Patent Description:
Intermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. Such catheters are typically provided as single use, individually packaged items and may include a gel-lubricant or hydrophilic coating as a lubricant for reducing friction during insertion into the urethra. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual's bladder. Individuals who suffer from urinary incontinence will self-catheterize several times a day.

Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the urethra.

Users of intermittent catheters are often required to self-catheterize outside the privacy of the home, such as in public restrooms. Thus, for these and other reasons, it is desirable that intermittent catheters are provided in discrete packaging that is easy to open, compact and portable, and easy to dispose.

Inasmuch as the male urethra is much longer than the female urethra, male catheters typically include a catheter tube that is likewise much longer than the catheter tube of a female intermittent catheter, making the compactness and portability of such catheters more challenging. Thus, it would be desirable to provide a compact intermittent urinary catheter that, at the time of use, can be extended and advanced into the male urethra. Extendable intermittent urinary catheters for use in a female urethra would also be desirable.

<CIT> discloses a medical device such as a catheter having in a proximal end a braided portion being operable between two configurations, one for insertion of the device into the body and one for retaining the catheter in the body. <CIT> discloses a medical device with a retention section for anchoring the medical device in the body of a living being, a drainage section for draining fluids from the body, e.g. urine, and a tip which facilitates insertion into the body.

The present invention is defined by independent claims <NUM>, <NUM> and subsequent dependent claims <NUM> - <NUM>, <NUM> - <NUM>.

There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

In one aspect, a urinary catheter assembly is provided that includes a catheter member and a sleeve member receiving at least a portion of the catheter member and having a greater flexibility than the catheter member. The assembly also includes a stylet having a proximal end movably positioned within the catheter member, with a distal portion of the stylet being positioned outside of the catheter member. The assembly is movable between a compact configuration and an extended configuration.

In another aspect falling outside the scope of the invention, a method is provided for using a urinary catheter assembly. According to the method, a urinary catheter assembly having a catheter member, sleeve member, and stylet is provided. The sleeve member receives at least a portion of the catheter member, while a proximal end of the stylet is movably positioned within the catheter member. A distal portion of the stylet is positioned outside of the catheter member and at least partially within the sleeve member. The stylet is moved distally with respect to the catheter member to position a larger distal portion of the stylet outside of the catheter member. A proximal end of the catheter member is advanced into a urethra until the proximal end of the catheter member is positioned within a bladder, with at least a distal end of the sleeve member and a distal end of the stylet positioned outside of the urethra.

In yet another aspect, a urinary catheter assembly is provided that includes a catheter member, a drainage member, and a sleeve member secured to the catheter member and drainage member. The assembly further includes a stylet positioned within the sleeve member and including a proximal end secured to the catheter member and a distal end secured to the drainage member.

<FIG> shows an embodiment of a urinary catheter assembly <NUM> according to an aspect of the present disclosure. The urinary catheter assembly <NUM> of <FIG> is configured for use by a male, but a urinary catheter assembly suitable for use by a female will also be described herein.

The urinary catheter assembly <NUM> includes a catheter member <NUM>, which may be provided as an elongated, hollow tube extending between a proximal end <NUM> and a distal end <NUM>. The catheter member <NUM> may be provided generally in accordance with a typical urinary catheter shaft (e.g., formed of the same or similar material and having the same or similar outer and inner diameters), but with a number of differences. For instance, a typical urinary catheter shaft may be provided with one or more drainage eyes or openings associated with the proximal end or proximal portion of the catheter shaft to allow urine from a bladder to flow into the hollow interior of the catheter shaft, where it flows to a drainage device (frequently provided as a funnel) to exit the catheter shaft. In contrast, the illustrated catheter member <NUM> includes at least one eye or opening <NUM> (shown as two) positioned at or adjacent to the proximal end <NUM> of the catheter member <NUM>, along with at least one drainage eye or opening <NUM> (shown as two) positioned at or adjacent to the distal end <NUM> of the catheter member <NUM>. Thus, whereas a typical urinary catheter shaft has differently configured proximal and distal ends, it will be seen that the proximal and distal ends <NUM> and <NUM> of the catheter member <NUM> of <FIG> are similarly configured (i.e., with a hemispherical end and one or more associated eyes or openings). While <FIG> illustrates a generally hemispherical distal end <NUM>, the distal end <NUM> of the catheter member <NUM> may be differently configured without departing from the scope of the present disclosure, provided that the distal end <NUM> is sized and configured to be advanced into a male urethra U and drain urine from the hollow interior of the catheter member <NUM>.

In addition to having a differently configured distal end <NUM>, the catheter member <NUM> of <FIG> may also differ from typical urinary catheter shafts due to its length. In particular, a typical male urethra U may have a length on the order of approximately <NUM>, thereby requiring a catheter shaft that is at least that long to allow the catheter shaft to extend through the entire urethra U, with a proximal end of the catheter shaft positioned within the bladder B and a distal end of the catheter shaft (including the associated drainage device) positioned outside of the body. In contrast, the illustrated catheter member <NUM> is shorter than a typical urinary catheter shaft. By way of illustration, a typical urinary catheter assembly for use by a male may be on the order of approximately <NUM> long, whereas the urinary catheter assembly <NUM> of <FIG> may have a length on the order of approximately <NUM> in the compact configuration of <FIG>. According to a method of using the urinary catheter assembly <NUM> (which will be described in greater detail), the entire catheter member <NUM> is positioned within the bladder/urethra (<FIG>), traversing only a portion of the length of the urethra U, while other portions of the urinary catheter assembly <NUM> traverse the remaining portion of the urethra U and are positioned outside of the body to drain urine from the urinary catheter assembly <NUM>.

The urinary catheter assembly <NUM> further includes a sleeve member <NUM>. The axially compressible or deformable sleeve member <NUM> may be provided as a thin film or material formed into a tube (e.g., a lay flat tubing), with at least the distal end <NUM> of the catheter member <NUM> received within the sleeve member <NUM>. In the illustrated embodiment, a proximal end <NUM> of the sleeve member <NUM> being secured to the outer surface of the catheter member <NUM> by a fluid-tight seal. The sleeve member <NUM> may be sealed to the catheter member <NUM> proximally of the distal eyes <NUM> (or whatever comparable drainage feature is provided at or adjacent to the distal end <NUM> of the catheter member <NUM>) to allow urine to drain from the catheter member <NUM> into the sleeve member <NUM>. Preferably, the proximal end <NUM> of the sleeve member <NUM> is sealed to the catheter member <NUM> just proximally of the distal eyes <NUM> (or comparable drainage feature), but it is also within the scope of the present disclosure for the sleeve member <NUM> to be secured to some other location of the catheter member <NUM>. While the illustrated sleeve member <NUM> is secured to the outer surface of the associated catheter member <NUM>, sleeve members according to the present disclosure may alternatively be secured to an inner surface of an associated catheter member having an open distal end.

