Implant device equipped with shunt channel sensor

Abstract

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

Description

[Technical Field]

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

[0002] The present disclosure generally relates to the field of medical implant devices. [Background Art]

[0003] Various medical procedures involve implanting a medical implant device within the cardiac anatomy. Certain physiological parameters associated with such anatomy, such as fluid pressure, can affect a patient's health prognosis. [Prior Art Documents] [Patent Documents]

[0004] [Patent Document 1] U.S. Patent No. 9789294 Specification [Patent Document 2] International Application No. PCT / US20 / 56746 [Patent Document 3] U.S. Patent Application Publication No. 2017 / 0325976 Specification [Patent Document 4] U.S. Patent Application Publication No. 2010 / 0193999 Specification [Patent Document 5] U.S. Patent No. 9410267 Specification [Summary of Invention] [Means for Solving the Problems]

[0005] This specification describes one or more methods and / or apparatus for facilitating the monitoring of physiological parameters associated with specific cardiac chambers and / or blood vessels of the heart, such as the left atrium, using one or more sensor implant devices.

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

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

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

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

[0010] The sensor implant device may further comprise a plurality of sensor-holding fingers configured to hold a first sensor device to a first anchor structure.

[0011] In some embodiments, the first anchor structure is configured to extend axially with respect to the axis of the fluid conduit in a delivery configuration of the sensor implant device. For example, when the sensor implant device is in a delivery configuration, the sensor transducer of the first sensor device may be located inside the fluid conduit. For example, when the sensor implant device is in a deployment configuration, the sensor transducer of the first sensor device may be located axially outside the fluid conduit.

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

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

[0014] In some implementation examples, the disclosure relates to a sensor implant device comprising a tubular frame having a first diametrical side and a second diametrical side and a first axial end and a second axial end; a first anchor arm associated with the first side and the first end of the tubular frame; a second anchor arm associated with the second side and the first end of the tubular frame; a third anchor arm associated with the first side and the second end of the tubular frame; and a fourth anchor arm associated with the second side and the second end of the tubular frame, wherein each of the first, second, third, and fourth anchor arms has a base and a distal end coupled to the tubular frame, and a first sensor device is coupled to the first anchor arm, and the first sensor device includes a sensor transducer associated with the sensor end of the first sensor device on the opposite side of the base end of the first sensor device. The sensor end of the first sensor device is associated with the base of the first anchor arm, and the base end of the first sensor device is associated with the distal end of the first anchor arm.

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

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

[0017] In some implementation examples, the present disclosure relates to a method for short-circuiting a fluid. The method includes the steps of advancing a shunt implant device to a tissue wall within a delivery catheter, forming an opening in the tissue wall, deploying a first anchor structure of the shunt implant device distal to the tissue wall, wherein the first anchor structure has a sensor device coupled thereto, deploying the body of the shunt implant device into the opening in the tissue wall, and deploying a second anchor structure of the shunt implant device proximal to the tissue wall. The sensor transducer of the sensor device protrudes into a channel region defined by a radial boundary around the axis of the body, the radial boundary being defined by the body.

[0018] For the purpose of summarizing this disclosure, specific aspects, advantages, and novel features are described. It should be understood that not all such advantages can necessarily be achieved according to any particular embodiment. Accordingly, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other advantages that can be taught or suggested herein.

[0019] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the invention. In addition, various features of different disclosed embodiments may be combined to form additional embodiments which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondences between reference elements. [Brief explanation of the drawing]

[0020] [Figure 1] Figure 1 shows an exemplary depiction of a human heart according to one or more embodiments. [Figure 2] Figure 2 shows exemplary pressure waveforms associated with various cardiac chambers and blood vessels of the heart according to one or more embodiments. [Figure 3] Figure 3 shows a graph illustrating the range of left atrial pressure. [Figure 4] Figure 4 is a block diagram representing an implant device according to one or more embodiments. [Figure 5] Figure 5 is a block diagram representing a system for monitoring one or more physiological parameters associated with a patient according to one or more embodiments. [Figure 6] Figure 6 shows an exemplary shunt structure according to one or more embodiments. [Figure 7] Figure 7 shows a shunt structure implanted in the atrial septum according to one or more embodiments. [Figure 8] Figure 8 shows a sensor implant device implanted in a tissue wall between the coronary sinus and the left atrium according to one or more embodiments. [Figure 9-1] Figure 9-1 shows a side view of a sensor implant device according to one or more embodiments. [Figure 9-2] Figure 9-2 shows a sensor assembly / device according to one or more embodiments. [Figure 10-1] Figure 10-1 shows exemplary channel regions associated with a fluid conduit of a respective shunt body according to one or more embodiments. [Figure 10-2] Figure 10-2 shows exemplary channel regions associated with a fluid conduit of a respective shunt body according to one or more embodiments. [Figure 10-3] Figure 10-3 shows exemplary channel regions associated with a fluid conduit of a respective shunt body according to one or more embodiments. [Figure 11]Figure 11 shows an axial view of one embodiment of a shunt-type sensor implant device according to one or more embodiments. [Figure 12] Figure 12 shows an axial view of one embodiment of a shunt-type sensor implant device according to one or more embodiments. [Figure 13] Figure 13 shows a sensor implant device having an associated sutured-wrapped sensor device according to one or more embodiments. [Figure 14] Figure 14 shows a sensor implant device having a sensor holding pouch according to one or more embodiments. [Figure 15] Figure 15 shows a sensor implant device having a sensor holding cup according to one or more embodiments. [Figure 16-1] Figure 16-1 shows a sensor implant device implanted in the tissue wall of the coronary sinus according to one or more embodiments. [Figure 16-2] Figure 16-2 shows a sensor implant device implanted in the tissue wall of the coronary sinus according to one or more embodiments. [Figure 16-3] Figure 16-3 shows a sensor implant device implanted in the tissue wall of the coronary sinus according to one or more embodiments. [Figure 16-4] Figure 16-4 shows a sensor implant device implanted in the tissue wall of the coronary sinus according to one or more embodiments. [Figure 17] Figure 17 shows a sensor implant device implanted in the atrial septum, in which the sensor of the device is exposed in the left atrium, according to one or more embodiments. [Figure 18] Figure 18 shows a sensor implant device implanted in the atrial septum, in which the sensor of the device is exposed in the right atrium, according to one or more embodiments. [Figure 19] Figure 19 shows a dual-sensor implant device implanted in the atrial septum according to one or more embodiments. [Figure 20] Figure 20 shows a dual-sensor implant device implanted in the wall separating the coronary sinus and the left atrium, according to one or more embodiments. [Figure 21] Figure 21 shows a sensor implant device having three associated sensor devices according to one or more embodiments. [Figure 22] Figure 22 shows a sensor implant device having four associated sensor devices according to one or more embodiments. [Figure 23-1] Figure 23-1 provides a flowchart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 23-2] Figure 23-2 provides a flowchart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 23-3] Figure 23-3 provides a flowchart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 23-4] Figure 23-4 provides a flowchart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 23-5] Figure 23-5 provides a flowchart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 24-1] Figure 24-1 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 23-1, according to one or more embodiments. [Figure 24-2] Figure 24-2 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 23-2, according to one or more embodiments. [Figure 24-3] Figure 24-3 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 23-3, according to one or more embodiments. [Figure 24-4] Figure 24-4 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 23-4, according to one or more embodiments. [Figure 24-5]Figure 24-5 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 23-5, according to one or more embodiments. [Figure 25] Figure 25 is a cross-section of the human heart and associated vascular system showing a specific catheter access route for pulmonary vein shunting according to one or more embodiments. [Modes for carrying out the invention]

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

[0022] While 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 uses, as well as their modifications and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred order and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a plurality of distinct operations in a manner that may be useful for understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other embodiments or advantages that may similarly be taught or suggested herein.

[0023] Certain reference numerals are reused across different drawings in the set of drawings of this disclosure for convenience of devices, components, systems, features, and / or modules that may have similar characteristics in one or more respects. However, the reuse of common reference numerals in the drawings with respect to any embodiment disclosed herein does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, a person skilled in the art may understand, by context, to the extent that the use of common reference numerals may imply similarity between the referenced subjects. It can be understood that the use of a particular reference numeral in the context of describing a particular drawing relates to a device, component, aspect, mechanism, module, or system identified in that particular drawing, and not necessarily to any device, component, aspect, mechanism, module, or system identified by the same reference numeral in another drawing. Furthermore, aspects in separate drawings identified by a common reference numeral may be interpreted as sharing characteristics or being completely independent of one another.

[0024] Specific standard anatomical terms for location are used herein to refer to animal, i.e., human, anatomical structures with respect to preferred embodiments. Certain spatially relative terms and similar terms such as “lateral,” “medial,” “upper,” “lower,” “below,” “upper,” “vertical,” “horizontal,” “apex,” and “bottom” are used herein to describe the spatial relationship of one apparatus / element or anatomical structure to another apparatus / element or anatomical structure, but it is understood that these terms are used herein for ease of explanation to describe the positional relationships between elements / structures illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of elements / structures in use or operation, in addition to the orientation shown in the drawings. For example, an element / structure described as being “above” another element / structure may mean that, with respect to the patient or alternative orientation of the element / structure in question, it may mean that it is located below or beside another such element / structure, and vice versa.

[0025] This disclosure relates to systems, apparatus, and methods for monitoring one or more physiological parameters of a patient (e.g., blood pressure) using cardiac shunts and / or other medical implant devices integrated with sensors. In some implementation examples, this disclosure relates to cardiac shunts and / or other cardiac implant devices that incorporate or are associated with pressure sensors or other sensor devices. The term “associated with” is used herein in accordance with its broad and ordinary meaning. For example, where a first feature, element, component, apparatus, or member is described as “associated with” a second feature, element, component, apparatus, or member, such description should be understood to indicate that the first feature, element, component, apparatus, or member is physically coupled, attached, connected, integrated, at least partially embedded, or otherwise physically related to the second feature, element, component, apparatus, or member, directly or indirectly. Specific embodiments relating to cardiac implant devices are disclosed herein. However, while certain principles disclosed herein are particularly applicable to the anatomical structure of the heart, it should be understood that the sensor implant devices relating to this disclosure may be implanted in or configured for implantation in any suitable or desired anatomical structure.

[0026] Cardiac Physiology The anatomical structure of the heart is described below to aid in understanding the concepts of the specific inventions 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, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. The valves may be configured to at least partially control the flow of blood to the respective regions of the heart and / or blood vessels (e.g., lungs, aorta, etc.) in response to the pressure gradient present during the different stages of the cardiac cycle (e.g., relaxation and contraction).

