Urethral 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 Art

[0001] Urinary incontinence occurs when a person loses the ability to control the bladder, resulting in leakage of large or small amounts of urine. This can be caused by a number of reasons. Users with paraplegia or quadriplegia lose bladder control and need to empty the bladder using a urethral catheter. These may be indwelling (where the catheter is placed in the bladder for an extended period of time and attached to a urine bag for collecting urine) or intermittent (where the catheter is inserted into the bladder periodically and urine is drained directly from the bladder into either a suitable drainage area or a collection bag). Intermittent catheters are preferred when a user can insert the catheter themselves or when they desire that their urine bag not be visible. Intermittent catheters allow users freedom of movement.

[0002] The catheter may be pre-lubricated. In some cases, lubricant can spill while opening the package, soiling or staining the user's clothes. In some cases, urethral catheters have a package shape that is not suitable for a person to carry, such as in a clothing pocket. Furthermore, in some cases, catheters can be difficult to manipulate during self-catheterization.

[0003] Disclosed herein are a urethral catheter and a method of inserting a catheter 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, lubricant can spill while opening the package, soiling or staining the user's clothes. In some cases, urethral catheters have a package shape that is not suitable for a person to carry, such as in a clothing pocket. Furthermore, in some cases, catheters can be difficult to manipulate during self-catheterization.

[0005] This specification discloses a urethral catheter and a method of catheter insertion that address the above-mentioned items. [Means for solving the problem]

[0006] In short, this specification discloses a urethral catheter including a catheter tube that defines a distal end and a proximal end. The catheter tube includes an inlet section extending proximal to the distal end, which is configured to advance within the user's urethra. The catheter tube also includes an outlet section extending proximal to the inlet section. The lumen of the catheter tube extends between the proximal and distal ends. The proximal end of the catheter tube is connected to an outlet connector of the catheter to define a loop of the catheter tube.

[0007] In some embodiments, the distal end of the catheter tube is connected to the catheter inlet connector so as to define a closed volume that extends along the lumen from the distal end to the proximal end.

[0008] In some embodiments, the distal end is configured to be selectively connected to and disconnected from the inlet connecting member, and the proximal end is configured to be selectively connected to and disconnected from the outlet connecting member.

[0009] In some embodiments, the lubricant is contained within a closed volume. In some embodiments, the catheter further includes an inlet collar connected to the catheter tube. The inlet collar is positioned 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 connecting member. In some embodiments, the catheter further includes a manipulative member attached to the catheter tube along an exit section. The manipulative member is configured to be grasped by the user during catheter deployment.

[0011] In some embodiments, the operating member includes a gripping function portion arranged along the outer surface of the operating member to improve the user's grip on the operating member. The gripping function portion includes one or more of the following: protrusions, recesses, axial ribs, axial grooves, annular ribs, annular grooves, or textured surfaces.

[0012] In some embodiments, the operating member includes an outlet connecting member and an inlet connecting 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 detach from the outlet connector in response to an axial separation force applied to the outlet section. The distal end is configured to detach from the inlet connector in response to an axial separation force applied to the inlet section.

[0013] In some embodiments, the distal end is connected to an inlet connecting member via an inlet collar. In some embodiments, the outlet connector and the inlet connector are positioned to define the parallel orientation of the proximal and distal ends of the catheter tube.

[0014] In some embodiments, the outlet connecting member and the inlet connecting member are arranged side by side so that axial forces 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 to its proximal end. The proximal end of the catheter tube is connected to an outlet connector via the outlet collar.

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

[0016] Furthermore, this specification discloses a urethral catheter comprising a catheter tube configured for insertion into the urethra. The catheter tube defines a lumen extending between the proximal end and the distal end of the catheter tube. The catheter is transitionable between a packaged state and a ready-to-use state such that (i) in the packaged state, a lubricant is sealedly contained within the lumen between the proximal and distal ends, and (ii) in the ready-to-use state, the lubricant is discharged from the lumen.

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

[0018] Furthermore, this specification discloses a method for draining urine from a patient's bladder. The method includes (i) providing a catheter having a catheter tube configured to be inserted into a patient's bladder, (ii) rupturing a closed volume portion of the catheter to drain a lubricant from the closed volume portion, the closed volume portion being defined by the lumen of the catheter tube between the proximal and distal ends, and (iii) inserting the catheter tube into the patient's bladder to establish a flow of urine through the lumen.

