Patent Description:
People suffering from neurogenic bladder disorders like spinal cord injury, spina bifida or multiple sclerosis, and non-neurogenic bladder disorders like obstruction due to prostate enlargement, urethral strictures or post-operative urinary retention, need to be continuously catheterized to empty their urinary bladders. However, continuous catheterization can lead to problems like urinary tract infections (UTI), urethral strictures or male infertility. Intermittent catheterization at regular intervals avoids many of the negative effects of continuous long term catheterization. There are four primary categories for intermittent catheters: (<NUM>) Bare Intermittents, (<NUM>) Hydrophilic Coated Intermittents, (<NUM>) Pre-Wetted Intermittents, and (<NUM>) Catheter in Bag or "Touchless" Intermittents.

Bare Intermittents require the use of an external lubrication method. These catheters are the least expensive and most commonly used. Typical materials include natural rubber (latex) (NRL), polyvinyl chloride (PVC) and silicone. The common lubrication method is a gel pack. The gel is either applied to the meatus of the urethra or the tip of the catheter itself. Hydrophilic Coated Intermittents have a lubricious coating applied typically to the first two-thirds of the shaft of the catheter and are activated by breaking a water sachet located inside the package prior to opening the package. When activated, the catheter is lubricious for insertion into the urethra. Potential issues with the Bare Intermittents and the Hydrophilic Coated Intermittents include the amount of mess they create (e.g., from the excess water from the water sachet and lubricant from the lubricant packs) and the time required for the user to complete the voiding process.

Pre-Wetted Intermittents may be packaged in a non-permeable package (e.g. foil, or rigid plastic) and suspended in water. Ideally, the catheters will stay wet over the length of their shelf life and may be much like hydrophilic coated intermittents that have been activated by water. Pre-Wetted Intermittents may have a lubricious coating in addition to being packaged in water. This can eliminate the process step of lubricating the catheter, but may still cause some mess to contend with (e.g., from the water stored in the package), and the coating may dry out over its shelf life making it unusable.

Catheter in Bag or "Touchless" Intermittents may include either a Bare Intermittent or Hydrophilic Coated Intermittent. There may be an insertion tip on an end of the bag with the distal end of the catheter captured in the insertion tip. Upon use, the user may advance the catheter out of the bag using the insertion tip to help guide the catheter into the urethra. The bag may be used for urine collection. However, use of a Touchless Catheter may be cumbersome and difficult.

The following are references relating to coatings: <CIT>, <CIT>, and <CIT>.

<CIT> discloses an intermittent urinary catheter assembly comprising a catheter tube having a proximal insertion end and a distal end remote from the proximal insertion end and a lumen which extends from at or near the proximal insertion end to the distal end for draining urine from a human bladder. The intermittent urinary catheter assembly includes a urine discharge sleeve associated with the discharge opening (<NUM>) of the catheter tube, and the urine discharge sleeve has a compact stowed configuration and is extendable into a deployed configuration for directing urine flow.

<CIT> discloses a package including an intermittent urinary catheter and a sleeve. The protective sleeve is adapted to cover the surface of the catheter prior to use, thereby preventing contamination of the surface. The protective sleeve is compressed in a storage-position, and in a use-position it is extended to cover most of the insertable length of the catheter. In the compressed state, the urinary catheter may be wetted if the catheter is provided with a hydrophilic coating. The protective sleeve may be made of flexible material, which may be folded or pre-folded into a concertina-like configuration.

In a first aspect of the present invention, there is provided a urinary catheter according to claim <NUM>.

The urinary catheters described herein provide a novel type of intermittent catheter not currently available. The coating may exhibit hygroscopic characteristics, described herein as the characteristic or intention of the coating to not only retain the moisture inherent in the coating but also to attract moisture from the environment. The coating may exhibit hydrophilic characteristics. The coating described herein is an improved formulation that is applied in a wet state and stays wet for an extended period of time. Accordingly, the urinary catheters described herein do not require an additional lubricant or wetting component, such as a water sachet or gel package, to accompany the catheters in the containers. The urinary catheters described herein may be packaged individually in a discrete container, such as an opaque foil. These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.

In one embodiment a urinary catheter may include a catheter shaft attached to a handle. The urinary catheter may also include a hygroscopic and/or hydrophilic coating disposed on an outer surface of the catheter shaft. The coating may include a hydrogel, glycerin or water, and a polyethylene glycol (PEG). In one embodiment, the hydrogel may be LUBRAJEL® RR CG hydrogel or LUBRAJEL® RR hydrogel, and the PEG may be one or both of PEG <NUM> and PEG <NUM>. In embodiments described herein with respect to specific hydrogels (e.g., LUBRAJEL® RR CG hydrogel), other hydrogels (e.g., LUBRAJEL® RR hydrogel) are contemplated as being substituted for, or added to, the specified hydrogel. Likewise, in embodiments described herein with respect to specific polyethylene glycols (e.g., PEG <NUM>), other polyethylene glycols are contemplated as being substituted for, or added to, the specified polyethylene glycol.

