Patent Publication Number: US-2023133471-A1

Title: Catheters having low viscosity lubricant

Description:
This application is a continuation of U.S. Pat. Application Serial No. 16/457,835, filed Jun. 28, 2019; which claims priority to U.S. Provisional Pat. Application Serial No. 62/691,360, filed Jun. 28, 2018; the contents of which are hereby incorporated by reference herein in their entirety into this disclosure. 
    
    
     BACKGROUND OF THE SUBJECT DISCLOSURE 
     Field of the Subject Disclosure 
     The present subject disclosure relates to urinary catheters. More specifically, the present subject disclosure relates to urinary catheters having low viscosity lubricants. 
     Background of the Subject Disclosure 
     Intermittent catheterization of an individual’s urinary bladder is a common practice today for many persons who are in a hospital setting, a nursing home, doctor’s office, rehabilitation facility, or at home. For instance, a patient is sometimes catheterized to treat such conditions as urinary retention, the inability to evacuate urine, or for the purpose of obtaining a sterile urine specimen from a patient in a doctor’s office or at home. 
     The need for intermittent catheterization of an individual sometimes arises due to problems typically associated with long term use of indwelling catheters, such as infections, urethral damage, and bladder damage. Long term use of an indwelling catheter is also a risk factor for bladder cancer. This is often the case for persons having a neurogenic urinary condition (neurogenic bladder), such as in a spinal cord injury, multiple sclerosis, stroke, or brain injury. Conditions that interfere with the individual’s ability to voluntarily void the bladder may also arise post-surgically or as a result of benign prostatic hypertrophy, prostate cancer or diabetes mellitus. Many of the affected individuals are capable of, and would prefer to perform, self-catheterization 
     For many, the level of risk and discomfort of repeated catheterizations carried out over the course of a day (at 3-6 hour intervals, for example) are offset by the accompanying convenience, privacy or self-reliance that is achieved. Some of the major difficulties that arise in self-catheterization are the lack of satisfactory catheterization kits, the problem of maintaining the required level of sanitation during the procedure, and the difficulty of sometimes performing the procedure under conditions of restricted space and privacy. 
     In most closed-system sterile units the collection bag doubles as a sterile cover. These catheters are extremely difficult for the user to grasp and insert. Many of these closed-system catheters have a cap that covers the introducer tip to maintain sterility. This is particularly a problem for self-catheterization users who may also have neurological problems that limit manual dexterity, because they have difficulty removing the cap. Also, with some of the available catheter kits and methods, the catheter is either not sufficiently lubricated during insertion (and thus requires the additional application of possibly non-sterile lubricant), or the catheter is too slick with lubricant and cannot effectively be grasped through an insufficiently flexible bag. As a practical matter, many individuals who would prefer to self-catheterize cannot conveniently do so using many of the existing catheterization apparatus while still maintaining the required level of sanitation. 
     Many catheterization tasks require a degree of dexterity to accomplish. People with normal dexterity, like paraplegics, may not have use of their lower extremities, but their hands have normal function. Some quadriplegics can have use of their upper extremities, having absolutely normal movement, like a paraplegic, except they lack normal hand dexterity. Thus, many tasks requiring a degree of hand dexterity are very difficult for quadriplegics to accomplish. 
     Spinal cord injuries at the fifth, sixth, and seventh cervical vertebrae level (C5, C6, C7) affect the use of a person’s hands and make these tasks difficult or impossible with current products. Moreover, people who have had strokes, brain injuries, or multiple sclerosis may also require catheterization but have limited dexterity. The current catheterization market does not currently support the needs of these individuals. 
     Insertion of a lubricated catheter is one such task. Devices currently on the market allow for different ways of lubricating a catheter. However, most of these closed-system catheter units have gel covering the catheter within the bag, which makes it difficult or impossible to grasp with limited dexterity and insert into the bladder. Another problem with the current closed-system catheters is that the catheter may not be circumferentially lubricated or the gel may be wiped away as it is pushed through the non-lubricated introducer tip. This can lead to urethral irritation, “sticking”, and discomfort or pain for the recipient. Some closed-system hydrophilic catheter are bathing in fluid and are therefore difficult to manipulate. 
