or more side ports being disposed within the hub chamber such that the sidewall of the outlet hub sealably covers the one or more side ports when the plug cap is in the closed position, and the one or more side ports being disposed proximally beyond the sidewall of the outlet hub when the plug cap is in the open position. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes positioning the plug cap away from the closed position to the open position.

[0024] In some embodiments of the method, the plug cap is coupled to the outlet hub so as to be tiltable relative to the outlet hub about a rotational axis extending laterally through the plug cap and the outlet hub, and the plug cap is oriented such that a proximal end face of the plug cap is perpendicular to a longitudinal axis of the outlet hub when the plug cap is in the closed position. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes tilting the plug cap away from its perpendicular orientation.

[0025] In some embodiments of the method, the plug cap is longitudinally positionable between a closed position and an open position. In some embodiments of the method, the outlet hub includes a ring extending circumferentially around the outside of the hub body, the ring operatively coupled between the plug cap and the hub body such that rotation of the ring relative to the hub body displaces the plug cap proximally from the closed position to the open position. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes rotating the ring.

[0026] In some embodiments of the method, the outlet hub includes a latch mechanism operably coupled between the plug cap and the hub body, the latch mechanism configured to position the plug cap in the open position when a distally directed force is (i) manually applied to and (ii) released from the plug cap when the plug cap is in the closed position. In such embodiments of the method, transitioning the engagement member from the closed state to the open state includes (i) applying a distally directed force to the plug cap and (ii) allowing the latch mechanism to proximally displace the plug from the closed position to the open position.

[0027] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts.

[0028] Embodiments of the present disclosure are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference symbols indicate similar elements and in which: [Brief explanation of the drawings]

[0029] [Figure 1A] FIG. 1 illustrates a urinary catheter in a packaged state, according to some embodiments. [Figure 1B] FIG. 1B is a diagram of the urinary catheter of FIG. 1A in an unpackaged state, according to some embodiments. [Figure 1C] FIG. 1B is a detailed view of the proximal end portion of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 1D] FIG. 1B is a detailed view of the proximal end portion of the urinary catheter of FIG. 1A with the cap in an open position, according to some embodiments. [Figure 1E] FIG. 1C is a detailed view of the proximal end portion of the urinary catheter of FIGS. 1C-1D, with the cap in a closed position, according to some embodiments. [Figure 2A] FIG. 1B is a view of a second embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 2B] FIG. 2B is a view of the outlet hub of FIG. 2A with the cap in an open position, according to some embodiments. [Figure 3A] FIG. 1B is a view of a third embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 3B] FIG. 3B is a view of the outlet hub of FIG. 3A with the cap in an open position, according to some embodiments. [Figure 4A] FIG. 1B is a view of a fourth embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 4B] FIG. 4B is a view of the outlet hub of FIG. 4A with the cap in an open position, according to some embodiments. [Figure 5A] FIG. 1B is a view of a fifth embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 5B] FIG. 5B is a view of the outlet hub of FIG. 5A with the cap in an open position, according to some embodiments. [Figure 6A] FIG. 1B is a diagram of a sixth embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 6B] FIG. 6B is a view of the outlet hub of FIG. 6A with the cap in an open position, according to some embodiments. [Figure 7A]FIG. 1B is a diagram of a seventh embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 7B] FIG. 7B is a view of the outlet hub of FIG. 7A with the cap in an open position, according to some embodiments. [Figure 8A] FIG. 1B is a view of an eighth embodiment of the outlet hub of the urinary catheter of FIG. 1A with the cap in a closed position, according to some embodiments. [Figure 8B] FIG. 8B is a view of the outlet hub of FIG. 8A with the cap in an open position, according to some embodiments. [Figure 9] FIG. 1C is a diagram of a ninth embodiment of the outlet hub of the urinary catheter of FIG. 1A, in which the hub includes a seal in the form of a film, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0030] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that are readily separable from the specific embodiment and that can optionally be combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0031] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the" also include plural references unless the context clearly dictates otherwise.

[0032] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0033] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes a length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes an end of the catheter intended to be near or within a patient when the catheter is used with the patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0034] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including, but not limited to, mechanical and fluid interactions. Two components can be coupled to one another even if they are not in direct contact with one another. For example, two components can be coupled to one another by an intermediate component.

[0035] Any method disclosed herein includes one or more steps or actions for performing the described method. Method steps and / or actions may be interchangeable with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0036] Throughout this specification, references to approximations may be made, such as by use of the term "substantially." For each such reference, it should be understood that in some embodiments, the value, feature, or characteristic may be specified without the approximation. For example, when modifiers such as "about" and "substantially" are used, these terms include within their scope the modified terms without those modifiers. For example, when the term "substantially linear" is recited with respect to a feature, it is understood that in further embodiments, the feature may have a strictly linear configuration.