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

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

[0021] In some embodiments, inserting the catheter tube comprises grasping the inlet collar to guide the distal tip of the catheter tube into the patient's urethra. In some embodiments, the catheter comprises an operating member attached to the catheter tube. Breaking the closed volume comprises applying a tensile force to a pull ring of the operating member.

[0022] In some embodiments, inserting the catheter tube comprises grasping the operating member to apply an axial force to the catheter tube. In some embodiments, breaking the closed volume comprises displacing the proximal end and the distal end away from the operating member.

[0023] In some embodiments, the method further comprises: (i) withdrawing the catheter tube from the patient's bladder; and (ii) reconnecting both the distal end and the proximal end to the operating member to reestablish the closed volume.

[0024] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe particular embodiments of such concepts in more detail.

[0025] A more specific description of the present disclosure is provided by reference to specific embodiments thereof illustrated in the accompanying drawings. These drawings only show exemplary embodiments of the present invention and therefore should not be considered as limiting the scope thereof. Exemplary embodiments of the present invention are described and illustrated more specifically and in detail by using the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] [Figure 1A] It is a diagram of a urinary catheter in a packaged state according to some embodiments. [Figure 1B] It is a diagram of the urinary catheter of FIG. 1A in an unpackaged state according to some embodiments. [Figure 1C] It is a detailed diagram of the distal end portion of the urinary catheter of FIG. 1A according to some embodiments. [Figure 1D] It is a diagram of the urinary catheter of FIG. 1A in an evacuated state according to some embodiments. [Figure 1E] It is a diagram of the urinary catheter of FIG. 1A in a ready-to-use state according to some embodiments. [Figure 1F] It is a diagram of the urinary catheter of FIG. 1A inserted into a patient according to some embodiments. [Figure 2A] It is a diagram of a second embodiment of a urinary catheter in a packaged state according to some embodiments. [Figure 2B] It is a diagram of the urinary catheter of FIG. 2A in a partially unpackaged state according to some embodiments. [Figure 2C] It is a diagram of the urinary catheter of FIG. 2A in a completely unpackaged state according to some embodiments. [Figure 3A] It is a detailed diagram of a first embodiment of the operating member of the catheters of FIGS. 2A and 2B according to some embodiments. [Figure 3B] It is a detailed diagram of a second embodiment of the operating member of the catheters of FIGS. 2A and 2B according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0027] Before certain specific embodiments are disclosed in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that are easily separable from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0028] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or steps and do not provide a sequential or numerical limitation. For example, the "1st," "2nd," and "3rd" features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Indications such as "left," "right," "up," "down," "front," "back," etc., are used for convenience and do not, for example, imply a specific fixed position, orientation, or direction. Instead, such indications are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" also include plural references unless explicitly indicated in the context.

[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. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, but does not necessarily include the proximal end of the catheter. That is, unless otherwise suggested by the 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, the “distal portion” or “distal end portion” of a catheter disclosed herein includes the portion of the catheter that is intended to be 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 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 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, but the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless indicated by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the 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 interactions. Two components can be connected to each other even if they are not in direct contact. For example, two components can be coupled to each other through an intermediate component.

[0032] Any method disclosed herein includes one or more steps or actions for carrying out the described method. The method steps and / or actions may be interchangeable with one another. In other words, the order and / or use of any particular steps and / or actions may be modified unless a particular order of steps or actions is required for the proper operation of the embodiment.

[0033] Throughout this specification, analogues may be referenced, such as by the use of the term “approximately.” For each such reference, it should be understood that in some embodiments, the value, characteristic, or feature may be specified without analogue. For example, where qualifiers such as “approximately” and “approximately” are used, these terms include within their scope the word that would be limited if the qualifier were absent. For example, if the term “approximately linear” is repeated in reference to a feature, it should be understood that in further embodiments, that feature may be strictly linear in its configuration.

[0034] Throughout this specification, any reference to “an embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. Therefore, not all cited terms or variations thereof listed throughout this specification necessarily refer to the same embodiment.

[0035] Figures 1A to 1F show a first embodiment of a urethral catheter in various uses. The urethral catheter (catheter) 100 is generally configured to be self-deploying by the user (also referred to herein as the patient) to drain urine from the user's bladder. The catheter 100 as shown is generally configured for use by male patients. However, the catheter 100 may be configured for use by female patients without departing from the features and functional aspects of the catheter 100 as illustrated and described below. The catheter 100 may be used by the patient in various locations, such as a medical facility, a home, or a public restroom.

