Shunt implantation device with over-channel sensor arm

Abstract

The sensor embedding device may include a shunt body forming a fluid conduit, a first anchor structure associated with a first axial end of the shunt body, a second anchor structure associated with a second axial end of the shunt body, and a first sensor device coupled to the first anchor structure, the first anchor structure configured to hold the first sensor device in a sensing position over a channel region of the fluid conduit.

Description

[Technical field]

[0001] [Related Applications] This application claims priority to U.S. Provisional Patent Application No. 63 / 161,385, filed March 15, 2021, and entitled “SHUNT IMPLANT DEVICES WITH OVER-CHANNEL SENSOR ARMS,” the complete disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates generally to the field of medical implantable devices.

[0003] Various medical procedures involve the placement of medical implant devices within cardiac anatomical structures. Certain physiological parameters associated with these anatomical structures, such as fluid pressure, can affect the health outlook of a patient. Summary of the Invention

[0004] Described herein are one or more methods and / or devices for facilitating monitoring of physiological parameters associated with particular chambers and / or blood vessels of the heart, such as the left atrium, using one or more sensor-embedded devices.

[0005] In some implementations, the present disclosure relates to a sensor implantation device comprising a shunt body forming a fluid conduit, a first anchor structure associated with a first axial end of the shunt body, a second anchor structure associated with a second axial end of the shunt body, and a first sensor device coupled to the first anchor structure, wherein the first anchor structure is configured to hold the first sensor device in a sensing position over a channel region of the fluid conduit.

[0006] In some embodiments, when in the sensing position, the first sensor device is aligned with the axis of the fluid conduit. For example, when in the sensing position, the first sensor device may be coaxial with the fluid conduit.

[0007] The first anchor structure may be wrapped around the body of the first sensor device.

[0008] The first anchor structure may comprise a first arm that extends from the shunt body across the channel region and holds the first sensor device. For example, the first anchor structure may further comprise a second arm that extends from the shunt body across the channel region and holds the first sensor device. In some embodiments, the first arm and the second arm emanate from opposite sides of the shunt body. For example, both the first arm and the second arm may be wrapped around a circumference of the body of the first sensor device.

[0009] In some embodiments, when the first sensor device is held in the sensing position, an axial blood flow gap exists between the first sensor device and the first axial end of the shunt body.

[0010] In some embodiments, the shunt body includes a helical wire form. For example, the first anchor structure may comprise a helical arm that is integral with the helical wire form of the shunt body. In some embodiments, the shunt body further comprises a covering disposed over at least a portion of the helical wire form.

[0011] The shunt body may further include a covering disposed within at least a portion of the helical wire form.

[0012] The sensor embedding device may further include a second sensor device coupled to a second anchor structure, the second anchor structure configured to hold the second sensor device over the channel region of the fluid conduit. For example, the sensor transducer of the first sensor device and the sensor transducer of the second sensor device may face in opposite directions. The first sensor device and the second sensor device are coaxial.

[0013] In some implementations, the present disclosure relates to a sensor embedding device that includes a coil wire form, the coil wire form being formed from a plurality of coil windings of the coil wire form in a deployed configuration, comprising a body portion having a first diameter, a first flange anchor portion emanating from a first axial end of the body portion and having a second diameter greater than the first diameter, a first sensor support arm emanating from the first flange portion and radially deflected across a channel region defined by the body portion, a distal portion of the first sensor support arm including a sensor retaining means for retaining a first sensor device, and a second flange anchor portion emanating from a second axial end of the body portion.

[0014] The sensor embedding device may further include a second sensor support arm emanating from the second flange portion and radially biased across the channel region.

[0015] In some embodiments, the sensor embedding device further comprises a second sensor support arm extending from the first flange portion and radially deflected across the channel region, a distal portion of the second sensor support arm being secured to the first sensor device.

[0016] In some embodiments, the first sensor support arm is axially biased relative to the axis of the body portion at an angle greater than an angle of deflection of the plurality of coil windings of the body portion.

[0017] The sensor retention means may include one or more coil windings.

[0018] The sensor retaining means may include a mechanical clip.

[0019] The sensor embedding device may further comprise a sealing means associated with the body portion. For example, the sealing means may include a fabric layer.

[0020] In some embodiments, the coil wire form includes a shape memory material configured to assume a deployed configuration when deployed from a delivery catheter For example, the coil wire form can be configured such that the body portion and the first flange anchor portion are compressed into a delivery configuration having a third diameter smaller than the first diameter.

[0021] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented 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. [Brief description of the drawings]

[0022] Various embodiments are depicted in the accompanying drawings for illustrative purposes and 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. [Figure 1] FIG. 1 shows an exemplary representation of a human heart in accordance with one or more embodiments. [Diagram 2] FIG. 2 shows an exemplary representation of a human heart in accordance with one or more embodiments. [Diagram 3] FIG. 3 illustrates example pressure waveforms associated with various heart chambers and blood vessels, in accordance with one or more embodiments. [Figure 4] FIG. 4 illustrates a graph showing left atrial pressure range. [Diagram 5] FIG. 5 is a block diagram illustrating a sensor embedding device according to one or more embodiments. [Figure 6] FIG. 6 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, in accordance with one or more embodiments. [Figure 7-1] FIG. 7-1 illustrates a side view of a sensor-embedded device according to one or more embodiments. [Figure 7-2] FIG. 7-2 illustrates a sensor assembly / device according to one or more embodiments. [Figure 8A] FIG. 8A shows an axial view of an embodiment of a shunt-type sensor implantation device according to one or more embodiments. [Figure 8B] FIG. 8B shows an axial view of an embodiment of a shunt-type sensor implantation device according to one or more embodiments. [Figure 9-1A] FIG. 9-1A shows exemplary channel regions associated with fluid conduits of each shunt body, according to one or more embodiments. [Figure 9-1B] FIG. 9-1B shows exemplary channel regions associated with fluid conduits of each shunt body according to one or more embodiments. [Figure 9-2] FIG. 9-2 shows exemplary channel regions associated with fluid conduits of each shunt body, according to one or more embodiments. [Figure 9-3A] FIG. 9-3A shows exemplary channel regions associated with fluid conduits of each shunt body, according to one or more embodiments. [Figure 9-3B] FIG. 9-3B shows exemplary channel regions associated with fluid conduits of each shunt body according to one or more embodiments. [Figure 10] FIG. 10 illustrates a sensor embedding device having a barrel cover associated therewith in accordance with one or more embodiments. [Figure 11A] FIG. 11A shows a side view of a sensor embedding device having a dual arm sensor holder according to one or more embodiments. [Figure 11B] FIG. 11B illustrates an axial view of a sensor embedding device having a dual arm sensor holder according to one or more embodiments. [Figure 12A] FIG. 12A illustrates a sensor implantation device implanted within a coronary sinus tissue wall, according to one or more embodiments. [Figure 12B] FIG. 12B illustrates a sensor implantation device implanted within the coronary sinus tissue wall, according to one or more embodiments. [Figure 13] FIG. 13 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the left atrium, in accordance with one or more embodiments. [Figure 14] FIG. 14 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the right atrium, in accordance with one or more embodiments. [Figure 15] FIG. 15 illustrates a dual sensor implant device implanted within a tissue wall, according to one or more embodiments. [Figure 16] FIG. 16 illustrates a dual sensor implant device implanted within a tissue wall, according to one or more embodiments. [Figure 17-1] FIG. 17-1 provides a flow diagram illustrating a process for embedding a sensor-embedded device, according to one or more embodiments. [Figure 17-2] FIG. 17-2 provides a flow diagram illustrating a process for embedding a sensor-embedded device according to one or more embodiments. [Figure 17-3] FIG. 17-3 provides a flow diagram illustrating a process for embedding a sensor-embedded device, according to one or more embodiments. [Figure 17-4] FIG. 17-4 provides a flow diagram illustrating a process for embedding a sensor-embedded device, according to one or more embodiments. [Figure 17-5] FIG. 17-5 provides a flow diagram illustrating a process for embedding a sensor-embedded device, according to one or more embodiments. [Figure 18-1] FIG. 18-1 provides images of cardiac anatomy and certain devices / systems corresponding to operations of the process of FIG. 17-1, in accordance with one or more embodiments. [Figure 18-2] FIG. 18-2 provides images of cardiac anatomy and certain devices / systems corresponding to operations of the process of FIG. 17-2, in accordance with one or more embodiments. [Figure 18-3]FIG. 18-3 provides images of cardiac anatomy and certain devices / systems corresponding to operations of the process of FIG. 17-3, in accordance with one or more embodiments. [Figure 18-4] FIG. 18-4 provides images of cardiac anatomy and certain devices / systems corresponding to operations of the process of FIG. 17-4, in accordance with one or more embodiments. [Figure 18-5] FIG. 18-5 provides images of cardiac anatomy and certain devices / systems corresponding to operations of the process of FIG. 17-5, in accordance with one or more embodiments. [Figure 19] FIG. 19 is a cutaway view of the human heart and associated vasculature showing a particular catheter access route for a pulmonary vein shunt procedure, in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0024] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments 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 embodiments 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 embodiment, 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 embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments 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.

[0025] 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 characteristics that may be similar in one or more respects. However, with respect to any of the embodiments 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 skilled in the art may be informed by the context as to the extent to which the use of common reference numbers may imply similarity between the referenced subject matter. The use of a particular reference number in the context of the description of a particular figure may be understood to relate to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number may be construed as sharing characteristics or being entirely independent of each other.

[0026] Certain standard anatomical terms of location are used herein to refer to animal, i.e., human, anatomical structures with respect to preferred embodiments. While certain spatially relative terms such as "outer," "inner," "upper," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," 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 is understood that the spatially relative terms are intended to encompass different orientations of the elements / structures during use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or beside such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa.

[0027] The present disclosure relates to systems, devices, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using a sensor-integrated cardiac shunt and / or other medical implant device. In some implementations, the present disclosure relates to cardiac shunts and / or other cardiac implant devices incorporating or associated with a pressure sensor or other sensor device. The term "associated with" is used herein according to its 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. Certain embodiments are disclosed herein in connection with cardiac implant devices. However, while certain principles disclosed herein are particularly applicable to cardiac anatomical structures, it should be understood that a sensor-implantation device according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure.

[0028] [Cardiac Physiology] The anatomical structure of the heart is described below to aid in the understanding of certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, the flow of which is at least partially controlled by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves can be configured to open and close in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to respective regions and / or vessels of the heart (e.g., the pulmonary artery, the aorta, etc.).

[0029] 1 and 2 respectively illustrate vertical / frontal and horizontal / superior cross-sectional views of an exemplary heart 1 with various features / anatomical structures relevant to certain embodiments of the present disclosure. Heart 1 includes four heart chambers, namely, left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. In terms of blood flow, generally, blood flows from the right ventricle 4 through pulmonary valve 9 to pulmonary artery 11, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood may be pumped towards the lungs and close during diastole to prevent blood from flowing back from pulmonary artery 11 into the heart. Pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.

