Implantable middle ear diagnostic transducer

Inventors

Glumac, Daniel E.Schiller, Peter J.

Assignees

Envoy Medical Inc

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Publication Number

US-10743812-B1

Patent

Publication Date

2020-08-18

Expiration Date


Abstract

Methods, devices, and systems for measuring vibration of an implanted elongate vibrating body coupled to a bone of the middle ear. One system includes an elongate vibratory body having a first and second piezoelectric body separated by a central vane. The piezoelectric bodies and central vane can be individually electrically coupleable to an implantable electronic device. The electronic device can have a switch, driving circuitry and sensing circuitry within. In normal use, the driving circuitry is coupled through the switch to drive both piezoelectric bodies causing the vibratory body to vibrate. In diagnostic use, one piezoelectric body is driven while the other piezoelectric body is sensed to detect changes in vibration indicative of decoupling or undesirable impedance of the vibratory body.

Core Innovation

An implantable middle-ear diagnostic transducer includes an elongate vibrating body comprising a bimorph with a first piezoelectric body and a second piezoelectric body separated by a central conductive vane. The first and second piezoelectric bodies are individually electrically connectable so that implantable electronics electrically drive the elongate vibrating body by forcing vibration from an electrical excitation source at a desired frequency. In normal operation, the implantable electronics drive both piezoelectric bodies in parallel via a switch.

In a diagnostic mode, the implantable electronics drive only one piezoelectric body and measure electrical potential or charge from the other piezoelectric body using an electrical sensing circuit. The measured electrical potential or charge changes are used to detect changes in vibration of the implanted elongate vibrator body over time. The diagnostic sensing detects decoupling from the middle ear bone and/or increased vibrational impedance or impediment.

The diagnostic approach compares sensed measurements taken over time to determine abnormal vibration behavior, including increased or decreased vibrational amplitude and abnormal spikes in amplitude. The document explains detection concepts such as determining whether vibration changes are associated with decoupling or additional impediment, including amplitude behavior relative to a normal roll-off frequency. This permits periodic switching between normal driving and diagnostic sensing to monitor for conditions such as scar tissue, fluid buildup, or unwanted growths.

Claims Coverage

The claim coverage identifies one independent claim directed to a diagnostic measurement technique with an elongate bimorph where only one piezoelectric body is driven while the other is sensed, yielding a first measurement based on electrical potential during vibration. The provided dependent claims refine the method using comparison to a previously obtained measurement and by specifying criteria such as increased amplitude and spikes above a normal roll-off frequency, and by requiring that the first measurement is obtained using an implanted device.

Drive only first piezoelectric body and sense second piezoelectric potential

Electrically drive the first piezoelectric body using the electrical excitation source without driving the second piezoelectric body to cause vibration of the elongate vibrator body; and measure electrical potential from the second piezoelectric body during the elongate vibrator body vibration to obtain a first measurement using the electrical sensing circuit.

Determine decoupling via longitudinal comparison to a previously obtained measurement

Compare a first measurement with a previously obtained second measurement and use the comparison to determine whether the elongate vibrator body has become decoupled from the middle ear bone.

Detect decoupling by detecting increased vibrational amplitude

Determine whether an elongate vibrator body has become decoupled by detecting an increased vibrational amplitude from a second measurement compared to a first measurement.

Detect decoupling via an amplitude spike above a normal roll-off frequency

Determine that an elongate vibrator body has become decoupled by detecting a spike in amplitude above a normal roll-off frequency, where the spike is added after the second measurement.

Determine additional impediment via comparison to a prior baseline measurement

Compare a first measurement to a second measurement previously obtained prior to the first measurement, and use the comparison to determine whether the elongate vibrator body vibration has become additionally impeded since the second measurement was taken.

Obtain the measurement using an implanted device

Perform the method such that the first measurement is obtained using an implanted device coupled to the elongate vibrator body.

Overall, the claim coverage focuses on a diagnostic vibration measurement method for an implanted elongate vibrator body coupled to a middle ear bone, using selective driving of one piezoelectric body while measuring electrical potential from the other, and optionally determining decoupling or additional impediment through longitudinal comparisons using amplitude changes, including spikes above a normal roll-off frequency, with the first measurement obtained by an implanted device.

Stated Advantages

Enables diagnostic detection of decoupling from the middle ear bone.

Enables diagnostic detection of increased vibrational impedance or impediment over time.

Provides a diagnostic sensing approach based on electrical potential/charge measurement from an undriven piezoelectric body during vibration.

Documented Applications

Monitoring an implanted middle-ear vibrator body over time to detect decoupling and/or additional impediment due to conditions such as scar tissue, fluid buildup, or unwanted growths.

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