# Patent

## Title
Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer and method of making and using the same

## Abstract

A catheter assembly including an elongate member having a proximal end and a distal end. The distal end has at least one drainage opening. A hydrophilic coating is provided on at least a portion of the elongate end of the catheter. A fluid containing member is provided and is either arranged on the elongate member or within a separate area of the container. The fluid containing member contains sufficient hydrating fluid to hydrate the coating of the catheter. A container contains the elongate member and the fluid containing member and incorporates at least one foil layer to prevent evaporation of the hydrating fluid. A method of using the catheter includes inserting a catheter into a user's body and draining fluid from the user's body.

## Background
PRIORITY
This application is a U.S. national stage application under 35 USC §371 of International Application No. PCT/US2011/026681, filed Mar. 1, 2011, which claims priority to U.S. Provisional Patent Application No. 61/310,535, filed Mar. 4, 2010, each of which is incorporated by reference into this application as if fully set forth herein.


BACKGROUND OF THE INVENTION
Intermittent catheterization is a sterile process of draining urine from the bladder when normal draining is impossible or difficult. Proper intermittent catheter use reduces the risk of urinary tract infections and kidney damage. Intermittent catheters come in many different sizes and lengths to fit the body. Some catheters are also available pre-lubricated. Of these, some catheters require their coating be hydrated before insertion. Other catheters have pre-hydrated lubricious coatings for immediate insertion upon opening the package.
Intermittent catheterization is generally performed a minimum of four times a day by the patient or a care giver. The genital area near the urethral opening is wiped with an antiseptic agent, such as iodine. A lubricant may then be used to facilitate the entry of the catheter into the urethra. A topical local anesthetic may also be applied to numb the urethral opening during the procedure. One end of the catheter is placed in a container, and the other end is inserted into and guided up the urethra and into the bladder until urine flow begins.
When urine flow stops, the catheter may be re-positioned, moved or rotated. The patient may also be made to change positions to ensure that all urine has emptied from the bladder. The catheter may then be withdrawn and cleaned for the next use. Recommended cleaning practices vary, from the use of soap and water, to submersion in boiling water or a disinfectant solution. Some patients prefer to use a new catheter with each insertion or catheterization. This is because improper cleaning of re-used catheters can contribute to the development of urinary tract infections (UTI). Patients with recurrent UTIs are encouraged to only use a new catheter for each catheterization
Intermittent catheters are generally catheters or tubes having a rounded, atraumatic distal tip that is inserted into the bladder of a patient. A molded funnel is typically connected to a distal end that remains outside the body of the patient or user. The distal tip may include slots or openings on the shaft to facilitate drainage of urine therefrom once the tip is positioned inside the bladder.
Hydrophilic-coated intermittent catheters are intermittent catheters having a highly lubricious coating on an outer surface thereof, which are either packaged with fluid or otherwise brought into contact with fluid in order to provide a catheter with a slippery outer surface to facilitate insertion into the patient or user.
Existing hydrophilic-coated intermittent catheters fall into three broad categories. In a first type, the catheter is packaged in a dry environment, but it contains a hydrophilic coating that requires a wetting fluid in order to become hydrated and lubricious. The wetting fluid is obtained from an external source by the user (e.g., sink, bottled water, etc.), and the catheter is positioned within the wetting fluid for a period of time to become hydrated. Use of this first type of intermittent catheter may prove difficult where no clean water or wetting fluid is readily available. Moreover, catheter sterility may be compromised due to the user's handling of the catheter when wetting fluid is applied.
A second type of hydrophilic-coated intermittent catheter is also packaged in a dry environment and contains a lubricious coating. However, the wetting fluid is positioned in a pouch or container within the catheter package itself. To hydrate the catheter, the pouch or container is opened when the user is ready for insertion. Suitable examples of such catheters are disclosed in U.S. Pat. No. 7,087,048 and U.S. Pat. No. 6,634,498 (the disclosures of which are incorporated herein by reference in their entireties). As with the first type, this second type may be disadvantageous because the catheter must be exposed to the wetting fluid for a period of time before insertion to ensure hydration of the lubricious coating. The sterility of the catheter can also be compromised during insertion. This concern, however, is no different than a pre-wetted catheter because package remains sealed during hydration.
A third type of pre-wetted intermittent catheter is packaged in a wet environment. That is, the catheter is exposed to a wetting fluid within the catheter package, thus hydrating the coating. Suitable examples of such catheters are disclosed in U.S. Pat. No. 7,380,658, U.S. Pat. No. 6,848,574 and U.S. Pat. No. 6,059,107 (the disclosures of which are incorporated herein by reference in their entireties). However, the user may have difficulty handling the catheter due to its slippery surface, and excessive or imprecise handling may result in contamination of the catheter by the user. This could then expose the user to a urinary tract infection.
An example of the third type is shown in FIGS. 1 and 2 of the instant application. As can be seen in these drawings, the catheter assembly utilizes a catheter 1 arranged in a package 2 made of two sheets 2a and 2b which can be separated from each other (see FIG. 2) so as to allow access to the catheter 1. The catheter 1 is arranged in a space 3 arranged within the package 2 along with a hydrating fluid. In this way, the coating C arranged on a tube portion 4 of the catheter 1 is maintained in a hydrated or pre-wetted state. The catheter 1 includes a funnel 7 arranged on a proximal end 8 and a closed and rounded end or tip at a distal end 9. One or more drainage eyelets 5 are arranged in an area of the distal end 9. When user desires to use the catheter assembly shown in FIG. 1, the user need only open the package 2 (see FIG. 2), remove the catheter 1 from the package 2 which is already pre-wetted, and insert the distal end 9 into the bladder.
Existing intermittent catheters may also drain urine into a bag. Following bladder drainage into the bag, the bag may be emptied by inverting and tearing a notch. Urine is then drained into a receptacle through the tear. That process can be slow, messy, and subject to urine spills.
Non-intermittent catheterization, which is used in a hospital or nursing home setting, uses the same basic technique for insertion of the urinary tract catheter. The catheter is inserted by a nurse or other health care professional, and, it remains in the patient until bladder function can be maintained independently. When the catheter is removed, patients experience a pulling sensation and may feel some minor discomfort. If the catheter is required for an extended period of time, a long-term, indwelling catheter, such as a Foley catheter, is used. To prevent infection, it should be regularly exchanged for a new catheter every three to six weeks.
Proper catheter use can also often be determined by the length of time that the process is necessary: long-term (often called indwelling) or short-term use. In some situations, incontinent patients are catheterized to reduce their cost of care. A condom catheter, which fits on the outside of the penis using adhesive, can be used for short-term catheterization in males. However, long-term catheterization is not recommended because chronic use carries a significant risk of urinary tract infection. This risk catheterization should only be considered as a last resort for the management of incontinence where other measures have proved unsuccessful and where there is significant risk to the skin.
A catheter that is left in place for a period of time may be attached to a drainage bag to collect the urine. There are two types of drainage bags. One is a leg bag being a smaller drainage device that attaches by elastic bands to the leg. A leg bag is usually worn during the day, as it fits discreetly under pants or skirts, and is easily emptied into a toilet. The second type of drainage bag is a larger device called a down drain that may be used during the night. This device is usually hung on the patient's bed or placed on the floor nearby.
