Surgery – Means or method for facilitating removal of non therapeutic... – Urinary catheter
Reexamination Certificate
2000-04-14
2001-05-29
Gilbert, Samuel G. (Department: 3736)
Surgery
Means or method for facilitating removal of non therapeutic...
Urinary catheter
C600S029000
Reexamination Certificate
active
06238383
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an apparatus and a method that facilitates safe and convenient intermittent self-catheterization of a fluid-containment body cavity by a user. More particularly, it relates to an apparatus and a method by which a female patient is initially prepared by her doctor and thereafter is enabled, safely and without further medical help, to intermittently insert a catheter into her urinary bladder to comfortably void urine as needed.
BACKGROUND OF THE RELATED ART
There are many circumstances, e.g., after pelvic reconstructive surgery and/or anti-incontinence surgery, abdominal trauma or hernia, urinary infection, or the like, which can result in unpredictable delays in urination and may require that a female patient be provided with a catheter to enable her efficiently to void urine from her bladder either as her needs dictate or continuously.
Initially, generally during a time when the patient is recuperating in a hospital and under medical observation, it may be desirable to provide for constant drainage of urine from her bladder. Sometimes such a need continues even after recuperation, and the healed patient may for a long time have to wear a catheter that provides continuous drainage of urine into a receptacle like a small bag that is worn on the body and has to be periodically replaced. There are certain problems and discomforts associated with this. For example, ambulatory patients typically have their urine-collection bag strapped to a leg so that it is lower than the pelvis, and urine flow is gravity-driven down into the bag. This can be physically awkward, can be unsightly, and may adversely affect the user's psychological sense of well-being.
A commonly used catheter for continuous drainage of urine is some form of the indwelling Foley catheter, a distal end of which is inserted into the user's bladder through her urethra and is thereafter retained in place by inflation of a balloon-like element. This type of catheter is known to cause discomfort and irritation of the trigone, often causing bladder spasm. Often the catheter must be replaced by a doctor after removal due to continued bladder dysfunction. Various improvements have been suggested to alleviate the problems of tissue compression, irritation, infection and the like that are sometimes encountered in use of the Foley catheter, for example, as disclosed in U.S. Pat. No. 5,562,622, to Tihon, titled “Self-cleansing Bladder Drainage Device”. U.S. Pat. No. 4,738,667, to Galloway, titled “Preformed Catheter Assembly” offers an alternative structure, in which the continuously draining catheter has a pre-curved distal end shape which, after its placement in functional position, tends to retain it in the bladder without a balloon or the like. A somewhat similar solution is taught in U.S. Pat. No. 3,490,456, to Kortum, titled “Intrauterine Catheter Anchor”. Among the complications that, while rare, can occur in the placement and use of a suprapubic catheter are hematuria, cellulitis, bowel injury, urine extravasation, and catheter fracture.
Another alternative for continuous drainage is the use of a suprapubic catheter, but this too has its own problems and is not particularly favored by patients.
Intermittent self-catheterization, a third alternative, is often difficult for many patients to perform, as they may not readily be able to locate the urethra.
It is considered that the ideal mechanism would be one which will enable the patient to void spontaneously and conveniently, to check the efficiency of her voiding, and to be so comfortable and manageable that she can do all this entirely on her own and free of the need to repeatedly call or visit her doctor. The mechanism and the method of using it should be safe, and should not lead to any infection rates higher than those encountered with conventional catheter systems.
The present invention is intended to fulfill this long felt but hitherto unmet need.
SUMMARY OF THE INVENTION
A principal object of this invention is to provide apparatus that enables a female who suffers from a urinary control problem to obtain efficiently, safely and comfortably intermittent drainage of urine from her bladder without assistance from others.
A further object of the invention is to enable a doctor of a female patient having urinary control problems to provide her with an efficient, safe and simple apparatus that enables her to obtain intermittent voiding of her bladder by herself, without discomfort and without incurring a higher risk of infection than is associated with known catheter systems.
A related object according to another aspect of this invention is to provide a method by which a female can be enabled to intermittently, safely and comfortably void urine efficiently when her natural urinary function is adversely affected or is dysfunctional.
A further related object of the invention is to provide a method by which a female who has problems voiding urine can obtain safe, comfortable, intermittent relief by self-catheterization after an initial catheterization by her doctor.
Accordingly, in a first aspect of this invention there is provided a catheter guidewire or other thin, flexible guide element that is initially placed substantially within a female patient's body by a doctor or other qualified person and is thereafter worn internally by her. The guide element includes a flexible distal end portion having an unstrained shape formed thereat or other features that allow the guide element to remain located within a fluid-containment body cavity following placement therein, and has a proximate end portion extendable out of an opening of the fluid-containment cavity. A proximate end of the guide element, during its use, is preferably shaped to be comfortably accessible by the user for insertion into a distal end of a catheter to guide the catheter into the opening of the fluid-containment cavity for voiding of fluid therefrom via the catheter along and past the guide element. A particularly beneficial application of this embodiment is realized when the guide element is located with its distal end portion in an unstrained form entirely within the urinary bladder of a female patient. The proximal end portion of the guide element adjacent the distal end portion would then be held non-leakingly in the urinary sphincter and the urethra, but would permit the user to void volitionally to the extent possible, with the proximal end of the guide element located substantially within or close to the user's vagina where she can access it easily to guide a catheter along the guide element into her bladder when she needs to void urine more completely.
In another aspect of the invention, there is provided a catheter system that comprises an initial placement tubular catheter and a cooperating guide element that is functionally disposed by a doctor or other qualified personnel within a female patient's body via the tubular catheter to guide subsequently used catheters. The guide element has a flexible distal end portion, which in an unstrained state has a flexibly deformable shape and size selected for retention within a fluid-containment cavity of the user's body, or other features for retaining the distal end portion, and a proximal end portion functionally disposable so that a proximate end thereof is readily accessible to the user. The elongate lumen of at least the initial placement catheter is sized to facilitate easy sliding conveyance therethrough of the entire length of the guide element even while, for example, the distal end portion is in a strained state. A particularly beneficial realization of this aspect of the invention involves an initial introduction of a distal end of a first catheter, via the user's vagina and urethra, into her urinary bladder by a doctor or other qualified personnel. This is followed, for example, by the forcible introduction of the distal end portion of the guide element through the proximal end of the catheter, with elastic straining of at least the distal end portion of the guide
Karram Mickey M.
Knodel Bryan D.
Cadugan Joseph A
Gilbert Samuel G.
Jones Jain, LLP
Medical Device Solutions
Nirmel Chittaranjan N.
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