Patent Application
20230301846
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.
The present disclosure provides improvements related to the following:
Exemplary embodiments will now be described further by way of example with reference to the following examples and figures, which are intended to be illustrative only and in no way limiting upon the scope of the disclosure.
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:
Referring to
In an exemplary use, the urine collection device 10 is 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 assembly 12, flow through the permeable core assembly and, by gravity, flow downwardly into a housing reservoir 18 where it can be removed through the suction tube 16. The general construction and function of the device 10 is known and described in USP 10226376 and therefore the broader aspects of the device will not be discussed in detail. The present disclosure focused on several improved material features as well as manufacturing and assembly processes.
Referring to
The fluid permeable core 20 may 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) (See
The fluid permeable wicking cover 22 is disposed on the outer surface of the core 20 and 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 element 24 may 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 wire 24 may 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 eyelets 24A 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. To further prevent injury to the user, the shape retention element may be imbedded within the core material 20 during 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 (see
The capsular-shaped housing 14 may be molded or formed from a water or fluid impermeable pliable polymer or other pliable material. The housing 14 may have a reservoir 18 at a lower end for collecting a volume of liquid, or urine, that has been wicked inwardly to the core assembly 12 and that has flowed downwardly by gravity towards the lower end of the device 10. The housing 14 may further comprise an outlet port 28 at an upper end thereof through which collected urine may be removed through the suction tube 16.
The housing 14 still further includes an elongated collection window 30 extending at least partially between the lower reservoir end and the upper outlet port end. The core assembly 12 is received within the housing 14 such that the core assembly is disposed within and extends across the elongated window 30.
The suction tube 16 may 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 lumen 26 of the core assembly 12 with a first end disposed in the reservoir and a second end exiting the housing 14 through the outlet port 28 where it can be attached to a vacuum source (not shown).
One noted improvement of the present device is that the core assembly 12 is adhered to an interior of the housing 14 during assembly. It has been found that in some cases, consumers may be reusing the housings 14 with 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 assembly 12 to the housing 14 prevents the consumer from disassembling the device and replacing the internal components for re-use and creates a more sanitary single-use device.
In some embodiments, the finished core assembly 12 may be placed into a mold and heated to release and reset the polymer core material into a more consistent cylindrical shape which will improve comfort and generally improve consistency in assembly of the core with the housing. In some embodiments, the mold may be provided with an arcuate curvature to 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, the shape retention element 24 may be formed from a ductile material which can be bent into a predefined curvature at the time of use.
With respect to production of the device components, an improved method of continuously forming a plurality of core assemblies 12 may comprise the steps of:
In some embodiments, the step of continuously securing the side edges 20A/20B may comprise continuously side stitching the opposing side edges with a bio-compatible polymer thread 32. When using side stitching, the method may comprise the step of flattening the stitched side seam such that the side edges 20A/20B become aligned in face-to-face relation.
In other embodiments, the step of continuously securing the side edges may comprise continuously ultrasonically welding the opposing side edges.
In some embodiments, the method may further comprise the step of placing each cut core assembly in a cylindrical mold and applying heat to the mold to release and reset the core material into a stable cylindrical shape.
An improved method of assembling a urine collecting device to prevent re-use comprises the steps of:
While there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.
This application claims the benefit of U.S. Provisional Application No. 63/322,249, filed Mar. 22, 2022, the entire contents of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63322249 | Mar 2022 | US |