During long-term use, the catheter may be left in place the entire duration, or a patient may be instructed on an intermittent self-catheterization procedure for placing a catheter just long enough to empty the bladder and then removing it. Patients undergoing major surgery are often catheterized and may remain so for long durations. Long-term catheterization can expose patients to an increased risk of infection. Long-term catheterization as a remedy for incontinence is not appropriate, as the risks outweigh the benefits.
In males, for example, the catheter tube is inserted into the urinary tract through the penis. Insertion in males can sometimes be difficult because of the abrupt angle in the male's urethra. An external device such as a condom catheter can also be used. In females, the catheter is inserted into the urethral meatus, after a cleansing. The procedure can be complicated in females due to varying layouts of the genitalia (due to age, obesity, childbirth, or other factors), but a good clinician should rely on anatomical landmarks and patience when dealing with such patients.
Common indications to catheterize a patient include acute or chronic urinary retention (which can damage the kidneys), orthopedic procedures that may limit a patient's movement, the need for accurate monitoring of input and output (such as in an ICU), benign prostatic hyperplasia, incontinence, and the effects of various surgical interventions involving the bladder and prostate.
For some patients the insertion and removal of a catheter can cause excruciating pain, so a topical anesthetic can be used for patients of both sexes. Catheterization should be performed as a sterile medical procedure and should only be done by trained, qualified personnel, using equipment designed for this purpose. However, in the case of intermittent self catheterization, the patient can perform the procedure his/her self. If correct technique is not used, trauma may be caused to the urethra or prostate (male). A urinary tract infection or paraphimosis may also occur (male uncircumcised patient).
Particular complications of catheter use may include: urinary tract or kidney infections, blood infections (sepsis), urethral injury, skin breakdown, bladder stones, and blood in the urine (hematuria). After many years of catheter use, bladder cancer may also develop. In using indwelling (long-term) catheters, it is particularly very important to take everyday care of the catheter and the drainage bag.
Catheters come in a large variety of sizes, materials (latex, silicone, PVC, or Teflon-coated), and types (Foley catheter, straight catheter, or coude tip catheter). In the case of internal catheters, those inserted into the urethra, the smallest size is usually recommended, although a larger size is sometimes needed to control leakage of urine around the catheter. A large size can also become necessary when the urine is thick, bloody or contains large amounts of sediment. Larger internal catheters, however, are more likely to cause damage to the urethra. Some people develop allergies or sensitivities to latex after long-term latex catheter use or prior latex exposure. In such cases, catheters made of materials other than natural rubber latex should be used. Silver coated urinary catheters may also be used to reduce infections.
Catheter diameters are sized by the French catheter scale (F). The most common sizes are 10 F to 28 F. The clinician selects a size large enough to allow free flow of urine, but large enough to control leakage of urine around the catheter. A larger size can become necessary when the urine is thick, bloody or contains large amounts of sediment: Larger catheters, however, are more likely to cause damage to the urethra. (Jeffrey AN et al., Surgery: Basic Science and Clinical Evidence Springer, 2nd ed., 2008, p. 281).
Catheters are regulated as class II medical devices under section 513 of the Federal Food, Drug, and Cosmetic Act (the act) and the appropriate panel (78 Gastroenterology/Urology) as described in 21 CFR 807.87(c).
Finally, it is noted that existing intermittent catheters typically have two staggered drainage eyelets or openings which are located on a distal end of the catheter, i.e., near the inserting tip. These openings allow the catheter to drain urine from the bladder.
SUMMARY OF THE INVENTION
The present invention is directed to easy-to-use urinary catheter assemblies that eliminate or minimize some of the shortcomings of prior art devices. The catheter can be a single-use catheter and/or may be packaged as a single-use device. Non-limiting embodiments of the invention include one or more features described herein and/or shown in the drawings in combination with one of more prior art features discussed above.
Non-limiting embodiments of the invention provide for an improved pre-wetted catheter which maintain a coating of the catheter tube in a hydrated state using a hydrating sleeve and a foil outer layer or package.
Non-limiting embodiments of the invention also provide for improved pre-wetted catheter whose package can be opened without any significant spilling of moisture or fluid from the package.
Non-limiting embodiments of the invention also provide for improved pre-wetted, catheter having a sleeve which contains all or substantially all of the hydrating fluid and that is packaged and/or arranged in a foil member.
Non-limiting embodiments of the invention also provide for a catheter assembly comprising an elongate member having a proximal end and a distal end. The distal end has at least one drainage opening. A fluid containing member is arranged on the elongate member. A foil container contains the elongate member and the fluid containing member.
Non-limiting embodiments of the invention also provide for a method of inserting the catheter assembly of any one of the types described above, wherein the method comprises removing the elongate member from the fluid containing member and inserting the elongate member into a user's body. The method may further comprise draining fluid or urine from the user's body.
Non-limiting embodiments of the invention also provide for a catheter assembly comprising an elongate member having a proximal end and a distal end. The distal end has at least one drainage opening. A fluid containing member is arranged on the elongate member or in close proximity to provide a means of maintaining the hydrophilic coating in its hydrated and lubricious state or to provide a fluid reservoir for hydration of the coating inside a package before the package is opened. In embodiments, the fluid containing member is arranged on the elongate member when in the package. In other embodiments, the fluid containing member is not arranged on the elongate member when in the package.
The invention comprises at least one of; a foil container containing the elongate member and the fluid containing member, a container having a foil layer and containing the elongate member and the fluid containing member, a foil layer surrounding a substantial portion of the fluid containing member, a package having at least one foil layer and containing therein at least the fluid containing member, a sealed package having at least one foil layer and containing therein the fluid containing member and the elongate member, a fluid impermeable package having at least one foil layer and containing therein the fluid containing member and the elongate member, a foil layer surrounding substantially all of the fluid containing member, at least one foil layer secured to an outer surface of the fluid containing member, a generally cylindrical foil layer containing therein a substantially portion of the fluid containing member, and a generally cylindrical foil layer containing therein substantially all of the fluid containing member.
The fluid containing member may be a hydrogel sleeve. The fluid containing member may have a wall thickness that is 1⁄8 inch or greater. The fluid containing member may be generally cylindrical. The fluid containing member may be structured and arranged to maintain a coating of the elongate member is a hydrated condition. The fluid containing member may be a tube having an inside diameter sized to receive therein the elongate member. The fluid containing member may comprise an extruded polyurethane tube. The fluid containing member may comprise a polyurethane hydrogel type material. A non-limiting example includes D6/40 (AdvanSource Biomaterials) which is a polyether polyurethane-urea. The fluid containing member may also comprise a hydrophilic polymer.
By way of non-limiting examples, the hydrophilic polymer of the fluid containing member may comprise at least one of; polyethylene oxide, polyethylene glycol, polypropylene glycol, poly vinyl alcohol, carboxy methyl cellulose, hydroxyethyl cellulose, hydroxyl ethyl methacrylate, polyacrylic acid, polyacrylamide, and collagen. The fluid containing member may comprise a material which swells when exposed to a fluid and which absorbs and retains fluid in a wall between an inner diameter and an outer diameter. The fluid containing member may be structured and arranged to swell when exposed to a fluid. The fluid containing member may be structured and arranged to swell when exposed to water. The fluid containing member may be structured and arranged to absorb about 90% of its weight in fluid. The fluid containing member may be structured and arranged to absorb about 90% of its weight in water. The fluid containing member comprises a hydrated polyurethane tube.
