Surgery – Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
1998-11-06
2001-03-20
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
active
06203488
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical devices; more particularly to bladder control devices; and still more particularly to insertion apparatus for placement of bladder control apparatus within the urethra of a patient.
2. Description of the Prior Art
The value and advantages of bladder control apparatus, often referred to as artificial sphincters, is well-known to those of skill in the medical art. As can be seen in the prior art, it is desirable to place certain bladder control devices within the urethra of a patient for direct control of the flow of fluid form the bladder through the urethra and thence from the patient. The prior art has recognized various devices for such implantation of bladder control apparatus. Certain of these prior art devices have the disadvantage of being somewhat difficult or clumsy for the medical personnel to manipulate during insertion, and others carry the disadvantage of potentially damaging the urethra or the bladder, for example, if an insertion device is placed too far into the bladder from the urethra and damages the bladder wall.
It is to overcome these potential disadvantages and to provide a sure and simple insertion device that the present invention has been made.
SUMMARY OF THE INVENTION
The present invention overcomes the disadvantages of the prior art by providing a method and apparatus for atraumatically inserting and removing a bladder control apparatus.
In the preferred mode of practicing the present invention, the insertion apparatus consists of an outer tube having a retention collar, a solid urethral dilation probe, a device handling tube, and a device insertion rod, in addition to the bladder control device. The outer tube has a length greater than that of the urethra and a lumen of sufficient size to slideably accommodate the solid urethral dilation probe. Using suitable topical lubricants, antiseptics, and pain control, the dilation probe is inserted through the lumen of the outer tube, and the assembly is advanced through the urethra, until the neck of the bladder is located via manual sensation. The dilation probe is removed leaving the outer tube extending the entire length of the urethra and about 1 cm. into the bladder. The distal end of the outer tube is stabilized by sliding the retention collar proximally until it rests against the meatus, where it is removably locked in place by a retention screw.
The device handling tube has an outside diameter sufficiently small to position slideably within the distal end of the outer tube and has an inside diameter sufficiently large to slideably accommodate the bladder control device. The bladder control device is loaded into the device handling tube to restrain the proximal retaining elements of the bladder control device against the inner walls of the device handling tube. The insertion rod is removably attached to the distal end of the bladder control device. The proximal end of the device handling tube is inserted into the distal end of the outer tube and the bladder control device is advanced proximally into the outer tube. The device handling tube is removed distally from the insertion rod.
The insertion rod is advanced proximally until the bladder control device traverses the length of the outer tube permitting the retaining means to expand within the bladder. The outer tube and its retention collar are removed from the patient leaving the bladder control device and insertion rod in place. The insertion rod is pulled distally until the distal end of the bladder control device is visually positioned at the distal end of the urethra. This assumes that the bladder control device is of a proper length which may necessitate the use of an extension. The insertion rod is disconnected from the bladder control device and the distal retaining ring is attached. Removal of the bladder control device is accomplished using the reverse of the above explained procedure.
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Kulisz Andre A.
Migachyov Valery
Crompton Seager & Tufte LLC
HK Medical Technologies Incorporated
Lacyk John P.
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