Implant device with shunt channel sensor

Abstract

The sensor implant device includes a shunt body forming a fluid conduit having an axis, a first anchor structure associated with a first end of the shunt body, and a first sensor device coupled to the first anchor structure such that a sensor transducer of the first sensor device protrudes into a channel region defined by a radial boundary about the axis of the fluid conduit, the radial boundary being defined by the fluid conduit.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 150,031, filed February 16, 2022, entitled "IMPLANT DEVICES WITH SHUNT CHANNEL SENSORS," the complete disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of medical implant devices. [Background technology]

[0003] Various medical procedures involve the implantation of medical implant devices within cardiac anatomical structures, and certain physiological parameters associated with such anatomical structures, such as fluid pressure, can affect the health outlook of a patient. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,789,294 [Patent Document 2] International Application No. PCT / US20 / 56746 [Patent Document 3] US Patent Application Publication No. 2017 / 0325976 [Patent Document 4] US Patent Application Publication No. 2010 / 0193999 [Patent Document 5] U.S. Patent No. 9,410,267 Summary of the Invention [Means for solving the problem]

[0005] 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 implant devices.

[0006] In some implementations, the present disclosure relates to a sensor implant device comprising a shunt body forming a fluid conduit having an axis, a first anchor structure associated with a first end of the shunt body, and a first sensor device coupled to the first anchor structure, such that a sensor transducer of the first sensor device protrudes into a channel region defined by a radial boundary about the axis of the fluid conduit, the radial boundary being defined by the fluid conduit.

[0007] The first anchor structure may include an arm configured to extend radially outward from the axis of the fluid conduit.

[0008] In some embodiments, the first sensor device has a cylindrical form, and when the sensor implant device is in a deployed configuration in which the first anchor structure protrudes radially away from the axis of the fluid conduit, the axis of the first sensor device is substantially perpendicular to the axis of the fluid conduit.

[0009] The sensor implant device may further include a second anchor structure associated with a second end of the shunt body opposite the first end, and a second sensor device coupled to the second anchor structure, such that the sensor transducer of the second sensor device protrudes into the channel region. For example, the second anchor structure may emerge from an opposite region of the shunt body from the region of the shunt body from which the first anchor structure exits. In some embodiments, the sensor transducer of the second sensor device faces in a direction substantially opposite the direction in which the sensor transducer of the first sensor device faces.

[0010] The sensor implant device may further include a plurality of sensor retention fingers configured to retain the first sensor device to the first anchor structure.

[0011] In some embodiments, the first anchor structure is configured to extend axially relative to the axis of the fluid conduit when the sensor implant device is in the delivery configuration. For example, the sensor transducer of the first sensor device can be disposed within the fluid conduit when the sensor implant device is in the delivery configuration. For example, the sensor transducer of the first sensor device can be disposed axially external to the fluid conduit when the sensor implant device is in the deployed configuration.

[0012] In some implementations, the present disclosure relates to a sensor implant device comprising a shunt body forming a fluid conduit having an axis, a first anchoring means associated with a first end of the shunt body, and a first sensor device coupled to the first anchoring means, such that a sensor transducer of the first sensor device protrudes into a channel region defined by a radial boundary about the axis of the fluid conduit, the radial boundary being defined by the fluid conduit.

[0013] In some embodiments, the first anchoring means includes an arm configured to extend radially outward from the axis of the fluid conduit, for example the arm may have a curved clamping configuration.

[0014] In some implementations, the present disclosure relates to a sensor implant device comprising: a tubular frame having first and second diametric sides and first and second axial ends; a first anchor arm associated with the first side and first end of the tubular frame; a second anchor arm associated with the second side and first end of the tubular frame; a third anchor arm associated with the first side and second end of the tubular frame; and a fourth anchor arm associated with the second side and second end of the tubular frame, wherein each of the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm has a base coupled to the tubular frame and a distal end, and a first sensor device coupled to the first anchor arm, the first sensor device including a sensor transducer associated with a sensor end of the first sensor device opposite the base end of the first sensor device. The sensor end of the first sensor device is associated with the base of the first anchor arm, and the base end of the first sensor device is associated with the distal end of the first anchor arm.

[0015] In some embodiments, the sensor implant device is configured to assume a deployed configuration in which the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm project radially away from the tubular frame. The sensor implant device may further include a second sensor device coupled to the fourth anchor arm, wherein a sensor end of the second sensor device is associated with a base of the fourth anchor arm and a proximal end of the second sensor device is associated with a distal end of the fourth anchor arm. For example, the sensor end of the second sensor device and the sensor end of the first sensor device may both project radially above the tubular frame relative to the axis of the tubular frame. In some embodiments, when the sensor implant device is in the deployed configuration, the sensor end of the first sensor device projects radially past the base of the first sensor arm relative to the axis of the tubular frame.

[0016] The sensor implant device can be configured to assume a delivery configuration in which the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm protrude axially away from the tubular frame. For example, when the sensor implant device is in the delivery configuration, the sensor end of the first sensor device and the sensor end of the second sensor device can be disposed within the tubular frame between the first axial end and the second axial end of the tubular frame.

[0017] In some implementations, the present disclosure relates to a method for shunting a fluid, the method including: advancing a shunt implant device within a delivery catheter to a tissue wall, forming an opening in the tissue wall, deploying a first anchor structure of the shunt implant device distal to the tissue wall, the first anchor structure having a sensor device coupled thereto, deploying a body of the shunt implant device at the opening in the tissue wall, and deploying a second anchor structure of the shunt implant device proximal to the tissue wall, wherein a sensor transducer of the sensor device protrudes into a channel region defined by a radial boundary about an axis of the body, the radial boundary being defined by the body.

[0018] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features are described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0019] Various embodiments are shown 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. [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 shows an exemplary depiction of a human heart, according to one or more embodiments. [Figure 2] FIG. 2 illustrates exemplary pressure waveforms associated with various chambers and vessels of the heart, according to one or more embodiments. [Figure 3] FIG. 3 shows a graph showing the range of left atrial pressure. [Figure 4] FIG. 4 is a block diagram illustrating an implant device according to one or more embodiments. [Figure 5] FIG. 5 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. [Figure 6] FIG. 6 illustrates an exemplary shunt configuration according to one or more embodiments. [Figure 7] FIG. 7 illustrates a shunt structure implanted in the atrial septum, according to one or more embodiments. [Figure 8] FIG. 8 illustrates a sensor implant device implanted in the tissue wall between the coronary sinus and the left atrium, according to one or more embodiments. [Figure 9-1] FIG. 9-1 illustrates a side view of a sensor implant device according to one or more embodiments. [Figure 9-2] FIG. 9-2 illustrates a sensor assembly / device according to one or more embodiments. [Figure 10-1] FIG. 10-1 illustrates exemplary channel regions associated with fluid conduits of each shunt body according to one or more embodiments. [Figure 10-2] FIG. 10-2 illustrates exemplary channel regions associated with the fluid conduits of each shunt body according to one or more embodiments. [Figure 10-3] FIG. 10-3 illustrates exemplary channel regions associated with the fluid conduits of each shunt body according to one or more embodiments. [Figure 11]FIG. 11 shows an axial view of an embodiment of a shunt-type sensor implant device according to one or more embodiments. [Figure 12] FIG. 12 shows an axial view of an embodiment of a shunt-type sensor implant device according to one or more embodiments. [Figure 13] FIG. 13 illustrates a sensor implant device having a suture wrapped sensor device associated therewith, according to one or more embodiments. [Figure 14] FIG. 14 illustrates a sensor implant device having a sensor-holding pouch according to one or more embodiments. [Figure 15] FIG. 15 illustrates a sensor implant device having a sensor retaining cup according to one or more embodiments. [Figure 16-1] FIG. 16-1 illustrates a sensor implant device implanted in the tissue wall of the coronary sinus, according to one or more embodiments. [Figure 16-2] FIG. 16-2 illustrates a sensor implant device implanted in the tissue wall of the coronary sinus, according to one or more embodiments. [Figure 16-3] FIG. 16-3 illustrates a sensor implant device implanted in the tissue wall of the coronary sinus, according to one or more embodiments. [Figure 16-4] FIG. 16-4 illustrates a sensor implant device implanted in the tissue wall of the coronary sinus, according to one or more embodiments. [Figure 17] FIG. 17 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the left atrium, according to one or more embodiments. [Figure 18] FIG. 18 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the right atrium, according to one or more embodiments. [Figure 19] FIG. 19 illustrates a dual sensor implant device implanted in the atrial septum, according to one or more embodiments. [Figure 20] FIG. 20 illustrates a dual sensor implant device implanted in the wall separating the coronary sinus and the left atrium, according to one or more embodiments. [Figure 21] FIG. 21 illustrates a sensor implant device having three sensor devices associated therewith, according to one or more embodiments. [Figure 22] FIG. 22 illustrates a sensor implant device having four sensor devices associated therewith, according to one or more embodiments. [Figure 23-1] FIG. 23-1 provides a flow diagram illustrating a process for implanting a sensor implant device, according to one or more embodiments. [Figure 23-2] FIG. 23-2 provides a flow diagram illustrating a process for implanting a sensor implant device, according to one or more embodiments. [Figure 23-3] FIG. 23-3 provides a flow diagram illustrating a process for implanting a sensor implant device, according to one or more embodiments. [Figure 23-4] FIG. 23-4 provides a flow diagram illustrating a process for implanting a sensor implant device, according to one or more embodiments. [Figure 23-5] FIG. 23-5 provides a flow diagram illustrating a process for implanting a sensor implant device, according to one or more embodiments. [Figure 24-1] FIG. 24-1 provides images of cardiac anatomy and specific devices / systems corresponding to the operation of the process of FIG. 23-1, according to one or more embodiments. [Figure 24-2] FIG. 24-2 provides images of cardiac anatomy and specific devices / systems corresponding to the operation of the process of FIG. 23-2, according to one or more embodiments. [Figure 24-3] FIG. 24-3 provides images of cardiac anatomy and specific devices / systems corresponding to the operation of the process of FIG. 23-3, according to one or more embodiments. [Figure 24-4] FIG. 24-4 provides images of cardiac anatomy and specific devices / systems corresponding to the operation of the process of FIG. 23-4, according to one or more embodiments. [Figure 24-5]FIG. 24-5 provides images of cardiac anatomy and specific devices / systems corresponding to the operation of the process of FIG. 23-5, according to one or more embodiments. [Figure 25] FIG. 25 is a cutaway view of a human heart and associated vasculature showing a particular catheter access route for a pulmonary venous shunt procedure, according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0021] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0022] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, 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 particular embodiments, the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated or 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.