[0027] Figure 1 shows an exemplary depiction of a heart 1 having various features relating to a particular embodiment of the disclosure of the present invention. The heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. With respect to blood flow, blood generally flows from the right ventricle 4 through the pulmonary valve 9 into the pulmonary artery 11, which is configured to open during systole to separate the right ventricle 4 from the pulmonary artery 11 so that blood can be pumped toward the lungs, and to close during diastole to prevent backflow of blood 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.

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

[0029] A heart valve may generally consist of a relatively dense fibrous ring, referred herein to as the annulus, and several leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that, when the heart contracts, the resulting increase in blood pressure generated in the corresponding chamber forces the leaflets to open at least partially, allowing flow from the chamber. As the pressure in the chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant, pushing the leaflets back. As a result, the leaflets / cusps juxtapose with each other, thereby closing the flow path. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can result in valve leakage and / or other health complications.

[0030] Atrioventricular (i.e., mitral and tricuspid) heart valves may further include a group of chordae tendineae and papillary muscles (not shown) for fixing the leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by chordae tendineae. A wall of muscle called a septum separates the left and right cardiac chambers. In particular, the atrial septum portion 18 (referred to herein as the "atrial septum," "atrial septum," or "septum") separates the left atrium 2 and the right atrium 5, while the ventricular septum portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates the left ventricle 3 and the right ventricle 4. The lower end of the heart 1 is called the apex and is generally located on or near the midclavicular line within the fifth intercostal space.

[0031] The coronary sinuses 16 are a group of interconnected veins that form a large vessel for collecting blood from the heart muscle (myocardium). In some patients, the opening of the coronary sinuses, which may be protected at least partially by the Thebesia valve, opens into the right atrium 5, as shown in the figure. The coronary sinuses pass along the posterior surface of the left atrium 2, delivering unoxygenated blood to the right atrium 5. The coronary sinuses generally pass transversely through the groove of the left atrioventricular region, located on the posterior surface of the heart.

[0032] Health status associated with cardiac pressure and other parameters As referenced above, certain physiological conditions or parameters associated with cardiac anatomical structures can affect a patient's health. For example, congestive heart failure is a condition associated with the relatively slow movement of blood through the heart and / or body, which increases fluid pressure in one or more chambers of the heart. As a result, the heart does not pump enough oxygen to meet the body's needs. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood to pump through the body, or by becoming relatively stiff and / or thicker. The heart walls may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the heart's inefficiency by allowing the body to retain fluid. Accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs can cause the body to become congested, a condition known as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and death, and therefore, the treatment and / or prevention of congestive heart failure is a matter of great concern in medicine.

[0033] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may, to their advantage, include monitoring pressure within one or more cardiac chambers or regions of the heart or other anatomical structures. As described above, elevated pressure within one or more cardiac 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 development of congestive heart failure. For example, treatments or techniques that do not involve direct or indirect pressure monitoring may include measuring or observing other current physiological conditions of the patient, such as measuring body weight, chest impedance, right heart catheter insertion, etc. In some solutions, pulmonary artery wedge pressure may be measured as a substitute for left atrial pressure. For example, a pressure sensor may be placed or implanted in the pulmonary artery, and the associated reading may be used as a substitute for left atrial pressure. However, with respect to catheter-based pressure measurement in the pulmonary artery or certain other cardiac chambers or regions of the heart, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be uncomfortable or difficult to implement. Furthermore, certain lung-related conditions can affect pressure readings within the pulmonary artery, potentially leading to an undesirable weakening of the correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurement, pressure measurements in the right ventricular outflow tract may also be relevant to left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be used for the diagnosis, prevention, and / or treatment of congestive heart failure.

[0034] Additional solutions may be employed to derive or infer left atrial pressure. For example, the E / A ratio, a marker of left ventricular function of the heart, which represents the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow in late diastole (A wave) caused by atrial contraction, can be used as an alternative to measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques, and generally, an abnormal E / A ratio may suggest that the left ventricle is unable to adequately fill with blood during the interval between contractions, which can lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide a measure of absolute pressure.

[0035] Various methods for identifying and / or treating congestive heart failure include observing the worsening of symptoms and / or changes in body weight. However, such signs may appear relatively delayed and / or relatively unreliable. For example, daily body weight measurements can fluctuate significantly (e.g., by up to 9%) and may be unreliable in signaling cardiac complications. Furthermore, treatments induced by monitoring signs, symptoms, body 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.

[0036] This disclosure provides systems, apparatus, and methods for inducing the administration of drugs at least partially related to the treatment of congestive heart failure, such as in patients with congestive heart failure, by directly monitoring the left atrium or pressure in other cardiac chambers or vessels where pressure measurements indicate left atrial pressure and / or pressure levels in one or more vascular / cardiac chambers, in order to reduce readmission, morbidity, and / or improve the patient's health outlook.

[0037] Monitoring of cardiac pressure Cardiac pressure monitoring according to the embodiments of this disclosure may provide an active intervention mechanism for preventing or treating congestive heart failure and / or other physiological conditions. Generally, increases in ventricular filling pressure associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, indicators of cardiac pressure may appear in some patients several weeks before hospitalization. Therefore, pressure monitoring systems according to the embodiments of this disclosure may be advantageously implemented to reduce hospitalization cases by inducing appropriate or desired titration and / or administration of medications before the onset of heart failure.

[0038] Dyspnea represents a cardiac pressure index characterized by shortness of breath or a feeling of being unable to breathe properly. Dyspnea may result from elevated atrial pressure, which can cause fluid accumulation in the lungs due to pressure regurgitation. Pathological dyspnea may result from congestive heart failure. However, a significant time may elapse between the initial pressure increase and the onset of dyspnea, and therefore, the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to embodiments of this disclosure, normal ventricular filling pressure can be favorably maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

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

[0040] Left atrial pressure can generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may show a significant correlation, such correlations can weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate well 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% to 83% of heart failure patients, can affect the reliability of pulmonary artery pressure measurement for estimating left-sided filling pressure. Therefore, as represented by waveform 24, pulmonary artery pressure measurement alone can be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, especially in patients with complications such as lung disease and / or thromboembolism. Left atrial pressure can further correlate, at least partially, with the presence and / or degree of mitral regurgitation.

[0041] Left atrial pressure readings may be relatively less likely to be distorted or affected by other conditions, such as respiratory status, compared to other pressure waveforms shown in Figure 2. In general, left atrial pressure can significantly predict heart failure, up to two weeks before its onset. For example, an increase in left atrial pressure, as well as both diastolic and systolic heart failure, can occur several weeks before hospitalization; therefore, recognizing such an increase can be used to predict the onset of congestive heart failure, such as acute debilitating symptoms of congestive heart failure.

[0042] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide a mechanism for inducing the administration of medications to treat and / or prevent congestive heart failure. Such treatments may, advantageously, reduce readmission and morbidity, and may also provide other benefits. Implantable pressure sensors according to embodiments of this disclosure may be used to predict heart failure at least two weeks before the onset of symptoms or markers of heart failure (e.g., dyspnea). If predictors of heart failure are recognized using embodiments of the cardiac pressure sensors according to this disclosure, certain precautionary measures may be taken, including pharmacological interventions such as modifications to the patient's medication regimen, which may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium may advantageously provide an accurate indicator of pressure elevation that may lead to heart failure or other complications. For example, a trend of atrial pressure elevation may be analyzed or used to determine or predict the onset of cardiac dysfunction, and medications or other therapies may be extended to induce pressure reduction and prevent or reduce further complications.

[0043] Figure 3 shows a graph 300 showing left atrial pressure ranges, including a normal range 301 of left atrial pressure that is not generally associated with a substantial risk of postoperative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of the present disclosure provide systems, apparatus, 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, using a specific sensor implant device. With respect to left atrial pressure detected above the normal range, which may correlate with an increased risk of heart failure, embodiments of the present disclosure, as detailed below, may report the effort required to reduce the left atrial pressure until it is within the normal range 301. Furthermore, with respect to 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, as detailed below, may function to facilitate the effort required to increase the left atrial pressure to bring the pressure level within the normal range 301.

[0044] Implant device with built-in sensor In some implementations, this disclosure relates to sensors associated with or integrated with cardiac shunts or other implantable devices. Such integrated devices may be used to provide controlled and / or more effective therapies for treating and preventing heart failure and / or other health complications associated with cardiac function. Figure 4 is a block diagram showing an implantable device 30 comprising a shunt (or other type of implant) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 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 integrated, for example, within an application-specific integrated circuit (ASIC).

[0045] The control circuit 34 may be configured to process signals received from the transducer 32 and / or to communicate signals associated with the transducer wirelessly through biological tissue using the antenna 38. The term “control circuit” is used herein in accordance with its broad and ordinary meaning and may refer to any group of devices that manipulate signals (analog and / or digital) based on hardcoding of circuits and / or operation instructions, including processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including one or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or circuits and / or operation instructions. The control circuits referred herein may further comprise a single memory device, multiple memory devices, and / or one or more memory devices that can be integrated within the embedded circuitry of a device. Such data storage units 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 devices for storing digital information. In embodiments in which the control circuit includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, it should be noted that data storage devices / registers for storing any associated operation instructions may be incorporated within or outside the circuit including the state machine, analog circuits, digital circuits, and / or logic circuits. The transducer 32 and / or antenna 38 may be considered part of the control circuit 34.

[0046] The antenna 38 may comprise one or more coils or loops of a conductive material, such as copper wire. In some embodiments, the transducer 32, the control circuit 34, and / or at least a portion of the antenna 38 may comprise any kind of material and, advantageously, be at least partially disposed or contained within a sensor housing 36 that can be at least partially sealed. For example, the housing 36 may comprise glass or other rigid material that can 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 comprise a polymer or other flexible structure / material that can advantageously allow the sensor 37 to be bent, flexed, or crushed, and allow its transport through a catheter or other introduction means.

[0047] The transducer 32 may comprise any type of sensor means or mechanism. For example, 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 a region / surface thereof. The transducer 32 may be associated with the housing 36 such that at least a portion of it is contained within or mounted therein. With respect to sensor devices / components "associated with" a stent or other implant structure, such term may refer to sensor devices or components that are physically coupled, attached, connected to, or integrated with the implant structure.

[0048] In some embodiments, the transducer 32 may include, or be, a component of a piezoresistive strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain caused by applied pressure, the resistance of which increases as the 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 similar.

