Patent Description:
This disclosure relates generally to packaging for medical devices such as urinary catheters. More particularly, this disclosure relates to compact catheters, such as urinary catheters, and the packaging, storing and hydrating/lubricating of such catheters.

Intermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. A common situation is where single use, individually packaged, sterile catheters are used. Catheters often include a surface treatment that reduces friction to allow for easier and less traumatic insertion into and through the user's urethra.

One such surface treatment includes providing a hydrophilic coating on the exterior surface of the catheter. In a hydrophilic coated catheter, the catheter is provided with a thin coating disposed on the outer surface of the catheter. When this coating is activated by contact with a hydrating medium, such as liquid water or water vapor, it becomes lubricious and provides an extremely low coefficient of friction surface.

The hydrating medium may be added to the catheter package after opening. Another embodiment provides liquid water in a separate compartment that is opened to allow the water to enter the catheter containing compartment for direct contact with the hydrophilic coating. Or the hydrating medium could be a wick, sachet or liquid sequestering element wetted with a liquid, such as water. Water vapor from the wick hydrates the catheter. Catheter packages employing a wick are described in greater detail in <CIT> and <CIT> and in <CIT> and <CIT>.

Another type of surface treatment is a gel-coated catheter in which a gel- lubricant is applied to the surface of the catheter. The gel-lubricant may be applied to the catheter surface just before or during the packaging operation or as the catheter is being inserted by the user.

Regardless of whether a surface treatment is used or what type of surface treatment is used, some type of package for the catheter is required. In the past various kinds of packages have been used, including molded containers of assorted sizes and shapes, bags and pouches made of plastic or metal foil, and similar kinds of devices. An example of a tubular type of package is shown in <CIT>. <CIT> describes a catheter and package assembly, comprising a catheter having an elongated tubing and a funnel attached to one end of the tubing, an elongated case having a rim defining an open end, the rim being sized to permit entry of at least the catheter tubing; a hydrating medium in the case where it is effective to lubricate the catheter tubing; and a cap connected to the case by a hinge and movable between closed and open positions. While these prior art packages generally accomplish the objective of protecting the catheter during transport, storage and preparation for use, they suffer from disadvantages that range from fundamental - the packages break open prematurely; to economic - the package designs are wasteful of material and labor; to the annoying - the packages confuse users as to how to open them, or the packages tend to spill the hydrating medium upon opening. What is needed is a catheter package that is economical to manufacture and fill, reliable throughout its useful life, and simple and intuitive to use. It is also desirable to have a compact package whose transport and use can be discreet.

According to the present invention there is provided a catheter and package assembly comprising the features of claim <NUM>.

In one aspect, the catheter package of the present disclosure includes an elongated case having a closed end and a rim at the opposite end. The rim defines an open end of the case. The package further includes a cap which is tethered to the case by a flexible strap. The case is sized to receive and enclose the tubing portion of a catheter. The funnel of the catheter is releasably engageable with the package case at or near the rim, with all or most of the funnel remaining on the exterior of the case. The engagement of the funnel with the case near the rim seals any hydrating medium in the case. The cap is releasably engageable with the funnel. The strap length is such that when the cap is engaged with the funnel the strap and cap will retain the funnel in contact with the case at the open end. Preferably the cap snaps into and closes the open end of the funnel to prevent entry of contaminants into the funnel and to prevent any hydrating medium from exiting the package through the tubing and funnel. A user can flip the cap off the funnel and flex the strap slightly away from the axis of the case to permit removal of the catheter from the case. After use the catheter can be replaced in the case and the cap can be reclosed if a user so chooses. The strap may be integrally molded.

In another aspect, the present disclosure concerns a package of the type described having a grommet in the interior of the case. The grommet is filled with a lubricating gel. Upon removal of the catheter from the package the catheter tubing is drawn through the lubricating gel in the grommet, thereby coating the catheter tubing with gel and making it ready for use.

In still another aspect, the present disclosure is directed to a catheter specially adapted for use with the package of the type described. Since the package does not have a hygienic sleeve for the catheter, the user is dependent on the funnel for catheterization as they cannot touch the catheter tube (due to possible contamination issues). To improve the user's grip on the funnel during general use of the catheter it is beneficial to provide ridges on the funnel. Alternately, the funnel's overall shape could also improve grip. From a touch perspective a tactile zone on the funnel ends allows the user to feel when they are near an end of the funnel. This decreases the probability of the user's fingers accidentally slipping from the funnel and contacting the catheter tubing or urine.

The package of the present disclosure can also be adapted for use with a male catheter. Male catheters are difficult to fit inside a compact package. The male catheter of the present disclosure addresses this by being folded inside the case of the package. The outer grip portion of the catheter may be made slideable along the catheter to be used as a gripper and enhance hygienic benefits.

In packages having a hydrating sachet it may be advantageous to add an adaptor to the top of the package case. The adaptor is press fit into the opening at the top of the case. The adaptor has an external cross section that matches the internal cross section of the package case. It also has an internal passageway whose cross section matches that of a seal section on either the bottom of the funnel or the end of the catheter.

An alternate form of hydration can be the straightforward addition of liquid water to the package case prior to installation of the catheter. Following introduction of about <NUM>. <NUM> of water to the case, a molded liner is inserted into the case. The liner has a flange on one end that is press fit into the opening at the top of the case to form a seal between the liner and the case. Then the catheter is inserted into the liner. The bottom of the funnel has a portion which may fit inside the liner in a press fit seal. Then the strap of the case is folded up and the cap on the end of the strap is folded down onto the top end of the funnel. Finally, a tamper-evident label may be placed on the closed cap to complete the package. A further alternate form uses the liner as just described but replaces the strap-retained cap with a fully removable hollow cap that encloses the catheter funnel and is removably connectable to the case. A further alternate form of hydration could be the addition of liquid water in the package case but without the liner just described. In this embodiment the liquid water would be in the package case alongside the catheter.

In another aspect a flexible label could be substituted for the molded strap. The label may be adhesively secured to the case and extend to a point of attachment with the cap. Attachment of the label to the cap may be either adhesive or mechanical or both.

