Patent Description:
Urinary catheters are often used to void urine from a patient's bladder by being inserted through a urethra and into the bladder. The urinary catheter may be temporarily inserted and removed after the bladder is voided.

An example of a prior art catheter is known from <CIT>, which describes the catheter comprising: a tubular member having a lumen and an outer surface; a proximal member disposed on a proximal end of the tubular member, the proximal member being configured to engage a urethra meatus, a distal member disposed on a distal end of the tubular member; a sleeve configured to be positioned in the lumen of the tubular member in a retracted configuration and to evert over at least a portion of the outer surface of the tubular member in an everted configuration; a filament configured to retract the sleeve (<NUM>) into the retracted configuration; and an aperture, wherein the filament extends from the lumen through the aperture and out of the catheter.

The present inventors recognize that there is a need to improve one or more features of the catheter. For example, the urinary catheter can be a source of a catheter-associated urinary tract infection (CAUTI) by introducing pathogens into the urethra and/or bladder. Insertion and removal of the catheter can also cause substantial pain by kinetic friction between the catheter and the mucosa of the urethra. A lubricant coating can also be unfavorable due to potential drying of the lubricant coating during storage and/or insertion, and/or discharging of the lubricant coating during use which can stain clothes of a user. The disclosed devices and non-claimed methods are directed to mitigating or overcoming one or more of the problems set forth above and/or other problems of the prior art.

The invention disclosed herein is directed to a catheter including: a tubular member having a lumen and an outer surface; a proximal member disposed on a proximal end of the tubular member, the proximal member being configured to engage a urethra meatus, a distal member disposed on a distal end of the tubular member; a sleeve configured to be positioned in the lumen in a retracted configuration and to evert over at least a portion of the outer surface in an everted configuration; a filament configured to retract the sleeve into the retracted configuration; and an aperture disposed through a side wall of the tubular member or a side wall of the distal member; the aperture being proximal of a distal end of the catheter, wherein the filament extends from the lumen through the aperture and out of the catheter. In some embodiments, the catheter may further include a pull member on a distal end of the filament. In some embodiments, the pull member may include a pull ring or a pull tab. In some embodiments, the filament may be looped, coiled, and/or bunched in the catheter when the sleeve is in the retracted configuration. In some embodiments, a shuttle may be attached to a distal end of the sleeve, where the shuttle is a tubular member configured to maintain patency of the sleeve, and the filament engages the shuttle to retract the sleeve into the lumen. In some embodiments, the filament may extend past the shuttle in the retracted configuration. In some embodiments, the filament may be attached to the shuttle. In some embodiments, the catheter may include a second shuttle proximal of the shuttle, where the filament is attached to the second shuttle, and retraction of the filament causes the second shuttle to abut the shuttle and retract the sleeve. In some embodiments, the tubular member may include at least one cut or hole extending through a proximal portion of the tubular member to increase flexibility of the proximal portion. In some embodiments, the at least one cut or hole extends along less than half of a length of the tubular member. In some embodiments, the at least one cut or hole varies along a length of the proximal portion to provide variable flexibility. In some embodiments, the catheter may include a proximal member secured to a proximal portion of the sleeve, where the proximal member is configured to slide over at least a portion of the tubular member to evert the sleeve over the tubular member. In some embodiments, the catheter may include a bag distal of the tubular member.

A non-claimed method of draining a volume of fluid with the catheter is described herein for illustrative purposes, the method including inserting the tubular member into a bodily lumen; everting the sleeve over the outer surface of the tubular member from the lumen of the tubular member; and pulling the filament to pull the sleeve through the lumen to remove the tubular member from the bodily lumen. The filament may be looped, coiled, or bunched in the lumen of the catheter before inserting the tubular member. The pulling the filament may include pulling the filament through the aperture of the catheter. The pulling the filament may include pulling a pull tab or a pull ring attached to a distal end of the filament. The method may further include sliding a proximal member secured to a proximal end of the sleeve to evert the sleeve over the outer surface.

There are, of course, additional aspects of the various embodiments of the invention disclosed herein that will be described below and which will form the subject matter of the claims. In this respect, before explaining at least one aspect of the disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The disclosure is capable of aspects in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the Abstract, are for the purpose of description and should not be regarded as limiting.

In order that the disclosure may be readily understood, aspects of the disclosure are illustrated by way of examples in the accompanying drawings.

Aspects of a catheter according to aspects of the disclosure are described with reference to the drawings, in which like reference numerals refer to like parts throughout.

The presently disclosed invention is generally directed to frictionless catheters, which partially or completely eliminate kinetic friction of the catheter when inserted into a lumen contacting tissue, such as the urethra. The catheter includes a tubular member having a lumen housing a rolling sleeve. As used herein, the term "sleeve" or "rolling sleeve" shall refer to a generally flexible, thin membrane or sheath, in tubular or hollow form, defining an internal lumen therethrough, which can be continuously everted from an inner lumen of the tubular member, over a proximal opening of the tubular member, and then distally over the outer surface of the tubular member. The term "proximal" shall refer to in the direction of insertion into the body during the intended use, and term "distal" shall refer to in the opposite direction toward the portion of the catheter handled by the user during the intended use.

A proximal portion of the rolling sleeve may be attached to a proximal member configured to slide over at least a portion of an outer surface of the tubular member. In some embodiments, the outer diameter of the tube and an inner diameter of the proximal portion may have an oval cross-section to reduce relative rotation and twisting of the sleeve. In some embodiments, a distal portion of the rolling sleeve may be stored in a chamber adjacent to or near a distal portion of the tubular member, and the rolling sleeve may be folded and/or pleated in the stored and/or retracted configuration in said chamber. During insertion of the catheter, the proximal member is configured to engage female or male anatomy (e.g., the urethra meatus) and slide distally over the tubular member, drawing the rolling sleeve out of the lumen of the tubular member and everting the rolling sleeve over an outer surface of the tubular member as the tubular member advances into the urethra. The catheter allows passage of urine from the bladder into the proximal opening of the tubular member and out of a distal opening of a distal member. The distal member may include an inner funnel section to provide favorable fluid flow into a bathroom receptacle (e.g., a toilet or urinal). In some embodiments, the distal member may be attached to a bag that collects the urine for later disposal.

The rolling sleeve is attached to a filament, which may be pulled to draw the rolling sleeve back through the lumen of the tubular member. The filament may have a pull member (e.g., a pull ring or a pull tab). The pull member may be larger than the filament and be made of a more rigid material than the filament to facilitate grasping and pulling by a patient with reduced dexterity. The filament extends through an aperture proximal of a distal end of the catheter to provide an improved angle for self-administration and to improve sanitation by reducing urine contact with the filament and pull member. The pull member may be enlarged to prevent passage of the pull member through the aperture. The positioning of the aperture may allow for attachment of a bag on a distal end of the catheter without interference with the filament or pull member.