[0023] Certain reference numbers are reused across different figures of the set of figures of this disclosure as a matter of convenience for devices, components, systems, features, and / or modules having characteristics that may be similar in one or more respects. However, with respect to any of the embodiments disclosed herein, the reuse of a common reference number in a figure does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, those skilled in the art may be informed by context as to the extent to which the use of a common reference number may imply similarity between the referenced subject matter. It may be understood that the use of a particular reference number in the context of a description of a particular figure relates to the device, component, aspect, mechanism, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, mechanism, 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 one another.

[0024] 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," "above," "vertical," "horizontal," "top," "bottom," and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it is understood that these terms are used herein for ease of description to describe the positional relationships between elements / structures illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of elements / structures during use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as being "above" another element / structure may represent a position below or beside the other such element / structure, and vice versa, with respect to the patient or alternative orientations of the element / structure in question.

[0025] The present disclosure relates to systems, devices, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using cardiac shunts and / or other medical implant devices integrated with sensors. In some implementations, the present disclosure relates to cardiac shunts and / or other cardiac implant devices incorporating or associated with pressure sensors or other sensor devices. The term “associated with” is used herein in accordance with 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 to, integrated with, at least partially embedded within, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member. Certain embodiments are disclosed herein in connection with cardiac implant devices. However, it should be understood that while certain principles disclosed herein are particularly applicable to cardiac anatomy, a sensor implant device according to the present disclosure may be implanted or configured for implantation in any suitable or desirable anatomy.

[0026] Cardiac Physiology The anatomy of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, flow of which is controlled at least in part by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves can be configured to at least in part control the flow of blood to respective regions of the heart and / or blood vessels (e.g., lungs, aorta, etc.) in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole).

[0027] FIG. 1 shows an exemplary depiction of a heart 1 having various features relevant to certain embodiments of the present disclosure. Heart 1 includes four chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. With regard to blood flow, blood generally flows from the right ventricle 4 through pulmonary valve 9 to pulmonary artery 11, which separates the right ventricle 4 and pulmonary artery 11 and is configured to open during systole to allow blood to be pumped toward 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.

[0028] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to support the circulation of blood therein, including the tricuspid valve 8, the aortic valve 7, and the mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps or leaflets and generally closes during ventricular contraction (i.e., systole) and may 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, if functioning properly, close during systole to prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood exiting the left ventricle 3 to enter the aorta 12 and close during diastole to prevent backflow of blood into the left ventricle 3.

[0029] 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, when the heart contracts, the resulting elevated blood pressure generated within the corresponding heart chamber forces the leaflets to at least partially open, allowing flow from the heart chamber. When pressure within a heart chamber decreases, pressure within 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 a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can result in valve leakage and / or other health complications.

[0030] Atrioventricular (i.e., mitral and tricuspid) heart valves may further include a group of chordae tendineae and papillary muscles (not shown) to anchor the leaflets of each valve to promote and / or facilitate proper coaptation of the leaflets and prevent their prolapse. For example, papillary muscles may generally include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by 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 left atrium 2 from right atrium 5, while interventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates left ventricle 3 from right ventricle 4. The inferior tip of heart 1 is referred to as the apex and is generally located at or near the midclavicular line in the fifth intercostal space.

[0031] The coronary sinus 16 is a group of veins joined together to form a large vessel that collects blood from the heart muscle (myocardium). In some patients, the ostium of the coronary sinus, which may be protected at least in part by the Thebesian valve, opens into the right atrium 5 as shown. The coronary sinus passes along the posterior aspect of the left atrium 2 and delivers deoxygenated blood to the right atrium 5. The coronary sinus typically passes transversely at the left atrial groove on the posterior aspect of the heart.

[0032] Health status associated with cardiac pressure and other parameters As referenced above, certain physiological conditions or parameters associated with cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with relatively slow movement of blood through the heart and / or body, which increases fluid pressure in one or more chambers of the heart. 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 to pump 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 heart's inefficiency by causing the body to retain fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs, and / or other organs can cause the body to become congested, referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and therefore, treatment and / or prevention of congestive heart failure is a significant medical concern.

[0033] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously include monitoring pressure within one or more chambers or regions of the heart or other anatomical structures. As described above, elevated pressure within one or more 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 procedures that do not include direct or indirect pressure monitoring may include measuring or observing other current physiological conditions of the patient, such as measuring body weight, thoracic impedance, right heart catheterization, etc. In some solutions, pulmonary artery wedge pressure may be measured as a surrogate for left atrial pressure. For example, a pressure sensor may be disposed or implanted in the pulmonary artery, and the associated readings 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 chambers or regions of the heart, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be uncomfortable or difficult to implement. Furthermore, certain pulmonary conditions may affect pressure readings in the pulmonary artery, resulting in undesirably weakened correlations 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.

[0034] Additional solutions can be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of left ventricular function that represents 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), can be used as a surrogate for measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques, and abnormalities in the E / A ratio generally indicate an inability of the left ventricle to properly fill with blood during the period between contractions, which can lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide an absolute pressure measurement.

[0035] Various methods for identifying and / or treating congestive heart failure include monitoring worsening symptoms of congestive heart failure and / or changes in weight. However, such indications may be relatively delayed and / or appear relatively unreliable. For example, daily weight measurements may vary significantly (e.g., by up to 9% or more) and may be unreliable in signaling cardiac complications. Furthermore, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. Additionally, for discharged patients, such treatments may require telemedicine systems.

[0036] 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 heart chamber or vessel where the pressure measurements are indicative of left atrial pressure and / or pressure levels in one or more vessels / chambers, such as for patients with congestive heart failure, to reduce hospital readmissions, morbidity, and / or improve the patient's health outlook.

[0037] 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. Increased ventricular filling pressures associated with diastolic and / or systolic heart failure generally may precede the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators may appear several weeks before hospitalization for some patients. Thus, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce hospitalizations by guiding appropriate or desired titration and / or administration of medications prior to the onset of heart failure.

[0038] Dyspnea represents a cardiac pressure index characterized by shortness of breath or a feeling of inadequate breathing. Dyspnea may be due to elevated atrial pressure, which may cause fluid accumulation in the lungs due to backflow of pressure. Pathological dyspnea may result from congestive heart failure. However, a significant amount of time may elapse between the initial pressure rise and the onset of dyspnea, and thus symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure in accordance with embodiments of the present disclosure, normal ventricular filling pressure may be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0039] As referenced above, with respect to cardiac pressure, elevated left atrial pressure may be particularly correlated with heart failure. FIG. 2 illustrates exemplary pressure waveforms associated with various chambers and vessels of the heart, according to one or more embodiments. The various waveforms illustrated in FIG. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors to the respective illustrated and labeled chambers or vessels of the heart. As shown in FIG. 2, a waveform 25 representing left atrial pressure may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, generally, there may be a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0040] Left atrial pressure generally correlates 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, including certain patients with congestive heart failure. For example, pulmonary hypertension, which affects approximately 25% to 83% of heart failure patients, can affect the reliability of pulmonary artery pressure measurements to estimate left-sided filling pressure. Thus, as represented by waveform 24, pulmonary artery pressure measurements alone may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly for patients with comorbid pulmonary disease and / or thromboembolism. Left atrial pressure may further correlate, at least in part, with the presence and / or degree of mitral valve insufficiency.

[0041] Left atrial pressure readings may be relatively less likely to be distorted or affected by other conditions, such as respiratory status, compared to the other pressure waveforms shown in Figure 2. 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, and both diastolic and systolic heart failure, may occur several weeks before hospitalization, and therefore, recognizing such increases may be used to predict the onset of congestive heart failure, such as the acute debilitating symptoms of congestive heart failure.

[0042] Cardiac pressure monitoring, such as left atrial pressure monitoring, may provide a mechanism for guiding the administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce rehospitalizations and morbidity, as well as provide other benefits. Implantable pressure sensors according to embodiments of the present disclosure may be used to predict heart failure two weeks or more before the onset of heart failure symptoms or markers (e.g., dyspnea). When predictors of heart failure are recognized using embodiments of cardiac pressure sensors according to the present disclosure, specific preventative measures may be implemented, including pharmaceutical interventions such as modifications to a patient's drug regimen, that may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium may advantageously provide an accurate indicator of elevated pressure that may lead to heart failure or other complications. For example, trends in elevated atrial pressure may be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other therapies may be escalated to cause pressure reduction and prevent or reduce further complications.

[0043] FIG. 3 illustrates a graph 300 depicting left atrial pressure ranges, including a normal range 301 of left atrial pressure that is generally not associated with a substantial risk of postoperative 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 normal range 301, above normal range 303, or below normal range 302 using a specific sensor implant device. With respect to a detected left atrial pressure above the normal range, which may correlate with an increased risk of heart failure, embodiments of the present disclosure, described in detail below, may report an effort to reduce the left atrial pressure until it is within normal range 301. Additionally, with respect to a detected left atrial pressure below normal range 301, which 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 function to facilitate an effort to increase the left atrial pressure to bring the pressure level within normal range 301.

[0044] Implantable device with built-in sensor In some implementations, the present disclosure relates to sensors associated with or integrated with cardiac shunts or other implant devices. Such integrated devices can 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. 4 is a block diagram illustrating an implant device 30 including a shunt (or other type of implant) 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 can be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 37 includes a transducer 32, such as a pressure transducer, as well as specific control circuitry 34, which can be integrated, for example, within an application-specific integrated circuit (ASIC).

[0045] Control circuitry 34 may be configured to process signals received from transducer 32 and / or communicate signals associated with the transducer wirelessly through biological tissue using antenna 38. The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any group of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including 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 devices that manipulate signals (analog and / or digital) based on hard-coding of circuit and / or operating instructions. Control circuitry referred to herein may further comprise one or more storage devices, which may be integrated into a single memory device, multiple memory devices, and / or the device's embedded circuitry. Such data storage may include read-only memory, random-access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. Note 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.