The present disclosure is directed to a catheter package for an intermittent catheter. The catheter itself is shown at <NUM> in <FIG>. It has an elongated, hollow tubing <NUM> attached at one end to a hollow funnel <NUM>. The funnel is sometimes alternately referred to as a connector or a grip. The tubing and funnel each define a central lumen therein. The tubing lumen 12A and the funnel lumen 14A can be seen in <FIG>. The lumens of the tubing and funnel fluidly communicate with one another as is conventional. The catheter <NUM> can be an injection molded component with the grip/funnel <NUM> being integral with the tubing <NUM>. Other manufacturing methods for the catheter are possible.

The funnel <NUM> has an upper body portion <NUM> and a lower seal portion shown generally at <NUM>. The upper or free end <NUM> (<FIG>) of the body portion <NUM> defines a funnel opening <NUM>. While the body portion <NUM> is shown having a gently curved outer surface that is somewhat hyperbolic in nature, it will be understood that other exterior shapes for the funnel are possible, such as a frusto-conical shape, perhaps with a suitable lip on the free end. Whatever the exterior shape, the funnel <NUM> generally has an outer diameter greater than that of the catheter's tubing <NUM>. This size, plus the fact that the funnel is not lubricated, makes the funnel <NUM> a convenient location for grasping the catheter <NUM> to manipulate it. The funnel may be suitable for connection to a drainage bag, other tubing or any other appropriate apparatus as is conventional. For example, the opening <NUM> defined in the free end <NUM> of the funnel may be large enough to receive a urine bag connector.

Further details of the seal <NUM> at the lower end of the funnel include a beveled lower portion <NUM> joining a cylindrical transition section <NUM> which is adjacent to a bead <NUM>. The bead <NUM> may have a somewhat larger outside diameter than the transition section <NUM> for reasons that will become evident below. The beveled lower portion <NUM> assists in guiding the seal portion <NUM> into the package as explained below. Other embodiments for the seal portion are possible as each of the components described above may not be necessary in all instances.

At least one radial eyelet <NUM> is formed in the tubing <NUM> at the end of the tubing farthest from the funnel <NUM>. The eyelet provides fluid access to the central lumen 12A of the tubing <NUM>. Adjacent the eyelet <NUM> is a rounded tip <NUM> that provides a smooth surface to facilitate insertion of the tubing into a urethra. In some embodiments it may be desirable to include more than one eyelet.

Turning now to the catheter package, it is shown generally at <NUM> in <FIG>. The package may include an elongated, hollow case <NUM> which has an axis A defined by a generally tubular wall <NUM>. The wall may have cylindrical inside and outside diameters. Or the inside dimension of the wall <NUM> may be cylindrical while the outside dimension may be non-cylindrical, e.g., a shape with flat sides joined by arcuate corners. Alternately, the entire case <NUM> could have a non-circular cross- section. The tubular wall <NUM> joins a bottom or end wall <NUM> that closes the bottom of the case <NUM>. At the other end of the case there may be an annular band <NUM> that merges with an externally tapered section <NUM> of the wall <NUM>. Tapered section <NUM> terminates at a rim <NUM>. The rim <NUM> defines an opening <NUM> at the top of the tubular wall <NUM>. From the rim <NUM> and extending axially for at least the distance opposite the tapered section <NUM>, and preferably somewhat axially beyond the tapered section, the internal surface of the tubular wall <NUM> defines an internal seal face <NUM>. Thus, in one embodiment, when the catheter <NUM> is installed in the package <NUM>, the internal seal face <NUM> may engage the bead <NUM> and transition section <NUM> of the funnel seal <NUM> in an interference fit which provides a seal between the funnel and package.

In one embodiment, the package further may include a strap <NUM>. The strap <NUM> is an elongated, flexible member which is fixedly attached to the tubular wall <NUM>, preferably at the annular band <NUM> and tapered section <NUM> of the tubular wall <NUM> as best seen in <FIG>. The other end of the strap <NUM> mounts a cap <NUM>. The cap is joined to the strap by, for example, a living hinge <NUM>. It will be understood that while a living hinge is a convenient method of connecting the cap and strap, other types of hinges are possible. The underside of the cap <NUM> carries a boss <NUM>. The boss may have a rounded edge <NUM>. In the present embodiment the strap <NUM> extends axially beyond the rim <NUM> such that the cap <NUM>, strap <NUM> and rim <NUM> define a pocket <NUM> or space for receiving the funnel <NUM>. The pocket <NUM> is sized to accommodate the funnel <NUM> between the cap <NUM> and the rim <NUM>. Thus, the cap <NUM> does not engage the case <NUM>, rather it is releasably engageable with the body portion <NUM> of the funnel <NUM>.

The boss <NUM> is spaced laterally from the strap <NUM> so that there is a space <NUM> for the free end <NUM> of the funnel to fit between the boss <NUM> and the strap <NUM>, as best seen in <FIG>. When the cap is closed on the funnel, the rounded edge <NUM> of the boss <NUM> leads into the opening <NUM> in the free end of the funnel <NUM>, producing contact between the boss and the internal wall of the funnel. This creates an interference fit and a seal between the boss and the internal surface of the funnel.

Cooperation between the catheter <NUM> and package <NUM> is illustrated in <FIG>. To install the catheter in the package the strap <NUM> may optionally be moved away from the case opening <NUM> by flexing the strap <NUM> generally in a radial direction. The catheter tubing <NUM> enters the case <NUM> through the opening <NUM>. The inside diameter of the tubular wall <NUM> is greater than the outside diameter of the tubing <NUM> so the tubing fits in readily. However, the inside diameter of the opening <NUM> is slightly less than the outside diameter of the funnel body portion <NUM>. Thus, while the seal <NUM> of the funnel <NUM> will enter the case <NUM> in an interference fit, the remainder of the funnel will not enter the case. Accordingly the body portion <NUM> of the funnel remains external to the case <NUM> and in the space which defines the pocket <NUM>.

