Patent Description:
Intermittent self-catheterization (ISC) is an intimidating procedure for first-time catheter users. Clinicians usually teach first-time users how to perform the ISC procedure. In fact, a significant amount of time each year is spent training first-time catheter users. Despite having received training, many of these users remain apprehensive about self-catheterizing because they do not feel comfortable performing the procedure alone or did not initially receive proper training. When a person either refuses to catheterize or is improperly trained on the procedure, he is likely to develop a urinary tract infection. Thus, it is imperative that ISC users are both comfortable and adequately trained on the procedure.

Generally, catheter packaging is sold with enclosed instructions. These instructions are typically written and geared toward the experienced catheter user. While the instructions may generally provide the user with direction, the steps are presented in a manner that may be daunting or confusing to a new user. For example, the directions may instruct a user to "clean the gland" without providing any additional details regarding how the gland should be cleaned. This type of ambiguity may leave a new user hesitant to complete the ISC procedure. For these reasons, there exists a need for a catheter training kit that makes the ISC procedure simple to understand and easier to handle. <CIT> discloses a packaging assembly for a hydrophilic catheter which permits activation of a hydrophilic coating on the catheter and introduction of the catheter into a urethra in a sterile condition. <CIT> discloses a catheterization tray which is intuitively arranged and includes instructions printed thereon to improve the catheterization implementation and results.

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

In one aspect of the present disclosure, there is provided a packaging assembly for a self-catheterization that includes a urinary catheter and a package having a plurality of panels including step-by-step written and/or pictorial instructions for use of the urinary catheter. The plurality of panels may be superimposed one atop of the other and sequentially arranged in the order of the step-by-step instructions with a first step being on the top panel and subsequent steps being on lower panels. The panels are moveable relative to succeeding panels to reveal instructions for the subsequent step in the use of the urinary catheter.

In another aspect, a medical packaging assembly includes a medical device and a package having a plurality of panels including step-by-step written and/or pictorial instructions for use of the medical device. The plurality of panels may be superimposed one atop of the other and sequentially arranged in the order of the step-by-step instructions with a first step being on the top panel and subsequent steps being on lower panels. The panels are panels being moveable relative to succeeding panels to reveal instructions for the subsequent step in the use of the medical device.

In yet another aspect, a method, not being part of the present invention, of intermittent self-catheterization training includes providing a user with a supply of training catheter packaging assemblies wherein the training catheter packaging assemblies reveal step-by-step instructions as the user opens the packaging assembly.

An exemplary packaging assembly <NUM> for a self-catheterization kit is shown in <FIG>. <FIG> illustrates the packaging assembly <NUM> at each progressive step in the catheterization process. The packaging assembly <NUM> reveals the proper or suggested order of contamination-free self-catheterization and may be particularly useful in a training regimen for new catheter users. For example, a healthcare professional may provide initial in-person training to the user regarding the proper or suggested steps for intermittent self-catheterization. The user may then be provided with a supply of training packaging assemblies, such a packaging assembly <NUM>, which the user will use for a suggested or set period of time, e.g., a week to a month. The training packaging assemblies allow the user to become comfortable with performing self-catheterization, i.e., become comfortable with the procedure and the physical steps required to perform contamination-free self-catheterization.

The training packages include step-by-step instructions that are revealed as the user opens the package. Alternatively or in conjunction with the instructions, the training packages may also include one or more machine readable codes that could be read by a machine reader that displays additional content, such as written or oral instructions or an instructional video. For example, the machine readable code could be a bar code or a two dimensions bar code, such as a QR code, and the machine reader could include a camera to capture the code wherein the machine retrieves and displays additional content related to the instructions. In one embodiment, the machine reader could be a portable/mobile device, such as a mobile phone, tablet or computer. In another embodiment, the machine readable code could be wirelessly connected or detectable by the machine reader. For example the machine readable code could be an RFID tag that is wirelessly connected or detectable by the machine reader, which may be any of the above mentioned devices.

Once the user has become comfortable with self-catheterization, the user will discontinue use of the training packaging assembly and graduate to using common everyday self-catheterization packaging assemblies.