     SUMMARY OF THE SUBJECT DISCLOSURE 
     The present subject disclosure describes catheter devices, systems, and methods that contain a low viscosity lubricant in a sachet contained within the sheath that surrounds the catheter. The sachet may have an area that is weakened in manufacturing (or the entire sachet may be breakable) such that it is able to allow the low viscosity gel to pour out onto the catheter within the sheath when the sachet is compressed by someone with limited dexterity. 
     The present subject disclosure addresses long felt needs in the field of catheters, in particular, urinary catheters. Urinary catheters require lubrication prior to insertion into the urethra. The two options today include placing a small amount of higher viscosity water-soluble gel [Cp (centipoise) usually ranging from 15,000-30,000] on the catheter or using a hydrophilic coating of the catheter combined with a water or saline wetting fluid. The higher viscosity gel catheters are more difficult to insert for individuals with limited hand dexterity because of friction resistance. The hydrophilic catheters are very slick and easier to insert than high viscosity gel covered catheters, but can still be very difficult to manipulate and insert because of this slickness. The hydrophilic catheters and their coating may also be affected by environmental controls. 
     The present subject disclosure uses a low viscosity water-based gel which quickly travels down and covers the catheter after the sachet is ruptured just prior to use. This gives a functionality to the catheter insertion similar to a hydrophilic catheter, but without the difficulty in grasping the catheter with the sheath. The low viscosity lubricating gel ensures that there are no uncoated dry spots on the catheter during insertion, which often happens with the higher viscosity standard gel (Cp 15,000-30,000). No other catheters on the market use an uncoated catheter with a low viscosity water-based gel, preferably contained within a sachet. 
     The present subject disclosure describes an uncoated catheter, but could also be combined with a hydrophilic coated catheter. The low viscosity lubricating gel within the sachet uniformly coats the catheter when the sachet is ruptured just prior to use. Therefore, this prevents the variability that occurs with either a hydrophilic catheter or a non-lubricated catheter with high viscosity gel. 
     In one exemplary embodiment, a urinary catheter according to the present subject disclosure has a proximal end that enters the patient first. The distal end of the catheter is inserted into a port that is attached to the urine collection bag. The proximal end of the catheter sits in the guide mechanism which is the distal end of the introducer. The cap and stem mechanism covers a 1 cm part of the introducer that enters the urethra. The area between this insertable part and the expanded gripping device is a radial phalange that acts as a stop mechanism when inserting the introducer into the urethra. A pliable and cylindrical sheath is attached via heat shrink to the guide portion of the introducer. It also attaches to the port component on the proximal end of the urine collection bag. A low viscosity liquid gel is in a sachet that is located within the sheath and external to the catheter. When this is sachet is ruptured, typically right before use of the catheter, liquid gel flows upon the urinary catheter that is located within the sheath. No liquid gel touches the user’s hands because it is enclosed within the sheath. 
     In one exemplary embodiment, the present subject disclosure is a catheter system. The system includes a catheter; a sheath surrounding the catheter; and a sachet positioned within the sheath and external to the catheter, the sachet containing a lubricating fluid having a viscosity of less than 2,000 cP. 
     In another exemplary embodiment, the present subject disclosure is a catheter system. The system includes a catheter; a sheath surrounding the catheter; a collection bag positioned at one of the catheter; and a sachet comprised of a pliable foil and plastic and positioned within the sheath and external to the catheter, the sachet containing a lubricating fluid having a viscosity of less than 2,000 cP. 