Once the catheter tubing <NUM> is inside the case <NUM> and the funnel seal portion <NUM> is snug against the seal face <NUM>, the strap <NUM> may, if need be, be flexed somewhat to return the strap to a position where it is adjacent the funnel body <NUM> and generally parallel to the case axis A. Then the cap <NUM> is rotated essentially <NUM>° about the hinge <NUM> as shown by the phantom line positions of the cap in <FIG>. This will allow the boss <NUM> to fit in the funnel opening <NUM> as seen in <FIG>. The cap <NUM> and strap <NUM>, together with the interference fit between the seal <NUM> and case <NUM>, retain the catheter <NUM> in the package <NUM>. The strap has sufficient tensile strength to prevent elongation that might otherwise permit the catheter to come out of the case.

<FIG> illustrate a possible embodiment of a hydrating medium. This could take the form of a wick <NUM> or a sachet. The wick is placed in the case <NUM> either prior to or simultaneous with the installation of the catheter. The wick in this embodiment is basically a rectangle initially. It will become curved once it is placed in the cylindrical case <NUM>. Water vapor emanating from the wick <NUM> will lubricate the coating on the tubing. The seal <NUM> on the inner end of the funnel <NUM> will close the case opening <NUM> and the cap <NUM> will close the funnel opening <NUM> to prevent dissipation of the moisture from the interior of the case <NUM>.

<FIG> further illustrate the two seals just described. Here it can be seen that with the catheter <NUM> installed in the package <NUM>, there is an interference fit between the internal seal face <NUM> of the case <NUM> and the bead <NUM> and transition section <NUM> of the funnel seal <NUM>. That is, at least the bead <NUM>, and preferably the bead <NUM> and transition section <NUM>, are compressed as they enter the top of the case <NUM>. The resulting interference fit provides a seal between the funnel <NUM> and package <NUM>. This seals the space inside the case <NUM>. The funnel lumen 14A is sealed by the cap <NUM> and its boss <NUM>. The boss fits down inside the opening <NUM> of the funnel in an interference fit while the underside of the cap engages the outer edges of the funnel to complete the seal of the funnel lumen 14A.

When the time comes for the catheter to be put to use, a user can simply flip open the cap <NUM>, removing the boss <NUM> and cap <NUM> from engagement with the funnel <NUM>. The strap <NUM> can be pressed aside slightly to permit the user to grasp the funnel and pull the catheter out of the package. If a surface coating was applied to the catheter tubing and a hydrating medium was placed in the package, then the catheter is immediately ready to use. If not, a hydrating medium could be added to the package to lubricate the catheter. Or a gel-coating could be applied to the tubing <NUM>.

It will be noted that the flip open cap <NUM> is intuitive and familiar to open as it has a similar feature to standard package openings, e.g. a plastic ketchup bottle lid. The product signifies the correct orientation for opening such that there will not be spillage upon opening the product. There can be a tamper-evident label joining the cap to the funnel. The package <NUM> can be molded as one piece and the catheter can also be a molded component thereby minimizing the cost. The product size can be minimized by keeping to a minimum diameter required for connection to a drainage bag. Another advantage is the package is recloseable and allows for carrying the product after use for later disposal without any leakage or odors.

<FIG> and <FIG> illustrate an alternate embodiment of the package generally at <NUM>. This embodiment has a case <NUM> which is similar to the case <NUM>. The case <NUM> terminates at a rim <NUM> which defines an opening <NUM>. As in the previous embodiment the case <NUM> is sized to receive a catheter tubing and the seal portion of a funnel body. The body portion of the funnel will remain on the exterior of the case. The package <NUM> has a strap <NUM> which is attached at one end to the case <NUM> at a hinge <NUM>. A cap <NUM> is attached to the other end of the strap <NUM> by a second hinge <NUM>. Hinges <NUM> and <NUM> are preferably living hinges although it could be otherwise. The cap <NUM> is similar to cap <NUM> and thus it includes a boss <NUM>. The cap <NUM> may further include a tab <NUM> extending from an edge of the cap to assist a user in removing the cap from a catheter funnel.

As can be seen in <FIG> and <FIG> the strap <NUM> initially extends radially of the case <NUM>, rather than axially as in the previous embodiment. In a common orientation of the package as shown in the drawings, this will place the strap in a horizontal plane. Accordingly, once a catheter has been installed in the case, the strap will be folded up approximately <NUM>° about the hinge <NUM>, thereby placing the strap adjacent the funnel. At this point the cap <NUM> will be folded down approximately <NUM>° about the hinge <NUM>, placing the cap over the free end of the funnel body, with the boss <NUM> inside the opening <NUM> of the funnel.

It is pointed out that while the cap is shown as a part that snaps into the free end of the funnel, it could be otherwise. <FIG> illustrates such an alternate embodiment generally at <NUM> wherein a variation of the cap is shown. Package <NUM> has a cap in the form of a fork having a pair of spaced apart fingers <NUM>. The fingers are sized and spaced so as to be engageable with the side wall of the funnel at its point of smallest diameter. The pair of fingers <NUM> engage the funnel between them. In this case an additional cover for the funnel opening may be needed.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein. For example, while the funnel is shown engaging the internal surface of the case, the arrangement could be reversed. That is, the funnel could have an external flange or the like that engages the external surface of the case, leaving the internal surface of the case spaced from an interior portion of the funnel.

Also, while it is considered advantageous to manufacture the case, strap and cap as one integral part, alternatively these components could be formed initially as one or more separate parts which are subsequently fastened together. Thus, the strap could be manufactured as a part separate from the case and then subsequently fastened to the case using a suitable connection method. Similarly, the cap could initially be formed separate from the strap and then connected to the strap. In a similar vein, the case could be made of separate parts, such as a separate bottom wall that is fixed to the tubular wall.

While the strap has been shown having initial (that is, prior to closure on a funnel) orientations that are either axial or radial to the case axis, it will be understood that other initial orientations are possible so long as the strap can be moved to a point where the cap can releasably engage the exposed portion of the catheter. Also, the initial angle of the cap relative to the strap could also be other than as shown. Thus, the cap could have an initial position similar to one of the phantom showings of <FIG>. Also, the strap and cap need not necessarily fold abruptly about the hinge lines shown. The strap could form a loop that gradually transitions from the case to a point where the cap attaches to the funnel.