The container may be a fluid impermeable package and substantially or nearly all fluid contained in the container is disposed in the fluid containing member. The elongate member may comprise one of; a hydrateable coating arranged at least on an outer surface of the distal end thereof, a lubricious coating arranged at least on an outer surface of the distal end thereof, and a hydrophilic biocompatible coating arranged at least on an outer surface of the distal end.
The catheter assembly is an intermittent catheter assembly. The fluid containing member may be the only device containing fluid in the container. The fluid containing member may be non-removably coupled to the container. The elongate member may be removable from the container without fluid leaking out of the container. The elongate member may be removable from the container while the fluid containing member is retained within the container. The elongate member may comprise a proximal end which is not wetted and/or covered by the fluid containing member. The elongate member may be removable from the container with the fluid containing member. The fluid containing member may comprise a gripping end which does not contain fluid and/or which allows a user to grip the fluid containing member without the user's fingers becoming wetted by fluid.
The container may comprise a first compartment containing the elongate member and a second compartment containing the fluid containing member. The elongate member may be removable from the first compartment and insertable into the second compartment. The elongate member may be removable from the first compartment and insertable into the fluid containing member of the second compartment. A first removable cover may allow the user to access and remove the elongate member from the first compartment and a second removable cover allowing the user to insert the elongate member into the second compartment. The first compartment and the second compartment may comprise separate fluid impermeable compartments.
The container may comprise a foil outer member which substantially encloses the elongate member and completely encloses the fluid containing member. The fluid containing member may be non-removably coupled to the foil outer member. The fluid containing member may be non-removably coupled to an inside diameter of the foil outer member. The foil outer member may comprise a first portion that surrounds a proximal portion of the elongate member and a second portion that surrounds the fluid containing member. The foil outer member may comprise a first portion that surrounds a funnel portion of the elongate member and a second portion that surrounds the fluid containing member and a coated tube portion of the elongate member. The foil outer member may have a length that is substantially equal to a length of the elongate member and the fluid containing member has a length that is substantially equal to the coated tube portion of the elongate member.
The container may comprise an outer tubular member having at least one foil inner layer which completely encloses the elongate member and completely encloses the fluid containing member. The fluid containing member may be arranged within another container arranged within the outer tubular member. The other container containing the fluid containing member may be removable from the outer tubular member. The other container containing the fluid containing member may be non-removable from the outer tubular member. The outer tubular member may comprise a removable cover.
The container may enclose the elongate member and the fluid containing member while axially separated from each other. The container may contain a single compartment which encloses the elongate member and the fluid containing member while axially separated from each other. The container may comprise a single flexible compartment which encloses the elongate member and the fluid containing member while axially separated from each other and is configured to allow the user to position the elongate member into the fluid containing member while the elongate member and the fluid containing member remain enclosed within the single flexible compartment.
The invention also provides for a method of inserting the catheter assembly of any one of the types described herein, wherein the method comprises removing the elongate member from the fluid containing member and inserting the elongate member into a user's body. The method may further comprise draining fluid or urine from the user's body.
The invention also provides for a catheter assembly comprising a catheter having a proximal end, a distal end, and a tubular portion arranged therebetween. The distal end has at least one drainage opening. A fluid containing sleeve is arranged on the tubular portion and maintains a coating of the tubular portion in a hydrated state. A container has at least one foil inner layer and contains therein the catheter and the fluid containing sleeve. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
At least one of; the fluid containing sleeve may be a hydrogel sleeve, the fluid containing sleeve may have a wall thickness that is 1⁄8 inch or greater, the fluid containing sleeve may comprise an extruded polyurethane tube, the fluid containing sleeve may comprise D6/40 polyurethane, the fluid containing sleeve may comprise a hydrophilic polymer and the hydrophilic polymer may comprise at least one of; polyethylene oxide, poly vinyl alcohol, carboxy methyl cellulose, hydroxyl ethyl methacrylate, acrylic polymers, and callagen.
The fluid containing sleeve may comprise a material which swells when exposed to a fluid and which absorbs and retains fluid in a wall between an inner diameter and an outer diameter. The fluid containing sleeve may be structured and arranged to swell when exposed to a fluid. The fluid containing sleeve may be structured and arranged to swell when exposed to water. The fluid containing sleeve may be structured and arranged to absorb about 90% of its weight in fluid. The fluid containing member may be structured and arranged to absorb about 90% of its weight in water. The fluid containing member may comprise a hydrated polyurethane tube.
The invention also provides for a catheter assembly comprising a catheter having a funnel, a tubular portion and at least one drainage opening and a fluid containing sleeve structured and arranged to swell when exposed to a fluid. The fluid containing sleeve is arranged on the tubular portion and maintains a coating of the tubular portion in a hydrated state. An outer sleeve has at least one foil inner layer arranged to surround substantially all of the fluid containing sleeve. A container contains therein the catheter, the fluid containing sleeve, and the outer sleeve. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
The invention also provides for a catheter assembly comprising a catheter having a funnel, a tubular portion and at least one drainage opening and a fluid containing sleeve structured and arranged to swell when exposed to a fluid. The fluid containing sleeve is arranged on the tubular portion and maintains a coating of the tubular portion in a hydrated state. An outer sleeve has at least one foil layer arranged to surround substantially all of the fluid containing sleeve. A fluid impermeable container contains therein the catheter, the fluid containing sleeve, and the outer sleeve. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
The invention also provides for a catheter assembly comprising a catheter having a funnel, a tubular portion and at least one drainage opening and a fluid containing sleeve structured and arranged to swell when exposed to a fluid. The fluid containing sleeve is sized and configured to slide onto and off of the tubular portion and, when slid on, to maintain a coating of the tubular portion in a hydrated state. At least one foil layer is arranged to surround substantially all of the fluid containing sleeve. A container contains therein the catheter, the fluid containing sleeve, and the outer sleeve. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
The invention also provides for a catheter assembly comprising a catheter having a funnel, a tubular portion and at least one drainage opening and a fluid containing sleeve structured and arranged to swell when exposed to a fluid. The fluid containing sleeve is sized and configured to slide onto and off of the tubular portion and, when slid on, to maintain a coating of the tubular portion in a hydrated state. A container contains therein the catheter and the fluid containing sleeve. At least one foil layer is arranged between an inner surface of the container and an outer surface of the fluid containing sleeve. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
The invention also provides for a catheter assembly comprising a catheter having a funnel, a tubular portion and at least one drainage opening and a fluid containing sleeve structured and arranged to swell when exposed to a fluid. The fluid containing sleeve is sized and configured to slide onto and off of the tubular portion and, when slid on, to maintain a coating of the tubular portion in a hydrated state. A container contains therein the catheter and the fluid containing sleeve and comprises at least one foil inner layer. Substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.