[0049] In some embodiments, the transducer 32 includes, or is, a component of a capacitive pressure sensor, which includes a diaphragm and a pressure cavity configured to form a variable capacitor in order to detect strain resulting from pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor can generally decrease as the pressure deforms the diaphragm. The diaphragm can include, but is not limited to, any material, including metal, ceramic, silicon, etc. In some embodiments, the transducer 32 includes, or is, a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by change in inductance, function as a linear variable displacement transducer (LVDT), 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 a sensor may measure strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0050] In some embodiments, the transducer 32 includes or is a component of a strain gauge. For example, an embodiment of the strain gauge may include a pressure-sensitive element on or associated with the exposed surface of the transducer 32. In some embodiments, a metal strain gauge may be bonded to the surface of the sensor, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. The transducer 32 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionizing, or other type of strain or pressure sensor.

[0051] Figure 5 shows 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 in, for example, the patient 44's heart (not shown) or related physiological function. For example, the implant device 30 may be at least partially implanted in the left atrium and / or coronary sinus of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as one or more microelectromechanical systems (MEMS) devices (e.g., MEMS pressure sensors or other types of sensor transducers).

[0052] In certain embodiments, the monitoring system 40 may comprise at least two subsystems, including a portable internal subsystem or device 30, which includes a control circuit 34 comprising a sensor transducer 32, as well as 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-portable) subsystem, which may include an external reader 42 (e.g., a coil) that includes a wireless transceiver electrically and / or communicatively coupled to a particular control circuit 41. In certain embodiments, both the internal subsystem 30 and the external subsystem 42 include corresponding coil antennas for wireless communication and / or power supply through patient tissue positioned between them. The sensor implant device 30 can be any type of implant device. For example, in some embodiments, the implant device 30 comprises a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or stent device / structure.

[0053] Specific details of the implant device 30 are shown in the enlarged block 30 shown in the illustration. The implant device 30 may include an implant / anchor structure 39 as described herein. For example, the implant / anchor structure 39 may include a percutaneously deliverable shunt device configured to be fixed to and / or within a tissue wall to provide a flow path between two cardiac chambers and / or blood vessels of the heart, as described in detail throughout this disclosure. While certain components are shown in Figure 5 as part of the implant device 30, it should be understood that the sensor implant device 30 may comprise only a subset of the illustrated components / modules and may comprise additional components / modules not shown. The implant device may represent an embodiment of the implant device shown in Figure 4, and vice versa. The implant device 30 may advantageously include one or more sensor transducers 32, which may be configured to provide a response indicating one or more physiological parameters of a patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducer 32 may comprise any suitable or desirable type of sensor transducer for providing signals related to physiological parameters or conditions associated with the implant device 30 and / or the patient 44.

[0054] The sensor transducer 32 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, diaphragm-based sensors, and / or other types of sensors that can 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 its area / surface. The transducer 32 may be associated with a sensor housing 36 such that at least a portion of it is contained within or mounted therein.

[0055] In some embodiments, the transducer 32 may include or be a component of a strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain resulting from applied pressure. For example, the transducer 32 may include or be a component of a piezoresistive strain gauge, where the resistance increases as the pressure deforms the component / material of the strain gauge. The transducer 32 may incorporate any type of material, including but not limited to silicon, polymers, silicon (e.g., single crystal), polysilicon thin films, bonded metal foil, thick films, silicon-on-sapphire, sputtered thin films, and / or similar. In some embodiments, the metal strain gauge may be bonded to the sensor surface, or the thin film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. The transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonance, thermal, ionization, or other types of strain or pressure sensors.

[0056] In some embodiments, the transducer 32 includes or is a component of a capacitive pressure sensor, which includes a diaphragm and a pressure cavity configured to form a variable capacitor in order to detect strain resulting from pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor can generally decrease as the pressure deforms the diaphragm. The diaphragm can include any material, but is not limited to, metal, ceramic, silicon, silicon or other semiconductors. In some embodiments, the transducer 32 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by a change in inductance, the function of a linear variable displacement transducer (LVDT), the Hall effect, or eddy current sensing. In some embodiments, the transducer 32 comprises or is a component of a piezoelectric strain sensor. For example, such a sensor may measure strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0057] In some embodiments, the converter 32 is electrically and / or communicatively coupled to a control circuit 34, which may include one or more application-specific integrated circuit (ASIC) microcontrollers or chips. The control circuit 34 may further include one or more discrete electronic components such as tuning capacitors, resistors, diodes, and inductors.

[0058] In certain embodiments, the sensor transducer 32 may be configured to generate an electrical signal that can be transmitted wirelessly to a device outside the patient's body, such as the illustrated local external monitoring system 42. To carry out such wireless data transmission, the implantable device 30 may include a signal processing circuit and a radio frequency (RF) (or other frequency band) transmission circuit, such as an antenna 38. The antenna 38 may include an antenna coil implanted in the patient. The control circuit 34 may comprise any kind of transceiver circuit configured to transmit an electromagnetic signal, which may be emitted by the antenna 38, which may comprise one or more conductive wires, coils, substrates, etc. The control circuit 34 of the implantable device 30 may comprise one or more chips or dies configured to perform some amount of processing on the signal generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implantable device 30 may not include independent processing capabilities in some embodiments.

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

[0060] The external local monitor 42 may use an external antenna 48, such as a wand device, to receive radio signal transmissions from the implant device 30 and / or provide radio power to the implant device 30. The reader / antenna interface circuit 43 may include a radio frequency (RF) (or other frequency band) front-end circuit configured to receive and amplify signals from the implant device 30, such a circuit may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, etc. The reader / antenna interface circuit 43 may be further configured to transmit signals to the remote monitoring subsystem or device 46 via the network 49. The RF circuit of the reader / antenna interface circuit 43 may further include one or more digital-to-analog converters (DACs), power amplifiers, low-pass filters, antenna switch modules, antennas, etc., for handling / processing the transmitted signals via the network 49 and / or for receiving signals from the implant device 30. In certain embodiments, the local monitor 42 includes a control circuit 41 for processing signals received from the implant device 30. The local monitor 42 may be configured to communicate with a network 49 according to known network protocols such as Ethernet®, Wi-Fi®, etc. In certain embodiments, the local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0061] In certain embodiments, the implant device 30 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating-gate transistors. The control circuit 34 may utilize the data storage to store sensed data collected over a period of time, and the stored data may be periodically transmitted to the local monitor 42 or another external subsystem. In certain embodiments, the implant device 30 does not include any data storage. The control circuit 34 may be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuit 34 may be further configured to receive input from one or more external subsystems, for example, from the local monitor 42 or from the remote monitor 46 via the network 49. For example, the implant device 30 may be configured to receive signals that at least partially control the operation of the implant device 30, such as by activating / deactivating one or more components or sensors, or by otherwise affecting the operation or performance of the implant device 30.

[0062] One or more components of the implant device 30 may be powered by one or more power sources 35. Due to concerns about size, cost, and / or electrical complexity, it may be desirable for the power sources 35 to be relatively minimal in nature. For example, high-power drive voltages and / or currents within the implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In certain embodiments, the power sources 35 are at least partially passive in nature so that power can be received wirelessly from an external power source by the passive circuit of the implant device 30, such as through short-range or near-range wireless power transmission or the use of other electromagnetic coupling mechanisms. For example, a local monitor 42 may act as an initiator that actively generates an RF field that can supply power to the implant device 30, thereby allowing the power circuit of the implant device to take on relatively simple configuration factors. In certain embodiments, the power sources 35 may be configured to obtain energy from an environmental source such as fluid flow or motion. Additionally or alternatively, the power supply 35 may be equipped with a battery, which may be advantageously configured to provide sufficient power as needed over the monitoring period (e.g., 3 days, 5 days, 10 days, 20 days, 30 days, 40 days, or 90 days, or other periods).

[0063] In some embodiments, the local monitoring device 42 may function as an intermediate communication device between the implant device 30 and the remote monitor 46. The local monitoring device 42 may be a dedicated external unit designed to communicate with the implant device 30. For example, the local monitoring device 42 may be a wearable communication device or other device that can be easily positioned in close proximity to the patient 44 and the implant device 30. The local monitoring device 42 may be configured to continuously, periodically, or sporadically examine the implant device 30 to extract or request sensor-based information from it. In certain embodiments, the local monitor 42 may have a user interface that the user can utilize to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implant device 30.

[0064] System 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device, configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. In one embodiment, the local monitor 42 may be a wearable device or other device or system configured to be positioned in physical proximity to the patient and / or implant device 30, and the local monitor 42 is primarily designed to receive / transmit signals to and from the implant device 30 and provide such signals to the secondary local monitor 47 for viewing, processing, and / or manipulating. The external local monitoring system 42 may be configured to receive and / or process certain metadata from or associated with the implant device 30, such as a device ID, which may also be provided via data linkage from the implant device 30.

[0065] The remote monitoring subsystem 46 may be any type of computing device or group of computing devices configured to receive, process, and / or present monitoring data received from the local monitoring device 42, the secondary local monitor 47, and / or the implant device 30 via the network 49. For example, the remote monitoring subsystem 46 may be operated and / or controlled to the advantage of a healthcare entity, such as a hospital, a physician, or other care entity associated with the patient 44. Although certain embodiments disclosed herein describe communication with the remote monitoring subsystem 46 indirectly from the implant device via the remote monitoring device 42, in certain embodiments the implant device 30 may include a transmitter capable of communicating with the remote monitoring subsystem 46 via the network 49 without the need to relay information through the remote monitoring device 42.

[0066] In some embodiments, at least a portion of the transducer 32, control circuit 34, power supply 35, and / or antenna 38 is at least partially disposed or contained within a sensor housing 36, which may comprise any kind of material and may be at least partially sealed. For example, in some embodiments, the housing 36 may comprise glass or other rigid material that can 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 comprise a polymer or other flexible structure / material that may advantageously allow the sensor 30 to be bent, flexed, or crushed, and allow its transport through a catheter or other percutaneous delivery means.

[0067] Cardiac shunt implant Figure 6 shows 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., an anchor and / or cardiac implant structure 39 associated with Figure 4 or Figure 5) that can be integrated with the function of a pressure sensor according to a particular embodiment disclosed herein. The shunt structure 150 may be an expandable shunt. The central flow channel 166 of the shunt 150 may define a substantially circular or oval opening when expanded. The channel 166 may be configured to hold the sides of a puncture opening in a tissue wall to form a blood flow pathway between cardiac chambers or blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be implanted in a wall separating the coronary sinus from the left atrium. The central flow channel 166 may be partially formed by a pair of side walls 170a, 170b defined by a substantially parallelogram arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, the substantially entire shunt 150 is formed by a superelastic support configured to be compressed, inserted into a catheter (not shown), and then expanded to return to a relaxed shape, as shown in Figure 6.

