Catheter device

Abstract

Disclosed herein is a catheter (100) that is generally configured for self-deployment. The catheter includes a lubricant (108) disposed within the catheter lumen. The catheter also includes a sheath (125) covering the catheter tubing, wherein the lumen of the sheath also contains 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 an engagement member are disclosed herein. The cap may also be held in an open position for positioning away from urine exiting the catheter lumen during use.

Description

BACKGROUND OF THE INVENTION

[0001] Urinary incontinence causes a person to lose control of their bladder, resulting in the discharge of large or small amounts of urine. This can be caused by a variety of reasons. Users with paraplegia or quadriplegia lose control of their bladders and they need to use catheters to empty their bladders. These catheters can be indwelling (the catheter is placed in the bladder for a long time and attached to a urine bag to collect urine) or can be intermittent (the catheter is periodically inserted into the bladder and urine is drained directly from the bladder into an appropriate drainage area or into a urine bag). Intermittent catheters are preferred when the user can insert the catheter themselves or does not want to be seen carrying a urine bag. Intermittent catheters allow the user to move freely.

[0002] The catheter can be pre-lubricated. In some cases, when the package is opened, the lubricant may spill out, which may stain or soil the user's clothes. Similarly, residual urine within the catheter lumen can exit the catheter lumen and stain or soil the user's clothes. In some cases, the catheter includes a packaging shape that is not conducive to carrying around (such as in a clothing pocket).

[0003] A catheter and a catheter insertion method for solving the foregoing problems are disclosed herein. SUMMARY OF THE INVENTION

[0004] Briefly summarized, according to some embodiments, a catheter is disclosed herein that includes: (i) a catheter tube member that defines a catheter lumen extending between a distal end and a proximal end, wherein the catheter tube member is configured for insertion into a patient's bladder; (ii) a sheath that defines a sheath lumen extending along the catheter tube member, wherein the catheter tube member is disposed within the sheath lumen; (iii) an outlet bushing that is coupled to the catheter tube member at the proximal end. The outlet bushing includes a bushing body that defines a bushing chamber, and the bushing chamber defines the catheter lumen extending through the outlet bushing. The catheter further includes an engagement member coupled to the outlet bushing, wherein the engagement member is capable of selectively transitioning between: (i) a closed state, wherein fluid is prevented from leaving the catheter lumen at the proximal end; and (ii) an open state, wherein fluid is allowed to leave the catheter lumen at the proximal end.

[0005] In some embodiments, the catheter further includes a lubricant disposed within the catheter lumen. In some embodiments, the lubricant is also disposed within the sheath lumen along the exterior of the catheter tube member. In some embodiments, the fluid includes the lubricant.

[0006] In some embodiments, the engagement member includes a cap coupled to the outlet bushing via a hinge. The cap is capable of rotating between a closed position that defines the closed state and an open position that defines the open state, wherein the cap extends across the proximal end of the outlet bushing in the closed position, and wherein the cap rotates away from the proximal end of the outlet bushing in the open position.

[0007] In some embodiments, when the lid is in the open position, the lid rotates away from the closed position by at least 90 degrees. In some embodiments, when the lid is in the open position, the lid rotates away from the closed position by at least 180 degrees. In some embodiments, the lid is rotatably biased towards the open position via a hinge.

[0008] In some embodiments, the lid includes a first protrusion extending away from the circumferential edge of the lid, and the outlet bushing includes a corresponding second protrusion extending away from the sidewall of the outlet bushing, wherein the corresponding second protrusion is positioned adjacent to the hinge. The interference between the corresponding second protrusion and the first protrusion defines a stop device for maintaining the lid in the open position.

[0009] In some embodiments, the outlet bushing includes a protrusion extending away from the sidewall of the outlet bushing, and the lid includes a protrusion receiving member disposed on the top side of the lid, wherein the receiving member is configured to inhibit separation of the protrusion from the protrusion receiving member in the absence of a separating force. The protrusion is inserted into the protrusion receiving member to maintain the lid in the open position.

[0010] In some embodiments, the lid includes a plug disposed on the lower side of the lid, and when the lid is in the closed position, at least a portion of the plug is disposed within the bushing chamber. In some embodiments, the plug is formed of an elastomeric material.

[0011] In some embodiments, the engagement member includes a lid coupled to the outlet bushing via a tether. The lid is capable of being positioned between a closed position defining a closed state and an open position defining an open state, wherein the lid extends across the proximal end of the outlet bushing in the closed position, and wherein the lid is positioned away from the proximal end of the outlet bushing in the open position. The tether biases the lid away from the closed position towards the open position.

[0012] In some embodiments, the engagement member includes a plug cap disposed within the bushing chamber, wherein the plug cap includes a fluid flow path extending through the plug cap between the lower side of the plug cap and one or more side ports positioned along the cylindrical sidewall of the plug cap. The plug cap is capable of being positioned between a closed position defining a closed state and an open position defining an open state, wherein when the plug cap is in the closed position, the one or more side ports are disposed within the bushing chamber such that the sidewall of the outlet bushing sealingly covers the one or more side ports, and wherein when the plug cap is in the open position, the one or more side ports are disposed proximally beyond the sidewall of the outlet bushing.

[0013] In some embodiments, the plug cap is coupled to the outlet bushing so as to be tiltable relative to the outlet bushing about a rotational axis that extends laterally through the plug cap and the outlet bushing. The plug cap is oriented such that when the plug cap is in the closed position, the proximal face of the plug cap is perpendicular to the longitudinal axis of the outlet bushing, and the plug cap is tilted such that when the plug cap is in the open position, the proximal face rotates away from the perpendicular orientation.

[0014] In some embodiments, the plug cap is longitudinally positionable between a closed position and an open position.

[0015] In some embodiments, the outlet bushing includes a ring that circumferentially extends around an outer perimeter of the bushing body, and the ring is operatively coupled between the plug cap and the bushing body such that (i) rotation of the ring relative to the bushing body in one direction causes the plug cap to proximally displace from the closed position to the open position, and (ii) rotation of the ring relative to the bushing body in the opposite direction causes the plug cap to distally displace from the open position to the closed position.

[0016] In some embodiments, the outlet bushing includes a latching mechanism that is operatively coupled between the plug cap and the bushing body such that when the plug cap is in the closed position, the latching mechanism positions the plug cap in the open position when a distally-directed force (i) is manually applied to the plug cap and (ii) is released from the plug cap, and when the plug cap is in the open position, the latching mechanism positions the plug cap in the closed position when a distally-directed force (i) is manually applied to the plug cap and (ii) is released from the plug cap.