[0037] Throughout this specification, a reference to "one embodiment" or "the embodiment" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, references to recited phrases or variations thereof found throughout this specification do not necessarily all refer to the same embodiment.

[0038] 1A-1D show a first embodiment of a urinary catheter in various states of use. The urinary catheter (catheter) 100 is generally configured for self-deployment by a user (also referred to herein as a patient) to drain urine from the user's bladder. The catheter 100 as shown is generally configured for use by a male patient. However, the catheter 100 can be configured for use by a female patient without departing from the features and functional aspects of the catheter 100, as shown and described below. The catheter 100 can be used by a patient in a variety of environments, such as, for example, a medical facility, a home, or a public restroom.

[0039] The catheter 100 is generally configured to be used multiple times per day by a patient. More specifically, a patient may deploy multiple catheters 100 (one at a time) in a single day. Accordingly, a patient may carry or hold one or more catheters 100 on their person, such as in a clothing pocket or a handbag. Accordingly, the catheter 100 may be disposed in a package having a compact configuration consistent with placing the catheter 100 in a clothing pocket or a handbag. The catheter 100 is also configured to maintain the sterility of the catheter 100 in the package.

[0040] In some cases, users may be concerned about soiling their clothing with, for example, urine or catheter lubricant during the urinary drainage process. Accordingly, the catheter 100 is configured for deployment while preventing the catheter 100 lubricant from spilling onto clothing or other items during use. Additionally, the catheter 100 is generally configured to contain residual urine within the catheter tube after use.

[0041] Because catheter 100 is configured for self-deployment, catheter 100 may be configured for ease of handling (i.e., grasping, directing, guiding, applying force, etc.) by a user during deployment. Thus, catheter 100 may be configured for deployment by a user with limited dexterity.

[0042] 1A shows a front perspective view of the catheter 100 in its packaged state. The catheter 100 may be disposed in its packaged state prior to use. The catheter 100 may be disposed within an outer package 104, such as a bag or pouch. In some embodiments, the outer package 104 may be resealable. In other words, the outer package 104 may be configured to (i) sealably house the catheter 100 prior to use, and (ii) sealably house the catheter 100 after use.

[0043] The catheter 100 generally includes a catheter tube 110 having a proximal end 111 and a distal end 112. The catheter tube 110 may be formed from any suitable thermoplastic material by an extrusion process. A catheter lumen 115 extends along the catheter tube 110 and is sized to facilitate the flow of urine therethrough from the distal end 112 to the proximal end 111 during use. The catheter tube 110 includes an entrance section 113 extending proximally away from the distal end 112, the entrance section 113 being configured for insertion into a user's urethra and advancement along the urethra to the patient's bladder. Thus, the entrance section 113 defines a length sufficient to extend from the end of the patient's penis to the bladder. Similarly, the entrance section defines an outer diameter compatible with placement within the urethra. The catheter tube 110 also includes an exit section 114 extending distally away from the proximal end 111. The outlet portion 114 is configured for use outside the patient's body and defines a length that, during use, is adapted to position the proximal end 111 over a urine receptacle, such as a toilet bowl.

[0044] The catheter tube 110 includes an entrance collar 130 coupled to the entrance section 113 to also provide a user with insertion assistance. The entrance collar 130 is configured for gripping by a user during use. Accordingly, the exterior surface of the entrance collar 130 may include gripping features 131, such as protrusions, depressions, ribs, or troughs, to allow the entrance collar 130 to be grasped during use. In some embodiments, the entrance collar 130 includes a seal 132 that closes the distal end of the entrance collar 130 in its packaged state prior to use, as described further below. In some embodiments, the seal 132 may include a film 133 sealably coupled to the entrance collar 130, and in some embodiments, the film 133 may include a pull ring 134 to facilitate removal of the film 133 from the entrance collar 130.

[0045] The catheter tube 110 also includes an outlet hub (hub) 150. The hub 150 includes gripping features 151 located on an exterior surface of the hub 150 to allow the hub 150 to be grasped during use. 150 defines a hub chamber 155. The hub chamber 155 is in fluid communication with the catheter lumen 115, i.e., the hub chamber 155 defines the catheter lumen 115 at the proximal end 111. The hub 150 includes an outlet seal 152 at the proximal end of the hub 150.

