Shunt implantation device with over-channel sensor arm

Abstract

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

Description

Technical Field

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

Background Art

[0002] This disclosure generally relates to the field of medical implant devices.

[0003] Various medical procedures involve the implantation of medical implant devices within the anatomical structures of the heart. Certain physiological parameters associated with such anatomical structures, such as fluid pressure, can affect the outlook of a patient's health.

Summary of the Invention

[0004] This specification describes one or more methods and / or devices for facilitating the monitoring of physiological parameters associated with specific heart chambers and / or blood vessels of the heart, such as the left atrium, using one or more sensor implant devices.

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

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

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

[0008] The first anchor structure may include a first arm extending from the shunt body across the channel region and holding the first sensor device. For example, the first anchor structure may further include a second arm extending from the shunt body across the channel region and holding the first sensor device. In some embodiments, the first and second arms originate from opposing sides of the shunt body. For example, both the first and second arms may be wrapped around the body of the first sensor device.

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

[0010] In some embodiments, the shunt body includes a helical wire configuration. For example, the first anchor structure may include a helical arm that is integrated with the helical wire configuration of the shunt body. In some embodiments, the shunt body further includes a cover positioned outside at least a portion of the helical wire configuration.

[0011] The shunt body may further include a cover positioned within at least a portion of the helical wire configuration.

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

[0013] In some implementations, the present disclosure relates to a sensor embedding device including a coil wire configuration. The coil wire configuration, in an unfolded configuration, is formed from a plurality of coil windings of the coil wire configuration and comprises a body portion having a first diameter; a first flange anchor portion extending from a first axial end of the body portion and having a second diameter greater than the first diameter; a first sensor support arm extending from the first flange portion and radially deflected across a channel region defined by the body portion; a distal portion of the first sensor support arm including a sensor holding means for holding the first sensor device; and a second flange anchor portion extending from a second axial end of the body portion.

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

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

[0016] In some embodiments, the first sensor support arm is deflected axially with respect to the axis of the main body at an angle greater than the deflection angle of the multiple coil windings of the main body.

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

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

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

[0020] In some embodiments, the coil wire form includes a shape memory material configured to take on a deployed configuration when deployed from a delivery catheter. For example, the coil wire form may be configured to be compressed into a delivery configuration in which a body portion and a first flange anchor portion have a third diameter that is smaller than a first diameter.

