Patent Description:
Catheters are used to treat many different types of medical conditions and typically include an elongated catheter tube that is inserted into and through a passageway or lumen of the body. Urinary catheters and, in particular, intermittent urinary catheters are commonly used by individuals who suffer from certain abnormalities of the urinary system, such as urinary incontinence. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual's bladder. Individuals who suffer from urinary incontinence will self-catheterize several times a day.

Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the user's urethra. In many cases, users of intermittent urinary catheters have limited or diminished dexterity that is often the result of spinal cord injuries. Users of intermittent catheters are often required to self-catheterize outside the privacy of the home, such as in public restrooms. Thus, for these and other reasons, it is desirable that the intermittent catheters are provided in discreet packaging that is easy to open, compact and portable.

In addition to the desire for discreet packaging, portability and compactness, ease of handling and patient comfort during insertion of the catheter into the urethra are also goals of urinary catheter manufacturers. Properly positioning the catheter, manipulating the catheter and advancing the catheter in a way that limits or avoids discomfort and irritation to the urethral canal is not without its challenges. Thus, it would be desirable to provide a catheter and catheter assembly that can accommodate different ways of grasping the assembly in accordance with the user's preference. It would also be desirable to provide a compact catheter wherein the insertable portion is preconfigured to compliment the shape of the urethra and, more particularly, the female urethra. It would also be desirable to provide a combined catheter and handle that includes a curved angle of insertion for a female user that is in accordance with the female anatomy, and also allows for insertion in a difficult to view manner (i.e., "blinded insertion").

<CIT> discloses a urinary catheter assembly.

In one aspect, the present disclosure is directed to a urinary catheter assembly according to claim <NUM>. The urinary catheter assembly includes an elongated housing that has a closed proximal end, an open distal end and wherein the housing defines a catheter chamber. The catheter assembly also includes a catheter subassembly that has a gripping member and a catheter tube extending therefrom. The gripping member includes an internal flow path in flow communication with the flow path of the catheter tube and an outlet in the gripping member. The gripping member and the open distal end of the housing are mutually sized and shaped to fixedly retain the gripping member whereby in a first configuration the catheter tube is concealed within the chamber and whereby in a another configuration the catheter extends away from the housing.

In another aspect, the present disclosure is directed to a catheter assembly that includes a handle that has a closed proximal end, an open distal end. The handle has a non-linear profile of a selected curvature. The catheter assembly also includes a catheter subassembly carried by the handle. The catheter subassembly includes a gripping member attached to the handle at the open distal end and a catheter tube that extends from the gripping member in a direction away from the handle.

In a more particular aspect, the catheter assembly may define a generally continuous curved profile wherein the catheter tube extends from said gripping member in the same directional curve as the handle. Alternatively, the catheter assembly may define a profile wherein the catheter tube extends from the gripping member in a direction that curves away from the curvature of the handle.

The present disclosure is directed to urinary catheters and, in particular, urinary catheters for females that are compact when in their undeployed condition. The catheter assemblies disclosed herein may include a catheter subassembly that can be removed from a housing and mounted onto the housing to provide the user with an enlarged handling or grasping area. Catheter assemblies of the type disclosed herein typically include a curved catheter tube that substantially compliments the curvature of the female urethra. The catheter assemblies disclosed herein also allow the user (typically female) to adapt the assembly for different use positions.

<FIG> shows a catheter assembly in accordance with the present disclosure. As shown in <FIG>, catheter assembly <NUM> includes a housing <NUM> having a proximal end <NUM> and an open distal end <NUM>. Housing <NUM> defines an interior chamber <NUM> (shown in <FIG>) for receiving at least the catheter tube of a catheter subassembly described further below. Housing <NUM> is preferably made of a lightweight, relatively rigid polymeric material. Preferably, the polymeric material is a relatively rigid material that protects the contents of the catheter assembly <NUM>. The polymeric material also may have a low Moisture Vapor Transmission Ratio (MVTR). In addition, it is preferable that the polymeric material of housing <NUM> be non-transparent and opaque (and, for example, available in different colors), such that the contents of housing <NUM> cannot be easily identified. Polymeric materials that are suitable for use in housing <NUM> include polyvinyl chloride, polycarbonate, nylon, ABS and polyethylene. As noted earlier, catheter assembly <NUM> is preferably of a compact size, which is suitable for transporting in a purse, a small pouch, or on the person in a discreet manner.

