Patent Description:
Intermittent urinary catheters are commonly used by those who suffer neurogenic conditions that affect bladder function, such as but not limited to SCI or multiple sclerosis, and for those with urinary retention. Urinary catheters drain urine from the bladder through a shaft and out a proximal end without the urine contacting any portion of the urinary tract. Because the users are unable to void directly through the urethra, the urethra no longer experiences the continuous flushing and re-wetting of the tissues that normally occurs during active voluntary urination. The first <NUM> / <NUM> of the distal urethra is densely populated with micro-organisms. The absence of flushing and rewetting may lead to an increased risk of urinary tract infections. Furthermore, although catheters are provided in sterile and contamination free state, users are at risk to contract a urinary tract infection due to contamination by, for example, the user touching the catheter before insertion, reuse of catheters, and not following proper catherization techniques.

There remains a need for catheters having a design that reduces the risk of UTIs. <CIT>, <CIT> and <CIT> disclose three exemplary urinary catheters proposing different approaches to reduce UTI.

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. Preferable embodiments are defined in the dependent claims.

In one aspect, a catheter includes a catheter shaft with a proximal portion and a distal portion. There is at least one eyelet in the proximal portion being in communication with an inner lumen of the proximal portion. There is at least one drainage opening in the catheter shaft for draining fluid from the inner lumen. The drainage opening is between the proximal portion and the distal portion of the catheter shaft. The distal portion includes at least one rod. The at least one drainage opening is for draining fluid from the inner lumen to the outside of the at least one rod of the catheter shaft.

The present disclosure is directed to catheters that include a catheter shaft which enables fluid to flush a portion of the urethra of the urinary tract, helping to potentailly prevent urinary tract infections. The catheter shaft has a distal portion with a proximal end having a tip that is inserted through a user's urethra and into the bladder for draining urine therefrom. The catheter shaft also includes a distal portion that supports insertion of the proximal portion and allows urine flow to contact the urethra wall during catheterization, which may assist in wetting and flushing out the urethra.

<FIG> illustrates a urinary catheter <NUM> having a catheter shaft <NUM> with a proximal portion 13a which has a proximal end <NUM> and a distal portion 13b which has a proximal end <NUM>. The catheter shaft <NUM> may be made of a polymeric material. The polymeric material may include, but is not limited to, polyethylenes, polypropylenes, polyvinylchlorides, polytetrafluoroethylenes, polyvinylacetates, polystyrenes, polyesters, polyurethanes, polyamides, ethylene vinyl acetate copolymers, and combinations thereof.

The proximal end <NUM> of the catheter shaft has a tip that can be any appropriate shape for insertion through the urethra and into the bladder. In one embodiment, the proximal end <NUM> has a straight rounded shape, such as the illustrated nelaton shape. Other shapes are applicable such as curved and tapered (Coudé, Tiemann, Olive tip).

The proximal portion 13a of the catheter shaft <NUM> includes one or more draining holes or eyelets 40a, 40b in communication with an inner lumen <NUM> (<FIG>) of the proximal portion 13a of the catheter shaft. <FIG> shows a cross-sectional view of the proximal portion 13a of the catheter shaft <NUM> toward the proximal end <NUM> of the catheter shaft. As shown in this figure, the proximal portion 13a of the catheter shaft <NUM> includes an inner lumen <NUM>. The at least one eyelet 40a, 40b may be for the drainage of bodily fluids therethrough and into an inner lumen <NUM> (<FIG>) of the catheter shaft. As shown in <FIG>, in one embodiment, the proximal portion 13a can include at least two eyelets 40a and 40b. As shown in the figure, the eyelets 40a, 40b can be distally spaced from the proximal tip of the proximal end of the catheter. However, the eyelet or eyelets 40a, 40b may be closer to the proximal tip or may arranged in any effective manner. In one alternative, the eyelet 40a, 40b may be in or at the proximal end <NUM>. The eyelet(s) 40a, 40b may be configured to be located within a bladder when the catheter is inserted to drain urine from the bladder.

The proximal portion 13a of the catheter <NUM> transitions at area <NUM> to the distal end portion 13b. The distal end portion 13b includes at least one rod <NUM> that may extend to the distal end <NUM> of the catheter shaft <NUM>. The transition may be such that the axis of the rod is offset from the axis of the proximal end portion (<FIG>). Alternatively, the transition my be such that the axis of the rod is aligned with the axis of the proximal end portion.