     In yet another exemplary embodiment, the present subject disclosure is a catheter system. The method includes a catheter; a sheath surrounding the catheter; a collection bag positioned at one of the catheter; an introducer coupled to a proximal end of the catheter, the introducer in liquid communication with a volume between the sheath and the catheter; and a sachet comprised of a pliable foil and plastic and positioned within the sheath and external to the catheter, the sachet containing a lubricating fluid having a viscosity of less than 2,000 cP. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1 A  shows a catheter assembly, according to an exemplary embodiment of the present subject disclosure. 
         FIG.  1 B  shows more detail of the introducer portion of a catheter assembly, according to an exemplary embodiment of the present subject disclosure. 
         FIG.  2 A  shows a catheter assembly with a collection bag, according to an exemplary embodiment of the present subject disclosure. 
         FIG.  2 B  shows a catheter assembly with the cap removed, according to an exemplary embodiment of the present subject disclosure. 
         FIG.  3    shows an introducer portion of a catheter assembly, according to another exemplary embodiment of the present subject disclosure. 
         FIG.  4    shows an introducer portion of a catheter assembly, according to another exemplary embodiment of the present subject disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE SUBJECT DISCLOSURE 
     The present subject disclosure addresses the shortcomings of conventional catheters, as discussed above. In various exemplary embodiments, the present subject disclosure describes disposable lubricating catheterization assemblies used for inserting a catheter into the urethra of an individual for the purpose of evacuating the bladder. The catheter assembly includes a substantially rigid catheter introducer with a member for positioning the introducer tip against the urethral opening or into the first part of the urethra, a flexible catheter and a flexible thin-walled sheath surrounding the catheter and optionally partially covering the catheter introducer. The catheter introducer may include an insertion tip portion, a gripping portion, and a catheter guide portion. The lubricant is a low viscosity gel in a contained housing, such as a sachet, which is ruptured prior to use and coats the catheter within the sheath, in order to facilitate grasping of the catheter and feeding of the tube into the urethra and into the bladder. 
     A catheterization assembly in accordance with the present subject disclosure is suitable for use for self-catheterization in the home, a public restroom, a busy emergency room or clinic office, and elsewhere, and lessens the chances of contamination and subsequent infection of the urinary tract. The catheterization assembly is also ideal for medical settings where it is important but difficult to maintain sterile technique, such as an emergency room or medical clinic. The improved easy-to-use disposable catheterization kit is also economically practical for use for temporary catheterizations in hospitals, mobile emergency facilities, doctors’ offices, rehabilitation facilities, nursing homes and the like. This design is specially made to allow individuals with limited dexterity the ability to perform intermittent self-catheterization. 
     As stated above, urinary catheters require lubrication prior to insertion into the urethra. The two options today include a small amount of higher viscosity gel on the catheter or a hydrophilic coating of the catheter and a wetting fluid. The higher viscosity gel catheters are typically more difficult to insert for individuals with limited hand dexterity. The hydrophilic catheters are usually very slick, so can be very difficult to manipulate and insert because of the slickness. The hydrophilic catheters are also at times affected by the environmental controls. The present subject disclosure claimed here addresses these shortcomings of conventional devices and techniques. 
     According to the present subject disclosure, a closed-system urinary catheter may have an uncoated catheter surrounded by a pliable protective sheath. Within the sheath is a low viscosity lubricating water-based gel. More specifically, a contained housing, such as a sachet, is used to contain the lubricating gel prior to use and catheter insertion. By rupturing the sachet, the low viscosity lubricating gel covers the uncoated catheter completely and provides a lubrication to the catheter tube that provides characteristics which fall between the commonly used, high viscosity, thick lubricating gel covered catheter, and the also commonly used hydrophilic catheter. This allows for easy insertion into the urethra for individuals with limited dexterity but is not easily affected by the environment ensuring the patient receives a catheter that is ready to use when needed and its gel has maintained its integrity. 
