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

Catheters are used to treat many different types of medical conditions and typically include an elongated shaft 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. With the advent of intermittent catheters, individuals with urinary system abnormalities can self-insert and self-remove intermittent catheters several times a day.

Urinary catheters are frequently provided as disposable, single-use items. A user will remove the catheter from a package, use the catheter once, and then dispose of the catheter and the package. Reusable urinary catheters could, thus, be advantageous in reducing the amount of waste created by the use of disposable catheters, but there are various challenges associated with the use of reusable catheters (including storage, transport, and sterilization) that must be overcome before widespread acceptance and use of reusable catheters. <CIT> and <CIT> disclose an at-home sterilization, data acquisition, and deposition device for sterilizing multiple medical devices.

There is a need for reusable catheter products and methods of sterilizing the same.

According to the presently claimed invention, a reusable urinary catheter product includes a case comprising a body and a re-closable cap. The body defines a first compartment and a second compartment wherein the first compartment and second compartment are separated by a barrier that allows the passage of sterilizing light. A urinary catheter is located in the first compartment. A sterilizing light source is located in the second compartment, wherein sterilizing light emitted from the light source passes through the barrier and into the second compartment.

Reusable urinary catheter products 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 reusable urinary catheter product <NUM> is configured as shown in <FIG>.

<FIG> show a reusable urinary catheter product <NUM>. The product <NUM> includes a storage and sterilization device, such as a case <NUM>. The case <NUM> includes a body <NUM> and re-closable cap <NUM>. The re-closable cap <NUM> and body <NUM> may be attached to one another in any manner that allows the cap <NUM> to be removed and reattached to the body <NUM> to open and close the opening <NUM> (<FIG>) in the distal end <NUM> of the body <NUM>. For example, the re-closable cap <NUM> may be attached by threads, snap-fit, friction fit, or the like. Referring to <FIG>, the cap <NUM> is removed from the body <NUM> to open the opening <NUM> of the case <NUM> so that the user may access the catheter <NUM> stored within the case <NUM>. Optionally, the cap <NUM> also may be tethered to the body <NUM> by a tether (not shown), so that when the re-closable cap <NUM> is removed from the body <NUM> to open the case <NUM>, the cap <NUM> is tethered to the body <NUM> to reduce the risk of dropping or losing the cap <NUM>.

Referring to <FIG>, the body <NUM> of the case <NUM> may be an elongated body that defines a first compartment <NUM> and a second compartment <NUM> separated by a barrier <NUM>. In the illustrated embodiment, the body may be generally cylindrical. In other embodiments, the body may have a polygonal cross-sectional shape. The first compartment <NUM> is at least partially defined by a portion <NUM> of the body <NUM> that is distal of the barrier <NUM>, and the second compartment <NUM> is at least partially defined by a portion <NUM> of the body <NUM> that is proximal of the barrier <NUM>. In the illustrated embodiment, the second compartment is defined or located at the proximal end portion of the case. Also, in the illustrated embodiment, the plane of the barrier <NUM> extends generally perpendicular to the longitudinal axis A of the case <NUM><NUM>/body <NUM>.

The first compartment <NUM> is configured to hold the catheter <NUM>, and optionally, a liquid or fluid. The catheter <NUM> includes a proximal insertable end <NUM> and a distal end <NUM>. A drainage member <NUM> may be associated with the distal end <NUM> of the catheter <NUM>. The catheter <NUM> may be a hydrophilic catheter that includes a lubricious hydrophilic coating on the catheter shaft <NUM>. When the hydrophilic coating is hydrated, it is activated and becomes lubricious so easing insertion and removal during catheterization.

When a fluid is included in the first compartment <NUM>, the fluid may be a sterilization fluid, a hydration fluid or both. The sterilization fluid may be any suitable sterilization fluid, and when the catheter is a hydrophilic catheter, the sterilization fluid also may serve as a hydration medium that hydrates the hydrophilic material of the coating. For example, the fluid may include one or more of chlorhexidine, FimH inhibitors, antibacterial materials, nanoparticles with bactericidal effects, oxazolidinones, antibacterial proteins, honey, glucose oxidase, silver, and a surfactant configured to loosen a biofilm from the catheter.