[0046] The catheter 100 further includes a sheath 120 that extends along the catheter tube 110 from the inlet collar 130 to the hub 150. The sheath 120 defines a sheath lumen 125, and the catheter tube 110 is disposed within the sheath lumen 125. The sheath lumen 125 is in fluid communication with the hub chamber 155, i.e., the sheath lumen 125 extends into the hub chamber 155. The sheath 120 (or more specifically, the distal end of the sheath 120) is sealably attached to the inlet collar 130, and the sheath 120 is also sealably attached to the hub 150.

[0047] The sheath lumen 125, catheter lumen 115, and hub chamber 155 combine to form a closed volume within which, in the packaged state, is sealably contained a lubricant 108. The lubricant 108 is configured to permit slidable displacement of the inlet portion 113 along the urethra during use.

[0048] 1B shows the catheter 100 in an unpackaged state, i.e., with the catheter 100 removed from the outer package 104, the catheter tube 110 extended, and the inlet seal 132 and outlet seal 152 breached. The catheter 100 is oriented so that the lubricant 108 can flow out of the catheter lumen 115 and / or sheath lumen 125 through the outlet hub 150.

[0049] 1C-1E show various detailed views of outlet hub 150. FIG. 1C shows hub 150 with outlet seal 152 in a closed state. Hub 150 includes an engaging member in the form of cap 160 rotatably coupled to hub body 153 via hinge 154 (e.g., a living hinge). Cap 160 is rotated to a closed position, defining outlet seal 152 in a closed state.

[0050] 1D shows the hub 150 with the outlet seal 152 breached. As shown, the cap 160 is rotated away from the hub body 153 toward its open position, defining an open state of the proximal end 111 of the catheter tube 110, i.e., defining an open end of the catheter tube lumen 115 via the open proximal end of the hub chamber 155. Because the sheath lumen 125 is in fluid communication with the hub chamber 155, the proximal end of the sheath lumen 125 is also open via the open proximal end of the hub chamber 155. The cap 160 includes a tab (or flange) 163 that projects away from the periphery of the cap 160 and is configured to facilitate application of an opening force by a user.

[0051] In some embodiments, the hinge 154 may bias the cap 160 toward the open position. More specifically, the hinge 154 may be configured to apply a rotational force to the cap 160 to (i) rotate the cap 160 toward the open position after a user applies an opening force to the tab 163 to rotate the cap 160 away from the closed position, and / or (ii) maintain the cap 160 in the open position. The cap 160 is generally positioned away from urine that exits the catheter tube 110 during use when the cap 160 is in the open position.

[0052] 1E is a detailed view of the proximal portion of hub 150. Cap 160 is disposed in the closed position. A portion of hub body 153 has been cut away to show hub wall 156 of hub body 153 in cross section. Cap 160 includes a cylindrical wall 161 coupled to end wall 162. In the illustrated embodiment, end wall 162 and at least a portion of cylindrical wall 161 are disposed within hub chamber 155 when cap 160 is disposed in the closed position. End wall 162 may include an end wall surface 162A that is flat or convex (i.e., not concave) to prevent (i) collection of lubricant 108 across end wall 162 during drainage of lubricant 108 from catheter 100 and / or (ii) collection of urine during drainage of urine from a patient during use. In other embodiments, cap 160 may extend over the proximal end of hub body 153 such that cylindrical wall 161 and end wall 162 are disposed outside of hub chamber 155 .

[0053] The outlet seal 152 is defined by the engagement of corresponding seal members on the hub body 153 and the cap 160. The cylindrical wall 161 includes an annular rib 152A extending radially outward from the cylindrical wall 161. The hub body 153 includes an annular trough 152B extending radially outward from the inner surface of the hub wall 156. The annular rib 152A and the annular trough 152B define a corresponding seal member. The annular rib 152A and the annular trough 152B are configured to define the outlet seal 152 when the cap 160 is disposed in the closed position. In the illustrated embodiment, the annular rib 152A and the annular trough 152B may also define a detent for securing the cap 160 in the closed position in the absence of an opening force applied to the cap 160. As will be understood by one skilled in the art, the hub 150 may include corresponding seal members other than the annular rib 152A and the annular trough 152B. In other words, the hub 150 may include any configuration of compliant sealing members suitable for defining the outlet seal 152 .

[0054] In use, a user can remove the film 133 from the inlet collar 130 to break the inlet seal 132. Removing the film 133 can include pulling the pull ring 134. In use, a user can break the outlet seal 152 by rotating the cap 160 away from the closed position. For further use, a user can re-establish the outlet seal 152 by rotating the cap 160 to the closed position.

