Systems and methods for estimating skin flap thickness

Abstract

A method includes receiving information about an individual at a computing system from a user of the computing system and generating an estimation of a thickness of a skin flap of the individual based on the information about the individual using an estimator tool in the computing system. The method can also include providing the estimation of the thickness of the skin flap to the user using a user interface generated by the computing system.

Description

Systems And Methods For Estimating Skin Flap ThicknessCROSS REFERENCE TO RELATED APPLICATION

[0001] This patent application claims priority to U.S. provisional patent application 63 / 539,890, filed September 22, 2023, which is incorporated by reference herein in its entirety.TECHN ICAL FIELD

[0002] The present disclosure relates to systems and methods for estimating skin flap thickness.BACKGROUN D

[0003] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0004] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as "implantable medical devices," now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.BRI EF SU MMARY

[0005] According to an embodiment, a method comprises receiving information about an individual at a computing system from a user of the computing system, and generating an estimation of a thickness of a skin flap of the individual based on the information about the individual using an estimator tool in the computing system.

[0006] According to another embodiment, a non-transitory computer readable storage medium comprising computer readable instructions stored thereon, when executed by a computing system, cause the computing system to generate an estimate of a thickness of a skin flap of a recipient, and generate a prediction of at least one magnetic field strength or magnet configuration for retaining a component of an implant system on the recipient based on the estimate of the thickness of the skin flap of the recipient.

[0007] According to yet another embodiment, a computing system comprises at least one processor configured to generate an estimate of a depth of soft tissue of a recipient and to generate a prediction of an eligibility of the recipient for an external component of a medical system to be placed over the soft tissue of the recipient based on the estimate of the depth of the soft tissue of the recipient.

[0008] According to still another embodiment, a computing system comprises a processing unit for generating an estimate of a thickness of external soft tissue of an individual based on a body mass index of the individual; and a user interface for outputting the estimate of the thickness of the external soft tissue of the recipient.BRI EF DESCRI PTION OF DRAWI NGS

[0009] Figure 1A depicts a schematic diagram of an exemplary cochlear implant system that can be configured to be used with aspects of the techniques presented herein, according to some exemplary embodiments.

[0010] Figure IB depicts a functional block diagram of the cochlear implant system of Figure 1A.

[0011] Figure 1C is a diagram illustrating an example of an auditory prosthesis that can include one or more embodiments disclosed herein.

[0012] Figure ID is a functional block diagram of an exemplary totally implantable cochlear implant system.

[0013] Figure 2 is a diagram that illustrates an example of a computing device that includes an estimator tool operable to function according to any of the embodiments disclosed herein.

[0014] Figure 3 is a flow chart that illustrates examples of operations that can be performed by a computing system for generating an estimation of skin flap thickness of an individual.

[0015] Figure 4 is a diagram that illustrates an example of a computing system within which one or more of the disclosed embodiments can be implemented.DETAILED DESCRIPTION

[0016] Merely for ease of description, the techniques presented herein are primarily described herein with reference to an illustrative medical device, namely a cochlear implant system. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from the teachings herein used in other medical devices. For example, any techniques presented herein described for one type of hearing prosthesis, such as a cochlear implant system, corresponds to a disclosure of another embodiment of using such teaching with another hearing prostheses, including bone conduction devices (percutaneous, active transcutaneous and / or passive transcutaneous), middle ear auditory prostheses, direct acoustic stimulators, and also utilizing such with other electrically simulating auditory prostheses (e.g., auditory brain stimulators), etc. The techniques presented herein may also be used with vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation, etc.

[0017] The teachings detailed herein can be implemented in or with sensory prostheses, such as hearing implants. Other types of sensory prostheses can include retinal implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings in / with a hearing implant and in / with a retinal implant, unless otherwise specified, providing the art enables such. Moreover, with respect to any teachings herein, such corresponds to a disclosure of utilizing those teachings with a cochlear implant, a bone conduction device (active and passive transcutaneous bone conduction devices, and percutaneous bone conduction devices) and a middle ear implant, providing that the art enables such, unless otherwise noted. To be clear, any teachingherein with respect to a specific sensory prosthesis corresponds to a disclosure of utilizing those teachings in / with any of the aforementioned hearing prostheses, and visa-versa. Corollary to this is at least some teachings detailed herein can be implemented in somatosensory implants and / or chemosensory implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings with / in a somatosensory implant and / or a chemosensory implant.

[0018] While the teachings detailed herein will be described for the most part with respect to hearing prostheses, in keeping with the above, it is noted that any disclosure herein with respect to a hearing or auditory prosthesis corresponds to a disclosure of another embodiment of utilizing the associated teachings with respect to any of the other prostheses noted herein, whether a species of a hearing prosthesis, or a species of a sensory prosthesis, such as a retinal prosthesis. In this regard, any disclosure herein with respect to evoking a hearing percept corresponds to a disclosure of evoking other types of neural percepts in other embodiments, such as a visual / sight percept, a tactile percept, a smell precept or a taste percept, unless otherwise indicated and / or unless the art does not enable such. Any disclosure herein of a device, system and / or method that is used to, or results in, ultimate stimulation of the auditory nerve corresponds to a disclosure of an analogous stimulation of the optic nerve utilizing analogous components, methods, and systems.

