Shunt sensor embedding device

Abstract

The sensor embedding device includes a shunt body forming a fluid conduit, a first anchor structure associated with a first end of the shunt body, a second anchor structure associated with a second end of the shunt body, a sensor device coupled to the first anchor structure, and an antenna coupled to the second anchor structure.

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 146,263, entitled SHUNT SENSOR IMPLANT DEVICES, filed February 5, 2021, the complete disclosure of which is incorporated herein by reference in its entirety.

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

[0003] 2. Description of Related Art Various medical procedures involve the placement of medical implant devices within cardiac anatomical structures. Certain physiological parameters associated with these anatomical structures, such as fluid pressure, can affect the health outlook of a patient. Summary of the Invention

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

[0005] In some implementations, the present disclosure relates to a sensor implantation device that includes a shunt body forming a fluid conduit, a first anchor structure associated with a first end of the shunt body, a second anchor structure associated with a second end of the shunt body, a sensor device coupled to the first anchor structure, and an antenna coupled to the second anchor structure.

[0006] The sensor implantation device may further comprise an electrical connector that electrically connects the sensor device to the antenna. For example, the electrical connector may be disposed at least partially within the fluid conduit of the shunt body. In some embodiments, the antenna includes a coil wound around a magnetic core.

[0007] In some embodiments, the first anchor structure includes one or more anchor arms configured to extend radially outward relative to the axis of the fluid conduit, and the sensor device is coupled to one of the one or more anchor arms. For example, the sensor device may include a sensor transducer including a sensor membrane that faces in a direction within 30° of the axis of the fluid conduit.

[0008] The shunt body may include a frame having a plurality of openings therein. In some embodiments, the first anchor structure and the second anchor structure are configured to hold a portion of the tissue wall therebetween, such that when the first anchor structure and the second anchor structure hold the portion of the tissue wall, the portion of the tissue wall is disposed between the sensor device and the antenna.

[0009] 2. The sensor embedding device of claim 1, wherein when the first anchor structure and the second anchor structure protrude radially outward relative to an axis of the fluid conduit, the sensor device and antenna are radially outward of an axial channel of the fluid conduit. For example, in some embodiments, when the first anchor structure and the second anchor structure protrude axially relative to an axis of the fluid conduit in a delivery configuration of the sensor embedding device, the sensor device and antenna are within the axial channel of the fluid conduit.

[0010] In some implementations, the present disclosure relates to a sensor assembly including a sensor device configured to be attached to a first anchor of an artificial shunt implantation device, an antenna coil configured to be attached to a second anchor of the artificial implantation device, and an electrical connector coupled between the sensor device and the antenna coil.

[0011] The electrical connector may be dimensioned to extend through a tissue wall separating the sensor device and the antenna coil, hi some embodiments, the antenna coil is configured to receive a sensor signal from the sensor device via the electrical connector and to transmit the sensor signal wirelessly.

[0012] In some implementations, the present disclosure relates to a sensor embedding device including a tubular frame, a first anchoring means associated with a first end of the tubular frame, a second anchoring means associated with a second end of the tubular frame, a sensor device coupled to the first anchoring means, and a wireless transmitter means coupled to the second anchoring means.

[0013] The sensor embedding device may further comprise a wire electrically connecting the sensor device to the transmitter means. For example, the wire may axially traverse the tubular frame. In some embodiments, the wire runs inside the tubular frame between the first and second ends.

[0014] In some embodiments, the wireless transmitter means includes a conductive coil, for example the conductive coil may be wound around a cylindrical magnetic core.

[0015] In some embodiments, the first anchoring means comprises a first anchoring arm configured to extend radially outwardly relative to the axis of the tubular frame, the sensor device is coupled to the first anchoring arm, the second anchoring means comprises a second anchoring arm configured to extend radially outwardly relative to the axis of the tubular frame, and the transmitter means is coupled to the second anchoring arm.

[0016] In some embodiments, when the first and second anchoring means protrude radially outward relative to the axis of the tubular frame, the sensor device and antenna are radially outward of the tubular frame. For example, when the first and second anchoring means are axially oriented relative to the axis of the tubular frame, the sensor device and antenna may be radially within the tubular frame.

[0017] In some implementations, the present disclosure relates to a method of shunting a fluid, the method including advancing a shunt implantation device into a tissue wall within a delivery catheter, forming an opening in the tissue wall, deploying a first anchor structure of the shunt implantation device distal to the tissue wall, the first anchor structure associating a sensor device, deploying a body of the shunt implantation device at the opening in the tissue wall, and deploying a second anchor structure of the shunt implantation device proximal to the tissue wall, the second anchor structure associating an antenna.

[0018] In some embodiments, the distal tissue wall is within the left atrium of the heart and the proximal tissue wall is within the coronary sinus of the heart.

[0019] In some implementations, the present disclosure relates to a method of manufacturing a shunt implantation device, the method including forming a shunt structure including a shunt body configured to form a tubular conduit, a first anchor structure associated with a first axial end of the shunt body, and a second anchor structure associated with a second axial end of the shunt body, coupling a sensor device to the first anchor structure, and coupling an antenna to the second anchor structure.

[0020] The sensor device may be tethered to the antenna by an electrical connector. For example, the method may further include running the electrical connector through an interior of the tubular conduit.

[0021] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein. [Brief description of the drawings]

[0022] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements.

[0023] [Figure 1] FIG. 1 shows an exemplary representation of a human heart in accordance with one or more embodiments. [Diagram 2] FIG. 2 shows example pressure waveforms associated with various heart chambers and vessels, according to one or more embodiments. [Diagram 3] FIG. 3 illustrates a graph showing left atrial pressure range. [Figure 4] FIG. 4 is a block diagram illustrating an embedding device according to one or more embodiments. [Diagram 5] FIG. 5 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, in accordance with one or more embodiments. [Figure 6] FIG. 6 illustrates an exemplary shunt structure 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 implantation device implanted in the tissue wall between the coronary sinus and the left atrium, in accordance with one or more embodiments. [Figure 9-1] FIG. 9-1 illustrates a side view of a sensor-embedded device according to one or more embodiments. [Figure 9-2] FIG. 9-2 illustrates a sensor assembly according to one or more embodiments. [Figure 10] FIG. 10 shows an axial view of one embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 11]FIG. 11 shows an axial view of one embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 12] FIG. 12 illustrates a sensor implantation device implanted in the coronary sinus tissue wall with its sensor exposed to the left atrium, in accordance with one or more embodiments. [Figure 13] FIG. 13 illustrates a sensor implantation device implanted in the coronary sinus tissue wall with its sensor exposed to the coronary sinus, in accordance with one or more embodiments. [Figure 14] FIG. 14 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the left atrium, in accordance with one or more embodiments. [Figure 15] FIG. 15 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the right atrium, in accordance with one or more embodiments. [Figure 16-1] 16-1, 16-2, 16-3, 16-4, and 16-5 provide flow diagrams illustrating a process for embedding a sensor-embedding device according to one or more embodiments. [Figure 16-2] Same as above. [Figure 16-3] Same as above. [Figure 16-4] Same as above. [Figure 16-5] Same as above. [Figure 17-1] 17-1, 17-2, 17-3, 17-4, and 17-5 provide images of cardiac anatomy and specific devices / systems corresponding to the operation of the processes of FIGS. 16-1, 16-2, 16-3, 16-4, and 16-5, in accordance with one or more embodiments. [Figure 17-2] Same as above. [Figure 17-3] Same as above. [Figure 17-4] Same as above. [Figure 17-5] Same as above. [Figure 18]FIG. 18 is a cutaway view of the human heart and associated vasculature showing a particular catheter access route for a pulmonary vein shunt procedure, in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0025] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order, and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular embodiment, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0026] Certain reference numbers are reused across different figures in the set of figures of this disclosure as a matter of convenience for devices, components, systems, features, and / or modules that have characteristics that may be similar in one or more respects. However, with respect to any of the embodiments disclosed herein, the reuse of common reference numbers in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art may be informed by the context as to the extent to which the use of common reference numbers may imply similarity between the referenced subject matter. The use of a particular reference number in the context of the description of a particular figure may be understood to relate to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number may be construed as sharing characteristics or being entirely independent of each other.

[0027] Certain standard anatomical terms of location are used herein to refer to animal, i.e., human, anatomical structures with respect to preferred embodiments. While certain spatially relative terms such as "outer," "inner," "upper," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationships between the elements / structures illustrated in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the elements / structures during use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or beside such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa.

