Membrane diaphragm capacitive electrode

Abstract

An implantable sensor device comprises: a deflectable membrane layer comprising a vapor deposited thin film metal; a first capacitive electrode, the first capacitive electrode being conformally formed on a first side of the deflectable diaphragm layer; and a second capacitive electrode coupled to the rigid substrate, the second capacitive electrode and the first capacitive electrode forming a variable capacitor. Implantable sensor devices are fabricated by depositing a thin film metal layer on a substrate using a physical vapor deposition process and depositing a conformal electrical conductor layer on a stack comprising the thin film metal layer.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 581,226, filed on September 7, 2023, entitled “Thin-FilmDiaphragm Capacitive Electrode,” the entire disclosure of which is hereby incorporated by reference. Background Technology

[0003] This disclosure generally relates to the field of sensor devices. Some sensor devices (such as those suitable for medical implantation) may include a deflectable diaphragm. The size, elasticity, flexibility, biocompatibility, shape, and other characteristics of such a deflectable diaphragm assembly can affect its suitability for implementation in implantable sensor devices. Summary of the Invention

[0004] This document describes methods, systems, and apparatuses for facilitating the conversion of pressure (such as blood / fluid pressure levels in the human body) into electrical signals for the purpose of sensing pressure. Specifically, this document discloses various pressure sensor packaging solutions that provide deposited metal or other material layers to form diaphragm structures comprising one or more layers, at least one of which includes / forms a conductive capacitive electrode (e.g., an 'anode') layer. Such diaphragm structures / stacks can advantageously have a relatively thin profile and / or hyperelastic properties. For example, sensor devices according to various aspects of this disclosure, which can serve as biocompatible sensor implantation devices for cardiac or other implants, may include one or more diaphragms formed from a thin, hyperelastic vapor-deposited layer that can be formed of nitinol or a similar material, wherein a capacitive electrode layer is formed on the nitinol layer. The conductive electrode layer may be directly disposed on the deposited thin film, hyperelastic metal (e.g., nitinol) layer, or one or more dielectric / insulating layers may be formed between the electrode and the hyperelastic metal layer. The thin-film superelastic metal and / or electrode layer may have certain topological / surface features that advantageously increase the linear deflection and / or effective surface area of ​​the diaphragm on one or more sides, such as corrugations, ridges, valleys, bumps, pillars, columns, spikes / pyramids, cones, clusters and / or other geometric / uniform and / or amorphous / irregular features.

[0005] Examples of this disclosure may include thin, superelastic metal (e.g., nitinol) membranes on which one or more layers of high-k dielectric are deposited / formed, wherein the superelastic metal layers provide a mechanical structure / substrate for dielectric and conductor stacking. The deposited thin-film metal layers can advantageously provide a superelastic, biocompatible facet / shell for sensor devices.

[0006] Any of the various systems, apparatuses, devices, etc. disclosed herein can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods herein may include sterilizing the associated systems, apparatuses, devices, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0007] The methods and structures disclosed herein for treating patients also encompass similar methods and structures for performing or placing on simulated patients, which can be used for, for example, training; demonstration; program and / or device development; and so on. Simulated patients can be physical, virtual, or a combination of physical and virtual. Simulations can include simulations of all or part of a patient, such as the whole body, parts of the body (e.g., chest), systems (e.g., cardiovascular system), organs (e.g., heart), or any combination thereof. Physical elements can be: natural, including human or animal carcasses or parts thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in a computer simulation or overlaid on one or more physical elements. Virtual elements can be presented on any combination of a screen, headphones, holographic projection, speakers, headsets, pressure transducers, temperature transducers, or any combination using suitable technologies.

[0008] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that, depending on any particular instance, not all such advantages may be realized. Therefore, the disclosed instances may be carried out in a manner that implements or optimizes one or a set of advantages as taught herein, without necessarily implementing other advantages as may be taught or suggested herein. Attached Figure Description

[0009] For illustrative purposes, various examples are depicted in the accompanying drawings, and these examples should in no way be construed as limiting the scope of the invention. Furthermore, various features of different disclosed examples can be combined to form other examples that are part of this disclosure. Throughout the drawings, reference numerals may be used repeatedly to indicate correspondences between reference elements.

[0010] Figure 1 The illustration shows certain human anatomy structures that demonstrate the location of the instance sensor implantation based on one or more instances.

[0011] Figure 2 It is a block diagram representing a system for wirelessly monitoring one or more physiological parameters associated with a patient, based on one or more instances.

[0012] Figure 3A and 3B A cross-sectional side view of a piezoresistive pressure sensor device according to one or more examples is shown.

[0013] Figure 4A and 4B A cross-sectional side view of a capacitive pressure sensor device according to one or more examples is shown.

[0014] Figure 5A and 5B A cross-sectional view of a sensor implantation device including a pressure transmission medium, according to one or more examples, is shown.

[0015] Figure 6 It is a graph showing the relationship between sensor diaphragm thickness, surface area, and sensitivity based on one or more examples.

[0016] Figure 7 This is a block diagram illustrating a thin film deposition system according to one or more examples.

[0017] Figure 8 A side cross-sectional schematic diagram of a sensor device having capacitive electrodes that are structurally conformal to a thin film or a superelastic diaphragm, according to one or more examples, is shown.

[0018] Figure 9-1 and 9-2 Together, flowcharts are provided illustrating the process for manufacturing a capacitive electrode stack based on one or more examples.

[0019] Figure 10-1 , 10-2 Tables 10-3, 10-4, and 10-5 illustrate the relationship between one or more instances and... Figure 9-1 and 9-2 The flowchart shows the side cross-sectional view of the capacitive electrode stack / structure corresponding to the various operations.

[0020] Figure 11 Various surface topologies that can be implemented for the diaphragm and / or electrode layers of various sensor devices of this disclosure, according to one or more examples, are shown.

[0021] Figure 12 A schematic diagram of a wafer having multiple membrane structures formed thereon, according to one or more examples, is shown.

[0022] Figure 13A and 13B A front perspective view and a rear perspective view of an electrode-integrated sensor diaphragm structure according to one or more examples are shown.

[0023] Figure 14 The base electrode structure of a sensor device according to one or more examples is shown.

[0024] Figure 15A sensor device comprising one or more diaphragm structures physically coupled to a base structure is shown according to one or more examples.

[0025] Figure 16 The electrical connections of components of a capacitive sensor device according to one or more examples are shown.

[0026] Figure 17 A sensor with one or more corrugated diaphragms is shown according to one or more examples.

[0027] Figure 18 A cross-sectional side view of a corrugated diaphragm with conformal capacitive electrodes according to one or more examples is shown.

[0028] Figure 19 It is a cross-sectional view of the human heart and associated vascular system, illustrating certain catheter access pathways for sensor device implantation procedures according to one or more examples.

[0029] Figure 20A , 20B Figure 20C shows a plan view of an electrode-integrated sensor diaphragm structure design based on one or more examples.

[0030] Figure 21A A plan view of a thin-film diaphragm sensor device according to one or more examples is shown.

[0031] Figure 21B and 21C Exploded side views and combined / assembled views of a thin-film diaphragm sensor device according to one or more examples are shown respectively. Detailed Implementation

[0032] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0033] Although certain preferred examples are disclosed below, it should be understood that the subject matter of the invention extends beyond the specific examples disclosed herein, reaching other alternative examples and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any of the specific examples described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple discrete operations in a manner that may aid in understanding certain examples; however, the order of description should not be construed as implying that these operations are sequentially related. Furthermore, the structures, systems, and / or apparatuses described herein may be embodied as integrated components or separate components. For the purpose of comparison, certain aspects and advantages of these examples are described. Not all of these aspects or advantages are necessarily achieved through any particular example. Thus, for example, various examples may be performed in a manner that achieves or optimizes one or a set of advantages taught herein, without necessarily achieving other aspects or advantages also taught or suggested herein.

[0034] This document uses certain spatial relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” “distal,” “proximal,” and similar terms, to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure. It should be understood that these terms are used herein for ease of description of the positional relationship between elements / structures, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, spatial relative terms are intended to cover different orientations of elements / structures in use or operation. For example, an element / structure described as “above” another element / structure may indicate a position below or beside such other element / structure relative to the subject patient or an alternative orientation of the element / structure, and vice versa. It should be understood that spatial relative terms (including those listed above) can be understood relative to the corresponding orientations shown in the reference figures.

[0035] For convenience, certain reference numerals are repeated in different figures within the group of figures disclosed herein for the purpose of identifying devices, components, systems, features, and / or modules that have similar characteristics in one or more aspects. However, with respect to any instance disclosed herein, the reuse of common reference numerals in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, those skilled in the art will understand from the context that the use of common reference numerals may imply the degree of similarity between the referenced subjects. The use of a particular reference numeral in the context of the description of a particular figure can be understood to relate to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference numeral in another figure. Furthermore, aspects of individual figures identified by common reference numerals can be interpreted as sharing characteristics or being completely independent of each other.

[0036] When using alphanumeric reference numerals that include both numerical and alphabetic parts (e.g., '10a', where '10' is the numerical part and 'a' is the alphabetic part), a written description referring only to the numerical part (e.g., '10') may refer to any feature identified in the figure using such a numerical part (e.g., '10a', '10b', '10c', etc.), even if those features are identified using reference numerals that concatenate their numerical part with one or more alphabetic characters (e.g., 'a', 'b', 'c', etc.). That is, a reference to feature '10' in this written description can be understood to refer to the identified feature '10a' in a particular figure of this disclosure, or to the identifier '10' or '10b' in the same or another figure as an example.

[0037] This disclosure relates to systems, apparatus, and methods for encapsulating devices configured to sense and / or telemetry monitor one or more physiological parameters (e.g., blood pressure) of a patient. Such pressure sensing / monitoring can be performed using a cardiac implantable device having a thin-film pressure sensor diaphragm with integrated and / or conformal capacitor electrodes. The term "thin film" is used herein according to its broad and general meaning and can refer to any membrane, layer, sheet, skin, veneer, coating, covering, plating, enamel, finish, shell, overlay, or other type of sheet with a thickness ranging from several nanometers (nm) to several micrometers (µm). Thin-film sheets of this disclosure can be applied to a substrate during manufacturing and can be produced using various deposition techniques, including but not limited to sputtering, electrodeposition, thermal deposition, chemical vapor deposition (CVD), and physical vapor deposition (PVD). The formation of thin-film sheets according to various aspects of this disclosure may involve a phase transition from a solid source material to a gas, and the recombination of the gas into a solid state during the deposition process. The thin film membrane disclosed herein may comprise any suitable or desired material, including: metals such as gold, silver, platinum, titanium, nickel, copper, aluminum, etc., and their alloys; alloys such as nickel-titanium or other superelastic materials, NiTiCu (nickel-titanium-copper), AuSn (gold-tin), nickel-cobalt-iron alloys (e.g., Kovar). ® Materials used in the production of aluminum oxides include: Ni29Co17Fe54, stainless steel, etc.; semiconductors such as silicon, gallium arsenide (GaAs), indium phosphide (InP), cadmium telluride (CdTe), etc.; oxides such as aluminum oxide (Al2O3), titanium dioxide (TiO2), zinc oxide (ZnO), etc.; nitrides such as titanium nitride (TiN), silicon nitride (Si3N4), gallium nitride (GaN), etc.; polymers such as polytetrafluoroethylene (PTFE), polyimide, polyethylene terephthalate (PET), etc.; and ceramics such as silicon carbide (SiC), aluminum nitride (AlN), etc. For example, depending on the desired material properties, the thickness of the thin film can be as small as 1 nm or as large as 10 µm, 15 µm, 20 µm or greater. The films disclosed herein can be formed using any type of sputtering process, including any process in which atoms or molecules are ejected from a target material due to bombardment by energetic particles such as ions from plasma, wherein the ejected particles travel through a vacuum or low-pressure gas environment and condense onto a target substrate to form a thin film. As used herein, “sputtering” can encompass any type of DC, RF, magnetron, or reactive sputtering or any other vapor deposition process.

[0038] Sensor devices according to various aspects of this disclosure can be advantageously packaged for long-term implantation in a cardiac environment and can therefore have certain biocompatibility characteristics associated with them. The terms “associated” and “related to” are used herein in their broad and general sense. For example, where a first feature, element, component, device, or member is described as being associated with a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is directly or indirectly physically coupled, attached, connected, integrated, at least partially embedded therein, or otherwise physically associated with the second feature, element, component, device, or member.

[0039] Examples of capacitive pressure sensor devices disclosed herein may advantageously include electrode structures having one or more layers formed by physical vapor deposition and / or other thin-film deposition / forming processes. Such examples may advantageously combine multilayered hyperelastic deflectable substrates, dielectrics, and capacitive conductors / electrodes into a single thin-film structure suitable for implantation in the human body.

[0040] As described in detail below, implantable pressure sensors can be used to measure pressure levels in various catheters and chambers of the body, such as the various chambers of the heart. However, due to the accessibility and environmental conditions typically associated with cardiac catheters / chambers and / or other potential sensor implantation sites within the patient, only certain types of sensors and sensor packages may be suitable for implantation in a given application. Examples of this disclosure relate to the packaging of pressure sensor implantation devices that include certain electronic and telemetry features to allow for data and / or electrical wireless communication between the implantable sensor device and one or more devices or systems outside the patient's body.

[0041] This disclosure relates to sensor devices, such as wireless implantable pressure sensor devices and other devices including deflectable diaphragm assemblies. Specifically, the inventive features disclosed herein can be implemented in the context of implantable sensor devices, wherein the integrated diaphragm feature can advantageously provide a biocompatible seal and / or encapsulation of internal sensor assemblies, such as capacitive electrodes and other circuitry, as well as other structural components.

[0042] Regarding implantable pressure sensor devices, anatomical considerations may necessitate the use of sensor devices with relatively small shape factors. For example, it may be desirable to implant sensor devices, such as pressure sensor devices, using a transcatheter procedure, where the sensor device advances to the target implantation site via one or more venous or arterial vessels and / or various tortuous access paths. Examples of this disclosure are advantageously implemented in sensor devices with sufficiently small profiles / sizes for delivery by and / or within a catheter, sheath, or other instrument configured for transcatheter access / use. In addition to the size design constraints associated with implantable sensor devices (e.g., pressure sensor devices), sensor sensitivity and / or dynamic range requirements or expectations can also drive sensor design. For example, with respect to pressure sensor devices, the deflectable pressure diaphragm associated with such devices can be designed in a manner that provides sufficient sensitivity to the pressure conditions to which the device is exposed.

[0043] Furthermore, implantable sensor devices, such as pressure sensor devices equipped with diaphragms, may also require biocompatibility and / or encapsulation properties suitable for in vivo implantation. For example, regarding implantation within certain anatomical structures, such as within a heart chamber or other fluid-filled anatomical container / chamber, such environments may present certain pressure, turbulence, and corrosive conditions that may be associated with fluid / blood properties and / or cardiac circulation. The human body represents a relatively harsh environment for electrically implantable devices compared to non-implantable environments. Examples of this disclosure provide sensor implantation devices that provide hermetically sealed / sealed components to extend duration and / or lifetime, which is advantageous and / or critical for implantable sensor applications. For example, such hermetically sealed components can prevent degradation or otherwise interference by components of ambient blood. Additionally, the hermetically sealed embodiments of this disclosure can help prevent any non-biocompatible components of the sensor implantation device or any non-biocompatible components associated with the sensor implantation device from creating / causing toxic conditions in vivo. Examples of this disclosure also provide ion gas-deposited diaphragm layers / assemblies for sensor implantation devices that are relatively thin and provide hermetically sealed integrated sensor diaphragms. Compared to certain other welded metal solutions, this type of design can have a reduced package thickness, which may include interfaces between its metal and / or ceramic components occupying an undesirable amount of space. By integrating multiple functional components into a single thin outer layer / shell, the overall package thickness / size can be minimized.

[0044] Physiological sensor implantation site

[0045] This document discloses certain examples in the context of cardiac implantable devices. However, while some principles disclosed herein may be particularly applicable to the anatomy of the heart, it should be understood that sensor implantable devices according to this disclosure can be implanted or configured for implantation in any suitable or desired anatomical structure. Furthermore, the examples of this disclosure can also be used in non-biological environments.