In one embodiment, a urinary catheter includes a catheter shaft attached to a handle, and a first coating disposed on an outer surface of the catheter shaft, the first coating including a hydrogel or polyacrylic acid (PAA), glycerin and/or water, and polyethylene glycol (PEG), the first coating exhibiting hygroscopic and/or hydrophilic characteristics. In one embodiment, the outer surface of the catheter shaft includes a second coating over which the first coating is disposed. In one embodiment, the second coating is a hydrophilic coating.

In one embodiment, the coating formulations described herein provide non-adhesion (or anti-blocking) toward the packaging material. In one embodiment, a catheter with the coating can be sterilized through electron beam ("e-beam") sterilization or ethylene oxide (EtO) sterilization. In one embodiment, an additional ultraviolet (UV)-curable silicone film can be applied over a catheter with the coating described herein. The silicone film may restrict the coating on the catheter. In one embodiment, the film may be moved, e.g., toward the catheter handle, thereby acting as a touchless layer while maintaining the lubricity of the catheter. In one embodiment, the UV-curable silicone film is disposed on the coating via an UV curing process.

In one embodiment of the packaged urinary catheter, a coating formulation (e.g., a formulation for a base coating and/or outer coating) for the catheter may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment the coating formulation may include LUBRAJEL® RR CG hydrogel at <NUM> wt%, water at <NUM> wt%, and PEG <NUM> at <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, PEG <NUM> in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, propylene glycol (PEG) in a range of <NUM> wt% to <NUM> wt%, and ethanol (anhydrous) in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the LUBRAJEL® RR CG hydrogel is <NUM> wt%, the glycerin is <NUM> wt%, and both the PEG and ethanol are <NUM> wt%.

In one embodiment, a coating formulation may include LUBRAJEL® RR hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR hydrogel at <NUM> wt%, glycerin at <NUM> wt%, and both PEG <NUM> and PEG <NUM> at <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR hydrogel at <NUM> wt%, glycerin at <NUM> wt%, PEG <NUM> at <NUM> wt%, and PEG <NUM> at <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%.

In one embodiment, a coating formulation may include polyacrylic acid (PAA) in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include PAA in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt% and PEG, such as PEG <NUM> and/or PEG <NUM>, in a range of <NUM> wt% to <NUM> wt%.

In one embodiment, a silicone film may be formed over a coating on a catheter. In one embodiment, a method of forming a catheter with a coating includes dipping a coated catheter, such as a hydrophilic coated catheter, into a solution containing any of the coating formulations herein, such as a coating formulation including PAA, water, and PEG or a coating formulation including hydrogel, glycerin and/or water, and PEG, then dipping the twice-coated catheter into a UV curable solution, then exposing the coated areas to a UV source, and then directly placing the catheter into a package. In one embodiment, the hydrophilic coated catheter is dipped into a PAA/water/PEG solution for a dwell time in a range of <NUM> seconds to <NUM> seconds. In one embodiment, after the catheter is dipped into the PAA/water/PEG solution, it is dipped into a silicone solution with UV curable agents several times to achieve a desired film thickness. In one embodiment, the desired thickness is <NUM> in. to <NUM> in. In one embodiment, the catheter is dipped into the silicone solution with UV curable agents <NUM> to <NUM> times. In one embodiment, after being dipped into the silicone solution with UV curable agents, the catheter is exposed to a UV source, such as a UV light, in a time range of <NUM> to <NUM>. In one embodiment, following the exposure to the UV source, the catheter is placed directly into a film, foil, and/or Tyvek package without a further drying process.

In one embodiment, a method of making a urinary catheter includes applying a first coating to a catheter shaft, the first coating comprising a hydrogel or polyacrylic acid (PAA), glycerin and/or water, and polyethylene glycol (PEG) to form a coated catheter, and placing the coated catheter into a package comprising a gas impermeable foil material. In one embodiment, the catheter shaft includes a base hydrophilic coating, and the first coating is applied over the base hydrophilic coating. In one embodiment, the applying includes dipping the catheter shaft with the base hydrophilic coating into a solution containing a formulation of the first coating. In one embodiment, the first coating formulation comprises only the PAA, the water, and the PEG, further comprising dipping the coated catheter into a silicone solution including ultraviolet (UV) curable agents to form a silicone film over the first coating. In one embodiment, the method includes exposing the silicone film to a UV light source for a period of time to cure the silicone solution.

