Urethral device with anchoring system

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S175000, C600S029000, C600S030000

Reexamination Certificate

active

06221060

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates generally to urethral apparatuses and methods of use, and more particularly to a urethral apparatus that can be positioned in the urethra for short-term or long-term use, relatively comfortably but securely.
Urinary problems can have serious consequences, particularly when the problem is one of retention or ischuria. Urine flow problems include urine retention, incontinence, and difficult urination. Retention can result from any of a number of causes, including without limitation, spinal cord injury or tumors, coma, typhoid, peritonitis, prostatic enlargement, urethral stricture, urethritis, cystitis, bladder tumors, urethral calculus, Parkinson's disease, prostatitis, or multiple sclerosis. Patients suffering from these and other conditions often require some interventional means to periodically drain the bladder. Failure to do so can result in damage of the epithelium and detrusor muscles associated with the bladder, and an increased potential for bacterial invasion and urinary tract infection potentially leading to life-threatening kidney failure.
Another urine flow problem is that of incontinence, which is the inability to retain urine because of paralysis or relaxation of sphincters or contraction of longitudinal muscular layers of the bladder. Incontinence can also occur in coma, epileptic seizure, spinal cord injury or tumors associated with the spinal cord, spinal meningitis, or local irritation of the bladder. Incontinence is usually categorized as either stress incontinence, in which urine is expelled during stresses such as exercise, coughing, and laughing; urge incontinence, in which the patient in unable to control the urge to urinate in part due to uninhibited bladder contractions; or mixed incontinence, in which the patient experiences both stress and urge incontinence.
Difficult urination or dysuria can result from urethral strictures, enlarged prostates, atony and impairment of the bladder's muscular power, and inflammatory conditions involving the urethra, bladder, or lower ureter.
Devices have been developed to be positioned in the urethra and/or bladder to correct the problems of urine flow. Urinary drainage catheters and devices have a long history, and many approaches have been taken to keeping these devices in place. Many of these devices suffer from one or more problems. For example, some of these devices may have been difficult or uncomfortable to place into position or to retain in position after placement. Also, some of these devices may have tended to leak or become dislodged unintentionally. Further, some of these devices have led to infections.
Accordingly, it is an object to provide a device that is easily and atraumatically inserted and remove. It is another object to provide a device that can be positioned in the urethra with a minimum of stress to the urethra and with a minimum of bacterial migration. It is still a further object to provide a device that can remain in position in the urethra and withstand pressure impulses due to stresses such as coughing, laughing, or exercising.
SUMMARY OF THE INVENTION
To address the above concerns, the present invention provides a device that comprises a tubular-shaped body that in insertable into a body passageway or cavity, in particular the urethra, and that has an exterior surface having one or more anchors located thereon that aid in movement of the device with a minimum of trauma during placement and that aid in securing the device within the passageway or cavity during use. The device may be inserted into either the urethra, bladder neck, or bladder.
According to a further aspect, the one or more anchors on the device are in the form of partial spiral helixes that function to move and secure the device within the human urethra. The partial spiral helical anchors have structures that allow for the longitudinal movement of the device during positioning procedures. These anchors can vary in height, length, number, compressiveness, axial placement, material characteristics, and helix angle. In addition, leading and trailing edges associated with each of the anchors provide a tapered gradual increase up to a maximum height of each of the anchors to ease insertion and removal of the device and to prevent a shearing effect that could result from a blunt or aggressive leading edge.


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