The sleeve member <NUM> is configured to be more flexible than the catheter member <NUM>, such as being sufficiently flexible to move between a bunched or pleated or folded condition when the urinary catheter assembly <NUM> is in a compact configuration (<FIG>) to an elongated or extended condition in which there is a greater distance between the proximal and distal ends <NUM> and <NUM> of the sleeve member <NUM> (<FIG>). As shown in <FIG>, at least a proximal portion of the sleeve member <NUM> is configured to be advanced into a urethra U during use of the urinary catheter assembly <NUM>, such that it may be advantageous for the sleeve member <NUM> (or at least a proximal portion thereof) to be formed of a material suited for such use and/or for the sleeve member <NUM> (or at least a proximal portion thereof) to be treated with a coating that renders the coated portion of the sleeve member <NUM> suitable for temporary residence within a urethra U. In one embodiment, the outer surface of one or both of the catheter member <NUM> and the sleeve member <NUM> may be coated with a lubricious coating (which may comprise a hydrophilic or oleophilic substance, for example) to allow for easier advancement of the catheter member <NUM> and sleeve member <NUM> through the urethra U.

The distal end <NUM> of the sleeve member <NUM> may be associated with or secured to a drainage member <NUM>. The drainage member <NUM> of <FIG> is illustrated as a funnel provided generally in accordance with conventional design. The drainage member <NUM> is configured to remain outside of the body during use of the urinary catheter assembly <NUM> (as shown in <FIG>), so it may be formed of a generally rigid material, rather than being provided as a generally flexible or semi-rigid member. It also within the scope of the present disclosure for the drainage member <NUM> to be formed of a generally flexible or semi-rigid material, which may be advantageous when the drainage member <NUM> is used to hold a drainage bag connector. If the drainage member <NUM> is to be used in combination with a drainage bag, the drainage bag may be separately provided for connection to the drainage member <NUM> or may be pre-attached to define a closed system. Regardless of the material composition of the drainage member <NUM>, the distal end <NUM> of the sleeve member <NUM> may be sealed around an outer perimeter of the drainage member <NUM> (e.g., to the outer surface of the cuff of the drainage member <NUM>, if provided as a funnel) to direct urine from the sleeve member <NUM>, to the drainage member <NUM>, and then out of the urinary catheter assembly <NUM> for disposal in a waste location (e.g., a toilet or drainage bag). In other embodiments, the drainage member <NUM> may be differently configured and/or the sleeve member <NUM> may be differently associated with the drainage member <NUM>.

The urinary catheter assembly <NUM> also includes a stylet <NUM>. The stylet <NUM> extends between a proximal end <NUM>, which is movably positioned within the hollow interior of the catheter member <NUM>, and a distal end <NUM>, which is positioned outside of the catheter member <NUM> and may be secured to the drainage member <NUM> (if provided). If a drainage member <NUM> is not provided, then the distal end <NUM> of the stylet <NUM> may be secured to the sleeve member <NUM> (e.g., at or adjacent to the distal end <NUM> of the sleeve member <NUM>). During use of the urinary catheter assembly <NUM>, the stylet <NUM> is advanced into the urethra U (<FIG>), but it does not come into contact with the body (being positioned within the catheter member <NUM> and the sleeve member <NUM>), so the material composition and surface treatment issues which inform the designs of the catheter member <NUM> and sleeve member <NUM> are not necessarily present for the stylet <NUM>. It may be advantageous for the stylet <NUM> to be formed of a semi-rigid material (similar to the catheter member <NUM>), which is sufficiently flexible to move between a generally straight or linear configuration (<FIG>) to a curved or less linear configuration (<FIG>) to allow the stylet <NUM> to move through the pathway defined by the urethra U. Additionally, as will be described in greater detail, the stylet <NUM> transmits a pushing force to the catheter member <NUM> in order to advance the urinary catheter assembly <NUM> through a urethra U, such that semi-rigidity (namely, a greater rigidity or stiffness than the catheter member <NUM>) may be preferred to general flexibility to provide the stylet <NUM> with sufficient column strength to be pushed through the urethra U from its distal end <NUM> without buckling.

As will be described in greater detail, the stylet <NUM> allows for a telescoping urinary catheter assembly <NUM> having a variable length. However, it is also within the scope of the present disclosure for the stylet <NUM> itself to have a variable length (e.g., by the inclusion of a telescopic joint or hinge joint or the like), rather than having a fixed length. In an exemplary configuration employing a telescopic joint, the stylet may be comprised of two or more pieces and be movable between a compact configuration having a relatively short length (with at least one piece configured to be at least partially positioned within another piece, for example) and an elongated or extended configuration having a greater length (with said at least one piece of the stylet being moved at least partially out of said other piece to provide the increased length). If a telescopic stylet is provided, each of its two or more pieces may be configured to be locked together with the adjacent piece or pieces by any suitable locking mechanism to maintain the stylet in the elongated or extended configuration for use of the urinary catheter assembly. Similarly, a hinged joint may allow for two adjacent pieces of a stylet to be positioned side-by-side in a compact configuration and then moved to an elongated or extended configuration in which the two pieces are arranged end-to-end for an increased length. The provision of a variable length stylet may make it possible to further decrease the total length of the urinary catheter assembly in the compact configuration, while maintaining the same total length in the extended or elongated configuration, compared to a stylet having a fixed length. This allows for easier transportation of the urinary catheter assembly prior to use, while decreasing the amount of packaging required to contain the urinary catheter assembly and the amount of space the urinary catheter assembly occupies in a garbage can or other waste container.

The stylet <NUM> may have a proximal end <NUM> with a larger diameter than the portion <NUM> of the stylet <NUM> intermediate the proximal and distal ends <NUM> and <NUM>. Such a configuration may be advantageous for retaining the proximal end <NUM> of the stylet <NUM> within the hollow interior of the catheter member <NUM>. In particular, the distal end <NUM> of the catheter member <NUM> may include an opening or aperture <NUM> through which the intermediate portion <NUM> of the stylet <NUM> passes. In the illustrated embodiment, the opening <NUM> is centrally positioned at the distal end <NUM> of the catheter member <NUM> (i.e., at the location where a central axis of the catheter member <NUM> would intercept the distal end <NUM> of the catheter member <NUM>), but the opening <NUM> may be positioned elsewhere without departing from the scope of the present disclosure.

Regardless of the location of the opening <NUM>, it is preferably at least as large as the intermediate portion <NUM> of the stylet <NUM> (to allow the intermediate portion <NUM> to be movably received therein), while being smaller than the proximal end <NUM> of the stylet <NUM>. By such a configuration, the stylet <NUM> may be moved with respect to the catheter member <NUM> without the two becoming dissociated (because the proximal end <NUM> of the stylet <NUM> cannot be moved distally out of the opening <NUM> at the distal end <NUM> of the catheter member <NUM>). This effectively limits the range of motion of the stylet <NUM> with respect to the catheter member <NUM>, as the stylet <NUM> is limited to movement between a position in which the proximal end <NUM> of the stylet <NUM> abuts the proximal end <NUM> of the catheter member <NUM> (<FIG>) and a position in which the proximal end <NUM> of the stylet <NUM> abuts the distal end <NUM> of the catheter member <NUM> (<FIG>). The configuration of <FIG>, in which the stylet <NUM> is in its most proximal position, with a distal portion of the stylet <NUM> positioned outside of the catheter member <NUM> (and at least partially within the sleeve member <NUM>), is referred to herein as the compact configuration. The configuration of <FIG>, in which the stylet <NUM> is in its most distal position, with a larger distal portion of the stylet <NUM> positioned outside of the catheter member <NUM> (and at least partially within the sleeve member <NUM>), is referred to herein as the elongated or extended configuration. The urinary catheter assembly <NUM> may be considered to be in an intermediate or transitional configuration when moving between the compact and extended configurations.