In one embodiment, the urinary catheter may include an eyelet or a plurality of staggered, opposing eyelets (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more eyelets) proximal to a catheter tip, the eyelets may be arranged in a variety of ways, including circumferentially positioned about <NUM> degrees apart and positioned in a non-overlapping configuration. In one embodiment, the urinary catheter shaft includes a funnel shaped proximal end and ridges configured to facilitate gripping. In one embodiment, the urinary catheter may have a coating that exhibits hygroscopic characteristics. In another embodiment, the urinary catheter may have a coating that exhibits hydrophilic characteristics.

In one embodiment, a packaged urinary catheter may include a container and a urinary catheter. The urinary catheter may include a catheter shaft attached to a handle and a coating disposed on an outer surface of the catheter shaft. In one embodiment, the coating may include a hydrogel, glycerin or water, and PEG, such as one or both of PEG <NUM> and PEG <NUM>. In one embodiment, the coating may include PAA, glycerin, water, and PEG, such as PEG <NUM> and/or PEG <NUM>. In one embodiment, the coating may include PAA, water, and PEG, such as PEG <NUM> and/or PEG <NUM>.

In one embodiment of the packaged urinary catheter, the container may include a gas impermeable foil material. In one embodiment of the packaged urinary catheter, the container may include an adhesive tab covering a perforated section of the foil material, the adhesive tab may include a pull loop. In one embodiment, the container may include a water sachet, gel package, or other type of lubricant therein. In one embodiment, the container may include a moisture source (in contact or separated from the catheter) from which a hygroscopic coating and/or a hydrophilic coating on the urinary catheter may absorb or obtain moisture. In one embodiment of the packaged urinary catheter, the container does not include any water sachet, gel package, or other type of lubricant or moisture source therein.

In one embodiment, a method of catheterizing may include obtaining a urinary catheter that may include a handle and a catheter shaft. The catheter shaft may include a hydrophilic coating and/or a hygroscopic coating on an outer surface thereof. In one embodiment, the coating may include a coating formulation described herein. The method may further include inserting the urinary catheter into a bladder. In one embodiment, the method of catheterizing may include obtaining the urinary catheter from a container in which the urinary catheter has been stored. In one embodiment, the method of catheterizing does not include application of a lubricant or water to the catheter shaft at any time prior to insertion into the bladder, including while in the package.

Also provided herein is a urinary catheter including a handle and a catheter shaft attached to the handle. The handle includes a plurality of ridges configured to facilitate gripping the handle. The handle also includes one or more loops integral with the handle configured for manipulating the catheter during at least catheterization. The catheter shaft includes opposing eyelets proximate a tip of the catheter shaft in fluid communication with an opening in a proximal end of the handle by a lumen disposed in the catheter connecting the catheter shaft and the handle.

In such embodiments, a first plane including a transverse cross-section of the handle is orthogonal to a second plane including at least one opening of the one or more loops.

In such embodiments, the handle is configured to rest in a hand of a patient or a caregiver while the one or more loops respectively receive one or more fingers of the patient or the caregiver.

In such embodiments, the one or more loops are respectively one or more rings, each attached to the handle by a tab extension of the handle.

In such embodiments, the opposing eyelets include at least two pairs of staggered eyelets, the at least two pairs of eyelets staggered along a length of the catheter shaft and offset by about <NUM> degrees around the catheter shaft in a non-overlapping configuration.

In such embodiments, the catheter further includes a hydrophilic base coating over the catheter shaft, the base coating of PAA in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%.

In such embodiments, the catheter further includes a hydrophilic base coating over the catheter shaft, the base coating of PAA in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG in a range of <NUM> wt% to <NUM> wt%.

In such embodiments, the catheter further includes a hygroscopic outer coating over the catheter shaft, the outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%.

In such embodiments, the catheter further includes a hygroscopic outer coating over the catheter shaft, the outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, PEG <NUM> in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%.

In such embodiments, the catheter further includes a hygroscopic outer coating over the catheter shaft, the outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%.

In such embodiments, the catheter further includes a hygroscopic outer coating over the catheter shaft, the outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt%, and PEG <NUM> is in a range of <NUM> wt% to <NUM> wt%.

Also provided herein is a urinary catheter including a handle and a catheter shaft attached to the handle. The handle includes a plurality of ridges configured to facilitate gripping the handle. The handle also includes one or more loops integral with the handle configured for manipulating the catheter during at least catheterization. A first plane including a transverse cross-section of the handle is orthogonal to a second plane including at least one opening of the one or more loops. The catheter shaft includes opposing eyelets proximate a tip of the catheter shaft in fluid communication with an opening in a proximal end of the handle by a lumen disposed in the catheter connecting the catheter shaft and the handle.