[0046] 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 transducer 32, control circuitry 34, and / or antenna 38 are at least partially disposed or contained within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially sealed. For example, housing 36 may, in some embodiments, include glass or other rigid material that may provide mechanical stability and / or protection to the components housed therein. In some embodiments, housing 36 is at least partially flexible. For example, housing may advantageously include a polymer or other flexible structure / material that may allow sensor 37 to be folded, flexed, or crushed, enabling its delivery through a catheter or other introduction means.

[0047] Transducer 32 may comprise any type of sensor means or mechanism. For example, transducer 32 may be a force collector-type pressure sensor. In some embodiments, transducer 32 comprises a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures applied strain or deflection across its area / surface. Transducer 32 may be associated with housing 36 such that at least a portion of transducer 32 is contained within or attached to housing 36. With respect to a sensor device / component "associated with" a stent or other implant structure, such term may refer to a sensor device or component that is physically coupled, attached, connected, or integrated with the implant structure.

[0048] In some embodiments, transducer 32 includes or is a piezoresistive strain gauge component, which may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, where the resistance increases as pressure deforms the component / material. 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.

[0049] In some embodiments, transducer 32 includes 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 generally decreases when pressure deforms the diaphragm. The diaphragm may comprise any material, including but not limited to metal, ceramic, silicon, etc. In some embodiments, transducer 32 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement through inductance changes, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors may measure strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0050] In some embodiments, transducer 32 includes or is a strain gauge component. For example, strain gauge embodiments may include a pressure-sensitive element on or associated with the exposed surface of 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 to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonance, thermal, ionization, or other types of strain or pressure sensors.

[0051] 5 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, for example, a medical implant device 30 implanted in the patient's 44's heart (not shown) or associated physiology. 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 microelectromechanical systems (MEMS) devices (e.g., MEMS pressure sensors, or other types of sensor transducers).

[0052] In certain embodiments, the monitoring system 40 may include at least two subsystems, including an implantable internal subsystem or device 30 including a sensor transducer 32 and a control circuit 34 comprising one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further include 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 specific control circuit 41. In certain embodiments, both the internal subsystem 30 and the external subsystem 42 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.

[0053] Specific details of the implant device 30 are shown in the enlarged block 30 shown in the figure. The implant device 30 may include an implant / anchor structure 39 as described herein. For example, the implant / anchor structure 39 may include a percutaneously deliverable shunt device configured to be anchored to and / or within a tissue wall to provide a fluid path between two chambers and / or blood vessels of the heart, as described in detail throughout this disclosure. While certain components are shown in FIG. 5 as part of the implant device 30, it should be understood that the sensor implant device 30 may include only a subset of the illustrated components / modules and may include additional components / modules not shown. The implant device may represent the embodiment of the implant device shown in FIG. 4, or vice versa. The implant device 30 may advantageously include one or more sensor transducers 32, which 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 desirable type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the implant device 30 and / or the patient 44.

[0054] 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 comprises a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures applied strain or deflection 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.

[0055] In some embodiments, transducer 32 includes or is a strain gauge component, which may be configured to use bonded or formed strain gauges to detect strain due to applied pressure. For example, transducer 32 may include or be a piezoresistive strain gauge component, where resistance increases when pressure deforms the strain gauge component / material. Transducer 32 can 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 glued to the sensor surface, or a thin film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonance, thermal, ionization, or other types of strain or pressure sensors.

[0056] In some embodiments, transducer 32 includes 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 generally decreases when 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, transducer 32 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement through inductance changes, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors may measure strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0057] 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.

[0058] 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 monitoring system 42. To accomplish such wireless data transmission, the implant 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 include any type of transceiver circuit configured to transmit electromagnetic signals, which may be emitted by the antenna 38, which may include one or more conductive wires, coils, substrates, etc. The control circuitry 34 of the implant device 30 may include, 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 implant device 30 may not include independent processing capabilities in some embodiments.

[0059] The wireless signals generated by the implanted device 30 may be received by a local external monitoring device or subsystem 42, which may include a reader / antenna interface circuit module 43 configured to receive wireless signal transmissions from the implanted device 30, the module being at least partially disposed within the patient 44. For example, the module 43 may include a transceiver device / circuitry.

[0060] The external local monitor 42 may use an external antenna 48, such as a wand device, to receive wireless signal transmissions from and / or provide wireless power to the implant device 30. 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 implant 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, etc. 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, etc., for handling / processing transmitted signals via the network 49 and / or receiving signals from the implant device 30. In certain embodiments, the local monitor 42 includes control circuitry 41 for performing processing of signals received from the implant device 30. The local monitor 42 may be configured to communicate with the network 49 according to known network protocols such as Ethernet, Wi-Fi, etc. In certain embodiments, the local monitor 42 includes a smartphone, a laptop computer, or other mobile computing device, or any other type of computing device.

[0061] In certain embodiments, the implant 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 implant device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as from the local monitor 42 or from the remote monitor 46 via a network 49. For example, the implant device 30 may be configured to receive signals that at least partially control the operation of the implant device 30, such as by activating / deactivating one or more components or sensors, or otherwise affecting the operation or performance of the implant device 30.

[0062] One or more components of the implant 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 implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In certain embodiments, the power source 35 is at least partially passive in nature, such that power can be received wirelessly from an external power source by passive circuitry in the implant device 30, such as 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 supplying power to the implant device 30, thereby allowing the power circuitry of the implant device to take on 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, which may be advantageously configured to provide sufficient power as needed for a monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period).

[0063] In some embodiments, the local monitoring device 42 may function as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 may be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 may be a wearable communication device or other device that may be easily disposed in proximity to the patient 44 and the implanted device 30. The local monitoring device 42 may be configured to continuously, periodically, or sporadically interrogate 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 may utilize to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0064] System 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. In certain embodiments, 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 implanted device 30, with local monitor 42 designed primarily to receive / transmit signals to and / or from implanted device 30 and provide such signals to secondary local monitor 47 for viewing, processing, and / or manipulation. External local monitor system 42 may be configured to receive and / or process certain metadata from or associated with implanted device 30, such as device ID, which may also be provided via a data link from implanted device 30.

[0065] The remote monitoring subsystem 46 may be any type of computing device or group of computing devices configured to receive, process, and / or present monitoring 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 through the remote monitoring device 42, in certain embodiments, the implanted device 30 may include a transmitter capable of communicating with the remote monitoring subsystem 46 over the network 49 without having to relay information through the remote monitoring device 42.

[0066] 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 contained 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, 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 for folding, flexing, or crushing of the sensor 30 and enable its transport through a catheter or other percutaneous introduction means.

[0067] Cardiac Shunt Implants FIG. 6 illustrates an exemplary shunt / anchor structure 150 according to one or more embodiments. The shunt structure 150 may represent an embodiment of a cardiac implant (e.g., the anchor and / or cardiac implant structure 39 associated with FIG. 4 or FIG. 5) that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. The central flow channel 166 of the shunt 150 may define a generally circular or oval opening when expanded. The channel 166 may be configured to retain the sides of a puncture opening in a tissue wall to form a blood flow pathway between cardiac chambers or vessels separated by the tissue wall. For example, the shunt 150 may be configured to be implanted in the wall separating the coronary sinus and the left atrium. The central flow channel 166 may be formed in part by a pair of side walls 170a, 170b defined by a generally parallelogram-shaped arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, substantially the entire shunt 150 is formed by superelastic struts that are configured to be compressed, loaded into a catheter (not shown), and then expanded and return to a relaxed shape, as shown in FIG.

[0068] Forming the shunt 150 using multiple interconnected struts forming cells therebetween may serve to at least partially increase the shunt's flexibility, thereby allowing for its compression and expansion at the implant site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold punctured tissue in an open position. The end walls 172a, 172b of the central flow channel 166 may connect the side walls 170a, 170b and function as distal and proximal flanges, or extending between the arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b may together define a tubular lattice, as shown. The end walls 172a, 172b may include thin struts 179 extending at a slight angle from the central flow axis of the shunt 150.

[0069] While the illustrated shunt 150 includes struts that define a tubular or circular lattice of open cells that form the central flow channel 166, in some embodiments, the structures making up the channel form a substantially continuous wall surface over at least a portion of the channel 166. In the illustrated embodiment, the angle of the shunt structure 150 can facilitate collapse of the shunt into a delivery catheter (not shown) and expansion of the flanges / arms 152, 154 on either side of the target tissue wall. While the central flow channel 166 can remain essentially unchanged between the collapsed and expanded states of the shunt 150, the flanges / arms 152, 154 can transition into and out of alignment with the angled flow channel.

[0070] While certain embodiments of the shunts disclosed herein include flow channels / barrels 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, relatively elongated sidewalls compared to the illustrated configuration of Figure 6 may produce rectangular or oval flow channels. Shunt flow channels of such shapes are desirable for larger punctures while still being configured to collapse to a relatively small delivery profile.

[0071] In some embodiments, each of the distal and proximal flanges / arms 152, 154 is configured to curve outward from the end walls 172a, 172b, pointing generally radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms may function to secure the shunt 150 to the target tissue wall. Additional aspects and mechanisms of shunt, implant, and / or anchor structures that may be integrated with sensor devices / functionality of embodiments of the present disclosure are disclosed in U.S. Patent Application Publication No. 2017 / 0129999, entitled “Expandable Cardiac Shunt,” issued October 17, 2017, the disclosure of which is expressly incorporated herein by reference in its entirety. While certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 6 and described above, it should be understood that a shunt structure or other implant 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.

[0072] 7 illustrates a shunt implant / anchor device / structure 73 implanted in the interatrial septum 18, according to one or more embodiments. A particular location within the interatrial septal wall 18 may be selected or determined to provide a relatively stable anchoring location for the shunt structure 73. Furthermore, the shunt device / structure 73 may be implanted in a desired location to allow for future recrossing of the interatrial septal wall 18 for future interventions. Implantation of the shunt device / structure 73 within the interatrial septal wall 18 may advantageously allow fluid communication between the left atrium 2 and the right atrium 5.

