Patent Description:
The present disclosure generally relates to urinary catheters. More particularly, the present disclosure relates to urinary catheter drainage members.

Catheters are used to treat many different types of medical conditions and typically include an elongated tube that is inserted into and through a passageway or lumen of the body. Catheters, and in particular intermittent catheters, are commonly used by those who suffer from various abnormalities of the urinary system, such as urinary incontinence. Urinary catheters generally comprise a tube surface with two ends. A first end has a catheter tip; the tip may be inserted into a user's urethra. A second end generally has a funnel that is used to help facilitate drainage of bodily fluids.

Because urinary catheter drainage members are meant to be inundated with fluids, their connections to the catheter tube must be strong. Single use catheters are known to be manufactured with techniques such as insert molding and glue bonding, using UV curable glues. These glues help connect the catheter tube to the drainage member. When applying glues there are two methods known in the prior art: vertical manufacture and horizontal manufacture.

A problem with the current known manufacturing methods is that they produce imprecise and inefficient results. For example, when catheter sizes are large (i.e. Ch <NUM>), currently known catheter drainage member designs do not have enough space for receiving the glues. Because of current drainage members' deficient designs, glue often overflows from the drainage member during manufacturing and this overflow creates a defective part. Additionally, current catheter drainage members do not have a design that allows for consistent and even application of glue when the vertical and horizontal dispensing methods are used. Uneven application may result in contamination of the catheter, rendering the catheter inoperable. Consequently, there is a need for new catheter drainage members which yield more viable connections using both the horizontal and vertical adhesive distribution methods. An example of catheter drainage members is known from documents <CIT> and <CIT>.

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

In one aspect, the catheter drainage member is configured to be attached to a catheter tube and includes a body having an inner surface and a well that is defined by the inner surface of the body. The well is configured to receive the catheter tube and an adhesive. The well is also configured to selectively distribute the adhesive between the inner surface and the tube.

Urinary catheter drainage members according to the present disclosure and their individual components may be variously configured without departing from the scope of the present disclosure, but in one embodiment, a urinary catheter drainage member is configured as shown in <FIG>.

<FIG> shows an example of an embodiment of a urinary catheter <NUM> including a drainage member <NUM> connected to a catheter tube <NUM>. The drainage member <NUM> includes a body <NUM> having a proximal 115a end and a distal end 115b. The catheter shaft <NUM> includes a proximal portion, a distal portion, and a drainage lumen <NUM>. The drainage member <NUM> includes a lumen <NUM> that is fluidically connected to the catheter drainage lumen <NUM>.

<FIG> and <FIG> show an embodiment of a urinary catheter drainage member <NUM> configured to be attached to a catheter tube <NUM>. The drainage member <NUM> comprises a body <NUM> having an inner surface <NUM>. The inner surface <NUM> defines a well <NUM> that is configured to receive the catheter tube <NUM> and an adhesive <NUM>. The adhesive <NUM> may be any suitable adhesive for attaching the catheter tube <NUM> and drainage member <NUM> to each other. For example, the adhesive <NUM> may comprise a UV-light curable glue, such as Dymax adhesives <NUM>-MSK, <NUM>-M, <NUM>-M-UR, <NUM>-M or Henkel adhesives Loctite <NUM>, <NUM> or <NUM>. The well <NUM> is configured to selectively distribute the adhesive <NUM> between the inner surface <NUM> and the tube <NUM>. The well <NUM> also may be configured to evenly distribute the adhesive <NUM>. The adhesive <NUM> may bond the catheter tube <NUM> to the inner surface <NUM>, forming a joint between the tube <NUM> and the drainage member <NUM>. A gap <NUM> is defined between the inner surface <NUM> and the tube <NUM> (<FIG>). The gap <NUM> may be configured to receive the adhesive <NUM>. The adhesive <NUM> moves or is distributed throughout the gap <NUM> (throughout the space between the inner surface <NUM> of the drainage member and the outer surface of the tube <NUM>), as the tube <NUM> is inserted into the well <NUM>. Consequently, more selectively distributed and/or evenly distributed adhesive <NUM> is located between the inner surface <NUM> and the tube <NUM>, which assists in creating a stronger and more durable bond. This distribution of the adhesive occurs with very minimal movement between the tube <NUM> and the drainage member <NUM>. For example, this distribution occurs from inserting the tube <NUM> into the well <NUM> the drainage member <NUM>, with little or no rotation of the tube or the drainage member to distribute the adhesive within the gap <NUM>.

