# US 11,027,129 B2 · Patient-customized electrode arrays based on patient-specific cochlear information, and designing/selecting methods and applications of same

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- Number: US 11,027,129 B2
- Document ID: US11027129B2
- Status: Granted
- Kind: B2
- Application number: 16/607,507
- Filed: 2018-04-24
- Published: 2020-05-07
- Granted: 2021-06-08
- Earliest claimed: 2017-04-24
- Assignees: Vanderbilt University
- Applicants: Vanderbilt University
- Inventors: Jack H. Noble; Robert F. Labadie; Benoit M. Dawant
- Web page: https://patentgrep.com/patent/US11027129B2

## CPC

- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/36039: {fitting procedures}
- A61B 5/1072: {measuring distances on the body, e.g. measuring length, height or thickness (A61B5/1076 takes precedence)}
- A61B 5/1076: {for measuring dimensions inside body cavities, e.g. using catheters (A61B3/1005 takes precedence)}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 6/03: Computed tomography [CT]
- A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61N 1/0541: {Cochlear electrodes}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- G06T 7/12: Edge-based segmentation
- G06T 7/181: involving edge growing; involving edge linking
- G06T 12/10: Image preprocessing, e.g. calibration, positioning of sources or scatter correction
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2505/05: Surgical care
- A61B 2562/043: in a linear array
- G06T 2207/30008: Bone
- G06T 2211/424: Iterative
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A method for designing a patient-customized EA or selecting an existing EA that fits the patient best includes segmenting shapes of SOIs of the cochlea in a pre-operative CT image using a shape model; defining a 3D curve of interest within the shape model of the SOIs as a sequence of points-; automatically transforming the defined 3D curve to the pre-operative CT image so as to obtain a structure curve in the cochlea; determining a length and curvatures of the structure curve at the sequence of points; and designing a patient-customized EA or selecting an existing EA based on the determined length and curvatures of the structure curve such that after the EA shape model, which estimates the resting state shape of the EA, is rigidly registered to the structure curve in the cochlea, the EA shape model has a registration error smaller than a preset value.

## Claims

### Claim 1

A method for designing a patient-customized electrode array (EA) or selecting an existing EA that fits the patient best, comprising:
segmenting shapes of structures of interest (SOIs) of a cochlea of the patient in a pre-operative computed tomography (CT) image of the cochlea using a shape model, wherein the EA is to be placed in the cochlea;
defining a three dimensional (3D) curve of interest within the shape model of the SOIs as a sequence of points, {P,}, wherein i=1, 2, 3, . . . N, N is an integer greater than zero;
automatically transforming the defined 3D curve to the pre-operative CT image so as to obtain a structure curve in the cochlea;
determining a length and curvatures of the structure curve at the sequence of points {Pi}; and
designing a patient-customized EA or selecting an existing EA based on the determined length and curvatures of the structure curve such that after the EA shape model, which estimates the resting state shape of the EA, is rigidly registered to the structure curve in the cochlea, the EA shape model has a registration error smaller than a preset value;
wherein the structure curve is a lateral wall curve in the cochlea, and the EA is a straight EA; and
wherein the straight EA has a length determined such that when placed along the lateral wall curve, an angular insertion depth of the distal electrode reaches about 500 degrees, while a proximal electrode falls safely within the cochlea being greater than 30 degrees.

### Claim 2 (depends on 1)

The method of claim 1, wherein the EA comprises a plurality of electrodes, {Ei}, wherein the i-th electrode Ei is to be placed in a location corresponding to the i-th point Pi of the structure curve in the cochlea, wherein i=1, 2, 3, . . . N, N is an integer greater than zero.

### Claim 3 (depends on 2)

The method of claim 2, wherein the curvature of the EA at the i-th electrode E, is characterized with a curvature Ri that matches the curvature of the i-th point Pi of the structure curve in the cochlea.

### Claim 4 (depends on 2)

The method of claim 2, wherein the i-th electrode Ei is a flat electrode, or a curved electrode that is characterized with a curvature that matches the curvature of the i-th point P, of the structure curve in the cochlea.

### Claim 5 (depends on 1)

The method of claim 1, wherein the structure curve is a modiolar curve in the cochlea, and wherein the EA is a pre-curved EA.

### Claim 6 (depends on 1)

The method of claim 1, wherein the SOIs are temporal bone anatomy.

### Claim 7 (depends on 6)

The method of claim 6, wherein the SOIs are intra-cochlear structures.