[0073] Inter-atrial shunting using a shunt device / structure 73 may be well-suited for patients who are relatively sensitive to elevated atrial pressure. For example, when pressure increases in the ventricles and / or atria and is exerted against the myocardial cells, the heart muscle may generally tend to contract more difficultly to handle the excess blood. Therefore, for patients with impaired ventricular contractility as the ventricles expand or stretch, the heart may be unable to respond or react appropriately, making such patients more sensitive to higher pressures in the ventricles and / or atria. Furthermore, increased left atrial pressure can lead to respiratory distress, and therefore, reducing left atrial pressure through inter-atrial shunting may be desirable to reduce respiratory distress and / or the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they are unable to accommodate increased fluid pressure, such fluid may backflow into the atria, thereby increasing atrial pressure. With respect to heart failure, minimizing left ventricular end-diastolic pressure may be paramount. Because left ventricular end-diastolic pressure can be related to left atrial pressure, backflow of fluid within the atria can cause backflow of fluid within the lungs, thereby causing undesirable and / or dangerous accumulation of fluid within the lungs. An inter-atrial shunt, such as using a shunt device according to embodiments of the present disclosure, can divert excess fluid within the left atrium into the right atrium, which can accommodate the additional fluid due to the relatively high compliance within the right atrium.

[0074] 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. Figure 8 shows a shunt device / structure 83 implanted in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. Figure 8, as well as several following figures, show a cross-section of the heart from a top-down, upper oblique view, with the posterior surface oriented at the top of the page.

[0075] In some cases, a left-to-right shunt through implantation of a shunt device 83 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable to a shunt through the interatrial septum. For example, a shunt through the coronary sinus 16 may offer a reduced risk of thrombus and emboli. The coronary sinus is less likely to have thrombi / emboli present for several reasons. First, blood draining from the coronary vasculature into the right atrium 5 is essentially filtered blood because it has just passed through the capillaries. Second, the ostium 14 of the coronary sinus in the right atrium is often partially covered by a false valve called the Thebesian valve (not shown). While not always present, some studies suggest that the Thebesian valve is present in most hearts and may block the 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 drains and the right atrium is generally relatively low, resulting in a thrombus or other emboli in the right atrium being likely to remain there. Fourth, in the event that a thrombus / embolus enters the coronary sinus, a much greater gradient will exist between the right atrium and the coronary vasculature than between the right and left atria. The thrombus / embolus will likely travel further along the coronary vasculature until right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0076] Some additional benefits of placing the shunt structure 83 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the atrial septum. By shunting left atrial blood into the coronary sinus, sinus pressure may increase by a small amount. This allows blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygenation, which may be more efficient and help the dying myocardium recover. Furthermore, by implanting the shunt device / structure 83 in the wall of the coronary sinus 83, damage to the atrial septum 18 may be prevented. Thus, the atrial septum 18 may be preserved for later transseptal access for alternative therapies. Preserving transseptal access may be advantageous for various 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.

[0077] It should be noted that in addition to the various advantages of placing the implant structure 83 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 be passed to the right atrium 5, and / or deoxygenated blood from the right atrium 5 may be passed to the left atrium 2, both of which may be undesirable with respect to the proper functioning of the heart.

[0078] Sensor-embedded implant device As described above, shunts and / or 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. Sensor devices according to embodiments of the present disclosure may be integrated with cardiac shunt structures / devices or other implanted devices using any suitable or desirable attachment or integration mechanism or configuration.

[0079] 9-1 illustrates a side view of a sensor implant device 70, according to one or more embodiments. FIG. 9-2 illustrates an exemplary sensor device / assembly 60 that may be used in a sensor implant device, such as the sensor implant device 70 shown in FIG. 9-1, according to one or more embodiments of the present disclosure.

[0080] 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 detailed above. In some embodiments, the sensor device 60 may be attached to or integrated with an arm member 94 of the shunt structure 90, as shown. For example, the arm 94 with which the sensor device 60 is associated may generally be associated with a distal or proximal axial portion / end of the shunt structure 90. That is, when the shunt structure 90 is implanted, one or more arms of the shunt structure 90 may be associated with an inlet / distal portion of the shunt structure 90, while one or more other anchor arms may be associated with an outlet / proximal portion of the shunt structure 90. While distal and proximal sides / portions are referred to herein in some context, it should be understood that the identified distal portions / sides, as well as the identified proximal portions / sides, may be the 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 relative orientation with respect to the delivery system / device used to implant the associated sensor implant device and / or shunt structure.

[0081] The sensor transducer component 65 includes a sensor element 67, such as a pressure sensor transducer / membrane. With respect to the arm members 94 of the shunt structure 90, the sensor device 60 may be attached / positioned on the distal 64, medial 66, or proximal 68 portions or regions of the arms / anchors 94, or anywhere in between. For example, the illustrated embodiment of FIG. 9-1 includes the sensor device 60 positioned primarily on the medial region 66 and distal region 64 of the arms / anchors 94. In some embodiments, readings obtained by the sensor device 60 may be used to guide the titration of medication for treatment of a patient in whom the implant device 70 is implanted.

[0082] As described herein, sensor device 60 may be configured to implement wireless data and / or power transfer. Sensor device 60 may include an antenna component 61 for such purposes. Antenna 61, as well as one or more other components of sensor device 60, may be at least partially contained within a sensor housing 69, which may further have disposed therein certain control circuitry 62 configured to facilitate wireless data and / or power communication functionality. In some embodiments, antenna component 61 includes one or more conductive coils 63 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.

[0083] In some embodiments, the arm 94 includes an elongated strut / arm mechanism to which the sensor device 60 is secured. The sensor device 60 may be secured to the anchor arm 94 using any suitable means or mechanism. For example, a securing / attachment means / mechanism that may be suitable for attaching the sensor device 60 to any of the arms of the shunt structure 90 may be any of the mechanisms disclosed in U.S. Patent Application Publication No. 2020 / 0122999, 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 arms 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 an arm, strut, or other structural feature of the shunt structure 90.

[0084] The sensor device 60 may be associated with either axial side / end of the shunt structure 90, with different axial sides / ends of the shunt structure 90 being exposed at opposite sides (S1, S2) of the tissue wall when the implant device 70 is implanted in the tissue wall. As described herein, reference to an axial side of the shunt structure may refer to opposite sides of a plane P1 that axially (as in FIG. 9-1 and / or diagonally) bisects the shunt structure 90 and / or its barrel portion 98. 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 into which the shunt structure 90 is implanted. That is, when the shunt structure 90 is implanted into a tissue wall (not shown in FIG. 9-1 , see FIGS. 15-22), the axis A1 of the barrel 98 may be oblique / angled relative to a line / plane A2 normal to the tissue wall surface, and it should be understood that references herein to the shunt axis refer to an axis / line that is substantially normal to the tissue-engaging plane (e.g., plane P1 shown in FIG. 9-1 ), even in embodiments / cases where the shunt barrel has a true axis A1 that is angled relative to the tissue-engaging plane P1, as in FIG. 9-1 . References herein to the axial side of the implant structure may be understood to refer to different sides of the tissue-engaging plane P1. Plane P1 may be aligned (e.g., within 5° or 10° of exact alignment) with at least some of the struts 91 (e.g., circumferentially arranged struts) of the barrel / conduit portion 98 of the shunt structure 90.

[0085] Additionally, descriptions herein of sensor devices disposed on different radial sides of a shunt structure may refer to diametrically opposite sides of diametric plane P2, as shown in Figure 9-1. For example, if a shunt structure includes arms on a given axial side of the shunt structure that emerge from substantially opposite circumferential portions of the barrel / conduit portion of the shunt structure and / or that project in substantially opposite radial directions relative to the axis of the barrel / conduit of the shunt structure, such arms may be considered to be on different and / or opposite radial sides of the shunt structure.

[0086] Sensor device 60 may advantageously be biocompatible. For example, housing 69 may advantageously be biocompatible, such as a housing comprising glass or other biocompatible material. However, at least a portion of 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. Housing 69 may comprise an at least partially rigid cylindrical or tubular form, such as a glass cylinder form. In some embodiments, sensor transducer component 65 / 67 is approximately 3 mm or less in diameter. Antenna 61 may be approximately 20 mm or less in length.

[0087] 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 the external system and / or communicate sensed data or waveforms to and / or from the external system. The sensor device 60 may be attached to or integrated with the shunt structure 90 in any suitable or desirable manner. For example, in some implementations, the sensor device 60 may be attached to or integrated with the shunt structure 90 using mechanical attachment means. In some embodiments, the sensor device 60 may be contained in a pouch or other receptacle that is attached to the shunt structure 90.

[0088] 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, which may be made of silicon or other flexible material. The diaphragm component may be configured to flex or compress in response to changes in environmental pressure. The control circuitry 62 may be configured to process signals generated in response to the flexing / 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 component 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 a hermetic seal for at least some of the sensor components.

[0089] 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 sensor signals. The antenna 61 may include a ferrite core 79 in the form of multiple coils 63 (e.g., wire coils) wrapped with a conductive material. In some embodiments, the coils include copper or other metals. The antenna 61 may advantageously be 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 implant device 70 may be delivered to the target implant site using a delivery catheter (not shown), which includes a cavity or channel configured to accommodate advancement of the sensor device 60 therethrough.

[0090] The sensor implant device 70 comprises a shunt structure 90, which may include a central barrel structure 98, which may include one or more struts 91 or other structural features that form an oval, circular, rectangular, and / or elliptical cylindrical fluid conduit. It should be understood that references herein to the fluid conduits, cylinders, and / or barrel structures of and / or formed thereby the shunt structure may have any axial cross-sectional shape.

[0091] The shunt structure 90 may generally have a first axial end 75 and a second axial end 77 of a barrel / conduit structure 98, from which a particular tissue anchoring mechanism may emerge, at least partially, as shown in FIG. 9-1. For example, as described in more detail herein, one or more anchoring arms 97 may emerge from the barrel 98, and in the deployed configuration as shown in FIG. 9-1, the arms extend radially outward from the fluid conduit 98. Conversely, in the delivery configuration, as described in more detail below, the arms 97 may extend generally axially relative to the barrel / conduit axis A1.