[0068] Forming the shunt 150 using multiple interconnected struts that form cells in between may serve to at least partially increase the flexibility of the shunt, thereby allowing its compression and expansion at the implant site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold the punctured tissue in an open position. The end walls 172a, 172b of the central flow channel 166 may connect the side walls 170a, 170b and serve to extend between the distal and proximal flanges, or between the arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b together may define a tubular grid 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.

[0069] The illustrated shunt 150 includes supports defining a tubular or circular grid of open cells forming a central flow channel 166, although in some embodiments, the structures constituting the channel form a substantially continuous wall surface over at least a portion of the channel 166. In the illustrated embodiments, the inclination of the shunt structure 150 can facilitate the collapse of the shunt into a delivery catheter (not shown), as well as the expansion of flanges / arms 152, 154 on both sides of the target tissue wall. The central flow channel 166 may remain essentially unchanged between the collapsed and expanded states of the shunt 150, while the flanges / arms 152, 154 can transition between alignment and misalignment with the angled flow channel.

[0070] While certain embodiments of the shunts disclosed herein include flow channels / barrels having substantially circular cross-sections, in some embodiments, the shunt structures according to this disclosure have oval, rectangular, rhomboid, or oval flow channel configurations. For example, relatively elongated sidewalls compared to the configuration illustrated in Figure 6 may produce rectangular or oval flow channels. Shunt flow channels of such shapes are desirable for larger punctures, while still configured to collapse to a relatively small delivery profile.

[0071] In some embodiments, the distal and proximal flanges / arms 152, 154, respectively, are configured to curve outward from the end walls 172a, 172b and point substantially radially away from the central flow channel 166 of the expanded configuration. The expanded flanges / arms may function to anchor the shunt 150 to the target tissue wall. Additional embodiments and mechanisms of shunt, implant, and / or anchor structures that may be integrated with the sensor device / function of embodiments of this disclosure are disclosed in Patent Document 1, entitled “Expandable Cardiac Shunt,” published October 17, 2017, the entire disclosure of which is expressly incorporated herein by reference. While certain embodiments are shown in Figure 6 and disclosed herein in relation to shunt structures similar to those described above, it should be understood that shunt structures or other implant devices integrated with the function of a pressure sensor according to embodiments of this disclosure may have any kind, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether for short-circuiting or other purposes or functions.

[0072] Figure 7 shows a shunt implant / anchor device / structure 73 implanted in the atrial septum 18 according to one or more embodiments. A specific location within the atrial septum 18 may be selected or determined to provide a relatively stable anchor position for the shunt structure 73. Furthermore, the shunt device / structure 73 may be implanted in a desirable location considering future recrossing of the atrial septum 18 for future interventions. Implantation of the shunt device / structure 73 within the atrial septum 18 may advantageously enable fluid communication between the left atrium 2 and the right atrium 5.

[0073] Interatrial shunts using shunt devices / structures 73 may be well-suited for patients who are relatively sensitive to increased atrial pressure. For example, when pressure rises in the ventricles and / or atria and is applied to the cardiomyocytes, the heart muscle may generally be relatively less able to contract to process the excess blood. Therefore, in patients with impaired ventricular contractility when the ventricles expand or contract, the heart may not be able to respond or react appropriately to it, and such patients may be more sensitive to higher pressures in the ventricles and / or atria. Furthermore, increased left atrial pressure can lead to dyspnea, and therefore, reducing left atrial pressure by an interatrial shunt may be desirable to reduce dyspnea and / or lower the incidence of readmission. For example, if the ventricles experience dysfunction that prevents them from coping with increased fluid pressure, such fluid may flow back into the atria, thereby increasing atrial pressure. With regard to heart failure, minimizing left ventricular end-diastolic pressure may be of paramount importance. Because left ventricular end-diastolic pressure may be related to left atrial pressure, fluid regurgitation within the atrium can cause fluid regurgitation within the lungs, thereby leading to an undesirable and / or dangerous accumulation of fluid in the lungs. An interatrial shunt, such as using a shunt device according to the embodiments of this disclosure, can divert excess fluid from the left atrium to the right atrium, which, due to the relatively high compliance of the right atrium, can accommodate additional fluid.

[0074] In some implementations, the shunt device / structure according to the embodiments of this disclosure may be implanted in the wall separating the coronary sinus from the left atrium, thereby enabling an interatrial shunt 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 of the following figures, show cross-sections of the heart from an upper oblique view, from top to bottom, with the posterior surface oriented on top of the page.

[0075] In some cases, a left-to-right shunt through the implantation of a shunt device 83 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable to a shunt through the atrial septum. For example, a shunt through the coronary sinus 16 may offer a reduced risk of thrombosis and embolism. The coronary sinus is less likely to have thrombi / embolus present for several reasons. Firstly, the blood draining from the coronary vascular system into the right atrium 5 is essentially filtered blood, having just passed through the capillaries. Secondly, the opening 14 of the coronary sinus in the right atrium is often partially covered by a false valve called the Thebesius valve (not shown). The Thebesius valve is not always present, but some studies suggest it is present in most hearts and can block thrombi or other embolisms from entering during events of spikes in right atrial pressure. Thirdly, the pressure gradient between the coronary sinus and the right atrium through which it is drained is generally relatively low, and as a result, thrombi or other embolisms in the right atrium may remain there. Fourthly, in cases where a thrombus / embolus enters the coronary sinus, there is a much greater gradient between the right atrium and the coronary vascular system than between the right and left atria. The thrombus / embolus will most likely continue to move along the coronary vascular system until the right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0076] One additional advantage of placing the shunt structure 83 between the left atrium and the coronary sinus is that this anatomical structure is generally more stable than the atrial septal tissue. By diverting left atrial blood to the coronary sinus, sinus pressure can increase by a small amount. This allows blood in the coronary vascular system to move more slowly through the heart, increasing perfusion and oxygen delivery, which can be more efficient and may help in the recovery of dying myocardium. Furthermore, by implanting the shunt device / structure 83 into the wall of the coronary sinus 83, damage to the atrial septum 18 can be prevented. Thus, the atrial septum 18 can be preserved for later transseptal access for alternative therapies. Preserving transseptal access can be advantageous for a variety of reasons. For example, patients with heart failure often have several other comorbidities, such as atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions require transseptal access.

[0077] It should be noted that, in addition to the various advantages of placing the implant structure 83 between the coronary sinus 16 and the left atrium 2, certain disadvantages may also 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 into the right atrium 5 and / or unoxygenated blood from the right atrium 5 may pass into the left atrium 2, both of which may be undesirable in terms of proper cardiac function.

[0078] Sensor-integrated implant device As described above, shunts and / or other implant devices / structures may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. Sensor devices according to embodiments of this disclosure may be integrated with cardiac shunt structures / devices or other implant devices using any suitable or desirable mounting or integration mechanism or configuration.

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

[0080] In some embodiments, the sensor device / assembly 60 includes components of a sensor transducer 65 and components of an antenna 61. The sensor transducer components 65 may include any type of sensor transducer detailed above. In some embodiments, the sensor device 60 may be attached to or integrated with an arm member 94 of a shunt structure 90, as shown in the figures. For example, the arm 94 to which the sensor device 60 is associated may generally be associated with a distal or proximal axial portion / end of the shunt structure 90. That is, if the shunt structure 90 is implanted, one or more arms of the shunt structure 90 may be associated with the inlet / distal portion of the shunt structure 90, while one or more other anchor arms may be associated with the outlet / proximal portion of the shunt structure 90. While distal and proximal lateral / parts are relevant to some extent herein, it should be understood that an identified distal portion / lateral, like an identified proximal portion / lateral, may be the outlet or inlet side of the associated shunt structure. Furthermore, the terms “distal” and “proximal” are used for convenience and may or may not refer to the relative orientation of the delivery system / device used to implant the associated sensor implant device and / or shunt structure.

[0081] The sensor transducer components 65 include a sensor element 67 such as a pressure sensor transducer / membrane. With respect to the arm member 94 of the shunt structure 90, the sensor device 60 may be mounted / positioned on the distal 64, inner 66, or proximal 68 portion or region of the arm / anchor 94, or any portion in between. For example, the embodiment illustrated in Figure 9-1 includes a sensor device 60 positioned primarily on the inner region 66 and distal region 64 of the arm / anchor 94. In some embodiments, readings obtained by the sensor device 60 may be used to guide the titration of a drug for the treatment of a patient to whom the implant device 70 is implanted.

[0082] As described herein, the sensor device 60 may be configured to implement wireless data and / or power transmission. The sensor device 60 may include an antenna component 61 for such purposes. The antenna 61, as well as one or more other components of the sensor device 60, may be at least partially contained within a sensor housing 69, the sensor housing may further house certain control circuits 62 configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna component 61 includes one or more conductive coils 63 that can facilitate inductive power feeding and / or data transmission. In embodiments including conductive coils, such coils may be at least partially packaged / arranged around a magnetic (e.g., ferrite, iron) core 79.

[0083] In some embodiments, the arm 94 includes an elongated column / arm mechanism to which the sensor device 60 is fixed. The sensor device 60 may be fixed to the anchor arm 94 using any suitable means or mechanism. For example, suitable fixing / mounting means / mechanisms for attaching the sensor device 60 to any of the arms of the shunt structure 90 may be any mechanism disclosed in Patent Document 2, filed October 22, 2020, entitled “Sensor Integration in Cardiac Implant Devices,” the contents of which are expressly incorporated herein in their entirety by reference. For example, the shunt structure 90 and / or its arms may include one or more sensor-holding fingers, clamps, wraps, bands, belts, clips, pouches, housings, casings, and / or similar configured to fix the sensor device 60 to an arm, column, or other structural feature of the shunt structure 90.