Further alternate structures could include a cap having a gripping member that is adhesively attached to the outer wall of the funnel. That is, the end of the strap could carry an adhesive gripping member arranged to releasably engage the side and/or the top of the funnel. In another arrangement both the strap and cap could comprise an integral adhesive gripping member. In this case the strap and cap would be a piece of flexible tape adhered at one portion of the tape to the exterior surface of the case's tubular wall and at another portion of the tape to the funnel. The tape would have a length enabling it to extend from the tubular wall to the funnel. It would be advantageous to have the tape extend over the free end of the funnel to close off and seal the funnel opening. Or the tape could extend from one side of the tubular wall, up and over the free end or top of the funnel and then back down to the other side of the tubular wall. The user would remove the tape from the funnel to enable pulling the catheter out of the package for use.

An alternate method of catheter hydration is shown in the catheter package assembly shown in <FIG>. The catheter itself is shown at <NUM>. It has an elongated, hollow tubing <NUM> attached at one end to a hollow funnel <NUM><NUM>. The funnel is sometimes alternately referred to as a connector or a grip. The tubing and funnel each define a central lumen therein. The tubing lumen 112A and the funnel lumen 114A can be seen in <FIG>. The lumens of the tubing and funnel fluidly communicate with one another as is conventional. The catheter <NUM> can be an injection molded component with the grip/funnel <NUM> being integral with the tubing <NUM>. Other manufacturing methods for the catheter are possible.

The funnel <NUM> has an upper body portion <NUM> and a lower seal portion shown generally at <NUM>. The upper or free end <NUM> of the body portion <NUM> defines a funnel opening <NUM>. While the body portion <NUM> is shown having a gently curved outer surface that is somewhat parabolic in nature, it will be understood that other exterior shapes for the funnel are possible, such as a frusto-conical shape, perhaps with a suitable lip on the free end. Whatever the exterior shape, the funnel <NUM> generally has an outer diameter greater than that of the tubing <NUM>. This size, plus the fact that the funnel is not lubricated, makes the funnel <NUM> a convenient location for grasping the catheter <NUM> to manipulate it. The funnel may be suitable for connection to a drainage bag, other tubing or any other appropriate apparatus. For example, in one embodiment the opening <NUM> defined in the free end <NUM> of the funnel may be large enough or otherwise adapted to receive a urine bag connector.

Near the end of the catheter tubing <NUM> opposite the funnel <NUM> is at least one radial eyelet (not shown). The eyelet provides fluid access to the central lumen 112A of the tubing <NUM>. Adjacent the eyelet is a rounded tip <NUM> that provides a smooth surface to facilitate insertion of the tubing into a urethra. In some embodiments it may be desirable to include more than one eyelet.

Turning now to the catheter package assembly, it is shown generally at <NUM> in <FIG>. The package may include an elongated, hollow case <NUM> which has an axis A (<FIG>) defined by a generally tubular wall <NUM>. The inside or outside dimension of the tubular wall may have either circular or non-circular cross sections. The tubular wall <NUM> joins a bottom or end wall <NUM> that closes the bottom of the case <NUM>. At the other end of the case the wall <NUM> terminates at a rim <NUM>. The rim <NUM> defines an opening <NUM> at the top of the tubular wall <NUM>. From the rim <NUM> and extending axially for a short distance the internal surface of the tubular wall <NUM> defines an internal seal face <NUM>. When the catheter <NUM><NUM> is installed in the package <NUM>, the internal seal face <NUM> engages the seal <NUM><NUM> of the funnel in an interference fit which provides a seal between the funnel and the package case <NUM>.

The package <NUM> further includes a strap <NUM>. The strap <NUM> is an elongated, flexible member which is fixedly attached to the tubular wall <NUM>, preferably at or near the rim <NUM>, by a living hinge <NUM>. The other end of the strap <NUM> mounts a cap <NUM>. The cap is joined to the strap by a living hinge <NUM>. It will be understood that while a living hinge is a convenient method of connecting the cap and strap, other types of hinges are possible. The underside of the cap carries a boss <NUM>. The length of the strap and the size of the cap and boss are such that the cap <NUM> will engage the opening <NUM> of a funnel <NUM> installed in the case <NUM>. Thus, the cap does not engage the case <NUM>, rather it is releasably engageable with the body portion <NUM> of the funnel <NUM>.

When the cap is closed on the funnel, the boss <NUM> leads into the opening <NUM> in the free end of the funnel <NUM>, producing contact between the boss and the internal wall of the funnel. This creates an interference fit and a seal between the boss and the internal surface of the funnel.

In the embodiment of <FIG> a gel grommet <NUM> is placed inside the tubular wall <NUM> of the case <NUM> near the opening <NUM>. The gel grommet <NUM> has a wall <NUM> whose external dimensions matches the internal dimensions of the wall <NUM> and are just slightly less than the internal diameter of the case <NUM>. Thus, the grommet fits closely within the case <NUM>. The ends of the wall <NUM> each carry a radially-disposed washer <NUM> with a central aperture <NUM> therein. The aperture <NUM> is sized to permit passage of the catheter tubing <NUM>. The grommet is filled with a lubricating gel. The grommet may be made of a suitable silicone material.

Cooperation between the catheter <NUM> and package <NUM> is illustrated in <FIG> and <FIG>. To install the catheter in the package the catheter tubing <NUM> enters the case <NUM> through the opening <NUM>. The inside dimension of the tubular wall <NUM> is greater than the outside diameter of the tubing <NUM> so the tubing fits in readily. There is a somewhat tighter fit between the tubing <NUM> and the washer apertures <NUM> but the tubing still has a small enough outer diameter to fit past the grommet. However, the inside dimensions of the opening <NUM> are slightly less than the outside dimensions of the funnel body portion <NUM><NUM>. Thus, while the seal <NUM> of the funnel <NUM> will enter the case <NUM> in an interference fit, the remainder of the funnel will not. Accordingly, the body portion <NUM> of the funnel remains external to the case <NUM>.

Once the catheter tubing <NUM> is inside the case <NUM> and the funnel seal portion <NUM> is snug against the seal face <NUM> , the strap <NUM> may be rotated <NUM>° about the hinge <NUM> to place the strap in a position where it is adjacent the funnel body <NUM> and generally parallel to the case axis A. Then the cap <NUM> is rotated <NUM>° about the hinge <NUM>. This will allow the boss <NUM> to fit in the funnel opening <NUM>. The cap <NUM> and strap <NUM>, together with the interference fit between the seal <NUM><NUM> and case <NUM>, retain the catheter <NUM> in the package <NUM>.