[0030] 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 or 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 in the left atrium 2 to flow into the left ventricle 3, and close during systole to prevent backflow of blood into the left atrium 2, if functioning properly. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood exiting the left ventricle 3 to enter the aorta 12 and to close during diastole to prevent backflow of blood into the left ventricle 3.

[0031] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that the resulting increased blood pressure in the corresponding heart chamber when the heart contracts will at least partially open the leaflets and allow flow from the heart chamber. When the pressure in the heart chamber decreases, the pressure in the subsequent heart chamber or blood vessel may prevail and push back against the leaflets. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0032] Atrioventricular (i.e., mitral and tricuspid) heart valves further include 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. Papillary muscles may generally include, for example, finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae. A muscular wall called the septum separates the left and right heart chambers. In particular, interatrial septal wall portion 18 (referred to herein as the "atrial septum," "atrial septum," or "septum") separates the left atrium 2 from the right atrium 5, while interventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates the left ventricle 3 from the right ventricle 4. The inferior tip 14 of heart 1 is called the apex, and is generally located at or near the midclavicular line, in the fifth intercostal space.

[0033] The coronary sinus 16 comprises a collection of veins that combine to form a relatively large vessel that collects blood from the heart muscle (myocardium). The ostium of the coronary sinus 16, which may be at least partially protected in some patients by the Thebesian valve, opens into the right atrium 5 as shown. The coronary sinus runs along the posterior surface of the left atrium 2 and delivers less oxygenated blood to the right atrium 5. The coronary sinus generally runs transverse to the left atrioventricular groove at the posterior side of the heart.

[0034] [Health status associated with cardiac pressure and other parameters] As referenced above, certain physiological conditions or parameters associated with cardiac anatomy may affect the health of a patient. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, which causes an increase in fluid pressure in one or more heart chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. 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 stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the inefficiency of the heart by causing the body to retain fluid. The accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs causes the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and therefore, the treatment and / or prevention of congestive heart failure is of significant concern in medicine.

[0035] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As explained above, pressure buildup in one or more heart chambers or regions of the heart may be associated with congestive heart failure. 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. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve assessing or observing other current physiological conditions of the patient, such as assessing weight, thoracic impedance, right heart catheterization, etc. In some solutions, pulmonary capillary 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 therewith may be used as a surrogate for left atrial pressure. However, with regard to catheter-based pressure measurements in the pulmonary artery or certain other cardiac chambers or regions, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be inconvenient or difficult to implement. Furthermore, certain lung-related conditions may affect pressure readings in the pulmonary artery, resulting in undesirably weakened correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurements, pressure measurements in the right ventricular outflow tract may be similarly 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 the diagnosis, prevention, and / or treatment of congestive heart failure.

[0036] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of the function of the left ventricle of the heart, representing the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow in late diastole caused by atrial contraction (A wave), may be used as a proxy to measure left atrial pressure. The E / A ratio may be determined using echocardiography or other imaging techniques, and generally, abnormalities in the E / A ratio may suggest that the left ventricle is unable to properly fill with blood during the period between contractions, which may lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide a measurement of absolute pressure.

[0037] Various methods for identifying and / or treating congestive heart failure involve monitoring the worsening of congestive heart failure symptoms and / or changes in weight. However, such indications may appear to be relatively delayed and / or relatively unreliable. For example, daily weight measurements may vary significantly (e.g., up to 9% or more) and may be unreliable as an indication of heart-related complications. Furthermore, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. In addition, for discharged patients, such treatments may require telemedicine systems.

[0038] The present disclosure provides systems, devices, and methods for directing administration of medications associated with the treatment of congestive heart failure, at least in part, by directly monitoring pressure in the left atrium, or other chambers or vessels, whose pressure measurements are indicative of left atrial pressure and / or pressure levels in one or more other vessels / chambers, for example, to reduce re-hospitalizations, morbidity, and / or improve patient health outlook for patients with congestive heart failure.

[0039] [Cardiac Pressure Monitoring] Cardiac pressure monitoring according to embodiments of the present disclosure may provide a proactive intervention mechanism for preventing or treating congestive heart failure and / or other physiological conditions. In general, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur prior to the onset of symptoms that lead to hospitalization. For example, cardiac pressure indicators may appear for some patients several weeks prior to hospitalization. Thus, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce hospitalization cases by guiding appropriate or desired drug titration and / or administration prior to the onset of heart failure.

[0040] Dyspnea represents a cardiac pressure index characterized by shortness of breath or a feeling of not being able to breathe adequately. Dyspnea may be due to elevated atrial pressure, which may cause fluid accumulation in the lungs due to backflow of pressure. Pathological dyspnea may be due to congestive heart failure. However, significant time may elapse between the initial pressure rise and the onset of dyspnea, and thus symptoms of dyspnea may not provide sufficient early signaling of elevated atrial pressure. By directly monitoring pressure according to embodiments of the present disclosure, normal ventricular filling pressures can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0041] As referenced above, with respect to cardiac pressure, elevated left atrial pressure may be particularly correlated with heart failure. FIG. 3 shows examples of pressure waveforms associated with various cardiac chambers and vessels, according to one or more embodiments. The various waveforms shown in FIG. 3 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors to the respective illustrated and labeled cardiac chambers or vessels. As shown in FIG. 3, a waveform 125 representing left atrial pressure may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, in general, there may be a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0042] Left atrial pressure may generally correlate well with left ventricular end diastolic pressure. However, while 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, which affects approximately 25%-83% of heart failure patients, may affect the reliability of pulmonary artery pressure measurements to estimate left filling pressure. Thus, as represented by waveform 124, pulmonary artery pressure measurements alone may be an insufficient or inaccurate indicator of left ventricular end diastolic pressure, especially for patients with comorbid conditions 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 valve regurgitation.

[0043] Left atrial pressure readings may be less likely to be distorted or affected by other conditions, such as respiratory conditions, compared to the other pressure waveforms shown in Figure 3. In general, left atrial pressure may significantly predict heart failure, such as up to two weeks before the onset of heart failure. For example, increases in left atrial pressure, as well as both diastolic and systolic heart failure, may occur several weeks prior to hospitalization, and thus knowledge of such increases may be used to predict the onset of congestive heart failure, such as acute debilitating symptoms of congestive heart failure.

[0044] Cardiac pressure monitoring, such as left atrial pressure monitoring, may provide a mechanism to guide administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce re-hospitalizations and morbidity, as well as provide other benefits. An implantable pressure sensor according to an embodiment 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 heart failure prediction is recognized using an embodiment of a cardiac pressure sensor according to the present disclosure, certain preventative measures may be implemented, including drug interventions, such as modifications to a patient's drug regimen, that may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurements in the left atrium may advantageously provide an accurate indicator of pressure buildup that may lead to heart failure or other complications. For example, a trend in atrial pressure rise may be analyzed or used to determine or predict the onset of cardiac dysfunction, where drugs or other therapies may be augmented to provide a reduction in pressure and prevent or reduce further complications.

[0045] FIG. 4 generally illustrates a graph 300 showing left atrial pressure ranges including normal ranges 301 of left atrial pressure that are not associated with substantial risk of post-operative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of the present disclosure provide systems, devices, and methods for determining whether a patient's left atrial pressure is within the normal range 301, above the normal range 303, or below the normal range 302 through the use of certain sensor-embedded devices. With respect to a left atrial pressure detected above the normal range that may correlate with an increased risk of heart failure, embodiments of the present disclosure described in detail below may report efforts to reduce the left atrial pressure until it is within the normal range 301. Additionally, with respect to a left atrial pressure detected below the normal range 301 that may correlate with an increased risk of acute kidney injury, myocardial injury, and / or other health complications, embodiments of the present disclosure described in detail below may serve to facilitate efforts to increase the left atrial pressure to bring the pressure level within the normal range 301.

[0046] [Sensor embedded device] In some implementations, the present disclosure relates to a sensor associated with or integrated with a cardiac shunt or other implanted device. Such an integrated device may be used to provide controlled and / or more effective therapy for treating and preventing heart failure and / or other health complications related to cardiac function. FIG. 5 is a block diagram illustrating an implanted device 30 comprising a shunt (or other type of implanted) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 may be, for example, a pressure sensor, or other type of sensor. In some embodiments, the sensor 37 comprises a transducer 32, such as a pressure transducer, and a specific control circuit 34, which may be embodied, for example, in an application specific integrated circuit (ASIC).

[0047] The control circuitry 34 may be configured to process signals received from the transducer 32 and / or to wirelessly communicate signals associated with the transducer through biological tissue using the antenna 38. 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 containing one or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any device that manipulates signals (analog and / or digital) based on hard-coding of circuit and / or operational instructions. The control circuitry referred to herein may further comprise one or more storage devices, which may be embodied in a single memory device, multiple memory devices, and / or the device's embedded circuitry. Such data stores 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 embodiments in which the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage / registers that store any associated operating instructions may be incorporated within or external to the circuitry that includes the state machines, analog circuits, digital circuits, and / or logic circuits. The transducer 32 and / or antenna 38 may be considered part of the control circuitry 34.

[0048] The antenna 38 may include one or more coils or loops of conductive material, such as copper wire. 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 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 36 may, in some embodiments, include glass or other rigid material that may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may advantageously include a polymer or other flexible structure / material that may allow the sensor 37 to bend, flex, or collapse to enable transport through a catheter or other introduction means.

[0049] 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 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures the applied strain or deflection across its area / surface. The transducer 32 may be associated with the housing 36 such that at least a portion of the transducer 32 is contained within or attached to the housing 36. With respect to a sensor device / component "associated with" a stent or other implanted structure, such terms may refer to a sensor device or component that is physically coupled, attached, or connected to, or integrated with, the implanted structure.

[0050] In some embodiments, the transducer 32 includes or is a piezoresistive strain gauge component that may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, where resistance increases as pressure deforms the component / material. 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.

[0051] In some embodiments, the transducer 32 comprises or is a component of a capacitive pressure sensor including a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material including, but not limited to, metal, ceramic, silicon, and the like. In some embodiments, the transducer 32 comprises or is a component of an electromagnetic pressure sensor and may be configured to measure the displacement of the diaphragm by inductance changes, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 comprises or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials such as quartz.

[0052] In some embodiments, the transducer 32 includes or is a strain gauge component. For example, a strain gauge embodiment may include a pressure sensitive element on or associated with an exposed surface of the transducer 32. In some embodiments, a metal strain gauge may be glued to the surface 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.

[0053] 6 illustrates a system 40 for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) in a patient 44, according to one or more embodiments. The patient 44 may have a medical implant device 30 implanted, for example, in the heart (not shown) or associated physiology of the patient 44. For example, the implant device 30 may be at least partially implanted within the left atrium and / or coronary sinus of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as one or more micro-electromechanical system (MEMS) devices (e.g., MEMS pressure sensors, or other types of sensor transducers).