Referring to <FIG>, <FIG>, in the illustrate embodiment, packaging assembly <NUM> has a box-like configuration that includes a compartment <NUM> (<FIG> and <FIG>) for containing catheter <NUM>, which may be any suitable urinary catheter. The box-like packaging assembly <NUM> may be made from paper/cardboard, metal foil, polymer films, metal/polymer multi-layered foils or combinations thereof. In one embodiment, for example, the packaging assembly may take the form of a pliable or flexible package made from metal and/or polymer films.

<FIG> and <FIG> illustrate an exemplary catheter <NUM> that includes a catheter shaft <NUM> having a proximal insertion end <NUM> and a distal drainage end <NUM> having a funnel <NUM> associated therewith. The catheter <NUM> may, optionally, include an insertion aid <NUM> associated with the proximal insertion <NUM> of the catheter shaft <NUM>. The insertion aid <NUM> includes a passageway in which the catheter <NUM> is advanced therethrough. The insertion aid <NUM>, optionally, may include an insertion tip <NUM> that is inserted into the urethral opening prior to advancement of the catheter <NUM>. The insertion tip <NUM> may, optionally, be covered by a removable cap (not shown). The distal end of the insertion tip <NUM> includes a normally closed opening <NUM> through which the catheter <NUM> is advanced to insert the catheter into the urethra. The insertion aid <NUM> may be gripped by the user to handle the catheter and insert the insertion tip <NUM> of the insertion aid <NUM> into the urethral opening. After the insertion tip <NUM> is inserted into the urethra, the catheter <NUM> is then advanced through the insertion aid <NUM> and the insertion tip <NUM> into urethra. If the insertion aid <NUM> does not have an insertion tip, the insertion aid <NUM> may be used to insert the insertable end <NUM> of catheter <NUM> directly into the urethra.

In the embodiment shown, the insertion aid <NUM> has an oversized gripping portion <NUM> that may be easier for a newer user to grip. For example, the gripping portion <NUM> may have a length A of about <NUM> to <NUM> in the direction of the axis of the catheter <NUM> and a cross-sectional width B of between about <NUM> or greater. As illustrated in <FIG> the oversized gripping portion <NUM> may have different shapes and sizes, as shown for example by gripping portions 28a, 28b, 28c, 28d and 28e. For example, the gripping portion may have a triangular, rectangular, round or star-shaped cross-section. The gripping portion may also have contoured, curved or indented outer surface(s). For example, gripping portion 28a includes an indent 29a between the proximal and distal ends 31a and 33a of the gripping portion 28a. The indent 29a may circumscribe the gripping portion or may be on one or more sides. Gripping portion 28d includes concaved sides 29d. Also, the gripping portion <NUM> may be textured. For example, it may include bumps or ridges. The shape and size of the gripping portion <NUM> may be tailored to the individual users comfort and preference.

<FIG> shows top side of the packaging assembly <NUM> and <FIG> shows the bottom side of the packaging assembly. Referring to <FIG>, on the top side of the packaging assembly <NUM> there is a first removable panel <NUM> which includes the first step <NUM> of the instructions for use of the catheter. The instructions and associated steps may be in written textual and/or pictorial format and the order of the steps may be indicated by alpha or numeric indicators (i.e., A, B, C or <NUM>, <NUM>, <NUM>). In the illustrated embodiment, the first step <NUM> of washing the user's hands is shown pictorially and indicated by the numeral "<NUM>". The removable panel <NUM> may optionally include a machine readable code 35a that may be read by a machine reader. The machine readable code 35a, and those discussed below, may be any of the above discussed machine readable codes. In the illustrated embodiment, the machine readable code 35a is a QR code that may be read by an optical machine reader, such as the camera of a mobile phone or tablet. The code may be associated with content obtainable from the internet or stored in the machine reader. When the machine reader reads the machine readable code 35a, the machine reader displays or is connected to a device that displays the associated content, which may be additional written or oral instructions or a video. For example, the user may use his/her mobile phone to read the QR code wherein the mobile phone accesses the associated content and displays such content to the user. The panel <NUM> also includes a gripping portion, such as a ring <NUM>, which the user may grip and pull to remove or peel back the first panel.

