Implantable pulse generator with automatic jump-start

Inventors

Jacobson, Peter • Ostroff, Alan

Assignees

Coloplast AS

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Publication Number

US-12605542-B2

Patent

Publication Date

2026-04-21

Expiration Date


Abstract

The subject matter of this specification can be embodied in, among other things, an implantable pulse generator device having one or more electrodes, and circuitry that includes one or more processors and memory, the memory having instructions stored thereon which, when executed by the one or more processors, cause the one or more processors to perform operations including driving the one or more electrodes to deliver a first set of stimulation sessions having a first duty cycle, and subsequently driving the one or more electrodes to deliver a second set of stimulation sessions having a second duty cycle that is less frequent than the first duty cycle.

Core Innovation

The disclosed method operates a medical device implanted proximate a medial malleolus to electrically stimulate a tibial nerve for treating urinary incontinence, including an overactive bladder condition. The medical device drives electrodes according to stored instructions to deliver a first set of stimulation sessions at a first treatment frequency. After determining that a first period of time has elapsed, the device automatically transitions to a second set of stimulation sessions at a less frequent treatment frequency.

The therapy schedule accelerates symptom relief while conserving battery life through low-duty-cycle operation intended to support long implant life. The associated system configurations include miniature implanted devices, electrode assemblies, stimulation circuitry, processors, batteries, telemetry, and programmers with therapy-control states depicting treatment phases and completion decisions. A feasibility study demonstrates improvement in overactive bladder symptoms following implantable neurostimulation therapy.

Claims Coverage

The claims identify one independent claim comprising three inventive features directed to implanted tibial nerve stimulation, initial stimulation sessions, and an automatic frequency switch.

Implanted tibial nerve stimulation

A medical device implanted proximate a medial malleolus drives electrodes to electrically stimulate a tibial nerve for treating an overactive bladder condition.

Initial stimulation sessions

Instructions stored in the medical device memory initiate electrodes to deliver a first set of stimulation sessions at a first treatment frequency for a first period of time.

Automatic frequency switch

The medical device determines that the first period of time has elapsed and automatically switches based on stored instructions from the first treatment frequency to a second set of stimulation sessions at a less frequent treatment frequency.

The independent claim covers an implanted medical device configured to stimulate the tibial nerve for an overactive bladder condition and automatically transition from an initial treatment frequency to a less frequent treatment frequency after a defined time period.

Stated Advantages

The automatic jump-start schedule is intended to accelerate symptom relief while conserving battery life.

Low-duty-cycle operation is intended to support at least five years of implant life.

A feasibility study reported improvement in overactive bladder symptoms after implantable therapy.

Documented Applications

Treatment of urinary incontinence, including an overactive bladder condition, using implantable electrical stimulation of the tibial nerve proximal to the medial malleolus.

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