[0054] In certain embodiments, the monitoring system 40 may comprise at least two subsystems, including an implantable internal subsystem or device 30 including a sensor transducer 32, and a control circuit 34 including one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further comprise an external (e.g., non-implantable) subsystem including 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 embodiments, both the internal 30 and external 42 subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implant device 30 may be any type of implant device. For example, in some embodiments, the implant device 30 comprises a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or stent device / structure.

[0055] Specific details of the implantation device 30 are shown in the enlarged block 30 shown. The implantation device 30 may include an implantation / anchor structure 39 as described herein. For example, the implantation / anchor structure 39 may include a percutaneously deliverable shunt device configured to be anchored to and / or within a tissue wall to provide a flow path between two chambers and / or blood vessels of the heart, as described in detail throughout this disclosure. The implantation / anchor structure 39 may, in some embodiments, include a helical / coiled wire configuration, as disclosed in detail herein.

[0056] While certain components are illustrated in FIG. 6 as being part of the implanted device 30, it is understood that the sensor implanted device 30 may comprise only a subset of the components / modules shown and may comprise additional components / modules not shown. The implanted device may represent the embodiment of the implanted device shown in FIG. 5, or vice versa. The implanted device 30 may advantageously include one or more sensor transducers 32 and may be configured to provide a response indicative of one or more physiological parameters of the patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducer 32 may comprise any suitable or desired type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the implanted device 30 and / or the patient 44.

[0057] The sensor transducer 32 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, diaphragm-based sensors and / or other types of sensors that may be positioned within the patient 44 to sense one or more parameters related to the patient's health. The transducer 32 may be a force collector type pressure sensor. In some embodiments, the transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied across an area / surface thereof. The transducer 32 may be associated with the sensor housing 36 such that at least a portion of the transducer 32 is contained within or attached to the housing 36.

[0058] In some embodiments, the transducer 32 includes or is a strain gauge component that may be configured to use bonded or formed strain gauges to detect strain due to applied pressure. For example, the transducer 32 may include or be a piezoresistive strain gauge component, where the resistance increases as pressure deforms the strain gauge component / material. The transducer 32 may incorporate any type of material, including but not limited to silicon, polymer, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, sputtered thin film, and / or the like. In some embodiments, a metal strain gauge may be bonded to the sensor surface 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, resonant, thermal, ionization, or other types of strain or pressure sensors.

[0059] In some embodiments, the transducer 32 includes or is a component of a capacitive pressure sensor that includes a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicon, silicon, or other semiconductors. 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 the diaphragm by inductance changes, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0060] In some embodiments, the converter 32 is electrically and / or communicatively coupled to a control circuit 34, which may include one or more application specific integrated circuit (ASIC) microcontrollers or chips. The control circuit 34 may further include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, etc.

[0061] In certain embodiments, the sensor transducer 32 may be configured to generate an electrical signal that can be wirelessly transmitted to a device outside the patient's body, such as the illustrated local external monitor system 42. To effectuate such wireless data transmission, the implanted device 30 may include signal processing circuitry and radio frequency (RF) (or other frequency band) transmission circuitry, such as an antenna 38. The antenna 38 may include an antenna coil implanted within the patient. The control circuitry 34 may comprise any type of transceiver circuitry configured to transmit electromagnetic signals, which may be radiated by the antenna 38, which may include one or more conductive wires, coils, substrates, and the like. The control circuitry 34 of the implanted device 30 may comprise, for example, one or more chips or dies configured to perform some amount of processing on signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implanted device 30 may not include independent processing capabilities in some embodiments.

[0062] The wireless signals generated by implanted device 30 can be received by a local external monitoring device or subsystem 42, which can include a reader / antenna interface circuit module 43 configured to receive wireless signaling from implanted device 30 and is located at least partially within the patient 44. For example, module 43 can include a transceiver device / circuitry.

[0063] The external local monitor 42 may receive wireless signaling from the implanted device 30 and / or provide wireless power to the implanted device 30 using an external antenna 48, such as a wand device. The reader / antenna interface circuit 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 circuit 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 circuit 43 may further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, and the like, for handling / processing signals transmitted via the network 49 and / or for receiving signals from the implanted device 30. In certain 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 with network 49 according to known network protocols such as Ethernet, Wi-Fi, etc. In certain embodiments, local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0064] In certain embodiments, the embedded device 30 includes some amount 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 data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 42 or 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 communication of data generated by the sensor transducer 32, or other data associated therewith. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as, for example, from the local monitor 42 or from the remote monitor 46, 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.

[0065] 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 minimalist in nature. For example, high power driving voltages and / or currents within the implanted device 30 may adversely affect or interfere with the 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 can be wirelessly received from an external source by passive circuitry of the implanted device 30, e.g., through the use of short-range or near-field wireless power transfer, or other electromagnetic coupling mechanisms. For example, the local monitor 42 may act as an initiator that actively generates an RF field capable of powering the implanted device 30, thereby allowing the power circuitry of the implanted device to obtain a relatively simple form factor. In certain embodiments, the power source 35 may be configured to obtain energy from environmental sources, such as fluid flow, motion, etc. Additionally or alternatively, power source 35 may comprise a battery and may be advantageously configured to provide sufficient power as needed for the monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period).

[0066] 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 placed 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 poll the implanted device 30 to extract or request sensor-based information therefrom. In certain embodiments, the local monitor 42 includes a user interface that a user can utilize to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0067] 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 displaying and / or interacting with the monitored cardiac pressure data. In one embodiment, 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, and the local monitor 42 is designed primarily to receive / transmit signals to and / or from the implanted device 30 and provide such signals to the secondary local monitor 47 for display, processing, and / or manipulation. The external local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implanted device 30, such as, for example, a device ID, which may be provided from the implanted device 30 via a data link.

[0068] The remote monitoring subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitor data received over the network 49 from the local monitoring device 42, the secondary local monitor 47, and / or the implanted 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 embodiments disclosed herein describe communicating with the remote monitoring subsystem 46 indirectly from the implanted device via the local monitoring device 42, in certain embodiments, the implanted device 30 may be equipped with a transmitter capable of communicating with the remote monitoring subsystem 46 over the network 49 without the need to relay information through the local monitoring device 42.

[0069] In some embodiments, at least a portion of the transducer 32, control circuitry 34, power source 35, and / or antenna 38 are at least partially disposed or housed within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially sealed. For example, the housing 36 may, in some embodiments, comprise glass or other rigid material that may provide mechanical stability and / or protection to the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may advantageously comprise a polymer or other flexible structure / material that may allow the sensor 30 to bend, flex, or collapse to enable transport through a catheter or other percutaneous introduction means.

[0070] [Cardiac shunt implantation] As discussed above, shunts and other implanted devices / structures may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. A sensor device according to an embodiment of the present disclosure may be integrated with a cardiac shunt structure / device or other implanted device using any suitable or desired attachment or integration mechanism or configuration. FIG. 7-1 illustrates a side view of a sensor implantation device 70 according to one or more embodiments. FIG. 7-2 illustrates an example of a sensor assembly / device 60 that may be a component of a sensor implantation device such as the sensor implantation device 70 illustrated in FIG. 7-1. FIGS. 8A and 8B illustrate axial views of an embodiment of the shunt-type sensor implantation device 70 of FIG. 7-1 according to one or more embodiments.

[0071] The sensor implantation device 70 comprises a shunt structure 90, which may have a coil shape including structures formed into one or more coil windings, and one or more wires or other materials or structures forming a fluid conduit / barrel portion 98 and axial end flanges 94, 95. Although described herein as flanges, it should be understood that such features may be any type of anchor structure configured to secure the shunt structure / body in position within a tissue wall. The shunt structure 90 may represent an embodiment of a cardiac implant (e.g., anchor and / or cardiac implant structure 39 associated with FIG. 5 or FIG. 6) that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 90 is configured to hold a sensor device 60 configured to provide a sensor reading related to one or more physiological parameters associated with a target implantation site.

[0072] The sensor device 60 may be associated with either of the axial sides / ends of the shunt structure 90, with different axial sides / ends of the shunt structure 90 being exposed at opposing sides (S1, S2) of the tissue wall when the implantation device 70 is implanted in the tissue wall. As described herein, reference to an axial side of the shunt structure may refer to an opposing side of a plane P1 that axially (and / or diagonally) bisects the shunt structure 90 and / or its barrel portion 98. The plane P1 may be orthogonal to the axis of the barrel portion 98 of the shunt structure 90 and / or may be substantially parallel to (e.g., on / within) the tissue wall in which the shunt structure 90 is configured to be embedded. References herein to axial sides of the implant structure may be understood to refer to different sides of the tissue-engaging plane P1. The plane P1 may be aligned with at least a portion of the coil / winding 91 of the barrel / conduit portion 98 of the shunt structure 90 (e.g., within 5° or 10° of exact alignment).

[0073] Additionally, descriptions herein of sensor devices and / or sensor arms disposed on different radial sides of a shunt structure may refer to opposing sides of diametric plane P2, as shown in Figure 7-1. For example, if a shunt structure includes sensor arms on a given axial side of the shunt structure that emanate from substantially opposing circumferential portions of the barrel / conduit portion of the shunt structure and / or that project in substantially opposing radial directions relative to the axis of the barrel / conduit of the shunt structure, such arms may be considered to be on or emanate from different and / or opposing radial sides of the shunt structure.

[0074] The barrel portion 98 of the shunt structure 90 can advantageously be self-adjusting with respect to its axial length. For example, the shape / geometry of the helical wire coil allows the barrel 98 to expand axially, thereby introducing gaps between adjacent windings 91 of the coil barrel 98. Thus, the shunt structure 90 may be configured to be implanted into a range of anatomical structures and / or tissue walls having various characteristics and / or dimensions. In some embodiments, the barrel coil 98 is biased in an axially compressed configuration, as shown in FIG. 7-1, where adjacent windings of the coil are in contact with or relatively close to one another. The barrel portion 98 may be considered a body portion of the shunt structure 90.

[0075] The sensor device 60 may be advantageously arranged, positioned, secured, oriented, and / or otherwise located in a configuration in which its sensor transducer component 65 is disposed within the channel region 88 of the shunt structure 90. The term "channel region" is used herein in accordance with its broad and ordinary meaning and may refer to a three-dimensional space defined by the radial boundaries of a fluid conduit and extending axially from the fluid conduit. For example, with respect to a given fluid conduit structure, such as the fluid conduit / barrel structure 98 of the shunt structure 90, the channel region 88 associated therewith may be considered to be defined in accordance with any of the channel regions 88 shown and described in Figures 9-1A, 9-1B, 9-2, 9-3A, and 9-3B.