[0092] In some embodiments, one or more of the arms 97 may include a particular sensor retention mechanism configured to hold, secure, or otherwise retain the sensor device 60, as shown. For example, the sensor device 60 may include a generally cylindrical housing or form 69 that may house one or more internal sensor components and may advantageously be at least partially hermetically sealed. In some embodiments, the housing 69 comprises glass or another at least partially rigid material.

[0093] The sensor retention mechanism 80 associated with the anchoring arm 94 may have any suitable or desirable configuration. For example, the sensor retention mechanism 80 may include one or more sensor retention fingers 84, or other bands, straps, wraps, coils, wires, adhesive, clamps, clips, apertures, engagement protrusions or configurations, locks, or other retention mechanisms. In some embodiments, the anchoring arm 94 includes a distal stop mechanism 82, such as a tab or similar configuration / structure, configured to limit distal movement of the sensor device 60 beyond the distal end 64 of the shunt arm 94. For example, the stop mechanism 82 may be a tab that folds over to cover the radial profile of the sensor device 60 in a manner that limits axial movement of the sensor device 60 in at least one direction. In some embodiments, the sensor device 60 is integrated with the arm 94 such that a separate retention mechanism is not required to secure the sensor device 60 to the shunt structure 90. For example, the anchoring arm 94 may be integrated with the housing 69 of the sensor device 60. In some embodiments, the barrel / conduit form / body 98 that defines the shunt orifice may be at least partially covered internally and / or externally with a fabric or other covering that may provide a seal to the device.

[0094] The sensor device 60 may advantageously be 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 according to its broad and ordinary meaning and may refer to the three-dimensional space defined by the radial boundaries of and extending from a 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 associated therewith may be considered to be defined according to any of the illustrated and described channel regions 88 shown in FIGS. 10-1-10-3.

[0095] FIG. 10-1 illustrates 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 discussed 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 / disposed. For example, the fluid conduit 98 may represent the conduit structure of a shunt implant device described herein. In the specific embodiment of FIG. 10-1 , the fluid conduit 98 has an axis A1 that is generally orthogonal, perpendicular, and / or normal to the tissue plane P1. In such an embodiment / configuration, 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 about the axis A1 and bounded by the wall 93, as shown. Thus, the channel region 88 may be the three-dimensional area 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. 10-1 may be considered to be located within a region defined by the radial boundaries of the fluid conduit 98 about the axis A1 of the fluid conduit 98. Additionally, the sensor transducer may be located within a region of the channel region 88 axially outward of the fluid conduit structure 98, similar to the illustrated sensor implant device 70 shown in FIG. 9-1, with the sensor transducer 65 located within the channel region 88 axially outward of the shunt barrel structure 98.

[0096] 10-2 illustrates another exemplary fluid conduit 98 formed by one or more outer walls 93, where the fluid conduit 98 is 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. 10-2 may be configured to be implanted within a tissue wall (e.g., a tissue wall that is 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. 10-2, for a slanted / 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 the 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 angled relative to the tissue plane P1, as shown. For example, with respect to the embodiment shown in FIG. 9-1, in which the channel region 88 of the fluid conduit 98 of the shunt structure 90 is defined according to the scheme shown in FIG. 10-2, the sensor transducer 65 may be considered to be within the channel region 88 of the fluid conduit 98 in that it is within the angled channel region 88a that is coaxial with the slanted / angled conduit / barrel 98.

[0097] 10-3 illustrates another exemplary fluid conduit 98 formed by one or more outer walls 93, where the fluid conduit 98 is 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. 10-3 may be configured to be implanted in a tissue wall (e.g., a tissue wall that is coplanar with the tissue plane P1), where 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 a 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. 10-1, 10-2, and 10-3, A1 represents the axis of the respective fluid conduit and A2 represents the axis(es) of the channel region 88 of the fluid conduit; in some cases, A1 and A2 may be the same). Thus, the channel region 88 of FIG. 10-3 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, with the channel region 88 extending therefrom in an orientation / direction that is perpendicular, orthogonal, and / or normal to the plane P1, as shown in FIG. 10-3. For example, with respect to the embodiment shown in FIG. 9-1, the channel region 88 of the fluid conduit 98 of the shunt structure 90 is defined according to the scheme shown in FIG. 10-3, and the sensor transducer 65 can be considered to be within the channel region 88 of the fluid conduit in that it is within the orthogonal / normal channel region 88b defined by the radial boundaries of the opening 96 of the conduit / barrel structure 98 extending / protruding therefrom in an orthogonal / normal orientation / direction that is not coaxial with the inclined / angled conduit structure 98 of the shunt structure 90.

[0098] 11 illustrates an axial view of the implant device 70 of FIGS. 9-1 in accordance with one or more embodiments of the present disclosure. Specifically, FIG. 11 illustrates an axial view corresponding to an axial side of the implant 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 94, the side that is shown facing out of the page in FIG. 11. The side that is shown facing out of the page in FIG. 11 may be the distal side or the proximal side.

[0099] The sensor device 60 may be mechanically attached or secured to a portion of the arm 94 by any suitable or desirable attachment means, including adhesive attachment or mechanical engagement. For example, the arm 94 may include or be associated with one or more retention mechanisms, which may include one or more clamps, straps, ties, sutures, collars, clips, tabs, etc. Such retention mechanisms may circumferentially encapsulate or secure the sensor device 60, or a portion thereof. In some embodiments, the sensor device 60 may be attached to the arm 94 by applying a mechanical force, either through clipping, locking, or otherwise engaging the sensor 60 with the arm 94 by sliding the sensor 60 through a particular retention mechanism or by applying a pressing or other mechanical force thereto. In some embodiments, the shunt structure 90 may include one or more tabs that may be configured to pop up or extend from one or more sides of the sensor device 60 for mechanical securement. Such tabs may comprise a shape memory metal (e.g., nitinol) or other at least partially rigid material. In some embodiments, the sensor device 60 is pre-attached to the arm 94 and / or integrated therewith prior to implantation. In some embodiments, the sensor 60 may be constructed or manufactured into the shunt structure 90 to form an integral structure. For example, in some embodiments, the sensor 60 may be attached to or integrated with the arm member 94 of the shunt structure 90.

[0100] 12 shows another axial view of the implant device 70 of FIG. 9-1 in accordance with one or more embodiments of the present disclosure. Specifically, FIG. 11 shows an axial view corresponding to the axial side of the implant device 70 opposite the sensor device 60. The side shown facing out of the page in FIG. 12 may be the distal side or the proximal side.

[0101] 13 illustrates a sensor implant device 120 having a suture-wrapped sensor device 126 associated therewith, according to one or more embodiments. The device 126 includes one or more suture wraps 128 (e.g., PET stitches, fabric strips, etc.) configured to at least partially secure the sensor device 126 to the anchor arms 124. In some embodiments, the wraps 128 are wrapped in strands circumferentially and / or axially over the sensor cylinder and around the anchor arms 124.

[0102] The suture wrap 128 may be wrapped around the cylinder / sensor 126 in a circumferential direction across at least a portion of the length of the sensor 126. In some embodiments, the suture wrap 128 has a sheet-like cover / wrap that is drawn or applied over the sensor 126 and / or anchor arms 124. For example, sutures or other types of lines or stitches may be wrapped around the cover / wrap to secure the cover / wrap to the sensor 126 and arms 124. The sutures / lines 128 may comprise ePTFE, PET, etc. It may be desirable to protect the suture mechanism from tissue ingrowth using an appropriate coating, covering, or the like. As with other embodiments of the present disclosure, the suture wrap 128 may be configured to hold the sensor device 126 in an orientation such that its sensor component 127 is disposed within the channel region of the barrel 129 of the implant device 120 (i.e., radially inward relative to the fluid conduit formed by the barrel 129), as shown.

[0103] FIG. 14 illustrates a sensor implant device 130 having a sensor retention pouch 138, according to one or more embodiments. The pouch 130 may include a membrane sock or wrap type retention means or mechanism configured to at least partially secure the sensor implant device 130 to the sensor support post / arm. The membrane pouch / wrap may include polytetrafluoroethylene (PTFE) and / or polyurethane (PU) (e.g., electrospun or rotary jet spun) membrane. The pouch or sock 138 may be attached to or otherwise associated with the anchor arm 134 or another portion of the shunt structure. For example, the pouch 138 may be a suture-based or fabric-based (e.g., fiber and / or polymer fabric) pouch, wrap, or other retention material and / or form.

[0104] The pouch 138 may comprise any suitable or desirable material, including polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), etc., and / or combinations of similar materials. Such materials may, in some implementations, be electrospun onto the sensor 136 or applied using rotary jet spinning.

[0105] In some embodiments, the sensor 136 is configured to be slidably disposed within the pouch 138, with tension and / or compression of the pouch 138 acting to hold the sensor 136 in a fixed position within the pouch 138. While FIG. 14 illustrates a pouch / wrap encasing at least a portion of the sensor 136 in a sock / tube-like manner, in some embodiments, the pouch 138 includes a band or other non-encircling retention means. In some embodiments, the sensor 136 may be sewn or otherwise attached or secured to the pouch 138. Additionally, the pouch 138 may be sewn or otherwise secured or attached to the arm members 134 of the shunt structure 139. The pouch 138 may advantageously be open on one or both axial ends to allow fluid contact with the sensor element / transducer 137 associated with the sensor 136. That is, the sensor 136 may be exposed through an open portion on the distal or proximal end of the arm 134 and / or pouch 138 .

[0106] In some embodiments, pouch 138 comprises a fabric. In some embodiments, pouch 138 comprises a polymer film having specific thermal and voltage characteristics for its application process so as not to cause undesirable effects / damage to sensor 137. Wraps, socks, sleeves, membranes, coatings, or similar types of features described herein in connection with various disclosed embodiments may be applied to the sensor retention structure and / or sensor in any suitable or desirable manner. For example, such materials may, in some implementations, be applied using an electrospinning process. Specific methods, apparatus, and systems relating to electrospinning concepts that may be applied to embodiments of the present disclosure are disclosed in U.S. Patent No. 6,275,999, the disclosure of which is incorporated herein by reference in its entirety. Electrospun PTFE is described in U.S. Patent No. 6,275,999, the disclosure of which is incorporated herein by reference in its entirety. Other processes that may be implemented to apply wraps, socks, sleeves, membranes, or similar features may include rotary jet spinning. Specific methods, apparatus, and systems relating to rotary jet spinning concepts that may be applied to embodiments of the present disclosure are disclosed in U.S. Patent No. 6,275,999, the disclosure of which is incorporated herein by reference in its entirety. As with other embodiments of the present disclosure, the pouch 138 may be configured to hold the sensor device 136 in an orientation such that its sensor component 127 is positioned within the channel region of the barrel 131 of the implant device 130 (i.e., radially inward relative to the fluid conduit formed by the barrel 131), as shown.