When the catheter is to be used, a user flips the cap <NUM> off of the funnel and grasps the outer surface of the funnel with one hand and the case <NUM> with the other hand. A gentle tilting, twisting or pulling of the funnel relative to the case will dislodge the funnel from the case and allow the user to withdraw the catheter from the case. In the withdrawal process the majority of the tubing <NUM> passes through the gel grommet <NUM>. As it does so the tubing will become coated with the lubricant. Once the catheter is entirely removed from the case it will be almost completely coated with lubricating gel and thus ready for use.

The gel lubrication of the device will significantly reduce the overall cost of the product. Also, the package is recloseable and allows for carrying the catheter after use for later disposal without any leakage or odor.

Several alternate embodiments of the catheter funnel are shown in <FIG>. The first form of catheter having a funnel is shown at <NUM><NUM> in <FIG>. It has an elongated, hollow tubing <NUM> attached at one end to a hollow funnel <NUM>. As before, the tubing and funnel each define a central lumen therein. The tubing lumen 112A can be seen in <FIG>. Near the end of the tubing <NUM> are a pair of radial eyelets <NUM>. The eyelets provide fluid access to the central lumen 112A of the tubing <NUM><NUM>. Adjacent the eyelet is a rounded tip <NUM> that provides a smooth surface to facilitate insertion of the tubing into a urethra.

The funnel <NUM><NUM> has an upper body portion <NUM><NUM> and a lower seal portion shown generally at <NUM><NUM>. The upper or free end <NUM> of the body portion <NUM> defines a funnel opening <NUM>. As in the previous embodiment, the funnel <NUM> generally has an outer dimension greater than that of the tubing <NUM>. Further details of the seal <NUM><NUM> at the lower end of the funnel include a beveled lower portion <NUM> joining a cylindrical section <NUM> on which is mounted an O-ring <NUM>. The O-ring <NUM> engages the interior of the package case in an interference fit that seals the funnel to the case. The beveled lower portion <NUM> assists in guiding the seal portion <NUM> into the case. Other embodiments for the seal portion are possible as each of the components described above may not be necessary in all instances.

The upper body portion <NUM><NUM> in <FIG> may be characterized by a cross section having a circular internal diameter and an external shape that varies from square ends to a circular middle. More particularly, the external surface may have two tactile rings <NUM> and the ends of the funnel. The tactile rings have a generally square cross section, as seen in <FIG>. Adjacent sides of the tactile rings are joined by arcuate corners of comparatively large radius, thus providing rather soft corners instead of the sharp corners of a true square shape. Nevertheless, the flat sides have a width (or height depending on the orientation of the funnel) that is large enough to provide a clear tactile distinction between the sides and the corners. A user can readily distinguish the sides from the corners, thus providing a more secure grip on the funnel. Intermediate the tactile rings <NUM> the funnel has a generally circular cross section, as seen in <FIG>. Thus, the external shape gradually undergoes a metamorphosis along its length as the external shape modulates from square at one end to circular intermediate the ends and then back to square at the other end.

Looking at <FIG>, it can be seen that internal diameter of the funnel is defined by the circular cross section of the funnel opening <NUM> and the funnel lumen 114A. The circular internal diameter may allow for attachment to standard drainage bags. The external shape of the tactile rings <NUM> of the funnel are defined by at least substantially flat sides <NUM>, <NUM>, <NUM> and <NUM>. The pair of sides <NUM> and <NUM> are parallel to one another. Similarly, the pair of sides <NUM> and <NUM> are parallel to one another. Sides <NUM> and <NUM> are joined by arcuate corner portion <NUM>. Sides <NUM> and <NUM> are joined by arcuate corner portion <NUM>. Sides <NUM> and <NUM> are joined by arcuate corner portion <NUM>. Sides <NUM> and <NUM> are joined by arcuate corner portion <NUM>.

While the preferred arrangement of at least four substantially flat sides is shown, it will be understood that other arrangements are possible for the tactile rings, with the number of flat sides varying from one to several. For example, two spaced, parallel, at least substantially flat sides could be joined by arcuate sides.

<FIG> illustrates additional features that enhance the ability of the user to securely grip the funnel <NUM>. These may include a series of ridges <NUM> on the external surfaces of the funnel body <NUM>. The ridges are local protrusions from the external surface of the body <NUM>. They may be spiral, like a screw thread, or they could be separate, individual rings, as shown here. As seen in <FIG> they could have a variable helix angle from one end of the funnel body to the other. The ridges may be formed from the same material as the funnel. Alternately, the ridges could be of a different material or different stiffness. That is, the ridges could be comparatively soft to improve grip while the funnel body would be stiff to prevent the funnel from collapsing when gripped.

<FIG> illustrates another grip enhancing feature in the form of the tactile rings <NUM> at each end of the funnel body <NUM>. In this embodiment the tactile ring <NUM> is a portion of slightly increased external dimension compared to the ridges <NUM>. The ring itself has a smooth surface to distinguish it from the ridged portion of the funnel. This tactile surface allows the user to feel when he or she is nearing the end of the funnel. As the funnel may be relatively short, this ring would indicate to the user if his or her fingers are nearing the funnel ends and thereby avoid accidental finger contact with the catheter tubing, which could result in contamination of the catheter tubing.

<FIG> show another alternate configuration of a funnel <NUM>. This funnel has a generally circular external diameter with a somewhat parabolic shape along its axial dimension. The external surface is generally smooth except where enlarged tactile rings <NUM> protrude near the ends of the funnel. The rings <NUM> are more pronounced than the ring <NUM> of the previous embodiment but they still provide the same indication to the user of approach to the end of the funnel.

<FIG> shows still another variation of a funnel <NUM>. In this version spiral ridges <NUM> are formed along virtually the entire axial extent of the funnel body. The ridges <NUM> could have different designs or orientations.