     The present subject disclosure differs in a number of ways from what currently exists in the marketplace. The present product may include an uncoated catheter that sits within a protective sheath. This protective sheath is made of a material that improves the ability to grasp the catheter. A sachet that holds between 3 and 15 mL of low viscosity (&lt; 2,000 cP) water-based lubricating gel prevents the gel from contacting the catheter until just seconds or minutes prior to use. In an exemplary embodiment, the viscosity of the lubricating fluid is 300-600 cP. This sachet maintains the low viscosity lubricating gel in the best possible condition by preserving it and thereby maintaining its intended qualities. Gels that are exposed to air have a greater propensity to age and lose their viscosity and thereby decrease their lubricating characteristics. Specifically, the present catheter system functions best if the viscosity is 2,000 cP or less. As used herein and throughout this disclosure, “low viscosity” in describing the lubricating gel is defined as 2,000 cP or less. 
     Hydrophilic catheters are commonly used in the field, but are limited by their higher price and the possibility of being affected by environmental factors such as humidity, heat, and freezing temperatures. Other adverse possibilities related to environmental concerns are mechanical bending of the catheter, which could include cracking or flaking which can create an uneven surface and friction against the urethra during insertion. This could be a factor that affects the sensation or mechanical changes of the patient’s urethra. Other factors with the hydrophilic catheters are the possibility of sticking to the urethra during insertion or removal and the possibility of burning the urethra. The chemical makeup of the hydrophilic coating is a variable that is different between different manufacturer’s hydrophilic catheter products. Hydrophilic catheter coating material often flakes off into the wetting-fluid and may enter the bladder lumen and create a nidus for stone formation or urinary tract infection. 
     High viscosity gel catheters are typically more difficult to insert and may not be evenly and uniformly coated. Studies have shown that high viscosity gel catheters may cause irritation and even scarring of the urethra. Scarring is in the form of strictures which may create a situation that prevents catheter insertion in the future and/or require surgical intervention. 
     The present subject disclosure addresses the shortcomings of the various conventional urinary catheters by providing a separately packaged gel insert which maintains the integrity of the gel and prevents it from breaking down before its use. In an exemplary embodiment, the present catheter includes an uncoated catheter with a sheath containing a sachet therein. A low viscosity lubricating gel within the sachet uniformly coats the catheter when the sachet is ruptured just prior to use. Therefore, this low viscosity gel covers the catheter only when needed and eliminates the variability that occurs with a hydrophilic catheter and a non-lubricated catheter with high viscosity gel. 
     Throughout the disclosure, components of the subject disclosure may include a proximal end and a distal end. The proximal end describes an end of the component nearest the point of insertion into the urethra of a user. The distal end describes an end of the component farthest away from this point of insertion. When proximal and distal are used as adjectives to distinguish elements, the proximal element is closer to the proximal end and the distal element is closer to the distal end. 
     For the following description, it can be assumed that most correspondingly labeled structures across the figures having the same last two digits (e.g.,  110 ,  210 ,  310 , etc.) possess the same characteristics and are subject to the same structure and function. If there is a difference between correspondingly labeled elements that is not pointed out, and this difference results in a non-corresponding structure or function of an element for a particular embodiment, then that conflicting description given for that particular embodiment shall govern. 
       FIGS.  1 A,  1 B,  2 A, and  2 B  show a system for housing and delivering a volume of low viscosity lubricating gel prior to use, according to an exemplary embodiment of the present subject disclosure. In this embodiment, the system includes a catheter  110 , a sheath  112  surrounding catheter  110 , a catheter introducer tip  113 , an introducer  114  coupled to the catheter introducer tip  113 , an outlet  120 , and a catheter cap  100 . Catheter  110 , sheath  112 , catheter introducer tip  113 , introducer  114 , and outlet  120  are generally described, for instance, in commonly owned U.S. Pat. 6,090,075, issued on Jul. 18, 2000, the contents of which are incorporated hereby incorporated by reference herein in their entirety. 