[0028] The present disclosure relates to systems, devices, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using a sensor-integrated cardiac shunt and / or other medical implant device. In some implementations, the present disclosure relates to cardiac shunts and / or other cardiac implant devices incorporating or associated with a pressure sensor or other sensor device. The term "associated with" is used herein according to its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly. Certain embodiments are disclosed herein in connection with cardiac implant devices. However, while certain principles disclosed herein are particularly applicable to cardiac anatomical structures, it should be understood that a sensor-implantation device according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure.

[0029] Cardiac Physiology The anatomical structure of the heart is described below to aid in the understanding of certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, the flow of which is at least partially controlled by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves can be configured to open and close in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to respective regions and / or blood vessels of the heart (e.g., lungs, aorta, etc.).

[0030] 1 illustrates an exemplary representation of a heart 1 having various features associated with certain embodiments of the present disclosure. Heart 1 includes four heart chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. In terms of blood flow, generally, blood flows from the right ventricle 4 through a pulmonary valve 9 into a pulmonary artery 11, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood may be pumped toward the lungs and to close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.

[0031] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in the circulation of blood therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps or leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood in the left atrium 2 to flow into the left ventricle 3, and close during systole to prevent blood from flowing back into the left atrium 2, if functioning properly. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to exit the left ventricle 3 and enter the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0032] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that the resulting increased blood pressure in the corresponding heart chamber when the heart contracts will at least partially open the leaflets and allow flow from the heart chamber. When the pressure in the heart chamber decreases, the pressure in the subsequent heart chamber or blood vessel may prevail and push back against the leaflets. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0033] Atrioventricular (i.e., mitral and tricuspid) heart valves further include a collection of chordae tendineae and papillary muscles (not shown) that anchor the leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. Papillary muscles may generally include, for example, finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae. A muscular wall called the septum separates the left heart chamber from the right heart chamber. In particular, interatrial septal wall portion 18 (referred to herein as the "atrial septum," "interatrial 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 14 of heart 1 is called the apex, and is generally located at or near the midclavicular line, in the fifth intercostal space.

[0034] The coronary sinus 16 comprises a collection of veins that combine to form a large vessel that collects blood from the heart muscle (myocardium). The ostium of the coronary sinus, which may be at least partially protected in some patients by the Thebesian valve, opens into the right atrium 5 as shown. The coronary sinus runs along the posterior surface of the left atrium 2 and delivers less oxygenated blood to the right atrium 5. The coronary sinus generally runs transverse to the left atrioventricular groove at the posterior side of the heart.

[0035] Health status associated with cardiac pressure and other parameters As referenced above, certain physiological conditions or parameters associated with cardiac anatomy may affect the health of a patient. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, which causes an increase in fluid pressure in one or more heart chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the inefficiency of the heart by causing the body to retain fluid. The accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs causes the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and therefore, the treatment and / or prevention of congestive heart failure is of significant concern in medicine.

[0036] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As explained above, pressure buildup in one or more heart chambers or regions of the heart may be associated with congestive heart failure. Without direct or indirect monitoring of cardiac pressure, it may be difficult to estimate, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve assessing or observing other current physiological conditions of the patient, such as assessing 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 placed or implanted in the pulmonary artery and readings associated therewith may be used as a surrogate for left atrial pressure. However, with regard to catheter-based pressure measurements in the pulmonary artery or certain other heart chambers or regions, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be inconvenient or difficult to implement. Additionally, 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.

[0037] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of the function of the left ventricle of the heart, representing the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow in late diastole caused by atrial contraction (A wave), may be used as a proxy to measure left atrial pressure. The E / A ratio may be determined using echocardiography or other imaging techniques, and generally, abnormalities in the E / A ratio may suggest that the left ventricle is unable to properly fill with blood in the period between contractions, which may lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide an absolute pressure measurement.

[0038] Various methods for identifying and / or treating congestive heart failure involve monitoring the worsening of congestive heart failure symptoms and / or changes in weight. However, such indications may appear to be relatively delayed and / or relatively unreliable. For example, daily weight measurements may vary significantly (e.g., up to 9% or more) and may be unreliable as an indication of heart-related complications. Furthermore, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. In addition, for discharged patients, such treatments may require telemedicine systems.

[0039] The present disclosure provides systems, devices, and methods for directing administration of medications associated with the treatment of congestive heart failure, at least in part, by directly monitoring pressure in the left atrium, or other chambers or vessels, whose pressure measurements are indicative of left atrial pressure and / or pressure levels in one or more other vessels / chambers, for example, to reduce re-hospitalizations, morbidity, and / or improve patient health outlook for patients with congestive heart failure.

[0040] Cardiac Pressure Monitoring Cardiac pressure monitoring according to embodiments of the present disclosure may provide a proactive intervention mechanism for preventing or treating congestive heart failure and / or other physiological conditions. In general, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur prior to the onset of symptoms that lead to hospitalization. For example, cardiac pressure indicators may appear for some patients several weeks prior to hospitalization. Thus, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce hospitalization cases by guiding appropriate or desired drug titration and / or administration prior to the onset of heart failure.

[0041] Dyspnea represents a cardiac pressure index characterized by shortness of breath or a feeling of not being able to breathe adequately. Dyspnea may be due to elevated atrial pressure, which may cause fluid accumulation in the lungs due to backflow of pressure. Pathological dyspnea may be due to congestive heart failure. However, significant time may elapse between the initial pressure rise and the onset of dyspnea, and thus symptoms of dyspnea may not provide a sufficient early indication of elevated atrial pressure. By directly monitoring pressure according to embodiments of the present disclosure, normal ventricular filling pressures can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0042] As referenced above, with respect to cardiac pressure, elevated left atrial pressure may be particularly correlated with heart failure. FIG. 2 shows examples of pressure waveforms associated with various cardiac chambers and vessels, according to one or more embodiments. The various waveforms shown in FIG. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors to the respective illustrated and labeled cardiac chambers or vessels. As shown in FIG. 2, a waveform 25 representing left atrial pressure may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, in general, there may be a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0043] Left atrial pressure may generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlation may weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate adequately with left ventricular end-diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension, which affects approximately 25%-83% of heart failure patients, may affect the reliability of pulmonary artery pressure measurements to estimate left-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, especially for patients with comorbidities such as pulmonary disease and / or thromboembolism. Left atrial pressure may further correlate, at least in part, with the presence and / or degree of mitral regurgitation.

[0044] Left atrial pressure readings may be less likely to be distorted or affected by other conditions, such as respiratory conditions, compared to the other pressure waveforms shown in Figure 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, as well as both diastolic and systolic heart failure, may occur several weeks prior to hospitalization, and thus knowledge of such increases may be used to predict the onset of congestive heart failure, such as acute debilitating symptoms of congestive heart failure.

[0045] Cardiac pressure monitoring, such as left atrial pressure monitoring, may provide a mechanism to guide administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce re-hospitalizations and morbidity, as well as provide other benefits. An implantable pressure sensor according to an embodiment of the present disclosure may be used to predict heart failure two weeks or more prior to the onset of symptoms or markers of heart failure (e.g., dyspnea). When a heart failure prediction is recognized using a cardiac pressure sensor embodiment according to the present disclosure, certain preventative measures may be implemented, including drug interventions, such as modifications to a patient's drug regimen, that may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurements in the left atrium may advantageously provide an accurate indicator of pressure buildup that may lead to heart failure or other complications. For example, a trend in atrial pressure rise may be analyzed or used to determine or predict the onset of cardiac dysfunction, where drugs or other therapies may be augmented to provide a reduction in pressure and prevent or reduce further complications.

[0046] FIG. 3 generally illustrates a graph 300 showing left atrial pressure ranges, including normal ranges 301 of left atrial pressure that are not associated with substantial risk of post-operative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of the present disclosure provide systems, devices, and methods for determining whether a patient's left atrial pressure is within the normal range 301, above the normal range 303, or below the normal range 302, through the use of certain sensor-embedded devices. With respect to a left atrial pressure detected above the normal range, which may correlate with an increased risk of heart failure, embodiments of the present disclosure described in detail below may report efforts to reduce the left atrial pressure until it is within the normal range 301. Additionally, with respect to a left atrial pressure detected below the normal range 301, 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 serve to facilitate efforts to increase the left atrial pressure to bring the pressure level within the normal range 301.