[0076] The shunt structure 90 may be a radially expandable shunt. When expanded, the central flow channel 96 of the shunt 90 may define a generally circular or elliptical opening. The channel 96 may be configured to hold the sides of the puncture opening to a tissue wall to form a blood flow path between a heart chamber or vessel (or other anatomical structure) separated by a tissue wall. For example, the shunt structure 90 may be configured to be embedded in a wall separating the coronary sinus and the left atrium. The central flow channel 96 may be formed in part by one or more windings 91 of the E. coli-shaped structure 90. In some embodiments, substantially the entire shunt 90 is formed by a superelastic wire (shape memory alloy, nitinol) that is configured to be compressed to fit into a catheter (not shown) and then expanded to return to a relaxed shape as shown in FIG. 7-1.

[0077] The shunt structure / frame 90 may have a helical shape in one or more portions thereof, including one or more distal and / or proximal curved arms on one or both ends of the frame 90, which may at least partially form the respective flanges 94, 95. The shape of the barrel 98 and / or flanges 94, 95 portions of the shunt structure / frame 90 may be pre-shaped to assume the deployed configuration of FIG. 7-1 when deployed from the delivery system / catheter. For example, the shunt structure wire form may be constrained or compressed for insertion into the delivery system / catheter, and such compression is substantially automatically reversed when the shunt structure 90 is deployed from the catheter / system.

[0078] Forming the shunt 90 using one or more elongated wires may serve to at least partially increase the flexibility of the shunt, thereby allowing for its compression and expansion at the implantation site. As discussed above, the coil-shaped shunt structure 90 may include a barrel / body portion 98 and one or more flange portions 94, 95. For example, in some embodiments, the barrel portion 98 may include one or more windings 91 of a coil having a diameter D1, the windings 91 defining a barrel or fluid conduit structure 98 through which fluid may be diverted according to aspects of the present disclosure. That is, the interior of the barrel 98 and / or coil windings 91 may define a fluid path / conduit. In some embodiments, such conduit 98 is substantially fluid-tight. For example, the windings 91 may be sufficiently sealed and compressed together in the deployed configuration shown in FIG. 7-1 to substantially prevent leakage of fluid (e.g., blood) through the barrel portion 98. In some embodiments, some amount of fluid leakage between the coil windings 91 is permitted in the implanted / deployed configuration. The diameter D1 of the shunt barrel 98 may have any suitable or desired dimension, such as, for example, about 20 mm or less, such as, for example, about 10 mm or less (e.g., 7.5 mm). In some embodiments, there may be a gap between the windings 91 of the barrel portion 98 of the shunt structure 90, between at least one adjacent pair of windings 91, and / or between the windings 91 of the barrel portion 98 and one or more of the adjacent flange portions 94, 95.

[0079] The coil windings 91 forming the central flow channel 96 advantageously provide a tube with sufficient rigidity and structure to hold tissue at the puncture site in an open position. A barrel portion 98 extends axially between distal 94 and proximal 95 flanges, or coils, on each side. For example, the flange portions 94, 95 of the coil form 90 may generally be associated with the proximal and distal axial ends, respectively, of the shunt structure 90. In some embodiments, the flange portions 94, 95 are configured to function as tissue anchors to hold and / or pinch the tissue wall therebetween and / or otherwise prevent axial movement of the shunt structure 90 or dislodgement of the shunt structure 90 from the tissue wall in which it is embedded. For example, one or both of the flanges 94, 95 may have a coil shape having a diameter D2 greater than the diameter D1 of the barrel 98 such that when the embedding structure 90 is sufficiently sealed and embedded within the tissue wall such that the barrel 98 occupies an area at least partially within / through the tissue wall, the expanded diameter D2 of the flanges prevents the barrel 98 and shunt structure 90 from passing through the open tissue in one or more directions. The flange diameter D2 may have any suitable or desirable dimension, such as, for example, about 40 mm or less, e.g., about 30 mm or less (e.g., 10 mm to 15 mm). Although both the proximal 95 and distal 94 flange portions are shown in FIG. 7-1 and described in connection with various embodiments disclosed herein, it should be understood that a sensor embedding device having an anchor flange according to aspects of the present disclosure may, in some embodiments, include a flange only at one axial end of the shunt structure. Although distal and proximal sides / portions of the shunt structure are described to some extent herein, it should be understood that an identified distal portion / side, as well as an identified proximal portion / side, may be an outlet or inlet side of the associated shunt structure. Additionally, the terms "distal" and "proximal" are used for convenience and may or may not refer to a relative orientation with respect to the associated sensor embedding device and / or delivery system / device used to implant the shunt structure.

[0080] While certain embodiments of the shunt structures disclosed herein include flow channels having a substantially circular cross-section, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond, or elliptical flow channel configurations. For example, one or more coils / windings 91 of FIG. 7-1, or other structural features of the shunt structure 90, may form oval, circular, oblong, and / or elliptical cylindrical fluid conduits. When reference is made herein to fluid conduits, cylinders, and / or barrel structures of and / or formed thereby, it should be understood that they may have any axial cross-sectional shape.

[0081] In some embodiments, each of the distal and proximal flanges / coils 94, 95 are configured to radiate outward in a helical manner from the circumference 87 of the barrel 98. Such helical flange coils / wires 94, 95 are aligned with the flange plane P in the expanded / deployed configuration shown in FIG. f The expanded flanges / coils 94, 95 may serve to anchor the shunt 90 to the target tissue wall. Although certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 7-1, it should be understood that a shunt structure or other implanted device integrated with pressure sensor functionality according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether as a shunt or other purpose or function.

[0082] The coil-shaped shunt 90 further includes one or more sensor arms 92, which may emanate from one or more flanges 94, 95. For example, where the shunt structure 90 comprises one or more coiled wires, such coil shapes may have one or more wire ends, which may generally be associated with either or both of the proximal 702 and distal 701 ends and / or associated flanges of the shunt structure 90. One or more of such wire end portions may be implemented as a sensor arm configured to support and hold a sensor device 60 for purposes of facilitating monitoring / sensing of a physiological parameter according to aspects of the present disclosure. With respect to the embodiment illustrated in FIG. 7-1, the sensor arm 92 may include an extension / base portion 75, which may generally extend over the channel region 88 of the barrel 98 of the shunt structure 90 to at least partially enable positioning of the sensor device 60, generally supported and / or held by the sensor arm 92, generally within the channel region 88.

[0083] In some embodiments, the sensor arm 92 is aligned with the tissue engaging plane P1 of the shunt structure 90 and / or the plane P of the flange 94 from which the arm 92 emanates at an amount / angle θ1. f 7-1 illustrates the sensor embedding device 70 in a configuration in which the sensor arm 92 is axially biased distally relative to the tissue engagement plane P1, it should be understood that embodiments of the present disclosure may be practiced without such axial bias. For example, the sensor arm 92 may be biased axially relative to the plane P1 of the flange 94 such that the deployed shunt structure retains the sensor 60 axially closer to the barrel 98 than in other embodiments having an axially biased sensor arm, as shown in FIG. f The ion exchange layer 20 may be located substantially within the ion exchange layer 20 .

[0084] The deflection of the sensor 60 and sensor arm 92 distal to the flange 94 may be important to provide a flow path for the fluid to be shunted around the sensor 60 and / or through the fluid conduit 98 of the shunt structure 90. For example, the sensor 92 may be deflected to provide an axial gap G between the sensor 60 and / or sensor retaining portion 93 of the shunt structure 90 and the flange 94 and / or the fluid conduit opening 96. The axial gap G can provide an area for blood or other fluid to flow around the sensor arm 92 and into the opening 96 of the fluid conduit 98. The angle θ1 may be determined by the angle θ1 between the extension portion 75 of the sensor arm 92 and the tissue engaging plane P1 and / or plane P2 of the flange 94. f or any desired angle between 90° and 90°. In some embodiments, the deflection angle θ1 is between about 30° and 60°, such as about 35°, 40°, or 45°. For embodiments in which the arm 92 is deflected by an angle greater than 90°, such implementations may position at least a portion of the sensor device 60 outside of the channel region 88. Thus, it may be desirable to implement a sensor arm deflection angle θ1 of less than 90° to maintain the sensor device 60 and / or its transducer component 65 within the channel region 88 of the shunt structure 90. Furthermore, by deflecting the sensor arm 92 to position the sensor 60 at or near the center of the flow channel 88 and / or the axis A1 of the fluid conduit 98, the fluid flow gap area can be maximized for a given gap distance G. For example, in such embodiments, a substantially equal amount of blood flow may be permitted from around the circumference 87 of the fluid conduit 98. In some embodiments, the arm 92 may be biased to position the sensor 60 and sensor arm 92 on one side or area of ​​the fluid conduit 98 to allow for a greater area or amount of fluid flow within a desired area of ​​the fluid conduit and / or from a desired direction.

[0085] Specifically, FIG. 8A shows an axial view corresponding to an axial side of the implantation device 70 associated with the sensor device 60. That is, the sensor component 65 is attached to, integrated with, or otherwise associated with the arm 92, with that side shown outwardly from the page in FIG. 8A. The side shown outwardly from the page in FIG. 8A may be the distal side or the proximal side. FIG. 8B shows an axial view corresponding to an axial side of the implantation device 70 opposite the sensor device 60. The side shown outwardly from the page in FIG. 8B may be the distal side or the proximal side.

[0086] As shown in FIGURE 8A, the sensor arm 92 may be radially deflected inward by an amount θ2 relative to a tangent 801 to the flange coil 94 at the base of the extension portion 75 of the arm 92, and such radial deflection may serve to position the sensor 60 at least partially within the channel region 88. For example, if the sensor arm 92 were not radially deflected inward as in FIGURE 8A, the sensor arm 92 would at least partially retain the sensor 60 in an area at or near the outer periphery 89 of the flange 94, and possibly radially outward of the channel region 88. As shown in FIGURES 8A and 8B, by radially deflecting the arm 92, the sensor arm 92 may protrude from the outer periphery 89 of the flange 94 into an area within the channel region 88 of the barrel 98. In some embodiments, the sensor arm 92 is radially deflected by an amount sufficient to place the sensor 60 in substantially coaxial alignment with the axis A1 of the barrel 98, although such coaxial alignment with the barrel 98 is not required and embodiments of the present disclosure may be configured such that the sensor device 60 is supported at a position within the channel region 88 but at least partially off-axis relative to the barrel 98.