The catheter may include one or more tubular shuttles. The sleeve may have a tubular shuttle attached to a distal end. The tubular shuttle may have a greater hoop strength than the sleeve to maintain patency of the sleeve. The filament may directly or indirectly engage with the shuttle to retract the sleeve. For example, in some embodiments, the catheter system may include a single shuttle attached to the distal end of the filament and the proximal end of the sleeve, such that pulling the filament directly pulls the shuttle and sleeve distally through the lumen of the tubular member. In these embodiments, the filament may be looped, coiled, and/or bunched between the attachment of the pull member and the attachment of the shuttle and disposed in the lumen of the catheter during storage to ensure that a sufficient length of filament is provided and maintained sterile. In other embodiments, the catheter may include a first shuttle attached to a distal end of the sleeve and a second shuttle fixed to the filament, where the second shuttle is positioned proximally of the first shuttle. In these embodiments, the second shuttle may maintain tension on the filament during storage, and during retraction of the filament, the second shuttle may abut and slide the first shuttle distally to pull the sleeve into the tubular member. The filament may extend proximally past the shuttle attached to the sleeve to maintain sufficient length of filament in the lumen of the catheter during storage to enable retraction of the sleeve after voiding. For example, in some embodiments, the stored length of filament may be at least half of the length of the tubular member or catheter overall. In some embodiments, the stored length of filament may be at least three-quarters of the length of the tubular member or catheter overall. In some embodiments, the stored length of filament may be at least substantially equal to or greater than the length of the tubular member or catheter overall.

The drawing of the rolling sleeve through the tubular member and the interaction between the rolling sleeve and the outer surface of the tubular member delivers internal friction to the catheter. However, the relative movement of the rolling sleeve along the mucosa of the urethra is minimal or zero, thus delivering minimal or zero kinetic friction to the urethra. The catheter shaft and the rolling sleeve may be dry and uncoated to prevent cracking of the sleeve. The rolling sleeve may be ultra-thin having a thickness less than <NUM> microns. The catheters of the present disclosure may reduce the likelihood of CAUTI since the rolling sleeve does not draw pathogens into the urethra and bladder. In some embodiments, the likelihood of CAUTI may be even further reduced with the storage of the distal portion of the rolling sleeve in the chamber of the catheters.

The catheters of the various embodiments may be compact with ergonomic attributes lending to ease of use and device handling. In some embodiments, the user may handle the tubular member to facilitate handling during insertion. The catheters do not require lubricant coatings or fluid activation, reducing the risk of stained clothes of the user during insertion. The dwell-time of the catheters may be irrelevant, without any coating or osmolality concerns. The dry sleeves and catheters may also be odorless, with reduced user aseptic preparation. Furthermore, the dry sleeves of the present disclosure do no provide nourishment for pathogen colonization. The components of the catheters may be assembled completely mechanically (e.g., snap-fit), without the use of adhesives to produce simpler and more environment-friendly catheters. The catheters may further permit fluid lumen patency regardless of insertion length. In some embodiments, the catheters may be reassembled to limit dripping of urine during disposal of the catheters.

<FIG> illustrate a first exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal housing <NUM> enclosing a chamber <NUM>. <FIG> shows the catheter <NUM> in a partially inserted configuration, with the tubular member <NUM> partially advanced past the proximal member <NUM>, and the sleeve <NUM> everted over a proximal opening of tubular member <NUM>. <FIG> shows the catheter <NUM> in an exploded disassembled form. <FIG> and <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> and <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> shows the catheter <NUM> in the middle of being retracted after insertion. <FIG> shows the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

As illustrated in <FIG>, the distal housing <NUM> may include a distal member <NUM>, a chamber member <NUM>, and a tubular jacket <NUM>. The chamber member <NUM> may at least partially enclose the chamber <NUM>, and the distal member <NUM> may have a tubular extension <NUM> at least partially received in the chamber member <NUM>. The chamber <NUM> and/or the chamber member <NUM> may have a diameter larger than the tubular member <NUM> to receive a distal portion of the sleeve <NUM> in a stored and/or retracted configuration. The distal housing <NUM> may be releasably secured through an interference and/or snap fit. For example, the chamber member <NUM> may include one or more protrusions configured to snap into a groove on the distal member <NUM>, and/or vice versa. The one or more protrusions may be configured to release the distal member <NUM> when sufficient force is applied to the distal member <NUM> and/or the chamber member <NUM>.

The chamber member <NUM> may be attached to a distal portion of the tubular member <NUM>, and the distal member <NUM> may be attached to the distal portion <NUM> of the sleeve <NUM>. Therefore, after the distal member <NUM> is released from the chamber member <NUM>, the distal member <NUM> may be retracted away from the chamber member <NUM> to retract the sleeve <NUM> through the tubular member <NUM>. The retraction of the sleeve <NUM> through the tubular member pulls the sleeve <NUM> and the tubular member <NUM> through the urethra for removal of the catheter <NUM>, as discussed herein. The distal member <NUM> may include a distal opening and an inner funnel section to facilitate passage of urine out of the distal opening when in communication with the urethra and/or bladder. The distal opening may also be fluidly connected to a urinary bag to collect the urine.

As further illustrated in <FIG>, the proximal member <NUM> may be configured to slide along the tubular member <NUM> to draw the sleeve <NUM> through (into or out) of the tubular member <NUM>. For example, when the proximal member <NUM> slides distally along the tubular member <NUM>, the sleeve <NUM> is pulled out of the tubular member <NUM>. The proximal member <NUM> slides proximally along the tubular member <NUM>, when the sleeve <NUM> is pulled into the tubular member <NUM>. The proximal member <NUM> may also function as an introducer aid to facilitate handling and insertion into the urethra. The proximal member <NUM> may have a gripping or handling portion <NUM> on a distal portion and a tissue engaging member <NUM> on a proximal portion. The handling portion <NUM> may include one or more ribs and/or grooves, or the like to enhance grip of the user. The tissue engaging member <NUM> may include a convex mushroom-shaped portion to engage anatomy, such as the urethra meatus. The convex portion may include a concave portion on its distal side configured to shield the convex portion from the handling portion <NUM>, reducing manual contact of the convex portion and introduction of pathogens into the urethra. The handling portion <NUM> and the tissue engaging member <NUM> may be separable, as illustrated in <FIG>.