[0046] The anatomy of the heart is described below to aid in understanding some of the inventive concepts disclosed herein. In humans and other vertebrates, the heart typically comprises a muscular organ with four pumping chambers, where blood flow is at least partially controlled by individual heart valves: the aortic valve, the mitral valve (or bileaflet valve), the tricuspid valve, and the pulmonary valve. These valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., relaxation and contraction) to control blood flow to various regions of the heart and / or blood vessels (e.g., the lungs, aorta, etc.). Contraction of the various myocardial muscles can be facilitated by signals generated by the heart's electrical system, which will be discussed in detail below.

[0047] Figure 1 Examples of a heart 1 and associated anatomical structures having various features associated with certain instances of the present invention disclosure are shown. The illustrated anatomical structures show example implantation sites of sensor devices according to aspects of the present disclosure. Generally, the heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. In terms of blood flow, blood typically flows from the right ventricle 4 into the pulmonary artery via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped to the lungs, and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11.

[0048] The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. Blood is then returned from the lungs to the left atrium 2 via the pulmonary vein 23. The pulmonary artery 11 includes the pulmonary trunk and the left pulmonary artery 15 and right pulmonary artery 13, branches from the pulmonary trunk, as shown in the figure. In addition to the pulmonary valve 9, the heart 1 includes three additional valves that assist in the circulation of blood within it: the tricuspid valve 8, the aortic valve 7, and the mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 typically has three tips / leaflets and is normally closed during ventricular systole (i.e., systole) and open during ventricular dilation (i.e., diastole). The mitral valve 6 typically has two tips / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood in the left atrium 2 to flow into the left ventricle 3, and to close during systole when functioning normally to prevent blood from flowing back into the left atrium 2. Aortic valve 7 separates the left ventricle 3 from the aorta 12. Aortic valve 7 is configured to open during cardiac systole to allow blood leaving the left ventricle 3 into the aorta 12, and to close during cardiac diastole to prevent blood from leaking back into the left ventricle 3.

[0049] Heart valves typically consist of a relatively dense fibrous ring (referred to herein as the annulus), and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps is such that when the heart contracts, the resulting increase in blood pressure within the corresponding heart chamber forces the leaflets to open at least partially to allow flow from the heart chamber. As the pressure within the heart chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant and compress the leaflets posteriorly. Thus, the leaflets / cusps juxtapose with each other, thereby closing the flow passage. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can lead to valvular leakage and / or other health complications.

[0050] Atrioventricular (i.e., mitral and tricuspid) heart valves are typically coupled to an assembly of chordae tendineae and papillary muscles (not shown) to secure the leaflets of the respective valves, facilitating and / or ensuring proper engagement of the leaflets and preventing their prolapse. For example, the papillary muscles may typically contain finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles via chordae tendineae. A muscular wall 17 called the septum separates the left atrium 2 and right atrium 5, and the left ventricle 3 and right ventricle 4.

[0051] Health conditions associated with heart stress and other parameters

[0052] As mentioned above, certain physiological conditions or parameters associated with cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, leading to increased fluid pressure in one or more chambers of the heart. Consequently, the heart cannot pump enough oxygen to meet the body's needs. The individual chambers of the heart may respond to the increased pressure by stretching to keep more blood pumped through the body or by becoming relatively stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump effectively. In some cases, the kidneys may respond to the decline in heart function by keeping the body fluid. The accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs can lead to congestion in the body, a condition known as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality, therefore, the treatment and / or prevention of congestive heart failure is a critical concern in medical care.

[0053] Various methods for identifying and / or treating congestive heart failure include observing worsening symptoms and / or weight changes. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements can vary considerably (e.g., up to 9% or more) and may be unreliable in signaling cardiac-related complications. Furthermore, treatment guided by monitoring signs, symptoms, weight, and / or other biomarkers has not shown significant improvements in clinical outcomes. Therefore, using implantable devices to directly or indirectly measure / monitor pressure and / or other parameters can provide better results than purely observation-based solutions. For example, without direct or indirect monitoring of cardiac pressure, it may be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure or other pathologies. Treatments or methods that do not involve direct or indirect pressure monitoring may include measuring or observing other current physiological conditions of the patient, such as measuring weight, chest impedance, right heart catheterization, etc.

[0054] Cardiac stress monitoring

[0055] Cardiac pressure monitoring according to examples of this disclosure can provide an active intervention mechanism for the prevention or treatment of congestive heart failure. Typically, an increase in ventricular filling pressure associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, in some patients, cardiac pressure parameters may be present several weeks prior to hospitalization. Therefore, a pressure monitoring system according to examples of this disclosure can be advantageously implemented to reduce hospitalization by guiding appropriate or desired drug dosing and / or administration prior to the onset of heart failure.

[0056] Dyspnea is a cardiac stress indicator characterized by shortness of breath or a feeling of difficulty breathing. Dyspnea can be caused by elevated atrial pressure, which can lead to fluid buildup in the lungs due to pressure rebound. Pathological dyspnea can be caused by congestive heart failure. However, a considerable time may pass between the initial pressure rise and the onset of dyspnea, so the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to the examples of this disclosure, normal ventricular filling pressure can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0057] The pressure sensor device disclosed herein can be implanted in any chamber / vessel of the heart or other blood vessels (e.g., aorta, vena cava). Figure 1 An implantable sensor device according to various aspects of this disclosure is shown (in...) Figure 1 Multiple implantation sites (represented by 's'). For example, such as... Figure 1 As shown, the sensor implantation device with an integrated diaphragm assembly according to this disclosure can be implanted in the right atrium, right ventricle, left atrium, left ventricle, pulmonary artery, inferior vena cava, aorta, or other anatomical structures. Typically, increased pressure in the left atrium may be particularly associated with heart failure, therefore, in some cases, it may be desirable to implant the sensor implantation device in the left atrium.

[0058] Left atrial pressure typically correlates well with left ventricular end-diastolic pressure. However, while a significant correlation may exist between left atrial pressure and pulmonary artery end-diastolic pressure, this correlation can be weakened when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure often cannot adequately correlate with left ventricular end-diastolic pressure in the presence of multiple acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension can affect the reliability of pulmonary artery pressure measurements used to estimate left-sided filling pressure. Therefore, pulmonary artery pressure measurements alone may be an inadequate or inaccurate indicator of left ventricular end-diastolic pressure, particularly in patients with comorbidities such as lung disease and / or thromboembolism. Left atrial pressure can also be correlated, at least partially, with the presence and / or extent of mitral regurgitation.

[0059] In some solutions, pulmonary capillary wedge pressure can be measured as a substitute for left atrial pressure. For example, a pressure sensor can be placed or implanted in the pulmonary artery, and the associated readings can be used as a substitute for left atrial pressure. However, catheter-based pressure measurements of the pulmonary artery or certain other chambers or regions of the heart may require the use of invasive catheters to maintain such a pressure sensor, which can be uncomfortable or difficult to implement. Furthermore, certain lung-related conditions can affect pressure readings in the pulmonary artery, potentially weakening the correlation between pulmonary artery pressure and left atrial pressure undesirably. As an alternative to pulmonary artery pressure measurement, pressure measurements in the right ventricular outflow tract can also be correlated with left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough for the diagnosis, prevention, and / or treatment of congestive heart failure. This disclosure provides systems, apparatus, and methods for encapsulating an implantable pressure sensor configured to provide direct measurement of pressure conditions at the implantation site.

[0060] Additional solutions can be implemented to derive or infer left atrial pressure. For example, the E / A ratio can be used as an alternative measure of left atrial pressure; the E / A ratio is a measure of the heart's left ventricle, representing the ratio of peak velocity blood flow (E wave) caused by gravity during early diastole due to atrial contraction to peak velocity blood flow (A wave) during late diastole. The E / A ratio can be determined using echocardiography or other imaging techniques; typically, an abnormal E / A ratio may indicate that the left ventricle is not properly filled with blood during the intervals between systole, which can lead to symptoms of heart failure, as described above. However, E / A ratio determination typically does not provide an absolute pressure measurement but rather an estimated information, which in some cases may not provide the necessary specificity. Furthermore, since ultrasound or similar imaging equipment is often not available in home settings and is not typically accessible to patients, relatively easy-to-operate mobile devices according to various aspects of this disclosure may be desirable in certain situations.

[0061] Cardiac pressure monitoring (e.g., left atrial pressure monitoring) can provide an apparatus to guide medication administration for the treatment and / or prevention of congestive heart failure. Such treatment can advantageously reduce readmissions and morbidity, as well as provide other benefits. Implantable pressure sensors according to examples of this disclosure can be used to predict heart failure up to two weeks or longer before the onset of symptoms or markers of heart failure (e.g., dyspnea). When using examples of cardiac pressure sensors according to this disclosure to identify predictors of heart failure, certain preventative measures, including pharmacological interventions such as modifying a patient's medication regimen, can be implemented, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement within the left atrium can advantageously provide an accurate indication of pressure buildup that may lead to heart failure or other complications. For example, trends in elevated atrial pressure can be analyzed or used to identify or predict the onset of cardiac dysfunction, where medications or other treatments can be increased to induce a decrease in pressure and prevent or reduce further complications.

[0062] Figure 2 This is a block diagram representing a system 200 for wirelessly monitoring one or more physiological parameters associated with a patient, based on one or more instances. Figure 2 An implantable device 30 comprising a sensor device 37 is shown, which may have a specific anchoring structure 31 associated therewith. For example, the anchoring structure 31 may be configured to anchor in and / or to one or more biological tissue walls. Although various examples of implantable sensor devices have been shown and described in this disclosure without a separate anchoring structure, it should be understood that such omissions are for clarity only, and any example disclosed herein may have a specific anchoring structure associated therewith for anchoring the device to a biological tissue / anatomical structure at the implantation site.

[0063] Sensor device 37 may be a pressure sensor according to any of the examples disclosed herein. In some examples, sensor 37 includes a transducer 32 and certain control circuitry 34, which may be implemented in, for example, an application-specific integrated circuit (ASIC) and / or one or more passive devices (e.g., resistors, capacitors, inductors, etc.). Sensor device 37 further includes a diaphragm 33 formed of a hyperelastic material, on which one or more electrode layers or other electronic devices representing portions of the transducer circuitry are layered / integrated. Diaphragm 33 may be at least partially integrated with the outer layer of sensor housing 36. In some examples, sensor housing 36 includes an RF transparent structure housing at least a portion of antenna 38.

[0064] The control circuitry 34 of the sensor device 37 can be configured to process signals received from the transducer 32 and / or wirelessly transmit associated signals through biological tissue using the antenna 38. The antenna 38 may comprise one or more coils or loops of conductive material, such as copper wire, or piezoelectric resonators, or other wireless signal transmission components. In some instances, at least a portion of the transducer 32, control circuitry 34, and / or antenna 38 is at least partially housed or contained within a sensor housing / encapsulation 36 structure, which may comprise any type of material and may advantageously be at least partially hermetically sealed. The housing 36 and the diaphragm 33 may be at least partially formed using vapor deposition, as described in more detail below.

[0065] The term "control circuit system" is used herein in its broad and general sense and can refer to any collection of processors, processing circuit systems, processing modules / units, chips, dies (e.g., semiconductor dies comprising one or more active and / or passive devices and / or interconnecting circuit systems), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuit systems, analog circuit systems, digital circuit systems, and / or any means of manipulating signals (analog and / or digital) based on circuit systems and / or hard-coded operating instructions. The control circuit system mentioned herein may also include one or more storage devices, which (analog and / or digital) can be implemented in a single storage device, multiple storage devices, and / or embedded circuit systems. Such data memory can include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any means of storing digital information. It should be noted that in instances where the control circuit system includes hardware and / or software state machines, analog circuit systems, digital circuit systems, and / or logic circuit systems, the data storage device / register storing any associated operation instructions may be embedded within or outside the circuit system that includes the state machine, analog circuit system, digital circuit system, and / or logic circuit system.

[0066] For example, in some instances, the housing / package 36 may comprise one or more tubes, cans, substrates / plates, or other structures comprising glass, epoxy resin, ceramics, metals, and / or other rigid materials, which can provide mechanical stability and / or protection for the components housed therein. In some instances, the housing / package 36 is at least partially flexible. For example, the housing / package may comprise polymers or other flexible structures / materials that can advantageously allow aspects of the sensor 37 to fold, bend, or retract to allow it to pass through a channel via a conduit or other introduction device. However, embodiments of this disclosure can be advantageously implemented in a manner that provides long-term hermetic protection, wherein the diaphragm, flexible diaphragm, and associated circuitry for pressure transduction are integrated into a single component, assembly, and / or device.

[0067] Transducer 32 can comprise any type of sensor component or mechanism. For example, transducer 32 can be a force harvester type pressure sensor. Transducer 32 is shown and described as comprising one or more diaphragms. However, it should be understood that the pressure sensor device disclosed herein can utilize any type of deflectable strain or deflection measurement component configured to measure strain or deflection applied above its region / surface, such as one or more pistons, Bourdon tubes, bellows, etc. Transducer 32 can be associated with housing / package 36 such that at least a portion thereof is contained within or attached to housing / package 36. In some instances, electrode-integrated diaphragm 33 can serve as a component of a piezoresistive MEMS pressure sensor, which can be configured to use bonded or shaped conductors to detect strain resulting from applied pressure, wherein the resistance increases as the pressure deforms the component / material. That is, the integrated electrode 33 of transducer 32 can be a component of a piezoresistive resistor. In such embodiments, the conductor can be applied to a thin-film nitinol diaphragm layer; piezoresistive pressure sensors are referred to below. Figure 3A and 3B The description is as follows. Alternatively, the diaphragm 33 may be a component of a capacitive pressure sensor, wherein a capacitive plate / electrode layer is applied to the nitinol diaphragm layer, as described in detail throughout this disclosure; the capacitive pressure sensor is generally referred to below in conjunction with Figure 4A and 4B Describe it.

[0068] In some instances, transducer 32 includes an electromagnetic pressure sensor or an assembly of an electromagnetic pressure sensor, which can be configured to measure diaphragm displacement by means of capacitance change, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some instances, transducer 32 includes a piezoelectric strain sensor or an assembly of a piezoelectric strain sensor. For example, such a sensor can determine strain (e.g., pressure) on the sensing mechanism based on the piezoelectric effect in certain materials such as quartz. In some instances, transducer 32 includes a strain gauge or an assembly of a strain gauge. In any such embodiment, the associated sensor electrodes / conductors can be applied to the thin-film nitinol diaphragm assembly, as described in detail herein.

[0069] Transducer 32 may be integrated with one or more layers of vapor-deposited biocompatible material, or may comprise one or more layers of vapor-deposited biocompatible material, as described in detail below. In some instances, transducer 32 is electrically and / or communicatively coupled to control circuitry 34, which may comprise one or more application-specific integrated circuit (ASIC) microcontrollers or chips. Control circuitry 34 may further comprise one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, etc.

[0070] exist Figure 2 In system 200, an implantable device 30 is implanted in patient 44 to monitor one or more physiological parameters (e.g., left atrial pressure). Patient 44 may have a medical implantable device 30 implanted in, for example, his / her heart (not shown) or associated physiology. For example, the implantable device 30 may be implanted at least partially in the left atrium of the patient's heart.

[0071] In some instances, the monitoring system 200 may include at least two subsystems: an implantable internal subsystem or device 30 comprising a sensor transducer 32, and a control circuitry system 34 comprising one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 200 may further include an external (e.g., non-implantable) subsystem comprising an external reader 42 (e.g., a coil), which may include a wireless transceiver electrically and / or communicatively coupled to some control circuitry system 41. In some instances, both the internal and external subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue positioned between the internal and external subsystems. The sensor implantation device 30 may be any type of implantation device. For example, in some instances, the implantation device 30 includes a pressure sensor integrated with another functional implantation structure, such as a prosthesis shunt or stent device / structure, valve, clip, etc.

[0072] The implantation device 30 may include a specific anchoring structure 31 as described above. For example, the anchoring structure 31 may include a percutaneously deliverable shunt configured to be secured to and / or within a tissue wall. Although some components are... Figure 2 The sensor implantation device 30 is shown as part of the implantation device 30; however, it should be understood that the sensor implantation device 30 may contain only a subset of the components / modules shown and may include additional components / modules not shown. The implantation device 30 may represent... Figure 8-18 Examples of any implanted devices shown, and vice versa.