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

Brief Description of the Drawings

[0022] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the invention in any way. Additionally, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numbers may be reused to indicate corresponding between reference elements. [Figure 1] FIG. 1 shows an exemplary representation of a human heart according to one or more embodiments. [Figure 2] FIG. 2 shows an exemplary representation of a human heart according to one or more embodiments. [Figure 3] FIG. 3 shows examples of pressure waveforms associated with various heart chambers and blood vessels according to one or more embodiments. [Figure 4] FIG. 4 illustrates a graph showing left atrial pressure ranges. [Figure 5] FIG. 5 is a block diagram representing a sensor implant device according to one or more embodiments. [Figure 6] FIG. 6 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 7-1] FIG. 7-1 shows a side view of a sensor-embedded device according to one or more embodiments. [Figure 7-2] FIG. 7-2 shows a sensor assembly / device according to one or more embodiments. [Figure 8A] FIG. 8A shows an axial view of an embodiment of a shunt-type sensor-embedded device according to one or more embodiments. [Figure 8B] FIG. 8B shows an axial view of an embodiment of a shunt-type sensor-embedded device according to one or more embodiments. <00XXXXX0>FIG. 9-1A shows an exemplary channel region associated with the fluid conduit of each shunt body according to one or more embodiments. [Figure 9-1B] FIG. 9-1B shows an exemplary channel region associated with the fluid conduit of each shunt body according to one or more embodiments. [Figure 9-2] FIG. 9-2 shows an exemplary channel region associated with the fluid conduit of each shunt body according to one or more embodiments. [Figure 9-3A] FIG. 9-3A shows an exemplary channel region associated with the fluid conduit of each shunt body according to one or more embodiments. [Figure 9-3B] FIG. 9-3B shows an exemplary channel region associated with the fluid conduit of each shunt body according to one or more embodiments. [Figure 10] FIG. 10 shows a sensor-embedded device having a barrel cover associated therewith according to one or more embodiments. [Figure 11A] FIG. 11A shows a side view of a sensor-embedded device having a dual-arm sensor holder according to one or more embodiments. [Figure 11B] FIG. 11B shows an axial view of a sensor-embedded device having a dual-arm sensor holder according to one or more embodiments. [Figure 12A] FIG. 12A shows a sensor-embedded device embedded in the coronary sinus tissue wall according to one or more embodiments. [Figure 12B] Figure 12B shows a sensor implantation device embedded in the coronary sinus tissue wall according to one or more embodiments. [Figure 13] Figure 13 shows a sensor implantation device embedded in the atrial septum, having a sensor of a device exposed in the left atrium, according to one or more embodiments. [Figure 14] Figure 14 shows a sensor implantation device embedded in the atrial septum, having a sensor of a device exposed in the right atrium, according to one or more embodiments. [Figure 15] Figure 15 shows a dual sensor implantation device embedded within a tissue wall according to one or more embodiments. [Figure 16] Figure 16 shows a dual sensor implantation device embedded within a tissue wall according to one or more embodiments. [Figure 17-1] Figure 17-1 provides a flowchart illustrating the process for embedding a sensor implantation device according to one or more embodiments. [Figure 17-2] Figure 17-2 provides a flowchart illustrating a process for embedding a sensor implantation device according to one or more embodiments. [Figure 17-3] Figure 17-3 provides a flowchart illustrating a process for embedding a sensor implantation device according to one or more embodiments. [Figure 17-4] Figure 17-4 provides a flowchart illustrating the process for embedding a sensor implantation device according to one or more embodiments. [Figure 17-5] Figure 17-5 provides a flowchart illustrating a process for embedding a sensor implantation device according to one or more embodiments. [Figure 18-1] Figure 18-1 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process in Figure 17-1, according to one or more embodiments. [Figure 18-2] Figure 18-2 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process in Figure 17-2, according to one or more embodiments. [Figure 18-3]Figure 18-3 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 17-3, according to one or more embodiments. [Figure 18-4] Figure 18-4 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 17-4, according to one or more embodiments. [Figure 18-5] Figure 18-5 provides images of cardiac anatomical structures and specific devices / systems corresponding to the operation of the process shown in Figure 17-5, according to one or more embodiments. [Figure 19] Figure 19 is a cutaway view of the human heart and associated vascular structure showing a specific catheter access route for pulmonary vein shunt procedures according to one or more embodiments. [Modes for carrying out the invention]

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

[0024] 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, structures, systems, and / or apparatus 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 specific 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.

[0025] 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, with respect to any embodiment disclosed herein, the reuse of common reference numerals in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, a person skilled in the art may be informed by the context of the use of common reference numerals to the extent that it may imply similarity between the referenced subjects. The use of a particular reference numeral in the context of a description of a particular drawing can be understood to relate to an identified device, component, aspect, feature, module, or system in that particular drawing, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference numeral in another drawing. Furthermore, aspects of separate drawings identified by a common reference numeral can be interpreted as either sharing characteristics or being completely independent of each other.

[0026] 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 “above” another element / structure may mean a position below or beside such other element / structure with respect to the patient or alternative orientation of the element / structure in question, and vice versa.

[0027] This disclosure relates to systems, apparatus, and methods for monitoring one or more physiological parameters of a patient (e.g., blood pressure) using sensor-integrated cardiac shunts and / or other medical implantable devices. In some implementations, this disclosure relates to cardiac shunts and / or other cardiac implantable devices that incorporate or are associated with pressure sensors or other sensor devices. The term “associated” 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, whether directly or indirectly. Specific embodiments relating to cardiac implantable 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 implantation devices according to this disclosure may be implanted in or configured for implantation in any suitable or desired anatomical structure.

[0028] [Cardiac Physiology] The anatomical structure of the heart is described below to aid in understanding the concepts of the particular 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 open and close in response to pressure gradients present during different stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to the respective regions of the heart and / or to the blood vessels (e.g., the pulmonary artery, aorta, etc.).

[0029] Figures 1 and 2 illustrate vertical / anterior and horizontal / superior cross-sectional views of an exemplary heart 1 having various features / anatomical structures relevant to a particular aspect 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, generally, blood flows from the right ventricle 4 through the pulmonary valve 9 into the pulmonary artery 11, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood can be pumped toward the lungs and close during diastole to prevent blood from flowing backward 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.

