Urinary catheter devices and methods

Abstract

Disclosed herein is a urinary catheter generally configured for self-expanding. The catheter includes a closed volume within a lumen of the catheter that contains a lubricant. The proximal and distal ends of the catheter tube are coupled with a manipulation member disposed along the catheter tube to define a compact package shape of the catheter tube that includes one or more loops. The closed volume is breached by simultaneously applying a separation force to the proximal and distal ends to separate the proximal and distal ends from the manipulation member in a single step. The manipulation member includes a pull ring for applying opposing separation forces to the manipulation member. The catheter includes an entrance section configured to be inserted into a patient. An entrance collar is slidably coupled to the entrance section and serves as a guide during insertion of the catheter.

Description

[Background technology]

[0001] Urinary incontinence results in the leakage of large or small amounts of urine due to a person's inability to control the bladder. This can be caused by multiple reasons. Paraplegic or quadriplegic users lose control of the bladder and need to empty it using a urinary catheter. These can be indwelling (where the catheter is placed in the bladder for a longer period and attached to a urine bag to collect the urine) or intermittent (where the catheter is inserted periodically into the bladder and urine drains directly from the bladder, either into a suitable drainage area or into a collection bag). Intermittent catheters are preferred when the user is able to insert the catheter themselves or does not wish to be able to see the urine bag. Intermittent catheters allow the user freedom of movement.

[0002] The catheter may be pre-lubricated. In some cases, the lubricant may be spilled during opening of the package, soiling or staining the user's clothing. In some cases, the urinary catheter includes a package shape that is not suitable for a person to carry, such as in a clothing pocket. Additionally, in some cases, the catheter may be difficult to manipulate during self-catheterization.

[0003] Disclosed herein are urinary catheters and catheter insertion methods that address the above items. Summary of the Invention [Problem to be solved by the invention]

[0004] The catheter may be pre-lubricated. In some cases, the lubricant may be spilled during opening of the package, soiling or staining the user's clothing. In some cases, the urinary catheter includes a package shape that is not suitable for a person to carry, such as in a clothing pocket. Additionally, in some cases, the catheter may be difficult to manipulate during self-catheterization.

[0005] Disclosed herein are urinary catheters and catheter insertion methods that address the above items. [Means for solving the problem]

[0006] Briefly summarized, disclosed herein is a urinary catheter including a catheter tube defining a distal end and a proximal end. The catheter tube includes an entrance section extending proximally from the distal end, the entrance section configured for advancement within a user's urethra. The catheter tube also includes an exit section extending proximally from the entrance section. A lumen of the catheter tube extends between the proximal and distal ends. The proximal end of the catheter tube is coupled with a catheter exit connection member to define a catheter tube loop.

[0007] In some embodiments, the distal end of the catheter tube is coupled with the inlet connection member of the catheter to define a closed volume extending along the lumen from the distal end to the proximal end.

[0008] In some embodiments, the distal end is configured to be selectively coupled and decoupled to the inlet connection member, and the proximal end is configured to be selectively coupled and decoupled to the outlet connection member.

[0009] In some embodiments, the lubricant is contained within the enclosed volume. In some embodiments, the catheter further includes an inlet collar coupled to the catheter tube, the inlet collar positionable along the inlet section between the distal end of the catheter tube and the proximal end of the inlet section.

[0010] In some embodiments, the inlet collar includes an outlet connection member. In some embodiments, the catheter further includes a manipulation member attached to the catheter tube along the exit section, the manipulation member configured to be grasped by a user during deployment of the catheter.

[0011] In some embodiments, the manipulation member includes a gripping feature disposed along an outer surface of the manipulation member to enhance grip of the manipulation member by a user, the gripping feature including one or more of a protrusion, a recess, an axial rib, an axial groove, an annular rib, an annular groove, or a textured surface.

[0012] In some embodiments, the manipulation member includes an outlet connection member and an inlet connection member, such that the outlet section defines a loop and the inlet section defines a loop. In some embodiments, the proximal end is configured to decouple from the outlet connection member in response to an axial separation force applied to the outlet section, and the distal end is configured to decouple from the inlet connection member in response to an axial separation force applied to the inlet section.

[0013] In some embodiments, the distal end is coupled to the inlet connection member via an inlet collar. In some embodiments, the outlet and inlet connecting members are arranged to define a parallel orientation of the proximal and distal ends of the catheter tube.

[0014] In some embodiments, the outlet connection member and the inlet connection member are arranged side-by-side such that an axial force can be applied to the outlet section and the inlet section simultaneously. In some embodiments, the catheter further includes an outlet collar fixedly attached to the catheter tube adjacent the proximal end, the proximal end of the catheter tube being coupled with the outlet connection member via the outlet collar.

