Patent Description:
Intermittent catheters are typically used by patients suffering from urinary incontinence or by individuals unable to have voluntary urination. In our highly mobile culture, the ability to have the freedom to leave home for the day or longer is an important part of life. To accommodate this need, single use catheters have been developed to allow patients to perform self-catheterization, and are termed intermittent urinary catheters.

Most intermittent urinary catheters are lubricated in some manner to facilitate introduction to and advancement through the urethra. The two main techniques of lubrication are automatically or manually applying a gel to the exterior of the catheter, or breaking a water sachet within the sealed catheter package to activate a hydrophilic surface coating on the catheter. Hydrophilic catheters have a polymer coating that binds to the surface of the catheter. When the polymer coating is submersed in water, it absorbs and binds the water to the catheter, which becomes smooth and very slippery.

Whichever way the catheter is lubricated, it becomes slick and difficult to handle once removed from the package. The rounded tip of the catheter must be inserted into the urethra, and often the users of intermittent catheters have limited dexterity. For example, spinal injuries leading to partial paralysis of the limbs, and limited use of fingers, sometimes also results in the need for urinary catheters. The process for manipulating a urinary catheter is somewhat difficult, especially in light of the need to maintain sterility, which makes gripping and inserting a lubricated catheter into the urethra extremely hard even for fully functioning users.

Various solutions to this problem have been developed in the art. For example, <CIT> to Gustavsson discloses an elastomeric tubular insertion aid that fits over the catheter and has an external ribs so as to be used as a handle to move the catheter back and forth without touching it (e.g., see Fig. 3b). The insertion aid slides back and forth on the catheter while the patient inches the catheter forward. However, this molded design is relatively complex and thus prohibitively expensive for a product which is used multiple times a day and disposable.

<CIT> issued to McBride discloses another urinary catheter set having a tubular cuff <NUM> disposed so as to be movable along the length of the catheter (see <FIG>). The cuff <NUM> is a flat-compressed plastic sheeting tube, tapered on the front end, with welded longitudinal edges, much like construction of a plastic bag. This has the advantage of low manufacturing costs and a low profile which facilitates storage inside the package. However, the cuff <NUM> sometimes creates discomfort, especially in male users, which limits widespread adoption. <CIT> discloses a gripping sleeve for handling a urinary catheter, comprising: a pair of flexible flat sheets of material having each proximal and distal ends defining a longitudinal axis therebetween and being bonded together at juxtaposed longitudinal edges to form a sleeve which may be expanded into a tubular shape sized to loosely receive a urinary catheter.

Though a number of solutions for manually manipulating hydrophilic urinary catheters are known in the art, there remains a need for a more comfortable and thus accepted gripping cuff or sleeve.

Embodiments of the present invention seek to provide an enhanced sleeve for handling a urinary catheter. The present application provides a number of features that render usage of urinary catheters much easier, and in particular reduce discomfort. According to an aspect of the present invention, there is provided a gripping sleeve for handling a urinary catheter according to the appended claims.

The present application provides an improved gripping cuff or sleeve for use with intermittent urinary catheters. Hydrophilic catheters often use a sleeve-like gripping device to assist users to feed the catheter once the hydrophilic coating is hydrated and slippery. The user typically grasps the catheter tube using the gripping device and is then able to push the catheter forward to insert it into the urethra. This provides greater friction and avoids the mess inherited touching a lubricated catheter. Moreover, the gripping device provides a sanitary barrier between the user's hand and the catheter to help avoid transferring bacteria to the urethra, which might lead to infection.

As mentioned in the background, existing catheter handling or gripping cuffs or sleeves can create discomfort. Specifically, some patients complain that sharp corners of the front of the gripping sleeve are irritating to the patient skin when they come into contact with the skin. The improved gripping sleeve described herein are particularly beneficial for catheters designed for males, but it should be understood that the same principles can just as easily be incorporated into a catheter for use by females.

<FIG> illustrates a prior art intermittent urinary catheter package assembly <NUM> exploded, including outer packaging <NUM>, a catheter <NUM> with a gripping sleeve <NUM> slidable thereover, and a water sachet <NUM>. When packaged, the catheter <NUM> with gripping sleeve <NUM> along with water sachet <NUM> are contained in a sterile manner within the outer packaging <NUM>. In the illustrated embodiment, the prior art urinary catheter package assembly <NUM> is the Hydrophilic Cure Catheter® for men available from Cure Medical, LLC, of Newport Beach, CA.