<FIG> shows the first panel <NUM>, which was superimposed over a second panel <NUM>, removed to expose the second panel <NUM> to the user. In the illustrated embodiment, the second panel <NUM> includes the second and third steps <NUM>, <NUM> for self-catheterization contained thereon. The second panel <NUM> may optionally include machine readable codes 35b and 35c associated with steps <NUM> and <NUM>, respectively. The second step <NUM> of using an antiseptic wipe to clean the gland of the penis is provided pictorially and in text and is indicated by the number "<NUM>". The antiseptic wipe may be supplied separately from the packaging assembly <NUM> or may be attached or contained within the packaging assembly <NUM>. For example, the wipe may be held in a compartment that is integral with the second panel <NUM> or a package containing the antiseptic wipe may be attached to the second panel <NUM> or to the outside of the packaging assembly <NUM>. The third step <NUM> of disposing of the spent antiseptic wipe is also provided pictorially and in text and is indicated by the number "<NUM>".

The second panel <NUM> also includes a gripping portion, such as a ring <NUM>, which the user may grip and pull to remove or peel back the second panel <NUM>. Referring to <FIG>, when the second panel <NUM>, which is superimposed over the third panel <NUM>, is removed, the third panel <NUM> is revealed to provide the user with further instructions. Additionally, in the illustrated embodiment, when the second panel <NUM> is removed, an opening or access to the compartment <NUM> containing the catheter <NUM> is exposed so that the use may remove the catheter <NUM>.

In the illustrated embodiment, the third panel <NUM> includes the fourth, fifth, sixth and seventh steps <NUM>, <NUM>, <NUM>, and <NUM> for self-catheterization. The third panel <NUM> may optionally include machine readable codes 35d, 35e, 35f and <NUM> associated with steps <NUM>, <NUM>, <NUM>, and <NUM>, respectively. The fourth step <NUM> of removing the catheter <NUM> from the packaging assembly and directing the funnel <NUM> of the catheter <NUM> into the toilet is provided pictorially and in text and is indicated by the number "<NUM>". The fifth step <NUM> of removing the protective cap from the introducer aid <NUM> is also provided pictorially and in text and is indicated by the number "<NUM>". The sixth step of pushing the catheter <NUM> into the insertion aid <NUM> is provided pictorially and in text and is indicated by the number "<NUM>". The seventh step of inserting the insertion aid <NUM> and catheter <NUM> are provided pictorially and in text and are indicated by the number "<NUM>".

Referring to <FIG>, when the catheter <NUM> is removed from the compartment <NUM>, the eighth step <NUM> of disposing the catheter <NUM> and washing hands are exposed. In the illustrated embodiment, the eighth step <NUM> is provided on a bottom panel <NUM> defining a portion of compartment <NUM> that contains the catheter <NUM>. The bottom panel <NUM> may also include a machine readable code <NUM>, which is associated with step <NUM>.

It will be understood that the package <NUM> may be used with any suitable urinary catheter and that depending on the catheter and its intended use, the instructions and additional content associate with the machine readable code may vary depending on such use. For example, instructions for use may vary between male catheters and female catheters or between hydrophilic catheters and gel-lubricated catheters.

Claim 1:
A self-catheterization intermittent urinary catheter training packaging assembly (<NUM>), comprising:
an intermittent urinary catheter (<NUM>);
a package having a compartment (<NUM>)
containing the intermittent urinary catheter;
the package comprising a plurality of panels (<NUM>, <NUM>, <NUM>) including step-by-step written and/or pictorial self-catheterization training instructions for using the intermittent urinary catheter, the plurality of panels being superimposed one atop of the other and sequentially arranged in the order of the step-by-step self-catheterization training instructions;
wherein a top superimposed panel is removable from a succeeding underlying panel to reveal the step-by-step self-catheterization training instructions of the succeeding underlying panel; and
wherein one of the underlying panels has an opening therethrough for removing the intermittent catheter from the compartment of the package.