Integral Pressure Diaphragm

Abstract

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

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 321,556, filed March 18, 2022, and entitled “INTEGRATED PRESSURE DIAPHRAGM,” the complete disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure generally relates to the field of sensor devices. Some sensor devices, such as those suitable for medical implantation, may include a deflectable diaphragm. The mechanical seal between such a diaphragm and an associated sensor housing / structure may affect the suitability of such devices for a particular application. Summary of the Invention

[0003] Described herein are methods, systems, and devices that 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 integral diaphragm layer. In some embodiments, the diaphragm of the inventive sensor device disclosed herein is advantageously oriented sideways.

[0004] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features are described. It will be understood that not all such advantages may necessarily be achieved in accordance with any particular example. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0005] Various examples are shown in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 illustrates certain human anatomical structures showing exemplary sensor implantation locations, according to one or more embodiments. [Diagram 2] FIG. 2 is a block diagram illustrating a system for wirelessly monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. [Diagram 3] Figure 3A is a side view of a piezoresistive pressure sensor device according to one or more embodiments, and Figure 3B is a side view of the piezoresistive pressure sensor of Figure 3A with the diaphragm of the sensor deflected according to one or more embodiments. [Figure 4] Figure 4A is a side view of a capacitive pressure sensor device according to one or more embodiments, and Figure 4B is a side view of the capacitive pressure sensor of Figure 4A with the diaphragm of the sensor deflected according to one or more embodiments. [Diagram 5] 5A shows a front and side perspective view of a sensor-embedded device according to one or more embodiments, and FIG 5B shows an exploded view of a sensor-can package of the sensor-embedded device of FIG 5 according to one or more embodiments. [Figure 6] 6A and 6B show cross-sectional views of a distal portion of a sensor-embedded device according to one or more embodiments. [Figure 7] FIG. 7 is a graph illustrating the relationship between sensor diaphragm thickness, surface area, and sensitivity in accordance with one or more embodiments. [Figure 8] FIG. 8 is a block diagram illustrating a deposition system according to one or more embodiments. [Figure 9A]FIG. 9A illustrates a perspective view of a sensor device having an integrated diaphragm according to one or more embodiments. [Figure 9B] FIG. 9B illustrates a longitudinal cross-sectional view of a sensor device having an integral diaphragm according to one or more embodiments. [Figure 9C] FIG. 9C illustrates an axial cross-sectional view of a sensor device having an integral diaphragm according to one or more embodiments. [Figure 9D] FIG. 9D illustrates a sensor device having a dimpled diaphragm configuration according to one or more embodiments. [Figure 10] 10-1, 10-2, and 10-3 provide a flow diagram illustrating a process for packaging a sensor device according to one or more embodiments. [Figure 11] 11-1, 11-2, and 11-3 provide images of pressure sensor packaging components corresponding to the operation of the process of FIGS. 10-1, 10-2, and 10-3, according to one or more embodiments. [Figure 12] FIG. 12 illustrates an axial cross-sectional view of a sensor device with three or more circumferentially distributed diaphragms according to one or more embodiments. [Figure 13] FIG. 13 illustrates a side view of a sensor device with multiple axially offset diaphragms according to one or more embodiments. [Figure 14] FIG. 14 shows a perspective view of a sensor device having an axially and / or circumferentially offset diaphragm. [Figure 15] 15-1 and 15-2 show perspective views of a sensor device having an integral axial diaphragm according to one or more embodiments. [Figure 16] FIG. 16 is a cutaway view of the human heart and associated vasculature showing a particular catheter access route for a sensor device implantation procedure, according to one or more embodiments. [Figure 17]17-1, 17-2, 17-3, and 17-4 provide flow diagrams illustrating a process for packaging a sensor device according to one or more embodiments. [Figure 18] 18-1, 18-2, 18-3, 18-4, 18-5, 18-6, and 18-7 provide images of pressure sensor packaging components corresponding to operation of the processes of FIGS. 17-1, 17-2, 17-3, and 17-4, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0008] Although certain preferred examples are disclosed below, it should be understood that the subject matter of the invention extends beyond the specifically disclosed examples to other alternative examples and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular example, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not all such aspects or advantages are necessarily achieved by any particular example. Thus, the various examples may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0009] Certain standard anatomical terms of location are used herein to refer to animal, i.e. human, anatomical structures with respect to various embodiments. While certain spatially relative terms such as "outer", "inner", "superior", "lower", "down", "upper", "vertical", "horizontal", "top", "bottom", "distal", "proximal" and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationships between the elements / structures illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or to the side of such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa. It should be understood that the spatially relative terms, including those listed above, may be understood with respect to the depicted orientation of each of the referenced figures.

[0010] Certain reference numbers are reused across different figures in the set of figures of this disclosure as a matter of convenience for devices, components, systems, features, and / or modules that have similar characteristics in one or more respects. However, with respect to any of the examples disclosed herein, the reuse of common reference numbers in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one of ordinary skill in the art can learn from the context as to the extent to which the use of common reference numbers may suggest similarity between the referenced objects. The use of a particular reference number in the context of a description of a particular figure can be understood as relating to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number can be interpreted as sharing features or as being entirely independent of each other.

[0011] When an alphanumeric reference identifier is used that includes a numeric portion and an alphabetic portion (e.g., "10a" where "10" is the numeric portion and "a" is the alphabetic portion), a reference in the written description to only the numeric portion (e.g., "10") may refer to any feature identified in a figure using such a numeric portion (e.g., "10a," "10b," "10c," etc.), even if such feature is identified using a reference identifier that connects its numeric portion with one or more alphabetic letters (e.g., "a," "b," "c," etc.). That is, a reference in the written description herein to the feature "10" may be understood to refer, by way of example, to either the identified feature "10a" in a particular figure of the present disclosure, or to the identifiers "10" or "10b" in the same or another figure.

[0012] The present disclosure relates to systems, devices, and methods for packaging devices configured for sensing and / or telemetric monitoring of one or more physiological parameters (e.g., blood pressure) of a patient. Such pressure sensing / monitoring may be performed using a cardiac implant device having an integrated pressure sensor diaphragm and / or associated components. Such devices may be advantageously packaged for long-term implantation in a cardiac environment. The terms "associated" and "connected to" are used herein according to their broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "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 physically coupled, attached, or connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.

[0013] As described in detail below, implantable pressure sensors can be used to measure pressure levels within various conduits and chambers of the body, such as various chambers of the heart. Typically, however, only certain types of sensors and sensor packaging may be suitable for implantation for a given application due to the accessibility and environmental conditions associated with the cardiac conduits / chambers and / or other potential sensor implantation locations within the patient. Examples of the present disclosure relate to packaging for pressure sensor-embedded devices that include certain electronics and telemetry features that enable wireless data and / or power communication between the implanted sensor device and one or more devices or systems outside the patient's body.

[0014] Aspects of the present disclosure relate to sensor devices, such as wireless, implantable pressure sensor devices, and other apparatus that include a deflectable diaphragm component. In particular, the inventive features disclosed herein can be implemented in the context of an implantable sensor device, and the integral diaphragm feature can advantageously provide biocompatible sealing and / or encapsulation of internal sensor components, such as the pressure transduction medium, circuitry, and / or structural components of the device.

[0015] With respect to implantable pressure sensor devices, anatomical considerations may necessitate the use of sensor devices 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, where the sensor device is advanced 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 be advantageously implemented with sensor devices having a profile / size small enough to be transported by and / or within a catheter, sheath, or other instrument configured for transcatheter access / use. In addition to size constraints associated with implantable sensor devices (e.g., pressure sensor devices), sensor sensitivity and / or dynamic range requirements or desires may drive sensor design as well. For example, with respect to pressure sensor devices, a deflectable pressure diaphragm associated with such a device may be designed to provide sufficient sensitivity to the pressure conditions to which the device is exposed.

[0016] Additionally, implantable sensor devices, such as diaphragm-equipped pressure sensor devices, may further need to provide biocompatibility and / or encapsulation properties suitable for in vivo implantation. For example, with respect to implantation within a particular anatomical structure, such as within a cardiac chamber, or within other fluid-filled anatomical vessels / cavities, such environments may present particular pressure, turbulence, and corrosive conditions that may be associated with fluid / blood characteristics and / or cardiac cycles. Compared to non-implanted environments, the human body represents a very hostile environment for electrical implant devices. Examples of the present disclosure provide sensor-embedded devices that provide an extended and / or lifelong hermetic seal / seal, which may be advantageous and / or important for a variety of reasons. For example, such hermetic sealing may prevent components of the environmental blood from degrading or otherwise interfering with the sensor and associated electronics. Additionally, the hermetic sealing of examples of the present disclosure may help prevent any non-biocompatible components of or associated with the sensor-embedded device from creating / causing toxic conditions within the body. The embodiments of the present disclosure further provide a sensor-embedded device having ion-deposited shell components that provide a relatively thin and hermetically sealed integral sensor diaphragm. Such designs can have a reduced package thickness compared to certain other welded metal solutions that may include interfaces between their metal and / or ceramic components that take up undesirable amounts of space. By integrating multiple functional components into a single thin shell, the total package thickness / size can be minimized.

[0017] Certain examples are disclosed herein in terms of cardiac implanted devices. However, while certain principles disclosed herein may be particularly applicable to cardiac anatomy, it should be understood that sensor-embedded devices according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure. Additionally, embodiments of the present disclosure may also be utilized in non-biological environments.

[0018] The anatomical structure of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, in which blood flow is controlled, at least in part, by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to control the flow of blood to respective regions of the heart and / or blood vessels (e.g., pulmonary artery, aorta, etc.) in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole). Contraction of the various cardiac muscles may be facilitated by signals generated by the heart's electrical system, which is discussed in detail below.

[0019] FIG. 1 illustrates an exemplary representation of a heart 1 and associated anatomical structures having various features relevant to certain examples of the present disclosure. The illustrated anatomical structures show exemplary implantation locations of sensor devices according to aspects of the present disclosure. Generally, the heart 1 includes four heart chambers, namely, the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. With respect to blood flow, generally, blood flows from the right ventricle 4 to 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 towards the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart.

[0020] The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. As shown, the pulmonary artery 11 includes a pulmonary trunk and left 15 and right 13 pulmonary arteries that branch off from the pulmonary trunk. In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in the circulation of blood therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps / leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally 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 to allow blood from the left atrium 2 to flow into the left ventricle 3, and when functioning properly, to close during systole to prevent blood from flowing 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 from the left ventricle 3 to flow into the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0021] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and a number of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts, the increased blood pressure generated within the corresponding heart chamber causes the leaflets to at least partially open, thereby allowing flow from the heart chamber. When pressure within a heart chamber decreases, the subsequent pressure within the heart chamber or blood vessel may prevail and push the leaflets back. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0022] The atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with a collection of chordae tendineae and papillary muscles (not shown) that anchor the leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. The papillary muscles may generally include, for example, finger-like projections from the ventricular wall. The leaflets of the valves are connected to the papillary muscles by the chordae tendineae. A muscular wall 17 called the septum separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0023] Health Status Associated with Cardiac Pressure and Other Parameters As referenced above, certain physiological conditions or parameters associated with the anatomy of the heart can affect the health of a patient. For example, congestive heart failure is a disease associated with the relatively slow movement of blood through the heart and / or body that causes an increase in fluid pressure within one or more chambers of the heart. As a result, the heart does not pump enough oxygen as the body requires. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiffer and / or thicker. Over time, the walls of the heart may weaken and may not be able to pump efficiently. In some cases, the kidneys may respond to the heart's failure by retaining fluid within the body. Fluid may accumulate in the arms, legs, ankles, feet, lungs, and / or other organs, causing the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality and therefore, the treatment and / or prevention of congestive heart failure is of significant medical concern.

[0024] Various methods for identifying and / or treating congestive heart failure involve monitoring worsening symptoms of congestive heart failure and / or changes in body weight. However, such indications may be relatively delayed and / or relatively unreliable. For example, daily weight measurements may vary widely (e.g., up to 9% or more) and may be unreliable in indicating cardiac-related complications. Furthermore, treatments guided by monitoring signs, symptoms, body weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. Thus, direct or indirect measurement / monitoring of pressure and / or other parameters using implanted devices may provide better outcomes than purely observation-based solutions. For example, without direct or indirect monitoring of cardiac pressure, it may be difficult to estimate, determine, or predict the presence or occurrence of congestive heart failure or other medical conditions. Treatments or approaches that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring body weight, thoracic impedance, right heart catheterization, etc.

[0025] Cardiac Pressure Monitoring Monitoring cardiac pressure according to examples of the present disclosure may provide a proactive intervention mechanism to prevent or treat congestive heart failure. In general, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur prior to the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators may appear several weeks prior to hospitalization in some patients. Thus, pressure monitoring systems according to examples of the present disclosure may be advantageously implemented to reduce hospitalization cases by guiding appropriate or desired titration of medications and / or administration of medications prior to the onset of heart failure.