Referring to <FIG>, the transition area <NUM> includes a neckdown or stepdown from the proximal portion 13a to the rod <NUM>. Optionally, the neckdown may be a partial neckdown of one side of the catheter shaft. In one example, the neckdown extends around about half of the catheter. When this optional neckdown is present, the central axis 21b of the rod <NUM> may be offset from the central axis 21a of the proximal portion 13a. When the central axis of the rod is offset from the central axis of the proximal portion, the axes may be parallel to each other. In other embodiments, the axes may be at angles to one another.

Referring to <FIG>, optionally, the neckdown or stepdown at the transition area may be a circumferential neckdown or on that extends substantially about the circumference of the catheter. When this optional neckdown is present, the central axis 22b of the rod <NUM> may be aligned with the central axis 22a of the proximal portion 13a.

The catheter shaft <NUM> also includes at least one drainage opening <NUM> that drains fluid from the inner lumen <NUM>. <FIG> shows a cross-sectional view of the catheter shaft <NUM> near transition area <NUM>. Inner lumen <NUM> of catheter shaft <NUM> is in communication with drainage opening <NUM> which allows the urine to exit and flush the urethra outside rod <NUM> of the distal portion. The location of the drainage opening(s) <NUM> along the catheter shaft <NUM> is such that during catheterization, the drainage opening(s) <NUM> is located within the urethra. As such, during catheterization, urine exits drainage opening(s) <NUM> and flows into and through the urethra. The urine flows outside of at least one rod <NUM> and wets and flushes out the urethra.

In <FIG>, the at least one drainage opening <NUM> is shown within the vicinity of area <NUM>. The at least one drainage opening <NUM> may be below or above area <NUM>. In one alternative, the drainage opening(s) <NUM> may between the proximal portion 13a and the distal portion 13b. The at least one drainage opening <NUM> may be about <NUM>% down the length of the catheter shaft or equidistant between a terminal distal end <NUM> and a terminal proximal end <NUM> of the catheter shaft. In another alternative, the drainage opening(s) <NUM> may also be located closer to a terminal proximal end <NUM> of the catheter shaft <NUM> than to a terminal distal end <NUM> of the catheter shaft <NUM>. Additionally, draining opening(s) may be located closer to a terminal distal end <NUM> than to a terminal proximal end <NUM> of the catheter shaft <NUM>. Although one drainage opening <NUM> is shown in the figure, additional drainage openings may be present. They may also be configured to be located within the urethra. Multiple drainage openings can be placed in the same place or along different parts of the urethra. The catheter of the current disclosure, therefore, does not require a draining member or funnel at the distal end of the catheter shaft, unlike traditional catheter designs.

The proximal section 13a of the catheter <NUM> can be softer than the distal portion 13b of the catheter <NUM>, which aids in easier catheter insertion, control and manipulation. Alternatively, the distal portion 13b of the catheter may be softer than the proximal portion 13a of the catheter <NUM>. The varying in flexibility may be especially beneficial in a male catheter where the catheter is inserted along the curved or serpentine path of the urethra.

In <FIG>, the catheter is shown having a single rod <NUM> of the distal portion 13b, which may be a solid structure, as shown in <FIG>, or may include an inner lumen. The rod <NUM> may maintain a consistent or similar outer diameter or may taper inward toward the proximal end or distal end. The cross-sectional shape of the rod may be any various shape, such as a circle, ellipsis, square, triangle, pentagon, hexagon, polygon, and other shapes. The rod can also be u-shaped.

The cross-sectional width of the proximal portion 13a and the distal portion 13b of the catheter may vary. Preferably, the cross-sectional width of the proximal portion 13a of the catheter is larger than the cross-sectional width of the distal portion 13b of the catheter and/or rod <NUM>. The proximal portion 13a may gradually decrease in diameter or abruptly shift/step to a smaller diameter at the transition area <NUM> between the proximal portion 13a and the distal portion 13b. Furthermore, when the catheter <NUM> is a male catheter, it may have a length of about <NUM>, where the proximal portion 13a has a length between about <NUM> and about <NUM>, and the distal portion 13b has a length between about <NUM> and about <NUM>. In one embodiment, the ratio of the length of the proximal portion 13a to that of the length of distal portion 13b may be from <NUM>: <NUM> to <NUM>:<NUM>.