[0084] The sensor device 60 may be associated with either an axial side / end of the shunt structure 90, and the different axial sides / ends of the shunt structure 90 are exposed on opposing sides (S1, S2) of the tissue wall when the implant device 70 is implanted in the tissue wall. When referring to an axial side of the shunt structure as described herein, it may refer to the opposing side of a plane P1 that bisects the shunt structure 90 and / or its barrel portion 98 axially (as in Figure 9-1 and / or diagonally). Plane P1 may be perpendicular to the axis of the barrel portion 98 of the shunt structure 90 and / or substantially parallel (e.g., above / inside) the tissue wall into which the shunt structure 90 is implanted. In other words, when the shunt structure 90 is implanted in a tissue wall (not shown in Figure 9-1, see Figures 15-22), the axis A1 of the barrel 98 may be oblique / angled with respect to a line / plane A2 normal to the surface of the tissue wall, and it should be understood that the herein description of the shunt axis refers to an axis / line that is substantially normal to the tissue engagement plane (e.g., plane P1 shown in Figure 9-1), even in embodiments / cases where the shunt barrel has a true axis A1 angled with respect to the tissue engagement plane P1, as shown in Figure 9-1. The herein description of the axial side of the implant structure may be understood to refer to a different side of the tissue engagement plane P1. Plane P1 may be aligned (e.g., within 5° or 10° of precise alignment) with at least a portion of the struts 91 (e.g., struts arranged circumferentially) of the barrel / conduit portion 98 of the shunt structure 90.

[0085] Furthermore, the description herein of sensor devices positioned on different radial sides of a shunt structure may refer to opposite sides of the diameter plane P2, as shown in Figure 9-1. For example, if a shunt structure includes an arm on a given axial side of the shunt structure that extends from substantially opposing circumferential portions of the barrel / conduit portion of the shunt structure and / or projects radially substantially opposite to the axis of the barrel / conduit portion of the shunt structure, such an arm may be considered to be on different and / or opposing radial sides of the shunt structure.

[0086] The sensor device 60 may be biocompatible, which is advantageous. For example, the housing 69 may be biocompatible, such as a housing containing glass or other biocompatible material. However, at least a portion of the sensor transducer element / membrane 67, such as a diaphragm or other component, may be exposed to the external environment in some embodiments to allow pressure reading or other parameter sensing to be implemented. The housing 69 may include at least partially rigid cylindrical or tubular forms, such as a glass cylinder form. In some embodiments, the sensor transducer components 65 / 67 have a diameter of about 3 mm or less. The antenna 61 may have a length of about 20 mm or less.

[0087] The sensor device 60 may be configured to communicate with an external system when implanted in the heart or other areas of the patient's body. For example, the antenna 61 may wirelessly receive power from an external system and / or communicate data or waveforms sensed therefrom. The sensor device 60 may be attached to or integrated with the shunt structure 90 in any preferred or desirable manner. For example, in some implementations, the sensor device 60 may be attached to or integrated with the shunt structure 90 using mechanical mounting means. In some embodiments, the sensor device 60 may be contained in a pouch or other receptacle attached to the shunt structure 90.

[0088] The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include a diaphragm component that is at least partially flexible or compressible, which may be made from silicon or other flexible material. The diaphragm component may be configured to bend or compress in response to changes in ambient pressure. The control circuit 62 may be configured to process the generated signal in response to the bending / compression to provide a pressure reading. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride). The diaphragm component and / or other components of the pressure transducer 67 may be advantageously fused to / with the housing 69 of the sensor device 60, or otherwise sealed, to provide hermetically sealed at least some of the sensor components.

[0089] The control circuit 62 may include one or more electronically specific integrated circuit (ASIC) chips or dies that can be programmed and / or customized or configured to perform the monitoring functions described herein and / or to facilitate the wireless transmission of sensor signals. The antenna 61 may include a ferrite core 79 wrapped in a conductive material in the form of a plurality of coils 63 (e.g., wire coils). In some embodiments, the coils include copper or other metals. The antenna 61 may be advantageously configured with a coil geometric shape that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementation examples, the sensor implant device 70 may be delivered to a target implant site using a delivery catheter (not shown), the delivery catheter including a cavity or channel configured to adapt to the advance of the sensor device 60 through it.

[0090] The sensor implant device 70 comprises a shunt structure 90 which may include one or more columns 91, or a central barrel structure 98 which may include other structural features forming an oval, circular, rectangular, and / or oval cylindrical fluid conduit. Where the shunt structure and / or the fluid conduit, cylinder, and / or barrel structure formed thereby are referred to herein, it should be understood that they may have any axial cross-sectional shape.

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

[0092] In some embodiments, one or more of the arms 97 may include a specific sensor holding mechanism configured to hold, fix, or otherwise hold the sensor device 60, as shown in the figure. For example, the sensor device 60 may comprise a substantially cylindrical housing or form 69 that can house one or more internal sensor components and, advantageously, can be at least partially airtight. In some embodiments, the housing 69 comprises glass or other at least partially rigid material.

[0093] The sensor retaining mechanism 80 associated with the anchor arm 94 may have any suitable or desirable form. For example, the sensor retaining mechanism 80 may include one or more sensor retaining fingers 84, or other bands, straps, wraps, coils, wires, adhesives, clamps, clips, openings, engaging protrusions or forms, locks, or other retaining mechanisms. In some embodiments, the anchor arm 94 includes a distal stopper mechanism 82, such as a tab or similar form / structure, configured to restrict the distal movement of the sensor device 60 beyond the distal end 64 of the shunt arm 94. For example, the stopper mechanism 82 may be a tab that folds to cover the radial outline of the sensor device 60 in such a manner that it restricts axial movement of the sensor device 60 in at least one direction. In some embodiments, the sensor device 60 is integrated with the arm 94 so that a separate retaining mechanism is not required to secure the sensor device 60 to the shunt structure 90. For example, the anchor arm 94 may be integrated with the housing 69 of the sensor device 60. In some embodiments, the barrel / conduit form / body 98 defining the shunt orifice may be covered internally and / or externally, at least partially, with a fabric or other cover that can provide sealing to the device.

[0094] The sensor device 60 may be advantageously positioned, positioned, fixed, oriented, and / or otherwise positioned in a configuration in which its sensor transducer components 65 are located within the channel region 88 of the shunt structure 90. The term “channel region” is used herein in accordance with its broad and common sense and may refer to a three-dimensional space defined by the radial boundary of a fluid conduit and extending from the fluid conduit. For example, with respect to a given fluid conduit structure such as the fluid conduit / barrel structure 98 of the shunt structure 90, the associated channel region may be considered to be defined according to any of the illustrated and described channel regions 88 shown in Figures 10-1 to 10-3.

[0095] Figure 10-1 shows an exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1. For example, as described above, the tissue plane P1 may generally represent a plane located within or parallel to a tissue wall configured to accommodate the fluid conduit 98. For example, the fluid conduit 98 may represent the conduit structure of a shunt implant device described herein. In a particular embodiment of Figure 10-1, the fluid conduit 98 has an axis A1 that is substantially orthogonal, perpendicular, and / or normal to the tissue plane P1. In such an embodiment / configuration, the channel region 88 associated with the fluid conduit 98 can be considered, as shown, a three-dimensional projection / extension of the region of the fluid conduit around axis A1 and enclosed by walls 93. Thus, the channel region 88 may be a three-dimensional region enclosed by a cylinder having the same axial cross-sectional area as the fluid conduit 98 and positioned around axis A1 of the fluid conduit 98. Therefore, the sensor transducer located within the channel region 88 of the fluid conduit 98 shown in Figure 10-1 can be considered to be located within the region defined by the radial boundary of the fluid conduit 98 around the axis A1 of the fluid conduit 98. Furthermore, the sensor transducer may be located within the axially outer channel region 88 of the fluid conduit structure 98, similar to the illustrated sensor implant device 70 shown in Figure 9-1, and the sensor transducer 65 is located within the axially outer channel region 88 of the shunt barrel structure 98.

[0096] Figure 10-2 shows another exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1, which may be defined / represented in the manner detailed above. The fluid conduit 98 in the embodiment of Figure 10-2 may be configured to be transplanted into a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the fluid conduit 98 is angled with respect to the tissue plane P1 (i.e., the axis A1 of the conduit 98 is not perpendicular, orthogonal, or normal to the tissue plane P1). That is, the fluid conduit 98 may be an inclined cylinder, as shown. Therefore, in some embodiments, as shown in Figure 10-2, with respect to an inclined / angled fluid conduit 98, the associated channel region 88 can be considered a three-dimensional region defined by the radial boundary of the fluid conduit 98 around an axis A1 of the fluid conduit extending axially away from the fluid conduit 98 in one or more directions, and as a result, the boundary of the channel region 88 is defined by a cylinder having an axis angled with respect to the structural plane P1, as shown. For example, in the embodiment shown in Figure 9-1, where the channel region 88 of the fluid conduit 98 of the shunt structure 90 is defined according to the scheme shown in Figure 10-2, the sensor transducer 65 can be considered to be within the channel region 88 of the fluid conduit 98 in that it is coaxial with the inclined / angled conduit / barrel 98 and is located within the angled channel region 88a.

[0097] Figure 10-3 shows another exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1, which may be defined / represented in the manner detailed above. The fluid conduit 98 in the embodiment of Figure 10-3 may be configured to be transplanted into a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the conduit 98 is angled with respect to the tissue plane P1 (i.e., the axis A1 of the conduit 98 is not perpendicular, orthogonal, or normal to the tissue plane P1). However, it may be desirable to identify the channel region 88 associated with the fluid conduit 98 as having axis A2 which is parallel, orthogonal, and / or normal to the plane P1 (in relation to Figures 10-1, 10-2, and 10-3, A1 represents the axis of each fluid conduit, and A2 represents the axis (or multiple axes) of the channel region 88 of the fluid conduit; in some cases, A1 and A2 may be the same). Therefore, the channel region 88 in Figure 10-3 may not be coaxial with the conduit 98, but rather may be defined at one end by the radial boundary of the opening 96 of the conduit 98, and the channel region 88 extends from there in an orientation / direction which is perpendicular, orthogonal, and / or normal to the plane P1, as shown in Figure 10-3. For example, with respect to the embodiment shown in Figure 9-1, the channel region 88 of the fluid conduit 98 of the shunt structure 90 is defined according to the scheme shown in Figure 10-3, and the sensor transducer 65 can be considered to be within the channel region 88 of the fluid conduit, in that it is within the orthogonal / normal channel region 88b, which is defined by the radial boundary of the opening 96 of the conduit / barrel structure 98 extending / projecting therefrom, in an orthogonal / normal orientation / direction that is not coaxial with the inclined / angled conduit structure 98 of the shunt structure 90.

[0098] Figure 11 shows an axial view of the implant device 70 of Figure 9-1 according to one or more embodiments of the present disclosure. Specifically, Figure 11 shows an axial view corresponding to the axial side of the implant device 70 associated with the sensor device 60. That is, the sensor component 65 is attached to and integrated with the arm 94, or otherwise associated with it, and its side is shown facing outward on the page of Figure 11. The side shown facing outward on the page of Figure 11 may be distal or proximal.

