Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2000-02-14
2002-11-19
Shaver, Kevin (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
Reexamination Certificate
active
06482145
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an anal incontinence treatment apparatus and method. More specifically, the invention relates to an anal incontinence treatment apparatus and method for surgical application in the body of an anal incontinence patient for restricting the colon or rectum of a patient.
Anal incontinence is a widespread problem. Many different solutions to this problem have been tried. Several kinds of sphincter plastic surgery are used today to remedy anal incontinence. There is a prior manually operated sphincter system in an initial clinical trial phase with the hydraulic sphincter system connected to a reservoir placed in the scrotum. Disadvantage of this system is that hard fibrosis created around the reservoir over time may cause malfunction of pumping components. Thus, the created fibrosis will sooner or later become a hard fibrotic layer which may make it difficult to pump the reservoir. Yet a further disadvantage is that the use of hydraulic fluid always entails a risk of fluid leaking from the prosthetis. Furthermore, it is a rather complicated task to mechanically manually pump the reservoir when defaecation is needed . U.S. Pat. No. 5,593,443 discloses hydraulic anal sphincter under both reflex and voluntary control. An inflatable artificial sphincter with the pump system in scrotum is disclosed in U.S. Pat. No. 4,222,377.
SUMMARY OF THE INVENTION
A prime object of the present invention is to provide an anal incontinence treatment apparatus, which does not require manual manipulation of a combined reservoir a pump mechanism placed in the scrotum or labia majora region of the patient.
Another object of the invention is to provide an anal incontinence treatment apparatus, which does not require complicated surgery.
Yet another object of the invention is to provide an anal incontinence treatment apparatus, which may be conveniently remotely controlled by the patient.
Accordingly, the present invention provides an anal incontinence treatment apparatus, comprising an adjustable restriction device implanted in a patient, who suffers from anal incontinence, and engaging a portion of the colon or rectum of the patient to restrict the fecal passageway therein, an adjustment device which adjusts the restriction device to restrict the colon or rectum to close the fecal passageway, or release the colon or rectum to open the fecal passageway, and a powered hydraulic operation device for adjusting the adjustment device.
Preferably the hydraulic operation device adjusts the adjustment device in a non-manual manner. The expression “non-manually manner” should be understood to mean that the restriction device is not adjusted by manually touching subcutaneously implanted components of the apparatus or not manipulated by touching the skin of the patient. Preferably, the adjustment device adjusts the restriction device in a non-invasive manner. The expression powered should be understood as energised with everything without manual force, preferable electric energy.
The adjustment device may adjust the restriction device in a non-magnetic manner, i.e. magnetic forces may not be involved when adjusting the restriction device.
The adjustment device may also adjust the restriction device in a non-thermal manner, i.e. thermal energy may not be involved when adjusting the restriction device. Furthermore, as opposed to prior art anal incontinence treatment devices the adjustment device of the invention is not operated by manual forces, such as by manually compressing a fluid containing balloon implanted in the scrotum. Instead the apparatus of the invention may further comprise a powered operation device for operating the adjustment device.
In the various embodiments hereinafter described the restriction device generally forms an at least substantially closed loop. However, the restriction device may take a variety of different shapes, such as the shape of a square, rectangle or ellipse. The substantially closed loop could for example be totally flat, i.e. thin as seen in the radial direction. The shape of restriction device may also be changed during use, by rotation or movements of the restriction device in any direction.
Preferably the restriction device controls the size of the area of the fecal passageway in the colon or rectum, preferably to change steplessly with a preselected size that is satisfactory for the patient.
A control device for controlling the restriction device may conveniently be provided and may comprise an internal programmable control unit implanted in the patient and, possibly an external control unit outside the patient's body for programming the programmable internal control unit. Alternatively, the external control unit may be programmable and wirelessly control the restriction device.
At least one sensor for sensing at least one physical parameter of the patient may conveniently be implanted in the patient. The sensor preferably senses the pressure against the restriction device or the colon or rectum or other important parameters and either the internal control unit or the external control unit of the control device may suitably control the restriction device to release the fecal passage way. For safety the restrictor device may release the fecal passageway in response to the sensor sensing for example an abnormally high pressure value. The internal control unit may directly controls the restriction device in response to signals by the sensor.
The apparatus preferably comprises a control device which may comprise both an internal or an external control unit for controlling the restriction device preferable for wirelessly controlling the restriction device. Preferable the implanted internal control unit being programmable by the external control unit. The external control unit may also be programmable.
Preferably, a hydraulic operation device, suitably electrically powered, is implanted in the patient for operating the adjustment device and a reservoir is also implanted in the patient and contains a predetermined amount of hydraulic fluid, wherein the hydraulic operation device operates the adjustment device by using the hydraulic fluid of the reservoir.
In accordance with a first main embodiment of the invention, the adjustment device comprises an expandable cavity in the restriction device, the colon or rectum being sqeezed upon expansion of the cavity and released upon contraction of the cavity, and the hydraulic operation device distributes hydraulic fluid from the reservoir to expand the cavity, and distributes hydraulic fluid from the cavity to the reservoir to contract the cavity.
A fluid distribution tube may readily be connected between the reservoir and the cavity in a manner so that the tube does not interfere with other implanted components of the apparatus.
Preferably, the reservoir defines a chamber for the predetermined amount of fluid and the hydraulic operation device changes the size of the chamber. The hydraulic operation device suitably comprises first and second wall portions of the reservoir, which are displaceable relative to each other to change the size of the chamber of the reservoir. The hydraulic operation device may distribute fluid from the reservoir to the cavity of the restriction member in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir and may distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion.
The first and second wall portions of the reservoir may be displaceable relative to each other by manual manipulation, such as by manually pushing, pulling or rotating any of the wall portions in one direction, or alternatively, may be displaceable relative to each other by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor). In this embodiment no pump is used, only the volume of the reservoir is varied. This is of great advantage compared to the soluti
Cadugan Joseph A.
Nixon & Vanderhye P.C.
Obtech Medical AG
Shaver Kevin
LandOfFree
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