     Catheter  110  is generally a flexible tube for evacuating urine from the bladder of the user. Catheter  110  is inserted into the urethra of the user using catheter introducer tip  113 . Catheter  110  has a proximal end and a distal end. At or near the proximal end is a urine inlet. At the distal end of catheter  110  is outlet  120 . The catheter  110  may be comprised of PVC, silicon, rubber or other suitable material type, as known to one having ordinary skill in the art. Alternatively, a hydrophilic catheter could be used, but is not a requirement because of the use of a sachet  140  containing gel, as described herein. 
     The sheath  112  may be comprised of a material that is pliable and aids in grasping the catheter. It may be cylindrical or semi-cylindrical and attaches to the designated part of the introducer tip  113 . Alternatively, the sheath  112  may attach to various closure points or areas, such as  126 . 
     Sheath  112  surrounds catheter  110  and provides protection for catheter  110 . Sheath  112  has a proximal end, a distal end, a lumen  111 , and closure point  126 . The proximal end of sheath  112  connects to the distal end of catheter introducer tip  113  at a proximal closure point. The distal end of sheath  112  connects to the distal end of catheter  110  or outlet  120  at a distal closure point  126 . These closure points such as  126  may use any type of tie, band, adhesive, sealing mechanism, etc., in order to attach sheath  110  at these points. Lumen  111  is generally the space between catheter  110  and the material of sheath  112  surrounding catheter  110 . Lumen  111  is large enough to house a sachet  140  and permit catheter  110  to rotate and slide therein when sheath  112  collapses and is gathered up during use, yet is not so large that sheath  112  is cumbersome. Sheath  112  generally benefits from a means of venting to allow air to escape as sheath  112  is bunched together during insertion. This may be accomplished through vents in sheath  112  located anywhere on sheath  112 . However, because introducer  114  does not require a membrane, venting may occur through catheter introducer tip  113  when catheter cap  100  is removed. 
     Catheter introducer tip  113  is generally a guide for inserting catheter  110  into the urethra of the user. Introducer  114  includes a catheter introducer tip  113  having a proximal tip end  118 , an insertion stop point  116 , and a guide portion  124 . Catheter introducer tip  113  has a longitudinal throughbore with a bore diameter that is at least as large as catheter  110 ’s outer diameter, so that catheter  110  can rotate and slide through the throughbore. The elongated tip  113  is generally sized such that it fits into the opening of the urethra of the user. At the base of introducer tip  113  is an insertion stop point  116 . Insertion stop point  116  is a radial flange generally between elongated tip  113  and introducer  114 . Insertion stop point  116  prevents further insertion of catheter introducer tip  113  into the urethra. Insertion stop point  116  also serves as a coupling point with catheter cap  100 , such that a lip  108  of catheter cap  100  may surround insertion stop point  116  when coupled. The proximal edge of insertion stop point  116  may be a beveled edge, such that catheter cap  100  may easily fit over insertion stop point  116  and secure to the distal edge of insertion stop point  116 . Alternatively, it could be solid for gripping. 
     The introducer 13 includes an elongated tip 18 comprised of silicon or similar material that extends beyond the radial phalange or insertion stop 16 by approximately 1 cm – 1.5 cm. This elongated tip 18 enters the urethra and bypasses a significant amount of bacteria. The flange  116  may be circular, square, or any other variable shape that prevents the introducer  114  from entering the urethra beyond the 1 cm – 1.5 cm extension. The elongated tip  113  that enters the urethra is crosscut at its proximal tip so that the catheter  110  can exit the introducer easily and enter the urethra. The introducer portion that is opposite the elongated tip  113  may include a surface area that allows for the sheath  112  to be attached. See, for example,  FIG.  3   . Methods of attachment of the sheath  112  to the introducer tip  113  can include, but are not limited to, shrink, collar, ultrasonic welding, etc. 
