METHODS OF MAKING SLEEVED HYDROPHILIC CATHETER PRODUCTS

Methods of making sleeved hydrophilic urinary catheters (10).

TECHNICAL FIELD

The present disclosure generally relates to methods of making sleeved hydrophilic catheter assemblies wherein the catheter assemblies include a catheter tube that has an activated or hydrated hydrophilic outer surface and a barrier sleeve surrounds the catheter tube wherein the sleeve is used to grasp the catheter for manipulation and insertion into the patient. The method of making the assembly includes venting air from the sleeve as hydration medium is injected into the sleeve.

Background

It is known to coat medical devices, such as urinary catheters, with a hydrophilic coating. When the hydrophilic coating is wetted or hydrated with a hydration medium it becomes extremely lubricous. The hydration medium may be, for example, liquid or vapor water or an aqueous solution. The lubriciousness of the hydrophilic coating eases introduction of the device into the body and aids in reducing pain and discomfort associated with such introduction.

In some urinary catheter products, the user directly contacts the urinary catheter with the user's fingers to remove the catheter from the package and inserts it into the urethra. In such products there may be a disadvantage in that the handling of the catheter by the user may introduce microorganisms onto the surface of the catheter which can cause infectious problems after being introduced into the body during catheter insertion. To address this issue, manufacturers have devised systems that include a protective or barrier sleeve surrounding the catheter. In this type of product, the catheter tube is located in a barrier sleeve. The sleeve may loosely fit the diameter of the catheter so that the user may grasp the catheter tube through the sleeve to manipulate the catheter, e.g., remove the catheter from its package and advance the catheter into the urethra. In some products, the distal end of the sleeve may be attached to the drainage member of the catheter and an insertion aid may be attached to or otherwise associated with the proximal end of the sleeve.

SUMMARY

In one aspect, a method of making a catheter product that has a sleeve having a cavity wherein at least a portion of a catheter shaft of a urinary catheter is located within the cavity such that the sleeve surrounds the portion of catheter shaft, and a distal portion of the sleeve is attached to a distal portion of the urinary catheter and a proximal portion of the sleeve is attached an introducer aid. The method includes injecting a hydration medium into the cavity of the sleeve, wherein the hydration medium is in contact with the catheter shaft. Additionally, during the injection of the hydration medium, air is vented out of the cavity of the sleeve through at least one vent located at the distal end of the sleeve.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

The present disclosure is directed to methods of making a sleeved hydrophilic urinary catheter assembly wherein the sleeved catheter is packaged and the urinary catheter is ready-to-use right out of the package. That is, while in the package, the hydrophilic outer surface of the catheter tube within the interior cavity of the sleeve is in a hydrated/activated state, so that the catheter is ready-to-use right out of the package.

FIGS.1-3illustrate one embodiment of a urinary catheter10in accordance with present disclosure. The catheter10includes an elongated catheter tube or shaft12having a proximal end portion14, a distal end portion16and a lumen12a(FIGS.3and4). The proximal end portion14of the catheter shaft12is suitable for insertion into a lumen or a passageway of the body, such as the urethra. The proximal end portion14may include drainage holes or eyelets18for draining urine from the bladder. Optionally, a drainage member20may be associated with the distal end portion16of the catheter shaft12. The drainage member20may be a funnel or connector for connecting the shaft12to a collection receptacle. The catheter shaft12includes an outer hydrophilic surface that becomes lubricious when hydrated or activated by a hydration medium. The outer surface may be, for example, any suitable hydrophilic coating. The hydration medium may be a foamed liquid.

The catheter assembly10also includes a sleeve22, which may be a protective or barrier sleeve, that has a proximal portion24and a distal portion26. The sleeve22defines a cavity28(FIGS.3and4) that contains at least a portion of the catheter shaft12such that the sleeve surrounds the portion of the catheter shaft12. The sleeve22separates and encloses the portion of the catheter shaft12from the outside environment. In one embodiment, the sleeve22extends over the length of the catheter shaft12. Optionally, an insertion aid30(FIGS.2and3) may be located at the proximal portion24of the sleeve22. When an insertion aid28is present, the proximal portion24of the sleeve22may be attached to a wall or barrel32of the insertion aid30, by for example, welding or adhesive. The distal portion26of the sleeve22may be attached to the drainage member20, as will be described in greater detail below. Alternatively, the distal portion26of the sleeve22could be attached to the distal end portion16of the catheter shaft12.

The sleeve22may be made of a flexible material which may be vapor permeable or vapor impermeable, depending on the desired use and packaging. The material of the sleeve22may also be liquid impermeable. The sleeve22may be formed of any of a variety of thin, flexible polymeric film materials, such as polyethylene, plasticized PVC, or polypropylene, but elastomeric film materials such as polyurethane, and particularly elastomeric hydrogel materials, may be particularly suitable. The thickness of the film from which the sleeve22is formed may vary considerably depending on factors such as stretchability and flexibility of the material selected but, in general, the thickness may fall within the range of about 10 to 150 microns, preferably about 13 to 50 microns.