Preferably, some portion of the stylet <NUM> (e.g., its proximal end <NUM>) and/or some portion of the catheter member <NUM> (e.g., its distal end <NUM>) are configured to at least temporarily lock the proximal end <NUM> of the stylet <NUM> in place when the stylet <NUM> has moved to its most distal location (as shown in <FIG>). This may be achieved by an interference or friction fit between the proximal end <NUM> of the stylet <NUM> and the distal end <NUM> of the catheter member <NUM> or some other relationship (e.g., providing some portion of the stylet <NUM> with external threads that mate with internal threads of the catheter member <NUM> when the stylet <NUM> is in its most distal location) that temporarily or permanently locks the stylet <NUM> in place. A locking relationship between the stylet <NUM> and the catheter member <NUM> may also be provided to temporarily hold the stylet <NUM> in place when the stylet <NUM> has moved to its most proximal location (as shown in <FIG>). This may be the initial position of the stylet <NUM>, in which case there may be a weak adhesive bond between a portion of the stylet <NUM> (e.g., its proximal end <NUM>) and a portion of the catheter member <NUM> (e.g., its proximal end <NUM>) or some other temporary locking relationship between the stylet <NUM> and the catheter member <NUM> when the urinary catheter assembly <NUM> is initially provided to retain the urinary catheter assembly <NUM> in the compact configuration of <FIG>. In other embodiments, rather than a locking relationship between a stylet and catheter member, a frictional fit therebetween may be sufficient, provided that the force required to dislodge the stylet from the catheter member in the extended configuration is greater than the insertion force required for catheterization.

In use, the urinary catheter assembly <NUM> (which may be provided in a sealed package or container) is moved from the compact configuration of <FIG> (in which the stylet <NUM> is in its most proximal location, with the proximal end <NUM> of the stylet <NUM> abutting or adjacent to the proximal end <NUM> of the catheter member <NUM>) to the extended or elongated configuration of <FIG> (in which the stylet <NUM> is in its most distal location, with the proximal end <NUM> of the stylet <NUM> abutting or adjacent to the distal end <NUM> of the catheter member <NUM>). This may be achieved by gripping the catheter member <NUM> and a distal portion of the sleeve member <NUM> (or the drainage member <NUM>, if provided) and moving them apart, with the catheter member <NUM> being moved in a proximal relative direction and the sleeve member <NUM> (or drainage member <NUM>) being moved in a distal relative direction. If the catheter member <NUM> and stylet <NUM> are initially locked together, the lock therebetween is first overcome before moving the urinary catheter assembly <NUM> out of its compact configuration. Upon sufficient relative movement, the urinary catheter assembly <NUM> reaches the extended configuration, at which time the stylet <NUM> and catheter member <NUM> may be locked together (if a locking relationship is provided).

With the urinary catheter assembly <NUM> in the extended configuration, the proximal end <NUM> of the catheter member <NUM> may be advanced into a male urethra U and then advanced further through the urethra U. As described above, the stylet <NUM> preferably has sufficient column strength that a proximally directed force applied to the stylet <NUM> (e.g. by gripping the drainage member <NUM>, if provided, and moving the drainage member <NUM> proximally) is transmitted to the catheter member <NUM> by the stylet <NUM>. The catheter member <NUM> is advanced through the urethra U until the portion proximal of the sleeve member <NUM> is fully positioned within the urethra U (<FIG>) and then further advanced to move the sleeve member <NUM> (with at least a portion of the stylet <NUM> positioned therein) into the urethra U. The urinary catheter assembly <NUM> may be further advanced through the urethra U until the proximal eyes <NUM> of the catheter member <NUM> are positioned within the bladder B. <FIG> illustrates this position with the drainage member <NUM> just distal of the urethral opening, but depending on the length of the urethra U, the proximal eyes <NUM> may reach the bladder B with the drainage member <NUM> farther spaced from the urethra U (e.g., with a larger portion of the sleeve member <NUM> and stylet <NUM> positioned outside of the urethra U).

As shown in <FIG>, the catheter member <NUM> traverses a portion of the urethra U, while the sleeve member <NUM> (with a portion of the stylet <NUM> positioned therein) traverses the remainder of the urethra U. The exact dimensions of the individual components of the urinary catheter assembly <NUM> may vary without departing from the scope of the present disclosure, although it may be advantageous for the components to be sized and configured to conform to the anatomy of the male urethra U. For example, it may be advantageous for the catheter member <NUM> to be sized and configured to be positioned within the bladder neck N and external sphincter E of the urethra U (e.g., with a length no greater than approximately <NUM>), while the sleeve portion <NUM> and stylet <NUM> are sized and configured to be positioned within the bulbous urethra L and penile urethra P during use, as shown in <FIG>. The bladder neck N and external sphincter E may require more radial strength to open than the bulbous urethra L and penile urethra P, which may be an advantage in providing the non-uniform strength design of the present disclosure, with a proximal portion (i.e., the catheter member <NUM>) having a greater radial strength and a distal portion (i.e., the sleeve portion <NUM>) having a lesser radial strength. In addition to having a non-uniform radial strength along its length, a urinary catheter assembly according to the present disclosure may also have a non-uniform flexural stiffness, with a more rigid distal portion (i.e., the stylet <NUM>) providing pushability and a less rigid, more flexible proximal portion (i.e., the catheter member <NUM>) providing low insertion force and comfort advantages.

With the urinary catheter assembly <NUM> in the position of <FIG>, urine from the bladder B enters the hollow interior of the catheter member <NUM> via the proximal eyes <NUM> and flows through the catheter member <NUM> to the distal eyes <NUM>. The urine flows out of the catheter member <NUM> via the distal eyes <NUM> and into the sleeve member <NUM>. The urine travels the length of the sleeve member <NUM> to exit the urinary catheter assembly <NUM> at the distal end <NUM> of the sleeve member <NUM> or via the drainage member <NUM> (if provided). The urine may be emptied into a disposable bag or container associated with the urinary catheter assembly <NUM> or be directly drained into a waste container (e.g., a toilet). After use, the urinary catheter assembly <NUM> may be moved distally out of the urethra for disposal. The urinary catheter assembly <NUM> may be disposed of in its extended or elongated configuration (of <FIG>) or be returned to its initial compact configuration (of <FIG>) to take up less space in a waste container.

While the foregoing method involves the urinary catheter assembly <NUM> being moved into its extended configuration prior to the catheter member <NUM> being advanced into a male urethra U, it is also within the scope of the present disclosure for the catheter member <NUM> to be at least partially advanced into the urethra U before being moved to the extended configuration. Other variations to the described method may also be practiced without departing from the scope of the present disclosure.

It should be understood that the configuration of the urinary catheter assembly <NUM> shown in <FIG> is merely exemplary and that variations may be made to the illustrated design without departing from the scope of the present disclosure. For example, rather than having a generally linear configuration, the stylet <NUM> may be provided with a curved configuration (preferably while still providing a semi-rigid stylet that may be flexed into a generally linear configuration or different curved configuration). If the stylet <NUM> has a curved configuration, it may be rotated with respect to the catheter member during drainage of urine in order to direct the urine to the appropriate disposal location (e.g., into a toilet). In another embodiment, the sleeve member <NUM> may be formed using a water permeable material, in which case the space inside a package in which the urinary catheter assembly <NUM> is initially stored may be used as the vapor hydration source for a coating on the outer surface of the catheter member <NUM>.