[0036] The catheter 100 is generally configured to be used by a patient multiple times a day. More specifically, a patient may deploy multiple catheters 100 (one at a time) per day. Therefore, a patient can carry one or more catheters 100 with them, for example, in a clothing pocket or wallet. Accordingly, the catheter 100 may be provided in a package having a compact shape suitable for being placed in a clothing or wallet pocket. The catheter 100 is also configured to maintain sterility in its packaged state.

[0037] In some cases, users may be concerned about soiling their clothing during the urination process, for example, with urine or catheter lubricant. Therefore, catheter 100 is configured to deploy while also preventing the lubricant of catheter 100 from spilling onto clothing or other items during use. Furthermore, catheter 100 is generally configured to contain some residual urine in the catheter tube after use.

[0038] Since the catheter 100 is configured to self-deploy, it may be configured to allow the user to easily handle it during deployment (i.e., grasp, orient, guide, or apply force, etc.). Therefore, the catheter 100 may be configured to be deployable even by users who are not dexterous.

[0039] Figure 1A shows a front perspective view of the catheter 100 in its packaged state. The catheter 100 may be placed inside the package before use. The catheter 100 may be placed inside an outer package 105, such as 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 flexible material sheath. A lumen 115 extends along the catheter tube 110, and the lumen 115 is 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 inlet section 113 and an outlet section 114. The inlet section 113 is inserted into the user's urethra and is configured to advance along the urethra to the patient's bladder. Thus, the inlet section 113 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 the patient's body and defines a length suitable for positioning its proximal end over a urine container, such as a urinal, during use.

[0040] The catheter 100 includes an operating member 120 configured to provide insertion assistance to the user. The operating member 120 is positioned along an intermediate section 119 of the catheter tube 110. The intermediate section 119 is positioned along the proximal portion of the exit section 114. The operating member 120 is configured to be grasped by the patient during use. The operating member 120 includes an outer surface 121. A gripping function 121A is positioned on the outer surface 121 to enhance the gripping ability of the operating member 120. The gripping function 121A may include protrusions, recesses, ribs, troughs, rough surfaces, or any combination thereof. The operating member also includes a pull ring 124, as further described below. The operating member 120 may be attached to the catheter tube 110 by any preferred method, such as adhesive bonding, thermal bonding, insert molding, or a treadlock.

[0041] The catheter tube 110 includes an inlet collar 131 connected to the inlet section 113 to also provide the user with insertion assistance. The inlet collar 131 is configured to be grasped by the user during use. Therefore, the outer surface of the inlet collar 131 may include a gripping function 131A, such as a gripping function 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 function 132A, such as a gripping function 121A. In some embodiments, the outlet collar 132 may be omitted.

[0043] The proximal end 111 and distal end 112 are connected to the operating member 120 in the packaged state. When the proximal end 111 and distal end 112 are connected to the operating member 120, the operating member 120 defines a closed volume section 116 within the lumen 115 by sealing the proximal end 111 and distal end 112.

[0044] The connection of the proximal end 111 and distal end 112 to the operating member 120 defines the package shape of the catheter 100 in its packaged state. In some embodiments, the package shape may include several loops, such as the loop 151 of the inlet section 113 and the loop 152 of the outlet section 114. In some embodiments, the proximal end 111 and distal end 112 may be arranged parallel to each other laterally adjacent to each other, as shown, so that the proximal end 111 and distal end 112 face the same direction. The proximal end 111 and distal end 112 may be connected to the operating member 120 on the opposite side of the pull ring 124.

[0045] The catheter 100 includes a lubricant 140 located within the closed volume section 116 in its packaged state. The lubricant 140 is configured to allow sliding displacement of the inlet section 113 along the urethra during use.

[0046] Figure 1B shows the catheter 100 in an unpackaged state, i.e., with the proximal end 111 and distal end 112 detached from the operating member 120 so that the closed volume section 116 is broken.

[0047] The operating member 120 includes an outlet connecting member 125 for facilitating the connection of the proximal end 111 to the operating member 120. The outlet connecting member 125 allows the proximal end 111 to be securely connected to the operating member 120. In some embodiments, the proximal end 111 is connected to the outlet connecting member 125 by a snap-fit ​​or locking mechanism. Thus, the proximal end 111 is selectively connected to and disconnected from the outlet connecting member 125. The proximal end 111 may be initially connected to the outlet connecting member 125 in the catheter 100 manufacturing facility.