[0015] In some embodiments, the inlet collar and / or the outlet collar include one or more gripping features disposed along an outer surface. In some embodiments, the inlet section includes a plurality of openings adjacent the distal end, the openings extending between the lumen and an outer surface of the inlet section, and the inlet collar is configured to cover the openings when the inlet collar is disposed at the distal end.

[0016] Also disclosed herein is a urinary catheter including a catheter tube configured for insertion into the urethra, the catheter tube defining a lumen extending between a proximal end of the catheter tube and a distal end of the catheter tube, the catheter being transitionable between the packaged state and the ready-to-use state such that (i) in the packaged state, a lubricant is sealably contained within the lumen between the proximal and distal ends, and (ii) in the ready-to-use state, the lubricant is expelled from the lumen.

[0017] In some embodiments, when the catheter is placed in the package, the catheter tube defines a shape having two or more loops. In further embodiments, when the catheter is placed in the package, the proximal end is positioned adjacent to the distal end. In additional embodiments, when the catheter is placed in the package, the proximal and distal ends are oriented parallel to one another. In yet other embodiments, when the catheter is placed in the package, the proximal and distal ends face in the same direction.

[0018] Also disclosed herein is a method for draining urine from a patient's bladder, the method including: (i) providing a catheter having a catheter tube configured for insertion into the patient's bladder, (ii) breaching a closed volume of the catheter to drain lubricant from the closed volume, the closed volume being defined by a lumen of the catheter tube between a proximal end and a distal end, and (iii) inserting the catheter tube into the patient's bladder to establish a flow of urine through the lumen.

[0019] In some embodiments, breaching the enclosed volume includes breaching a first seal at the proximal end and breaching a second seal at the distal end. In some embodiments, breaching the enclosed volume includes separating the proximal end from the distal end.

[0020] In some embodiments, the method further includes slidably displacing an inlet collar of the catheter proximally along the catheter tube from the distal end to expose a distal tip of the catheter tube.

[0021] In some embodiments, inserting the catheter tube includes gripping an entrance collar to guide a distal tip of the catheter tube into the patient's urethra. In some embodiments, the catheter includes a manipulation member attached to the catheter tube. Breaking the enclosed volume includes applying a tensile force to a pull ring of the manipulation member.

[0022] In some embodiments, inserting the catheter tube includes gripping a manipulation member to apply an axial force to the catheter tube. In some embodiments, breaching the enclosed volume includes displacing the proximal and distal ends away from the manipulation member.

[0023] In some embodiments, the method further includes (i) withdrawing the catheter tube from the patient's bladder; and (ii) coupling both the distal and proximal ends to a manipulation member to re-establish the closed volume.

[0024] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts.

[0025] A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings, which depict only typical embodiments of the invention and therefore should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0026] [Figure 1A] FIG. 1 illustrates a packaged urinary catheter 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 a distal end portion of the urinary catheter of FIG. 1A, according to some embodiments. [Figure 1D] FIG. 1B is a diagram of the urinary catheter of FIG. 1A in a drained state, according to some embodiments. [Figure 1E] FIG. 1B illustrates the urinary catheter of FIG. 1A in a ready-to-use state, according to some embodiments. [Figure 1F] FIG. 1B is a diagram of the urinary catheter of FIG. 1A inserted into a patient, according to some embodiments. [Figure 2A] FIG. 1 illustrates a second embodiment of a packaged urinary catheter, according to some embodiments. [Figure 2B] FIG. 2B is a diagram of the urinary catheter of FIG. 2A in a partially unpackaged state, according to some embodiments. [Figure 2C] FIG. 2B is a diagram of the urinary catheter of FIG. 2A in a complete, unpackaged state, according to some embodiments. [Figure 3A] 2C is a detailed view of a first embodiment of a manipulation member of the catheter of FIGS. 2A and 2B, according to some embodiments. FIG. [Figure 3B] FIG. 4 is a detailed view of a second embodiment of a manipulation member of the catheter of FIGS. 2A and 2B, in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 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 can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0028] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain embodiments, and that the 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 within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "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", "up", "down", "front", "rear", etc. 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 "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0029] 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. Although the proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise indicated by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0030] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, end portion, or length of a catheter can include the distal end of the catheter, but a distal portion, end portion, or length of a catheter need not include the distal end of the catheter. That is, unless otherwise indicated by context, a distal portion, end portion, or length of a catheter is not a terminal portion or length of a catheter.

[0031] The phrases "connected to," "coupled to / with," and "in communication with" refer to any form of interaction between two or more elements, including, but not limited to, mechanical and fluid interaction. Two components may be connected to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0032] Any method disclosed herein includes one or more steps or actions for performing the described method. The 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.