[0087] The sensor arm 92 may further include a sensor retaining portion 93, which may comprise one or more wraps / windings 99 of the coil arm 92 in a relatively tightly wound configuration around the body / housing 69 of the sensor device 60, thereby at least partially restraining / retaining the sensor device 60 and holding the sensor device 60 in a desired sensing position. It may be desirable for the coil winding 99 within the retaining portion 93 of the sensor arm 92 to be sufficiently sealed and / or secured to reduce the risk of dislodgement / escape of the sensor device 60 in the presence of fluid flow and / or other fluid conditions (e.g., pressure) within the implantation environment. Although FIG. 7-1 illustrates the sensor retaining portion 93 of the sensor arm 92 as including a coil-shaped winding 99 wound around the body 69 of the sensor 60, it should be understood that the sensor device 60 may be coupled to the sensor arm 92 in any suitable or desirable manner. The sensor device 60 may be secured to the anchor arm 94 using any suitable means or mechanism. For example, a fastening / attachment means / mechanism that may be suitable for attaching the sensor device 60 to the sensor arm of the shunt structure 90 may be any of the mechanisms disclosed in PCT Application No. PCT / US20 / 56746, entitled "Sensor Integration in Cardiac Implant Devices," filed October 22, 2020, the contents of which are expressly incorporated herein by reference in their entirety. For example, the shunt structure 90 and / or its sensor arm may include one or more sensor retaining fingers, clamps, wraps, bands, belts, clips, pouches, housings, enclosures, and / or the like configured to secure the sensor device 60 to another structural feature of the arm and / or shunt structure 90. For example, one or more clips, hooks, adhesives, or other attachment features may be associated with the sensor retaining portion 93 of the sensor arm 92, such features configured to secure the sensor 60 to the sensor arm 92.

[0088] In some embodiments, the sensor-carrying portion 93 of the sensor arm 92 includes multiple coil turns 99 separated by gaps 71. A bridge wire portion 97 may connect between the coils 99 that span the gaps 71. In some embodiments, no such gaps exist between adjacent sensor-carrying coil turns 99.

[0089] Referring to FIG. 7-2, which shows a detailed view of an exemplary embodiment of a sensor device 60 that may be associated with any of the sensor embedding devices disclosed herein, such as the sensor embedding device 70 shown in FIGS. 7-1, 8A, and 8B, in some embodiments, the sensor device / assembly 60 includes a sensor transducer component 65 and an antenna component 61. The sensor transducer component 65 may include any type of sensor transducer as detailed above. In some embodiments, the sensor device 60 may be attached to or integrated with an arm member 92 of a shunt structure 90, as shown in FIGS. 7-1, 8A, and 8B.

[0090] The sensor transducer component 65 includes a sensor element 67, such as a pressure sensor transducer / membrane. As described herein, the sensor device 60 may be configured to implement wireless data and / or power transfer. The sensor device 60 may include an antenna component 61 for such purposes. The antenna 61, as well as one or more other components of the sensor device 60, may be at least partially contained within a sensor housing 69, which may further include certain control circuitry 62 disposed therein configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna component 61 includes one or more conductive coils / windings 67 that may facilitate inductive powering and / or data transmission. In embodiments including conductive coils, such coils may be at least partially wrapped / disposed around a magnetic (e.g., ferrite, iron) core 79.

[0091] The sensor device 60 may advantageously be biocompatible. For example, the housing 69 may advantageously be biocompatible, such as a housing including glass or other biocompatible material. However, at least a portion of the sensor transducer element / membrane 67, such as a diaphragm or other component, may be exposed to the external environment in some embodiments to allow pressure readings or other parameter sensing to be implemented. The housing 69 may include an at least partially rigid cylindrical or tubular form, such as a glass cylinder form. In some embodiments, the sensor transducer components 65 / 67 are about 3 mm or less in diameter. The antenna 61 may be about 20 mm or less in length.

[0092] The sensor device 60 may be configured to communicate with an external system when implanted in the heart or other region of the patient's body. For example, the antenna 61 may wirelessly receive power from and / or communicate sensed data or waveforms to and / or from the external system. The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include an at least partially flexible or compressible diaphragm component that may be made from silicon or other flexible material. The diaphragm component may be configured to bend or compress in response to changes in environmental pressure. The control circuitry 62 may be configured to process the generated signal in response to the bending / compression to provide a pressure reading. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride). The diaphragm components and / or other components of the pressure transducer 67 may advantageously be fused or otherwise sealed to / with the housing 69 of the sensor device 60 to provide an airtight seal of at least a portion of the sensor components.

[0093] The control circuitry 62 may include one or more electronic application specific integrated circuit (ASIC) chips or dies that may be programmed and / or customized or configured to perform the monitoring functions described herein and / or facilitate wireless transmission of the sensor signal. The antenna 61 may include a ferrite core 79 wrapped with a conductive material in the form of multiple coils / windings 63 (e.g., wire coils). In some embodiments, the coils / windings include copper or other metals. The antenna 61 may be advantageously configured with a coil geometry that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementations, the sensor implantation device 70 may be delivered to the target implantation site using a delivery catheter (not shown), which includes a cavity or channel configured to accommodate advancement of the sensor device 60 therethrough.

[0094] As mentioned above, some embodiments of the present disclosure include a shunt structure having a sensor arm configured to hold a sensor in a channel region of the shunt structure, which can advantageously facilitate sensing of fluid dynamics associated with fluid flow through the shunt structure. Figures 9-1A, 9-1B, 9-2, 9-3A, and 9-3B show exemplary channel regions 88 associated with fluid conduits 98 of a respective shunt body, according to one or more embodiments. In particular, Figures 9-1A, 9-2, and 9-3A show side views of the fluid conduits and associated channel regions, while Figures 9-1B and 9-3B show axial and / or top-down views of the respective fluid conduits and channel regions.

[0095] 9-1A and 9-1B show an exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1. For example, as described above, the tissue plane P1 may generally represent a plane lying within or parallel to a tissue wall in which the fluid conduit 98 is configured to be implanted / placed. For example, the fluid conduit 98 may represent a conduit structure (e.g., formed of multiple windings in a coiled wire form) of a shunt implantation device described herein. In certain embodiments of FIG. 9-1A and 9-1B, the fluid conduit 98 has an axis A1 that is approximately orthogonal, perpendicular, and / or normal to the tissue plane P1. In such embodiments / configurations, the channel region 88 associated with the fluid conduit 98 may be considered to be a three-dimensional projection / extension of the area of ​​the fluid conduit around the axis A1 and surrounded by the walls 93, as shown. Thus, the channel region 88 may be a three-dimensional region bounded by a cylinder having the same axial cross-sectional area as the fluid conduit 98 and disposed about the axis A1 of the fluid conduit 98. The sensor transducer disposed within the channel region 88 of the fluid conduit 98 shown in FIGS. 9-1A and 9-1B may be considered to be disposed within a region defined by the radial boundary of the fluid conduit 98 about the axis A1 of the fluid conduit 98. Additionally, the sensor transducer may be disposed within a region of the channel region 88 axially outboard of the fluid conduit structure 98, similar to the illustrated sensor embedding device 70 shown in FIG. 7-1, with the sensor transducer 65 disposed within the channel region 88 axially outboard of the shunt barrel structure 98.

[0096] 9-2 illustrates another exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1, which may be defined / indicated in the manner detailed above. The fluid conduit 98 of the embodiment of FIG. 9-2 may be configured to be embedded within a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the fluid conduit 98 is angled relative to the tissue plane P1 (i.e., the axis A1 of the conduit 98 is not perpendicular, orthogonal, or normal to the tissue plane P1). That is, the fluid conduit 98 may be an inclined cylinder, as shown. Thus, in some embodiments, as shown in FIG. 9-2, for an inclined / angled fluid conduit 98, the associated channel region 88 may be considered a three-dimensional region defined by the radial boundaries of the fluid conduit 98 about a fluid conduit axis A1 that extends axially away from the fluid conduit 98 in one or more directions, such that the boundaries of the channel region 88 are defined by a cylinder having an axis that is angled relative to the tissue plane P1, as shown.

[0097] 9-3A and 9-3B show another exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1, which may be defined / labeled in the manner detailed above. The fluid conduit 98 of the embodiment of FIG. 9-3A and 9-3B may be configured to be embedded in a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the conduit 98 is angled relative to the tissue plane P1 (i.e., the axis A1 of the conduit 98 is not perpendicular, orthogonal, or normal to the tissue plane P1). However, it may be desirable to identify the channel region 88 associated with the fluid conduit 98 as being a channel region having an axis A2 that is parallel, orthogonal, and / or normal to the plane P1, as shown (with respect to FIGS. 9-1A, 9-1B, 9-2, 9-3A, and 9-3B, A1 represents the axis of the respective fluid conduit and A2 represents the axis (or axes) of the channel region 88 of the fluid conduit, and in some cases A1 and A2 may be the same). Thus, the channel region 88 in FIGS. 9-3A and 9-3B may not be coaxial with the conduit 98, but rather may be defined on one end by the radial boundary of the opening 96 of the conduit 98, from which the channel region 88 extends in an orientation / direction that is perpendicular, orthogonal, and / or normal to the plane P1, as shown in FIGS. 9-3A and 9-3B. 9-3A and 9-3B may correspond to the primary orientation / path of a true flow channel of fluid that may flow through the fluid conduit 98 when the conduit 98 is embedded in a tissue wall between two vessels / chambers. That is, fluid may flow within the opening 96 of the fluid conduit 98, in some cases, primarily in a direction perpendicular to the tissue plane P1.

[0098] 10 illustrates a sensor embedding device 170 having a barrel cover 150 associated therewith, according to one or more embodiments. The sensor embedding device 170 may be similar in certain respects to any of the sensor embedding device embodiments disclosed herein. For example, the sensor embedding device 170 may include a barrel portion 198 and one or more flange portions 194, 195, such portions of the embedding device 170 formed from respective coil windings of a coil / wire form shunt structure 190.

[0099] As referenced, the sensor embedding device 170 includes a seal or cover 150, which may include any suitable or desired material and / or structure / shape, such as fabric / cloth, polymer, mesh, etc., formed of any type of material. The cover 150 may be disposed over one or more portions or regions of the shunt structure 190. For example, as shown in FIG. 10, the cover 150 may be disposed over and / or within a barrel portion 198 of the shunt structure 190. Although the cover 150 is illustrated as disposed around the outside of the barrel 198, it should be understood that embodiments of the present disclosure may include a cover disposed within the barrel portion of the shunt structure.

[0100] In some embodiments, the cover 150 is at least partially fluid-tight such that when implanted, the cover 150 serves to prevent or reduce fluid leakage from outside the implanted device 170. Additionally, in some embodiments, the cover 150 may be configured to promote or encourage tissue ingrowth between the implanted device 170 and the surrounding tissue of the tissue wall in which the implanted device 170 is implanted. Although illustrated as a cover / skirt type structure, the cover 150 may in some implementations be a coating or other application to the wireform shunt structure 190 (e.g., barrel 198). The cover 150 is advantageously biocompatible allowing for long-term maintenance of the implanted device 170 in the implanted position.

[0101] 11A and 11B respectively show side and axial views of a sensor embedding device 50 having a dual-arm sensor holder according to one or more embodiments. The sensor embedding device 50 may be similar in certain respects to the sensor embedding device 70 shown in FIG. 7-1 and described in detail above. For example, the sensor embedding device 50 of FIGS. 11A and 11B may include one or more wire forms formed within the barrel portion 28 and the distal 24 and / or proximal 25 flange portions. Additionally, the embedding device 50 may include a sensor arm 22 including a base or extension portion 76 and a sensor holding portion 23. The arm 22 may emanate from the distal flange 24 and / or the helical wire 24a associated therewith, as described above with respect to FIG. 7-1.

