Patent Description:
Among the conditions to which neural modulation may be applied is obstructive sleep apnea (OSA). OSA is a respiratory disorder characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep. During the sleep of a person with OSA, the pharyngeal muscles relax during sleep and gradually collapse, narrowing the airway. The airway narrowing limits the effectiveness of the sleeper's breathing, causing a rise in CO2 levels in the blood. The increase in CO2 results in the pharyngeal muscles contracting to open the airway to restore proper breathing. The largest of the pharyngeal muscles responsible for upper airway dilation is the genioglossus muscle, which is one of several different muscles in the tongue. The genioglossus muscle is responsible for forward tongue movement and the stiffening of the anterior pharyngeal wall. In patients with OSA, the neuromuscular activity of the genioglossus muscle is decreased compared to normal individuals, accounting for insufficient response and contraction to open the airway as compared to a normal individual, This lack of response contributes to a partial or total airway obstruction, which significantly limits the effectiveness of the sleeper's breathing. In OSA patients, there are often several airway obstruction events during the night. Because of the obstruction, there is a gradual decrease of oxygen levels in the blood (hypoxemia). Hypoxemia leads to night time arousals, which may be registered by EEG, showing that the brain awakes from any stage of sleep to a short arousal. During the arousal, there is a conscious breath or gasp, which resolves the airway obstruction. An increase in sympathetic tone activity rate through the release of hormones such as epinephrine and noradrenaline also often occurs as a response to hypoxemia. As a result of the increase in sympathetic tone, the heart enlarges in an attempt to pump more blood and increase the blood pressure and heart rate, further arousing the patient. After the resolution of the apnea event, as the patient returns to sleep, the airway collapses again, leading to further arousals.

These repeated arousals, combined with repeated hypoxemia, leaves the patient sleep deprived, which leads to daytime somnolence and worsens cognitive function. This cycle can repeat itself up to hundreds of times per night in severe patients. Thus, the repeated fluctuations in and sympathetic tone and episodes of elevated blood pressure during the night evolve to high blood pressure through the entire day. Subsequently, high blood pressure and increased heart rate may cause other diseases.

Efforts for treating OSA include Continuous Positive Airway Pressure (CPAP) treatment, which requires the patient to wear a mask through which air is blown into the nostrils to keep the airway open. Other treatment options include the implantation of rigid inserts in the soft palate to provide structural support, tracheotomies, or tissue ablation.

Another condition to which neural modulation may be applied is the occurrence of migraine headaches. Pain sensation in the head is transmitted to the brain via the occipital nerve, specifically the greater occipital nerve, and the trigeminal nerve. When a subject experiences head pain, such as during a migraine headache, the inhibition of these nerves may serve to decrease or eliminate the sensation of pain,.

Neural modulation may also be applied to hypertension. Blood pressure in the body is controlled via multiple feedback mechanisms. For example, baroreceptors in the carotid body in the carotid artery are sensitive to blood pressure changes within the carotid artery. The baroreceptors generate signals that are conducted to the brain via the glossopharyngeal nerve when blood pressure rises, signaling the brain to activate the body's regulation system to lower blood pressure, e.g. through changes to heart rate, and vasodilation/vasoconstriction. Conversely, parasympathetic nerve fibers on and around the renal arteries generate signals that are carried to the kidneys to initiate actions, such as salt retention and the release of angiotensin, which raise blood pressure. Modulating these nerves may provide the ability to exert some external control over blood pressure.

The foregoing are just a few examples of conditions to which neuromodulation may be of benefit, however embodiments of the invention described hereafter are not necessarily limited to treating only the above-described conditions.

An implant unit with a two-layer encapsulation structure is known from <CIT>.

A first aspect of the invention refers to a method for encapsulating an implant unit in accordance with claim <NUM>. A second aspect of the invention refers to an implant unit in accordance with claim <NUM>. Specific embodiments of the invention are set out in dependent claims <NUM>-<NUM> and <NUM>-<NUM>, respectively.

The implant unit comprises: a substrate; an implantable circuit arranged on the substrate; and a primary capsule encapsulating the implant unit, wherein the primary capsule comprises a first polymer material configured to remain flexible after implantation of the implant unit, wherein the primary capsule comprises silicone, or polyimides, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, liquid polyimide, laminated polyimide, polyimide, Kapton, black epoxy, polyether ketone (PEEK) and/or Liquid Crystal Polymer (LCP) wherein the implant unit further comprises a secondary capsule comprising a second polymer material, wherein the first polymer material has a density which is less than the density of the second polymer material.

Another embodiment of the disclosure includes a method for encapsulating an implant unit. The method comprises: providing a substrate, the substrate including an implantable circuit arranged on the substrate; disposing an encapsulation structure over at least a portion of the substrate and at least a portion of the implantable circuit, wherein the encapsulation structure includes a first polymer layer and a second polymer layer, and wherein disposing the encapsulation structure comprises: disposing the first polymer layer on at least a portion of the substrate and at least a portion of the implantable circuit; and disposing the second polymer layer on the first polymer layer, wherein the first polymer layer has a first density and the second polymer has a second density, wherein the second density is less than the first density.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the embodiments disclosed herein.

Reference will now be made in detail to exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings.

Although the present disclosure is being initially described in the context of treatment of OSA through modulating nerve, the present medical device may be employed in any patient/portion of a body where nerve modulation may be desired. That is, in addition to use in patients with migraine headaches, or hypertension, embodiments of the present disclosure may be used in many other areas, including, but not limited to: deep brain stimulation (e.g., treatment of epilepsy, Parkinson's, and depression); cardiac pace-making, stomach muscle stimulation (e.g., treatment of obesity), back pain, incontinence, menstrual pain, and/or any other condition that may be affected by neural modulation.

Embodiments of the present disclosure relate generally to a device for modulating a nerve through the delivery of energy. Nerve modulation may take the form of nerve stimulation, which may include providing energy to the nerve to create a voltage change sufficient for the nerve to activate, or propagate an electrical signal of its own. Nerve modulation may also take the form of nerve inhibition, which may include providing energy to the nerve sufficient to prevent the nerve from propagating electrical signals. Nerve inhibition may be performed through the constant application of energy, and may also be performed through the application of enough energy to inhibit the function of the nerve for some time after the application. Other forms of neural modulation may modify the function of a nerve, causing a heightened or lessened degree of sensitivity. As referred to herein, modulation of a nerve may include modulation of an entire nerve and/or modulation of a portion of a nerve. For example, modulation of a motor neuron may be performed to affect only those portions of the neuron that are distal of the location to which energy is applied.

In patients with OSA, for example, a primary target response of nerve stimulation may include contraction of a tongue muscle {e.g., the muscle) in order to move the tongue to a position that does not block the patient's airway. In the treatment of migraine headaches, nerve inhibition may be used to reduce or eliminate the sensation of pain. In the treatment of hypertension, neural modulation may be used to increase, decrease, eliminate or otherwise modify nerve signals generated by the body to regulate blood pressure.

<FIG> illustrates an implant unit and external unit, according to an exemplary embodiment of the present disclosure. An implant unit <NUM>, may be configured for implantation in a subject, in a location that permits it to modulate a nerve <NUM>. The implant unit <NUM> may be located in a subject such that intervening tissue <NUM> exists between the implant unit <NUM> and the nerve <NUM>. Intervening tissue may include muscle tissue, connective tissue, organ tissue, or any other type of biological tissue. Thus, location of implant unit <NUM> does not require contact with nerve <NUM> for effective neuromodulation. The implant unit <NUM> may also be located directly adjacent to nerve <NUM>, such that no intervening tissue <NUM> exists.

In treating OSA, implant unit <NUM> may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. Implant unit <NUM> may also be configured for placement in other locations. For example, migraine treatment may require subcutaneous implantation in the back of the neck, near the hairline of a subject, or behind the ear of a subject, to modulate the greater occipital nerve and/or the trigeminal nerve. Treating hypertension may require the implantation of a neuromodulation implant intravascularly inside the renal artery or renal vein (to modulate the parasympathetic renal nerves), either unilaterally or bilaterally, inside the carotid artery or jugular vein (to modulate the glossopharyngeal nerve through the carotid baroreceptors). Alternatively or additionally, treating hypertension may require the implantation of a neuromodulation implant subcutaneously, behind the ear or in the neck, for example, to directly modulate the glossopharyngeal nerve.

External unit <NUM> may be configured for location external to a patient, either directly contacting, or close to the skin <NUM> of the patient. External unit <NUM> may be configured to be affixed to the patient, for example, by adhering to the skin <NUM> of the patient, or through a band or other device configured to hold external unit <NUM> in place. Adherence to the skin of external unit <NUM> may occur such that it is in the vicinity of the location of implant unit <NUM>.

<FIG> illustrates an exemplary embodiment of a neuromodulation system for delivering energy in a patient <NUM> with OSA. The system may include an external unit <NUM> that may be configured for location external to the patient As illustrated in <FIG>, external unit <NUM> may be configured to be affixed to the patient <NUM>, <FIG> illustrates that in a patient <NUM> with OSA, the external unit <NUM> may be configured for placement underneath the patient's chin and/or on the front of patient's neck. The suitability of placement locations may be determined by communication between external unit <NUM> and implant unit <NUM>, discussed in greater detail below. In alternate embodiments, for the treatment of conditions other than OSA, the external unit may be configured to be affixed anywhere suitable on a patient, such as the back of a patient's neck, i.e. for communication with a migraine treatment implant unit, on the outer portion of a patient's abdomen, i.e. for communication with a stomach modulating implant unit, on a patient's back, i.e. for communication with a renal artery modulating implant unit, and/or on any other suitable external location on a patient's skin, depending on the requirements of a particular application.

