Magnetic actuation urethral valve

Surgery – Body inserted urinary or colonic incontinent device or... – Implanted

Reexamination Certificate

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Reexamination Certificate

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06234956

ABSTRACT:

BACKGROUND OF THE PRESENT INVENTION
1. Field of the Present Invention
The present invention relates to urethral valves, and more particularly to a magnetic actuation urethral valve adapted for inserting into the urethra of a patient who suffering from urinary incontinence in order to recover control of urine flow.
2. Description of Related Arts
Urinary incontinence is a common and serious problem that may be caused by old age, some forms of neurological dysfunction or injuries, or prostate and bladder surgeries. Such problem is hard to treat or, generally, incurable. Patients suffering from this problem not only may experience discomfort and embarrassment, but also may lose some normal human activities.
Many efforts have been taken to solve this problem. Use of indwelling catheters and associated bags often leads to infections of the bladder because the catheter provides a direct passage to microorganisms into the human body. Use of diapers is uncomfortable and embarrassing. Use of artificial urethral sphincters needs surgical implantation that is expensive, complicated, and has a low success rate, sometimes leading to serious complications. Use of various kinds of urethral valve for non-surgical insertion into the urethra is a simple, low-cost, and easy-to-accept way to recover urinary continence.
U.S. Pat. Nos. 4,909,785 and 5,112,306 introduce a device for valving urine involving a flexible tubular body with a drainage canal therethrough, which includes collapsible means for blocking the passageway of urine. It is manually actuated to an open position by means of pressing the flexible valve body. It also includes means for closing the valve automatically after a period delay in which allows voiding of the bladder. The structure of this device is complicated while its size is considerably large.
There are a few different types of magnetic actuation urethral valves such as U.S. Pat. Nos. 3,812,841, 5,004,454, and5,140,999. These devices have some basic properties in common. They are all magnetic in nature and respond to a magnetic fields generated at the exterior of the body. They all need a bias from a spring to maintain their closed position. Their differences are present mainly in the forms of the interactions between the magnetic valve and the controlling magnetic field.
In U.S. Pat. No. 3,812,841, the valve member is pulled directly by external force. The magnet in the valve must be large enough in size to get enough pulling force from the controlling magnetic field against the bias to open the valve. Due to the weak pulling force from direct attraction, it does not work reliably and increases the possibility of malfunction of the unit and consequential repair or replacement. Furthermore, its physical size presents extreme difficulties in insertion and removal.
U.S. Pat. No. 5,004,454 is much simpler and smaller in size then U.S. Pat. No. 3,812,841. Instead of using direct pulling force to open the valve member, it takes the mechanical advantage by using a lever to gain more force to open the valve member than the direct attraction. Because of the efficiency of this mechanism, the size of the magnet in the valve can be reduced. The lever is the valve member itself in a special shape inside the valve body. The valve body limits the range of the lever and the valve that is actuated is quite small, so that urine flow is reduced to a trickle.
U.S. Pat. No. 5,140,999 is very similar to U.S. Pat. No. 5,004,454. The main progress made by U.S. Pat. No. 5,140,999 is that there is an actuator rod which extends out of the valve body and into the bladder, providing greater torque and range for opening the valve. One problem of this design is that the valve might leak when the patient moves tremendously such as running or jumping due to the vibration of relatively long actuator rod with a magnet on its top. Another problem is the possibility of formation of bladder stones caused by a foreign object, which is the extending actuator rod inside the bladder.
SUMMARY OF THE PRESENT INVENTION
The main objective of the present invention is to provide a magnetic actuation urethral valve adapted for inserting into the urethra of a patient who suffering from urinary incontinence in order to recover control of urine flow, wherein the valve member is driven by a magnet rotor which is magnetically actuated by a rotating magnetic field generated from a controller outside the body.
Another objective of the present invention is to provide a magnetic actuation urethral valve which further comprises an actuation device for the user to discharge by inserting an indwelling catheter into the valve in case the valve does not work for any reason.
Accordingly, a magnetic actuation urethral valve according to the present invention is adapted for introduction into a portion of an urethra of a patient suffering from lesions or disorders of the urethra, the prostate or the urinary sphincters. It has a tubular body with a valve member at is proximal end opening to the bladder and a magnet rotor in its roomy central cavity.
The movable valve member connects to the magnet rotor with an actuation axle which is supported by a control nut. The magnet rotor is actuated by a rotating magnetic field generated from a magnetic controller outside of the body and the rotational motion of the magnet rotor is translated into linear motion by the actuation axle and the control nut to push the valve member open to the bladder or pull the valve member back to its closed state.
When the rotor turns clockwise, the movable valve member moves away from the valve seat to its open position through which urine can be released from the bladder. When the magnet rotor turns counterclockwise, the valve member moves back to its normal closed position and shuts off the passageway of urine.
This mechanism, which has the same principle as that of a car jack, gains much greater force for the linear motion of valve member from the force of rotational motion of the rotor. In other words, the force driving the valve member is much greater than the force driving the magnet rotor from the direct interaction between the magnet rotor and the controlling magnetic field.
To get strong force is very important to make sure the operation of the valve can be reliably performed and the size of the valve body can be reduced. That is the basic point to make this valve reliable, and easy to install or remove.
The limited range of the thread area of the actuation axle and the control nut are designed to prevent the valve from getting stuck when the threaded hole and the control nut is over-tightened. The springs at each side of the control nut are for the purpose of being able to secure the threaded portion of the actuation axle going back into the control nut after the threaded portion runs out of the control nut in both directions.
The present invention further comprises an actuation device for the user to discharge the urine in the bladder by inserting a catheter into the valve in case the valve is not working properly for any reason. The nut, which is normally urged to the valve body by a spring, can be moved axially in the valve body. Since these four members of the valve member, the actuation axle, the control nut, and the magnet rotor, are assembled as a firm assembly, the whole assembly can be moved in axial direction in the valve body.
In the case of emergency, user can insert a catheter into the distal end of the valve body through the urethra to push the magnet rotor. The assembly is moved toward the proximal end and the spring is compressed. As a result, the valve member moves to the open position and the urine in the bladder is released. When the catheter is removed, the compressed spring urges the assembly back to normal position and the valve is closed.


REFERENCES:
patent: 5380268 (1995-01-01), Wheeler
patent: 5634878 (1997-06-01), Grundei et al.
patent: 5713877 (1998-02-01), Davis
patent: 5762599 (1998-06-01), Sohn
patent: 5989288 (1999-11-01), Pintauro et al.

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