MATERIALS AND METHODS OF MANUFACTURING RELATED TO APPARATUS FOR COLLECTING URINE

A device for collecting urine comprises a permeable core assembly, an exterior housing and a suction tube assembly. The core assembly has a tubular fluid permeable core with a fluid permeable wicking cover. The exterior housing is capsular-shaped and has a reservoir at a lower end, an outlet port at an upper end, and an elongated window opening. The core assembly is received within the housing with the core assembly extending across the elongated window. The suction tube assembly extends through an interior of the core assembly and has a first end disposed in the reservoir and a second end exiting the outlet port. The suction tube assembly comprises an elongated shape retention element and a suction tube body having a suction lumen providing a suction path from a first end thereof to a second end thereof, and a second shape retention lumen receiving the elongated shape retention element.

BACKGROUND OF THE DISCLOSURE

The present disclosure relates generally to external urinary collection apparatus. Disabled or injured persons, or persons with restricted movement during long periods of time, i.e. pilots, may have an impaired or limited mobility that prevents them from urinating in a sanitary manner.

External urinary collection apparatus are known in the art. U.S. patent Ser. No. 10/226,376 discloses and describes a well known external urinary collection apparatus which has wide industry acceptance. The entire contents and disclosure of USP10226376 are incorporated herein by reference.

As with all high-volume medical products there are always continuing efforts to improve the product and materials, improve manufacturing techniques, and to reduce costs.

SUMMARY OF THE DISCLOSURE

The present disclosure provides improvements related to the following:the addition of a Zeolite material into the internal core material as an ammonia absorbing material;the placement of a shape retention element within a secondary lumen in the suction tube body;providing the shape retention element with external embossed formations to prevent longitudinal slippage within the suction tube body;providing a D-shaped suction tube body to allow for additional cushioning material adjacent to the wearer's body;creating the core material using multiple different denier fibers and a rando-webber air lay process to concentrate finer denier fibers toward a top (outer) surface for a softer feel; andproviding the finished core with a ribbed outer surface through a blossoming process of heating and cooling the core while trapped in a confining curved mold with internal longitudinal ribs.

DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the device and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Further, in the present disclosure, like-numbered components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-numbered component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Further, to the extent that directional terms like top, bottom, up, or down are used, they are not intended to limit the systems, devices, and methods disclosed herein. A person skilled in the art will recognize that these terms are merely relative to the system and device being discussed and are not universal.

The present disclosure generally provides improvements related to the following features and methods of manufacturing or assembly of a urine collecting device:(1) improved wicking materials for use in the external permeable membrane (outer bandage covering);(2) the placement of a forming wire within the core wherein the forming wire may have rolled ends to prevent any sharp ends; and(3) improved production and assembly methods related to continuous processing of the external covering and core, continuous seaming or sewing of the core assembly, automatic cutting to length during production, vacuum hold for insertion of the core into the outer impermeable covering, and heat mold glueing/forming of the outer housing to the inner core.

Referring toFIGS.1and2a device for collecting urine is illustrated and generally indicated at10. The device10comprises a fluid permeable core assembly12, an elongated capsular-shaped, fluid impermeable housing14, and a suction tube16.

In an exemplary use, the urine collection device10is arranged in a generally vertical position in contact with or close proximity to the subject's urethra, such that a fluid, such as urine, can be absorbed by the permeable core assembly12, flow through the permeable core assembly and, by gravity, flow downwardly into a housing reservoir18where it can be removed through the suction tube16. The general construction and function of the device10is known and described in USP 10226376 and therefore the broader aspects of the device will not be discussed in detail.

Referring toFIGS.2-4, the permeable core assembly12comprises a tubular, fluid permeable core20having a generally cylindrical external surface, a fluid permeable wicking cover22disposed on the external surface of the tubular fluid permeable core20, and may also include an elongated shape retention element24extending along a longitudinal extent of the core, the shape retention element24being entirely imbedded within the core20.

The fluid permeable core20may be a non-woven fibrous bio-compatible polymer material (such as non-woven nylon or polyester) which is produced as a flat slab, or bat, of material (batting) (SeeFIG.2) with thickness and planar dimensions which will result in, when rolled and seamed at the side edges, a cylindrical core (FIGS.3-4) having a diameter of approximately 1.0 to 2.5 inches. The rolled material may form an internal axial lumen26extending longitudinally through the center of the core.