Catheter subassembly <NUM> includes a base or gripping member <NUM>. At least a portion of gripping member <NUM> may likewise be made of a suitable polymeric material, such as the polymeric material used for housing <NUM> as described above. Extending from gripping member <NUM> is a catheter tube <NUM>. Catheter tube <NUM> includes a proximal end <NUM> and a distal end <NUM> attached to gripping member <NUM>. The terms "distal" and "proximal" are used throughout this disclosure. When used in the context of the catheter tube that is inserted into the body of the user, the term "proximal" is used to refer to that end or portion of the catheter tube that during use is closer in proximity to the user's body and/or initially enters the user's body upon insertion. The term "distal" is used to refer to an end or portion of the catheter tube that is opposite the proximal end or portion and is typically further away from the user's body. For the sake of consistency, when the terms "distal" and "proximal" are used in the context of a housing that receives the catheter tube such as housing <NUM> described above and shown in the Figures, which are not intended for introduction into the user's body, a proximal end or proximal portion is that end or portion closer to the proximal end of the catheter tube when the catheter tube is housed within such housing, while the distal end or portion is located opposite to such proximal end or portion. Catheter tube <NUM> defines an internal flow path <NUM> for transporting urine therethrough. Catheter tube <NUM> includes eyelets <NUM> at or near the proximal end of catheter tube <NUM> for receiving liquid flow and communicating liquid (e.g., urine) to flow path <NUM>.

Catheter tube <NUM> may be made of a biocompatible polymeric material having sufficient stiffness that it can be provided in and maintain a curved profile as shown in the Figures. The material should be such that catheter tubes made therefrom can be easily inserted into the body of the user, yet flexible enough to avoid causing pain or discomfort to the user and to allow for movement within the urinary canal. Materials that are suitable for use as catheter tube <NUM> include polyvinyl pyrrolidone (PVP), polyamide, polyanhydride, polyether, poly(ether imide), poly(ester imide), polyvinyl alcohol, polyvinyl chloride, polycarbonate, poly(c-caprolactone) with polymethylvinylsiloxane, poly(ethylene-co-(vinylacetate)) with dicumylperoxide, poly(D-lactide), poly(L-lactide), poly(DL-lactide) and poly(glycolide-co-(c-caprolactone))-segments, multiblock copolyesters from poly(c-caprolactone) and PEG and chain extender based on cinnamic acid groups, poly(c-caprolactone) dimethacrylate and n-butyl acrylate, oligo(c-caprolactone) diols, oligo (p-dioxanone) diols and diisocyanate, linear density polyethylene, linear low density polyethylene, high density polyethylene, and polypropylene. Catheter tube <NUM> may also be entirely made of a hydrophilic material or a material that has been made hydrophilic. Additional details of such hydrophilic catheters and activation thereof are described in <CIT>.

As seen in <FIG>, flow path <NUM> of catheter tube <NUM> communicates with an internal flow path <NUM> of gripping member <NUM>. Flow path <NUM> of gripping member <NUM> terminates in outlet <NUM>. Outlet <NUM> is preferably located on gripping member <NUM> in a location where, during use, urine flowing through flow path <NUM> of gripping member <NUM> will be directed toward the toilet. For example, as shown in <FIG>, flow path <NUM> gradually curves approximately <NUM>-<NUM>° from the point where it receives the distal end of catheter tube <NUM> to the point where it terminates in outlet <NUM>. This allows the (female) user in a typical self-catheterizing position to direct and insert the curved catheter tube into her urethra with outlet <NUM> open to urine receptacle (e.g., toilet), thereby allowing for direct drainage of urine into the receptacle. Outlet <NUM> may include an inner surface, such as a threaded surface <NUM> or other surface to which an external urine collection bag may optionally be attached to the gripping member at outlet <NUM>.