[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 fitting configured to be inserted into the patient's bladder, wherein the catheter fitting defines a catheter lumen. The method further includes converting a mating member of the catheter from a closed state to an open state, wherein the mating member is configured to prevent fluid from exiting a proximal end through an outlet bushing coupled to the catheter fitting at the proximal end of the catheter lumen. The method further includes: (i) draining a lubricant from the catheter lumen; (ii) inserting the catheter fitting into the patient's bladder to establish a urine flow through the catheter lumen; and (iii) converting the mating member from the open state to the closed state.

[0018] In some embodiments of the method, the catheter further includes a sheath that extends along the catheter fitting, wherein the catheter fitting is disposed within a lumen of the sheath, wherein a portion of the lubricant is disposed within the lumen of the sheath, and wherein this portion of the lubricant contacts an outer surface of the catheter fitting.

[0019] In some embodiments of the method, the engagement member includes a lid coupled to the outlet bushing via a hinge. The lid is rotatable between a closed position defining a closed state and an open position defining an open state, wherein the lid extends across the proximal end of the outlet bushing in the closed position, and wherein the lid rotates away from the proximal end of the outlet bushing in the open position. Converting the engagement member from the closed state to the open state includes rotating the lid away from the closed position by at least 90 degrees.

[0020] In some embodiments, the lid includes a first protrusion extending away from the circumferential edge of the lid, and the outlet bushing includes a corresponding second protrusion extending away from the sidewall of the outlet bushing, wherein the corresponding second protrusion is positioned adjacent to the hinge, and wherein the interference between the corresponding second protrusion and the first protrusion defines a rotational stop for the lid. In such embodiments of the method, converting the engagement member from the closed state to the open state includes rotating the lid beyond the stop to secure the lid in the open state.

[0021] In some embodiments of the method, the outlet bushing includes a protrusion extending away from the sidewall of the outlet bushing, and the lid includes a protrusion receiving member disposed on the top side of the lid, wherein the protrusion receiving member is configured to inhibit separation of the protrusion from the protrusion receiving member in the absence of a separating force. In such embodiments of the method, converting the engagement member from the closed state to the open state includes rotating the lid to insert the protrusion into the receiving member to constrain the lid in the open position.

[0022] In some embodiments of the method, the engagement member includes a lid coupled to the outlet bushing via a tie. The lid is positionable between a closed position defining a closed state and an open position defining an open state, wherein the lid extends across the proximal end of the outlet bushing in the closed position, and wherein the lid is positioned away from the proximal end of the outlet bushing in the open position. The tie biases the lid away from the closed position toward the open position, and in such embodiments of the method, converting 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 tie 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 bushing, wherein the plug cap includes a fluid flow path extending through the plug cap between a lower side of the plug cap and one or more side ports positioned along a cylindrical sidewall of the plug cap. The plug cap is capable of being positioned between a closed position defining a closed state and an open position defining an open state, wherein when the plug cap is in the closed position, the one or more side ports are disposed within the bushing chamber such that a sidewall of the outlet bushing sealingly covers the one or more side ports, and wherein when the plug cap is in the open position, the one or more side ports are disposed proximally beyond the sidewall of the outlet bushing. 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 bushing so as to be tiltable relative to the outlet bushing about a rotational axis extending laterally through the plug cap and the outlet bushing, and the plug cap is oriented such that a proximal face of the plug cap is perpendicular to a longitudinal axis of the outlet bushing 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 the perpendicular orientation.

[0025] In some embodiments of the method, the plug cap is capable of being longitudinally positioned between a closed position and an open position.

[0026] In some embodiments of the method, the outlet bushing includes a ring extending circumferentially around an exterior of the bushing body, wherein the ring is operatively coupled between the plug cap and the bushing body such that rotation of the ring relative to the bushing body causes the plug cap to shift 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.

[0027] In some embodiments of the method, the outlet bushing includes a latching mechanism operatively coupled between the plug cap and the bushing body, wherein the latching mechanism is configured to position the plug cap in the open position when a distally directed force (i) is manually applied to the plug cap and (ii) is 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 latching mechanism to shift the plug from the closed position proximally to the open position.

[0028] In view of the drawings and the following description, these and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art, the drawings and the following description more particularly disclose specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments of the disclosure are shown by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals indicate like elements, and in which:

[0030] Figure 1A is a diagram of a urinary catheter in a packaged state according to some embodiments;

[0031] Figure 1B is of a urinary catheter in an unpackaged state according to some embodiments Figure 1A ;

[0032] Figure 1C is a detailed diagram of the proximal portion of a urinary catheter according to some embodiments Figure 1A where the cap is in the closed position;

[0033] Figure 1D is a detailed diagram of the proximal portion of a urinary catheter according to some embodiments Figure 1A where the cap is in the open position;

[0034] Figure 1E is a detailed diagram of the proximal portion of a urinary catheter according to some embodiments Figures 1C to 1D where the cap is in the closed position;

[0035] Figure 2A is a diagram of a second embodiment of the outlet bushing of a urinary catheter according to some embodiments Figure 1A where the cap is in the closed position;

[0036] Figure 2B is a diagram of an outlet bushing according to some embodiments Figure 2A where the cap is in the open position;

[0037] Figure 3A is a diagram of a third embodiment of the outlet bushing of a urinary catheter according to some embodiments Figure 1A where the cap is in the closed position;

[0038] Figure 3B is a diagram of an outlet bushing according to some embodiments Figure 3A where the cap is in the open position;

[0039] Figure 4A is a diagram of a fourth embodiment of the outlet bushing of a urinary catheter according to some embodiments Figure 1A where the cap is in the closed position;

[0040] Figure 4B is a diagram of an outlet bushing according to some embodiments Figure 4A where the cap is in the open position;

[0041] Figure 5A is an illustration of a fifth embodiment of an outlet bushing of a urinary catheter according to some embodiments, wherein the cap is in a closed position; Figure 1A

[0042] Figure 5B is an illustration of an outlet bushing according to some embodiments, wherein the cap is in an open position; Figure 5A

[0043] Figure 6A is an illustration of a sixth embodiment of an outlet bushing of a urinary catheter according to some embodiments, wherein the cap is in a closed position; Figure 1A

[0044] Figure 6B is an illustration of an outlet bushing according to some embodiments, wherein the cap is in an open position; Figure 6A