[0055] FIGS. 2A and 2B illustrate another embodiment of an outlet hub (hub) 250 that may be used with the catheter 100. The hub 250 may be similar in certain respects to the components of the hub 150 described in connection with FIGS. 1A-1E. It will be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are designated with similar reference numerals, with the leading digit incremented by "2." For example, in FIGS. 1A-1E, the hub chamber is designated as "155," while in FIGS. 2A and 2B, the hub chamber is designated as "255." Accordingly, relevant disclosures set forth above regarding similarly identified features may not be repeated below. Additionally, certain features of the hub 150 and related components shown in FIGS. 1A-1E may not be shown or identified by reference numerals in the drawings or specifically described in the following description. However, such features may be clearly the same or substantially the same as features shown in and / or described with respect to other embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of hub 250. Any suitable combination of features and variations thereof described with respect to hub 150 and components shown in Figures 1A-1E may be used with hub 250 and components of Figures 2A and 2B, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0056] Figure 2A shows a proximal portion of hub 250 with outlet seal 252 in a closed state, and Figure 2B shows a proximal portion of hub 250 with outlet seal 252 in a breached state. With reference to Figures 2A and 2B, hub 250 includes a cap 260 rotatably coupled to a hub body 253 via a hinge 254 (e.g., a living hinge). Cap 260 is rotated to a closed position in Figure 2A, defining the closed state of outlet seal 252, and cap 260 is rotated to an open position in Figure 2B, defining the open state of outlet seal 252.

[0057] The hub 250 includes a cap retention mechanism for retaining the cap 260 in the open position (see FIG. 2B ). The hub body 253 includes a protruding member 272 disposed on a side surface of the hub body 253. The cap 260 includes a receiving member 271 on an upper side of the cap 260. The receiving member 271 includes a recess configured to receive the protruding member 272. The receiving member 271 is positioned on the cap 260, and the protruding member 272 is positioned on a side surface of the hub body 253 such that the receiving member 271 is positioned to coincide with the protruding member 272 when the cap 260 is rotated to the open position. In other words, the receiving member 271 and the protruding member 272 are positioned such that the protruding member 272 is disposed within the receiving member 271 when the user rotates the cap 260 to the open position.

[0058] The receiving member 271 and the protruding member 272 may be configured to define a detent configured to hold the cap 260 in the open position when no separation force is applied to the cap 260. In some embodiments, the protruding member 272 may snap into the receiving member 271 when the cap 260 is rotated to the open position. The receiving member 271 and the protruding member 272 may be configured to facilitate separation of the receiving member 271 from the protruding member 272 (e.g., by applying a separation force) to allow a user to rotate the cap 260 away from the open position toward the closed position. As will be appreciated by those skilled in the art, other configurations of the receiving member 271 and the protruding member 272 may be consistent with holding the cap 260 in the open position. For example, the cap 260 may include the protruding member 272, and the hub body 253 may include the receiving member 271.

[0059] In use, a user can break the outlet seal 252 by rotating the cap 260 away from the closed position. The user can also secure the cap 260 to the wall 256 of the hub body 253 by rotating the cap 260 to a fully open position and engaging the receiving member 271 with the protruding member 272. For further use, the user can re-establish the outlet seal 252 by rotating the cap 260 to the closed position.

[0060] 3A and 3B illustrate another embodiment of an outlet hub (hub) 350 that can be used with the catheter 100. FIG. 3A illustrates a proximal portion of the hub 350 with the outlet seal 352 in a closed state, and FIG. 3B illustrates a proximal portion of the hub 350 with the outlet seal 352 in a breached / open state. With reference to FIGS. 3A and 3B, the hub 350 includes a cap 360 rotatably coupled to a hub body 353 via a hinge 354 (e.g., a living hinge). The cap 360 is rotated to a closed position in FIG. 3A to define the closed state of the outlet seal 352, and the cap 360 is rotated to an open position in FIG. 3B, where the cap 360 is rotated an angle 373 away from the closed position. In some embodiments, the angle 373 can be greater than about 80 degrees, greater than about 90 degrees, greater than about 170 degrees, or about 180 degrees.

[0061] The hub 350 includes a cap retention mechanism for retaining the cap 360 in the open position. The hub body 353 includes a protruding member 372 disposed on a side of the hub body 353. The cap 360 includes a protrusion 371 extending away from the periphery of the cap 360 adjacent the hinge 354. The hub body 353 also includes a corresponding protrusion 372 extending away from the wall 356 of the hub body 353 adjacent the hinge 354. The protrusions 371 and the corresponding protrusions 372 are configured to slidingly interfere with each other when the cap 360 is rotated between the closed and open positions by a user. The protrusions 371 and the corresponding protrusions 372 are also configured such that the interference retains the cap 360 in the open position unless the user rotates the cap 360 toward the closed position. Stated another way, protrusion 371 and corresponding protrusion 372 define a detent for maintaining cap 360 in the open position unless the user rotates cap 360 toward the closed position.

