ELECTRONICALLY OPENING/CLOSING URETHRA VALVE
The present invention relates to an electronically opening/closing urethra valve.
An almost unavoidable problem experienced by a large proportion of the population with advancing age is urinary incontinence.
Attempts have been made to address the problem in different ways, although in each case the object has simply been to collect the fluid that is passed involuntarily in a reliable and non-embarrassing manner.
For a long time persons suffering from urinary incontinence have expressed a desire to be able to control, at least to a certain degree, their discharge of urine so that it takes place at convenient times.
In both sexes the urinary bladder lies at the bottom of the abdominal cavity and a urinary tube, the urethra, carries urine from the bladder to the vulva in women and to the tip of the penis in men. Consequently, the male urethra is much longer than the female urethra.
A sphincter surrounds the first portion of the urethra in both sexes. In men the upper or proximal part of the urethra is surrounded by a large gland, the prostate gland, which in many middle-aged men begins to increase in size and in doing so starts to press against the urethra.
The volume of urine in the bladder increases, on urination the pressure drops, but before the urinary bladder is completely empty the prostate gland presses against the urethra and prevents the bladder from being completely voided. With advancing age, there is also a gradual increase in the residual volume.
This means that in men urination takes place often, but only a little urine is passed at a time, and the need to urinate comes quickly. It becomes more and more difficult to maintain continence, and this leads to embarrassing, involuntary urination.
It should be pointed out that these problems are not a sign of prostate cancer, a phenomenon which may develop in addition to these problems. Prostate trouble in men can be relieved by surgical procedures, by internal "planing" or "cylinder boring", or by microwave "cooking" of some prostatic tissue and also by using drugs which cause the prostate gland to shrink a little.
Women have no prostate gland, but they may also experience problems in "controlling their bladder", i.e., they may also suffer from urinary incontinence.
There has been no shortage of attempts to solve these problems.
An obvious means is, of course, absorbent pads or napkins or other devices which, at least in the case of today's napkins, absorb considerable volumes of fluid.
For men with major prostate problems and an accumulation of urine in the urinary bladder, a well-known means is the insertion of a tube, a catheter, all the way along the urethra into the bladder, so as to void the bladder.
In addition to single-use catheters there are catheters which can be inserted and remain in place for several days. A clamping device on the tube that projects from the penis allows complete draining several times per day, but there is a not inconsiderable risk of infection with this device.
This catheter technique has led to extensive work with a view to improving the opening/closing technology.
The solution was found in a combination where the catheter was given the form of a valve of the remote-control type, where the opening/closing technology has been taken from the field of electronics as applied, e.g., in connection with central door locking for cars.
The factors that must be taken into account when designing an electronically remote- controlled valve of this type are as follows: a) the valve/catheter must be short, it should pass through the prostate, but need not go much further. b) An electronic chip that controls a lifting/opening/closing mechanism must be inserted in the catheter wall in the proximal end of the catheter. There must also be some form of safety valve that opens automatically at a pre-determined excess pressure, as a safeguard for, e.g., senile dementia patients who are not capable of controlling the valve themselves. c) By keeping the catheter/valve short, the chances of bacterial infection in the urinary bladder are reduced considerably. It goes without saying that the materials used
5 in the construction of the valve/catheter are body-compatible. d) In the same way as with pacemakers, there are possibilities of incorporating batteries in the catheter. Another possibility is that the remote control has such strong signals that a separate power source is not necessary. e) The proximal end of the valve/catheter, the end that is in the urinary bladder, 0 must be shaped so that it is held in place, e.g., a funnel or bladder shape. This may be rendered unnecessary if the prostate gland per se exerts a "natural" pressure that holds the valve/catheter in place.