[0102] The sensor implantation device 50 may further include a second sensor arm 27 that may be configured to at least partially secure and / or retain the sensor device 60, such as in the region of the sensor retaining portion 23 of the sensor arm 22, 27. In some embodiments, the second sensor arm 27 may be similar to the first sensor arm 22 and may emanate from an opposing side and / or circumferential region of the flange 24 and / or shunt structure 20, which may advantageously provide a desired degree of stability for sensor retention. For example, in single-arm embodiments such as those shown in FIG. 7-1, such sensor arms may be prone to post-implantation arm deflection caused by certain fluid dynamics (e.g., flow, pressure, etc.) at the implantation site, which may affect sensor readings and / or compromise the structural integrity of the shunt structure. Thus, embodiments having multiple sensor arms, such as those shown in FIGS. 11A and 11B, may provide increased stability. Such embodiments may prevent and / or reduce post-implantation movement or deflection of the sensor 60 and / or associated support arms.

[0103] In some embodiments, the second sensor arm 27 may have a radial deflection θ3 similar to the deflection θ2 of the first sensor arm 22. Although two arms 22, 27 are shown in Figures 11A and 11B, it should be understood that embodiments of the present disclosure may have any suitable or desirable number of sensor arms, including three arms, four arms, or more.

[0104] In some embodiments, the shunt structure 20 and / or the sensor arms 22, 27 are formed from multiple / separate wires, rather than a single common wire, as is the case in certain other embodiments. For example, the shunt structure 20 may be constructed from at least two separate wires that may be coiled / wound together to provide the shunt structure 20. In some such embodiments, both / all wires may traverse the barrel portion 28 and each may have an end on each axial side of the shunt structure 20. In some embodiments, the two separate wires of the shunt structure 20 may be helical in the same direction (e.g., winding both clockwise and counterclockwise in a given axial direction) or may be wound / coiled in opposite directions.

[0105] In some embodiments, the two sensor arms 22, 27 are associated with opposing ends of the same wire. For example, such a wire may be wrapped around the sensor 60 in the sensor-holding portion 23 of the sensor arm 22, traverse the distal flange 24, the barrel 28, the proximal flange 25, and back, and terminate at the sensor-holding region / portion 23 at the end of the sensor arm 27. In some embodiments, the end of the wire is not in the region of the sensor arms 22, 27 (e.g., not in the sensor-holding region / portion 23), but rather in another region of the shunt structure 20, such as at or near the proximal flange 25. For example, the wire may start at the proximal end / flange 25, traverse through the barrel 98, the flange 24, and the sensor arm 22 to the sensor-holding portion 23, where the wire is wrapped around the sensor 60 in the sensor-holding region 23, travels / traverses proximally back through the sensor arm 27, the flange 24, and the barrel 28 to the proximal end 25. Of course, the shunt structure 20 may include any number of wires that may be wound to form the proximal flange 25, barrel 28, distal flange 24, and sensor arms 22, 27, including the sensor retention configuration / structure 23, in any suitable or desirable manner.

[0106] In some implementations, a shunt device / structure according to embodiments of the present disclosure may be implanted in the wall separating the coronary sinus and the left atrium, such that an inter-atrial shunt may be achieved through the coronary sinus. Figures 12A and 12B show a shunt-type sensor implantation device 80 implanted in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. Figure 12, and several following figures, show a cross-section of the heart in an all-encompassing top-down perspective with the posterior surface oriented at the top of the page.

[0107] In some cases, a left-to-right shunt through implantation of a shunt device 80 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferred over a shunt through the interatrial septum 18. For example, a shunt through the coronary sinus 16 may provide a reduced risk of thrombus and emboli. In general, the coronary sinus may be less likely to have the presence of thrombi / emboli for several reasons. First, the drainage of blood from the coronary vasculature into the right atrium 5 has just passed through the capillaries and is essentially filtered blood. Second, the ostium 14 of the coronary sinus in the right atrium is often partially covered by a false valve (not shown) called the Thebesius valve. The Thebesius valve is not always present, but several studies indicate that it is present in most hearts and may block entry of thrombi or other emboli in the event of a spike in right atrial pressure. Third, the pressure gradient between the coronary sinus through which it exits and the right atrium is generally relatively low, so that a thrombus or other embolus in the right atrium is likely to remain there. Fourth, in the event that a thrombus / embolus enters the coronary sinus, there will typically be a much larger gradient between the right atrium and the coronary vasculature than between the right atrium and the left atrium. Presumably, the thrombus / embolus will travel further down the coronary vasculature until right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0108] Some additional advantages of placing the sensor implantation device 80 in the wall between the left atrium and the coronary sinus relate to the consideration that such an anatomical structure is generally more stable than the atrial septal tissue. By shunting left atrial blood to the coronary sinus, sinus pressure may be increased by a small amount. This may cause blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygen transfer, which may be more efficient and may help the dying myocardium recover. Furthermore, by implanting the shunt device / structure 83 in the wall of the coronary sinus, damage to the atrial septum 18 may be prevented. Thus, the atrial septum 18 may be preserved for later transseptal access for other therapies. Preservation of transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have several other comorbidities, such as atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions require transseptal access.

[0109] It should be noted that in addition to the various advantages of placing the sensor implantation device 80 between the coronary sinus 16 and the left atrium 2, certain disadvantages may be considered. For example, by shunting blood from the left atrium 2 to the coronary sinus 16, oxygenated blood from the left atrium 2 may pass to the right atrium 5 and / or deoxygenated blood from the right atrium 5 may pass to the left atrium 2, both of which may be undesirable with respect to proper functioning of the heart.

[0110] 12A and 12B, the coronary sinus 16 is generally continuous around the left atrium 2, and therefore, there are a variety of possible acceptable placements for the implanted device 80. The target site selected for placement of the implanted device 80 may be within an area where the tissue of a particular patient is thin or less dense, as previously determined by non-invasive diagnostic means, such as CT scan or radiography, fluoroscopy or intravascular coronary vasculature echo (IVUS).

[0111] As with the other embodiments, the sensor implantation device 80 includes a sensor device 60 having a sensor transducer component 65 and certain connection components (e.g., antenna components and / or other control circuitry). The sensor implantation device 80 is disposed on, attached to, and / or otherwise secured to, or associated with, one or more sensor arms 82 of an implantation structure 81 (e.g., a shunt structure) of the sensor implantation device 80 such that the sensor transducer 65 is disposed within or near a channel region associated with a barrel / conduit portion 78 of the shunt structure 81. For example, the implantation device 80 may be configured such that the sensor transducer component 65 is at least partially exposed on the atrial side of the tissue wall 21, as shown. When the sensor transducer component 65 is disposed within the channel region of the shunt conduit 78, the sensor transducer 65 may be advantageously disposed within a region of relatively high flow, thereby generating sensor readings indicative of flow characteristics through the conduit 78 of the shunt structure 81.

[0112] 13 illustrates a sensor implantation device 80 implanted in the atrial septum 18, according to one or more embodiments. A particular location within the atrial septal wall 18 may be selected or determined to provide a relatively stable anchor location for the shunt structure 81 of the sensor implantation device 80. Additionally, the implantation device 80 may be implanted in a desired location to allow for future re-crossing of the septal wall 18 for future interventions. Implantation of the sensor implantation device 80 in the atrial septal wall 18 may advantageously allow for fluid communication between the left atrium 2 and the right atrium 5.

[0113] An interatrial shunt using the sensor-embedded device 80 may be suitable for patients who are relatively sensitive to elevated atrial pressure. For example, when pressure increases in the ventricles and / or atria and the myocardial cells are subjected to pressure, the heart muscle generally tends to contract and may have a relatively difficult time processing the excess blood. Thus, for patients with impaired ventricular contractility, such patients may be more sensitive to higher ventricular and / or atrium pressures as the heart may not be able to respond or react appropriately to them as the ventricles expand or elongate. Furthermore, elevated left atrial pressure may cause dyspnea, and therefore, it may be desirable to reduce left atrial pressure through an interatrial shunt to alleviate dyspnea and / or reduce the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they cannot adapt to the accumulation of fluid pressure, such fluid may stagnate in the atria, thereby increasing atrial pressure. With respect to heart failure, minimization of left ventricular end-diastolic pressure may be paramount. Because left ventricular end-diastolic pressure can be related to left atrial pressure, stagnation of fluid in the atrium can cause stagnation of fluid in the lungs, thereby causing undesirable and / or dangerous accumulation of fluid in the lungs. An interatrial shunt, such as using a shunt device according to an embodiment of the present disclosure, can divert excess fluid in the left atrium to the right atrium, which may be able to accommodate the additional fluid due to its relatively high compliance.

[0114] 13 includes a sensor device 60 including a sensor transducer component 65 and a cylindrical (or other shaped) housing 69. The sensor device is disposed within, attached to, and / or otherwise secured to, or associated with a sensor arm 82 in a manner such that the sensor transducer 65 is disposed in a channel region associated with the barrel / conduit portion 78 of the shunt structure 81, the associated channel region being within the left atrium. The sensor arm 82 and its sensor carrying portion 83 may have any of the sensor arms and associated sensor carrying portions disclosed herein in connection with any of the embodiments of the present disclosure.

[0115] 14 illustrates a sensor implantation device 80 implanted in the atrial septum 18 with the device's sensor 60 exposed to the right atrium 5, according to one or more embodiments. As with the other embodiments, the sensor implantation device 80 illustrated in FIG. 14 includes a sensor device 60 including a sensor transducer component 65 and a cylindrical (or other shaped) housing 69. The sensor device 60 is disposed on, attached to, and / or otherwise secured to, or associated with, a sensor arm 82 of the shunt structure 81 of the implantation device 80 in a manner such that the sensor transducer 65 is disposed in a channel region associated with a barrel / conduit portion 78 of the shunt structure 81, with the associated channel region being within the right atrium 5.

[0116] FIG. 15 illustrates a dual sensor implantation device 220 implanted in the atrial septum 18, according to one or more embodiments. Although certain embodiments are disclosed herein in connection with a sensor implantation device including a single sensor device associated with a shunt structure, it should be understood that a shunt sensor implantation device according to aspects of the disclosure may have any suitable or desired number of sensor devices associated therewith. For example, the sensor implantation device 220 illustrated in FIG. 15 includes two sensor devices 260, 262, one of the sensor devices 260 associated with a first sensor arm 292, while the other sensor device 262 is associated with a second sensor arm 297. The sensors 260, 262 are advantageously positioned, secured, and / or configured in a position / orientation such that their respective sensor transducer components (265, 267) are exposed at respective channel regions of the shunt structure 290 of the sensor implantation device 220 on respective sides of the septum 18, as shown. For example, sensor arm 292 may extend from a first flange 294 while sensor arm 297 may extend from a second flange 295, with flanges 294, 295 extending from opposite axial sides of a barrel portion 298 of the shunt structure 290. By utilizing two or more sensors, with one or more sensors on each axial side / end of the associated shunt structure, improved shunt flow information can be provided in addition to atrial pressure information. Furthermore, when the sensor transducers of the two sensor devices face in opposite / opposite directions, as in the embodiment of FIG. 15, improved directional flow information can be derived.