All of the embodiments of <FIG> address the issue of gripping a catheter that has no sleeve and rely on gripping of the funnel for hygienic catheter use. In such situations it can happen that a user's fingers may slip off the funnel and contaminate the catheter tubing or come into contact with urine. The designs of the present disclosure aid in funnel grip and positioning and limit the potential for slippage. They permit the user to use his or her sense of touch during use so they can feel when they are nearing the end of the funnel. The ridges will help limit slippage if the funnel is wet due to hydration or other causes. The ridges give the user a sense of a more secure grip. The tactile ring will also help during attachment to a drainage bag as it is slightly raised, giving an improved grip during attachment.

<FIG> illustrates another alternate embodiment of the present disclosure. This is a package having a case <NUM>, a strap <NUM> and a cap <NUM>. This case may have a rectangular cross section and does not include a gel grommet, but it is otherwise similar to the package of <FIG>. This particular package may be particularly well suited for a male catheter, shown generally at <NUM>. The male catheter tubing <NUM> is longer than that of a female catheter. The extra length creates packaging challenges. The present disclosure addresses this problem by folding the tubing at fold <NUM>. The catheter is placed in the case in a folded position to minimize the overall package size. The outer part of the grip <NUM> is slideable along the catheter tubing to be used as a gripper and enhance hygienic benefits.

<FIG> illustrate a sequence of steps for assembling a package <NUM> according to the present disclosure. This particular embodiment utilizes a hydrating medium in the form of a wick <NUM> or a sachet. The wick may be, for example, a fabric strip, an absorbent paper strip, an absorbent open-celled foam strip or anything else that will emit a vapor. The method then also advantageously includes wetting the wick with an aqueous liquid prior to inserting it into the package <NUM> to thereafter produce a water vapor atmosphere within the sealed cavity to activate the hydrophilic coating. The wick is placed in the case <NUM> prior to the installation of the catheter. The wick in this embodiment is basically a rectangle that is partially folded into a shape with two portions perpendicular to one another. This allows it to bear against the inside surface of the case walls, which in this embodiment have a generally square cross section, although the case walls could have a different cross section, such as a circular cross section. Water vapor emanating from the wick <NUM> will lubricate the coating on the catheter tubing.

<FIG> illustrates the package generally at <NUM>. This embodiment has a case <NUM> which has a generally square cross section. The case <NUM> terminates at a rim <NUM> which defines an opening <NUM>. The case <NUM> is sized to receive a catheter tubing and an adaptor or liner as will be described below. The body portion of the catheter funnel will remain on the exterior of the case. The package <NUM> has a strap <NUM> which is attached at one end to the case <NUM> at a hinge <NUM>. A cap <NUM> is attached to the other end of the strap <NUM> by a second hinge <NUM>. Hinges <NUM> and <NUM> are preferably living hinges although it could be otherwise. The cap <NUM> includes a boss <NUM>. The cap <NUM> may further include a tab <NUM> extending from an edge of the cap to assist a user in removing the cap from a catheter funnel.

The first step in the assembly process is installation of the folded sachet <NUM> into the case <NUM>, as illustrated by arrow B in <FIG>. The second step in the assembly process is shown in <FIG> and entails installation of an adaptor <NUM> into the opening <NUM> of the case <NUM>. The adaptor is moved in the direction of arrow C to form an adaptor/case sub-assembly. The adaptor has, in this case, a rectangular, hollow ferrule <NUM> that terminates at its upper end at a flange <NUM>. The flange engages the internal surface of the case wall in a press fit as seen in <FIG>.

The third step in the assembly process is shown in <FIG> and entails installation of a catheter into the adaptor/case sub-assembly. The catheter may be similar to that shown at <NUM> in <FIG>. The seal portion <NUM> of the catheter is inserted into the ferrule <NUM> of the adaptor as shown by arrow D in <FIG>. The O- ring <NUM> of the funnel seal portion <NUM> engages the internal surface of the ferrule in a press fit to seal the funnel to the adaptor. This is best seen in <FIG>.

Once the catheter <NUM> is in the adaptor/case sub-assembly the package will be in the state shown at the left hand side of <FIG>. The cap can then be closed as shown in the successive middle and right hand views of <FIG>. First the strap <NUM> is folded up <NUM>° about hinge <NUM> as indicated by arrow E. This places the strap <NUM> essentially parallel to the funnel body <NUM><NUM> with the cap <NUM> located above the free end <NUM> of the funnel body. Then, as shown by arrow F, the cap <NUM> is folded <NUM>° about hinge <NUM>. This places the boss <NUM> of the cap inside the funnel opening <NUM> to seal the funnel lumen and retain the catheter in the package.

The final assembly steps are shown in <FIG>. Here a tamper evident label <NUM> is placed over the cap <NUM>. The label may have tabs <NUM> that are long enough to extend down onto and engage the funnel as indicated by arrow G. If the cap <NUM> is opened these tabs will break, indicating a post-assembly opening of the cap. The right hand view of <FIG> shows the complete assembly of the package.

<FIG> illustrate an alternate embodiment of the catheter package assembly <NUM> of the present disclosure. This version uses a different hydrating method from the sachet <NUM> used in <FIG>. Instead of the sachet, about <NUM>. <NUM> of liquid water is added to the case and a liner is inserted into the case to separate the catheter tubing from the liquid water. The liner is an elongated tube that fits within the case. The liner has an upper end that engages the internal walls of the case in a press fit. Once that press fit is established the liner and case form a liner/case sub-assembly. That sub-assembly presents a structure that it is ready to receive a catheter.

<FIG> illustrate the external portions of the catheter package assembly <NUM>. It includes a case <NUM> that is similar to the previous cases in that it is a hollow tube. In this embodiment, however, the case has an outer cross section with generally flat sides joined by broadly radiused corners. The internal cross section of the case <NUM>, however, is circular. The case <NUM> terminates at a rim <NUM> which defines an opening. The case <NUM> is sized to receive a catheter tubing and the seal portion of a catheter funnel, as well as a liner as will be described below. The body portion of the catheter funnel will remain on the exterior of the case.

