Integrated pressure diaphragm

Abstract

An implantable sensor device includes a cylindrical housing, a deflectable diaphragm associated with a sidewall of the housing, and a pressure sensor device housed within the housing. A transduction medium is disposed within the housing over at least a portion of the pressure sensor device.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 321,556, filed on March 18, 2022, and entitled “INTEGRATED PRESSURE DIAPHRAGM,” the entire disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] The present disclosure relates generally to the field of sensor devices. Some sensor devices, such as those suitable for medical implantation, may include a deflectable diaphragm. The mechanical seal between such a diaphragm and the associated sensor housing / structure may affect the suitability of such a device for certain applications. Summary of the invention

[0004] Methods, systems and devices are described herein to facilitate integration of a sensor diaphragm with a sensor housing / enclosure structure and / or layer. In particular, various pressure sensor packaging solutions are disclosed that provide for deposition of a layer of metal or other material on a substrate structure to form an integrated diaphragm layer. In some instances, the diaphragm of the inventive sensor device disclosed herein is advantageously oriented laterally.

[0005] To summarize the present disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all such advantages may be achieved according to any particular example. Therefore, the disclosed examples may be performed in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] For the purpose of illustration, various examples are depicted in the accompanying drawings, and these examples should not be construed as limiting the scope of the present invention. In addition, the various features of the different disclosed examples can be combined to form additional examples as part of the present disclosure. In all the accompanying drawings, reference numerals may be reused to represent the corresponding relationship between the reference elements.

[0007] Figure 1 Certain human anatomy illustrating example sensor implantation locations according to one or more examples is shown.

[0008] Figure 2 is a block diagram representing a system for wirelessly monitoring one or more physiological parameters associated with a patient according to one or more examples.

[0009] Figure 3A is a side view of a piezoresistive pressure sensor device according to one or more examples.

[0010] Figure 3B Based on one or more instances Figure 3A Side view of a piezoresistive pressure sensor where the sensor's diaphragm is deflected.

[0011] Figure 4A is a side view of a capacitive pressure sensor device according to one or more examples.

[0012] Figure 4B Based on one or more instances Figure 4A Side view of a capacitive pressure sensor with the sensor's diaphragm being deflected.

[0013] Figure 5A Front and side perspective views of a sensor implant device according to one or more examples are shown.

[0014] Figure 5B According to one or more examples, Figure 5A Exploded view of the sensor canister package of the sensor implant device.

[0015] Fig. 6A and 6B A cross-sectional view of a distal portion of a sensor implant device according to one or more examples is shown.

[0016] Figure 7 is a graph illustrating the relationship between sensor diaphragm thickness, surface area, and sensitivity according to one or more examples.

[0017] Figure 8 is a block diagram illustrating a deposition system according to one or more examples.

[0018] Fig.9A , 9B 9C illustrate a perspective view, a longitudinal cross-sectional view, and an axial cross-sectional view, respectively, of a sensor device with an integrated diaphragm according to one or more examples.

[0019] Fig.9D A sensor device having a concave diaphragm form factor is shown according to one or more examples.

[0020] Figure 10-1 , 10-2 and 10 - 3 provide flowcharts illustrating a process for packaging a sensor device according to one or more examples.

[0021] Figure 11-1 , 11-2 and 11-3 provide corresponding to one or more examples Figure 10-1 , 10-2 and images of the pressure sensor package assembly for the 10-3 process operation.

[0022] Fig.12 An axial cross-sectional view of a sensor device including more than two circumferentially distributed diaphragms according to one or more examples is shown.

[0023] Fig.13 A side view of a sensor device including multiple axially offset diaphragms is shown according to one or more examples.

[0024] Fig.14 A perspective view of a sensor device with an axially and / or circumferentially offset diaphragm is shown.

[0025] Figure 15-1 A perspective view of a sensor device with an integrated axial diaphragm is shown according to one or more examples.

[0026] Figure 15-2 A perspective view of a sensor device with an integrated axial diaphragm is shown according to one or more examples.

[0027] Fig.16 is a cross-sectional view of a human heart and associated vasculature illustrating certain catheter access paths for a sensor device implantation procedure according to one or more examples.

[0028] Figure 17-1 , 17-2 , 17-3, and 17-4 provide flowcharts illustrating processes for packaging sensor devices according to one or more examples.

[0029] Figure 18-1 , 18-2 , 18-3, 18-4, 18-5, 18-6 and 18-7 provide corresponding to one or more examples Figure 17-1 , 17-2 , 17-3 and 17-4 are images of pressure sensor package assemblies for operation of the processes. DETAILED DESCRIPTION

[0030] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0031] Although certain preferred examples are disclosed below, it should be understood that the subject matter of the present invention extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the resulting claims 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 as multiple discrete operations in turn in a manner that may help understand certain examples; however, the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems and / or devices described herein may be implemented as integrated components or independent components. In order to compare various embodiments, certain aspects and advantages of these examples are described. Not all of these aspects or advantages are necessarily implemented by any particular example. Therefore, for example, various examples may be performed in a manner that implements or optimizes an advantage or a set of advantages taught herein, without necessarily implementing other aspects or advantages also taught or suggested herein.

[0032] Some standard anatomical terms of position are used herein to refer to the anatomy of animals (i.e., humans) of various examples. Although some spatially relative terms, such as "external", "interior", "upper", "lower", "below", "above", "vertical", "horizontal", "top", "bottom", "distal", "proximal" and similar terms, are used to describe the spatial relationship between a device / element or anatomical structure and another device / element or anatomical structure in this article, it should be understood that for ease of description, these terms are used to describe the positional relationship between elements / structures in this article, as shown in the figure. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are intended to cover the different orientations of elements / structures in use or operation. For example, an element / structure described as "above" another element / structure can represent a position below or beside such other element / structure relative to the alternative orientation of the subject patient or element / structure, and vice versa. It should be understood that spatially relative terms (including those listed above) can be understood relative to the corresponding illustrated orientations of the reference drawings.

[0033] For the convenience of devices, components, systems, features and / or modules having similar features in one or more aspects, certain reference numerals are reused in different figures of the group of figures of the present disclosure. However, with respect to any one of the examples disclosed herein, the reuse of common reference numerals in the figures does not necessarily indicate that such features, devices, components or modules are the same or similar. On the contrary, those of ordinary skill in the art can understand the degree of similarity between the referenced subjects by the context. The use of specific reference numerals in the context of the description of a specific figure can be understood as involving the identified device, component, aspect, feature, module or system in the specific figure, without having to involve any device, component, aspect, feature, module or system identified by the same reference numeral in another figure. In addition, the various aspects of the separate figures identified with common reference numerals can be interpreted as sharing characteristics or being completely independent of each other.

[0034] In the case of using an alphanumeric reference identifier that includes a numeric portion and an alphabetic portion (e.g., '10a', where '10' is the numeric portion and 'a' is the alphabetic portion), reference in the written description to only the numeric portion (e.g., '10') may refer to any feature identified in the drawings using such numeric portion (e.g., '10a', '10b', '10c', etc.), even where such feature is identified by a reference identifier that concatenates its numeric portion with one or more alphabetic characters (e.g., 'a', 'b', 'c', etc.). That is, reference to feature '10' in this written description may be understood to refer to the identified feature '10a' in a particular figure of the present disclosure, or to the identifiers '10' or '10b' in the same figure or another figure as an example.

[0035] The present disclosure relates to systems, devices and methods for packaging devices, which are configured to sense and / or telemetrically monitor one or more physiological parameters (e.g., blood pressure) of a patient. Such pressure sensing / monitoring can be performed using a cardiac implant device with an integrated pressure sensor diaphragm and / or associated components. Such devices can be advantageously packaged for long-term implantation in a cardiac environment. The terms "associated" and "associated with..." are used herein according to their broad and common meanings. 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 or connected, integrated, at least partially embedded therein or otherwise physically associated with the second feature, element, component, device or member.

[0036] As described in detail below, implantable pressure sensors can be used to measure pressure levels in various conduits and chambers of the body, such as pressure levels in various chambers of the heart. However, due to the accessibility and environmental conditions typically associated with conduits / chambers of the heart and / or other potential sensor implantation locations within a patient, only certain types of sensors and sensor packages may be suitable for implantation for a given application. Examples of the present disclosure relate to packaging for pressure sensor implant devices that include certain electronic and telemetry features to allow wireless communication of data and / or power between the implantable sensor device and one or more devices or systems outside the patient's body.

[0037] Aspects of the present disclosure relate to sensor devices, such as wireless implantable pressure sensor devices and other devices that include a deflectable diaphragm assembly. In particular, the inventive features disclosed herein can be implemented in the context of an implantable sensor device, where an integrated diaphragm feature can advantageously provide a biocompatible seal and / or encapsulation of internal sensor components, such as the pressure transducing medium, circuitry, and / or structural components of the device.

[0038] With respect to implantable pressure sensor devices, anatomical considerations may require the use of a sensor device having a relatively small form factor. For example, it may be desirable to implant a sensor device, such as a pressure sensor device, using a transcatheter procedure, wherein the sensor device advances to a target implantation site through one or more venous or arterial vessels and / or various tortuous access paths. Examples of the present disclosure may advantageously be implemented in a sensor device having a sufficiently small profile / size to be delivered by and / or within a catheter, sheath, or other device 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 may also drive sensor design. For example, with respect to pressure sensor devices, a deflectable pressure diaphragm associated with such a device may be designed in a manner that provides sufficient sensitivity to the pressure conditions to which the device is exposed.

[0039] In addition, implantable sensor devices, such as pressure sensor devices equipped with diaphragms, may also need to provide biocompatibility and / or encapsulation properties suitable for in vivo implantation. For example, with respect to implantation in certain anatomical structures, such as implantation in a chamber of the heart, or other fluid-filled anatomical containers / chambers, such environments may present certain pressure, turbulence, and corrosive conditions, which may be associated with fluid / blood properties and / or cardiac circulation. Relative to non-implanted environments, the human body represents a very harsh environment for electrical implants. Examples of the present disclosure provide sensor implant devices that provide airtight seals / seals with extended duration and / or service life, which may be advantageous and / or critical for various reasons. For example, such an airtight seal can prevent components of environmental blood from degrading or otherwise interfering with the sensor and associated electronic devices. In addition, the airtight seal of the examples of the present disclosure can help prevent any non-biocompatible components of the sensor implant device or any non-biocompatible components associated with the sensor implant device from generating / causing toxic conditions in vivo. Examples of the present disclosure also provide an ion deposition shell component for a sensor implant device, which is relatively thin and provides an integrated sensor diaphragm with an airtight seal. Such designs can have reduced package thickness compared to certain other welded metal solutions, which can include interfaces between their metal and / or ceramic components that occupy an undesirable amount of space. By integrating multiple functional components into a single thin shell, the overall package thickness / size can be minimized.

[0040] Certain examples are disclosed herein in the context of cardiac implant devices. However, although certain principles disclosed herein may be particularly applicable to the anatomical structure of the heart, it should be understood that sensor implant devices according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure. In addition, examples of the present disclosure may also be used in non-biological environments.

[0041] The anatomical structure of the heart is described below to assist in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart typically includes a muscular organ having four blood-pumping chambers, wherein blood flow is at least partially controlled by various heart valves (i.e., the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve). The valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to control the flow of blood to corresponding regions and / or blood vessels of the heart (e.g., the pulmonary artery, the aorta, etc.). Contraction of the various myocardium can be facilitated by signals generated by the heart's electrical system, which will be discussed in detail below.

[0042] Figure 1An example representation of a heart 1 and associated anatomical structures having various features relevant to certain examples of the present disclosure is shown. The anatomical structures shown show example implantation locations of sensor devices according to aspects of the present disclosure. In general, the heart 1 includes 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 generally 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 so that blood can be pumped to the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11.

[0043] The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 includes a pulmonary trunk and a left pulmonary artery 15 and a right pulmonary artery 13 branching from the pulmonary trunk, as shown. In addition to the pulmonary valve 9, the heart 1 also includes three additional valves that assist blood circulation therein, including 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 cusps / leaflets and can typically close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 typically has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and when working normally, closes during systole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood exiting the left ventricle 3 to enter the aorta 12 , and to close during diastole to prevent blood from leaking back into the left ventricle 3 .

[0044] A heart valve can typically include a relatively dense fibrous ring (referred to herein as an annulus), and a plurality of leaflets or cusps attached to the annulus. Typically, the leaflets or cusps are sized such that when the heart contracts, the resulting increased blood pressure generated in the corresponding heart chamber forces the leaflets to at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber drops, the pressure in the subsequent chamber or vessel may become dominant and press back on the leaflets. As a result, the leaflets / cusps become juxtaposed to one another, closing the flow channel. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can result in valve leakage and / or other health complications.

[0045] Atrioventricular (i.e., mitral and tricuspid) heart valves are typically connected to a collection of chordae tendineae and papillary muscles (not shown) for securing the leaflets of the respective valves to promote and / or facilitate proper engagement of the valve leaflets and prevent their prolapse. For example, the papillary muscles may typically include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by chordae tendineae. A muscle wall 17, called the septum, separates the left atrium 2 from the right atrium 5 and the left ventricle 3 from the right ventricle 4.

[0046] Health conditions associated with heart stress and other parameters

[0047] As mentioned above, certain physiological conditions or parameters associated with cardiac anatomical structures can affect the health of patients. For example, congestive heart failure is a disease associated with the relatively slow movement of blood through the heart and / or body, which causes the fluid pressure in one or more chambers of the heart to increase. Therefore, the heart cannot pump enough oxygen to meet the needs of the body. The various chambers of the heart can respond to the pressure increase by stretching to keep more blood pumped through the body or by becoming relatively hard and / or thickening. The walls of the heart may eventually weaken and become unable to pump effectively. In some cases, the kidneys may respond to heart function decline by making the body retain fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs and / or other organs may cause body congestion, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is the main cause of morbidity and mortality, so treatment and / or prevention of congestive heart failure is an important concern in medical care.