Optionally, the distal portion 13b of the catheter shaft <NUM> may have a gripper or handle <NUM>. The handle <NUM> may aid with insertion, manipulation and/or control, and withdrawal of the catheter. The handle <NUM> may be solid and include indentations or raised portions for better grasping by the user. The handle <NUM> may also be flat. The handle can be any practical shape. In one embodiment, the handle may be circular or oval shaped. The handle may be stationary or flexibly move up and down to a desired angle.

The handle <NUM> may extend from the distal end <NUM> of the catheter shaft <NUM>. In one embodiment, the handle <NUM> may extend at an angle from the catheter shaft <NUM>. For example, the distal end <NUM> of the catheter shaft <NUM> may have a bend or curve projecting out at a desired angle before transitioning to the handle <NUM>. The angle may be between <NUM>° (no angle) and <NUM>°. Preferably, the angle is between <NUM>° and <NUM>°. The handle may be orientated in any plane around the central catheter axis or be orientated in any plane around central axis of the angular extension.

Both the bend and the handle <NUM> can be effectively sized for use while inserting, manipulating and/or withdrawing the catheter. The handle is spaced at a sufficient distance from the bend to reduce the risk of urine contacting the user's hands. In one embodiment, length of catheter rod between the bend or curve and the handle may be about <NUM>. Optionally, the length may be about <NUM> to about <NUM>. The gripper or handle may have a length and/or width of about <NUM>. Preferably the gripper or handle has a length and/or width of about <NUM> to about <NUM>.

The method of making the catheter shown in <FIG> may include processing or forming a catheter tube into the above described structure. For example, the tip at the proximal end <NUM> and eyelet(s) 40a, 40b may be formed in the proximal portion 13a of the shaft <NUM>. The distal portion 13b of the shaft <NUM> may then be crimped or necked down by a heating and compression process. For example, the distal portion 13b of the catheter shaft <NUM> may be placed in a tool that heats and compresses the distal portion 13b of the catheter shaft <NUM> into a rod <NUM> with or without a central lumen. Optionally, the distal portion 13b of catheter shaft <NUM> may include a central (core) axial mandrel/reinforcment member 15a. If present, the mandrel/reinforcement member 15a may be made from various metals and/or plastics. The mandrel/reinforcement member 15a may be for example a stainless steel or polymer spring or rod. The drainage opening <NUM> may be formed in the shaft <NUM> before or after forming the distal portion 13b.

<FIG> illustrates another embodiment of a female catheter <NUM> according to the current disclosure. Catheter <NUM> is similar to that of catheter <NUM> shown in <FIG>, in that catheter <NUM> has several of the same or similar features of the catheter <NUM>. Similar features are numbered in a similar manner. Similar to catheter <NUM>, catheter <NUM> has a catheter shaft <NUM> with a proximal portion 113a that includes a proximal end <NUM> and a proximal portion 113b that includes a proximal end <NUM>.

The proximal portion 113a of the catheter shaft includes one or more draining holes or eyelets 140a, 140b in communication with an inner lumen (not shown) of the proximal portion of the catheter shaft. The at least one eyelet 140a, 140b may be for the drainage of bodily fluids therethrough and into an inner lumen of the catheter shaft.

The proximal portion 113a of the catheter shaft <NUM> transitions at area <NUM> to at least one rod <NUM> toward the distal portion 113b of the catheter shaft. Similar to that of <FIG>, the central axis of the rod <NUM> may be aligned with the central axis of the proximal portion 113a or the central axis of the rod <NUM> may be offset from the central axis of the proximal portion 113a. When the central axis of the rod is offset it may be parallel to the central axis of the proximal portion. Below, at or near area <NUM>, at least one drainage opening <NUM> drains fluid from the inner lumen to flush out the urethra to the outside of the distal portion which includes at least one rod <NUM>.

The proximal portion 113a may gradually decrease in diameter or abruptly shift/step to a smaller diameter at the transition area <NUM> between the proximal portion 113a and the distal end portion 113b. Furthermore, when the catheter <NUM> is a female catheter, it may have a catheter shaft length of about <NUM>, where the proximal portion 113a has a length between about <NUM> and about <NUM>, and the distal end has a length between about <NUM> and about <NUM>. In one embodiment, the ratio of the length of the proximal portion 113a to that of the length of distal portion 113b may be from <NUM>:<NUM> to <NUM>:<NUM>.