[0047] IMPLANTED DEVICE HAVING INTEGRATED SENSORS - Patent application In some implementations, the present disclosure relates to a sensor associated with or integrated with a cardiac shunt or other implanted device. Such an integrated device may be used to provide controlled and / or more effective therapy for treating and preventing heart failure and / or other health complications related to cardiac function. FIG. 4 is a block diagram illustrating an implanted device 30 comprising a shunt (or other type of implanted) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 may be, for example, a pressure sensor, or other type of sensor. In some embodiments, the sensor 37 comprises a transducer 32, such as a pressure transducer, and a specific control circuit 34, which may be embodied, for example, in an application specific integrated circuit (ASIC).

[0048] The control circuitry 34 may be configured to process signals received from the transducer 32 and / or to wirelessly communicate signals associated with the transducer through biological tissue using the antenna 38. The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies containing one or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any device that manipulates signals (analog and / or digital) based on hard-coding of circuit and / or operational instructions. The control circuitry referred to herein may further comprise one or more storage devices, which may be embodied in a single memory device, multiple memory devices, and / or the device's embedded circuitry. Such data stores may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in embodiments in which the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage / registers that store any associated operating instructions may be incorporated within or external to the circuitry that includes the state machines, analog circuits, digital circuits, and / or logic circuits. The transducer 32 and / or antenna 38 may be considered part of the control circuitry 34.

[0049] The antenna 38 may include one or more coils or loops of conductive material, such as copper wire. In some embodiments, at least a portion of the transducer 32, control circuitry 34, and / or antenna 38 are at least partially disposed or housed within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 36 may, in some embodiments, include glass or other rigid material that may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may advantageously include a polymer or other flexible structure / material that may allow the sensor 37 to bend, flex, or collapse to enable transport through a catheter or other introduction means.

[0050] The transducer 32 may comprise any type of sensor means or mechanism. For example, the transducer 32 may be a force-collecting type pressure sensor. In some embodiments, the transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures the applied strain or deflection across its area / surface. The transducer 32 may be associated with the housing 36 such that at least a portion of the transducer 32 is contained within or attached to the housing 36. With respect to a sensor device / component "associated with" a stent or other implanted structure, such terms may refer to a sensor device or component that is physically coupled, attached, or connected to, or integrated with, the implanted structure.

[0051] In some embodiments, the transducer 32 includes or is a piezoresistive strain gauge component that may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, where resistance increases as pressure deforms the component / material. The transducer 32 may incorporate any type of material, including but not limited to silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0052] In some embodiments, the 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 may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material including, but not limited to, metal, ceramic, silicon, and the like. In some embodiments, the transducer 32 includes or is a component of an electromagnetic pressure sensor and may be configured to measure the displacement of the diaphragm by inductance changes, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials such as quartz.

[0053] In some embodiments, the transducer 32 includes or is a strain gauge component. For example, a strain gauge embodiment may include a pressure sensitive element on or associated with an exposed surface of the transducer 32. In some embodiments, a metal strain gauge may be glued to the surface of the sensor, or a thin film gauge may be applied onto the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. The transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonance, thermal, ionization, or other type of strain or pressure sensor.

[0054] 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 a medical implant device 30 implanted, for example, in the heart (not shown) or associated physiology of the patient 44. For example, the implant device 30 may be at least partially implanted within the left atrium and / or coronary sinus of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as one or more micro-electromechanical system (MEMS) devices (e.g., MEMS pressure sensors, or other types of sensor transducers).

[0055] In certain embodiments, the monitoring system 40 may comprise at least two subsystems, including an implantable internal subsystem or device 30 including a sensor transducer 32, and a control circuit 34 including one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further comprise an external (e.g., non-implantable) subsystem including an external reader 42 (e.g., coil), which may include a wireless transceiver electrically and / or communicatively coupled to the particular control circuit 41. In certain embodiments, both the internal 30 and external 42 subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implant device 30 may be any type of implant device. For example, in some embodiments, the implant device 30 comprises a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or stent device / structure.

[0056] Certain details of the implantation device 30 are shown in the enlarged block 30 shown. The implantation device 30 may include an implantation / anchor structure 39 as described herein. For example, the implantation / anchor structure 39 may include a percutaneously deliverable shunt device configured to be anchored to and / or within a tissue wall to provide a flow path between two chambers and / or blood vessels of the heart, as described in detail throughout this disclosure. Although certain components are shown in FIG. 5 as part of the implantation device 30, it is understood that the sensor implantation device 30 may include only a subset of the components / modules shown and may include additional components / modules not shown. The implantation device may represent an embodiment of the implantation device shown in FIG. 4, or vice versa. The implantation device 30 may advantageously include one or more sensor transducers 32 and may be configured to provide a response indicative of one or more physiological parameters of the patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducer 32 may include any suitable or desired type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the implantation device 30 and / or the patient 44.

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

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

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

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

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

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

[0063] The external local monitor 42 may receive wireless signaling from the implanted device 30 and / or provide wireless power to the implanted device 30 using an external antenna 48, such as a wand device. The reader / antenna interface circuit 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30, which may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, and the like. The reader / antenna interface circuit 43 may further be configured to transmit signals to the remote monitor subsystem or device 46 via a network 49. The RF circuitry of the reader / antenna interface circuit 43 may further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, and the like, for handling / processing signals transmitted via the network 49 and / or for receiving signals from the implanted device 30. In certain embodiments, local monitor 42 includes control circuitry 41 for performing processing of signals received from embedded device 30. Local monitor 42 may be configured to communicate with network 49 according to known network protocols such as Ethernet, Wi-Fi, etc. In certain embodiments, local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0064] In certain embodiments, the embedded device 30 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may include solid state memory utilizing an array of floating gate transistors or the like. The control circuitry 34 may utilize data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 42 or another external subsystem. In certain embodiments, the embedded device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate wireless communication of data generated by the sensor transducer 32, or other data associated therewith. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as, for example, from the local monitor 42 or from the remote monitor 46, via a network 49. For example, the embedded device 30 may be configured to receive signals that at least partially control the operation of the embedded device 30, such as by activating / deactivating one or more components or sensors, or by affecting the operation or performance of the embedded device 30.

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

[0066] In some embodiments, the local monitoring device 42 can function as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 can be a wearable communication device or other device that can be easily placed in close proximity to the patient 44 and the implanted device 30. The local monitoring device 42 can be configured to continuously, periodically, or sporadically poll the implanted device 30 to extract or request sensor-based information therefrom. In certain embodiments, the local monitor 42 includes a user interface that a user can utilize to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0067] The system 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for displaying and / or interacting with the monitored cardiac pressure data. In one embodiment, the local monitor 42 may be a wearable device or other device or system configured to be placed in physical proximity to the patient and / or the implanted device 30, and the local monitor 42 is designed primarily to receive / transmit signals to and / or from the implanted device 30 and provide such signals to the secondary local monitor 47 for display, processing, and / or manipulation. The external local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implanted device 30, such as, for example, a device ID, which may be provided from the implanted device 30 via a data link.

[0068] The remote monitoring subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitor data received over the network 49 from the local monitoring device 42, the secondary local monitor 47, and / or the implanted device 30. For example, the remote monitoring subsystem 46 may be advantageously operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient 44. While certain embodiments disclosed herein describe communicating with the remote monitoring subsystem 46 indirectly from the implanted device via the local monitoring device 42, in certain embodiments, the implanted device 30 may be equipped with a transmitter capable of communicating with the remote monitoring subsystem 46 over the network 49 without the need to relay information through the local monitoring device 42.

[0069] In some embodiments, at least a portion of the transducer 32, control circuitry 34, power source 35, and / or antenna 38 are at least partially disposed or housed within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially 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 the sensor 30 to bend, flex, or collapse to enable transport through a catheter or other percutaneous introduction means.

[0070] Cardiac shunt implantation 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 associated with FIG. 4 or 5) that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular or elliptical opening. The channel 166 may be configured to hold the sides of the puncture opening to a tissue wall to form a blood flow pathway between heart chambers or blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be embedded in a 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 parallel 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 to fit within a catheter (not shown) and then expanded and return to a relaxed shape as shown in FIG. 6.

[0071] Forming the shunt 150 using multiple interconnected struts forming cells between them may serve to at least partially increase the flexibility of the shunt, thereby allowing for its compression and expansion at the implantation site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold tissue at the puncture in an open position. The end walls 172a, 172b of the central flow channel 166 may serve to connect the side walls 170a, 170b and extend between the distal and proximal flanges or arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b together may define a tubular lattice as shown. The end walls 172a, 172b may include thin struts 179 that extend at a slight angle from the central flow axis of the shunt 150.