[0048] Various methods for identifying and / or treating congestive heart failure include observing worsening congestive heart failure symptoms and / or weight changes. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements may vary greatly (e.g., up to 9% or more) and may be unreliable in signaling heart-related complications. In addition, treatments guided by monitoring signs, symptoms, weight and / or other biomarkers have not been shown to significantly improve clinical outcomes. Therefore, using an implanted device to directly or indirectly measure / monitor pressure and / or other parameters can provide better results than purely observation-based solutions. For example, without directly or indirectly monitoring 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, thoracic impedance, right heart catheterization, etc.

[0049] Heart stress monitoring

[0050] Cardiac pressure monitoring according to examples of the present disclosure can provide an active intervention mechanism for preventing or treating congestive heart failure. Typically, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, for some patients, cardiac pressure indicators may be present several weeks before hospitalization. Therefore, a pressure monitoring system according to examples of the present disclosure can be advantageously implemented to reduce instances of hospitalization by guiding appropriate or desired drug dosing and / or administration before the onset of heart failure.

[0051] Dyspnea is an indicator of cardiac stress characterized by shortness of breath or a feeling of being short of breath. Dyspnea may be caused by elevated atrial pressures, which may result in fluid accumulation in the lungs due to the pressure rebound. Pathological dyspnea may be caused by congestive heart failure. However, a considerable period of time may elapse between the initial pressure increase and the onset of dyspnea, and thus the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to examples of the present disclosure, normal ventricular filling pressures may be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0052] The pressure sensor devices disclosed herein may be implanted in any chamber / vessel of the heart or other blood vessels (eg, aorta, vena cava). Figure 1 An implantable sensor device according to various aspects of the present disclosure is shown (in Figure 1 Multiple example implantation sites (denoted as 's' in the figure). For example, as shown in the figure, the sensor implant device with an integrated diaphragm assembly according to the present disclosure can be implanted in the right atrium, right ventricle, left atrium, left ventricle, pulmonary artery, inferior vena cava, aorta or other anatomical structures. In general, elevated pressure in the left atrium may be particularly associated with heart failure, so in some cases, it may be desirable to implant the sensor implant device in the left atrium.

[0053] Left atrial pressure is usually well correlated with left ventricular end-diastolic pressure. However, although left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, this correlation may be weakened when pulmonary vascular resistance increases. That is, pulmonary artery pressure is usually not fully correlated with left ventricular end-diastolic pressure in the presence of a variety of 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 filling pressure. Therefore, a single pulmonary artery pressure measurement may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly for patients with comorbidities (such as lung disease and / or thromboembolism). Left atrial pressure can also be at least partially related to the presence and / or degree of mitral regurgitation.

[0054] In some solutions, pulmonary capillary wedge pressure can be measured as a substitute for left atrial pressure. For example, a pressure sensor can be set or implanted in the pulmonary artery, and the readings associated therewith can be used as a substitute for left atrial pressure. However, with respect to catheter-based pressure measurements in the pulmonary artery or certain other chambers or regions of the heart, it may be necessary to use an invasive catheter to maintain such a pressure sensor, which may be uncomfortable or difficult to implement. In addition, certain lung-related conditions may affect the pressure readings in the pulmonary artery, so that the correlation between the pulmonary artery pressure and the left atrial pressure may be undesirably weakened. As an alternative to pulmonary artery pressure measurements, 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 to be used for the diagnosis, prevention and / or treatment of congestive heart failure. The present disclosure provides systems, devices and methods for packaging an implantable pressure sensor, which is configured to provide a direct measurement of pressure conditions at the implantation site.

[0055] Additional solutions may be implemented to derive or infer left atrial pressure. For example, an E / A ratio, which is a marker of the function of the left ventricle of the heart, representing the ratio of the peak velocity blood flow (E wave) caused by gravity in early diastole caused by atrial contraction to the peak velocity blood flow (A wave) in late diastole, may be used as a substitute for measuring left atrial pressure. The E / A ratio may be determined using echocardiography or other imaging techniques; typically, an abnormality in the E / A ratio may indicate that the left ventricle is not properly filled with blood during the period between contractions, which may lead to symptoms of heart failure, as described above. However, the E / A ratio determination does not typically provide an absolute pressure measurement, but rather estimated information, which in some cases may not provide the necessary specificity. In addition, since ultrasound or similar imaging equipment is typically not available in a home environment and typical patients do not have access to such equipment, in some cases, a relatively easy-to-operate mobile device according to various aspects of the present disclosure may be desirable.

[0056] Cardiac pressure monitoring (e.g., left atrial pressure monitoring) can provide a mechanism to guide drug administration to treat and / or prevent congestive heart failure. Such treatment can advantageously reduce rehospitalization and morbidity, as well as provide other benefits. An implantable pressure sensor according to an example of the present disclosure can be used to predict heart failure two weeks or more before the symptoms or signs of heart failure (e.g., dyspnea) occur. When using the cardiac pressure sensor example according to the present disclosure to identify heart failure predictors, certain preventive measures can be implemented, including drug interventions, such as modifying the patient's drug regimen, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium can advantageously provide an accurate indication of pressure accumulation that may lead to heart failure or other complications. For example, a trend in elevated atrial pressure can be analyzed or used to determine or predict the onset of cardiac dysfunction, where drugs or other treatments can be added to cause pressure reduction and prevent or reduce further complications.

[0057] Figure 2 is a block diagram representing a system 200 for wirelessly monitoring one or more physiological parameters associated with a patient according to one or more examples. Figure 2 An implant device 30 is shown that includes a sensor device 37, which can have a specific anchoring structure 31 associated therewith. For example, the anchoring structure 31 can be configured to anchor in and / or to one or more biological tissue walls. Although various examples of implantable sensor devices are shown and described in the present disclosure without separate anchoring structures, it should be understood that such omissions are for clarity purposes only, and any example disclosed herein can have a specific anchoring structure associated therewith for anchoring the device to biological tissue / anatomical structure at the implantation site.

[0058] The sensor device 37 can be a pressure sensor according to any of the examples disclosed herein. In some examples, the sensor 37 includes a transducer 32, such as a MEMS pressure transducer, and some control circuit system 34, which can be implemented in, for example, an application-specific integrated circuit (ASIC) and / or one or more passive devices (e.g., resistors, capacitors, inductors, etc.). The sensor device 37 further includes an integrated diaphragm 33, which is integrated as an integral layer with at least a portion of the sensor housing 36. In some examples, the sensor housing 36 includes a radio-frequency transparent base housing, the base housing accommodating at least a portion of the antenna 38, and a transducer enclosure shell, wherein the shell includes at least one integral layer, the integral layer including side walls and / or end cap walls and the diaphragm 33 formed therein. Other details about such features are presented in detail below. A pressure transducing medium 39, such as oil, gel, epoxy, or another medium, is disposed within the housing 36 above the transducer 32 in a manner so as to convert the deflection of the diaphragm 33 into a pressure against the transducer 32 to allow monitoring of such pressure.

[0059] The control circuit system 34 of the sensor device 37 can be configured to process signals received from the transducer 32 and / or wirelessly transmit signals associated therewith through biological tissue using an antenna 38. The antenna 38 can include one or more coils or loops of conductive material, such as copper wire, or a piezoelectric resonator, or other wireless signal transmission components. In some examples, at least a portion of the transducer 32, the control circuit system 34, and / or the antenna 38 is at least partially housed or contained within a sensor housing / package 36 structure, which can include any type of material and can be advantageously at least partially hermetically sealed. The housing 36 and the diaphragm 33 can be at least partially formed using vapor deposition, as described in more detail below.

[0060] The term "control circuit system" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies containing one or more active and / or passive devices and / or connecting circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any device that manipulates signals (analog and / or digital) based on hard coding of circuits and / or operating instructions. The control circuit system referred to herein may also include one or more storage devices, which (analog and / or digital) may be implemented in a single storage device, multiple storage devices, and / or embedded circuits of the device. Such data storage may 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 device that stores digital information. It should be noted that in examples 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 operating instructions can be embedded within or external to the circuit system including the state machine, analog circuit system, digital circuit system and / or logic circuit system.

[0061] For example, in some instances, the housing / encapsulation 36 may include one or more tubes, cans, substrates / plates, or other structures including glass or other rigid materials, which may provide mechanical stability and / or protection for components housed therein. In some instances, the housing / encapsulation 36 is at least partially flexible. For example, the housing / encapsulation may include a polymer or other flexible structure / material that may advantageously allow aspects of the sensor 37 to be folded, bent, or contracted to allow it to be passed through a passage through a catheter or other introduction device.

[0062] The transducer 32 may include any type of sensor device or mechanism. For example, the transducer 32 may be a force collector type pressure sensor. In some examples, the transducer 32 includes a diaphragm, piston, spring tube, bellows, or other strain or deflection measurement component to measure the strain or deflection applied above its area / surface. The transducer 32 may be associated with a housing / package 36 such that at least a portion thereof is contained within or attached to the housing / package 36. In some instances, the transducer 32 includes a piezoresistive MEMS pressure sensor or a component of a piezoresistive MEMS pressure sensor, which may be configured to detect strain due to applied pressure using a bonded or formed conductor, wherein the resistance increases as the pressure deforms the component / material, as described above in conjunction with Figure 3A and 3BAlternatively, the transducer may include a capacitive pressure sensor or a component of a capacitive pressure sensor, as described below in conjunction with Figure 4A and 4B The transducer 32 may incorporate any type of material, including but not limited to silicon (eg, single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0063] In some examples, the transducer 32 includes an electromagnetic pressure sensor or a component of an electromagnetic pressure sensor, which can be configured to measure the displacement of the diaphragm by means of capacitance changes, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some examples, the transducer 32 includes a piezoelectric strain sensor or a component of a piezoelectric strain sensor. For example, such a sensor can determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials such as quartz.

[0064] In some examples, transducer 32 includes a strain gauge or is an assembly of a strain gauge. For example, a strain gauge example may include a pressure sensitive element on or associated with an exposed surface of transducer 32. In some examples, a metal strain gauge is adhered to the surface of the sensor, or a thin film strain gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0065] The transducer 32 may include one or more MEMS pressure sensor devices mounted in or to a plate or the like, as described in detail herein. In addition, the transducer 32 may be covered in one or more layers of transducing medium 39 and / or vapor deposited biocompatible material, as described in detail below. In some instances, the transducer 32 is electrically and / or communicatively coupled to a control circuit system 34, which may include one or more application specific integrated circuits (ASIC) microcontrollers or chips. The control circuit 34 may also include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, etc.

[0066] exist Figure 2 In the system 200, in order to monitor one or more physiological parameters (e.g., left atrial pressure), the implant device 30 is implanted in the patient 44. The patient 44 may have a medical implant device 30 implanted, for example, in his / her heart (not shown) or in an associated physiology. For example, the implant device 30 may be at least partially implanted in the left atrium of the patient's heart.

[0067] In some instances, the monitoring system 200 may include at least two subsystems, including an implantable internal subsystem or device 30, the implantable internal subsystem or device including a sensor transducer 32, and a control circuit system 34, the control circuit system including 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 also include an external (e.g., non-implantable) subsystem, the external subsystem including an external reader 42 (e.g., a coil), the external reader may include a wireless transceiver electrically coupled and / or communicatively coupled to certain control circuit systems 41. In some instances, both the internal subsystem and the external subsystem include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed between the internal subsystem and the external subsystem. The sensor implant device 30 may be any type of implant device. For example, in some instances, the implant device 30 includes a pressure sensor integrated with another functional implant structure such as a prosthetic shunt or stent device / structure.

[0068] The implant device 30 may include a specific anchoring structure 31 as referenced above. For example, the anchoring structure 31 may include a percutaneously deliverable shunt device configured to be fixed to and / or in a tissue wall. Although certain components are Figure 2 30 is shown as part of the implant device 30, but it should be understood that the sensor implant device 30 may include only a subset of the components / modules shown and may include additional components / modules not shown. The implant device 30 may represent Figures 9A-9D Examples of implant devices shown in , and vice versa.

[0069] In some instances, the sensor transducer 32 can be configured to generate electrical signals that can be wirelessly transmitted to a device external to the patient's body, such as the local external monitoring system 42 shown. The control circuit 34 can include any type of transceiver circuit configured to transmit electromagnetic signals, where the signals can be radiated by an antenna 38, which can include one or more wires, coils, plates, etc. The control circuit 34 of the implant device 30 can include, for example, one or more chips or dies that are configured to perform a certain amount of processing on the signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implant device 30 may not include independent processing capabilities in some instances.

[0070] The wireless signals generated by implant device 30 may be received by a local external monitoring device or subsystem 42, which may include a reader / antenna interface circuit module 43 configured to receive wireless signal transmissions from implant device 30 disposed at least partially within a patient 44. For example, module 43 may include a transceiver device / circuitry.

[0071] The external local monitor 42 may receive wireless signal transmissions and / or provide wireless power using an external antenna 48 such as a wand device. The reader / antenna interface circuit module 43 may include a radio frequency (RF) (or other frequency band) front-end circuit configured to receive and amplify signals from the implant device 30, wherein such circuit 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 circuits, phase-locked loop (PLL) circuits, signal mixers, etc. The reader / antenna interface circuit 43 may also be configured to transmit signals to a remote monitoring subsystem or device 46 via a network 49. The RF circuit of the reader / antenna interface circuit module 43 may also include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc., for processing / processing signals transmitted via the network 49 and / or for receiving signals from the implant device 30. In some examples, the local monitor 42 includes a control circuit system 41 for performing processing of signals received from the implant device 30. Local monitor 42 may be configured to communicate with network 49 according to known network protocols such as Ethernet, Wi-Fi, etc. In some examples, local monitor 42 comprises a smartphone, a laptop or other mobile computing device, or any other type of computing device.