Also provided herein is a urinary catheter package including, in some embodiments, a urinary catheter and packaging for the catheter. The catheter includes a catheter shaft attached to a catheter handle. The handle includes one or more loops integral with the handle configured for manipulating the catheter during at least catheterization. A first plane including a transverse cross-section of the handle is orthogonal to a second plane including at least one opening of the one or more loops. The catheter shaft includes opposing eyelets proximate a tip of the catheter shaft in fluid communication with an opening in a proximal end of the handle by a lumen disposed in the catheter connecting the catheter shaft and the handle. The packaging includes an adhesive pull tab over a perforated area of the packaging configured to expose the catheter disposed in the packaging when the pull tab is pulled.

In such embodiments, the one or more loops of the catheter handle are respectively one or more rings, each attached to the handle by a tab extension of the handle.

In such embodiments, the opposing eyelets in the tip of the catheter shaft include at least two pairs of staggered eyelets, the at least two pair of eyelets staggered along a length of the catheter shaft and offset by about <NUM> degrees around the catheter shaft in a non-overlapping configuration.

In such embodiments, the urinary catheter further includes a hydrophilic base coating including PAA over the catheter shaft, a hygroscopic outer coating including a hydrogel over the catheter shaft, or a combination of the hygroscopic outer coating over the hydrophilic base coating over the catheter shaft.

In such embodiments, the urinary catheter further includes a UV-cured silicone film over at least a portion of the hydrophilic base coating, the hygroscopic outer coating, or the combination of the hygroscopic outer coating and the hydrophilic base coating.

The disclosed systems and methods can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but rather the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate, in a non-limiting manner, several possible configurations of a catheter according to various aspects and features of the present disclosure. While the description herein, by way of example, is focused primarily on a description of a urinary catheter and associated methods, the inventions described herein are not so limited and the concepts may be applied to other types of catheters and devices.

The urinary catheter described herein is ready to use immediately when the container is opened, and may be inserted by the patient or patient's caregiver in a homecare setting, managed care / assisted living setting, or in hospitals. Within the homecare setting, the catheter can be used in a range of restroom and non-restroom environments. <FIG> and <FIG> show urinary catheters and methods of using them according to embodiments described herein.

<FIG> illustrates the male urinary catheter <NUM>, the packaging <NUM> for the male urinary catheter <NUM>, and the exemplary use (e.g., steps <NUM>-<NUM>) thereof according to embodiments described herein, and <FIG> illustrates the female urinary catheter <NUM>, the packaging <NUM> for the female urinary catheter <NUM>, and the exemplary use (e.g., steps <NUM>-<NUM>) thereof according to embodiments described herein. The methods shown in <FIG> and <FIG> do not require the user to take any step to apply lubricant, such as water or gel, directly to the catheter, either while the catheter is within the package or when after the package has been opened. Accordingly, the user may move directly from the step of removing the catheter from the package <NUM>, <NUM> to the step of inserting the catheter <NUM>, <NUM> without an intervening direct lubrication or hydration step (see example steps <NUM>, <NUM>, which indicate the catheter is ready to use upon removing from the packaging, without requiring the addition of water or lubricant). The catheters used in <FIG> and <FIG> can be catheters of any of the embodiments discussed herein, e.g., the catheters may have a coating formulation that exhibits hygroscopic and/or hydrophilic characteristics (which eliminates the need for the user to take steps to lubricate or hydrate the catheter). In the case of a catheter with a hygroscopic coating, while some water from the surrounding environment may be naturally attracted by the coating, this is not considered a direct lubrication or hydration step taken in the method. After use, the catheter <NUM>, <NUM> may be disposed of according to sanitary procedure. Example disposal steps <NUM>, <NUM> depict one possible procedure for disposal, including returning the catheter to the packaging and discarding the packaging in a trash can or similar receptacle. The packaging may be sealable (e.g., by adhesive, zip-lock, etc.), such that the package may be sealed shut after the urinary catheter is disposed therein.

Referring to <FIG>, in one embodiment, a urinary catheter <NUM> includes a handle <NUM> on a proximal end and a catheter shaft <NUM> attached to the handle <NUM>. The urinary catheter may be one of a variety of different types of urinary catheters. The handle <NUM> may have a funnel-like shape <NUM> on the proximal end thereof, and may be adapted to connect to drain bags, extension tubes, and/or the like. Also, handle shapes other than a funnel-like shape may be utilized within the scope of the present disclosure. The handle <NUM> may indicate the size of the catheter, and may have a color to indicate sex (e.g., pink for female, blue for male). In one embodiment, the catheter shaft <NUM> is made from a silicone material. In one embodiment, the silicone material has a durometer in the range of shore 70A to 85A and a thickness in the range of <NUM> to <NUM>. It is appreciated that the composition of the catheter shaft <NUM> may include other materials that possess similar physical properties which falls within scope of the present disclosure. In one embodiment, the column strength of the catheter shaft <NUM> is configured or designed to facilitate insertion, e.g., requiring less force than current polyvinyl chloride (PVC) catheters. In one embodiment, the catheter <NUM> will be at least partially transparent to an unaided eye.