[0072] The illustrated shunt 150 includes struts that define a tubular or circular lattice of open cells that form a central flow channel 166, although in some embodiments the structures making up the channel form a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated embodiment, the angle of the shunt structure 150 may facilitate collapsing 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. The central flow channel 166 may remain essentially unchanged between the collapsed and expanded states of the shunt 150, whereas the flanges / arms 152, 154 may transition into and out of alignment with the angled flow channel.

[0073] While certain embodiments of the shunts disclosed herein include flow channels having a substantially circular cross-section, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond, or elliptical flow channel configurations. For example, relatively elongated side walls compared to the illustrated configuration of FIG. 5 may produce rectangular or oval flow channels. Shunt flow channels of such shapes are desirable for larger punctures, yet are still configured to collapse into a relatively small delivery profile.

[0074] In some embodiments, each of the distal and proximal flanges / arms 152, 154 are configured to curve outwardly from the end walls 172a, 172b and point generally radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms may serve to anchor the shunt 150 to the target tissue wall. Additional aspects and features of shunt, implantation, and / or anchor structures that may be integrated with the sensor devices / functionality of the presently disclosed embodiments are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 5 and described above, it should be understood that a shunt structure or other implanted device integrated with pressure sensor functionality according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether shunt or other purpose or function.

[0075] 7 illustrates a shunt implant / anchor device / structure 73 implanted in the atrial septum 18, according to one or more embodiments. A particular location within the atrial septal wall 18 may be selected or determined to provide a relatively stable anchor location for the shunt structure 73. Additionally, the shunt device / structure 73 may be implanted in a desired location to allow for future re-crossing of the septal wall 18 for future interventions. Implantation of the shunt device / structure 73 in the atrial septal wall 18 may advantageously allow for fluid communication between the left atrium 2 and the right atrium 5.

[0076] An interatrial shunt using a shunt device / structure 73 may be suitable for patients who are relatively sensitive to elevated atrial pressure. For example, when pressure increases in the ventricles and / or atria and the myocardial cells are subjected to pressure, the heart muscle generally tends to contract and may have a relatively difficult time processing the excess blood. Thus, for patients with impaired ventricular contractility, such patients may be more sensitive to higher ventricular and / or atrium pressures as the heart may not be able to respond or react appropriately to them as the ventricles expand or elongate. Furthermore, elevated left atrial pressure may create dyspnea, and therefore, through an interatrial shunt, it may be desirable to reduce the left atrial pressure to alleviate dyspnea and / or reduce the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they cannot adapt to the accumulation of fluid pressure, such fluid may stagnate in the atria, thereby increasing the atrial pressure. With respect to heart failure, minimization of left ventricular end diastolic pressure may be paramount. Because left ventricular end-diastolic pressure can be related to left atrial pressure, stagnation of fluid in the atrium can cause stagnation of fluid in the lungs, thereby causing undesirable and / or dangerous accumulation of fluid in the lungs. An interatrial shunt, such as using a shunt device according to an embodiment of the present disclosure, can divert excess fluid in the left atrium to the right atrium, which may be able to accommodate the additional fluid due to its relatively high compliance.

[0077] In some implementations, a shunt device / structure according to an embodiment of the present disclosure may be implanted in the wall separating the coronary sinus from the left atrium, such that an interatrial shunt can 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, and several following figures, show a cross-section of the heart in an all-encompassing top-down perspective, with the posterior surface oriented toward the top of the page.

[0078] 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 in some circumstances to a shunt through the interatrial septum. For example, a shunt through the coronary sinus 16 may offer reduced risk of thrombus and emboli. The coronary sinus is less likely to have the presence of thrombi / emboli for several reasons. First, the drainage of blood from the coronary vasculature into the right atrium 5 has just passed through the capillaries and is essentially filtered blood. Second, the ostium 14 of the coronary sinus in the right atrium is often partially covered by a false valve (not shown) called the Thebesius valve. The Thebesius valve is not always present, but several studies indicate that it is present in most hearts and may block 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, so that a thrombus or other emboli in the right atrium is more 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 atrium and the left atrium, and the thrombus / embolus will likely travel further down the coronary vasculature until right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0079] 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 septal tissue. By shunting left atrial blood to the coronary sinus, sinus pressure may be increased by a small amount. This causes blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygen transfer, which may be more efficient and may help the dying myocardium recover. Additionally, by implanting the shunt device / structure 83 into the wall 83 of the coronary sinus, damage to the atrial septum 18 may be prevented. Thus, the atrial septum 18 may be preserved for later transseptal access for alternative therapies. Preservation of transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have several other comorbidities, such as atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions require transseptal access.

[0080] 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 pass to the right atrium 5, and / or deoxygenated blood from the right atrium 5 may pass to the left atrium 2, both of which may be undesirable with respect to the proper functioning of the heart.

[0081] Sensor-integrated embedded devices As mentioned above, the shunt and / or other implanted device / structure may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. A sensor device according to an embodiment of the present disclosure may be integrated with a cardiac shunt structure / device or other implanted device using any suitable or desired attachment or integration mechanism or configuration. FIG. 9-1 shows a side view of a sensor implantation device 60 including a shunt structure 90 and an integrated sensor assembly 61 according to one or more embodiments. In some embodiments, the sensor assembly 61 may be incorporated into or manufactured to the shunt structure 90, at least in part, to form a unitary structure. FIG. 9-2 shows an isolated view of the sensor assembly 61.

[0082] In some embodiments, the sensor assembly 61 includes a sensor component 65 and an antenna component 69. The sensor component 65 may comprise any type of sensor device as described in detail above. In some embodiments, the sensor 65 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 component 65 is associated may generally be associated with a distal or proximal shaft portion 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 (e.g., arm 95) may be associated with an outlet / proximal portion of the shunt structure 90. Although the distal and proximal sides / portions are identified in FIG. 9-1, it should be understood that the identified distal portion / side may be the outlet or inlet side of the shunt structure 90, as well as the identified proximal portion / side. Additionally, the terms “distal” and “proximal” are used for convenience and may or may not refer to a relative orientation with respect to the delivery system / device used to implant the sensor embedding device 60 and / or shunt structure 90.

[0083] The sensor 65 includes a sensor element 67, such as a pressure sensor transducer. With respect to the arm members 94 of the shunt structure 90, the sensor device 65 may be attached / positioned at the distal 64, mid 66, or proximal 68 portions or regions of the arm / anchor 94, or any portion therebetween. For example, the illustrated embodiment of FIG. 9-1 includes a sensor 65 located at the mid region 66 of the arm / anchor 94. In some embodiments, readings obtained by the sensor 65 may be used to guide the titration of medication for the treatment of a patient in which the implanted device 60 is implanted.

[0084] As described herein, the sensor assembly 61 may be configured to implement wireless data and / or power transmission. The sensor assembly 61 may include an antenna component 69 for such purposes. The antenna 69 may be at least partially contained within an antenna housing 79, which may further include certain control circuitry disposed therein configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna component 69 includes one or more conductive coils 62 that may facilitate inductive powering and / or data transmission. In embodiments including conductive coils, such coils may be at least partially wound / disposed around a magnetic (e.g., ferrite, iron) core 63.

[0085] The antenna component 69 may be attached to, integrated with, or otherwise associated with an arm / anchor feature 95 of the shunt structure 90, which arm 95 is a separate arm / anchor from the arm / anchor 94 that supports the sensor device 65. For example, like the sensor component 65, the antenna component 69 may be attached to or otherwise associated with one or more of a distal portion, a middle portion, and / or a proximal portion of the arm 95. In some embodiments, the arm 95 includes an elongated post / arm feature 98 to which the antenna component 69 is secured, while the sensor device 65 may or may not be secured to a similar post / arm mechanism of the arm 94 to which it is associated. For example, fastening / attachment means / mechanisms that may be suitable for attaching the antenna component 69 and / or the sensor component 65 to the respective arms / anchors of the shunt structure 90 may be any of the features disclosed in PCT Application No. PCT / US20 / 56746, filed October 22, 2020, entitled "Sensor Integration in Cardiac Implant Devices," 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 and / or antenna retaining fingers, clamps, wraps, bands, belts, clips, pouches, housings, encasements, and / or the like configured to secure the sensor component 65 and / or antenna component 69 to the respective arms and / or posts, or other structural features of the shunt structure 90.