The fluid permeable wicking cover22is disposed on the outer surface of the core20and comprises a bio-compatible natural fiber material, which may in some embodiments comprise at least one layer of non-woven bamboo material. In some embodiments, the wicking cover may comprise two-layers of bamboo material (2-ply). Non-woven, natural bamboo fiber material has been tested and shown to provide a superior wicking or capillary action to draw urine away from the user's skin into the core and thus provide improved comfort with less skin irritation.

The shape retention element24may comprise a wire or other formed material which may retain a predefined arcuate curvature which is suitable for the intended anatomy of the end user. In this regard, the wire24may be pre-shaped with a specific arcuate curvature. In the case of a pre-shaped wire, it is also preferable that the wire ends be rolled over or formed into eyelets24A so that wire end turned back inwardly and the terminal end of the element has a rounded surface to prevent piercing through the device and injuring the user. In some embodiments, the shape retention element24may be formed from a ductile material which can be bent into a predefined curvature at the time of use.

To further prevent injury to the user, the shape retention element24may be imbedded within the core material20during formation of the batted core material or may be inserted and imbedded between the side edges of the core material during seaming of the edges to form the core (seeFIGS.3-4).

The capsular-shaped housing14may be molded or formed from a water or fluid impermeable pliable polymer or other pliable material. The housing14may have a reservoir18at a lower end for collecting a volume of liquid, or urine, that has been wicked inwardly to the core assembly12and that has flowed downwardly by gravity towards the lower end of the device10. The housing14may further comprise an outlet port28at an upper end thereof through which collected urine may be removed through the suction tube16.

The housing14still further includes an elongated collection window30extending at least partially between the lower reservoir end and the upper outlet port end. The core assembly12is received within the housing14such that the core assembly is disposed within and extends across the elongated window30.

The suction tube16may generally be formed from a flexible PVC or urethane tubing material and be of a sufficient length such that it may extend through the interior lumen26of the core assembly12with a first end disposed in the reservoir and a second end exiting the housing14through the outlet port28where it can be attached to a vacuum source (not shown).

In some embodiments, the core assembly12may be adhered to an interior of the housing14during assembly. It has been found that in some cases, consumers may be reusing the housings14with new core materials to save costs. This is not a recommended activity due to the potential for unsanitary conditions if proper cleaning and disinfecting of the housing is not provided. Adhering the core assembly12to the housing14prevents the consumer from disassembling the device and replacing the internal components for re-use and creates a more sanitary single-use device.

Referring toFIGS.5-11another exemplary device for collecting urine is illustrated and generally indicated at100.

The device100comprises a fluid permeable core assembly112, an elongated capsular-shaped, fluid impermeable housing114, and a suction tube assembly115.

As described hereinabove, the capsular-shaped housing114may be molded or formed from a water or fluid impermeable pliable polymer or other pliable material. The housing114may have a reservoir118at a lower end for collecting a volume of liquid, or urine, that has been wicked inwardly to the core assembly112and that has flowed downwardly by gravity towards the lower end of the device100. The housing114may further comprise an outlet port128at an upper end thereof through which collected urine may be removed through the suction tube assembly115. The housing114may still further includes an elongated collection window130extending at least partially between the lower reservoir end and the upper outlet port end. The core assembly112is received within the housing114such that the core assembly is disposed within and extends across the elongated window130.

The suction tube assembly115comprises an elongated shape retention element124, and a suction tube body116having a suction lumen117A providing a suction path from a first end thereof to a second end thereof, and a second shape retention lumen117B receiving the elongated shape retention element124therein.

The suction tube body116may generally be formed from a flexible PVC or urethane tubing material and be of a sufficient length such that it may extend through an interior lumen126of the core assembly112with a first end disposed in the reservoir and a second end exiting the housing114through the outlet port128where it can be attached to a vacuum source (not shown).

The shape retention element124may be formed with a predefined rigid curvature or may comprise a ductile metal which is bendable to a predefined shape during use. In order to prevent potential injury, the shape retention element124is provided with rounded or semispherical terminal ends125. These rounded ends125are provided during a cutting and forming process for each shape retention element.