     The sachet  140  is filled with a low viscosity water-based gel. Viscosity is in the range of 100-2000. It is made of a material that prevents evaporation and is stable in transport, but with the appropriate amount of force can be ruptured or fractures, expelling the low viscosity gel. The volume of gel that is contained within the sachet  140  ranges from 3 mL-15 mL. The liquid may be sterilized via gamma or e-beam radiation. After the sachet  140  is ruptured and the gel is expelled, the material that the sachet is made of is pliable and does not interfere with the scrunching of the sheath  112  as the distal end moves closer to the proximal end and the catheter  110  enters the bladder. If this sachet  140  were more rigid, it would likely resist collapsing of the sheath  112  and interfere with insertion of the catheter  110  into the bladder. The sachet  140  may be made of, for example, a thin and pliable plastic such as foil. 
     When catheter  110  is being inserted, catheter  110  travels through introducer  114 . Introducer  114  has a proximal end and a distal end. The proximal end of introducer  114  has an opening in its tip end  118  at elongated introducer tip  113 , while the distal end has a distal opening extending to the guide portion  124 . The guide portion  124  is at the distal end of catheter introducer tip  113 , and is near where sheath  112  secures to catheter introducer tip  113  at proximal closure point. Before insertion into the urethra, the proximal end of catheter  110  is positioned in the guide portion  124 , ready to be pushed through catheter introducer tip  113 . 
     Outlet  120  is at the distal end of catheter  110 . Outlet  120  allows catheter  110  to attach, for instance, to a urine collection bag  130 , a drain, etc. The urine collection bag  130  may be comprised of plastic and is attached to the distal end of the catheter  120  or sheath  112 . The bag  130  may include one or more thumb holes  131  (not shown actual size) at top of the bag  130  that allow for easy tear-away opening to assist urine drainage from the bag for individuals with limited dexterity. Further, a hook  132  (not shown actual size) may be attached to the distal end  120  of the catheter  110  and the proximal end of the urine collection bag  130  where the two meet. This allows the user the ability to hang the bag  130  on a chair or another object while the urine collection bag  130  is filling with urine. This allows the user to use both hands for the purpose of catheterization instead of attempting to hold the urine collection bag  130  with one hand as it becomes heavy when it fills with urine. 
     As shown in  FIGS.  2 A- 2 B , catheter cap  100  may be removably coupled to catheter introducer tip  113 . When coupled to catheter introducer tip  113 , catheter cap  100  snaps around or otherwise secures to insertion stop point  116 , covering the elongated tip  113 . Catheter cap  100  prevents airflow into the elongated tip  113 . An elongate stem  102  of catheter cap  100  extends into the elongated tip  113  and through introducer  114  to seal the distal opening of introducer  114 . Elongate stem  102  includes a stopper  104  at the distal end of elongate stem  102 . Stopper  104  is sized such that it releasably engages with the distal opening at the base of introducer  114  in order to seal the distal opening. For example, stopper  104  may be a spherical shape which fits into a semispherical distal opening at the base of introducer  114 . Stopper  104  may also simply be the distal end of elongate stem  102 . The size and shape of stopper  104  and the distal opening may be designed based upon the desired amount of force necessary to remove catheter cap  100 . Catheter cap  100  may further include a ring  106 . Ring  106  is preferably sized to fit a finger or thumb easily. Ring  106  may be used to remove catheter cap  100  from introducer tip  113 . Ring  106  allows users having limited manual dexterity to more easily remove catheter cap  100  from introducer tip  113 , allowing a greater amount of force to hold the seal. 
     As shown more clearly in  FIG.  2 B , a cap  100  has a ring  106  at the top and a stem  102  that runs from the inside of the cap  100  and extends approximately 1 inch. This is made so that it inserts through the introducer elongated tip  113  and to plug the guide  124 . The guide  124  is the area that the sheath  112  is attached to. The stem  102  then is pulled out of the elongated tip  113  prior to use and helps to pre-lubricate the pathway in the tip  113  that the catheter  110  will travel. This helps to ensure the catheter  110  remains lubricated prior to insertion. 