The tubular member <NUM> may be sized and shaped for any type of anatomy. When configured to treat male and/or female urethra, the tubular member <NUM> may have a round cross-section, not necessarily reflective of the urethra. However, it is contemplated that the tubular member <NUM> may have non-round cross-sections. An oval cross-section for the tubular member <NUM> and/or proximal member <NUM> is particularly advantageous to prevent relative rotation and torsion on the sleeve <NUM>, that would produce tearing or friction relative to the urethra. In some embodiments, the tubular member <NUM> may be curved along a length in order to accommodate a curvature of a male urethra. In some embodiments, the tubular member <NUM> may be shorter in length to traverse a female urethra. The tubular member <NUM> may receive a cuff <NUM> on a proximal opening.

As illustrated in <FIG>, the sleeve <NUM> may extend from the distal housing <NUM>, through the lumen <NUM> of the tubular member <NUM>, and evert over at least a portion of an outer surface of the tubular member <NUM> at its proximal end. The sleeve <NUM> may have a proximal portion <NUM> attached to the proximal portion of the proximal member <NUM> and a distal portion <NUM> received in the chamber <NUM>. The distal portion <NUM> of the sleeve <NUM> may be secured around the tubular extension <NUM> of the distal member <NUM>, thus extending between the distal member <NUM> and the chamber member <NUM>. As illustrated in <FIG>, the distal portion <NUM> may be folded and/or pleated when positioned over the tubular extension <NUM> in the chamber <NUM> in a stored and/or retracted configuration. The sleeve <NUM> may elongate and the distal portion <NUM> may unfold, for example, when the proximal member <NUM> slides distally along the tubular member <NUM> (e.g., <FIG>) and/or the distal member <NUM> is retracted relative to the chamber member <NUM>. However, the folded and/or pleated configuration ensures patency of the sleeve <NUM>, by preventing bunching of the sleeve <NUM> in the lumen of the catheter <NUM> and allowing bladder voiding function independent of the length of the urethra and/or the extension of the tubular member <NUM>.

<FIG> illustrate exemplary steps of a non-claimed method of using the catheter <NUM> of <FIG>. As illustrated in <FIG>, the proximal member <NUM> may act as an introducer aid and facilitate handing of the catheter and location/engagement of a bodily lumen, such as the urethra meatus (UM). A covered proximal length of the tubular member <NUM> may extend proximally out of the proximal member <NUM>, for example, promoting navigation through the labia majora and labia minora and location of the urethra meatus (UM) for females. However, because the proximal portion of the tubular member <NUM> is sheathed by the sleeve <NUM> and the sleeve <NUM> everts, further insertion of the tubular member <NUM> and the sleeve <NUM> into the urethra does not push pathogens from the initial location of the urethra meatus.

As illustrated in <FIG>, the tubular member <NUM> and the sleeve <NUM> may be advanced into a urethra (U) and/or a bladder (B) to void the bladder. The tubular member <NUM> and the sleeve <NUM> may be advanced by pushing the tubular member <NUM> proximally relative to the proximal member <NUM> and/or pulling the proximal member <NUM> relative to the tubular member <NUM>. Once inserted into the urethra (U) and/or the bladder (B), urine may pass through the proximal opening of the tubular member <NUM>, which may be lined by the sleeve <NUM>, and out the distal opening of the distal member <NUM>. In some embodiments, the urine may then be received in a bag attached to the distal member <NUM>.

As illustrated in <FIG>, after voiding is complete, the distal member <NUM> may be released from the chamber member <NUM> to remove the tubular member <NUM> and the sleeve <NUM> from the urethra (U) and bladder (B). The distal member <NUM> may be retracted relative to the chamber member <NUM> to retract the tubular member <NUM> through the proximal member <NUM> and the sleeve <NUM> through the lumen of the tubular member <NUM>. Thus, the distal member <NUM>, which may be initially attached to the distal end of sleeve <NUM> and separates from the chamber member <NUM> during retraction. The distal housing <NUM> may then be reassembled to reduce dripping of urine prior to disposal, for example, by feeding the sleeve <NUM> back into the chamber member <NUM> and reassembling the distal member <NUM> and the chamber member <NUM>.

<FIG> illustrate a second exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal housing <NUM> having an inner chamber <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG> show the catheter <NUM> fully retracted after insertion. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line E-E. <FIG> is another view of the catheter <NUM> from a side rotated <NUM> degrees relative to <FIG>. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The proximal member <NUM> may have a handling portion <NUM> of substantial length to facilitate handling and navigating harder to reach anatomy, and a tissue engaging member <NUM> for insertion into the urethral meatus, as well as to attach to a proximal end <NUM> of the sleeve <NUM>. The sleeve <NUM> is thus attached to the proximal member <NUM> at its proximal end. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal portion <NUM> to a distal member <NUM> of the distal housing <NUM>. The distal portion <NUM> may be folded, pleated, or otherwise longitudinally compressed over a tubular extension <NUM> of the distal member <NUM> and inside of a chamber member <NUM>, when in the ready-to-insert and retracted configuration. Thus, the sleeve <NUM> may extend between the distal member <NUM> and chamber <NUM> to maintain patency of the sleeve <NUM>.

The sleeve <NUM> everts or rolls into the inner lumen of tubular member <NUM> over the proximal end opening of tubular member <NUM>, as the catheter <NUM> is inserted into a urethra. The proximal member <NUM> slides over the tubular member <NUM>, such that when a user inserts the tissue engaging member <NUM> of the proximal member <NUM> into the urethral meatus and pushes the tubular member <NUM> and/or distal housing <NUM>, the tubular member <NUM> advances into the urethra while the proximal member <NUM> slides distally over tubular member <NUM>. The sleeve <NUM> is pulled proximally from inside the lumen of the tubular member <NUM> to continuously evert over the proximal opening of the tubular member <NUM> to form a barrier or layer between the tubular member <NUM> and the urethra. Thus, the sleeve <NUM> is stationary relative to the urethra during insertion and retraction, thereby allowing for zero or low kinetic friction during such insertion and retraction. The tubular member <NUM> may key with an inner surface of the proximal member <NUM>, preventing relative rotation between the tubular member <NUM> and the proximal member <NUM> to prevent twisting of the sleeve <NUM> which may block bladder voiding.