[0073] In some instances, sensor transducer 32 may be configured to generate electrical signals that can be wirelessly transmitted to a device outside the patient's body, such as the local external monitoring system 42 shown. Control circuitry 34 may comprise any type of transceiver circuitry configured to transmit electromagnetic signals, which may be radiated by antenna 38, which may include one or more wires, coils, plates, etc. Control circuitry 34 of implantable device 30 may include, for example, one or more chips or dies configured to perform a certain amount of processing on signals generated and / or transmitted using device 30. However, due to size, cost, and / or other constraints, implantable device 30 may not include independent processing capabilities in some instances.

[0074] The wireless signals generated by the implanted device 30 can be received by a local external monitoring device or subsystem 42, which may include a reader / antenna interface circuit system module 43 configured to receive wireless signal transmissions from the implanted device 30, which is at least partially placed within the patient 44. For example, module 43 may include a transceiver device / circuit system.

[0075] The external local monitor 42 can use an external antenna 48, such as a rod device, to receive wireless signal transmissions and / or provide wireless power. The reader / antenna interface circuitry module 43 may include a radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30. This RF front-end circuitry may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuitry, phase-locked loop (PLL) circuitry, signal mixers, etc. The reader / antenna interface circuitry module 43 may also be configured to transmit signals to a remote monitoring subsystem or device 46 via a network 49. The RF circuitry of the reader / antenna interface circuitry module 43 may further include one or more of a digital-to-analog converter (DAC) circuitry, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc., for processing / manipulating signals transmitted via the network 49 and / or for receiving signals from the implanted device 30. In some instances, the local monitor 42 includes a control circuitry system 41 for performing processing of signals received from the implanted device 30. Local monitor 42 can be configured to communicate with network 49 according to known network protocols such as Ethernet or Wi-Fi. In some instances, local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0076] In some instances, the implantable device 30 includes a quantity of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing a floating-gate transistor array, etc. The control circuitry 34 may utilize the data storage to store sensing data collected over a period of time, wherein the stored data may be periodically transmitted to the local monitor 42 or another external subsystem. In some instances, the implantable device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate the wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuitry 34 may also be configured to receive input from one or more external subsystems (e.g., from the local monitor 42 or from a remote monitor 46) via, for example, a network 49. For example, the implantable device 30 may be configured to receive signals that at least partially control the operation of the implantable device 30, such as by activating / deactivating one or more components or sensors, or otherwise affecting the operation or performance of the implantable device 30.

[0077] One or more components of the implantable device 30 may be powered by one or more power sources 35. Due to considerations of size, cost, and / or electrical complexity, it may be desirable for the power source 35 to be inherently relatively minimal. For example, high-power drive voltages and / or currents in the implantable device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implantable device. In some instances, the power source 35 is inherently at least partially passive, allowing power to be wirelessly received from an external source via the passive circuitry of the implantable device 30, for example, through the use of short-range or near-field wireless power transmission or other electromagnetic coupling mechanisms. For example, a local monitor 42 may act as an initiator for actively generating an RF field that can power the implantable device 30, thereby allowing the implantable device's electrical circuitry to adopt a relatively simple form factor. This interrogation may be performed / implemented intermittently / occasionally, quasi-continuously, and / or continuously. In some instances, the power source 35 may be configured to draw energy from environmental sources such as fluid flow, motion, etc. Additionally or alternatively, the power source 35 may include a battery, which may be advantageously configured to provide sufficient power as needed during the monitoring period (e.g., 3, 5, 10, 20, 30, 40 or 90 days, or other time periods).

[0078] In some instances, the local monitor device 42 may act as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitor device 42 may be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitor device 42 may be a wearable communication device or other devices that can be easily placed near the patient 44 and the sensor implanted device 30. The local monitor device 42 may be configured to continuously, periodically, or intermittently query the implanted device 30 to extract or request sensor-based information. In some instances, the local monitor 42 includes a user interface through which a user can view sensor data, request sensor data, or otherwise interact with the local monitor system 42 and / or the implanted device 30.

[0079] System 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device, configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. Troubleshooting may be performed using / utilizing the local monitor 47, the monitoring performed thereunder, and / or the monitored data. In one example, local monitor 42 may be a wearable device or other device or system configured to be physically located close to the patient and / or implanted device 30, wherein local monitor 42 is primarily designed to receive signals from and / or transmit signals to the implanted device 30, and to provide these signals to the secondary local monitor 47 for viewing, processing, and / or manipulation. External local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implanted device 30, such as a device ID, which may also be provided via data coupling from the implanted device 30.

[0080] The remote monitoring subsystem 46 can be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received via network 49 from local monitoring device 42, secondary local monitoring device 47, and / or implanted device 30. For example, the remote monitoring subsystem 46 can advantageously be operated and / or controlled by a healthcare entity, such as a hospital, physician, or other care entity associated with patient 44. Although some examples disclosed herein describe communication between the implanted device and the remote monitoring subsystem 46 indirectly via local monitoring device 42, in some instances, the implanted device 30 may include a transmitter capable of communicating with the remote monitoring subsystem 46 via network 49 without relaying information via local monitoring device 42.

[0081] In some instances, the antenna 48 of the external monitor system 42 includes an external coil antenna that is matched and / or tuned to inductively pair with the antenna 38 of the internal implant 30. In some instances, the implant 30 is configured to receive wireless ultrasonic power charging and / or data communication between the external monitor system 42 and the external monitor system 42. As described above, the local external monitor 42 may include a stick or other handheld reader. In some instances, the antenna 48 includes a piezoelectric crystal.

[0082] Implantable pressure sensor device with deflectable diaphragm

[0083] Pressure sensors that can be used in medical implant applications include sensors utilizing microelectromechanical systems (MEMS) technology. Such devices can incorporate relatively small mechanical and electrical components on a substrate such as silicon or other semiconductor substrates, and can incorporate a deformable diaphragm for measuring its pressure-induced deflection, wherein the degree of deflection of the diaphragm indicates the pressure conditions exposed to the sensor diaphragm at the implantation site. Examples of this disclosure improve certain MEMS technologies by applying a conductive layer and / or other conductive features to a deflectable diaphragm stack formed on a diaphragm substrate comprising a thin-film nitinol or similar material. The thin-film diaphragm of the sensor devices disclosed herein can be configured as components of any type of deflection-based sensor device, such as piezoresistive pressure sensors and capacitive pressure sensors. Such sensors advantageously include a flexible diaphragm layer that acts as a deformable diaphragm deflected under pressure, wherein integrated conductive features of the diaphragm stack generate a mechanism for measuring the displacement of the diaphragm. This structure can advantageously provide both transducer structure / function and protection against hostile external environments.

[0084] Regarding resistive (e.g., piezoresistive) pressure sensors, certain conductive sensing elements can be fabricated directly on the diaphragm of the device (or on an insulating layer formed on the diaphragm) using sputtering, vapor deposition, or other application processes. Changes in the resistance of such conductors can be determined to indicate a measurement of the pressure applied to the diaphragm. Typically, the change in resistance can be proportional to the strain on the conductor, where the change in conductor resistance is related to a change in conductor length caused by the deflection of the diaphragm on which the conductor is placed.

[0085] Figure 3A This is a side view of a resistive pressure sensor device 320 implemented on a substrate 328 according to one or more examples. Figure 3B It is based on one or more instances Figure 3AA side view of a piezoresistive pressure sensor 320, wherein the sensor's diaphragm 325 is deflected. The deflection of the diaphragm 325 can be caused by pressure conditions to which the diaphragm 325 is exposed. The diaphragm 325 can be formed from a substrate material (such as thin-film nitinol), or other materials that can be formed using physical vapor deposition or other processes. In some instances, the thin diaphragm 325 can be formed by etching a substrate 326 to create a relatively thin membrane for the diaphragm 325, which can enclose a cavity 329.

[0086] The diaphragm 325 may have one or more conductive traces or elements 322 disposed thereon and / or applied thereon. For example, the conductive element 322 may comprise a trace of metal or other electrical conductor, wherein one or more length portions of the conductor extend over the diaphragm 325, such that deflection of the diaphragm 325 causes one or more portions of the conductor 322 to elongate / stretch, thereby changing its resistance / impedance. Figure 3B As shown, when the diaphragm 325 deflects, the current and / or voltage through the conductive element 322 can be measured to determine its corresponding resistance / impedance, thereby providing a measurement result indicating the degree of deflection of the diaphragm 325; this deflection indicates the environmental pressure experienced by the diaphragm 325.

[0087] Figure 4A This is a side view of a capacitive pressure sensor device 420 according to one or more examples. Figure 4B It is based on one or more instances Figure 4A A side view of a capacitive pressure sensor 420, wherein the diaphragm 425 of the sensor is deflected. For a capacitive pressure sensor with an electrode-integrated diaphragm structure according to the present disclosure, one or more conductive layers 422 may be deposited / applied onto / to the thin-film nitinol diaphragm 425 to create a capacitive electrode (e.g., an anode). Corresponding electrodes / plates 421 may be formed on opposing substrates 428 such that a cavity or other dielectric 429 exists between the electrodes / plates 422, 421. In some embodiments, the electrodes 421 provide a stationary / static electrode, while the diaphragm electrode 422 provides a flexible, dynamically deflectable diaphragm electrode 422. With such electrodes 422, 421 having a fixed area, the capacitance between the electrodes can be proportional to the distance between the electrodes.

[0088] like Figure 4B As shown, inward / downward deflection / deformation of the diaphragm 425 can alter the spacing between conductors 421, 422 above at least a portion of the diaphragm 425, thereby changing the capacitance of the capacitor formed between the diaphragm electrode 422 and the base electrode 422. Such changes in capacitance can be measured by coupling a sensor device 420 to, for example, a tuning circuit that may have a fundamental frequency proportional to the degree of deflection of the diaphragm 425 and the electrode 422.

[0089] Figure 3A Any of the devices shown in / 3B and 4A / 4B may have certain oxide and / or other insulating layers (e.g., high-k dielectric) formed on the electrode assembly to provide increased capacitance, reduced leakage current, improved breakdown voltage, and / or allow for reduced electrode / device size.

[0090] Pressure sensor using pressure transmission medium

[0091] In some pressure sensor solutions, such as MEMS pressure sensors, the sensor element can be housed within a housing enclosed in an area by a deflectable diaphragm. A pressure-transmitting fluid or other medium (e.g., oil, gel, epoxy resin) surrounds the sensor element within the housing, such that external pressure causing the diaphragm to deflect inward is transferred to the pressure sensor for sensing. Figure 5A and 5B A cross-sectional view of a sensor implantation device 550 according to one or more examples is shown, the sensor implantation device including a pressure transmission medium 552 disposed within a housing 554 covered by a diaphragm 555.

[0092] The diaphragm 555 can advantageously be deflectable, such that pressure conditions outside the enclosure 554 can cause the diaphragm 555 to deflect inward in a manner that applies pressure to the sensor element surface / diaphragm 525. For example, in some instances, the pressure transmission medium 552 may comprise an incompressible fluid or medium. Alternatively, the medium 552 may be compressible, wherein deflection of the diaphragm 555 can result in a reduction in the volume of the internal chamber of the canister 554, thereby compressing the fluid / medium and resulting in an increased pressure transmitted within the canister 554 to the sensor element 520. Deflection of the diaphragm 555 can move the diaphragm 555 from a non-deflected state or configuration in which the diaphragm is located in or substantially parallel to the transverse plane P1 (e.g., transverse to the axis of the diaphragm and / or sensor device) to a deflected state or configuration in which the diaphragm 555 is in contact with the concave / deflection plane P2 (see [link to relevant documentation]). Figure 5B The concave / deflection plane is deflected relative to the transverse plane P1 in a certain direction (e.g., toward the sensor element 520).

[0093] The pressure transmission medium 552 is sealed within a housing 554 and disposed within an outer enclosure surrounding the sensor element 520. A portion of the housing 554 contains a diaphragm assembly 555. While the use of a pressure transmission medium for the purpose of transferring external pressure to an internally housed pressure sensor device may be effective in terms of pressure readings, such implementations present certain disadvantages in terms of size and / or manufacturing complexity. For example, with respect to the sensor assembly 550, mechanical welding / filling may be necessary in the area where the transmission medium 552 is injected or applied within the housing 554. The risk of leakage of the transmission medium 552 can represent a potential health hazard for a pressure sensor implanted in a human patient. Furthermore, the need for a sensor assembly large enough to accommodate and seal the necessary volume of the transmission medium 552 may hinder the feasibility of the desired low-profile design for the sensor implant. As the size of the sensor device design is reduced to allow greater flexibility regarding minimally invasive (e.g., transcatheter) delivery and implantation in vivo, the materials and processes associated with such devices may require increased handling complexity, failure modes, and / or impose ultimate limitations on further reductions.

[0094] Determining the diaphragm size and sensitivity of the pressure sensor

[0095] As mentioned above, due to the size constraints associated with implantable sensor devices, the available area of ​​the diaphragm assembly can also be constrained depending on the design of the sensor device. When the effective area of ​​the diaphragm decreases, it may also be necessary to decrease the thickness T1 of the diaphragm in order to maintain sufficient sensitivity within the diaphragm. For example, Figure 6 This is a graph showing the relationship between sensor diaphragm thickness, surface area, and sensitivity based on one or more examples. For example... Figure 6 As shown in the graph, diaphragms with relatively small surface areas typically need to be relatively thin in order to achieve comparable sensitivity compared to diaphragms with relatively large surface areas and otherwise similar designs.

[0096] The process of forming a thin foil can cause variable strain hardening of the formed material, which can lead to relatively large changes in the mechanical properties of the formed diaphragm. Furthermore, the relatively thin material used for diaphragm formation may require careful handling and assembly processes to weld the diaphragm structure to a larger sealing body. At this scale, the process can affect the material properties and mechanics of the diaphragm, thereby causing additional variations in diaphragm performance. Additionally, the original forged material prior to formation may possess defects and grain structures that are problematic at the micrometer scale for sensor diaphragms disclosed herein.

[0097] Additionally, some sensor devices are designed to have a sensor diaphragm positioned / placed at the distal end of the sensor device assembly. For example... Figure 6As indicated in the document, since increasing the diaphragm area to provide the desired sensitivity may be advantageous, such an increase in diaphragm area may come at the cost of increasing the sensor device diameter / profile, potentially interfering with the ability to be assembled within a tubular conduit / shaft for delivery, particularly according to Figure 6 The relationship shown in the graph takes into account diaphragm material thickness and deflection sensitivity. As sensor device designs evolve toward devices with increasingly smaller profiles (e.g., millimeter-scale integrated implants), the ability to form and integrate such sensor device assemblies may become untenable relative to axial diaphragm designs. Thin-film nitinol diaphragm deposition, as detailed herein, can facilitate lateral / lateral diaphragms relative to the long dimension / axis of the sensor device. Sensor designs including lateral / lateral diaphragms are shown and described in more detail below with reference to examples of this disclosure.

[0098] Thin film separator layer deposition

[0099] Examples of this disclosure advantageously provide solutions for using vapor-deposited thin-film nitinol (or similar) diaphragm assemblies in implantable pressure sensors. Such thin-film diaphragms can advantageously facilitate the design of relatively small devices while providing sufficient and / or improved sensor performance / sensitivity by allowing diaphragm configurations with sufficiently large area and / or material thickness characteristics to provide such sensitivity. Furthermore, the thin-film deposited diaphragm structures disclosed in detail herein can facilitate the integration of sensor electrodes with such diaphragm structures / stacks. Additionally, in some cases, suitable and / or improved biocompatibility properties and / or relatively simplified manufacturing processes can be provided through thin-film nitinol diaphragm deposition. The thin-film nitinol diaphragm can be further deposited in such a manner that the diaphragm is integrated with other structural / mechanical housing / encapsulation components of the associated sensor device within one or more uniform and integrated layers of deposited material. For example, while some pressure sensor devices require manufacturing processes involving multi-part and / or multi-process fabrication to hermetically / mechanically couple the diaphragm assembly to other structural components, examples of this disclosure can allow fabrication without such hermetically / coupling steps / processes concerning the diaphragm and adjacent structures of the device.

[0100] In some instances, the sensor devices disclosed herein include a plate structure in which one or more deflectable diaphragms are formed, along with surrounding mechanical structures, wherein the plate is formed by thin-film vapor deposition. Such integration of the device's diaphragm with at least some of the additional mechanical structures can reduce the number of manufacturing steps / processes required to fabricate the device and, moreover, can provide superior mechanical properties relative to certain non-integrated diaphragm solutions. Furthermore, the integration of the device's diaphragm with other mechanical structures can reduce the component count and process steps required to produce the resulting sensor package. With fewer components and areas requiring hermetic sealing, a more robust protective housing with a reduced risk of failure / leakage can be produced.