The distal portion 113b of the catheter shaft may have a gripper or handle <NUM>. The handle <NUM> may aid with insertion, manipulation and/or control, and withdrawal of the catheter.

<FIG> illustrates an additional example of the current disclosure, catheter <NUM>. Catheter <NUM> has a catheter shaft with a proximal portion 214a that includes a proximal end <NUM> and a distal portion 214b that includes a distal end <NUM>. The catheter shaft can be made of any of the polymeric material described herein.

The proximal end <NUM> of the catheter shaft has a tip that can be any appropriate shape, such as a rounded shape. In the illustrated example, the proximal end <NUM> has a nelaton shape.

The proximal portion 214a of the catheter shaft includes one or more draining holes or eyelets 241a, 241b in communication with an inner lumen <NUM> of the proximal portion 214a of the catheter shaft <NUM>. <FIG> shows a cross-sectional view of the proximal portion 214a of the catheter shaft <NUM> toward the proximal end <NUM> of the catheter shaft. At cross section 5A, there is an inner lumen <NUM>. The at least one eyelet may be for the drainage of bodily fluids therethrough and into an inner lumen of the catheter shaft. As shown in <FIG>, in one example, the proximal portion 214a can include at least two eyelets 241a and 241b. As shown in the figure, the eyelets can be distally spaced from the proximal tip of the proximal end of the catheter. However, the eyelet or eyelets can be closer to the proximal tip and arranged in any effective manner. The eyelet or eyelets may be configured to be located within a bladder when the catheter is inserted.

The proximal portion 214a of the catheter shaft <NUM> transitions at area <NUM> to the distal portion 214b. The distal portion includes at least two rods 232a and 232b that extend toward the distal end <NUM> of the catheter shaft <NUM>. <FIG> shows a cross-section at a point on the catheter shaft near transition area <NUM>. Below, at or near area <NUM>, at least one drainage opening <NUM> drains fluid from the inner lumen to the outside of the distal portion 214b and rods 232a and 232b. The drainage opening <NUM> can be the end of the inner lumen or can be a side opening in the catheter shaft <NUM>. The drainage opening <NUM> at transition area <NUM> allows the urine to exit to outside of the catheter shaft <NUM> and into the urethra, where the urine wets and flushes out the urethra as it flows therethrough.

Similar to the catheters of <FIG> and <FIG>, the drainage opening is between the proximal portion 214a and the distal portion 214b. The at least one drainage opening <NUM> may be about <NUM>% down the length of the catheter shaft or equidistant between a terminal distal end and a terminal proximal end of the catheter shaft. The drainage opening <NUM> may also be located closer to a terminal proximal end of the catheter shaft than to a terminal distal end of the catheter shaft. Additionally, the draining opening <NUM> may be located closer to a terminal distal end than to a terminal proximal end of the catheter shaft. The transition area and drainage opening are preferably configured to be located within the urethra when the catheter is inserted. Although one drainage opening <NUM> is shown in the figure, additional drainage openings may be present. They may also be configured to be located within the urethra. Multiple drainage openings can be placed in the same place or along different parts of the urethra. The catheter of the current disclosure, therefore, does not require a draining member or funnel at the distal end of the catheter shaft, unlike traditional catheter designs.

The rods 232a and 232b may be solid structures. The rods may maintain a consistent or similar outer diameter and may taper out to the edge. The crosssections of these rods can have various shapes, such as a circle, ellipsis, square, triangle, pentagon, hexagon, polygon, and other shapes. The rod can also be u-shaped. Cross section 5B shows the catheter shaft portion <NUM> including rods 232a and 232b.

The cross-sectional width of the proximal portion 214a and the distal portion 214b of the catheter may be similar or vary. Preferably, the cross-sectional width of the proximal portion 214a of the catheter is smaller than the cross-sectional width of the distal portion 214b of the catheter.

The distal portion 214b of the catheter shaft may have a gripper or handle <NUM>. The handle <NUM> can be formed from the two rods 232a and 322b. The handle <NUM> can join the two rods 232a and 232b at the distal end of the catheter shaft.