The container may comprise a first compartment containing the catheter and a second compartment containing the fluid containing sleeve.



BRIEF DESCRIPTION OF DRAWINGS OF THE EXEMPLARY EMBODIMENTS
FIG. 1 shows a pre-wetted catheter assembly package in accordance with the prior art.
FIG. 2 shows the catheter assembly of FIG. 1 being opened for use by separating two portions which form the package.
FIG. 3 shows a pre-wetted catheter assembly package in accordance with one non-limiting embodiment of the invention.
FIG. 4 shows a side cross-sectional view of the catheter and hydrating sleeve used in the assembly package of FIG. 3.
FIG. 5 shows a side cross-sectional view of the hydrating sleeve used in the assembly package of FIG. 3.
FIG. 6 shows a side cross-sectional view of the catheter used in the assembly package of FIG. 3. In embodiments, the coating can terminate about one inch from the funnel.
FIG. 7 shows a pre-wetted catheter assembly package in accordance with another non-limiting embodiment of the invention.
FIG. 8 shows a pre-wetted catheter assembly package in accordance with still another non-limiting embodiment of the invention.
FIG. 9 shows a pre-wetted catheter assembly package in accordance with still another non-limiting embodiment of the invention.
FIGS. 10 and 11 show a pre-wetted catheter assembly package in accordance with still another non-limiting embodiment of the invention.



DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
The following description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the reference terms “proximal” and “distal” (proximal being closer than distal) refer to proximity with respect to a health care professional catheterizing a patient. For example, the region or section of the catheter apparatus that is closest to the health care professional during catheterization is referred to herein as “proximal,” while a region or section of the catheter apparatus closest to the patient's bladder is referred to as “distal.” In the case of a self-catheterizing patient, proximal refers to a point external to the patient's body, and distal refers to a point within the patient's body (i.e., the bladder).
The catheter assemblies as described herein are discussed in the context of a urinary catheter for insertion into a bladder for drainage of urine therefrom. The instant catheter assemblies, however, may also be used for other applications not specifically mentioned herein. As such, the instant invention is not limited to urinary catheter applications.
FIG. 3 shows a non-limiting embodiment of a pre-wetted urinary catheter assembly package of the present invention. FIG. 3 shows the catheter assembly package in a storage position and/or prior to use configuration.
The assembly package 10 shown in FIG. 3 includes a catheter 11 arranged within a container 12 which can be in the form of a generally flexible material package such as the type shown in FIG. 2. The catheter assembly 11 includes a catheter having an insertable elongate tube portion 14, one or more drainage eyelets 15, a funnel 17, a proximal end 18, and a distal end 19. A fluid containing sleeve 20 is arranged in the package 12 and is positioned over a substantial portion of the tube 14. The sleeve 20 contains all or nearly all of the fluid that is arranged in the container 12 and is in direct contact with a coating of the tube 14. In embodiments, the funnel 17 remains in a dry state in a non-fluid containing space 13 of the package 12. Thus, only the portion of the catheter in contact with the sleeve 20, i.e., all, nearly all, or most of the tube 14, is wetted or maintained in a pre-wetted state. In embodiments, the sleeve 20 is non-removably connected to the package 12 so that when the user tears (e.g., along the dashed-line in space 13) or splits open the end of the package 12 defining space 13, the user can grip the funnel 17 and slide the catheter out of the package 12 and the sleeve 20 (which remains in the package 12). Since all or nearly all of the fluid which hydrates the coating of the tube 14 is disposed in the sleeve 20, removing the catheter will not cause any fluid to spill out of the package 12 when opened. Furthermore, if the sleeve 20 remains in the package 12, the user need not come into contact with the fluid. Once the catheter is removed from the package 12, it can be inserted into the user's body while the user grips the funnel 17. As is the case with conventional catheters, the coating of the tube 14 is, in embodiments, a lubricious coating to facilitate insertion of the catheter into the user's body.
In embodiments, the package 12 is made of foil material which ensures that the catheter assembly 11 and the sleeve 20 are not dehydrated. The package 12 also ensures that its contents are sealed in a gas and/or fluid tight and/or impermeable manner so that hydrating fluid will not leak out. In embodiments, at least an inner layer, i.e., the layer in contact with the sleeve 20, of the package 12 is made of a foil material. In embodiments, the package 12 is made of a single layer foil material. In embodiments, the package 12 is made of plural layers of different materials with at least one layer being a foil material.
In order to form the assembly package of FIG. 3, in embodiments, a catheter of the type shown in, e.g., FIG. 6, can be inserted into a fluid containing sleeve 20 so as to form a sub-assembly. However, prior to insertion into the sleeve 20, the sleeve 20 can be exposed to or immersed in a fluid such as water. Since the sleeve 20 is made of a material that can absorb fluid and expand, this causes the sleeve 20 to swell until it reaches a wall thickness (similar to thickness T in FIG. 5). In this swollen state, the sleeve 20 retains the fluid between an inside diameter and an outside diameter. Once the sleeve 20 is slid onto the catheter, it can maintain the coating of the tube 14 is a hydrated state. This sub-assembly can then be slid into the package 12. Furthermore, since the package 12 is fluid impermeable, it ensures that the fluid in the sleeve 20 cannot escape the package 12 or be contaminated with outside the package 12. In embodiments, the inside diameter of the sleeve 20 is fluid permeable and wets and hydrates the coating of the tube 14 when contacting the tube 14. In embodiments, the outside diameter of the sleeve 20 is also fluid permeable and slightly wets the package 12 when contacting the same. However, unlike the coating of the tube 14, the package 12 does not absorb the fluid. In embodiments, the outside diameter of the sleeve 20 can alternatively be made fluid impermeable so as not to wet the package 12 when contacting the same.
In order to form the assembly package of FIG. 3, in other embodiments, a catheter, e.g., of the type shown in FIG. 6, can be inserted into a fluid containing sleeve 20 after the sleeve 20 is already installed in the package 12. However, prior to insertion into the package 12, the sleeve 20 can be exposed to or immersed in a fluid such as water. Since the sleeve 20 is made of a material that can absorb fluid and expand, this causes the sleeve 20 to swell until it reaches a full or nearly fill fluid swollen wall thickness. In this swollen state, the sleeve 20 retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 20 already disposed in the package 12, it can maintain the coating of the tube 14 is a hydrated state.
In order to form the assembly package of FIG. 3, in still other embodiments, a catheter, e.g., of the type shown in FIG. 6, can be inserted into a fluid containing sleeve 20 after the sleeve 20 is already installed in the package 12. After insertion into the package 12, the sleeve 20 and package 12 can be exposed to or immersed in a fluid such as water. Since the sleeve 20 is made of a material that can absorb fluid and expand (even while the package 12 cannot absorb fluid), this causes the sleeve 20 to swell until it reaches a swollen wall thickness. In this swollen state, the sleeve 20 retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 20 disposed in the package 12, the package 12 is sealed closed. The sleeve 20 can then maintain the coating of the tube 14 in a hydrated state while both are inside the package 12.