[0086] As shown in FIG. 9-1, the sensor component 65 and antenna component 69 may advantageously be associated with opposing axial sides / ends / portions of the shunt structure 90, such that when the shunt structure 90 is implanted in a tissue wall, the sensor device 65 and antenna device 69 may be disposed on opposing sides (S1, S2) of the tissue wall. Such a configuration may be advantageous for a variety of reasons. For example, by distributing the sensor device 65 and antenna device across opposing axial sides S1 / S2 (e.g., distal / proximal and / or inlet / outlet sides) of the shunt structure 90, the structural bulk and / or profile of the sensor assembly 61 on any given side of the device 60 may be relatively less than if the entire sensor assembly 61 were disposed on the same axial side of the device 60.

[0087] As described herein, references to an axial side of the shunt structure may refer to the opposite side of a plane P1 that bisects the shunt structure 90 and / or barrel 98 axially (and / or diagonally as in FIG. 9-1). The plane P1 may be orthogonal to the axis of the barrel portion 98 of the shunt structure 90 and / or may be substantially parallel to the tissue wall into which the shunt structure 90 is embedded. That is, when the shunt structure 90 is embedded in a tissue wall (not shown in FIG. 9-1, see FIGS. 12-14), the axis of the barrel 98 may be oblique / angled relative to a line / plane that is perpendicular to the tissue wall surface, and it will be appreciated that references herein to a shunt axis may be understood to refer to an axis / line that is substantially perpendicular to a tissue wall engaging plane (e.g., plane P1 as shown in FIG. 9-1) even in embodiments / cases in which the shunt barrel has a true axis that is angled relative to the tissue engaging plane P1, as shown in FIG. 9-1. Descriptions herein of devices / components disposed on separate axial sides of the implantation structure may be understood to refer to different sides of tissue-engaging plane P1. Plane P1 may be aligned with at least a portion of the struts 91 of the barrel portion 98 of the shunt structure 90 (e.g., within 5° or 10° of exact alignment).

[0088] Additionally, descriptions herein of a sensor assembly and / or components thereof being located 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 the shunt structure includes arms on a given axial side of the shunt structure that emanate from substantially opposing circumferential portions of the barrel 98 of the shunt structure and / or that project in substantially opposing radial directions relative to the axis of the barrel 98 of the shunt structure, such arms may be considered to be on different and / or opposing radial sides of the shunt structure.

[0089] Locating the sensor component 65 and antenna component 69 on opposing axial sides of the shunt structure 90 may further be preferred to allow for placement / exposure of the sensor transducer 67 in one cavity / vessel associated with one side S1 of the tissue wall in which the implantation device 60 is implanted, where side S1 is associated with a vessel / cavity that is a target for monitoring pressure and / or other physiological parameters associated with the sensor component 65, while the antenna component 69 may be located in another vessel / cavity associated with the opposing side S2 of the shunt structure 90 that is not necessarily the target / subject of monitoring. For example, in some instances, the fluid dynamics may be different in the target cavity / vessel on the sensor side S1 than on the opposing side S2 of the tissue wall in which the shunt structure 90 is implanted, and the fluid dynamics of the cavity / vessel on the side S2 associated with the antenna component 69 may be less turbulent than the side S1. Additionally, by locating the structure of the antenna component 69 on the opposing side S2 of the sensor component 65, undesirable obstruction of the sensor target side S1 that may otherwise be introduced by locating the antenna component 69 on the same axial side as the sensor component 65 may be avoided. Additionally, locating the sensor component 69 on the same axial side as the sensor component 65 may result in undesirable obstruction or interference with sensor functionality and / or fluid dynamics associated with the fluid being sensed / monitored, such that the particular configuration shown in FIG. 9-1 may advantageously allow for integration of the sensor assembly 61 with the shunt structure 90 without undesirable interference or impact on the sensor functionality of the sensor device 65. Additionally, by separating / distributing the sensor component 65 and the antenna component 69 as shown in FIG. 9-1 and described in detail herein, delivery of the device 60 in a delivery catheter / sheath and / or other delivery system components may be facilitated and / or the sensor-embedded device 60 may be able to assume a relatively smaller profile delivery / compression configuration, as described in more detail below.

[0090] The sensor assembly 61 may further include an electrical connector 72, which may comprise one or more wires or other electrical conductors configured to transmit electrical signals between the sensor component 65 and the antenna component 69. In some embodiments, the connector 72 includes a coating or other covering configured to provide electrical and / or hermetic sealing / covering of the connector 72. In addition to providing an electrical coupling between the sensor 65 at the antenna 69, the connector 72 may provide a physical tether / coupling between such components of the sensor assembly 61. The physical tethering / coupling of the sensor 65 and the antenna 69 may provide a mechanism to prevent either the sensor 65 or the antenna 69 from becoming detached from the sensor assembly 61, which may result in serious health complications that may result from free movement of components in the cardiac circulation. For example, if one of the sensor 65 or the antenna 69 is removed or detached from the shunt structure 90 and / or the sensor assembly 61, the connector 72 may prevent such detached component from becoming free in the circulation.

[0091] The connector 72 may have a length sufficient to allow for distributed placement of the sensor component 65 and the antenna component 69 on opposite axial sides of the shunt structure, as shown. For example, the length of the connector 72 may be about 0.5 inches or more. For example, the connector 72 may be longer than necessary for purposes of signal communication between the sensor component 65 and the antenna component 69, the purpose of which is to provide a tether between such components having a length sufficient to traverse the axial length of the barrel 98 of the shunt structure 90, as well as certain proximal and / or medial portions of each of the arms 94, 95 of the shunt structure 90 that separates the sensor 65 from the antenna 69.

[0092] 9-1 and various other depicted embodiments of the present disclosure relate to a sensor assembly in which the sensor and antenna components are secured to the shunt / implantation structure on opposite axial sides of the structure, in some embodiments the sensor and antenna components may be associated with the same axial side of the shunt / implantation structure, and the sensor and antenna components may be associated with opposite radial sides of the shunt / implantation structure. For example, connectors electrically and / or physically coupling the sensor and anchor components may traverse the barrel 98 of the shunt structure 90 (such as by crossing the fluid channel 96 formed thereby) or may run along the outside or inside of the shunt barrel 98.

[0093] The sensor assembly 61 may advantageously be biocompatible. For example, the sensor 65 and antenna 69 may comprise a biocompatible housing, such as a housing comprising glass or other biocompatible material. However, at least a portion of the sensor element 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. With respect to the antenna housing 79, the housing 79 may comprise an at least partially rigid cylindrical or tubular form, such as a glass cylinder. In some embodiments, the sensor 65 / 67 components are about 3 mm or less in diameter. The antenna 69 may be about 20 mm or less in length.

[0094] The sensor assembly 61 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 69 may wirelessly receive power from the external system and / or communicate sensed data or waveforms to and / or from the external system. The sensor assembly 61 may be attached to or integrated with the shunt structure 90 in any suitable or desirable manner. For example, in some implementations, the sensor 65 and / or antenna 69 may be attached to or integrated with the shunt structure 90 using mechanical attachment means. In some embodiments, the sensor 65, connector 72, and / or antenna 69 may be housed in a pouch or other receptacle that is attached to the shunt structure 90.

[0095] The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include an at least partially flexible or compressible diaphragm component that may be made from silicone or other flexible material. The diaphragm component may be configured to bend or compress in response to changes in environmental pressure. The control circuitry 74 may be configured to process signals generated in response to said bending / compression to provide a pressure reading. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride). The diaphragm component and / or other components of the pressure transducer 67 may advantageously be fused to or otherwise sealed by the base / housing 77 of the sensor component 65 to provide airtight sealing of at least some of the sensor assembly components.

[0096] The control circuitry 74 may include one or more electronic application specific integrated circuit (ASIC) chips or dies that may be programmed and / or customized or configured to perform the monitoring functions described herein and / or facilitate wireless transmission of the sensor signal. The antenna 69 may include a ferrite core 63 wound with a conductive material in the form of multiple coils 62 (e.g., wire coils). In some embodiments, the coils include copper or other metals. The antenna 69 may be advantageously configured with a coil geometry that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementations, the sensor implantation device 60 may be delivered to the target implantation site using a delivery catheter (not shown), which includes a cavity or channel configured to accommodate advancement of the sensor assembly 61 therethrough.