[0030] 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 diastole (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.

[0031] 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 in the corresponding chamber opens the leaflets at least partially, allowing flow from the chamber. When the pressure in the chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant and push back towards the leaflets. 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.

[0032] The atrioventricular (i.e., mitral and tricuspid) heart valves further include assemblies of chordae tendineae and papillary muscles (not shown) that fix the leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. The papillary muscles may generally include, for example, finger-like projections from the ventricular wall. The leaflets of the valves are connected to the papillary muscles by chordae tendineae. Muscular walls, called septa, separate 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 14 of the heart 1 is called the apex and is generally located on or near the midclavicular line, in the fifth intercostal space.

[0033] The coronary sinus 16 contains a collection of veins that connect to form a relatively large vessel that collects blood from the cardiac muscle (myocardium). The opening of the coronary sinus 16 is open to the right atrium 5, as shown, although in some patients it may be at least partially protected by the Thebesius valve. The coronary sinus runs along the posterior surface of the left atrium 2, delivering less oxygenated blood to the right atrium 5. The coronary sinus generally runs transversely across the left atrioventricular groove, which is located at the back of the heart.

[0034] [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 causes increased fluid pressure in one or more cardiac chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. The various cardiac chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the heart's inefficiency by allowing fluid to be retained in the body. Accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs causes congestion in the body, which is referred to 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.

[0035] The treatment and / or prevention of heart failure (e.g., congestive heart failure) may, advantageously, involve monitoring pressure in one or more cavities or regions of the heart or other anatomical structures. As described above, pressure accumulation in 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 approaches without direct or indirect pressure monitoring may involve evaluating or observing other current physiological conditions of the patient, such as assessing body weight, chest impedance, right heart catheterization, etc. In some solutions, pulmonary capillary 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 regard to catheter-based pressure measurement in the pulmonary artery or certain other cardiac chambers or regions of the heart, the use of invasive catheters may be required to maintain such pressure sensors, which can be inconvenient or difficult to implement. Furthermore, certain pulmonary-related conditions may affect pressure readings in the pulmonary artery, resulting in an undesirably weakened correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurement, pressure measurement 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.

[0036] Additional solutions may be implemented 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, may 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.

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

[0038] This disclosure provides a system, apparatus, and method for inducing the administration of drugs at least partially related to the treatment of congestive heart failure by directly monitoring pressure in the left atrium or in other lumens or vessels where the pressure measurement indicates left atrial pressure and / or pressure levels of one or more other vessels / lumens, for example in patients with congestive heart failure, in order to reduce readmission, morbidity, and / or improve the patient's health outlook.

[0039] [Cardiac pressure monitoring] Cardiac pressure monitoring according to embodiments of the present 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 embodiments of the present disclosure may be advantageously implemented to reduce hospitalization cases by inducing the titration and / or administration of appropriate or desired drugs before the onset of heart failure.

[0040] Dyspnea represents a cardiac pressure index characterized by shortness of breath or the feeling of being unable to breathe adequately. Dyspnea can result from elevated atrial pressure, which can cause fluid accumulation in the lungs due to pressure regurgitation. Pathological dyspnea can 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 sufficient early signaling 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.

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

[0042] Left atrial pressure can generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlations can weaken when pulmonary vascular resistance increases. 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 124, pulmonary artery pressure measurement alone can be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, especially in patients with comorbidities 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.

[0043] 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 3. 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, may occur several weeks before hospitalization, and knowledge of such an increase can therefore be used to predict the onset of congestive heart failure, such as the acute debilitating symptoms of congestive heart failure.

[0044] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide a mechanism to guide the administration of medications to treat and / or prevent congestive heart failure. Such treatments may, advantageously, reduce readmission and morbidity, as well as provide other benefits. Implantable pressure sensors according to embodiments of the present disclosure may be used to predict heart failure at least two weeks before the onset of symptoms or markers of heart failure (e.g., dyspnea). When a prediction of heart failure is recognized using embodiments of the cardiac pressure sensors according to the present disclosure, certain precautionary measures may be implemented, 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 buildup that could lead to heart failure or other complications. For example, a trend of elevated atrial pressure may be analyzed or used to determine or predict the onset of cardiac dysfunction, where medications or other therapies may be enhanced to reduce pressure and prevent or reduce further complications.