[0107] 15 illustrates a sensor implant device 140 having a sensor support cup 148, according to one or more embodiments. The cup 148 may include an overmolded support form. The sensor 146 is at least partially nested within the cup form 148. The cup 148 may be rigid or flexible. In some embodiments, the cup 148 is bonded to the sensor 146 and / or anchor arms 144 via a heat treatment or other process. The sensor 146 may be inserted into the cup form 148, or the cup 148 may be applied over the sensor 146 and anchor arms 144 after placing the sensor 146 on the anchor arms 144. A polymer wrap may be applied over the cup 148 and sensor 146 to further secure the sensor 146 within the cup 148. As with other embodiments of the present disclosure, the cup 148 may be configured to hold the sensor device 146 in an orientation such that its sensor component 147 is positioned within the channel region of the barrel 149 of the implant device 140 (i.e., radially inward relative to the fluid conduit formed by the barrel 149), as shown.

[0108] 16-1, 16-2, 16-3, and 16-4 show a sensor implant device 70 implanted at various locations within the coronary sinus tissue wall 21, according to one or more embodiments. The coronary sinus 16 is generally continuous around the left atrium 2, and therefore, there are a variety of possible acceptable placements for the implant device 70. The target site selected for placement of the implant device 70 may be created within an area where the tissue of a particular patient is thin or sparse, as predetermined by non-invasive diagnostic means, such as fluoroscopy or intravascular coronary ultrasound (IVUS), CT scan, or radiography.

[0109] As with the other embodiments, the sensor implant device 70 includes a sensor device 60 that includes a sensor transducer component 65 and certain connection components (e.g., antenna components and / or other control circuitry). In each of the implementations shown in FIGS. 16-1 , 16-2 , 16-3 , and 16-4 , the sensor device 60 is positioned, attached, and / or otherwise secured to or associated with the implant structure 90 (e.g., shunt structure) of the sensor implant device 70 in a manner such that the sensor transducer 65 is disposed within or near a channel region associated with the barrel / conduit portion 98 of the shunt structure 90. For example, the implant device 70 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.

[0110] For the particular implementation of FIG. 16-1 , the sensor device 60 is associated with an arm 93 positioned on the atrial side of the tissue wall 21 and on a side of the shunt structure 90 positioned distally to the right atrium. That is, the sensor device 60 is secured to an anchor arm 93 positioned generally away from the right atrium (e.g., within the generally narrow region of the coronary sinus 16). When the sensor transducer component 65 is positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may advantageously be positioned within a region of relatively high flow, thereby generating sensor readings indicative of flow characteristics through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in FIG. 16-1 , with the sensor transducer 65 facing radially inward relative to the axis of the conduit 98, may provide sensor readings that are more indicative of shunt flow characteristics, compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98.

[0111] For the particular implementation of FIG. 16-2 , the sensor device 60 is associated with an arm 94 positioned on the atrial side of the tissue wall 21 and on a side of the shunt structure 90 positioned proximally to the right atrium. That is, the sensor device 60 is secured to the anchor arm 94 positioned generally toward the right atrium (e.g., in the generally wide region of the coronary sinus 16). When the sensor transducer component 65 is positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may advantageously be positioned within a region of relatively high flow, thereby generating sensor readings indicative of flow characteristics through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in FIG. 16-2 , with the sensor transducer 65 facing radially inward relative to the axis of the conduit 98, may provide sensor readings that are more indicative of shunt flow characteristics, compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98.

[0112] For the particular implementation of FIG. 16-3 , the sensor device 60 is associated with an arm 95 positioned on the coronary sinus side of the tissue wall 21 and on a side of the shunt structure 90 positioned proximally relative to the right atrium. That is, the sensor device 60 is secured to the anchor arm 95 positioned generally toward the right atrium (e.g., in the generally wide region of the coronary sinus 16). When the sensor transducer component 65 is positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may advantageously be positioned within a region of relatively high flow, thereby generating sensor readings indicative of flow characteristics through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in FIG. 16-3 , with the sensor transducer 65 facing radially inward relative to the axis of the conduit 98, may provide sensor readings more indicative of shunt flow characteristics, compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98. Additionally, when the sensor 60 is positioned within the coronary sinus 16, the sensor 60 can be used to generate a signal indicative of flow within the coronary sinus, including flow distal to the implant device 70 within the coronary sinus 16. Due to size constraints within the coronary sinus, it may be preferable for the sensor 60 to be associated with an arm 95 in a larger region of the coronary sinus (e.g., the ostium of the coronary sinus and the region generally oriented toward the right atrium), as shown in FIG.

[0113] For the particular implementation of FIG. 16-4 , the sensor device 60 is associated with an arm 92 positioned on the coronary sinus side of the tissue wall 21 and on a side of the shunt structure 90 positioned distally relative to the right atrium. That is, the sensor device 60 is secured to an anchor arm 92 positioned generally away from the right atrium (e.g., within the generally narrow region of the coronary sinus 16). When the sensor transducer component 65 is positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may advantageously be positioned within a region of relatively high flow, thereby generating sensor readings indicative of flow characteristics through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in FIG. 16-4 , with the sensor transducer 65 facing radially inward relative to the axis of the conduit 98, may provide sensor readings that are more indicative of shunt flow characteristics, compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98. Additionally, when the sensor 60 is positioned within the coronary sinus 16, the sensor 60 can be used to generate a signal indicative of flow within the coronary sinus, including flow distal to the implant device 70 within the coronary sinus 16. However, due to size constraints within the coronary sinus, it may not be desirable for the sensor 60 to be associated with the arm 92 in narrower regions of the coronary sinus (e.g., regions generally distal to the ostium of the coronary sinus and the right atrium), as shown in FIG. 16-4 . Therefore, in such implementations, it may be desirable for the sensor device 60 to be a relatively small device and / or oriented relatively close to parallel to the tissue wall 21 and / or the axis of the coronary sinus 16 to reduce or avoid contact with the coronary sinus wall and / or cause blockages or other problems.

[0114] 17 illustrates a sensor implant device 70 implanted in the atrial septum 18, with the device's sensor 60 exposed to the left atrium 2, according to one or more embodiments. Similar to other embodiments, the sensor implant device 70 illustrated in FIG. 17 includes a sensor device 60 that includes a sensor transducer component 65 and a cylindrical housing. The sensor device is positioned, attached, and / or otherwise secured to or associated with an implant structure 90 (e.g., a shunt structure) of the implant device 70 such that the sensor transducer 65 is positioned in a channel region associated with the barrel / conduit portion 98 of the shunt structure 90, with the associated channel region being within the left atrium.

[0115] 18 illustrates a sensor implant device 70 implanted in the atrial septum 18, with the device's sensor 60 exposed to the right atrium 2, according to one or more embodiments. Similar to other embodiments, the sensor implant device 70 illustrated in FIG. 18 includes a sensor device 60 that includes a sensor transducer component 65 and a cylindrical housing. The sensor device is positioned, attached, and / or otherwise secured to or associated with an implant structure 90 (e.g., a shunt structure) of the implant device 70 such that the sensor transducer 65 is positioned in a channel region associated with the barrel / conduit portion 98 of the shunt structure 90, with the associated channel region being within the right atrium.

[0116] FIG. 19 illustrates a dual sensor implant device 170 implanted in the atrial septum 18 according to one or more embodiments. While certain embodiments are disclosed herein in connection with a sensor implant device including a single sensor device associated with a shunt structure, it should be understood that a shunt sensor implant device according to aspects of the present disclosure may have any suitable or desirable number of sensor devices associated therewith. For example, the sensor implant device 170 illustrated in FIG. 19 includes two sensor devices 160, 165, where one of the sensor devices 160 is associated with a first sensor arm 194 while the other sensor device 165 is associated with a second sensor arm 195. The sensors 160, 165 are advantageously positioned, secured, and / or configured in a position / orientation such that their respective sensor transducer components (167, 169) are exposed at respective channel regions of the shunt structure 190 of the sensor implant device 170 on each side of the septum 18, as shown. 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 face in opposite / opposite directions, as in the embodiment of FIG. 19, improved directional flow information can be derived.

[0117] 19 illustrates a sensor implant device 170 implanted in the atrial septal wall 18 such that one sensor 160 and associated sensor transducer 167 are exposed to the right atrium 5, while another sensor 165 and associated sensor transducer 169 are exposed to the left atrium 2. In some embodiments of dual-sensor implant devices, which may be similar in certain respects to implant device 170, both sensors may be exposed in the left atrium 2 or the right atrium 5. With respect to multi-sensor shunt implant devices according to aspects of the present disclosure, the sensor transducer associated with at least one of the sensor devices may advantageously be at least partially disposed within a channel region associated with an associated conduit / barrel structure. Furthermore, it should be understood that any description herein regarding the location / 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] 19 illustrates two sensor devices 160, 165 associated with retaining arms that exit from opposite axial sides / ends of the fluid conduit / barrel structure 198, such that the sensor devices are exposed on opposite sides of the tissue wall 18, it should be understood that a dual sensor shunt implant device according to aspects of the present disclosure may have sensor devices associated with any anchoring arm / mechanism. For example, as an alternative to the particular illustrated embodiment of FIG. 19, the sensor implant device 170 may include sensor devices associated with anchoring arms that are associated with and / or exit from a common axial side of the conduit / barrel structure 198, such that both sensors are exposed on a common side of the tissue wall in which the sensor implant device 170 is implanted.

[0119] Additionally, while the illustrated embodiment of FIG. 19 shows sensor devices 160, 165 associated with respective anchor arms 194, 195 exiting from opposite circumferential sides / portions of the conduit / barrel structure 198, it should be understood that embodiments of the present disclosure may include multiple sensor devices associated with the same circumferential side / portion of the fluid conduit formed by the shunt structure.

