Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2000-03-10
2001-11-06
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C600S029000, C128SDIG008
Reexamination Certificate
active
06311689
ABSTRACT:
FIELD OF INVENTION
The present invention relates generally to incontinence prevention devices, and more particularly to an incontinence prevention devices having a non-concentric retention structures.
BACKGROUND OF INVENTION
Many adults suffer urinary incontinence although urinary incontinence is more common in women than in men. The increased frequency in women is due primarily to the laxity of the bladder support structures resulting from pregnancy and aging. Surgical correction is possible in some cases, but surgery is invasive, costly and dangerous. Urethral incontinence prevention devices, such as for example catheters, plugs and other similar devices, in most cases offer a better solution but can be cumbersome to use, can be expelled during bowel movements, and are typically relatively expensive to manufacture.
There are a wide variety of incontinence prevention devices available, including: catheters that have lumen for urine to flow through; valved catheters; plugs that prevent the flow of urine until the plug is removed; and cylindrical supports against which the sphincter seals the urethra to prevent the flow of urine. Foley catheters are one type of commonly used catheter. Foley catheters are essentially elongated tubes. They are placed in the urethra to drain urine through the central lumen. An inflatable balloon is included near the distal end of the tube serves as a retention structure. When inflated, the balloon holds the catheter in place. The proximal end of a Foley catheter typically has two ports: a drainage port to drain urine from the bladder and a balloon inflation port to inflate and deflate the balloon. The drainage port creates a permanent opening between the bladder and outside environment. Because the bladder is continuously emptied, the bladder's dome continuously rests on the tip of the catheter above the retention balloon causing compression, irritation and erosion of tissue as well as other tissue problems. Therefore, a need exists for a retention structure that does not protrude into the bladder such that it contacts the bladder's dome.
Plugs totally block the flow of urine. Therefore, the plugs typically require removal for the user to urinate. After removal, the old plug is not sterile and a new sterile plug must inserted into the urethra Plugs' retention structures are typically cumbersome to operate and traumatic to the tissue. Thus, improper use can lead to irritation and infection from tissue traumatization. Further, the retention devices on the plugs are typically fluid filled and therefore relatively complex to manufacture. Therefore, a need exists for an incontinence prevention device that provides an atraumatic and simple means for insertion and removal and further reduces manufacturing costs.
Further, some urethral incontinence devices include open loop or pigtail type retention structures. These devices may be expelled when a user tenses the abdomen, such as when a user bears down during a bowel movement, because of a phenomenon called bladder neck drop often associated with incontinent female patients. With bladder neck drop, the bladder neck extends downward to encompass at least a portion of the urethra. The open loop type retention structures are thought to drop into the downward extension and thereafter could be entrapped in the urethra rendering it quasi-rectilinear as the bladder neck resumes its original shape. The improperly positioned device no longer functions properly and the quasi-rectilinear bladder retention structure can no longer maintain the device at its proper location permitting the user to later expel the device. Therefore, a need exists for an incontinence prevention device having a retention structure that maintains its appropriate position within the bladder neck regardless the physical forces acting on it, and can recover after momentary bladder neck drop.
In addition, typical incontinence prevention devices require, at least to some extent, that a proximal end extend from the urethral meatus. The proximal ends tend to scatter urine droplets during urination. The scattering of urine is inconvenient and unsanitary. Therefore, a need exists for a catheter that permits a directed stream of urine.
The present invention meet these needs and provides additional improvements and advantages that will be recognized by those skilled in the art upon review of the following description and figures.
SUMMARY OF THE INVENTION
The present invention further provides an incontinence prevention device that is simple and inexpensive to construct and easy to use. The incontinence prevention device of the present invention includes a shaft and a retention structure. The retention structure is configured as a closed loop non-concentrically disposed about a longitudinal axis of the shaft. The retention structure's closed loop tends to maintain the incontinence prevention device within the bladder neck. The retention structure's non-concentrically orientation accounts for the bladder's asymmetry. The retention structure may further include a protuberance projecting from the retention structure. The protuberance may project from a midpoint of the closed loop. The shaft may further include a lumen configured to receive a stylet. The lumen is typically coextensive with the shaft and substantially coextensive with the retention structure. In addition, the lumen may be coextensive with the protuberance. The device may also include a hydrogel coating disposed on its outer surface. The shaft may include an orientation marking at its proximal end. The proximal end of the shaft may also have a beveled edge to prevent the spraying of urine during urination. A segment of the retention structure may additionally define a cavity to receive another portion of the retention structure to further reduce the diameter for insertion. For insertion, the retention structure is rendered substantially rectilinear. A stylet may be provided to insert into a lumen in the device to render the retention structure substantially rectilinear. Once rectilinear, the device is inserted into the urethra so that the retention structure is placed within the bladder. Once in the bladder, the retention structure is reformed into a loop. The retention structure is then positioned adjacent the neck of the bladder with the non-concentrically disposed retention structure in a predetermined orientation
REFERENCES:
patent: 4738667 (1988-04-01), Galloway
patent: 5176664 (1993-01-01), Weisman
patent: 5352182 (1994-10-01), Kalb et al.
patent: 5562622 (1996-10-01), Tihon
patent: 5738654 (1998-04-01), Tihon
patent: WO 97/32542 (1997-09-01), None
Brown Michael A.
ContiCare Medical, Inc.
Nikolai & Mersereau , P.A.
LandOfFree
Female incontinence prevention device does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Female incontinence prevention device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Female incontinence prevention device will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2586126