The outer packaging <NUM> of the Hydrophilic Cure Catheter® for men is a simple tubular sleeve of flexible water-impermeable material, such as thin polyethylene. In a preferred embodiment, a front face of the outer packaging <NUM>, shown in <FIG>, is opaque and has a number of markings thereon, such as the product enclosed, instructions for use, and the size (e.g., <NUM> Fr). A rear face (not shown) may be transparent so that the contents can be easily viewed. Catheters for men typically range between <NUM> - <NUM> (<NUM>-<NUM> inches) long, and the outer packaging <NUM> is thus slightly longer.

The catheter <NUM> shown in <FIG> has a catheter tube <NUM> with a polymeric hydrophilic coating on its exterior that terminates at a front or distal end in a rounded distal tip <NUM>. One or more drainage openings <NUM> are formed adjacent the rounded distal tip <NUM>. An elastomeric funnel <NUM> attaches to a rear or proximal end of the catheter tube <NUM>.

In use, prior to opening the sterile packaging <NUM>, the user squeezes or bends the water sachet <NUM> which is filled with purified water causing the sachet to burst and distribute the water within the package and around the catheter tube <NUM>. This activates the hydrophilic coating on the catheter tube <NUM>, thus rendering it lubricious. The user opens the sterile packaging <NUM>, typically by tearing apart the two sheets of material that form the front and rear faces, much like opening a Band-Aid. The user can handle the catheter <NUM> at the funnel <NUM>, which is not slippery, as well as by grasping the gripping sleeve <NUM> which is typically conveniently positioned near the distal end of the catheter tube <NUM>. Manipulation of the catheter tube <NUM>, and in particular by aiming the distal tip <NUM>, the catheter can be inserted into the urethra.

<FIG> is an enlarged perspective view of the distal end of the prior art urinary catheter <NUM> with the gripping sleeve <NUM> on the catheter tube <NUM>. The gripping sleeve <NUM> of the Hydrophilic Cure Catheter® for men has a textured inner surface <NUM> which enhances the frictional qualities and thus the user's grip. The two drainage openings <NUM> are shown axially spaced apart adjacent the distal tip <NUM>. In a preferred embodiment, the drainage openings <NUM> have rounded edges that are recessed into the wall of the catheter tube <NUM> for greater comfort to the user.

The construction of the gripping sleeve <NUM> is illustrated clearly in <FIG>. In particular, the sleeve comprises two identical flat sheets of flexible material <NUM> that are bonded (e.g., heat welded) together along the entirety of their juxtaposed longitudinal edges <NUM>. The sheets of flexible material <NUM> remain disconnected at front and rear ends <NUM>, <NUM> of the sleeve <NUM> to form tubular shape sized to loosely receive a urinary catheter <NUM> for sliding movement therethrough. The gripping sleeve <NUM> further includes a slightly narrowing tapered section <NUM> toward the front end <NUM>, but otherwise has a constant lateral dimension, as seen best in <FIG>.

The enlargement of <FIG> illustrates the welded seams formed along the juxtaposed longitudinal edges <NUM>. These seams terminate at the front end <NUM> of the gripping sleeve <NUM> in relatively sharp corners <NUM>. These corners <NUM> tend to create discomfort for the patient if they come in contact with the outer opening of the urethra, as will be described below.

<FIG> illustrates advancement of the prior art urinary catheter <NUM> and gripping sleeve <NUM> just prior to insertion into the external urethral opening <NUM> of a male penis <NUM>. Typically, the user will hold with one hand the gripping sleeve <NUM> to maneuver the distal catheter tip <NUM> close to the urethral opening <NUM>, and then advance the catheter tube <NUM> using the other hand typically holding the rear funnel <NUM> (<FIG>). The process of aiming the distal tip <NUM> to successfully enter the urethral opening <NUM> requires the user to bring the gripping sleeve <NUM> holding the tip into close proximity with the opening. Some patients have complained that the sharp corners <NUM> of the front of the sleeve <NUM> are irritating to the patient's skin when they come into contact with the skin; often times this is the meatus of the user's penis <NUM> which is a sensitive area. The sharp corners <NUM> are reinforced by the stiffness of the welded sides <NUM> extending to the distal end of the sleeve <NUM>. After several times experiencing such discomfort, the natural behavioral result is a much more careful and thus timeconsuming catheterization process. In extreme cases the user may choose to not use the sleeve and touch the catheter with their bare hand.

To alleviate this discomfort, and facilitate the process, the present application presents a number of different catheter gripping sleeves which have a front-end that eliminates any sharp corners, and in some cases are more flexible than the prior sleeve.