[0072] In some examples, the implant device 30 includes a certain amount of volatile and / or non-volatile data storage devices. For example, such data storage devices may include solid-state memory using a floating gate transistor array, etc. The control circuit 34 may utilize the data storage device to store the sensing data collected over a period of time, wherein the stored data may be periodically transmitted to a local monitor 42 or another external subsystem. In some examples, the implant device 30 does not include any data storage device. The control circuit 34 may be configured to facilitate the wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuit 34 may also be configured to receive inputs from one or more external subsystems (e.g., from a local monitor 42 or from a remote monitor 46) via, for example, a network 49. For example, the implant device 30 may be configured to receive a signal that at least partially controls the operation of the implant device 30, such as by starting / deactivating one or more components or sensors, or otherwise affecting the operation or performance of the implant device 30.

[0073] One or more components of the implant device 30 can be powered by one or more power sources 35. Due to size, cost and / or electrical complexity considerations, it may be desirable that the power source 35 is relatively minimized in nature. For example, high power drive voltages and / or currents in the implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In some examples, the power source 35 is at least partially passive in nature, so that power can be wirelessly received from an external source by the passive circuit of the implant device 30, such as by using short-range or near-field wireless power transmission or other electromagnetic coupling mechanisms. For example, the local monitor 42 can act as a starter for actively generating an RF field, which can provide power to the implant device 30, thereby allowing the power circuit of the implant device to take a relatively simple form factor. This inquiry can be performed / implemented intermittently / occasionally, quasi-continuously and / or continuously. In some examples, the power source 35 can be configured to obtain energy from an environmental source such as fluid flow, motion, etc. Additionally or alternatively, power source 35 may include a battery, which may advantageously be configured to provide sufficient power as needed over a monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other time period).

[0074] In some examples, the local monitoring device 42 can act as an intermediate communication device between the implant device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implant device 30. For example, the local monitoring device 42 can be a wearable communication device, or other device that can be easily set near the patient 44 and the sensor implant device 30. The local monitoring device 42 can be configured to continuously, periodically or irregularly query the implant device 30 to extract or request sensor-based information therefrom. In some examples, the local monitor 42 includes a user interface, wherein the user can utilize the interface to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implant device 30.

[0075] The 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. The local monitor 47, the monitoring performed thereby, and / or the monitored data may be used / utilized for troubleshooting. In an example, the local monitor 42 may be a wearable device or other device or system configured to be physically located close to the patient and / or implant device 30, wherein the local monitor 42 is primarily designed to receive signals from and / or transmit signals to the implant device 30, and provide these signals to the secondary local monitor 47 for viewing, processing, and / or manipulation thereof. The external local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implant device 30, such as a device ID, etc., which metadata may also be provided by coupling data from the implant device 30.

[0076] The remote monitor subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received from the local monitoring device 42, the secondary local monitor 47, and / or the implant device 30 via the network 49. For example, the remote monitor subsystem 46 may advantageously be operated and / or controlled by a health care entity, such as a hospital, a physician, or other care entity associated with the patient 44. Although certain examples disclosed herein describe communicating with the remote monitor subsystem 46 indirectly from the implant device via the local monitor device 42, in certain examples, the implant device 30 may include a transmitter capable of communicating with the remote monitor subsystem 46 via the network 49 without relaying the information via the local monitor device 42.

[0077] In some instances, the antenna 48 of the external monitoring system 42 comprises 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 device 30 is configured to receive wireless ultrasonic power charging from the external monitoring system 42 and / or data communication therebetween. As described above, the local external monitor 42 may include a wand or other handheld reader. In some instances, the antenna 48 comprises a piezoelectric crystal.

[0078] Implantable pressure sensor device

[0079] Pressure sensors that may be used in medical implant applications include sensors utilizing micro-electromechanical systems (MEMS) technology. Such devices may incorporate relatively small mechanical and electrical components on a substrate such as silicone or other semiconductor substrate, and may incorporate a deformable membrane for measuring its pressure-induced deflection, wherein the degree of deflection of the membrane indicates the pressure conditions to which the sensor membrane is exposed at the implant location.

[0080] MEMS sensors may be desirable for cardiac implant applications due to their relatively small form factor and packaging. For example, a MEMS pressure sensor device may be considered to be a relatively small, stable, and cost-effective device, where these characteristics can accommodate the relatively limited space and / or cost requirements of certain implant devices. MEMS pressure sensor devices according to examples of the present disclosure can be manufactured in silicon using certain doping and / or etching processes. Such processes can be performed at the chip level, providing relatively small devices that can be co-packaged with certain signal conditioning electronics (including passive devices and / or active devices). For example, an electronic circuit system electrically coupled to a MEMS pressure sensor in conjunction with any of the examples disclosed herein may include signal amplification, analog-to-digital conversion, filtering, and / or other signal processing functionality and control circuit systems.

[0081] Various types of pressure sensors can be constructed using MEMS technology, including piezoresistive pressure sensors and capacitive pressure sensors. Such sensors typically include an at least partially flexible layer that acts as a deformable membrane that is configured to act as a diaphragm that deflects under pressure. Piezoresistive sensors and capacitive sensors use different mechanisms to measure the displacement of such a diaphragm component.

[0082] With respect to piezoresistive MEMS pressure sensors, certain conductive sensing elements may be fabricated directly on the diaphragm of the device, wherein changes in the resistance of such conductors may be determined to indicate a measure of the pressure applied to the diaphragm. Typically, the change in resistance may be proportional to the strain on the conductor, wherein 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 disposed.

[0083] Figure 3Ais a side view of a piezoresistive pressure sensor device 320 according to one or more examples. Figure 3B Based on one or more instances Figure 3A 320, wherein the diaphragm 325 of the sensor is deflected. The deflection of the diaphragm 325 can be caused by the pressure conditions to which the diaphragm 325 is exposed. The diaphragm 325 can be formed from a substrate material 326, such as silicon or other semiconductors or materials. For example, a groove or cavity 329 can be etched or formed in the substrate 326 to create a relatively thin membrane for the diaphragm 325.

[0084] The diaphragm 325 may have one or more conductive traces or elements 322 disposed thereon and / or applied thereto. For example, the conductive element 322 may include a trace of a metal or other electrical conductor, wherein one or more length portions of the conductor extend above the diaphragm 325, such that deflection of the diaphragm 325 can cause one or more portions of the conductor 322 to stretch / elongate, thereby changing its resistance / impedance. Figure 3B As shown, when the diaphragm 325 is deflected, the current and / or voltage through the conductive element 322 can be measured to determine its corresponding resistance / impedance, thereby providing a measurement indicating the degree of deflection of the diaphragm 325; such deflection is indicative of the environmental pressure experienced by the diaphragm 325. The diaphragm 325 can include any material, including but not limited to metals, ceramics, silicon, and the like.

[0085] Figure 4A is a side view of a capacitive pressure sensor device according to one or more examples. Figure 4B Based on one or more instances Figure 4A 420 is a side view of a capacitive pressure sensor in which the diaphragm of the sensor is deflected. For a capacitive MEMS pressure sensor, one or more conductive layers 421, 422 can be deposited / applied to the bottom of the cavity 429 on the diaphragm 425 and behind / below the diaphragm 425, respectively, to create a capacitor. For example, in some embodiments, the diaphragm 425 itself can include a conductive material used as a capacitor electrode, or a separate conductive electrode can be applied to the side of the diaphragm 425 exposed within the cavity 429. That is, the sensor device 420 can include a rigid plate electrode 422 and a flexible membrane electrode 425. In the case where the area of ​​such electrodes is fixed, the capacitance between the electrodes can be proportional to the distance between them.

[0086] like Figure 4BAs shown, the inward / downward deflection / deformation of the diaphragm 425 can change the spacing between the conductors 421, 422 above at least a portion of the diaphragm 425, thereby changing the capacitance of the capacitor formed between the diaphragm 425 and the base electrode 422. This capacitance change can be measured by coupling the sensor device 420 to, for example, a tuned circuit, which can have a fundamental frequency that is proportional to the degree of deflection of the diaphragm 425. The diaphragm 425 can include any material, including but not limited to metals, ceramics, silicon, etc.

[0087] Implantable Pressure Sensor Package

[0088] Figure 5A Front and side perspective views of a sensor implant device 550 are shown according to one or more examples. Figure 5B According to one or more examples, Figure 5A An exploded view of the sensor can package of the sensor implant device 550. Fig. 6A and 6B A cross-sectional view of a sensor implant device 550 according to one or more examples is shown. Figure 5A , 5B , 6A and / or 6B to understand the following description of sensor device 550.

[0089] The sensor device 550 can be used for certain pressure monitoring applications and can utilize a relatively low-cost MEMS sensor 520 that is protected from environmental influences when the pressure transmission fluid / medium 552 contacts the secondary diaphragm / membrane 555. Such secondary diaphragms 555 can be made of materials suitable for being placed in a relatively corrosive environment with repeated cycles, such as conditions in certain blood vessels / chambers associated with the cardiac system. For example, the sensor 550 can be suitable for implantation in the patient's cardiac system (e.g., a chamber of the heart). As shown, the secondary membrane 555 and tank structure 554 of the device 550 may include metal components that can be welded, brazed, cold formed, bonded or otherwise coupled together to produce a fluid-tight pressure transmission unit.

[0090] A sensor element 520, which may include, for example, a MEMS pressure sensor, may be disposed within a can / unit 554, wherein a transmission fluid or other medium (e.g., oil, gel, epoxy) is disposed within the can structure 554 around the sensor element 520, such that a pressure transmission medium 552 is sealed within the can structure 554 and disposed within an outer enclosure around the sensor element 520. A portion of the enclosure 550, such as its relative Fig. 6A and 6B The distal axial region of the particular example shown in , includes a diaphragm assembly 555 .

[0091] In terms of manufacturing the sensor device 550, mechanical welding / joining may be necessary around the diaphragm 555 and around the base 571 of the canister 554. For example, referring to Figure 5A , the can base 571 can be welded / coupled to the housing 570. Such welding / coupling may introduce complexity to the manufacturing process and / or potential opportunities for defective sealing. As the size of sensor device designs decreases to allow greater flexibility with respect to minimally invasive (e.g., transcatheter) delivery and in vivo implantation, the materials and processes associated with such devices may require increased processing complexity, failure modes, and / or impose ultimate limits on further reduction. The housing 570 may be at least partially transparent to electromagnetic radiation.

[0092] The diaphragm 555 can advantageously be deflectable such that pressure conditions external to the enclosure 554 can cause the diaphragm 555 to deflect inwardly in a manner that applies pressure to the sensor element surface / diaphragm 525. For example, in some instances, the pressure transmission medium 552 can include an incompressible fluid or medium. Alternatively, the medium 552 can be compressible, wherein deflection of the diaphragm 555 can cause the volume of the internal chamber of the tank 554 to decrease, thereby compressing the fluid / medium and causing an increased pressure within the tank 554 that is transmitted to the sensor element 520. Deflection of the diaphragm 555 can cause the diaphragm 555 to move from a non-deflected state or configuration in which the diaphragm is located in a transverse plane P1 (e.g., transverse to an axis of the diaphragm and / or sensor device) or primarily parallel to the transverse plane to a deflected state or configuration in which the diaphragm 555 conforms to a concave / deflected plane P2 (see Figure 6B ), the concave / deflected plane is deflected in a certain direction, for example towards the sensor element 520 relative to the transverse plane P1.

[0093] To allow for in vivo implantation, the diaphragm 555 may include a metal or other material suitable for the relatively harsh environment of the target anatomical structure. For example, a metal (e.g., stainless steel, nickel titanium (i.e., Nitinol)), a polymer, or other biocompatible material may be implemented for the diaphragm 555. In addition, it may be necessary or desirable to design the diaphragm 555 in such a manner as to provide a sufficiently high sensitivity with respect to the deflection tendency within the expected range of pressure conditions associated with the target physiology. In order to provide increased deflection sensitivity, the diaphragm 555 (or any diaphragm disclosed herein) may include one or more corrugations 559. For example, such corrugations 559 may include annular ridges and / or grooves that may be concentric with the axis A1 of the diaphragm 555. Such corrugations 559 may provide the diaphragm with a sufficiently large linear range and improved sensitivity. Depending on the specific corrugation design, the corrugations may also provide the diaphragm with a relatively larger deflection and / or an accurate spring stiffness and / or extend the cycle life of the diaphragm by reducing mechanical stress in one or more regions of the diaphragm. The corrugations 559 may be produced by cold pressing the diaphragm material into a corrugated shape or by any other means.

[0094] As described above, due to the size constraints associated with implantable sensor devices, the available area of ​​the diaphragm assembly may also be constrained depending on the design of the sensor device. For example, with respect to an axial diaphragm, such as Figure 5A , 5B , 6A and 6B, the diameter and area of ​​such a diaphragm may be constrained by the diameter dimension D1 of the device. For example, an elongated sensor device suitable for delivery via a catheter may generally be limited in profile / size relative to its diameter / width, while in some cases, the length of the sensor device may be less constrained. Therefore, as the sensor device profile decreases, the axial diaphragm area may also decrease. When the diaphragm active area is reduced, it may also be necessary to reduce the thickness T1 of the diaphragm in order to maintain adequate sensitivity in the diaphragm. For example, Figure 7 is a graph showing the relationship between sensor diaphragm thickness, surface area, and sensitivity according to one or more examples. Figure 7 As shown in the graph of , a diaphragm having a relatively small surface area must generally be relatively thin in order to achieve comparable sensitivity compared to a diaphragm having a relatively large surface area and being otherwise similarly designed.

[0095] The processes implemented to form the thin foils may cause variable strain hardening of the formed material, which may cause relatively large variations in the mechanical properties of the formed diaphragm. In addition, the relatively thin materials used for diaphragm formation may require careful handling and assembly processes to weld the diaphragm structure to the larger sealing body. At such scales, the processes implemented may affect the material properties and mechanics of the diaphragm, thereby causing additional variations in diaphragm performance.