As shown in <FIG> and <FIG>, a portion of the inner surface <NUM> is tapered (the tapered portion <NUM>). The tapered portion <NUM> tapers outwardly from shoulder <NUM> to end wall <NUM>. The tapered portion <NUM> of the inner surface <NUM> results in the inner surface <NUM> defining a non-symmetrical well <NUM> that has a wider side 118b and a narrower side 118a. The tapered portion <NUM> may be configured such that when the tube <NUM> is inserted angular momentum is applied to the adhesive <NUM> to distribute adhesive <NUM> about the well <NUM>.

The tapered portion <NUM> controls the motion and flow of the adhesive <NUM> relative to the inner surface <NUM>. Specifically, in the embodiment shown in <FIG>, before the catheter tube <NUM> is inserted into the drainage member <NUM>, adhesive <NUM> is placed on one side of the catheter tube <NUM>, the adhesive side 116a. The adhesive side 116a is aligned with the wider side 118b of the tapered portion <NUM>. The catheter tube <NUM> is then inserted into the drainage member <NUM>. As the drainage member <NUM> and catheter tube <NUM> are coupled for attachment, the motion between the adhesive <NUM>, the inner surface <NUM>, and the tube <NUM> applies angular, axial, and radial momentum to the adhesive <NUM>. The angular momentum distributes adhesive <NUM> about the well <NUM> and moves the adhesive <NUM> around the circumference or periphery of the tube <NUM>, increasing the contact area between the adhesive <NUM> and the catheter tube <NUM>, as well as increasing contact area between the adhesive <NUM> and the drainage member <NUM>. Thus, the tapered portion <NUM>, which defines the non-symmetrical well <NUM>, facilitates increased adhesive coverage of the inner surface <NUM> with little or no rotation of the catheter tube <NUM> relative to the drainage member <NUM>. The increased contact area caused by the tapered portion <NUM>, leads to a stronger joint and a more efficient and effective manufacturing process.

<FIG> shows the drainage member <NUM> just prior to being assembled using a horizontal method. In the horizontal method the catheter tube <NUM> is placed horizontally relative to the drainage member <NUM> and adhesive <NUM> is applied directly onto the catheter tube <NUM>. In the embodiment shown a small continuous amount of adhesive <NUM> is placed on the catheter tube <NUM>. Alternatively, in other embodiments, a plurality of discontinuous dots of adhesive <NUM> may be placed on the catheter tube <NUM>. The number of adhesive <NUM> dots may be any appropriate number. For example, two dots of adhesive may be placed on the catheter tube <NUM>. The distance apart of the dots may be any appropriate distance. For example, when the tube <NUM> is cylindrical, the dots may be placed at <NUM> degrees from each other. In one embodiment, the dots may be placed at <NUM> and <NUM> o'clock wherein the reference point <NUM> o'clock is at the top of the tube. The tube <NUM> is attached to the drainage member by pushing the catheter tube <NUM> into the well <NUM> of the drainage member <NUM>. The attachment also may occur by pushing the drainage member <NUM> into the catheter tube <NUM>. When a UV cured adhesive <NUM> is used, after insertion of the tube and distribution of the adhesive, the joint may be formed by applying UV light <NUM> to cure the adhesive <NUM>.

<FIG> shows an embodiment of the drainage member <NUM> where the drainage member <NUM> has a well <NUM> that includes a symmetrical conical cavity <NUM>. The symmetrical conical cavity <NUM> facilitates adhesive <NUM> dispensing, while minimizing the amount of adhesive <NUM> used. Dispensing of adhesive <NUM> is controlled by positioning the adhesive dispensing needle in the well <NUM>. The well <NUM> reduces and/or contains spillage and enables the adhesive <NUM> to flow into the adhesive gap <NUM> (or <NUM>) where the adhesive is effective to bond the two components. Moreover, when a UV light <NUM> is present to cure the adhesive <NUM>, the symmetrical conical cavity <NUM> may optimize UV light <NUM> penetration and curing speed. Curing speed is optimized due to the design of the symmetrical conical cavity <NUM>. The symmetrical conical <NUM> cavity minimizes the volume of adhesive needed to affect a secure bond between the funnel <NUM> and the catheter tube <NUM>. Smaller amounts of adhesive <NUM> require less UV energy to cure, so minimizing the amount of adhesive <NUM> can speed up the curing process, since less UV light energy is needed.

A gap <NUM> is defined in the space between the catheter tube <NUM> and the inner surface <NUM>. The gap <NUM> is configured to receive adhesive <NUM> and allow bonding and an interference fit between the catheter tube <NUM> and the drainage member <NUM>. The gap <NUM> is wider when the catheter tube <NUM> is smaller in size and narrower when the catheter tube <NUM> is larger in size.