[0026] Dyspnea represents a cardiac pressure index characterized by shortness of breath or a feeling of not being able to breathe adequately. Dyspnea may result from elevated atrial pressure, which may cause fluid accumulation in the lungs due to backflow of pressure. Pathological dyspnea may result from congestive heart failure. However, a significant amount of time may elapse between the initial rise in blood pressure and the onset of dyspnea, and thus symptoms of dyspnea may not signal an elevated atrial pressure early enough. Direct pressure monitoring according to examples of the present disclosure can advantageously maintain normal ventricular filling pressures, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0027] The pressure sensor devices disclosed herein may be implanted in any of the chambers / vessels of the heart or other vessels (e.g., vena cava, vena cava). FIG. 1 shows some exemplary implantation sites for implantable sensor devices according to embodiments of the present disclosure (shown as "s" in FIG. 1). For example, as shown, a sensor-embedded device having an integrated diaphragm component according to the present disclosure may be implanted in the right atrium, right ventricle, left atrium, left ventricle, pulmonary artery, inferior vena cava, aorta, or other anatomical structures. Generally, elevated pressure in the left atrium may be particularly correlated with heart failure, so in some cases implantation of a sensor-embedded device in the left atrium may be desirable.

[0028] Left atrial pressure generally correlates well with left ventricular end-diastolic pressure. However, although left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlation may weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate adequately with left ventricular end-diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension may affect the reliability of pulmonary artery pressure measurements to estimate left-sided filling pressure. Thus, pulmonary artery pressure measurements alone may be insufficient or inaccurate as an indicator of left ventricular end-diastolic pressure, especially for patients with comorbidities such as pulmonary disease and / or thromboembolism. Left atrial pressure may further correlate at least in part with the presence and / or degree of mitral regurgitation.

[0029] In some solutions, pulmonary artery wedge pressure may be measured as a surrogate for left atrial pressure. For example, a pressure sensor may be placed or implanted in the pulmonary artery, and readings associated with that pressure sensor may be used as a proxy for left atrial pressure. However, catheter-based pressure measurements in the pulmonary artery, as well as in certain other chambers or regions of the heart, may require the use of invasive catheters to maintain such pressure sensors, which may be uncomfortable or difficult to implement. Furthermore, certain lung-related diseases may affect pressure readings in the pulmonary artery, which may undesirably reduce the correlation between pulmonary artery pressure and left atrial pressure. As an alternative approach to measuring pulmonary artery pressure, pressure measurements in the right ventricular outflow tract may also be related to left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be utilized in diagnosing, preventing, and / or treating congestive heart failure. The present disclosure provides systems, devices, and methods for packaging an implantable pressure sensor configured to provide a direct measurement of pressure conditions at an implantation site.

[0030] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, which is an indicator of the function of the left ventricle of the heart and represents the ratio of the peak velocity blood flow due to gravity in early diastole (E wave) to the peak velocity blood flow caused by atrial contraction in late diastole (A wave), may be used as a proxy for left atrial pressure measurement. The E / A ratio may be determined using echocardiography or other imaging techniques, and an abnormality in the E / A ratio may generally indicate that the left ventricle is not able to fill with blood properly in the period between contractions, which may lead to symptoms of heart failure, as explained above. However, E / A ratio determinations generally do not provide absolute pressure measurements, but rather provide estimated information, which may not provide the required specificity in some cases. Furthermore, ultrasound, or similar imaging equipment, is typically not found in a home environment, and a typical patient does not have the ability to use such equipment, so a relatively easy-to-operate portable device according to aspects of the present disclosure may be desirable in certain situations.

[0031] Monitoring cardiac pressure, such as monitoring left atrial pressure, can provide a mechanism to guide drug administration for treating and / or preventing congestive heart failure. Such treatment may advantageously reduce re-hospitalization and morbidity, as well as provide other benefits. An implantable pressure sensor according to an example of the present disclosure may be used to predict heart failure two weeks or more prior to the onset of symptoms or markers of heart failure (e.g., dyspnea). When a prediction of heart failure is recognized using an example of a cardiac pressure sensor according to the present disclosure, certain preventative measures, including drug interventions, such as modifications to the patient's medication regimen, may be implemented to help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurements in the left atrium may advantageously provide an accurate indication of pressure build-up that may lead to heart failure or other complications. For example, by analyzing or using trends in atrial pressure increase, the onset of cardiac dysfunction may be determined or predicted, in which case drug or other therapy may be augmented to reduce pressure and prevent or reduce further complications.

[0032] 2 is a block diagram depicting a system 200 for wirelessly monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. FIG. 2 illustrates an implanted device 30 including a sensor device 37 that may be associated with a particular anchor structure 31. For example, the anchor structure 31 may be configured to anchor in and / or to one or more biological tissue walls. Although various embodiments of an implantable sensor device are illustrated and described in this disclosure without a separate anchor structure, such omission is for purposes of clarity only, and it should be understood that any of the embodiments disclosed herein may be associated with a particular anchor structure for anchoring the device to biological tissue / anatomical structure at an implantation site.

[0033] The sensor device 37 may be a pressure sensor according to any of the embodiments disclosed herein. In some embodiments, the sensor 37 comprises a transducer 32, such as a MEMS pressure transducer, and a specific control circuit 34, which may be embodied, for example, in an application specific integrated circuit (ASIC) and / or one or more passive devices (e.g., resistors, capacitors, inductors, etc.). The sensor device 37 further comprises an integral diaphragm 33 integrated as a single layer with at least a portion of the sensor housing 36. In some embodiments, the sensor housing 36 comprises a radio frequency transparent base housing that houses at least a portion of the antenna 38, and a transducer encapsulation shell, the shell comprising at least one single layer including side walls and / or end cap walls and the diaphragm 33 formed therein. Further details regarding such features are presented in detail below. A pressure transduction medium 39, such as oil, gel, epoxy, or another medium, is disposed within the housing 36 above the transducer 32 in such a manner as to transduce deflection of the diaphragm 33 into pressure on the transducer 32 to enable monitoring of such pressure.

[0034] The control circuitry 34 of the sensor device 37 may be configured to process signals received from the transducer 32 and / or communicate signals associated with the transducer wirelessly through biological tissue using an antenna 38. The antenna 38 may comprise one or more coils or loops of conductive material, such as copper wire, or a piezoelectric resonator, or other wireless signaling components. In some embodiments, at least a portion of the transducer 32, control circuitry 34, and / or antenna 38 are at least partially disposed or housed within a sensor housing / packaging 36 structure, which may comprise any type of material and may advantageously be at least partially hermetically sealed. The housing 36, as well as the diaphragm 33, may be at least partially formed using vapor deposition, as described in more detail below.

[0035] The term "control circuitry" 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 including one or more active devices and / or including one or more passive devices and / or including connecting circuitry), 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 circuitry and / or operational instructions. Control circuitry as referred to herein may further include one or more storage devices, which may be embodied in a single memory device, in multiple memory devices, and / or in embedded circuitry of a 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 circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage devices / registers that store any associated operational instructions may be embedded within the circuitry including the state machines, analog circuits, digital circuits, and / or logic circuits, or may be external to such circuitry.

[0036] The housing / packaging 36, in some embodiments, can comprise one or more tubes, cans, substrates / substrates, or other structures including glass or other rigid materials, which may provide mechanical stability and / or protection for components housed therein. In some embodiments, the housing / packaging 36 is at least partially flexible. For example, the housing / packaging can comprise a polymer or other flexible structure / material, which may advantageously allow aspects of the sensor 37 to fold, bend, or bend to allow for passage through a catheter or other introduction means.

[0037] The transducer 32 may comprise any type of sensor means or mechanism. For example, the transducer 32 may be a force-collecting type pressure sensor. In some embodiments, the transducer 32 may include a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring member to measure the strain or deflection applied over the area / surface of the transducer. The transducer 32 may be associated with the housing / packaging 36 such that at least a portion of the transducer 32 is contained within or attached to the housing / packaging 36. In some embodiments, the transducer 32 may comprise or be a component of a piezoresistive MEMS pressure sensor and may be configured to detect strain due to applied pressure using bonded or formed conductors, which increase in resistance as the pressure deforms the component / material, as described below in connection with FIGS. 3A and 3B. Alternatively, the transducer may comprise or be a component of a capacitive pressure sensor, as described below in connection with FIGS. 4A and 4B. The transducer 32 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0038] In some embodiments, the transducer 32 includes or is a component of an electromagnetic pressure sensor that may be configured to measure the displacement of a diaphragm by a change in capacitance, by a Linear Variable Displacement Transducer (LVDT) function, by the Hall effect, or by eddy current sensing. In some embodiments, the transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0039] In some examples, the transducer 32 includes or is a component of a strain gauge. For example, an example of a strain gauge may include a pressure sensitive element disposed on or associated with an exposed surface of the transducer 32. In some examples, a metal strain gauge may be glued to the face of the sensor, or a thin film gauge may be applied onto the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. The transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonance, thermal, ionization, or other type of strain or pressure sensor.

[0040] The transducer 32 may comprise one or more MEMS pressure sensor devices mounted on a substrate or the like, as described in detail herein. Additionally, the transducer 32 may be covered with one or more layers of a transduction medium 39 and / or a deposited biocompatible material, as described in detail below. In some examples, the transducer 32 is electrically and / or communicatively coupled to a control circuit 34, which may include one or more application specific integrated circuits (ASIC) microcontrollers or chips. The control circuit 34 may further include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, or the like.

[0041] 2, the implanted device 30 is implanted in a patient 44 for purposes of monitoring one or more physiological parameters (e.g., left ventricular pressure). The patient 44 may have the medical implanted device 30 implanted, for example, in a heart (not shown) or associated physiology. For example, the implanted device 30 may be at least partially implanted within the left atrium of the patient's heart.

[0042] In certain embodiments, the monitoring system 200 may include at least two subsystems, including an implantable internal subsystem or device 30, which includes a sensor transducer 32 and a control circuit 34 having one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 200 may further include an external (e.g., non-implantable) subsystem having an external reader 42 (e.g., coil), which may include a wireless transceiver electrically and / or communicatively coupled to the particular control circuit 41. In certain examples, both the internal and external subsystems include corresponding coil antennas for wireless communication and / or power supply through patient tissue disposed therebetween. The sensor-embedded device 30 may be any type of implanted device. For example, in some embodiments, the implanted device 30 includes a pressure sensor integrated with another functional implanted structure, such as an artificial shunt or a stent device / structure.

[0043] The implantation device 30 may include a particular anchor structure 31, as mentioned above. For example, the anchor structure 31 may include a percutaneously deliverable shunt device configured to be anchored to and / or into a tissue wall. Although certain components are shown in FIG. 2 as part of the implantation device 30, it should be understood that the sensor implantation device 30 may include only a subset of the components / modules shown and may include additional components / modules not shown. The implantation device 30 may represent the embodiment of the implantation device shown in FIGS. 9A-9D, or vice versa.

[0044] In certain examples, the sensor transducer 32 can be configured to generate electrical signals that can be wirelessly transmitted to a device located outside the patient's body, such as the illustrated local external monitor system 42. The control circuitry 34 can include any type of transceiver circuitry configured to transmit electromagnetic signals, where the signals can be radiated by an antenna 38, which may include one or more conductive wires, coils, plates, or the like. The control circuitry 34 of the implant device 30 can include, for example, one or more chips or dies configured to perform some degree of processing on 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 examples.

[0045] The wireless signals generated by the implant device 30 can be received by a local external monitoring device or subsystem 42, which can include a reader / antenna interface circuit module 43 disposed at least partially within the patient 44 and configured to receive wireless signal transmissions from the implant device 30. For example, the module 43 can include a transceiver device / circuitry.

[0046] The external local monitor 42 may receive wireless signaling and / or provide wireless power using an external antenna 48, such as a wand device. The reader / antenna interface circuitry 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30, which 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, and the like. The reader / antenna interface circuitry 43 may further be configured to transmit signals to the remote monitor subsystem or device 46 via a network 49. The RF circuitry of the reader / antenna interface circuitry 43 may further include one or more of a digital-to-analog converter (DAC) circuitry, a power amplifier, a low-pass filter, an antenna switch module, an antenna, or the like, for handling / processing the transmitted signals via the network 49 and / or for receiving signals from the implanted device 30. In particular embodiments, local monitor 42 includes control circuitry 41 for performing processing of signals received from embedded device 30. Local monitor 42 may be configured to communicate over network 49 according to known network protocols, such as Ethernet, Wi-Fi, or the like. In particular embodiments, local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0047] In certain embodiments, the embedded device 30 includes some degree of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating gate transistors, or the like. The control circuitry 34 may utilize the data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 42 or to another external subsystem. In certain embodiments, the embedded device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated with the sensor transducer 32. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as from the local monitor 42, or from a remote monitor 46, for example, via a network 49. For example, the embedded device 30 may be configured to receive signals that at least partially control the operation of the embedded device 30, such as by activating / deactivating one or more components or sensors, or by affecting the operation or performance of the embedded device 30.