The case <NUM> further includes a strap <NUM> which is attached at one end to the case at a hinge <NUM>. A cap <NUM> is attached to the other end of the strap <NUM> by a second hinge <NUM>. Hinges <NUM> and <NUM> are preferably living hinges although they could be otherwise. The strap <NUM> includes a longitudinal rib <NUM> that extends generally perpendicular to the main body of the strap, thereby producing a T-shaped cross section in the strap. The free edge of the rib <NUM> has a shape that closely conforms to the contour of the funnel's exterior surface. This construction not only strengthens the strap but it also leaves little or no gap between the strap and the funnel. This prevents entanglement of the strap with items that might otherwise be inserted between the strap and the funnel.

The funnel of a catheter is also visible at <NUM> in <FIG>. Details of the catheter construction are shown in <FIG>. As in previous embodiments the funnel <NUM> has an upper body portion <NUM> and a lower seal portion generally at <NUM>. The upper or free end <NUM> of the body portion <NUM> defines a funnel opening <NUM>. While the upper body portion <NUM> is shown having a gently curved outer surface that is somewhat parabolic in nature, it will be understood that other exterior shapes for the funnel are possible. In this case both the internal and external cross sections of the funnel are circular throughout the length of the funnel. Thus, the seal portion <NUM> fits into the opening at the rim <NUM> of the case <NUM> without the need for an adaptor.

The upper body portion <NUM> in the illustrated embodiment may be a two- shot molded component. In such embodiment, the first or internal shot is preferably a relatively rigid material such as ABS or a similar alternative. It forms the seal portion <NUM> and the body of the funnel <NUM>. The second or external shot is preferably a softer material such as TPE and forms the gripping surface <NUM> of the funnel, including ridges <NUM>. Interlocking grooves and ribs at <NUM> near the bottom of the second shot help retain the gripping surface in position on the body. The extreme lower edge of the gripping surface overlies a flange <NUM> at the top of the seal portion <NUM>. The flange adjoins the top land of the case's rim <NUM> when the catheter is installed in the case, as will be explained below.

Further details of the seal portion <NUM> include a beveled lower portion <NUM> joining a cylindrical section <NUM>. There is a groove <NUM> in the cylindrical section for receiving an O-ring as shown below. The beveled lower portion <NUM> assists in guiding the seal portion <NUM> into the case as explained below. A bore through the center of the seal portion receives the top portion of the catheter tubing <NUM> in a press fit.

Turning now to <FIG>, a liner <NUM> is shown. The liner may be a relatively rigid plastic such as LDPE or HDPE. The liner is generally a hollow tube. At its upper end there is a seat portion <NUM> of slightly increased outside diameter compared to the remainder of the liner's tube. A pair of interference ribs <NUM> may be formed on the seat <NUM>. At the top edge there is, for example, a crab claw seal <NUM>. The walls of the liner have formed therein one or more passages or windows <NUM> in it. The windows will be covered with a patch <NUM> of liquid impermeable/vapor permeable material such as, but not limited to, calcium carbonate. The patches <NUM> will allow passage of water vapor (for hydration of the catheter) but will block passage of liquid water droplets. The patch might be heat sealed around the perimeter of the window.

<FIG> illustrates the internal construction of the catheter package assembly <NUM> after installation of the liner <NUM> and catheter funnel <NUM>. It will be noted that the internal surface of the case <NUM> has upper and lower undercuts <NUM>, <NUM> formed therein. The upper undercut <NUM> cooperates with an O-ring <NUM> disposed in the groove <NUM>. The lower undercut <NUM> cooperates with the crab claw seal <NUM> on the liner <NUM> resist withdrawal of the liner from the case <NUM>. Together with the interference ribs <NUM>, the O-ring <NUM> and crab claw seal <NUM> seal the top of the case and prevent release of liquid water or water vapor from the case.

<FIG> illustrates details of the engagement of the cap <NUM> and the body portion <NUM> of the funnel <NUM>. The cap includes a boss <NUM>. The boss has a bump <NUM> just above a groove that receives an O-ring <NUM>. On the internal wall surface of the funnel, just inside the opening <NUM> there is a bump undercut <NUM>. The bump <NUM> and bump undercut <NUM> cooperate with one another and with the O-ring <NUM> to seal the top of the funnel and prevent release of water vapor or the entry of contaminants.

Among the advantages of the packaging assembly with a liner is the liner is relatively easy to install in the case. The liner separates liquid water from the catheter tubing while allowing water vapor to maintain the coating on the tubing in a lubricious condition. When the time comes for the catheter to be put to use, a user can simply flip open the cap <NUM>, removing the boss <NUM> and cap <NUM> from engagement with the funnel <NUM>. The strap <NUM> can be pressed aside slightly to permit the user to grasp the funnel and pull the catheter out of the package. Due to the hydration the catheter is ready for immediate use.

A further alternate embodiment form of a hydrating mechanism is to place liquid water in the case <NUM> alongside the catheter. This would negate the need for hydration via either a sachet or a hydration liner.

It will be noted that the product signifies the correct orientation for opening such that there will not be spillage upon opening the product. There can be a tamper-evident label joining the cap to the funnel. Another advantage is the package is recloseable and allows for carrying the product after use for later disposal without any leakage or odors.

As mentioned above, it is possible to manufacture the strap as a separate member from the case and then attach the strap to the case at a hinge. One embodiment of such a structure is shown in <FIG>. Here a catheter funnel <NUM> is shown installed in a case <NUM>, only the top portion of the case being shown in <FIG>. The case has a pair of hinge blocks <NUM> formed on the exterior walls of the case, on opposite sides thereof. Each hinge block <NUM> has a U- shaped socket <NUM> cut in a side of the hinge block. A pin <NUM> is mounted for rotation in each socket <NUM>. The sockets may be arranged to permit the pins to be twisted into the sockets. Flexibly interengaging portions of the hinge block retain the pins. Each of the two pins <NUM> is fixed to a leg <NUM>, on an inwardly facing surface thereof. There are two legs <NUM>, each leg carrying one of the pins286. Together the legs <NUM> define a stirrup at the bottom of a semi-cylindrical strap <NUM>. A cap <NUM> is hinged to the stop of the strap <NUM>. The cap is releasably engageable with the funnel as in the embodiments shown above. The cap <NUM> may have a tamper evident feature <NUM> connecting it to the strap <NUM> for indicating whether the cap has been opened.