[0096] Additionally, some sensor devices are designed with a sensor diaphragm positioned / located at the distal end of the sensor device assembly, such as Figures 5A-6B As shown in the example of . Since it may be advantageous to increase the area of ​​the diaphragm to provide the desired sensitivity, as Figure 7 As shown, the increase in septum area of ​​such designs may come at the expense of increased sensor device diameter / profile, potentially interfering with the ability to fit within a tubular catheter / shaft for delivery, particularly in light of Figure 7 The relationship shown in the graph of takes into account the diaphragm material thickness and deflection sensitivity. As sensor device designs move toward smaller and lower profile devices (e.g., millimeter-scale integrated implant devices), the ability to form and integrate such sensor device assemblies has increased relative to Figures 5A-6B The design examples shown in may become unfeasible.

[0097] Examples of the present disclosure provide alternative sensor device design solutions that allow for increased diaphragm area while maintaining a relatively small diameter profile. In some examples, the increased sensor diaphragm area is achieved at least in part by positioning the sensor diaphragm in a transverse orientation on the circumferential wall of a cylindrical sensor body / shell rather than on an axial end of the sensor device. In some examples, the diaphragm is contained on the cylindrical sidewall of the shell and on the axial end of the sensor device shell / structure. In these cases, the diameter of the diaphragm on the cylindrical sidewall can be larger than the diameter of the axially facing diaphragm of the same device with respect to at least one dimension thereof.

[0098] The examples of the present disclosure advantageously provide solutions for implantable pressure sensor devices of relatively small size, while providing sufficient and / or improved sensor performance / sensitivity by incorporating a sensor diaphragm having a sufficiently large area and / or material thickness characteristics to provide such sensitivity. In some cases, such examples also provide suitable and / or improved biocompatibility characteristics and / or relatively simplified manufacturing processes. The inventive sensor implant device solution proposed herein can achieve these benefits at least in part by integrating the pressure sensor diaphragm assembly with other structural / mechanical housing / encapsulation components of the device in one or more uniform and integrated deposited material layers. For example, while some pressure sensor devices require a manufacturing process involving multi-component and / or multi-process manufacturing to seal / mechanically connect the diaphragm assembly to other structural components, the examples of the present disclosure allow manufacturing without the need for such sealing / connection steps / processes. In addition, in addition to the advantages associated with manufacturing the structural components and diaphragm components of the sensor device as a single integrated / net component in relatively few manufacturing steps / processes, such devices according to aspects of the present disclosure can also provide excellent mechanical properties relative to certain non-integrated diaphragm solutions. Furthermore, the integration of the diaphragm and shell assembly can significantly reduce the component count and process steps required to produce the resulting sensor implant device and / or associated packaging. With fewer components and areas requiring an airtight seal, a more robust protective shell can be produced, which reduces the risk of failure / leakage. Additionally, as described in detail herein, a pressure sensor device including an integrated diaphragm assembly can advantageously integrate and improve the consistency and / or transmission performance of a sensor membrane / diaphragm that separates a biological environment from an internal sensor assembly of the sensor device.

[0099] Certain examples of the present disclosure provide alternatives to wrought metal machining, stamping, grinding, etc. of sensor diaphragms in order to provide diaphragms of reduced thickness and increased sensitivity. Such diaphragms can advantageously be formed using an ion deposition process, rather than by stamping, welding, or other more complex and / or inconsistent / error-prone processes. In addition, depositing the diaphragm in a manner that is integrated with the sensor housing / shell structure can provide an improved hermetic seal while also involving a reduced risk of error due to reduced process variation. In some examples, the diaphragm deposited / formed according to aspects of the present disclosure includes a Nitinol metal alloy rather than titanium, which can be used in other sensor designs.

[0100] As described above, in some embodiments, ionized metal vapor deposition may be used to fabricate / form sensor membranes according to aspects of the present disclosure. Figure 88 is a block diagram illustrating a vacuum deposition system 800 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 the system 800, a source material 830 (e.g., a metal) is transformed from a condensed phase to a gas phase 870 and then transformed back to a thin film condensed phase 840. Sputtering or evaporation can be performed to produce a vaporized / plasma gas 870. The plasma gas 870 is deposited on a substrate 820 to form a layer 840 of the deposited source material. The vacuum chamber 810 can be advantageously free of air and particles that might otherwise interfere with the directional deposition on the substrate 820.

[0101] The transformation from solid 830 to gas 870 can be achieved by applying energy from energy source 850. Energy source 850 can be any type of energy, including heat / thermal current, current and / or voltage potential relative to a potential 860 associated with substrate 820. The energy can energize source material 830 to produce plasma form 870. The potential 860 relative to source material 830 can be used to create a direction of deposition flow 870 toward substrate 820. In some cases, source material 830 can be positively charged, while the potential 860 of substrate 820 can be negatively charged.

[0102] With respect to the various processes and apparatus disclosed herein, any type of deposition process can be implemented to produce the shell shell assembly of the present invention with an integrated diaphragm layer. Examples may include cathodic arc deposition, in which a high-power arc is discharged at the target (source) material to blast some materials into highly ionized vapor for deposition on the workpiece. For electron beam physical vapor deposition embodiments, the material to be deposited is heated to a relatively high vapor pressure by electron bombardment in a vacuum, and is transported by diffusion to be deposited on a relatively cold workpiece by condensation. For evaporative deposition, the material to be deposited can be heated to a relatively high vapor pressure by resistive heating in a vacuum. As another example, confined space sublimation may involve placing the source material and the substrate relatively closely adjacent to each other and radiative heating. 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 a plasma under non-equilibrium conditions.

[0103] In some exemplary embodiments, sputtering deposition can be implemented, wherein the source material can be bombarded by a luminous plasma discharge positioned around a target substrate by a magnet, thereby sputtering away some of the source material as vapor for subsequent deposition. For sputtering applications, a magnetron can be used, which uses strong electric and magnetic fields to confine charged plasma particles to the surface near the sputtering target. Typically, in a magnetic field, electrons follow a spiral path around the magnetic field lines, and ionization collisions with gaseous neutral points near the target surface occur more than they would otherwise. The additional ions of the sputtering gas generated by these collisions can lead to a higher deposition rate. Plasma can also be maintained at a lower pressure in this way. The sputtered atoms are neutrally charged and are therefore not affected by magnetic traps. 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 the like.

[0104] The substrate / mandrel 820 may be configured to rotate to allow for the formation of a three-dimensional form / shell. The rotation may be controlled in a manner that produces a relatively uniform distribution of the deposited material over the mandrel 820 around the three-dimensional form.

[0105] A sensor implant device with an integrated and / or laterally facing diaphragm according to aspects of the present disclosure may include a housing comprising a shell formed from one or more vapor deposited layers. For example, such layered deposition may involve depositing a thin layer of a deposition material, then masking a portion of the deposition (e.g., a diaphragm portion) and then depositing another, possibly thicker layer. Alternatively, a thicker layer may be deposited over a masked diaphragm (or the diaphragm may then be removed), after which a relatively thin layer may be applied without a mask over the diaphragm to produce an integrated diaphragm and shell structure.

[0106] Fig.9A , 9B 9C illustrate a perspective view, a longitudinal cross-sectional view, and an axial cross-sectional view, respectively, of a sensor device 900 having an integrated diaphragm 955 according to one or more examples. Fig.9D A view of an alternative sensor device example is shown having a concave diaphragm form 955. Diaphragm 955 and at least a portion of housing package 939 may be formed in one or more stages using a vapor deposition process.

[0107] The sensor implant device 900 includes a wireless telemetry component 908. The wireless telemetry function associated with the implant device disclosed herein can be configured to transmit and / or receive radio frequency electromagnetic signals, ultrasonic signals and / or other wireless signal types. Although wireless data and / or energy transmission is described in conjunction with various examples disclosed herein, it should be understood that such examples can be implemented using wired data and / or power transmission features. For example, the sensor implant device disclosed herein can be implemented as a component of a catheter assembly, wherein such a device may not be used for long-term implantation, but can be positioned in a target anatomical structure by advancement and positioning of such a catheter and / or its distal end.

[0108] The implant device 900 includes a housing package 939 that may have one or more MEMS (or other type) pressure sensor devices 920 mounted or secured therein. The implant device 900 may include a circuit board or other substrate 991 (e.g., a printed circuit board) having certain electronics mounted thereon. As shown in the various figures (see, e.g., Fig.9A , Figure 11-3 1110), the shell 939 may have a silo-type shape. The silo-type shape may include a first closed (e.g., conical or dome-shaped) end / end cover and a cylindrical side wall and a second end that can be closed and opened.

[0109] In some instances, a coil antenna 908 or other type of transmitter / receiver is electrically coupled to the board 991 and / or an electrical component mounted thereon. For example, in the illustrated example, a conductive coil (e.g., copper wire) can be wound around a ferrite core 907 that is colinear or coplanar with the axis A2 of the cylindrical sensor housing 970, and the conductive coil is at least partially disposed in the cylindrical sensor housing. The ferrite core 907 can be configured to concentrate magnetic field flux so that the signal radiated by the antenna 908 is concentrated and / or guided. In some instances, the ferrite core 907 can be configured to suppress relatively high frequency electronic noise. The ferrite core 907 can include iron, ceramic, or the like, and relatively high frequency current dissipation can be used to prevent electromagnetic interference in one or more dimensions.

[0110] Various control circuit system components including board 991 and antenna 908 can be maintained at least partially within the rigid base housing 970. The tubular base housing 970 can include ceramic, zirconium oxide, glass or other at least partially rigid structures that are hard enough to protect the internal components from damage and fluid and ion ingress during implantation and / or when exposed for a long time at the implant site. The housing 970 can advantageously provide a complete airtight seal and moisture barrier to prevent moisture from penetrating the housing 970 and interacting with the components contained therein. The electronics housing 970 can also include a material that is sufficiently transparent to radio frequency electromagnetic radiation, which can be transmitted to and / or from the antenna 908 to allow data and / or power communication with the implant device 900. In some instances, the sensor implant device 900 is configured to transmit data and / or power / energy through the transmission of ultrasonic signals and / or other sound signal communications. Therefore, in some instances, it may be desirable to construct the housing 970 from a material that is sufficiently transparent to ultrasound and / or other sound signals. In some examples, the distal end 979 of the base housing / tube 970 may be covered with a metal or other sealing shell that seals the distal end of the sensor device 900 and surrounds the sensor element 920 .

[0111] In some examples, the shell package / housing 939 includes one or more sidewalls / sidewall portions 954 and a cover / end cap portion 956. The diaphragm 955 can be formed from one or more deposited material layers having one or more deposited layers forming the sidewalls 954 such that the interface between the diaphragm 955 and the sidewalls 954 is a fluid-tight configuration. The shell 939 is secured to the base housing 970 in some manner. For example, a brazing process can be implemented to mount the shell 939 to the base housing 970, which can include dissimilar materials. The deflection of the diaphragm 955 can be transmitted to the diaphragm / membrane of one or more sensor (e.g., MEMS) devices 920 disposed within the shell package 939 through a transducing medium 934 such as silicone oil.

[0112] The diaphragm 955 may have a corrugated form as shown, or may have any other form. The corrugated topology of the diaphragm 955 may help the diaphragm 955 deflect in a manner that transmits pressure to the sensor device 920. The shell 939 may be sealed to the base housing 970 to enclose a cavity or chamber within the shell 939. In some examples, the chamber 952 is filled with a liquid material, such as silicone oil or the like, where such liquid may be compressible or incompressible; the inward deflection of the membrane 955 increases the pressure within the chamber 952 and / or pushes the medium 934 against the diaphragm / membrane of the sensor 920.

[0113] In instances where the chamber 934 is filled with a liquid, it may be desirable to fill the chamber 934 so that no air or bubbles are present within the chamber. For example, the air / gas may be generally pressure compressible such that the presence of air / gas within the chamber 952 may reduce the pressure conversion from the deflection of the diaphragm 955 to the pressure within the chamber 952. In some embodiments, the chamber 952 may be filled via a port / channel formed in the internal support structure 945 of the sensor device 900. For example, the port / channel may be used to pipe a liquid into the chamber 952, wherein the port / channel is then sealed in some manner to prevent fluid from leaking out of the chamber 952 and / or to prevent gas or other substances from entering the chamber after the chamber 952 is filled. In some embodiments, the chamber 952 may be filled under vacuum conditions. In some instances, the pressure transducing medium 934 includes a polymer potting that may be injected or poured / flowed into the shell 939.

[0114] In some examples, board 991 can be held in place by internal structure 945 of sensor device 900. A portion of circuit board 991 can be configured and / or positioned to extend distally past end 979 of housing 970 such that sensor device 920, which can be positioned on the portion of board 991 extending past the end of housing 979 and into the interior region of shell 939, is not axially covered by housing 970 but is axially covered by shell 939.

[0115] Sensor device 900 may have any suitable or desired diaphragm topology. Figures 9A-9C is shown with a corrugated diaphragm, as described in detail above, but Fig.9D An alternative diaphragm design is shown for a sensor device 900D having a recessed diaphragm which may include a concave depression defined by concentric ridges / grooves.

[0116] The diaphragm 955 may include a thin layer of deposited metal, such as nitinol, titanium, or other metal. The relatively thin diaphragm layer 955 may be in the form of an integral body / sidewall portion 954 of the sensor enclosure 939. By integrating the diaphragm 955 with the shell 939, the diaphragm 955 may have an inherent seal with the shell structure encapsulating the sensor 920, thereby providing increased protection for the internal components and / or preventing biological damage over time. The diaphragm 955 provides a transmission window through which external pressure conditions are transmitted to the internal sensor device 920 via the encapsulated pressure transmission medium 934 (e.g., oil). The diaphragm 955 can be formed by a final deposited layer that provides an external skin layer above the shell 939, which provides a structure for holding the internal components within the sensor device 900.