[0045] Figure 7A is an illustration of a seventh embodiment of an outlet bushing of a urinary catheter according to some embodiments, wherein the cap is in a closed position; Figure 1A

[0046] Figure 7B is an illustration of an outlet bushing according to some embodiments, wherein the cap is in an open position; Figure 7A

[0047] Figure 8A is an illustration of an eighth embodiment of an outlet bushing of a urinary catheter according to some embodiments, wherein the cap is in a closed position; Figure 1A

[0048] Figure 8B is an illustration of an outlet bushing according to some embodiments, wherein the cap is in an open position; Figure 8A

[0049] Figure 9 is an illustration of a ninth embodiment of an outlet bushing of a urinary catheter according to some embodiments, wherein the bushing includes a seal in the form of a membrane. Figure 1A DETAILED DESCRIPTION

[0050] Before disclosing some specific embodiments 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 can be easily separated from the specific embodiments, and these features can optionally be combined with the features of any of the many other embodiments disclosed herein or replace the features of any of the many other embodiments disclosed herein.

[0051] ​​​​​​​​​Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and these terms 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 in a group of features or steps, and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a specific embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0052] With respect to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter as disclosed herein includes a part of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be placed near the clinician when the catheter is used in a patient. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0053] With respect to "distal", for example, the "distal portion" or "distal end portion" of a catheter as disclosed herein includes a part of the catheter that is intended to be placed near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be placed near or within the patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be placed near or within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0054] The phrases "connected to", "coupled with", 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 may be coupled to each other even if they do not directly contact each other. For example, two components may be coupled to each other through an intermediate component.

[0055] Any method disclosed herein includes one or more steps or acts for performing the described method. These method steps and / or acts may be interchanged with one another. In other words, unless the proper operation of an embodiment requires a particular order of steps or acts, the order and / or use of particular steps and / or acts may be modified.

[0056] Throughout the specification, approximations may be referred to, 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 approximation. For example, in cases where qualifiers such as "about" and "substantially" are used, these terms include within their scope the case where the qualified word is without its qualifier. For example, in the case of reciting the term "substantially straight" with respect to a feature, it should be understood that in other embodiments, the feature may have an exactly straight configuration.

[0057] Throughout the specification, references to "an embodiment" or "the embodiment" mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, phrases or variations thereof as recited throughout the specification do not necessarily all refer to the same embodiment.

[0058] Figures 1A to 1D A first embodiment of a urinary catheter in various states of use is shown. The urinary catheter (catheter) 100 is generally configured to be self-deployed by a user (also referred to herein as a patient) to drain urine from the user's bladder. The illustrated catheter 100 is generally configured for use by a male patient. However, the catheter 100 may be configured for use by a female patient without departing from the features and functions of the catheter 100 as shown and described below. The catheter 100 may be used by a patient, for example, in various environments, such as at a medical facility, at home, or at a public toilet.

[0059] The catheter 100 is generally configured to be used by a patient multiple times in a day. More specifically, a patient may deploy multiple catheters 100 (one at a time) within a day. Thus, a patient may, for example, keep one or more catheters 100 carried on their person, such as in a clothing pocket or wallet. Thus, the catheter 100 may be arranged in a packaged state having a compact shape consistent with placement of the catheter 100 within a clothing pocket or wallet. The catheter 100 is also configured to maintain the sterility of the catheter 100 in the packaged state.

[0060] In some cases, a user may be concerned about soiling clothing, for example, via urine or a catheter lubricant during urine drainage. Thus, the catheter 100 is configured for deployment while also inhibiting the lubricant of the catheter 100 from spilling onto clothing or other items during use. Additionally, the catheter 100 is generally configured to contain any residual urine within the catheter tubing after use.

[0061] Since the catheter 100 is configured for self-deployment, the catheter 100 can be configured to facilitate user manipulation (i.e., grasping, orienting, guiding, or applying force, etc.) during deployment. Thus, the catheter 100 can be configured for deployment by a user with limited dexterity.

[0062] Figure 1A A perspective front view of the catheter 100 in a packaged state is shown. The catheter 100 can be arranged in a packaged state prior to use. The catheter 100 can be arranged, for example, within an outer package 104 (such as a bag or pouch). In some embodiments, the outer package 104 can be resealable. In other words, the outer package 104 can be configured to (i) sealably contain the catheter 100 prior to use and (ii) sealably contain the catheter 100 after use.

[0063] The catheter 100 generally includes a catheter tubing 110 having a proximal end 111 and a distal end 112. The catheter tubing 110 can be formed from any suitable thermoplastic material via an extrusion process. A catheter lumen 115 extends along the catheter tubing 110, wherein the catheter lumen 115 is sized to facilitate the flow of urine from the distal end 112 therethrough to the proximal end 111 during use. The catheter tubing 110 includes an inlet segment 113 that extends proximally away from the distal end 112, the inlet segment being configured for insertion into a user's urethra and advancement along the user's urethra to the patient's bladder. Thus, the inlet segment 113 defines a length sufficient to extend from the tip of the penis to the patient's bladder. Similarly, the inlet segment defines an outer diameter compatible with placement within the urethra. The catheter tubing 110 also includes an outlet segment 114 that extends distally away from the proximal end 111. The outlet segment 114 is configured for use outside the patient's body and defines, for example, a length compatible with placement of the proximal end 111 on a urine receptacle (such as a toilet) during use.

[0064] The catheter fitting 110 includes an inlet ferrule 130 coupled to the inlet section 113 to also provide insertion assistance to the user. The inlet ferrule 130 is configured to be grasped by the user during use. Accordingly, the outer surface of the inlet ferrule 130 may include grasping features 131, such as protrusions, depressions, ribs, or grooves, for example, to enable grasping of the inlet ferrule 130 during use. In some embodiments, the inlet ferrule 130 includes a seal 132 that closes the distal end of the inlet ferrule 130 in the pre-use packaged state, as further described below. In some embodiments, the seal 132 may include a membrane 133 that is sealably coupled to the inlet ferrule 130, and in some embodiments, the membrane 133 may include a pull tab 134 to facilitate removal of the membrane 133 from the inlet ferrule 130.

[0065] The catheter fitting 110 also includes an outlet bushing (bushing) 150. The bushing 150 includes grasping features 151 disposed on the outer lateral surface of the bushing 150 to enable grasping of the bushing 150 during use. The bushing 150 defines a bushing chamber 155. The bushing chamber 155 is in fluid communication with the catheter lumen 115, i.e., the bushing chamber 155 defines the catheter lumen 115 at the proximal end 111. The bushing 150 includes an outlet seal 152 at the proximal end of the bushing 150.