[0099] The sensor device 60 may be mechanically attached to or secured to a portion of the arm 94 by any suitable or desirable attachment means, including adhesive adhesion or mechanical engagement. For example, the arm 94 may have or be associated with one or more retaining mechanisms, which may include one or more clamps, straps, ties, sutures, collars, clips, tabs, etc. Such retaining mechanisms may enclose or hold the sensor device 60 or a portion thereof in the circumferential direction. In some embodiments, the sensor device 60 may be attached to the arm 94 by applying mechanical force, either by sliding the sensor 60 by a particular retaining mechanism or by applying pressing or other mechanical force to it, or by clipping, locking, or otherwise engaging the sensor 60 with the arm 94. In some embodiments, the shunt structure 90 may have one or more tabs that can be configured to pop up or extend from one or more sides of the sensor device 60 for mechanical fastening. Such tabs may include shape memory metal (e.g., Nitinol) or other at least partially rigid material. In some embodiments, the sensor device 60 is pre-attached to the arm 94 and / or integrated with it before transplantation. In some embodiments, the sensor 60 may be built or manufactured on the shunt structure 90 to form a single unit. For example, in some embodiments, the sensor 60 may be attached to or integrated with the arm member 94 of the shunt structure 90.

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

[0101] Figure 13 shows a sensor implant device 120 having an associated sutured-wrapped sensor device 126 according to one or more embodiments. The device 126 includes one or more sutured wraps 128 (e.g., PET stitches or cloth strips) configured to at least partially secure the sensor device 126 to the anchor arm 124. In some embodiments, the wraps 128 are wrapped in strands circumferentially and / or axially on the sensor cylinder and around the anchor arm 124.

[0102] The suture wrap 128 may wrap around the cylinder / sensor 126 in a circumferential direction that traverses at least a portion of the length of the sensor 126. In some embodiments, the suture wrap 128 has a sheet-like cover / wrap that is pulled out or applied over the sensor 126 and / or anchor arm 124. For example, a suture or other type of line or stitch may be wrapped around the cover / wrap, securing the cover / wrap to the sensor 126 and arm 124. The suture / line 128 may include ePTFE, PET, etc. It may be desirable to protect the suture mechanism from tissue proliferation using an appropriate coating, covering, or similar. As with other embodiments of the present disclosure, the suture wrap 128 may be configured to hold the sensor device 126 in an orientation such that its sensor components 127 are located within the channel region of the barrel 129 of the implant device 120 (i.e., radially inward with respect to the fluid conduit formed by the barrel 129), as shown.

[0103] Figure 14 shows a sensor implant device 130 having a sensor retaining pouch 138 according to one or more embodiments. The pouch 130 may comprise a membrane sock or wrap-type retaining means or mechanism configured to at least partially secure the sensor implant device 130 to a sensor support column / arm. The membrane pouch / wrap may include a polytetrafluoroethylene (PTFE) and / or polyurethane (PU) (e.g., electrospun or rotary jetspun) membrane. The pouch or sock 138 may be attached to the anchor arm 134 or another part of the shunt structure, or otherwise associated with it. For example, the pouch 138 may be a suture-based or cloth-based (e.g., fiber and / or polymer cloth) pouch, packaging, or other retaining material and / or form.

[0104] Pouch 138 may contain any suitable or desired material, including polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), and / or combinations of similar materials. Such material may be electrospinned onto sensor 136 or applied using rotary jet spinning in some implementation examples.

[0105] In some embodiments, the sensor 136 is configured to slide within a pouch 138, and the tension and / or compression of the pouch 138 functions to hold the sensor 136 in a fixed position within the pouch 138. Although a pouch / wrap enclosing at least a portion of the sensor 136 in a sock / tubular manner is illustrated in Figure 14, in some embodiments, the pouch 138 includes a band or other non-enclosing retaining means. In some embodiments, the sensor 136 may be sutured or otherwise attached to or fixed to the pouch 138. Furthermore, the pouch 138 may be sutured or otherwise fixed to or attached to an arm member 134 of a shunt structure 139. The pouch 138 may, advantageously, be opened on one or both of its axial ends to allow fluid contact with the sensor element / transducer 137 associated with the sensor 136. In other words, the sensor 136 may be exposed through an open portion on the distal or proximal end of the arm 134 and / or pouch 138.

[0106] In some embodiments, the pouch 138 includes a cloth. In some embodiments, the pouch 138 includes a polymer film having specific thermal and voltage characteristics related to its application process so as not to cause undesirable effects / damage to the sensor 137. Wraps, socks, sleeves, films, coatings, or similar types of mechanisms described herein in relation to various disclosed embodiments may be applied to the sensor holding structure and / or sensor in any suitable or preferred manner. For example, such materials may be applied using an electric spinning process in some implementation examples. Specific methods, apparatuses, and systems relating to the concept of electric spinning that may be applied to embodiments of this disclosure are disclosed in Patent Document 3, the disclosure of which is incorporated herein by reference in its entirety. Electrically spun PTFE is described in Patent Document 4, which is incorporated herein by reference. Other processes that may be carried out to apply wraps, socks, sleeves, films, or similar mechanisms may include rotary jet spinning. Specific methods, apparatuses, and systems relating to the concept of rotary jet spinning that may be applied to embodiments of this disclosure are disclosed in Patent Document 5, the disclosure of which is incorporated herein by reference in its entirety. As in other embodiments of the present disclosure, the pouch 138 may be configured to hold the sensor device 136 in an orientation such that its sensor component 127 is located within the channel region of the barrel 131 of the implant device 130 (i.e., radially inward with respect to the fluid conduit formed by the barrel 131), as shown in the figure.

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

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

[0109] As in other embodiments, the sensor implant device 70 includes a sensor device 60 which includes a sensor transducer component 65 and specific connection components (e.g., antenna components and / or other control circuits). In each of the implementation examples shown in Figures 16-1, 16-2, 16-3, and 16-4, the sensor device 60 is positioned, mounted, and / or otherwise fixed or associated with the implant structure 90 (e.g., shunt structure) of the sensor implant device 70, such that the sensor transducer 65 is positioned within or near a channel region associated with the barrel / conduit portion 98 of the shunt structure 90. For example, the implant device 70 may be configured such that the sensor transducer component 65 is at least partially exposed on the atrial side of the tissue wall 21, as shown.

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

[0111] In a particular implementation example shown in Figure 16-2, the sensor device 60 is associated with an arm 94 positioned on the side of the shunt structure 90, which is positioned on the atrial side of the tissue wall 21 and proximal to the right atrium. That is, the sensor device 60 is fixed to an anchor arm 94 which is generally positioned toward the right atrium (for example, over a substantially wide area of ​​the coronary sinus 16). When the components 65 of the sensor transducer are positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may be advantageously positioned within a region of relatively high flow, thereby generating sensor readings that characterize the flow through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in Figure 16-2 with the sensor transducer 65 facing radially inward with respect to the axis of the conduit 98 may provide sensor readings that better characterize the shunt flow characteristics compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98.

[0112] In a particular implementation example shown in Figure 16-3, the sensor device 60 is associated with an arm 95 positioned on the side of the shunt structure 90, which is positioned on the coronary sinus side of the tissue wall 21 and proximal to the right atrium. That is, the sensor device 60 is fixed to an anchor arm 95 which is generally positioned toward the right atrium (for example, over a substantially wide area of ​​the coronary sinus 16). When the sensor transducer component 65 is positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may be advantageously positioned within a region of relatively high flow, thereby generating sensor readings that characterize the flow through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in Figure 16-3 with the sensor transducer 65 facing radially inward with respect to the axis of the conduit 98 may provide sensor readings that better characterize the shunt flow characteristics compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98. Furthermore, if the sensor 60 is positioned within the coronary sinus 16, it may be used to generate signals indicating flow within the coronary sinus, including distal flow of the implant device 70 within the coronary sinus 16. Due to size constraints within the coronary sinus, it may be preferable for the sensor 60 to be associated with an arm 95 in a wider area of ​​the coronary sinus (e.g., the orifice of the coronary sinus and an area generally directed towards the right atrium), as shown in Figure 16-3.

[0113] In a particular implementation example shown in Figure 16-4, the sensor device 60 is associated with an arm 92 positioned on the side of the shunt structure 90, which is positioned on the coronary sinus side of the tissue wall 21 and distal to the right atrium. That is, the sensor device 60 is fixed to an anchor arm 92 positioned substantially away from the right atrium (e.g., within a substantially narrow area of ​​the coronary sinus 16). When the sensor transducer components 65 are positioned within the channel region of the shunt conduit 98, the sensor transducer 65 may be advantageously positioned within a region of relatively high flow, thereby generating sensor readings that characterize the flow through the conduit 98 of the shunt structure 90. For example, the particular arrangement shown in Figure 16-4 with the sensor transducer 65 facing radially inward with respect to the axis of the conduit 98 may provide sensor readings that better characterize the shunt flow characteristics compared to embodiments in which the sensor transducer is not positioned within the channel region of the conduit and / or is oriented / facing radially away from the conduit 98. Furthermore, if the sensor 60 is positioned within the coronary sinus 16, it may be used to generate signals indicating flow within the coronary sinus, including distal flow of the implant device 70 within the coronary sinus 16. However, due to size constraints within the coronary sinus, it may be undesirable for the sensor 60 to be associated with the arm 92 in a narrower region of the coronary sinus (e.g., the orifice of the coronary sinus and a region substantially away from the right atrium), as shown in Figure 16-4. Therefore, in such implementation examples, it may be desirable for the sensor device 60 to be a relatively small device and / or oriented relatively close to the axis of the tissue wall 21 and / or the coronary sinus 16 to reduce or avoid contact with the coronary sinus wall and / or cause occlusion or other problems.

[0114] Figure 17 shows a sensor implant device 70 implanted in the atrial septum 18, in which the device's sensor 60 is exposed in the left atrium 2, according to one or more embodiments. As in other embodiments, the sensor implant device 70 shown in Figure 17 includes a sensor device 60 comprising a sensor transducer component 65 and a cylindrical housing. The sensor device is positioned, mounted, and / or otherwise fixed or associated with the implant structure 90 (e.g., the shunt structure) of the implant device 70, such that the sensor transducer 65 is positioned in a channel region associated with a barrel / conduit portion 98 of the shunt structure 90, and the associated channel region is within the left atrium.