As shown in <FIG>, at least a portion of gripping member <NUM> may include a textured or other roughened gripping surface or region <NUM>. In one embodiment, gripping surface <NUM> may be provided as a defined region of gripping member <NUM>. In that regard, housing <NUM> may include a cutout portion <NUM> which leaves the gripping surface <NUM> exposed and accessible for grasping by the user.

Housing <NUM> may further include a hydration element <NUM> or other element for making tube <NUM> more lubricious contained within chamber <NUM> of housing <NUM>, as shown in <FIG>. Hydration element <NUM> contains an agent that may activate the hydrophilic coating of catheter tube <NUM>, thereby making tube <NUM> more lubricious. In one embodiment, hydration element <NUM> may be provided as a sealed sachet or pillow <NUM> that includes water or other aqueous solution within it. Hydration element <NUM> may be secured to the wall of interior chamber <NUM> or freely placed within chamber <NUM>.

In one embodiment, hydration element <NUM> may preferably be made of a suitable material that is selected to release the hydrating agent, such as water vapor, through its walls. In addition, the hydration element may include an insert made of a material that retains water or other aqueous solution. In one embodiment, the insert may be made of calcium carbonate, while the walls of the hydration element containing the insert may be made of a polymeric material that is vapor permeable but liquid impermeable.

In another embodiment, the system of hydrating or for otherwise making tube <NUM> more lubricious may include a liner or sleeve <NUM> received by housing <NUM>. As shown in <FIG>, liner <NUM> may be a substantially cylindrical tube closed at its proximal end <NUM> with an opening <NUM> at its distal end for receiving catheter tube <NUM>. Liner <NUM> may be curved similarly to housing <NUM> and catheter tube <NUM> to be received by housing <NUM> and receive catheter tube <NUM>, respectively. Liner <NUM> may include windows <NUM> that allow for passage of liquid or vapor and contact with catheter tube <NUM>. Where vapor hydration is used to make the catheter tube more lubricious, a vapor-providing medium may be provided between the outer surface of liner <NUM> and the inner surface of housing <NUM>. Windows <NUM> may be covered with a water-impermeable, vapor permeable material to allow for the passage of (water) vapor. The vapor-providing medium may be an amount of liquid (e.g., water) in the space between the outer surface of liner <NUM> and inner surface of housing <NUM>, or an insert that retains an amount of water or other liquid, as described above.

In yet another embodiment, a lubricating gel may be provided with a closed liner (without windows) or other compartment, such as a gel grommet, that resides within housing <NUM> and receives at least a portion of catheter tube <NUM>. Liner and gel lubricating systems which may be used in the catheter assemblies described above are also disclosed in International Patent Application No. <CIT>.

As shown in the Figures, housing <NUM> may have a non-linear, curved profile. Likewise, catheter tube <NUM> may also have a non-linear, curved profile that is at least substantially identical to the curvature of housing <NUM>. In an embodiment, catheter tube <NUM> is preferably molded, such as injection molded, or may be otherwise formed, such as by a combination of molding and extrusion to arrive at the non-linear, curved profile, as shown in the Figures. In accordance with the present disclosure, the curvature of catheter tube <NUM> may preferably compliment the curvature of the female urethra. In an embodiment, the curvature of catheter tube <NUM> substantially matches the curvature of housing <NUM>.

Catheter assemblies of the present disclosure are capable of existing in several different and various conditions. Catheter assembly <NUM> may exist in a non-deployed condition, as generally shown in <FIG>. In the non-deployed condition, catheter subassembly <NUM> is associated with housing <NUM>, such that catheter tube <NUM> resides within chamber <NUM> of housing <NUM>. Open distal end <NUM> of housing <NUM> and gripping member <NUM> are mutually sized and shaped so that catheter subassembly <NUM> may be retained by housing <NUM>. Retention of gripping member <NUM> at the open distal end <NUM> of housing <NUM> may be by friction-fit or snap-fit.

