The present disclosure is generally directed to a catheter assembly having a catheter shaft with a hydrophilic outer surface and, more particularly, to a catheter assembly having a protective sleeve that provides a barrier through which the catheter may be gripped/manipulated for inserting the catheter through the urethra and wherein, at point of use, the protective sleeve is dry to the touch.
Catheter assemblies are a good option for many users who suffer from various abnormalities of the urinary system. A common situation is where single use, individually packaged, sterile ready-to-use catheters are utilized. An important criterion for single use, ready-to-use products is that they be entirely user-friendly upon removal from the packaging
It is quite common for single use, ready-to-use catheters to be provided with a surface treatment which uses a lubricant adapted to reduce friction in order to allow for easier and less traumatic catheter insertion and withdrawal. Currently, there are two major categories of catheters having lubricated surfaces, i.e., catheters having a gel lubricant (typically a water based lubricant) applied to the catheter shaft and catheters having a hydrated hydrophilic outer surface on the catheter shaft.
In a hydrophilic lubricated catheter, the catheter is typically provided with a thin hydrophilic coating adhered to the outer surface of the catheter shaft. When this hydrophilic coating is activated by a swelling medium, it provides a low coefficient-of-friction surface to facilitate catheter insertion and withdrawal. Hydrophilic lubricated catheters are activated when a hydrating agent such as liquid water or water vapor comes into direct contact with the hydrophilic coating on the catheter shaft.
In another form, the catheter can be made from a hydrophilic material in which case there need be no coating on the outer surface of the catheter shaft. Instead, the outer surface of the catheter itself is a hydrophilic material, and it provides the low coefficient-of-friction surface to facilitate catheter insertion. As with a hydrophilic coated catheter, a catheter made from a hydrophilic polymer material is activated when a hydrating agent directly contacts the outer surface.
When a catheter is removed from the package for insertion into the urethra, there are some disadvantages encountered. First, when the proximal insertion end of the catheter is introduced into the urethra it may pick up microorganisms that are likely to be prevalent in the distal portion of the urethra. These microorganisms are often carried by the proximal insertion end of the catheter into the bladder as it is fully inserted, thereby increasing the risk of infection. Second, the handling of the catheter by the user may also introduce microorganisms onto the surface of the catheter which can cause infection after catheter insertion. For hydrophilic lubricated catheters, these issues should be solved without interfering with activation of the hydrophilic outer surface.
Specifically, for a hydrophilic lubricated catheter, any attempt to: i) prevent pathogens from being picked up by the proximal insertion end of the catheter upon introduction into the distal portion of the urethra, and ii) prevent the introduction of microorganisms onto the surface of the catheter as a result of handling by the user, should be addressed in a manner that does not interfere with the hydrating agent coming into direct contact with the hydrophilic outer surface.
For hydrophilic lubricated catheters, sleeves covering the catheter shaft have generally not been available because the sleeve interferes with the flow of liquid water to the catheter surface that is required for activation by direct liquid contact. To overcome this problem, a recent alternative provides a vapor atmosphere inside the catheter package and forms the sleeve of a liquid impermeable, vapor permeable material so the vapor can reach the hydrophilic outer surface of the catheter. While this approach has proved to be quite successful, one drawback is that, as the vapor penetrates the sleeve, it leaves moisture on the outer surface of the sleeve which must be gripped by the user for advancement of the catheter through the urethra and into the bladder.
A hydrophilic catheter that is fully hydrated in its packaging and delivered in a manner that is dry to the user's touch is achieved by various embodiments of the present disclosure. In each embodiment, an intermittent catheter having a hydrophilic coating is provided in a sleeve including opposing walls of a water impermeable material. Water impermeable polymers that are commonly known in the industry include homo- or copolymers of polycholorotrifluoroethylene, polyvinylidene chloride, polyolefins, polyethyleneterephthalate, polyethylenenaphthalenedicarboxylate, or coated or metalized or metal oxide coated polymers which improve their barrier performance to water vapor permeation. Lists of other water impermeable polymers can be found in the literature such as “Permeability Properties of Plastics and Elastomers”, Second Edition: A Guide to Packaging and Barrier Materials, by L. K. Massey. Also in Polymer Handbook, 3rd Ed, pages VI/437 to VI/445, by J. Brandrp and E. H. Immergut.