[0066] The catheter 100 also includes a sheath 120 that extends along the catheter fitting 110 from the inlet ferrule 130 to the bushing 150. The sheath 120 defines a sheath lumen 125, and the catheter fitting 110 is disposed within the sheath lumen 125. The sheath lumen 125 is in fluid communication with the bushing chamber 155, i.e., the sheath lumen 125 extends into the bushing chamber 155. The sheath 120 (or more specifically, the distal end of the sheath 120) is sealably attached to the inlet ferrule 130, and the sheath 120 is also sealably attached to the bushing 150.

[0067] The sheath lumen 125, the catheter lumen 115, and the bushing chamber 155 combine to form an enclosed volume, and a lubricant 108 is sealably contained within the enclosed volume in the packaged state. The lubricant 108 is configured such that the inlet section 113 can slide and displace along the urethra during use.

[0068] Figure 1B The catheter 100 is shown in the unpackaged state, i.e., the state in which the catheter 100 is removed from the outer package 104, the catheter fitting 110 is deployed, and the inlet seal 132 and the outlet seal 152 are breached. The catheter 100 is oriented such that the lubricant 108 can flow out of the catheter lumen 115 and / or the sheath lumen 125 via the outlet bushing 150.

[0069] Figures 1C to 1E Various detailed views of the outlet bushing 150 are shown. Figure 1CThe bushing 150 is shown with the outlet seal 152 in the closed state. The bushing 150 includes an engagement member in the form of a cap 160 that is rotatably coupled to the bushing body 153 via a hinge portion 154 (e.g., a living hinge). The cap 160 rotates to a closed position to define the outlet seal 152 in the closed state.

[0070] Figure 1D The bushing 150 is shown with the outlet seal 152 in a damaged state. As shown, the cap 160 rotates away from the sheath body 153 toward the open position of the cap 160 to define an open state of the proximal end 111 of the catheter fitting 110, i.e., the open end of the catheter fitting lumen 115 via the open proximal end of the bushing chamber 155. Since the sheath lumen 125 is in fluid communication with the bushing chamber 155, the proximal end of the sheath lumen 125 is also open via the open proximal end of the bushing chamber 155. The cap 160 includes a tab (or flange) 163 that protrudes away from the circumferential edge of the cap 160, where the tab 163 is configured to facilitate a user applying an opening force.

[0071] In some embodiments, the hinge portion 154 can bias the cap 160 toward the open position. More specifically, the hinge portion 154 can 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. During use, when the cap 160 is in the open position, the cap 160 is generally positioned away from urine exiting the catheter fitting 110.

[0072] Figure 1E is a detailed illustration of the proximal portion of the bushing 150. The cap 160 is shown in the closed position. A portion of the bushing body 153 is cut away to show, in cross-section, the bushing wall 156 of the bushing body 153. The cap 160 includes a cylindrical wall 161 coupled to an end wall 162. In the illustrated embodiment, when the cap 160 is shown in the closed position, at least a portion of the end wall 162 and the cylindrical wall 161 are disposed within the bushing chamber 155. The end wall 162 can include a flat or convex (i.e., non-concave) end wall surface 162A to inhibit (i) the accumulation of the lubricant 108 on the end wall 162 when draining the lubricant 108 from the catheter 100, and / or (ii) the accumulation of urine during use when draining urine from the patient's body. In other embodiments, the cap 160 can extend over the proximal end of the bushing body 153 such that the cylindrical wall 161 and the end wall 162 are disposed outside of the bushing chamber 155.

[0073] The outlet seal 152 is defined by the engagement of corresponding seal members of the bushing body 153 and the cap 160. The cylindrical wall 161 includes an annular rib 152A that extends radially outward from the cylindrical wall 161. The bushing body 153 includes an annular groove 152B that extends radially outward from the inner surface of the bushing wall 156. The annular rib 152A and the annular groove 152B define the corresponding seal members. The annular rib 152A and the annular groove 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 groove 152B may also define a stop device to fix the cap 160 in the closed position in the absence of an opening force applied to the cap 160. As will be understood by those of ordinary skill in the art, the bushing 150 may include corresponding seal members other than the annular rib 152A and the annular groove 152B. In other words, the bushing 150 may include corresponding seal members of any configuration suitable for defining the outlet seal 152.

[0074] In use, the user can remove the membrane 133 from the inlet gasket 130 to break the inlet seal 132. Removing the membrane 133 may include pulling the pull tab 134. In use, the user can break the outlet seal 152 by rotating the cap 160 away from the closed position. In further use, the user can re - establish the outlet seal 152 by rotating the cap 160 to the closed position.

[0075] Figures 2A to 2B Another embodiment of an outlet bushing (bushing) 250 that can be used with the conduit 100 is shown. The bushing 250 may be similar in some aspects to the components of the bushing 150 described in connection with Figures 1A to 1E It should be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are denoted by similar reference numerals, where the leading digit is incremented to "2". For example, the bushing chamber is designated as "155" in Figures 1A to 1E and the bushing chamber is designated as "255" in Figures 2A to 2B Accordingly, the relevant disclosures set forth above regarding features with similar identifications may not be repeated hereinafter. In addition, specific features of the bushing 150 and related components shown in Figures 1A to 1E may not be shown in the drawings or denoted by reference numerals, or specifically discussed in the subsequent written description. However, such features may clearly be the same or substantially the same as the features depicted and / or described with respect to such other embodiments. Accordingly, the relevant descriptions of such features equally apply to the features of the bushing 250. Any suitable combination of features described with respect to the bushing 150 and components shown in FIGS. 1 through Figure 1E and their variations may be combined with Figures 2A to 2BThe bushing 250 is used together with the component, and vice versa. This pattern of the disclosure text also applies to other embodiments depicted in the subsequent figures and described below.