[0048] One or more components of the implanted device 30 may be powered by one or more power sources 35. Due to size, cost, and / or electrical complexity concerns, it may be desirable for the power source 35 to be relatively minimal in nature. For example, high power driving voltages and / or currents within the implanted device 30 may adversely affect or disrupt operation of the heart or other body parts associated with the implanted device. In certain embodiments, the power source 35 is at least partially passive in nature, such that power may be received wirelessly from an external source by passive circuitry of the implanted device 30, such as by use of short-range or near-range wireless power transfer, or by use of other electromagnetic coupling mechanisms. For example, the local monitor 42 may act as an initiator that actively generates an RF field that may provide power to the implanted device 30, thereby allowing the power circuitry of the implanted device to take a relatively simple form factor. Such interrogations may be performed / implemented intermittently / sporadic, quasi-continuously, and / or continuously. In certain embodiments, power source 35 may be configured to obtain energy from an environmental source, such as fluid flow, movement, or the like. Additionally or alternatively, power source 35 may include a battery, which may be advantageously configured to provide sufficient power as needed for a monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period).

[0049] In some embodiments, the local monitoring device 42 can function as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 can be a wearable communication device or other device that can be easily disposed in close proximity to the patient 44 and the implanted device 30. The local monitoring device 42 can be configured to continuously, periodically, or sporadically interrogate the implanted device 30 to extract or request sensor-based information from the implanted device 30. In certain embodiments, the local monitor 42 includes a user interface that allows a user to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0050] 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 the monitored cardiac pressure data. The local monitor 47, the monitoring performed thereby, and / or the monitored data may be used / utilized for troubleshooting. In one example, the local monitor 42 may be a wearable device or other device or system configured to be placed in physical proximity to the patient and / or the implanted device 30, where the local monitor 42 is primarily designed to transmit signals to and / or receive signals from the implanted device 30 and provide such signals to the secondary local monitor 47 for viewing, processing, and / or manipulation. The external local monitor system 42 may be configured to receive and / or process certain metadata, such as a device ID or the like, from or associated with the implanted device 30, which may also be provided via a data link from the implanted device 30.

[0051] The remote monitoring subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received over the network 49 from the local monitoring device 42, from the secondary local monitor 47, and / or from the embedded device 30. For example, the remote monitoring subsystem 46 may be advantageously operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient 44. While certain examples disclosed herein describe communication from the embedded device to the remote monitoring subsystem 46 indirectly through the local monitoring device 42, in certain embodiments, the embedded device 30 may include a transmitter that may communicate over the network 49 to the remote monitoring subsystem 46 without having to relay information through the local monitoring device 42.

[0052] In certain embodiments, the antenna 48 of the external monitor 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 embodiments, the implanted device 30 is configured to receive wireless ultrasonic power charging and / or data communication therebetween from the external monitor system 42. As referenced above, the local external monitor 42 may include a wand or other handheld reader. In some embodiments, the antenna 48 includes a piezoelectric crystal.

[0053] Embedded Pressure Sensor Device Pressure sensors that can be used in medical implant applications include sensors that utilize microelectromechanical systems (MEMS) technology. Such devices can combine relatively small mechanical and electrical components on a substrate, such as a silicone or other semiconductor substrate, and can incorporate a deformable membrane that is used to measure its pressure-induced deflection, the degree of membrane deflection being indicative of the pressure conditions to which the sensor membrane is exposed at the implanted location.

[0054] MEMS sensors may be desirable for cardiac implantation applications due to their relatively small form factor and packaging. For example, MEMS pressure sensor devices may be considered relatively small, stable, and cost-effective devices, and such characteristics may fit the relatively constrained space and / or cost requirements of certain implanted devices. MEMS pressure sensor devices according to embodiments of the present disclosure may be fabricated in silicone using certain doping and / or etching processes. Such processes may be performed on a chip scale to provide relatively small devices that may be co-packaged with certain signal conditioning electronics, including passive and / or active devices. For example, electronic circuitry electrically coupled to the MEMS pressure sensor in association with any of the embodiments disclosed herein may include signal amplification, analog-to-digital conversion, filtering, and / or other signal processing functions and control circuits.

[0055] Various types of pressure sensors can be constructed using MEMS technology, including piezoresistive and capacitive pressure sensors. Such sensors generally include an at least partially flexible layer that acts as a deformable membrane configured to act as a diaphragm that deflects under pressure. Piezoresistive and capacitive sensors use different mechanisms to measure the displacement of such a diaphragm component.

[0056] For piezoresistive MEMS pressure sensors, certain conductive sensing elements can be fabricated directly on the diaphragm of the device, and changes in the electrical resistance of such conductors can be determined to indicate a measurement of the pressure applied to the diaphragm. In general, the change in resistance can be proportional to the strain of the conductor, which is related to the change in the length of the conductor induced by the deflection of the diaphragm on which the conductor is located.

[0057] FIG 3A is a side view of a piezoresistive pressure sensor device 320, according to one or more embodiments. FIG 3B is a side view of the piezoresistive pressure sensor 320 of FIG 3A, according to one or more embodiments, with the diaphragm 325 of the sensor deflected. The deflection of the diaphragm 325 can be caused by pressure conditions to which the diaphragm 325 is exposed. The diaphragm 325 can be formed from a substrate material 326, such as silicone or other semiconductor or material. 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.

[0058] The diaphragm 325 may have one or more conductive traces or elements 322 disposed and / or applied thereon. For example, the conductive elements 322 may include traces of metal or other electrical conductors, with one or more lengths of conductor extending over the diaphragm 325 such that deflection of the diaphragm 325 stretches / elongates one or more portions of the conductor 322, thereby altering its electrical resistance / impedance. As shown in FIG. 3B, as the diaphragm 325 deflects, the current and / or voltage through the conductive elements 322 may be measured to determine their respective resistance / impedance, thereby providing a measurement indicative of the degree of deflection of the diaphragm 325, with such deflection being indicative of the environmental pressure to which the diaphragm 325 is subjected. The diaphragm 325 may include any material, including, but not limited to, metal, ceramic, silicone, and the like.

[0059] FIG. 4A is a side view of a capacitive pressure sensor device according to one or more embodiments. FIG. 4B is a side view of the capacitive pressure sensor of FIG. 4A with the diaphragm of the sensor deflected according to one or more embodiments. In the case of a capacitive MEMS pressure sensor, one or more conductive layers 421, 422 can be deposited / applied on / against the diaphragm 425 and on / behind the diaphragm 425 at the bottom of the cavity 429 to create a capacitor. For example, in some implementations, the diaphragm itself 425 can include a conductive material that functions 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 one rigid plate electrode 422 and one flexible membrane electrode 425. If the extent of such electrodes is fixed, the capacitance between the electrodes can be proportional to the distance between them.

[0060] 4B, the inward / downward deflection / deformation of the diaphragm 425 may change the spacing between the conductors 421, 422 over at least a portion of the diaphragm 425, thereby changing the capacitance of a capacitor formed between the diaphragm 425 and the base electrode 422. Such a change in capacitance may be measured by coupling the sensor device 420 to, for example, a tuned circuit that may have a fundamental frequency proportional to the degree of deflection of the diaphragm 425. The diaphragm 425 may comprise any material, including, but not limited to, metal, ceramic, silicone, etc.

[0061] Embedded Pressure Sensor Packaging FIG 5A illustrates front and side perspective views of a sensor-embedded device 550, according to one or more embodiments. FIG 5B provides an exploded view of the sensor-can package of the sensor-embedded device 550 of FIG 5A, according to one or more embodiments. FIG 6A and FIG 6B illustrate cross-sectional views of the sensor-embedded device 550, according to one or more embodiments. The following description of the sensor device 550 can be understood with reference to any of FIG 5A, FIG 5B, FIG 6A and / or FIG 6B.

[0062] The sensor device 550 may be utilized for certain pressure monitoring applications and may utilize a relatively low-cost MEMS sensor 520 that is protected from the environment with a pressure transmitting fluid / medium 552 in contact with a secondary diaphragm / membrane 555. Such secondary diaphragm 555 may be made from a material suitable for placement in a relatively corrosive environment with repeated cycling, such as may be the conditions in certain vessels / chambers associated with the cardiac system. For example, the sensor can 550 may be suitable for implantation within a patient's cardiac system (e.g., a heart chamber). The secondary membrane 555 and can structure 554 of the device 550 may include metallic components that may be welded, brazed, cold formed, bonded, or otherwise joined together in such a manner as to create a fluid-tight pressure transmitting cell, as shown.

[0063] For example, a sensor element 520, which may include a MEMS pressure sensor, may be disposed within a can / cell 554, and a transfer fluid or other medium (e.g., oil, gel, epoxy) is disposed around the sensor element 520 within the can structure 554 such that a pressure transfer medium 552 is sealed within the can structure 554 and disposed around the sensor element 520 within an outer enclosure. For the particular embodiment illustrated in Figures 6A and 6B, a portion of the enclosure 550, such as a distal axial region thereof, comprises a diaphragm component 555.

[0064] With regard to the manufacture of the sensor device 550, mechanical welding / bonding may be required around the diaphragm 555 as well as around the base 571 of the can 554. For example, referring to FIG. 5A, the can base 571 may be welded / bonded to the housing 570. Such welding / bonding may introduce complexity into the manufacturing process and / or the possibility of sealing failure. As the size of the sensor device designs is reduced to allow greater flexibility with respect to minimally invasive (e.g., transcatheter) delivery and implantation within the body, the materials and processes associated with such devices may require increased processing complexity, failure modes, and / or provide maximum limitations for further reduction. The housing 570 may be at least partially transparent to electromagnetic radiation.

[0065] Diaphragm 555 may advantageously be deflectable such that pressure conditions outside of enclosure 554 may cause an inward deflection of diaphragm 555 in such a manner as to apply pressure to sensor element surface / diaphragm 525. For example, pressure transmission medium 552 may include an incompressible fluid or medium in some embodiments. Alternatively, medium 552 may be compressible, and deflection of diaphragm 555 may cause a decrease in the volume of an interior chamber of can 554, thereby compressing the fluid / medium and resulting in an increase in pressure within can 554 that is translated to sensor element 520. Deflection of the diaphragm 555 may move the diaphragm 555 from an undeflected state or configuration in which the diaphragm 555 lies in or is primarily parallel to a transverse plane P1 (e.g., transverse to the axis of the diaphragm and / or sensor device) to a deflected state or configuration in which the diaphragm 555 coincides with a concave / deflection plane P2 deflected relative to the transverse plane P1 (see FIG. 6B), e.g., in a direction toward the sensor element 520.

[0066] 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 anatomy. For example, a metal (e.g., stainless steel, nickel titanium (i.e., nitinol)), polymer, or other biocompatible material may be implemented for the diaphragm 555. Additionally, it may be necessary or desirable to design the diaphragm 555 in a manner that provides a sufficiently high sensitivity in terms of deflection tendency over an expected range of pressure conditions associated with the target physiology. 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 comprise ring-shaped ridges and / or grooves, which 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. The corrugations may further provide a relatively large deflection and / or a precise spring rate for the diaphragm and / or extend the cycle life of the diaphragm by reducing mechanical stress in one or more regions of the diaphragm, depending on the particular corrugation design. The corrugations 559 may be manufactured by cold pressing the diaphragm material into a corrugated shape or by any other means.

[0067] As mentioned above, size limitations associated with implantable sensor devices may similarly limit the area available for diaphragm components, depending on the design of the sensor device. For example, with respect to axial diaphragms, such diaphragm diameters and areas may be limited by the device diameter dimension D1, as in the examples of Figures 5A, 5B, 6A, and 6B. For example, elongated sensor devices suitable for transcatheter delivery may generally be limited in profile / dimension relative to their diameter / width, although in some examples the length of the sensor device may be less limited. Thus, as the profile of the sensor device decreases, the axial diaphragm area may decrease as well. As the diaphragm effective area decreases, the thickness T1 of the diaphragm may also need to decrease to maintain sufficient sensitivity of the diaphragm. For example, Figure 7 is a graph illustrating the relationship between thickness, surface area, and sensitivity of a sensor diaphragm, according to one or more embodiments. As shown in the graph of Figure 7, a diaphragm having a relatively small surface area must generally be relatively thin to achieve comparable sensitivity compared to a diaphragm having a relatively large surface area and an otherwise similar design.