[0019] Figure (FIG.) 1A is a schematic diagram of an exemplary conventional cochlear implant system 100 configured to be used with aspects of the techniques presented herein. FIG. IB is a block diagram of the conventional cochlear implant system 100 of FIG. 1A. For ease of illustration, FIGS. 1A and IB will be described together. The cochlear implant system 100 comprises an external component 102 and an internal / implantable component 104. The external component 102 is directly or indirectly attached to the body of the recipient and typically comprises an external coil 106 and, generally, a magnet (not shown in FIGS. 1A- 1B) fixed relative to the external coil 106. The external component 102 also comprises one or more input elements / devices 113 for receiving input signals at a sound processing unit 112. In this example, the one or more input devices 113 include sound input devices 108 (e.g., microphones positioned by auricle 110 of the recipient, telecoils, etc.) configured to capture / receive input signals, one or more auxiliary input devices 109 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a wireless transmitter / receiver (transceiver) 111, each located in, on, or near the sound processing unit 112.

[0020] The sound processing unit 112 also includes, for example, at least one power source 107, a radio-frequency (RF) transceiver 121, and a processing module 125. The processing module 125 comprises a number of elements, including an environmental classifier 131, a sound processor 133, and an individualized own voice detector 134. Each of the environmental classifier 131, the sound processor 133, and the individualized own voice detector 134 can be formed by one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more processing cores, etc.), firmware, software, etc. arranged to perform operations described herein. That is, the environmental classifier 131, the sound processor 133, and the individualized own voice detector 134 can each be implemented as firmware elements, partially or fully implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially or fully in software, etc.

[0021] In the examples of FIGS. 1A and IB, the sound processing unit 112 is a behind-the- ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient's ear. However, it is to be appreciated that sound processing unit 112 can have other arrangements, such as an off the ear (OTE) processing unit (e.g., a component having a generally cylindrical shape and which is configured to be magnetically coupled to the recipient's head), etc., a mini or micro-BTE unit, an in-the-canal unit that is configured to be located in the recipient's ear canal, a body-worn sound processing unit, etc.

[0022] In the exemplary embodiment of FIGS. 1A and IB, the implantable component 104 comprises an implant body (main module) 114, a lead region 116, and an intra-cochlear stimulating assembly 118, all configured to be implanted under the skin / tissue (tissue) 105 of the recipient. The implant body (main module) 114 includes a hermetically-sealed housing 115 and an implantable coil 122. The housing 115 houses RF interface circuitry 124 and a stimulator unit 120. The implantable coil 122 is generally external to the housing 115, but which is connected to the RF interface circuitry 124 via a hermetic feedthrough (not shown in FIG. IB).

[0023] Stimulating assembly 118 is configured to be at least partially implanted in the recipient's cochlea 137. Stimulating assembly 118 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 126 that collectively form a contact or electrode array 128 for delivery of electrical stimulation (current) to the recipient's cochlea 137. The electrode array 128 includes all of the electrodes 126 in the stimulating assembly 118. Stimulating assembly 118 extends through an opening in the recipient's cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to stimulator unit 120 via lead region 116 and a hermetic feedthrough (notshown in FIG. IB). Lead region 116 includes a plurality of conductors (wires) that electrically couple the electrodes 126 to the stimulator unit 120.

[0024] As noted, the cochlear implant system 100 includes the external coil 106 and the implantable coil 122. The coils 106 and 122 are typically wire antenna coils each comprised of multiple turns of electrically insulated single-strand or multi-strand wire. Generally, a magnet is fixed in position relative to each of the external coil 106 and the implantable coil 122, but the magnet may rotate or change orientation. In some embodiments, the external component 102 and / or the implantable component 104 can include magnet assemblies that each have more than one magnet component. The magnets fixed relative to the external coil 106 and the implantable coil 122 facilitate the operational alignment of the external coil with the implantable coil. This operational alignment of the coils 106 and 122 enables the external component 102 to transmit data, as well as possibly power, to the implantable component 104 via a closely-coupled wireless link formed between the external coil 106 and the implantable coil 122. In certain examples, the closely-coupled wireless link is a radio frequency (RF) link. However, various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, can be used to transfer the power and / or data from an external component to an implantable component and, as such, FIG. IB illustrates only one exemplary arrangement.

[0025] As noted above, sound processing unit 112 includes the processing module 125. The processing module 125 is configured to convert input audio signals into stimulation control signals 136 for use in stimulating a first ear of a recipient (i.e., the processing module 125 is configured to perform sound processing on input audio signals received at the sound processing unit 112). Stated differently, the sound processor 133 (e.g., one or more processing elements implementing firmware, software, etc.) is configured to convert the captured input audio signals into stimulation control signals 136 that represent electrical stimulation for delivery to the recipient. The input audio signals that are processed and converted into stimulation control signals can be audio signals received via the sound input devices 108, signals received via the auxiliary input devices 109, and / or signals received via the wireless transceiver 111.

[0026] In the embodiment of FIG. IB, the stimulation control signals 136 are provided to the RF transceiver 121, which transcutaneously transfers the stimulation control signals 136 (e.g., in an encoded manner) to the implantable component 104 via external coil 106 and implantable coil 122. That is, the stimulation control signals 136 are received at the RF interface circuitry 124 via implantable coil 122 and provided to the stimulator unit 120 (e.g.,as an N number of signals). The stimulator unit 120 is configured to utilize the stimulation control signals 136 to generate electrical stimulation signals (e.g., current signals) for delivery to the recipient's cochlea via lead region 116 and one or more stimulating contacts 126. In this way, cochlear implant system 100 electrically stimulates the recipient's auditory nerve cells, bypassing absent or defective hair cells that normally transduce acoustic vibrations into neural activity, in a manner that causes the recipient to perceive one or more components of the input audio signals.

[0027] Figure (FIG.) 1C is a diagram illustrating an example of an auditory prosthesis 150 that can include one or more embodiments disclosed herein. The auditory prosthesis 150 of FIG. 1C is an example of a cochlear implant. As more specific examples, auditory prothesis 150 can be a mostly implantable cochlear implant (MICI) or a totally implantable cochlear implant (TICI).