[0076] Figure 2A The proximal portion of the bushing 250 is shown, where the outlet seal 252 is in a closed state, and Figure 2B The proximal portion of the bushing 250 is shown, where the outlet seal 252 is in a damaged state. Referring Figures 2A to 2B , the bushing 250 includes a cap 260 rotatably coupled to the bushing body 253 via a hinge portion 254 (e.g., a movable hinge). The cap 260 rotates to a closed position to define Figure 2A the closed state of the outlet seal 252 in Figure 2B and the cap 260 rotates to an open position to define

[0077] The bushing 250 includes a cap retaining mechanism to hold the cap 260 in the open position (see Figure 2B ). The bushing body 253 includes a protrusion member 272 disposed on one side of the bushing body 253. The cap 260 includes a receiving member 271 on the top side of the cap 260. The receiving member 271 includes a recess configured to receive the protrusion member 272. The receiving member 271 is positioned on the cap 160, and the protrusion member 272 is positioned on one side of the bushing body 253 such that when the cap 260 rotates to the open position, the receiving member 271 is positioned to coincide with the protrusion member 272. In other words, the receiving member 271 and the protrusion member 272 are positioned such that when the user rotates the cap 260 to the open position, the protrusion member 272 is disposed within the receiving member 271.

[0078] The receiving member 271 and the protrusion member 272 can be configured to define a stop device configured to hold the cap 260 in the open position in the absence of a separating force applied to the cap 260. In some embodiments, when the cap 260 rotates to the open position, the protrusion member 272 can snap into the receiving member 271. The receiving member 271 and the protrusion member 272 can be configured to facilitate the separation of the receiving member 271 from the protrusion member 272 (e.g., via the application of a separating force) to allow the user to rotate the cap 260 away from the open position towards the closed position. As can be understood by those of ordinary skill in the art, other configurations of the receiving member 271 and the protrusion member 272 can be consistent with holding the cap 260 in the open position. For example, the cap 260 can include the protrusion member 272, and the bushing body 253 can include the receiving member 271.

[0079] In use, a user can break the outlet seal 252 by rotating the cap 260 away from the closed position. The user can also rotate the cap 260 to the fully open position and secure the cap 260 to the wall 256 of the bushing body 253 by engaging the receiving member 271 with the protrusion member 272. In further use, the user can re - establish the outlet seal 252 by rotating the cap 260 to the closed position.

[0080] Figures 3A to 3B Another embodiment of an outlet bushing (bushing) 350 that can be used with the conduit 100 is shown. Figure 3A A proximal portion of the bushing 350 is shown, where the outlet seal 352 is in the closed state, and Figure 3B A proximal portion of the bushing 350 is shown, where the outlet seal 352 is in the broken / open state. Referring Figures 3A to 3B , the bushing 350 includes a cap 360 that is rotatably coupled to the bushing body 353 via a hinge portion 354 (e.g., a living hinge). The cap 360 rotates to the closed position to define Figure 3A the closed state of the outlet seal 352 in Figure 3B the open position, where the cap 360 rotates 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.

[0081] The bushing 350 includes a cap retention mechanism to hold the cap 360 in the open position. The bushing body 353 includes a protrusion member 372 disposed on one side of the bushing body 353. The cap 360 includes a protrusion 371 that extends away from the circumferential edge of the cap 360 at a location adjacent to the hinge portion 354. The bushing body 353 also includes a corresponding protrusion 372 that extends away from the wall 356 of the bushing body 353 at a location adjacent to the hinge portion 354. The protrusion 371 and the corresponding protrusion 372 are configured to slide interfere with each other when the cap 360 is rotated by the user between the closed position and the open position. The protrusion 371 and the corresponding protrusion 372 are also configured such that the interference holds the cap 360 in the open position unless the user rotates the cap 360 toward the closed position. In other words, the protrusion 371 and the corresponding protrusion 372 define a stop device to maintain the cap 360 in the open position unless the user rotates the cap 360 toward the closed position.

[0082] In the illustrated embodiment, the cap 360 can extend over the proximal end of the bushing body 353 such that the cylindrical wall 361 and the end wall 362 are disposed outside the bushing chamber 355. In other embodiments, the cap 360 can be configured such that when the cap 360 is disposed in the closed position, a portion of the cap 360 is disposed within the bushing chamber 355. More specifically, the cap 360 can be configured such that when the cap 360 is disposed in the closed position, the end wall 362 and at least a portion of the cylindrical wall 361 are disposed within the bushing chamber 355.

[0083] In use, the user can disrupt the outlet seal 352 by rotating the cap 360 away from the closed position. The user can also rotate the cap 360 to the open position such that the cap 360 is held in the open position via a cap retention mechanism. In further use, the user can re - establish the outlet seal 352 by rotating the cap 360 to the closed position.

[0084] Figures 4A to 4B Another embodiment of an outlet bushing (bushing) 450 that can be used with the catheter 100 is shown. Figure 4A The proximal portion of the bushing 450 is shown, where the outlet seal 452 is in the closed state, and Figure 4B The proximal portion of the bushing 450 is shown, where the outlet seal 452 is in the disrupted / open state. Referring Figures 4A to 4B , the bushing 450 includes a cap 460 attached to the bushing body 453 via a tether 454. The cap 460 is disposed in the closed position to define Figure 4A the closed state of the outlet seal 452 in Figure 4B and the cap 460 is disposed in the open position in

[0085] to define the open state of the outlet seal 452. The tether 454 is attached to the cap 460 at the circumferential edge of the cap 460. The tether 454 is attached to the bushing body 453 at the attachment point 457. The attachment point 457 is spaced distally from the proximal end of the bushing body 453 to define the length 458 of the tether 454. In some embodiments, the wall 456 of the bushing body 453 can include a groove 459, where the groove 459 is configured to receive the tether 454 therein when the cap 460 is disposed in the closed position.

[0086] In the illustrated embodiment, the cap 460 may extend over the proximal end of the bushing body 453 such that the cylindrical wall 461 and the end wall 462 are disposed outside of the bushing chamber 455. In other embodiments, the cap 460 may be configured such that when the cap 460 is disposed in the closed position, a portion of the cap 460 is disposed within the bushing chamber 455. More specifically, the cap 460 may be configured such that when the cap 460 is disposed in the closed position, the end wall 462 and at least a portion of the cylindrical wall 461 are disposed within the bushing chamber 455.

[0087] In some embodiments, the tie 454 may be configured to bias the cap 460 toward the open position. More specifically, the tie 454 may be configured to maintain the cap 460 in a position away from the open proximal end of the bushing body 453 when the cap 460 is not disposed in the closed position. Biasing the cap 460 in a position away from the open proximal end of the bushing body 453 when the cap 460 is not disposed in the closed position may inhibit contact of the cap 460 with urine draining from the outlet bushing 450 during use.