[0068] The processes performed to form the thin foils can cause variable strain hardening of the formed material, which can result in relatively large variations in the mechanical performance of the formed diaphragms. Additionally, the relatively thin materials utilized in diaphragm formation can require careful handling and assembly processes to weld the diaphragm structure to a larger enclosure. At such a scale, the processes performed can affect the material properties and mechanics of the diaphragm, thereby causing further variations in diaphragm performance.

[0069] Furthermore, certain sensor devices are designed with a sensor diaphragm located / disposed at the distal end of the sensor device assembly, as shown in the examples of Figures 5A-6B. As shown in Figure 7, it may be advantageous to increase the area of ​​the diaphragm to provide the desired sensitivity, but the increase in diaphragm area of ​​such designs comes at the cost of an increase in the diameter / profile of the sensor device, which may hinder the ability to fit within a tubular catheter / shaft for delivery, especially when considering the thickness of the diaphragm material and the deflection sensitivity according to the relationship shown in the graph of Figure 7. As sensor device designs evolve toward smaller and smaller profile devices (e.g., millimeter-scale integrated implant devices), the ability to form and integrate such sensor device assemblies may become untenable with respect to the design paradigm shown in Figures 5A-6B.

[0070] The embodiments of the present disclosure provide an alternative sensor device design solution that allows for an increase in diaphragm area while maintaining a relatively small diameter profile. In some embodiments, the increase in sensor diaphragm area is achieved at least in part by positioning the sensor diaphragm laterally on the circumferential wall of a cylindrical sensor body / shell, rather than on the axial end of the sensor device. In some embodiments, a diaphragm is included both on the cylindrical sidewall of the housing, as well as on the axial end of the sensor device housing / structure. In such cases, the diameter of the diaphragm on the cylindrical sidewall may be larger for at least one dimension thereof than the diameter of the diaphragm facing the axial direction of the same device.

[0071] The embodiments of the present disclosure advantageously provide a solution for an implantable pressure sensor device that is relatively small in 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. Such embodiments may, in some cases, further provide suitable and / or improved biocompatibility characteristics and / or a relatively simplified manufacturing process. The inventive sensor embedding device solutions presented herein may achieve these benefits, at least in part, by integrating the pressure sensor diaphragm components with other structural / mechanical housing / encapsulating components of the device in one or more uniform and integrated layers of deposited material. For example, certain pressure sensor devices require manufacturing processes involving multi-part and / or multi-process manufacturing to seal / mechanically bond the diaphragm components to other structural components, whereas the embodiments of the present disclosure allow for manufacturing without the need for such sealing / bonding steps / processes. Moreover, in addition to the advantages associated with manufacturing the structure and diaphragm components of the sensor device as a single integral / net component with relatively few manufacturing steps / processes, such devices according to embodiments of the present disclosure can provide superior mechanical properties compared to certain non-integral diaphragm solutions. Furthermore, the integration of the diaphragm and shell components can significantly reduce the number of components and process steps required to manufacture the resulting sensor-embedded device and / or associated packaging. Fewer components and areas require hermetic sealing, resulting in a more robust protective shell that exhibits reduced risk of failure / leakage. Additionally, as described in detail herein, pressure sensor devices including an integrated diaphragm component can advantageously consolidate and improve the consistency and / or transduction performance of the sensor membrane / diaphragm that separates the biological environment from the internal sensor components of the sensor device.

[0072] Certain embodiments of the present disclosure provide an alternative to forged metal machining, stamping, grinding, or the like of sensor diaphragms to provide diaphragms with reduced thickness and improved sensitivity. Such diaphragms may advantageously be formed using ionized deposition processes rather than stamping, welding, or other more complicated and / or inconsistent / error-prone processes. Furthermore, deposition of the diaphragm in an integrated manner with the sensor housing / shell structure may provide improved hermetic sealing while also reducing the risk of error due to reduced process variations. In some embodiments, diaphragms deposited / formed according to aspects of the present disclosure include Nitinol metal alloy rather than titanium, which may be utilized in other sensor designs.

[0073] As mentioned above, the sensor diaphragm according to the embodiments of the present disclosure may be fabricated / formed using ionized metal deposition in some implementations. FIG. 8 is a block diagram illustrating a vacuum deposition system 800 according to one or more embodiments. Physical vapor deposition (PVD) and other vacuum deposition processes may be used to produce relatively thin films and coatings. In the system 800, the source material 830 (e.g., metal) transitions from a condensed phase to a gas phase 870 and then back to a thin film condensed phase 840. Sputtering or evaporation may be performed to generate a vaporization / plasma gas 870. The plasma gas 870 is deposited on the substrate 820 to form a layer 840 of deposited source material. The vacuum chamber 810 may advantageously be devoid of air and particles that may impede directed deposition onto the substrate 820.

[0074] The conversion of solid 830 to gas 870 can be accomplished through the application of energy from energy source 850. Energy source 850 can be any type of energy including heat / hot air flow, electric current, and / or voltage potential relative to electrical potential 860 associated with substrate 820. The energy can energize source material 830 to generate plasma form 870. Electric potential 860 relative to source material 830 can function to create a direction of deposition flow 870 toward substrate 820. Source material 830 can be positively charged in some cases while electrical potential 860 of substrate 820 can be negatively charged.

[0075] With respect to the various processes and devices disclosed herein, any type of deposition process may be performed to produce the shell housing components of the present invention with an integral diaphragm layer. An example may include cathodic arc deposition, in which a high-power electric arc is discharged at a target material (raw material) to blast a portion into a highly ionized vapor and deposit on a workpiece. For electron beam physical vapor deposition implementations, the material to be deposited is heated to a relatively high vapor pressure by electron bombardment in a vacuum, transported by diffusion, and deposited by condensation on a relatively cool workpiece. For evaporative deposition, the material to be deposited may be heated to a relatively high vapor pressure by electrical resistance heating in a vacuum. As another example, close-in sublimation may involve placing the raw material and the substrate in relatively close proximity to each other and radiative heating, pulsed laser deposition may be performed by ablating the raw material into a vapor using a high-power laser. Pulsed electron deposition may be performed by ablating the raw material to generate a plasma under non-equilibrium conditions using a high-energy pulsed electron beam.

[0076] In some examples, sputter deposition can be performed in which a glow plasma discharge, which can be localized around the target substrate by magnets, bombards the source material, thereby sputtering some as vapor for subsequent deposition. For sputtering applications, magnetrons can be used that utilize strong electric and magnetic fields to confine charged plasma particles near the surface of the sputter target. Generally, in a magnetic field, electrons follow a spiral path around the magnetic field lines and undergo ionizing collisions with neutral gases closer to the target surface than would otherwise occur. The extra ions of the sputter gas that are generated as a result of these collisions can lead to higher deposition rates. The plasma can also be maintained at lower pressures in this way. The sputtered atoms are neutrally charged and therefore not affected by magnetic traps. Other sputtering techniques that can be implemented include ion beam sputtering, reactive sputtering, ion-assisted deposition, high power impulse magnetron sputtering, gas flow sputtering, etc.

[0077] The substrate / mandrel 820 may be configured to rotate to enable the formation of a three-dimensional feature / shell. The rotation may be controlled to produce a relatively uniform distribution of deposition material on the mandrel 820 around the three-dimensional feature.

[0078] A sensor-embedded device having an integral and / or laterally facing diaphragm according to embodiments of the present disclosure may include a housing with a shell formed of one or more layers of deposition. For example, such layered deposition may involve depositing a thin layer of deposition material, followed by masking a portion of the deposition (e.g., the diaphragm portion), and then depositing another, possibly thicker, layer. Alternatively, a thicker layer may be deposited over the masked diaphragm (or the diaphragm may then be removed), and then a relatively thinner layer may be applied with no mask over the diaphragm to produce an integral diaphragm and shell structure.

[0079] 9A, 9B, and 9C show perspective, longitudinal, and axial cross-sectional views, respectively, of a sensor device 900 having an integral diaphragm 955, according to one or more embodiments. FIG 9D shows a diagram of an alternative sensor device embodiment having a dimpled diaphragm configuration 955. The diaphragm 955 and at least a portion of the shell housing 939 may be formed using a deposition process in one or more stages.

[0080] The sensor-embedded device 900 includes a wireless telemetry component 908. The wireless telemetry capabilities associated with the implanted devices disclosed herein may 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 transfer is described in connection with various embodiments disclosed herein, it should be understood that such embodiments may be implemented using wired data and / or power transfer mechanisms. For example, the sensor-embedded devices disclosed herein may be implemented as components of a catheter assembly, such devices not intended for long-term implantation, but rather may be positioned in the target anatomy via advancement and positioning of such a catheter and / or its distal end.

[0081] The implantation device 900 includes a shell housing 939, which may have one or more MEMS (or other type) pressure sensor devices 920 mounted or secured therein. The implantation 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 various figures (see, e.g., FIG. 9A, image 1110 of FIG. 11-3), the shell 939 may have a silo-shaped shape. The silo-shaped shape may include a first closed (e.g., cone- or dome-shaped) end / end cap and a cylindrical sidewall, and a second end that may be opened or closed.

[0082] In some embodiments, a wire coil antenna 908 or other type of transmitter / receiver is electrically coupled to the substrate 991 and / or electrical components attached thereto. In the embodiment shown, the wire coil (e.g., copper wire) may be wound around a ferrite core 907 that is collinear or coplanar with an axis A2 of the cylindrical sensor housing 970 in which it is at least partially disposed. The ferrite core 907 may be configured to concentrate the magnetic field flux such that the signal radiated by the antenna 908 is concentrated and / or directed. In some embodiments, the ferrite core 907 may be configured to suppress relatively high frequency electronic noise. The ferrite core 907 may include iron, ceramic, etc., and may employ relatively high frequency current dissipation to prevent electromagnetic interference in one or more dimensions.

[0083] The various control circuitry components, including the substrate 991 and antenna 908, may be maintained at least partially within the rigid base housing 970. The tubular base housing 970 may comprise ceramic, zirconia, glass, or other at least partially rigid structures that are sufficiently rigid to protect the internal components from damage and fluid and ion ingress during implantation and / or over extended exposure at the implantation site. The housing 970 may advantageously provide a complete hermetic seal and moisture barrier to prevent moisture from penetrating the housing 970 and interacting with the components housed therein. The electronics housing 970 may further comprise a material that is sufficiently transparent to high frequency electromagnetic radiation that may be transmitted to and / or from the antenna 908 to enable data and / or power communication with the implanted device 900. In some embodiments, the sensor-embedded device 900 is configured to transfer data and / or power / energy through transmission of ultrasonic signals and / or other sonic signal communication. Thus, in some embodiments, it may be desirable to construct the housing 970 from a material that is sufficiently transparent to ultrasonic and / or other sonic signals. In some embodiments, 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 encapsulates the sensor element 920 .

[0084] In some embodiments, the shell enclosure / housing 939 includes one or more sidewalls / sidewall portions 954 and a cover / end cap portion 956. The diaphragm 955 may be formed of one or more layers of deposited material with one or more deposited layers forming the sidewall 954 such that the interface between the diaphragm 955 and the sidewall 954 is in a fluid-tight configuration. The shell 939 is secured to the base housing 970 in some manner. For example, a brazing process may be performed to attach the shell 939 to the base housing 970, which may include a different material. Deflection of the diaphragm 955 may be translated via a translation medium 934, such as silicone oil, to the diaphragms / membranes of one or more sensor (e.g., MEMS) devices 920 disposed within the shell package 939.

[0085] The diaphragm 955 may have a corrugated form as shown, or any other form. The corrugated topology of the diaphragm 955 may facilitate deflection of the diaphragm 955 in such a way as to convert 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, which may be compressible or incompressible, and the inward deflection of the membrane 955 increases the pressure in the chamber 952 and / or pushes the medium 934 against the diaphragm / membrane of the sensor 920.

[0086] In embodiments in which the chamber 934 is filled with a liquid, it may be desirable to fill the chamber 934 such that there are no air or gas bubbles in the chamber. For example, the air / gas may generally be pressure compressible such that the presence of air / gas in the chamber 952 may reduce the pressure translation from the deflection of the diaphragm 955 to the pressure in the chamber 952. In some implementations, the chamber 952 may be filled through 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, which is then sealed in some manner to prevent leakage of fluid from the chamber 952 and / or to prevent gas or other substances from entering it after the chamber 952 is filled. In some implementations, the chamber 952 may be filled under vacuum conditions. In some embodiments, the pressure transduction medium 934 includes a polymer potting, which may be injected or poured / flowed into the shell 939.

[0087] In some embodiments, the substrate 991 may be held in place by an internal structure 945 of the sensor device 900. A portion of the circuit board 991 may be disposed over a portion of the substrate 991 that extends beyond the end of the housing 979 and into the interior region of the shell 939, and may be configured and / or positioned to extend axially past the end 979 of the housing 970 such that the sensor device 920 is not covered by the housing 970, but rather by the shell 939.