[0115] Figure 18 shows a sensor implant device 70 implanted in the atrial septum 18, in which the device's sensor 60 is exposed in the right atrium 2, according to one or more embodiments. As in other embodiments, the sensor implant device 70 shown in Figure 18 includes a sensor device 60 comprising a sensor transducer component 65 and a cylindrical housing. The sensor device is positioned, mounted, and / or otherwise fixed or associated with the implant structure 90 (e.g., the shunt structure) of the implant device 70, such that the sensor transducer 65 is positioned in a channel region associated with a barrel / conduit portion 98 of the shunt structure 90, and the associated channel region is within the right atrium.

[0116] Figure 19 shows a dual sensor implant device 170 implanted in an atrial septum 18 according to one or more embodiments. While specific embodiments are disclosed herein in relation to sensor implant devices including a single sensor device associated with a shunt structure, it should be understood that a shunt sensor implant device according to aspects of this disclosure may have any suitable or desirable number of sensor devices associated therewith. For example, the sensor implant device 170 shown in Figure 19 includes two sensor devices 160, 165, where one of the sensor devices 160 is associated with a first sensor arm 194, and the other sensor device 165 is associated with a second sensor arm 195. The sensors 160, 165 are advantageously positioned, fixed, and / or configured such that their respective sensor transducer components (167, 169) are exposed in the respective channel regions of the shunt structure 190 of the sensor implant device 170 on the respective sides of the septum 18, as shown. By utilizing two or more sensors, each having one or more sensors on the axial side / end of the associated shunt structure, improved shunt flow information can be provided in addition to atrial pressure information. Furthermore, as in the embodiment of Figure 19, improved directional flow information can be derived when the sensor transducers face opposite directions.

[0117] Figure 19 shows a sensor implant device 170 implanted in the atrial septum 18 such that one sensor 160 and its associated sensor transducer 167 are exposed in the right atrium 5, while another sensor 165 and its associated sensor transducer 169 are exposed in the left atrium 2. In some embodiments of dual-sensor implant devices that may be similar in certain respects to implant device 170, both sensors may be exposed in either the left atrium 2 or the right atrium 5. With respect to multi-sensor shunt implant devices according to aspects of this disclosure, the sensor transducer associated with at least one of the sensor devices may be advantageously located at least partially within a channel region associated with the associated conduit / barrel structure. Furthermore, it should be understood that any description herein regarding the arrangement / presence of a sensor transducer within a channel region associated with a shunt structure may be interpreted as meaning that the sensor transducer is located entirely or partially within the associated channel region.

[0118] While the example in Figure 19 shows two sensor devices 160, 165 associated with retaining arms extending from opposing axial sides / ends of a fluid conduit / barrel structure 198, resulting in the sensor devices being exposed on opposing sides of the tissue wall 18, it should be understood that a dual sensor shunt implant device according to an aspect of the present disclosure may have sensor devices associated with any anchor arm / mechanism. For example, as an alternative to the particular illustrated embodiment in Figure 19, a sensor implant device 170 may include sensor devices associated with an anchor arm extending from and / or from a common axial side of the conduit / barrel structure 198, such that both sensors are exposed on a common side of the tissue wall into which the sensor implant device 170 is implanted.

[0119] Furthermore, while the embodiment illustrated in Figure 19 shows sensor devices 160, 165 associated with the respective anchor arms 194, 195, extending from opposing circumferential sides / parts of the conduit / barrel structure 198, it should be understood that embodiments of the present disclosure may include multiple sensor devices associated with the same circumferential sides / parts of the fluid conduit formed by the shunt structure.

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

[0121] Figure 21 shows a sensor implant device 270 having three associated sensor devices according to one or more embodiments of the present disclosure. Each sensor device 260a, 260b, and 260c is associated with each anchor arm 294a, 294b, and 294c. Generally, in the embodiment of three sensors, two sensor devices 260a and 260b may be associated with the first axial side / end of the shunt structure 290 of the implant device 170, while the third sensor 260c may be associated with arm 294c which is associated with the opposite side / end of the shunt structure 290. For example, in an implementation where the device 270 is implanted in an atrial septum, two sensor devices may be positioned on the left atrial side of the septum, while the third sensor device may be positioned on the right atrial side, or vice versa. Similarly, in an implementation where the device 270 is implanted in such a wall, two sensors may be positioned either on the coronary sinus side or the left atrial side of the wall separating the coronary sinus from the left atrium. Although each of the sensor transducers is shown as being located within a channel region associated with the shunt structure 290, it should be understood that any of the sensor devices may be oriented / configured to be outside the channel region. For example, with respect to the multiple sensor embodiments of this disclosure, one or more sensor devices may be oriented such that their associated sensor transducers face substantially radially outward with respect to the axis of the associated conduit / barrel structure of the shunt structure, while at least one other sensor transducer may be configured / located within the channel region of the shunt structure as described herein.

[0122] Figure 22 shows a sensor implant device 370 having four associated sensor devices according to one or more embodiments. Specifically, the device 370 includes sensor devices 360a, 360b, 360c, and 360d associated with the respective anchor arms 394a, 394b, 384c, and 394d. The sensor implant device 370 may be implanted in the atrial septum, the wall separating the coronary sinus from the left atrium, or any other tissue wall. Although the sensor implant device 370 is shown having four associated sensor devices, it should be understood that a sensor implant device according to an embodiment of the present disclosure may have five or more associated sensor devices, and each of the sensor transducers of each sensor device may be positioned within and / or without a channel region. That is, the sensor devices may be in any suitable or desirable configuration or orientation with respect to the associated shunt structure.

[0123] Left-to-right shunts associated with physiological parameter (e.g., pressure) sensing function, achieved according to any of the devices and / or implants associated with Figures 9 to 22, may be advantageously suitable for patients who are relatively sensitive to elevated atrial pressure. For example, when pressure increases in the ventricles and / or atria and is applied to the cardiomyocytes, the cardiac muscle may generally be more difficult to contract as it processes the excess blood. Therefore, in patients with impaired ventricular contractility when the ventricles expand or contract, such patients may be more sensitive to higher pressures in the ventricles and / or atria, as the heart may not be able to respond or react appropriately to it. Furthermore, elevated pressure on the left side (e.g., left atrium) can cause dyspnea, and therefore, it may be desirable to reduce the pressure on the left side by a left-to-right shunt to alleviate dyspnea and / or reduce the incidence of readmission. For example, if the ventricles experience dysfunction that prevents them from coping with increased fluid pressure, such fluid may flow back into the atria, thereby increasing atrial pressure. In the case of heart failure, minimizing left ventricular end-diastolic pressure may be of paramount importance. Because left ventricular end-diastolic pressure may be related to left atrial pressure, fluid regurgitation within the atrium can cause fluid regurgitation within the lungs, thereby leading to undesirable and / or dangerous fluid accumulation in the lungs. A left-to-right shunt, such as using a shunt device according to embodiments of this disclosure, can divert excess fluid from the left side of the heart to the right side, which may be able to regulate the additional fluid due to the relatively high adaptability of the right atrium.

[0124] In some situations, left-to-right shunting may not be sufficiently effective 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 expel excess fluid from the patient. Therefore, by using a pressure sensor-integrated implant according to embodiments of the present disclosure, a mechanism may be provided to inform a technician or physician / surgeon regarding how to titrate such drugs to adjust / correct the fluid state. Thus, embodiments of the present disclosure may advantageously function to direct drug interventions to reduce or prevent an undesirable increase in left atrial pressure.

[0125] Figures 23-1, 23-2, 23-3, 23-4, and 23-5 provide flowcharts illustrating a process 2300 for implanting a sensor implant device according to one or more embodiments. Figures 24-1, 24-2, 24-3, 24-4, and 24-5 provide images of cardiac anatomical structures and specific devices / systems corresponding to the operation of process 2300 in Figures 23-1, 23-2, 23-3, 23-4, and 23-5 according to one or more embodiments.

[0126] In block 2302, process 2300 includes providing the delivery system 51 with a sensor implant device 70 to be placed within the delivery configuration, such as a shunt-type sensor implant device as disclosed in detail herein. Image 2402 of Figure 24-1 shows a partial cross-sectional view of the delivery system 51 for the sensor implant device 70 according to one or more embodiments of the present disclosure. Image 2402 shows the sensor implant device 70 placed within the outer sheath 50 of the delivery system 51. While specific embodiments of the delivery system are shown in Figure 24-1, it should be understood that sensor implant devices according to aspects of the present disclosure can be delivered and / or implanted using any suitable or preferred delivery system and / or delivery system components.

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

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

[0129] In some embodiments, the delivery system 51 includes a tapered nose cone mechanism 52 that may be associated with the sheath 50, the catheter 55, and / or the distal end of the delivery system 51. In some implementations, the nose cone mechanism 52 may be used to expand an opening in the tissue wall through which a sensor implant device 70 is implanted or through which the delivery system is advanced. The nose cone mechanism 52 may facilitate the advancement of the distal end of the delivery system 51 through the patient's tortuosic anatomical structure and / or using an external 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 catheter 55. In some embodiments, the nose cone 52 may have and / or be formed of a plurality of flap-shaped forms that can be biased / spread apart when the sensor implant device 70 and / or any part thereof, the internal catheter 55, or other device is advanced through it.

[0130] In some embodiments, the sensor implant device 70 may be located within a delivery system 51 equipped with a sensor device 60, which is attached to or otherwise associated with it, as described in detail herein. In some embodiments, the inner catheter 55 includes one or more cutouts, recesses, recesses, gaps, openings, holes, slits, or other mechanisms configured to accommodate the presence of the sensor device 60 and / or other mechanisms or embodiments of the implant device 70. For example, the sensor device 60 may be located at least partially within the inner diameter of the shunt structure 90 in the delivery configuration shown in Figure 24-1. In such a configuration, the sensor assembly components may interfere with the ability of the shunt structure 90 to be located relatively tightly around the inner catheter 55, thereby increasing the external shape of the delivery system and / or affecting the ability of the sensor implant device 70 to be delivered using the delivery system 51. Thus, as shown in Figure 24-1, the inner catheter 55 may include one or more sensor device adjustment mechanisms, such as a sensor cutout or other adjustment mechanism 57. In some embodiments, the adjustment mechanism 57 may be longitudinal and circumferential cutouts of the inner catheter 55. The adjustment mechanism 57 may, advantageously, be sized to accommodate the size and / or external shape of the sensor device, as shown in the figure, allowing the sensor device to protrude radially into the inner diameter / space of the inner catheter 55.