External unit <NUM> may further be configured to be affixed to an alternative location proximate to the patient. For example, in one embodiment, the external unit may be configured to fixedly or removably adhere to a strap or a band that may be configured to wrap around a part of a patient's body. Alternatively, or in addition, the external unit may be configured to remain in a desired location external to the patient's body without adhering to that location.

The external unit <NUM> may include a housing. The housing may include any suitable container configured for retaining components. In addition, while the external unit is illustrated schematically in <FIG>, the housing may be any suitable size and/or shape and may be rigid or flexible. Non-limiting examples of housings for the external unit <NUM> include one or more of patches, buttons, or other receptacles having varying shapes and dimensions and constructed of any suitable material. In one embodiment, for example, the housing may include a flexible material such that the external unit may be configured to conform to a desired location. For example, as illustrated in <FIG>, the external unit may include a skin patch, which, in turn, may include a flexible substrate. The material of the flexible substrate of the external unit may include, but is not limited to, plastic, silicone, woven natural fibers, and other suitable polymers, copolymers, and combinations thereof. Any portion of external unit <NUM> may be flexible or rigid, depending on the requirements of a particular application.

As previously discussed, in some embodiments external unit <NUM> may be configured to adhere to a desired location. Accordingly, in some embodiments, at least one side of the housing may include an adhesive material. The adhesive material may include a biocompatible material and may allow for a patient to adhere the external unit to the desired location and remove the external unit upon completion of use. The adhesive may be configured for single or multiple uses of the external unit. Suitable adhesive materials may include, but are not limited to biocompatible glues, starches, elastomers, thermoplastics, and emulsions.

<FIG> schematically illustrates a system including external unit <NUM> and an implant unit <NUM>. In some embodiments, internal unit <NUM> may be configured as a unit to be implanted into the body of a patient, and external unit <NUM> may be configured to send signals to and/or receive signals from implant unit <NUM>.

As shown in <FIG>, various components may be included within a housing of external unit <NUM> or otherwise associated with external unit <NUM>. As illustrated in <FIG>, at least one processor <NUM> may be associated with external unit <NUM>, For example, the at least one processor <NUM> may be located within the housing of external unit <NUM>. In alternative embodiments, the at least one processor may be configured for wired or wireless communication with the external unit from a location external to the housing.

The at least one processor may include any electric circuit that may be configured to perform a logic operation on at least one input variable. The at least one processor may therefore include one or more integrated circuits, microchips, microcontrollers, and microprocessors, which may be all or part of a central processing unit (CPU), a digital signal processor (DSP), a field programmable gate array (FPGA), or any other circuit known to those skilled in the art that may be suitable for executing instructions or performing logic operations.

<FIG> illustrates that the external unit <NUM> may further be associated with a power source <NUM>. The power source may be removably couplable to the external unit at an exterior location relative to external unit. Alternatively, as shown in <FIG>, power source <NUM> may be permanently or removably coupled to a location within external unit <NUM>. The power source may further include any suitable source of power configured to be in electrical communication with the processor. In one embodiment, for example the power source <NUM> may include a battery.

The power source may be configured to power various components within the external unit. As illustrated in <FIG>, power source <NUM> may be configured to provide power to the processor <NUM>. In addition, the power source <NUM> may be configured to provide power to a signal source <NUM>. The signal source <NUM> may be in communication with the processor <NUM> and may include any device configured to generate a signal (e.g., a sinusoidal signal, square wave, triangle wave, microwave, radio-frequency (RF) signal, or any other type of electromagnetic signal). Signal source <NUM> may include, but is not limited to, a waveform generator that may be configured to generate alternating current (AC) signals and/or direct current (DC) signals. In one embodiment, for example, signal source <NUM> may be configured to generate an AC signal for transmission to one or more other components. Signal source <NUM> may be configured to generate a signal of any suitable frequency. In some embodiments, signal source <NUM> may be configured to generate a signal having a frequency of from about <NUM> to about <NUM>. In additional embodiments, signal source <NUM> may be configured to generate a signal having a frequency of from about <NUM> to about <NUM>, In further embodiments, signal source <NUM> may generate a signal having a frequency as low as <NUM> or as high as <NUM>.

Signal source <NUM> may be configured for direct or indirect electrical communication with an amplifier <NUM>. The amplifier may include any suitable device configured to amplify one or more signals generated from signal source <NUM>. Amplifier <NUM> may include one or more of various types of amplification devices, including, for example, transistor based devices, operational amplifiers, RF amplifiers, power amplifiers, or any other type of device that can increase the gain associated one or more aspects of a signal. The amplifier may further be configured to output the amplified signals to one or more components within external unit <NUM>.

The external unit may additionally include a primary antenna <NUM>. The primary antenna may be configured as part of a circuit within external unit <NUM> and may be coupled either directly or indirectly to various components in external unit <NUM>. For example, as shown in <FIG>, primary antenna <NUM> may be configured for communication with the amplifier <NUM>.

The primary antenna may include any conductive structure that may be configured to create an electromagnetic field. The primary antenna may further be of any suitable size, shape, and/or configuration. The size, shape, and/or configuration may be determined by the size of the patient, the placement location of the implant unit, the size and/or shape of the implant unit, the amount of energy required to modulate a nerve, a location of a nerve to be modulated, the type of receiving electronics present on the implant unit, etc. The primary antenna may include any suitable antenna known to those skilled in the art that may be configured to send and/or receive signals. Suitable antennas may include, but are not limited to, a long-wire antenna, a patch antenna, a helical antenna, etc. In one embodiment, for example, as illustrated in <FIG>, primary antenna <NUM> may include a coil antenna. Such a coil antenna may be made from any suitable conductive material and may be configured to include any suitable arrangement of conductive coils (e.g., diameter, number of coils, layout of coils, etc.). A coil antenna suitable for use as primary antenna <NUM> may have a diameter of between about <NUM> and <NUM>, and may be circular or oval shaped. In some embodiments, a coil antenna may have a diameter between <NUM> and <NUM>, and may be oval shaped. A coil antenna suitable for use as primary antenna <NUM> may have any number of windings, e.g. <NUM>, <NUM>, <NUM>, or more. A coil antenna suitable for use as primary antenna <NUM> may have a wire diameter between about <NUM> and <NUM>. These antenna parameters are exemplary only, and may be adjusted above or below the ranges given to achieve suitable results.

As noted, implant unit <NUM> may be configured to be implanted in a patient's body (e.g., beneath the patient's skin). <FIG> illustrates that the implant unit <NUM> may be configured to be implanted for modulation of a nerve associated with a muscle of the subject's tongue <NUM>, Modulating a nerve associated with a muscle of the subject's tongue <NUM> may include stimulation to cause a muscle contraction. In further embodiments, the implant unit may be configured to be placed in conjunction with any nerve that one may desire to modulate. For example, modulation of the occipital nerve, the greater occipital nerve, and/or the trigeminal nerve may be useful for treating pain sensation in the head, such as that from migraines. Modulation of parasympathetic nerve fibers on and around the renal arteries (i.e.. the renal nerves), the vagus nerve, and /or the glossopharyngeal nerve may be useful for treating hypertension. Additionally, any nerve of the peripheral nervous system (both spinal and cranial), including motor neurons, sensory neurons, sympathetic neurons and parasympathetic neurons, may be modulated to achieve a desired effect.

Implant unit <NUM> may be formed of any materials suitable for implantation into the body of a patient. In some embodiments, implant unit <NUM> may include a substrate such as, for example, flexible carrier <NUM> (<FIG>) including a flexible, biocompatible material, Such materials may include, for example, silicone, polyimides, phenylfrimethoxysilane (PTMS), polymetbyl methacrylate (PMMA), Parylene C, polyimsde, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), Liquid Crystal Polymer (LCP), Kapton, etc. Implant unit <NUM> and flexible carrier <NUM> may also be fabricated with a thickness suitable for implantation under a patient's skin. Implant <NUM> may have thickness of less than about <NUM> or less than about <NUM>. The term "flexible" as used herein may refer to a capability of changing a component physical shape while maintaining its desired functionality. For example, a component may be considered flexible if it can bend or flex or stretch, etc. allowing the component to conform to tissue (e.g., muscle, adipose, bone, connective, etc.) in a subject's body,.

Implant unit <NUM> may further include an implantable circuit arranged on the substrate. The implantable circuit <NUM> may be in electrical communication (e.g., either directly or indirectly connected) with at least a pair of modulation electrodes and/or an antenna on the substrate. The implantable circuit and/or modulation electrodes may include conductive materials, such as gold, platinum, titanium, or any other biocompatible conductive material or combination of materials. In some embodiments, the implantable circuit may include one or more meandering electrical traces <NUM> (<FIG>) configured to maintain electrical contact during flexing. The implantable circuit may various components such as diodes, capacitors, resistors, etc..