[0088] Sensor device 900 may have any suitable or desirable diaphragm topology. For example, while sensor device 900 is shown in Figures 9A-9C as having a corrugated diaphragm, Figure 9D illustrates an alternative diaphragm design for sensor device 900D having a dimpled diaphragm, which may include concave depressions defined by concentric ridges / grooves, as described in detail above.

[0089] The diaphragm 955 may include a thin layer of deposited metal, such as Nitinol, titanium, or other metal. The relatively thin layer of diaphragm 955 may be in unitary form with at least a portion of the body / sidewall portion 954 of the sensor enclosure shell 939. By integrating the diaphragm 955 with the shell 939, the diaphragm 955 may have an inherent seal with the shell structure that encapsulates the sensor 920, thereby providing improved protection to the internal components and / or protection from biological degradation over time. The diaphragm 955 provides a transmission window through which external pressure conditions are transmitted to the internal sensor device 920 via the enclosed pressure transmission medium 934 (e.g., oil). The diaphragm 955 may be formed with a final deposited layer that provides an outer skin over the shell 939, providing a structure to hold the internal components within the sensor device 900.

[0090] When the outer layer of the encapsulating shell 939 is formed of a deposition metal deposited in a single 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 embodiments where separate metal components / layers form the diaphragm and the structural housing, slight differences in the metal structures and / or the interfaces therebetween can result in imperfections and / or structural defects in the overall structure of the housing. Thus, forming such components of a common source material through a common deposition application can provide structural benefits to the shell 939.

[0091] The structural shell 939 may be formed with one or more coatings, layers, or processes such that the body portion 954 may have a different thickness than certain other portions, such as the diaphragm 955. For example, in some implementations, an initial relatively thick layer 937 (e.g., about 100 μm to 300 μm, 250 μm) may be deposited on a substrate to form a relatively thicker and / or more rigid body 954 of the shell 939 outside of the diaphragm region 955. For example, such a layer may be deposited / formed while the diaphragm region 955 is masked. Alternatively, a thicker coating / deposition of metal (e.g., Nitinol) may be deposited over the entire shell 939, including the diaphragm portion 955, and the thickness of the material deposited on the diaphragm may be etched away or otherwise thinned to produce a relatively thin diaphragm, which may be desirable with respect to the sensitivity / flexibility of the diaphragm. In some examples, the thickness of the diaphragm may be about 10 μm such that the diaphragm is about 3%-15% (e.g., 4%, 5%, 10%, or any number therebetween) thick of the structure of the shell 939 outside the diaphragm area (i.e., of the body portion 954 of the shell 939). For example, if 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 deposition of the same metal / material over the entire shell 939, including portions of the diaphragm and areas immediately adjacent thereto, and such subsequent layering / deposition may be a relatively thin skin / layer (e.g., about 10 μm thick, or 10 μm-40 μm thick).

[0092] In some implementations, a thin layer diaphragm may be deposited onto the mandrel / substrate surface, and then the diaphragm 955 may be masked to allow for subsequent deposition of a thicker layer 937 over areas of the mandrel / substrate, and a thin deposition layer outside of the diaphragm area 955 to completely form the shell 939. The diaphragm mask and mandrel / substrate are removed to produce a complete, integrated shell and diaphragm.

[0093] With further reference to the manufacturing process for producing the sensor device 900, as mentioned above, in some implementations, a deposition process may be performed to deposit a thickness / layer of metal or other material (e.g., Nitinol) on a mandrel or other substrate, and a laser process may be performed to selectively remove at least a portion of such deposition in the area of ​​the diaphragm 955. For example, in some limits, substantially all of the material deposited in the area of ​​the diaphragm may be removed. After such diaphragm removal, the structure may be placed back into a deposition chamber (e.g., a PVD vacuum chamber) and a final skin / layer may be applied over the previously deposited material that has not been removed, as well as over the diaphragm areas where the previous deposition has been removed / thinned or blocked.

[0094] In some implementations, masking of the diaphragm may be performed by using a resist layer over the diaphragm to prevent accumulation of deposited material in the covered areas. A robust hermetic seal may be created along the entire shell 939 by depositing a final integration layer / coating over the structure including the diaphragm. That is, the process of applying a first thick film layer over the body of the shell and then a final thin film coating over the diaphragm and the body of the shell, including the area surrounding the diaphragm, may provide desirable adhesion between the thin outer skin / diaphragm layer and the remaining structure, provided that the surfaces of the structure are kept relatively clean between process steps and the same deposition material is applied in both steps. If contamination is allowed between process steps, adhesion may be compromised, but in some cases the structural integrity may be sufficient to meet certain needs. Deposition materials used to form the layers of the shell 939 include nitinol, titanium, stainless steel, and other metals with similar properties. The base housing component 970 that is bonded to the shell 939 to form the enclosed housing vessel may include zirconium, ceramic, or other materials with similar properties. The base housing 970 may be bonded or brazed to the shell 939 in such a manner as to maintain a hermetic seal between the two components of the device 900 .

[0095] The shell 939 formed at various deposition process steps / stages may be removed from the mandrel and / or other substrate material to produce a hollow shell 939 configured to encapsulate / contain the internal sensor elements / components. The shell 939 may then be slid / placed over or into an open end of an open cylindrical base housing 970, which may be configured to hold various internal components of the sensor device 900. For example, the shell 939 may be comprised of a conductive material (e.g., a metal such as Nitinol), although it may be desirable for the housing 970 to not include a conductive material. For example, in implementations 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 housing 970. Thus, the base housing 970 may advantageously include a material that is transparent to wireless electromagnetic signal transmission, such as glass, ceramic, polymer, or other material. Thus, the combined assembly of device 900 may advantageously provide both metallic and non-metallic housing components, which may facilitate a desirable combination of biocompatibility, mechanical integrity, and wireless transmission transparency. In some embodiments, antenna 908 comprises one or more coils wound around a magnetic core 907 (e.g., a ferrite core), which may provide a desirable mechanism for data and / or power transmission.

[0096] The internal components of the device 900 include a substrate or other base material 991 onto which the sensor device 920 can be attached. The substrate 991 may be held in place by a certain spacer / structural component / material 945. For example, the spacer material 945 may include an epoxy, or the material is more solid, such as a polymer / plastic material. The spacer material 945 may provide structural integrity to the device 900 and may be utilized to hold, secure, and / or protect certain internal components of the device. Additionally, the internal spacer / structural component 945 may function to secure the shell 939 to the housing 970 and / or may help to retain the cylindrical form of such components under stress / pressure. In some examples, the spacer / structural component 945 includes a slug form configured to be placed / disposed within the housing 970 in a manner that allows for the placement of the shell 939 over the slug and housing 970.

[0097] The exemplary embodiment of sensor device 900 includes a dual diaphragm shell 939 as well as multiple (e.g., two) internal sensor elements 920, with a first sensor device 920a disposed behind a first diaphragm 955a and a second sensor device 920b disposed behind a second diaphragm 955b. Both sensor devices 920 may be attached to a substrate 991 or other structural component.

[0098] The diaphragm 955 is in communication with the internal fluid / medium 934 and transmits the deflection of the diaphragm to an increase in pressure and / or force within the fluid-filled chamber 952, thereby generating a pressure condition readable by the sensor device 920 that reflects the external pressure. In some embodiments, the shell 939 is sealed in an overlapping area 969 with the housing 970 to provide an airtight seal between such components. For example, the slug / body component 945 may be sealed against the inner diameter of the shell 939. Unlike certain other solutions, as described in detail above, only a single sealing area of ​​the sensor components may be necessary to provide a complete airtight seal of the assembled device 900. Such a seal may be between the shell 939 and the housing 970 in the overlapping area 969 of such components, as described above. The seal between the shell 939 and the housing 970 may be made in any suitable or desirable manner, such as through the use of certain materials curing at certain rates, through adhesive applications, brazing, and the like.

[0099] The diaphragm 955 may have any suitable or desirable shape or form, including a corrugated diaphragm as shown in Figures 9A-9C, a dimpled / depressed diaphragm as shown in the alternative embodiment shown in Figure 9D, a flat diaphragm (e.g., flat along the curvature of the cylindrical form of the shell 939, or diametrically flat across an arc segment of the cylindrical body 954). For example, the diaphragm may be formed of a layer of material deposited on and in a plane tangential to the circumference / perimeter of the cylinder, which is radially submerged within the outer diameter of the cylinder.

[0100] As mentioned above, the diaphragm 955 advantageously faces laterally. That is, the face / plane of the diaphragm 955 may face in a radially outward direction from the axis A2 of the sensor device 900 and the shell 939. The lateral orientation of the sensor diaphragm may allow for the implementation of a diaphragm with a relatively large area compared to a diaphragm limited to the axial end of the shell / sensor. For example, the area of ​​the end cap 956 may be limited by the diameter of the sensor / shell, but the area of ​​the side wall portion 954 of the shell 939 may correspond to an area larger than that of the end cap 956. Furthermore, the length of the shell 939 may be designed to any desired length suitable for accommodating a larger size diaphragm, and such length may be increased without requiring an increase in the diameter of the shell / sensor. Because the delivery catheter in which the sensor device 900 is transported may be elongated, an increase in the length dimension of the shell 939 may be less detrimental than a corresponding increase in the lateral end cap diameter, and thus the laterally facing diaphragm may be relatively large for a small profile sensor device.

[0101] Figures 10-1-10-3 provide a flow diagram illustrating a process 1000 for packaging a sensor device, according to one or more embodiments. Figures 11-1-11-3 provide images of pressure sensor packaging corresponding to the operation of the process of Figures 10-1-10-3, according to one or more embodiments.

[0102] At block 1002, the process 1000 involves forming or providing a sacrificial mandrel 990 for the formation of a sensor shell, as described in detail herein. For example, the sacrificial mandrel 990 shown in image 1102 of FIG. 11-1 may include a material configured to be selectively etched after deposition of the associated process material onto its outer surface. In some examples, the mandrel 990 may include stainless steel. The use of a conductive material may be desirable to facilitate the direction of deposition vapors in the vacuum chamber, which may depend on the implementation of an electrical potential between the source material and the mandrel substrate.

[0103] The mandrel 990 may be primarily cylindrical in shape and may be solid or hollow. An embodiment incorporating a hollow mandrel may be advantageous as it requires less sacrificial material etching / removal when deposition is complete. The mandrel 990 may include a dome shape and / or flat end cap portion 992. That is, while a hemispherical dome-shaped form is shown for the end cap portion 992 in image 1102, it should be understood that the end portion 992 may have any suitable or desired shape. Additionally, while the mandrel 990 is shown as having a cylindrical shape, in some implementations the mandrel (and the resulting sensor shell deposition) is rectangular or elliptical / oval in shape.

[0104] The 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 its surface, the deposition of material on such regions may generate a desired diaphragm shape / form for the sensor shell. 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, as shown in image 1103 of FIG. 11-1 with respect to the illustrated alternative mandrel 991. In the example of image 1103, the long axis Am of the diaphragm is parallel to the axis A3 of the shell. As shown from the cross-sectional side view of image 1101 of FIG. 11-1, the diaphragm 995 defined by the shape of the mandrel 990 may be recessed from the outer diameter OD of the cylinder to provide the diaphragm with protection from structural damage associated with the implant environment and / or manufacturing, delivery, and maintenance in vivo.

[0105] Although a three-dimensional mandrel configuration is shown and described in which the shell is formed by depositing a three-dimensional cylindrical form over a mandrel, it should be understood that embodiments of the present disclosure may perform a two-dimensional deposition of a sheet of material that is shaped and configured to form a three-dimensional shell from the deposited sheet of material after deposition. Thus, any embodiment disclosed herein may be understood to include a cylindrical sensor shell deposition, or a deposition of a sheet that is later formed into a sensor shell. However, forming a shell from a sheet of material introduces complications into the manufacturing process and may complicate sealing of the shell for biocompatibility purposes.

[0106] At block 1004, the process 1000 involves depositing one or more layers of material onto the mandrel 990. For example, such layers may be applied onto the outer surface of the 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 compatible with the deposition processes disclosed herein. For example, the deposited layer of material 937 may include nitinol, titanium, and / or other metals.

[0107] The operations associated with block 1004 may involve forming a shell of material over and / or at least a portion of the sacrificial mandrel 990 using physical vapor deposition. The target material may be applied to the mandrel 990 in one or more layers to create a relatively uniform deposition of material 937 over a surface of the mandrel 990, such as over substantially the entire surface thereof, with respect to one or more views or angles of the mandrel. In some implementations, an initial deposition of a layer of shell material is applied over the diaphragm portion 995, as well as the sidewall portion 996 and / or end portion 992 of the mandrel 990. The initial layer 937 of deposited material may be about 100 μm to 300 μm thick, such as about 150 μm to 250 μm thick, in some implementations. For example, in some implementations the thickness may be about 150 μm to 180 μm.