[0062] In the illustrated embodiment, cap 360 may extend over the proximal end of hub body 353 such that cylindrical wall 361 and end wall 362 are disposed outside of hub chamber 355. In other embodiments, cap 360 may be configured such that a portion of cap 360 is disposed within hub chamber 355 when cap 360 is disposed in the closed position. More specifically, cap 360 may be configured such that end wall 362 and at least a portion of cylindrical wall 361 are disposed within hub chamber 355 when cap 360 is disposed in the closed position.

[0063] In use, a user can break the outlet seal 352 by rotating the cap 360 away from the closed position. The user may also rotate the cap 360 to the open position such that the cap 360 is held in the open position by the cap retention mechanism. For further use, the user can re-establish the outlet seal 352 by rotating the cap 360 to the closed position.

[0064] Figures 4A and 4B show another embodiment of an outlet hub (hub) 450 that may be used with catheter 100. Figure 4A shows the proximal portion of hub 450 with outlet seal 452 in a closed state, and Figure 4B shows the proximal portion of hub 450 with outlet seal 452 in a broken / open state. With reference to Figures 4A and 4B, hub 450 includes a cap 460 attached to hub body 453 via tether 454. Cap 460 is positioned in a closed position in Figure 4A, defining the closed state of outlet seal 452, and cap 460 is positioned in an open position in Figure 4B, defining the open state of outlet seal 452.

[0065] Tether 454 is attached to cap 460 at a periphery of cap 460. Tether 454 is attached to hub body 453 at attachment points 457. Attachment points 457 are spaced distally away from the proximal end of hub body 453 and define a length 458 of tether 458. In some embodiments, wall 456 of hub body 453 can include a trough 459 configured to receive tether 454 therein when cap 460 is disposed in the closed position.

[0066] In the illustrated embodiment, cap 460 may extend over the proximal end of hub body 453 such that cylindrical wall 461 and end wall 462 are disposed outside of hub chamber 455. In other embodiments, cap 460 may be configured such that a portion of cap 460 is disposed within hub chamber 455 when cap 460 is disposed in the closed position. More specifically, cap 460 may be configured such that end wall 462 and at least a portion of cylindrical wall 461 are disposed within hub chamber 455 when cap 460 is disposed in the closed position.

[0067] In some embodiments, tether 454 may be configured to bias cap 460 toward the open position. More specifically, tether 454 may be configured to maintain cap 460 away from the open proximal end of hub body 453 when cap 460 is not disposed in the closed position. Biasing cap 460 away from the open proximal end of hub body 453 when cap 460 is not disposed in the closed position may prevent contact between cap 460 and urine flowing from outlet hub 450 during use.

[0068] In use, a user can break the outlet seal 452 by displacing the cap 460 away from the closed position. For further use, a user can re-establish the outlet seal 452 by returning the cap 460 to the closed position.

[0069] Figures 5A and 5B illustrate another embodiment of an outlet hub (hub) 550 that may be used with catheter 100. Figure 5A illustrates a proximal portion of hub 550 with outlet seal 552 in a closed state, and Figure 5B illustrates a proximal portion of hub 550 with outlet seal 552 in a breached / open state. With reference to Figures 5A and 5B, hub 550 includes a cap 560 rotatably coupled to a hub body 553 via a hinge 554 (e.g., a living hinge). Cap 560 is positioned in a closed position in Figure 5A, defining the closed state of outlet seal 552, and cap 560 is positioned in an open position in Figure 5B, defining the open state of outlet seal 552.

[0070] In some embodiments, hinge 554 may be configured to bias cap 560 toward the open position. More specifically, hinge 554 may be configured to (i) apply a rotational force to cap 560 to rotate cap 560 toward the open position after a user applies an opening force to tab 563 to rotate cap 560 away from the closed position, and / or (ii) maintain cap 560 in the open position.

[0071] The hub 550 includes a plug member 564 attached to an underside of the cap 560 such that the plug member 564 is disposed within the chamber 555 when the cap 560 is disposed in the closed position. The plug member 564 may be formed from a soft material, such as, for example, an elastomeric material. The plug member 564 may cover portions of the cap 560 (e.g., pockets, recesses, interior corners, etc.) that may collect lubricant and / or urine in the absence of the plug member 564. In some embodiments, the plug member 564 may engage the hub body 553 (or more specifically, the interior surface of the hub body 553) to define (or partially define) the outlet seal 552. The underside 564A of the plug member 564 may be flat or convex (i.e., not concave).

[0072] In use, a user can break the outlet seal 552 by displacing the cap 560 away from the closed position. For further use, a user can re-establish the outlet seal 552 by returning the cap 560 to the closed position.