Other components that may be included in or otherwise associated with the implant unit are illustrated in <FIG>. For example, implant unit <NUM> may include a secondary antenna <NUM> mounted onto or integrated with flexible carrier <NUM>. Similar to the primary antenna, the secondary antenna may include any suitable antenna known to those skilled in the art that may be configured to send and/or receive signals. The secondary antenna may include any suitable size, shape, and/or configuration. The size, shape and/or configuration may be determined by the size of the patient, the placement location of the implant unit, the amount of energy required to modulate the nerve, etc. Suitable antennas may include, but are not limited to, a long-wire antenna, a patch antenna, a helical antenna, etc. In some embodiments, for example, secondary antenna <NUM> may include a coil antenna having a circular shape (see also <FIG>) or oval shape. Such a coil antenna may be made from any suitable conductive material and may be configured to include any suitable arrangement of conductive coils (e.g., diameter, number of coils, layout of coils, etc.). A coil antenna suitable for use as secondary antenna <NUM> may have a diameter of between about <NUM> and <NUM>, and may be circular or oval shaped. A coil antenna suitable for use as secondary antenna <NUM> may have any number of windings, e.g., <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. A coil antenna suitable for use as secondary antenna <NUM> may have a wire diameter between about <NUM> and <NUM>. These antenna parameters are exemplary only, and may be adjusted above or below the ranges given to achieve suitable results.

<FIG> illustrate a double-layer crossover antenna <NUM> suitable for use as either primary antenna <NUM> or secondary antenna <NUM>. While a double-layer crossover antenna is shown and described, other antenna configurations may be suitable for primary antenna <NUM> and/or secondary antenna <NUM>. For example, single layer antennas may be used where antenna components (e.g., coils) are arranged in a single layer, e.g., either on or within a dielectric or insulating material. Also, while a crossover pattern is shown, other patterns may also be suitable. For example, in some embodiments, a wire associated with primary antenna <NUM> and/or secondary antenna <NUM> may include a pattern of traces of progressively decreasing dimension. In the case of traces arranged in coils, for example, each loop could include rings of progressively decreasing diameter to create a pattern that spirals inwardly, A similar approach may be viable using traces of other shapes as well.

Returning to <FIG>, this figure illustrates a single coil of double-layer crossover antenna <NUM> , while <FIG> illustrates two layers of double layer crossover antenna <NUM>. Antenna <NUM> may include a first coil of wire <NUM> arranged on a first side of a dielectric carrier <NUM> and a second coil of wire <NUM> on a second side of a dielectric carrier <NUM>.

Arranging the antenna coils in a double layer may serve to increase the transmission range of the antenna without increasing the size of the antenna. Such an arrangement, however, may also serve to increase capacitance between the wires of each coil. In each wire coil, an amount of parasitic capacitance between wires may partially depend on the distance each wire is from its neighbor. In a single layer coil, capacitance may be generated between each loop of the coil and its neighbors to either side. Thus, more compact coils may generate more parasitic capacitance. When a second layer coil is added, additional capacitance may then be generated between the wires of the first coil and the wires of the second coil. This additional capacitance may be further increased if corresponding loops of the first and second coils have the same or similar diameters, and/or if a dielectric carrier separating the loops is made very thin. Increased parasitic capacitance in an antenna may serve to alter characteristics, such as resonant frequency, of the antenna in unpredictable amounts based on manufacturing specifications. Additionally, resonant frequency drift, caused, for example by moisture incursion or antenna flexing, may be increased by the presence of increased parasitic capacitance. Thus, in order to decrease variability in the manufactured product, it may be advantageous to reduce the levels of parasitic capacitance in a dual layer antenna.

<FIG> illustrates a double layer crossover antenna <NUM> which may serve to reduce the parasitic capacitance in a manufactured antenna. As illustrated in <FIG>, a first coil of wire <NUM> is concentrically offset from a second coil of wire <NUM>. In contrast to a configuration where each loop of a first coil <NUM> has the same diameter as corresponding loop of the second coil <NUM>, concentrically offsetting corresponding loops of each wire coil serves to increase the distance between a single loop of the first coil <NUM> with a corresponding loop of the second coil <NUM>. This increased distance, in turn, may decrease the parasitic wire-to-wire capacitance between loops of first coil <NUM> and corresponding loops of second coil <NUM>. This configuration may be particularly advantageous in reducing parasitic capacitance in a situation where a dielectric carrier <NUM> is thin enough such that the concentric distance by which each coil is offset is relatively large compared to the thickness of the dielectric carrier <NUM>. For example, in a situation where a dielectric carrier is <NUM> thick, a concentric offset of <NUM> or more may produce a large change in parasitic capacitance. In contrast, in a situation where a dielectric carrier is <NUM> thick, a concentric offset of <NUM> may produce a smaller change in parasitic capacitance. The concentric offset between a first coil <NUM> and a second coil <NUM> may be achieved, for example, by a plurality of electrical trace steps <NUM> that offset each loop of the coils from each preceding loop. Electrical trace steps <NUM> on a first side of dielectric carrier <NUM> cross over electrical trace steps <NUM> on a second side of dielectric carrier <NUM>, thus providing the crossover feature of double-layer crossover antenna <NUM>.

In additional embodiments, double layer crossover antenna <NUM> may include openings <NUM> in dielectric carrier <NUM> to facilitate the electrical connection of first and second coils <NUM>, <NUM>. First and second coils <NUM>, <NUM> of double layer crossover antenna <NUM> may also include exposed electrical portions <NUM> configured to electrically connect with a connector of a device housing that may be coupled to antenna <NUM>. Exposed electrical portions <NUM> may be configured so as to maintain electrical contact with the connector of a device housing independent of the axial orientation of the connection. As shown in <FIG>, for example, exposed electrical portions <NUM> may be configured as continuous or discontinuous circles in order to achieve this. A first exposed electrical portion <NUM> configured as a discontinuous circle may provide a space through which an electrical trace may pass without contacting the first exposed electrical portion, for example to connect with a second exposed electrical portion located inside the first, or to other components located within the circle of the first exposed electrical portion <NUM>. <FIG> illustrates an antenna having substantially elliptical coils; other shapes, such as circular, triangular, square, etc., may be also be used in different embodiments. Elliptical coils may facilitate placement of external unit <NUM> in certain areas (e.g., under the chin of a subject) while maintaining desirable electrical performance characteristics.

Implant unit <NUM> may additionally include a plurality of field-generating implant electrodes 158a, 158b. The electrodes may include any suitable shape and/or orientation on the implant unit so long as the electrodes may be configured to generate an electric field in the body of a patient. Implant electrodes 158a and 158b may also include any suitable conductive material (e.g., copper, silver, gold, platinum, iridium, platinum-iridium, platinum-gold, conductive polymers, etc) or combinations of conductive (and/or noble metals) materials. In some embodiments, for example, the electrodes may include short line electrodes, circular electrodes, and/or circular pairs of electrodes. As shown in <FIG>, electrodes 158a and 158b may be located on an end of a first extension 162a of an elongate arm <NUM>. The electrodes, however, may be located on any portion of implant unit <NUM>. Additionally, implant unit <NUM> may include electrodes located at a plurality of locations, for example on an end of both a first extension 162a and a second extension 162b of elongate arm <NUM>, as illustrated, for example, in <FIG>, Implant electrodes may have a thickness between about <NUM> nanometers and <NUM> millimeter. Anode and cathode electrode pairs may be spaced apart by about a distance of about <NUM> to <NUM>. In additional embodiments, anode and cathode electrode pairs may be spaced apart by a distance of about <NUM> to <NUM>, or between <NUM> and <NUM>. Adjacent anodes or adjacent cathodes may be spaced apart by distances as small as <NUM> or less, or as great as <NUM> or more. In some embodiments, adjacent anodes or adjacent cathodes may be spaced apart by a distance between about <NUM> and <NUM>.

<FIG> provides a schematic representation of an exemplary configuration of implant unit <NUM>. As illustrated in <FIG>, in one embodiment, the field-generating electrodes 158a and 158b may include two sets of four circular electrodes, provided on flexible carrier <NUM> , with one set of electrodes providing an anode and the other set of electrodes providing a cathode. Implant unit <NUM> may include one or more structural elements to facilitate implantation of implant unit <NUM> into the body of a patient. Such elements may include, for example, elongated arms, suture holes, polymeric surgical mesh, biological glue, spikes of flexible carrier protruding to anchor to the tissue, spikes of additional biocompatible material for the same purpose, etc. that facilitate alignment of implant unit <NUM> in a desired orientation within a patient's body and provide attachment points for securing implant unit <NUM> within a body. For example, in some embodiments, implant unit <NUM> may include an elongate arm <NUM> having a first extension 162a and, optionally, a second extension 162b. Extensions 162a and 162b may aid in orienting implant unit <NUM> with respect to a particular muscle (e.g., the genioglossus muscle), a nerve within a patient's body, or a surface within a body above a nerve. For example, first and second extensions 162a, 162b may be configured to enable the implant unit to conform at least partially around soft or hard tissue (e.g., nerve, bone, or muscle, etc.) beneath a patient's skin. Further, implant unit <NUM> may also include one or more suture holes <NUM> located anywhere on flexible carrier <NUM>. For example, in some embodiments, suture holes <NUM> may be placed on second extension 162b of elongate arm <NUM> and/or on first extension 162a of elongate arm <NUM>. Implant unit <NUM> may be constructed in various shapes. Additionally, or alternatively, implant unit <NUM> may include surgical mesh or other perforatable material, e.g., within suture holes <NUM>, described in greater detail below with respect to <FIG>. In some embodiments, implant unit may appear substantially as illustrated in <FIG>. in other embodiments, implant unit <NUM> may lack illustrated structures such as second extension 162b, or may have additional or different structures in different orientations. Additionally, implant unit <NUM> may be formed with a generally triangular, circular, or rectangular shape, as an alternative to the winged shape shown in <FIG>. In some embodiments, the shape of implant unit <NUM> (e.g., as shown in <FIG>) may facilitate orientation of implant unit <NUM> with respect to a particular nerve to be modulated. Thus, other regular or irregular shapes may be adopted in order to facilitate implantation in differing parts of the body.