[0045] Figure 4 shows a graph 300 showing left atrial pressure ranges, including a normal range 301 of left atrial pressure that is generally not associated with a substantial risk of postoperative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of the present disclosure provide systems, 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, through the use of a specific sensor implantation 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 described in detail below, may report efforts 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 described in detail below, may play a role in facilitating efforts to increase the left atrial pressure to bring the pressure level within the normal range 301.

[0046] [Sensor implantation device] 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 5 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, which may be embodied in, for example, an application-specific integrated circuit (ASIC), and a specific control circuit 34.

[0047] 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 processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including coming or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any group of devices that operate signals (analog and / or digital) based on hardcoding of circuits and / or operation instructions. The control circuits referred herein may further comprise one or more memory devices that can be embodied in a single memory device, multiple memory devices, and / or embedded circuits 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 can be considered part of the control circuit 34.

[0048] The antenna 38 may include 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 are at least partially arranged or housed within a sensor housing 36, which may comprise any type of material and, advantageously, can be at least partially sealed. For example, in some embodiments, the housing 36 may include 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 include a polymer or other flexible structure / material that can advantageously allow the sensor 37 to be bent, flexed, or folded to enable transport through a catheter or other introduction means.

[0049] The transducer 32 may comprise any type of sensor means or mechanism. For example, the transducer 32 may be a force-collecting type pressure sensor. In some embodiments, the transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied across its area / surface. The transducer 32 may be associated with the housing 36 such that at least a portion of it is housed within or attached to the housing 36. With respect to sensor devices / components "associated with" a stent or other implantation structure, such term may refer to sensor devices or components that are physically coupled, attached, connected to, or integrated with the implantation structure.

[0050] In some embodiments, the transducer 32 includes or is a component of a piezoresistive strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain resulting from an applied pressure, where the resistance increases as the pressure deforms the component / material. The transducer 32 can incorporate any type of material, including but not limited to silicon (e.g., single crystal), polysilicon thin films, bonded metal foils, thick films, silicon-on-sapphire, sputtered thin films, and / or similar materials.

[0051] 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 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, 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 inductance change, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such a sensor can determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0052] In some embodiments, the transducer 32 includes or is a 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.

[0053] Figure 6 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 implantable device 30 implanted in, for example, the patient 44's heart (not shown) or related physiological function. For example, the implantable device 30 may be at least partially implanted in the left atrium and / or coronary sinus of the patient's heart. The implantable 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).

[0054] In certain embodiments, the monitoring system 40 may comprise at least two subsystems, including an implantable internal subsystem or device 30 comprising a sensor transducer 32, and a control circuit 34 comprising one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further comprise an external (e.g., non-implantable) subsystem comprising an external reader 42 (e.g., a coil) which may include a wireless transceiver electrically and / or communicatively coupled to a particular control circuit 41. In certain embodiments, both the internal 30 and external 42 subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue positioned between them. The sensor implantation device 30 may be any type of implantation device. For example, in some embodiments, the implantation device 30 comprises a pressure sensor integrated with another functional implantation structure 39, such as an artificial shunt or stent device / structure.

[0055] Specific details of the implantable device 30 are shown in the enlarged block 30 provided herein. The implantable 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 cavities and / or blood vessels of the heart, as described in detail throughout this disclosure. In some embodiments, the implant / anchor structure 39 may include a helical / coiled wire form, as disclosed in detail herein.

[0056] While certain components are shown in Figure 6 as part of the implantable device 30, it should be understood that the sensor implantable device 30 may comprise only a subset of the components / modules shown, and may comprise additional components / modules not shown. The implantable device may represent an embodiment of the implantable device shown in Figure 5, and vice versa. The implantable 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 the patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducers 32 may comprise any preferred or desired type of sensor transducer for providing a signal associated with the physiological parameters or conditions associated with the implantable device 30 and / or the patient 44.

[0057] The sensor transducer 32 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, diaphragm-based sensors, and / or other types of sensors that 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 an area / surface thereof. The transducer 32 may be associated with a sensor housing 36 such that at least a portion of it is housed within or attached to the housing 36.