[0120] FIG. 20 illustrates a dual sensor implant device 170 implanted in the wall 21 separating the coronary sinus 16 and the left atrium 2, according to one or more embodiments. Similar to the implementation of FIG. 19, the sensor implant device 170 may be implanted in any configuration of the tissue wall 21 separating the coronary sinus 16 and the left atrium 2. For example, both the sensor devices 160, 165 and associated sensor transducers 167, 169 may be positioned on the coronary sinus side of the shunt structure 190 and tissue wall 21, on the left atrial side of the shunt structure 190 and tissue wall 21, or on opposing axial sides as shown in FIG. 20. That is, the sensor devices 160, 165 and associated sensor transducers 167, 169 may be associated with the shunt structure 190 in any of the configurations described above in connection with FIGS. 16-1-16-4 and / or otherwise contemplated herein.

[0121] FIG. 21 illustrates a sensor implant device 270 having three sensor devices associated therewith, in accordance with one or more embodiments of the present disclosure. Each sensor device 260a, 260b, 260c is associated with a respective anchor arm 294a, 294b, 294c. Generally, in a three-sensor embodiment, two of the sensor devices 260a, 260b may be associated with a first axial side / end of the shunt structure 290 of the implant device 170, while the third sensor device 260c may be associated with an arm 294c associated with the opposite side / end of the shunt structure 290. For example, for implementations in which the device 270 is implanted in the atrial septal wall, two sensor devices may be positioned on the left atrial side of the septal wall, while the third sensor device may be positioned on the right atrial side, or vice versa. Similarly, two sensors may be positioned on either the coronary sinus side or the left atrial side of the wall separating the coronary sinus and the left atrium, in implementations in which the device 270 is implanted in such a wall. Although each respective sensor transducer is shown as being disposed within a channel region associated with the shunt structure 290, it should be understood that any of the sensor devices may be oriented in an orientation / configuration outside the channel region. For example, with respect to multiple sensor embodiments of the present disclosure, one or more of the sensor devices may be oriented such that its associated sensor transducer faces generally radially outward relative to the axis of the associated conduit / barrel structure of the shunt structure, while at least one other sensor transducer may be configured / positioned within the channel region of the shunt structure as described herein.

[0122] FIG. 22 illustrates a sensor implant device 370 having four sensor devices associated therewith, according to one or more embodiments. Specifically, device 370 includes sensor devices 360a, 360b, 360c, and 360d associated with respective anchor arms 394a, 394b, 394c, and 394d. Sensor implant device 370 may be implanted in the atrial septum wall, the wall separating the coronary sinus and left atrium, or any other tissue wall. While sensor implant device 370 is shown as having four sensor devices associated therewith, it should be understood that sensor implant devices according to embodiments of the present disclosure may have five or more sensor devices associated therewith, and each of the sensor transducers of each sensor device may be positioned within and / or without a channel region. That is, the sensor devices may be in any suitable or desirable configuration or orientation relative to the associated shunt structure.

[0123] Left-to-right shunting in conjunction with physiological parameter (e.g., pressure) sensing, achieved according to any of the devices and / or implants associated with FIGS. 9-22, may advantageously be suitable for patients who are relatively sensitive to elevated atrial pressure. For example, when elevated pressure in the ventricles and / or atria is exerted against the cardiac muscle, the heart muscle may generally tend to contract relatively more difficultly as it processes the excess blood. Thus, for patients with impaired ventricular contractility as the ventricles expand or stretch, such patients may be more sensitive to higher pressures in the ventricles and / or atria because the heart may not be able to respond or react appropriately. Furthermore, elevated pressure on the left side (e.g., the left atrium) can cause respiratory distress; therefore, it may be desirable to reduce pressure on the left side via left-to-right shunting to alleviate respiratory distress and / or reduce the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they are unable to accommodate elevated fluid pressure, such fluid may backflow into the atria, thereby increasing atrial pressure. With respect to heart failure, minimizing left ventricular end-diastolic pressure may be paramount. Because left ventricular end-diastolic pressure may be related to left atrial pressure, backflow of fluid within the atrium may cause backflow of fluid within the lungs, thereby causing undesirable and / or dangerous fluid accumulation within the lungs. A left-to-right shunt, such as using a shunt device according to an embodiment of the present disclosure, can divert excess fluid from the left side of the heart to the right side of the heart, which may be able to accommodate the additional fluid due to the relatively high compliance of the right atrium.

[0124] In some situations, left-to-right shunting may not be effective enough because the patient is subject to a drug regimen designed to control the patient's fluid output and / or pressure. For example, diuretics may be used to induce the patient to expel excess fluid. Thus, use of an integrated pressure sensor implant according to embodiments of the present disclosure may provide a mechanism for informing a technician or physician / surgeon as to how to titrate such drugs to adjust / correct the fluid status. Thus, embodiments of the present disclosure may advantageously function to prescribe drug intervention to reduce or prevent undesired increases in left atrial pressure.

[0125] Figures 23-1, 23-2, 23-3, 23-4, and 23-5 provide a flow diagram illustrating a process 2300 for implanting a sensor implant device, according to one or more embodiments. Figures 24-1, 24-2, 24-3, 24-4, and 24-5 provide images of cardiac anatomy and specific devices / systems corresponding to operations of process 2300 of Figures 23-1, 23-2, 23-3, 23-4, and 23-5, according to one or more embodiments.

[0126] At block 2302, process 2300 includes providing a delivery system 51 with a sensor implant device 70 disposed therein in a delivery configuration, such as a shunt-type sensor implant device as disclosed in detail herein. Image 2402 in FIG. 24-1 illustrates a partial cross-sectional view of a delivery system 51 for a sensor implant device 70, according to one or more embodiments of the present disclosure. Image 2402 illustrates the sensor implant device 70 disposed within the outer sheath 50 of the delivery system 51. While a particular embodiment of a delivery system is illustrated in FIG. 24-1 , it should be understood that a sensor implant device according to aspects of the present disclosure may be delivered and / or implanted using any suitable or desirable delivery system and / or delivery system components.

[0127] The illustrated delivery system 51 includes an inner catheter 55, which may be at least partially disposed within the outer sheath 50 during one or more portions of the process 2300. In some embodiments, the shunt structure 90 of the sensor implant device 70 may be at least partially disposed around the inner catheter 55, with the shunt structure 90 being at least partially disposed within the outer sheath 50 during one or more portions of the process 2300. For example, the inner catheter 55 may be disposed within the barrel portion 98 of the shunt structure 90, as shown.

[0128] In some embodiments, delivery system 51 can be configured such that a guidewire 53 can be at least partially disposed therein. For example, guidewire 53 can pass within a region of the shaft of sheath 50 and / or inner catheter 55, such as within inner catheter 55 as shown. Delivery system 51 can be configured to be advanced over guidewire 53 to guide delivery system 51 to the target implant site.

[0129] In some examples, the delivery system 51 includes a tapered nosecone mechanism 52 that may be associated with the sheath 50, the catheter 55, and / or the distal end of the delivery system 51. In some implementations, the nosecone mechanism 52 may be utilized to dilate an opening in a tissue wall into which the sensor implant device 70 is implanted or through which the delivery system is advanced. The nosecone mechanism 52 may facilitate advancement of the distal end of the delivery system 51 through a patient's tortuous anatomy and / or with an outer delivery sheath or other conduit / pathway. The nosecone 52 may be a separate component from the catheter 55 or may be integrated with the catheter 55. In some embodiments, the nosecone 52 is adjacent to and / or integrated with the distal end of the catheter 55. In some embodiments, the nosecone 52 may comprise and / or be formed from a multiple flap-type configuration that may be biased / spread apart when the sensor implant device 70 and / or any portion thereof, the inner catheter 55, or other device is advanced therethrough.

[0130] In some embodiments, the sensor implant device 70 may be disposed within the delivery system 51 with the sensor device 60 attached thereto or otherwise associated therewith, as described in detail herein. In some examples, the inner catheter 55 includes one or more cutouts, depressions, recesses, gaps, openings, apertures, holes, slits, or other features configured to accommodate the presence of the sensor device 60 and / or other features or aspects of the implant device 70. For example, the sensor device 60 may be disposed at least partially within the inner diameter of the shunt structure 90 in the delivery configuration shown in FIG. 24-1. In such a configuration, the sensor assembly components may cause interference with the ability of the shunt structure 90 to be positioned relatively tightly around the inner catheter 55, thereby increasing the profile of the delivery system and / or affecting the ability of the sensor implant device 70 to be delivered using the delivery system 51. Accordingly, as shown in FIG. 24-1, the inner catheter 55 may include one or more sensor device adjustment features, such as a sensor cutout or other adjustment feature 57. In some embodiments, the adjustment mechanism 57 may be a longitudinal and circumferential cutout in the inner catheter 55. The adjustment mechanism 57 may advantageously be sized to accommodate the size and / or geometry of the sensor device, as shown, and may allow the sensor device to protrude radially into the inner diameter / space of the inner catheter 55.

[0131] The sensor implant device 70 can be positioned within the delivery system 51 with its first end (i.e., the distal anchor arm 94) disposed distally relative to the barrel 98 of the shunt structure 90. The second end (i.e., the proximal anchor arm) is positioned at least partially proximal relative to the barrel 98 of the shunt structure 90 and / or the sensor device 60.

[0132] The outer sheath 50 may be used to deliver the sensor implant device 70 to the target implant site. That is, the sensor implant device 70 may be advanced to the target implant site at least partially within the lumen of the outer sheath 50 such that the sensor implant device 70 is at least partially retained and / or secured within the distal portion of the outer sheath 50.

[0133] At block 2304, the process 2300 includes accessing the right atrium 5 of the patient's heart using a delivery system 51 with a sensor implant device 70 disposed therein. In some implementations, accessing the cardiac anatomy with the delivery system 51 may be performed according to one or more procedures or steps, including placing a guidewire 53 and / or forming and / or dilating an opening between the left atrium 2 and the coronary sinus 16 of the patient's heart, details of which are omitted for convenience and clarity.

