Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2002-02-04
2003-12-09
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C607S041000
Reexamination Certificate
active
06659936
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to prosthetic devices for the treatment of urinary incontinence and, in particular, to prosthetic devices employing transplanted tissue.
BACKGROUND OF THE INVENTION
The present invention is concerned with forms of incontinence caused wholly or partly by inadequate sphincter function. This may include forms of stress incontinence, urge incontinence and total incontinence. The invention has been developed initially for use in treating male incontinence and will be described principally with respect to that application. However, it will be appreciated by those skilled in the art that the invention is also applicable for use in treating female incontinence.
Incontinence is a major health problem, particularly with the ageing population, for which there is no well-accepted medical treatment. For females, surgically constructed slings are increasingly being used for stress incontinence and with increasing success. However, here is no low risk and reliably effective treatment for moderate to severe male stress incontinence particularly after treatment of prostate cancer. As the incidence of prostate cancer is increasing, this is a growing health issue.
The internal sphincter of the urethra consists of smooth muscle cells interposed with elastic tissue and is located in the proximal urethra. Its constant tone is crucial to maintaining mechanical resistance in the proximal urethra sufficient to hold back the passive pressure exerted by urine in the bladder. Weakness in this area is a common cause of urinary incontinence, for example after treatment for prostate cancer.
Prosthetic sphincter valves have been proposed in numerous forms, including mechanical, hydraulic and electrical devices which replace or supplement the defective damaged internal sphincter of the urethra (e.g. PT 101841, SE 931516, GB 2266844, FR 2638964, WO97/01309 and U.S. Pat. No. 4,619,245). Electrical stimulation of the muscles of the sphincter has also been proposed (DE 29614895). Other approaches have proposed the use of external or implanted electrodes to stimulate existing sphincter function.
A variety of approaches have been proposed in relation to the electrical stimulation of the muscles of the sphincter, most of which are directed towards stimulating an existing sphincter and/or muscles disposed about, for example, a bladder(DE 29614895).
Another group of prior art proposals for the treatment of incontinence are directed towards the stimulation of sacral nerves and the like. Such proposals again seek to use the existing muscle structures. (U.S. Pat. No. 4,771,779, U.S. Pat. No. 4,703,775, U.S. Pat. No. 4,607,639, U.S. Pat. No. 3,870,051, U.S. Pat. No. 4,688,575, U.S. Pat. No. 4,389,719 and U.S. Pat. No. 5,702,428).
Other stimulation means have been proposed, for example U.S. Pat. No. 5,562,717, wherein stimulating electrodes are disposed on the skin of a person to externally stimulate existing muscles to control incontinence. This method is disadvantageous in that it requires electrodes to be disposed in a predetermined location of the person and be electrically connected to a power source therefore not allowing complete freedom.
It has also been proposed to implant part of a small skeletal muscle from the thigh around the patient's urethra, and then to electrically stimulate the muscle to “retrain” it to function as a replacement sphincter (New Scientist, Jun. 29 1996). However, this approach, even if successful, would require relatively high levels of electrical stimulation to allow sufficient contracture of the replacement sphincter.
It is an object of the present invention to provide an improved prosthetic device for use in treating incontinence.
SUMMARY OF THE INVENTION
Broadly, the present invention utilises innervated smooth muscle to provide an auxiliary sphincter. This is stimulated by a suitable device in order to provide a functional sphincter in the patient. As a consequence, the stimulator device can operate with lower power consumption, and produce a superior sphincter action.
According to a first aspect of the invention there is provided an implantable sphincter stimulator configured for operatively providing electrical stimulation to a surgically implanted innervated smooth muscle sphincter disposed about a urethra so as to control the flow of urine therethrough, the stimulator including:
a stimulus generating unit in electrical communication with a receiver, the stimulus generating unit operatively configured to provide a first predetermined electrical stimulation signal adapted to contract said sphincter, and a second predetermined signal adapted to allow said sphincter to relax, one of said predetermined signals being selected in response to a signal received at the receiver from a remote controller.
In preferred embodiments, the stimulator applies the first stimulation signal, unless a signal is received indicating that the patient wishes to empty the bladder. The second stimulation signal may be simply the absence of a stimulation, a lower level signal or an alternative signal.
Preferably, the stimulation signal is one which will maintain a continuous tone in the innervated sphincter. In other preferred embodiments of the invention the stimulation signal is pulsatile. Preferably, the stimulator provides multiple channel pulse generation. Preferably also, the stimulation pulse frequency is in the range of 0.25 to 2.5 Hz and having a width in the range of 0.05 to 0.20 milliseconds.
Preferably the stimuli applied have a current less than or equal to 30 mA. More preferably, the stimulation signal is generally rectangular and symmetrical biphasic, although alternative biphasic pulses may be used.
Preferably, the sphincter stimulator includes a replaceable or rechargeable battery power source, preferably one which is in-situ rechargeable, for example inductively.
Preferably, the signal to the receiver is communicated by microwave or radio means, optically or by magnetic energy and the receiver respectively is a microwave, radio, photon or magnetic energy receiver.
Preferably, the stimulus generating unit includes a demodulator responsive to the received signal for providing a modulated signal to a stimulus encoder which in turn provides a signal to a stimulus driver. The stimulator preferably includes two or more electrodes for operatively delivering the stimuli to the sphincter. The stimuli may differ between electrodes, or may be the same at each.
Preferably, after the sphincter has been relaxed, the stimulator is adapted to supply the first stimulation signal to contract the sphincter when a predetermined signal to contract the sphincter is not received by the receiver after a predetermined period.
Preferably, the sphincter stimulator includes a transmitter for transmitting sphincter stimulator telemetry information indicative of one or more parameters of the stimulator for detection remotely. Preferably, the information is transmitted by means of radio waves, microwaves, optically or by magnetic energy. More preferably, the parameters include one or more of the stimulation signal frequency, current, width and/or shape, and/or of the received signal strength and battery status. Preferably, the stimulus generating unit includes a processing device with non-volatile memory.
Preferably, the receiver is configured to accept a remotely generated sphincter stimulator calibration signal and in response, the stimulus generation unit selectively varies one or more of the stimulation signals. More preferably, the calibration signal is transmitted in response to received sphincter stimulator telemetry information, for example the telemetry signals from the stimulator.
Preferably, the stimulator is in electrical communication with the sphincter by at least one electrical lead having two or more electrodes which are operatively implanted into the sphincter at a predetermined location. More preferably, the lead includes three electrodes disposed in an epimysal, cuff or tripolar configuration about the sphincter.
Preferably, the smooth muscle is taken f
Barnett Robert W
Furness John B
Hirst George D
O'Connell Helen E
Akerman & Senterfitt
Lacyk John P.
University of Melbourne
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