[0097] FIG 10 illustrates an axial view of the implanted device 60 of FIG 9-1, in accordance with one or more embodiments of the present disclosure. Specifically, FIG 10 illustrates an axial view corresponding to an axial side of the implanted device 60 associated with a sensor component 65. That is, the sensor component 65 is attached to, integrated with, or otherwise associated with an arm 94, with the side shown facing out of the page in FIG 10. The side shown facing out of the page in FIG 10 may be the distal side or the proximal side.

[0098] The sensor component 65 may be mechanically attached or fixed to a portion of the arm 94. The sensor 65 may be attached to the anchor / arm 94 by any suitable or desired attachment means, including adhesive attachment or mechanical engagement. For example, the arm 94 may include or be associated with one or more retention features, which may include one or more clamps, straps, ties, sutures, collars, clips, tabs, and the like. Such retention features may circumferentially house or hold the sensor 65, or a portion thereof. In some embodiments, the sensor 65 may be mechanically attached to the arm 94 by applying a force, either by sliding the sensor 65 through a particular retention feature, or by applying a pressing or other mechanical force to clip, lock, or otherwise engage the sensor 65 to the arm 94. In some embodiments, the shunt structure 90 may include one or more tabs that may be configured to pop up or extend to one or more sides of the sensor 65 for mechanical fixation. Such tabs may include a shape memory metal (e.g., Nitinol) or other at least partially rigid material. In some embodiments, the sensor 65 is pre-attached to the arm 94 and / or integrated therewith prior to implantation. In some embodiments, the sensor 65 may be incorporated into or manufactured into the shunt structure 90 to form a unitary structure. For example, in some embodiments, the sensor 65 may be attached to or integrated with the arm member 94 of the shunt structure 90.

[0099] FIG 11 illustrates another axial view of the implanted device 60 of FIG 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 implanted device 60 associated with the antenna 69. That is, the antenna component 69 is attached to, integrated with, or otherwise associated with the arm 95, with that side shown facing out of the page in FIG 11. The side shown facing out of the page in FIG 11 may be the distal side or the proximal side.

[0100] The antenna component 69 may be mechanically attached or fixed to a portion of the arm 95. The antenna 69 may be attached to the anchor / arm 95 by any suitable or desired attachment means, including adhesive attachment or mechanical engagement. For example, the arm 95 may include or be associated with one or more retention features, which may include one or more clamps, straps, ties, sutures, collars, clips, tabs, and the like. Such retention features may circumferentially receive or hold the antenna 69, or a portion thereof. In some embodiments, the antenna 69 may be attached to the arm 95 by applying a mechanical force, either by sliding the antenna 69 through a particular retention feature, or by applying a pressing or other mechanical force to clip, lock, or otherwise engage the antenna 69 to the arm 95. In some embodiments, the shunt structure 90 may include one or more tabs that may be configured to pop up or extend to one or more sides of the antenna 69 for mechanical fixation. Such tabs may include a shape memory metal (e.g., Nitinol) or other at least partially rigid material. In some embodiments, the antenna 69 is pre-attached to the arm 95 and / or integrated therewith prior to implantation. In some embodiments, the antenna 69 may be incorporated into or manufactured into the shunt structure 90 to form a unitary structure. For example, in some embodiments, the antenna 69 may be attached to or integrated with the arm member 95 of the shunt structure 90.

[0101] As mentioned above, a sensor-integrated shunt implant device according to an embodiment of the present disclosure may be implanted in the wall separating the coronary sinus from the left atrium. FIG. 12 shows a sensor implant device 60 implanted in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. The coronary sinus 16 is generally continuous around the left atrium 2, and thus there are a variety of possible acceptable placements for the implant device 60 and / or the shunt structure 90. The target site selected for placement of the implant device 60 may be within an area where the tissue of a particular patient is thin or low density, as previously determined by non-invasive diagnostic means, such as CT scan or radiography, fluoroscopy or intravascular coronary vasculature echo (IVUS).

[0102] Similar to the other embodiments, the sensor implantation device 60 includes a sensor assembly 61 including a sensor component 65, an antenna component 69, and a connector component 72 that electrically and / or physically couples the sensor component 65 to the antenna component 69. The sensor assembly 61 is disposed, attached, and / or otherwise secured or associated with the implantation structure 90 (e.g., a shunt structure) in a distributed manner as detailed above. For example, as shown, the implantation device 60 can be configured such that the sensor assembly 61 is attached to the implantation device 60 in a manner such that, when implanted, the sensor component 65 is at least partially exposed on the atrial side of the tissue wall 21, while the antenna component 69 is at least partially exposed / disposed on the coronary sinus side of the tissue wall 21. As indicated by the sensor assemblies shown in dashed lines on opposing radial sides of the sensor assembly 61, it should be understood that the sensor assembly 61 may be positioned on any radial / circumferential side / portion of the structure 90, such as, for example, a side relatively closer to the ostium of the coronary sinus and / or the right atrium, or a side oriented away from the ostium of the coronary sinus and / or the right atrium.

[0103] The sensor implantation device 60 may have two sensor assemblies attached to opposite radial sides of the shunt structure 90. In such embodiments, the sensor components (and antenna components) of each sensor assembly may be located on the same axial side or on opposite axial sides of the shunt structure 90. For example, including two sensor assemblies, where the sensor components are located on opposite axial sides of the shunt structure 90, may advantageously allow for measurement of physiological parameters (e.g., pressure) in two cavities / vessels on either side of a tissue wall in which the device 60 is implanted. With pressure sensor capabilities for measuring pressure in both cavities / vessels on either side of a tissue wall, the sensor implantation device 60 may advantageously be configured to provide a sensor signal that may be used to determine a differential pressure across the cavities / vessels. In some embodiments, two sensor assemblies are implemented with the implantation device 60, where the sensor assemblies include different types of sensor components for measuring different parameters. Such sensor components may be located on the same axial side or on opposite sides of the structure 90.

[0104] 13 illustrates a sensor implantation device 60 that is implanted and configured in such a manner that the sensor component 65 is at least partially exposed on the coronary sinus side of the tissue wall 21, while the antenna component 69 is at least partially exposed / located on the atrial side of the tissue wall 21, as shown. As illustrated by the sensor assembly shown in dashed lines on opposing radial sides of the sensor assembly 61, it should be understood that the sensor assembly 61 may be located on any radial / circumferential side / portion of the structure 90, such as, for example, a side relatively closer to the ostium of the coronary sinus and / or right atrium, or a side oriented away from the ostium of the coronary sinus and / or right atrium.

[0105] As mentioned above, a sensor-integrated shunt implant device according to an embodiment of the present disclosure may be implanted in the atrial septum. FIG. 14 shows a sensor implant device 60 implanted in the septal wall 18 between the left atrium 2 and the right atrium 5.

[0106] 14 includes a sensor assembly 61 including a sensor component 65, an antenna component 69, and a connector component 72 that electrically and / or physically couples the sensor component 65 to the antenna component 69. The sensor assembly 61 is disposed, attached, and / or otherwise secured or associated with an implantation structure 90 (e.g., a shunt structure) in a distributed manner as detailed above. For example, as shown, the sensor assembly 61 may be attached to the implantation device 60 in a manner such that, when implanted, the sensor component 65 is at least partially exposed / located on the left atrial side of the septal wall 18, while the antenna component 69 is at least partially exposed / located on the right atrial side of the tissue wall 21, thereby configuring the implantation device 60.

[0107] FIG. 15 shows a sensor implantation device 60 that is implanted and configured in a manner such that the sensor component 65 is at least partially exposed / located on the right atrial side of the tissue wall 21, while the antenna component 69 is at least partially exposed / located on the left atrial side of the tissue wall 21, as shown.

[0108] A particular location of the atrial septal wall 18 may be selected or determined to provide a relatively safe anchor location for the shunt structure 90 and to provide a relatively low risk of thrombus. Additionally, the sensor implantation device 60 may be implanted in a desired location to allow for future recrossing of the septal wall 18 for future interventions. Implantation of the sensor implantation device 60 in the atrial septal wall may advantageously allow for fluid communication between the left atrium 2 and the right atrium 5. With the device 60 in the atrial septum 18, the sensor 65 of the sensor implantation device 60 may advantageously be configured to measure pressure in the right atrium 5, the left atrium 2, or both atria. For example, in some embodiments, the device 60 includes multiple sensors, one sensor located in each of the right atrium 5 and the left atrium 2. With pressure sensor capabilities for measuring pressure in both atria, the sensor implantation device 60 may advantageously be configured to provide a sensor signal that may be used to determine a differential pressure between the atria. Determining the differential pressure may be useful in monitoring fluid accumulation in the lungs that may be associated with congestive heart failure.