In an alternative embodiment, which may be practiced with any of the urinary catheter assemblies described herein (as well as other types of urinary catheters), a vapor hydration source may be positioned inside of the urinary catheter assembly <NUM> itself. In particular, a vapor hydration source (e.g., water) may be loaded into the urinary catheter assembly <NUM> (e.g., into the hollow interior of the catheter member <NUM> and/or sleeve member <NUM>) during assembly. In an embodiment that includes a stylet <NUM> of the type described herein, it may be advantageous for the stylet <NUM> to create a temporary seal distal to the proximal eyes <NUM> and for the open distal end of the drainage member <NUM> to be provided with a removable seal to prevent leakage of the vapor hydration source prior to use. If the stylet <NUM> is not present or is present but does not form such a temporary seal, then an alternative approach may be provided to prevent leakage via the proximal eyes <NUM> (e.g., a fluid-tight, removable cover or cap or film or other seal may overlay the proximal eyes <NUM> and/or extend into the proximal eyes <NUM> to prevent fluid flow therethrough).

If provided, an internally located vapor hydration source may interact with a coating on the outer surface of the catheter member <NUM> (preferably while the urinary catheter assembly <NUM> is positioned within a sealed package) by passing vapor through a vapor-transmissive portion of the urinary catheter assembly <NUM>. In one embodiment, all or a portion of the sleeve member <NUM> may be formed of a material that prevents the passage of the liquid (e.g., urine or a vapor hydration source in a liquid state), while allowing for vapor from the vapor hydration source to pass therethrough. Alternatively (or additionally), all or a portion of one or more of the other components of the urinary catheter assembly <NUM> (e.g., the catheter member <NUM>, drainage member <NUM>, and/or one of the seals/covers/caps associated with the proximal eyes <NUM> and/or drainage member <NUM>) may be configured to allow for the passage of vapor therethrough to allow vapor from the internally located vapor hydration source to interact with a coating on the outer surface of the catheter member <NUM>.

The internally located vapor hydration source keeps the coated portion of the catheter member <NUM> lubricated during storage and before use of the urinary catheter assembly <NUM>. Just prior to use, the vapor hydration source may be removed from inside of the urinary catheter assembly <NUM> by any suitable approach (e.g., by removing a seal associated with the open distal end of the drainage member <NUM> and draining the vapor hydration source into a toilet or other waste receptacle). Then, with the internally located vapor hydration source removed from the urinary catheter assembly <NUM>, the user may proceed to use the urinary catheter assembly <NUM> for catheterization as described above (or as described below for the other embodiments of the present disclosure).

<FIG> illustrate another possible variation to the urinary catheter assembly design of <FIG>. In the embodiment of <FIG>, the urinary catheter assembly <NUM> is provided in accordance with the foregoing description of the urinary catheter assembly <NUM> of <FIG>, but further includes a gripper member <NUM>. The gripper member <NUM> remains outside of the body during use (<FIG>), so it may be formed of one or more of any of a variety of suitable materials (e.g., a soft plastic material), without specific regard to lubricity.

The gripper member <NUM> may be generally tubular, with a hollow interior in which the distal end <NUM> of the catheter member <NUM> may be positioned when the urinary catheter assembly <NUM> is in the compact configuration of <FIG>. In addition to surrounding the distal end <NUM> of the catheter member <NUM>, the gripper member <NUM> may also surround a portion of the sleeve member <NUM>, as shown in <FIG>. It may be advantageous for the gripper member <NUM> to be distally movable with respect to the catheter member <NUM> (as will be described in greater detail) without being proximally movable with respect to the catheter member <NUM>. As for the outer surface of the gripper member <NUM>, it may be variously configured without departing from the scope of the present disclosure, although it may be advantageous for the outer surface of the gripper member to be contoured or otherwise configured for improved gripping and handling by a user (e.g., with raised ridges or ribs to prevent the digit of a user from slipping off of the gripper member <NUM> during use).

Regardless of its particular configuration, the gripper member <NUM> provides a location at which the urinary catheter assembly <NUM> may be gripped to move the urinary catheter assembly <NUM> from the compact configuration (<FIG>) to the extended or elongated configuration (<FIG>). In particular, rather than gripping a portion of the catheter member <NUM> when extending the urinary catheter assembly <NUM>, the user may grip the gripper member <NUM> and the drainage member <NUM>. The user may then move the gripper member <NUM> and drainage member <NUM> away from each other (pinching the gripper member <NUM> against the catheter member <NUM>, as necessary) to move the stylet <NUM> distally with respect to the catheter member <NUM>, as described above with respect to the embodiment of <FIG>. Thus, the gripper member <NUM> allows for a user to move the urinary catheter assembly <NUM> from its compact configuration to its extended or elongated configuration with a decreased risk of directly handling a portion of the urinary catheter assembly <NUM> that is advanced into the urethra U.

With the urinary catheter assembly <NUM> in its extended or elongated configuration, the gripper member <NUM> and/or drainage member <NUM> may be gripped while proximally advancing the catheter member <NUM> into the urethra U (<FIG>). The catheter member <NUM> may be fully advanced until the gripper member <NUM> is positioned adjacent to the urethral opening (<FIG>), at which time the gripper member <NUM> may be held in place while the drainage member <NUM> is moved proximally with respect to the gripper member <NUM>. Such relative movement causes the sleeve member <NUM> and stylet <NUM> to move through the hollow interior of the gripper member <NUM> and into the urethra U, effectively advancing the gripper member <NUM> distally along the sleeve member <NUM> to be spaced distally of the distal end <NUM> of the catheter member <NUM>. The drainage member <NUM> may be moved toward the gripper member <NUM> until the gripper member <NUM> contacts the drainage member <NUM> or until the proximal eyes <NUM> of the catheter member <NUM> are positioned within the bladder B. With the urinary catheter assembly <NUM> in the position of <FIG>, urine may be drained from the bladder B, in accordance with the foregoing description of the embodiment of <FIG>. The drainage member <NUM> and/or the gripper member <NUM> may then be grasped and moved distally to withdraw the remainder of the urinary catheter assembly <NUM> from the urethra U.

<FIG> illustrate another variation of the urinary catheter assembly <NUM> of <FIG>. In the embodiment of <FIG>, the urinary catheter assembly <NUM> includes a catheter member <NUM> and stylet <NUM>, which may be provided generally in accordance with the above description of the catheter member <NUM> and stylet <NUM> of <FIG>. In addition to providing a substantially tubular sleeve member <NUM> (which may be referred to as a distal sleeve member in this embodiment), an additional proximal sleeve member <NUM> having a closed proximal end is also provided. The catheter member <NUM> is fully positioned within the sleeve members <NUM> and <NUM>, with a proximal portion of the catheter member <NUM> positioned within the proximal sleeve member <NUM> and a distal portion of the sleeve member <NUM> positioned within the distal sleeve member <NUM> when the urinary catheter assembly <NUM> is in the compact configuration of <FIG>. The sleeve members <NUM> and <NUM> may be formed of the same or different materials and/or with different surface treatments (e.g., with the proximal sleeve member <NUM> having a lubricious outer surface and the distal sleeve member <NUM> being non-lubricious).