As shown inFIG.1, optionally, a removable protective cap30amay cover the insertion aid30. InFIGS.2and3, the urinary catheter10is shown without the protective cap30a. The insertion aid30includes a proximal portion34that defines an introducer tip36. The introducer tip36has a proximal end opening defined by one or more slits between one or more flexible petals38. The petals38may move, bend and/or resiliently deform from the generally closed configuration shown in the figures to an open configuration (not shown) to allow for advancement of the catheter shaft12therethrough. The insertion aid30may also include an intermediate flange40that may contact the user about the urethra opening and act as a stop to limit the insertion of the introducer tip36.

Turning now toFIGS.5-8, the urinary catheter10may have at least one vent42at the distal end of the urinary catheter10. The vents42are in communication with the cavity28of the sleeve22and allow air to vent/flow from the cavity28to the atmosphere outside of the sleeve22. The vents42may be at least partially defined by sleeve22. In the illustrate embodiment, distal portion26the sleeve22is attached to select portions46of the drainage member20. In other words, there may be two or more select attachment between the sleeve22and drainage member20. For example, the drainage member20may include a barrel44, wherein the distal portion26of the sleeve22is attached to select portions46of the barrel44of the drainage member20. In the illustrated embodiment, the distal portion26of sleeve22is not fully attached around the barrel's44outer wall and portions of the distal portion26of the sleeve22are left unattached from the barrel44. In other words, the distal portion26of sleeve22may be intermittently attached to the drainage member20. The vents42are defined by or between the distal portion26of the sleeve22and the drainage member20.

In an alternative embodiment, the sleeve22may be partially attached to the catheter shaft12instead of a drainage member20. In such embodiments, the vents may be defined by or between the distal portion26of the sleeve22and the catheter shaft12. In yet another alternative, the vents42may be fully defined by the sleeve or in the sleeve wall. For example, the vents may be slits, perforations, micro-perforations, or other suitable openings in the sleeve wall. When the vents42are fully defined by the sleeve, the distal portion26of the sleeve may be fully attached to the drainage member20or the catheter shaft12.

In the illustrate embodiment, the urinary catheter10includes two vents42. In other embodiments, the urinary catheter10may include one vent42or more than two vents42. Also, in the illustrated urinary catheter, the vents42are shown to have a substantially equal size and shape. However, in an alternative, the vents42could have different sizes and shapes. Each of the vents42has a vent opening area A. In the illustrated embodiment, the vent opening area is defined by the unattached area between the distal portion26of the sleeve22the barrel44of the drainage member20. The combined area of the vent opening areas A may be between about 30 square millimeters and about 40 square millimeters. Thus, in the illustrated embodiment, each vent42may have an opening area A of between about 15 square millimeters and about 20 square millimeters.

Turning now toFIG.9, this figure provides a schematic representation of a fill method that includes an injection system50. The urinary10may be docked or otherwise operatively connected to a hydration medium injection system or machine50. The hydration medium injection system50may include a source52of hydration medium, which could be a reservoir or tank containing an amount of hydration medium56. The hydration medium may be a foamed liquid. The system may include a conduit58, one end60of which is connected to the source52of hydration medium and the end62of which is configured to be connected to the urinary catheter10so that hydration medium56can be injected into the cavity of the sleeve22. For example, the end62of the conduit58may include a nozzle configured to be releasably connectable to the sleeve22or the introducer aid30, if one is present. In another embodiment, the nozzle may be connected to the drainage member20, wherein hydration medium is pumped through lumen12a(FIGS.3and4) of the catheter shaft12and the eyelets (FIGS.1and3) into the cavity28of the sleeve22. The system50also includes a pump or metering valves or other element66for moving/pumping hydration medium56so as to inject hydration medium56into the cavity of the sleeve22.

In a method of making a catheter product, hydration medium56, such as foamed liquid, is injected into the cavity of the sleeve22so that the hydration medium56is in contact with the catheter shaft12. During the injection of the hydration medium56, venting the air68out of the cavity of the sleeve22through at least one vent42located at the distal portion26of the sleeve22. During the injection of hydration medium42, air flow out of the vents may have a combined air flow of between about 1 milliliters per second and about 40 milliliters per second. In one embodiment, the vents allow a combined maximum air flow of about 40 milliliters per second. In another embodiment, the vents allow a combined air flow of at least about 1 milliliters per second. Furthermore, during injection of the hydration medium56, the pressure within the cavity of the sleeve22does not exceed 6 bar. Alternatively, during the injection of the hydration medium56the pressure within the cavity of the sleeve22is between about 0.1 bar and about 6 bar. Furthermore, an injection pressure of the hydration medium56is between about 0.5 and about 4 bar. The at least one vents42and/or the injection pressure of the hydration medium56may be tailored or selected so that the pressure within the cavity sleeve is maintained within a desired range, such as the above discussed ranges. For example, the opening area of the vents and/or the injection pressure may be modified to control the pressure within the sleeve. Optionally, the hydration medium56may be injected into the cavity of the sleeve22at a flow rate of between about 1 L/hr and about 24 L/hr.

After the hydration medium56has been injected into the sleeve, the urinary catheter may be placed with a compartment of a package. The package may be sealed to seal urinary catheter within the compartment. The package may be a gas impermeable package, such as a package made from a gas impermeable material. Such package may be a foil package that is made from metal foil and polymer laminates.