Referring to <FIG>, the catheter <NUM> includes openings <NUM> in a distal end <NUM> that are in fluid communication with a lumen <NUM> that extends through the catheter shaft and handle. In one embodiment, the catheter includes four staggered, opposing eyelets <NUM> proximate a catheter tip <NUM>, the eyelets <NUM> are circumferentially positioned about <NUM> degrees apart and positioned in a non-overlapping configuration. It is appreciated that other numbers and configurations of openings fall within the scope of the present disclosure. The handle <NUM> includes ridges <NUM> to provide a gripping surface for easier gripping and handling. The catheter shaft <NUM> may include the lumen <NUM>, a catheter wall <NUM>, a hydrophilic base coating <NUM> (e.g., polyacrylic acid), and may also include a pre-hydrated outer coating applied thereover <NUM> (e.g., over the base coating). The pre-hydrated coating may remain wet without the application of water or lubricant gel.

In one embodiment, the catheter <NUM> includes a hygroscopic coating <NUM> (e.g. a top or outer pre-hydrated coating). In one embodiment, the catheter <NUM> includes a hygroscopic coating <NUM> including a hydrogel, glycerin, water, and a polyethylene glycol (PEG) with a molecular weight equal to or less than <NUM>, for example one or more of polyethylene glycol (PEG) <NUM> and PEG <NUM>. In one embodiment, the hydrogel is a LUBRAJEL® hydrogel. For coating embodiments described herein, the type of LUBRAJEL® hydrogel may be LUBRAJEL® RR CG hydrogel, having an INCI name of Glycerin (and) Glyceryl Acrylate/Acrylic Acid Copolymer (and) Propylene Glycol. For coating embodiments described herein, the type of LUBRAJEL® hydrogel may be LUBRAJEL® RR hydrogel. In one embodiment, the catheter includes a coating including a hydrogel (e.g., LUBRAJEL® hydrogel), glycerin, propylene glycol (PEG), and ethanol. In one embodiment, the catheter includes a coating including a hydrogel (e.g., LUBRAJEL® hydrogel), glycerin or water, and propylene glycol (PEG), such as PEG <NUM> and/or PEG <NUM>. In one embodiment, the catheter may be sold and packaged in sizes ranging in diameter from 8Fr to 24Fr (e.g., 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr) with a length L of greater than <NUM> and intended for female use. However, other sizes of catheters may also be used. In other embodiments, the catheter may be sold and packaged in various sizes for male use.

In one embodiment, the base coating <NUM> and/or the outer coating <NUM> may be applied to the catheter shaft by a method involving either dipping, brushing, spraying or extruding. It is appreciated that other methods of applying one or both of the coatings to the catheter may be utilized and fall within the scope of the present disclosure. In one embodiment, the catheter shaft may be dipped into a volume of coating formulation. In one embodiment, the components of the coating formulation are mixed together, then the catheter shaft dipped into the volume thereof. For example, the hydrophilic coating or outer coating may be produced by mixing LUBRAJEL® with water and PEG for between <NUM> to <NUM> hours. The catheter (with or without a base coating) may be dipped into the coating solution and left to dwell for between <NUM> - <NUM> seconds. The catheter may then be removed from the coating solution and directly placed into packaging without any further drying process.

In one embodiment, the eyelets are punched into the catheter prior to dipping into one or more coating formulations to form a coating (e.g., a base coating and/or outer coating) such that both interior and exterior of the catheter is coated, i.e., at least a portion of the outer surface of the catheter shaft and at least a portion of the inner wall defining the lumen <NUM> of the catheter shaft are coated with the coating formulation. In other embodiments, one or more coating formulations may be brushed onto an outer surface of the catheter shaft (e.g., doctor blade method). In one embodiment, the coating (e.g., the base coating and/or the outer coating) is only on the catheter shaft (either the entire catheter shaft or a distal portion thereof), not on the handle. The coating described herein provides the urinary catheter with a coefficient of friction (COF) in the range of <NUM> to <NUM>.

In one embodiment, a coating formulation (e.g., a formulation for a base coating and/or outer coating) for the catheter may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, water <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment the coating formulation may include LUBRAJEL® RR CG hydrogel at <NUM> wt%, water at <NUM> wt%, and PEG <NUM> at <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, PEG <NUM> in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, propylene glycol (PEG) in a range of <NUM> wt% to <NUM> wt%, and ethanol (anhydrous) in a range of <NUM> wt% to <NUM> wt%. In one embodiment, the LUBRAJEL® RR CG hydrogel is <NUM> wt%, the glycerin is <NUM> wt%, and both the PEG and ethanol are <NUM> wt%.