[0033] Throughout this specification, similar references may be made, such as by use of the term "generally." To each such reference, it is understood that in some embodiments, the value, property, or characteristic may be specified without the similar. For example, when qualifiers such as "about" and "generally" are used, these terms include within their scope the word they qualify in the absence of a qualifier. For example, when the term "generally linear" is recited with respect to a feature, it is understood that in further embodiments, the feature may be in a strictly linear configuration.

[0034] Throughout this specification, a reference to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the recited phrases or variations thereof listed throughout this specification do not necessarily all refer to the same embodiment.

[0035] 1A-1F show a first embodiment of a urinary catheter in various states of use. 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 catheter 100 as shown 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 functional aspects of the catheter 100 as shown and described below. The catheter 100 may be used by a patient in a variety of locations, such as, for example, a medical facility, a home, or a public restroom.

[0036] The catheter 100 is generally configured to be used by a patient multiple times per day. More specifically, a patient may deploy multiple catheters 100 (one at a time) per day. Thus, a patient may hold and carry one or more catheters 100 on their person, such as in a clothing pocket or purse. Thus, the catheter 100 may be placed in a packaged state having a compact shape suitable for placing the catheter 100 in a clothing or purse pocket. The catheter 100 is also configured to maintain the catheter 100 sterile in the packaged state.

[0037] In some instances, a user may be concerned about soiling clothing during the urinary drainage process, for example, with urine or catheter lubricant. Thus, the catheter 100 is configured to deploy while also preventing the catheter 100 lubricant from spilling onto clothing or other items during use. Additionally, the catheter 100 is generally configured to contain some residual urine within the catheter tube after use.

[0038] Because catheter 100 is configured to self-deploy, catheter 100 may be configured to allow a user to easily handle (i.e., grasp, orient, guide, or apply force, etc.) during deployment. Thus, catheter 100 may be configured to allow deployment by a user with limited dexterity.

[0039] FIG. 1A shows a front perspective view of the catheter 100 in a package. The catheter 100 may be disposed within a package prior to use. The catheter 100 may be disposed within an outer package 105, such as, for example, a bag or pouch. 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 a material suitable for defining a soft material sheath. A lumen 115 extends along the catheter tube 110, the lumen 115 being sized to facilitate the flow of urine from the distal end 112 to the proximal end 111 during use. The catheter tube 110 includes an entrance section 113 and an exit section 114. The entrance section 113 is configured to be inserted into a user's urethra and advanced along the urethra to the patient's bladder. The entrance section 113 thus defines a length sufficient to extend from the end of the penis to the patient's bladder. Similarly, the inlet section defines an outer diameter suitable for placement within the urethra. The outlet section 114 is configured for use outside a patient's body and defines a length suitable for placing a proximal end over a urine receptacle, such as a toilet bowl, during use.

[0040] The catheter 100 includes a manipulation member 120 configured to provide insertion assistance to a user. The manipulation member 120 is disposed along a mid-section 119 of the catheter tube 110. The mid-section 119 is disposed along a proximal portion of the outlet section 114. The manipulation member 120 is configured to be gripped by a patient during use. The manipulation member 120 includes an outer surface 121. Gripping features 121A are disposed on the outer surface 121 to enhance the gripping ability of the manipulation member 120. The gripping features 121A may include protrusions, recesses, ribs, troughs, roughened surfaces, or any combination thereof. The manipulation member also includes a pull ring 124, as described further below. The manipulation member 120 may be attached to the catheter tube 110 by any suitable method, such as, for example, adhesive bonding, thermal bonding, insert molding, or an interference fit.

[0041] The catheter tube 110 includes an entrance collar 131 coupled to the entrance section 113 to also provide insertion assistance to the user. The entrance collar 131 is configured to be gripped by a user during use. Accordingly, an outer surface of the entrance collar 131 may include a gripping feature 131A, such as gripping feature 121A.

[0042] The catheter tube 110 may also include an outlet collar 132. The outlet collar 132 is fixedly attached to the catheter tube 110 at the proximal end 111. In some embodiments, the outlet connector may include a gripping feature 132A, such as gripping feature 121A. In some embodiments, the outlet collar 132 may be omitted.

[0043] In the packaged state, the proximal end 111 and the distal end 112 are coupled to an operating member 120. When the proximal end 111 and the distal end 112 are coupled to the operating member 120, the operating member 120 sealably closes the proximal end 111 and the distal end 112 to define a closed volume 116 within the lumen 115.

[0044] The coupling of the proximal end 111 and the distal end 112 to the manipulation member 120 defines a package shape of the catheter 100 in the packaged state. In some embodiments, the package shape may include several loops, such as loop 151 in the inlet section 113 and loop 152 in the outlet section 114. In some embodiments, the proximal end 111 and the distal end 112 may be disposed laterally adjacent and parallel to one another as shown, such that the proximal end 111 and the distal end 112 face in the same direction. The proximal end 111 and the distal end 112 may be coupled to the manipulation member 120 on opposite sides of the pull ring 124.