[0048] In some embodiments, the connection between the proximal end 111 and the outlet connector 125 may be facilitated by a separation force applied by the user, allowing the proximal end 111 to be easily separated from the outlet connector 125. More specifically, the user may apply a tensile force 160 to the pull ring 124 and an opposing tensile force 161 to the outlet section 114 or outlet collar 132 in order to separate the proximal end 111 from the outlet connector 125. For example, the user may disengage the snap fit by applying tensile forces 160 and 161.

[0049] Furthermore, the outlet connecting member 125 may be configured to allow the proximal end 111 to be reconnected to the operating member 120 so that the outlet connecting member 125 reseals (i.e., closes in a sealable manner) the proximal end 111a. More specifically, in order to reattach the proximal end 111 to the operating member 120, the outlet connecting member 125 may be configured to allow the user to reconnect the proximal end 111 to the operating member 120 by applying a pressing force (i.e., a force opposite to the tensile force 160) to the operating member 120 and an opposing pressing force (i.e., a force opposite to the tensile force 161) to the outlet section 114.

[0050] Similarly, the operating member 120 includes an inlet connecting member 126 to facilitate connection of the distal end 112 to the operating member 120. In some embodiments, the inlet connecting member 126 allows the inlet collar 131 to connect to the operating member 120. In some embodiments, the inlet collar 131 is connected to the inlet connecting member 126 via a snap fit. Thus, the distal end 112 is selectively connected to and disconnected from the inlet connecting member 126 (via the inlet collar 131). The inlet collar 131 may be initially connected to the inlet connecting member 126 in the catheter 100 manufacturing facility.

[0051] In some embodiments, the connection between the distal end 112 and the inlet connecting member 126 may facilitate the separation of the distal end 112 from the inlet connecting member 126 via a separation force, such as one applied by the user. More specifically, the user may apply a tensile force 160 to the pull ring 124 and an opposite tensile force 162 to the inlet collar 131 in order to separate the inlet collar 131 from the inlet connecting member 126. For example, the user may apply tensile force 160 and an opposite tensile force 162 to disengage a snap fit. In some embodiments, the opposite tensile force 162 may be applied to the inlet section 113.

[0052] Similarly, the inlet connecting member 126, in combination with the inlet collar 131, may also be configured to allow the inlet collar 131 to be reconnected to the operating member 120, so that the inlet connecting member 126, in combination with the inlet collar 131, reseals (i.e., sealably closes) the distal end 112. More specifically, in order to reattach the distal end 112 to the operating member 120, the inlet connecting member 126 may be configured to allow the user to reconnect the distal end 112 to the operating member 120 by applying a pressing force (i.e., a force opposite to the tensile force 160) to the operating member 120 and an opposing pressing force (i.e., a force opposite to the tensile force 162) to the inlet collar 131. The closed volume section 116 may be redefined to contain some residual urine in the lumen after use by reconnecting the distal end 112 to the operating member 120 in combination with reconnecting the proximal end 111 to the operating member 120.

[0053] During use, the user may orient the catheter 100 such that the pull ring 124 is positioned vertically above the proximal end 111 and distal end 112, thereby preventing the lubricant 140 from leaking out of the lumen 115 through the proximal end 111 and / or distal end 112 when the proximal end 111 and inlet collar 131 are separated from the operating member 120. During use, the user can simultaneously separate the proximal end 111 and inlet collar 131 from the operating member 120 in a single step by applying opposing tensile forces 161, 162 simultaneously.

[0054] Figure 1C is a detail view of the distal end portion of a urethral catheter 100 according to several embodiments. The inlet collar 131 is shown at a package position 138 adjacent to the distal end 112 of the catheter tube 110, which is aligned with the catheter 100 in its packaged state. The inlet collar 131 is slidably connected to the inlet section 113, as indicated by double-ended arrows 137, so that the inlet collar 131 can be positioned along the inlet section 113.

[0055] The inlet 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., hemispherical shape) to facilitate insertion of the inlet section 113 into the user's urethra and further into the bladder.

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

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

[0058] In some embodiments, the inlet collar 131 may be constrained so as not to displace distally beyond the distal end 122, for example, beyond the package position 138. In some embodiments, the inlet section 113 may include a radially extended portion 113B, for example, an annular projection rib. In such embodiments, the radially extended portion 113B may be configured to engage with the sealing member 136 to restrict the inlet collar 131 from displacing distally beyond the package position 138 along the inlet section 113.