In an exemplary assembly method, the retention element124may be formed to be about 6 inches in length, where the entire suction tube body116may be about 10 inches in length. The purpose of a shorter retention element124is to prevent the end(s) of the retention element from extending beyond the end of the suction tube body116where it could possibly contact the wearer. In this regard, a conventional co-extrusion method would not be suitable for imbedding the retention element (wire)124within the suction body116as the retention wire would extend along the entire length of the suction tube body and potentially protrude from the end when the shape retention element is curved into a final shape. In this regard, a novel insertion method is disclosed where a 0.080″ diameter retention wire124(6 inches in length) may be inserted into the longitudinal center area of a smaller 0.050″ diameter lumen117B (10 inches in length) by forcing high pressure air through the lumen117B at one end to expand the lumen and lubricate insertion of the larger diameter retention wire124into the smaller diameter lumen from the opposing end. Once the wire is inserted into the central location between the ends, the air pressure is removed and the lumen shrinks back down onto the outside of the retention wire124. The result is a near permanent fixation of the retention wire124in the lumen117B where it cannot be moved out of position. In a further embodiment, the shape retention element (wire)124may also be provided with embossed surface features127(SeeFIG.8) on at least a portion of the exterior surface. These surface features will imbed within the inner surface of the lumen further preventing any possible longitudinal movement of the wire within the lumen.

In some embodiments, as seen inFIGS.10-11, the suction tube body126has a D-shaped cross-section with a planar front surface and a rounded back surface, wherein the suction lumen117A is oriented adjacent the planar surface and wherein the shape retention lumen117B is oriented adjacent the rounded surface.

When the suction tube assembly115is assembled within the core112and the outer housing114, the planar surface of the body116is oriented toward the window130to provide a flatter engagement surface toward the user. A primary complaint of the user is a longitudinal pressure ridge that creates discomfort. By forming a flatter surface facing the body, the width of the pressure ridge or engagement area is enlarged and localized linear pressure is minimized. The flatter facing surface also allow for additional cushioning material to be located between the suction tube body116and the user. Such additional cushioning material may be provided by an additional layer of core material along the planar surface or in some embodiments, an additional thickness of the core material may be provided during production of the core material batting.

The permeable core assembly112comprises a tubular, fluid permeable core120having a generally cylindrical external surface, a fluid permeable wicking cover122disposed on the external surface of the tubular fluid permeable core120,

The fluid permeable core120may be a non-woven fibrous bio-compatible polymer material (such as non-woven nylon or polyester) which is produced as a flat slab, or bat, of material (batting) (SeeFIG.6) with thickness and planar dimensions which will result in, when rolled and seamed at the side edges, a cylindrical core (FIG.11) having a diameter of approximately 1.0 to 2.5 inches. The rolled material may form an internal axial lumen126extending longitudinally through the center of the core120.

The fluid permeable wicking cover122is disposed on the outer surface of the core120and comprises a bio-compatible natural fiber material, which may in some embodiments comprise at least one layer of non-woven bamboo material. In some embodiments, the wicking cover may comprise two-layers of bamboo material (2-ply). Non-woven, natural bamboo fiber material has been tested and shown to provide a superior wicking or capillary action to draw urine away from the user's skin into the core and thus provide improved comfort with less skin irritation.

In assembly, the outer soft surface of the core material120is overlaid with the bamboo wicking layer122(these materials are the same width) and then overlaid again with the Kamisoft material132, which may be about ½ inch wider on each side, allowing the Kamisoft to be folded up the side edge wall of the ½ inch thick core. With the Kamisoft layer on the outside, the overlaid materials are folded like a taco to bring the opposing edges into contact and then heat/melt sealed along the longitudinal edge. Other polyester outer covering materials are also contemplated.

A known issue with the current commercial product is the softness or compressability of the absorbent core material120. Because the device must be worn in close conforming engagement with the wearer, softness of the core material is critical to patient/wearer comfort. As noted above, the core material is a non-woven fiber material which is laid down in a web with a thickness of about 0.5 in and then rolled into a cylindrical tube. The outer surface of the tubular core120(or cover122) that is exposed through the silicone reservoir housing114then presses against the wearer.