The second compartment <NUM> includes a sterilizing light source, such as a UV light source <NUM>. The second compartment <NUM> may also include a power source <NUM>. The power source <NUM> also could, alternatively, be located in a different location from the second compartment <NUM>. The UV light source <NUM> may include one or more light emitting diodes, and the power source <NUM> may include batteries, which may be rechargeable batteries. Sterilizing light, such as UV light, emitted from the light source <NUM>, is directed toward the catheter <NUM> and is used to sterilize or disinfect the catheter. The barrier <NUM> separating the first and second compartments <NUM> and <NUM> allows the passage of sterilizing light, therethrough. Thus, the light travels from the second compartment <NUM> through the barrier <NUM> and into the first compartment <NUM> so that the catheter <NUM> is exposed to the sterilizing light. The barrier <NUM> may be transparent or translucent. The barrier <NUM> may be made of glass or plastic. Optionally, the case <NUM> may include reflective material (not shown) that reflects the UV light within the case <NUM>. For example, the inner wall of the body <NUM> and/or cap <NUM> may be lined with a reflective material. The reflective material may be continuous or may be segments of material that are selectively placed on the inner wall of the case <NUM>.

As shown in <FIG> and <FIG>, the case <NUM> may include a switch <NUM> to activate the light source <NUM> to emit sterilizing light. The switch <NUM> may protrude through the outer surface of the case <NUM> or otherwise be accessible so that it can be operated by the user. The switch <NUM> could be, for example, a push button or knob that is operated by the user's fingers. Alternatively, the switch <NUM> may be associated with the cap <NUM>, such that when the cap <NUM> is reattached to the body <NUM>, the switch activates the light source <NUM>. The switch <NUM>, light source <NUM>, power source <NUM>, and/or a timer (not shown) may be configured so that the light source <NUM> emits sterilizing light for a selected period of time, such as a time sufficient to disinfect the catheter <NUM>.

In any of the embodiments disclosed herein, the catheter may include an outer surface containing titanium oxide. The titanium oxide may be integrated with the polymer forming the catheter. Alternatively, the titanium oxide may be included in a coating on the surface of the catheter <NUM>. For example, the coating may be a hydrophilic coating containing titanium oxide. The combination of the titanium oxide with UV light sterilization can result in faster sterilization times and/or reduced bacterial attachment or colonization on the catheter.

<FIG> illustrates an alternative embodiment of a catheter product 10a having a case 12a for storing and sterilizing a catheter 22a. Similar to that of <FIG>, the case 12a includes a body 14a and a cap 16a. The body 14a includes a first compartment 24a for holding the catheter 22a, and optionally, a sterilization and/or hydration fluid. The body 14a also includes a second compartment 26a containing a sterilizing light source 42a, such as a UV light source, and power source 44a. The first and second compartments 24a and 26a are separated by a barrier 28a that allows the passage of sterilizing light therethrough. The barrier 28a may be made of the same materials as the barrier <NUM> described above.

The first and second compartments 24a and 26a are at least partially defined by the barrier 28a. In the illustrated embodiment, the first compartment 24a is concentric with the second compartment 26a, wherein the first compartment 24a is substantially formed by the barrier 28a. The second compartment 26a is defined between the barrier 28a and the wall 29a of the body 14a, wherein the barrier 28a forms an inner wall of the second compartment 26a and the wall 29a of the body 14a forms an outer wall of the compartment 26a.

The sterilizing light source 42a and power source 44a may be similar to that described above with respect to <FIG>. In the illustrated embodiment, the light source 42a extends along the wall of the body 14a of the case 12a, and may be coextensive or at least partially coextensive with the catheter shaft. Similar to above, the case 12a may include a switch 46a to activate the UV light source. The switch 46a may be activated by the user's fingers or may be associated with the closing of the cap 16a. Additionally, the light source 42a, switch 46a, power source 44a and/or timer may be configured such that the light source 42a emits light for a selected period of time.