<FIG> is a perspective view of an alternate embodiment of an implant unit <NUM>, according to an exemplary embodiment of the present disclosure. As illustrated in <FIG>, implant unit <NUM> may include a plurality of electrodes, located, for example, at the ends of first extension 182a and second extension 162b. <FIG> illustrates an embodiment wherein implant electrodes 158a and 158b include short line electrodes.

As illustrated in <FIG>, secondary antenna <NUM> and electrodes 158a, 158b may be mounted on or integrated with flexible carrier <NUM>. Various circuit components and connecting wires may be used to connect secondary antenna with implant electrodes 158a and 158b. To protect the antenna, electrodes, and implantable circuit components from the environment within a patient's body, implant unit <NUM> may include a protective coating that encapsulates implant unit <NUM>. In some embodiments, the protective coating may be made from a flexible material to enable bending along with flexible carrier <NUM>. The encapsulation material of the protective coating may also resist humidity penetration and protect against corrosion. In some embodiments, the protective coating may include a plurality of layers, including different materials or combinations of materials in different layers.

In some embodiments of the present disclosure, the encapsulation structure of implanted unit may include two layers. For example, a first layer may be disposed over at least a portion of the implantable circuit arranged on the substrate, and a second layer may be disposed over the first layer. In some embodiments, the first layer may be disposed directly over the implantable circuit, but in other embodiments, the first layer may be disposed over an intervening material between the first layer and the implantable circuit. In some embodiments, the first layer may provide a moisture barrier and the second layer may provide a mechanical protection (e.g., at least some protection from physical damage that may be caused by scratching, impacts, bending, etc.) for the implant unit. The terms "encapsulation" and "encapsulate" as used herein may refer to complete or partial covering of a component. n some embodiments component may refer to a substrate, implantable circuit, antenna, electrodes, any parts thereof, etc. The term layer" as used herein may refer to a thickness of material covering a surface or forming an overlying part or segment. The layer thickness can be different from layer to layer and may depend on the covering material and the method of forming the layer. For example, a layer disposed by chemical vapor may be thinner than a layer disposed through other methods.

Other configurations may also be employed. For example, another moisture barrier may be formed over the outer mechanical protection layer. In such embodiments, a first moisture barrier layer (e.g., parylene) may be disposed over (e.g., directly over or with intervening layers) the implantable circuit, a mechanical protection layer (e.g., silicone) may be formed over the first moisture barrier, and second moisture barrier (e.g., parylene) may be disposed over the mechanical protection layer.

<FIG> illustrates exemplary embodiment of encapsulated implant unit <NUM>. Exemplary embodiments may incorporate some or ail of the features illustrated in <FIG> as well as additional features. A protective coating of implant unit <NUM> may include a primary capsule <NUM>. Primary capsule <NUM> may encapsulate the implant unit <NUM> and may provide mechanical protection for the implant unit <NUM>. For example, the components of implant unit <NUM> may be delicate, and the need to handle the implant unit <NUM> prior to implantation may require additional protection for the components of implant unit <NUM>, and primary capsule <NUM> may provide such protection. Primary capsule <NUM> may encapsulate all or some of the components of implant unit <NUM>. For example, primary capsule <NUM> may encapsulate antenna <NUM>, flexible carrier <NUM> , and implantable circuit <NUM>. The primary capsule may leave part or all of electrodes 158a, 158b exposed enabling them to deliver energy for modulating a nerve unimpeded by material of the primary capsule. In alternative embodiments, different combinations of components may be encapsulated or exposed.

Primary capsule <NUM> may be fashioned of a material and thickness such that implant unit <NUM> remains flexible after encapsulation. Primary capsule <NUM> may include any suitable bio-compatible material, such as silicone, or polyimides, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, liquid polyimide, laminated polyimide, polyimide, Kapton, black epoxy, polyether ketone (PEEK), Liquid Crystal Polymer (LCP), or any other suitable biocompatible coating.

<FIG> is a diagrammatic sectional view showing an encapsulated implant unit <NUM> according to an exemplary disclosed embodiment. The protective coating of implant unit <NUM> may include primary capsule <NUM> along with a secondary capsule <NUM>. In some embodiments, primary capsule <NUM> may be formed of a polymer material having a density less than a density of a polymer material used to form secondary capsule <NUM>. For example, in some embodiments, primary capsule <NUM> may include silicone, polyurethane, epoxy, acrylic, etc., and secondary capsule <NUM> may include parylene N, parylene C, parylene HD, parylene D, etc. Additionally, other embodiments may include an outer barrier formed over the primary capsule <NUM>. The outer barrier may serve as a moisture barrier or may be selected to provide other desired properties. For example, in some embodiments the outer barrier may be formed of a polymer having a density greater than the density of the primary capsule <NUM>. The outer barrier may be formed of parylene, for example.

Secondary capsule <NUM> may provide environmental protection for the implant unit <NUM> when it is implanted in the body. For example, primary capsule <NUM> may be constructed of silicone, which may be subject to moisture incursion from the body. Such moisture incursion may limit a life-span of the implant unit <NUM> due to possible corrosive effects. Secondary capsule <NUM> may be provided underneath the primary capsule <NUM> to protect implant unit <NUM> from the corrosive effects of bodily implantation. For example, a layer of parylene may serve as a secondary capsule and may be provided to encapsulate ail or some of the components of implant unit <NUM>.

In exemplary embodiments, secondary capsule <NUM> may encapsulate any or all components associated with implant unit <NUM> and may fully or partially cover those components. For example, secondary capsule <NUM> may cover the substrate, secondary antenna <NUM>, carrier <NUM> , implantable circuit <NUM>, and electrodes 158a, 158b. The secondary capsule <NUM> may, in turn, be encapsulated by primary capsule <NUM>.

In some embodiments, secondary capsule <NUM> may cover less than all of the components of implant unit <NUM>. For example, in some embodiments, at least a portion of electrode 158a and/or 158b may remain uncovered by secondary capsule <NUM>. Similarly, as noted above, portions of electrode 158a and/or 158b may remain uncovered by primary capsule <NUM> , In some embodiments, a window of exposure through secondary capsule <NUM> may be smaller than a window of exposure through primary capsule <NUM>. Thus, from a perspective above electrode 158a, for example, an exposed lip of material associated with secondary capsule <NUM> the edge of which forms the window of exposure through secondary capsule <NUM> would extend beyond a boundary of the window of exposure through primary capsule <NUM>.

Secondary capsule <NUM>, may include, for example parylene, parylene C or any other suitable material for preventing the effects of moisture incursion on implant unit <NUM>. In some embodiments, a secondary capsule layer <NUM> may be deposited by chemical vapor deposition and may have a thickness of about <NUM> molecule in thickness, between <NUM> and <NUM> molecules in thickness, or any other suitable film thickness.

Some combinations of primary and secondary capsule materials, such as silicone and parylene C, may bond relatively weakly to one another, Where such combinations of materials are used, a plurality perforations or penetrating holes <NUM> (<FIG>) may be provided to pass through both carrier <NUM> and a secondary capsule <NUM> to improve the adherence of the primary capsule <NUM> to implant unit <NUM>. For example, when penetrating holes <NUM> are provided, the material of primary capsule <NUM> may flow through the penetrating holes during fabrication, permitting the material of primary capsule <NUM> to flow into and adhere to itself. A plurality of penetrating holes <NUM> provided through carrier <NUM> and a secondary capsule <NUM> may provide anchor points to permit the self-adherence of the material used to form primary capsule <NUM>. Penetrating holes <NUM> may be provided and sized such that, after encapsulation by primary capsule <NUM> , at least some portion of holes <NUM> remain free of primary capsule material, or they may be provided and sized such that, after encapsulation, holes <NUM> are filled in (as illustrated in <FIG>).

Also illustrated in <FIG> are suture holes <NUM>, which may include surgical mesh disposed therein. The surgical mesh may provide a larger target area for surgeons to use when suturing implant unit <NUM> into place during implantation. The entire surgical mesh may be encapsulated by primary capsule <NUM> , permitting a surgeon to pass a needle through any portion of the mesh without compromising the integrity of implant unit <NUM>. Surgical mesh may additionally be used to cover one or more suture holes <NUM>, permitting larger suture holes <NUM> that may provide surgeons with a greater target area. Surgical mesh may also encourage surrounding tissue to bond with implant unit <NUM>. In some embodiments, a surgeon may pass a surgical suture needle through suture holes <NUM>, located on one extension 162a of an elongate arm <NUM> of implant unit <NUM>, through tissue of the subject, and through surgical mesh provided on a second extension 162b of elongate arm <NUM> of implant unit <NUM>. In this embodiment, the larger target area provided by suture holes <NUM> may facilitate the suturing process because it may be more difficult to precisely locate a suture needle after passing it through tissue. Implantation and suturing procedures may be further facilitated through the use of a delivery tool, described in greater detail below.