[0109] A left-to-right shunt in conjunction with a physiological parameter (e.g., pressure) sensing function, as achieved according to any of the devices and / or implants associated with Figures 12-15, may be advantageously suited to patients who are relatively sensitive to elevated atrial pressure. For example, as pressure increases in the ventricles and / or atria and the myocardial cells are stressed, the heart muscle generally tends to contract and has a relatively difficult time processing the excess blood. Thus, for patients with impaired ventricular contractility, such patients may be more sensitive to higher ventricular and / or atrium pressures as the ventricles expand or elongate, as the heart may not be able to respond or react appropriately thereto. Additionally, elevated pressure on the left side (e.g., left atrium) may create dyspnea, and thus, through a left-to-right shunt, it may be desirable to reduce pressure on the left side to alleviate dyspnea and / or reduce the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they are unable to adapt to the accumulation of fluid pressure, such fluid may stagnate in 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, fluid stagnation in the atrium may cause fluid stagnation in the lungs, thereby causing undesirable and / or dangerous fluid accumulation in the lungs. A left-to-right shunt, such as using a shunt device according to an embodiment of the present disclosure, may divert excess fluid on the left side of the heart to the right side of the heart, where the relatively high compliance of the right atrium may accommodate the additional fluid.

[0110] 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 force the patient to flush excess fluid. Thus, the use of pressure sensor integrated implants according to embodiments of the present disclosure may provide a mechanism to inform 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 serve to prescribe drug interventions to reduce or prevent undesirable increases in left atrial pressure.

[0111] Figures 16-1, 16-2, 16-3, 16-4, and 16-5 provide a flow diagram illustrating a process 1600 for implanting a sensor-embedding device, according to one or more embodiments. Figures 17-1, 17-2, 17-3, 17-4, and 17-5 provide images of cardiac anatomy and specific devices / systems corresponding to the operation of process 1600 of Figures 16-1, 16-2, 16-3, 16-4, and 16-5, according to one or more embodiments of the present disclosure.

[0112] At block 1602, the process 1600 includes providing a delivery system 70 with a sensor embedding device 60 disposed therein in a delivery configuration, such as a shunt-type sensor embedding device as disclosed in detail herein. Image 1702 in FIG. 17-1 illustrates a partial cross-sectional view of a delivery system 70 for a sensor embedding device 60, in accordance with one or more embodiments of the present disclosure. Image 1702 illustrates the sensor embedding device 60 disposed within the outer sheath 50 of the delivery system 70. Although a particular embodiment of a delivery system is illustrated in FIG. 17-1, it should be understood that a sensor embedding device according to aspects of the present disclosure may be delivered and / or implanted using any suitable or desired delivery system and / or delivery system components.

[0113] The illustrated delivery system 70 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 1600. In some embodiments, the shunt structure 90 of the sensor embedding device 60 may be at least partially disposed about 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 1600. For example, the inner catheter 55 may be disposed within a barrel portion 98 of the shunt structure 90, as shown.

[0114] In some embodiments, delivery system 70 may be configured such that guidewire 53 may be at least partially disposed therein. For example, guidewire 53 may run within a region of the shaft of sheath 50 and / or inner catheter 55, such as within inner catheter 55 as shown. Delivery system 70 may be configured to be advanced over guidewire 53 to guide delivery system 70 to the target implantation site.

[0115] In some embodiments, the delivery system 70 includes a tapered nose cone feature 52 that may be associated with the sheath 50, the catheter 55, and / or the distal end of the delivery system 70. In some implementations, the nose cone feature 52 may be utilized to expand an opening in a tissue wall into which the sensor embedding device 60 is embedded or through which the delivery system is advanced. The nose cone feature 52 may facilitate advancement of the distal end of the delivery system 70 through a tortuous anatomy of a patient and / or with an outer delivery sheath or other conduit / pathway. The nose cone 52 may be a separate component from the catheter 55 or may be integrated with the catheter 55. In some embodiments, the nose cone 52 is adjacent to and / or integrated with the distal end of the outer sheath 50. In some embodiments, the nose cone 52 may include and / or be formed from multiple flap-type forms that are urged / spread apart as the sensor embedding device 60 and / or any portion thereof, the inner catheter 55, or other device is advanced therethrough.

[0116] In some embodiments, the sensor-embedding device 60 may be disposed within the delivery system 70 with the sensor assembly 61 attached thereto or otherwise associated therewith, as described in detail herein. In some embodiments, the inner catheter 55 includes one or more cutouts, depressions, recesses, gaps, openings, holes, slits, or other features configured to accommodate the presence of the sensor component 65, antenna component 69, connector 72, and / or other features or aspects of the sensor assembly 61. For example, the sensor assembly 61 may be disposed at least partially within the inner diameter of the shunt structure 90 in the delivery configuration shown in FIG. 17-1. In such a configuration, the sensor assembly components may cause interference with the ability of the shunt structure 90 to be disposed relatively tightly around the inner catheter 55, thereby increasing the profile of the delivery system and / or affecting the ability of the sensor-embedding device 60 to be delivered using the delivery system. 17-1, the inner catheter 55 may include one or more sensor component adjustment features, such as a sensor cutout or other adjustment feature 57 and / or an antenna cutout or other adjustment feature 59. In some embodiments, the adjustment features 57, 59 may be longitudinal and circumferential cutouts in the inner catheter 55. The adjustment features 57, 59 may advantageously be dimensioned to correspond to the size and / or geometry of the respective sensor assembly components, as shown, and may allow the sensor assembly components (e.g., the sensor component 65 and / or the antenna component 69) to protrude radially into the inner diameter / space of the inner catheter 55.

[0117] The implanted sensor device 60 may be positioned within the delivery system 70 with its first end (i.e., the distal anchor arm) disposed distal to the barrel 98 of the shunt structure 90 and / or one or more components of the sensor assembly 61. The second end (i.e., the proximal anchor arm) is positioned at least partially proximal to the barrel 98 of the shunt structure 90 and / or one or more components of the sensor assembly 61.

[0118] The outer sheath 50 may be used to move the sensor implantation device 60 to the target implantation site. That is, the sensor implantation device 60 may be advanced to the target implantation site at least partially within the lumen of the outer sheath 50 such that the sensor implantation device 60 is at least partially retained and / or secured within a distal portion of the outer sheath 50.

[0119] At block 1604, the process 1600 includes accessing the right atrium of the patient's heart using a delivery system 70 having a sensor-embedding device 60 disposed therein. In some implementations, accessing the cardiac anatomy with the delivery system 70 may be performed according to one or more procedures or steps to place a guidewire 53 and form and / or dilate an opening between the left atrium and the coronary sinus of the patient's heart, details of which are omitted for convenience and clarity.

[0120] At block 1606, the process 1600 includes advancing the delivery system into the coronary sinus 16 to a target implantation site adjacent a wall 21 separating the coronary sinus 16 from 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 into the superior vena cava (not shown), into the right atrium 5, and from there into 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.

[0121] In some implementations, the 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 may be placed in a spiral configuration within the left atrium 2, 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, for example, by use of a dilator. A delivery catheter may be advanced through the superior vena cava to the coronary sinus of the heart, where the introducer sheath may provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to create and prepare an opening in the wall of the left atrium, and a separate deployment delivery system 70 is used to deliver the sensor implantation device 60, as shown. In other embodiments, the deployment system 70 may be used as both a fully functional puncture preparation and implantation delivery catheter. In this application, the term "delivery system" is used to refer to a catheter, or introducer, having one or both of these functions.

[0122] At block 1608, the process 1600 includes accessing the left atrium through an opening 99 formed in the wall 21. For example, a guidewire 53 may be positioned to run through the opening 99 prior to penetration of the opening 99 by the nosecone 52. The opening 99 may be first formed using a needle (not shown) associated with the delivery system 70 or other delivery system implemented prior to block 1608. In some implementations, the nosecone feature 52 may be used to at least partially dilate the opening 99, although the opening 99 may have previously been dilated using a balloon dilator or other device.

[0123] At block 1610, the process 1600 includes deploying one or more anchor arms 94, which may be considered as distal anchor arms of the sensor implantation device 60, on the atrial side of the wall 21. The distal arms 94 may be associated with a sensor 65 component of the sensor assembly 61 such that a sensor transducer of the sensor component 65 is exposed within the left atrium 2, such that the sensor component 65 may be used to obtain a signal indicative of a physiological parameter associated with the left atrium, such as pressure.