Examples of such sleeve materials include SARANEX® barrier films, which are liquid and water vapor impermeable multilayer films available from The Dow Chemical Company. The opposing walls may be formed as two separate sheets of such sleeve films ultimately sealed to one another along all sides, or preferably as a single sheet of the sleeve film that is folded over and ultimately sealed on three sides.
A membrane (formed from what is known as a breathable polymer film, i.e., water vapor permeable material, such as micro porous polyethylene films—commonly made by addition of calcium carbonate particles to polyethylene. The film is made from the mixture and stretched to produce a porous film with high permeability to water vapor-copolyurethane, or copolyester films) is sealed to an inner side of at least one of the sleeve sheets (i.e., on the side of at least one of the sleeve sheets facing the catheter), and, after vapor phase water permeates through the membrane, the region of the sleeve containing the catheter eventually contains a sufficient amount of water vapor to activate the hydrophilic coating on the catheter, the liquid phase water having been introduced to the region defined between the water vapor permeable membrane and the wall of the water impermeable sleeve to which the water vapor permeable material is sealed. In other words, initially, the water is isolated from the catheter. However, over a period of time (the length of which depends upon the permeability of the water vapor permeable material, among other factors), at least some of the water changes from a liquid to a vapor phase, migrates across the water vapor permeable material, and humidifies the region between the two water impermeable sleeves in which the catheter is disposed, thereby contacting and activating the hydrophilic coating. As used herein, a breathable polymer film or a water vapor permeable material refers to a membrane having a water vapor permeability (moisture vapor transmission rate) greater than 300 g/m2/day, greater than 500 g/m2/day, greater than 1000 g/m2/day, greater than 2000 g/m2/day or preferably greater than 3000 g/m2/day, as measured according to ASTM E-96 Procedure E—Desiccant Method at 100° F. (37.8° C.) and 75% Relative Humidity.
In certain embodiments of the present disclosure, a strip of fabric is provided between the inner side of at least one of the sleeve sheets to which the water vapor permeable material is sealed. The fabric strip soaks in the liquid water, avoiding sloshing within the sleeve. The water-soaked fabric strip also helps to distribute water across the entire length of at least the hydrophilic-coated region of the catheter, by means of wicking or capillary action. The fabric strip also serves to conceal the water from view through the sleeve, particularly when the sleeve walls are made of a transparent or translucent material.
In certain additional embodiments of the present disclosure, the water-soaked strip of fabric or similar source of liquid phase water is embedded within a water vapor permeable sheath that is provided in the sleeve and extends substantially the length of the hydrophilic-coated region of the catheter while the catheter is disposed within the package.
In other embodiments of the present disclosure, no fabric strip is provided, and the water in liquid phase is loose within the region between the inner side of at least one of the sleeve sheets to which the water vapor permeable material is sealed, and the water vapor permeable material, or alternately, the liquid phase water is provided within one or more bladders of a liquid impermeable, water vapor permeable sheath provided in the sleeve and extending substantially the length of the hydrophilic-coated region of the catheter while the catheter is disposed within the package. To minimize sloshing, the region in which the liquid-phase water is provided may be supplied with a volume of water that completely fills that region.
An introducer tip may be provided at a first end of the sleeve, adjacent an eyed tip end of the catheter. The catheter may be removed from the sleeve for use by maneuvering the catheter through the sleeve, and beginning with the eyed tip end, urging the catheter through the introducer tip. A drainage opening may be provided at an end of the sleeve opposite from the introducer tip by tearing off a sealed end portion of the sleeve adjacent a funnel end of the catheter. A notch may be provided in at least one side of the sealed end portion of the sleeve to facilitate initiation of the tear. Since the funnel end of the catheter does not fit through the introducer tip, the funnel serves as a stop, maintaining communication between the catheter and the sleeve, and the sleeve may be used to direct flow of urine into a collection container or a toilet. Alternately, the end of the sleeve adjacent the funnel when the sleeve is fully extended over the catheter may be sealed, wholly or partially, to a neck at the base of the funnel (i.e. at the smaller-diameter end of the funnel in which the tube of the catheter is received). In one aspect, a dry-to-the touch, ready-to-use catheter assembly is provided. The catheter assembly includes a catheter having an insertable portion with a hydrophilic outer surface in an activated condition. A liquid and vapor impermeable sleeve covers at least the insertable portion of the catheter. An amount of liquid is disposed between the sleeve and the insertable portion of the catheter wherein the amount of liquid is contained by a liquid flow interfering element that substantially interferes with liquid flow. A vapor atmosphere within the liquid and vapor impermeable sleeve wherein the vapor atmosphere is produced by vapor donated from the amount of liquid contained by the liquid flow interfering element. The liquid flow interfering element is disposed between the sleeve and the insertable portion of the catheter such that the liquid flow interfering element substantially prevents direct liquid contact between the amount of liquid contained by the liquid flow interfering element and the hydrophilic outer surface of the insertable portion of the catheter while permitting sufficient direct vapor contact to place the hydrophilic outer surface in the activated condition.