<FIG> shows an embodiment of the drainage member <NUM> where the drainage member <NUM> has a well <NUM> that includes a concave profile <NUM> and the inner surface <NUM> of the drainage member <NUM> has a convex profile. The concave profile <NUM> is configured to facilitate dispensing of the adhesive <NUM> and may minimize the amount of the adhesive <NUM> needed for attachment. Additionally, the concave profile <NUM> reduces the penetration length of UV light <NUM> beams, making it easier to cure the adhesive <NUM> at the joint <NUM>. This embodiment also includes a gap <NUM>, similar to that described above.

<FIG> shows an embodiment of the drainage member <NUM> where the drainage member <NUM> has a well <NUM> that includes a convex profile <NUM> and the inner surface <NUM> of the drainage member <NUM> has a concave profile. The convex profile <NUM> is configured to facilitate dispensing of the adhesive <NUM> and may be used in those embodiments wherein additional adhesive <NUM> is desired.

<FIG> shows an embodiment of the drainage member <NUM> where the drainage member <NUM> includes a body <NUM> having a longitudinal axis L. The inner surface <NUM> includes at least one channel <NUM> extending in the direction of the longitudinal axis L. The at least one channel <NUM> is in communication with the well <NUM>. Additionally, the at least one channel <NUM> may include a plurality of channels <NUM>.

In the embodiment shown in <FIG>, the drainage member <NUM> has four channels <NUM>. Though this embodiment has four channels <NUM>, other embodiments may have more than four channels <NUM> or less than four channels. The number of channels <NUM> may be selected according to the desired use. In <FIG> the channels <NUM> are axial channels that are aligned with the long axis L. At least one channel <NUM> extends from a proximal opening <NUM> in the drainage member <NUM>. The channels <NUM> are configured to communicate with the well <NUM> and may be configured to communicate between the well <NUM> and the gap between the inner surface <NUM> of the drainage member <NUM> and the catheter tube <NUM>, when the catheter tube <NUM> is located within the well <NUM>. Furthermore, the channels <NUM> may communicate with each other. For example, the inner surface <NUM> of the drainage member <NUM> may include additional channels (not shown) that extend about the circumference of the inner surface <NUM> and connect the channels <NUM>.

The channels <NUM> increase the volume of the well <NUM> by creating a pathway for a greater amount of adhesive <NUM> to fit between the catheter tube <NUM> and the drainage member <NUM>. The increased amount of space created by the channels <NUM> allows a larger quantity of adhesive <NUM> to be moved into the gap between the inner surface <NUM> and the catheter tube <NUM> and to fill the surface area between the catheter tube <NUM> and the inner surface <NUM> of the drainage member <NUM>. The greater amount of adhesive <NUM> in the gap may assist in creating a stronger bond between the catheter tube <NUM> and the drainage member <NUM>. Thus, the channels <NUM> improve the distribution of adhesive <NUM> in the gap.

Any suitable method may be used to create the channels <NUM>. One method may include using a profiled core pin to create the channels <NUM> in the long axis L of the drainage member <NUM>. The channels <NUM> may be created as the drainage member <NUM> is being molded.

<FIG> show an embodiment of the drainage member <NUM> where the well <NUM> defines an opening <NUM> and the inner surface <NUM> defines a profile <NUM>. The profile <NUM> changes from a circular configuration <NUM> at the well opening <NUM> to an oblong configuration <NUM> at a section <NUM> distal from the opening <NUM>. Thus, the profile <NUM> of the inner surface <NUM> is configured to change from the circular configuration <NUM> at the well opening <NUM> (without an inserted catheter tube <NUM>) to the oblong configuration <NUM> when a catheter tube <NUM> is inserted into the drainage member <NUM>. Thus, the drainage member <NUM> has different cross-sectional profiles at the well <NUM> and the distal section <NUM>.

An enlarged view of the difference in profile shapes is shown in <FIG>. The shape of the well opening <NUM> with the circular configuration <NUM> is visible, and the shape of the distal section <NUM> with the oblong configuration <NUM> is visible.

<FIG> shows the drainage member <NUM> without the catheter tube <NUM> inserted. The circular profile <NUM> of the well <NUM> is visible, and the change to an oblong profile <NUM> at the distal section <NUM> is visible.