In still other embodiments, in order to form the assembly package of FIG. 3, a catheter, e.g., of the type shown in FIG. 6, can be inserted into the package 12 after an inner surface of the package 12 is coated with a fluid containing material which, due to the shape of the package 12, can produce a sleeve 20. After or before insertion of the catheter into the package 12, at least the sleeve 20 can be exposed to or immersed in a fluid such as water. Since the sleeve 20 is made of a material that can absorb fluid and expand, this causes the sleeve 20 to swell until it reaches a swollen wall thickness. In this swollen state, the sleeve 20 retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 20 disposed in the package 12, the package 12 is sealed closed. The sleeve 20 can then maintain the coating of the tube 14 in a hydrated state while both are inside the package 12.
In still other embodiments, the material forming the sleeve 20 can be applied to and/or coated onto the material forming the package 12 so as to form a package having a fluid absorbing and storing inner liner material. In other embodiments, the material forming the sleeve 20 can be co-extruded with the material forming the package 12 so as to form a package having a fluid absorbing and storing inner liner material. In other embodiments, the material forming the sleeve 20 is laminated with the material forming the package 12 so as to form a package having a fluid absorbing and storing inner liner material.
The elongate member 14 can have any size and shape typically utilized in conventional catheters such as generally cylindrical and defines an interior lumen or space which allows fluid to pass and/or drain through. The proximal end 18 includes a funnel which can be of any type that is typically utilized in catheters. The funnel can be connected to any type fluid collection system or bag that is typically utilized in catheters. By way of non-limiting example, the funnel can be a rubber or plastic drainage funnel disposed and friction-fitted on the proximal end of the member 14. A disposable bag (not shown) may be disposed on and/or coupled to the drainage funnel to collect the patient's urine. The distal end 19 of member 14 also includes a tip. The tip is arranged on a forward most portion of the distal end and defines the insertion end of the catheter. The elongate member 14 also preferably contains a biocompatible, hydrophillic, or lubricious coating on its outer surface which is hydrated by the sleeve 20. The coating may also have antimicrobial properties or contain an antimicrobial agent.
FIGS. 4 and 5 show a non-limiting embodiment of a catheter coating hydrating sleeve 20. The sleeve 20 is made of a material that can absorb fluid and expand, this causes the sleeve 20 to swell until it reaches a wall thickness T (see FIG. 5). In this swollen state, the sleeve 20 retains the fluid between an inside diameter 20b and an outside diameter 20a. In embodiments, the sleeve 20 includes an outer generally cylindrically shaped foil layer whose outside diameter defines an outside diameter 20a of the sleeve 20 and an inner generally cylindrical layer of fluid absorbing material which defines an inside diameter 20b of the sleeve 20.
According to another non-limiting embodiment, the hydrating sleeve 20 shown in FIGS. 4 and 5 can be utilized in the type of package 12 shown in FIG. 3.
FIG. 7 shows another non-limiting embodiment of a pre-wetted urinary catheter of the present invention. In FIG. 7, the catheter assembly package is in a storage position and/or prior to use configuration.
The assembly package 110 shown in FIG. 7 includes a catheter 111 arranged within a container 112 which can be in the form of a generally flexible material package similar to that shown in FIG. 2, but somewhat larger to allow (or provide space for) the catheter 111 to more freely move therein. In embodiments, the package 112 can be formed of package sheets 112a and 112b which are connected together in peripheral seam areas. The catheter assembly 111 includes a catheter having an insertable elongate tube portion 114, one or more drainage eyelets 115, a funnel 117 arranged on a proximal end, and a distal end. A fluid containing sleeve 120 is arranged in the package 112, and is positioned over a substantial portion of the tube 114. The sleeve 120 utilizes a gripping portion 121 secured to a forward end of the sleeve 120 which allows the user to grip and remove the sleeve 120 from the catheter. As with the previous embodiments, the sleeve 120 contains all or nearly all of the fluid that is arranged in the container 112, and is in direct contact with a coating of the tube 114. The package can be designed such that, in embodiments, the funnel 117 and gripping portion 121 generally remain in a dry or mostly dry state in a non and/or generally low-fluid containing space 113 of the package 112. Thus, only the portion of the catheter in contact with the sleeve 120, i.e., all, nearly all, or most of the tube 114, is wetted or maintained in a pre-wetted state.
In embodiments, the sleeve 120 is removable from the package 112 with the catheter as assembly 111 when the user tears or splits open one end of the package 112. Once removed from the package 112, the user can grip the funnel 117 with one hand and the gripping portion 121 with the other hand, and then slide the catheter out of the sleeve 120 and/or slide the sleeve 120 off of the catheter 111. Since all or nearly all of the fluid which hydrates the coating of the tube 114 is disposed in the sleeve 120, removing the catheter assembly 111 from the package 112 will not cause any (or hardly any) fluid to spill out of the package 112 when opened. Furthermore, if the sleeve 120 is gripped by the end 121 and placed back into the package 112, the user need not come into contact with the fluid. Once the catheter 111 is removed from the package 112, it can be inserted into the user's body while the user grips the funnel 117. As is the case with conventional catheters, the coating of the tube 114 is, in embodiments, a lubricious coating to facilitate insertion of the catheter into the user's body.
In order to form the assembly package of FIG. 7, in embodiments, a catheter, e.g., of the type shown in FIG. 6, can be inserted into the fluid containing sleeve 120 shown in FIG. 7. However, prior to insertion into the sleeve 120, the sleeve 120 can be exposed to or immersed in a fluid such as water. Since the sleeve 120 is made of a material that can absorb fluid and expand, this causes the sleeve 120 to swell until it reaches a wall thickness (similar to thickness T that shown in FIG. 5). In this swollen state, the sleeve 120 retains the fluid between an inside diameter and an outside diameter. Once the sleeve 120 is slid onto the catheter as shown in FIG. 7, it can maintain the coating of the tube 114 is a hydrated state. This sub-assembly of the catheter 111 and sleeve 120 can then be slid into the package 112. Furthermore, since the package 112 is fluid impermeable, it ensures that the fluid in the sleeve 120 cannot escape the package 112 or be contaminated with outside the package 112. In embodiments, the inside diameter of the sleeve 120 is fluid permeable and wets and hydrates the coating of the tube 114 when contacting the tube 114. In embodiments, the outside diameter of the sleeve 120 is also fluid permeable and slightly wets the package 112 when contacting the same. However, unlike the coating of the tube 114, the package 112 does not absorb the fluid. In embodiments, the outside diameter can alternatively be made fluid impermeable so as not to wet the package 112 when contacting the same.
In embodiments, the package 112 is made of foil material which ensures that the catheter assembly 111 and the sleeve 120 are not contaminated. The package 112 also ensures that its contents are sealed in a gas and/or fluid tight and/or impermeable manner so that hydrating fluid will not leak out. In embodiments, at least an inner layer, i.e., the layer in contact with the sleeve 120, of the package 112 is made of a foil material. In embodiments, the package 112 is made of a single layer foil material. In embodiments, the package 112 is made of plural layers of different materials with at least one layer being a foil material.
According to another non-limiting embodiment, the hydrating sleeve 120 shown in FIG. 7 can utilize a sleeve configuration of the type shown in FIGS. 4 and 5, i.e., the sleeve 120 can have a hydration containing inner sleeve layer and a foil outer layer.
