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Publication Number
US-10994134-B2
Publication Date
2021-05-04
Expiration Date
Abstract
A stimulator device for controlling waste storage for a subject, having one electrode placed in proximity to a portion of each of the right and left pudendal nerves, which contains efferent fibers that, when stimulated, produce contraction of the urethral or anal sphincter. The stimulator device having a pulse generator connected to electrodes, bilaterally, to provide stimulation for each electrode to stimulate pudendal efferent axons. The pulse generator adapted to provide a first type of stimulation to cause waste to be stored within the subject. The pulse generator adapted to provide a second type of stimulation, different from the first type of stimulation, to allow waste to be voided from the subject by blocking nerve impulses that accompany sphincter dyssynergia. An input device to allow an end user to select the first type of stimulation, the second type of stimulation, or no stimulation. Variations of the concept are disclosed.
Core Innovation
The disclosed invention relates to a neurostimulation system and method for treating urinary and fecal incontinence by providing control to at least one end user of storage and voiding of urine and feces for a patient. Electrodes are placed in proximity to a left pudendal nerve and a right pudendal nerve of the patient to provide bilateral stimulation to the pudendal nerves under a control system that selectively conveys stimulation to the electrodes. The patient receives end-user selections including “Store” and “Void,” and the system reacts by starting or ceasing application of a first stimulation in response to the selections.
During “Store,” the first stimulation is adapted to bilaterally generate action potentials in efferent motor nerves to directly promote concurrent sustained contractions of an external urethral sphincter and an external anal sphincter to preclude a release of urine and feces, respectively. The “Store” application is maintained for a duration of at least ten minutes, and additional “Store” selections resume the application of the first stimulation. During “Void,” the system reacts by ceasing application of the first stimulation to allow relaxation of the external urethral sphincter to allow voiding of urine and to allow relaxation of the external anal sphincter to allow voiding of feces, and it can be followed by another “Store” selection.
The invention further includes monitoring adaptations that use pressure sensing devices and corresponding reactions to detected elevated pressure during active stimulation. In particular, one described method monitors a fecal pressure sensing device and changes the first stimulation to provide for an enhanced level of contraction of at least the external anal sphincter for a period of time upon detection of elevated pressure. Another described method monitors a urinary pressure sensing device and, while applying the first stimulation, responds to a detection of prolonged period of elevated pressure by ceasing application of the first stimulation without waiting for receipt of the “Void” selection.
Claims Coverage
The provided material includes four independent claims. Across these, the core inventive features are bilateral pudendal nerve stimulation with end-user “Store” and “Void” control to alternately contract and relax external urethral and external anal sphincters, optionally including pressure-sensing feedback adaptations for urinary and/or fecal pressure.
Bilateral pudendal electrode placement and selective stimulation control
placing a pair of electrodes in proximity to a left pudendal nerve and a right pudendal nerve of the patient to provide bilateral stimulation to the pudendal nerves; placing the pair of electrodes in communication with a control system that can selectively convey stimulation to the pair of electrodes
End-user Store selection to start sustained sphincter contraction
receiving a selection of “Store” from at least one end user; reacting to the received selection of “Store” by starting application of a first stimulation to the pair of electrodes; the first stimulation adapted to bilaterally generate action potentials in efferent motor nerves to directly promote concurrent sustained contractions of both: an external urethral sphincter to preclude a release of urine from the external urethral sphincter; and an external anal sphincter to preclude a release of feces from the external anal sphincter; maintaining the first stimulation to produce the sustained contractions for a duration of at least ten minutes
End-user Void selection to cease stimulation and allow voiding
receiving a selection of “Void” from at least one end user; reacting to the received selection of “Void” by ceasing application of the first stimulation to the pair of electrodes; ceasing application of the first stimulation allowing relaxation of: an external urethral sphincter to allow voiding of urine through the external urethral sphincter; and an external anal sphincter to allow voiding of feces through the external anal sphincter; receiving another selection of “Store” from at least one end user; and reacting to the received another selection of “Store” by resuming application of the first stimulation to the pair of electrodes