For instance, <FIG> illustrates advancement of a urinary catheter <NUM> and gripping sleeve <NUM> of the present application toward the external urethral opening <NUM> of a male. The urinary catheter <NUM> is desirably constructed the same as in the prior art, and thus like elements will be given like numbers.

<FIG> is a top plan view of an exemplary non-claimed gripping sleeve <NUM> which includes a generally tubular body <NUM> extending from a proximal end <NUM> to a tapered portion <NUM> adjacent a distal end <NUM>. As before, the tubular body <NUM> is desirably formed of a pair of identical flexible strips of material, such as polyethylene, with a textured inner or outer surface <NUM> to increase friction. The texturing may be on the inner or outer surfaces of the sheets, and conceivably on the inside of one and the outside of the other. Ideally the texturing would be on both the inner and outer surfaces, but manufacturing constraints limit it to one or the other. The texturing is typically formed by a heated knurled or cross-hatched roller on one side of a large blank of material which is then cut to size and shape for the sheets to form each side of the tubular body <NUM>. Alternatively, two blanks are bonded together, before or after forming the individual sleeve sheets, and texturing added on the outside of both, which is a more efficient process.

Juxtaposed longitudinal edges <NUM> of the strips are bonded together, such as with heat welding, to form the sleeve <NUM> which may be expanded into the tubular body <NUM> sized to loosely receive a urinary catheter. As will be explained below, the entire length of the adjacent longitudinal edges <NUM> may be bonded, or only the parallel, longitudinal portions may be bonded with some or all of the distal tapered portion <NUM> remaining unattached. It should also be noted that the distal tapered portion <NUM> includes an elongated constantly tapered section <NUM> transitions to a shorter rounded portion <NUM> that terminates at the laterally-oriented distal end <NUM>.

With reference to <FIG>, advancement of the catheter <NUM> using the gripping sleeve <NUM> occurs as usual. Should the user bring the gripping sleeve <NUM> into contact with the penis <NUM> in this process, the distal end <NUM> and the relatively shallow corners leading to the rounded portion <NUM> will be the first to touch. Due to the elimination of the sharp <NUM>° corners <NUM> in the prior art sleeves, the discomfort to the user is greatly reduced. Specifically, the intersection of the rounded portions <NUM> with the laterally-oriented distal end <NUM> may form corners having a <NUM>° included angle or less. Furthermore, and as will be clear in certain embodiments below, the sleeves that make up the tubular body <NUM> of the sleeve <NUM> may be left unattached in the tapered portion <NUM>. This eliminates the bonded seams that would have extended to the distal end <NUM>, leaving two relatively flexible flaps which easily bend, and which the user will not feel.

With reference back to <FIG>, certain exemplary dimensions are provided. As will be understood, these dimensions are guidelines only, are provided to indicate relative sizes, and may vary by up to <NUM>% each. An exemplary total length L is <NUM> ± <NUM>, and an exemplary total width W is <NUM> ± <NUM> at the proximal end <NUM>. The length Lt of the tapered portion <NUM> is desirably between <NUM>-<NUM>% of the total length L, for example <NUM>. For instance, the short rounded portion <NUM> may have a length Lt' of <NUM>, and the longer gradually tapered portion <NUM> may have a length Lt" of <NUM>. The width Wt at the narrow end of the tapered portion <NUM> is desirably between <NUM>-<NUM>% of the total width, for example <NUM>-<NUM>.

<FIG> is a top plan view of a second non-claimed gripping sleeve <NUM> of the present application. This gripping sleeve <NUM> has a shape identical to the prior art gripping sleeve <NUM>, with a proximal portion <NUM> commencing at a proximal end <NUM> having sides <NUM> that are parallel and longitudinally-oriented, and a distal tapered portion <NUM> terminating at a distal end <NUM>. In this embodiment, the distal tapered portion <NUM> has a constant narrow taper out to the distal end <NUM>. Although the intersection of the distal tapered portion <NUM> and the distal end <NUM> forms sharp corners <NUM>, the two strips of material that comprise the gripping sleeve <NUM> are only bonded together along the sides <NUM> in the proximal portion <NUM>, but remain detached in the distal tapered portion <NUM>. It should be noted that the lack of bonding may not be along the whole length of the tapered portion <NUM> as long as at least about <NUM>-<NUM> is detached adjacent the distal end <NUM>.

This leaves two relatively loose flaps at the distal end <NUM>, which easily bend and create no discomfort to the male user if they contact the penis <NUM>, for example. Once again, the benefits of the improved gripping sleeves described herein are equally realized when incorporated into a catheter for use by females.