FIG. 8 shows another non-limiting embodiment of a pre-wetted urinary catheter of the present invention. In FIG. 8, the catheter assembly package is in a storage position and/or prior to use configuration.
The assembly package 210 shown in FIG. 8 includes a catheter arranged within a first compartment 213a of a container 212 which can be in the form of a generally flexible package similar to the type shown in FIG. 2. A fluid containing sleeve 220 is arranged within a second compartment 213b of the container 212. The catheter has an insertable elongate tube portion 214, one or more drainage eyelets, a funnel 217 arranged on a proximal end, and a distal end. The fluid containing sleeve 220 is sized to be positioned over and onto a substantial portion of the tube 214. When the user desires to use the catheter, the user removes sealing covers 222 and 223. Next, the user removes the catheter from the compartment 213a. The user then inserts the catheter into the compartment 213b making sure to insert the tube 214 into the lumen of the sleeve 220. After fully inserting the tube 214 into the sleeve 220 and waiting for a short predetermined time period, i.e., a few seconds to a few minutes (a time period sufficient to allow the coating of the tube 214 to become sufficiently hydrated and/or pre-wetted), the user can remove the catheter from the compartment 213b (while the sleeve 220 remains in the compartment 213b) and then insert the same into the user's (or another user's) body.
As with the previous embodiment, the sleeve 220 contains all or nearly all of the fluid that is arranged in the container 212 and can be placed in direct contact with a coating of the tube 214. The funnel 217 can remain in a dry state in a non-fluid containing space 213a of the package 212.
In embodiments, the package 212 is made of foil material which ensures that the catheter assembly and the sleeve 220 are not contaminated. The package 212 also ensures that its contents are sealed in a gas and/or fluid tight and/or impermeable manner so that hydrating fluid will not leak out. In embodiments, at least an inner layer, i.e., the layer in contact with the sleeve 220, of the package 212 is made of a foil material. In embodiments, the package 212 is made of a single layer foil material. In embodiments, the package 212 is made of plural layers of different materials with at least one layer being a foil material.
In embodiments, the caps 222 and 223 are optional. These can, in embodiments, can be formed by sealing the ends of the package (after inserting the catheter members into the package). These ends can then be torn or pealed open. Such an alternative configuration to the caps 222 and 223 would likely be cheaper to manufacture.
In still other embodiments, the material forming the sleeve 220 can be applied to and/or coated onto the material forming the compartment 213b of the package 212 so as to form a package compartment having a fluid absorbing and storing inner liner material. In other embodiments, the material forming the sleeve 220 can be co-extruded with the material forming the compartment 213b of the package 212 so as to form a package having a fluid absorbing and storing inner liner material in compartment 213b. In other embodiments, the material forming the sleeve 220 is laminated with the material forming the compartment 213b of the package 212 so as to form a package compartment 213b having a fluid absorbing and storing inner liner material.
In order to form the assembly package of FIG. 8, in embodiments, a catheter, e.g., of the type shown in FIG. 6, can be inserted into compartment 213a shown in FIG. 8 and then the cap 222 can be installed. A sleeve 220 can be inserted into compartment 213b shown in FIG. 8 and then the cap 223 can be installed. However, prior to installation of the cap 223, the sleeve 220 can be exposed to or immersed in a fluid such as water (which can be poured into the chamber 213b). Since the sleeve 220 is made of a material that can absorb fluid and expand, this causes the sleeve 220 to swell until it reaches a swollen wall thickness. In this swollen state, the sleeve 220 retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 220 located in the compartment 213b, it can sufficiently hydrate the coating of the tube 214 (after a predetermined amount of time). Furthermore, since the package 212 is fluid impermeable (especially compartment 213b), it ensures that the fluid in the sleeve 220 cannot escape the package 212 or be contaminated with outside the package 212.
In embodiments, the inside diameter of the sleeve 220 is fluid permeable and wets and hydrates the coating of the tube 214 when contacting the tube 214. In embodiments, the outside diameter of the sleeve 220 is also fluid permeable and slightly wets the package 212 when contacting the same. However, unlike the coating of the tube 214, the package 212 does not absorb the fluid. In embodiments, the outside diameter of the sleeve 220 can alternatively and/or additionally be made fluid impermeable so as not to wet the package 212 when contacting the same.
According to another non-limiting embodiment, the hydrating sleeve 220 shown in FIG. 8 can utilize a sleeve configuration of the type shown in FIGS. 4 and 5, i.e., the sleeve 220 can have a hydration containing inner sleeve layer and a foil outer layer.
FIG. 9 shows another non-limiting embodiment of a pre-wetted urinary catheter assembly package of the present invention. In FIG. 9, the catheter assembly package is in a storage position and/or prior to use configuration.
The assembly package 310 shown in FIG. 9 includes a catheter assembly arranged within a container which is in the form of an outer sleeve 320B and end cap 321 affixed thereto. An alternative sealing device can also be utilized instead of the end cap 321. The catheter assembly includes a catheter having an insertable elongate tube portion 314, one or more drainage eyelets 315, a funnel 317, a proximal end 318, and a distal end 319. A fluid containing sleeve 320A is arranged in the package sleeve 320B and is positioned over a substantial portion of the tube 314. The sleeve 320A contains all or nearly all of the fluid that is arranged in the container 320B, and is in direct contact with a coating of the tube 314. The funnel 317 remains in a dry state in a non and/or low-fluid containing space of the package 320B. Thus, only the portion of the catheter in contact with the sleeve 320A, i.e., all, nearly all, or most of the tube 314, is wetted or maintained in a pre-wetted state. In embodiments, the sleeve 320A is not non-removably connected to the outer sleeve 320B. In other embodiments, the sleeve 320A may be non-removably connected to the outer sleeve 320B. In this way, the user can slide off the sleeve 320A when the user removes the cap 318, then grips the funnel 317 with one hand and the sleeve 320B with the other hand, and then slides the catheter out of the package 320B (the sleeve 320A remains in the package 320B). Since all or nearly all of the fluid which hydrates the coating of the tube 314 is disposed in the sleeve 320A, removing the catheter will not cause any fluid to spill out of the package 320B when opened. Furthermore, as the sleeve 320A remains in the package 320B, the user need not come into contact with the fluid. Once the catheter is removed from the package 320B, it can be inserted into the user's body while the user grips the funnel 317. As is the case with conventional catheters, the coating of the tube 314 is, in embodiments, a lubricious coating to facilitate insertion of the catheter into the user's body.
In order to form the assembly package of FIG. 9, in embodiments, a catheter, e.g., of the type shown in FIG. 6, can be inserted into a fluid containing sleeve 320A shown in FIG. 9 which is already arranged within an outer sleeve 320B. Prior to or after insertion of the sleeve 320A into the sleeve 320B, the sleeve 320A can be exposed to or immersed in a fluid such as water. Since the sleeve 320A is made of a material that can absorb fluid and expand, this causes the sleeve 320A to swell until it reaches a swollen wall thickness. In this swollen state, the sleeve 320A retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 320A, it can maintain the coating of the tube 314 is a hydrated state. Alternatively, the sleeve 320A can be slid onto the catheter tube 314 and then exposed to a hydrating fluid. This sub-assembly can then be slid into the sleeve package 320B.