[0073] Figures 6A and 6B show another embodiment of an outlet hub (hub) 650 that can be used with the catheter 100. Figure 6A shows a proximal portion of the hub 650 with the outlet seal 652 in a closed state, and Figure 6B shows the proximal portion of the hub 650 with the outlet seal 652 in a broken / open state. With reference to Figures 6A and 6B, the hub 650 includes a cap 660 pivotally coupled to a hub body 653 for pivoting about an axis of rotation 657, which passes through the hub body 653 and the cap 660. The cap 660 is pivoted to a closed position in Figure 6A to define the closed state of the outlet seal 652, and the cap 660 is pivoted to an open position in Figure 6B to define the open state of the outlet seal 652.

[0074] The cap 660 generally takes the form of a plug disposed within the hub chamber 655. The cap 660 includes a peripheral wall 667 coupled to an end wall 666. In some embodiments, the end wall 666 is oriented perpendicular to the longitudinal axis 617 of the outlet hub 650. In the closed state, the peripheral wall 667 sealably engages the wall 656 of the hub body 653 to define the outlet seal 652. The cap 660 defines a fluid flow path 606 that extends through the cap 660 from a bottom side of the cap to a port 668 that extends through the peripheral wall 667. The port 668 is positioned such that the hub wall 656 extends over (i.e., covers) the port 668 when the cap 660 is pivoted to the closed position.

[0075] Cap 660 is configured to pivot toward an open position (FIG. 6B) in response to a force 605 applied to cap 660 by a user. When cap 660 is pivoted to the open position, port 668 is disposed proximal to the proximal end of hub body 653 to define a fluid flow path 606 from hub chamber 655. Thus, when cap 660 is pivoted to the open position, lubricant 608 and / or urine 609 can exit chamber 655.

[0076] In some embodiments, the hub body 653 may include a finger rest 659. The finger rest can allow a user to apply force 605 to pivot the cap 660 from a closed position to an open position.

[0077] In use, a user can break the outlet seal 652 by pivoting the cap 660 away from the closed position, exposing the port 668. For further use, the user can re-establish the outlet seal 652 by pivoting the cap 660 back to the closed position, again covering the port 668.

[0078] 7A and 7B illustrate another embodiment of an outlet hub (hub) 750 that may be used with catheter 100. FIG. 7A illustrates a proximal portion of hub 750 with outlet seal 752 in a closed state, and FIG. 7B illustrates a proximal portion of hub 750 with outlet seal 752 in a broken / open state. Referring to FIGS. 7A and 7B, hub 750 includes a cap 760 coupled to hub body 753 such that cap 760 is longitudinally positionable relative to hub body 753. Cap 760 is positioned in a closed position in FIG. 7A to define the closed state of outlet seal 752, and cap 760 is positioned in an open position in FIG. 7B to define the open state of outlet seal 752, with the open position being proximal to the closed position.

[0079] The cap 760 is generally disposed within the hub chamber 755. The cap 760 includes a cylindrical wall 767 coupled to an end wall 766. In the closed state, the cylindrical wall 767 sealably engages the wall 756 of the hub body 753 to define the outlet seal 752. The cap 760 includes one or more ports 768 extending through the cylindrical wall 767. The ports 768 are positioned such that the hub wall 756 extends over (i.e., covers) the ports 768 when the cap 760 is disposed in the closed position. In the open position, the cap 760 extends proximally beyond the proximal end of the hub body 753 to expose the ports 768. Thus, when the cap 760 is longitudinally displaced to the open position, the lubricant 708 and / or urine 709 can exit the chamber 755 through the ports 768.

[0080] Hub 750 includes a ring 770 that surrounds hub body 753. Ring 770 is rotatably coupled to hub body 753. Ring 770 is also operably coupled to cap 760 such that rotation of ring 770 in one direction displaces cap 760 proximally away from the closed position toward the open position. Similarly, rotation of ring 770 in the opposite direction displaces cap 760 distally away from the open position toward the closed position.

[0081] In use, a user can rotate ring 770 in one direction to extend cap 760 proximally, breaking outlet seal 752 and exposing port 768. For further use, a user can re-establish outlet seal 752 by rotating ring 770 in the opposite direction, displacing cap 760 distally to a closed position and re-covering port 768.

[0082] Figures 8A and 8B show another embodiment of an outlet hub (hub) 850 that can be used with catheter 100. Figure 8A shows a proximal portion of hub 850 with outlet seal 852 in a closed state, and Figure 8B shows a proximal portion of hub 850 with outlet seal 852 in a breached state. With reference to Figures 8A and 8B, hub 850 includes a cap 860 coupled to hub body 853 such that cap 860 is longitudinally positionable relative to hub body 853. Cap 860 is positioned in a closed position in Figure 8A to define the closed state of outlet seal 852, and cap 860 is positioned in an open position in Figure 8B to define the open state of outlet seal 852, the open position being proximal to the closed position.