[0028] Auditory prothesis 150 includes an internal / implantable component 154. In some embodiments, auditory prothesis 150 can also have an external component (not shown) that is positioned by an auricle 159 of the recipient and that is configured to be attached to, and worn adjacent to, the recipient's ear. However, the external component can have other arrangements, such as an off the ear (OTE) processing unit (e.g., a component configured to be magnetically coupled to the recipient's head), an in-the-canal unit that is configured to be located in the recipient's ear canal 156, etc.

[0029] The implantable component 154 comprises an implant body 160, a lead region 116, and an elongated intra-cochlear stimulating assembly 118, all configured to be implanted under the skin / tissue 155 of the recipient. The implant body 160 comprises a hermetically sealed housing that houses various components. The housing of implant body 160 operates as a protective barrier between the components within the housing of implant body 160 and the recipient's tissue and bodily fluid.

[0030] Stimulating assembly 118 is configured to be at least partially implanted in the recipient's cochlea 162. Stimulating assembly 118 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 126 that collectively form a contact or electrode array 128 for delivery of electrical stimulation (current) to the recipient's cochlea 162. Stimulating assembly 118 extends through an opening in the recipient's cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to a stimulator unit in implant body 160 via lead region 116 and a hermetic feedthrough (not shown in FIG. 1C). Lead region 116 includes a plurality of conductors (wires) that electrically couple the stimulating contacts 126 to the stimulator unit.

[0031] FIG. ID is a functional block diagram of an exemplary totally implantable cochlear implant system 170. Because the cochlear implant system 170 is totally implantable, all components of cochlear implant system 170 are configured to be implanted under skin / tissue 175 of a recipient. Because all components are implantable, cochlear implant system 170 operates, for at least a finite period of time, in an "invisible hearing" mode without the need of an external device. An external device 172 can be used to, for example, charge an internal power source (battery) 177. External device 172 can be a dedicated charger or a conventional cochlear implant sound processor. External device 172 can include an off-the-ear (OTE) sound processor.

[0032] Cochlear implant system 170 includes an implant body (main implantable component) 174, one or more input elements for capturing / receiving input audio signals (e.g., using one or more implantable microphones 178 and a wireless transceiver 181), an implantable coil 182, and an elongated intra-cochlear stimulating assembly 118 as described above. The microphone 178 and / or the implantable coil 182 can be positioned in, or electrically connected to, the implant body 174. The implant body 174 further comprises the battery 177, RF (radio frequency) interface circuitry 184, a processing module 185, and a stimulator unit 180. The processing module 185 can be similar to processing modules described previously, and includes environmental classifier 191, sound processor 193, and individualized own voice detector 195.

[0033] In the embodiment of FIG. ID, the one or more implantable microphones 178 are configured to receive input audio signals. The processing module 185 is configured to convert received input audio signals into stimulation control signals 196 for use in stimulating a first ear of a recipient. Stated differently, sound processor 193 is configured to convert the input audio signals into stimulation control signals 196 that represent electrical stimulation for delivery to the recipient.

[0034] In the embodiment of FIG. ID, the processing module 185 is implanted in the recipient. As such, in the embodiment of FIG. ID, the stimulation control signals 196 do not traverse an RF link, but instead are provided directly to the stimulator unit 180. The stimulator unit 180 is configured to utilize the stimulation control signals 196 to generate electrical stimulation signals that are delivered to the recipient's cochlea via one or more stimulation channels that include lead region 116 and stimulating assembly 118 having electrode array 128. The electrode array 128 includes all of the electrodes 126 in the stimulating assembly 118.

[0035] In addition to the sound processing operations, the environmental classifier 191 is configured to determine an environmental classification of the sound environment associated with the input audio signals, and the individualized own voice detector 195 is configured to perform individualized own voice detection (OVD).

[0036] Skin flap thickness typically refers to the thickness of a portion of the external soft tissue of an individual that overlies a rigid underlying structure, such as a bone or an implanted device. In the context of FIGS. 1A-1B, the thickness of the layer of the soft tissue / skin 105 (i.e., the skin flap thickness) that lies between the implantable coil 122 and the external coil 106 is a significant factor that influences the retention of the external coil 106 to the head of the recipient by the magnets and the RF link performance between the external and implantable coils. For cochlear implant systems that have off-the-ear (OTE) sound processors, such as the cochlear implant system 170 of FIG. ID, the skin flap thickness between the implantable coil and the external coil is often the main factor that influences the retention of the external component of the cochlear implant system to the head of the recipient by the magnets. The thickness of the hair of the recipient between implantable coil 122 and external coil 106 is another factor that influences the retention of external coil 106 to the head of the recipient by the magnets and the RF link performance between the external and implantable coils.

[0037] Individuals who are considering receiving cochlear implant systems often want to know in advance of cochlear implant surgery if they are candidates for an OTE sound processor. A recipient of a cochlear implant system may be disappointed if a determination is made after implantation of the implantable component of the cochlear implant system that available OTE sound processors do not provide adequate retention for the recipient's skin flap thickness. For this reason, it is often desirable to determine the skin flap thickness of an individual at a location (e.g., on the individual's head) over an implantable coil of a cochlear implant system or at a proposed location to implant an implantable coil of a cochlear implant system in an individual.