[0088] In use, the user may disrupt the outlet seal 452 by displacing the cap 460 away from the closed position. In further use, the user may re - establish the outlet seal 452 by displacing the cap 460 to the closed position.

[0089] Figures 5A to 5B Another embodiment of an outlet bushing (bushing) 550 that may be used with the catheter 100 is shown. Figure 5A The proximal portion of the bushing 550 is shown, where the outlet seal 552 is in the closed state, and Figure 5B The proximal portion of the bushing 550 is shown, where the outlet seal 552 is in the disrupted / open state. Referring Figures 5A to 5B , the bushing 550 includes a cap 560 that is rotatably coupled to the bushing body 553 via a hinge 554 (e.g., a living hinge). The cap 560 is disposed in the closed position to define Figure 5A the closed state of the outlet seal 552 in Figure 5B and the cap 560 is disposed in the open position in

[0090] In some embodiments, the hinge 554 may be configured to bias the cap 560 toward the open position. More specifically, the hinge 554 may be configured to apply a rotational force to the cap 560 to (i) rotate the cap 560 toward the open position after the user applies an opening force to the tab 563 to rotate the cap 560 away from the closed position, and / or (ii) maintain the cap 560 in the open position.

[0091] The bushing 550 includes a plug member 564 attached to the lower side of the cap 560 such that when the cap 560 is in the closed position, the plug member 564 is disposed within the chamber 555. The plug member 564 may be formed of a soft material, such as an elastomeric material. The plug member 564 may cover portions of the cap 560 (e.g., pockets, recesses, internal corners, etc.) that could collect lubricant and / or urine in the absence of the plug member 564. In some embodiments, the plug member 564 may engage the bushing body 553 (or more specifically, the inner surface of the bushing body 553) to define (or partially define) the outlet seal 552. The lower side 564A of the plug member 564 may be flat or convex (i.e., non-concave).

[0092] In use, the user may disrupt the outlet seal 552 by shifting the cap 560 away from the closed position. In further use, the user may re-establish the outlet seal 552 by shifting the cap 560 to the closed position.

[0093] Figures 6A to 6B Another embodiment of an outlet bushing (bushing) 650 that may be used with the catheter 100 is shown. Figure 6A A proximal portion of the bushing 650 is shown where the outlet seal 652 is in the closed state, and Figure 6B A proximal portion of the bushing 650 is shown where the outlet seal 652 is in the disrupted / open state. Referring Figures 6A to 6B , the bushing 650 includes a cap 660 that is pivotally coupled to the bushing body 653 for pivoting about a rotational axis 657, where the rotational axis 657 passes through the bushing body 653 and the cap 660. The cap 660 pivots to a closed position to define Figure 6A the closed state of the outlet seal 652 in Figure 6B and the cap 660 pivots to the

[0094] open position in

[0095] to define the open state of the outlet seal 652. The cap 660 generally takes the form of a plug disposed within the bushing chamber 655. The cap 660 includes a circumferential 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 bushing 650. In the closed state, the circumferential wall 667 may sealingly engage the wall 656 of the bushing body 653 to define the outlet seal 652. The cap 660 defines a fluid flow path 606 that extends from the bottom side of the cap through the cap 660 to a port 668, and the port extends through the circumferential wall 667. The port 668 is positioned such that the bushing wall 656 extends across (i.e., covers) the port 668 when the cap 660 pivots to the closed position.

[0095] The cap 660 is configured to pivot toward the open position in response to a force 605 applied to the cap 660 by the user (Figure 6B ) When the cap 660 is pivoted to the open position, the port 668 is disposed proximal to the proximal end of the bushing body 653 to define a fluid flow path 606 out of the bushing chamber 655. Thus, when the cap 660 is pivoted to the open position, the lubricant 608 and / or urine 609 can leave the chamber 655.

[0096] In some embodiments, the bushing body 653 may include a finger clearance portion 659. The finger clearance portion may enable a user to apply a force 605 to pivot the cap 660 from the closed position to the open position.

[0097] In use, the user may disrupt the outlet seal 652 by pivoting the cap 660 away from the closed position to expose the port 668. In further use, the user may re - establish the outlet seal 652 by pivoting the cap 660 back to the closed position to re - cover the port 668.

[0098] Figures 7A to 7B Another embodiment of an outlet bushing (bushing) 750 that may be used with the catheter 100 is shown. Figure 7A The proximal portion of the bushing 750 is shown, where the outlet seal 752 is in the closed state, and Figure 7B The proximal portion of the bushing 750 is shown, where the outlet seal 752 is in the disrupted / open state. Referring Figures 7A to 7B , the bushing 750 includes a cap 760 that is coupled to the bushing body 753 such that the cap 760 is longitudinally positionable relative to the bushing body 753. The cap 760 is disposed in the closed position to define Figure 7A the closed state of the outlet seal 752 in Figure 7B and the cap 760 is disposed in the open position in

[0099] to define the open state of the outlet seal 752, where the open position is proximal to the closed position. The cap 760 is generally disposed within the bushing chamber 755. The cap 760 includes a cylindrical wall 767 coupled to an end wall 766. In the closed state, the cylindrical wall 767 may sealingly engage the wall 756 of the bushing body 753 to define the outlet seal 752. The cap 760 includes one or more ports 768 that extend through the cylindrical wall 767. The ports 768 are positioned such that the bushing wall 756 extends across (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 bushing 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 leave the chamber 755 through the ports 768.

[0100] The bushing 750 includes a ring 770 surrounding a bushing body 753. The ring 770 is rotatably coupled to the bushing body 753. The ring 770 is also operatively coupled to a cap 760 such that rotation of the ring 770 in one direction causes the cap 760 to proximally displace away from a closed position to an open position. Similarly, rotation of the ring 770 in the opposite direction causes the cap 760 to distally displace away from the open position to the closed position.

[0101] In use, a user can disrupt an outlet seal 752 by rotating the ring 770 in one direction to proximally extend the cap 760 to expose a port 768. In further use, the user can re - establish the outlet seal 752 by rotating the ring 770 in the opposite direction to distally displace the cap 760 to the closed position to re - cover the port 768.