The distal housing <NUM> may also include a locking member <NUM> configured to prevent release of a distal member <NUM> from a chamber member <NUM> during handling and insertion of the tubular member <NUM>. The distal member <NUM> may house the chamber member <NUM>. The locking member <NUM> may include a latching member and/or lever attached to the distal member <NUM> and biased into engagement with the chamber member <NUM>. The locking member <NUM> may prevent retraction of the distal member <NUM> from the chamber member <NUM> before actuation. For example, the locking member <NUM> may have a proximal protrusion pivotally received in a locking aperture of the chamber member <NUM>. Upon completion of the voiding of the bladder, a user may actuate the locking member <NUM> (e.g., by pressing and/or pivoting) to release the distal member <NUM> from the chamber member <NUM>. Release of the locking member <NUM> allows retraction of a distal portion <NUM> of the sleeve <NUM> relative to the tubular member <NUM> to facilitate removal of the catheter <NUM> from the urethra. Thus, the distal member <NUM> which may be attached to the distal end of sleeve <NUM> and separates from the chamber member <NUM> during retraction.

<FIG> illustrate a third exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal housing <NUM> having an inner chamber <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG>, <FIG> show the catheter <NUM> fully retracted after insertion. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line E-E. <FIG> shows the catheter <NUM> in a collapsed configuration for disposal. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end. The sleeve <NUM> may evert or roll into the inner lumen of tubular member <NUM> over the proximal end opening of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal end <NUM> to a distal member <NUM> on the distal housing <NUM>. The distal portion of the sleeve <NUM> may be folded, pleated, or otherwise longitudinally compressed over a tubular extension <NUM> of the distal member <NUM> and inside of the distal housing <NUM>, when in the ready-to-insert and retracted configuration. Thus, the sleeve <NUM> may extend over the distal member <NUM> to maintain patency of the sleeve <NUM>. The distal housing <NUM> may include an outer tube housing <NUM> and an inner tube housing <NUM>.

A slider <NUM> may be configured to slide along a slot <NUM> in the outer tube housing <NUM> and the inner tube housing <NUM>. The slider <NUM> may be configured to advance the tubular member <NUM> from the distal housing <NUM> by pushing a distal end of the tubular member <NUM>. The slider <NUM> may also include an actuator <NUM> configured to be depressed and pinch and/or grip the sleeve <NUM> to retract the sleeve <NUM> through the tubular member <NUM> and retract the tubular member <NUM>. The pinching and/or gripping of the sleeve <NUM> by the actuator <NUM> may eliminate any slack in the sleeve <NUM>, such that the retraction of the sleeve <NUM> and tubular member <NUM> commences immediately upon retraction of the slider <NUM>. The slack in the sleeve <NUM> may be due to the advancement of the catheter <NUM> into the urethra to a distance where voiding commences. This distance can vary due to anatomy and user size variances, and the catheter <NUM> is designed to accommodate full shaft length insertion. Thus, slack is generated by the difference between the insertion length and the full shaft length.

As illustrated in <FIG> and <FIG>, the slider <NUM> may be retracted distally and may eventually engage with the inner tube housing <NUM>. The slider <NUM> pushes the inner tube housing <NUM> out from the outer tube housing <NUM> until the entire tubular member <NUM> is retracted from the urethra in a frictionless manner and is received in the outer tube housing <NUM>. The inner tube housing <NUM> may manage the sleeve <NUM>, and the user may have no visual of the sleeve-tubular member mechanism. The slider <NUM> only pushes the tubular member <NUM>, and the slider <NUM> disengages from the tubular member <NUM> when the slider <NUM> is retracted. Thus, the tubular member <NUM> may be floating and only be retracted by the slider <NUM> retracting the sleeve <NUM>. After the slider <NUM> is retracted, the inner tube housing <NUM> may be slid back into the outer tube housing <NUM> to form a fully collapsed, compact configuration.

<FIG> illustrate a fourth exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal housing <NUM> enclosing a chamber <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region C shown in <FIG> is an enlarged view of the region B shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG>, <FIG> show the catheter <NUM> fully retracted after insertion. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line E-E. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The sleeve <NUM> may invert or roll into the inner lumen of tubular member <NUM> over the proximal end opening of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal portion <NUM> to a distal member <NUM> on the distal housing <NUM>. The distal portion <NUM> of the sleeve <NUM> may be folded, pleated, or otherwise longitudinally compressed over a tubular extension <NUM> of the distal member <NUM> and inside of the distal housing <NUM>, when in the ready-to-insert and retracted configuration to maintain patency of the sleeve <NUM>.

The catheter <NUM> may have a compact, enclosed tubular member <NUM> with ergonomical attributes lending to ease of use and device handling. The catheter <NUM> may be provided to the user in a compact state where the tubular member <NUM> and the sleeve <NUM> residing the distal housing <NUM>. The distal housing <NUM> may include an outer housing tube or chamber member <NUM> to provide a favorable low-profile and handling for self-insertion. The distal housing <NUM> may also include the distal member <NUM> configured to be releasably secured to the chamber member <NUM>. A slider <NUM> may be configured to slide along the chamber member <NUM> and engage the tubular member <NUM> through a slot (not shown) in the chamber member <NUM>. The slider <NUM> may be configured to advance the tubular member <NUM> from the chamber member <NUM> into the urethra by pushing a distal end of the tubular member <NUM>. The advancement of the tubular member <NUM> may draw the sleeve <NUM> from the chamber <NUM>, and the sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> is advanced into the urethra and/or bladder. Although <FIG> depicts the chamber <NUM> being disposed in the chamber member <NUM>, the chamber <NUM> may, additionally or alternatively, be in the distal member <NUM>.

The distal housing <NUM> may further include a locking member <NUM> configured to prevent release of the distal member <NUM> from the chamber member <NUM> during handling and insertion of the tubular member <NUM>. The locking member <NUM> may include a latching member and/or lever attached to the distal member <NUM> and biased into engagement with the chamber member <NUM>. The locking member <NUM> may prevent retraction of the distal member <NUM> from the chamber member <NUM> before actuation. Upon completion of the voiding of the bladder, a user may actuate the locking member <NUM> (e.g., by pressing and/or pivoting) to release the distal member <NUM> from the chamber member <NUM>. The locking member <NUM> may have a proximal protrusion received in an aperture of the chamber member <NUM>, such that pressing a proximal portion of the locking member <NUM> may release the distal member <NUM> from the chamber member <NUM>. Release of the locking member <NUM> may allow retraction of the distal portion <NUM> and and extension of the sleeve <NUM> relative to the tubular member <NUM> to facilitate removal of the catheter <NUM> from the urethra.

<FIG> illustrate a fifth exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a housing <NUM> having a chamber <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG> is an enlarged view of the region D shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line E-E. <FIG> shows the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The sleeve <NUM> may invert or roll into the inner lumen of tubular member <NUM> over the proximal end opening of tubular member <NUM> and extend through the inner lumen of tubular member <NUM>. The sleeve <NUM> may attach at its distal end <NUM> over a tubular extension <NUM> inside the housing <NUM>. The sleeve <NUM> may extend over the tubular extension <NUM> to maintain patency of the sleeve <NUM>. The catheter <NUM> may be provided to a user in a compact state where the tubular member <NUM> is received in the chamber <NUM> of the housing <NUM> in a stored configuration.