Preferably, the proximal end of the proximal sleeve member <NUM> fits snugly over the proximal end <NUM> of the catheter member <NUM>, with the proximal end of the proximal sleeve member <NUM> optionally being sealed or otherwise secured to the proximal end <NUM> of the catheter member <NUM> to prevent separation of the proximal ends of the proximal sleeve member <NUM> and the catheter member <NUM>. By positioning the catheter member <NUM> fully within the sleeve members <NUM> and <NUM>, the catheter member <NUM> does not come into contact with the urethra U or with the hand of the user during use of the urinary catheter assembly <NUM>, allowing for a wider variety of materials to be used for the catheter member <NUM> and for less regard to surface treatment than a catheter member that directly contacts the urethra U.

As described above with regard to the catheter member <NUM> of <FIG>, the catheter member <NUM> of <FIG> may be provided with one or more eyes or openings for allowing fluid into and out of the hollow interior of the catheter member <NUM>. If the proximal end of the proximal sleeve member <NUM> is configured to overlay the proximal end <NUM> of the catheter member <NUM>, it is advantageous for the proximal sleeve member <NUM> to be configured so as to not hinder the passage of urine from the bladder B into the hollow interior of the catheter member <NUM> via the proximal eyes <NUM>. This may be achieved in any of a number of ways, such as by providing a proximal sleeve member <NUM> that has a perforated portion with holes or openings aligned with the proximal eyes <NUM> to allow fluid flow through the proximal eyes <NUM>. Alternatively, the proximal sleeve member <NUM> may include a mesh portion or portions configured to overlay at least a portion of the proximal eyes <NUM>. In yet another embodiment, rather than providing a proximal sleeve member <NUM> that overlays the proximal end <NUM> of the catheter member <NUM>, a substantially tubular proximal sleeve member may be provided, with a proximal end of the sleeve member being secured or sealed to the catheter member <NUM> just distally of the proximal eyes <NUM>, thereby allowing unhindered flow of urine through the proximal eyes <NUM>.

The distal end <NUM> of the distal sleeve member <NUM> may be secured to a drainage member <NUM>. The drainage member <NUM> of <FIG> is illustrated as a generally annular structure with a through hole <NUM> for draining urine from the urinary catheter assembly <NUM>. In other embodiments, the drainage member <NUM> may be differently configured, such as being configured as a funnel, as in <FIG>. The distal end <NUM> of the stylet <NUM> may also be secured to the drainage member <NUM>, although it may be advantageous for the distal end <NUM> of the stylet <NUM> to be detachably secured to the drainage member <NUM> for reasons that will be described in greater detail herein.

The urinary catheter assembly <NUM> further includes an introducer tip <NUM>, which extends between a distal end <NUM> and a proximal end <NUM>, defining an interior chamber <NUM> therebetween. The proximal end <NUM> of the introducer tip <NUM> may be configured for insertion into a urethral opening prior to advancement of the catheter member <NUM> into the urethra U (as will be described). The proximal end <NUM> of the introducer tip <NUM> may include an aperture or opening <NUM> (<FIG>) that may be moved between a closed configuration (in which there is no object positioned within the opening <NUM>, as in <FIG>) and an open configuration (in which the catheter member <NUM> or proximal sleeve member <NUM> and stylet <NUM> are partially positioned within or extending through the opening <NUM>, with a portion of the object positioned within the introducer tip <NUM> and another portion positioned outside of the introducer tip <NUM>, as in <FIG>). In one embodiment, the proximal opening <NUM> is provided as a slit opening with one or more slits or cuts defining a plurality of deformable petals that may be moved to define the aforementioned open and closed configurations. In other embodiments, the opening <NUM> may be differently configured, provided that it is configured to allow passage of the catheter member <NUM>, proximal sleeve member <NUM>, and stylet <NUM> therethrough. The distal end <NUM> of the introducer tip <NUM> may be generally annular, with a central opening or passage through which the catheter member <NUM> and stylet <NUM> extend, with distal portions of the catheter member <NUM> and stylet <NUM> positioned outside of the interior chamber <NUM> in the compact configuration of <FIG>. The distal end of the proximal sleeve member <NUM> may be secured to the distal end <NUM> of the introducer tip <NUM> (e.g., to a proximally facing surface of the distal end <NUM> so as to encircle the central opening), while the proximal end of the distal sleeve member <NUM> may also be secured to the distal end <NUM> of the introducer tip <NUM> (e.g., to a distally facing surface of the distal end <NUM> so as to encircle the central opening). Alternatively, the outer surface of one of the sleeve members may be secured to the inner surface of the other sleeve member, with the outer sleeve member being secured to the distal end <NUM> of the introducer tip <NUM> (e.g., along the perimeter of the central opening).

Proximal portions of the catheter member <NUM> and stylet <NUM>, along with the entire proximal sleeve member <NUM> are positioned within the interior chamber <NUM> of the introducer tip <NUM> when the urinary catheter assembly <NUM> is in the compact configuration of <FIG>. In use, a user grasps the introducer tip <NUM> and either advances the proximal end <NUM> of the introducer tip <NUM> into the urethra U or positions the proximal end <NUM> of the introducer tip <NUM> directly adjacent to the urethral opening. The user then applies a proximally directed force to the drainage member <NUM>, which presses the proximal end <NUM> of the stylet <NUM> against the proximal end <NUM> of the catheter member <NUM>. This proximally directed force urges the catheter member <NUM> out of the proximal opening <NUM> of the introducer tip <NUM> and into the urethra U. The proximal end <NUM> of the stylet <NUM> (which transmits the proximally directed force to the catheter member <NUM>) and the proximal sleeve member <NUM> move along with the proximal end <NUM> of the catheter member <NUM> into the urethra U. Continued application of the proximally directed force to the drainage member <NUM> further advances the catheter member <NUM>, proximal sleeve member <NUM>, and stylet <NUM> into the urethra U.

Eventually, the distal end <NUM> of the stylet <NUM> and/or the proximal end of the drainage member <NUM> comes is brought into contact with the distal end <NUM> of the introducer tip <NUM>. Preferably, the distal end <NUM> of the stylet <NUM> and/or the proximal end of the drainage member <NUM> is larger than the distal opening of the introducer tip <NUM>, which prevents the distal end <NUM> of the stylet <NUM> and the drainage member <NUM> from advancing into the interior chamber <NUM> of the introducer tip <NUM>. Preferably, the catheter member <NUM> and stylet <NUM> are configured such that the proximal eyes <NUM> of the catheter member <NUM> move into the bladder B before the distal end <NUM> of the stylet <NUM> or the proximal end of the drainage member <NUM> comes into contact with the distal end <NUM> of the introducer tip <NUM> (<FIG>).

With the catheter member <NUM>, proximal sleeve member <NUM>, and stylet <NUM> so fully positioned within the urethra U (with the catheter member <NUM> received entirely within the proximal sleeve member <NUM>), the drainage member <NUM> may be detached from the distal end <NUM> of the stylet <NUM>. The manner in which the drainage member <NUM> is detached from the stylet <NUM> depends upon the connection between the drainage member <NUM> and the stylet <NUM> and may vary without departing from the scope of the present disclosure. By way of example, the drainage member <NUM> may be detached from the stylet <NUM> by distal movement of the drainage member <NUM> with respect to the stylet <NUM> or by rotation of the drainage member <NUM> with respect to the stylet <NUM>. Detaching the drainage member <NUM> from the stylet <NUM> allows the drainage member <NUM> (along with the distal end <NUM> of the distal sleeve member <NUM>) to be moved distally away from the introducer tip <NUM>, as shown in <FIG>. The drainage member <NUM> is moved to a convenient location (e.g., over a toilet or other disposal device) to direct urine out of the urinary catheter assembly <NUM>.