[0038] The thickness of the skin flap of an individual at a location or at a potential location of an implantable component of an implant system can be used for several purposes. As an example, the external components of some types of cochlear implant systems can only be retained on an individual's head by magnets if the individual has a skin flap thickness over the implantable component that is within a supported range of skin flap thicknesses. A needle is often used to measure skin flap thickness during surgery. If the skin flap of an individual over the potential location of an implantable component is too thick to support aparticular cochlear implant system, the skin flap can be thinned by performing a skin flap thinning surgery prior to implantation of the implantable component. However, surgeons often do not want to perform skin flap thinning surgery because of the risk of infection.

[0039] According to some embodiments disclosed herein, an estimator tool in a computing system generates an estimate of the thickness of the skin flap (or a depth of soft tissue) at a location on an individual using information about the individual, such as for example, a body mass index (BMI) of the individual. The information about the individual that the estimator tool can use to estimate the thickness of the skin flap can also, or alternatively, include parameters, such as one or more of a sex of the individual, an age of the individual, a selected region on the body of the individual (e.g., on an individual's head), a location or a potential location on the body of the individual of an implantable or external component of an implant system, a type of implantable component in the individual, and / or a time period after implantation of the implantable component in the individual. The information about the individual can be input to the computing system by a user of the computing system through a user interface.

[0040] The estimator tool can be used to estimate skin flap thickness of an individual without using medical equipment or an invasive procedure, such as a needle. The estimator tool can generate and output a non-invasive estimate of skin flap thickness of a recipient of an implant system, which obviates the need to test different implant systems to determine which external components of the implant systems can be retained on the recipient. As a result, the estimator tool can reduce the time and energy required to select an implant system having a magnetic configuration and / or magnetic field strength that is suitable for the recipient. A recipient is therefore more likely to receive an implant system having an appropriate strength magnet on the first fitting of the implant system after using the estimator tool, which reduces the need for return visits for additional fittings.

[0041] The estimator tool can be used to estimate the skin flap thickness of a recipient over a component that has already been implanted in the recipient (e.g., the implanted coil of a cochlear implant system) or over the potential location of an implantable component to be implanted in the recipient (e.g., a predicted implantable coil site for a candidate of a cochlear implant system). The estimator tool can estimate the skin flap thickness of a recipient prior to implantation of an implantable component of an implant system (e.g., a cochlear implant system) in the recipient and / or after the implantable component of the implant system has been implanted in the recipient. As used herein, the term "recipient" includes individuals that have received an implantable component of an implant system(e.g., have had an implantable component surgically implanted) and individuals that are candidates for receiving an implantable component of an implant system in the future (e.g., are being evaluated for receiving an implantable component). The implant system can be any type of implant system placed on and / or below soft tissue of a recipient.

[0042] The estimator tool can be used to generate and output an estimation of the skin flap thickness of a recipient at a location on the recipient's body where an implantable component of an implant system has been implanted or at a potential location of an implantable component of an implant system in an individual. The location on the recipient or the potential location on the individual can be input by a user to the estimator tool or selected by the estimator tool based on the type of implant system. The estimator tool can, for example, output a tolerance range for the estimated skin flap thickness. The estimation of the skin flap thickness at a potential location on an individual's body can be used by the estimator tool to predict whether the external component of the implant system can be retained by the implantable component of the implant system after implantation at the potential location. The estimation of the skin flap thickness of an individual can be used by the estimator tool to determine whether a particular combination or configuration of external and implantable components of an implant system (such as a cochlear implant system) can be retained on the individual through the skin flap at the location or potential location. The estimation of the skin flap thickness of an individual can also be used by the estimator tool to predict the magnetic field strength or magnet configuration required for adequate retention of an external component of an implant system by an implantable component of the implant system.

[0043] An estimation of the skin flap thickness of the individual at the potential location of a cochlear implant system generated by the estimator tool can be used by a clinician to determine whether an external component (e.g., an off the ear (OTE) sound processor) can be retained on the individual at the potential location of the implantable component of the cochlear implant system. The estimator tool running on the computing system can calculate an estimation of skin flap thickness before surgery is performed to implant an implantable component in the individual. Providing a clinician with an estimation of the skin flap thickness prior to implantation of an implantable component (such as an implantable component of a cochlear implant system) under the skin flap allows the clinician to be able to successfully manage a recipient's expectations and to achieve an improved overall experience. The estimation of the skin flap thickness generated by the estimator tool can also be used by a surgeon to determine which implant system to implant in an individual(e.g., an OTE sound processor, if preferred by an individual). The estimation of the skin flap thickness generated by the estimator tool can also be used by a surgeon to determine whether a skin flap thinning procedure would be beneficial for the individual prior to implantation of an implant system in the individual.

[0044] The estimator tool can include software and / or a website that generates and presents one or more user interfaces (e.g., on a display screen) to a user for entering information about the individual. The software and / or website can, for example, be run on a handheld computing device, a tablet computer, a laptop computer, a personal computer, one or more networked server computers, and / or other types of computing systems, that present the one or more user interfaces to the user. The software can be, as examples, clinical software designed for clinicians (e.g., audiologists) or applications that run on consumer computing devices. The website can be a publicly available website or a website only available on a computing system internal to an organization. Thus, the user can be a candidate for an implant system, a recipient of an implant system, or a professional clinician, as examples.

[0045] The estimator tool uses the information about the individual entered by the user through the user interface to generate the estimate of the skin flap thickness (e.g., in millimeters) at a location on the individual. The user interface generated by the estimator tool can allow the user to enter the information about the individual related to the estimation of the skin flap thickness of the individual including, for example, a sex of the individual, an age of the individual, a region or location on the individual to generate the estimate (e.g., a location or potential location of an implantable or external component of an implant system), a hair thickness at the location on the individual, a body mass index (BMI) of the individual, and / or an activity level of the individual.