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

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

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

[0134] In block 2306, process 2300 includes advancing the delivery system 51 into the coronary sinus 16 to a target implant site adjacent to the 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 can be achieved using any preferred or desired procedure. For example, various access routes can be utilized when manipulating guidewires and catheters within and around the heart to deploy an expandable shunt integrated with or associated with a pressure sensor, as in embodiments of the present disclosure. In some embodiments, access to the superior vena cava (not shown), right atrium 5, and from there to the coronary sinus 16 can be achieved via the subclavian or jugular vein. Alternatively, the access route may begin in the femoral vein and enter the heart via 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, and from there the system may be designed or configured to allow a physician to control the distal end of the device from outside the body.

[0135] In some implementations, the guidewire 53 is introduced through the superior vena cava 19 via the subclavian or jugular vein into the coronary sinus 16 via the right atrium 5. The guidewire 53 may be arranged in a spiral configuration within the left atrium 2, as shown in Figure 24-6, which may help to fix the guidewire in place. Once the guidewire 53 has provided the route, the introducer sheath may be routed along the guidewire 53 into the patient's vascular system, for example, by the use of a dilator. The delivery catheter may be advanced through the superior vena cava to the coronary sinus 16 of the heart, and the introducer sheath may provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to form and create an opening in the wall 21 of the left atrium, and a separate deployment delivery system 51 is used for the delivery of a sensor implant device 70, as shown. In other embodiments, the deployment system 51 may be used as both a fully functional puncture-creation and implant delivery catheter. In this application, the term “delivery system” is used to refer to a catheter or introducer having one or both of these functions.

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

[0137] In block 2310, process 2300 includes deploying one or more anchor arms 94, which may be considered distal anchor arms of a sensor implant device 70 on the atrial side of the wall 21. The distal arms 94 may be associated with the sensor device 60 such that the sensor transducer 65 of the sensor device 60 is exposed within the left atrium 2, and as a result the sensor transducer 60 may be used to acquire signals indicating physiological parameters associated with the left atrium, such as pressure.

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

[0139] Additional aspects and mechanisms of the process for delivering a shunt structure, which can be integrated with a sensor device / function, according to embodiments of this disclosure for implantation in the wall between the coronary sinus and the left atrium, are disclosed in Patent Document 1, entitled "Expandable Cardiac Shunt," published October 24, 2017, which is expressly incorporated herein in its entirety by reference. Although the implant device 70 is shown within the left atrium / coronary sinus wall 21, the implant device 70 may be positioned between other cardiac chambers, such as between the left atrium and the right atrium.

[0140] Figure 25 is a cutaway view of the human heart and associated vascular system showing specific catheter access routes for implanting a sensor implant device according to one or more embodiments. Figure 25 shows various catheters 111 that may be used to implant a sensor device according to embodiments of the present disclosure. The catheter 111 may be maneuverable and have a relatively small cross-sectional profile to allow traversal of various blood vessels and cardiac chambers through which it may advance en route, for example, to the right atrium 5, coronary sinus 16, left atrium 2, or other anatomical structures or cardiac chambers. Catheter access to the right atrium 5, coronary sinus 16, or left atrium 2 according to specific transcatheter solutions may be made via the inferior vena cava 16 (indicated by catheter 111a) or the superior vena cava 19 (indicated by catheter 111b). Further access to the left atrium may include traversing the atrial septum (e.g., in or near the fossa ovalis).

[0141] While access to the left atrium is exemplified and described in relation to specific embodiments, such as via the right atrium and / or inferior vena cava, including through transfemoral or other transcatheter procedures, other access routes / methods may be implemented according to embodiments of this disclosure. For example, if the septum cannot pass through the atrial septal wall, other access routes may be employed to the left atrium 2. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable and would result in further injury to the patient. Furthermore, in some patients, the septal wall may be occupied by one or more implant devices or other treatments, and traversing the septal wall is unsustainable in terms of such treatments. As an alternative to transseptal access, transaortic access may be performed, in which the delivery catheter 111c may pass through the descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7 and reach the left atrium 2 through the mitral valve 6. Alternatively, transapical access may be performed to access a target anatomical structure, as shown by the delivery catheter 111d.

[0142] Additional Embodiments Depending on the embodiment, any particular action, event, or function of any process or algorithm described herein may be performed in a different order, added, merged, or completely excluded. Therefore, in a particular embodiment, not all described actions or events are necessary for the practice of the process.

[0143] In particular, conditional statements used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” are intended in their ordinary sense unless otherwise stated or understood differently in the context in which they are used, and are generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in other embodiments. Therefore, such conditional statements are not generally intended to imply that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these features, elements, and / or steps are included or performed in any particular embodiment. Terms such as “comprising,” “including,” and “having” are synonymous and are used in their ordinary sense, comprehensively and non-restrictively, without excluding additional elements, features, actions, or functions. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense), and therefore, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Connecting phrases such as "at least one of X, Y, and Z" are understood in context to be used to generally convey that an item, term, element, etc., may be one of X, Y, or Z, unless otherwise specified. Thus, such connecting phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0144] In the above descriptions of embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than those explicitly enumerated in that claim. Furthermore, any component, feature, or step illustrated and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment. Moreover, there is no component, feature, step, or group of components, features, or steps that is necessarily required or essential to each embodiment. Accordingly, it is intended that the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0145] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, ordinal terms used herein to modify elements such as structure, components, and actions (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of the element relative to any other element, but rather may generally distinguish the element from other elements having similar or identical names (apart from the use of ordinal terms). In addition, the indefinite articles used herein ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a certain condition or event may also be performed on the basis of one or more other conditions or events not explicitly listed.

[0146] All terms used herein (including technical and scientific terms) have the same meaning as generally understood by those skilled in the art to which the exemplary embodiments belong, unless otherwise defined. It should be further understood that terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not as idealized or overly formal unless expressly defined herein.

[0147] The spatially relative terms “outside,” “inside,” “top,” “bottom,” “down,” “up,” “vertical,” “horizontal,” and similar terms may be used herein to facilitate explanation and to describe the relationship between one element or component and another, 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 shown in the drawings. For example, if the device shown in the drawings is inverted, the device positioned “below” or “directly below” another device may be positioned “above” the other device. Thus, the exemplary term “bottom” may include both the bottom and top positions. The device may also be oriented in other directions, and therefore, the spatially relative terms may have different interpretations depending on the orientation.

[0148] Comparative and / or quantitative terms such as "less," "more," and "greater" are intended to encompass the concept of equality unless otherwise explicitly stated. For example, "less" can mean not only "less" in the strict mathematical sense, but also "less than or equal to." [Explanation of Symbols]

[0149] 21 Tissue wall, 30, 70, 120, 130, 140, 170, 270, 370 Sensor implant device, 39 Anchor structure, 55, 111c, 111d Delivery catheter, 60, 126, 136, 146, 160, 165, 260a, 260b, 260c, 360a, 360b, 360c, 360d Sensor device, 64 Distal end, 65, 167, 169 Sensor transducer, 75 First axial end, 77 Second axial end, 84 Sensor holding finger, 88 Channel region, 92, 93, 94, 95, 97, 124, 134, 194, 195, 294a, 294b, 294c, 394a, 394b, 384c, 394d Anchor arm, 98 Fluid conduit, 99 openings, A1,A2 axis

Claims

1. A sensor implant device, A shunt body that forms a fluid conduit having an axis, A first anchor structure associated with the first end of the shunt body, A first sensor device comprising: a first sensor device whose sensor transducer is coupled to the first anchor structure such that it protrudes into a channel region defined by the radial boundary of the fluid conduit around the axis, wherein the radial boundary is defined by the fluid conduit; The first sensor device has a cylindrical shape, and the sensor implant device is in an unfolded configuration in which the first anchor structure protrudes radially away from the axis of the fluid conduit, wherein the axis of the first sensor device is perpendicular to the axis of the fluid conduit.

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

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

4. The sensor implant device according to claim 3, wherein the second anchor structure extends from the shunt body in a region opposite to the region of the shunt body from which the first anchor structure extends.

5. The sensor implant device according to claim 3 or claim 4, wherein the sensor converter of the second sensor device faces in a direction opposite to the direction facing the sensor converter of the first sensor device.

6. The sensor implant device according to any one of claims 1 to 5, further comprising a plurality of sensor-holding fingers configured to hold the first sensor device in the first anchor structure.

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

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

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

10. A sensor implant device, A shunt body that forms a fluid conduit having an axis, A first anchoring means associated with the first end of the shunt body, A first sensor device comprising: a first sensor device whose sensor transducer is coupled to the first anchor means such that it protrudes into a channel region defined by the radial boundary of the fluid conduit around the axis, wherein the radial boundary is defined by the fluid conduit; The first sensor device has a cylindrical shape, and the sensor transducer of the first sensor device protrudes into the channel region such that the axis of the first sensor device is transverse to the axis of the fluid conduit, wherein the sensor implant device is a sensor implant device.

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

12. The sensor implant device according to claim 11, wherein the arm has a curved clamp shape.

13. A sensor implant device, A tubular frame having a first diameter side surface and a second diameter side surface and a first axial end and a second axial end, forming a fluid conduit having an axis, A first anchor arm associated with the first diametrical side and the first axial end of the tubular frame, A second anchor arm associated with the second diametrical side and the first axial end of the tubular frame, A third anchor arm associated with the first diametrical side and the second axial end of the tubular frame, A fourth anchor arm associated with the second diametrical side and the second axial end of the tubular frame, wherein each of the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm has a base and a distal end connected to the tubular frame, A first sensor device coupled to the first anchor arm, the first sensor device includes a sensor transducer associated with the sensor end of the first sensor device located opposite the base end of the first sensor device, The sensor end of the first sensor device is associated with the base of the first anchor arm, and the base end of the first sensor device is associated with the distal end of the first anchor arm. A sensor implant device wherein the sensor transducer of the first sensor device protrudes into a channel region defined by a radial boundary around the axis of the fluid conduit, and the radial boundary is defined by the fluid conduit.

14. The sensor implant device according to claim 13, wherein the sensor implant device is configured to have an unfolded configuration in which the first anchor arm, the second anchor arm, the third anchor arm, and the fourth anchor arm protrude radially away from the tubular frame.

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

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

17. The sensor implant device according to claim 15 or claim 16, wherein, when the sensor implant device is in the deployed configuration, the sensor end of the first sensor device protrudes radially from the axis of the tubular frame, passing through the base of the first anchor arm.

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

19. The sensor implant device according to claim 18, referencing any one of claims 15 to 17, wherein, when the sensor implant device is in the delivery configuration, the sensor end of the first sensor device and the sensor end of the second sensor device are arranged within the tubular frame between the first axial end and the second axial end of the tubular frame.

Images