[0101] Certain embodiments of this disclosure provide alternatives to malleable metal processing, stamping, grinding, etc., for sensor diaphragms to provide diaphragms with reduced thickness, increased sensitivity, and suitability for forming conformal electrodes / conductors thereon. For example, methods for forming thin-film deposited diaphragm layers as described herein can provide the necessary precision and tolerances for micron-level layers, which may be difficult or impossible to achieve using certain cutting and stamping processes. In some embodiments, physical vapor deposition processes for sensor diaphragms as disclosed herein can produce nanometer-level precision and tolerances. Such diaphragms can advantageously be formed using ionization deposition processes rather than by stamping, welding, or other more complex and / or inconsistent / error-prone processes. In some instances, the diaphragms deposited / formed according to aspects of this disclosure comprise a nickel-titanium alloy instead of titanium, which can be used in other sensor designs.

[0102] As described above, in some embodiments, ionized metal vapor deposition can be used to fabricate / form sensor diaphragms according to various aspects of this disclosure. Figure 7 This is a block diagram illustrating a thin film vapor deposition system 700 according to one or more examples. Physical vapor deposition (PVD) and other vacuum deposition processes can be used to produce relatively thin films and coatings. In system 700, a source material 730 (e.g., a metal) is transformed from a condensed phase to a gas phase 770, and then transformed back to a thin film condensed phase 740 applied to or applied to a target substrate 720. Sputtering or evaporation can be performed to generate a vaporized / plasma gas 770. The plasma gas 770 is deposited on the substrate 720 to form a layer 740 of the deposited source material. The vacuum chamber 710 is advantageously free of air and particles that could otherwise interfere with directional deposition on the substrate 720.

[0103] The transformation from solid 730 to gas 770 can be achieved by applying energy from energy source 750. Energy source 750 can be any type of energy, including thermal / thermal current, current, and / or voltage potentials relative to a potential 760 associated with substrate 720. The energy can energize source material 730 to generate plasma mold 770. The potential 760 relative to source material 730 can be used to generate deposition flow 770 directed toward substrate 720. In some cases, source material 730 can be positively charged, while the potential 760 of substrate 720 can be negatively charged.

[0104] With respect to the various processes and apparatuses disclosed herein, any type of deposition process, such as any deposition process referenced or described herein, can be implemented to produce any of the diaphragm components / layers and / or integrated conductor / electrode layers of the present invention, including or as an alternative to physical vapor deposition. Examples may include cathodic arc deposition, in which a high-power arc discharges at the target (source) material to blast some of the material into highly ionized vapor for deposition onto the workpiece. For electron beam physical vapor deposition embodiments, the material to be deposited is heated to a relatively high vapor pressure in a vacuum by electron bombardment and transported by diffusion to be deposited onto a relatively cool workpiece by condensation. For evaporation deposition, the material to be deposited may be heated to a relatively high vapor pressure by resistance heating in a vacuum. As another example, confined space sublimation may involve placing the source material and substrate relatively close to each other and radiatively heating them. Pulsed laser deposition can be implemented by ablating the source material into vapor using a high-power laser. Pulsed electron deposition can be implemented by ablating the source material using a high-energy pulsed electron beam to generate plasma under non-equilibrium conditions.

[0105] In some examples, sputtering deposition can be implemented where a luminescent plasma discharge, positioned around a target substrate by a magnet, bombards the source material, thereby sputtering some of the source material as vapor for subsequent deposition. For sputtering applications, magnetrons can be used, which utilize strong electric and magnetic fields to confine charged plasma particles close to the surface of the sputtering target. Typically, in a magnetic field, electrons follow a helical path around the magnetic field lines, resulting in more ionizing collisions with gaseous neutral points near the target surface than would otherwise occur. The additional ions in the sputtered gas generated by these collisions can lead to a higher deposition rate. The plasma can also be maintained at a lower pressure in this way. Sputtered atoms are neutrally charged and therefore unaffected by the magnetic trap. Other sputtering techniques that can be implemented include ion beam sputtering, reactive sputtering, ion-assisted deposition, high-power pulsed magnetron sputtering, gas flow sputtering, or similar techniques.

[0106] Thin film separator layer deposition

[0107] As described above, some pressure sensor solutions may include a sensor encapsulated in a rigid housing (e.g., a metal housing / canister) with a transport fluid disposed between an external flexible diaphragm and an internal capacitive sensor element. Such solutions can be adapted for pressure sensors that conduct pressure in humid and / or corrosive environments, such as within the bloodstream. Examples of this disclosure provide alternative solutions in which the external flexible diaphragm itself serves as a source of capacitive (or resistive) electrical signals for pressure sensing due to integration with the diaphragm stack / structure of conductive electrodes. Although capacitor plate electrodes are disclosed in some contexts herein, it should be understood that any examples disclosed herein are also applicable to resistive or piezoresistive conductor elements integrated with a diaphragm stack. For example, any capacitive sensor example disclosed herein, described as including a flexible nitinol diaphragm with a conformal capacitive plate / electrode associated therewith, may alternatively or additionally have a resistive or piezoresistive sensor element integrated / associated with a deflectable nitinol diaphragm. The fabrication of such novel sensor solutions can be facilitated by providing thin-film deposition of materials such as nickel-titanium, titanium, etc., as diaphragm substrates and processing techniques, wherein electrode conductors can be additionally deposited on the diaphragm substrate (directly or on an insulating layer) in a similar manner to create diaphragm electrode stacks, which can advantageously provide the desired profile and suitable capacitive performance for implanted devices.

[0108] The ability to deposit superelastic nitinol in thin diaphragm layers via physical vapor deposition as described above allows for the direct / conformal fabrication / construction of thin, flexible capacitive electrodes (e.g., anodes) on diaphragm stacks. Such implementations can produce sensor implantation devices with relatively thin profiles while providing suitable deflection and capacitance variations within the expected operating pressure range. For example, various electronic / conductive layers, components, and / or elements can be added to diaphragm structures (e.g., stacks) including thin nitinol layers, thereby enabling the integration of passive and / or active electrical components with relatively thin diaphragm structures. Applying electrical and / or insulating elements (such as conductive layers configured to act as capacitive plates / electrodes in circuits and associated dielectrics) to nitinol or other thin-film diaphragms can be implemented via chemical or physical vapor deposition, sputtering, masking / etching, photolithography, screen / inkjet printing, electroplating, epitaxy, thermal oxidation, atomic layer deposition, anodizing, etc.

[0109] Figure 8A side cross-sectional schematic diagram of a sensor device 820 is shown, having a capacitive electrode 822 structurally conformal to a hyperelastic diaphragm 825 with a thin film (e.g., less than 20 µm thick, such as 5 µm-10 µm). As with any deflectable diaphragm layer disclosed herein, the diaphragm layer 825 can comprise any type of deposited thin film, hyperelastic metallic material. Although the deflectable diaphragm layer is described in some contexts herein as comprising nitinol, it should be understood that such diaphragm layers can comprise any type of deposited (e.g., physical vapor deposition) thin film (e.g., less than 15 µm), hyperelastic metal, including alloys such as nitinol (NiTi), NiTiCu, etc. As described in detail above, the use of physical vapor deposition of nitinol, titanium, gold, and / or other materials provides a basis for producing sensor diaphragm / electrode stacks / structures suitable for implantation in the human body, as disclosed herein.

[0110] Converting internal pressure into capacitance may require relatively high biocompatibility and stable diaphragm electrodes. To achieve the flexibility required for minimally invasive implantation devices, limiting the thickness of deflectable diaphragm stacks / structures to micrometer-scale dimensions can produce suitable products. Furthermore, a relatively large diaphragm surface area may be necessary or desirable to achieve relatively large capacitance values ​​that can be measured using passive or active circuitry systems. However, such parameters may conflict with the goal of achieving minimally invasive implantation due to the limitations of lateral dimensions typically associated with such devices. This will be discussed in the following sections. Figure 11 In more detail, a large surface area of ​​nitinol and other metal layers associated with the diaphragm electrode stack of this disclosure can be achieved using embedded three-dimensional surface features (such as trenches, spikes, fractals, etc.) implemented on one or more surface layers. The use of nitinol and similar materials for a flexible diaphragm substrate on which capacitive electrodes can be mounted can provide a biocompatible layer that meets the above requirements and allows for the creation of low-profile, highly flexible / capacitive sensor elements.

[0111] With the pressure transmission medium including the diaphragm and the sensor element Figure 5A and 5B The apparatus differs from that in other examples disclosed herein. Figure 8The device 820 can advantageously allow pressure sensing without requiring a separate pressure transmission medium (e.g., an incompressible fluid / oil), or a separate pressure sensor device / element other than the diaphragm electrode and mating electrode. That is, due to the integration of the capacitive electrode 822 and its conformal placement on the hyperelastic diaphragm 825, the flexible stack 827 of the diaphragm 825 (which may be referred to as a thin-film 'stack structure') can act as a capacitive electrode without the need to additionally transfer pressure from the diaphragm 825 to a separate sensor element. Such an implementation may be advantageous compared to an oil-filled sensor device due to the space and complexity associated with such an oil-filled device. For example, injecting oil into the pressure sensor chamber and its hermetically sealed / closed may be difficult to achieve and may involve certain cost and safety complexities. Figure 8 In this example, as with other examples disclosed herein, sensor 820 can be considered a dry capacitive sensor due to the absence of a pressure-transmitting fluid, wherein the encapsulation of sensor 820 itself (e.g., an outer nitinol shell / layer) forms an assembly of the pressure-transmitting element, i.e., a plate / electrode of the capacitor element. That is, the outer nitinol layer / shell 825 provides both biocompatible / hermetic encapsulation and, due to its integration with the capacitive electrode 822, converts pressure into a sensor electrical signal.

[0112] The diaphragm electrode 822 is combined with the corresponding electrode 821 to form a capacitor electrically coupled to the circuit system 834 of the sensor 820. The capacitor plates 821, 822 can be electrically coupled to the resonant circuit of the circuit system 834 via certain electrical leads / connectors 824a, 824b, which can be integrated with the structure of the base substrate / structure 805 in any suitable or desired manner, for example, through various traces, vias, etc. A nitinol diaphragm 825, which may have associated sidewalls / protrusions 828, can be physically sealed to the base structure / substrate 805 and the connector / joint 823 to provide a hermetically sealed volume / space 829 between the capacitor plates 821, 822. The base substrate / structure 805 may contain nitinol or other metals or materials. The volume 829 may contain a vacuum volume.

[0113] Some implantable sensor solutions include a thin layer of glass serving as a substrate for a diaphragm. However, such glass layers may typically lack sufficient flexibility to generate interpretable or desirablely sensitive pressure sensor signals in devices containing relatively small surface area diaphragms. Therefore, the use of a vapor-deposited nitinol diaphragm layer in the devices of this disclosure, which can advantageously provide greater flexibility than glass and can typically be deposited in a relatively thin layer, can produce sensor devices with a relatively low profile that still provide a dynamic capacitive range to produce relatively high granularity in pressure sensor readings. In some embodiments, the diaphragm structure of examples of this disclosure may include a thin layer of nitinol, an insulator, and a metal / conductor capacitive electrode, said thin layer being generally thinner than a single layer of glass with sufficient strength to meet bioimplantation requirements.

[0114] The nitinol layer 825 provides a thin, compliant, ultra-elastic, biocompatible, externally facing shell for the device 820. Furthermore, the thin-film diaphragm 825 provides relatively large deflection and correspondingly large variations in capacitance and signal amplitude while remaining elastic. The conductor layer 822 can advantageously insulate the memory metal structure diaphragm 825, thereby electrically isolating the nitinol layer 825 from the circuitry of the capacitors 822 / 821. In other words, the nitinol layer 825 can serve as a substrate for depositing / applying the conductor layer 822, wherein the conductor 822 is electrically isolated from the diaphragm 825 by an insulating layer 826a (e.g., oxide).

[0115] Further reference to solutions incorporating deflectable capacitive sensor diaphragms formed of glass layers, as described herein, suggests that the use of nitinol in thin-film applications can offer additional benefits. For example, when comparing the elasticity of nitinol and glass in the context of deflectable diaphragms, nitinol can be considered to offer excellent hyperelastic properties. Typically, nitinol can withstand significant elastic deformation and return to its original shape upon stress removal, which can be beneficial for applications requiring a considerable degree and amount of deflection. Conversely, glass, as a relatively brittle material, typically exhibits relatively low elasticity, making it unable to effectively withstand large strains and capable of fracturing under high stress. Furthermore, the strength of a glass substrate can depend on the surface finish of the glass, where cracks or fissures on the surface can act as stress concentrators, potentially compromising its structural strength. In contrast, the nitinol diaphragm 825 can advantageously withstand high stress and strain without yielding to permanent deformation, while glass, due to its brittleness, may be prone to catastrophic failure under stress.

[0116] Compared to glass diaphragms, the thin-film nitinol diaphragm 825 offers additional benefits, including the ability to form shaped surfaces (such as corrugations or extrusions) within the diaphragm layer, which can increase the effective surface area of ​​the diaphragm 825. Furthermore, forming corrugations, extrusions, and / or other surface topological features in the diaphragm layer (e.g., diaphragm layer 825) of the embodiments of this disclosure can increase the linear deflection range of the diaphragm. That is, such surface features can provide advantageous mechanical characteristics / behavior for thin-film diaphragms as disclosed herein. Corrugations and other surface formations can also allow tuning of the sensitivity and linearity of capacitive sensor devices. Additionally, such corrugations and other surface formations can provide thermal and packaging stress reduction and / or increased shape to produce a more stable shape during handling and assembly. It should be understood that any sensor diaphragm features disclosed herein (which can be formed using physical vapor deposition and similar processes) can advantageously provide increased surface area and / or increased linear deflection. On the other hand, forming shaped surfaces in glass presents certain challenges due to its structural brittleness / fragility and the lack of available processes for precisely generating surface features in glass surfaces. Nitinol can be mechanically tuned in ways that glass and other separators cannot, and when implemented with a conformal electrode layer covering a large portion of the nitinol separator as described herein, it provides a large deflection to generate a large capacitance change. For corrugations in the separator layer (e.g., separator 825; separator corrugation features described in detail below with respect to various examples), such three-dimensional features can be formed by depositing thin-film metal onto a surface / mold / mandrel having such surface features. Regarding fractal and / or porous surface features, their formation may involve masking, electroplating, etc.

[0117] One or more of dielectric layers 826a and 826b may comprise a high-k dielectric material. In addition to electrically isolating the plates 822 and 821 from the physically proximate substrates 825 and 805 to prevent sensor signal damage, the presence of dielectric 826 also protects the circuitry associated with the electrodes 821 and 822 from circuit failures caused by capacitance between the plates 822 and the substrates 825 and 805, which may be at least partially conductive, as in the case of nitinol. The use of a high-dielectric material can inhibit the formation of capacitance between the nitinol layer 825 and the electrode layer 822, thereby reducing unwanted stray capacitance that could otherwise negatively impact the circuitry. When implanted in the sensor device 820, the nitinol layer 825 is exposed and faces the biological environment, while the electrodes 821 and 822 are internal to the device 820.

[0118] The capacitance of sensor 820 can be at least partially based on the area of ​​plates 822 and 821. Therefore, by covering most of the area of ​​the nitinol diaphragm 825 with a conformal layer of conductor 822, the capacitance of device 820 can be maximized. For example, compared to some solutions where only a small portion of the deflectable diaphragm corresponds to an area of ​​the sensor capacitor plate of the device, Figure 8 An embodiment of device 820 can generate a large capacitance range per membrane region, wherein the dynamic / deflectable capacitor plate 822 covers most of the region of diaphragm 825 (e.g., more than half of the region).

[0119] Capacitor electrodes 821, 822 are electrically coupled to certain circuitry 834, including an antenna configured to facilitate wireless transmission of sensor signals and / or signals derived therefrom. In some embodiments, circuitry 34 includes active circuitry components, including amplifiers configured to convert the capacitance of plates 821, 822 into readable signals. In general, the capacitor formed by plates 821, 822 can be electrically coupled to the antenna in such a way that changes in the capacitance of the capacitor produce resonant changes in the antenna, wherein such resonances of the antenna can be decoded to determine the stress level causing the resulting capacitance.