Referring back to <FIG>, in use, the user removes cap <NUM> from the body <NUM> to open opening <NUM> of the case <NUM>. As shown in <FIG>, when the cap <NUM> is removed, the drainage member <NUM> of the catheter <NUM> is presented. The user removes the catheter <NUM> from the case <NUM>. If a sterilization or hydration fluid is present in first compartment <NUM>, optionally, the user removes the fluid from the compartment <NUM>. For example, the user may pour the fluid out of the compartment <NUM> into a sink or toilet. The user then performs catheterization. After catheterization, optionally, the user may rinse the catheter <NUM>, if a clean water supply is available. The user then places the catheter <NUM> back into the case <NUM>, and if a sterilization fluid or hydration fluid is being employed, the user may add fluid to the case <NUM>. The sterilizing light source <NUM> is activated to emit sterilizing light, such as UV light. The light source <NUM> may be activated by switch <NUM> or may be activated by attachment of cap <NUM>. After a select period of time, the light source <NUM> turns off. The catheter product <NUM> may include a visual or audio indicator indicating to the user that the catheter <NUM> has been sufficiently sterilized and is ready for reuse. The indicator may be, for example, an indicator light.

<FIG> illustrate another embodiment of a reusable catheter product <NUM>. The reusable catheter product includes a case <NUM>. The case <NUM> may include a top portion <NUM> and a bottom portion <NUM> that define a re-closable compartment that holds a catheter <NUM>, a sterilizing light source <NUM> and, optionally, a sterilization and/or hydration fluid (not shown). The catheter <NUM> and the sterilization fluid may be any of those described herein. In the illustrated embodiment, the top and bottom portions <NUM> and <NUM> may be configured so as to be completely separated when the compartment is opened. Alternatively, the top and bottom portions <NUM> and <NUM> may have a clamshell configuration wherein the top and bottom portions are hingedly connected to each other.

<FIG> illustrates the top portion <NUM> of the case <NUM>, and <FIG> illustrates the bottom portion <NUM> of the case <NUM>. It should be understood that the terms "top" and "bottom" are being used for a convenient description of the case, and that the top and bottom portions could be interchanged. Referring to <FIG>, the top portion <NUM> of the case <NUM> includes the sterilizing light source <NUM> and a power source <NUM>. The sterilizing light source <NUM> may be associated with the bottom surface <NUM> of the top portion <NUM>. The sterilizing light source <NUM> may be located behind a translucent or transparent barrier. The light source <NUM> and power source <NUM> may be any of the light sources and power sources disclosed herein. In the illustrated embodiment, the power source <NUM> may include rechargeable batteries and include a port <NUM> that may be connected to a power cord (not shown) for recharging the batteries. The case <NUM> may also include a switch (not shown) for activating the UV light source. The switch may be accessible and activated by the user. Alternatively, the switch may be configured so that the light source <NUM> is activated upon the closing of the case <NUM>. Additionally, the light source <NUM>, power source <NUM>, switch and/or a timer may be configured so that the light source emits light for a select period of time.

In the illustrated embodiment, the case <NUM> is held in the closed configuration by magnetic material. As shown in <FIG>, the top portion <NUM> has a magnetic segment <NUM> that extends about the periphery or rim <NUM> of the top portion <NUM>. Referring to <FIG>, the bottom portion <NUM> may have a magnetic segment <NUM> extending about the periphery or rim <NUM> of the bottom portion <NUM>. The magnetic segment <NUM> of the top portion <NUM> and the magnetic segment <NUM> of the bottom portion <NUM> are aligned, coextensive and/or commensurate when the case <NUM> is in a closed configuration. In one embodiment, both the top and bottom portions <NUM> and <NUM> include magnetic segments. Alternatively, one of the top and bottom portions <NUM> and <NUM> includes a magnetic segment and the other of the portions includes a segment attracted to the magnetic material.