     The low viscosity gel which is released by compromising the sachet  140  also ensures that the catheter  110  is fully and evenly lubricated during this process. The cap  100  also contains approximately 1 milliliter of higher viscosity gel that is similar to other products. This pre-lubricates the first portion of the tip  118  prior to insertion. After the stem  102  is pulled out of the introducer tip  113 , it can then be used to evenly spread this higher viscosity gel evenly over the external portion of the introducer tip  113 . This ensures the introducer tip  113  entering the first part of the urethra is thoroughly lubricated. Conventional catheter systems in the market with introducer tips do not have this mechanism and often have dry or partially lubricated introducer tips entering the urethra. 
     In use, the catheter system according to the present subject disclosure may be packaged as a kit, and ready to use by an end user, who may be a medical professional or a patient. A user opens the package and pulls out the closed-system catheter. Just prior to use, the user would compress or rupture the sachet  140  that is located within the sheath  112  and external to the catheter  110 . This causes the low viscosity liquid gel to flow on the catheter  110  and coating the part of the catheter  110  that will enter the urethra. The user then removes the cap  100  and stem  102  component by pulling it out of the introducer tip  113 . There will be a small amount of high viscosity gel in the cap  100  that is partially coating the 1 cm portion  113  of the introducer  114  that will enter the urethra. The user then takes the lubricating stem  102  and spreads the high viscosity (18,000-26,5000 Cp) gel (standard, thicker type) evenly over the introducer tip  113  that will enter the urethra. The user then inserts the proximal 1 cm portion  113  of the introducer tip  113  into the urethra up until the radial flange stop  116 . Once it is in the urethra the radial phalange  116  prevents it from entering too far. The user then grabs the sheath  112  and catheter  110  and inserts the catheter  110  into the bladder. The sheath  112  then collapses on itself allowing the catheter  110  to enter the bladder. Urine then flows in the urine collection bag  130 . When urine stops flowing, the catheter  110  is removed and the entire product is discarded into an appropriate receptacle. 
     From a practical use perspective, an individual would take the catheter system out of the packaging. The user would then rupture the sachet  140  by applying pressure between the palms of their hands, within their fingers, or on a hard surface by compressing it. This would cause the low viscosity liquid gel to flow from the sachet  140  within sheath  112  and onto the catheter  110 . The user would then rock the catheter  110  back-and-forth so that the liquid gel covers the urinary catheter  110  that will be inserted into the urethra or at least the first proximal half. The user would then take off the cap  100  and lubricating stem  102 . The user would then use the end  104  of the lubricating stem  102  to spread the high viscosity gel that is in the introducer tip 18 so that it is evenly covered with gel. The user would then insert the introducer tip  113  into the first 1 cm of the urethra. Once it is in the urethra the catheter  110  would then be inserted into the bladder. Once the bladder has completely drained by the catheter  110 , it is pulled back into the sheath  112 . The urine collection bag  130  (not shown actual size) can be drained into the toilet after tearing it open with the two loophole tearing mechanism  131  (not shown actual size). This can be done by using the loops  131  on the urine collection bag that are pulled apart at a pre-designed tear area. After the urine is drained into the toilet, the entire catheter system is thrown into the trash or an appropriate disposable location. 