The capsules of implant unit <NUM> may be provided such that implant unit <NUM> remains flexible after encapsulation. Additionally, implant unit <NUM> may include meandering electrical traces <NUM> in order to maintain electrical contact under flexural conditions. As used herein, meandering electrical traces <NUM> may include any electrical trace that is longer than the shortest distance between the points that it connects. Meandering electrical traces <NUM> may also include any trace of sufficient length so as to maintain electrical conductivity during flexing of a carrier on which it is located. For example, as shown in <FIG>, meandering electrical traces <NUM> may be configured as lines having successive curves, such as waves or the like. Repeated flexing of carrier <NUM> on which electrical traces are deposited may cause degradation of the electrical traces, as they are repeatedly stressed with the flexure of carrier <NUM>. Meandering electrical traces <NUM> may provide an increased lifetime, as the additional slack provided may serve to reduce stress in the traces during flexing of carrier <NUM>. Meandering electrical traces <NUM> may include any suitable conductive material, such as gold, platinum, titanium, copper, silver, iridium, platinum-iridium, platinum-gold, conductive polymers, any conductive biocompatible material, and/or combinations of conductive (and/or noble metals) materials.

in additional embodiments consistent with the present disclosure, conductive electrical elements of implant unit <NUM>, such as meandering traces <NUM> and electrodes 158a, 158b may be provided through a progressive metallization layering method. In some embodiments, flexible carrier <NUM> may include a material, such as liquid crystal polymer, that bonds relatively weakly to conductive metals desirable for use as conductive electrical elements, such as titanium and/or gold. A progressive metallization layering method may utilize a temporary bonding layer, including a metal, such as nickel, that may bond more strongly to flexible carrier <NUM>. The temporary bonding layer may be layered with the metals desirable for use as conductive electrical elements and used to provide an initial bond with the material of flexible carrier <NUM>. The temporary bonding layer may then be removed through dissolution, erosion, or similar technique, through flexible carrier <NUM> , leaving the desirable metals in place in flexible carrier <NUM>.

In one embodiment, a progressive metallization layering method may be utilized to provide gold and titanium conductive elements on a liquid crystal polymer carrier <NUM>. The conductive elements may be constructed from progressive layers of nickel, gold, and titanium. Next, liquid crystal polymer may be molded around the conductive elements, bonding strongly with the nickel layer and forming a recess containing the layered conductive element. Finally, the nickel may be removed through the liquid crystal polymer through dissolution, erosion, or similar technique. The removal of nickel leaves the gold/titanium layered conductive element in place, held tightly in the liquid crystal polymer recess created during the molding process.

Returning to <FIG> and <FIG>, external unit <NUM> may be configured to communicate with implant unit <NUM>. For example, in some embodiments, a primary signal may be generated on primary antenna <NUM>, using, e.g., processor <NUM>, signal source <NUM>, and amplifier <NUM>. More specifically, in one embodiment, power source <NUM> may be configured to provide power to one or both of the processor <NUM> and the signal source <NUM>. The processor <NUM> may be configured to cause signal source <NUM> to generate a signal (e.g., an RF energy signal). Signal source <NUM> may be configured to output the generated signal to amplifier <NUM>, which may amplify the signal generated by signal source <NUM>. The amount of amplification and, therefore, the amplitude of the signal may be controlled, for example, by processor <NUM>. The amount of gain or amplification that processor <NUM> causes amplifier <NUM> to apply to the signal may depend on a variety of factors, including, but not limited to, the shape, size, and/or configuration of primary antenna <NUM>, the size of the patient, the location of implant unit <NUM> in the patient, the shape, size, and/or configuration of secondary antenna <NUM>, a degree of coupling between primary antenna <NUM> and secondary antenna <NUM> (discussed further below), a desired magnitude of electric field to be generated by implant electrodes 158a, 158b, etc. Amplifier <NUM> may output the amplified signal to primary antenna <NUM>.

External unit <NUM> may communicate a primary signal on primary antenna to the secondary antenna <NUM> of implant unit <NUM>. This communication may result from coupling between primary antenna <NUM> and secondary antenna <NUM>. Such coupling of the primary antenna and the secondary antenna may include any interaction between the primary antenna and the secondary antenna that causes a signal on the secondary antenna in response to a signal applied to the primary antenna. In some embodiments, coupling between the primary and secondary antennas may include capacitive coupling, inductive coupling, radiofrequency coupling, etc. and any combinations thereof.

Coupling between primary antenna <NUM> and secondary antenna <NUM> may depend on the proximity of the primary antenna relative to the secondary antenna. That is, in some embodiments, an efficiency or degree of coupling between primary antenna <NUM> and secondary antenna <NUM> may depend on the proximity of the primary antenna to the secondary antenna. The proximity of the primary and secondary antennas may be expressed in terms of a coaxial offset (e.g., a distance between the primary and secondary antennas when central axes of the primary and secondary antennas are co-aligned), a lateral offset (e.g., a distance between a central axis of the primary antenna and a central axis of the secondary antenna), and/or an angular offset (e.g., an angular difference between the central axes of the primary and secondary antennas). In some embodiments, a theoretical maximum efficiency of coupling may exist between primary antenna <NUM> and secondary antenna <NUM> when both the coaxial offset, the lateral offset, and the angular offset are zero. Increasing any of the coaxial offset, the lateral offset, and the angular offset may have the effect of reducing the efficiency or degree of coupling between primary antenna <NUM> and secondary antenna <NUM>.

As a result of coupling between primary antenna <NUM> and secondary antenna <NUM>, a secondary signal may arise on secondary antenna <NUM> when the primary signal is present on the primary antenna <NUM>. Such coupling may include inductive/magnetic coupling, RF coupling/transmission, capacitive coupling, or any other mechanism where a secondary signal may be generated on secondary antenna <NUM> in response to a primary signal generated on primary antenna <NUM>. Coupling may refer to any interaction between the primary and secondary antennas. In addition to the coupling between primary antenna <NUM> and secondary antenna <NUM>, circuit components associated with implant unit <NUM> may also affect the secondary signal on secondary antenna <NUM>, Thus, the secondary signal on secondary antenna <NUM> may refer to any and all signals and signal components present on secondary antenna <NUM> regardless of the source.

While the presence of a primary signal on primary antenna <NUM> may cause or induce a secondary signal on secondary antenna <NUM>, the coupling between the two antennas may also lead to a coupled signal or signal components on the primary antenna <NUM> as a result of the secondary signal present on secondary antenna <NUM>. A signal on primary antenna <NUM> induced by a secondary signal on secondary antenna <NUM> may be referred to as a primary coupled signal component. The primary signal may refer to any and all signals or signal components present on primary antenna <NUM>, regardless of source, and the primary coupled signal component may refer to any signal or signal component arising on the primary antenna as a result of coupling with signals present on secondary antenna <NUM>. Thus, in some embodiments, the primary coupled signal component may contribute to the primary signal on primary antenna <NUM>.

Implant unit <NUM> may be configured to respond to external unit <NUM>. For example, in some embodiments, a primary signal generated on primary coil <NUM> may cause a secondary signal on secondary antenna <NUM>, which in turn, may cause one or more responses by implant unit <NUM>. In some embodiments, the response of implant unit <NUM> may include the generation of an electric field between implant electrodes 158a and 158b.

<FIG> illustrates circuitry <NUM> that may be included in external unit <NUM> and circuitry <NUM> that may be included in implant unit <NUM>. Additional, different, or fewer circuit components may be included in either or both of circuitry <NUM> and circuitry <NUM>. As shown in <FIG>, secondary antenna <NUM> may be arranged in electrical communication with implant electrodes 158a, 158b. In some embodiments, circuitry connecting secondary antenna <NUM> with implant electrodes 158a and 158b may cause a voltage potential across implant electrodes 158a and 158b in the presence of a secondary signal on secondary antenna <NUM>, This voltage potential may be referred to as a field inducing signal, as this voltage potential may generate an electric field between implant electrodes 158a and 158b. More broadly, the field inducing signal may include any signal (e.g., voltage potential) applied to electrodes associated with the implant unit that may result in an electric field being generated between the electrodes.

The field inducing signal may be generated as a result of conditioning of the secondary signal by circuitry <NUM>. As shown in <FIG>, circuitry <NUM> of external unit <NUM> may be configured to generate an AC primary signal on primary antenna <NUM> that may cause an AC secondary signal on secondary antenna <NUM>. In certain embodiments, however, it may be advantageous (e.g., in order to generate a unidirectional electric field for modulation of a nerve) to provide a DC field inducing signal at implant electrodes 158a and 158b. To convert the AC secondary signal on secondary antenna <NUM> to a DC field inducing signal, circuitry <NUM> in implant unit <NUM> may include an AC-DC converter. The AC to DC converter may include any suitable converter known to those skilled in the art. For example, in some embodiments the AC-DC converter may include rectification circuit components including, for example, diode <NUM> and appropriate capacitors and resistors. In alternative embodiments, implant unit <NUM> may include an AC-AC converter, or no converter, in order to provide an AC field inducing signal at implant electrodes 158a and 158b.

As noted above, the field inducing signal may be configured to generate an electric field between implant electrodes 158a and 158b. In some instances, the magnitude and/or duration of the generated electric field resulting from the field inducing signal may be sufficient to modulate one or more nerves in the vicinity of electrodes 158a and 158b. In such cases, the field inducing signal may be referred to as a modulation signal. In other instances, the magnitude and/or duration of the field inducing signal may generate an electric field that does not result in nerve modulation. In such cases, the field inducing signal may be referred to as a sub-modulation signal.

Various types of field inducing signals may constitute modulation signals. For example, in some embodiments, a modulation signal may include a moderate amplitude and moderate duration, while in other embodiments, a modulation signal may include a higher amplitude and a shorter duration. Various amplitudes and/or durations of field-inducing signals across electrodes 158a, 158b may result in modulation signals, and whether a field-inducing signal rises to the level of a modulation signal can depend on many factors (e.g., distance from a particular nerve to be stimulated; whether the nerve is branched; orientation of the induced electric field with respect to the nerve; type of tissue present between the electrodes and the nerve: etc.).