In another aspect, a dry-to-the touch, ready-to-use hydrophilic intermittent catheter assembly includes a catheter having an insertable portion with a hydrophilic outer surface in an activated condition. A liquid and vapor impermeable sleeve covers at least the insertable portion of the catheter. An amount of liquid is disposed between the sleeve and the insertable portion of the catheter. The amount of liquid is contained within a liquid flow interfering element that substantially interferes with liquid flow. A vapor atmosphere present within the liquid and vapor impermeable sleeve is produced by vapor donated from the amount of liquid contained within the liquid flow interfering element. The liquid flow interfering element is formed of a material and disposed between the sleeve and the insertable portion of the catheter in a manner that substantially prevents direct liquid contact between the amount of liquid contained by the liquid flow interfering element and the hydrophilic outer surface of the catheter while permitting sufficient direct vapor contact to place the hydrophilic outer surface in the activated condition. Additionally, the liquid flow interfering element includes a liquid impermeable, vapor permeable membrane sealed to an inner surface of the sleeve with the liquid being confined between the membrane and the inner surface of the sleeve. The sleeve is sealed in a manner defining a closed cavity containing at least the insertable portion of the catheter, the liquid flow interfering element, and the amount of liquid contained within the liquid flow interfering element.
In a further aspect, a dry-to-the touch, ready-to-use hydrophilic intermittent catheter assembly includes a catheter having an insertable portion with a hydrophilic outer surface in an activated condition. The catheter includes an eyed inlet end and a funnel at an opposite end. A liquid water impermeable, water vapor permeable inner sleeve covers the insertable portion of the catheter and is sealed to a collar of the funnel. A liquid water impermeable and water vapor impermeable outer sleeve encloses at least the inner sleeve and the insertable portion of the catheter and an amount of liquid water is disposed between an exterior of the inner sleeve and an interior of the outer sleeve. A vapor atmosphere present within the inner sleeve is produced by vapor donated by the amount of liquid. The inner sleeve substantially prevents direct liquid contact between the amount of liquid disposed between the inner and outer sleeves while permitting sufficient direct vapor contact to place the hydrophilic outer surface in the activated condition.
A catheter 10, such as an intermittent urinary catheter, is provided within a sleeve 12 of a liquid water and water vapor impermeable film, such as SARANEX® barrier film available from The Dow Chemical Company. The sleeve may be comprised of an elongate tubular film, or may include sleeve walls 16, 18 formed either by a single sheet of film folded over onto itself and sealed along the overlapping longitudinal end, or two distinct sheets of film bonded to one another. At least an insertable portion of the catheter 10, i.e. that portion of the catheter 10 which is insertable into a urethra of a patient to facilitate the drainage of urine from a patient's bladder, is provided with a hydrophilic coating 14. The first and second sleeve walls 16, 18 may be independent sheets of barrier film ultimately sealed to one another along all sides, or may be a single sheet of barrier film folded onto itself and ultimately sealed to itself along its perimeter. An intermediate liquid water impermeable, water vapor permeable membrane 20 is sealed to an inner surface of at least one of the first and second sleeve walls 16, 18 to form a region or pocket 23 therebetween. The liquid water impermeable, water vapor permeable membrane 20 may be made, for example, of PU copolymers, such as those offered by Mylan Technologies, Smith & Nephew, Bayer, or Lubrizol; stretched CaCO3-filled polyethylene (or polypropylene) film, available from RKW or Tredegar, or copolyesters offered by RKW under the trade name of APTRA® M, or any similar products with greater than 300 g/m2/day, greater than 500 g/m2/day, greater than 1000 g/m2/day, greater than 2000 g/m2/day or preferably greater than 3000 g/m2/day, as measured according to ASTM E-96 Procedure E—Desiccant Method at 100° F. (37.8° C.) and 75% Relative Humidity, including thin films made of at least one of the group of copolyurethanes, copolyesters, calcium carbonate-filled polyethylene, and calcium carbonate-filled polypropylene, and preferably extends at least as long as the length of the hydrophilic coated portion of the catheter 10.