[0046] The user interface generated by the estimator tool can also, or alternatively, allow the user to enter a type (e.g., model) of implantable component of an implant system in the recipient (or to be implanted in an individual), a type of implant system (e.g., a cochlear implant system, a pacemaker, etc.), a type of magnet in the implantable component (e.g., a diametric or axial magnet), a magnetic field strength of the magnet in the implantable component, and / or a time period after implantation of the implantable component in the recipient. The estimator tool can then determine the estimation of the thickness of the skin flap of the individual based on the BMI of the individual entered through the user interface and data indicating known correlations between skin flap thickness and the BMI of individuals. BMI is particularly useful for generating estimations of skin flap thicknessesbecause of known correlations between BMI and skin flap thicknesses. The estimator tool can also generate the estimation of the thickness of the skin flap of the individual based on any of the other information about the individual entered through the user interface and known correlations between this other information and skin flap thicknesses. The estimator tool can then output the estimation of the skin flap thickness to the user using the user interface (e.g., on a display screen) in an easy-to-understand format.

[0047] The data indicating the known correlations can be generated in advance based on data indicating skin flap thicknesses of many individuals and their respective individual characteristics and then stored in a database. As examples that are not intended to be limiting, the data indicating the known correlations between skin flap thickness and individual characteristics can indicate that skin flap thickness generally increases with increasing BMI, increases with increasing age from childhood into adulthood, increases 1 month after implantation of an implantable component of an implant system (e.g., as a result of swelling) under the skin flap, decreases by 12 months after implantation of an implantable component of an implant system under the skin flap, and / or varies based on the location or region of the skin flap on the body of the individual. As another example, skin flap thickness is on average larger in men than in women.

[0048] The estimator tool can, for example, generate a user interface that presents the user with a questionnaire having editable fields for the sex, age, hair thickness, body mass index (BMI), and / or activity level of the individual. The user interface can also include, for example, an editable field for the user to enter the region or location on the individual's body for estimating the skin flap thickness (e.g., above a location or potential location of an implantable component of an implant system). Each of these editable fields can include, for example, a drop down list of predetermined values for one of the individual's characteristics. The estimator tool can, for example, calculate a BMI of the individual using a standard BMI calculation (e.g., BMI = kg / m2), where the user enters a mass of the individual in kilograms (kg) and a height of the individual in meters (m). The estimator tool can then estimate the skin flap thickness using a known BMI to skin flap thickness model. The estimator tool can also generate the estimation of the skin flap thickness of the individual based on other information entered by the user through the user interface, such as sex, age, or the region or location on the individual's body for the skin flap thickness estimate. The estimator tool can also estimate changes in the skin flap thickness of a recipient of an implant system based on changes to various characteristics of the recipient that are expected over time,such as changes in age, hair thickness, and BMI. The estimator tool can display the estimated changes to the skin flap thickness of the recipient over any time period.

[0049] The estimator tool can also, or alternatively, display to the user on a user interface other information that the estimator tool determines based on the estimation of the thickness of the skin flap of the individual, such as a recommendation for an external component of an implant system (such as a cochlear implant system) for the individual, a recommendation for a magnet configuration of an external component of an implant system that can be retained on the skin flap by an implantable component of the implant system, or eligibility of the individual for a particular external component (such as an OTE sound processor) of an implant system. The estimator tool can determine this other information (e.g., recommendations, eligibility, etc.), for example, by comparing the estimation of the skin flap thickness of the individual to known values that are associated with particular external and / or implantable components of implant systems. The known values can be, for example, skin flap thickness ranges that can retain particular magnet configurations of external and implantable components of implant systems on recipients. The magnet configurations can include magnets polarized in different directions or with a different number of magnetic poles, and / or a variation in a single magnetic field strength value. The known values can also include, for example, correlations between skin flap thickness ranges and magnetic field strengths of magnets required for retention of one or more external components of an implant system on a recipient with a particular skin flap thickness.

[0050] The estimator tool can also determine the other information (such as recommendations or eligibility for external components, magnet configurations, etc.), for example, based on behaviors or characteristics of recipients, such as activity level or hair thickness, as well as skin flap thickness. As a specific example, an increased activity level of a recipient may correlate to needing a reduced skin flap thickness or an increased magnetic field strength to achieve retention of an external component of an implant system on the recipient. Also, hair thickness affects whether an external component (e.g., an OTE sound processor) of an implant system can be retained on a recipient at a potential location of an implantable component of the implant system. Thus, a recipient with thicker hair may need a reduced skin flap thickness or an increased magnetic field strength to achieve retention of an external component of an implant system on the recipient. In an embodiment, the estimator tool can add hair thickness to the skin flap thickness estimation to estimate the overall distance between an external component of an implant system and an implantable component of the implant system after the implantable component has been implanted inthe recipient and the external component is worn by the recipient. The estimator tool can use the overall distance to determine estimations of retention of an external component on the recipient, magnetic field strength of magnets, and / or eligibility of the recipient for the external component or the implant system.

[0051] The estimator tool can calculate whether an estimated skin flap thickness at a location on a recipient is supported by a range of magnet configurations that are available in external and implantable components of an implant system (such as a cochlear implant system). The estimator tool can also use an estimation of the skin flap thickness at a location on a recipient to determine which magnet configurations of external and implantable components of an implant system, such as a cochlear implant system, are recommended for the recipient having the estimated skin flap thickness. The estimator tool can also use an estimation of the skin flap thickness at a location on a recipient, for example, to determine a suitable magnetic field strength (or range of magnetic field strengths within a tolerance) and / or to assist a clinician in selecting a combination of external and implantable components of an implant system having the suitable magnetic field strength. The estimator tool can determine suitable magnetic field strengths for multiple different types of current commercially available implant systems (e.g., sound processors for cochlear implant systems) using the estimated skin flap thickness. The magnet configurations and / or magnetic field strengths determined and / or output by the estimator tool can correspond to components of an implant system that are likely to be retained on the recipient at the location having the estimated skin flap thickness.