[0059] As described above, the inlet collar 131 is configured to define a fluid seal with the inlet connecting member 126 (see Figure 1B). In some embodiments, the inlet collar 131 may include a sealing function portion 139 at the open end 135 of the inlet collar 131, which is configured to define a fluid seal between the inlet collar 131 and the inlet connecting member 126.

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

[0061] Figure 1D shows the catheter 100 in a discharge state, i.e., the closed volume section 116 is broken and the catheter is oriented to allow the lubricant 140 to be discharged from the lumen 115. In other words, the user can unwind / straighten the catheter tube 110 and orient the catheter tube 110 to an inclined position so that the lubricant flows out of the lumen 115 by gravity. The catheter 100 may be inclined such that the distal end 112 is above the proximal end 111, or vice versa.

[0062] Figure 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 can be slidably positioned along the inlet section 113. In the ready-to-use state, the inlet collar 131 is positioned proximal to the distal end 112 so as to expose the distal tip 117.

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

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

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

[0066] Figure 2A shows the catheter 200 in its packaged state, and Figure 2B shows the catheter 200 in a partially unpackaged state. The urethral catheter (catheter) 200 is generally configured to be self-deployed by the user to drain urine from the user's bladder. The catheter 200 is generally configured for use by male users. However, the catheter 200 may be configured for use by female users without deviating from the characteristics and functional aspects of the catheter 200 as shown and described below. The catheter 200 may be used by the user in various locations, such as a medical facility, home, or public restroom.

[0067] The catheter 200 is generally configured to be used by the user multiple times a day. More specifically, the user may deploy multiple catheters 200 (one at a time) per day. Thus, the user can carry one or more catheters 200 with them, for example, in a clothing pocket or wallet. Therefore, the catheter 200 may be packaged in a form suitable for being placed in a clothing or wallet pocket.

[0068] Since the catheter 200 is configured to self-deploy, it may be configured to allow the user to easily handle it during deployment (i.e., grasp, orient, guide, or apply force to it).

[0069] The catheter 200 may be arranged in a package before use. Although not shown, the catheter 200 may be arranged in an outer package, such as an 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 and is sized to facilitate the flow of urine from the distal end 212 to the proximal end 211 during use. The catheter tube 210 includes an inlet section 213 and an outlet section 214. The inlet section 213 is inserted into the user's urethra and is configured to advance along the urethra to the user's bladder. Thus, the inlet section 213 defines a length sufficient to extend from the end of the penis to the user's bladder. Similarly, the inlet section defines an outer diameter suitable for placement within the urethra. The outlet section 214 is configured for external use and defines a length suitable for positioning the proximal end 211 over a urine container, such as a toilet, during use.

[0070] The operating member 220, including the pull ring 224, is positioned along the intermediate section 219 of the catheter tube 210. The intermediate section 219 is positioned along the distal portion of the outlet section 214. The operating member 220 may be attached to the catheter tube 210 by any preferred method, such as adhesive bonding, thermal bonding, insert molding, or crimp fitting.

[0071] The catheter tube 210 includes an inlet collar 231 connected to an inlet section 213, the inlet collar 231 being slidably positioned 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 connected to the inlet collar 231 to define a closed space 216 within the lumen 215. A lubricant 240 is placed in the closed space 216. The lubricant 240 is configured to allow sliding displacement of the inlet section 213 along the urethra during use.

[0072] The exit collar 232 includes a mounting mechanism 234 configured to selectively secure the exit collar 232 to an intermediate section 219 of the catheter tube 210 in order to define the package shape of the catheter 200 in its packaged state. In some embodiments, the package shape may include several (i.e., one, two, or more) loops 251 of the catheter tube 210.

[0073] Figure 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 tensile force 260 applied to the pull ring 224 and an opposing force 261 applied to the outlet collar 232. The attachment mechanism 234 may include a clip as shown or any other preferred mechanism for securing the outlet collar 232 to the intermediate section 219, so that the outlet collar 232 (i) remains attached to the intermediate section 219 when no tensile force 260 is applied to the pull ring 224, and (ii) separates from the intermediate section 219 when the tensile force 260 is applied.