Alternatively, rather than detaching the drainage member <NUM> from the stylet <NUM> after fully advancing the catheter member <NUM> and stylet <NUM> into the urethra U, the drainage member <NUM> may be detached from the stylet <NUM> earlier in the procedure and moved into position for drainage of urine prior to the proximal eyes <NUM> of the catheter member <NUM> being advanced into the bladder B. When practicing such a method, the distal end <NUM> of the stylet <NUM> may be grasped through the thin, flexible distal sleeve member <NUM> to proximally advance the stylet <NUM> (and, hence, the catheter member <NUM> and proximal sleeve member <NUM>) through the urethra U, rather than advancing the urinary catheter assembly <NUM> through the urethra U by applying a proximally directed force to the drainage member <NUM>.

<FIG> illustrate another variation of the urinary catheter assembly <NUM> of <FIG>. The urinary catheter assembly <NUM> of <FIG> includes a catheter member <NUM>, sleeve member <NUM>, stylet <NUM>, and optional drainage member (not illustrated), which may be arranged and interconnected according to the above description of the urinary catheter assembly <NUM> of <FIG>. If the urinary catheter assembly <NUM> omits a drainage member (as shown), the distal end <NUM> of the sleeve member <NUM> may be secured to the distal end <NUM> of the stylet <NUM>, with the distal end <NUM> of the stylet <NUM> having one or more holes or openings through which urine may be drained from the urinary catheter assembly <NUM>. Otherwise, if the urinary catheter assembly <NUM> is provided with a drainage member (of the type illustrated in <FIG> or <FIG>, for example), the distal ends <NUM> and <NUM> of the sleeve member <NUM> and stylet <NUM> may be fixedly secured to the drainage member rather than to each other. In other embodiments, the urinary catheter assembly <NUM> of <FIG> may be provided with a gripper member and/or introducer tip of the type described above with respect to the embodiments of <FIG>.

A difference between the urinary catheter assembly <NUM> of <FIG> and the urinary catheter assembly <NUM> of <FIG> is that the urinary catheter assembly <NUM> of <FIG> is designed and configured for use in a female urethra F, rather than a male urethra U. Accordingly, any one or more of the catheter member <NUM>, the sleeve member <NUM>, and the stylet <NUM> may be shorter than the corresponding component of the urinary catheter assembly <NUM> of <FIG>, on account of the female urethra F being shorter than the male urethra U. However, it is also within the scope of the present disclosure for any of the components of the female urinary catheter assembly <NUM> to be the same length or longer than the corresponding component of the male urinary catheter assembly <NUM> of <FIG> or to otherwise be the same or differently sized (e.g., with a smaller or larger outer diameter) and/or shaped.

It will be seen that the stylet <NUM> of <FIG> is provided in a generally straight or linear initial configuration, while the stylet <NUM> of <FIG> is provided in a curved initial configuration. A generally straight or linear initial configuration is also possible for the stylet <NUM>, although a curved configuration may be especially advantageous for the stylet <NUM> of a female urinary catheter assembly <NUM> according to the present disclosure to match the contours of the female urethra F. As noted above, male catheters according to the present disclosure may also be provided with an initial curved configuration. In comparison to the stylet <NUM> of the male urinary catheter assemblies described herein, the stylet <NUM> of the female urinary catheter assembly <NUM> may have the same rigidity, a greater rigidity, or a lesser rigidity without departing from the scope of the present disclosure.

In the illustrated embodiment, the proximal end <NUM> of the stylet <NUM> is positioned proximally of the proximal eyes <NUM> of the catheter member <NUM>, such that applying a proximally directed force to the distal end <NUM> of the stylet <NUM> (either directly or through a drainage member associated with the stylet <NUM>) will impart a proximally directed force to the proximal end <NUM> of the catheter member <NUM>. Thus, by positioning the proximal end <NUM> of the catheter member <NUM> adjacent to the urethral opening and applying a proximally directed force to the stylet <NUM>, the catheter member <NUM> will be advanced into and through the urethra F to the position of <FIG>. From the position of <FIG>, the stylet <NUM> may be moved distally with respect to the catheter member <NUM> (which remains in place within the urethra F) to move the urinary catheter assembly <NUM> from a compact configuration (<FIG>) to an extended or elongated configuration (<FIG>), in which a greater portion of the stylet <NUM> is positioned outside of the catheter member <NUM> and within the sleeve member <NUM>. The distal ends <NUM> and <NUM> of the sleeve member <NUM> and stylet <NUM>, now positioned farther from the distal end <NUM> of the catheter member <NUM>, may be repositioned by rotating the stylet <NUM> with respect to the catheter member <NUM>. This may be advantageous depending on the environment in which the urinary catheter assembly <NUM> is being used. For example, if urine is to be drained into a toilet, then it may be preferred to orient the distal ends <NUM> and <NUM> of the sleeve member <NUM> and stylet <NUM> backwards, whereas it may be preferred to orient the distal ends <NUM> and <NUM> of the sleeve member <NUM> and stylet <NUM> forwards for drainage into a receptacle if the urinary catheter assembly <NUM> is being used while in a chair.

It should be understood that the illustrated configuration of the female urinary catheter assembly <NUM> is merely exemplary and that variations may be made to the illustrated design without departing from the scope of the present disclosure. For example, rather than having the proximal end <NUM> of the stylet <NUM> positioned proximally of the proximal eyes <NUM> of the catheter member <NUM> in the compact (insertion) configuration (as shown in <FIG>), the stylet <NUM> and the catheter member <NUM> may be configured so as to position the proximal end <NUM> of the stylet <NUM> distally of the proximal eyes <NUM>. Preferably, if the proximal end <NUM> of the stylet <NUM> is positioned distally of the proximal eyes <NUM>, it is only positioned a short distance distally of the proximal eyes <NUM> (e.g., much closer to the proximal eyes <NUM> than to the distal eyes <NUM>) to avoid increasing the length of the urinary catheter assembly <NUM> in the compact configuration. In another embodiment, a proximal portion of the sleeve member <NUM> may be configured to be advanced into the urethra F during use.

By initially positioning the proximal end <NUM> of the stylet <NUM> distally of the proximal eyes <NUM>, the proximal end <NUM> may act as a plug (by being sized and configured to press against the inner wall of the catheter member <NUM>), which prevents the flow of urine through the catheter member <NUM> when the proximal eyes <NUM> are positioned within the bladder B. With the proximal eyes <NUM> positioned within the bladder B, the stylet <NUM> may be moved distally with respect to the catheter member <NUM> until the proximal end <NUM> of the stylet <NUM> is positioned distally of the distal eyes <NUM> of the catheter member <NUM> (as in <FIG>). Moving the proximal end <NUM> of the stylet <NUM> distally beyond the distal eyes <NUM> effectively "unplugs" or opens fluid flow through the catheter member <NUM>, from the proximal eyes <NUM> to the distal eyes <NUM>, into the sleeve member <NUM>, and then out of the urinary catheter assembly <NUM> via an opening in the distal end <NUM> of the stylet <NUM> (or via a drainage member associated with the distal end <NUM> of the stylet <NUM>, if provided). As the proximal end <NUM> of the stylet <NUM> does not contact the proximal end <NUM> of the catheter member <NUM> in the compact configuration, a proximally directed force applied to the distal end <NUM> of the stylet <NUM> (or to an associated drainage member, if provided) may press against the distal end <NUM> of the catheter member <NUM> (or press the folded or bunched sleeve member <NUM> against the distal end <NUM> of the catheter member <NUM>) to advance the catheter member <NUM> into and through the urethra F during insertion.