Once the user has engaged the catheter <NUM> with the urethra meatus, the user may advance the tubular member <NUM> by sliding a slider <NUM> through a slot <NUM> in the housing <NUM>. The slider <NUM> may thus advance a portion of the sleeve <NUM> while a proximal portion <NUM> of the sleeve <NUM> is attached to the proximal member <NUM> and a distal portion <NUM> of the sleeve <NUM> is attached to the tubular extension <NUM>. The sleeve <NUM> may be folded in the distal housing with a substantially <NUM> degree turn, which may be engaged by a hook or pulley-type member <NUM>. The pulley-type member <NUM> may be connected to the slider <NUM> or be free floating and slide with the sleeve <NUM> along the longitudinal axis of the housing <NUM>.

Once the catheter <NUM> reaches the bladder, the catheter <NUM> may void urine from the bladder. The urine may pass through the tubular member <NUM> and the sleeve <NUM>, around the substantially <NUM> degree turn, and out of the sleeve <NUM>. The urine may then pass through another substantially <NUM> degree turn, and though a channel <NUM> of the housing <NUM> and out of a distal end of the catheter <NUM>.

On completion of voiding, the user may retract the slider <NUM> slider distally along the housing <NUM> to retract the tubular member <NUM> and the sleeve <NUM> back into the housing <NUM>. The advancement/retraction rate of the tubular member <NUM> is the same as the advancement/retraction rate of the slider <NUM>, facilitating insertion and removal of the tubular member <NUM> into the urethra and bladder. The tubular member <NUM> and the sleeve <NUM> is retained within the housing <NUM> before and after device use for easier and more hygienic handling, storage, and disposal.

<FIG> illustrate a sixth exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a housing member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG> shows the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The sleeve may evert or roll into the inner lumen of tubular member <NUM> over the proximal end opening of tubular member <NUM>. The sleeve may extend through the inner lumen of tubular member <NUM> and attach at its distal end <NUM> to a distal portion <NUM> of the housing member <NUM>. The housing member <NUM> may be profiled to favor device handling for self-insertion. A slider <NUM> may be configured to slide along a slot <NUM> in the housing member <NUM>. The slider <NUM> may be configured to advance or retract the tubular member <NUM> relative to and within the housing member <NUM> by pushing an attachment portion 650A on the tubular member <NUM>. The slider <NUM> may thus translate the tubular member <NUM> and the sleeve <NUM> in a conveyor-like manner. The tubular member <NUM> and the sleeve may translate between a distal configuration prior to insertion, and a proximal configuration to insert the catheter <NUM> into the urethra and/or bladder. The slider <NUM> may also retract the tubular member <NUM> and the sleeve <NUM> back to the distal configuration to remove the catheter <NUM> from the urethra and/or bladder. In the distal configuration, the tubular member <NUM> and sleeve <NUM> may extend distally from the housing <NUM>. In the proximal configuration, the tubular member <NUM> and sleeve <NUM> may extend proximally from the housing <NUM>. The catheter <NUM> may be used without a connected bag.

<FIG> illustrate a first exemplary embodiment of a frictionless catheter <NUM> of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG>, <FIG> show the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in the retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The proximal end <NUM> may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal end <NUM> to a shuttle <NUM> which slides within the inner lumen of tubular member <NUM>. The shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>. The tubular member <NUM> has a low-profile to provide favorable handling, insertion, and drainage. Once the user has engages the proximal member <NUM> with the urethra meatus, the user may advance the tubular member <NUM> into the urethra by pushing the catheter <NUM> and/or retracting the proximal member <NUM> which slides over the tubular member <NUM>. The sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> advances through the urethra and/or bladder.

The catheter <NUM> includes a filament <NUM> which facilitates removal and/or retraction of the tubular member <NUM> upon completion of bladder voiding. The filament <NUM> may be attached to the shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. Retraction of the filament <NUM> may reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra. The filament <NUM> may be attached at its distal end to a pull member <NUM>, such as a pull tab, a pull flag, or a pull rod, to facilitate handling and pulling. The filament <NUM> extends through an aperture <NUM> through a sidewall of the tubular member <NUM> or distal member <NUM> and out of the catheter <NUM>, where the aperture <NUM> is proximal of the distal end of the catheter <NUM>. The aperture <NUM> extending through the sidewall of the distal member <NUM> may be especially desirable due to an improved angle and minimizing interference with the insertion of the catheter <NUM>. The filament <NUM> may be stored in a coiled configuration and housed in the distal member <NUM> and/or tubular member <NUM>. In some embodiments, the filament <NUM> may be heat-set to make the filament <NUM> assume a particular form, such as a coil, or to have resilient and/or springy qualities in such particular form when the sleeve <NUM> is in the retraction configuration. The filament <NUM> lengthens and straightens as the sleeve <NUM> advances proximally through the tubular member <NUM> and everts over the outer surface of the tubular member <NUM> to the everted configuration. After voiding, the user may pull the pull member <NUM> to pull the filament <NUM> through the aperture <NUM> from outside of the catheter <NUM>, which in turn pulls the shuttle <NUM> and sleeve <NUM> through the lumen of the tubular member <NUM> back to the retracted configuration.

The catheter <NUM> may be connected to a urine bag as the funnel section is not effected by the filament <NUM> or pull member <NUM>. The aperture <NUM> may allow for pulling in a lateral or outward direction while still providing frictionless removal, facilitating the use of the catheter <NUM> with a bag or when a user is on a toilet. The catheter <NUM> also improves hygienic handling, storage, and disposability.

<FIG> illustrate a seventh exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG> shows the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in the retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The proximal end <NUM> may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of the tubular member <NUM> and attach at its distal end <NUM> to a shuttle <NUM> which slides within the inner lumen of tubular member <NUM>. Once the user has engaged the proximal member <NUM> with the urethra meatus, the user may advance the tubular member into the urethra by pushing the distal member <NUM> and/or retracting the proximal member <NUM> which slides over the tubular member <NUM>. The sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> advances through the urethra and/or bladder.

The catheter <NUM> may further include a filament <NUM> which facilitates removal of the tubular member <NUM> upon completion of bladder voiding. The filament <NUM> may be attached to the shuttle <NUM> to which the distal end <NUM> of sleeve <NUM> is attached. The shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>. The filament <NUM> may be attached to the shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. The tubular member <NUM> has a low-profile to provide favor handling, insertion, and drainage. Retraction of the shuttle <NUM> may reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra.