[0124] At block 1612, the process 1600 includes deploying one or more proximal arms of the sensor implantation device 60 on 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. One of the proximal arms 95 may advantageously be associated therewith with an antenna component 69 that is physically and / or electrically coupled / tethered to the sensor component 65 via a connector 72, as described in detail herein. At block 1614, the process 1600 includes withdrawing the delivery system, leaving the sensor implantation device 60 embedded in the tissue wall 21, such that blood flow may be shunted by the implantation device 60 from the left atrium to the right side of the heart via the coronary sinus 16.

[0125] Additional aspects and features of a process for delivering a shunt structure that 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 No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although the implant device 60 is shown in the left atrium / coronary sinus wall, the implant device 60 may be positioned between other heart chambers, such as between the left and right atrium.

[0126] FIG. 18 is a cutaway view of a human heart and associated vasculature showing a particular catheter access route for implanting a sensor implantation device according to one or more embodiments. FIG. 18 shows various catheters 111 that may be used for implanting a sensor device according to aspects of the present disclosure. The catheters 111 may advantageously be relatively small in cross-sectional profile and steerable to allow for traversal of various blood vessels and cavities through which they may be advanced, such as en route to the right atrium 5, coronary sinus 16, left atrium 2, or other anatomical structures or cavities. Catheter access to the right atrium 5, coronary sinus 16, or left atrium 2 with certain transcatheter solutions may be via the inferior vena cava 16 (shown by catheter 111a) or superior vena cava 19 (shown by catheter 111b). Further access to the left atrium may involve crossing the interatrial septum (e.g., in the area at or near the fossa ovalis).

[0127] Although access to the left atrium is illustrated and described in connection with certain embodiments as via the right atrium and / or inferior vena cava, such as through a transfemoral or other transcatheter procedure, other access routes / methods may be implemented in accordance with embodiments of the present disclosure. For example, other access routes may be employed to the left atrium 2 if septal crossing through the atrial septal wall is not possible. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable, resulting in further damage to the patient. Furthermore, in some patients, the septal wall may be occupied with one or more implanted devices or other therapies, and crossing the septal wall is not tolerable in light of such therapies. As an alternative to transseptal access, transaortic access may be performed, with delivery catheter 111c passing through descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7, and through mitral valve 6 into left atrium 2. Alternatively, transapical access may be performed to access the target anatomical structure, as shown by delivery catheter 111d.

[0128] Additional Embodiments Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0129] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether those features, elements, and / or steps are included or performed in any particular embodiment. Terms such as "comprises," "including," "having," and the like, are synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or" is used in its inclusive sense (and not its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, conjunctive language such as "at least one of X, Y, and Z" is understood with the context as being used generally to convey that an item, term, element, etc., can be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, each be present.

[0130] In the description of the above 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 the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the invention herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0131] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements of structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish the element from other elements having a similar or identical name (other than the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0132] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0133] The spatially relative terms "outside," "inside," "top," "bottom," "lower," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as shown in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device shown in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the illustrative term "below" may include both a lower and upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0134] Unless expressly stated otherwise, comparison and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass the notion of equality. For example, "less" can mean "less than" in the strict mathematical sense as well as "less than or equal to."

Claims

1. A sensor embedding device (60), a shunt body (90) forming a fluid conduit; a first anchor structure (94) associated with a first end of the shunt body; a second anchor structure (95) associated with a second end of the shunt body, the second anchor structure (95) comprising an arm; a sensor device coupled to the first anchor structure; an antenna coupled to the second anchor structure; when the first anchor structure and the second anchor structure protrude radially outward relative to an axis of the fluid conduit, the sensor device and the antenna are radially outward of an axial channel of the fluid conduit; the sensor device and the antenna are within an axial channel of the fluid conduit when the first anchor structure and the second anchor structure protrude axially relative to an axis of the fluid conduit in a delivery configuration of the sensor embedding device; a) the antenna is attached to a distal portion of the arm; or b) the arm comprises an elongated post feature (98), the antenna being attached to the elongated post feature.

2. The sensor embedding device of claim 1 , further comprising an electrical connector electrically connecting said sensor device to said antenna.

3. The sensor implantation device of claim 2 , wherein the electrical connector is disposed at least partially within the fluid conduit of the shunt body.

4. The sensor embedding device of any preceding claim, wherein the antenna comprises a coil wound around a magnetic core.

5. A sensor embedding device as described in any one of claims 1 to 4, wherein the first anchor structure comprises one or more anchor arms configured to extend radially outward relative to an axis of the fluid conduit, and the sensor device is coupled to one of the one or more anchor arms.

6. 6. The sensor implantation device of claim 5, wherein the sensor device includes a sensor transducer including a sensor membrane facing in a direction within 30 degrees of the axis of the fluid conduit.

7. The sensor embedding device of any preceding claim, wherein the shunt body comprises a frame having a plurality of openings therein.

8. 8. A sensor implantation device as described in any of claims 1 to 7, wherein the first anchor structure and the second anchor structure are configured to hold a portion of a tissue wall therebetween, and when the first anchor structure and the second anchor structure hold the portion of the tissue wall, the portion of the tissue wall is positioned between the sensor device and the antenna.

9. 1. A sensor assembly comprising: a sensor device configured to be attached to a first anchor of the artificial shunt implantation device; an antenna coil configured to be attached to a second anchor of the artificial implant device; an electrical connector coupled between the sensor device and the antenna coil.

10. The sensor assembly of claim 9 , wherein the electrical connector is dimensioned to extend through a tissue wall separating the sensor device and the antenna coil.

11. The sensor assembly of claim 9 or claim 10, wherein the antenna coil is configured to receive a sensor signal from the sensor device via the electrical connector and to transmit the sensor signal wirelessly.

12. A sensor-embedded device, comprising: A tubular frame; a first anchoring means associated with a first end of said tubular frame; a second anchoring means associated with a second end of said tubular frame; a sensor device coupled to the first anchoring means; and a wireless transmitter means coupled to said second anchor means.

13. 13. The sensor implantation device of claim 12, further comprising a wire electrically connecting said sensor device to said transmitter means.

14. The sensor embedding device of claim 13 , wherein the wire axially traverses the tubular frame.

15. The sensor embedding device of claim 14 , wherein the wires run inside the tubular frame between the first end and the second end.

16. A sensor embedding device according to any of claims 12 to 15, wherein the wireless transmitter means comprises a conductive coil.

17. 17. The sensor embedding device of claim 16, wherein the conductive coil is wound around a cylindrical magnetic core.

18. the first anchoring means comprising a first anchoring arm configured to extend radially outward relative to an axis of the tubular frame; the sensor device is coupled to the first anchor arm; the second anchoring means comprising a second anchoring arm configured to extend radially outward relative to the axis of the tubular frame; A sensor embedding device according to any of claims 12 to 17, wherein the transmitter means is coupled to the second anchor arm.

19. A sensor embedding device as described in any of claims 12 to 18, wherein when the first anchor means and the second anchor means protrude radially outward relative to the axis of the tubular frame, the sensor device and antenna are radially outward of the tubular frame.

20. 20. The sensor embedding device of claim 19, wherein when the first anchor means and the second anchor means are oriented axially relative to the axis of the tubular frame, the sensor device and the antenna are radially within the tubular frame.

21. 1. A method of manufacturing a shunt implantation device, comprising: forming a shunt structure including a shunt body configured to form a tubular conduit, a first anchor structure associated with a first axial end of the shunt body, and a second anchor structure associated with a second axial end of the shunt body, the second anchor structure comprising an arm; a sensor device coupled to the first anchor structure and an antenna coupled to the second anchor structure such that when the first anchor structure and the second anchor structure protrude radially outward relative to an axis of the tubular conduit, the sensor device and the antenna are radially outward of an axial channel of the tubular conduit, and when the first anchor structure and the second anchor structure protrude axially relative to the axis of the tubular conduit in a delivery configuration of a sensor embedding device, the sensor device and the antenna are within the axial channel of the tubular conduit; a) the antenna is attached to a distal portion of the arm; or b) said arm comprising an elongated post feature (98), said antenna being attached to said elongated post feature.

22. The method of claim 21 , wherein the sensor device is tethered to the antenna by an electrical connector.

23. 23. The method of claim 22, further comprising running the electrical connector through an interior of the tubular conduit.

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