# US 12,214,203 B2 · Detection and treatment of neotissue

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- Number: US 12,214,203 B2
- Document ID: US12214203B2
- Status: Granted
- Kind: B2
- Application number: 17/636,665
- Filed: 2020-09-22
- Published: 2022-09-01
- Granted: 2025-02-04
- Earliest claimed: 2019-09-23
- Assignees: Cochlear Limited
- Applicants: Cochlear Limited
- Inventors: Filiep Vanpoucke; Floris Heutink; Berit Verbist
- Web page: https://patentgrep.com/patent/US12214203B2

## CPC

- A61N 1/0464: {Specially adapted for promoting tissue growth}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/0541: {Cochlear electrodes}
- A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)}
- A61N 1/3614: {based on impedance measurement}
- A61N 1/375: Constructional arrangements, e.g. casings
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/37: Monitoring; Protecting
- A61N 1/3925: {Monitoring; Protecting}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Disclosed examples include technology for the detection and treatment of neotissue formation proximate an implantable stimulator. Neotissue formation can include ossification, scar tissue, soft tissue fibrosis, and other tissue growth. The neotissue formation can be detected by analyzing (e.g., using a machine-learning framework) stimulation data relating to the implantable stimulator. Neotissue formation characteristics can be analyzed to determine appropriate treatment actions for ameliorating the effects of neotissue formation.

## Claims

### Claim 1

A system, comprising:
a stimulator assembly having one or more electrodes;
a biocompatible housing connected to the stimulator assembly;
a stimulation source disposed in the biocompatible housing and configured to deliver electrical stimulation to target tissue of a recipient via the one or more electrodes; and
one or more processors configured to:
generate a current flow path using the one or more electrodes for stimulating tissue;
measure one or more transimpedance matrices for the one or more electrodes based on the current flow path;
determine neotissue formation characteristics relating to tissue growth proximate the one or more electrodes based on the one or more transimpedance matrices;
determine a treatment modification instruction to modify stimulation parameters to account for the tissue growth; and
apply the treatment modification instruction to modify ongoing stimulation provided by the apparatus.

### Claim 2 (depends on 1)

The system of claim 1, wherein to apply the treatment modification instruction to modify ongoing treatment provided by the apparatus includes to:
modify a threshold stimulation level provided by the stimulation source; and
modify a maximum stimulation level provided by the stimulation source.

### Claim 3 (depends on 1)

The system of claim 1, wherein to apply the treatment modification instruction to modify ongoing treatment provided by the apparatus includes to:
disable at least one of the one or more electrodes.

### Claim 4 (depends on 1)

The system of claim 1, wherein the one or more transimpedance matrices are based on a polarity of current flow, a phase width timing, or a stimulus intensity.

### Claim 5 (depends on 1)

The system of claim 1, wherein to measure the one or more transimpedance matrices includes to:
measure a transimpedance matrix at multiple times during a stimulation pulse or to measure a transimpedance matrix longitudinally.

### Claim 6 (depends on 1)

The system of claim 1, wherein to measure one or more characteristics relating to the current flow path to generate stimulation data includes measuring at least one of voltage profile data, evoked compound action potential data, electrical field imaging data, or electrical sounding data.

### Claim 7

A method comprising:
determining a transimpedance matrix for a plurality of electrodes of an implanted stimulator;
detecting neotissue formation characteristics proximate at least one of the plurality of electrodes based on the transimpedance matrix; and
performing a treatment action based on the neotissue formation characteristics.

### Claim 8 (depends on 7)

The method of claim 7, wherein determining the transimpedance matrix includes:
causing a current flow path to be generated from an active electrode of the plurality of electrodes of the implanted stimulator through tissue of a recipient of the implanted stimulator, wherein the tissue includes neotissue growth proximate the active electrode that occurred since implantation of the implanted stimulator.

### Claim 9 (depends on 8)

The method of claim 8, wherein causing the current flow path to be generated includes:
forming the current flow path from the active electrode to a return electrode of the implanted stimulator.

### Claim 10 (depends on 7)

The method of claim 7, wherein performing the treatment action includes:
administering a therapeutically-effective amount of an anti-inflammatory drug to a recipient of the implanted stimulator to reduce neotissue growth or resist formation of unwanted tissue growth proximate the plurality of electrodes.

### Claim 11 (depends on 7)

The method of claim 7, wherein detecting neotissue formation characteristics includes:
determining a metric estimating an extent of tissue growth proximate one or more electrodes of the implanted stimulator.

### Claim 12 (depends on 7)

The method of claim 7, wherein performing the treatment action includes:
modifying maximum or minimum stimulation thresholds for one or more electrodes of the implanted stimulator.

### Claim 13 (depends on 7)

The method of claim 7, wherein the detecting neotissue formation characteristics is further based on at least one of measured electrically-evoked compound action potential data, measured voltage profile data, measured evoked compound action potential data, measured electrical field imaging data, or measured electrical sounding data.

### Claim 14

A system comprising: one or more processors; and a non-transitory computer-readable memory comprising instructions that, when executed, cause the one or more processors to: obtain a transimpedance matrix for a plurality of electrodes of an implanted stimulator; determine neotissue formation characteristics relating to tissue growth proximate one or more electrodes of the implanted stimulator based on the transimpedance matrix, determine a treatment modification to modify stimulation parameters of the implanted stimulator to account for the tissue growth, and apply the treatment modification to the implanted stimulator to modify ongoing stimulation provided by the implanted stimulator.

### Claim 15 (depends on 14)

The system of claim 14, wherein to determine the neotissue formation characteristics includes to: extract, from stimulation data of the implanted stimulator, indications of a local voltage field around an electrode associated with a current flow path, wherein determining the neotissue formation characteristics includes processing the indications.

### Claim 16 (depends on 14)

The system of claim 14, wherein to determine the neotissue formation characteristics includes to: determine whether stimulation data regarding the implanted stimulator satisfies one or more thresholds.

### Claim 17 (depends on 14)

The system of claim 14, wherein to determine the neotissue formation characteristics includes to: provide stimulation data regarding the implanted stimulator as input parameters into a decision tree procedure or a trained machine learning procedure.

### Claim 18 (depends on 14)

The system of claim 14, wherein the instructions further cause the one or more processors to: obtain medical imaging data associated with the implanted stimulator, wherein the neotissue formation characteristics are further generated based on the medical imaging data.

### Claim 19 (depends on 14)

The system of claim 14, wherein determining neotissue formation characteristics includes providing stimulation data as input to a machine-learning framework and obtaining output from the machine-learning framework.