In a first embodiment, illustrated in
In this first embodiment, the water vapor permeable membrane 20, together with the wicking element 22, serve as a liquid flow interfering element disposed between the sleeve 12 and the insertable portion of the catheter 10 in a manner that prevents sufficient direct liquid contact with the hydrophilic coating on the catheter 10 to place the hydrophilic outer surface of the catheter 10 in an activated condition. Due to the liquid and vapor impermeability of the sleeve 12 and the vapor permeability of the liquid impermeable, water vapor permeable membrane 20, as the liquid water changes phase from liquid to vapor, the liquid flow interfering element permits water vapor to permeate across the water vapor permeable membrane 20, eventually achieving sufficient direct vapor contact with the insertable length of the catheter 10 to place the hydrophilic outer surface in the activated condition. After such sufficient direct vapor contact has placed the hydrophilic outer surface in the activated condition, the catheter assembly is ready for patient use. As used herein, the term “ready-to-use” refers to a catheter assembly having a hydrophilic outer surface in the activated condition such that the catheter 10 is ready for insertion into a patient's urethra without the need for further lubrication of the catheter 10.
In a second embodiment, illustrated in
As illustrated in
Additionally, in the illustrated embodiment, there are a total of six sachets 23a—three above the catheter 10 and three below the catheter 10. In other embodiments, there may be more or less than six sachets 23a and the sachets may be arranged only above or below the catheter 10 or may be arranged in an alternating arrangement wherein the sachets 23a alternate between being above and below the catheter 10. In still other embodiments, the sachets may be attached to form groups of sachets or may be aligned immediately adjacent to each other.
In a third embodiment, illustrated in
Alternately, the liquid water impermeable, water vapor permeable membrane 20 may be formed as an integral portion of the sleeve 12. As such, the membrane 20 is not left behind in a package surrounding the sleeve 12 upon removal of the sleeve 12 from the package. The sleeve may be sealed (with the seal preferably including an openable tear propagation line) beyond a funnel end of the catheter (as illustrated in the first embodiment of
In any of the embodiments of the present disclosure, the catheter 10 has an eyed tip end 26 (
Turning back to the first embodiment, as illustrated in
In embodiments where the sleeve 12 extends beyond the funnel 28, as illustrated in
Turning now to
According to a seventh alternate embodiment,
According to an eighth embodiment,
The following table provides coefficient of friction data for the hydrophilic coated catheters of the embodiments of the present disclosure after 6 weeks of storage with liquid contained intermediate the exterior of the sleeve 12, the membrane 20, or the sleeve-like membrane 21, and the interior of the outer sleeve 42, of the respective embodiments. These coefficients of friction were measured using Harland Friction tester model FTS5500. The test is set-up such that a 200 g load is applied to a 127 mm section of a fully hydrated catheter. The catheter is then pulled through 2 pieces of silicon rubber with 60 A Shore hardness at 10 mm/s The force required for the pulling the catheter over a distance of 80 mm, out of a total length of 127 mm, is measured using a universal tester equipped with 200N load cell. The CoF value is calculated from the ratio of applied to recorded loads when a steady state is reached. At least 5 measurements were carried out in each case and an average CoF value is reported.
While various embodiments have been described above, variations may be made thereto that fall within the scope of the appended claims.
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/725,282, filed Nov. 12, 2012, the contents of which are incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2013/030851 | 3/13/2013 | WO | 00 |
Number | Date | Country | |
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61725282 | Nov 2012 | US |