<FIG> and <FIG> show the strap installed on the funnel <NUM>, with a partially opened cap <NUM> shown in phantom lines in <FIG> shows how the strap <NUM> would pivot about the pins to a fully open position. The catheter has been withdrawn from the case in <FIG>.

<FIG> illustrates another embodiment having a strap initially formed separate from the case and subsequently attached at a hinge to the case. In this embodiment the case <NUM> has a hinge receptacle <NUM> at the upper edge of the case. The strap <NUM> has a tongue <NUM> that is engageable with the receptacle <NUM> for pivoting motion therein. Another tongue <NUM> at the top of the strap <NUM> engages a receptacle <NUM> which is similar to receptacle <NUM>. It permits the cap <NUM> to pivot on the outer end of the strap <NUM>. In each case the tongue snaps into pivotable engagement with the receptacles. If desired, the attachment of the strap could be done after installation of the funnel and cap.

An additional embodiment of a strap separate from the case is shown in <FIG>. Here a case <NUM> receives a funnel <NUM> in a manner similar to the embodiments described above. A strap <NUM> has an elongated body member <NUM>. Attached to one end of the body <NUM> is an anchor ring <NUM>. The anchor ring has a central opening <NUM> of a diameter that allows the anchor ring to fit snugly about the top of the case <NUM>. Alternately, the top of the case may have a groove for receiving the anchor ring. The end of the strap <NUM> opposite the anchor ring has a second ring <NUM> with an aperture <NUM> therein. The aperture receives a cap <NUM>. The body member <NUM> has sufficient flexibility to permit it to be folded back on itself as shown in <FIG> to permit the cap <NUM> to be inserted into the opening of the funnel <NUM>. A user can flip the cap off the funnel to allow extraction of the funnel and catheter tubing from the case <NUM>.

An alternative arrangement for the strap <NUM> is to have a hyperbolic funnel, with flared ends as in <FIG> and size the anchor opening <NUM> fit around the narrower parts of the funnel at or near its longitudinal center. The opening permits the anchor to slide up and down the funnel somewhat but it does not fall off the funnel due to the flared funnel ends.

Until now the various illustrated embodiments of the strap contemplate the strap being a molded plastic part. The strap could also be an elongated piece of label stock attached to the cap and case in various manners as will now be illustrated. <FIG> show a version with a mechanical attachment of the label <NUM> to the cap <NUM> and an adhesive attachment of the label to the case. A portion of the funnel is shown at <NUM> in <FIG>. The cap has two pieces, a cover <NUM> and a seat <NUM>. The underside of the cover <NUM> carries a spud <NUM>. The seat has a socket <NUM> that receives the spud <NUM>. The seat also has a flange <NUM> on its upper edge. An O-ring seal <NUM> surrounds the body of the seat. Assembly of the label <NUM> to the cap <NUM> is shown in <FIG>, with the label disposed between the cover <NUM> and seat <NUM>. The label may have a perforation which the spud <NUM> penetrates to extend through the label. The spud then snaps into the socket <NUM> of the seat <NUM>, locking the cover and seat together with the label secured between them. The label extends past the funnel <NUM> to a point adjacent the case (not shown). That portion of the label will have an adhesive that is secured to the outer surface of the case. The label is sufficiently flexible to allow bending of it when the user flips the cap <NUM> off the funnel <NUM>. While the label can be readily flexed away from the funnel, the label has sufficient tensile strength to prevent stretching it lengthwise.

<FIG> illustrate an alternate version of a label <NUM> as a strap. The label is adhesively attached to the case <NUM> and to the cap <NUM>. The cap may include a depending leg <NUM> extending from one side thereof. However, this leg is not attached to the case <NUM>. It fills any space between the label and the funnel. If there is adhesive throughout the length of the label the leg <NUM> also prevents the label from sticking to the funnel. The label may extend somewhat beyond the edge of the cap so that it can be grasped by a user to assist in flipping the cap off the funnel.

<FIG> show still another alternate form of a label <NUM> as a strap. The strap has wing areas at <NUM>. These are covered on the underside with adhesive as shown by the hatching. A similar adhesive area is at <NUM> near the bottom of the strap. A cap <NUM> fits in the funnel <NUM>. The wings <NUM> fold down over the cap and the label extends past the funnel <NUM> to the case <NUM>, where the adhesive zone <NUM> adheres the label <NUM> to the case.

A liner hydrating mechanism similar to that shown in <FIG> is incorporated in an alternate embodiment of a package, as shown in <FIG>. This catheter packaging assembly <NUM> includes a case <NUM>. The case is hollow and has a ferrule <NUM> of reduced outside diameter at its open end. The ferrule may have an outwardly facing groove for receiving an O-ring (not shown). A cap <NUM> is an elongated hollow member having an inside diameter that allows it to just fit over the ferrule <NUM>, with an interference fit with the O-ring providing a seal between the cap <NUM> and the case <NUM>. The cap <NUM> also has sufficient height to permit the cap to enclose a funnel <NUM> of a catheter while engaging the ferrule <NUM>. Inside the case <NUM> there is a liner <NUM> (<FIG>) similar to the liner <NUM>. As in the <FIG> embodiment, the liner has hydration windows covered by a patch of water vapor permeable material. This allows hydration of a catheter by placing liquid water in the case prior to installation of the liner. The liner prevents direct contact between the liquid water and the coating on the catheter's tubing but permits water vapor to keep the coating in condition where the catheter is ready to use when withdrawn from the case.

Claim 1:
A catheter (<NUM>) and package (<NUM>) assembly, comprising:
a catheter having an elongated tubing (<NUM>) and a funnel (<NUM>) attached to one end of the tubing, the funnel has a body portion (<NUM>) and a plurality of ridges (<NUM>) are formed on the exterior surface of the body portion and protruding upwardly from said surface;
an elongated case (<NUM>) having a rim (<NUM>) defining an open end, the rim being sized to permit entry of at least the catheter tubing;
a hydrating medium in the case where it is effective to lubricate the catheter tubing; and
a cap (<NUM>) connected to the case by a hinge (<NUM>) and movable between closed and open positions, the cap when in the open position permitting withdrawal of the catheter from the case and installation of the catheter into the case, the cap when in the closed position preventing withdrawal of the catheter from the case and preventing loss of the hydrating medium from the case.