The present invention is a contribution to the solution of the problems outlined above s which involves a relatively permanent valve device for persons with urinary incontinence problems. Accordingly, the present invention relates to a urethra valve that is characterised by a substantially circular-cylindrical, tubular body, optionally having external sealing and/or securing means at the end that is passed into the urinary bladder, and having an internal, remote-controlled valve having a valve seat, valve head, o valve rod and valve spring with spring seat, optionally having a pressure sensor, and an electrical control unit for remote control/opening of the valve.
In a preferred embodiment of the invention the valve involved is a solenoid valve.
5 It is an advantage that the spring load is set so that it is opened at a pre-determined excess pressure in the urinary bladder.
The securing means may advantageously be a double-walled bladder which can be caused to expand by means of a fluid for in order to hold the valve in place. However, o it may also be a twist-release, preferably perforated, collar or fan.
The invention will be described in more detail with reference to the attached drawings, wherein Fig. 1 is a schematic illustration of the upper part of the urinary system with a valve according to the invention in place; and 5 Fig. 2 shows the inventive valve in greater detail.
In Fig. 1 the urinary bladder is indicated by means of the letter A. At the outlet of the urinary bladder the prostate gland found in men is indicated by means of the letter C.
The urinary tube, the urethra, runs from the urinary bladder A and carries urine from the body, as mentioned above, to the penis in men and to the vulva in women.
In Fig. 1 it is indicated how the inventive valve can be placed at the outlet from the urinary bladder in the proximal part of the urethra.
As mentioned, the valve is shown in greater detail in Fig. 2.
It should be noted that different embodiments are possible and that the figure should therefore be regarded as merely illustrative.
The valve has the general shape of a preferably circular-cylindrical, tubular body (2), whose proximal end (2') is narrowed in order to provide the means for a valve seat on the internal wall of the narrowed end.
A valve with valve spindle (1) and valve head (1 ') is arranged coaxial with the valve tube or sleeve (2). The valve head (1 ') has been given a shape that allows sealing on contact with the valve seat (2').
Around the valve rod (1) there is arranged a spring (6), fastened at its distal part to the valve rod and resting at its proximal part against a spring seat (5). This spring normally keeps the valve closed but, as indicated earlier, the spring force is adjusted so that if there is a slight excess pressure the valve opens. This is a safety precaution that is necessary in particular for senile dementia patients who are not capable of controlling the electronic part themselves.
The reference numeral (8) is used to indicate an electronic chip which, together with a winding (7), can be electronically commanded to open or close the valve.
The reference numeral (4) is used to indicate an adjusting screw for adjusting stroke length and spring force. As mentioned above, it is desirable that at the proximal end of the valve, in the urinary bladder, there are provided securing means that are funnel or bladder-shaped to hold the valve in place.
This may be done in various ways, e.g., with the aid of a ring-shaped, balloon-like device that can be filled with liquid or another fluid in order to hold the valve in place and which collapses when the pressure is relieved. Another possibility is a diaphragmlike fan or collar device which, e.g., is made to spread out when turned with the aid of a tool, and which can be drawn together again by turning the tool in the other direction.
A suitable tool may advantageously be incorporated in C as indicated by the insertion tool (10) with a connecting screw (9).
The connection between the valve and the insertion tool may, e.g., be in the form of a bayonet socket, and the actual insertion tool will also be in the form of a flexible catheter that is known per se, in this case with an internally extending rotatable tool/screw device.
The actual insertion and removal of the inventive urethra valve must, of course, take place in a medically safe manner, preferably under local anaesthetic, where it is conceivable that the anaesthetic , e.g., is located in that part of the valve device that moves first through the urethra.
The inventive valve allows persons with problems of urinary incontinence, at least to a certain degree, to control their urinary discharge themselves when external factors so allow, that is in practice when they have the chance to go to a toilet or similar in the normal way.
However, as mentioned, the valve is also controlled by safety means which enable it to be used also by persons suffering from senile dementia who are unable to control the electronics themselves. In this case it will be necessary to use conventional fluid- absorbing means as well.
The invention thus represents an important aid for persons suffering from problems of urinary incontinence, so that they feel very much more at ease socially and less inhibited.