Urine management system for human females

Details Urine management system for human females Urine management system for human females

2001-04-05

2003-05-27

Bennett, Henry (Department: 3761)

Surgery

Means and methods for collecting body fluids or waste material

Receptacle attached to or inserted within body to receive...

C604S327000, C600S574000

Reexamination Certificate

active

06569133

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of collecting urine and conveying it from point of collection to storage. More particularly, this invention relates to an apparatus for urine collection from a female human, storage, and disposal, and that addresses the problems associated with such devices of current art. Most particularly, this invention relates to an apparatus that addresses the problem of female human incontinence.
2. Description of Related Art
Urine incontinent human females whose condition does not require use of an internal or “indwelling” catheter are faced with two alternatives to manage their condition: using a system of devices worn on the body to collect and to store the urine separately for periodic disposal, or wearing an absorbent garment (also including pads and diapers) that collects and stores the urine in the crotch area for periodic changing. For some individuals, the system of devices alternative may be preferable to the absorbent garment alternative because of various personal and social reasons. Such systems of devices consist of separate devices for urine collection, conveyance to storage, and storage. Several urine management systems for females have been described in the prior art using collection devices constructed for female anatomical needs, and conveyance tubing and leg bag technology that are essentially similar to those used for males. Despite the number of such ideas and patents, no devices or systems intended for females are commercially available at this time, suggesting that the prior art devices have not proven to be practicable or practical vis-a-vis the abundant range of absorbent garment products commercially available for incontinent human females.
All prior art urine collectors for females are configured as cups, pouches, bags and cones, and span the range of coverage from the entire vulval area to simply the urethral opening. All such devices require a tight seal between the body and the device. To achieve this seal, some make use of adhesives, together with pliable foam or similar materials.
Prior art collectors require connection to some form of external storage device. In some cases, the collectors are integrated with, or permanently attached to, the urine storage device. Other collectors, which are detachable from the storage devices, use conventional rubber tubing
All prior art urine collectors for females are configured as cups, pouches, bags and cones, and span the range of coverage from the entire vulval area to simply the urethral opening. All such devices require a tight seal between the body and the device. To achieve this seal, some make use of adhesives, together with pliable foam or similar materials.
Prior art collectors require connection to some form of external storage device. In some cases, the collectors are integrated with, or permanently attached to, the urine storage device. Other collectors, which are detachable from the storage devices, use conventional rubber tubing for connection. Appendages to collection devices used for transporting urine away are susceptible to crimping which could block the discharge of urine.
Prior art collectors for females use either gravitational flow or a wicking mechanism to transport urine away from the discharge area. Thus, these collectors are unable to move urine along an ascending flow path from the point of discharge to a leg-mounted storage bag. This situation is especially problematic when the user is seated. Instead of draining, urine will pool in the collector risking overflow and embarrassment. In addition, prolonged skin exposure to urine and urine decomposition products (e.g. ammonia), can cause skin injury, breakdown, and infection.
Urine conveyance tubing generally makes use of small-bore rubber tubing. For a female urine management system, it would be desirable if the tubing is comfortable for skin contact, minimally visible under clothing, and sufficiently resistant to crimping, kinking, or other types of flow blockage resulting from body movements. To provide kinking resistance, prior art devices resort to using heavy wall thickness, relatively rigid materials, internal protrusions molded into the tube's inner wall for preventing the tube wall from collapsing or incorporating axial pleats or convoluted tube walls for guiding the bends. All these prior art techniques fail to satisfy the need for the user's comfort.
In addition to the collapse of the tube lumen, flow blockage in prior-art conveyance tubes can also result from formation of liquid slugs when displaced air from the storage device is prevented from uprising in the narrow bore. While venting the storage device circumvents this problem, it emits unpleasant odor.
The simple use of a thin-walled tube in place of the thicker-walled urinary tubing in current use could result in a poorer performance with respect to collapsing and sealing off of periodic, low volume flows such as urine incontinence leakage. While any open tube may be used as a conduit for gravity flow, to provide active fluid transport in an ascendant path to a higher point prior to reaching the descendent path, as in the situation of a seated user, urine flow needs to proceed from the urethral opening up the thigh to a higher point near the knee and then flow “down” to a storage container attached to the lower leg. A simple open tube will not work.
In the prior art, the storage device is normally a flexible-wall reservoir that is either attached to the user's leg or suspended from the waist. These reservoirs are made from heavy-gauge sheeting of latex rubber, vinyl, or similar polymer with a single storage chamber. All containers are provided with outlet valve to allow for periodical draining. In addition, the containers must be cleaned and disinfected regularly to avoid odor and buildup of bacteria. However, most urine containers are discarded after 1-2 weeks because they cannot be thoroughly cleaned.
In single-chamber flexible wall storage devices, collected urine accumulates at the bottom to give a localized bulge under clothing, which is visible and impedes movement of the wearer. The contained liquid tends to slosh around when the wearer moves creating noise and a disconcerting feeling. There are some prior art baffles or other internal attachments between the walls to reduce the wall bulging and the liquid sloshing; however the overall container still bulges. In addition, if the storage device becomes accidentally disconnected, the spill of contained liquid urine can be very messy. As mentioned earlier, all prior art storage devices require venting of urine-displaced air, which emits an unpleasant odor.
Storage devices containing liquid-absorbent materials such as gel-forming polymeric absorbents, are found in the prior art. In general, the prior art describes liquid absorption and gel formation in a single chamber envelope or bag with an inlet and containing a gelling agent or absorbent either in a highly confined mass or in an undefined shape. No provisions are described for deliberate distribution or mixing of the fluid to ensure rapid wetting and gel formation, nor are any provisions made for ensuring a particular shape or form of the absorbed or gelled fluid other than noting the geometric shape of the envelope or bag. Moreover, placement of unconfined dry solids such as these absorbents in a bag with angular corners often results in accumulation in one corner or along one edge as a result of settling and movement during shipping and handling.
Storage devices that take the form of leg bags rely on elasticized straps around the calf or suspension from a waist belt to maintain a desired position on the leg. Putting on these straps is tedious and time consuming. In addition, an improperly fastened leg bag may be more easily dislodged from the secure fastened position with consequent possible urine spillage.
One approach described in prior art to reduce localized bulging and liquid sloshing in storage devices is to immobilize the liquid into suitable absorbe

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