[0117] In the case where the outer layer of the encapsulating shell 939 is formed of a deposited metal deposited in an integral form, such deposition can provide structural continuity between the diaphragm 955 and the body 954 of the shell 939. Such continuity can be advantageous for a variety of reasons. In instances where separate metal components / layers form the diaphragm and the structural shell, slight differences in the metal structures and / or the interfaces therebetween can introduce flaws and / or structural defects in the overall structure of the shell. Therefore, such components formed from a common source material and applied through a co-deposition can provide structural benefits to the shell 939.

[0118] The structural shell 939 can be formed from one or more coatings, layers, or processes such that the body portion 954 can have a different thickness than certain other portions, such as the diaphragm 955. For example, in some embodiments, an initial relatively thick layer 937 (e.g., approximately 100-300 μm; 250 μm) can be deposited on the substrate to form a relatively thicker and / or more rigid body 954 of the shell 939 outside the diaphragm region 955. For example, such a layer can be deposited / formed while the diaphragm region 955 is masked. Alternatively, a thicker coating / deposition of a metal (e.g., nitinol) can be deposited over the entire shell 939, including the diaphragm portion 955, where the thickness of the deposited material on the diaphragm can be etched away or otherwise thinned to produce a relatively thin diaphragm, which may be desirable for the sensitivity / flexibility of the diaphragm. In some examples, the diaphragm thickness may be approximately 10 μm, such that the thickness of the diaphragm is approximately 3%-15% (e.g., 4%, 5%, 10%, or any amount therebetween) of the structure of the shell 939 outside the diaphragm region (i.e., in the main body portion 954 of the shell 939). For example, where the diaphragm 955 is masked during deposition of the thicker layer 937 of the shell 939, after such deposition, the mask may be removed to allow the same metal / material to be deposited over the entire shell 939, including over portions of the diaphragm and areas immediately adjacent thereto, wherein such subsequent layering / deposition may be a relatively thin surface layer / layer (e.g., approximately 10 μm thick, or between 10-40 μm thick).

[0119] In some embodiments, a thin layer of diaphragm may be deposited over the mandrel / substrate surface, after which the diaphragm 955 may be masked to allow subsequent deposition of a thicker layer 937 over the region of the mandrel / substrate and the thin deposited layer outside the diaphragm region 955 to completely form the shell 939. The diaphragm mask and mandrel / substrate are removed to produce a complete integrated shell and diaphragm.

[0120] With further reference to the manufacturing process for producing the sensor device 900, as mentioned above, in some embodiments, a deposition process can be implemented to deposit a thickness / layer of metal or other material (e.g., Nitinol) over a mandrel or other substrate, wherein a laser process can be implemented to selectively remove at least a portion of such deposition in the area of ​​the diaphragm 955. For example, in some limitations, substantially all of the deposited material in the diaphragm area can be removed. After such diaphragm removal, the structure can be placed back into a deposition chamber (e.g., a PVD vacuum chamber), wherein a final surface layer / layer can be applied over previously deposited material that has not been removed and over the diaphragm area where the previous deposition was removed / thinned or blocked.

[0121] In some embodiments, the masking of the diaphragm can be achieved by using a resist layer above the diaphragm to prevent the accumulation of deposited materials in the covered area. By depositing the final integrated layer / coating above the structure containing the diaphragm, a stable airtight seal can be produced along the entire shell 939. That is, the process of applying the first thick film layer above the body of the shell and then applying the final thin film coating (including the area around the diaphragm) above the body of the diaphragm and the shell can provide the desired adhesion between the thin outer layer / diaphragm layer and the remaining structure, provided that the surface of the structure remains relatively clean between the processing stages and the same deposited material is applied in the two stages. In the case of allowing contamination between the process steps, adhesion may be impaired, but in some cases, structural integrity may be sufficient to meet specific needs. The deposited materials for forming the layers of the shell 939 include nitinol, titanium, stainless steel and other metals with similar properties. The base shell assembly 970 connected to the shell 939 to form a closed shell container may include zirconium, ceramics or other materials with similar properties. The base shell 970 can be combined or brazed to the shell 939 in a way that keeps the airtight seal between the two components of the device 900.

[0122] The shell 939 formed by the various deposition process steps / stages can be removed from the mandrel and / or other substrate materials to produce a hollow shell 939, which is configured to enclose / contain internal sensor elements / components. Then, the shell 939 can be slid / placed above or within the open end of the open cylindrical base shell 970, which can be configured to hold various internal components of the sensor device 900. For example, although the shell 939 may include a conductive material (e.g., a metal, such as nitinol), it may be desirable that the shell 970 does not include a conductive material. For example, in an embodiment in which the device 900 is configured for wireless data and / or power transmission, one or more antenna / transmitter elements 908 may be disposed within the base shell 970. Therefore, the base shell 970 may advantageously include a material that is transparent to wireless electromagnetic signal transmission, such as glass, ceramic, polymer or other material. Therefore, the combined assembly of the device 900 can advantageously provide both metal and non-metallic shell components, which can promote the desired combination of biocompatibility, mechanical integrity and wireless transmission transparency. In some examples, antenna 908 includes one or more coils wound around a magnetic core 907 (eg, a ferrite core), which may provide desired dynamics for data and / or power transmission.

[0123] The internal components of the device 900 include a plate or other substrate 991 on which the sensor device 920 can be mounted. The plate 991 can be held in place by certain spacers / structural components / materials 945. For example, the spacer material 945 can include epoxy resin, or the material is more solid, such as a polymer / plastic material. The spacer material 945 can provide structural integrity for the device 900 and can be used to maintain, fix and / or protect certain internal components of the device. In addition, the internal spacer / structural component 945 can be used to fix the shell 939 to the housing 970 and / or help to maintain the cylindrical form of such components under stress / pressure. In some instances, the spacer / structural component 945 includes a block form that is configured to be placed / arranged in the housing 970 in a manner that allows the shell 939 to be placed above the block and the housing 970.

[0124] The illustrated example of sensor device 900 includes a double diaphragm housing 939 and a plurality (e.g., two) of internal sensor elements 920, wherein a first sensor 920a is disposed behind a first diaphragm 955a and a second sensor device 920b is disposed behind a second diaphragm 955b. The two sensor devices 920 may be mounted to a plate 991 or other structural assembly.

[0125] The diaphragm 955 is in communication with the internal fluid / medium 934, which transmits the deflection of the diaphragm to the increased pressure and / or force in the fluid-filled chamber 952, thereby generating a pressure condition that reflects the external pressure that is readable by the sensor device 920. In some examples, the shell 939 is sealed in an area 969 that overlaps with the housing 970 to provide an airtight seal between such components. For example, the block / body assembly 945 can be sealed against the inner diameter of the shell 939. Unlike some other solutions as described in detail above, only a single sealing area of ​​the sensor assembly may be required in order to provide a complete airtight seal of the assembly device 900. As mentioned above, such a seal can be between the shell 939 and the housing 970 in the area 969 where such components overlap. The seal between the shell 939 and the housing 970 can be produced in any suitable or desired manner, such as by using certain materials that solidify at a specified rate, by applying an adhesive, brazing or the like.

[0126] The diaphragm 955 can have any suitable or desired shape or form, including Figures 9A-9C The corrugated diaphragm shown in Fig.9D Alternative examples shown are concave / recessed diaphragms, flat diaphragms (e.g., flat along the curvature of the cylindrical form of the shell 939, or flat in diameter across an arc segment of the cylindrical body 954). For example, the diaphragm can be formed from a layer of material deposited on and located in a plane tangential to the circumference / periphery of the cylinder, the plane being radially sunken into the outer diameter of the cylinder.

[0127] As described above, the diaphragm 955 is advantageously oriented transversely. That is, the face / plane of the diaphragm 955 can face in a direction radially outward from the axis A2 of the sensor device 900 and the shell 939. The transverse orientation of the sensor diaphragm can allow for the implementation of a relatively large area diaphragm compared to a diaphragm limited to the axial end of the shell / sensor. For example, while the area of ​​the end cap 956 may be limited by the diameter of the sensor / shell, the area of ​​the sidewall portion 954 of the shell 939 can correspond to an area greater than the area of ​​the end cap 956. In addition, the length of the shell 939 can be designed to be suitable for accommodating any desired length of a larger size diaphragm, wherein such length can be increased without increasing the diameter of the shell / sensor. Because the delivery catheter in which the sensor device 900 is transported can be elongated, an increase in the length dimension of the shell 939 may be less disadvantageous than a corresponding increase in the diameter of one side of the end cap, and therefore, for a small profile sensor device, a transversely oriented diaphragm may be relatively larger.

[0128] Figures 10-1 to 10-3 A flow chart is provided that illustrates a process 1000 for packaging a sensor device according to one or more examples. Figures 11-1 to 11-3 Provided according to one or more examples corresponding to Figures 10-1 to 10-3Image of the process operation of the pressure sensor package.

[0129] At block 1002, process 1000 involves forming or providing a sacrificial mandrel 990 for use in forming a sensor housing as described in detail herein. Figure 11-1 The sacrificial mandrel 990 shown in image 1102 may include a material configured to be selectively etched away after the associated process material is deposited on its outer surface. In some examples, the mandrel 990 may include stainless steel. It may be desirable to use a conductive material to facilitate directing the deposition vapor in the vacuum chamber, which may rely on the implementation of the potential between the source material and the mandrel substrate.

[0130] Mandrel 990 can be primarily cylindrical in shape, and can be solid or hollow. Examples incorporating a hollow mandrel can be advantageous because less sacrificial material etching / removal is required when deposition is complete. Mandrel 990 can include dome-shaped and / or flat end cap portions 992. That is, although a hemispherical dome-type form is shown as end cap portion 992 in image 1102, it should be understood that end portion 992 can have any suitable or desired shape. In addition, although mandrel 990 is shown as having a cylindrical shape, in some embodiments, the mandrel (and the resulting sensor shell deposition) is rectangular or elliptical / oval in shape.

[0131] Mandrel 990 may include a diaphragm portion 995 having a shape / form corresponding to a desired diaphragm shape or form, such that when a conformal deposition is applied to the surface of the sensor housing, the deposition of material over such regions may produce a desired diaphragm shape / form for the sensor housing. Although examples are disclosed herein in the context of a sensor device including a substantially circular diaphragm, it should be understood that any shape of diaphragm may be implemented, including an elliptical diaphragm, such as Figure 11-1 1103 with respect to the alternative mandrel 991. In the example of image 1103, the long axis A of the diaphragm m Parallel to the shell axis A3. Figure 11-1 As shown in the cross-sectional side view of image 1101, the septum 995 as defined by the form of the mandrel 990 can be stepped back from the outer diameter OD of the cylinder to protect the septum from the implantation environment and / or structural damage associated with manufacturing, delivery, and in vivo maintenance.

[0132] Although a three-dimensional mandrel form is shown and described, wherein the shell is formed by depositing a three-dimensional cylindrical form over the mandrel, it should be understood that examples of the present disclosure may implement two-dimensional deposition of a sheet of material that is shaped and configured to form a three-dimensional shell from the deposited material sheet after deposition. Thus, any example disclosed herein may be understood to include a cylindrical sensor shell deposition or a sheet deposition that is later formed into a sensor shell. However, for biocompatibility purposes, forming the shell from a sheet of material may introduce complexity in the manufacturing process and complicate the sealing of the shell.

[0133] At block 1004, process 1000 involves depositing one or more material layers over mandrel 990. For example, such layers may be applied over the outer surface of mandrel 990 using physical vapor deposition or other deposition or sputtering processes, as described in detail above. The deposited material may be any suitable or desired material that is compatible with the deposition processes as disclosed herein. For example, deposited material layer 937 may include nitinol, titanium, and / or other metals.

[0134] Operations associated with block 1004 may involve forming a shell of material over the sacrificial mandrel 990 and / or over at least a portion thereof using physical vapor deposition. The target material may be applied to the mandrel 990 in one or more layers to produce a relatively uniform deposition of material 937 over the surface of the mandrel 990, e.g., over substantially the entire surface thereof at one or more viewing angles or angles relative to the mandrel. In some embodiments, an initial deposition of a layer of shell material is applied over a diaphragm portion 995 and a sidewall 996 and / or end 992 portion of the mandrel 990. In some embodiments, the thickness of the initial layer 937 of deposited material may be approximately 100-300 μm, e.g., between approximately 150-250 μm. For example, in some embodiments, the thickness may be between approximately 150-180 μm.

[0135] The specific deposition process implemented can utilize sputtering or evaporation to generate vapor in the form of molecules or ions from the target source material. Such vapor can be transported and deposited on the outer surface of the sacrificial mandrel 990 to form a coating 937. The deposition process can continue until the desired thickness is reached. In some embodiments, a planar magnetron physical vapor deposition is implemented to deposit layer 937 on the mandrel 990. Such a process can advantageously produce a relatively flat applied layer. In addition, an inverted cylindrical magnetron deposition process can advantageously allow deposition to occur above a three-dimensional cylindrical surface, such as the mandrel 990 shown and described in conjunction with Figures 10 and 11. Compared to a forged form / material that is cut, machined, ground or stamped into a shell form having a diaphragm as described herein, the deposited layer produced by such a process can produce a relatively more original and isotropic layer.

[0136] At box 1006, process 1000 may involve removing one or more material layers in the area of ​​diaphragm 955 to completely remove diaphragm portion 957 of shell 939 formed by initial deposited layer 937 or at least some of its thickness, thereby producing a relatively thin diaphragm deposition or completely removing the deposition above diaphragm portion 995 of mandrel 990.

[0137] In some embodiments, a femtosecond laser is utilized to mill away the diaphragm region 957 of the shell 937. Such milling may be performed in any suitable or desired manner. For example, the diaphragm portion 957 of the shell 937 may be completely removed, thereby exposing the diaphragm portion 995 of the mandrel 990 below. Alternatively, in some embodiments, only a portion of the thickness of the diaphragm portion 957 of the shell 937 may be removed, or a selective region or thickness of the deposited shell 937 may be removed, wherein certain regions of the diaphragm portion 957 may be removed down to the substrate 990, while some deposited material is selectively left in the diaphragm region 957, thereby allowing / providing a relatively high degree of customization with respect to the mechanics of the final diaphragm assembly. The material removal associated with block 1006 may advantageously involve removing material that follows the contour / topology of the diaphragm portion 995 of the mandrel 990, thus implementing any shape. The contour around the diaphragm 995 of the mandrel 990 may advantageously conform to the minimum angle requirement for uniform deposition according to the deposition process implemented.