<FIG> is a top plan view of a third non-claimed gripping sleeve <NUM> of the present application, and <FIG> is a perspective view of the gripping sleeve surrounding a urinary catheter <NUM>. Much like the previous gripping sleeve, the gripping sleeve <NUM> is formed by the attachment of two strips of flexible material connected together in a tubular fashion and have a proximal portion <NUM> commencing at a proximal end <NUM> having sides <NUM> that are parallel and longitudinally-oriented, and a distal tapered portion <NUM> terminating at a distal end <NUM>. In contrast to the earlier embodiment, the entire distal end <NUM> is rounded from the end of the tapered portion <NUM> on either side. This alleviates any discrete corners whatsoever and greatly reduces patient discomfort from inadvertent contact between the sleeve <NUM> and the area surrounding the urethral opening <NUM>.

With reference to <FIG>, the sleeve <NUM> is shown near the distal end of the catheter <NUM>. In this version, the distal portion of the sleeve <NUM> including the tapered portion <NUM> and distal end <NUM> are detached from one another, thus forming two loose flaps <NUM>. As explained above, the strips of material are only bonded together at seams along the sides <NUM> that are parallel and longitudinally oriented. The two loose flaps <NUM> at the distal end <NUM> thus present almost no structural resistance and attendant discomfort if they inadvertently come in contact with the user's penis <NUM>.

<FIG> is a top plan view of a an embodiment of a gripping sleeve <NUM> according to the invention. As before, the gripping sleeve <NUM> comprises two strips of flexible material connected together in a tubular fashion to form a proximal portion <NUM> commencing at a proximal end <NUM> having sides <NUM> that are parallel and longitudinally-oriented, and a distal tapered portion <NUM>. In contrast with the earlier embodiment, the two strips of flexible material may not be identical, with a first strip being shorter than a second strip such that a first distal end <NUM> terminates short of a second distal end <NUM>. Alternatively, the strips could be the same size but offset at each end.

For instance, the first distal end <NUM> terminates short of the second distal end <NUM> by <NUM>-<NUM>, preferably <NUM>. In the illustrated embodiment, the first strip is positioned on top of the second strip, though this arrangement could be reversed. The distal tapered portion <NUM> is shaped similar to that in the gripping sleeve <NUM> shown in <FIG>, with an elongated constantly tapered section <NUM> leading to a shorter rounded portion <NUM> that terminates at the distal ends <NUM>, <NUM>. The two strips of material that form the gripping sleeve <NUM> are desirably not connected along their sides <NUM> along the distal tapered portion <NUM>, though as explained below they may alternatively be welded.

<FIG> is a perspective view of the gripping sleeve <NUM> surrounding a urinary catheter <NUM>. It is readily apparent that the distal end of the sleeve <NUM> forms two separated flaps terminating at the two distal ends <NUM>, <NUM>. Due to the extremely flexible nature of the separated flaps and the shape of the sleeve at the distal ends <NUM>, <NUM>, the user will experience almost no structural resistance if the sleeve <NUM> inadvertently contacts the penis during use. Only one thin sheet of soft, flexible material can touch the user.

In the prior art sleeve, the weld line between the <NUM> sheets formed a sharp corner, yet even if the two sheets shown in <FIG> remain welded together, the offset ends <NUM>, <NUM> eliminate the weld in that area. That is, the juxtaposed edges of the two strips of flexible material may be bonded up to the termination of the shorter distal end <NUM>. In addition, the tapering plus semi-rounded front contour further acts to deflect forces. In still another embodiment, not shown, the sleeve <NUM> may have a straight (constant) taper in the distal tapered portion <NUM> without the rounded portion <NUM>, and be bonded up to the termination of the shorter distal end <NUM>. Even though the distal corners of the second distal end <NUM> are sharp, the lack of a bond between the two sheets at the distal corners reduces the stiffness considerably.

Another non-claimed aspect of the present application is a provision of two gripping sleeves for one catheter package. Having two gripping sleeves enables the user to "inchworm" the catheter into the urethra. The two sleeves can be brought close together to meet up, then the catheter is advanced by gripping and moving one while letting the catheter slide through the other. This provides an advantage over simply gripping and pushing the catheter from the proximal funnel.