<FIG> illustrates the well <NUM> with the catheter tube <NUM> inserted. As shown in <FIG>, the catheter tube <NUM> and/or the well <NUM> may change shape as the catheter tube <NUM> passes through the oblong profile <NUM> of the distal section <NUM>. The catheter tube <NUM> is compressed by the distal section <NUM>. The compression causes the catheter tube <NUM> to make contact with the sides of the drainage member <NUM>. The compressed catheter tube <NUM> also creates two spaces at the top and bottom of the well <NUM> (the glue gaps <NUM>): a top gap 436a and a bottom gap 436b. Adhesive <NUM> may be placed on one or both sides of the catheter tube <NUM>-- the catheter tube top 416a and the catheter tube bottom 416b. A strong interference fit may be formed between the drainage member <NUM> and the catheter tube <NUM>. The oblong profile <NUM> creates a mechanical bond between the sides of the compressed drainage member <NUM> which directly contact the catheter tube <NUM>, while the gaps 436a, 436b create increased space for containing adhesive <NUM> to bond the top 416a and/or bottom 416b of the catheter tube <NUM> to the drainage member <NUM>. Additionally, in one embodiment the oblong profile <NUM> may cause two gaps, such that one of the gaps (436a, 436b) is larger than the other. For example, in one embodiment the top gap 436a may be larger than the bottom gap 436b so that the top gap 436a has more space for receiving adhesive <NUM> than the bottom gap 436b. The uneven gap sizes create two different sized sites for dispensing adhesive <NUM>. The different sized sites lend versatility to the drainage member <NUM>.

<FIG> show an embodiment of the drainage member <NUM>, where the drainage member <NUM> includes a proximal end portion <NUM> that has a sloped diagonal profile which defines a well <NUM> having a sloped diagonal end profile. <FIG> shows a side view of the drainage member <NUM> and <FIG> shows a perspective view of the drainage member <NUM>. The sloped diagonal end <NUM> increases the volume of a standard circular shaped well by increasing the length of one side of the well <NUM>. The diagonal end <NUM> deepens one side of the well <NUM> and creates a bigger space so that the well <NUM> is able to receive an increased amount of adhesive <NUM>. The diagonal end <NUM> may be used with the horizontal dispensing method and in situations where a larger catheter tube <NUM> is attached to the drainage member <NUM>.

<FIG> shows an embodiment of the drainage member <NUM> wherein the proximal end <NUM> of the drainage member <NUM> includes at least one slot <NUM>. The slot <NUM> may be configured to extend from the proximal end <NUM> of the drainage member <NUM> toward the distal end. Using a slot <NUM> increases portions of the well <NUM> without having to increase the entire portion of the drainage member <NUM> defining the well <NUM>. That is, the slot <NUM> provides the benefits of a larger well <NUM> with use of less material. Also, the increased portions of the well <NUM> provide an increase in volume of the well <NUM>, which in turn allows for the well <NUM> to receive an increased amount of adhesive <NUM>. The slot <NUM> may be utilized with the horizontal dispensing method wherein the axis of the catheter tube <NUM> and the axis of the drainage member <NUM> are horizontal to the ground when being assembled and the adhesive <NUM> is dispensed onto the tube <NUM> and in line with the slot <NUM>. As shown in <FIG>, the drainage member <NUM> may also be used with a vertical method of adhesive <NUM> dispensing. In the vertical method, the catheter tube <NUM> is inserted into the well <NUM> of the drainage member <NUM>, followed by dispensing the adhesive <NUM> into the well <NUM>. <FIG> shows the adhesive <NUM> being dispensed by two glue dispensers <NUM> on at least one peak <NUM> between the slot <NUM>. After the adhesive <NUM> is dispensed, the adhesive <NUM> moves around the catheter tube <NUM> and then may move along the gap <NUM>. The flow of adhesive <NUM> is driven primarily by gravity, excess surface free energy of the adhesive <NUM>, and injection pressure of the adhesive <NUM>. Adhesives <NUM>, with appropriate surface viscosity and surface tension may be selected. Once the adhesive <NUM> is dispensed, a UV light <NUM> may be used to cure the adhesive <NUM>.

The drainage member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) embodiments described above may be at least partially made of a rigid polymeric material. For example, at least a surface of the drainage member may be molded or extruded from plasticized polyvinyl chloride (PVC), polyethylene, polypropylene, or other suitable, biocompatible polymeric materials.

Claim 1:
A catheter drainage member (<NUM>) configured to be attached to a catheter tube (<NUM>), the drainage member (<NUM>) comprising:
a body (<NUM>) having an inner surface (<NUM>) that includes a tapered portion (<NUM>); characterized in:
a non-symmetrical well (<NUM>) defined by the tapered portion (<NUM>) of the inner surface (<NUM>) of the body (<NUM>), the non-symmetrical well (<NUM>) extending from a shoulder (<NUM>) to an end wall (<NUM>) of the body (<NUM>) and having a wider side (118b) and a narrower side (118a), the non-symmetrical well (<NUM>) configured to receive a distal end (115b) of a catheter tube (<NUM>) and an adhesive (<NUM>); and
wherein the non-symmetrical well (<NUM>) is configured to selectively distribute the adhesive (<NUM>) between the inner surface (<NUM>) and the catheter tube (<NUM>).