[0083] The cap 860 is generally disposed within the hub chamber 855 such that a proximal end portion of the cap 860 extends beyond the proximal end of the hub body 853. The cap 860 includes a cylindrical wall 867 coupled to an end wall 866. In the closed position, the cylindrical wall 867 sealably engages the hub wall 856 of the hub body 853 to define the outlet seal 852. The cap 860 includes one or more ports 868 extending through the cylindrical wall 867. The ports 868 are positioned such that the hub wall 856 extends across (i.e., covers) the ports 868 when the cap 860 is disposed in the closed position. In the open position, the cap 860 extends further beyond the proximal end of the hub body 853, exposing the ports 868. Thus, when cap 860 is longitudinally displaced to the open position, lubricant 808 and / or urine 809 can exit chamber 855 through port 868 .

[0084] The hub 850 includes a latch mechanism 870 operably coupled between the cap 860 and the hub body 853. The latch mechanism 870 facilitates selective positioning of the cap 860 between a closed position and an open position. The latch mechanism 870 biases the cap 860 in a proximal direction, and the latch mechanism 870 selectively limits the position of the cap 860 (i.e., prevents proximal displacement of the cap 860) in the closed and open positions. The latch mechanism 870 is configured to transition the cap 860 from the closed position to the open position in response to a force 805 applied to the cap 860 by a user. Similarly, the latch mechanism 870 is configured to transition the cap 860 from the open position to the closed position in response to a force 805 applied to the cap 860 by a user. In other words, the user can apply force 805 to the cap 860 when the cap 860 is in the closed position. In response, when force 805 is removed, cap 860 displaces itself from the closed position to the open position. Similarly, a user can apply force 805 to cap 860 when cap 860 is in the open position to displace cap 860 to the closed position. In response, when force 805 is removed, latch mechanism 870 limits proximal displacement of cap 860 in the closed position.

[0085] In use, a user can break the outlet seal 852 by pushing the cap 860 distally to expose the port 868, allowing the cap 860 to displace itself to the open position. For further use, a user can re-establish the outlet seal 852 by pushing the cap 860 distally to the closed position to cover the port 868 again.

[0086] Figure 9 shows another embodiment of an outlet hub (hub) 950 that can be used with the catheter 100. Figure 9 shows the proximal portion of the hub 950 with the outlet seal 952 in a closed state. The outlet seal 952 includes a film 933 that is sealably coupled with a hub body 953 to close the proximal end of a hub chamber 955. The film 933 can be attached to the hub body 953 by a heat sealing process. The film 933 can include a pull ring 934 to allow a user to remove the film 933 from the hub body 953.

[0087] In use, a user can break the exit seal 952 by removing the film 933. In some embodiments, removing the film may include pulling the pull ring 934.

[0088] A method of using a catheter to drain urine from the bladder may include all or any subset of the following steps or processes performed by a user: One step may include the user removing the catheter from the outer packaging.

[0089] Another step may involve the user breaking the entrance seal and / or the exit seal. Another step may include draining the lubricant from the lumen of the catheter tube. Draining the lubricant may include transitioning the catheter tube from a looped shape to an extended shape. Draining the lubricant may also include orienting the catheter tube toward a vertical position so that gravity may drain the lubricant from the lumen toward the proximal or distal end.

[0090] Another step may include orienting and / or positioning the distal end of the catheter tube relative to the user's urethra. Another step may include inserting the distal tip of the introitus into the urethra. Another step may include advancing the introitus along the urethra to the bladder. Another step may include draining urine from the bladder. In some embodiments, draining urine from the bladder may include positioning the proximal end of the tube at a vertical position lower than the distal end to allow urine to flow (i) into the opening, (ii) proximally along the lumen, and (iii) out the proximal end. In some embodiments, draining urine from the bladder may include positioning the proximal end of the tube over a urine container, such as a toilet, to allow urine to enter the container. Another step may include withdrawing the introitus from the urethra.

[0091] Another step may include re-establishing a seal at the proximal end of the catheter. Another step may include replacing the catheter in the outer packaging. Another step may include disposing of the catheter in a trash receptacle.

