Patent Application
20100312225
A patent(s) relating to the internal workings of the valve portion of the present invention, which has public domain counterparts in various industries, will be applied for subsequent to the present application. However, simple, verbal descriptions of the valve will be given to aid readers in understanding the functionality of such—in the medical context of the present application.
Benign prostate gland enlargement now affects, or will affect, a large portion of the adult male population over the age of fifty. As the prostate gland enlarges with age, prostate tissue compresses inward toward the duct which passes urine through it. The rate of urine flow is slowed, and the ability to completely void urine from the bladder is often lost. A consequence of the latter is bladder over-distension, sometimes beyond its ability to expel urine at all. Kidney damage or failure can result unless medical remedies are sought.
Surgical procedures that cut out the compressed tissue within an enlarged prostate can have the undesirable consequence of causing a man to loose his ability to father children, naturally. Cells within the prostate which produce the watery seminal fluid which both aids the ejaculation of semen, and serves as a transport medium for the sperm while such travel to fertilize an ovum, are reduced in number. Because surgical over-enlargement of the inside of the prostate gland can sometimes result, the path of least resistance for a man's ejaculate is too often retrograde, or toward the bladder—making normal sexual reproduction impossible.
Another undesirable consequence of prostate gland duct enlargement is incontinence. Such can occur if the bladder outlet muscles which are adjacent to the prostate gland get enlarged, too, or if their controlling nerves get damaged.
For the above reasons, including the pain and suffering associated both with the surgery and the recovery period, and the negative life-long psychological factors that can accompany the surgical enlargement of the prostate duct—it is highly advantageous that men who have prostate gland enlargement consider alternatives to surgery such as present invention.
The most common emergency procedure for urine over-retention due to an enlarged prostate gland is catheterization via a rubber tube that is inserted through the urethra, the prostate, and up into the bladder. An opening on the bladder end of such tube allows the retained urine to flow out through the opposite end. The initial flow of urine that's released in the doctor's office or in an emergency room can be collected in a pitcher. But since the prostate enlargement which caused the problem hasn't been corrected, that catheter will need to remain in place. A plastic urine collection bag is connected to the rubber tube. Because such tube passes through the nerve-concentrated tip of the penis, the man will experience discomfort while making simple bodily movements, and he will be precluded from having sexual relations for as long as the catheter remains in place.
The above conditions of duress cause many men to undergo internal surgery on the prostate gland. Heretofore—other than via a catheter that extends out the tip of the penis—there hasn't been a simple, non-surgical way to confidently drain most of the accumulated urine from the bladder. Prostate duct surgery puts the quality of men's lives at risk, and diminishes their masculinity, because they will likely loose the ability to father children, naturally—needed or not.
A conventional urinary catheter, such as the Foley, releases urine into the collection bag as soon as such arrives from the kidneys. The normal reservoir functions of the bladder aren't being used, even though the urine storage capacity of the bladder is still there. If at any time a clamp were to be placed on the portion of the catheter extending from the tip of the penis, the bladder would again function as a reservoir. In bladders which have been over-distended to their limit, it is desirable to avoid having the urine ever again accumulate beyond the normal volumes as when that man was younger. Under the latter conditions, the muscles of the bladder wall will eventually contract so that the bladder will shrink in volume—in much the same way that a woman's abdomen, after giving birth, will eventually shrink to be close to the size it was before pregnancy.
An extensive network of nerves within the bladder triggers the urge to urinate. If not for prostate gland enlargement, the bladder muscles, once they've received the neurological signals to expel urine, would normally be able to generate the necessary pressure to do so. If, as suggested above, a clamp were to be placed on the lower end of the rubber catheter, the pressure of the urine buildup within the bladder should create an urge to void. Such will cause the man to go to the toilet and release the clamp on the rubber tubing. In effect, that clamp will be being released because of the pressure/pain feelings within the bladder.
The present invention capitalizes on the bladder having normal sensations of fullness. But instead of having the “clamp” be located just outside the overly sensitive tip of the penis, a “clamp”—actually a valve—is inserted into the back of the urethra. There, such can be opened or closed by easy finger tip pressure through the lower penis next to the scrotum, and up through the urethra. The proximal, catheter portion which extends into the bladder is analogous to a Foley catheter. But the offending distal portion of rubber tubing that had extended out the sensitive tip of the penis is eliminated!