[0117] FIG. 15 illustrates a sensor implantation device 220 implanted in the atrial septal wall 18 such that a first sensor 260 and associated sensor transducer 265 are exposed to the left atrium 2, while a second sensor 262 and associated sensor transducer 267 are exposed to the right atrium 5. In some embodiments of dual sensor implantation devices, which may be similar in certain respects to the implantation device 220, both sensors may be exposed in the left atrium 2 or the right atrium 5. With respect to a multi-sensor shunt implantation device according to aspects of the present disclosure, the sensor transducer associated with at least one of the sensor devices may advantageously be disposed at least partially within a channel region associated with an associated conduit / barrel structure. Furthermore, it should be understood that any description herein of the placement / presence of a sensor transducer within a channel region associated with a shunt structure may be interpreted to mean that the sensor transducer is disposed completely within the associated channel region or partially within the channel region.

[0118] 15 illustrates two sensor devices 260, 262 associated with retention arms 292, 297 emanating from opposite axial sides / ends of a fluid conduit / barrel structure 298 such that the sensor devices are exposed on opposite sides of the tissue wall 18, it should be understood that a dual sensor shunt implantation device according to aspects of the present disclosure may have a sensor device associated with any sensor arm / feature. For example, as an alternative to the particular illustrated embodiment of FIG. 15, the sensor embedding device 220 may include a sensor device associated with a sensor arm associated with and / or emanating from a common axial side of the conduit / barrel structure 298 and / or a common anchor flange such that both sensors are exposed on a common side of the tissue wall in which the sensor embedding device 220 is embedded.

[0119] 16 illustrates a dual sensor implantation device 330 implanted in the atrial septum 18, in accordance with one or more embodiments. The sensor implantation device 330 may be similar in any respect to the sensor implantation device 220 illustrated in FIG. 15 and described above, except that the sensor implantation device 330 includes a sensor holding structure with multiple sensor arms supporting each (or at least one) of the two sensor devices 360, 362.

[0120] The sensor embedding device 330 includes two (or more) sensors 360, 362, each of which may be supported by two arms, as described above in connection with FIGS. 11A and 11B. The sensor 360 is at least partially supported by a first sensor arm 392 on a given axial side 304 of the shunt structure 390. A second sensor arm 393, which may be similar to the first sensor arm 392 and may emanate from a flange 394 and / or an opposing side and / or circumferential region of the shunt structure 390, may also be included as part of the shunt structure 390 and may advantageously provide a desired degree of stability for retention of the sensor 360. One or more arms 396, 397 may likewise be included on opposing axial sides 305 of the shunt structure. Each of the sensor arms 392, 393, 396, 397 may be radially biased to position the respective sensor device in a channel region of the shunt structure 390, as described above. Although two arms are shown associated with each axial side of the shunt structure 390 in FIG. 16, it should be understood that embodiments of the present disclosure may have any suitable or desired number of sensor arms on a given axial side of the shunt structure, including three arms, four arms, or more.

[0121] In some embodiments, the shunt structure 390 and / or the sensor arms 392, 393, 396, 397 are formed from multiple / separate wires, rather than a single common wire, as is the case in certain other embodiments. For example, the shunt structure 390 may be comprised of at least two separate wires that may be coiled / wrapped together to provide the shunt structure 390. In some such embodiments, both / all wires may traverse the barrel portion 398 and each may have an end on each axial side of the shunt structure 390. In some embodiments, the two separate wires of the shunt structure 390 may be helical (i.e., wound / coiled) in the same direction (e.g., wound both clockwise and counterclockwise in a given axial direction) or may be wound / coiled in opposite directions.

[0122] In some embodiments, the two sensor arms 392, 393 associated with a given axial side 304 of the shunt structure 390 are associated with opposing ends of the same wire. For example, such a wire may be wrapped around the sensor 360 in the sensor retaining portion 383 at sensor arm 392, extend across flange 394, barrel 398, flange 395 to sensor arm 396, the wire further wrapped around the sensor 362 or otherwise secured / attached to the sensor device 362 at the sensor retaining portion 384 to further form sensor arm 397, return across flange 395, barrel 398, flange 394 to form sensor arm 393, wrapped around or otherwise secured to the sensor 360 on the side 304. In some embodiments, the sensor structure 390 includes two wires, with opposing ends of each wire wrapped around or otherwise secured to the sensor 360, 362 at the sensor retaining areas 383, 384, respectively.

[0123] 15 and 16 are described in the context of a sensor-embedded device implanted in the atrial septum, it should be understood that, as with any other embodiment disclosed herein, such a sensor-embedded device may be implanted in any tissue wall or anatomical structure. Additionally, the identified sides 304, 305 of the shunt structure 390 may be implanted on either side of the atrial septum or other wall.

[0124] 17-1, 17-2, 17-3, 17-4, and 17-5 provide a flow diagram illustrating a process 1700 for implanting a sensor-embedding device, according to one or more embodiments. 18-1, 18-2, 18-3, 18-4, and 18-5 provide images of cardiac anatomy and specific devices / systems corresponding to the operation of process 1700 of 17-1, 17-2, 17-3, 17-4, and 17-5, according to one or more embodiments.

[0125] At block 1702, the process 1700 includes providing a delivery system 55 with a sensor embedding device 70 disposed therein in a delivery configuration, such as a wireform shunt-type sensor embedding device as disclosed in detail herein. Image 1802 of FIG. 18-1 illustrates a partial cross-sectional view of a delivery system 55 for a sensor embedding device 70, according to one or more embodiments of the present disclosure. Image 1802 illustrates the sensor embedding device 70 disposed within the outer sheath 51 of the delivery system 55. Although a particular embodiment of a delivery system is illustrated in FIG. 18-1, it should be understood that a sensor embedding device according to aspects of the present disclosure may be delivered and / or embedded using any suitable or desired delivery system and / or delivery system components.

[0126] The illustrated delivery system 55 includes an inner catheter 52, which may be at least partially disposed within the outer sheath 51 during one or more periods of the process 1700. In some embodiments, the shunt structure 90 of the sensor embedding device 70 may be at least partially wrapped / disposed around the inner catheter 52, with the shunt structure 90 being at least partially disposed within the outer sheath 51 during one or more periods of the process 1700. For example, the inner catheter 55 may be disposed within at least a barrel portion 98 of the shunt structure 90, as shown.

[0127] In some embodiments, delivery system 51 can be configured such that guidewire 54 can be at least partially disposed therein. For example, guidewire 54 can run within a region of the shaft of sheath 51 and / or inner catheter 52, such as within inner catheter 52 as shown. Delivery system 55 can be configured to be advanced over guidewire 54 to guide delivery system 55 to the target implantation site.

[0128] Although not shown in FIG. 18-1 , in some embodiments, the delivery system 55 includes a tapered nose cone feature that may be associated with the sheath 51, the catheter 52, and / or the distal end of the delivery system 55. Such a nose cone feature may be utilized to expand an opening in a tissue wall into which the sensor embedding device 70 is embedded or through which the delivery system is advanced. Additionally, the nose cone feature may facilitate advancement of the distal end of the delivery system 55 through a tortuous anatomy of a patient and / or with an outer delivery sheath or other conduit / pathway. In some embodiments, the delivery system may include a nose cone feature that includes and / or is formed from multiple flap-type forms that are urged / spread apart as the sensor embedding device 70 and / or any portion thereof, the inner catheter 55, or other device is advanced therethrough.

[0129] In some embodiments, the sensor embedding device 70 may be disposed within the delivery system 55 with the sensor device 60 attached thereto or otherwise associated therewith, as described in detail herein. In some embodiments, the inner catheter 52 includes one or more sensor accommodating features (not shown), such as one or more cutouts, depressions, recesses, gaps, openings, apertures, holes, slits, or other mechanisms configured to accommodate the presence of the sensor device 60 and / or other features or shapes of the embedding device 70. Such sensor accommodating features may be, for example, longitudinal and circumferential cutouts in the inner catheter 52 and may be dimensioned to accommodate the size and / or geometry of the sensor device and may allow the sensor device to protrude radially into the inner diameter / space of the inner catheter 55. In some embodiments, as shown in image 1802, the sensor 60 and sensor holding portion 93 of the sensor arm 92 may be disposed distally beyond the distal end of the inner catheter 52 when in the delivery configuration.

[0130] The sensor implantation device 70 may be positioned within the delivery system 55 with its first / distal end disposed distally relative to the barrel 98 of the shunt structure 90. One or more of the distal coils / windings of the shunt structure 90 may be associated with and / or form the sensor arm 92 as described herein. Additionally, one or more of the windings / coils of the shunt structure 90 at its distal portion may be associated with and / or form the distal flange 94 when deployed and expanded. A second / proximal end is positioned at least partially proximally relative to the barrel 98 of the shunt structure 90 and / or the sensor device 60. One or more of the windings / coils of the shunt structure 90 at its proximal portion may be associated with and / or form the proximal flange 95 when deployed and expanded.

[0131] The outer sheath 51 may be used to deliver the sensor embedding device 70 to the target implantation site. That is, the sensor embedding device 70 may be advanced to the target implantation site at least partially within the lumen of the outer sheath 51 such that the sensor embedding device 70 is at least partially retained and / or secured within a distal portion of the outer sheath 51.

[0132] The delivery system 55 further includes a pusher 53 comprising an at least partially hollow tube configured to slide over the inner catheter 52, and when the distal end of the pusher 53 is in contact with the proximal end of the shunt structure 90, the pusher 53 is advanced distally relative to the inner catheter 52, thereby moving the shunt structure 90 up / out of the inner catheter 52.

[0133] At block 1704, the process 1700 includes accessing the right atrium 5 of the patient's heart using a delivery system 55 having a sensor-embedding device 70 disposed therein. In some implementations, accessing the cardiac anatomy with the delivery system 55 may be performed according to one or more procedures or steps, such as placing a guidewire 54 to form and / or dilate an opening in the atrial septum 18 (such as in the region of the fossa ovalis 1811), the details of which are omitted for convenience and clarity.

[0134] At block 1706, the process 1700 involves advancing the delivery system 55 through the atrial septum 18 and into the left atrium 2. Access to the septum 18 and left atrium 2 via the right atrium 5 may be achieved using any suitable or desired procedure. For example, various access routes may be utilized in manipulating guidewires and catheters in and around the heart to deploy an expandable shunt integrated with or associated with a pressure sensor according to embodiments of the present disclosure. In some embodiments, access may be achieved through the subclavian or jugular vein, to the superior vena cava (not shown), and from there to the right atrium 5. Alternatively, the access route may begin in the femoral vein and enter the heart through the inferior vena cava (not shown). Other access routes may also be used, each of which typically utilizes a percutaneous incision where a guidewire and catheter are inserted into the vascular system, usually through a sealed introducer, from which the system may be designed or configured to allow the physician to control the distal end of the device from outside the body.