[0108] The particular deposition process performed may utilize sputtering or evaporation to generate vapor in the form of molecules or ions from the target source material. Such vapor may be transported and deposited on the outer surface of the sacrificial mandrel 990 to form the coating 937. The deposition process may continue until a desired thickness is achieved. In some implementations, planar magnetron physical vapor deposition is performed to deposit the layer 937 on the mandrel 990. Such a process may advantageously produce a relatively flat applied layer. Furthermore, an inverted cylindrical magnetron deposition process may advantageously allow deposition to occur on a three-dimensional cylindrical surface, similar to the mandrel 990 shown and described in connection with Figures 10 and 11. The deposition layer created by such a process may produce a relatively cleaner and more isotropic layer compared to a wrought form / material that is cut, machined, milled, or stamped into a shell form with a diaphragm as described herein.

[0109] At block 1006, the process 1000 may involve removing one or more layers of material in the area of ​​the diaphragm 955, completely removing the diaphragm portion 957 of the shell 939 formed from the initial deposition layer 937, or removing at least a portion of its thickness, to produce a relatively thin diaphragm deposition on the diaphragm portion 995 of the mandrel 990, or completely removing the deposition on the diaphragm portion 995 of the mandrel 990.

[0110] In some implementations, a femtosecond laser is utilized to planarize the diaphragm region 957 of the shell layer 937. Such planing may be performed in any suitable or desirable manner. For example, the diaphragm portion 957 of the shell layer 937 may be completely removed, thereby exposing the diaphragm portion 995 of the mandrel 990 underneath. Alternatively, in some implementations, only a portion of the thickness of the diaphragm portion 957 of the shell layer 937 may be removed, or selective areas or thicknesses of the deposited shell layer 937 may be removed, with certain areas of the diaphragm portion 957 being removed down to the substrate 990, while some deposited material is selectively left in the diaphragm region 957, thereby enabling / providing a relatively high degree of customization to the features of the final diaphragm component. The material removal associated with block 1006 may advantageously involve removing material along the contour / topology of the diaphragm portion 995 of the mandrel 990, whatever shape is implemented. The contour around the diaphragm 995 of the mandrel 990 may advantageously conform to minimum angular requirements for uniform deposition with the deposition process performed.

[0111] Ultimately, the formed sensor shell 939 will include a diaphragm 955 that is thinner than the sidewalls 937 of the shell 939. The deposited material properties also allow for relatively accurate high resolution laser milling and ablation, potentially allowing for sub-micron tolerances in the removed material.

[0112] In some implementations, the generated shell 939 with the removed / missing diaphragm portion, as shown in image 1106 of FIG. 11-2, may be generated in any suitable or desired manner. For example, a previously deposited layer 937 of the shell 939 on the diaphragm 995 may be removed or thinned, as described above. Alternatively, in some implementations, a masking structure or masking agent may be placed / applied over the diaphragm region 995 of the substrate 990 when the layer 937 of the shell 939 is first deposited. The mask may then be removed to expose the diaphragm portion 995 of the mandrel 990 to allow further deposition in such region.

[0113] In implementations where laser milling or other processes are performed to create the desired thickness of the diaphragm 955, the formation of the final shell 939 may be completed according to the operations associated with block 1006. In some implementations, laser milling may further be utilized to remove the deposited material in the area of ​​the open edge of the shell 939 to create a proximal edge 933 having a relatively clean axial line around the circumference of the mandrel 990.

[0114] In implementations in which the mandrel and shell 939 are removed from a vacuum deposition chamber for the purposes of laser etching or otherwise removing material in the region of the diaphragm 957 and deposition of an additional deposition layer onto the shell 939 is intended, such removal and / or replacement from / in the vacuum chamber may adversely affect adhesion between the first deposited layer 937 and any subsequently deposited layers. However, such detrimental effects may nevertheless be desirable as a means of achieving a monolithic diaphragm structure having a relatively thin diaphragm, as described in connection with the embodiments disclosed herein. The diaphragm region 957 may be selectively etched in a manner that avoids etching portions of the sidewalls and / or edge portions of the shell 939.

[0115] In some implementations, the process 1000 involves depositing one or more relatively thin layers over the shell 939 and diaphragm portion 995 of the mandrel 990 at block 1008 (e.g., in implementations in which the mandrel 995 is exposed in the diaphragm area).

[0116] The additional secondary layer 961 applied over the shell 939 and diaphragm 995 may be, for example, 10 μm to 50 μm thick. Such thickness 961 may combine 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 that may be 3% to 20% thicker than the combined layer 963 in the sidewall portion. The new deposited skin / layer 961 may include a relatively thin diaphragm 955 integrated with the thin layer 961 placed over the previously deposited shell 937 / 939 in the sidewall portion 964, the new / outer layer / skin 961 bonding to the outer surface of the shell 937 / 939 to form a single / integrated body for the shell 939. The material used for the second deposition 961 associated with block 1008 may advantageously be the same deposition material applied in the initial deposition process, which may improve adhesion and integration between the layers. The different layers of the stack may be bonded at a molecular level, thereby providing the desired integration. The diaphragm layer may be electrodeposited in some implementations. Furthermore, the surfaces of such stacks may be configured in some implementations to reduce tissue growth and adhesion thereon.

[0117] In some implementations, as an initial deposition operation / step, a thin layer is deposited on the mandrel 990, including on the area of ​​the diaphragm 995. After depositing such a thin layer on the diaphragm 995 and surrounding areas (e.g., end portion 992 and / or sidewall 996 portions), the diaphragm area 995 / 955 may be masked such that the thin diaphragm layer 955 is protected from further deposition / layering. Then, with the diaphragm 955 masked, an additional layer of deposition material may be deposited on the mandrel and / or the previously deposited thin layer of shell. Such additional deposition may be relatively thicker than the thin diaphragm layer, thereby producing the relatively thick shell 937. The masking may then be removed, thereby revealing the relatively thin diaphragm layer 955 integrated with the relatively thicker shell structure 937. The operations described in this paragraph may be implemented in whole or in part as an alternative to or in addition to the operations shown in FIG. 10-2, or as example implementations of the various layers shown in FIG. 10-2.

[0118] While some examples are disclosed in which the primary 937 and secondary 961 deposited layers comprise the same material (e.g., metal or metal alloy), in some implementations the shell 939 may be formed with primary deposits 937 and secondary deposits 961 comprising different materials, and such layers may include materials selected to improve or tailor 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 an inner layer 937 may be designed to provide a desired structural stiffness / strength to the shell 939. The deposited shell 939 provides a unique design having a lateral / radial diaphragm.

[0119] At block 1010, the process 1000 entails removing the sacrificial mandrel 990. For example, the mandrel substrate (e.g., stainless steel, copper, etc.) may be removed from the completed deposition shell / form 939 to leave a hollow shell. Once the inner mandrel is etched away, the complete final form of the shell 939 may be left with 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.

[0120] Once the mandrel 990 is etched away, a complete final shell form 939 is isolated, the shell 939 including a structural body configured for connection to a base component 970 of a sensor device housing as described herein. The shell 939 includes a thin layer 961 tailored to a diaphragm region 955 to provide a desired pressure transduction function, the diaphragm 955 being substantially integrated at a molecular level with the body 954 of the shell 939 without welding, brazing, or other bonding methods that, for reasons discussed above, may introduce undesirable complications and / or risk of error into the process.

[0121] Image 1110 of FIG. 11-3 shows the formed shell 939 with the sacrificial mandrel removed therefrom. As is evident in the cross-sectional view of image 1111, shell 939 is substantially hollow after removal of the mandrel. Cross-sectional image 1111 shows a relatively thicker body portion 954 integrated with a thinner diaphragm portion 955.

[0122] At block 1012, the process 1000 involves combining the formed shell 939 with a base sensor component 977, which includes a cylindrical (or other shaped) open partial 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 the base sensor assembly 977, the sensor device 900 may be fully assembled. In some implementations, a sealing or brazing process may be performed to secure and / or seal the shell 939 to the housing 970.

[0123] The base assembly 977 may be combined with the shell 939, and a plug or other structure 945 may be disposed at least partially within the base housing 970, such structural features configured to hold or secure certain electronic and / or other components within the sensor device 900 and / or otherwise provide structural support / integrity to the assembled device 900. The sensor device 900 shown in images 1112 and 1113 of FIG. 11-3 may have any of the features and / or characteristics of the sensor devices shown in FIGS. 9A-9D. For example, the sensor 900 of image 1113 may include a substrate or other substrate 991 held in place by structural components 945 and having a sensor device 920, such as a piezo-resistive and / or piezo-capacitive pressure sensor device, or a resistive or capacitive pressure sensor (e.g., a MEMS pressure sensor device), disposed on one or more sides thereof. Oil or other pressure transduction means / 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 deflection of the diaphragm 955 to increase pressure on the sensor device 920 and enable pressure sensing of the external environment. The oil or other medium 934 may be injected / placed in the interior chamber 952 in any suitable or desirable manner. For example, the structure 945 within the capsule 900 may include a fluid injection port that provides fluid access to the interior volume 952 around the sensor device 920. The diaphragm 955 may have the illustrated dimple / speaker type shape or form, or may be corrugated, or may have any other shape or form (e.g., flat / curved).

[0124] FIG. 12 illustrates an axial cross-sectional view of a sensor device 820 including three or more circumferentially distributed diaphragms 125 according to one or more embodiments. As described in detail above, various embodiments are disclosed herein including two circumferentially distributed diaphragms, the diaphragms being positioned on opposite sides of the circumference of a cylindrical sensor encapsulation shell such that the diaphragms are separated by approximately 180°. It should be understood that the embodiments disclosed herein may include three or more circumferentially distributed diaphragms. For example, the sensor device 820 of FIG. 12 includes three circumferentially distributed diaphragms 125 that are angularly separated by an angle θ. In some embodiments, the separation angle θ represents an even division of radians around the circumference of the shell 129. That is, for a three diaphragm embodiment, the angular separation θ may be equal to approximately 120°.

[0125] 12 includes three circumferentially distributed diaphragms, it should be understood that four or more circumferentially distributed diaphragms may be implemented. In some embodiments, four circumferentially distributed diaphragms are implemented in a common axial plane. In such embodiments, the separation angle θ between adjacent diaphragms may be approximately 90° such that the diaphragms are evenly distributed around the circumference of the cylindrical shell.

[0126] Embodiments including three or more circumferentially distributed diaphragms may include any number of internal sensor devices 122. For the embodiment of FIG. 12, the internal chamber 852 within the shell 129 may include two sensor devices 122a, 122b disposed on opposite sides of the substrate 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 shell 129. For example, for the particular embodiment of FIG. 12, the internal chamber 852 may include three sensor devices.

[0127] FIG. 13 illustrates a side view of a sensor device 130 with multiple axially distributed diaphragms, according to one or more embodiments. As described in detail above, various embodiments are disclosed herein with two or more diaphragms integrated with a sensor encapsulation shell, where 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) sensor device. In the embodiment of FIG. 13, the sensor device 130 includes multiple sets of axially offset diaphragms, where the diaphragms of each set are axially aligned with a separate axial plane. For example, the most distal set of diaphragms 135 may be aligned with each other about a first axial plane P1, while a second set of diaphragms 137 is positioned proximal to the first set 135 and is aligned about a second axial plane P2 that is axially offset proximally from the first plane P1. Although two diaphragms are shown in each axially offset set, it should be understood that any number of diaphragms, including one diaphragm, may be implemented at each axial location P1, P2. Additionally, although two sets of axially offset diaphragms are illustrated, it should be understood that a sensor device according to an embodiment of the present disclosure may include three or more sets of actually offset diaphragms. The diaphragms 135, 137 are integral with the shell 139 and may be formed using a deposition process that produces a single layer that includes the sidewall portion of the shell 139 as well as the diaphragms.

[0128] FIG. 14 illustrates a perspective view of a sensor device 140 having axially and / or circumferentially offset diaphragms according to one or more embodiments. In the embodiment of FIG. 14, a shell 149 includes multiple diaphragms 145, 147 axially offset from each other by a distance d, with a first diaphragm 145 centered on a first axial plane P1, while a second diaphragm 147 centered on a second axial plane P2 that is proximal to the more distal plane P1. Unlike the embodiment of FIG. 13, the axially offset diaphragms 145, 147 may at least partially axially overlap. Additionally, the diaphragms 145, 147 may be circular or elliptical / oval in shape, as in the illustrated embodiment. The diaphragms 145, 147 are further illustrated as being circumferentially offset by an angular offset θ with respect to the axis A5 of the device 140. The angular offset θ between the diaphragms 145, 147 may be approximately 180°, such that the diaphragms are on substantially opposite circumferential sides of the shell 149, or may be offset by an amount less than 180°, such that both diaphragms 145, 147 are at least partially disposed on a common diametric side of the shell 149, as in the illustrated embodiment of FIG.