[0045] The catheter 100 includes a lubricant 140 disposed within the enclosed volume 116 in its packaged state. The lubricant 140 is configured to permit slidable displacement of the entrance section 113 along the urethra during use.

[0046] FIG. 1B shows the catheter 100 in an unpackaged state, ie, with the proximal and distal ends 111, 112 separated from the manipulation member 120 such that the enclosed volume 116 is breached.

[0047] The operating member 120 includes an outlet connection member 125 to facilitate connection of the proximal end 111 to the operating member 120. The outlet connection member 125 allows the proximal end 111 to be sealably coupled to the operating member 120. In some embodiments, the proximal end 111 is coupled to the outlet connection member 125 by a snap fit or a detent. Thus, the proximal end 111 is selectively coupled and decoupled to the outlet connection member 125. The proximal end 111 may be initially coupled to the outlet connection member 125 at a manufacturing facility for the catheter 100.

[0048] In some embodiments, the connection between the proximal end 111 and the outlet connection member 125 may facilitate decoupling of the proximal end 111 from the outlet connection member 125 by a separation force applied by a user. More specifically, the user may apply a pulling force 160 to the pull ring 124 and an opposing pulling force 161 to the outlet section 114 or the outlet collar 132 to separate the proximal end 111 from the outlet connection member 125. For example, the user applies pulling force 160 and opposing pulling force 161 to break the snap fit.

[0049] Also, the outlet connection member 125 may be configured to allow reconnection of the proximal end 111 to the operating member 120 such that the outlet connection member 125 reseals (i.e., sealably closes) the proximal end 111a. More specifically, to reattach the proximal end 111 to the operating member 120, the outlet connection member 125 may be configured to allow a user to reconnect the proximal end 111 to the operating member 120 by applying a pushing force (i.e., a force opposite to the pulling force 160) to the operating member 120 and applying an opposite pushing force (i.e., a force opposite to the pulling force 161) to the outlet section 114.

[0050] Similarly, the manipulation member 120 includes an inlet coupling member 126 to facilitate coupling of the distal end 112 to the manipulation member 120. In some embodiments, the inlet coupling member 126 allows an inlet collar 131 to couple with the manipulation member 120. In some embodiments, the inlet collar 131 is coupled to the inlet coupling member 126 via a snap fit. Thus, the distal end 112 is selectively coupled and decoupled to the inlet coupling member 126 (via the inlet collar 131). The inlet collar 131 may be initially coupled to the inlet coupling member 126 at the manufacturing facility for the catheter 100.

[0051] In some embodiments, the coupling between the distal end 112 and the inlet coupling member 126 may facilitate decoupling of the distal end 112 from the inlet coupling member 126 via a separation force, as applied by a user. More specifically, a user may apply a pulling force 160 to the pull ring 124 and an opposing pulling force 162 to the inlet collar 131 to separate the inlet collar 131 from the inlet coupling member 126. For example, the user applies pulling force 160 and an opposing pulling force 162 to break a snap fit. In some embodiments, the opposing pulling force 162 may be applied to the inlet section 113.

[0052] Similarly, the inlet coupling member 126 may also be configured to allow recoupling of the inlet collar 131 to the operating member 120 such that the inlet coupling member 126 in combination with the inlet collar 131 reseals (i.e., sealably closes) the distal end 112. More specifically, to reattach the distal end 112 to the operating member 120, the inlet coupling member 126 may be configured to allow a user to recoupling the distal end 112 to the operating member 120 by applying a pushing force (i.e., a force opposite to the pulling force 160) to the operating member 120 and applying an opposite pushing force (i.e., a force opposite to the pulling force 162) to the inlet collar 131. Recoupling the distal end 112 to the operating member 120 in combination with recoupling the proximal end 111 to the operating member 120 may redefine the closed volume 116 to contain some residual urine within the lumen after use.

[0053] In use, a user may orient the catheter 100 so that the pull ring 124 is disposed vertically above the proximal end 111 and the distal end 112, thereby preventing lubricant 140 from exiting the lumen 115 via the proximal end 111 and / or the distal end 112 when the proximal end 111 and inlet collar 131 are separated from the operating member 120. In use, a user can simultaneously apply opposing pulling forces 161, 162 to simultaneously separate the proximal end 111 and inlet collar 131 from the operating member 120 in a single step.

[0054] 1C is a detailed view of a distal end portion of a urinary catheter 100, according to some embodiments. An inlet collar 131 is shown in a packaged position 138 adjacent the distal end 112 of the catheter tube 110 in correspondence with the packaged catheter 100. The inlet collar 131 is slidably coupled to the inlet section 113, as indicated by a double-headed arrow 137, such that the inlet collar 131 is positionable along the inlet section 113.