### Claim 8 (depends on 1)

The method of claim 1, wherein the shape model is a non-rigid statistical shape model created with μCT images of a plurality of cochlea specimens in which intra-cochlear structures are visible.

### Claim 9 (depends on 1)

The method of claim 1, wherein the defined 3D structure curve is automatically transformed to the pre-operative CT image using a thin plate spline registration.

### Claim 10 (depends on 1)

The method of claim 1, wherein the EA shape model is rigidly registered to the structure curve in the cochlea using an iterative closest point registration, thereby placing the resting state shape of the EA within the SOIs in the cochlea such that the EA matches the structure curve in the cochlea.

### Claim 11 (depends on 1)

The method of claim 1, further comprising determining a patient-customized insertion plan for electrode insertion using the registered EA shape model, wherein the patient-customized insertion plan comprises at least a recommended depth.

### Claim 12 (depends on 11)

The method of claim 11, wherein when inserted, the base depth of electrode insertion of the EA matches the recommended depth.

### Claim 13 (depends on 1)

The method of claim 1, wherein the segmenting step comprises automatically fitting the shape model to an external boundary of the cochlea that is visible in the pre-operative CT, thereby allowing highly accurate estimation of positions and shapes of intra-cochlear structures of the cochlea that are not visible in the pre-operative CT.

### Claim 14

A non-transitory computer-readable medium storing instructions which, when executed by a processor, cause a computer or system to perform a method for designing a patient-customized electrode array (EA) or selecting an existing EA that fits the patient best, the method comprising:
segmenting shapes of structures of interest (SOIs) of a cochlea of the patient in a pre-operative computed tomography (CT) image of the cochlea using a shape model, wherein the EA is to be placed in the cochlea;
defining a three dimensional (3D) curve of interest within the shape model of the SOIs as a sequence of points, {Pi}, wherein i=1, 2, 3, . . . N, N is an integer greater than zero;
automatically transforming the defined 3D structure curve to the pre-operative CT image so as to obtain a structure curve in the cochlea;
determining a length and curvatures of the structure curve at the sequence of points {Pi}; and
designing a patient-customized EA or selecting an existing EA based on the determined length and curvatures of the structure curve such that after the EA shape model, which estimates the resting state shape of the EA, is rigidly registered to the structure curve in the cochlea, the EA shape model has a registration error smaller than a preset value;
wherein the structure curve is a lateral wall curve in the cochlea, wherein the EA is a straight EA; and
wherein the straight EA has a length determined such that when placed along the lateral wall curve, an angular insertion depth of the distal electrode reaches about 500 degrees, while a proximal electrode falls safely within the cochlea being greater than 30 degrees.

### Claim 15 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the EA comprises a plurality of electrodes, {Ei}, wherein the i-th electrode Ei is to be placed in a location corresponding to the i-th point P, of the structure curve in the cochlea, wherein i=1, 2, 3, . . . N, N is an integer greater than zero.

### Claim 16 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the curvature of the EA at the i-th electrode Ei is characterized with a curvature Ri that matches the curvature of the i-th point Pi of the structure curve in the cochlea.

### Claim 17 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the i-th electrode Ei is a flat electrode, or a curved electrode that is characterized with a curvature that matches the curvature of the i-th point Pi of the structure curve in the cochlea.

### Claim 18 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the structure curve is a modiolar curve in the cochlea, and wherein the EA is a pre-curved EA.

### Claim 19 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the SOIs are a temporal bone anatomy or a lateral wall in the cochlea.

### Claim 20 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the shape model is created with μCT images of a plurality of cochlea specimens in which intra-cochlear structures are visible.

### Claim 21 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the defined 3D structure curve is automatically transformed to the pre-operative CT image using a thin plate spline registration.

### Claim 22 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the EA shape model is rigidly registered to the structure curve in the cochlea using an iterative closest point registration, thereby placing the resting state shape of the EA within the SOI in the cochlea such that the EA matches the structure curve in the cochlea.

### Claim 23 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the method further comprises determining a patient-customized insertion plan for electrode insertion using the registered EA shape model, wherein the patient-customized insertion plan comprises at least a recommended depth.

### Claim 24 (depends on 23)

The non-transitory computer-readable medium of claim 23, wherein when inserted, the base depth of electrode insertion of the EA matches the recommended depth.

### Claim 25 (depends on 14)

The non-transitory computer-readable medium of claim 14, wherein the segmenting step comprises automatically fitting the shape model to an external boundary of the cochlea that is visible in the pre-operative CT, thereby allowing highly accurate estimation of positions and shapes of intra-cochlear structures of the cochlea that are not visible in the pre-operative CT.