[0120] Figure 9-1 and 9-2 Together, a flowchart is provided illustrating a process 900 for manufacturing a capacitive electrode stack according to one or more examples. Figure 10-1 , 10-2 Tables 10-3, 10-4, and 10-5 illustrate the relationship between one or more instances and... Figure 9-1 and 9-2 The flowchart shows a side cross-sectional view of the capacitive electrode stack / structure 1000 corresponding to the various operations.

[0121] At frame 902, process 900 involves forming a diaphragm 925 and a peripheral structure 928 using thin-film deposition (e.g., PVD) or other techniques. For example, such a diaphragm and peripheral layer may comprise nitinol or other shape memory alloys. The layering associated with frame 902 can advantageously produce a superelastic diaphragm structure 1000a.

[0122] Figure 10-1Structure 1000a, including a formed diaphragm 925, is shown, along with a support side structure 928 that can provide spacing for the diaphragm 925. One or both of the diaphragm 925 or the support structure 928 can be formed by vapor deposition from nitinol or other hyperelastic materials, as described in detail herein. The diaphragm 925 can be formed by depositing its layers onto / against a mandrel or other substrate or forming mold 903. Such a forming mold 903 may have a generally flat surface and / or may include certain surface features configured to produce a three-dimensional plywood material on the outer surface 931 of the diaphragm 925.

[0123] In some embodiments, the volume / space 994 within the diaphragm 925 and support structure 928 can be formed by trenching or other mechanisms. For example, in such embodiments, the electrode stack can be layered on top of the diaphragm film 925 at the bottom of the trench. In some embodiments, the support structure 928 can be added to the base structure 905 (see...). Figure 10-5 ), and protrudes from the base structure in addition to protruding from the diaphragm layer 925 or as an alternative to protruding from the diaphragm layer.

[0124] At frame 904, process 900 involves forming an oxide or other insulating layer 926a on the inner surface 932 of the diaphragm 925. Although described in some contexts as an oxide layer, it should be understood that any insulating / dielectric layer described herein may comprise a non-oxide dielectric material that allows for flexibility. For example, such a layer may comprise polyimide, perylene, etc. In some embodiments, the respective oxide layers may be sandwiched between non-oxide layers such as polyimide, perylene, etc. Figure 10-2 A diaphragm structure 1000b is shown comprising one or more layers 926a of oxide disposed on the inner surface 932 of a diaphragm 925. As shown, the oxide / insulator 926a may be at least partially contained within a raised side structure 928. The diaphragm 925 and the side structure 928 may form a can structure in which additional layers may be deposited / formed. In some embodiments, the oxide / insulator layer 926 may be deposited against the inner sidewall of the raised side structure 928. As with any oxide / insulator / dielectric layer disclosed herein, layer 926a may comprise a single oxide layer, multiple oxide layers, perylene layers, alternating layers of flexible coatings similar to perylene and oxides, or other similar layers and / or compositions.

[0125] In some embodiments, a natural oxide layer may be formed on the inner surface 932 of the nitinol membrane 925, wherein such an oxide layer can provide a certain amount of insulation between the nitinol 925 and subsequently formed / deposited layers (e.g., conductor / electrode layers). However, a natural oxide layer, which can typically have a relatively low k value, may not provide sufficient insulation for the subsequently applied conductor 922 (see [link to relevant documentation]). Figure 10-3 It is fully insulated from the diaphragm 925. Conversely, applying a high-k dielectric by sputtering or other processes can provide the desired insulation to the circuit without requiring an undesirable thickness / profile.

[0126] The oxide layer 926a can be sputtered onto the inner surface 932 of the separator 925. In some embodiments, process 900 involves generating gas molecules of hafnium oxide, zirconium oxide, aluminum oxide, titanium oxide, or other high-k dielectrics, which can be directed onto the surface 932 of the substrate 925 using an electric field. The oxide 926 can be deposited layer by layer to achieve a desired thickness D2 of the oxide layer 926a. In some embodiments, chemical vapor deposition can be used to deposit the oxide 926a, wherein a precursor gas containing the desired oxide is introduced into a chamber in which the substrate 925 is disposed. The gas can react on the surface 932 to form the oxide layer 926a. Such processes may be suitable for materials that are not naturally oxidized to a sufficient degree, or when a particular oxide / insulator thickness or quality is desired. In some embodiments, physical vapor deposition or atomic layer deposition can be performed to deposit one or more individual oxide layers 926 onto the substrate 925. In some implementations, the insulating / oxide layer 926 may extend upward to the sidewall 928 to insulate the electrode 922 from the sidewall 928, which can be used to reduce stray capacitance.

[0127] At frame 906, process 900 involves forming an electrically conductive layer 922 over oxide 926a. Figure 10-3 A diaphragm / electrode stack 1000c is shown, wherein a capacitive electrode 922 is applied to the diaphragm / electrode stack. Structure 1000c may include an electrode of a capacitive sensor, such as its anode (or cathode).

[0128] In some embodiments, process 900 further involves forming an electrical contact 971 to the electrode 922. For example, the contact 971 may contact the electrode layer 922 and be upright relative to the electrode layer to provide electrical communication with the capacitive plate 922. The contact 971 may be sized to be coupled to the base when the diaphragm structure 1000c is coupled (see...). Figure 10-5 This refers to a protruding structure that provides contact with corresponding contacts / leads of the base structure when forming a closed sensor device. Although in Figure 10-3 The electrode 922 is shown as being directly deposited or otherwise formed (from the remaining structure of the etching process) on the inner surface of the electrode 922, but it should be understood that the electrical contact 971 to the electrode 922 can be configured in any way or in / on any structure of the stack 1000c.

[0129] Although process 900 is described and shown as involving the formation of a conductor layer 922 over the oxide layer 926a, in some embodiments, the conductor 922, which acts as a capacitive electrode (e.g., an anode plate) of a capacitive pressure sensor, can be formed directly on the inner surface 932 of the diaphragm 925. However, the implementation of the oxide layer 926a can allow electrical isolation between the conductor 922 and the diaphragm 925, which may be desirable for facilitating proper functionality of the associated circuitry. In some embodiments, a gap can be formed between the lateral surface 933 of the conductor 922 and the inner boundary 934 of the support structure 928, which can facilitate electrical isolation between the conductor 922 and the support structure 928. For example, in the case where the support structure 928 is in contact with and / or integrated with the diaphragm 925, the contact between the capacitive electrode 922 and the lateral structure 928 can short-circuit / shunt the conductor 922 to some extent to the body of the sensor. The conductivity of the nitinol diaphragm 925 and the side support structure 928 can be significantly lower than that of the electrode conductor 922, which may comprise gold (Au), platinum (Pt), or other conductive metals. To produce a sufficiently compliant diaphragm 925, a relatively thin nitinol layer 925 may be desirable. Therefore, physical vapor deposition or other techniques that allow the deposition of micrometer-scale plates / layers can be advantageously combined with process 900. Such fabrication can produce relatively high elasticity, which transduces to a relatively large capacitive signal range during operation.

[0130] The thin nitinol layer 925 can be advantageously used for pressure transduction via its pressure-sensitive mechanism, while still allowing the electrode 922 placed thereon to be relatively thin in combination with the nitinol membrane 925 so as not to interfere with the mechanical properties of the deflectable membrane 925. In some embodiments, both the nitinol layer 925 and the electrode layer 922 are deposited using physical vapor deposition instead of deposition or sputtering processes.

[0131] In some embodiments, process 900 involves forming a second layer 926b of insulator / oxide over conductive electrode 922, as shown in block 908. Figure 10-4 The stack 1000d shown illustrates an inner / secondary insulating layer 926b covering at least a portion of the electrode 922 on its inward-facing side. In some embodiments, the second dielectric layer 926b is omitted. Figure 10-4 In the example shown, dielectric layers 926a and 926b isolate conductor 922 from nitinol layer 925, which acts as a compliant mechanical mechanism for electrode structure 1000d.

[0132] The layers of the electrode stack 1000d can have any suitable or desired thickness. For example, in some embodiments, the outer nitinol separator layer 925 can have a thickness d1 of e, such as about 5 µm. In some embodiments, the overall stack thickness d5 can be less than 10 µm, such as about 6 µm or less. Figure 10-4 Further examples of the thicknesses of the various layers of the bioelectronic structure / platform 1000d shown herein, and similar structures disclosed herein including insulating and metallized membranes, include: for the bottom oxide layer 926a (e.g., hafnium oxide), the thickness d2 of such a layer may be less than 500 nm, such as about 300 nm (e.g., less than 350 nm) or smaller (e.g., about 250 nm, 200 nm, 150 nm, 100 nm or smaller); for the capacitive conductor layer 922, the thickness d3 of such a layer may be less than 500 nm, such as about 350 nm (e.g., less than 400 nm) or smaller (e.g., about 300 nm, 250 nm, 200 nm, 150 nm, 100 nm or smaller); for the second insulating layer 926b, the thickness d4 of such a layer may be less than 200 nm, such as about 100 nm (e.g., less than 150 nm) or smaller (e.g., about 90 nm, 80 nm, 70 nm, 60 nm or smaller).

[0133] At block 910, process 900 involves physically and electrically coupling the electrode stack 1000d to the base structure 905. Structure 905 may have any suitable or desired composition and may be conductive or may not be conductive.

[0134] The base 905 may have a stacked structure 909 formed thereon that is similar in one or more aspects to the stacked structure 907 of the diaphragm structure 1000d. The substrate 909 may include a second capacitive electrode 921 (e.g., a cathode), wherein the capacitance between the electrode 922 and the electrode 921 changes as the diaphragm 925 deflects, such that in operation, the conformal electrode 922 deflects dynamically, while the electrode 921 is a physically static electrode. Figure 10-5 A combined sensor capacitor structure 1000e is shown. In some embodiments, two electrodes 921, 922 are formed on a flexible diaphragm, such that both the electrode and the counter electrode are dynamically movable. For example, regarding... Figure 10-5 In some embodiments of the device 1000e, both layers 925 and 905 are flexible and / or formed from thin films or vapor-deposited materials.

[0135] The combination of the deflectable diaphragm stack 1000d with the base 905 and the associated electrode stack can create a combined capacitor and a hermetically sealed seal. The stack 1000e can create a pressure-sensitive sensor capable of withstanding relatively large deflections while allowing for significant changes in capacitance between plates 922, 921. The capacitance changes of plates 921, 922 in response to the deflection of the diaphragm 925 can be read using passive and / or active circuitry systems electrically and / or communicatively coupled to the electrode elements 921, 922. In some embodiments, certain electrical connectivity features associated with the base 905 couple the electrodes 922, 921 to provide a closed circuit. In some embodiments, a top oxide layer 926b or a top oxide layer 926d is included, but not both. That is, if the cathode or anode contains a top oxide layer at least partially disposed in the region between the electrodes 921, 922, the device 1000e can function as desired.

[0136] In some embodiments, a vacuum or air volume / space 929 exists between electrode stacks 907, 909. Further referring to the capacitive electrode 922 formed on the diaphragm 925, such deflection, when the nitinol diaphragm 925 is deflected, may subsequently cause a corresponding deflection in the conformal electrode 922, thereby bringing the electrode 922 close to a pair of corresponding capacitive plates / electrodes 921 in one or more regions (e.g., particularly in the central region of the electrode 922).

[0137] The diaphragm structure 1000d can be joined / coupled to the base structure 905 in any suitable or desired manner (e.g., by welding, flip-chip bonding, adhesion, or other coupling members). The base electrode stack 909 may include one or more oxide layers 926c, 926d, or alternatively, one or more such oxide layers may be omitted. The combined structure 1000e can advantageously be hermetically sealed, so that the electrodes 922, 921 and the associated electrical connectors / circuit systems are protected from the external environment of the device 1000e.

[0138] Electrode 921 can be constructed onto the main structure / substrate 905, while electrode plate 922 is associated with deflection diaphragm / plate structure 925. The base structure 905 can comprise a printed circuit board, silicone, plastic, ceramic, glass, or other at least partially rigid material. The height d6 of the diaphragm structure 1000d can be controlled to produce a desired plate spacing d7. This spacing can be controlled at least partially by controlling the thickness of the peripheral structure 928 to produce a desired base capacitance.

[0139] The combined device 1000e can be used to convert external pressure into capacitance on plates 922, 921. Typically, as described in detail above, converting pressure into capacitance requires a relatively highly compliant and stable diaphragm with high tolerances and precise dimensions. Applying NiTiNoL physical vapor deposition to the diaphragm 925 can provide a biocompatible layer that meets these requirements. Implementing a thin, superelastic diaphragm 925 with integrated insulating layers 926 and electrode 922 stacked relative to the stabilizing electrode 921 (which may have similar or different stacks / structures) can generate a device that can deflect external pressure onto the diaphragm 925, causing displacement of the diaphragm 925 and electrode 922, thereby inducing a measurable change in its capacitance.

[0140] In addition to implementing a conformally coated separator having a high-k dielectric layer 926 stacked with capacitive electrodes 922 to form a thin film stack, the nitinol layer 925 and / or electrode layer 922 may also contain certain three-dimensional surface features in one or more of their regions that provide an increased effective surface area for such components.

[0141] Figure 11 Various surface topologies that can be implemented for the diaphragm and / or electrode layer of the sensor device of this disclosure, according to one or more examples, are shown. Figure 11 A diaphragm / electrode stack / structure 1100 according to an example disclosed herein is shown, including a nitinol diaphragm 1125 on which a conformal capacitive electrode 1122 is formed. In some embodiments, the surfaces of the electrode 1104 (e.g., inner surface 1104) or the surfaces of the nitinol diaphragm 1125 (e.g., outer surface 1101 or inner surface 1102) may have certain surface protrusions / protrusions associated therewith. For example, the surfaces may be roughened, scratched, etched, or otherwise textured to increase the surface area of ​​the electrode 1122 (e.g., by one or two orders of magnitude or more) without necessarily increasing the lateral / planar surface area covered by the electrode. Such texturing can allow the use of a relatively small capacitive diaphragm with a relatively large surface area due to the topology / texturing of the electrode surfaces.

[0142] The protrusions / protrusions on the surface of the layer can be formed using various processes. In some embodiments, extrudate can be formed in the nitinol layer 1125 to create a surface with increased surface area. For example, grooves, pillars, needles, columns, etc., of any number or pattern can be formed in the nitinol diaphragm surface. Corresponding features, such as concentric rings / shapes with similar structures, can be formed / present on the corresponding electrodes of the sensor. Example pillar / pillar feature 1111 Figure 11As shown in the figure. Such extrusions may also be implemented on one or more sides of conductor layer 1122, either additionally or alternatively. Increased surface topology of the layers of stack 1100 can be created by trenching / etching to produce lateral surfaces in the extrusions in areas etched away from the base material.

[0143] In some embodiments, electroplating can be performed to produce a fractal-like surface 1113 that provides increased surface area. For example, such electroplating can be performed to form protrusions 1113 on the surface of an electrode. Electrochemical processes can produce electroplated extrusions. Alternatively, etching or growth processes can be performed to form surface area-enhancing extrusions on one or more surfaces of the electrode stack. In some embodiments, a cone / pyramidal die 1112 can be formed by masking with certain deposition processes. The formation of surface area-enhancing extrusions can be performed by additive or subtractive processes. Any surface texturing / topological patterns, formations, and / or configurations shown and / or described can be implemented on either side (1101, 1102, 1103, 1104) of either electrode 1122 or nitinol diaphragm 1125.

[0144] Return to reference Figure 9-1 and 9-2 In process 900, surface topological features can be formed on / in the thin film diaphragm 925 and / or electrode conductor 922 at any point in process 900. For example, surface features / formations can be formed in the bonding frame 908 ( Figure 10-4 The process is carried out before the formation / addition of oxide / insulator layer 926b (as shown in the diagram).

[0145] Any features 1111, 1112, 1113 described herein, as well as any conductor, shape memory metal, insulator, oxide, dielectric, or other (e.g., thin film layer), can be formed by any type of additive deposition process, which can be performed with or without masking.