[0055] The entrance section 113 includes a distal tip 117 at the distal end 122 of the catheter tube 110. The distal tip 117 may include a dome shape (e.g., a hemispherical shape) to facilitate insertion of the entrance section 113 into the urethra and further into the bladder of a user.

[0056] The inlet section 113 includes a number (e.g., one, two, three, or more) of openings 118 extending between the lumen 115 and an outer surface 113A of the inlet section 113 adjacent the distal end 112a. The openings 118 define a passageway for urine to flow from the bladder into the lumen 115.

[0057] In some embodiments, the inlet collar 131 may be generally configured to define a fluid seal with the outer surface 113A of the inlet section 113 when the inlet collar 131 is disposed in the packaging location 138. In some embodiments, the inlet collar 131 may also define a fluid seal when the inlet collar 131 is displaced away from the packaging location 138. The inlet collar 131 may include a seal member 136 to define the fluid seal. The seal member 136 may be defined, for example, by an inwardly projecting annular rib of the inlet collar 131 or a separate sealing device such as an O-ring. In some embodiments, the fluid seal 136 may be located adjacent a proximal end of the inlet collar 131.

[0058] In some embodiments, the inlet collar 131 may be constrained from distal displacement beyond the distal end 122, such as from distal displacement beyond the packaging location 138. In some embodiments, the inlet section 113 may include a radially expanded portion 113B, such as, for example, an annular protruding rib. In such embodiments, the radially expanded portion 113B may be configured to engage the seal member 136 to limit distal displacement of the inlet collar 131 along the inlet section 113 beyond the packaging location 138.

[0059] As discussed above, the inlet collar 131 is configured to define a fluid seal with the inlet coupling member 126 (see FIG. 1B ). In some embodiments, the inlet collar 131 may include a seal feature 139 at an open end 135 of the inlet collar 131 that is configured to define a fluid seal between the inlet collar 131 and the inlet coupling member 126.

[0060] When the inlet collar 131 is coupled with the inlet coupling member 126, the closed compartment 116A may be optionally defined as an extension of the closed volume 116. Thus, the closed compartment 116A is in fluid communication with the closed volume 116 through the opening 118. When the lubricant 140 is contained within the closed volume 116, the lubricant 140 may occupy a portion or more of the closed compartment 116A. As shown, the lubricant 140 within the closed compartment 116A may contact the outer surface 113A of the inlet section 113, thereby lubricating the outer surface 113A in preparation for advancement of the inlet section 113 along the urethra.

[0061] 1D shows the catheter 100 in an ejected state, i.e., oriented so that the enclosed volume 116 is breached and the lubricant 140 can be ejected from the lumen 115. In other words, the user can unwind / straighten the catheter tube 110 and orient it in an inclined position to allow gravity to cause the lubricant to flow from the lumen 115. The catheter 100 may be inclined such that the distal end 112 is above the proximal end 111, or vice versa.

[0062] 1E shows the catheter 100 in a ready-to-use state, i.e., ready to be inserted into the urethra 51 of the penis 50. As described above, the inlet collar 131 is slidably positioned along the inlet section 113. In the ready-to-use state, the inlet collar 131 is positioned proximally away from the distal end 112 to expose the distal tip 117.

[0063] The catheter 100 is generally configured to be deployed (i.e., inserted into the bladder) by a user grasping the entrance collar 131 with one hand 70 (e.g., between the thumb and fingers of the one hand 70) and grasping the handle member 120 with the other hand 71 (e.g., between the thumb and fingers of the other hand 71). During deployment, the user can grasp the entrance collar 131 to position and / or orient the distal tip 117 relative to the urethra 51. The user can grasp the manipulation member 120 to apply an axial force to the entrance section 113 to insert the entrance section 113 into the urethra 51. During insertion, the user can maintain the position of the entrance collar 131 relative to the urethra 51 such that the entrance section 113 slides through the entrance collar 131 as the entrance section 113 advances toward the bladder.

[0064] 1F shows the catheter 100 in a fully deployed state. The inlet section 113 is advanced entirely along the urethra 51 such that the distal tip 117 is disposed within the bladder 60. Urine 65 flows into the opening 118, through the lumen 115, and out the proximal end 111 of the outlet section 114. The inlet collar 131 is positioned sufficiently away from the distal end 112 and toward the operating member 120 to expose a sufficient length of the inlet section 113 to extend from the open end of the urethra 51 to the bladder 60.