[0129] FIG. 15-1 illustrates a perspective view of a sensor device 150 having an integral axial diaphragm 155, according to one or more embodiments. FIG. 15-2 illustrates a perspective view of another exemplary sensor device 160 having an integral axial diaphragm, according to one or more embodiments. The sensor devices 150, 160 of FIGS. 15-1 and 15-2 include shell portions / components 159, 169 formed in a deposition process according to an embodiment of the present disclosure, such as physical vapor deposition, or other sputtering techniques. The shells 159, 169 are formed in a deposition process to produce diaphragms 155, 165 integral with the sidewalls / bodies 154, 164 of the shells 159, 169. Unlike certain other embodiments disclosed herein, the integral diaphragm shells 159, 169 include axially facing diaphragms 155, 165 associated with the distal ends / portions of the respective shells 159, 169. The embodiments of Fig. 15-1 and Fig. 15-2 differ in that they include integral diaphragms having different structural configurations. For example, the diaphragm 155 of the device 150 may have a dimpled / speaker type configuration, while the diaphragm 165 of the device 160 may have a corrugated configuration including multiple concentric rings / corrugations, as described in detail herein. As with other embodiments disclosed herein, the shells 159, 169 may 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 may face radially or axially, depending on the particular design implemented.

[0130] A packaged sensor-embedded device according to one or more embodiments of the present disclosure may be advanced into an associated target cardiac chamber or blood vessel and / or vasculature using any suitable or desired procedure. For example, while access to various cardiac chambers / vessels of the heart is illustrated and described in connection with certain embodiments as via the right atrium and / or inferior vena cava, such as through a transfemoral or other transcatheter procedure, other access routes / methods may be implemented in accordance with embodiments of the present disclosure, as described / shown in connection with FIG. 16. For example, FIG. 16 illustrates various access routes through which access to the cardiac chambers may be achieved. Access to the left atrium or left ventricle may be achieved using transseptal access, which may be achieved from the right atrium 5, through the septal wall (not shown), into the left atrium 2, through the inferior vena cava 16 or superior vena cava 19, respectively, as shown. With regard to transaortic access 111c, a delivery catheter may pass through the descending aorta 32, the aortic arch 12, the ascending aorta, and the aortic valve 7, and through the mitral valve 6 into the left atrium 2. With regard to transapical access 111d, access may be through the apex 39 of the heart into the left ventricle 3 and directly through the mitral valve 6 into the left atrium 2. Other access routes are possible beyond those shown in Figure 16. The various transcatheter delivery systems and routes shown may involve transporting the sensor embedding device 1600 within the shaft / lumen of such an instrument and deploying the device 1600 from the delivery system at the target anatomical site.

[0131] Figures 17-1 through 17-4 provide flow diagrams illustrating a process for packaging a sensor device, according to one or more embodiments. Figures 18-1 through 18-7 provide images of pressure sensor packaging components corresponding to the operation of the process of Figures 17-1 through 17-4, according to one or more embodiments.

[0132] At block 1702, process 1700 involves forming or providing a sacrificial mandrel 690 for the formation of a sensor shell, as described in detail herein. For example, the sacrificial mandrel 690 shown in image 1802 of FIG. 18-1 may include a material configured to be selectively etched after deposition of the associated process material on its outer surface. In some examples, the mandrel 690 may include stainless steel. The use of a conductive material may be desirable to facilitate the direction of deposition vapors in the vacuum chamber, which may depend on the implementation of an electrical potential between the source material and the mandrel substrate.

[0133] The mandrel 690 may be primarily cylindrical in shape and may be solid or hollow. An embodiment incorporating a hollow mandrel may be advantageous as it requires less sacrificial material etching / removal when deposition is completed. The mandrel 690 may include a dome shape and / or flat end cap portion 692. That is, while a hemispherical dome-shaped form is shown for the end cap portion 692 in FIG. 18-1, it should be understood that the end portion 692 may have any suitable or desired shape. Additionally, while the mandrel 690 is shown as having a cylindrical shape, in some implementations the mandrel (and the resulting sensor shell deposition) is rectangular or elliptical / oval in shape.

[0134] Mandrel 690 can include diaphragm portions 695 having a shape / form that corresponds to a desired pressure diaphragm shape or form, such that when a conformal deposition is applied to its surface, the deposition of material on such areas can produce the desired diaphragm shape / form for the sensor shell. Although examples are disclosed herein in the context of sensor devices including substantially circular diaphragms, it should be understood that diaphragms of any shape may be implemented, including elliptical diaphragms.

[0135] Although a three-dimensional mandrel configuration is shown and described in which the shell is formed by depositing a three-dimensional cylindrical form over a mandrel, it should be understood that embodiments of the present disclosure may perform a two-dimensional deposition of a sheet of material that is shaped and configured to form a three-dimensional shell from the deposited sheet of material after deposition. Thus, any embodiment disclosed herein may be understood to include a cylindrical sensor shell deposition, or a deposition of a sheet that is later formed into a sensor shell. However, forming a shell from a sheet of material introduces complications into the manufacturing process and may complicate sealing of the shell for biocompatibility purposes.

[0136] At block 1704, the process 1700 involves depositing one or more layers 661 of material onto the mandrel 690. For example, such layer 661 may be applied onto an outer surface of the 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 compatible with the deposition processes disclosed herein. For example, the deposited layer of material 661 may include nitinol, titanium, and / or other metals.

[0137] The operations associated with block 1704 may involve forming a shell of material over and / or at least a portion of the sacrificial mandrel 690 using physical vapor deposition. The target material may be applied to the mandrel 690 in one or more layers to create a relatively uniform deposition of material 661 over the surface of the mandrel 690, such as across substantially the entire surface thereof, with respect to one or more views or angles of the mandrel. In some implementations, an initial deposition of a layer of shell material 661 is applied over the diaphragm portion 695 of the mandrel 690 to form the diaphragm layer 955, as well as the sidewall portion 696 and / or end portion 692. The initial layer 661 applied over the mandrel 690 may be relatively thin, such as, for example, 10 μm to 50 μm thick. FIG. 18-2 illustrates a thin shell layer 661 deposited on the mandrel 690.

[0138] The particular deposition process performed may utilize sputtering or evaporation to generate vapor in the form of molecules or ions from the target source material. Such vapor may be transported and deposited on the outer surface of the sacrificial mandrel 690 to form the coating 661. The deposition process may continue until a desired thickness is achieved. In some implementations, planar magnetron physical vapor deposition is performed to deposit the layer 661 on the mandrel 690. Such a process may advantageously produce a relatively flat applied layer. Additionally, an inverted cylindrical magnetron deposition process may advantageously allow deposition to occur on a three-dimensional cylindrical surface, similar to the mandrel 690 shown and described in connection with Figures 17 and 18. The deposition layer created by such a process may produce a relatively cleaner and more isotropic layer compared to a wrought form / material that is cut, machined, milled, or stamped into a shell form with a diaphragm as described herein.

[0139] At block 1706, process 1700 may involve masking areas of the deposited diaphragm 655 with any suitable or desired material to cover and protect the diaphragm layer 655 from subsequent deposition. The diaphragm mask / cover 657 may be placed / disposed over the diaphragm 655 using any type of application process known in the art or described herein. FIG. 18-3 shows the mask / cover 657 disposed over the diaphragm 655.

[0140] In implementations in which the mandrel 690 and shell 638 are removed from the vacuum deposition chamber for the purposes of masking material in the region of the diaphragm 655 and deposition of an additional deposition layer onto the shell 638 is intended, such removal and / or replacement from / in the vacuum chamber may adversely affect adhesion between the first deposited layer 661 and any subsequently deposited layers. However, such deleterious effects may nevertheless be desirable as a means of achieving a monolithic diaphragm structure having a relatively thin diaphragm, as described in connection with the embodiments disclosed herein. The diaphragm region 655 may be selectively masked in a manner that avoids the application of a subsequent layer onto the diaphragm layer 655.

[0141] The process 1700 further includes, at block 1708, depositing one or more relatively thick secondary layers 637 over the shell 638 and the diaphragm mask 657. The secondary layer 637 of deposited material may be about 170 μm to 300 μm thick, such as about 150 μm to 250 μm, in some implementations. For example, in some implementations, the thickness may be about 150 μm to 180 μm. Such thickness 637 may be combined with the thickness 661 of the end and sidewall portions to form the relatively thick 663 sidewall and end cap structure of the final shell 639 while producing a relatively thin diaphragm 655 that may be 3% to 20% thick of the combined layer 663 in the sidewall portion. A new deposited 637 may be placed over the thin layer 661 of the mask 657 and the sidewall portion 664, and the new / outer layer 637 may bond to the outer surface of the thinner shell 661 to form the single / integral body of the shell 639. The material used for the second deposition 637 associated with block 1708 may advantageously be the same deposition material applied in the initial deposition process, which may improve adhesion and integration between layers. The different layers of the deposition may be bonded at a molecular level, thereby providing the desired integration. Furthermore, the surface of such a deposition may be configured in some implementations to reduce tissue growth and adhesion thereon. Although some examples are disclosed in which the primary deposition layer 661 and the secondary deposition layer 637 include the same material (e.g., metal or metal alloy), in some implementations the shell 639 may be formed with the primary deposition 661 and the secondary deposition 637 including different materials, and such layers may include materials selected to improve or tune the mechanical properties of the shell 639. FIG. 18-4 shows a thick layer 637 deposited on the shell 611 (the outer region of the diaphragm) and the mask 657.

[0142] At block 1710, the process 1700 may involve removing the masking / mask 657, thereby revealing the relatively thin diaphragm layer 655 integrated with the relatively thicker shell structure 637. In some implementations, removal of the mask 657 may allow for further deposition in such areas. FIG. 18-5 shows the mask 657 being removed, exposing the thin layer diaphragm 655.

[0143] At block 1712, the process 1700 involves removing the sacrificial mandrel 690. For example, the mandrel substrate (e.g., stainless steel, copper, etc.) may be removed from the completed deposited shell / form 639 to leave a hollow shell. Once the inner mandrel is etched away, the complete final form of the shell 639 may be left with 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. FIG. 18-6 shows the separated shell 639 with the mandrel 690 removed.

[0144] The separated shell 639 includes a structural body configured for connection to a base component 670 of a sensor device housing as described herein. The shell 639 includes a thin layer 661 tailored to a diaphragm region 655 to provide a desired pressure transduction function, and the diaphragm 655 is substantially integrated at a molecular level with the body 654 of the shell 639 without welding, brazing, or other bonding methods that, for reasons discussed above, may introduce undesirable complications and / or risk of error into the process. The shell 639 is substantially hollow after removal of the mandrel 690.

[0145] At block 1712, the process 1700 involves combining the formed shell 639 with a base sensor component 677, which includes a cylindrical (or other shaped) open partial 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 the base sensor assembly 677, the sensor device 600 may be fully assembled. In some implementations, a sealing or brazing process may be performed to secure and / or seal the shell 639 to the housing 670.

[0146] A base assembly 677 may be combined with the shell 639, and a plug or other structure 645 may be disposed at least partially within the base housing 670, with such structural features configured to hold or secure certain electronic and / or other components within the sensor device 600 and / or otherwise provide structural support / integrity to the assembled device 600. The assembled sensor device 600 shown in Figures 18-7 may have any of the features and / or characteristics of the sensor devices shown in Figures 6A-9D.

[0147] Further description of the embodiment Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Additionally, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0148] Example 1: An implantable sensor device comprising a cylindrical housing, a deflectable diaphragm associated with a sidewall of the housing, a pressure sensor device contained within the housing, and a transduction medium disposed within the housing over at least a portion of the pressure sensor device.

[0149] Example 2: The implantable sensor device of any embodiment herein, especially example 1, wherein the diaphragm is integral with the housing.

[0150] Example 3: The implantable sensor device of any example herein, especially example 2, wherein the diaphragm is formed of a layer of deposited material extending across at least a portion of the sidewall of the housing.

[0151] Example 4: An implantable sensor device as described in any example herein, especially example 1, wherein the diaphragm is within a curved surface curved about an axis of the housing.

[0152] Example 5: An implantable sensor device as described in any example herein, particularly example 1, wherein the housing comprises a proximal base portion and a distal sensor encapsulating shell portion.

[0153] Example 6: An implantable sensor device as described in any of the examples herein, particularly Example 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.

[0154] Example 7: The implantable sensor device as described in any example herein, particularly example 1, wherein the diaphragm comprises a plurality of concentric corrugations.