By the simple act of installing the “clamp” (valve) inside the urethra, not only is near normal urination being made possible, but no portion of the installed valve, nor the attached catheter, will interfere with the free passage of seminal fluid from the prostate gland, and sperm from the testicles. In short, the man will be able to have sexual relations that will allow normal fertilization to occur! And not a single painful and invasive surgical procedure will have been required!
The detailed description of the present Wholly Indwelling, Valve-actuated Urinary Catheter, its installation and easy use, will be described in the following.
The schematic drawing is a vertical section cut through a typical man's penis, prostate, and bladder. The implement used for inserting the valved catheter is shown at the correct relative size just above the penis. For the present ‘medical’ patent application, the internal workings of the valve itself will be described in words, rather than being shown in section. There are a number of public domain valve types which can function, adequately, for this usage. The best embodiment of such a valve will be covered in a subsequent utility patent that will not repeat the medical claims which follow.
An enlarged prostate, 1, can restrict urine flow and cause urine, 6, to overly distend the bladder, 2. A valved catheter that has: An enlarged end portion, 17, at the neck of the bladder, 2; a patient-specific length of rubber tubing, 16; an enlarged middle portion, 15; a patient specific length of rubber tubing, 14; and a three part valve, 13, 12 and 11, is contained within the urethra, 3. Such valved catheter is inserted through the tip of the penis, 4, by means of a removable flexible tubing, 9, which has a threaded, hollow, metal tip, 10, and a knurled, hollow metal knob, 8, to allow screwing and unscrewing the metal tip, 10, into the female threads of the metal tip, 11, of the valve.
The diameter of the catheter portions, 16 & 14, is similar to the size of Foley catheters presently in use. The integral enlarged portions of the rubber catheter, 17 & 15, retain the valved catheter in place. To aid the insertion of the big end, 17, through the enlarged prostate, 1, a cone-shaped, water-soluble, dart-like insert, 18, which is lacquered only on the cone-shaped tip of such, will wedge the enlarged prostate, 1, open. Once the big end, 17, is in the correct position, the cone-shaped insert, 18, is removed via water pressure from a medical syringe inserted into opening, 7, of knurled knob, 8. The cylindrical back portion of insert, 18, fits tightly enough inside the catheter tubing, 16, that such insert, as a unit, can be hydraulically ejected into the urine, 6, of the bladder, 2. Because the back portion of insert 18 isn't protected by lacquer, such will immediately begin dissolving until no solid portions of insert 18 remain within the bladder, 2.
With the insert, 18, ejected from the big end, 17, the catheter portions, 16 and 14, are opened to the downward passage of urine toward the valve, 13, 12 and 11. In the at-rest position, the valve is closed. That means that no urine can pass through the metal tip, 11, until the valve is opened. The center portion of the valve, 12, is a flexible rubber covering which will function like a spring to keep the valve parts 11 and 13 in the closed position. However, the user can open the valve at will by placing a finger on position 5 between the penis and the scrotum. The metal tip, 11, can be felt. Simply by pushing such metal tip, 11, toward the prostate gland, 1, the rubber valve portion, 12 will bulge out slightly, opening the valve to the free passage of urine, 6.
The quantity of urine flow that's possible with just the small catheter is limited. But if the man, while holding the valve tip, 11, in the pushed-in or open position, will also squeeze closed, and hold, the tip of his penis, 4, then the hydrostatic pressure building up from the urine flowing out of the metal tip, 11, will swell the diameter of the urethra, 3, as well as the duct passing through the prostate, 1, so that a greater quantity of urine will start flowing around the catheter and valve. By controlling the amount of finger pressure on the tip of the penis, 4, a more powerful urine stream can be maintained.
Note: Unlike when the latter process was used without a catheter, near complete voiding of the bladder can be facilitated simply by holding the valve tip, 11, in the open position. An inward compression of tip 11 of as little as 1/16″ will open the valve. Internal O-rings will prevent urine from leaking when the valve is in the closed position. And because the valve is located out of the distal portion of the penis, the chance of the valve opening, accidentally, is small.
The valved catheter, as in the present invention, can be left in place for any length of time. Yet such can be removed, easily, by reinserting the tubing, 9; turning the knurled knob, 8, clockwise; and rethreading the metal tip, 10, into the metal valve portion, 11. The dilated prostate duct will allow the withdrawal of the tip, 17, without special procedures.