[0065] 2A-2C show another embodiment of a urinary catheter 200, which may be similar in some respects to the components of the urinary catheter 100 described in connection with FIGS. 1A-1F. It should be understood that all the illustrated embodiments may have similar features. Accordingly, similar features are indicated with similar reference numbers with the leading digit incremented to "2". For example, a catheter tube is indicated as "110" in FIGS. 1A-1F, and a similar catheter tube is indicated as "210" in FIGS. 2A-2C. Thus, the relevant disclosures set forth above with respect to similarly identified features may not be repeated hereafter. Furthermore, certain features of the catheter 100 and related components shown in FIGS. 1A-1F may not be indicated or identified by reference numbers in the drawings or described in detail in the following description. However, such features may obviously be the same or substantially the same as features shown in and / or described in connection with other embodiments. Thus, the relevant discussions of such features apply equally to the features of the catheter 100. Any suitable combination of features, and variations thereof, described with respect to catheter 100 and components shown in Figures 1A-1F can be used with catheter 200 and components of Figures 2A-2C, and vice versa.

[0066] FIG. 2A illustrates the catheter 200 in a packaged state, and FIG. 2B illustrates the catheter 200 in a partially unpackaged state. The urinary catheter (catheter) 200 is generally configured to be self-deployed by a user to drain urine from the user's bladder. The catheter 200 is generally configured for use by a male user. However, the catheter 200 may be configured for use by a female user without departing from the features and functional aspects of the catheter 200 as shown and described below. The catheter 200 may be used by a user in a variety of locations, such as, for example, a medical institution, a home, or a public restroom.

[0067] Catheter 200 is generally configured to be used by a user multiple times per day. More specifically, a user may deploy multiple catheters 200 (one at a time) per day. Thus, a user may hold and carry one or more catheters 200 on the user's person, such as in a clothing pocket or purse. Thus, catheter 200 may be disposed in a package having a shape suitable for disposing catheter 200 in a clothing or purse pocket.

[0068] Because catheter 200 is configured to self-deploy, catheter 200 may be configured to allow a user to easily handle (ie, grasp, orient, guide, or apply force, etc.) during deployment.

[0069] The catheter 200 may be disposed in a package prior to use. Although not shown, the catheter 200 may be disposed within an outer package, such as, for example, the outer package 105. The catheter 200 generally includes a catheter tube 210 having a proximal end 211 and a distal end 212. A lumen 215 extends along the catheter tube 210, the lumen 215 being sized to facilitate urine flow from the distal end 212 to the proximal end 211 during use. The catheter tube 210 includes an entrance section 213 and an exit section 214. The entrance section 213 is configured to be inserted into a user's urethra and advanced along the urethra to the user's bladder. Thus, the entrance section 213 defines a length sufficient to extend from the end of the penis to the user's bladder. Similarly, the entrance section defines an outer diameter suitable for placement within the urethra. The outlet section 214 is configured for use outside the body and defines a length suitable for positioning the proximal end 211 over a urine receptacle, such as a toilet bowl, during use.

[0070] A manipulation member 220 including a pull ring 224 is disposed along the mid-section 219 of the catheter tube 210. The mid-section 219 is disposed along a distal portion of the outlet section 214. The manipulation member 220 may be attached to the catheter tube 210 via any suitable method, such as, for example, adhesive bonding, thermal bonding, insert molding, or an interference fit.

[0071] The catheter tube 210 includes an inlet collar 231 coupled to the inlet section 213, the inlet collar 231 being slidably positionable along the inlet section 213. The catheter tube 210 also includes an outlet collar 232 at the proximal end 211. In the packaged state, the outlet collar 232 is sealably coupled to the inlet collar 231 to define a closed space 216 within the lumen 215. A lubricant 240 is disposed in the closed space 216. The lubricant 240 is configured to permit slidable displacement of the inlet section 213 along the urethra during use.

[0072] The outlet collar 232 includes an attachment mechanism 234 configured to selectively secure the outlet collar 232 to the mid-section 219 of the catheter tube 210 to define a packaging shape of the packaged catheter 200. In some embodiments, the packaging shape may include several (i.e., one, two, or more) loops 251 of the catheter tube 210.

[0073] 2B shows the catheter 200 in a semi-unpackaged state, i.e., with the catheter tube 210 separated from the attachment mechanism 234. As shown, the attachment mechanism 234 may be configured to facilitate separation by a user applying a pulling force 260 to the pull ring 224 and an opposing force 261 to the outlet collar 232. The attachment mechanism 234 may include a clip as shown or any other suitable mechanism to secure the outlet collar 232 to the mid-section 219, such that the outlet collar 232 (i) remains attached to the mid-section 219 in the absence of the pulling force 260 applied to the pull ring 224, and (ii) separates from the mid-section 219 when the pulling force 260 is applied.