Any of a number of variations may be made to the configurations of the catheter assemblies described herein. For example, while all of the catheter members illustrated herein include a plurality of drainage eyes defined in the tubular wall of the distal portion of catheter member, it is within the scope of the present disclosure for a drainage eye to be located at the distal end of the catheter member. For example, a catheter member according to the present disclosure may be provided with a distal portion having an "open-ended" design. <FIG> illustrates one embodiment of a urinary catheter assembly <NUM> having an "open-ended" catheter member <NUM>. The illustrated "open-ended" catheter member <NUM> has a distal portion <NUM> that is substantially tubular (rather than having a generally hemispherical end), with a drainage eye or opening <NUM> at the distal end <NUM> of the catheter member <NUM>. It should be understood that the configuration of <FIG> is merely exemplary and that the distal portion of an "open-ended" catheter member may be differently configured (e.g., with a generally hemispherical distal end including a drainage opening) without departing from the scope of the present disclosure.

Similar to the previously described embodiments, the catheter member <NUM> (e.g., the distal portion <NUM> or distal end <NUM> of the catheter member <NUM>) may be sealed to the proximal end or portion <NUM> of a sleeve member <NUM>, with a distal end or portion <NUM> of the sleeve member <NUM> being sealed to a drainage member <NUM> (if provided).

If the catheter member has an "open-ended" design, it may be advantageous to also modify the configuration of the associated stylet, although it is also within the scope of the present disclosure for a stylet of the type described above to be used in combination with an "open-ended" catheter member (or for a stylet of the type illustrated in <FIG> to be used in combination with any of the catheter members described herein). In the illustrated embodiment, the stylet <NUM> is "open-ended," with proximal and distal ends <NUM> and <NUM> each configured as a conical cage that defines one or more openings or passages that allow for urine to flow through (rather than around) the end of the stylet <NUM>. Each illustrated end <NUM>, <NUM> comprises a rim <NUM> with a plurality of extensions or arms <NUM> connecting the rim <NUM> to an intermediate or central portion <NUM> of the stylet <NUM>. The rim <NUM> has a relatively large diameter (compared to the intermediate portion <NUM> of the stylet <NUM>), but (at least the rim <NUM> of the proximal end <NUM>) is preferably sized to fit within the hollow interior of the catheter member <NUM> for sliding movement within the catheter member <NUM>. The proximal and distal ends <NUM> and <NUM> may be differently configured, for example with one being "open" (allowing urine flow through the end) and the other being "closed" (allowing urine flow around the end), or with differently configured "open" designs, such as a distal end <NUM> that is configured to remain outside of the catheter member <NUM> and may, therefore, have a rim <NUM> with a larger diameter than the rim <NUM> of the proximal end <NUM>. The distal end <NUM> is preferably fixedly secured to the drainage member <NUM>, but it may alternatively be removably secured to the drainage member <NUM>. It is also within the scope of the present disclosure for the exact configuration of the open end of a stylet to vary from the conical cage design of <FIG>, provided that the open end is configured to allow for urine flow through the end of the stylet.

Other than urine flowing through the ends <NUM> and <NUM> of the stylet <NUM> (rather than around the ends) and into the sleeve member <NUM> from a drainage opening <NUM> at the distal end <NUM> of the catheter member <NUM> (rather than through distal drainage openings in the tubular wall), a urinary catheter assembly <NUM> of the type shown in <FIG> may be used in accordance with the above-described methods to catheterize a male or female. In one exemplary method of use, the urinary catheter assembly <NUM> (which may be provided in a sealed package or container) is moved from the compact configuration of <FIG> to an extended or elongated configuration (in which the stylet <NUM> is in its most distal location, with the proximal end <NUM> of the stylet <NUM> abutting or adjacent to the distal end <NUM> of the catheter member <NUM>).

With the urinary catheter assembly <NUM> in the extended configuration, the proximal end <NUM> of the catheter member <NUM> may be advanced into a urethra and then advanced further through the urethra. The catheter member <NUM> is advanced through the urethra until its proximal drainage openings <NUM> are positioned within the bladder, typically with at least a portion of the stylet <NUM> and sleeve member <NUM> positioned within the urethra and the drainage member <NUM> positioned outside of the urethra.

With the urinary catheter assembly so positioned, urine from the bladder enters the hollow interior of the catheter member <NUM> via the proximal eyes <NUM> and flows through the catheter member <NUM> (passing through the open proximal end <NUM> of the stylet <NUM>) to the distal drainage opening <NUM>. The urine flows out of the catheter member <NUM> via the distal drainage opening <NUM> and into the sleeve member <NUM>. The urine travels the length of the sleeve member <NUM>, ultimately passing through the open distal end <NUM> of the stylet <NUM> to exit the urinary catheter assembly <NUM> via the drainage member <NUM>. The urine may be emptied into a disposable bag or container associated with the urinary catheter assembly <NUM> or be directly drained into a waste container (e.g., a toilet). After use, the urinary catheter assembly <NUM> may be moved distally out of the urethra for disposal. The urinary catheter assembly <NUM> may be disposed of in its extended or elongated configuration or be returned to its initial compact configuration (of <FIG>) to take up less space in a waste container. It should be understood that this method of use is merely exemplary and that other methods of use (including ones in which the urinary catheter assembly <NUM> is at least partially advanced into the urethra in its compact configuration) may be practiced without departing from the scope of the present disclosure.

<FIG> illustrates a variation of the open-ended stylet <NUM> of <FIG>. In the embodiment of <FIG>, an intermediate portion <NUM> of the stylet <NUM> between the proximal and distal ends <NUM> and <NUM> includes a support formation <NUM>. The support formation <NUM> has a larger diameter than the remainder of the intermediate portion <NUM> of the stylet <NUM> (but preferably smaller than the diameter of the proximal end <NUM> of the stylet <NUM>) and may be variously configured for improved gripping and handling of the stylet <NUM> through an associated sleeve member, while also preventing collapse of the sleeve member (which could hinder urine flow). It should be understood that a stylet incorporating a support formation is not limited to open-ended stylets, but that any stylet according to the present disclosure may be provided with a support formation.

<FIG> illustrate exemplary cross-sectional shapes of the support formation 158a-158c, having two petals or extensions <NUM> (<FIG>), three petals or extensions <NUM> (<FIG>), or four petals or extensions <NUM> (<FIG>), but it should be understood that the support formation <NUM> may have a single extension or more than four extensions. The illustrated petals or extensions <NUM> of each embodiment are substantially identical and may be symmetrically spaced apart from the adjacent extension(s) <NUM>, but it is within the scope of the present disclosure for them to be differently configured and/or to be non-uniformly spaced from each other. Additionally, more than one support formation <NUM> may be spaced along the length of the intermediate portion <NUM> of the stylet <NUM>, with the support formations being substantially identical or differently configured. Furthermore, the length of an individual support formation <NUM> may vary from what is illustrated in <FIG> (e.g., occupying a larger or smaller percentage of the length of the intermediate portion <NUM> of the stylet <NUM>) and/or an individual support formation <NUM> may be positioned at a different location relative to the ends <NUM> and <NUM> (e.g., positioned closer to one end than the other, rather than being substantially centered) without departing from the scope of the present disclosure.

