Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1998-01-23
2001-02-13
Weiss, John G. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S317000, C604S329000, C604S319000, C604S330000, C604S331000, C604S332000, C604S349000, C604S350000, C604S351000, C604S352000, C604S353000, C004S451000, C004S452000, C004S453000
Reexamination Certificate
active
06186990
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method of producing a low-cost and versatile human bodily fluid collection device, particularly to one containing an expandable, liquid permeable and insoluble pouch which encloses a proper volume of hydrophilic powder or granular material for absorbing the fluid, and which is impermeable to and therefore serves to prevent the hydrophilic material from leaking out of the collection device. This volume of hydrophilic powder or granule serves the purpose of absorbing any incoming fluid to the device and turning them into an expanding pile of soft gel. This expandable, liquid permeable and insoluble pouch, which is allowed to freely expand to a pre-determined size, holds the expanding gel pile without breaking apart. Thus, this pouch prevents the gel to flow freely, to clog the inlet, to slip out of the collection device either from the inlet or puncture during usage.
2. Description of Related Art
A human bodily fluid collection device is generally used to collect urine, vomit, or other human bodily fluid from physically challenged persons and immobilized patients. Such a fluid collection device usually comes in different forms and shapes depending on the needs of particular persons or organizations that deem it to be suitable and comfortable, and, thus, attends to the proper relief and minimum strain and stress to the body. One form of human bodily fluid collection device is known as a urine collection reservoir, a urine drainage bag, or part of an catheter system, generally used in hospitals. U.S. Pat. No. 4,840,625 to Ramona R. Bell shows an external catheter system which consists of a urine collection reservoir, a urine collection inlet, a urine collection tube, and an external catheter for male use. The urine collection reservoir is mainly used to store urine up to its capacity and later drained to the sewage system. However, this type of reservoir has had its problems, such as the the problem that the urine may travel along the tube back to the source and thus cause possible infection, known as the urinary track infection (UTI). Another problem is that the reservoir, generally made of soft plastic material, faces the possibility of puncturing either during transport or by accidentally pinching the reservoir via sharp edges. Thus, the urine may leak and contaminate the surroundings. Also, the urine, if already infected from its source, may expose the persons within the perimeters to contamination. Yet another problem is that during draining of the liquid waste, there is a possibility of accidentally disconnecting the collection tube from the collection inlet, which will cause the urine to pour out from the inlet uncontrollably due to the pressure built-up of the existing urine inside the bag.
Also, a 2
nd
type of urine collection unit as shown on U.S. Pat. No. 5,531,724 to Ruth E. Young has much better improvement to include a one-way valve which prevents back flow, and, gelling which turns the urine into gelled material and not allowing to flow backward. However, the drawback of such a device is that such a one-way valve is more costly to assemble during production since combining this one-way valve with the inlet nozzle and the collection bag itself requires precise molding or else leakage will occur. Besides, the gelled material can still leak out of the bag if the bag is punctured or torn open. Another problem lies within the design that this one-way valve is constructed, as stated in this patent, to close by itself upon contact with fluid and gelled material and preventing escape of both. This design does not prevent the escape of the hydrophilic material such as polymer particles from the collection unit before it turns into gelled material while this collection unit is been turned upside down during handling or transport.
Another form of human bodily fluid collection device is a light-weight, small, and portable urine collection bag or urinal, commonly used during traveling, camping and inside recreational vehicle and car. This type of urine collection device is shown in U.S. Pat. No. 5,318,549 to Chung-Rong Yang and U.S. Pat. No. 5,007,116 to Masao Yamamoto. Per U.S. Pat. No. 5,318,549 shows a fixed-rectangular-shaped absorbent material, which is enclosed inside a urine bag made of liquid impermeable paper material. The absorption of this type of material, similar to that of a sponge, is only limited to the porous space allowed within the material and small in its capacity to hold large amount of fluid. Since this type of material is not freely to expand, it hinders its capability to further absorb more liquid.
Per U.S. Pat. No. 5,007,116 shows yet another type of human bodily fluid collection device, called portable urinal. This urinal as devised consists of a urine-storage bag constructed of a water proof material and snap-fit seal that closes the upper portion of the urinal preventing spill, a pouch inside the bag constructed of water-permeable material containing water absorbent material. This water absorbent material upon contact with water will expand, turn into gel and break the pouch into fragments. This design poses few problems. One is that once the pouch breaks apart, the gel can move freely around inside the bag. Although the bag can be sealed from the upper portion, any puncture at any given location can still allow the gel to leak out of the bag. Second problem is associated with the comfort level of any person required to seal this bag manually and risk the possibility of contacting the bodily fluid waste. Then, if the bag is not full and is reused again, the seal needs to be reopened which also raises concern of possible human contact with the waste. Yet another problem is that before the urinal is sealed, there is possibility of spilling the gel during usage if the urinal is accidentally dropped or squeezed too hard from the outside. And, lastly, the snap-fit seal is much more difficult to manufacture and may lead to leaks and tears if not properly done so. Since the seal needs to be molded onto the soft plastic bag, it significantly weakens the structure of the bag itself during manufacturing. More stringent manufacturing procedures and quality controls are demanded and thus lead to higher manufacturing cost.
Another form of the bodily fluid collection device, known as the “Little John” as shown in
FIG. 7
, which is a widely used urinal in hospitals for many years. This urinal
20
, intended to be portable, reusable, convenient and spill-proof, is constructed of durable hard plastic with a handle
19
for carrying, a screw-on cap
21
for covering and an optional “Lady J Adapter”
22
for female use. Although the cap can be screwed on to prevent spill, the disadvantage of this design is that during usage dropping this urinal will spill the urine before this cap can even be used. Also, when this Lady J Adapter is used, the cap can not be screwed on, which is another possibility of allowing urine to spill during usage or transport.
None of the above devices provides a complete assurance of preventing back flow, leakage and spill problems nor can it be cheaply manufactured and assembled if sufficient design is added to prevent these problems. It is, therefore, an object of the invention to devise a simple and yet useful method of collecting and absorbing the human bodily fluid that provides effective seal from leakage and back flow.
Yet another object of the invention is to provide largest capacity of absorption power while maintaining the device, if unused, small, compact, light-weight, and, most important of all, versatile and suitable for many types of human bodily fluid collection devices. A further object of the invention is to manufacture this method inexpensively and to increase its ease of transport, handling and storage.
SUMMARY OF THE INVENTION
This invention has been devised to offer a simple and yet useful method of collecting and absorbing human bodily fluid that prevent leakage and back flow by utilizing an expandable, liquid permeable and insoluble, pouc
Chen Chen-Hsiung
Li Hung Shou
Lin Gary
Lin Mike Deni
Bacon & Thomas PLLC
Reachgood Industrial Company
Shanoski Paul
Weiss John G.
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