[0134] At block 2306, the process 2300 includes advancing the delivery system 51 into the coronary sinus 16 to a target implantation site adjacent the wall 21 separating the coronary sinus 16 and the left atrium 2. Access to the target wall 21 and left atrium 2 via the coronary sinus 16 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), the right atrium 5, and from there to the coronary sinus 16. 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 through which 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, a guidewire 53 is introduced through the subclavian or jugular vein, through the superior vena cava 19, and into the coronary sinus 16 via the right atrium 5. The guidewire 53 may be arranged in a spiral configuration within the left atrium 2, as shown in image 24-6, which may help secure the guidewire in place. Once the guidewire 53 provides a pathway, an introducer sheath may be routed along the guidewire 53 into the patient's vasculature, such as with the use of a dilator. A delivery catheter may be advanced through the superior vena cava to the coronary sinus 16 of the heart, and the introducer sheath may provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to form and create an opening in the left atrial wall 21, and a separate deployment delivery system 51 is used to deliver the sensor implant device 70, as shown. In other embodiments, the deployment system 51 may be used as both a fully functional puncture-creation and implant delivery catheter. In this application, the term "delivery system" is used to refer to a catheter or introducer that has one or both of these functions.

[0136] At block 2308, the process 2300 includes accessing the left atrium through an opening 99 formed in the wall 21. For example, a guidewire 53 may be positioned to pass through the opening 99 prior to penetration of the opening 99 by the nosecone 52. The opening 99 may originally have been formed using a needle (not shown) associated with the delivery system 51 or other delivery system implemented prior to block 2308. In some implementations, the nosecone mechanism 52 may be used to at least partially dilate the previously dilated opening 99 using a balloon dilator or other device.

[0137] At block 2310, process 2300 includes deploying one or more anchor arms 94, which may be considered distal anchor arms of sensor implant device 70 on the atrial side of wall 21. Distal arms 94 may be associated with sensor device 60 such that sensor transducer 65 of sensor device 60 is exposed within left atrium 2 so that sensor transducer 60 may be used to obtain a signal indicative of a physiological parameter associated with the left atrium, such as pressure.

[0138] At block 2312, the process 2300 includes deploying one or more proximal arms 95 of the sensor implant device 70 onto the coronary sinus side of the tissue wall 21, thereby sandwiching a portion of the wall 21 between the distal and proximal arms of the shunt structure 90. At block 2314, the process 2300 includes withdrawing the delivery system 51, leaving the sensor implant device 70 implanted in the tissue wall 21, thereby allowing blood flow to be shunted from the left atrium 2 through the implant device 70 to the right side of the heart via the coronary sinus 16.

[0139] Additional aspects and mechanisms of a process for delivering a shunt structure, which may be integrated with a sensor device / function, according to embodiments of the present disclosure for implantation in the wall between the coronary sinus and the left atrium, are disclosed in U.S. Patent Application Publication No. 2017 / 0129999, entitled "Expandable Cardiac Shunt," issued October 24, 2017, the disclosure of which is expressly incorporated herein by reference in its entirety. Although implant device 70 is shown within left atrial / coronary sinus wall 21, implant device 70 may be positioned between other heart chambers, such as between the left and right atria.

[0140] FIG. 25 is a cutaway view of the human heart and associated vasculature, illustrating a particular catheter access route for implanting a sensor implant device according to one or more embodiments. FIG. 25 illustrates various catheters 111 that can be used to implant a sensor device according to aspects of the present disclosure. The catheter 111 can advantageously be steerable and have a relatively small cross-sectional profile to enable traversal of various blood vessels and heart chambers through which it can be advanced, for example, en route to the right atrium 5, coronary sinus 16, left atrium 2, or other anatomical structures or chambers. According to certain transcatheter solutions, catheter access to the right atrium 5, coronary sinus 16, or left atrium 2 can 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 can include 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 the septum cannot be traversed through the atrial septal wall. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable and result in further injury to the patient. Furthermore, in some patients, the septal wall may be occupied by one or more implant devices or other therapies, making crossing the septal wall unsustainable in light of such therapies. As an alternative to transseptal access, transaortic access may be performed, with delivery catheter 111c passing through the descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7 and through the mitral valve 6 into the left atrium 2. 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. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0143] In particular, conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context of use, 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 for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without authorial input or prompting. The terms "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, etc. 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. Conjunctive language such as "at least one of X, Y, and Z" is understood in context as being used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z each be present.

[0144] In the foregoing description of embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in understanding 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 necessarily required or essential to each embodiment. Accordingly, it is intended that the scope of the invention(s) 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 ordinal terminology (e.g., "first" or "second") may be provided for ease of reference and does not necessarily imply a physical characteristic or order. Thus, as used herein, ordinal terminology (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., does 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 through the use of the ordinal terminology). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action 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 one of ordinary skill in the art to which the exemplary embodiments belong. It is further understood that 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 should not be interpreted in an idealized or overly formal sense unless expressly defined as such herein.

[0147] Spatially relative terms such as "outside," "inside," "top," "bottom," "below," "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, as shown in the figures. 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 shown in the figures. For example, if a device shown in the figures were turned upside down, a device positioned "below" or "directly below" another device would be positioned "above" that other device. Thus, the exemplary term "below" can include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may be interpreted differently depending on the orientation.

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

[0149] 21 tissue wall, 30, 70, 120, 130, 140, 170, 270, 370 sensor implant device, 39 anchor structure, 55, 111c, 111d delivery catheter, 60, 126, 136, 146, 160, 165, 260a, 260b, 260c, 360a, 360b, 360c, 360d sensor device, 64 distal end, 65, 167, 169 sensor transducer, 75 first axial end, 77 second axial end, 84 sensor retention fingers, 88 channel region, 92, 93, 94, 95, 97, 124, 134, 194, 195, 294a, 294b, 294c, 394a, 394b, 384c, 394d anchor arm, 98 Fluid conduit, 99 openings, A1,A2 axis

Claims

1. 1. A sensor implant device, comprising: a shunt body forming a fluid conduit having an axis; a first anchor structure associated with a first end of the shunt body; a first sensor device coupled to the first anchor structure such that a sensor transducer of the first sensor device projects into a channel region defined by a radial boundary about the axis of the fluid conduit, the radial boundary being defined by the fluid conduit; A sensor implant device, wherein the first sensor device has a cylindrical form, and when the sensor implant device is in a deployed configuration in which the first anchor structure protrudes radially away from the axis of the fluid conduit, the axis of the first sensor device is substantially perpendicular to the axis of the fluid conduit.

2. The sensor implant device of claim 1 , wherein the first anchor structure comprises an arm configured to extend radially outward from the axis of the fluid conduit.

3. The sensor implant device of claim 1 or claim 2, further comprising a second anchor structure associated with a second end of the shunt body opposite the first end, and a second sensor device coupled to the second anchor structure such that a sensor transducer of the second sensor device protrudes into the channel region.

4. The sensor implant device of claim 3 , wherein the second anchor structure exits from an opposing region of the shunt body beginning at a region of the shunt body from which the first anchor structure exits.

5. The sensor implant device of claim 3 or claim 4, wherein the sensor transducer of the second sensor device faces in a direction substantially opposite to a direction in which the sensor transducer of the first sensor device faces.

6. The sensor implant device of any one of claims 1 to 5, further comprising a plurality of sensor retaining fingers configured to retain the first sensor device to the first anchor structure.

7. The sensor implant device of any one of claims 1 to 6, wherein the first anchor structure is configured to extend axially relative to the axis of the fluid conduit in a delivery configuration of the sensor implant device.

8. The sensor implant device of claim 7 , wherein the sensor transducer of the first sensor device is disposed within the fluid conduit when the sensor implant device is in the delivery configuration.

9. The sensor implant device of any one of claims 1 to 8, wherein the sensor transducer of the first sensor device is positioned axially outside the fluid conduit when the sensor implant device is in a deployed configuration.

10. 1. A sensor implant device, comprising: a shunt body forming a fluid conduit having an axis; a first anchoring means associated with a first end of the shunt body; a first sensor device coupled to the first anchoring means such that a sensor transducer of the first sensor device protrudes into a channel area defined by a radial boundary about the axis of the fluid conduit, the radial boundary being defined by the fluid conduit; and

11. The sensor implant device of claim 10 , wherein the first anchoring means comprises an arm configured to extend radially outward from the axis of the fluid conduit.

12. The sensor implant device of claim 11 , wherein the arm has a curved clamp configuration.

13. 1. A sensor implant device, comprising: a tubular frame having a first diametric side and a second diametric side and a first axial end and a second axial end; a first anchor arm associated with the first diametric side and the first axial end of the tubular frame; a second anchor arm associated with the second diameter side and the first axial end of the tubular frame; a third anchor arm associated with the first diametric side and the second axial end of the tubular frame; a fourth anchor arm associated with the second diametric side and the second axial end of the tubular frame, the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm each having a proximal end and a distal end coupled to the tubular frame; a first sensor device coupled to the first anchor arm, the first sensor device including a sensor transducer associated with a sensor end of the first sensor device opposite a base end of the first sensor device; A sensor implant device, wherein the sensor end of the first sensor device is associated with the base of the first anchor arm and the base end of the first sensor device is associated with the distal end of the first anchor arm.

14. The sensor implant device of claim 13, wherein the sensor implant device is configured to assume a deployed configuration in which the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm project radially away from the tubular frame.

15. 15. The sensor implant device of claim 13 or claim 14, further comprising a second sensor device coupled to the fourth anchor arm, a sensor end of the second sensor device associated with the base of the fourth anchor arm and the base end of the second sensor device associated with the distal end of the fourth anchor arm.

16. The sensor implant device of claim 15 , wherein the sensor end of the second sensor device and the sensor end of the first sensor device both protrude radially above the tubular frame relative to an axis of the tubular frame.

17. 17. A sensor implant device as described in claim 15 or claim 16, wherein when the sensor implant device is in the deployed configuration, the sensor end of the first sensor device protrudes radially past the base of the first sensor arm relative to the axis of the tubular frame.

18. The sensor implant device of any one of claims 13 to 17, wherein the sensor implant device is configured to assume a delivery configuration in which the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm protrude axially away from the tubular frame.

19. 20. The sensor implant device of claim 18, wherein when the sensor implant device is in the delivery configuration, the sensor end of the first sensor device and the sensor end of the second sensor device are disposed within the tubular frame between the first axial end and second axial end of the tubular frame.

Images