Since the sleeve package 320B is fluid impermeable, it ensures that the fluid in the sleeve 320A cannot escape the package 320B or be contaminated with outside the package. In embodiments, the inside diameter of the sleeve 320A is fluid permeable and wets and hydrates the coating of the tube 314 when contacting the tube 314. In embodiments, the outside diameter of the sleeve 320A is also fluid permeable and slightly wets the sleeve package 320B when contacting the same. However, unlike the coating of the tube 314, the package 320B does not absorb the fluid. In embodiments, the outside diameter can alternatively be made fluid impermeable so as not to wet the package 320B when contacting the same. A removable cap 318 is arranged on one end of the sleeve 320B in order to prevent contact with the funnel 317 and to seal off the distal end of the sleeve package 320B.
In embodiments, the package 312B is made of foil material for protecting the catheter assembly and the sleeve 320A. The foil functions as a moisture barrier to prevent evaporation of water from the fluid hydrating the sleeve through the package and properly seals the same within the package. The package 312B (when its ends are covered with caps 318 and 321 or otherwise sealed) also ensures that its contents are enclosed in a gas and/or fluid tight and/or impermeable manner so that hydrating fluid will not leak out. In embodiments, at least an inner layer, i.e., the layer in contact with the sleeve 320, of the package 312B is made of a foil material. In embodiments, the package 312B is made of a single layer foil material. In embodiments, the package 312B is made of plural layers of different materials with at least one layer being a foil material.
According to another non-limiting embodiment, the hydrating sleeve 320A shown in FIG. 9 can utilize a sleeve configuration of the type shown in FIGS. 4 and 5, i.e., the sleeve 320A can have a hydration containing inner sleeve layer and a foil outer layer which may or may not be secured to an inner cylindrical surface of the sleeve 320B.
FIGS. 10 and 11 show another non-limiting embodiment of a pre-wetted urinary catheter of the present invention. FIG. 10 shows the catheter assembly package in a storage position and/or prior to use configuration. FIG. 11 shows the catheter assembly package in a position just prior to use.
The assembly package 610 shown in FIG. 11 includes a catheter arranged within a first compartment 613a of a flexible container 612 which can be in the form of a package such as the type shown in FIG. 2, but having a more elongate configuration. A fluid containing inner layer (or sleeve) 620 is arranged within a second compartment 613b of the container 612. The catheter has an insertable elongate tube portion 614, one or more drainage eyelets, a funnel 617 arranged on a proximal end, and a distal end. The fluid containing sleeve 620 is sized to be positioned over a substantial portion of the tube 614. When the user desires to use the catheter, the user manipulates the package 610 so that the catheter can be inserted into the sleeve 620 (see FIG. 11). Then, he can remove sealing cover or cap 621 (or otherwise unseal an end of the package) and remove the catheter from the compartment 613a. However, before the catheter is removed from the package 612, the tube 614 must be fully inserted into the sleeve 620 for a short predetermined time period (and retained in the configuration shown in FIG. 11). This time period can be, e.g., a few seconds to a few minutes and is, in embodiments, a time period sufficient to allow the coating of the tube 614 to become sufficiently hydrated and/or pre-wetted. As with the previous embodiment, the sleeve 620 contains all or nearly all of the fluid that is arranged in the container 612 and can be placed in direct contact with a coating of the tube 614. Prior to use, the funnel 617 and tube 614 remains in a dry state in a non-fluid containing space 613a of the package 612 (as shown in FIG. 10). Thus, catheter is not maintained in a pre-wetted state until it assumes the position shown in FIG. 11. In embodiments, the inner layer or sleeve 620 is not removable from the package 612 with the catheter and/or is secured or affixed to an inner surface of the package 612. Alternatively, it is possible to seal the package 612 between portion 613a and portion 613b with, e.g., a light “V” seal. The user could then push the member 614 through the seal into portion 613b having the hydration sleeve or material 620. Once removed from the package 612, the user can grip the funnel 617 with one hand and the package 612 with the other hand, and then slide the catheter out of the compartment 613a. Since all or nearly all of the fluid which hydrates the coating of the tube 614 is disposed in the inner layer or sleeve 620, removing the catheter assembly from the package 612 will not cause any fluid to spill out of the package 612 when opened. Furthermore, if the sleeve 620 is gripped from outside the package 612 and is retained in the compartment 613b, the user need not come into contact with the fluid. Once the catheter is properly hydrated while in the package 612, it can be removed therefrom and inserted into the user's body while the user grips the funnel 617. As is the case with conventional catheters, the coating of the tube 614 is, in embodiments, a lubricious coating to facilitate insertion of the catheter into the user's body.
In order to form the assembly package of FIG. 10, in embodiments, an inner material or sleeve 620 can be inserted into compartment 613b shown in FIG. 10, then a catheter can be inserted into compartment 613a shown in FIG. 10. Then, the cap 621 can be installed or alternatively the package can be otherwise sealed. However, prior to insertion into the package 612, the sleeve 620 can be exposed to or immersed in a fluid such as water. Since the sleeve 620 is made of a material that can absorb fluid and expand, this causes the sleeve 620 to swell until it reaches a swollen wall thickness. In this swollen state, the sleeve 620 retains the fluid between an inside diameter and an outside diameter. Once the catheter is slid into the sleeve 620 (as shown in FIG. 11), it can hydrate the coating of the tube 614. Furthermore, since the package 612 is fluid impermeable, it ensures that the fluid in the sleeve 620 cannot escape the package 612 or be contaminated with outside the package 612. In embodiments, the inside diameter (if and when the material 620 is deformed into a circular shape) of the sleeve 620 is fluid permeable and wets and hydrates the coating of the tube 614 when contacting the tube 614. In embodiments, the outside diameter of the sleeve 620 is also fluid permeable and slightly wets the package 612 when contacting the same. However, unlike the coating of the tube 614, the package 612 does not absorb the fluid. In embodiments, the outside diameter can alternatively be made fluid impermeable so as not to wet the package 612 when contacting the same.
In embodiments, the package 612 is made of foil material which ensures that the catheter assembly and the sleeve 620 are not contaminated. The package 612 (when it end is covered with cap 621) also ensures that its contents are sealed in a gas and/or fluid tight and/or impermeable manner so that hydrating fluid will not leak out. In embodiments, at least an inner layer, i.e., the layer in contact with the sleeve 620, of the package 612 is made of a foil material. In embodiments, the package 612 is made of a single layer foil material. In embodiments, the package 612 is made of plural layers of different materials with at least one layer being a foil material.
According to another non-limiting embodiment, the hydrating material or sleeve 620 shown in FIG. 10 can utilize a sleeve configuration of the type shown in FIGS. 4 and 5, i.e., the material or sleeve 620 can have a hydration containing inner sleeve layer and a foil outer layer which may or may not be secured to an inner surface of the package 612.