[0052] The estimator tool can provide data to the user through the user interface (e.g., on a display screen) that indicates one or more recommended magnet configurations for an implant system and / or that indicates recommended external and implantable components of an implant system based on the estimated skin flap thickness and / or the suitable magnetic field strength. The estimator tool can determine a suitability of one or more combinations of external and implantable components of an implant system for a recipient at a current or expected location of the implantable component based on pre-determined criteria. The pre-determined criteria can include, for example, whether the estimated skin flap thickness falls within a defined skin flap thickness range for which the one or more combinations are suitable and / or the expected activities of the recipient (e.g., sporting activities, sedentary activities, etc.). The estimator tool can also indicate to the user through the user interface if the recipient is likely to be eligible, may be eligible, or is not likely to be eligible for one or more particular magnet configurations or one or more particularcombinations of external and implantable components of an implant system (e.g., are likely or not likely to be retained on the recipient) based on the estimated skin flap thickness generated by the estimator tool.

[0053] The estimator tool can, for example, default to generating recommendations regarding magnetic field strength or magnet configurations of diametric magnets, if the user does not enter a particular implant system or magnet type (i.e., for a non-implanted individual). The estimator tool can default to using a certain type of implant system and / or a certain type of magnet to generate a recommendation for the implant system / magnet if the recipient has not yet received an implant system. Otherwise, the estimator tool can generate the recommendation based on the magnet type or implant system type selected by the user in the user interface.

[0054] The estimator tool can use an estimation of the skin flap thickness at a location on a recipient, for example, to determine if the recipient is eligible for a particular external component (e.g., an OTE sound processor) of a cochlear implant system or for a particular implantable or external component of another type of implant system at the location. For example, if a recipient has a large skin flap thickness, the estimator tool can provide information indicating that the recipient would be unlikely to achieve sufficient retention with a particular external component (e.g., an OTE sound processor) at the location. The estimator tool can also, or alternatively, provide a recommendation for an external component of an implant system that would likely be retained on the recipient at the location based on the estimation of the skin flap thickness. The estimator tool can provide the information and / or recommendation to the user, for example, on a display screen. A clinician can use the information and / or recommendation generated by the estimator tool to select a suitable external component or combination of external and implantable components of an implant system for a recipient without having to test the suitability of multiple different components on the recipient (e.g., test which components can be retained on the individual). A clinician can also use the information and / or recommendation generated by the estimator tool to manage expectations of the recipient prior to implantation of an implantable component or prior to upgrading the external component of an implant system.

[0055] As another example, the estimator tool can provide a more targeted recommendation, such as a recommendation for a surgeon to perform skin flap thinning on a particular recipient based on an estimation of the skin flap thickness of the recipient generated by the estimator tool. This recommendation can be provided for a recipienthaving a large skin flap thickness. If the estimator tool indicates that a recipient has a large skin flap thickness pre-operatively, and the recipient is made aware and still desires a particular external component that requires a smaller skin flap thickness, a surgeon may choose to perform skin flap thinning surgically on the recipient or may use a different external or implantable component of an implant system.

[0056] As still another example, an estimation of skin flap thickness generated by the estimator tool can be used to provide guidance on a surgical approach for implantation of an implantable component of an implant system in a recipient. As a specific example, a skin flap thickness estimation generated by the estimator tool can be used to determine the location to implant the implantable coil of a cochlear implant system (e.g., under the periosteum, on top of the periosteum, or on top of a muscle) and to assist a clinician in selecting a suitable magnetic field strength for a particular recipient and sound processor combination.

[0057] According to still other embodiments, the estimator tool can include (or be used with) clinical software that automatically records skin flap thickness estimations at one or more locations on a recipient. The clinical software can be run on the computing system. The clinical software can perform any desired functions with estimations of the skin flap thicknesses of one or more recipients made using the estimator tool. As examples, the clinical software can track changes in the skin flap thickness of a recipient of an implant system (e.g., a recipient of a cochlear implant system) over time, and / or prompt a clinician when a change in an implanted and / or external magnet is recommended. The clinical software can, for example, be used to make magnetic field strength recommendations for implant systems, such as the cochlear implant systems of FIGS. 1A-1D, and external components, such as sound processors.

[0058] Figure 2 is a diagram that illustrates an example of a computing device 200 that includes an estimator tool 201 operable to function according to any of the embodiments disclosed herein. The computing device 200 can be, for example, a smart phone, a tablet computer, a laptop computer, a personal computer, etc. As used herein, computing device200 is a type of computing system. The estimator tool 201 can perform any of the functions disclosed herein with respect to generating and outputting an estimation of skin flap thickness and / or the other information disclosed herein that is determined based on an estimation of skin flap thickness. The estimator tool 201 can be executed on a processor 203 or multiple processors (also referred to herein as processing units). The estimator tool201 can output the estimation of the skin flap thickness or the other information to a userthrough user interface 202 (e.g., a graphical user interface on a display screen) on computing device 200.