Referring to <FIG>, the bottom portion <NUM> is configured to hold the catheter <NUM> in a manner that allows the catheter to be removed and reattached to the bottom portion <NUM>. In the illustrated embodiment, the bottom portion <NUM> includes brackets or mounts <NUM> for releasably holding the catheter <NUM>. The mounts <NUM> may be U-shaped clips that hold a portion of the catheter <NUM> by friction or snap fit. In the illustrated embodiment, the mounts <NUM> hold the catheter in a curved configuration. Alternatively, or in addition to the mounts <NUM>, the bottom portion <NUM> also may include grooves to assist in holding the catheter.

In use, the catheter is removed from the case for catheterization, and then inserted back into the case for sterilization in a similar process as described above with respect to the embodiment of <FIG>.

<FIG> illustrate another embodiment of a reusable catheter product <NUM>. The reusable catheter product includes a sterilizing and storing device <NUM>. The device <NUM> includes a base <NUM> and a sterilization chamber <NUM>. The sterilization chamber <NUM> may be removably engageable with the base <NUM>. Alternatively, the sterilization chamber <NUM> may be permanently attached to the base <NUM>.

Referring to <FIG>, in the illustrated embodiment, the chamber <NUM> has a generally cylindrical shape that defines an inner cavity. Alternatively, the chamber <NUM> may have other shapes. The chamber <NUM> also includes an opening <NUM> in the top end <NUM> and an opening <NUM> in the bottom end <NUM>. A cradle <NUM> (<FIG>) is inserted into and located within the chamber <NUM> (<FIG> and <FIG>). The cradle <NUM> is configured to hold a catheter <NUM> within the chamber <NUM>. The cradle <NUM> includes a top section <NUM> that defines a chamber cap 230a which defines the top of the cavity of the chamber <NUM>. The chamber cap 230a includes a handle, such as the illustrated ring-shaped member <NUM>, that may be grasped by the user to manipulate the cradle <NUM>. The chamber cap 230a may also include a seal <NUM> for creating a fluid tight seal between the cap 230a and the chamber <NUM>, when the cradle <NUM> is inserted into the chamber <NUM>. The seal may be, for example, an O-ring within a groove <NUM>.

The cradle <NUM> also includes a bottom section <NUM> that is connected to the top section <NUM>. In the illustrated embodiment, the top section <NUM> and the bottom section <NUM> are connected by two rods <NUM> extending between the two sections. In other embodiments, the top and bottom sections <NUM> and <NUM> may be connected in any suitable manner.

Referring to <FIG>, when the cradle <NUM> is inserted into the chamber <NUM>, the bottom section <NUM> may define the bottom of cavity of the chamber <NUM>. Additionally, the bottom section <NUM> may form a fluid tight seal with the chamber <NUM>. Furthermore, the bottom section <NUM> may be axially recessed from the bottom edge <NUM> of the chamber <NUM>. Referring to <FIG> and <FIG>, the bottom section <NUM> of the cradle <NUM> includes a boss <NUM> extending upward from the top surface <NUM> of the bottom section <NUM>. The boss <NUM> is configured to engage the distal end of a drainage member <NUM> of the catheter <NUM>. The boss <NUM> defines a lumen <NUM> that extends through the bottom section <NUM> and allows the passage of flushing fluid therethrough and into the lumen <NUM> of the drainage member <NUM>. In the illustrated embodiment, the boss <NUM> includes a cone or truncated cone shape. In other embodiments, the boss <NUM> may be any suitable shape.

Turning to <FIG> and <FIG>, the base <NUM> includes a housing <NUM> that houses a fluid supply <NUM> and a pump <NUM>. The base <NUM>/housing <NUM> also includes a cavity <NUM> that accepts the bottom <NUM> of the chamber <NUM>. A mounting member <NUM> extends upward from the bottom surface <NUM> defining the cavity <NUM>. Referring to <FIG>, when the chamber <NUM> is inserted into the cavity <NUM>, the mounting member <NUM> is accepted into the recess defined by the bottom section <NUM> of the cradle <NUM> and the bottom of the chamber <NUM>. The mounting member <NUM> includes a lumen <NUM> that is aligned within and in fluid communication with the lumen <NUM> of the boss <NUM> of the bottom section <NUM> of the cradle <NUM>.