<FIG> illustrate a package <NUM> that may be used in combination with any of the urinary catheter assemblies described herein, but may have particular utility when used in combination with a urinary catheter assembly omitting a gripper member. The illustrated package <NUM> has proximal and distal portions <NUM> and <NUM> that are joined at a frangible section <NUM>, such as a tear strip. A urinary catheter assembly <NUM> is positioned within the package <NUM>, with a proximal portion (which may include the catheter member <NUM>) received within the proximal portion <NUM> of the package <NUM> and a distal portion (which may include the drainage member <NUM>) received within the distal portion <NUM> of the package <NUM> (<FIG>) when the package <NUM> is intact and sealed.

In use, the frangible section <NUM> of the package <NUM> is broken (e.g., by moving the two portions <NUM> and <NUM> of the package <NUM> apart or pulling a tear strip). Gripping the urinary catheter assembly <NUM> through the package <NUM> (by pinching the proximal portion <NUM> of the package <NUM> against the catheter member <NUM> and pinching the distal portion <NUM> of the package <NUM> against the drainage member <NUM>), the separated portions <NUM> and <NUM> of the package <NUM> may be moved apart to move the urinary catheter assembly <NUM> from the compact configuration of <FIG> to the extended or elongated configuration of <FIG> (or to an at least partially extended configuration). By such an arrangement, the urinary catheter assembly <NUM> may be initially provided in its compact configuration (to reduce the amount of packaging required) and moved to its extended configuration for use without directly handling the catheter member <NUM>, which may be especially advantageous if the urinary catheter assembly <NUM> is provided without a gripper member.

Alternatively, rather than requiring a user to grip the urinary catheter assembly <NUM> through the package <NUM>, a retention member or mechanism may be incorporated into one or both portions <NUM> and <NUM> of the package <NUM>. The retention member or mechanism (e.g., a weak adhesive bond) releasably connects the urinary catheter assembly <NUM> to the package <NUM>, such that separated portions <NUM> and <NUM> of the package <NUM> may be gripped and moved apart (without gripping the urinary catheter assembly <NUM> through the package <NUM>) to move the urinary catheter assembly <NUM> to its extended configuration. Once the urinary catheter assembly <NUM> reaches its extended configuration, additional movement of the portions <NUM> and <NUM> of the package <NUM> away from each other will cause the retention member or mechanism to fail or detach or release, thereby disconnecting the urinary catheter assembly <NUM> from the package <NUM> for use. While it may be advantageous for the package <NUM> to be involved in moving the urinary catheter assembly <NUM> to its extended configuration, it is also within the scope of the present disclosure for the urinary catheter assembly <NUM> to be removed from the package <NUM> while still in its compact configuration.

<FIG> illustrate a variation of a urinary catheter assembly <NUM> incorporating a stylet <NUM>. Similar to the embodiment of <FIG>, the urinary catheter assembly <NUM> of <FIG> includes a catheter member <NUM> that is connected to a drainage member <NUM> by a generally tubular sleeve member <NUM>, with an open-ended stylet <NUM> positioned within the sleeve member <NUM>. However, in contrast to the foregoing embodiments, the proximal end <NUM> of the stylet <NUM> is not configured to move within the hollow interior of the catheter member <NUM>, but is instead fixedly secured at or adjacent to the distal end <NUM> of the catheter member <NUM>. The distal end <NUM> of the stylet <NUM> is fixedly secured to the drainage member <NUM>, meaning that the urinary catheter assembly <NUM> of <FIG> is not telescopic, but instead has a fixed length.

While the urinary catheter assembly <NUM> has a fixed length, it is still capable of being moved between a compact configuration and an extended or elongated configuration. <FIG> shows the urinary catheter assembly <NUM> in a compact configuration (within a package <NUM>), with the urinary catheter assembly <NUM> being folded or bent onto itself (placing the proximal end <NUM> of the catheter member <NUM> adjacent to the drainage member <NUM>) for improved portability prior to use. This is possible by providing a deformable stylet <NUM>, which may be flexed or folded or otherwise deformed from a generally straight or linear configuration (<FIG>) to a less straight or linear configuration (<FIG>). While the stylet <NUM> of <FIG> has a generally linear configuration, it is also within the scope of the present disclosure for the stylet <NUM> to have a generally curved configuration (as in the embodiment of <FIG>), in which case the stylet may be moved from the generally curved configuration to a more curved, compact configuration. Preferably, the stylet <NUM> is formed of a resiliently or elastically deformable material (as opposed to a plastically deformable material) to allow the stylet <NUM> to move between its compact and elongated configurations without kinking or becoming permanently deformed or otherwise deviating from its intended elongated configuration.

Although the urinary catheter assembly <NUM> of <FIG> is not telescopic, it retains the same advantages as a telescopic urinary catheter assembly during use. In particular, the urinary catheter assembly <NUM> provides a variable-stiffness assembly in the elongated configuration, with a relatively soft or pliable proximal section (i.e., the catheter member <NUM>) for improved movement through a urethra and a more rigid or stiffer distal section (i.e., the stylet <NUM> within the sleeve member <NUM>) for improved pushability.

Aspects of the present subject matter described above may be beneficial alone or in combination with one or more other aspects.

Claim 1:
A urinary catheter assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), comprising:
a catheter member (<NUM>, <NUM>, <NUM>, <NUM>) extending between a proximal end (<NUM>, <NUM>, <NUM>) and a distal end (<NUM>, <NUM>, <NUM>);
a sleeve member (<NUM>, <NUM>, <NUM>, <NUM>) receiving at least a portion of the catheter member (<NUM>, <NUM>, <NUM>, <NUM>), the sleeve member being configured to be at least partially advanced into a urethra and having a greater flexibility than the catheter member (<NUM>, <NUM>, <NUM>, <NUM>); and
a stylet (<NUM>, <NUM>, <NUM>, <NUM>) including a proximal end (<NUM>, <NUM>, <NUM>, <NUM>) movably positioned within the catheter member (<NUM>, <NUM>, <NUM>, <NUM>) and a distal portion positioned outside of the catheter member (<NUM>, <NUM>, <NUM>, <NUM>), wherein the urinary catheter assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is movable between a compact configuration in which the proximal end (<NUM>, <NUM>, <NUM>, <NUM>) of the stylet (<NUM>, <NUM>, <NUM>, <NUM>) is positioned adjacent to the proximal end (<NUM>, <NUM>, <NUM>) of the catheter member (<NUM>, <NUM>, <NUM>, <NUM>) and an extended configuration in which the proximal end (<NUM>, <NUM>, <NUM>, <NUM>) of the stylet (<NUM>, <NUM>, <NUM>, <NUM>) is positioned adjacent to the distal end (<NUM>, <NUM>, <NUM>) of the catheter member (<NUM>, <NUM>, <NUM>, <NUM>) and the urinary catheter assembly (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) has a greater length than in the compact configuration, and in which the proximal end (<NUM>, <NUM>, <NUM>, <NUM>) of the stylet (<NUM>, <NUM>, <NUM>, <NUM>) is at least temporarily locked in place within the catheter member (<NUM>, <NUM>, <NUM>, <NUM>).