Whether a field inducing signal constitutes a modulation signal (resulting in an electric field that may cause nerve modulation) or a sub-modulation signal (resulting in an electric field not intended to cause nerve modulation) may ultimately be controlled by processor <NUM> of external unit <NUM>. For example, in certain situations, processor <NUM> may determine that nerve modulation is appropriate. Under these conditions, processor <NUM> may cause signal source <NUM> and amplifier <NUM> to generate a modulation control signal on primary antenna <NUM> (i.e., a signal having a magnitude and/or duration selected such that a resulting secondary signal on secondary antenna <NUM> will provide a modulation signal at implant electrodes 158a and 158b).

Processor <NUM> may be configured to limit an amount of energy transferred from external unit <NUM> to implant unit <NUM>. For example, in some embodiments, implant unit <NUM> may be associated with a threshold energy limit that may take into account multiple factors associated with the patient and/or the implant. For example, in some cases, certain nerves of a patient should receive no more than a predetermined maximum amount of energy to minimize the risk of damaging the nerves and/or surrounding tissue. Additionally, circuitry <NUM> of implant unit <NUM> may include components having a maximum operating voltage or power level that may contribute to a practical threshold energy limit of implant unit <NUM>. Processor <NUM> may be configured to account for such limitations when setting the magnitude and/or duration of a primary signal to be applied to primary antenna <NUM>.

In addition to determining an upper limit of power that may be delivered to implant unit <NUM>, processor <NUM> may also determine a lower power threshold based, at least in part, on an efficacy of the delivered power. The lower power threshold may be computed based on a minimum amount of power that enables nerve modulation (e.g., signals having power levels above the lower power threshold may constitute modulation signals while signals having power levels below the lower power threshold may constitute sub-modulation signals).

A lower power threshold may also be measured or provided in alternative ways. For example, appropriate circuitry or sensors in the implant unit <NUM> may measure a lower power threshold. A lower power threshold may be computed or sensed by an additional external device, and subsequently programmed into processor <NUM>, or programmed into implant unit <NUM>. Alternatively, implant unit <NUM> may be constructed with circuitry <NUM> specifically chosen to generate signals at the electrodes of at least the lower power threshold. In still another embodiment an antenna of external unit <NUM> may be adjusted to accommodate or produce a signal corresponding to a specific lower power threshold. The lower power threshold may vary from patient to patient, and may take into account multiple factors, such as, for example, modulation characteristics of a particular patient's nerve fibers, a distance between implant unit <NUM> and external unit <NUM> after implantation, and the size and configuration of implant unit components (e.g., antenna and implant electrodes), etc..

Processor <NUM> may also be configured to cause application of sub-modulation control signals to primary antenna <NUM>. Such sub-modulation control signals may include an amplitude and/or duration that result in a sub-modulation signal at electrodes 158a, 158b. While such sub-modulation control signals may not result in nerve modulation, such sub-modulation control signals may enable feedback-based control of the nerve modulation system. That is, in some embodiments, processor <NUM> may be configured to cause application of a sub-modulation control signal to primary antenna <NUM>. This signal may induce a secondary signal on secondary antenna <NUM>, which, in turn, induces a primary coupled signal component on primary antenna <NUM>.

To analyze the primary coupled signal component induced on primary antenna <NUM>, external unit <NUM> may include a feedback circuit <NUM> (e.g., a signal analyzer or detector, etc.), which may be placed in direct or indirect communication with primary antenna <NUM> and processor <NUM>. Sub-modulation control signals may be applied to primary antenna <NUM> at any desired periodicity. In some embodiments, the sub-modulation control signals may be applied to primary antenna <NUM> at a rate of one every five seconds (or longer). In other embodiments, the sub-modulation control signals may be applied more frequently (e.g., once every two seconds, once per second, once per millisecond, once per nanosecond, or multiple times per second). Further, it should be noted that feedback may also be received upon application of modulation control signals to primary antenna <NUM> (i.e., those that result in nerve modulation), as such modulation control signals may also result in generation of a primary coupled signal component on primary antenna <NUM>.

The primary coupled signal component may be fed to processor <NUM> by feedback circuit <NUM> and may be used as a basis for determining a degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. The degree of coupling may enable determination of the efficacy of the energy transfer between two antennas. Processor <NUM> may also use the determined degree of coupling in regulating delivery of power to implant unit <NUM>.

Processor <NUM> may be configured with any suitable logic for determining how to regulate power transfer to implant unit <NUM> based on the determined degree of coupling. For example, where the primary coupled signal component indicates that a degree of coupling has changed from a baseline coupling level, processor <NUM> may determine that secondary antenna <NUM> has moved with respect to primary antenna <NUM> (either in coaxial offset, lateral offset, or angular offset, or any combination). Such movement, for example, may be associated with a movement of the implant unit <NUM>, and the tissue that it is associated with based on its implant location. Thus, in such situations, processor <NUM> may determine that modulation of a nerve in the patient's body is appropriate. More particularly, in response to an indication of a change in coupling, processor <NUM>, in some embodiments, may cause application of a modulation control signal to primary antenna <NUM> in order to generate a modulation signal at implant electrodes 158a, 158b, e.g., to cause modulation of a nerve of the patient.

In an embodiment for the treatment of OSA, movement of an implant unit <NUM> may be associated with movement of the tongue, which may indicate the onset of a sleep apnea event or a sleep apnea precursor. The onset of a sleep apnea event of sleep apnea precursor may require the stimulation of the genioglossus muscle of the patient to relieve or avert the event. Such stimulation may result in contraction of the muscle and movement of the patient's tongue away from the patient's airway.

In embodiments for the treatment of head pain, including migraines, processor <NUM> may be configured to generate a modulation control signal based on a signal from a user, for example, or a detected level of neural activity in a sensory neuron (e.g. the greater occipital nerve or trigeminal nerve) associated with head pain. A modulation control signal generated by the processor and applied to the primary antenna <NUM> may generate a modulation signal at implant electrodes 158a, 158b, e.g., to cause inhibition or blocking of a sensory nerve of the patient. Such inhibition or blocking may decrease or eliminate the sensation of pain for the patient.

In embodiments for the treatment of hypertension, processor <NUM> may be configured to generate a modulation control signal based on, for example, pre-programmed instructions and/or signals from an implant indicative of blood pressure. A modulation control signal generated by the processor and applied to the primary antenna <NUM> may generate a modulation signal at implant electrodes 158a, 158b, e.g., to cause either inhibition or stimulation of nerve of a patient, depending on the requirements. For example, a neuromodulator placed in a carotid artery or jugular artery (i.e. in the vicinity of a carotid baroreceptor), may receive a modulation control signal tailored to induce a stimulation signal at the electrodes, thereby causing the glossopharyngeal nerve associated with the carotid baroreceptors to fire at an increased rate in order to signal the brain to lower blood pressure. Similar modulation of the glossopharyngeal nerve may be achieved with a neuromodulator implanted in a subcutaneous location in a patient's neck or behind a patient's ear. A neuromodulator place in a renal artery may receive a modulation control signal tailored to cause an inhibiting or blocking signal at the electrodes, thereby inhibiting a signal to raise blood pressure carried from the renal nerves to the kidneys.

Modulation control signals may include stimulation control signals, and sub-modulation control signals may include sub-stimulation control signals. Stimulation control signals may have any amplitude, pulse duration, or frequency combination that results in a stimulation signal at electrodes 158a, 158b. In some embodiments (e.g., at a frequency of between about <NUM>-<NUM>), stimulation control signals may include a pulse duration of greater than about <NUM> microseconds and/or an amplitude of approximately. <NUM> amps, or between <NUM> amps and <NUM> amp, or between <NUM> amps and <NUM> amps. Sub-stimulation control signals may have a pulse duration less than about <NUM>, or less than about <NUM> nanoseconds and/or an amplitude less than about <NUM> amp, <NUM> amps, <NUM> amps, <NUM> amps, or <NUM> amps. Of course, these values are meant to provide a general reference only, as various combinations of values higher than or lower than the exemplary guidelines provided may or may not result in nerve stimulation.

In some embodiments, stimulation control signals may include a pulse train, wherein each pulse includes a plurality of sub-pulses. An alternating current signal (e.g., at a frequency of between about <NUM>-<NUM>) may be used to generate the pulse train, as follows. A sub-pulse may have a duration of between <NUM>-<NUM> microseconds, or a duration of between <NUM> microsecond and <NUM> milliseconds, during which an alternating current signal is turned on. For example, a <NUM> microsecond sub-pulse of a <NUM> alternating current signal will include approximately <NUM> periods. Each pulse may, in turn, have a duration of between <NUM> and <NUM> milliseconds, during which sub-pulses occur at a frequency of between <NUM> and <NUM>. For example, a <NUM> millisecond pulse of <NUM> sub-pulses will include approximately <NUM> sub-pulses. Finally, in a pulse train, each pulse may be separated from the next by a duration of between <NUM> and <NUM> seconds. For example, in a pulse train of <NUM> millisecond pulses, each separated by <NUM> seconds from the next, a new pulse will occur every <NUM> seconds. A pulse train of this embodiment may be utilized, for example, to provide ongoing stimulation during a treatment session. In the context of OSA, a treatment session may be a period of time during which a subject is asleep and in need of treatment to prevent OSA. Such a treatment session may last anywhere from about three to ten hours. In the context of other conditions to which neural modulators of the present disclosure are applied, a treatment session may be of varying length according to the duration of the treated condition.