[0138] Ultimately, the resulting sensor housing 939 will contain a diaphragm 955 that is thinner than the sidewalls 937 of the housing 939. The deposited material properties may also allow for relatively precise, high-resolution laser milling and ablation, potentially allowing sub-micron tolerances for the removal of material.

[0139] In some embodiments, the method may be produced in any suitable or desired manner. Figure 11-2 1106 of the resulting shell 939 with the diaphragm portion removed / missing. For example, as described above, a previously deposited layer 937 of the shell 939 above the diaphragm 995 may be removed or thinned. Alternatively, in some embodiments, when the layer 937 of the shell 939 is initially deposited, a masking structure or reagent may be positioned / applied over the diaphragm region 995 of the substrate 990. The mask may then be removed to expose the diaphragm portion 995 of the mandrel 990 to allow further deposition in such region.

[0140] In embodiments where laser milling or other processes are implemented to produce the desired thickness of the diaphragm 955, the formation of the final shell 939 can be completed after the operations associated with box 1006. In some embodiments, laser milling can also be used to remove deposited material in the area of ​​the open edge of the shell 939 to produce a proximal edge 933 having a relatively clean axial line around the circumference of the mandrel 990.

[0141] In embodiments where the mandrel and shell 939 are removed from the vacuum deposition chamber in order to laser etch or otherwise remove material in the region of the diaphragm 957, where additional deposited layers are intended to be deposited on the shell 939, such removal and / or replacement from / in the vacuum chamber may adversely affect the adhesion between the initial deposited layer 937 and any subsequently deposited layers. However, such adverse effects may still be desirable as a means of achieving an integrated diaphragm structure with a relatively thin diaphragm, as described in conjunction with the examples disclosed herein. The diaphragm region 957 may be selectively etched away to avoid etching away portions of the sidewalls and / or ends of the shell 939.

[0142] In some embodiments, process 1000 involves, at block 1008, depositing one or more relatively thin layers over shell 939 and diaphragm portion 995 of mandrel 990 (eg, in embodiments where central shaft 995 thereof is exposed in the diaphragm region).

[0143] The additional secondary layer 961 applied over the shell 939 and diaphragm 995 may be, for example, between 10-50 μm thick. Such thickness 961 may be combined with the thickness 937 of the end and sidewall portions to form a relatively thick 963 sidewall and end cap structure of the final shell 939, while producing a relatively thin diaphragm 955, which may be between 3%-20% of the combined layer 963 in the sidewall portion. The newly deposited skin / layer 961 may include a relatively thin diaphragm 955 integrated with a thin layer 961 placed over the previously deposited shell 937 / 939 in the sidewall portion 964, wherein the new / outer layer / skin layer 961 is bonded to the outer surface of the shell 937 / 939 to produce a single / integrated body of the shell 939. The material used for the second deposition 961 associated with frame 1008 may advantageously be the same deposition material as the deposition material applied in the initial deposition process, which may improve adhesion and integration between layers. The different deposited layers can be joined at the molecular level to provide the desired integration. In some embodiments, the membrane layer can be electrodeposited. In addition, in some embodiments, the surface of such deposition can be configured to reduce tissue growth and adhesion thereon.

[0144] In some embodiments, as an initial deposition operation / step, a thin layer is deposited over the mandrel 990, over the region containing the diaphragm 995. After such thin layer is deposited over the diaphragm 995 and surrounding regions (e.g., end 992 and / or sidewall 996 portions), the diaphragm region 995 / 955 may be masked such that the thin diaphragm layer 955 is protected from further deposition / layering. With the diaphragm 955 masked, additional layers of deposited material may then be deposited over the mandrel and / or previously deposited thin layer of shell. Such additional deposition may be relatively thicker than the thin diaphragm layer, thereby producing a relatively thick shell 937. The masking may then be removed, thereby revealing the relatively thin diaphragm layer 955 integrated with the relatively thick shell structure 937. The operations described in this paragraph may be implemented in whole or in part as follows: Figure 10-2 Alternatively or in addition to the operations shown in Figure 10-2 Example implementations of the various operations shown in .

[0145] Although some examples are disclosed in which the primary deposited layer 937 and the secondary deposited layer 961 comprise the same material (e.g., a metal or metal alloy), in some embodiments, the shell 939 may be formed from a primary deposit 937 and a secondary deposit 961 comprising different materials, wherein such layers may include materials selected to improve or adjust the mechanical properties of the shell 939. For example, the different layers may include an outer layer 961 designed to provide suitable biocompatibility properties, corrosion resistance, superelasticity or other characteristics, while the inner layer 937 may be designed to provide the desired structural rigidity / strength to the shell 939. The deposited shell 939 provides a unique design with lateral / radial diaphragms.

[0146] At block 1010, process 1000 involves removing sacrificial mandrel 990. For example, a mandrel substrate (e.g., stainless steel, copper, or the like) may be removed from the completed deposited shell / form 939 leaving behind a hollow shell. With the internal mandrel etched out, the complete net form of shell 939 may leave behind a relatively thick structural body 954 and a relatively thinned / thin diaphragm 955. Removing the mandrel may involve dissolving the mandrel form using any suitable or desired type of etchant.

[0147] When the mandrel 990 is etched away, the entire clean shell form 939 is isolated, wherein the shell 939 includes a structural body configured for connection to the base assembly 970 of the sensor device housing, as described herein. The shell 939 includes a calibrated thin layer 961 in the diaphragm area 955 to provide the desired pressure transducing functionality, wherein the diaphragm 955 is substantially integrated with the body 954 of the shell 939 at a molecular level without the need for welding, brazing or other bonding methods, which may introduce undesirable complexity and / or risk of error into the process for the reasons described above.

[0148] Figure 11-3 The image 1110 in FIG. 1 shows the formed shell 939 with the sacrificial mandrel removed therefrom. As is apparent in the cross-sectional view of image 1111 , the shell 939 is substantially hollow after the mandrel is removed. The cross-sectional image 1111 shows the relatively thick body portion 954 integrated with the thinner diaphragm portion 955.

[0149] At block 1012, process 1000 involves combining the formed shell 939 with a base sensor assembly 977, which includes a cylindrical (or other shaped) open portion capsule 970 configured to house certain electronics, such as an antenna and / or other circuitry for wireless sensor data and / or power transmission. When combined with base sensor assembly 977, sensor device 900 can be fully assembled. In some embodiments, a sealing or brazing process can be implemented to secure and / or seal shell 939 to housing 970.

[0150] The base assembly 977 can be combined with the shell 939, wherein the plug or other structure 945 is at least partially disposed within the base housing 970, wherein such structural features are configured to retain or secure certain electronic components and / or other components within the sensor device 900 and or otherwise provide structural support / integrity for the assembled device 900. Figure 11-3 The sensor device 900 shown in images 1112 and 1113 may have Figures 9A-9D 1113. For example, the sensor 900 in image 1113 may include a plate or other substrate 991, which is held in place by a structural assembly 945 and has a sensor device 920 disposed on one or more sides thereof, such as a piezoresistive and / or piezoelectric capacitive pressure sensor device, or a resistive or capacitive pressure sensor (e.g., a MEMS pressure sensor device). Oil or other pressure transducer device / medium 934 may be injected into the space 952 around the sensor device 920 and between the diaphragm / membrane of the sensor device 920 and the diaphragm 955 of the shell 939, thereby allowing the diaphragm 955 to deflect to increase the pressure on the sensor device 920, thereby allowing pressure sensing of the external environment. The oil or other medium 934 may be injected / placed in the internal chamber 952 in any suitable or desired manner. For example, the structure 945 within the capsule 900 may include a fluid injection port, which provides fluid access to the internal volume 952 around the sensor device 920. The diaphragm 955 may have the dimple / speaker type shape or form as shown, or may be corrugated or have any other shape or form (eg, flat / curved).

[0151] Fig.12An axial cross-sectional view of a sensor device 820 including more than two circumferentially distributed diaphragms 125 according to one or more examples is shown. As described in detail above, various examples are disclosed herein that include two circumferentially distributed diaphragms, wherein the diaphragms are positioned on opposite sides of the periphery of a cylindrical sensor enclosure such that the diaphragms are approximately 180° apart. It should be understood that the examples disclosed herein may include more than two circumferentially distributed diaphragms. For example, Fig.12 The sensor device 820 includes three circumferentially distributed diaphragms 125 that are angularly separated by an angle θ. In some examples, the separation angle θ represents an even division of an arc around the circumference of the housing 129. That is, for the three-diaphragm example, the angular separation θ can be equal to about 120°.

[0152] although Fig.12 The illustrated example of includes three circumferentially distributed diaphragms, but it should be understood that more than three circumferentially distributed diaphragms can be implemented. In some examples, four circumferentially distributed diaphragms are implemented in a common axial plane. In such examples, the separation angle θ between adjacent diaphragms can be approximately 90°, so that the diaphragms are evenly distributed around the circumference of the cylindrical shell.

[0153] Examples including more than two circumferentially distributed diaphragms may include any number of internal sensor devices 122. Fig.12 In some embodiments, the interior chamber 852 within the housing 129 may include two sensor devices 122a, 122b disposed on opposite sides of a plate or other substrate 121. Alternatively, a single sensor device may be included in some embodiments. In some embodiments, the number of sensor devices 122 implemented is equal to the number of diaphragms integrated into the housing 129. For example, with respect to Fig.12 In a specific example, internal chamber 852 can contain three sensor devices.

[0154] Fig.13 A side view of a sensor device 130 including multiple axially distributed diaphragms according to one or more examples is shown. As described in detail above, various examples are disclosed herein including two or more diaphragms integrated with a sensor enclosure, wherein the diaphragms are positioned in a common axial plane. That is, the diaphragms are axially aligned with each other relative to the axis A4 of the cylindrical (or rectangular cuboid) sensor device. Fig.13In an example of the sensor device 130, the sensor device 130 includes multiple groups of axially offset diaphragms, wherein each group of diaphragms is axially aligned with a separate axial plane. For example, the distal-most group of diaphragms 135 can be aligned with each other and centered about a first axial plane P1, while the second group of diaphragms 137 are positioned proximal to the first group 135 and aligned and centered about a second axial plane P2, which is axially offset from the first plane P1 in the proximal direction. Although two diaphragms are shown in each group of axially offset diaphragms, it should be understood that any number of diaphragms, including one diaphragm, can be implemented in each axial position P1, P2. In addition, although two groups of axially offset diaphragms are shown, it should be understood that sensor devices according to various aspects of the present disclosure may include three or more groups of actual offset diaphragms. The diaphragms 135, 137 are integrated with a shell 139, which can be formed using a deposition process that produces an integral layer including a sidewall portion of the shell 139 and the diaphragms.

[0155] Fig.14 A perspective view of a sensor device 140 having an axially offset and / or circumferentially offset diaphragm is shown according to one or more examples. Fig.14 In the example of , the housing 149 includes a plurality of diaphragms 145, 147 axially offset from each other by a distance d, wherein the first diaphragm 145 is centered about a first axial plane P1 and the second diaphragm 147 is centered about a second axial plane P2 proximal to the more distal plane P1. Fig.13 Unlike the examples shown, the axially offset diaphragms 145, 147 can at least partially overlap axially. In addition, the shape of the diaphragms 145, 147 can be circular or elliptical / oblong, as in the example shown. The diaphragms 145, 147 are also shown as being circumferentially offset by an angular offset θ relative to the axis A5 of the device 140. The angular offset θ between the diaphragms 145, 147 can be about 180°, so that the diaphragms are on substantially opposite circumferential sides of the shell 149, or can be offset by an amount less than 180°, so that the two diaphragms 145, 147 are at least partially disposed on a common diametric side of the shell 149, as shown. Fig.14 In the example shown in .

[0156] Figure 15-1 A perspective view of a sensor device 150 with an integrated axial diaphragm 155 is shown, according to one or more examples. Figure 15-2 A perspective view of another example sensor device 160 with an integrated axial diaphragm is shown according to one or more examples. Figure 15-1 and 15-2The sensor device 150, 160 in the embodiment of the present invention includes a shell portion / assembly 159, 169 formed by a deposition process according to aspects of the present disclosure, such as physical vapor deposition or other sputtering techniques. The shell 159, 169 is formed in a deposition process to produce a diaphragm 155, 165 integrated with the sidewall / body 154, 164 of the shell 159, 169. Unlike certain other examples disclosed herein, the integrated diaphragm shell 159, 169 includes an axially facing diaphragm 155, 165 associated with the distal end / portion of the respective shell 159, 169. Figure 15-1 and 15-2 The examples of the present invention differ in that they include integrated diaphragms having different structural forms. For example, the diaphragm 155 of the device 150 can have a concave / speaker type form, while the diaphragm 165 of the device 160 can have a corrugated form including a plurality of concentric rings / corrugations, as described in detail herein. As with other examples disclosed herein, the shells 159, 169 can house / enclose one or more sensor devices / elements. With respect to the axially facing diaphragms 155, 165, the sensor devices disposed within the respective shells 159, 169 can be radially facing or axially facing, depending on the particular design implemented.