[0146] Figure 12 A schematic diagram of a wafer structure 1200 according to one or more embodiments is shown, the wafer structure having a plurality of diaphragm structures 1270 formed thereon / on thereon or substrate targets for depositing diaphragm structures. The wafer 1200 may have a plurality of diaphragm molds / substrates and / or thin film structures formed thereon, such that, according to aspects of this disclosure, a single wafer can be used to produce a relatively large number of diaphragm plates / stacks for pressure sensor devices. Reference '1270' in the following description may refer to a shaped substrate of the wafer 1200 on which a nitinol layer / plate is deposited, or may refer to a nitinol layer / plate structure deposited on a substrate.

[0147] The wafer 1200 includes multiple diaphragm structures / shapes 1270, each of which may contain a separate sensor diaphragm plate or be used to generate a separate sensor diaphragm plate. Each of the plates 1270 shown can act as a substrate / mandrel / mold, on which a thin-film diaphragm layer of nitinol metal alloy or similar material can be deposited to form a thin-film diaphragm plate comprising, for example, less than 10 µm thick (e.g., 4-6 µm; approximately 5 µm) nitinol or other hyperelastic material. Insulator and / or conductor layers can be applied to the nitinol or other hyperelastic material to generate conformal capacitive electrodes or other similar electronic devices integrated with a hyperelastic deflectable diaphragm, as described in detail herein. The nitinol layer may have a uniform thickness in both the diaphragm region 1225 and the surrounding structure 1229.

[0148] The mold / plate 1270 may be configured with a spacing 1201 around one or more portions of the periphery of the respective diaphragm plate mold 1270. This may facilitate the deposition of nitinol and / or other layers of the diaphragm plate in relatively precise regions and / or shapes, and / or facilitate the slicing of the individual diaphragm plates after their formation to mechanically separate the individual plates from the wafer structure 1200. A physical connector 1202 may be used to connect the diaphragm plate substrate 1270 to an outer structure 1205 of the wafer 1200 that can serve as a runner structure. Internal portions 1203 of the structure 1200 (e.g., the substrate 1270 for nitinol deposition) may be detached from the wafer 1200, or deposited material layers (e.g., nitinol, insulators, electrodes) may be removed from the substrate without disassembling it.

[0149] The wafer 1200 can be formed from any suitable or desired material, such as silicone, stainless steel, titanium, nickel, alumina, sapphire, glass, ceramic, etc. Once the nickel-titanium base diaphragm layer has been deposited on the plate structure 1270, additional layers can be applied to the diaphragm plate using masking and / or other suitable processes. For example, on the plate 1270 intended to be used as a deflectable diaphragm structure, one or more diaphragm regions 1225 of metal / conductor can be applied to create a capacitive diaphragm plate / electrode, as described in detail herein.

[0150] Figure 13A and 13B A front perspective view and a rear perspective view of an electrode-integrated sensor diaphragm structure / plate 1370 according to one or more embodiments are shown. The structure / plate 1370 can provide a structure for one side / plate of a pressure-sensing capacitor, wherein certain contacts / connectors 1371 of the plate 1370 can facilitate electrical connection between the electrode 1322 and the paired electrode base structure (see [link]). Figure 14The diaphragm plate 1370 is joined / bonded to the corresponding sensor structure in a manner that provides its hermetic seal. References herein to components 'bonded' to each other are to be understood as being joined in any manner (e.g., welding, adhesive bonding, etc.). Contact 1371 can interface with the electrode 1322 by physical contact with the electrode. Although the diaphragm plate 1370 and certain similar devices / structures disclosed herein are shown and described as having an elliptical shape, it should be understood that such devices / structures can have any suitable or desired shape, such as rectangular, circular, or similar shapes. In some embodiments, an active capacitive sensor can occupy the entire surface or a large portion of the surface of the plate 1370. Alternatively, the capacitive sensor can occupy multiple smaller diaphragm regions 1325, as shown. As shown, the diaphragm plate 1370 and / or associated sensor devices / assemblies can have an elliptical shape (referred to in some contexts as an "oblong" shape) of two semicircles joined on opposite sides of a rectangle, similar to a rectangle, thus providing a shape reminiscent of a speed skating rink or athletics track. In some contexts, the shape of the plate / sensor 1370 may be described as a "stadium" shape, a "disc" shape, or an elongated ellipse.

[0151] The separator plate 1370 includes a sheet / layer of superelastic thin-film nitinol 1321, wherein the nitinol can be deflected in one or more regions at a dimension perpendicular to the surface of layer 1321, such as at least in region 1325 corresponding to capacitor plate 1322. In terms of processing, the nitinol layer 1321, comprising the separator portion 1325 and a region 1329 outside the separator 1325, can be deposited on the substrate using physical vapor deposition or other deposition processes. The capacitor electrodes / separator 1325 can be distributed along a line or plane, such that the capacitor electrodes / separator are generally aligned in a linear arrangement.

[0152] The insulator / oxide layer 1326 can then be formed or deposited on the nitinol 1321 in any suitable or desired manner. For example, the insulator layer 1326 can be formed only in the region of the diaphragm 1325. Alternatively, the insulator 1326 can substantially cover the entire inner surface 1364 of the nitinol layer 1321 (i.e., Figure 13A The surface shown in the image; Figure 13BThe outer / back surface 1363 of the nitinol layer 1321 is shown to be applied / formed. For example, the thickness d1 of the nitinol layer 1321 can be any other value, such as approximately 5 µm or less than 10 µm. In some embodiments, although described as a 'thin film' membrane layer, it should be understood that the thickness of the flexible membrane layer disclosed herein can be up to 20 µm or greater. The insulator 1326 can be applied to the surface 1364 of the nitinol layer 1321 by masking a region outside the membrane 1325, such that the insulator / oxide 1326 is formed or deposited only in the exposed membrane region 1325. Electrode metal 1322 can be applied to the oxide layer 1326 and can also be confined within the region of the membrane 1325. Although three circular membranes 1325 are shown, it should be understood that the membrane plate / structure disclosed herein can have any number, configuration, or shape of membranes.

[0153] The diaphragm region 1325 of the nitinol layer 1321 may be identical in form and / or configuration to the region 1329 outside the diaphragm 1325, such that the division of the diaphragm 1325 may be defined by the regions where the insulator 1326 and / or electrode / metal 1322 are deposited / layered. In some embodiments, the nitinol layer 1321 may differ substantially in one or more aspects of the diaphragm region 1325 compared to the region 1329 outside the diaphragm. For example, the diaphragm portion 1325 may be thinner than the region 1329 outside the diaphragm. Additionally or alternatively, certain shape or surface features of the diaphragm region 1325 may distinguish the diaphragm from the remainder of the nitinol sheet / layer. For example, corrugations, protrusions, indentations, marks, or other features may define the outer periphery of the diaphragm region 1325 and / or other regions or features of the diaphragm 1325.

[0154] In some embodiments, an electrical conductor contact 1371 is applied to / formed on the electrode layer 1322 such that the mold 1371 is in electrical contact / communication with the electrode layer. For example, the electrical contact 1371 may be in physical contact with the electrode layer 1322. When the diaphragm plate 1370 is engaged (e.g., bonded) to the contact 1371, the contact may be physically coupled to the cathode structure (see [link to relevant documentation]) on the capacitor plate 1322. Figure 14 , 15 An electrical connection is provided between the diaphragm electrode 1322 and the associated capacitive resonant circuit of the sensor device. The electrical contact 1371 may have the form of a raised flange, edge, lip, rim, or similar structure, and typically provides a corresponding surface 1491 for interaction with the base structure (see [reference]). Figure 14 The physical contact surface of the dielectric.

[0155] In some embodiments, electrical contacts 1491 and / or 1371 may comprise conductive solder or other types of material, formed as flanges projecting in dimensions perpendicular to the plane of plate 1370, substrate 1401, and / or device 1500. Contact 1371 may be formed in any suitable or desired manner, such as by vapor deposition, sputtering, or other application processes. In some embodiments, due to the thickness of the contact layer 1371, the deflection of diaphragm 1325 may be limited in some respects to an area within the generally peripheral / boundary region of contact 1371, which may be positioned generally around the periphery of electrode 1322. This is for use in the default, unpressurized / undeflected state (see...). Figure 10-5 The precise design distance between electrodes 1322 and 1481 is achieved under dimension d7. This dimension can be forced by a physical hard stop / contact between contacts 1491 and 1371, allowing the vertical dimensions of contacts 1491 / 1371 (relative to the shown orientation) to produce the desired electrode spacing d7. In some embodiments, the surface 1364 of the metal layer 1321 is partially flexible to allow a certain amount of 'float' in the external / peripheral sealing contact 1372, which can contribute to producing the desired hermetic seal.

[0156] In some embodiments, a peripheral gap 1377 can separate adjacent portions / lengths of conductor 1371, which typically extends along the periphery of electrode 1322. The gap 1377 can provide a pathway for gas to be removed from the space within contact 1371, allowing for a vacuum seal of chamber 1509. In some instances, contact 1371 forms a continuous periphery around electrode 1322 without a circumferential gap, which can allow for the implementation of independent and / or isolated capacitors.

[0157] The diaphragm plate 1370 may further include a peripheral sealing structure 1372, which may be applied to and / or around the periphery of the plate 1370, such as by direct application to a thin-film metal (e.g., nitinol) layer 1321. The peripheral structure 1372 may take the form of a raised flange, edge, lip, rim, or similar structure, and typically provides a sealing contact surface 1379 to seal against a corresponding surface of the base structure. The sealing flange 1372 may, in some respects, function as a gasket and may be incompressible or compressible. The peripheral structure 1372 may project in a direction perpendicular to the surface of the nitinol layer 1321 to provide a structure that offsets the structure to which the capacitor electrode 1322 is coupled to the plate 1370. For example, the top surface 1379 of the peripheral structure 1372 may be configured to engage with a corresponding surface or feature of the base structure of the sensor device, of which the diaphragm plate 1370 is an assembly. The peripheral seal 1372 can be formed of any suitable or desired conductive or non-conductive material and can be applied to the plate 1370 using any suitable or desired process.

[0158] Relative to the rear surface 1363 of the nickel-titanium layer 1321, such as Figure 13B As shown, according to any of the examples disclosed herein, the diaphragm region 1325 may have certain topological surface features associated therewith, wherein such features can advantageously increase the effective surface area of ​​the diaphragm 1325. For example, when the nitinol layer 1321 is applied, such topological features can be formed in the nitinol layer 1321 by using a substrate / mandrel surface on which such features are formed. Alternatively, the surface topological features can be formed in the nitinol layer 1321 by additive or subtractive processes (e.g., etching, electroplating, etc.).

[0159] Figure 14 The diagram shows the relationship between one or more instances. Figure 13A and 13B The diaphragm plate 1370 shown is associated with the base electrode structure 1480 of the sensor device. That is, the electrode structure 1480 can serve as the base of the sensor device, which includes the physically bonded / assembled base structure 1480 and diaphragm plate 1370 (see [link to image]). Figure 13A and 13B ). Figure 15 An assembled sensor device 1500, comprising a diaphragm plate 1370 physically coupled / joined to a base structure 1480, is shown according to one or more embodiments. In some embodiments, the diaphragm plate 1370 is welded to the base structure 1480.

[0160] A sensor base 1480 may have capacitive electrodes 1481 formed thereon, each of which may be paired with a corresponding capacitive electrode among the capacitive electrodes 1322 of the diaphragm plate 1370, such that when the plate 1370 is coupled to the base 1480, a variable capacitance, at least partially based on the deflection state of the diaphragm 1325, exists between and is measurable between the plates 1322 and 1481. Electrodes 1481, which may have fixed non-deflection attachments / structures, may be combined with deflectable electrodes 1322 to form one or more variable capacitors having capacitance that varies according to the deflection state of the electrode 1322. The static properties of the base electrode (e.g., cathode) 1481 may be provided through its coupling and / or integration with a rigid or semi-rigid substrate structure 1401. Any of the electrodes 1322 and 1481 may have an elliptical (e.g., circular) shape, as shown.

[0161] The base 1480 may further include electrical contacts 1491 configured to contact / bond to corresponding electrical contacts 1371 of the diaphragm plate 1370. That is, the contacts 1491 of the base 1480 may be electrically isolated from the capacitor plate 1481, but electrically coupled to the electrode 1322 via the contacts 1371. When the diaphragm plate 1370 is bonded to the base structure 1480, the contacts may bond together at the coupling interface 1507, such as... Figure 15 As shown. Although contact 1491 can be configured such that it does not directly contact capacitor plate 1481 via various electrical interconnects, both capacitor plate 1481 and electrical contact 1491 can ultimately be connected in the same capacitive resident circuit to allow measurement of capacitance between plates 1322, 1481. When parts 1370, 1480 are combined / coupled together, static / fixed capacitor electrode 1481 can be axially aligned with and / or centered on dynamic capacitor electrode 1322. Electrical contact 1491 can take the form of a raised flange, edge, lip, rim, or similar structure, and typically provides a contact surface for electrically distributing with the corresponding surface 1371 of diaphragm plate 1370. In some instances, any of electrical contacts 1371, 1491 is formed as an elongated, curved contact, as shown.

[0162] The physical contact and sealing area between the diaphragm plate 1370 and the base plate 1480 can be via a peripheral protrusion 1492. The dimensions of the electrical contact flanges 1491 and 1372 can be designed and set at known distances to offset the capacitive electrodes 1322 and 1481 by a desired distance. For example, opposing flange contacts 1491 and 1371 can physically contact each other to create an electrical connection between the plates 1370 and 1480, and to define the offset accuracy of the electrodes 1481 and 1322. The contact flanges 1492 and 1372 can provide a peripheral seal for the hermetic seal of the device 1500. In some embodiments, the contact flanges 1492 and 1372 can have some flexibility to accommodate the relatively complex construction of the base plate 1401. The peripheral structure 1492 of the base 1480 can advantageously span the entire periphery of the base substrate 1401, such that the connection interface 1503 between these peripheral structures can provide an hermetically sealed protection for the inner cavity 1509 from external environmental influences when in close contact with the peripheral structure 1372 of the diaphragm plate 1370. The inner cavity 1509 can be filled with air or other inert gases, or it can be vacuum-sealed. In instances where the cavity 1509 contains a vacuum, the sensor can provide an absolute pressure sensor. Alternatively, some instances include the presence of gas in the cavity / volume of 1509, which can be used as a relative pressure sensor implementation. In the case of implementing a relative pressure sensor, it may be desirable to implement a tuned reservoir. For example, gaps in the electrode electrical interconnects 1491, 1371 can allow a relatively large reservoir in the body of the device 1500 to extend beyond the diaphragm 1325, or to enter another volume via a port.

[0163] The substrate 1401 of the base structure 1480 (e.g., a cathode structure) can comprise any suitable material, whether rigid or flexible. For example, the substrate 1401 may include and / or have associated printed circuit boards and / or application-specific integrated circuits (ASICs) containing certain circuitry configured to process the capacitive signals of the capacitor 1395. Electrical contacts having capacitor plates 1322, 1481 can be implemented using any suitable or desired interconnect design configured to electrically couple the top capacitor electrode 1322 and the bottom capacitor electrode 1481 to the associated circuitry. The base substrate 1401 may include certain electrical connections configured to facilitate appropriate electrical coupling of the respective capacitor plates 1322, 1481. For example, certain through holes or other connections can be made through at least a portion of the thickness of the substrate 1401 (such as the through hole connector 1405 shown), wherein electrical connections of the sensor 1500 can be implemented within / on the substrate 1401 and / or in / on other areas or structures of the sensor device 1500.

[0164] Each of the paired diaphragm plates 1322 and the capacitive electrodes of the base 1481 can be combined to form a separate capacitor 1395 for the sensor circuit; the sensor can have any number of capacitors 1395, including fewer or more than the three shown. In some embodiments, the deflection of the diaphragm 1325 is measured independently to provide separate sensor signals, thereby providing additional levels of sensitivity. For example, different capacitors 1395 can be tuned to have different mmHg / F profiles, thereby allowing consideration (e.g., zeroing) of tissue growth that may accumulate disproportionately on one capacitor diaphragm 1325 relative to the other capacitor diaphragm.

[0165] In the example of Figures 13-15, the three capacitors 1395 can operate concurrently to function as a single capacitor sensor, or the three capacitors can be separated by certain electrical contacts / connectors to create three separate capacitors. In some instances, capacitor electrodes 1322 and / or capacitor electrodes 1481 may comprise gold. During operation, such as when sensor 1500 is implanted in a cavity of the human body, electrodes / plates 1481 can generally remain stationary even as external pressure conditions fluctuate, while diaphragm electrodes / plates 1322 can dynamically deflect as pressure conditions outside device 1500 change. Device 1500 may provide a capsule configured to house an active circuitry system of the device, the capsule may include certain control circuitry systems configured to transduce capacitance changes indicated by the deflection states of diaphragm 1325 and electrodes 1322 into electrical signals, which can be interpreted locally or remotely to determine the current pressure conditions in the environment of the implanted device.