[0059] Figure 3 is a flow chart that illustrates examples of operations that can be performed by a computing system for generating an estimation of skin flap thickness of an individual. The computing system of Figure 3 can be, as examples, computing device 200 of Figure 2 or the computing system of Figure 4. In operation 301, the computing system receives information about an individual from a user of the computing system. In operation 302, the computing system generates an estimation of a thickness of a skin flap of the individual based on the information about the individual entered in operation 301 using an estimator tool (e.g., estimator tool 201). The computing system can generate the estimation of the thickness of the skin flap of the individual in operation 302, for example, above a location, or above a potential location, of an implantable component of an implant system in the individual. The location or potential location can be entered by a user through a user interface. As a more specific example, the computing system can generate the estimation of the thickness of the skin flap of the individual in operation 302 at a location on the head of the individual behind an ear of the individual for a cochlear implant system. The computing system can then output the estimation of the skin flap thickness or other information determined based on the estimation of the skin flap thickness, such as a recommendation or eligibility for a particular component or magnetic configuration of an implant system.

[0060] Figure 4 is a diagram that illustrates an example of a computing system 400 within which one or more of the disclosed embodiments can be implemented. For example, computing system 400 can run the estimator tool to generate an estimation of skin flap thickness of an individual as disclosed herein.

[0061] Computing systems, environments, or configurations that can be suitable for use with examples described herein include, but are not limited to, personal computers, server computers, hand-held devices, laptop devices, multiprocessor systems, microprocessorbased systems, programmable consumer electronics (e.g., smart phones), network computers, minicomputers, mainframe computers, tablets, distributed computing environments that include any of the above systems or devices, and the like. The computing system 400 can be a single virtual or physical device operating in a networked environment over communication links to one or more remote devices. The remote device can be an auditory prosthesis (e.g., the device or system of any one of FIGS. 1A-1D), a personal computer, a server, a router, a network personal computer, a peer device, or other common network node.

[0062] Computing system 400 includes at least one processing unit 402 and memory 404. The processing unit 402 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 402 can communicate with and control the performance of other components of the computing system 400. The memory 404 is one or more software-based or hardware-based computer- readable storage media operable to store information accessible by the processing unit 402.

[0063] The memory 404 can store instructions executable by the processing unit 402 to implement applications or cause performance of operations described herein, as well as store other data. The memory 404 can be volatile memory (e.g., random access memory or RAM), non-volatile memory (e.g., read-only memory or ROM), or combinations thereof. The memory 404 can include transitory memory or non-transitory memory. The memory 404 can also include one or more removable or non-removable storage devices. In examples, the memory 404 can include non-transitory computer readable storage media, such as RAM, ROM, EEPROM (Electronically-Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access. In examples, the memory 404 encompasses a modulated data signal (e.g., a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal), such as a carrier wave or other transport mechanism and includes any information delivery media. By way of example, and not limitation, the memory 404 can include wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, radio-frequency, infrared and other wireless media or combinations thereof.

[0064] In the illustrated example, the system 400 further includes a network adapter 406, one or more input devices 408, and one or more output devices 410. The system 400 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components.

[0065] The network adapter 406 is a component of the computing system 400 that provides network access to network 412. The network adapter 406 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as Ethernet, cellular, Bluetooth, near-field communication, and RF (radio frequency), among others. The network adapter 406 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols.

[0066] The one or more input devices 408 are devices over which the computing system 400 receives input from a user. The one or more input devices 408 can include physical ly- actuatable user-interface elements (e.g., buttons, switches, or dials), touch screens, keyboards, mice, pens, and voice input devices, among others input devices.

[0067] The one or more output devices 410 are devices by which the computing system 400 is able to provide output to a user. The output devices 410 can include, displays, speakers, and printers, among other output devices.

[0068] Any embodiment or any feature disclosed herein can be combined with any one or more other embodiments and / or other features disclosed herein, unless explicitly indicated otherwise. Any embodiment or any feature disclosed herein can be explicitly excluded from use with any one or more other embodiments and / or other features disclosed herein, unless explicitly indicated otherwise. It is noted that any method detailed herein also corresponds to a disclosure of a device and / or system configured to execute one or more or all of the method actions associated with the device and / or system as detailed herein. It is further noted that any disclosure of a device and / or system detailed herein corresponds to a method of making and / or using that device and / or system, including a method of using that device according to the functionality detailed herein.

[0069] The foregoing description of the exemplary embodiments of the present invention has been presented for the purpose of illustration. The foregoing description is not intended to be exhaustive or to limit the present invention to the examples disclosed herein. In some instances, features of the present invention can be employed without a corresponding use of other features as set forth. Many modifications, substitutions, and variations are possible in light of the above teachings, without departing from the scope of the present invention.

Claims

Claims1. A method comprising: receiving information about an individual at a computing system from a user of the computing system; and generating an estimation of a thickness of a skin flap of the individual based on the information about the individual using an estimator tool in the computing system.

2. The method of claim 1 further comprising providing the estimation of the thickness of the skin flap to the user using a user interface generated by the computing system.

3. The method of any one of claims 1-2, wherein generating the estimation of the thickness of the skin flap of the individual further comprises generating the estimation of the thickness of the skin flap of the individual using a body mass index of the individual.

4. The method of claim 3, wherein generating the estimation of the thickness of the skin flap of the individual further comprises generating the estimation of the thickness of the skin flap of the individual using the body mass index and using at least one of a sex or an age of the individual.

5. The method of any one of claims 1-4, wherein generating the estimation of the thickness of the skin flap of the individual further comprises generating the estimation of the thickness of the skin flap of the individual based on a time period after implantation of an implantable component in the individual.

6. The method of any one of claims 1-5 further comprising generating a prediction of an eligibility of the individual for a component of an implant system based on the estimation of the thickness of the skin flap of the individual.

7. The method of any one of claims 1-6 further comprising generating a recommendation for an external component of an implant system for the individual based on the estimation of the thickness of the skin flap of the individual.