In one embodiment, a silicone film may be formed over a coating on a catheter. In one embodiment, a method of forming a catheter with a coating includes dipping a coated catheter, such as a hydrophilic coated catheter, into a solution containing any of the coating formulations herein, such as a coating formulation including PAA, water, and PEG or a coating formulation including hydrogel, glycerin and/or water, and PEG, then dipping the twice-coated catheter into a UV curable solution, then exposing the coated areas to a UV source, and then directly placing the catheter into a package. In one embodiment, the hydrophilic coated catheter is dipped into a PAA/water/PEG solution for a dwell time in a range of <NUM> seconds to <NUM> seconds. In one embodiment, after the catheter is dipped into the PAA/water/PEG solution, it is dipped into a silicone solution with UV curable agents several times to achieve a desired film thickness. In one embodiment, the desired thickness is <NUM> in. to <NUM> in. In one embodiment, the catheter is dipped into the silicone solution with UV curable agents <NUM> to <NUM> times. In one embodiment, after being dipped into the silicone solution with UV curable agents, the catheter is exposed to a UV source, such as a UV light, in a time range of <NUM> to <NUM>. In one embodiment, following the exposure to the UV source, the catheter is placed directly into a film, foil, and/or Tyvek package without a further drying process. The silicone with UV curable agents, after curing forms a film that covers the coating on the catheter and can be moved when the catheter is ready for insertion. This acts to facilitate insertion without touching the lubricious coating while maintaining the lubricity of the coating on the catheter.

Referring to <FIG>, the urinary catheters described herein may be packaged individually in discrete containers. For example, the packaging or container may be opaque and resemble an item distinct from a urinary catheter, such as a food item or the like. In one embodiment, the packaging or container <NUM> is formed of and/or includes a foil material. In other embodiments, the container <NUM> includes a polyolefin film (e.g., polyethylene (PE)), an ethylene vinyl acetate (EVA) film, and/or a metallized polypropylene (PP) film. In one embodiment, the packaging material is gas impermeable. In one embodiment, of the lubricity of the coating is maintained or improved over time in the packaging while at normal environmental storage conditions. The packaging <NUM> may have a color to indicate sex (e.g., pink for female, blue for male). In one embodiment, the packaging <NUM> can be sterilized either by Electron Beam Processing (E-beam) or treatment with Ethylene Oxide (EtO).

Referring to <FIG>, a method of manufacturing the packaging for a catheter, discussed herein, including the following steps of producing the package, performed in any order: providing a sheet material <NUM>; providing a weakened area <NUM>, such as a perforation or kiss cut, in the sheet material by cutting the material; folding over and connecting the longitudinal edges <NUM> of the sheet <NUM> to form a back seam <NUM> and a cavity <NUM> (<FIG>). Disposing a catheter <NUM> within the cavity <NUM> and enclosed therein by sealing the ends to create a first end seam <NUM>, and a second end seam <NUM> (<FIG>). Adhering an adhesive tab <NUM> over the weakened area <NUM>.

In one embodiment, this arrangement may be similar to a packaging such as might be used on a candy bar, with overlapping edges forming a seam along the back and seams at the edges. The overlapping edges may be folded to one side or the other. The packaging material may present a smooth front. The front of the container may include a sealed opening <NUM>, covered by an adhesive tab <NUM> (<FIG>). The sealed opening may include a weakened area <NUM>, such as a perforation or kiss cut, in the packaging material covered by an adhesive portion of the adhesive tab <NUM>. The adhesive tab <NUM> may include features, such as a pull loop <NUM>, to hang the container after exposing the catheter <NUM> in the packaging in order to facilitate user access to the catheter <NUM> in the container <NUM>. The adhesive tab <NUM> may be formed of a material such as polyethylene terephthalate (PET) substrate, with an adhesive, such as an S6 adhesive, on part of or the entire bottom surface of the adhesive tab. In one embodiment, the adhesive tab may include a label. The label may have artwork printed on or otherwise associated with a top surface of the label. The label may be stamped out of a roll stock of material and a varnish may be applied over approximately <NUM> inch (<NUM>) of the distal end <NUM> of the label to facilitate lifting to begin the peeling process.