[0166] Figure 16 A schematic side view illustrating example electrical connections of the components of the capacitive sensor device 1500 as described above is shown. Figure 16 As schematically shown in the image, the diaphragm electrode 1322 can be electrically coupled to the electrical connector 1488 via some form of electrical connector 1601, ultimately providing a polarity opposite to that of the electrical connection 1487 coupled to the base capacitor plate 1481. As described above, such connections to the electrode plates 1322, 1481 can be implemented at least partially within / on the base substrate 1401, and such connections can have some insulation adjacent to them to prevent shunting between the respective electrodes. In some embodiments, the base electrode 1481 can be formed on an insulating / oxide layer 1426. The deflection electrode 1322 can be coupled to the connector 1601, which is configured to connect the electrode to a circuit.

[0167] Figure 17 A sensor 1700 having one or more corrugated diaphragms 1725 is shown according to one or more examples. Figure 18A cross-sectional side view of one of the corrugated diaphragms 1725 of a sensor 1700 according to one or more examples is shown, illustrating a conformal capacitive electrode on its underside. For clarity, Figure 18 The cross-sectional side view only shows Figure 17 A single diaphragm plate assembly of the dual-sided device 1700, which can correspond to either of the diaphragm plates 1770a and 1770b of the device 1700.

[0168] To provide increased deflection sensitivity, the diaphragm 1725 (or any diaphragm disclosed herein) may include one or more corrugations 1759. For example, such corrugations 1759 may include annular ridges and / or grooves that may be concentric with the axis A1 of the diaphragm 1725. Such corrugations 1759 can provide the diaphragm 1725 with a sufficiently large linear range and improved sensitivity. Depending on the specific corrugation design, the corrugations may also provide the diaphragm 1725 with relatively large deflection and / or accurate spring rate and / or extend the cycle life of the diaphragm 1725 by reducing mechanical stress in one or more regions of the diaphragm. The corrugations 1759 can be produced by cold pressing the diaphragm nitinol layer into a corrugated shape or by any other means. In some embodiments, the corrugations can be formed during the physical vapor deposition process by adding shape to the substrate during processing. For example, the corrugations can be formed by shaping a substrate / mandrel (e.g., silicon wafer, glass, etc.) on which the physical vapor deposition material is deposited. The corrugations can be coaxial with the axis A1 of the diaphragm 1725, as shown in the figure. The outer surface 1729 of the nitinol layer 1770 protects the device 1700 from the influence of the external environment during implantation.

[0169] The corrugated diaphragm 1725 can be implemented in such a way that the formed nitinol diaphragm 1725 can have different thicknesses in different regions. For example, the outer region 1728 of the nitinol layer 1721 outside the diaphragm 1725 can have a relatively large thickness compared to the thickness of the nitinol layer in the central diaphragm region 1723 or in the corrugations 1759 (which may or may not have different thicknesses). The larger thickness of the outer region 1728, which can be formed of multiple layers of nitinol and / or other structural materials, can provide a peripheral sealing structure configured to hold the electrode 1722 in its undeflected state at a set distance relative to the corresponding electrode associated with the base 1701 (see [link to documentation]). Figure 17 The central portion 1723 of the diaphragm, concentrically positioned within the corrugations 1759, may have a greater thickness than Nitinol in the region of the corrugations 1759, but the thickness of the diaphragm region 1723 may be less than that of the offset / sealing structure 1728. See reference... Figure 18 A cross-sectional side view like this visualizes such relative differences in thickness.

[0170] Electrode 1722 can be deposited on the inner surface of the inner diaphragm region 1723. In some embodiments, the inner surface of the diaphragm region 1723 may have recesses formed therein, such that electrode 1722 is deposited within the recesses formed in the inner surface of the diaphragm 1723, for example, by etching away its central region and / or constructing the peripheral region 1753. That is, with respect to the corrugated diaphragm examples of electrode-integrated deflectable nitinol diaphragms disclosed herein, the electrode portion can be confined to a region within the corrugations, such that the electrode is not formed and / or integrated with the corrugated portion itself.

[0171] although Figure 17 The example sensor 1700 shows two diaphragms 1725a, 1725b, but it should be understood that corrugated diaphragms can be implemented in combination with any of the examples disclosed herein and in combination with examples containing any number and / or configuration of diaphragms.

[0172] Figure 17 and Figure 18 Example sensor 1700 further represents an example of a bilateral sensor device. Although certain examples are shown and described herein only in the context of describing a unilateral sensor device having a deflectable diaphragm plate integrated with capacitive electrodes thereto, it should be understood that any example disclosed herein can be implemented as similar to in one or more respects. Figure 17 The device 1700 shown in the figure has a dual-side sensor device.

[0173] The bilateral sensor device of this disclosure can be symmetrical about one or more of its components across a plane / line P2 parallel to one or more capacitive electrodes of the device. For example, the bilateral sensor implantation device of this disclosure can be implemented by including opposing capacitive base electrodes on opposite faces / sides of a static base substrate, such as... Figure 17 The base 1701 shown in the figure (or Figure 14 and Figure 15 The base 1401), wherein the first diaphragm plate 1770a and the second diaphragm plate 1770b can be coupled to the base 1701 on their opposite sides, such as Figure 17 As shown. In some or all respects, diaphragm plates 1770a and 1770b may be similar or identical.

[0174] Vascular / cardiac access for sensor implantation

[0175] The encapsulated sensor implantation device according to one or more embodiments of this disclosure can be advanced to the relevant target chamber or vessel of the heart and / or vascular system using any suitable or desired procedure. For example, although access to the various chambers / vessels of the heart via the right atrium and / or inferior vena cava has been shown and described in conjunction with certain embodiments, such as via the femoral artery or other transcatheter procedures, other access routes / methods can be implemented according to embodiments of this disclosure, such as in conjunction with Figure 19 As described / shown. For example, Figure 19 Various access routes 111 are illustrated, through which a delivery system can be used to access the chambers of the heart. Access to the left atrium or ventricle can be achieved via transseptal access, which can be achieved through the inferior vena cava 29 or superior vena cava 19 (shown respectively) and from the right atrium 5, through the septal wall (not shown) and into the left atrium 2. For transaortic access 111c, the delivery catheter can pass through the descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7, and enter the left atrium 2 through the mitral valve 6. For transapical access 111d, the catheter can directly enter the left ventricle 3 through the apex of the heart 39 and enter the left atrium 2 through the mitral valve 6. Other... Figure 19 Other access routes besides those shown are also possible. The various transcatheter delivery systems and routes shown may involve delivering the sensor implantation device 1900 within the axis / lumen of such instruments, and deploying the device 1900 from the delivery system at the target anatomical site.

[0176] Electrode configuration

[0177] Figure 20A , 20B Figures 20C and 20C show a plan view of an example electrode integrated sensor diaphragm / cap structure design 570. According to one or more embodiments of this disclosure, the diaphragm / cap structure 570 may be formed at least partially from vapor-deposited nitinol and / or other hyperelastic materials. Figure 20A The design includes three diaphragms 525a and / or three electrodes 522a (e.g., anodes) linearly aligned at intervals. The electrodes 522a may operate uniformly to function as a single electrode, or the electrodes may have separate electrical contacts to an associated circuit system to function as three separate electrodes. Each electrode 522a may have a corresponding electrical contact 571a associated with it, which may comprise gold, gold-tin, or other conductive materials, wherein each contact 571a makes point contact with a corresponding one of the three electrodes 522a. The contact 571a electrically connects the corresponding electrode 522a (e.g., anode) to a corresponding electrode (e.g., cathode) at the sensor base, thereby forming a capacitor stack as described herein.

[0178] Figures 20A-20CThe sensor diaphragm structure 570 may include a peripheral seal 579, which may comprise nitinol, gold-tin, or other materials, providing a hermetically tight seal to maintain an internal sensor cavity as detailed herein, which may be filled with air, an inert gas, or a vacuum. In some embodiments, the peripheral seal 579 comprises a gold-tin alloy (AuSn) that allows electrical contact with the vapor-deposited nitinol film 521 and provides a hermetically tight seal. AuSn may be advantageous due to its relatively high eutectic temperature compared to the transition temperature of the adjacent nitinol 521.

[0179] The diaphragm structure 570 (e.g., a cover, plate, etc.) can be configured to be joined / bonded to the corresponding sensor base structure using a binder such as a gold (Au) or gold-tin (AuSn) alloy layer to provide its hermetic seal. References herein to components 'bonded' to each other can be understood as being joined in any manner (e.g., welding, adhesive bonding, etc.). Contacts 571, which may be at least partially formed of gold (Au) or AuSn, can interface with the sensor base electrodes via direct physical contact or routing of traces on the nitinol diaphragm substrate / layer 521. Although the diaphragm structure 570 is shown and described as having an elliptical shape, it should be understood that such a device / structure can have any suitable or desired shape, such as rectangular, circular, or similar shapes.

[0180] The diaphragm plate 570 comprises a sheet / layer of a superelastic nitinol film 521, wherein the nitinol can be deflected in one or more regions on a dimension perpendicular to the surface of the layer 521, such as at least in the deflectable diaphragm region 525 corresponding to the capacitor electrode 522. An insulating layer may be formed in the region of the diaphragm 525. For example, the thickness of the nitinol layer 521 may be approximately 5 µm or any other value less than 10 µm. Electrode metal 522 may be applied to the dielectric / oxide layer and confined within the region of the diaphragm 525. In some embodiments, the nitinol layer 521 in the diaphragm region 525 differs substantially from the region 529 outside the diaphragm. For example, the diaphragm portion 525 may be thinner than the region 529 outside the diaphragm. Additionally or alternatively, certain shape or surface features of the diaphragm region 525 may distinguish the diaphragm from the remainder of the nitinol sheet / layer. For example, corrugations, protrusions, indentations, marks, or other features may define the outer periphery of the diaphragm region 525 and / or other regions or features of the diaphragm 525.

[0181] Electrical contact 571 can physically contact the corresponding electrode layer 522. When diaphragm plate 570 is engaged (e.g., bonded) to contact 571, the contact can provide an electrical connection between capacitor electrode 522 and the physically coupled base sensor structure, thereby incorporating diaphragm electrode 522 into the associated capacitive resonant circuit of the sensor device. Electrical contact 571 can take the form of a raised flange, edge, lip, rim, or similar structure, and typically provides a physical contact surface for electrically distributing with the corresponding contact of the sensor base structure. Contact 571 can be formed in any suitable or desired manner, such as by vapor deposition, sputtering, or other application processes.

[0182] In some embodiments, the electrode contact 571 is formed with a peripheral gap 577 that separates adjacent portions / lengths of the conductor 571 extending along the periphery of the electrode 522. The gap 577 can provide a pathway for gas to be removed from the space within the contact 571 and / or allow for a vacuum seal between the sensor electrodes.

[0183] Such as by combining Figure 20A The images illustrate alternative contact configurations 501 and 502, showing that electrode contact 571 can be implemented with any desired number of segments. For example, contact configuration 501 shows an example embodiment where two contact segments 572 are formed on the periphery of electrode 522, such that two gaps 577a separate the different segments 572. As an example alternative, configuration 502 includes four contact segments 573 formed on electrode 522, wherein four gaps 577b surrounding the periphery of electrode 522 separate the different contact segments 573. In some instances, contact 571 forms a continuous periphery around electrode 522 without circumferential gaps, which can allow for the implementation of independent and / or isolated capacitors.

[0184] although Figure 20A Three circular diaphragms 525a are shown, but it should be understood that the diaphragm plates / structures disclosed herein can have any number, configuration, or shape of diaphragms. For example, Figure 20B and Figure 20C Sensor diaphragm plates 570b and 570c are shown with different numbers and arrangements of electrodes 522b and 522c and / or diaphragms 525b and 525c. As shown, the electrodes / diaphragms can be arranged in one or more columns and / or one or more rows with any desired number and spacing.

[0185] Figure 21A A plan view of a thin-film diaphragm sensor device 670 according to one or more examples is shown. Figure 21B and 21C They are shown respectively Figure 21AThe exploded side view and the combined / assembled cross-sectional view of an example portion of the thin-film diaphragm sensor device 670 are shown in the figure.

[0186] Figure 21B and 21C This includes aspects relating to the joints 601, 602 between the diaphragm / cover assembly 611 and the sensor base assembly 612, which provide a hermetically sealed and electrically connected connection between the nitinol substrate 632 of the diaphragm 611 and the non-nitinol substrate 648 of the sensor base 612. According to one or more embodiments, either or both of the substrates 632, 648 may integrate one or more conductive paths, passive electronics, and / or active electronics electrically connected across the joint 602. For example, the electrode joint 602 (and / or the peripheral sealing joint 601) may contain material providing the ability to electrically connect the functional thin-film nitinol 632 to a passive (e.g., printed circuit board (PCB), flexible cable, or microelectromechanical system (MEMS) substrate) or active (e.g., application-specific integrated circuit (ASIC), microprocessor, field-programmable gate array (FPGA), system-on-a-chip (SOC), microcontroller, radio frequency identification (RFID) chip, active MEMS, optoelectronic device, etc.) substrate 648.

[0187] Figure 21B A thin-film nitinol substrate 632 is shown, which may have a passive capacitive electrode 682 or other passive or active electrical element formed thereon. For example, the electrode 682 may comprise a gold (Au) or other conductive layer applied to the nitinol 632 by physical vapor deposition or other processes, as described in detail above. A high-k dielectric intermediate layer 673 (such as titanium oxide or other suitable oxide) may be interposed between the gold layer 682 and the nitinol 632. Furthermore, a mold 671 comprising gold-tin (AuSn), Au, or other conductors may be applied to the electrode 682 to provide electrical contacts to the electrode 682. The nitinol substrate 632 may further include bonding tracks 635 outside the region of the electrode 682 to provide a hermetically sealed connection for the device / structure 630, wherein the bonding tracks 635 may be configured to provide a hermetically sealed seal 601 around the electrode 682, such that the assembled device 630 may be suitable, for example, for implantation and long-term maintenance in the human body. The airtight mold 635 can be inoculated with seed material 633 (such as titanium or other suitable metals / oxides).

[0188] The base substrate 648 may contain any suitable material on which electrical components can be integrated. In some embodiments, the base substrate 648 includes a bonding protrusion / track 646 that can be bonded to an opposing bonding portion 635 of the diaphragm plate 611 to form a hermetically sealed seal 601. The substrate 648 may further include electrodes or other passive or active circuitry 681. The electrodes 681 may serve as counter electrodes to capacitive electrodes 682 associated with the nitinol substrate 632. Thus, when as Figure 21C When combined as shown, electrodes 682 and 681 can operate as plates of a capacitor, and these electrodes can be used in pressure sensing applications or other applications. Examples of such sensor devices have been described in detail above.

[0189] The base substrate 648 may further include electrical contacts 691, which may comprise gold or other conductive metals, wherein such contacts 691 are configured to be coupled to electrical contacts 671 associated with the diaphragm plate 601. Figure 21C The assembled configuration shown illustrates the formed electrical internal junction 602 and hermetic peripheral junction 601, which can connect any number / type of transducers directly integrated onto the thin-film nitinol substrate 632 to electronics / circuits associated with the corresponding active or passive substrate 648.

[0190] In some embodiments, the same joints may be formed on the interior 602 and the exterior 601 of the device 630 in terms of material composition and / or arrangement. Figure 21C The diagram illustrates the electrical connections of junction 602 using resistor icons. Typically, electrode junction 602 can provide sufficiently low resistance to suit use in sensor applications as described herein and other applications.

[0191] The mold 635 can be implemented as a flip chip bump / mold to allow flip chip assembly, such as... Figure 21B and Figure 21C As illustrated in the figure. Therefore, according to various aspects of this disclosure, sensor electronics integrated onto a thin-film nitinol substrate (e.g., multiple capacitive electrodes, multiple varistors) can be connected to a separate bonding die, wherein conventional flip-chip bonding techniques can be used to create the connectors of such bonding dies to bond nitinol to flexible cables or other substrates.