<FIG> illustrate a urinary catheter <NUM> having two gripping sleeves <NUM> thereon in use. In these illustrations, the gripping sleeves <NUM> are configured like the gripping sleeve <NUM> shown and described with respect to <FIG>. Initially, the user grasps the forward sleeve <NUM> with the first hand close to the distal tip of the catheter <NUM>, and grasps the rearward sleeve <NUM> with the second hand at a distance therefrom. <FIG> shows advancement of the second hand relative to the first hand and forward sleeve to advance the catheter <NUM>. Although not shown, the user then holds the forward sleeve <NUM> while sliding the rearward sleeve back on the catheter for further movement.

<FIG> illustrates an exemplary configuration of two gripping sleeves <NUM> nested over a urinary catheter <NUM> for shipping. That is, a rearward sleeve can be slid over the proximal funnel of the catheter <NUM>, and the forward sleeve slid partially over the rearward sleeve. This conveniently positions the two sleeves <NUM> at a clean (i.e., non-lubricated) end of the catheter <NUM> for ease-of-use.

<FIG> are alternative combinations of dual gripping sleeves on urinary catheters to illustrate several possible permutations. In the first embodiment of <FIG>, the two sleeves <NUM> are identical; in this case the sleeve shown and described with respect to <FIG>. In <FIG>, the sleeves are different, with the sleeve <NUM> of the present application on the forward end, with a prior art sleeve <NUM> on the rearward end. Because the forward sleeve <NUM> is the one that will potentially contact the user, the benefits of enhanced comfort are provided, and it is irrelevant what form the rear sleeve <NUM> takes. Finally, <FIG> is a version with two of the prior art sleeves <NUM> on the catheter <NUM>. Although this embodiment will not provide the comfort of the improved gripping sleeve described herein, it is included to show that the advantages of having two gripping sleeves on one catheter are present even with the earlier sleeves.

<FIG> are top plan views of alternative shapes and configurations of exemplary gripping sleeves. The standard shape for gripping sleeves in the urinary catheter field is as shown in <FIG>, which has a proximal rectangular section and the tapered distal section <NUM>. The tapered distal section <NUM> is provided to prevent the gripping sleeve <NUM> from sliding completely over the proximal funnel <NUM> to keep the assembly together. However, other shapes for the gripping sleeves are possible.

For example, <FIG> illustrates a gripping sleeve <NUM> formed by the juxtaposition of two identical rectangular sheets of flexible material, preferably textured on the inside. The longitudinal sides of the sheets of material are bonded together except at a distal or forward portion <NUM>, which as explained above, can be as small as <NUM>-<NUM> long. Because the two sheets of material are not bonded at the distal end, they do not present a sharp bonded corner which can cause irritation to the patient.

<FIG> illustrates another generally rectangular gripping sleeve <NUM> formed with two sheets of flexible material that are bonded along the longitudinal side edges. As with certain embodiments described above, distal corners <NUM> of the gripping sleeve <NUM> are rounded. The rounded corners <NUM> may be bonded together, or the two sheets may be bonded along their straight longitudinal edges all the way up to the beginning of the curvature of the rounded corners and <NUM>.

<FIG> shows a still further rectangular gripping sleeve <NUM> formed by two offset sheets of flexible material bonded together along their longitudinal side edges. A top sheet <NUM> is offset in a proximal direction over a bottom sheet <NUM>. This leaves a short distance of just the bottom sheet <NUM> at the distal end of the gripping sleeve <NUM>, which presents highly flexible and thus non-irritating distal corners to the user.

<FIG> shows a fully tapered gripping sleeve <NUM> that has a larger width at its proximal end of its distal formed by two identical sheets of flexible material bonded together along part of their long straight side edges. Much like the gripping sleeve <NUM> in <FIG>, the side edges along a distal or forward portion <NUM> remain unattached to avoid the sharp bonded corners that cause discomfort to the patient.

<FIG> shows another fully tapered gripping sleeve <NUM> formed by identical sheets of flexible material that are larger on their proximal ends and the distal ends. Distal corners <NUM> are again rounded to reduce discomfort to the patient. As before, the corners <NUM> may be bonded or not.

Claim 1:
A gripping sleeve (<NUM>) for handling a urinary catheter, comprising:
a pair of flexible flat sheets of material having textured inner or outer surfaces that each have proximal and distal ends (<NUM>, <NUM>, <NUM>) defining a longitudinal axis therebetween and are bonded together at juxtaposed longitudinal edges (<NUM>) to form the sleeve (<NUM>) which may be expanded into a tubular shape sized to loosely receive a urinary catheter (<NUM>), wherein the longitudinal edges transition to rounded portions (<NUM>) just before the distal ends (<NUM>, <NUM>), wherein the distal end (<NUM>) of a first sheet terminates shorter than the distal end (<NUM>) of a second sheet.