[0074] 2C illustrates the catheter 200 in a fully unpackaged state, i.e., with the outlet collar 232 separated from the inlet collar 231. In the packaged and quasi-packaged states, the outlet collar 232 is attached to the inlet collar 231. As a result, the outlet collar 232 remains attached to the inlet collar 231 in the absence of a release action by the user. That is, the outlet collar 232 remains attached to the inlet collar 231 until the user is ready to deploy the catheter 200. The outlet collar 232 includes an inlet connection member 226 configured to facilitate coupling between the inlet collar 231 and the outlet collar 232. Similarly, the inlet collar 231 includes a corresponding outlet connection member 225 configured to facilitate coupling between the outlet collar 232 and the inlet collar 231. The inlet and outlet connecting members 226, 225 are configured to apply a tensile force 264 to the outlet collar 232 or outlet section 214 and an opposing tensile force 265 to the inlet collar 231 or inlet section 213 to enable separation of the outlet collar 232 from the inlet collar 231.

[0075] The catheter 200 may be configured to be cleanly disposed of after use. Thus, the inlet and outlet connection members 226, 225 may facilitate reattachment of the outlet collar 232 to the inlet collar 231 such that a user may reattach the outlet collar 232 to the inlet collar 231 by applying opposing compressive forces (opposite the pulling forces 264, 265) to the outlet collar 232 and inlet collar 231. Reattachment of the outlet collar 232 to the inlet collar 231 may redefine a seal between the outlet collar 232 and the inlet collar 231, thereby redefining the closed space 216 to contain any residual urine within the lumen 215.

[0076] 3A illustrates a first embodiment of the manipulation member 220 including an attachment mechanism 350 for securing the pull ring 224 to the catheter tube 210. The attachment mechanism 350 may extend partially around the catheter tube 210 to define a gap 351. In some embodiments, the attachment mechanism 350 may extend more than 180° around the catheter tube 210 to grip or partially encapsulate the catheter tube 210. In some embodiments, the attachment mechanism 350 may include an adhesive. In other embodiments, the attachment mechanism 350 may include a thermal bond (a bond characterized by heat), such as heat staking or overmolding.

[0077] 3B illustrates a second embodiment of the operating member 220 including an attachment mechanism 360 for securing the pull ring 224 to the catheter tube 210. The attachment mechanism 360 may extend entirely around the catheter tube 210 to completely encapsulate the catheter tube 210. In some embodiments, the attachment mechanism 350 may define an interference fit with the catheter tube 210 to prevent sliding displacement of the pull ring 224 along the catheter tube 210. In other embodiments, the attachment mechanism 350 may include a thermal bond (a bond characterized by heat), such as heat staking or overmolding.

[0078] A method of using a catheter to drain urine from the bladder may include all or any subset of the following steps or processes as self-performed by a user. The methods described herein may refer to the male anatomy. However, the methods are not limited to male users, and thus the methods disclosed herein may also be performed by female users. In some embodiments, the catheter may be enclosed within an outer package, such as, for example, a bag or pouch.

[0079] Another step may include the user breaking the closed volume of the catheter. Such breaking step may include separating each of the distal and proximal ends of the catheter tube from their corresponding coupling members. In some embodiments, separating each of the distal and proximal ends may include decoupling the distal and proximal ends from a manipulation member of the catheter, the manipulation member being coupled with the catheter tube. In other embodiments, separating each of the distal and proximal ends may include decoupling the distal and proximal ends from one another.

[0080] 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 expanded shape. Draining the lubricant may also include orienting the catheter tube toward a vertical position such that gravity can induce the lubricant to drain from the lumen toward the proximal or distal end.

[0081] Another step may include displacing the entrance collar along the entrance section away from the distal end to expose a distal tip of the entrance section. In some embodiments, displacing the entrance collar along the entrance section may include placing the entrance collar in a first position that allows a user to define an orientation and / or location of the distal tip by grasping the entrance collar.

[0082] Another step may include orienting and / or positioning the distal end of the catheter tube relative to the user's urethra. In some embodiments, orienting and / or positioning the distal end may include grasping and manipulating the orientation / position of an inlet collar to orient and / or position the distal tip.

[0083] Another step may include inserting a distal tip of the entrance section into the urethra. In some embodiments, inserting the distal tip may include grasping the entrance collar with one hand and grasping the manipulation member with the other hand. In some embodiments, inserting the distal tip may further include maintaining a position of the entrance collar adjacent the urethra and applying an axial force to the manipulation member to advance the distal tip into the urethra.

[0084] Another step may include advancing the entrance section along the urethra to the bladder. In some embodiments, advancing the entrance section may include maintaining a position of the entrance collar adjacent the urethra and applying an axial biasing force to the manipulation member to displace the entrance section along the urethra. In some embodiments, advancing the entrance section may include sliding the entrance section through the entrance collar. In some embodiments, advancing the entrance section may further include positioning the entrance collar at a second position along the entrance section proximal to the first position. In some embodiments, the second position may be adjacent the manipulation member.

[0085] 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 lower vertical position than the distal end to cause 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, for example, placing the proximal end of the tube over a urine container, such as a toilet bowl, to cause urine to flow into the container.