[0102] Figures 8A to 8B Another embodiment of an outlet bushing (bushing) 850 that can be used with a catheter 100 is shown. Figure 8A A proximal portion of the bushing 850 is shown where the outlet seal 852 is in a closed state, and Figure 8B A proximal portion of the bushing 850 is shown where the outlet seal 852 is in a disrupted state. Referring Figures 8A to 8B , the bushing 850 includes a cap 860 that is coupled to a bushing body 853 such that the cap 860 is longitudinally positionable relative to the bushing body 853. The cap 860 is arranged in a closed position to define Figure 8A the closed state of the outlet seal 852 in Figure 8B and the cap 860 is arranged in an open position in

[0103] to define the open state of the outlet seal 852, where the open position is proximal to the closed position. The cap 860 is generally disposed within a bushing chamber 855 such that a proximal portion of the cap 860 extends beyond a proximal end of the bushing body 853. The cap 860 includes a cylindrical wall 867 coupled to an end wall 866. In the closed state, the cylindrical wall 867 sealingly engages a bushing wall 856 of the bushing 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 bushing wall 856 extends across (i.e., covers) the ports 868 when the cap 860 is arranged in the closed position. In the open position, the cap 860 further extends beyond the proximal end of the bushing body 853 to expose the ports 868. Thus, when the cap 860 is longitudinally displaced to the open position, lubricant 808 and / or urine 809 can leave the chamber 855 through the ports 868.

[0104] The bushing 850 includes a latch mechanism 870 operatively coupled between the cap 860 and the bushing body 853. The latch mechanism 870 facilitates selectively positioning 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 restricts the position of the cap 860 at the closed position and the open position (i.e., prevents proximal displacement of the cap 860). The latch mechanism 870 is configured to convert the cap 860 from the closed position to the open position in response to a force 805 applied by a user to the cap 860. Similarly, the latch mechanism 870 is configured to convert the cap 860 from the open position to the closed position in response to a force 805 applied by a user to the cap 860. In other words, when the cap 860 is in the closed position, the user can apply a force 805 to the cap 860. In response, upon removal of the force 805, the cap 860 self-displaces from the closed position to the open position. Similarly, when the cap 860 is in the open position, the user can apply a force 805 to the cap 860 to displace the cap 860 to the closed position. In response, the latch mechanism 870 restricts proximal displacement of the cap 860 at the closed position upon removal of the force 805.

[0105] In use, the user can break the outlet seal 852 by pressing the cap 860 distally and allowing the cap 860 to self-displace to the open position to expose the port 868. In further use, the user can re-establish the outlet seal 852 by pressing the cap 860 distally to the closed position to re-cover the port 868.

[0106] Figure 9 Another embodiment of an outlet bushing (bushing) 950 that can be used with the catheter 100 is shown. Figure 9 The proximal portion of the bushing 950 is shown, where the outlet seal 952 is in a closed state. The outlet seal 952 includes a membrane 933 that is sealably coupled to the bushing body 953 to enclose the proximal end of the bushing chamber 955. The membrane 933 can be attached to the bushing body 953 via a heat-sealing process. The membrane 933 can include a pull tab 934 to enable the user to remove the membrane 933 from the bushing body 953.

[0107] In use, the user can break the outlet seal 952 by removing the membrane 933. In some embodiments, removing the membrane can include pulling the pull tab 934.

[0108] A method of draining urine from the bladder using a catheter can include all or any subset of the following steps or procedures that can be performed by the user himself. The steps can include the user removing the catheter from the outer package.

[0109] Another step can include the user breaking the inlet seal and / or the outlet seal.

[0110] Another step may include draining lubricant from the lumen of the catheter fitting. Draining the lubricant may include causing the catheter fitting to transition from an annular shape toward an extended shape. Draining the lubricant may also include orienting the catheter fitting toward a vertical attitude such that gravity can cause the lubricant to drain from the lumen toward the proximal or distal end.

[0111] Another step may include orienting and / or positioning the distal end of the catheter fitting relative to the user's urethra. Another step may include inserting the distal end of the inlet segment into the urethra. Another step may include advancing the inlet segment along the urethra into the bladder. Another step may include draining urine from the bladder. In some embodiments, draining urine from the bladder may include placing the proximal end of the fitting in a vertical position lower than the distal end such that urine: (i) flows into the opening, (ii) flows proximally along the lumen, and (iii) exits the proximal end. In some embodiments, draining urine from the bladder may include positioning the proximal end of the fitting on a urine receptacle (such as a toilet), for example, such that urine enters the receptacle. Another step may include withdrawing the inlet segment from the urethra.

[0112] Another step may include re - establishing a seal at the proximal end of the catheter. Another step may include replacing the catheter into the outer package. Another step may include disposing of the catheter in a waste container.

[0113] Although some specific embodiments have been disclosed herein and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may occur to those of ordinary skill in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Accordingly, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A urinary catheter, comprising: A catheter fitting defining a catheter lumen extending between a distal end and a proximal end, the catheter fitting being configured for insertion into a patient's bladder; A sheath defining a sheath lumen extending along the catheter fitting, the catheter fitting being disposed within the sheath lumen; An outlet bushing coupled to the catheter fitting at the proximal end, the outlet bushing including a bushing body defining a bushing chamber, the bushing chamber defining the catheter lumen extending therethrough the outlet bushing; and An engagement member coupled to the outlet bushing, the engagement member being selectively convertible between: A closed state in which fluid is prevented from leaving the catheter lumen at the proximal end, and An open state in which the fluid is allowed to leave the catheter lumen at the proximal end.

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

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

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

5. The catheter according to any one of claims 1 to 4, wherein: The engagement member includes a lid coupled to the outlet bushing via a hinge portion, The lid is rotatable between a closed position defining the closed state and an open position defining the open state, The lid extends across a proximal end of the outlet bushing in the closed position, and The lid rotates away from the proximal end of the outlet bushing in the open position.

6. The catheter according to claim 5, wherein in the open position, the lid rotates away from the closed position by at least 90 degrees.

7. The catheter according to claim 5 or 6, wherein in the open position, the lid rotates away from the closed position by at least 180 degrees.

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

9. The catheter according to any one of claims 5 to 8, wherein: The lid includes a first protrusion extending away from a circumferential edge of the lid; The outlet bushing includes a corresponding second protrusion extending away from a sidewall of the outlet bushing, the corresponding second protrusion being positioned adjacent to the hinge portion; and Interference between the corresponding second protrusion and the first protrusion defines a stop device for maintaining the lid in the open position.

10. The catheter according to any one of claims 5 to 8, wherein: The outlet bushing includes a protrusion extending away from a sidewall of the outlet bushing, The lid includes a protrusion receiving member disposed on a top side of the lid, the receiving member being configured to inhibit separation of the protrusion from the protrusion receiving member in the absence of a separating force, and The protrusion is inserted into the protrusion receiving member to maintain the lid in the open position.