     There are many ways to create the device or system described in the present subject disclosure. One such exemplary technique may be used. It should be appreciated that many other ways of making the package are possible and within the scope of the present subject disclosure, as recognized by one having ordinary skill in the art after considering the present disclosure. The individual parts of the present device/system are combined together to make a “kit.” The catheter tube  110  proximal end is inserted into the guide mechanism  124  of the introducer  114 . The distal end of the catheter is inserted into a port tube  120  attached to a urine collection bag  130 . A sheath  112  is placed over the catheter  110  and using heat shrink (or another mechanism to adhere the sheath can be used such as a clamp) applied to the sides over the end part of the sheath on both sides  126 . This attaches the sheath  112  to the guide mechanism  124  of the introducer tip  113  and the distal end  120  of the catheter  110  or port tube. The cap  100  and lubricating stem is filled with gel in the cap portion and then inserted through the introducer tip  113  to where they snuggly fits against the introducer tip  113  and the distal stem  102  is in the junction between the gripping mechanism and the guide  124 . A sachet  140  filled with liquid gel with a low viscosity (200-2,0000 Cp) is placed within the sheath  112  prior to sealing the heat shrink or clamp around the proximal and distal ends of the sheath. The entire system is placed within a package and then sterilized. In some embodiments, it may be possible to fill the sheath  112  with liquid gel and prevent the need for the sachet  140 , or fill the sheath  112  with gel in addition to the gel that is in the sachet  140 . 
       FIG.  3    shows another exemplary embodiment of the introducer portion of the catheter assembly. In this embodiment, a catheter  210  is slideable within the body of an introducer  213  having a radial flange  217 . The introducer  213  has an elongated proximal tip portion  218  through which the catheter  210  slides into a urethra. The flange  217  acts as a stop to prevent the elongated tip portion  218  of the introducer from penetrating the urethra more than a given length, which is about 1 cm or less. A sachet  240  is contained within the sheath  212  and external to the catheter  210 . In this exemplary embodiment, the sheath  212  is directly adhered to a distal portion  219  of the introducer, positioned on an opposite end to the elongated introducer tip  218 , through a collar  218 , heat shrink or other mechanism appreciated by one having ordinary skill in the art. The use, function, and mechanism of operation of this embodiment is substantially the same as that described for the embodiment shown above in  FIGS.  1 - 2   , so it will not be repeated here again for sake of clarity. 
       FIG.  4    shows another exemplary embodiment of the introducer portion of the catheter assembly. In this embodiment, a catheter  310  is slideable within the body of a cup-shaped, cylindrical introducer  318  having a smaller cylindrical portion  319  positioned distally to the larger cylindrical introducer portion  318 . The introducer  318  has a large opening through which the catheter  310  slides into a urethra. A sachet  340  is contained within the sheath  312  and external to the catheter  310 . In this exemplary embodiment, the sheath  312  is directly adhered to the distal portion  319  of the introducer  318 , through a collar, heat shrink or other mechanism, as shown in  FIG.  3   , and appreciated by one having ordinary skill in the art. The use, function, and mechanism of operation of this embodiment is substantially the same as that described above for the embodiment shown in  FIGS.  1 - 2   , so it will not be repeated here again for sake of clarity. 
     In some exemplary embodiments of the present subject disclosure, the introducer  114  is shaped such that it may be more easily gripped in one hand while the catheter cap  100  is being removed with the opposite hand. For example, the introducer may be larger in size, such that one with limited manual dexterity can grip the introducer. Further, the angle of the introducer may be such that it may be used to pull in one direction as the cap  100  is pulled in the opposite direction. 
     In exemplary embodiments of the present subject disclosure, the catheter cap  100  is filled with the lubricant or gel before being coupled to the introducer tip. This may help to ensure that the external surface of the introducer tip is properly lubricated. The internal surface of the introducer tip may be further lubricated when the catheter cap is pulled off, as the stopper may draw lubrication from the introducer and into the introducer tip during cap removal. Thus, when the catheter is being inserted through the introducer tip, the introducer tip contributes to the lubrication of the catheter instead of scraping off the lubrication. 
     The foregoing disclosure of the exemplary embodiments of the present subject disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the subject disclosure to the precise forms disclosed. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure. The scope of the subject disclosure is to be defined only by the claims appended hereto, and by their equivalents. 
     Further, in describing representative embodiments of the present subject disclosure, the specification may have presented the method and/or process of the present subject disclosure as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process of the present subject disclosure should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present subject disclosure.