Implantable middle ear transducer having diagnostic detection sensor

Inventors

Glumac, Daniel E.

Assignees

Envoy Medical Inc

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Publication Number

US-9525949-B1

Patent

Publication Date

2016-12-20

Expiration Date


Abstract

Methods and devices for measuring vibration of an implanted driven vibrating elongate body coupled to a bone of the middle ear, for example using an accelerometer coupled to the vibrating body. The measured vibration can be taken during implantation and long again after implantation to check for possible decoupling, disease, or additionally impeded vibratory driving of the middle ear bone. An accelerometer signal can be converted to a displacement value and used to check for an under impeded or over impeded vibratory body. An implanted device can be used to periodically check the vibration of the vibratory body. Methods and devices can be used in conjunction with implanted devices which receive vibratory signals from a middle ear bone and use the signals to drive a disarticulated middle ear bone closer to the ear drum.

Core Innovation

Implantable middle-ear transducer systems are disclosed in which a vibrational device coupled to a middle ear bone drives vibration of the middle ear bone while an accelerometer is coupled to the middle ear bone for sensing. A signal indicative of acceleration from the accelerometer is measured at a first time after the coupling, with the sensed signal used for determining proper coupling of the accelerometer to the middle ear bone.

In embodiments, the coupling of the accelerometer and the first time signal measuring are performed during a surgery, and a second measuring of the acceleration-indicative signal is performed at a second time after the coupling. The second measuring time is at least one month after the coupling, and the first time and second time measuring signals are compared.

The measured acceleration-indicative signals are used to detect decoupling and/or impeded vibration and to assess vibratory driving characterized by under-imped or over-imped vibratory driving. The document also describes coupling and sensing via electrical or optical signal communication to an implanted electronic device, including embodiments with varying accelerometer placement and with self-powered accelerometers.

Claims Coverage

Two independent method claims are identified. Each claim centers on coupling an accelerometer to a middle ear bone and measuring an acceleration-indicative signal, with timing and comparative determinations distinguishing the claims.

Accelerometer coupling and proper coupling determination

Coupling an accelerometer and the vibrational device to the middle ear bone, driving the vibrational device to vibrate the middle ear bone, measuring a signal indicative of the acceleration from the accelerometer at a first time after the coupling, and determining proper coupling of the accelerometer to the middle ear bone using the first time signal measuring.

In-surgery measurement with later comparison

Coupling an accelerometer and the vibrational device to the middle ear bone, driving the vibrational device to vibrate the middle ear bone, measuring a signal indicative of the acceleration from the accelerometer at a first time after the coupling with the coupling performed during a surgery and the first time signal measuring performed during the surgery, performing a second measuring of the acceleration-indicative signal at a second time at least one month after the coupling, and comparing the first time and second time measuring signals.

Across the independent claims, the core inventive coverage lies in using an accelerometer to sense vibrational driving of a middle ear bone, determining proper coupling based on an initial post-coupling measurement, and, when measurement occurs during surgery, performing a later repeat measurement and comparing signals over time.

Stated Advantages

Enables determining proper coupling of the accelerometer to the middle ear bone using the first time signal measuring.

Enables assessing vibrational driving over time by comparing first time and second time measuring signals, including a second measurement at least one month after coupling.

Allows interpretation of vibrational driving as indicating that the vibrational device is uncoupled from the middle ear bone.

Allows interpretation of vibrational driving as indicating excessively impeded vibration of the middle ear bone.

Documented Applications

Sensing vibrational driving of a middle ear bone by a vibrational device coupled to the middle ear bone, including assessment of decoupling and/or impeded vibration due to scar tissue, fluid, disease, or unwanted growths.

Intraoperative assessment of accelerometer coupling and subsequent follow-up sensing of acceleration at least one month after coupling for comparison of signals.

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