Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2001-04-25
2004-02-24
Look, Edward K. (Department: 3754)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S334000
Reexamination Certificate
active
06695825
ABSTRACT:
BACKGROUND OF THE INVENTION
Thomas J. Castles has been an ostomate for 46 years, having had an “end colostomy” procedure.
According to the International Ostomy Association, and ostomy is best defined as “type of surgery required when a person has lost the normal function of the bladder or bowel due to birth defects, disease, injury or other disorders. Such operations include colostomy, ileostomy and urostomy. The surgery allows for normal bodily wastes to be expelled through a new surgical opening (stoma) on the abdominal wall. Most persons with ostomies must wear special appliances, named “ostomy bags”, over the stoma. The ostomy bag retains bodily wastes outside of the body cavity until such time as it can be disposed of properly. An ostomate is a person who has had ostomy surgery. ‘Related surgeries’ are surgeries of the bowel or urinary system that correct birth defects, illness or injury while preserving continence.”
Mr. Castles has done extensive traveling within the United States while vacationing and while serving as a delegate to the American Federation of Musicians. In addition, he has traveled locally as and active performing musician. During these times he has used airliners, cruise ships, trains, motor homes and automobiles, and has been required to maintain his colostomy, which is accomplished by “flushing out” the ostomy bag, using water. This requires Water to be inserted into the bag, and then released back into a portable container, waste basin or toilet. In the past, it has been difficult for such a procedure to be completed when the ostomy patient was away from home, where proper facilities were available, primarily due to the fact that evacuating an ostomy bag can be untidy, unsanitary, and cumbersome without some sort of portable, pressurized water delivery system.
Mr. Castles realized the need for ostomy patients to have a portable service device that allows for efficient, sanitary maintenance of the stoma. The “Portable Ostomy Management Device” provides ostomy patients with a device that is small, portable, and battery powered to provide ostomy maintenance anywhere, at any time. Ostomy patients have no ability to control the normal body function and therefore face extreme stress problems servicing their pouch while at work, visiting, traveling or during other intimate moments in life.
To overcome the difficulties of managing an ostomy when away from equipped facilities, it is necessary to have access to a portable, powered supply of pressurized water that can be used to evacuate and clean out the inside of an ostomy bag while still being worn by the patient. This requires a device that provides a refillable fluid reservoir (
1
), an on-demand pump (
6
), a portable power supply or battery (
9
), a water flow valve (
15
), and a proprietary, angled pressure wand.
Other devices have been produced to aid in the evacuation and cleaning of ostomy bags, such as those disclosed in the following US Patents:
U.S. Pat. No.
Inventor(s)
Issue Date
4,134,404
C.B. Williams Jr.
Jan. 16, 1979
4,642,106
W. Downey
Feb. 10, 1987
5,037,408
J.S. Henry
Aug. 6, 1991
5,096,503
S.E. Wellman
Mar. 17, 1992
5,330,447
R. Barth
Jul. 19, 1994
5,454,389
J.C. Hubbard et al.
Oct. 3, 1995
5,503,633
P.K. Saunders et al.
Apr. 2, 1996
6,224,521
Withers et al.
May 1, 2001
Williams ('404) discloses a colostomy kit, which consists of a small waste receptacle that straps around the waist of the user. The device requires either a plumbing water supply (faucet or spigot), or a water pouch suspended above the user's head, to deliver water to the device. Further, the device is designed for use while patient is sitting on a toilet. This does not provide the user with the ability to use the device when away from plumbing and/or a toilet. Further, the device does not include any sort of angled water delivery nozzle that would minimize the possibility of coming in contact with waste material, or spillage on the user's clothing.
Downey ('106) discloses a device for evacuating the contents of an ostomy bag wherein a pair of elongated members is spaced apart; the ostomy bag is inserted between the elongated members, and then pulled through. As the ostomy bag is pulled between the members, the contents are forced out. This method possibly does not completely clear all materials from the ostomy bag, requiring additional rinsing. This possibly exposes the user to contamination from waste contained within the bag. Further, this device does not provide the user with an angled water delivery nozzle, which is likely to expose the user to contact with unsanitary waste, or spillage on the user's clothing.
Henry ('408) discloses a tool designed to be secured to an ostomy bag so that the bag may be manipulated within a toilet in order to facilitate the evacuation of its contents. This method requires the user to place his or her hands into the toilet with the likely possibility of contamination from both waste within the bag, and from the toilet. Further, this device does not provide the user with an angled water delivery nozzle, which is likely to expose the user to contact with unsanitary waste, or spillage on the user's clothing. Wellman ('503) discloses a device that allows for a hose to be secured to a sink faucet with the purpose of delivering pressurized water inside an ostomy bag in order to flush out waste. This device, however, supplies no means to flush out an ostomy bag when a sink faucet is not available. Further, without an angled water delivery nozzle, the user can possibly make contact with unsanitary waste, or spillage on the user's clothing.
Barth ('447) discloses a device that provides irrigation for an ostomy patient by providing a two-chambered fluid delivery system for flushing out the internal waste channel by inserting a connector to the Stoma. Air-pressurized chamber forces water out of the bag, and into the stoma, using a manual hand-pump. This device is designed for flushing waste from the internal waste channel directly, without the use of an ostomy bag. Further, this device requires substantial effort with two hands in order to complete the flushing task. It provides no means for cleaning the interior of an ostomy bag.
Hubbard ('389) discloses a device for evacuating and capturing waste from an ostomy bag using water delivered with a submersible pump that is installed inside of a fluid reservoir. The device also provides a container for capturing waste. This device requires the user to fill the ostomy bag with fluid, than manually agitate the contents, in order to perform cleaning. Further, without an angled water delivery nozzle and pressurized delivery system, the user is required to agitate the bag, which exposes the risk of making contact with unsanitary waste, or spillage on the user's clothing.
Saunders ('633) discloses a device that provides fixed installation, bedside, or portable use adaptations with the purpose of providing a method for using pressurized water to flush the inside of an ostomy bag. In all three adaptations, the user is required to evacuate waste into a toilet using a specialized component that sits on top of a toilet seat to allow the user to sit and drain the bag contents into a drainage funnel. This device is large, and cumbersome. It is portable (can be moved around within a location), but not transportable (easily taken with a user on trips or vacations). Further, without an angled water delivery nozzle, the user can possibly make contact with unsanitary waste during the bag flushing process, or spillage on the user's clothing.
Withers ('581) provides an ostomy-cleaning device that requires the user to remove the ostomy bag in order to perform said cleaning. The device is designed to be permanently installed near a basin or toilet, and is not transportable or portable. Further, continuously removing and reapplying a new ostomy bag to the stoma can result in irritation to the skin, pain, and discomfort.
Ostomy patients are faced with a dilemma if cleaning is required when the patient
Fristol, Jr. John K
Look Edward K.
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