The adhesive tab may include a pull loop <NUM> to facilitate opening of the container <NUM>, which after opening (<FIG>) may be positioned over a hook or the like in order to suspend the container for ease of use. Alternatively, the adhesive portion of the adhesive tab <NUM> may be pressed against a hard surface (e.g., a wall, table, desk, equipment, etc.) in order to prevent movement of the container. In one embodiment, the catheter <NUM> may be reinserted into the container <NUM> and the adhesive tab <NUM> pressed back over the opening <NUM> to re-seal the container <NUM> for disposal in another location. The embodiment of <FIG> is easy to open by simply putting a finger through the pull loop <NUM> (<FIG>) and pulling the adhesive tab toward the proximal end of container <NUM>. The pulling action opens the container along the weakened area <NUM> to reveal the handle <NUM> of the catheter <NUM>, which has a gripping surface to facilitate handling. Also, the container can be folded in half to minimize space needed to transport in a purse, bag, or the like.

Referring now to <FIG>, schematics are provided illustrating urinary catheters including loops for manipulating the catheters in accordance with the invention. Referring to <FIG> and <FIG>, schematics are provided illustrating urinary catheters including loops for manipulating the catheters, not encompassed by the scope of the claims. Such loops are useful in manipulating the catheters during at least catheterization processes, especially for individuals with limited dexterity or lacking full control of their fingers for such catheterization processes.

Like the urinary catheter <NUM>, a urinary catheter <NUM>, <NUM>, <NUM> includes a catheter shaft <NUM>, <NUM> attached to a handle <NUM>, <NUM> about a proximal end portion of the catheter <NUM>, <NUM>. With respect to the catheter shaft <NUM>, <NUM>, it includes openings <NUM>, <NUM> in a distal end portion of the catheter shaft <NUM>, <NUM> that are in fluid communication with a lumen (see, for example, lumen <NUM> of catheter <NUM> of <FIG>) that extends through the catheter shaft <NUM>, <NUM> and the handle <NUM>, <NUM>. The catheter shaft <NUM>, <NUM> includes opposing eyelets <NUM>, <NUM> proximate a tip <NUM>, <NUM> of the catheter shaft <NUM>, <NUM> in fluid communication with an opening <NUM>, <NUM> in a proximal end of the handle <NUM>, <NUM> by way of the lumen of the catheter <NUM>, <NUM> that connects the catheter shaft <NUM>, <NUM> and the handle <NUM>, <NUM>. As shown, the opposing eyelets <NUM>, <NUM> can include, but are not limited to, at least two pairs of eyelets <NUM>, <NUM> longitudinally staggered along a length of the catheter shaft <NUM>, <NUM>, wherein the eyelets <NUM>, <NUM> are circumferentially positioned about <NUM> degrees apart in a non-overlapping configuration. In other words, the opposing eyelets <NUM>, <NUM> can include at least two pairs of staggered eyelets <NUM>, <NUM> that are staggered along a length of the catheter shaft <NUM>, <NUM> and offset by about <NUM> degrees around the catheter shaft <NUM>, <NUM> in a non-overlapping configuration. With respect the handle <NUM>, <NUM>, it includes a funnel-like shape <NUM>, <NUM> at a proximal end thereof adapted to connect to drain bags, extension tubes, or the like. The handle <NUM>, <NUM> further includes a plurality of ridges <NUM>, <NUM> configured to facilitate gripping the handle <NUM>, <NUM> by an individual, as well as one or more of the loops <NUM>, <NUM>, <NUM> useful in manipulating the catheter <NUM>, <NUM>, <NUM> during at least catheterization processes.

With respect to the one or more loops <NUM>, <NUM>, <NUM>, such loops are integral with the handle <NUM>, <NUM> such as molded with the handle <NUM>, <NUM> in order to provide the loops <NUM>, <NUM>, <NUM> with a structural integrity strong enough to withstand pulling and tugging on the loops <NUM>, <NUM>, <NUM> during a catheterization process. The one or more loops <NUM>, <NUM> of the catheter <NUM>, <NUM> are configured such that a first plane including a transverse cross-section of the handle <NUM>, <NUM> is orthogonal to a second plane including at least one of the one or more loops <NUM>, <NUM> or an opening of the one or more loops <NUM>, <NUM>. Such a configuration enables right or left handed individuals alike to perform catheterization processes with catheters like the catheter <NUM>, <NUM>, wherein the handle <NUM>, <NUM> rests in a hand of an individual (e.g., a patient or a caregiver) while the one or more loops <NUM>, <NUM> respectively receive one or more fingers of the individual. Alternatively, the foregoing first plane and second plane can be oblique to each other in some embodiments to provide a left or right handedness to the catheter <NUM>, <NUM>. That said, the one or more loops <NUM> of the catheter <NUM> are configured such that the first plane including the transverse cross-section of the handle <NUM> is parallel to a second plane including at least one of the one or more loops <NUM> or an opening of the one or more loops <NUM>. As such, the one or more loops <NUM>, <NUM>, <NUM> can be designed with any of a number of configurations including the foregoing configurations and mixtures thereof to accommodate different needs.