Still referring to <FIG>, a fluid flow path <NUM> extends between the pump <NUM> and lumen <NUM> of the mounting member <NUM> of the cavity <NUM>. The pump <NUM> pumps flushing fluid from the fluid supply <NUM>, through the fluid flow path <NUM> and lumens <NUM> and <NUM> into the lumen <NUM> of the drainage member <NUM> of the catheter <NUM>. The fluid flow path <NUM> and lumens <NUM> and <NUM> serve as a fluid conduit between the fluid supply <NUM> and the drainage member <NUM> of the catheter <NUM>. The flushing fluid flows through the catheter shaft <NUM> and out of the eye <NUM> in the proximal end of the catheter <NUM> to disinfect and remove microbials and particles from the inner surface of the lumen of the catheter shaft. The flushing fluid may be any of the sterilization and/or hydration fluids disclosed herein.

Optionally, the base <NUM> may also include a tower <NUM> extending upward from the base. When the chamber <NUM> is engaged with the base <NUM>, the tower also may extend at least partially along the length of the chamber <NUM>. The tower <NUM> includes a sterilizing light source <NUM>. For example, the tower <NUM> may include one or more light emitting diodes that emit sterilizing light, such as UV light. When a sterilizing light source is included with the base <NUM>, the chamber <NUM> may be made of a glass or plastic that is transparent, translucent or otherwise allows the sterilizing light to pass through the chamber <NUM> so that the catheter <NUM> is exposed to such light.

In use, the user removes the cradle <NUM> from the chamber <NUM> and removes the catheter <NUM> from the cradle. Catheterization is then preformed. Optionally, after catheterization the user rinses the catheter <NUM> with water. The catheter <NUM> is then placed back in the cradle <NUM> with the drainage member <NUM> engaged with the boss <NUM>. The cradle <NUM> is then placed back into the chamber <NUM>. If the chamber <NUM> was removed from the base <NUM>, the chamber <NUM> is placed into the cavity <NUM> of the base <NUM> for receiving the chamber. The pump <NUM> is then activated to flow flushing fluid from the fluid supply <NUM> through the fluid flow passageway <NUM> and lumens <NUM> and <NUM> into the lumen <NUM> of the drainage member <NUM>. The flushing fluid flows through the catheter <NUM> and out of the eyes <NUM> in the proximal end of the catheter. If a sterilizing light source <NUM> is included, the light source <NUM> is activated for a select amount of time to further sterilize the catheter <NUM> with sterilizing light. After sterilization is completed the catheter is ready for reuse.

In addition to sterilizing the catheter in the catheter products described herein, the light source may be used to refresh or replenish the hydrophilic coating of the catheter. Hydrophilic catheter coatings are formed from a hydrophilic polymer. In one embodiment the sterilization fluid or hydration medium may contain a hydrophilic polymer in the fluid/medium wherein the hydrophilic polymer is the same polymer as that in the coating or one that is compatible with the hydrophilic polymer of the coating. When the sterilization fluid or hydration medium comes into contact with the hydrophilic coating of the catheter, some of the hydrophilic polymer from the fluid/medium remains on or becomes entangled with the polymer of the hydrophilic coating. Exposure to the sterilizing light source promotes or initiates cross-linking between the hydrophilic polymer of the fluid/medium and the hydrophilic coating of the catheter, thereby refreshing or replenishing the hydrophilic coating with new or additional polymer material.

Claim 1:
A reusable urinary catheter product (<NUM>, 10a), comprising:
a case (<NUM>, 12a) comprising a body (<NUM>, 14a) and a re-closable cap (<NUM>, 16a), the body (<NUM>, 14a) defining a first compartment (<NUM>, 24a) and a second compartment (<NUM>, 26a), the first compartment (<NUM>, 24a) and second compartment (<NUM>, 26a) being separated by a barrier (<NUM>, 28a) that allows the passage of sterilizing light;
a urinary catheter (<NUM>, 22a) located in the first compartment (<NUM>, 24a); and
a sterilizing light source (<NUM>, 42a) located in the second compartment (<NUM>), wherein sterilizing light emitted from the light source (<NUM>, 42a) passes through the barrier (<NUM>, 28a) and into the (<NUM>, 26a) second compartment.