Processor <NUM> may be configured to determine a degree of coupling between primary antenna <NUM> and secondary antenna <NUM> by monitoring one or more aspects of the primary coupled signal component received through feedback circuit <NUM>. In some embodiments, processor <NUM> may determine a degree of coupling between primary antenna <NUM> and secondary antenna <NUM> by monitoring a voltage level associated with the primary coupled signal component, a current level, or any other attribute that may depend on the degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. For example, in response to periodic sub-modulation signals applied to primary antenna <NUM>, processor <NUM> may determine a baseline voltage level or current level associated with the primary coupled signal component. This baseline voltage level, for example, may be associated with a range of movement of the patient's tongue when a sleep apnea event or its precursor is not occurring, e.g. during normal breathing. As the patient's tongue moves toward a position associated with a sleep apnea event or its precursor, the coaxial, lateral, or angular offset between primary antenna <NUM> and secondary antenna <NUM> may change. As a result, the degree of coupling between primary antenna <NUM> and secondary antenna <NUM> may change, and the voltage level or current level of the primary coupled signal component on primary antenna <NUM> may also change. Processor <NUM> may be configured to recognize a sleep apnea event or its precursor when a voltage level, current level, or other electrical characteristic associated with the primary coupled signal component changes by a predetermined amount or reaches a predetermined absolute value.

<FIG> provides a graph that illustrates this principle in more detail. For a two-coil system where one coil receives a radio frequency (RF) drive signal, graph <NUM> plots a rate of change in induced current in the receiving coil as a function of coaxial distance between the coils. For various coil diameters and initial displacements, graph <NUM> illustrates the sensitivity of the induced current to further displacement between the coils, moving them either closer together or further apart. It also indicates that, overall, the induced current in the secondary coil will decrease as the secondary coil is moved away from the primary, drive coil, i.e. the rate of change of induced current, in mA/mm, is consistently negative. The sensitivity of the induced current to further displacement between the coils varies with distance. For example, at a separation distance of <NUM>, the rate of change in current as a function of additional displacement in a <NUM> coil is approximately -<NUM> mA/mm. If the displacement of the coils is approximately <NUM>, the rate of change in the induced current in response to additional displacement is approximately -<NUM> mA/mm, which corresponds to a local maximum in the rate of change of the induced current. Increasing the separation distance beyond <NUM> continues to result in a decline in the induced current in the secondary coil, but the rate of change decreases. For example, at a separation distance of about <NUM>, the <NUM> coil experiences a rate of change in the induced current in response to additional displacement of about -<NUM> mA/mm. With this type of information, processor <NUM> may be able to determine a particular degree of coupling between primary antenna <NUM> and secondary antenna <NUM>, at any given time, by observing the magnitude and/or rate of change in the magnitude of the current associated with the primary coupled signal component on primary antenna <NUM>.

Processor <NUM> may be configured to determine a degree of coupling between primary antenna <NUM> and secondary antenna <NUM> by monitoring other aspects of the primary coupled signal component. For example, in some embodiments, the non-linear behavior of circuitry <NUM> in implant unit <NUM> may be monitored to determine a degree of coupling. For example, the presence, absence, magnitude, reduction and/or onset of harmonic components in the primary coupled signal component on primary antenna <NUM> may reflect the behavior of circuitry <NUM> in response to various control signals (either sub-modulation or modulation control signals) and, therefore, may be used to determine a degree of coupling between primary antenna <NUM> and secondary antenna <NUM>.

As shown in <FIG>, circuitry <NUM> in implant unit <NUM> may constitute a non-linear circuit due, for example, to the presence of non-linear circuit components, such as diode <NUM>. Such non-linear circuit components may induce non-linear voltage responses under certain operation conditions. Non-linear operation conditions may be induced when the voltage potential across diode <NUM> exceeds the activation threshold for diode <NUM>. Thus, when implant circuitry <NUM> is excited at a particular frequency, this circuit may oscillate at multiple frequencies. Spectrum analysis of the secondary signal on secondary antenna <NUM>, therefore, may reveal one or more oscillations, called harmonics, that appear at certain multiples of the excitation frequency. Through coupling of primary antenna <NUM> and secondary antenna <NUM>, any harmonics produced by implant circuitry <NUM> and appearing on secondary antenna <NUM> may also appear in the primary coupled signal component present on primary antenna <NUM>.

In certain embodiments, circuitry <NUM> may include additional circuit components that alter the characteristics of the harmonics generated in circuitry <NUM> above a certain transition point. Monitoring how these non-linear harmonics behave above and below the transition point may enable a determination of a degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. For example, as shown in <FIG>, circuitry <NUM> may include a harmonics modifier circuit <NUM>, which may include any electrical components that non-linearly alter the harmonics generated in circuitry <NUM>. In some embodiments, harmonics modifier circuit <NUM> may include a pair of Zener diodes. Below a certain voltage level, these Zener diodes remain forward biased such that no current will flow through either diode. Above the breakdown voltage of the Zener diodes, however, these devices become conductive in the reversed biased direction and will allow current to flow through harmonics modifier circuit <NUM>. Once the Zener diodes become conductive, they begin to affect the oscillatory behavior of circuitry <NUM>, and, as a result, certain harmonic oscillation frequencies may be affected (e.g., reduced In magnitude).

<FIG> and <FIG> illustrate this effect. For example, <FIG> illustrates a graph 300a that shows the oscillatory behavior of circuitry <NUM> at several amplitudes ranging from about <NUM> nanoamps to about <NUM> microamps. As shown, the primary excitation frequency occurs at about <NUM> and harmonics appear both at even and odd multiples of the primary excitation frequency. For example, even multiples appear at twice the excitation frequency (peak 302a), four times the excitation frequency (peak 304a) and six times the excitation frequency (peak 306a), As the amplitude of the excitation signal rises between <NUM> nanoamps and <NUM> microamps, the amplitude of peaks 302a, 304a, and 306a all increase.

<FIG> illustrates the effect on the even harmonic response of circuitry <NUM> caused by harmonics modifier circuit <NUM>. <FIG> illustrates a graph 300b that shows the oscillatory behavior of circuitry <NUM> at several amplitudes ranging from about <NUM> microamps to about <NUM> microamps. As in <FIG>, <FIG> shows a primary excitation frequency at about <NUM> and second, fourth, and sixth order harmonics (peaks 302b, 304b, and 306b, respectively) appearing at even multiples of the excitation frequency. As the amplitude of the excitation signal rises, however, between about <NUM> microamps to about <NUM> microamps, the amplitudes of peaks 302b, 304b, and 306b do not continuously increase. Rather, the amplitude of the second order harmonics decreases rapidly above a certain transition level (e.g., about <NUM> microamps in <FIG>). This transition level corresponds to the level at which the Zener diodes become conductive in the reverse biased direction and begin to affect the oscillatory behavior of circuitry <NUM>.

Monitoring the level at which this transition occurs may enable a determination of a degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. For example, in some embodiments, a patient may attach external unit <NUM> over an area of the skin under which implant unit <NUM> resides. Processor <NUM> can proceed to cause a series of sub-modulation control signals to be applied to primary antenna <NUM>, which in turn cause secondary signals on secondary antenna <NUM>. These sub-modulation control signals may progress over a sweep or scan of various signal amplitude levels. By monitoring the resulting primary coupled signal component on primary antenna <NUM> (generated through coupling with the secondary signal on secondary antenna <NUM>), processor <NUM> can determine the amplitude of primary signal (whether a sub-modulation control signal or other signal) that results in a secondary signal of sufficient magnitude to activate harmonics modifier circuit <NUM>. That is, processor <NUM> can monitor the amplitude of the second, fourth, or sixth order harmonics and determine the amplitude of the primary signal at which the amplitude of any of the even harmonics drops. <FIG> and <FIG> illustrate the principles of detecting coupling through the measurement of non-linear harmonics. These Figures illustrate data based around a <NUM> excitation frequency. These principles, however, are not limited to the <NUM> excitation frequency illustrated, and may be used with a primary signal of any suitable frequency.

In some embodiments, the determined amplitude of the primary signal corresponding to the transition level of the Zener diodes (which may be referred to as a primary signal transition amplitude) may establish a baseline range when the patient attaches external unit <NUM> to the skin. Presumably, while the patient is awake, the tongue is not blocking the patient's airway and moves with the patients breathing in a natural range, where coupling between primary antenna <NUM> and secondary antenna <NUM> may be within a baseline range. A baseline coupling range may encompass a maximum coupling between primary antenna <NUM> and secondary antenna <NUM>. A baseline coupling range may also encompass a range that does not include a maximum coupling level between primary antenna <NUM> and secondary antenna <NUM>. Thus, the initially determined primary signal transition amplitude may be fairly representative of a non-sleep apnea condition and may be used by processor <NUM> as a baseline in determining a degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. Optionally, processor <NUM> may also be configured to monitor the primary signal transition amplitude over a series of scans and select the minimum value as a baseline, as the minimum value may correspond to a condition of maximum coupling between primary antenna <NUM> and secondary antenna <NUM> during normal breathing conditions.

As the patient wears external unit <NUM>, processor <NUM> may periodically scan over a range of primary signal amplitudes to determine a current value of the primary signal transition amplitude. In some embodiments, the range of amplitudes that processor <NUM> selects for the scan may be based on (e.g., near) the level of the baseline primary signal transition amplitude. If a periodic scan results in determination of a primary signal transition amplitude different from the baseline primary signal transition amplitude, processor <NUM> may determine that there has been a change from the baseline initial conditions. For example, in some embodiments, an increase in the primary signal transition amplitude over the baseline value may indicate that there has been a reduction in the degree of coupling between primary antenna <NUM> and secondary antenna <NUM> (e.g., because the implant has moved or an internal state of the implant has changed).