[0074] Figure 2C shows the catheter 200 in its fully unpackaged state, i.e., with the exit collar 232 separated from the inlet collar 231. In the packaged and semi-packaged states, the exit collar 232 is attached to the inlet collar 231. As a result, the exit collar 232 remains attached to the inlet collar 231 unless released by the user. That is, the exit collar 232 remains attached to the inlet collar 231 until the user is ready to deploy the catheter 200. The exit collar 232 includes an inlet connecting member 226 configured to facilitate connection between the inlet collar 231 and the exit collar 232. Similarly, the inlet collar 231 includes a corresponding exit connecting member 225 configured to facilitate connection between the exit collar 232 and the inlet collar 231. The inlet and outlet connecting members 226 and 225 are configured to allow separation of the outlet collar 232 from the inlet collar 231 by applying a tensile force 264 to the outlet collar 232 or outlet section 214 and an opposite tensile force 265 to the inlet collar 231 or inlet section 213.

[0075] The catheter 200 may be configured to be disposed of hygienically after use. Therefore, the inlet connector 226 and outlet connector 225 may facilitate the reattachment of the outlet collar 232 and the inlet collar 231 so that the user can reattach the outlet collar 232 to the inlet collar 231 by applying an opposing pressing force (a force opposite to the tensile forces 264, 265) to the outlet collar 232 and the inlet collar 231. Reattaching the outlet collar 232 to the inlet collar 231 may redefine the closed space 216 to accommodate any residual urine in the lumen 215 by redefining the seal between the outlet collar 232 and the inlet collar 231.

[0076] Figure 3A shows a first embodiment of the operating member 220, which includes an attachment mechanism 350 for securing the pull ring 224 to the catheter tube 210. The attachment mechanism 350 may partially extend 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 grasp or partially enclose 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 riveting or overmolding.

[0077] Figure 3B shows a second embodiment of the operating member 220, which includes a mounting mechanism 360 for securing the pull ring 224 to the catheter tube 210. The mounting mechanism 360 may extend around the entire circumference of the catheter tube 210 to completely enclose the catheter tube 210. In some embodiments, the mounting mechanism 350 may define an interlocking fit with the catheter tube 210 to prevent sliding displacement of the pull ring 224 along the catheter tube 210. In other embodiments, the mounting mechanism 350 may include a thermal bond (a bond characterized by heat), such as riveting 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, which are performed by the user. The methods described herein may refer to the anatomical structure of males. However, the methods are not limited to male users, and therefore the methods disclosed herein may also be performed by female users. In some embodiments, the catheter may be enclosed in an outer package, such as a bag or pouch.

[0079] Another step may include the user rupturing the closed volume portion of the catheter. Such a rupturing step may include separating the distal and proximal ends of the catheter tube from their corresponding connecting members. In some embodiments, separating the distal and proximal ends may include detaching the distal and proximal ends from the operating member of the catheter, which is connected to the catheter tube. In other embodiments, separating the distal and proximal ends may include detaching the distal and proximal ends from each other.

[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 loop shape to an expanded shape. Draining the lubricant may also include orienting the catheter tube to a vertical position so that gravity can guide the lubricant out of the lumen towards the proximal or distal end.

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

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

[0084] Another step may include advancing the inlet section along the urethra to the bladder. In some embodiments, advancing the inlet section may include maintaining the position of the inlet collar adjacent to the urethra and applying an axial pressing force to the operating member to displace the inlet section along the urethra. In some embodiments, advancing the inlet section may include sliding the inlet section through the inlet collar. In some embodiments, advancing the inlet section may further include positioning the inlet collar at a second position along the inlet section, proximal to the first position. In some embodiments, the second position may be adjacent to the operating 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 vertically lower than the distal end so that the urine flows (i) into the opening, (ii) proximal along the lumen, and (iii) out of the proximal end. In some embodiments, draining urine from the bladder may include, for example, positioning the proximal end of the tube over a urine container such as a toilet so that the urine flows into a container.

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

[0087] Another step may include re-establishing the closed volume to prevent residual urine in the lumen from flowing out of the lumen. In some embodiments, re-establishing the closed volume may include reconnecting the distal and proximal ends to or to the operating member. In some embodiments, re-establishing the closed volume may include transitioning the catheter from an extended shape to a loop shape.

[0088] Another step may include disposing of the catheter in a waste container. In some embodiments, disposing of the catheter may include returning the catheter to its outer packaging.