11. The catheter according to any one of claims 5 to 10, wherein: The lid includes a plug disposed on a lower side of the lid, and When the cap is in the closed position, at least a portion of the plug is disposed within the bushing chamber.

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

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

14. The catheter according to any one of claims 1 to 4, wherein: the engagement member includes a plug cap disposed within the bushing chamber, the plug cap includes a fluid flow path extending through the plug cap between a lower side of the plug cap and one or more side ports positioned along a cylindrical sidewall of the plug cap, the plug cap is positionable between a closed position defining the closed state and an open position defining the open state, when the plug cap is in the closed position, the one or more side ports are disposed within the bushing chamber such that a sidewall of the outlet bushing sealably covers the one or more side ports, and when the plug cap is in the open position, the one or more side ports are disposed proximally beyond the sidewall of the outlet bushing.

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

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

17. The catheter according to claim 15, wherein: the outlet bushing includes a ring extending circumferentially externally around the bushing body, and the ring is operatively coupled between the plug cap and the bushing body such that: rotation of the ring in one direction relative to the bushing body causes the plug cap to shift proximally from the closed position to the open position, and rotation of the ring in the opposite direction relative to the bushing body causes the plug cap to shift distally from the open position to the closed position.

18. The catheter according to claim 14, wherein the outlet bushing includes a latch mechanism operatively coupled between the plug cap and the bushing body such that: When the plug cap is in the closed position, when a distally-directed force (i) is manually applied to the plug cap and (ii) is released from the plug cap, the latch mechanism positions the plug cap in the open position, and when the plug cap is in the open position, when the distally-directed force (i) is manually applied to the plug cap and (ii) is released from the plug cap, the latch mechanism positions the plug cap in the closed position.

19. A method for draining urine from a patient's bladder, comprising: providing a catheter having a catheter fitting configured to be inserted into the patient's bladder, the catheter fitting defining a catheter lumen; converting a coupling member of the catheter from a closed state to an open state, the coupling member being configured to prevent fluid from exiting a proximal end through an outlet bushing coupled to the catheter fitting at the proximal end of the catheter lumen; draining a lubricant from the catheter lumen; inserting the catheter fitting into the patient's bladder to establish a urine flow through the catheter lumen, and converting the coupling member from the open state to the closed state.

20. The method according to claim 19, wherein: the catheter further includes a sheath extending along the catheter fitting, the catheter fitting is disposed within a lumen of the sheath, a portion of the lubricant is disposed within the lumen of the sheath, and the portion of the lubricant contacts an outer surface of the catheter fitting.

21. The method according to claim 19 or 20, wherein: the coupling member includes a cover coupled to the outlet bushing via a hinge, the cover is rotatable between a closed position defining the closed state and an open position defining the open state, the cover extends across a proximal end of the outlet bushing in the closed position, the cover rotates away from the proximal end of the outlet bushing in the open position, and converting the coupling member from the closed state to the open state includes rotating the cover away from the closed position by at least 90 degrees.

22. The method according to claim 21, wherein: the cover includes a first protrusion extending away from a circumferential edge of the cover; the outlet bushing includes a corresponding second protrusion extending away from a sidewall of the outlet bushing, the corresponding second protrusion being positioned adjacent to the hinge; interference between the corresponding second protrusion and the first protrusion defines a rotational stop for the cover; and converting the coupling member from the closed state to the open state includes rotating the cover beyond the stop to fix the cover in the open state.

23. The method according to claim 21, wherein: the outlet bushing includes a protrusion extending away from a sidewall of the outlet bushing; the cover includes a protrusion receiving member disposed on a top side of the cover, the protrusion receiving member being configured to inhibit separation of the protrusion from the protrusion receiving member in the absence of a separating force; and Converting the engagement member from the closed state to the open state includes rotating the lid so that the protrusion enters the receiving member to constrain the lid in the open position.

24. The method according to claim 19 or 20, wherein: The engagement member includes a lid coupled to the outlet bushing via a tie; The lid is capable of being positioned between a closed position defining the closed state and an open position defining the open state; The lid extends across the proximal end of the outlet bushing in the closed position; The lid is positioned away from the proximal end of the outlet bushing in the open position; The tie biases the lid away from the closed position towards the open position; and Converting the engagement member from the closed state to the open state includes: Displacing the lid away from the closed position; and Allowing the tie to displace the lid towards the open position.

25. The method according to claim 19 or 20, wherein: The engagement member includes a plug cap disposed within a chamber of the outlet bushing; The plug cap includes a fluid flow path extending through the plug cap between a lower side of the plug cap and one or more side ports positioned along a cylindrical sidewall of the plug cap; The plug cap is capable of being positioned between a closed position defining the closed state and an open position defining the open state; When the plug cap is in the closed position, the one or more side ports are disposed within the bushing chamber such that the sidewall of the outlet bushing sealably covers the one or more side ports; When the plug cap is in the open position, the one or more side ports are disposed proximally beyond the sidewall of the outlet bushing; and Converting 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.

26. The method according to claim 25, wherein: The plug cap is coupled to the outlet bushing so as to be tiltable relative to the outlet bushing about a rotational axis extending laterally through the plug cap and the outlet bushing; The plug cap is oriented such that a proximal end face of the plug cap is perpendicular to a longitudinal axis of the outlet bushing when the plug cap is in the closed position; and Converting the engagement member from the closed state to the open state includes tilting the plug cap away from the perpendicular orientation.

27. The method according to claim 25, wherein the plug cap is capable of being longitudinally positioned between the closed position and the open position.

28. The method according to claim 27, wherein: The outlet bushing includes a ring extending circumferentially around an outer periphery of a bushing body; The ring is operatively coupled between the plug cap and the bushing body such that rotation of the ring relative to the bushing body causes the plug cap to be displaced proximally from the closed position to the open position; and Converting the engagement member from the closed state to the open state includes rotating the ring.

29. The method according to claim 27, wherein: The outlet bushing includes a latch mechanism operatively coupled between the plug cap and the bushing body, The latch mechanism is configured to position the plug cap in the open position when a distally directed force (i) is manually applied to the plug cap and (ii) released from the plug cap when the plug cap is in the closed position, and Converting the engagement member from the closed state to the open state includes: Applying the distally directed force to the plug cap; and Allowing the latch mechanism to displace the plug cap proximally from the closed position to the open position.

Images