[0135] In some implementations, the guidewire 54 is introduced through the subclavian or jugular vein, through the superior vena cava 19, and into the right atrium 5. In some implementations, the guidewire 54 can be placed in a spiral configuration within the left atrium 2, which may help secure the guidewire in place. Once the guidewire 54 provides a pathway, an introducer sheath can be routed along the guidewire 54 into the patient's vasculature, for example, by use of a dilator. A delivery catheter can be advanced through the superior vena cava to the right atrium 5, where the introducer sheath can provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter can function to create and prepare an opening in the septum 18, and a separate placement delivery system 55 is used to deliver the sensor implantation device 70, as shown. In other embodiments, the delivery system 55 can be used as both a fully functional puncture preparation and implantation delivery catheter. In this application, the term "delivery system" is used to refer to a catheter, or introducer, having one or both of these functions.

[0136] Advancement of the delivery system 55 through the septum 18 may or may not be facilitated by a nose cone or other features of the delivery system 55. With the delivery system 55 advanced through the septum 18, the sheath 51 may be opened within the left atrium to allow deployment of the sensor implantation device 70 therefrom. The guidewire 54 may be positioned to run through the opening in the septum 18 before the sheath 51 penetrates. The opening in the septum 18 may be first formed using a needle (not shown) associated with the delivery system 55 or other delivery system implemented prior to block 1706. In some implementations, the opening in the septum 18 may have previously been dilated using a balloon dilator or other device.

[0137] At block 1708, the process 1700 involves deploying one or more distal coils of the shunt structure 90 such that the coils expand to form a sensor arm 92 and a distal flange 94 of the sensor implantation device 90 on the left atrial side of the septum 18. Deploying the coils of the shunt structure 90 may be performed at least in part by advancing a pusher or other component of the delivery system 55 relative to the sheath 51. The anchor arm 92 may have a sensor device 60 associated therewith, such that a sensor transducer 65 of the sensor device 60 is exposed within the left atrium 2 such that the sensor transducer 65 may be used to obtain a signal indicative of a physiological parameter associated with the left atrium, such as pressure.

[0138] In block 1710, the process 1700 involves deploying one or more proximal coils of the shunt structure 90 such that the coils expand to form a proximal flange 95 on the right atrial side of the septum 18, thereby sandwiching a portion of the septal wall 18 between the distal 94 and proximal 95 flanges of the shunt structure 90. Such deployment of the coils of the shunt structure 90 may be accomplished, at least in part, by advancing a pusher or other component of the delivery system 55 relative to the sheath 51.

[0139] At block 1712, the process 1700 withdraws the delivery system 55, leaving the sensor implant device 70 implanted in the septum 18, thereby allowing blood flow to be shunted from the left atrium 2 to the right side of the heart through the implant device 70. Although the implant device 70 is shown in some implementations within the atrial septum 18, the implant device 70 may be positioned in the wall separating the left atrium 2 and the coronary sinus, or between other heart chambers.

[0140] FIG. 19 illustrates various catheters 111 that may be used to implant a sensor device according to an embodiment of the present disclosure. The catheters 111 may advantageously be relatively small in cross-sectional profile and steerable to allow for traversal of various blood vessels and cavities through which they may be advanced, such as en route to the right atrium 5, coronary sinus 16, left atrium 2, or other anatomical structures or cavities. Catheter access to the right atrium 5, coronary sinus 16, or left atrium 2 with certain transcatheter solutions may be achieved via the inferior vena cava 16 (shown by catheter 111a) or the superior vena cava 19 (shown by catheter 111b). Further access to the left atrium may involve crossing the interatrial septum (e.g., in the region at or near the fossa ovalis).

[0141] Although access to the left atrium 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. For example, other access routes may be employed to the left atrium 2 if septal crossing through the atrial septal wall is not possible. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable and would result in further injury to the patient. Furthermore, in some patients, the septal wall may be occupied with one or more implanted devices or other therapies, and crossing the septal wall is not tolerable in light of such therapies. As an alternative to transseptal access, transaortic access may be performed, with delivery catheter 111c passing through descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7, and through mitral valve 6 into left atrium 2. Alternatively, transapical access may be performed to access the target anatomical structure, as shown by delivery catheter 111d.

[0142] [Additional embodiments] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0143] 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 embodiments include certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether those features, elements, and / or steps are included or performed in any particular embodiment. 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" is used in its inclusive sense (and not its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, conjunctive language such as "at least one of X, Y, and Z" is understood with the context as being used generally to convey that an item, term, element, etc., can be either X, Y, or Z. Thus, such conjunctive language is generally not 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, each be present.

[0144] In the description of the above embodiments, it should be understood that various features may be grouped together in a single embodiment, drawing, 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 may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the invention herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0145] 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 of 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 the element from other elements having a similar or identical name (other than 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 action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0146] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments 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.

[0147] The spatially relative terms "outside," "inside," "top," "bottom," "lower," "upper," "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 shown in the drawings. It should be 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 the 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 illustrative term "below" may include both a lower and upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0148] Unless expressly stated otherwise, comparison and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass the notion of equality. For example, "less" can mean "less than" as well as "less than" in the strict mathematical sense.

Claims

1. A sensor embedding device (70), a shunt body (90) forming a fluid conduit (98); a first anchor structure (94) associated with a first axial end of the shunt body (90); a second anchor structure (95) associated with a second axial end of the shunt body (90); a first sensor device (60) coupled to the first anchor structure (94), the first anchor structure (94) configured to hold the first sensor device (60) in a sensing position across a channel region (88) of the fluid conduit (98); The sensor embedding device, when in the sensing position, wherein the first sensor device (60) is aligned with an axis (A 1 ) of the fluid conduit (98).

2. The sensor implantation device of claim 1 , wherein the first sensor device is coaxial with the fluid conduit when in the sensing position.

3. The sensor implantation device of claim 1 or 2, wherein the first anchor structure comprises a first arm extending from the shunt body across the channel region and holding the first sensor device.

4. The sensor implantation device of claim 3 , wherein the first anchor structure further comprises a second arm extending from the shunt body across the channel region and holding the first sensor device.

5. The sensor embedding device of claim 4 , wherein the first arm and the second arm extend from opposite sides of the shunt body.

6. The sensor embedding device of claim 5 , wherein both the first arm and the second arm wrap around a body of the first sensor device.

7. A sensor implantation device as described in any one of claims 1 to 6, wherein when the first sensor device is held in the sensing position, an axial blood flow gap exists between the first sensor device and the first axial end of the shunt body.

8. The sensor implantation device of any one of claims 1 to 7, wherein the shunt body comprises a helical wire form.

9. The sensor implantation device of claim 8 , wherein the first anchor structure comprises a spiral arm that is integral with the spiral wire configuration of the shunt body.

10. 10. The sensor embedding device of claim 8 or 9, wherein the shunt body further comprises a cover disposed over at least a portion of the helical wire form.

11. The sensor embedding device of any one of claims 1 to 10, wherein the shunt body further comprises a cover disposed within at least a portion of the helical wire form.

12. 12. The sensor embedding device of claim 1, further comprising a second sensor device coupled to the second anchor structure, the second anchor structure configured to hold the second sensor device over the channel region of the fluid conduit.

13. The sensor embedding device of claim 12 , wherein the sensor transducer of the first sensor device and the sensor transducer of the second sensor device face in opposite directions.

14. The sensor embedding device of claim 13 , wherein the first sensor device and the second sensor device are coaxial.

15. A sensor embedding device, comprising: a shunt body forming a fluid conduit; a first anchor structure associated with a first axial end of the shunt body; a second anchor structure associated with a second axial end of the shunt body; and a first sensor device coupled to the first anchor structure, the first anchor structure configured to hold the first sensor device in a sensing position across a channel region of the fluid conduit; and a second sensor device coupled to the second anchor structure, the second anchor structure configured to hold the second sensor device over the channel region of the fluid conduit.

16. The first sensor device and the second sensor device each include a control circuit and one or more transducers, optionally including: a) the one or more transducers are pressure transducers; and / or 16. The sensor embedding device of claim 15, wherein b) the one or more transducers are configured to generate an electrical signal that can be wirelessly transmitted to an external reader.

17. A sensor embedding device as described in claim 15 or 16, wherein the sensor embedding device is configured to be embedded in the atrial septum or a wall separating the coronary sinus from the left atrium.

18. A sensor embedding device as described in any one of claims 15 to 17, further comprising a power source for powering one or more components of the embedding device.

19. A sensor embedding device as described in any one of claims 15 to 18, wherein the first sensor device and / or the second sensor device have a cylindrical housing.

20. A sensor embedding device as described in any one of claims 16 to 19, wherein the sensor embedding device is configured such that, when embedded in the atrial septum, the first sensor device and associated sensor transducer are exposed to the left atrium and the second sensor device and associated sensor transducer are exposed to the right atrium.

21. A sensor embedding device as described in any one of claims 16 to 20, wherein the sensor transducer of the first sensor device and the sensor transducer of the second sensor device face in opposite directions, and optionally the first sensor device and the second sensor device are coaxial.

22. A sensor embedding device as described in any one of claims 15 to 21, wherein when in the sensing position, the first sensor device is aligned with the axis of the fluid conduit, and optionally, when in the sensing position, the first sensor device is coaxial with the fluid conduit.

23. A sensor embedding device described in any one of claims 15 to 22, wherein the first anchor structure is wrapped around the main body of the first sensor device.

24. A sensor embedding device as described in any one of claims 15 to 23, wherein the first anchor structure includes a first sensor arm extending from the shunt body across the channel region and holding the first sensor device.

25. A sensor embedding device as described in claim 24, wherein the first anchor structure further comprises a second sensor arm extending from the shunt body across the channel region and holding the first sensor device, optionally the first sensor arm and the second sensor arm extending from opposite sides of the shunt body, and optionally both the first sensor arm and the second sensor arm wrapping around the body of the first sensor device.

26. A sensor implantation device as described in any one of claims 15 to 25, wherein when the first sensor device is held in the sensing position, an axial blood flow gap exists between the first sensor device and the first axial end of the shunt body.

27. The shunt body comprising a helical wire form, optionally comprising: a) the first anchor structure comprises a helical arm that is integral with the helical wire configuration of the shunt body; and / or A sensor embedding device according to any one of claims 15 to 26, wherein the shunt body further comprises a covering disposed over at least a portion of the helical wire form.

28. A sensor embedding device as described in claim 27, wherein the shunt body further comprises a cover disposed within at least a portion of the helical wire form.

29. A sensor embedding device as described in any one of claims 15 to 28, wherein the shunt body, the first anchor structure, the second anchor structure, the first sensor arm and the second sensor arm, when present, form a shunt, and substantially the entire shunt is formed from a superelastic wire configured to be radially expandable and compressible, optionally wherein one or more of the wires are formed from Nitinol.

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