[0192] Figure 21B and 21CThe cross-sectional view illustrates how a deterministic distance is set between the electrodes (e.g., anode and cathode) of the thin-film diaphragm sensor device according to this disclosure during sensor assembly / manufacturing. Setting the deterministic distance between electrodes 681, 682 can be accomplished primarily through structural formation on the sensor base substrate 612 rather than on the diaphragm plate 611.

[0193] The distance d8 between electrodes 681 and 682 can typically be set by controlling the difference between the height h2 of the base electrode 618 (e.g., cathode) and the electrode bonding height h1, which may include one or more of the diaphragm electrode contact 671, the base contact 691, and / or any oxide or seed layer (e.g., layer 377 and / or any existing seed layer 674 between the diaphragm contact 671 and electrode 682). Using microfabrication techniques, the two heights h1 and h2 can advantageously be repeatable and reproducible. For example, the electrode height h2 can be set by metal sputtering deposition, which can advantageously have a resolution of tens of nanometers. The electrode bonding height h1 can be set by an assembly process using a flip-chip bonder capable of adjusting the offset distance between the anode and cathode during bonding with a resolution as low as, for example, hundreds of nanometers. Hard stop features can be used to further control / set the bonding height h1. In some embodiments, the thin-film nitinol layer 632 includes three-dimensional surface features in one or more regions, which provide a significant increase in the effective surface area of ​​the diaphragm. The sensor 670 can advantageously be implemented with electrodes 681, 682 close to each other without touching, to provide highly sensitive conduction for a given sensing pressure.

[0194] The electrode distance d8 can advantageously be on the order of micrometers, typically ranging from a few micrometers to tens of micrometers. While other conductors (such as gold) can be used, it should be understood that gold-tin can provide certain advantages in producing hermetically tight and electrical contacts when used as a seed layer. Furthermore, although the diaphragm plate bonding portion 635 is shown as an additive metal bump / mold, it should be understood that such a feature can be formed by protrusions emanating from and integrated into the thin-film nitinol layer 632.

[0195] In manufacturing the sensor device 670, the diaphragm plate 611 can be precisely aligned and placed on top of the base structure 612, which can have similar or different stacked layer structures forming the capacitor and the hermetic seal. This stack produces a pressure-sensitive sensor capable of withstanding large deflections while allowing for large changes in capacitance. Passive resonant circuit systems (such as resonant circuits consisting of inductors and capacitors) can be used to read out capacitance changes, or active circuit systems can be configured to convert capacitance changes into digital signals for processing and transmission.

[0196] Another description of the instance

[0197] A list of examples is provided below, and each example may include aspects of any other examples disclosed herein. Furthermore, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0198] Example 1: An implantable sensor device comprising: a deflectable diaphragm layer comprising a vapor-deposited thin film metal; a first capacitive electrode conformally formed on a first side of the deflectable diaphragm layer; and a second capacitive electrode coupled to a rigid substrate, the second capacitive electrode and the first capacitive electrode forming a variable capacitor.

[0199] Example 2: According to any example of this document, specifically the implantable sensor device described in Example 1, it further includes a first dielectric layer disposed between the deflectable diaphragm layer and a first side of the first capacitive electrode.

[0200] Example 3: According to any example of this document, specifically the implantable sensor device described in Example 2, wherein the first dielectric layer electrically insulates the first capacitive electrode from the deflectable diaphragm layer.

[0201] Example 4: According to any example of this document, specifically the implantable sensor device described in Example 2, it further includes a second dielectric layer disposed on a second side of the first capacitive electrode.

[0202] Example 5: According to any example of this document, specifically the implantable sensor device described in Example 1, it further includes one or more electrical contacts protruding from the first capacitive electrode, the one or more electrical contacts physically contacting the first capacitive electrode.

[0203] Example 6: According to any example of this document, specifically the implantable sensor device described in Example 5, wherein the first capacitive electrode is elliptical in shape; and the one or more electrical contacts are elongated contacts disposed along the periphery of the first capacitive electrode.

[0204] Example 7: According to any example of this document, specifically the implantable sensor device described in Example 1, wherein the deflectable diaphragm layer and the first capacitive electrode form a stack with a thickness of less than 10 µm.

[0205] Example 8: According to any example of this document, specifically the implantable sensor device described in Example 1, wherein the deflectable diaphragm layer includes protrusions associated with one or more of its sides.

[0206] Example 9: According to any example in this document, specifically the implantable sensor device described in Example 8, wherein the protrusion is formed using etching, masking, or electroplating.

[0207] Example 10: According to any example in this document, specifically the implantable sensor device described in Example 8, wherein the protrusion is corrugated.

[0208] Example 11: According to any example of this document, specifically the implantable sensor device described in Example 1, wherein the first capacitive electrode includes a protrusion associated with one or more of its sides.

[0209] Example 12: According to any example in this document, specifically the implantable sensor device described in Example 11, wherein the protrusion is formed using etching, masking, or electroplating.

[0210] Example 13: An implantable sensor device comprising: a first deflectable diaphragm plate including a thin-film metal layer; and one or more first capacitor electrodes conformally formed on the metal layer. The implantable sensor device further comprises a base structure coupled to the first diaphragm plate to form a sealed cavity, the base structure including a rigid substrate and one or more second capacitor electrodes fixed to the rigid substrate.

[0211] Example 14: According to any example of this document, specifically the implantable sensor device described in Example 13, wherein the first diaphragm further comprises one or more dielectric layers disposed between the metal layer and the one or more first capacitor electrodes.

[0212] Example 15: According to any example of this document, specifically the implantable sensor device described in Example 13, wherein the first diaphragm plate further includes a first sealing flange protruding from the metal layer and extending along the periphery of the metal layer to provide a sealing contact surface, and a first electrical contact flange protruding from at least one of the one or more first capacitor electrodes.

[0213] Example 16: According to any example of this document, specifically the implantable sensor device described in Example 15, wherein the base structure further includes a second electrical contact flange projecting from the rigid substrate, the second electrical contact flange being spaced apart from the one or more second capacitor electrodes.

[0214] Example 17: According to any example of this document, specifically the implantable sensor device described in Example 16, wherein the base structure further includes a second sealing flange projecting from the rigid substrate around the periphery of the rigid substrate, the second sealing flange having a sealing surface forming a sealing contact surface abutting against the first sealing flange.

[0215] Example 18: According to any example of this document, specifically the implantable sensor device described in Example 13, wherein the first diaphragm plate and the base structure have a stadium shape.

[0216] Example 19: According to any example of this document, specifically the implantable sensor device described in Example 13, wherein the one or more first capacitor electrodes comprise a first plurality of capacitor electrodes distributed along a line, and the one or more second capacitor electrodes comprise a second plurality of capacitor electrodes distributed along the line and centered on the one or more first capacitor electrodes respectively.

[0217] Example 20: According to any example of this document, specifically the implantable sensor device described in Example 19, wherein the first plurality of capacitor electrodes and the second plurality of capacitor electrodes form a plurality of capacitors having a combined capacitance indicating a pressure level outside the implantable sensor device.

[0218] Example 21: According to any example of this document, specifically the implantable sensor device described in Example 13, it further includes a second deflectable diaphragm plate, the second deflectable diaphragm plate being coupled to the side of the base structure opposite to the first deflectable diaphragm plate.

[0219] Example 22: A method of manufacturing an implantable sensor device, the method comprising depositing a thin-film metal layer on a substrate using a physical vapor deposition process and depositing a conformal electrical conductor layer on a stack including the thin-film metal layer.

[0220] Example 23: According to any example of this document, specifically Example 22, the method further includes forming a first dielectric layer on the surface of the thin film metal layer after the deposition of the thin film metal layer and before the deposition of the electrical conductor layer, wherein the electrical conductor layer is deposited on the first dielectric layer.

[0221] Example 24: According to any example of this document, specifically Example 23, the method further includes forming a second dielectric layer on the electrical conductor layer.

[0222] Example 25: According to any example of this document, specifically Example 22, the method further includes forming an electrical contact flange on the electrical conductor layer.

[0223] Example 26: According to any example of this document, specifically Example 22, the method further includes forming surface protrusions on the surface of the thin-film metal layer.

[0224] Example 27: According to any example of this document, specifically Example 22, the method further includes forming surface protrusions on the electrical conductor layer.

[0225] Example 28: According to any example of this document, specifically Example 22, the method further comprises incorporating a plate structure comprising at least the thin-film metal layer and the electrical conductor layer to a base structure comprising a capacitive electrode to form a sealed cavity comprising a space between the electrical conductor layer and the capacitive electrode.

[0226] Example 29: According to any example of this document, specifically Example 28, the method further includes forming a sealing flange in or on the thin-film metal layer, wherein combining the plate structure to the base structure involves engaging the contact surface of the sealing flange to the base structure.

[0227] Example 30: According to any example of this document, specifically Example 22, the method further includes forming one or more ripples in a portion of the thin-film metal layer.

[0228] Example 31: The method described in Example 30, specifically according to any example in this document, wherein one or more corrugations are coaxial with the electrical conductor layer.

[0229] Example 32: A sensor device comprising: a deflectable diaphragm layer comprising a flexible material deposited using a vapor deposition process; a first capacitive electrode conformally formed on a first side of the deflectable diaphragm layer; and a second capacitive electrode forming a variable capacitor with the first capacitive electrode.

[0230] Example 33: A sensor device comprising: a deflectable diaphragm layer comprising a flexible material deposited using a vapor deposition process; and a conductive electrode conformally formed on a first side of the deflectable diaphragm layer.

[0231] Example 34: According to any example of this document, specifically the sensor device described in Example 33, wherein the conductive electrode is a piezoresistor.

[0232] Example 35: According to any example of this document, specifically the sensor device described in Example 33, wherein the conductive electrode is a capacitor plate.

[0233] The methods and structures disclosed herein for treating patients also encompass similar methods and structures for performing or placing on simulated patients, which can be used for, for example, training; demonstration; program and / or device development; and so on. Simulated patients can be physical, virtual, or a combination of physical and virtual. Simulations can include simulations of all or part of a patient, such as the whole body, parts of the body (e.g., chest), systems (e.g., cardiovascular system), organs (e.g., heart), or any combination thereof. Physical elements can be: natural, including human or animal carcasses or parts thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica or overlaid on one or more physical components. Virtual elements can be presented on any combination of a screen, headphones, hologram, projection, speaker, pressure transducer, temperature transducer, or any combination using suitable technologies.

[0234] Any of the various systems, apparatuses, devices, etc. disclosed herein can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods herein may include sterilizing the associated systems, apparatuses, devices, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0235] Depending on the instance, certain actions, events, or functions of any process or algorithm described herein may be performed in a different order, or may be added, combined, or omitted entirely. Therefore, in some instances, not all described actions or events are necessary for the practical process.

[0236] The conditional language used herein, such as “may,” “can,” “may,” “possibly,” “for example,” etc., unless otherwise specified or understood in the context in which they are used, is generally intended, and usually intended, to express that some instances include certain features, elements, and / or steps, while other instances do not include certain features, elements, and / or steps. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are necessary in any one or more instances, or that one or more instances must include, with or without author input or prompting, logic for determining whether such features, elements, and / or steps are included in or will be performed in any particular instance. The terms “comprise,” “include,” “have,” etc., are synonyms, used in their usual sense, and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that, for example, when used to connect a series of elements, the term “or” means one, some, or all of the elements in the list. Unless otherwise specified, connective language such as the phrase “at least one of X, Y, and Z” is generally understood in context to mean that an item, term, element, etc., can be X, Y, or Z. Therefore, such connective language is generally not intended to imply that certain instances require the presence of at least one of X, at least one of Y, and at least one of Z.

[0237] It should be understood that in the above description of the examples, various features are sometimes combined in a single example, drawing, or description for the purpose of simplifying this disclosure and aiding in the understanding of one or more aspects of the invention. However, this approach of the disclosure should not be construed as reflecting an intention in any claim to require more features than those expressly recited in the claim. Furthermore, any component, feature, or step shown and / or described in the specific examples herein can be applied to or used with any other example. Moreover, for each example, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention disclosed herein and claimed below is not intended to be limited by the specific examples described above, but should be determined solely by a careful reading of the appended claims.

[0238] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of said element relative to any other element, but rather can generally distinguish said element from another element with a similar or identical name (but using ordinal terms). Additionally, as used herein, indefinite articles ("a (a)" and "an (an)") may indicate "one or more" rather than "one." Furthermore, operations performed "based on" conditions or events may also be performed based on one or more other conditions or events not explicitly stated.

[0239] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the example instances pertain. It should be further understood that, unless expressly defined herein, terms (as defined in a common dictionary) shall be interpreted as having the meaning consistent with their meaning in the context of the relevant art and shall not be interpreted in an idealized or overly formal sense.

[0240] The spatial relative terms “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms are used herein to describe the relationship between one element or component and another, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, the spatial relative terms are intended to cover different orientations of the device in use or operation. For example, in the case where the device shown in the figures is flipped, a device positioned “below” or “below” another device may be placed “above” the other device. Thus, the illustrative term “below” can include both lower and upper positions. The device may also be oriented in another direction, and therefore the spatial relative terms can be interpreted differently depending on the orientation.

[0241] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” may mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. An implantable sensor device comprising: A deflectable membrane layer comprising a vapor-deposited thin film metal; A first capacitive electrode, conformally formed on a first side of the deflectable diaphragm layer; and A second capacitive electrode is coupled to a rigid substrate, and the second capacitive electrode and the first capacitive electrode form a variable capacitor.

2. The implantable sensor device of claim 1, further comprising a first dielectric layer disposed between the deflectable diaphragm layer and a first side of the first capacitive electrode.

3. The implantable sensor device of claim 2, wherein the first dielectric layer electrically insulates the first capacitive electrode from the deflectable diaphragm layer.

4. The implantable sensor device of claim 2, further comprising a second dielectric layer disposed on a second side of the first capacitive electrode.

5. The implantable sensor device according to any one of claims 1 to 4, further comprising one or more electrical contacts protruding from the first capacitive electrode, the one or more electrical contacts physically contacting the first capacitive electrode.

6. The implantable sensor device according to claim 5, wherein: The first capacitive electrode is elliptical in shape; and The one or more electrical contacts are elongated contacts arranged along the periphery of the first capacitive electrode.

7. The implantable sensor device according to any one of claims 1 to 4, wherein the deflectable diaphragm layer and the first capacitive electrode form a stack with a thickness of less than 10 µm.

8. The implantable sensor device according to any one of claims 1 to 4, wherein the deflectable diaphragm layer includes protrusions associated with one or more sides thereof.

9. The implantable sensor device of claim 8, wherein the protrusion is formed by etching, masking or electroplating.

10. The implantable sensor device of claim 8, wherein the protrusion is corrugated.

11. The implantable sensor device according to any one of claims 1 to 4, wherein the first capacitive electrode includes a protrusion associated with one or more sides thereof.

12. The implantable sensor device of claim 11, wherein the protrusion is formed by etching, masking or electroplating.

13. A method of manufacturing an implantable sensor device, the method comprising: A thin-film metal layer is deposited on a substrate using a physical vapor deposition process; and A conformal electrical conductor layer is deposited on a stack including the thin-film metal layer.

14. The method of claim 13, further comprising forming a first dielectric layer on the surface of the thin-film metal layer after the deposition of the thin-film metal layer and before the deposition of the electrical conductor layer, wherein the electrical conductor layer is deposited on the first dielectric layer.

15. The method of claim 14, further comprising forming a second dielectric layer on the electrical conductor layer.

16. The method according to any one of claims 13 to 15, further comprising forming an electrical contact flange on the electrical conductor layer.

17. The method according to any one of claims 13 to 15, further comprising forming surface protrusions on the surface of the thin-film metal layer.

18. The method according to any one of claims 13 to 15, further comprising forming a surface protrusion on the electrical conductor layer.

19. The method according to any one of claims 13 to 15, further comprising: A plate structure comprising at least the thin-film metal layer and the electrical conductor layer is incorporated into a base structure containing a capacitive electrode to form a sealed cavity, the sealed cavity including a space between the electrical conductor layer and the capacitive electrode; and A sealing flange is formed in or on the thin-film metal layer, wherein attaching the plate structure to the base structure involves engaging the contact surface of the sealing flange to the base structure.

20. The method according to any one of claims 13 to 15, further comprising forming one or more corrugations in a portion of the thin-film metal layer, wherein the one or more corrugations are coaxial with the electrical conductor layer.

Images