<FIG> shows an enlarged view of joint between a portion of the rod 232a and gripper/handle <NUM> at the distal end <NUM> of the catheter <NUM>. Handle <NUM> can have at least one piece <NUM> for enabling a range of movement of the gripper/handle <NUM>. Piece <NUM> is attached to rod 232a and handle <NUM>.

<FIG> illustrates a cross section of <FIG> shows that there may be two pieces 280a and 280b enabling a full range of movement for handle <NUM> for each rod of the handle <NUM>. Pieces 280a and 280b attach at one end to distal rod 232a and at the other end to gripper/handle <NUM>. Rod 232b may also have a similar set of pieces. Each of pieces 280a and 280b can be composed of independent parallel arms. Each set of arms can have elbow pivot points. In one embodiment, each piece has three parallel arms, with a central arm that may be longer in length. The pieces and the associated arms allow for the handle to be moved easily from one angular position to another. The handle may also include a hinge or any other device that enables it to easily move between angular positions. The handle angle may be able to move between <NUM>° (no angle) and <NUM>°. Preferably, the handle is able to move between <NUM>° and <NUM>°.

The catheters included in the current disclosure may be formed by any known manufacturing process. The catheters may be formed in a single process or multiple processing steps. The catheters may be formed by different types of molding, more particularly by injection molding. The catheters may also be formed by heating or extruding a portion or portions to the desired shape. In a particular embodiment a formed catheter shaft is further modified by any of the above described methods to form a distal rod portion or portions.

The catheters included in the current disclosure may be, but not limited to, hydrophilic catheters and parts of the catheter shaft may include a hydrophilic coating. When the hydrophilic coating is wetted or hydrated with a hydration medium, such as water, it becomes lubricious which eases introduction of the device into the body and aids in reducing pain and discomfort associated with such introduction. The hydrophilic coating can be a single layer or multilayer hydrophilic coating. Multiple layered coating can include at least a base coat and top layer. The catheters may also include a gel on the outer surface to aid with insertion.

The catheters included in the current disclosure, optionally, also may include a thin flexible sleeve that covers at least a section of the outer surface of the catheter shaft. The sleeve may be formed of any variety of thin flexible polymeric film materials, such as polyethylene, plasticized PVC, polypropylene, polyurethane or elastomeric hydrogels. When the catheter includes a hydrophilic coating thereon, the sleeve may be liquid and/or vapor permeable so as to allow liquid and/or vapor therethrough to hydrate the hydrophilic coating while the catheter is stored within a package. Alternatively, the sleeve may include a hydration liquid or a foamed hydration liquid within the sleeve and in contact with the hydrophilic material.

Any of the above-described catheters may be used by male or female patients. Males catheters tend to differ from female catheters in length because of difference in urethra length. Female catheters of the current disclosure may be shorter overall and may also have a shorter distal end portion.

The catheters of the present disclosure may be sterilized prior to use. The catheters may be sterilized by applying a sufficient amount of radiation, such as (but not limited to) gamma or E-Beam radiation. The catheters can be sterilized with radiation while the hydrophilic coating is in contact with the wetting fluid.

Claim 1:
A urinary catheter (<NUM>, <NUM>, <NUM>) having a catheter shaft (<NUM>, <NUM>, <NUM>) including a distal portion (13b, 113b, 213b) and a proximal portion (13a, 113a, 213a) having a tip that is inserted through a user's urethra;
at least one eyelet (40a, 140a, 241a, 40b, 140b, 241b) in the proximal portion; the at least one eyelet being in communication with an inner lumen (<NUM>, <NUM>) of the proximal portion to drain urine from the bladder;
at least one drainage opening (<NUM>, <NUM>, <NUM>) in the catheter shaft for draining fluid from the inner lumen, wherein the at least one drainage opening is between the proximal portion and the distal portion of the catheter shaft such that during catheterization, the drainage opening is configured to be located within the urethra;
the distal portion including at least one rod (<NUM>, <NUM>, 232a, 232b); and
the at least one drainage opening for draining fluid from the inner lumen to the outside of the at least one rod of the distal portion of the catheter shaft;
characterized in that a cross-sectional width of the at least one rod is smaller than a cross-sectional width of the proximal portion.