In a second condition, catheter assembly <NUM> may be removed from housing <NUM> and deployed for use by the patient. From the first condition, the user simply pulls on gripping member <NUM> to release it from housing <NUM>. Gripping surfaces <NUM> may be grasped by the user to separate catheter subassembly <NUM> from housing <NUM>. The user may then, by using gripping member <NUM>, manipulate and guide catheter tube <NUM> for insertion and advancement into the urethra. After catheterization, catheter tube <NUM> may be returned to chamber <NUM> and gripping member <NUM> may be fit into housing <NUM>, as generally shown in <FIG>. The used catheter assembly <NUM> may then be disposed of.

In a third condition, after removal of catheter assembly <NUM> from housing <NUM>, catheter assembly may be mounted onto and carried by housing <NUM>, such that catheter tube <NUM> extends away from housing <NUM>, as shown in <FIG>. Again, as previously described, gripping member <NUM> is mutually sized and shaped with open distal end <NUM> such that gripping member can be mounted by press-fit onto housing <NUM> at open distal end <NUM> with the catheter tube <NUM> extending from and carried by housing <NUM>. In this extended deployed condition, housing <NUM> also serves as an enlarged handle that can be more easily grasped by the user and better manipulated during insertion and advancement. In this regard, housing <NUM> may have a surface that improves gripping or grasping by the user. For example, housing <NUM> may include overmolded, rigid and soft sections in different textures and colors to aid in gripping and holding of catheter assembly <NUM>.

As shown in <FIG>, catheter subassembly <NUM> may be carried by handle <NUM> such that the profile of catheter assembly <NUM> is a continuous curve. In other words, when mounted on housing/handle <NUM>, catheter tube <NUM> extends from gripping member <NUM> in the same directional curve as housing/handle <NUM>. In such embodiment, the profile of the catheter assembly in the extended deployed condition resembles an open form of the letter "C" or is generally "C-shaped.

In an alternative configuration of the extended deployed condition, catheter subassembly <NUM> may be mounted on and carried by housing/handle <NUM> such that catheter tube extends from gripping member <NUM> in a direction that curves away from the curvature direction of handle/housing <NUM>, as generally shown in <FIG>. Thus, in this embodiment, the overall profile of catheter assembly <NUM> resembles an open form of the letter "S" or is generally "S-shaped.

The decision whether to mount catheter assembly <NUM> in the extended deployed condition in the "C" or "S" configuration may depend on user preference and what is more comfortable for the user when attempting to insert and advance catheter tube <NUM>. Inasmuch as many users of urinary catheters may suffer from impaired dexterity, certain users may find a generally "C-shaped" catheter assembly easier to use than a generally "S-shaped" catheter assembly or vice-versa.

In either configuration described above, opening <NUM> in housing <NUM> and gripping member <NUM> are, as previously described, sized and shaped such that gripping member may be snugly press-fit into opening <NUM> while still leaving gripping surface <NUM> and outlet <NUM> (e.g., due to cut-out portion <NUM>) outside of housing <NUM> during use such that the flow of urine is not obstructed and/or a collection container may be readily attached.

Claim 1:
A urinary catheter assembly (<NUM>) comprising:
a) an elongated removable housing (<NUM>) comprising a closed proximal end (<NUM>), an open distal end (<NUM>), said housing defining a catheter chamber (<NUM>); and
b) a catheter subassembly (<NUM>) comprising a gripping member (<NUM>) and a catheter tube (<NUM>) extending therefrom and defining a flow path (<NUM>), said gripping member (<NUM>) including an outlet (<NUM>) and an internal flow path (<NUM>) in flow communication with said flow path (<NUM>) of said catheter tube, wherein said gripping member (<NUM>) is attached to said housing in a first condition wherein said catheter tube (<NUM>) is concealed within said housing chamber (<NUM>), and whereby in another condition said housing is attached to said gripping member (<NUM>) wherein the catheter is exposed to define a non-linear catheter assembly (<NUM>).