[0092] Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A urinary catheter, a catheter tube defining a catheter lumen extending between a distal end and a proximal end, the catheter tube configured for insertion into a patient's bladder; a sheath defining a sheath lumen extending along the catheter tube, the catheter tube being disposed within the sheath lumen; an outlet hub coupled to the catheter tube at the proximal end, the outlet hub including a hub body defining a hub chamber, the hub chamber defining the catheter lumen extending through the outlet hub; an engagement member coupled to the outlet hub, the engagement member comprising: a closed state at the proximal end that prevents fluid from exiting the catheter lumen; an open state at the proximal end that allows the fluid to exit the catheter lumen; A urinary catheter that is selectively transferable between

2. The catheter of claim 1 , further comprising a lubricant disposed within the catheter lumen.

3. The catheter of claim 2 , wherein the lubricant is further disposed within the sheath lumen in contact with an outer surface of the catheter tube.

4. The catheter according to any one of claims 1 to 3, wherein the fluid includes the lubricant.

5. the engagement member includes a lid coupled to the outlet hub via a hinge; the lid is rotatable between a closed position defining the closed state and an open position defining the open state; the lid extends over a proximal end of the outlet hub in the closed position; The catheter of any one of claims 1 to 4, wherein the lid is rotated away from the proximal end of the outlet hub in the open position.

6. The catheter of claim 5 , wherein in the open position, the lid is rotated at least 90 degrees away from the closed position.

7. 7. The catheter of claim 5 or 6, wherein in the open position, the lid is rotated at least 180 degrees away from the closed position.

8. The catheter of any one of claims 5 to 7, wherein the lid is rotatably biased towards the open position by the hinge.

9. the lid includes a first protrusion extending away from a peripheral edge of the lid; the outlet hub includes a corresponding second protrusion extending away from a sidewall of the outlet hub, the corresponding second protrusion positioned adjacent the hinge; The catheter of any one of claims 5 to 8, wherein interference between the corresponding second protrusion and the first protrusion defines a detent for maintaining the lid in the open position.

10. the outlet hub includes a protrusion extending away from a sidewall of the outlet hub; the lid includes a protrusion receiving member disposed on an upper side of the lid, the receiving member configured to prevent separation of the protrusion from the protrusion receiving member in the absence of a separation force; The catheter according to any one of claims 5 to 8, wherein the protrusion is inserted into the protrusion receiving member to maintain the lid in the open position.

11. the lid includes a plug disposed on an underside of the lid; The catheter of any one of claims 5 to 10, wherein at least a portion of the plug is disposed within the hub chamber when the lid is in the closed position.

12. The catheter of claim 11 , wherein the plug is formed from an elastomeric material.

13. the engagement member includes a cap coupled to the outlet hub via a tether; the lid is positionable between a closed position defining the closed state and an open position defining the open state; the lid extends over a proximal end of the outlet hub in the closed position; the lid is positioned away from the proximal end of the outlet hub in the open position; The catheter of any one of claims 1 to 4, wherein the tether biases the lid toward the open position and away from the closed position.

14. The engagement member includes a plug cap disposed within the hub chamber; the plug cap includes a fluid passage extending through the plug cap between an underside of the plug cap and one or more side ports located along a cylindrical side wall of the plug cap; the plug cap is positionable between a closed position defining the closed condition and an open position defining the open condition; the one or more side ports are disposed within the hub chamber such that a side wall of the outlet hub sealably covers the one or more side ports when the plug cap is in the closed position; The catheter of any one of claims 1 to 4, wherein the one or more side ports are positioned proximally beyond the side wall of the outlet hub when the plug cap is in the open position.

15. the plug cap is coupled to the outlet hub so as to be tiltable relative to the outlet hub about a rotational axis extending laterally through the plug cap and the outlet hub; the plug cap is oriented such that a proximal end face of the plug cap is perpendicular to a longitudinal axis of the outlet hub when the plug cap is in the closed position; The catheter of claim 14 , wherein the plug cap is tilted such that the proximal end face is rotated away from its vertical orientation when the plug cap is in the open position.

16. The catheter of claim 14 , wherein the plug cap is longitudinally positionable between the closed position and the open position.

17. the outlet hub includes a ring extending circumferentially around the outside of the hub body; The ring is Rotation of the ring relative to the hub body in one direction displaces the plug cap proximally from the closed position to the open position; Rotation of the ring relative to the hub body in an opposite direction displaces the plug cap distally from the open position to the closed position. The catheter of claim 15 , wherein the plug cap is operably coupled between the plug cap and the hub body so as to

18. the outlet hub includes a latch mechanism operably coupled between the plug cap and the hub body; the latch mechanism is adapted to position the plug cap in the open position when a distally directed force is (i) manually applied to and (ii) released from the plug cap when the plug cap is in a closed position; and 15. The catheter of claim 14, wherein the latch mechanism is adapted to position the plug cap in the closed position when the distally directed force is (i) manually applied to and (ii) released from the plug cap when the plug cap is in the open position.

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