As used herein a "loop" includes an extension of the handle <NUM>, <NUM> of the catheter <NUM>, <NUM>, <NUM> configured to receive a finger of an individual such as during a catheterization process for manipulating the catheter <NUM>, <NUM>, <NUM>. Such a loop includes the loop <NUM> of the catheter <NUM> of <FIG> and <FIG>, which loop <NUM> is a ring attached to the handle <NUM> of the catheter <NUM> by a tab extension <NUM> of the handle, which ring and the tab extension <NUM>, together, are an integral loop of the handle <NUM>. Such a loop also includes the loop <NUM> of the catheter <NUM> of <FIG> and <FIG>, which loop <NUM> is a ring attached to the handle <NUM> of the catheter <NUM> by a tab extension <NUM> of the handle, which ring and the tab extension <NUM>, together, are an integral loop of the handle <NUM>, albeit of a different orientation than that of the catheter <NUM>. Such a loop also includes the loop <NUM> of the catheter <NUM> of <FIG> and <FIG>, which loop <NUM> need not, but can, include a tab extension of the handle such as the tab extension <NUM> of the catheter <NUM>.

The catheter <NUM>, <NUM>, <NUM> includes, in some embodiments, a hydrophilic base coating including, for example, PAA over the catheter shaft, a hygroscopic outer coating including, for example, a hydrogel over the catheter shaft, or a combination of the hygroscopic outer coating over the hydrophilic base coating over the catheter shaft. Such coatings are described herein for the catheter <NUM>. For example, the hydrophilic base coating over the catheter shaft can be a base coating of PAA in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. The hydrophilic base coating can alternatively be a base coating of PAA in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG in a range of <NUM> wt% to <NUM> wt%. For example, the hygroscopic outer coating over the catheter shaft can be an outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. The hygroscopic outer coating can alternatively be an outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. The hygroscopic outer coating can alternatively be an outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, glycerin in a range of <NUM> wt% to <NUM> wt%, PEG <NUM> in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. The hygroscopic outer coating can alternatively be an outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt% to <NUM> wt%, and PEG <NUM> in a range of <NUM> wt% to <NUM> wt%. The hygroscopic outer coating can alternatively be an outer coating of a hydrogel in a range of <NUM> wt% to <NUM> wt%, water in a range of <NUM> wt%, and PEG <NUM> is in a range of <NUM> wt% to <NUM> wt%. In addition, the catheter <NUM>, <NUM>, <NUM> can further include a UV-cured silicone film over at least a portion of the hydrophilic base coating, the hygroscopic outer coating, or the combination of the hygroscopic outer coating and the hydrophilic base coating as described herein for the catheter <NUM>.

Like the catheter <NUM>, the catheter <NUM>, <NUM>, <NUM> can be part of a catheter package wherein packaging (e.g., packaging <NUM> of <FIG>) of the catheter package includes an adhesive pull tab (e.g., adhesive pull tab <NUM> of <FIG>) over a perforated area (e.g., perforated area <NUM> of <FIG> and <FIG>) of the packaging configured to expose the catheter <NUM>, <NUM>, <NUM> disposed in the packaging when the pull tab is pulled.

Individuals who are confined to wheelchairs based on injuries that need to use catheters such as intermittent catheters to void their bladders often do not have full control of their fingers as needed to catheterize themselves in a consistent manner. The one or more loops <NUM>, <NUM>, <NUM>, of the catheter <NUM>, <NUM>, <NUM> provides those individuals independence by way of slipping one or more fingers respectively into the one or more loops <NUM>, <NUM>, <NUM> of the catheter <NUM>, <NUM>, <NUM> to help such individuals better manipulate the catheter <NUM>, <NUM>, <NUM> for insertion and removal during a catheterization process. Thus, the one or more loops <NUM>, <NUM>, <NUM> of the catheter <NUM>, <NUM>, <NUM> provides those (e.g., patients, caregivers, consumers, etc.) with limited dexterity a way to use as little as a single finger to manipulate and the catheter <NUM>, <NUM> (e.g., an intermittent catheter) in a more convenient and controllable fashion.

Claim 1:
A urinary catheter (<NUM>, <NUM>, <NUM>), comprising:
a handle (<NUM>) including:
a plurality of ridges (<NUM>, <NUM>) designed for gripping the handle; and
one or more rings (<NUM>, <NUM>, <NUM>) integral with the handle designed for manipulating the urinary catheter, wherein the one or more rings (<NUM>, <NUM>) are each attached to the handle by a tab extension (<NUM>, <NUM>) of the handle; and
a catheter shaft (<NUM>, <NUM>) attached to the handle, the catheter shaft including:
a catheter tip;
a lumen; and
a plurality of eyelets (<NUM>, <NUM>) proximate the catheter tip, the eyelets in fluid communication with the lumen.