An improved core material120according to the invention may be formed by using multiple different denier core fiber materials and modifying a non-woven web forming process to concentrate finer (smaller) denier fibers toward a top (outer) surface of the web thus forming a softer cotton like outer surface. Denier is a unit of measurement used to determine the fiber thickness of individual threads or filaments used in the creation of textiles and other materials. Fibers with a higher denier tend to be thick, sturdy, and durable while fibers with a lower (smaller) denier tend to be sheer, soft, and silky.

Using a rando-webber (random air lay process) an 8 denier bi-component (bico) (core/sheath) fiber of Polyester (core)/HDPE (high density polyethene) (sheath) or polyester CO-PET fiber was blended with 15 denier PET (polyethylene terephthalate) fiber to form web which is approximately 0.5 inch thick. As noted above, the thicker denier fibers are concentrated toward the lower inner surface while the smaller denier fibers are concentrated toward the upper (outer) surface to form a softer cotton like surface. The thickness may vary depending on the desired outer diameter of the device. Other bico fibers and non-bico fiber materials may be substituted as appropriate for various non-woven end product outcomes.

In an exemplary production method, a rando-webber system with a perforated screen may be used to form the described core material. The system used to prepare the material includes a vacuum source to pull the fibers onto the moving screen (7). Typical airlay processes use a single source material for a homogenous web.

The airlay process for forming the present core material web differs from a typical non-woven airlay process in that two different denier fibers are utilized. Due to the natural weight and size of the different fibers, the heavier (larger) denier fibers naturally fall quicker and are collected on the screen in a higher concentration first forming the lower (inner surface layer of the web). The smaller denier bico fibers naturally tend to float in air (like feather) and are concentrated more towards the top (outer surface) creating a softer upper layer. There is mixing of the thicker and thinner denier fibers throughout the web to create an interconnected non-woven material.

The resulting web is run through a primary oven section at around 350° F. to melt bond the bico fibers throughout the web, and then bonded web is flipped and spray coated on the second side (what will become the inner side of the core) before final curing on the third level. The spray mix may comprise a carboxylated SBR, (styrene butadiene) blended with around 2% melamine formaldehyde resin to crosslink the mix. One or more spray coating passes may be used. Other crosslinking formulations may also be appropriate depending on the web materials.

This unique process leaves a soft cotton wool like feeling on top (outer side), while giving the advantages of spray bonding on the back (inner) side. The new core material outer surface is found to be 15 times softer than the original core material when measured with a pillow durometer tester with the same flow.

In some embodiments, a zeolite material may be added to the core material during the air-lay process. A known issue with urinary products and collection devices is odor from urea and ammonia. An absorbent core according to the invention herein may include a powered zeolite material which is intermixed with the non-woven fiber materials at the time of formation of the non-woven web, i.e. during an airlay or other process for creating the non-woven core material. Zeolite is a type of mineral that is made up of a framework of silicon, aluminum, and oxygen. This framework acts as a cage and traps other molecules inside of the zeolite. There are many types of zeolites, and each type has a different type of cage structure. A natural zeolite (one that is naturally occurring called clinoptilolite) can be used to capture ammonia and therefore can act as an ammonia absorber. A powdered zeolite material contained within the absorbent core can therefore operate to trap ammonia within urine and reduce odors.

Referring now toFIG.12, in some embodiments, the finished core assembly12/112may be placed into a cylindrical mold140and heated and cooled (blossoming) to release and reset the polymer core assembly112into a more consistent cylindrical shape which will improve comfort and generally improve consistency in assembly of the core112with the housing114. In some embodiments, the mold140may be provided with an arcuate curvature and an internal curved shaping rod142to not only round the diameter of the core but also provide it with a predefined shape consistent with the arcuate curvature of the shape retention element generally improving the shape retention of the entire device after assembly.

In some embodiments, ribs144may be added to the inside of the blossoming mold140to create exterior surface ribs on the core which mimic the current exterior look of the product currently in production.

As explained above, the core assembly112and tubing assembly115are then secured within the outer housing114to complete the assembly.