A spring <NUM> may be connected to the filament <NUM> through a hook of the proximal end of the spring <NUM> and loop on a distal end of the filament <NUM>. However, in some embodiments, the spring <NUM> may be connected directly to the shuttle <NUM> or the distal portion <NUM> of the sleeve <NUM>, without any separate filament <NUM>. The spring <NUM> may be housed in the tubular member <NUM> and/or distal member <NUM>. The spring <NUM> may be a helical compression/extension filament and may be positioned along the longitudinal axis of the catheter <NUM>. The spring <NUM> may extend when the sleeve <NUM> is pulled proximally as the catheter <NUM> is advanced through the urethra and/or bladder. The spring <NUM> may provide a restoration force and/or re-coil to the sleeve <NUM> when an insertion counterforce is removed, for example, when the catheter <NUM> is removed from the urinary meatus. The restoration force of the spring <NUM> may pull the sleeve <NUM>, which retracts the sleeve <NUM> and the tubular member <NUM>. The catheter <NUM> can be connected to a urine bag.

<FIG> illustrate an eighth exemplary frictionless catheter <NUM>, which does not form part of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG>, <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG> shows the catheter <NUM> fully retracted after insertion. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in the retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The proximal end <NUM> may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal end <NUM> to a shuttle <NUM> which slides within the inner lumen of tubular member <NUM>. The shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>. The tubular member <NUM> has a low-profile to provide favor handling, insertion, and drainage. Once the user has engages the proximal member <NUM> with the urethra meatus, the user may advance the tubular member into the urethra by pushing the catheter <NUM> and/or retracting the proximal member <NUM> which slides over the tubular member <NUM>. The sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> advances through the urethra and/or bladder.

The catheter <NUM> may further include a filament <NUM> which facilitates removal of the tubular member <NUM> upon completion of bladder voiding. The filament <NUM> may be attached to the sliding shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. Retraction of the filament <NUM> may reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra. The filament <NUM> may be attached to a spring <NUM> housed within the distal member <NUM>. In another embodiment, the filament <NUM> may actually be just an extension of the spring <NUM> itself. The spring <NUM> may be a torsional spring (e.g., leaf spring) housed within an off-axis spring housing <NUM> of the distal member <NUM>. The spring <NUM> may be attached to a spool which winds or coils the filament <NUM> around an axis, and the filament <NUM> may be pulled when the catheter <NUM> is advanced through the urethra and/or bladder. The spring <NUM> may recoil and provide a restoration force to the filament <NUM> when an insertion counterforce is removed, for example, when the catheter <NUM> is removed from the urinary meatus. The restoration force of the spring <NUM> may pull the filament <NUM>, which retracts the sleeve <NUM> and the tubular member <NUM>. The spring <NUM> may provide a constant, or approximately constant, spring force for retraction. The spool may retain and/or store the filament <NUM> when the sleeve <NUM> is in the retracted configuration. The catheter <NUM> can be connected to a urine bag as the funnel section is not effected by the filament <NUM> or the spring <NUM>.

<FIG> illustrate a second exemplary embodiment of a frictionless catheter <NUM> of the present invention, having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> and <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line A-A. <FIG> is an enlarged view of the region B shown in <FIG> is an enlarged view of the region C shown in <FIG>. <FIG> and <FIG> show the catheter <NUM> in a fully inserted and everted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line D-D. <FIG> is an enlarged view of the region E shown in <FIG> is an enlarged view of the region F shown in <FIG>. <FIG> and <FIG> show the catheter <NUM> in a fully retracted configuration. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line G-G. <FIG> is an enlarged view of the region H shown in <FIG> is an enlarged view of the region I shown in <FIG>. <FIG> is a cross-sectional view of the catheter <NUM> in <FIG> taken along line J-J. <FIG> is an enlarged view of the region K shown in <FIG> is an enlarged view of the region L shown in <FIG>. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in the retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The proximal end <NUM> may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of the tubular member <NUM> and attach at its distal end <NUM> to a shuttle <NUM> which slides within the inner lumen of tubular member <NUM>. The shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>.

The catheter <NUM> further includes a filament <NUM> which facilitates removal of the tubular member <NUM> upon completion of bladder voiding. Retraction of the filament <NUM> may reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra. A shuttle <NUM> may be attached to a distal end portion <NUM> of the sleeve <NUM> and a distal portion of the filament <NUM>. The filament <NUM> may be attached to the shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. The filament <NUM> extends through an aperture <NUM> through a sidewall of the tubular member <NUM> or distal member <NUM> and out of the catheter <NUM>, where the aperture <NUM> is proximal of the distal end of the catheter <NUM>. The aperture <NUM> extending through the sidewall of the distal member <NUM> may be especially desirable due to an improved angle and minimizing interference with the insertion of the catheter <NUM>. The filament <NUM> may be attached to a pull member <NUM>, which may embody a pull ring, to facilitate handling and pulling. Thus, the filament <NUM> may extend from the shuttle <NUM> through aperture <NUM> and attached to the pull member <NUM>. A proximal portion of the filament <NUM> may be stored in a coiled configuration and housed in the tubular member <NUM> and/or distal member <NUM>. The filament <NUM> may also be heat-set to make the filament <NUM> take a particular form, such as a coil, or to have resilient and/or springy qualities to be biased into the particular form. The aperture <NUM> may allow for pulling in an upward direction while still providing frictionless removal, facilitating the use of the catheter <NUM> with a bag or when a user is on a toilet. The catheter <NUM> can be connected to a urine bag as the funnel section is not effected by the filament <NUM> or pull member <NUM>. The catheter <NUM> also improves hygienic handling, storage, and disposability.

The pull member <NUM> may include a securing member <NUM> configured to releasably secure the pull member <NUM> onto an outer surface of the tubular member <NUM>. The pull member <NUM> may be secured onto the tubular member <NUM> prior to insertion of the catheter <NUM> and during insertion of the catheter <NUM>. The securing member <NUM> may be in the form of a resilient clip configured to partially extend around the tubular member <NUM>. After voiding is complete, the securing member <NUM> may be released from the tubular member <NUM> and pulled to retract the sleeve <NUM> and remove the catheter <NUM>, as illustrated in <FIG>.