[0089] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be obvious to those skilled in the art, and in broader embodiments, these adaptations and / or modifications are also encompassed. Thus, it is possible to deviate from specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. It is a urinary catheter, The catheter tube comprises a distal end and a proximal end, and the catheter tube is An inlet section extending proximal to the distal end, configured to advance within the user's urethra, An exit section extending proximal to the aforementioned entrance section, A lumen extending between the proximal end and the distal end, An operating member attached to the catheter tube along the outlet section, configured to be grasped by the user during deployment of the urethral catheter, and including an outlet connecting member and an inlet connecting member, The proximal end is connected to the outlet connecting member such that the outlet section defines the first loop of the catheter tube. A urethral catheter, wherein the distal end is connected to the inlet connecting member such that the inlet section defines a second loop of the catheter tube, thereby defining a closed volume portion extending along the lumen from the distal end to the proximal end.

2. The distal end is configured to be selectively connected to and disconnected from the inlet connecting member. The urethral catheter according to claim 1, wherein the proximal end is configured to be selectively connected to and disconnected from the outlet connecting member.

3. The urethral catheter according to claim 1 or 2, further comprising a lubricant contained within the closed volume section.

4. The urethral catheter according to claim 1, further comprising an inlet collar connected to the catheter tube, wherein the inlet collar is configurable along the inlet section between the distal end of the catheter tube and the proximal end of the inlet section.

5. The urethral catheter according to claim 4, wherein the inlet collar includes the outlet connecting member.

6. The operating member includes a gripping function portion arranged along the outer surface of the operating member to improve the user's grip on the operating member, The urethral catheter according to claim 1, wherein the gripping function portion includes one or more of the following: a convex portion, a concave portion, an axial rib, an axial groove, an annular rib, an annular groove, or a textured surface.

7. The proximal end is configured to be detached from the outlet connecting member in response to an axial separation force applied to the outlet section. The urethral catheter according to claim 1, wherein the distal end is configured to be detached from the inlet connecting member in response to an axial separation force applied to the inlet section.

8. The urethral catheter according to claim 4, wherein the distal end is connected to the inlet connecting member via the inlet collar.

9. The urethral catheter according to claim 1, wherein the outlet connecting member and the inlet connecting member are arranged to define the parallel orientation of the proximal end and the distal end of the catheter tube.

10. The urethral catheter according to claim 7, wherein the outlet connecting member and the inlet connecting member are arranged side by side so that the axial separation force can be applied simultaneously to the outlet section and the inlet section.

11. The urethral catheter according to claim 1, further comprising an outlet collar fixedly attached to the catheter tube adjacent to the proximal end, wherein the proximal end of the catheter tube is connected to the outlet connecting member via the outlet collar.

12. The urethral catheter according to claim 4, wherein the inlet collar includes one or more gripping functions arranged along its outer surface, and the gripping functions include one or more of the following: a convex portion, a concave portion, an axial rib, an axial groove, an annular rib, an annular groove, or a textured surface.

13. The urethral catheter according to claim 11, wherein the outlet collar includes one or more gripping functions arranged along its outer surface, and the gripping functions include one or more of the following: a convex portion, a concave portion, an axial rib, an axial groove, an annular rib, an annular groove, or a textured surface.

14. The inlet section includes a plurality of openings adjacent to the distal end, the openings extending between the lumen and the outer surface of the inlet section, The urethral catheter according to any one of claims 4, 5, and 12, wherein the inlet collar is configured to cover the opening when the inlet collar is positioned at the distal end.

15. It is a urinary catheter, A catheter tube configured to be inserted into the urethra, comprising a catheter tube that defines a lumen extending between a proximal end and a distal end, The aforementioned urethral catheter is In the packaged state, the lubricant is sealed within the lumen between the proximal end and the distal end. When ready for use, the lubricant is discharged from the lumen. A urethral catheter that is transitionable between the aforementioned packaged state and the aforementioned ready-to-use state.

16. The urethral catheter according to claim 15, wherein in the packaged state, the catheter tube defines a shape having two or more loops.

17. The urethral catheter according to claim 15 or 16, wherein in the packaged state, the proximal end is positioned adjacent to the distal end.

18. The urethral catheter according to claim 15 or 16, wherein in the packaged state, the proximal end and the distal end are oriented parallel to each other.

19. The urethral catheter according to claim 15 or 16, wherein in the packaged state, the proximal end and the distal end face in the same direction.

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