[0157] The packaged sensor implant device according to one or more examples of the present disclosure may be advanced to the relevant target chamber or vessel of the heart and / or vasculature using any suitable or desired procedure. For example, although access to various chambers / vessels of the heart via the right atrium and / or the inferior vena cava is shown and described in connection with certain examples, such as via the femoral artery or other transcatheter procedures, other access routes / methods may be implemented according to examples of the present disclosure, such as in connection with Fig.16 As described / shown. For example, Fig.16 Various access pathways are shown by which access to the chambers of the heart can be achieved. Access to the left atrium or ventricle can be achieved using a transseptal approach, which can be achieved through the inferior vena cava 16 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, a delivery catheter can pass through the descending aorta 32, aortic arch 12, ascending aorta and aortic valve 7, and through the mitral valve 6 into the left atrium 2. For transapical access 111d, access can be gained directly through the apex 39 of the heart into the left ventricle 3, and through the mitral valve 6 into the left atrium 2. In addition to Fig.16 Other access routes beyond those shown are possible.The various transcatheter delivery systems and routes shown may involve delivering the sensor implant device 1600 within the shaft / lumen of such an instrument, and deploying the device 1600 from the delivery system at the target anatomical site.

[0158] Figures 17-1 to 17-4A flow chart illustrating a process for packaging a sensor device according to one or more examples is provided. Figures 18-1 to 18-7 Provided according to one or more examples corresponding to Figures 17-1 to 17-4 Image of the process operation of the pressure sensor package assembly.

[0159] At block 1702, process 1700 involves forming or providing a sacrificial mandrel 690 for use in forming a sensor housing as described in detail herein. Figure 18-1 The sacrificial mandrel 690 shown in image 1802 may include a material configured to be selectively etched away after the associated process material is deposited on its outer surface. In some examples, the mandrel 690 may include stainless steel. It may be desirable to use a conductive material to facilitate directing the deposition vapor in the vacuum chamber, which may rely on the implementation of the potential between the source material and the mandrel substrate.

[0160] The mandrel 690 may be primarily cylindrical in shape and may be solid or hollow. Examples incorporating a hollow mandrel may be advantageous because less sacrificial material etching / removal is required when deposition is complete. The mandrel 690 may include dome-shaped and / or flat end cap portions 692. That is, while the hemispherical dome-shaped form may be Figure 18-1 692, it will be appreciated that the end 692 may have any suitable or desired shape. In addition, although the mandrel 690 is shown as having a cylindrical shape, in some embodiments, the mandrel (and resulting sensor housing deposition) is rectangular or elliptical / oval in shape.

[0161] The mandrel 690 may include a diaphragm portion 695 having a shape / form corresponding to a desired pressure diaphragm shape or form, such that when a conformal deposition is applied to the surface of the sensor housing, the deposition of material over such regions may produce the desired diaphragm shape / form for the sensor housing. Although examples are disclosed herein in the context of a sensor device including a substantially circular diaphragm, it should be understood that any shape of diaphragm may be implemented, including an elliptical diaphragm.

[0162] Although a three-dimensional mandrel form is shown and described, wherein the shell is formed by depositing a three-dimensional cylindrical form over the mandrel, it should be understood that examples of the present disclosure may implement two-dimensional deposition of a sheet of material that is shaped and configured to form a three-dimensional shell from the deposited material sheet after deposition. Thus, any example disclosed herein may be understood to include a cylindrical sensor shell deposition or a sheet deposition that is later formed into a sensor shell. However, for biocompatibility purposes, forming the shell from a sheet of material may introduce complexity in the manufacturing process and complicate the sealing of the shell.

[0163] At block 1704, process 1700 involves depositing one or more material layers 661 over mandrel 690. For example, such layers 661 may be applied over the outer surface of mandrel 690 using physical vapor deposition or other deposition or sputtering processes, as described in detail above. The deposited material may be any suitable or desired material that is compatible with the deposition processes disclosed herein. For example, the deposited material layers 661 may include nitinol, titanium, and / or other metals.

[0164] Operations associated with block 1704 may involve forming a shell of material over the sacrificial mandrel 690 and / or over at least a portion thereof using physical vapor deposition. The target material may be applied to the mandrel 690 in one or more layers to produce a relatively uniform deposition of material 661 over the surface of the mandrel 690, e.g., over substantially the entire surface thereof at one or more viewing angles or angles relative to the mandrel. In some embodiments, an initial deposition of a layer of shell material 661 is applied over a diaphragm portion 695 of the mandrel 690 to form the diaphragm layer 955, as well as sidewalls 696 and / or end 692 portions. The initial layer 661 applied over the mandrel 690 may be relatively thin, e.g., between 10-50 μm thick. Figure 18-2 A thin shell layer 661 deposited on a mandrel 690 is shown.

[0165] The specific deposition process implemented can utilize sputtering or evaporation to generate vapor in the form of molecules or ions from the target source material. Such vapor can be transported and deposited on the outer surface of the sacrificial mandrel 690 to form a coating 661. The deposition process can continue until the desired thickness is reached. In some embodiments, a planar magnetron physical vapor deposition is implemented to deposit layer 661 on the mandrel 690. Such a process can advantageously produce a relatively flat applied layer. In addition, an inverted cylindrical magnetron deposition process can advantageously allow deposition to occur above a three-dimensional cylindrical surface, such as the mandrel 690 shown and described in conjunction with Figures 17 and 18. Compared to a forged form / material that is cut, machined, ground or stamped into a shell form having a diaphragm as described herein, the deposited layer produced by such a process can produce a relatively more original and isotropic layer.

[0166] At block 1706, process 1700 may involve masking the deposited diaphragm 655 area with any suitable or desired material to cover and protect the diaphragm layer 655 from subsequent depositions. Diaphragm mask / cap 657 may be placed / positioned over diaphragm 655 using any type of application process known in the art or described herein. Figure 18-3 A mask / cover 657 is shown positioned over the diaphragm 655 .

[0167] In embodiments where the mandrel 690 and shell 638 are removed from the vacuum deposition chamber in order to mask material in the region of the diaphragm 655, where additional deposited layers are intended to be deposited on the shell 638, such removal and / or replacement from / in the vacuum chamber may adversely affect the adhesion between the initial deposited layer 661 and any subsequently deposited layers. However, such adverse effects may still be desirable as a means of achieving an integrated diaphragm structure with a relatively thin diaphragm, as described in conjunction with the examples disclosed herein. The diaphragm region 655 may be selectively masked in a manner that avoids subsequent layers from being applied to the diaphragm layer 655.

[0168] The process 1700 further involves depositing one or more relatively thick secondary layers 637 over the shell 638 and the diaphragm mask 657 at box 1708. The thickness of the secondary layer 637 of deposited material can be about 170-300 μm, such as between about 150-250 μm in some embodiments. For example, in some embodiments, the thickness can be between about 150-180 μm. Such thickness 637 can be combined with the thickness 661 of the end and sidewall portions to form a relatively thick 663 sidewall and end cap structure of the final shell 639, while producing a relatively thin diaphragm 655, whose thickness can be between 3%-20% of the combined layer 663 in the sidewall portion. The newly deposited 637 can be placed over the mask 657 and thin layer 661 in the sidewall portion 664, where the new / outer layer 637 is bonded to the outer surface of the thinner shell 661 to produce a single / integrated body of the shell 639. The material used for the second deposition 637 associated with frame 1708 can advantageously be the same deposition material as the deposition material applied in the initial deposition process, which can improve adhesion and integration between layers. Different deposition layers can be bonded at the molecular level to provide the desired integration. In addition, in some embodiments, the surface of such a deposition can be configured to reduce tissue growth and adhesion thereon. Although some examples are disclosed in which the main deposition layer 661 and the secondary deposition layer 637 include the same material (e.g., a metal or a metal alloy), in some embodiments, the shell 639 can be formed by a main deposition 661 and a secondary deposition 637 including different materials, wherein such layers may include materials selected to improve or adjust the mechanical properties of the shell 639. Figure 18-4 A thick layer 637 is shown deposited over the shell 611 (in the area outside the diaphragm) and the mask 657 .

[0169] At block 1710, process 1700 can involve removing the masking / mask 657, thereby revealing the relatively thin membrane layer 655 integrated with the relatively thicker shell structure 637. In some embodiments, removing the mask 657 can allow for further deposition in such areas. Figure 18-5 The mask 657 is shown removed, exposing the thin layer of diaphragm 655 .

[0170] At block 1712, process 1700 involves removing sacrificial mandrel 690. For example, a mandrel substrate (e.g., stainless steel, copper, or the like) may be removed from the completed deposited shell / form 639 leaving behind a hollow shell. With the internal mandrel etched out, the complete net form of shell 639 may leave behind a relatively thick structural body 654 and a relatively thinned / thin diaphragm 655. Removing the mandrel may involve dissolving the mandrel form using any suitable or desired type of etchant. Figure 18-6 The isolation shell 639 is shown with the mandrel 690 removed.

[0171] The isolation shell 639 includes a structural body configured for connection to a base assembly 670 of a sensor device housing, as described herein. The shell 639 includes a thin layer 661 adjusted in the diaphragm region 655 to provide the desired pressure transducing functionality, wherein the diaphragm 655 is substantially integrated with the body 654 of the shell 639 at a molecular level without the need for welding, brazing or other bonding methods, which may introduce undesirable complexity and / or risk of error into the process for the reasons described above. After the mandrel 690 is removed, the shell 639 is substantially hollow.

[0172] At block 1712, process 1700 involves combining the formed shell 639 with a base sensor assembly 677, which includes a cylindrical (or other shaped) open portion capsule 670 configured to house certain electronics, such as an antenna and / or other circuitry for wireless sensor data and / or power transmission. When combined with base sensor assembly 677, sensor device 600 can be fully assembled. In some embodiments, a sealing or brazing process can be implemented to secure and / or seal shell 639 to housing 670.

[0173] The base assembly 677 can be combined with the shell 639, wherein the plug or other structure 645 is at least partially disposed within the base housing 670, wherein such structural features are configured to retain or secure certain electronic components and / or other components within the sensor device 600 and or otherwise provide structural support / integrity for the assembled device 600. Figure 18-7 The assembled sensor device 600 shown in FIG. Figures 6A-9D Any features and or characteristics of the sensor device shown in.

[0174] Additional description of the instance

[0175] A list of examples is provided below, each of which may include aspects of any other example disclosed herein. In addition, aspects of any of the above examples may be implemented in any of the numbered examples provided below.

[0176] Example 1: An implantable sensor device includes a cylindrical housing, a deflectable diaphragm associated with a sidewall of the housing, a pressure sensor device contained within the housing, and a transducing medium disposed within the housing over at least a portion of the pressure sensor device.

[0177] Example 2: An implantable sensor device according to any example herein, in particular example 1, wherein the diaphragm is integrated with the housing.

[0178] Example 3: The implantable sensor device according to any example herein, in particular example 2, wherein the diaphragm is formed by a layer of deposited material extending over at least a portion of the side wall of the housing.

[0179] Example 4: An implantable sensor device according to any example herein, in particular example 1, wherein the diaphragm lies in a curved plane that curves around the axis of the housing.

[0180] Example 5: The implantable sensor device according to any example herein, in particular example 1, wherein the housing comprises a proximal base portion and a distal sensor enclosure shell portion.

[0181] Example 6: An implantable sensor device according to any example herein, in particular Example 5, wherein the proximal base portion accommodates an antenna, which is electrically connected to the pressure sensor device and is configured for wireless transmission through the proximal base portion of the shell.

[0182] Example 7: An implantable sensor device according to any example herein, in particular example 1, wherein the diaphragm comprises a plurality of concentric corrugations.

[0183] Example 8: An implantable sensor device comprising a shell formed from a plurality of vacuum deposited metal layers, and a diaphragm formed in a layer of the plurality of metal layers, the layer further forming a body of the shell.

[0184] Example 9: The implantable sensor device according to any example herein, in particular example 8, wherein the housing has a silo shape including an end cap portion and a cylindrical sidewall portion.

[0185] Example 10: The implantable sensor device according to any example herein, in particular Example 9, wherein the diaphragm faces transversely relative to the axis of the shell and is formed in the sidewall portion of the shell.

[0186] Example 11: The implantable sensor device according to any example herein, in particular Example 9, wherein the diaphragm is one of a plurality of diaphragms formed in the sidewall portion of the shell.

[0187] Example 12: The implantable sensor device according to any example herein, in particular Example 11, wherein the plurality of diaphragms comprises at least two circumferentially distributed diaphragms.

[0188] Example 13: An implantable sensor device according to any example herein, in particular example 12, wherein the two circumferentially distributed diaphragms are disposed on opposite circumferential sides of the sidewall portion.

[0189] Example 14: The implantable sensor device according to any example herein, in particular Example 11, wherein the plurality of septa include at least two axially distributed septa.

[0190] Example 15: An implantable sensor device according to any example herein, in particular example 14, wherein the at least two axially distributed diaphragms are circumferentially aligned.

[0191] Example 16: The implantable sensor device according to any example herein, in particular Example 11, wherein the plurality of diaphragms include a first diaphragm and a second diaphragm facing radially oppositely.

[0192] Example 17: The implantable sensor device according to any example herein, in particular Example 16, further includes a plate substrate at least partially disposed within the shell, a first pressure sensor device and a second pressure sensor device mounted on opposite sides of the plate substrate, and a pressure transducer medium disposed between the first pressure sensor device and the second pressure sensor device and the corresponding diaphragms in the first diaphragm and the second diaphragm.

[0193] Example 18: The implantable sensor device according to any example herein, in particular Example 8, wherein the diaphragm has an elliptical shape, wherein the major axis of the elliptical shape is parallel to the axis of the shell.

[0194] Example 19: An implantable sensor device according to any example herein, in particular example 8, wherein the shell has a thickness at least three times the thickness of the diaphragm.

[0195] Example 20: A method for manufacturing an implantable sensor device, the method comprising: providing a mandrel form, the mandrel form comprising a main body portion including a sidewall portion and an end cap portion, and a lateral diaphragm portion on the sidewall portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more base material layers over at least a portion of the main body portion of the mandrel form; and depositing a surface layer over the diaphragm portion and at least a portion of the sidewall portion outside the diaphragm portion to form a shell comprising an integrated diaphragm.

[0196] Example 21: The method according to any example herein, in particular Example 20, further comprising removing a portion of one or more base layers in the region of the diaphragm portion before depositing the surface layer.