After removal of the catheter <NUM>, the pull member <NUM> may be clipped back onto the tubular member <NUM> and additionally locked to the proximal member <NUM>, as shown in <FIG>. For example, the pull member <NUM> may include a locking or securing element 1072A such as an extension of the securing member <NUM>, which mates or locks into a complementary locking or securing element 1072B, such as a recess, on the proximal member <NUM>. The recess 1072B may secure the extension 1072A with a frictional and/or interference fit. The retention of the extension 1072A in the recess 1072B maintains tension on the filament <NUM> to facilitate storage and/or disposal after use.

<FIG> illustrate a third exemplary embodiment of a catheter <NUM> having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> illustrates a perspective view of the catheter <NUM>. <FIG> illustrates an exploded view of the catheter <NUM>. <FIG> illustrates a frontal view of the catheter <NUM>. <FIG> illustrates a cross-sectional view of the catheter <NUM> along the plane indicated in <FIG>. <FIG> illustrates the catheter <NUM> having a proximal member <NUM>' for engaging male anatomy. <FIG> illustrates the catheter <NUM> having a pre-attached bag <NUM>. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in the retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end. The proximal end may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and may attach at its distal end to a first shuttle <NUM>. The first shuttle <NUM> may be configured to slide through the inner lumen of tubular member <NUM>. The first shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>. The tubular member <NUM> has a low-profile to provide favor handling, insertion, and drainage. Once the user engages the proximal member <NUM> with the urethra meatus, the user may advance the tubular member <NUM> into the urethra by pushing the catheter <NUM> and/or retracting the proximal member <NUM> which slides over the tubular member <NUM>. The sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> advances through the urethra and/or bladder (as similarly illustrated in <FIG>). The advancement of the sleeve <NUM> may also advance the first shuttle <NUM> through the tubular member <NUM>. In a fully advanced position of the sleeve <NUM>, the first shuttle <NUM> may approximate and/or abut a second shuttle <NUM> positioned in the lumen of the tubular member <NUM> proximal of the first shuttle <NUM>.

The catheter <NUM> further includes a filament <NUM> having a pull member <NUM>, which facilitates removal of the tubular member <NUM> upon completion of bladder voiding. The filament <NUM> extends from the pull member <NUM> through an aperture <NUM> through a sidewall of the tubular member <NUM> or distal member <NUM> and out of the catheter <NUM>, where the aperture <NUM> is proximal of a distal end of the catheter <NUM>. The aperture <NUM> extending through the sidewall of the distal member <NUM> may be especially desirable due to an improved angle and minimizing interference with the insertion of the catheter <NUM>. The filament <NUM> may then extend proximally through the distal member <NUM> and/or tubular member <NUM>. The filament <NUM> may extend through and proximally past the first shuttle <NUM>. The filament <NUM> may attach to the second shuttle <NUM> proximal of the first shuttle <NUM>. The filament <NUM> may be attached to the second shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. Attachment of the filament <NUM> to the second shuttle <NUM> may maintain tension on the filament <NUM> prior to insertion of the catheter <NUM>. Retraction of the filament <NUM> may reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra. Retraction of the filament <NUM> may cause retraction of the second shuttle <NUM>, which contacts and pulls the first shuttle <NUM> distally through the lumen of the tubular member <NUM>. The first shuttle <NUM> may pull the sleeve <NUM> into the lumen of the tubular member <NUM> to the retracted configuration.

As illustrated in <FIG>, the catheter <NUM> may be packaged with a pre-attached bag <NUM> in fluid communication with the distal member <NUM>. As packaged, the bag <NUM> may be wrapped around the distal member <NUM> and secured in the wrapped configuration with an overlying sleeve <NUM>. Thus, after opening the package, the user may remove the overlying sleeve <NUM> to unfold the bag <NUM> prior to use. In embodiments with the bag <NUM>, the distal member <NUM> may receive a tubular extension <NUM> to provide improved fluid flow into the bag <NUM>. The tubular extension <NUM> may be received in the lumen of the distal member <NUM> through an interference or threaded fit. The bag <NUM> may also receive the pull member <NUM> in the wrapped configuration. As further discussed above the proximal member <NUM> may include separable components including a tissue engaging member <NUM> of <NUM>' and a handling portion <NUM> or <NUM>'. The handling portion <NUM> or <NUM>' may include one or more ribs and/or grooves, or the like to enhance grip of the user. The tissue engaging member <NUM> may include a convex proximal surface to engage female anatomy. Alternatively, the tissue engaging member <NUM>' may include a concave proximal surface to engage male anatomy.

<FIG> illustrate a fourth exemplary embodiment of a catheter <NUM> having a tubular member <NUM>, a sleeve <NUM>, a proximal member <NUM>, and a distal member <NUM>. <FIG> show the catheter <NUM> in a ready-to-insert and retracted configuration. <FIG> illustrates a perspective view of the catheter <NUM>. <FIG> illustrates a top view of the catheter <NUM>. <FIG> illustrates a side cross-sectional view of the catheter <NUM>. <FIG> illustrates a close-up view of a filament <NUM>. The catheter <NUM> may be inserted through a urethra and/or into a bladder to facilitate drainage of a bladder, as discussed herein. Aspects and components of the catheter <NUM> may be further discussed with regard to the other embodiments of this disclosure. In that sense, similar components are provided with reference numbers having the same last two digits throughout the present disclosure.

The catheter <NUM> may be provided to the user in a retracted configuration where the sleeve <NUM> substantially resides within the tubular member <NUM>. The sleeve <NUM> may be attached to the proximal member <NUM> at its proximal end <NUM>. The proximal end <NUM> may evert or roll over the proximal end opening of tubular member <NUM> and into the inner lumen of tubular member <NUM>. The sleeve <NUM> may extend through the inner lumen of tubular member <NUM> and attach at its distal end <NUM> to a shuttle <NUM>. The shuttle <NUM> may be configured to slide within the inner lumen of tubular member <NUM>. The shuttle <NUM> may be a tubular member having a greater hoop strength than the sleeve <NUM> to maintain patency of the sleeve <NUM>. The filament <NUM> may be attached to the shuttle <NUM> with an eyelet, a knot, an adhesive, and/or a weld. The tubular member <NUM> has a low-profile to provide favor handling, insertion, and drainage. Once the user engages the proximal member <NUM> with the urethra meatus, the user may advance the tubular member into the urethra by pushing the catheter <NUM> and/or retracting the proximal member <NUM> which slides over the tubular member <NUM>. The sleeve <NUM> everts over the tubular member <NUM> as the tubular member <NUM> advances through the urethra and/or bladder (as similarly illustrated in <FIG>). The advancement of the sleeve <NUM> may also advance the shuttle <NUM> through the tubular member <NUM>.