[0086] Another step may include withdrawing the entrance section from the urethra. In some embodiments, withdrawing the entrance section may include maintaining a position of the entrance collar adjacent the urethra and applying an axial tensile force to the manipulation member to withdraw the entrance section from the urethra. In some embodiments, withdrawing the entrance section may include sliding the entrance section through the entrance collar. In some embodiments, withdrawing the entrance section may further include disposing an entrance collar on a distal end of the entrance section.

[0087] Another step may include re-establishing the closed volume to prevent residual urine within the lumen from exiting the lumen. In some embodiments, re-establishing the closed volume may include re-connecting the distal and proximal ends to the manipulation member or to each other. In some embodiments, re-establishing the closed volume may include transitioning the catheter from an extended shape to a looped shape.

[0088] Another step may include disposing of the catheter in a trash bin. In some embodiments, disposing of the catheter may include placing the catheter back into the outer packaging.

[0089] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. 1. A urinary catheter comprising: a catheter tube defining a distal end and a proximal end, the catheter tube comprising: an entrance section extending proximally from the distal end, the entrance section configured for advancement within a user's urethra; an outlet section extending proximally from the inlet section; a lumen extending between the proximal end and the distal end, The proximal end is coupled to an outlet connection member to define a loop of the catheter tube.

2. The catheter of claim 1 , wherein the distal end is coupled with an inlet connection member of the catheter to define a closed volume extending along the lumen from the distal end to the proximal end.

3. the distal end is configured to be selectively coupled to and decoupled from the inlet connection member; The catheter of claim 2 , wherein the proximal end is configured to be selectively coupled and decoupled to the outlet connection member.

4. The catheter of claim 2 or 3, further comprising a lubricant contained within the enclosed volume.

5. 5. The catheter of claim 1, further comprising an inlet collar coupled to the catheter tube, the inlet collar positionable along the inlet section between the distal end of the catheter tube and a proximal end of the inlet section.

6. The catheter of claim 5 , wherein the inlet collar includes the outlet connection member.

7. The catheter of claim 5 , further comprising a manipulation member attached to the catheter tube along the outlet section, the manipulation member configured to be grasped by a user during deployment of the catheter.

8. the control member includes a gripping feature disposed along an outer surface of the control member to enhance grip of the control member by the user; The catheter of claim 7 , wherein the gripping features include one or more of protrusions, recesses, axial ribs, axial grooves, annular ribs, annular grooves, or a textured surface.

9. The operating member is the exit section defines a loop; and such that the inlet section defines a loop. A catheter according to claim 7 or 8, comprising the outlet connection member and the inlet connection member.

10. the proximal end is configured to decouple from the outlet connection member in response to an axial separation force applied to the outlet section; The catheter of claim 9 , wherein the distal end is configured to decouple from the inlet connection member in response to an axial separation force applied to the inlet section.

11. The catheter of claim 9 or 10, wherein the distal end is coupled to the inlet connection member via the inlet collar.

12. A catheter according to any one of claims 9 to 11, wherein the outlet connection member and the inlet connection member are arranged to define a parallel orientation of the proximal and distal ends of the catheter tube.

13. A catheter according to any one of claims 9 to 12, wherein the outlet connection member and the inlet connection member are arranged side-by-side such that the axial force can be applied to the outlet section and the inlet section simultaneously.

14. 14. The catheter of claim 9, further comprising an outlet collar fixedly attached to the catheter tube adjacent the proximal end, the proximal end of the catheter tube being coupled with the outlet connection member via the outlet collar.

15. The catheter of claim 14 , wherein the inlet collar and / or the outlet collar include one or more gripping features disposed along an outer surface.

16. the inlet section includes a plurality of openings adjacent the distal end, the openings extending between the lumen and an exterior surface of the inlet section; The catheter of any one of claims 5 to 15, wherein the inlet collar is configured to cover the opening when the inlet collar is positioned at the distal end.

17. 1. A urinary catheter comprising: a catheter tube configured for insertion into the urethra, the catheter tube defining a lumen extending between a proximal end and a distal end; The catheter comprises: In a packaged state, a lubricant is sealably contained within the lumen between the proximal end and the distal end; In a ready-to-use state, the lubricant is expelled from the lumen. A catheter that is transitionable between the packaged state and the ready-to-use state.

18. The catheter of claim 17 , wherein in the packaged state, the catheter tube defines a shape having two or more loops.

19. The catheter of claim 17 or 18, wherein in the packaged state, the proximal end is disposed adjacent to the distal end.

20. The catheter of any one of claims 17 to 19, wherein in the packaged state, the proximal end and the distal end are oriented parallel to each other.

21. The catheter of any one of claims 17 to 20, wherein in the packaged state, the proximal end and the distal end face in the same direction.

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