Pulse generator configured for bilateral efferent action potentials via pudendal electrodes
placing of a pair of electrodes with one electrode in proximity to a left pudendal nerve of the patient and another electrode placed in proximity to a right pudendal nerve of the patient; placing a pulse generator adapted to provide pulses that bilaterally generate action potentials in pudendal efferent motor nerves through the pair of electrodes
Sustained bilateral sphincter contractions on Store to prevent urine and fecal escape
responding to a user input of “Store” by using the pulse generator to provide pulses that bilaterally generate action potentials in pudendal efferent motor nerves through the pair of electrodes to produce sustained contractions for a duration of at least ten minutes of: a left side of an external urethral sphincter; and a right side of the external urethral sphincter so as to prevent an escape of urine; and a left side of an external anal sphincter; and a right side of the external anal sphincter so as to prevent an escape of fecal matter
Closed-loop fecal pressure sensing to change stimulation for enhanced external anal sphincter contraction
the method further comprising: monitoring a fecal pressure sensing device; and while applying the first stimulation to the pair of electrodes—responding to a detection of elevated pressure measured by the fecal pressure sensing device by changing the first stimulation to provide for an enhanced level of contraction of at least the external anal sphincter for a period of time
Closed-loop urinary pressure sensing to cease stimulation without waiting for Void
the method further comprising: monitoring a urinary pressure sensing device; and while applying the first stimulation to the pair of electrodes—responding to a detection of prolonged period of elevated pressure by the urinary pressure sensing device by: ceasing application of the first stimulation without waiting for receipt of the selection of “Void” from at least one end user
End-user control of storage and voiding of waste using pudendal nerve efferent/afferent architecture
placing a pair of electrodes with each electrode in proximity to a pudendal nerve containing: efferent nerves for an external urethral sphincter and an external anal sphincter; and afferent nerves controlling a bladder and a colon; placing the pair of electrodes in communication with a control system that can selectively convey stimulation to the pair of electrodes; receiving a selection of “Store” from at least one end user; reacting to the selection of “Store” by starting application of a first stimulation to the pair of electrodes; the first stimulation adapted to bilaterally generate action potentials in efferent motor nerves to directly promote sustained contractions of the external urethral sphincter and the external anal sphincter to preclude a release of waste; applying the first stimulation for at least ten minutes before receiving a selection of “Void” from at least one end user; reacting to the selection of “Void” by ceasing application of the first stimulation to the pair of electrodes; receiving another selection of “Store” from at least one end user; and reacting to the selection of “Store” by starting application of the first stimulation to the pair of electrodes
Across the independent claims provided, the central claim coverage is directed to bilateral pudendal nerve stimulation controlled by end-user “Store” and “Void” selections to alternately generate sustained action-potential-driven contractions of the external urethral and external anal sphincters and then relax those sphincters to permit voiding. Additional claim coverage includes pressure-sensing based modifications, including changing stimulation for enhanced external anal sphincter contraction upon fecal pressure elevation and ceasing stimulation without waiting for a “Void” selection upon detection of prolonged elevated urinary pressure.
Stated Advantages
preclude a release of urine from the external urethral sphincter during “Store”
preclude a release of feces from the external anal sphincter during “Store”
allow voiding of urine through the external urethral sphincter during “Void”
allow voiding of feces through the external anal sphincter during “Void”
sustained contractions for a duration of at least ten minutes
provide enhanced level of contraction of at least the external anal sphincter in response to elevated fecal pressure
cease application of the first stimulation without waiting for receipt of the “Void” selection in response to prolonged elevated urinary pressure
Documented Applications
treating urinary and fecal incontinence for a patient using bilateral pudendal nerve stimulation with end-user control of “Store” and “Void”
closed-loop adaptation based on fecal pressure sensing device during application of the first stimulation
closed-loop adaptation based on urinary pressure sensing device to cease stimulation without waiting for a “Void” selection
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