The filament <NUM> may have a pull member <NUM>, which facilitates removal of the tubular member <NUM> upon completion of bladder voiding. The filament <NUM> may be attached to the shuttle <NUM> to which the distal end <NUM> of sleeve <NUM> is attached. In the ready-to-use and retracted configuration of the catheter <NUM>, the filament <NUM> may be longitudinally looped and/or bunched in the lumen of the catheter <NUM>. As illustrated in <FIG>, the filament <NUM> extends from the pull member <NUM> through an aperture <NUM> through a sidewall of the distal member <NUM> or tubular member <NUM> and out of the catheter <NUM>, where the aperture <NUM> is proximal of a distal end of the catheter <NUM>. The aperture <NUM> extending through the sidewall of the distal member <NUM> may be especially desirable due to an improved angle and minimizing interference with the insertion of the catheter <NUM>. The filament <NUM> extends proximally through the distal member <NUM> and/or tubular member <NUM>. The filament <NUM> may extend proximally past and through the shuttle <NUM>. The filament <NUM> may then make a first <NUM>° turn distally. The filament <NUM> may extend distally past and through the shuttle <NUM>. The filament <NUM> may then make a second <NUM>° turn proximally. The filament <NUM> may then extend proximally, and rigidly connect to the shuttle <NUM>. However, the filament <NUM> may be longitudinally looped and/or bunched with a single <NUM>° turn. The looping and/or bunching of the filament <NUM> may ensure storage and sterility of the filament in the catheter <NUM>. During insertion of the catheter <NUM>, the filament <NUM> may straighten as the sleeve <NUM> everts and extends over the outer surface of the tubular member <NUM>. After voiding of the bladder, the user may retract/pull the filament <NUM> to reverse the sleeve insertion mechanism, such that the tubular member <NUM> retracts from the urethra with no kinetic friction between the catheter <NUM> and urethra. Retraction of the filament <NUM> may pull the shuttle <NUM> distally through the lumen of the tubular member <NUM>. The shuttle <NUM> may pull the sleeve <NUM> through the lumen of the tubular member <NUM> to the retracted configuration.

As illustrated in <FIG>, the catheter <NUM> may be packaged with a pre-attached bag <NUM> in fluid communication with the distal member <NUM>. As packaged, the bag <NUM> may be wrapped around the distal member <NUM> and secured in the wrapped configuration with an overlying sleeve <NUM>. Thus, after opening the package, the user may remove the overlying sleeve <NUM> to unfold the bag <NUM> prior to use. In embodiments with the bag <NUM>, the distal member <NUM> may receive a tubular extension <NUM> to provide improved fluid flow into the bag <NUM>. The tubular extension <NUM> may be received in the lumen of the distal member <NUM> through an interference or threaded fit. A support member <NUM> may be disposed inside the bag <NUM> to prop the pull member <NUM> into a proximal configuration outside of the bag <NUM>. The support member <NUM> may be a sleeve or wrap disposed around the distal member <NUM> to abut the distal side of the pull member <NUM>. As further discussed above, the proximal member <NUM> may include separable components including a tissue engaging member <NUM> and a handling portion <NUM>. The handling portion <NUM> may include may include one or more ribs and/or grooves, or the like to enhance grip of the user. The tissue engaging member <NUM> may include a convex proximal surface to engage female anatomy. Alternatively, the tissue engaging member may include a concave proximal surface to engage male anatomy.

<FIG> show various configurations of a proximal portion of any of the tubular members disclosed herein, including tubular members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, having features that render the proximal portion of such tubular member relatively more flexible than the rest of the tubular member. Such features may include a pattern of holes. As one set of examples, shown in <FIG>, the holes are formed on four lines, one each on four sides of the tube, with a first line pair of holes, with one line each on two opposing sides that are longitudinally aligned and facing each other, and a second line of a pair of holes, with one line each on two other opposing sides that are longitudinally aligned and facing each other, but first line pair and second line pair are offset longitudinally relative to each other by a distance of one spacing between holes in a line. In the example shown in <FIG>, the holes can be oval or elliptical in shape, while in the example shown in <FIG>, the holes can be circular. In the example shown in <FIG>, a score line or cut in the wall of the tube is in a spiral pattern, with the pitch of the spiral being variable and becoming tighter, or lower, as the spiral progresses towards the tip of the tube. When the proximal portion of the tube is more flexible, it allows for easier insertion through the urethra, especially in cases where the path of travel is curved or tortuous. However, the various configurations shown in <FIG> can be used anywhere along the catheter tubes as disclosed herein, so as to render a particular length of tubing more or less flexible. Advantageously, the use of the various patterns shown in <FIG> in a tubular member such as tubular members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> with an external sleeve such as sleeve <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. , <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> facilitates folding or bending of the assembly yet still will carry fluid flow down the catheter lumen due to the presence of the sleeve.

The catheters of the present disclosure and various embodiments of the catheters <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be made from a variety of materials. Advantageously, it has been discovered that the sleeve <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> can be made of a high density polyethylene film, while the tubular member <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> can be made of polyvinyl chloride (PVC), the combination of which will produce superior performance in terms of low internal friction within the catheter system, with associated benefits in terms of lower cost relative to other materials. The sleeves <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be dry and uncoated to reduce the risk of contamination. The filaments <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be made of plastic or metal and embody a braided or woven string or a monofilament. Each of the catheters <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may include a proximal end portion for engagement with female anatomy (e.g., <NUM> illustrated in <FIG>) or a proximal end portion for engagement with male anatomy (e.g., <NUM>' illustrated in <FIG>). Each of the catheters <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be packaged with a pre-attached bag (e.g., <NUM> or <NUM> as illustrated in <FIG>, <FIG>) to collect urine, or packaged without a pre-attached bag (e.g. illustrated in <FIG>, <FIG>) to drain urine directly into a bathroom receptacle. The catheters <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> are primarily discussed herein as being inserted through a urethra and/or into a bladder to facilitate drainage of a bladder.

Claim 1:
A catheter (<NUM>) comprising:
a tubular member (<NUM>) having a lumen and an outer surface;
a proximal member (<NUM>) disposed on a proximal end (<NUM>) of the tubular member, the proximal member being configured to engage a urethra meatus, a distal member (<NUM>) disposed on a distal end (<NUM>) of the tubular member;
a sleeve (<NUM>) configured to be positioned in the lumen of the tubular member in a retracted configuration and to evert over at least a portion of the outer surface of the tubular member in an everted configuration;
a filament (<NUM>) configured to retract the sleeve into the retracted configuration; and
an aperture (<NUM>) disposed through a sidewall of the tubular member or through a sidewall of the distal member, the aperture being proximal of a distal end of the catheter, wherein the filament extends from the lumen through the aperture and out of the catheter.