[0155] Example 8: An implantable sensor device comprising a shell formed of a plurality of vacuum deposited metal layers and a diaphragm formed in one of the plurality of metal layers, said layer further forming a body of the shell.

[0156] Example 9: The implantable sensor device as described in any example herein, especially Example 8, wherein the shell has a silo shape including an end cap portion and a cylindrical sidewall portion.

[0157] Example 10: The implantable sensor device of any example herein, especially example 9, wherein the diaphragm faces transversely to the axis of the shell and is formed in a sidewall portion of the shell.

[0158] Example 11: The implantable sensor device of any example herein, especially example 9, wherein the diaphragm is one of a plurality of diaphragms formed in the sidewall portion of the shell.

[0159] Example 12: The implantable sensor device of any example herein, especially example 11, wherein the plurality of diaphragms comprises at least two circumferentially distributed diaphragms.

[0160] Example 13: An implantable sensor device as described in any of the examples herein, especially example 12, wherein two circumferentially distributed diaphragms are disposed on opposing circumferential sides of the sidewall portion.

[0161] Example 14: The implantable sensor device of any example herein, particularly example 11, wherein the plurality of diaphragms comprises at least two axially distributed diaphragms.

[0162] Example 15: An implantable sensor device as described in any embodiment herein, especially example 14, wherein the at least two axially distributed diaphragms are circumferentially aligned.

[0163] Example 16: The implantable sensor device of any example herein, especially example 11, wherein the plurality of diaphragms includes first and second radially opposing facing diaphragms.

[0164] Example 17: An implantable sensor device as described in any of the examples herein, particularly Example 16, further comprising a substrate substrate at least partially disposed within the shell, first and second pressure sensor devices attached to opposite sides of the substrate substrate, and a pressure transduction medium disposed between the first and second pressure sensor devices and the first and second diaphragms, respectively.

[0165] Example 18: The implantable sensor device of any example herein, especially example 8, wherein the diaphragm has an elliptical shape, the major axis of the elliptical shape being parallel to the axis of the shell.

[0166] Example 19: The implantable sensor device of any example herein, especially example 8, wherein the shell has a thickness at least three times that of the diaphragm.

[0167] Example 20: A method of manufacturing an implantable sensor device comprising: providing a mandrel form, the mandrel form including a 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 layers of material over at least a portion of the body portion of the mandrel form; and depositing an outer skin layer over the diaphragm portion and at least a portion of the sidewall portion exterior to the diaphragm portion to form a shell including an integral diaphragm.

[0168] Example 21: The method of any of the examples herein, especially example 20, further comprising removing a portion of the one or more base layers in the area of ​​the diaphragm portion prior to said depositing of the skin layer.

[0169] Example 22: The method of any of the examples herein, especially example 21, wherein said removing portions of one or more substrates is performed using a laser.

[0170] Example 23: The method of any of the examples herein, especially example 20, further comprising masking the diaphragm portion prior to said depositing one or more underlying layers of material.

[0171] Example 24: The method of any of the examples herein, especially Example 20, further comprising removing the mandrel form from the one or more base layers and the skin layer after said depositing the skin layer.

[0172] Example 25: The method of any of the examples herein, especially example 24, wherein said removing the mandrel form comprises dissolving the mandrel form using an etchant.

[0173] Example 26: The method of any of the examples herein, especially example 20, further comprising coupling the shell to a base housing having the antenna disposed therein.

[0174] Example 27: The method of any of the examples herein, especially example 20, further comprising injecting a pressure transduction medium into the shell around a pressure sensor device disposed within the shell.

[0175] Example 28: A method of manufacturing an implantable sensor device, the method comprising: providing a mandrel form, the mandrel form including a body portion including sidewall portions and end cap portions, and a lateral diaphragm on the sidewall portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more first layers of material over the lateral diaphragm portions and at least a portion of the body portion of the mandrel form to form a diaphragm integral with a shell body; placing a mask over the diaphragm; depositing one or more second layers of material over the masked diaphragm and at least a portion of the shell body to form an integral shell; and removing the mask from over the diaphragm.

[0176] Example 29: The method of any of the examples herein, especially Example 28, further comprising removing the mandrel form from the monolithic shell after said depositing of the one or more second layers of material.

[0177] Example 30: The method of any example herein, especially example 29, wherein said removing the mandrel form comprises dissolving the mandrel form using an etchant.

[0178] Example 31: The method of any of the examples herein, especially example 28, further comprising coupling the unitary shell to a base housing having the antenna disposed therein.

[0179] Example 32: The method of any of the examples herein, particularly example 28, further comprising injecting a pressure transduction medium into the one-piece shell around a pressure sensor device disposed within the one-piece shell.

[0180] Example 33: A method for manufacturing an integral flexible diaphragm, the method comprising: providing a mandrel form, the mandrel form including a body portion and a diaphragm; placing the mandrel form in a vacuum deposition chamber; depositing a plurality of base layers of material on at least a portion of the body portion of the mandrel form surrounding the diaphragm portion; and depositing an outer skin layer on the diaphragm portion and on the plurality of base layers deposited around the diaphragm portion to form an integral flexible diaphragm.

[0181] Example 34: The method of any of the examples herein, especially example 33, further comprising removing a portion of the plurality of base layers in the region of the diaphragm portion prior to said depositing of the skin layer.

[0182] Example 35: The method of any of the examples herein, especially example 34, wherein said removing portions of a plurality of substrates is performed using a laser.

[0183] Example 36: The method of any of the examples herein, especially example 33, further comprising masking the diaphragm portion with a sacrificial layer prior to said depositing multiple underlying layers of material.

[0184] Example 37: The method of any of the examples herein, especially Example 3, further comprising removing the mandrel form from the one or more base layers and the skin layer after said depositing the skin layer.

[0185] Example 38: The method of any example herein, especially example 37, wherein said removing the mandrel form involves dissolving the mandrel form using an etchant.

[0186] Example 39: The method of any of the examples herein, especially example 33, wherein the one-piece flexible diaphragm is flexible relative to the plurality of substrate layers.

[0187] Example 40: The method of any of the examples herein, especially example 33, wherein the integral flexible diaphragm has a thickness between 10 μm and 40 μm.

[0188] Example 41: The method of any of the examples herein, especially Example 33, wherein the integrated flexible diaphragm has a thickness of about 3% to 15% of the combined thickness of the outer skin layer and the multiple base layers.

[0189] Example 42: The method of any of the examples herein, especially example 33, wherein the integral flexible diaphragm comprises a plurality of corrugations.

[0190] Example 43: The method of any of the embodiments herein, particularly example 42, wherein the plurality of corrugated shapes comprises one or more concentric rings.

[0191] Example 44: The method of any example herein, especially Example 33, wherein the skin layer comprises multiple layers of material.

[0192] Example 45: The method of any example herein, especially example 33, wherein the skin layer comprises a superelastic nickel titanium material.

[0193] Example 46: The method of any of the examples herein, especially example 45, wherein the material of the plurality of substrates comprises superelastic nickel titanium.

[0194] Example 47: The method of any example herein, especially example 33, wherein the skin layer comprises a superelastic nickel titanium material.

[0195] Example 48: The method of any of the examples herein, especially example 33, wherein the portion of the mandrel-form body portion surrounding the diaphragm portion is planar.

[0196] Example 49: The method of any of the embodiments herein, especially example 33, wherein the portion of the mandrel-form body portion surrounding the diaphragm portion is curved.

[0197] Example 50: A method for manufacturing an integral flexible diaphragm, the method comprising: providing a mandrel form, the mandrel form including a body portion and a diaphragm portion; placing the mandrel form in a vacuum deposition chamber; depositing one or more first layers of material over the diaphragm portion and at least a portion of the body portion of the mandrel form surrounding the diaphragm portion to form an integral flexible diaphragm; placing a mask layer over the diaphragm; and depositing one or more second layers of material over the masked diaphragm and over at least a portion of the body portion of the mandrel form surrounding the diaphragm portion.

[0198] Example 51: The method of any example herein, especially example 50, further comprising masking the mandrel form with a sacrificial layer prior to said depositing of the one or more first layers of material.

[0199] Example 52: The method of any example herein, especially example 50, further comprising removing the mandrel form from the one or more first layers of material and the one or more second layers of material after said depositing of the one or more second layers of material.

[0200] Example 53: The method of any example herein, especially example 52, wherein said removing the mandrel form comprises dissolving the mandrel form or one or more layers thereof using an etchant.

[0201] Example 54: The method of any of the examples herein, especially example 50, wherein the integral flexible diaphragm is flexible relative to the one or more second layers of material.

[0202] Example 55: The method of any of the examples herein, especially example 50, wherein the one-piece flexible diaphragm has a thickness between 10 μm and 40 μm.

[0203] Example 56: The method of any example herein, especially example 50, wherein the one-piece flexible diaphragm has a thickness that is about 3% to 15% of the combined thickness of the one or more first layers of material and the one or more second layers of material.

[0204] Example 57: The method of any of the embodiments herein, especially example 50, wherein the integral flexible diaphragm comprises a plurality of corrugations.

[0205] Example 58: The method described in any of the embodiments herein, particularly example 57, wherein the plurality of corrugations comprises one or more concentric rings.

[0206] Example 59: The method of any of the examples herein, especially example 50, wherein the one-piece flexible diaphragm comprises a superelastic nickel titanium material.

[0207] The methods and structures disclosed herein for treating a patient also encompass similar methods and structures performed on or placed on a simulated patient, which are useful, for example, for training, for demonstration, for treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation may include a simulation of all or a portion of a patient, such as, for example, the entire body, a portion of the body (e.g., chest), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. The physical elements may be natural, including human or animal cadavers or portions thereof, synthetic, or any combination of natural and synthetic. The virtual elements may be entirely in computer or may be overlaid on one or more of the physical components. The virtual elements may be presented on any combination of screens, headsets, holographic, projection, loudspeakers, headphones, pressure transducers, temperature transducers, or presented using any combination of suitable technologies.

[0208] Any of the various systems, devices, equipment, etc. in this disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0209] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a differing order, may be added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0210] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain examples include certain features, elements, and / or steps, but other examples do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any manner required for one or more examples, or that one or more examples necessarily include logic for determining, with or without author input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular example. Terms such as "comprising," "including," "having," and the like, are synonymous and used in their ordinary sense and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," for example, when used to connect a list of elements, is used in its inclusive sense (and not its exclusive sense) so that the term "or" means one, some, or all of the elements in the list. Conjunctive language such as the phrase "at least one of X, Y, and Z" is understood with the context to be used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0211] In the above description of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein can be applied to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessarily required or essential to each embodiment. Thus, it is intended that the scope of the invention herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0212] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having a similar or identical name (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0213] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the illustrative examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0214] Spatially relative terms such as "outside," "inside," "upper," "lower," "bottom," "up," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as depicted in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0215] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like, are intended to encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. A cylindrical housing; a deflectable diaphragm associated with a sidewall of the housing; a pressure sensor device contained within the housing; a transduction medium 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 integral with the housing.

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

4. The implantable sensor device of claim 1 , wherein the diaphragm lies within a curved surface curved about an axis of the housing.

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

6. 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 of claims 1 to 4, wherein the diaphragm comprises a plurality of concentric corrugations.

8. a shell formed of a plurality of vacuum deposited metal layers; a diaphragm formed in one of the plurality of metal layers, the layer further forming a body of the shell.

9. The implantable sensor device of claim 8 , wherein the shell 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 to an axis of the shell and is formed in the sidewall portion of the shell.

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 shell.

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

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

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

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

16. The implantable sensor device of claim 11 , wherein the plurality of diaphragms includes first and second radially opposite facing diaphragms.

17. a substrate material at least partially disposed within the shell; first and second pressure sensor devices attached to opposite sides of the substrate material; 17. The implantable sensor device of claim 16, further comprising a pressure transduction medium disposed between said first and second pressure sensor devices and respective ones of said first and second diaphragms.

18. An implantable sensor device according to any of claims 8 to 17, wherein the diaphragm has an elliptical shape, the major axis of the elliptical shape being parallel to the axis of the shell.

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

20. 1. A method for manufacturing an implantable sensor device, comprising: providing a mandrel form, the mandrel form including a 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 layers of material over at least a portion of the mandrel-form body portion; and depositing an outer skin layer over the diaphragm portion and at least a portion of the sidewall portion exterior to the diaphragm portion to form a shell including an integral diaphragm.

21. 1. A method for manufacturing an implantable sensor device, comprising: providing a mandrel form, the mandrel form including a 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 layers of material over the lateral diaphragm portions and at least a portion of the mandrel-formed body portion to form a diaphragm integral with the shell body; placing a mask over the diaphragm; depositing one or more second layers of material over the masked diaphragm and at least a portion of the shell body to form an integral shell; and removing the mask from over the diaphragm.

Images