8. The method of any one of claims 1-7 further comprising generating a recommendation of a magnetic field strength or magnet configuration for retaining a medical device on the individual based on the estimation of the thickness of the skin flap of the individual.

9. The method of any one of claims 1-8, wherein generating the estimation of the thickness of the skin flap of the individual further comprises generating the estimation of the thickness of the skin flap of the individual above a location of an implantable component of an implant system in the individual.

10. The method of any one of claims 1-8, wherein generating the estimation of the thickness of the skin flap of the individual further comprises generating the estimation of the thickness ofthe skin flap of the individual above a potential location of an implantable component of an implant system in the individual.

11. The method of any one of claims 1-10 further comprising generating a recommendation for a surgeon to perform skin flap thinning on the individual based on the estimation of the thickness of the skin flap of the individual generated by the estimator tool.

12. A non-transitory computer readable storage medium comprising computer readable instructions stored thereon that, when executed by a computing system, cause the computing system to: generate an estimate of a thickness of a skin flap of a recipient; and generate a prediction of at least one magnetic field strength or magnet configuration for retaining a component of an implant system on the recipient based on the estimate of the thickness of the skin flap of the recipient.

13. The non-transitory computer readable storage medium of claim 12, wherein the computer readable instructions further cause the computing system to generate the estimate of the thickness of the skin flap of the recipient based on a body mass index of the recipient.

14. The non-transitory computer readable storage medium of claim 13, wherein the computer readable instructions further cause the computing system to generate the estimate of the thickness of the skin flap of the recipient based on a sex or an age of the recipient.

15. The non-transitory computer readable storage medium of any one of claims 12-14, wherein the computer readable instructions further cause the computing system to generate the estimate of the thickness of the skin flap of the recipient based on a time period after implantation of an implantable component of the implant system in the recipient.

16. The non-transitory computer readable storage medium of any one of claims 12-14, wherein the computer readable instructions further cause the computing system to generate the prediction of the at least one magnetic field strength or the magnet configuration for retaining the component of the implant system on the recipient based on a type of an implantable component of the implant system in the recipient.

17. The non-transitory computer readable storage medium of any one of claims 12-16, wherein the computer readable instructions further cause the computing system to generate the prediction of the at least one magnetic field strength or the magnet configuration for retaining the component of the implant system on the recipient based on a hair thickness of the recipient.

18. The non-transitory computer readable storage medium of any one of claims 12-17 wherein the computer readable instructions further cause the computing system to generate theprediction of the at least one magnetic field strength or the magnet configuration for retaining the component of the implant system on the recipient based on an activity level of the recipient.

19. The non-transitory computer readable storage medium of any one of claims 12-18, wherein the computer readable instructions further cause the computing system to generate a recommendation for the component of the implant system having the at least one magnetic field strength or the magnet configuration based on the estimate of the thickness of the skin flap.

20. The non-transitory computer readable storage medium of any one of claims 12-19, wherein the computer readable instructions further cause the computing system to generate the estimate of the thickness of the skin flap of the recipient using information about the recipient entered by a user through a user interface and data indicating correlations between individual characteristics and the thickness of the skin flap.

21. A computing system comprising: at least one processor configured to generate an estimate of a depth of soft tissue of a recipient and to generate a prediction of an eligibility of the recipient for an external component of a medical system to be placed over the soft tissue of the recipient based on the estimate of the depth of the soft tissue of the recipient.

22. The computing system of claim 21, wherein the external component is an off-the-ear component, and wherein the medical system is a cochlear implant system.

23. The computing system of any one of claims 21-22, wherein the at least one processor is further configured to generate the prediction of the eligibility of the recipient for the external component of the medical system based on an ability of the external component to be retained on the soft tissue of the recipient by an implantable component of the medical system.

24. The computing system of any one of claims 21-23, wherein the at least one processor is further configured to generate a recommendation for a magnetic field strength or a magnet configuration for the medical system based on the estimate of the depth of the soft tissue of the recipient.

25. The computing system of any one of claims 21-24, wherein the at least one processor is further configured to generate the estimate of the depth of the soft tissue of the recipient based on a body mass index of the recipient.

26. The computing system of claim 25, wherein the at least one processor is further configured to generate the estimate of the depth of the soft tissue of the recipient based on the bodymass index and based on at least one of an age of the recipient, a sex of the recipient, or a time period after implantation of an implantable component of the medical system in the recipient.

27. The computing system of any one of claims 21-26, wherein the at least one processor is further configured to generate the prediction of the eligibility of the recipient for the external component of the medical system based on a type of an implantable magnet of the medical system in the recipient.

28. The computing system of any one of claims 21-27, wherein the at least one processor is further configured to generate the prediction of the eligibility of the recipient for the external component of the medical system based on a hair thickness of the recipient.

29. The computing system of any one of claims 21-28, wherein the at least one processor is further configured to generate the prediction of the eligibility of the recipient for the external component of the medical system based on an activity level of the recipient.

30. A computing system comprising: a processing unit for generating an estimate of a thickness of external soft tissue of an individual based on a body mass index of the individual; and a user interface for outputting the estimate of the thickness of the external soft tissue of the individual.

31. The computing system of claim 30, wherein the processing unit generates the estimate of the thickness of the external soft tissue of the individual based on the body mass index and based on at least one of an age of the individual, a sex of the individual, or a time period after implantation of an implant in the individual.

32. The computing system of any one of claims 30-31, wherein the processing unit generates an estimation of a magnetic field strength or magnet configuration for retaining an external component of an implant system on the individual based on a type of an implantable component of the implant system in the individual.

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