Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-04-19
2003-12-09
Bockelman, Mark (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S059000, C607S060000, C607S061000
Reexamination Certificate
active
06662052
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to wireless communication capability of an external stimulator for neuromodulation, more specifically an external stimulator for neuromodulation therapy for urological, neurological, and neuropsychiatric disorders, having two-way wireless communication through a server.
BACKGROUND OF THE INVENTION
Biological and human clinical research has shown utility of electrical nerve stimulation therapy for urinary incontinence and a broad group of neurological disorders. This invention is directed to remotely controlling the stimulation therapy for these disorders, utilizing an implanted lead-receiver, and an external stimulator with predetermined (pre-packaged) stimulation programs. Some of the predetermined programs may be manually operated, but some programs are locked-out to the patient. These patient locked-out programs can be accessed by the physician either in person via a password or remotely. The remote activation of these programs is via the wireless Internet server, communicating with an external controller using a wireless interface. A physician situated remotely is also able to activate predetermined programs, as well as, interrogate the external stimulation devices of his/her patients. In addition, a physician is able to change which programs are accessible to the patient.
Urinary Incontinance
In considering first, the background of urinary urge incontinence.
FIG. 1
shows a sagittal section of the human female pelvis showing the bladder
10
and urethra
13
, in relation to other anatomic structures. Urinary continence requires a relaxed bladder during the collecting phase and permanent closure of the urethra
13
, whereas at micturition (urination), an intravesical pressure above the opening pressure of the simultaneously relaxing urethra has to be generated. These functions of the bladder
10
and urethra
13
are centrally coordinated and non-separable. At bladder filling, the sensation of urge is mediated by slowly adapting mechanoreceptors in the bladder wall and the same receptors provide the triggering signal for micturition and the main driving force for a sustained micturition contraction. The mechanoreceptors are, technically speaking, tension receptors. It has been found that they respond equally well to tension increases induced passively by bladder filling and those induced actively by a detrusor contraction. These receptors have high dynamic sensitivity and are easily activated by external pressure transients, as may occur during coughing or tapping of the abdominal wall. Their faithful response to active changes in bladder pressure is well illustrated.
When sufficiently activated, the mechanorecptors trigger a coordinated micturition reflex via a center in the upper pons
88
, as depicted schematically in FIG.
2
. The reflex detrusor
92
(muscle in the wall of the urinary bladder) contraction generates an increased bladder pressure and an even stronger activation of the mechanoreceptors. Their activity in turn reinforces the pelvic motor output to the bladder
10
, which leads to a further increase in pressure and more receptor activation and so on. In this way, the detrusor
92
contraction is to a large extent self generating once initiated. Such a control mechanism usually is referred to as a positive feedback, and it may explain the typical all-or-nothing behavior of the parasympathetic motor output to the bladder
10
. Once urine enters the urethra, the contraction is further enhanced by reflex excitation from urethral receptors. Quantitatively, the bladder receptors are most important.
A great advantage of the positive feedback system is that it ascertains a complete emptying of the bladder
10
during micturition. As long as there is any fluid left in the lumen, the intravesical pressure will be maintained above the threshold for the mechanoreceptors and thus provide a continuous driving force for the detrusor
92
. A drawback with this system is that it can easily become unstable. Any stimulus that elicits a small burst of impulses in mechanoreceptor afferents may trigger a fullblown micturition reflex. To prevent this from happening during the filling phase, the neuronal system controlling the bladder is equipped with several safety devices both at the spinal and supraspinal levels.
The best-known spinal mechanism is the reflex control of the striated urethral sphincter
90
, which increases its activity in response to bladder mechanoreceptor activation during filling. An analogous mechanism is Edvardsen's reflex, which involves machanoreceptor activation of inhibitory sympathetic neurons to the bladder. The sympathetic efferents have a dual inhibitory effect, acting both at the postganglionic neurons in the vesical ganglia and directly on the detrusor muscle of the bladder
92
. The sphincter and sympathetic reflexes are automatically turned off at the spinal cord level during a normal micturition. At the supraspinal level, there are inhibitory connections from the cerebral cortex and hypothalamus to the pontine micturition center. The pathways are involved in the voluntry control of continance. Other inhibitory systems seem to orignate from the pontine and medullary parts of the brainstem with at least partly descending connections.
Bladder over-activity and urinary urge incontinance may result from an imbalance between the excitatory positive feedback system of the bladder
10
and inhibitory control systems causing a hyperexcitable voiding reflex. Such an imbalance may occur after macroscopic lesions at many sites in the nervous system or after minor functional disturbances of the excitatory or inhibitory circuits. Urge incontinence due to detrusor instability seldom disappears spontaneoulsly. The symptomatic pattern also usually is consistent over long periods.
Based on clinical experience, subtypes of urge incontinance include, Phasic detrusor instability and uninhibited overactive bladder. Phasic detrusor instability is characterized by normal or increased bladder sensation, phasic bladder contractions occurring spontaneously during bladder filling or on provocation, such as by rapid filling, coughing, or jumping. This condition results from a minor imbalance between the bladder's positive-feedback system and the spinal inhibitory mechanisms. Uninhibited overactive bladder is characterized by loss of voluntary control of micturition and impairment of bladder sensation. The first sensation of filling is experienced at a normal or lowered volume and is almost immediately followed by involuntary micturition. The patient does not experience a desire to void until she/he is already voiding with a sustained detrusor contraction and a concomitant relaxation of the urethra, i.e., a well-coordinated micturitiori reflex. At this stage, she/he is unable to interrupt micturition voluntarily. The sensory disturbance of these subjects is not in the periphery, at the level of bladder mechanoreceptors, as the micturition reflex occurs at normal or even small bladder volumes. More likely, the suprapontine sensory projection to the cortex is affected. Such a site is consistent with the coordinated micturition and the lack of voluntary control. The uninhibited overactive bladder is present in neurogenic dysfunction.
Patients with stress and urge incontinence are difficult to treat adequately. Drug treatment often is insufficient and, even when effective, does not lead to restoration of a normal micturition pattern. Since bladder over-activity results from defective central inhibition, it seems logical to improve the situation by reinforcing some other inhibitory system. Successful therapy of the urge component does not influence the stress incontinence. While an operation for stress incontinence sometimes results in deterioration of urgency. Electrostimulation is a logical alternative in mixed stress and urge incontinence, since the method improves urethral closure as well as bladder control
Neuromodulation is a technique that uses electrical stimulation of the sacral nerves
85
, (a general di
Boveja Birinder R.
Sarwal Alok
Bockelman Mark
NAC Technologies Inc.
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