In addition to determining whether a change in the degree of coupling has occurred, processor <NUM> may also be configured to determine a specific degree of coupling based on an observed primary signal transition amplitude. For example, in some embodiments, processor <NUM> may have access to a lookup table or a memory storing data that correlates various primary signal transition amplitudes with distances (or any other quantity indicative of a degree of coupling) between primary antenna <NUM> and secondary antenna <NUM>. In other embodiments, processor <NUM> may be configured to calculate a degree of coupling based on performance characteristics of known circuit components,.

By periodically determining a degree of coupling value, processor <NUM> may be configured to determine, in situ, appropriate parameter values for the modulation control signal that will ultimately result in nerve modulation. For example, by determining the degree of coupling between primary antenna <NUM> and secondary antenna <NUM>, processor <NUM> may be configured to select characteristics of the modulation control signal (e.g., amplitude, pulse duration, frequency, etc.) that may provide a modulation signal at electrodes 158a, 158b in proportion to or otherwise related to the determined degree of coupling. In some embodiments, processor <NUM> may access a lookup table or other data stored in a memory correlating modulation control signal parameter values with degree of coupling. In this way, processor <NUM> may adjust the applied modulation control signal in response to an observed degree of coupling.

Additionally or alternatively, processor <NUM> may be configured to determine the degree of coupling between primary antenna <NUM> and secondary antenna <NUM> during modulation. The tongue, or other structure on or near which the implant is located, and thus implant unit <NUM>, may move as a result of modulation. Thus, the degree of coupling may change during modulation. Processor <NUM> may be configured to determine the degree of coupling as it changes during modulation, in order to dynamically adjust characteristics of the modulation control signal according to the changing degree of coupling. This adjustment may permit processor <NUM> to cause implant unit <NUM> to provide an appropriate modulation signal at electrodes 158a, 158b throughout a modulation event, For example, processor <NUM> may alter the primary signal in accordance with the changing degree of coupling in order to maintain a constant modulation signal, or to cause the modulation signal to be reduced in a controlled manner according to patient needs,.

More particularly, the response of processor <NUM> may be correlated to the determined degree of coupling. Sn situations where processor <NUM> determines that the degree of coupling between primary antenna <NUM> and secondary antenna has fallen only slightly below a predetermined coupling threshold (e. g, during snoring or during a small vibration of the tongue or other sleep apnea event precursor), processor <NUM> may determine that only a small response is necessary. Thus, processor <NUM> may select modulation control signal parameters that will result in a relatively small response (e.g., a short stimulation of a nerve, small muscle contraction, etc.). Where, however, processor <NUM> determines that the degree of coupling has fallen substantially below the predetermined coupling threshold (e.g., where the tongue has moved enough to cause a sleep apnea event), processor <NUM> may determine that a larger response is required, As a result, processor <NUM> may select modulation control signal parameters that will result in a larger response. In some embodiments, only enough power may be transmitted to implant unit <NUM> to cause the desired level of response. In other words, processor <NUM> may be configured to cause a metered response based on the determined degree of coupling between primary antenna <NUM> and secondary antenna <NUM>, As the determined degree of coupling decreases, processor <NUM> may cause transfer of power in increasing amounts, Such an approach may preserve battery life in the external unit <NUM>, may protect circuitry <NUM> and circuitry <NUM>, may increase effectiveness in addressing the type of detected condition (e.g., sleep apnea, snoring, tongue movement, etc.), and may be more comfortable for the patient,.

In some embodiments, processor <NUM> may employ an iterative process in order to select modulation control signal parameters that result in a desired response level. For example, upon determining that a modulation control signal should be generated, processor <NUM> may cause generation of an initial modulation control signal based on a set of predetermined parameter values. If feedback from feedback circuit <NUM> indicates that a nerve has been modulated {e.g. if an increase in a degree of coupling is observed), then processor <NUM> may return to a monitoring mode by issuing sub-modulation control signals. If, on the other hand, the feedback suggests that the intended nerve modulation did not occur as a result of the intended modulation control signal or that modulation of the nerve occurred but only partially provided the desired result (e. g, movement of the tongue only partially away from the airway), processor <NUM> may change one or more parameter values associated with the modulation control signal (e.g., the amplitude, pulse duration, etc.),.

Where no nerve modulation occurred, processor <NUM> may increase one or more parameters of the modulation control signal periodically until the feedback indicates that nerve modulation has occurred. Where nerve modulation occurred, but did not produce the desired result, processor <NUM> may re-evaluate the degree of coupling between primary antenna <NUM> and secondary antenna <NUM> and select new parameters for the modulation control signal targeted toward achieving a desired result. For example, where stimulation of a nerve causes the tongue to move only partially away from the patient's airway, additional stimulation may be desired. Because the tongue has moved away from the airway, however, implant unit <NUM> may be closer to external unit <NUM> and, therefore, the degree of coupling may have increased. As a result, to move the tongue a remaining distance to a desired location may require transfer to implant unit <NUM> of a smaller amount of power than what was supplied prior to the last stimulation-induced movement of the tongue. Thus, based on a newly determined degree of coupling, processor <NUM> can select new parameters for the stimulation control signal aimed at moving the tongue the remaining distance to the desired location,.

In one mode of operation, processor <NUM> may be configured to sweep over a range of parameter values until nerve modulation is achieved. For example, in circumstances where an applied sub-modulation control signal results in feedback indicating that nerve modulation is appropriate, processor <NUM> may use the last applied sub-modulation control signal as a starting point for generation of the modulation control signal. The amplitude and/or pulse duration (or other parameters) associated with the signal applied to primary antenna <NUM> may be iteratively increased by predetermined amounts and at a predetermined rate until the feedback indicates that nerve modulation has occurred.

Processor <NUM> may be configured to determine or derive various physiologic data based on the determined degree of coupling between primary antenna <NUM> and secondary antenna <NUM>. For example, in some embodiments the degree of coupling may indicate a distance between external unit <NUM> and implant unit <NUM>, which processor <NUM> may use to determine a position of external unit <NUM> or a relative position of a patient's tongue. Monitoring the degree of coupling can also provide such physiologic data as whether a patient's tongue is moving or vibrating (e. g, whether the patient is snoring), by how much the tongue is moving or vibrating, the direction of motion of the tongue, the rate of motion of the tongue, etc,.

In response to any of these determined physiologic data, processor <NUM> may regulate delivery of power to implant unit <NUM> based on the determined physiologic data. For example, processor <NUM> may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data. If the physiologic data indicates that the tongue is vibrating, for example, processor <NUM> may determine that a sleep apnea event is likely to occur and may issue a response by delivering power to implant unit <NUM> in an amount selected to address the particular situation. If the tongue is in a position blocking the patient's airway (or partially blocking a patient's airway), but the physiologic data indicates that the tongue is moving away from the airway, processor <NUM> may opt to not deliver power and wait to determine if the tongue clears on its own. Alternatively, processor <NUM> may deliver a small amount of power to implant unit <NUM> (e.g., especially where a determined rate of movement indicates that the tongue is moving slowly away from the patient's airway) to encourage the tongue to continue moving away from the patient's airway or to speed its progression away from the airway. The scenarios described are exemplary only. Processor <NUM> may be configured with software and/or logic enabling it to address a variety of different physiologic scenarios with particularity. In each case, processor <NUM> may be configured to use the physiologic data to determine an amount of power to be delivered to implant unit <NUM> in order to modulate nerves associated with the tongue with the appropriate amount of energy.

The disclosed embodiments may be used in conjunction with a method for regulating delivery of power to an implant unit. The method may include determining a degree of coupling between primary antenna <NUM> associated with external unit <NUM> and secondary antenna <NUM> associated with implant unit <NUM>, implanted in the body of a patient. Determining the degree of coupling may be accomplished by processor <NUM> located external to implant unit <NUM> and that may be associated with external unit <NUM>. Processor <NUM> may be configured to regulate delivery of power from the external unit to the implant unit based on the determined degree of coupling.

As previously discussed, the degree of coupling determination may enable the processor to further determine a location of the implant unit. The motion of the implant unit may correspond to motion of the body part where the implant unit may be attached. This may be considered physiologic data received by the processor. The processor may, accordingly, be configured to regulate delivery of power from the power source to the implant unit based on the physiologic data. Sn alternative embodiments, the degree of coupling determination may enable the processor to determine information pertaining to a condition of the implant unit. Such a condition may include location as well as information pertaining to an internal state of the implant unit. The processor may, according to the condition of the implant unit, be configured to regulate delivery of power from the power source to the implant unit based on the condition data.

Claim 1:
A method for encapsulating an implant unit (<NUM>), ttmt- the implant unit comprising:
providing a substrate (<NUM>), the substrate including an implantable circuit (<NUM>) arranged on the substrate;
disposing an encapsulation structure over at least a portion of the substrate and at least a portion of the implantable circuit, wherein
the encapsulation structure includes a first polymer layer (<NUM>) and a second polymer layer (<NUM>), and wherein disposing the encapsulation structure comprises:
disposing the first polymer layer on at least a portion of the substrate and at least a portion of the implantable circuit; and
disposing the second polymer layer on the first polymer layer,
wherein the first polymer layer has a first density and the second polymer has a second density, wherein the second density is less than the first density.