State-dependent peripheral neuromodulation to treat bladder dysfunction
Inventors
Grill, Warren M. • Hokanson, James A. • Langdale, Christopher L.
Assignees
Publication Number
US-12329967-B2
Publication Date
2025-06-17
Expiration Date
2036-10-14
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Abstract
The present invention relates to a neuromodulation apparatus and methods of using the neuromodulation apparatus for treating bladder dysfunction.
Core Innovation
The invention provides neuromodulation apparatuses and methods for treating bladder dysfunction by applying phase-specific stimulation to the pudendal nerve. The core concept is to deliver tailored neural stimulation based on the current or desired phase of the bladder activity cycle—specifically, delivering one type of signal during the bladder filling (storage) phase and a different type of signal during the voiding (micturition) phase. This approach allows both improvement of bladder capacity for urine storage and improvement of voiding efficiency during urination.
The problem being solved is that current artificial electrical stimulation protocols for bladder dysfunction do not differentiate between the filling and voiding phases of the bladder's natural cycle. Existing methods typically apply a fixed stimulus, regardless of the bladder phase, which can lead to conflicting effects such as increased storage when voiding is desired or vice versa. Furthermore, prior devices often require invasive spinal surgeries and offer only partial success in symptom reduction.
The innovation centers on a neuromodulation apparatus with a controller and at least one transducer to deliver phase-specific signals to the pudendal nerve, depending on physiological indicators or patient input about the bladder's phase. These signals may selectively stimulate sensory or motor fibers within the nerve and can be electrical, mechanical, electromagnetic, or thermal. The method allows for greater control and personalization by adjusting stimulation parameters in real time according to physiological measurements such as bladder pressure, nerve activity, or muscle activity in relevant structures.
Claims Coverage
There are two independent claims in this patent: one covering the neuromodulation apparatus with phase-specific stimulation responsive to physiological parameters, and one covering a method of treating bladder dysfunction by applying phase-specific stimulation using these physiological inputs.
Neuromodulation apparatus with phase-specific electrical stimulation responsive to physiological parameters
The neuromodulation apparatus is designed to apply phase-specific electrical stimulation to the pudendal nerve or its subcomponents. The delivery of stimulation is guided by control signals generated in response to outputs from one or more detector elements. These detector elements are responsive to physiological parameters, including nerve activity in the pudendal, hypogastric, or pelvic nerves, muscle activity in the bladder detrusor muscle, internal or external urethral sphincter, external anal sphincter, or bladder pressure. The apparatus distinguishes whether the bladder is in a filling or voiding phase based on the detected physiological parameter, and applies different stimulation patterns or parameters according to the phase.
Method for treating bladder dysfunction using phase-specific electrical stimulation based on physiological inputs
This inventive feature covers a method that applies phase-specific electrical stimulation to the pudendal nerve in a subject. The stimulation is adjusted based on one or more control signals, which are generated in response to detector elements monitoring physiological parameters such as nerve or muscle activity and bladder pressure. The pattern of electrical stimulation is specifically altered depending on whether the physiological parameter indicates a filling or voiding phase in the bladder cycle. The method aims to produce one or more clinical outcomes: reduction in number of incontinence episodes, decrease in urgency or frequency of urination, increase in bladder capacity, increase in bladder voiding efficiency, or decrease in urinary retention.
The independent claims protect both an apparatus and a method for treating bladder dysfunction by dynamically applying phase-specific, physiologically-responsive electrical stimulation to the pudendal nerve, distinguishing bladder cycle phases through monitored physiological parameters.
Stated Advantages
Provides improved control of bladder function by matching phase-specific stimulation to filling or voiding, enhancing both storage and voiding efficiency.
Reduces the need for significant and potentially dangerous spinal surgery by targeting the pudendal nerve peripherally.
Ensures stimulation augments appropriate bladder function in real time, preventing stimulation from acting in conflict with the patient's physiological needs or intentions.
May prolong battery life of the apparatus by enabling periods with no stimulation after voiding.
Allows for cumulative or synergistic effect when used in combination with pharmaceutical treatments for bladder dysfunction.
Documented Applications
Treatment of bladder dysfunction, including overactive bladder, neurogenic bladder, stress incontinence, chronic urinary retention, nocturia, and detrusor hyperactivity with impaired contractility (DHIC).
Prophylactic treatment to prevent episodes of bladder dysfunction in subjects known to have bladder dysfunction.
Therapeutic treatment to partially restore normal bladder function in subjects with symptoms such as incontinence, urgency, frequency, and retention.
Use in combination with pharmaceutical compositions such as antimuscarinics or β-adrenergic receptor agonists for treating bladder dysfunction.
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