[0197] Example 22: The method according to any example herein, in particular Example 21, wherein the removing the portion of the one or more base layers is performed using a laser.

[0198] Example 23: The method according to any example herein, in particular Example 20, further comprising masking the diaphragm portion before depositing the one or more base material layers.

[0199] Example 24: The method according to any example herein, in particular Example 20, further comprising removing the mandrel form from the one or more base layers and the skin layer after depositing the skin layer.

[0200] Example 25: The method according to any example herein, in particular Example 24, wherein the removing the mandrel form involves dissolving the mandrel form using an etchant.

[0201] Example 26: The method according to any example herein, in particular Example 20, further comprises coupling the shell to a base housing in which an antenna is disposed.

[0202] Example 27: The method according to any example herein, in particular Example 20, further comprising injecting a pressure transducing medium into the shell around the pressure sensor device disposed within the shell.

[0203] Example 28: A method for manufacturing an implantable sensor device, the method comprising: providing a mandrel form, the mandrel form comprising a main body portion including a sidewall portion and an end cap portion and a lateral diaphragm portion on the sidewall portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more first material layers over the lateral diaphragm portion and at least a portion of the main body portion of the mandrel form to form a diaphragm integrated with a shell body; placing a mask over the diaphragm; depositing one or more second material layers over the masked diaphragm and at least a portion of the shell body to form an integrated shell; and removing the mask from over the diaphragm.

[0204] Example 29: The method according to any example herein, in particular Example 28, further comprising removing the mandrel form from the integrated shell after depositing the one or more second material layers.

[0205] Example 30: The method according to any example herein, in particular Example 29, wherein the removing the mandrel form involves dissolving the mandrel form using an etchant.

[0206] Example 31: The method according to any example herein, in particular Example 28, further comprises coupling the integrated shell to a base shell in which an antenna is disposed.

[0207] Example 32: The method according to any example herein, in particular Example 28, further comprising injecting a pressure transducing medium into the integrated shell around the pressure sensor device disposed within the shell.

[0208] Example 33: A method for manufacturing an integrated flexible diaphragm, the method comprising: providing a mandrel form, the mandrel form comprising a main body portion and a diaphragm portion; placing the mandrel form in a vacuum deposition chamber; depositing multiple base material layers over at least a portion of the main body portion of the mandrel form surrounding the diaphragm portion; and depositing a surface layer over the diaphragm portion and over the multiple base layers deposited around the diaphragm portion to form the integrated flexible diaphragm.

[0209] Example 34: The method according to any example herein, in particular 33, further comprising removing a portion of the plurality of base layers in the region of the diaphragm portion before depositing the surface layer.

[0210] Example 35: The method according to any example herein, in particular Example 34, wherein the removing the portion of the plurality of base layers is performed using a laser.

[0211] Example 36: The method according to any example herein, in particular Example 33, further comprises: before depositing the plurality of base material layers, masking the diaphragm portion with a sacrificial layer.

[0212] Example 37: The method according to any example herein, in particular Example 3, further comprising: after depositing the surface layer, removing the mandrel form from the one or more base layers and the surface layer.

[0213] Example 38: The method according to any example herein, in particular Example 37, wherein the removing the mandrel form involves dissolving the mandrel form using an etchant.

[0214] Example 39: The method according to any example herein, in particular Example 33, wherein the integrated flexible membrane is flexible relative to the plurality of base layers.

[0215] Example 40: The method according to any example herein, in particular Example 33, wherein the integrated flexible membrane has a thickness between 10-40 μm.

[0216] Example 41: The method according to any example herein, in particular Example 33, wherein the integrated flexible membrane has a thickness of about 3%-15% of the combined thickness of the skin layer and the plurality of base layers.

[0217] Example 42: A method according to any example herein, in particular Example 33, wherein the integrated flexible diaphragm comprises a plurality of corrugations.

[0218] Example 43: A method according to any example herein, in particular Example 42, wherein the plurality of corrugations comprises one or more concentric rings.

[0219] Example 44: A method according to any example herein, in particular Example 33, wherein the surface layer comprises multiple material layers.

[0220] Example 45: A method according to any example herein, in particular Example 33, wherein the surface layer comprises a superelastic nickel titanium material.

[0221] Example 46: A method according to any example herein, in particular Example 45, wherein the material of the multiple base layers includes superelastic nickel titanium.

[0222] Example 47: A method according to any example herein, in particular Example 33, wherein the surface layer comprises a superelastic nickel titanium material.

[0223] Example 48: A method according to any example herein, in particular example 33, wherein the portion of the mandrel-form body portion surrounding the diaphragm portion is planar.

[0224] Example 49: A method according to any example herein, in particular Example 33, wherein the portion of the mandrel-form body portion surrounding the diaphragm portion is curved.

[0225] Example 50: A method for manufacturing an integrated flexible diaphragm, the method comprising: providing a mandrel form comprising a main body portion and a diaphragm portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more first material layers over the diaphragm portion and at least a portion of the main body portion of the mandrel form surrounding the diaphragm portion to form the integrated flexible diaphragm; placing a mask layer over the diaphragm; depositing one or more second material layers over the masked diaphragm and at least the portion of the main body portion of the mandrel form surrounding the diaphragm portion.

[0226] Example 51: The method according to any example herein, in particular Example 50, further comprises: before depositing the one or more first material layers, masking the mandrel form with a sacrificial layer.

[0227] Example 52: The method according to any example herein, in particular Example 50, further comprises: after depositing the one or more second material layers, removing the mandrel form from the one or more first material layers and the one or more second material layers.

[0228] Example 53: The method according to any example herein, in particular Example 52, wherein removing the mandrel form involves dissolving the mandrel form or one or more layers thereof using an etchant.

[0229] Example 54: The method according to any example herein, in particular Example 50, wherein the integrated flexible membrane is flexible relative to the one or more second material layers.

[0230] Example 55: The method according to any example herein, in particular Example 50, wherein the integrated flexible membrane has a thickness between 10-40 μm.

[0231] Example 56: The method according to any example herein, in particular Example 50, wherein the integrated flexible membrane has a thickness of approximately 3%-15% of the combined thickness of the one or more first material layers and the one or more second material layers.

[0232] Example 57: A method according to any example herein, in particular Example 50, wherein the integrated flexible diaphragm includes a plurality of corrugations.

[0233] Example 58: A method according to any example herein, in particular Example 57, wherein the plurality of corrugations comprises one or more concentric rings.

[0234] Example 59: A method according to any example herein, in particular Example 50, wherein the integrated flexible diaphragm comprises a superelastic nickel titanium material.

[0235] The methods and structures for treating patients disclosed herein also encompass similar methods and structures performed on or placed on simulated patients, which are suitable for, for example, training; demonstration; program and / or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation can include a simulation of all or part of a patient, for example, the entire body, a part of the body (e.g., chest), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. The physical element can be: natural, including a human or animal body or part thereof; synthetic; or any combination of natural and synthetic. The virtual element can be entirely in silica, or covered on one or more physical parts. The virtual element can be presented on any combination of a screen, headphones, holograms, projections, speakers, headphones, pressure transducers, temperature transducers, or any combination using suitable technology.

[0236] Any of the various systems, devices, equipment, etc. in the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use with patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, equipment, etc.

[0237] Depending on the example, some actions, events or functions of any process or algorithm described in this article may be performed in a different order, may be added, combined or omitted entirely. Therefore, in some examples, not all described actions or events are necessary for the practice of the process.

[0238] Conditional language used herein, such as "may", "can", "could", "might", "for example", etc., unless explicitly stated otherwise or otherwise understood as used in the context, is generally intended and generally intended to express that certain examples include certain features, elements and / or steps, while other examples do not include certain features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required in any case for one or more examples, or that one or more examples must contain logic for determining whether these features, elements and / or steps are included in any particular example or will be performed therein with or without author input or prompting. The terms "include", "comprising", "having", etc. are synonymous and used in their usual sense, and are used inclusively in an open-ended manner, and do not exclude additional elements, features, behaviors, operations, etc. The term "or" is used in a non-exclusive sense (and is not used in an exclusive sense), so that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is generally understood in context to convey that an item, term, element, etc. can be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain examples require that at least one of X, at least one of Y, and at least one of Z each be present.

[0239] It should be understood that in the above description of examples, various features are sometimes combined in a single example, drawings or its specification for the purpose of simplifying the present disclosure and helping to understand one or more of the various inventive aspects. However, this method of the present disclosure should not be interpreted as reflecting the intention that any claim requires more features than the features clearly recorded in the claim. In addition, any component, feature or step shown and / or described in the specific examples herein can be applied to any other example or used together with any other example. In addition, for each example, no component, feature, step or group of components, features or steps is necessary or indispensable. Therefore, it is expected that the scope of the present invention disclosed herein and claimed below should not be limited by the specific examples described above, but should only be determined by clearly reading the attached claims.

[0240] 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 (e.g., "first", "second", "third", etc.) used to modify elements (e.g., structures, components, operations, etc.) do not necessarily indicate the priority or order of the elements relative to any other elements, but can generally distinguish the elements from another element with a similar or identical name (but using ordinal terms). In addition, as used herein, indefinite articles ("a" and "an") can indicate "one or more" rather than "one". In addition, operations performed "based on" a condition or event can also be performed based on one or more other conditions or events that are not explicitly stated.

[0241] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the example embodiments belong. It should also be understood that unless explicitly defined as such herein, terms (such as those defined in commonly used dictionaries) should be interpreted as having a meaning consistent with their context in the relevant art and the present invention, and will not be interpreted in an idealized or overly formal sense.

[0242] Spatially relative terms "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," and similar terms may be used herein to describe the relationship between one element or component and another element or component, as shown in the figures. It should be understood that the spatially relative terms are intended to cover different orientations of the device in use or operation in addition to the orientations described in the drawings. For example, in the case where the device shown in the figures is flipped, a device positioned "below" or "below" another device can be placed "above" the other device. Thus, the illustrative term "below" can include a lower position and an upper position. The device can also be oriented in another direction, and thus the spatially relative terms can be interpreted differently depending on the direction.

[0243] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less", "more", "greater", etc. are intended to encompass the concept of equality. For example, "less" may not only mean "less" in the strictest mathematical sense, but also mean "less than or equal to".

Claims

1. An implantable sensor device comprising: Cylindrical shell; a deflectable diaphragm associated with a side wall of the housing; a pressure sensor device, the pressure sensor device being accommodated in the housing; as well as A transducing medium is disposed within the housing over at least a portion of the pressure sensor device.

2. The implantable sensor device of claim 1, wherein the diaphragm is integrated with the housing.

3. The implantable sensor device of claim 2, wherein the diaphragm is formed from a layer of deposited material extending over at least a portion of a side wall of the housing.

4. The implantable sensor device of claim 1, wherein the diaphragm lies in a curved plane that curves about an axis of the housing.

5. The implantable sensor device according to any one of claims 1 to 4, wherein the housing comprises a proximal base portion and a distal sensor enclosure shell portion.

6. The implantable sensor device of claim 5, wherein the proximal base portion houses an antenna electrically coupled to the pressure sensor device and configured for wireless transmission through the proximal base portion of the housing.

7. The implantable sensor device of any one of claims 1 to 4, wherein the diaphragm comprises a plurality of concentric corrugations.

8. An implantable sensor device comprising: a shell formed from a plurality of vacuum deposited metal layers; as well as A diaphragm is formed in a layer of the plurality of metal layers, the layer also forming the body of the shell.

9. The implantable sensor device of claim 8, wherein the housing has a silo shape including an end cap portion and a cylindrical sidewall portion.

10. The implantable sensor device of claim 9, wherein the diaphragm faces transversely relative to an axis of the housing and is formed in the sidewall portion of the housing.

11. The implantable sensor device of claim 9, wherein the diaphragm is one of a plurality of diaphragms formed in the sidewall portion of the housing.

12. The implantable sensor device of claim 11, wherein the plurality of diaphragms comprises at least two circumferentially distributed diaphragms.

13. The implantable sensor device of claim 12, wherein the two circumferentially distributed diaphragms are disposed on opposite circumferential sides of the sidewall portion.

14. The implantable sensor device of claim 11, wherein the plurality of septa comprises at least two axially distributed septa.

15. The implantable sensor device of claim 14, wherein the at least two axially distributed diaphragms are circumferentially aligned.

16. The implantable sensor device of claim 11, wherein the plurality of diaphragms include a first diaphragm and a second diaphragm facing radially opposite each other.

17. The implantable sensor device of claim 16, further comprising: a board substrate disposed at least partially within the housing; a first pressure sensor device and a second pressure sensor device, the first pressure sensor device and the second pressure sensor device being mounted on opposite sides of the board substrate; as well as A pressure transducing medium is disposed between the first and second pressure sensor devices and respective ones of the first and second diaphragms.

18. The implantable sensor device of any one of claims 8 to 17, wherein the diaphragm has an elliptical shape, wherein the major axis of the elliptical shape is parallel to the axis of the shell.

19. The implantable sensor device of any one of claims 8 to 17, wherein the shell has a thickness at least three times the thickness of the diaphragm.

20. A method of manufacturing an implantable sensor device, the method comprising: providing a mandrel form comprising a body portion including a sidewall portion and an end cap portion, and a transverse diaphragm portion on the sidewall portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more layers of base material over at least a portion of the body portion in the form of the mandrel; as well as A skin layer is deposited over the diaphragm portion and at least a portion of the sidewall portion external to the diaphragm portion to form a shell containing an integrated diaphragm.

21. A method of manufacturing an implantable sensor device, the method comprising: providing a mandrel form comprising a body portion including a sidewall portion and an end cap portion, and a transverse diaphragm portion on the sidewall portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more layers of a first material over the transverse diaphragm portion and at least a portion of the body portion in the form of the mandrel to form a diaphragm integrated with the shell body; placing a mask over the diaphragm; depositing one or more layers of a second material over the masked diaphragm and at least a portion of the shell body to form an integrated shell; as well as The mask is removed from over the diaphragm.

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