In each of the herein disclosed embodiments, the fluid containing member or sleeve may, in embodiments, be a hydrogel sleeve. In embodiments, the fluid containing member may also have at least one of the following: a wall thickness T that is 1/16 inch or greater, e.g., 1⁄8 inch, (in a fully hydrated condition); may be generally cylindrical; may also be structured and arranged to maintain a coating of the elongate member in a hydrated condition; may be a tube having an inside diameter sized to receive therein the elongate member; may comprise an extruded polyurethane tube; may comprise one or more materials described above; may comprise a material which swells when exposed to a fluid and which absorbs and retains fluid in a wall between an inner diameter and an outer diameter; may be structured and arranged to swell when exposed to a fluid; may be structured and arranged to swell when exposed to water; may be structured and arranged, in embodiments, to absorb about 90% of its weight in fluid; may be structured and arranged to absorb about 90% of its weight in water; and may comprise a hydrated polyurethane tube.
The catheter insertion tube member and hydrating sleeve may have a round cross-sectional shape, an oval cross-sectional shape, or any other cross-sectional shape that may facilitate insertion into the body of a user/patient, and, in particular, into the bladder of the user/patient through the urethra. The catheter insertion member in accordance with various embodiments) can preferably contain a biocompatible hydrophilic coating on at least an outer surface thereof. The coating may also have antimicrobial properties and/or contain antimicrobial agents. Suitable non-limiting examples of such lubricious and antimicrobial coatings are disclosed in U.S. Pat. Nos. 4,585,666; 5,558,900; 5,077,352; 5,179,174; 6,329,488 (suitable for, e.g., polysiloxane substrates); 6,716,895; 6,949,598; and U.S. Patent Application Publication No. 2004/0116551, and, WO 2007/050685, each of which is incorporated by reference in its entirety.
The antimicrobial agent used on the catheter may be one listed in an over the counter (OTC) monograph. Biocompatible coatings conform with the following tests: mucosal irritation, sensitization, cytotoxicity, acute systemic toxicity, and implantation. (“Tripartite Biocompatibility Guidance for Medical Devices,” DSMA (Apr. 24, 1987) (Updated May 21, 1996)). The purpose of the wetting fluid is to maintain hydration of the lubricious coating such that upon insertion of the conduit into a user, at least an outer portion thereof is extremely slippery, facilitating insertion.
The catheter insertion member may preferably be constructed from a suitable polymeric material, such as polyvinyl chloride (PVC), silicone, latex or other synthetic rubber. The components of the catheter disclosed herein can also be made from various well-known materials. For example, the portions of the assembly other than the catheter insertion member can be made of polyvinyl propylene, polyvinyl chloride, polyethylene, polypropylene, and other types of suitable polymeric materials. The components can be molded or extruded according to well-known manufacturing techniques.
Materials commonly used to make the catheter insertion member include, but are not limited to natural rubber latexes (available, for example, from Guthrie, Inc., Tucson, Ariz.; Firestone, Inc., Akron, Ohio; and Centrotrade USA, Virginia Beach, Va.), silicones (available, for example, from GE Silicones, Waterford, N.Y., Wacker Silicones, Adrian, Mich.; and Dow Corning, Inc., Midland, Mich.), polyvinyl chlorides (available, for example, from Kaneka Corp., Inc., New York, N.Y.), polyurethanes (available, for example, from Bayer, Inc., Toronto, Ontario, Rohm & Haas Company, Philadelphia, Pa.; and Ortec, Inc., Greenville, S.C.), plastisols (available, for example, from G S Industries, Bassett, Va.), polyvinyl acetate, (available, for example from Acetex Corp., Vancouver, British Columbia) polyacrylates (available, for example, from Rohm and Haas, Philadelphia, Pa.) and methacrylate copolymers (available, for example, from Heveatex, Inc., Fall River, Mass.). Synthetic and natural rubber latexes, polyurethanes, and silicones are preferred materials. Any combination of the foregoing materials may also be used in making catheters such as are used to produce latex Foley catheters.
The urinary catheter, and in particular, the insertion member thereof, of the present invention can be manufactured by a variety of well-known methods. The tubing can be extruded and the funnel injection molded and then attached to the desired length of tubing. The tip of the tube can then be closed and rounded by thermoforming (for example, for PVC tubes) or molded (for example, for silicone tubes). Eye holes can then be punched or otherwise formed near the tip of the distal end of the tube to provide an outlet for urine drainage thru the tube when it is inserted into a bladder. Alternatively, the entire catheter can be fabricated by dip molding. In this procedure, an elongated rod or “form” is dipped into a liquid coating material such as synthetic or natural rubber latex, for example, to form a layer of material on the form. The deposition of material can be increased by first dipping the form into a coagulant solution to coat the form with a film of chemical that causes the latex to coagulate onto the form. Calcium nitrate is commonly used as the coagulant, and other additives may be used to enhance the removal of the tube from the form once the catheter is formed and dried. The form has the shape and dimensions of the lumen of the catheter. The catheter may be formed from a single dip coating of the form or by multiple coating layers. When a suitable material thickness is achieved on a form, the forms are dried to produce the catheter. If multiple coatings are used to form the catheter, each coating may be dried before the next is applied. Once dried, the catheter may be stripped from the form. The catheters may then be washed and dried, and eyelets may then be formed thereon. Further manufacturing steps may be found in U.S. 2004/0133156, the disclosure of which is incorporated by reference herein.
The catheter insertion member may preferably be in the range of about 8 cm to about 18 cm, and, it may have an elliptical cross-sectional shape similar to the shape of the male urethra. Different lengths, sizes (e.g., diameter, width, etc.), and configurations are possible for the catheter, depending on the user's anatomy. For female users, the insertable length may range from 40 to 100 mm, for example 50 to 80 mm, such as 55 to 75 mm. For male users, the insertable length can range from 170 to 260 mm, such as 190 to 240 mm, for example 230 mm. The tip design can vary according to the needs of a user, for example, the catheters disclosed herein can be provided with a coude tip. The catheter may have a round or substantially round cross-sectional shape, an oval cross-sectional shape, or any other cross-sectional shape that may facilitate insertion into the body of a user/patient, and in particular, into the bladder of the user/patient through the urethra. According to various embodiments, the shape of the catheter can also be variable along its length.
This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations of figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.

## Claims

1. A catheter assembly comprising:
a catheter having a funnel, a tubular portion and at least one drainage opening;
a fluid containing material structured and arranged to swell when exposed to a fluid, the fluid containing material being arranged on the tubular portion and maintaining a coating of the tubular portion in a hydrated state;
an outer sleeve having at least one foil inner layer arranged to surround substantially all of the fluid containing material; and
a container containing therein the catheter, the fluid containing material, and the outer sleeve, wherein substantially or nearly all fluid contained in the container is disposed in the fluid containing material.

2. A catheter assembly comprising:
a catheter having a funnel, a tubular portion and at least one drainage opening;
a fluid containing sleeve structured and arranged to swell when exposed to a fluid, the fluid containing sleeve being sized and configured to slide onto and off of the tubular portion and, when slid on, to maintain a coating of the tubular portion in a hydrated state;
a container containing therein the catheter and the fluid containing sleeve; and
at least one foil layer arranged between an inner surface of the container and an outer surface of the fluid containing sleeve, wherein substantially or nearly all fluid contained in the container is disposed in the fluid containing sleeve.