[0058] In some embodiments, the transducer 32 includes or is a component of a strain gauge that 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 strain gauge component / material. The transducer 32 can 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, a metal strain gauge may be bonded to the sensor surface, or a thin film gauge may be coated onto 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.

[0059] 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 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, a linear variable displacement transducer (LVDT) function, the 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 determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

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

[0061] 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 local external monitoring system 42 shown. 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 type of transceiver circuit configured to transmit an electromagnetic signal, the signal which can be radiated 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.

[0062] The radio signals generated by the implanted device 30 can 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 signals from the implanted device 30 and is at least partially located within the patient 44. For example, module 43 may include a transceiver device / circuit.

[0063] An external local monitor 42 can receive radio signals from the embedded device 30 and / or supply radio power to the embedded device 30 using an external antenna 48, such as a wand device. 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 embedded 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 a 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 signals transmitted via the network 49 and / or for receiving signals from the embedded device 30. In certain embodiments, the local monitor 42 includes a control circuit 41 for processing signals received from the embedded device 30. The local monitor 42 can be configured to communicate with a network 49 according to known network protocols such as Ethernet or Wi-Fi. In certain embodiments, the local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0064] In certain embodiments, the implanted device 30 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory, such as 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 implanted 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, such as from the local monitor 42 or from the remote monitor 46, via the network 49. For example, the implanted device 30 may be configured to receive signals that at least partially control the operation of the implanted device 30, such as by activating / deactivating one or more components or sensors, or by affecting the operation or performance of the implanted device 30.

[0065] One or more components of the implantable 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 that the power sources 35 be relatively minimalist in nature. For example, high-power drive voltages and / or currents within the implantable device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implantable device. In certain embodiments, the power sources 35 are at least partially passive in nature so that the passive circuits of the implantable device 30 can receive power wirelessly from an external source, for example, 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 power the implantable device 30, thereby allowing the power circuits of the implantable device to obtain 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 and, advantageously, may be configured to provide sufficient power as needed over a monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other periods).

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

[0067] System 40 may include, for example, a secondary local monitor 47, which may be a desktop computer or other computing device configured to provide a monitoring station or interface for displaying 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 the implantable device 30, and the local monitor 42 is primarily designed to receive / transmit signals to and from the implantable device 30 and provide such signals to the secondary local monitor 47 for display, processing, and / or operation. The external local monitoring system 42 may be configured to receive and / or process certain metadata from or associated with the implantable device 30, such as a device ID, which may be provided from the implantable device 30 via data linkage.

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

[0069] 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 arranged or housed within a sensor housing 36, which may comprise any type of material and, advantageously, may be at least partially sealed. For example, in some embodiments, the housing 36 may include 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 include a polymer or other flexible structure / material that can advantageously allow the sensor 30 to be bent, flexed, or folded to enable transport through a catheter or other percutaneous delivery means.

[0070] [Cardiac shunt implantation] As described above, shunts and other implantable devices / structures may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. Sensor devices according to embodiments of the present disclosure may be integrated with cardiac shunt structures / devices or other implantable devices using any suitable or desirable mounting or integration mechanism or configuration. Figure 7-1 shows a side view of a sensor implantable device 70 according to one or more embodiments. Figure 7-2 shows an example of a sensor assembly / device 60 which may be a component of a sensor implantable device such as the sensor implantable device 70 shown in Figure 7-1. Figures 8A and 8B show axial views of one embodiment of the shunt-type sensor implantable device 70 of Figure 7-1 according to one or more embodiments.

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

[0072] The sensor device 60 may be associated with either of the axial sides / ends of the shunt structure 90, and the different axial sides / ends of the shunt structure 90 will be exposed on the opposing sides (S1, S2) of the tissue wall when the implantation device 70 is implanted in the tissue wall. Where the axial side of the shunt structure is referred to as described herein, it may refer to the opposing side of a plane P1 that axially (and / or diagonally) bisects the shunt structure 90 and / or its barrel portion 98. The plane P1 may be 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 in which the shunt structure 90 is configured to be implanted. Where the axial side of the implant structure is referred herein, it may be understood to refer to the different sides of the tissue engagement plane P1. The plane P1 may be aligned with at least a portion of the coil / winding 91 of the barrel / conduit portion 98 of the shunt structure 90 (e.g., within 5° or 10° of precise alignment).

[0073] Furthermore, the description herein of sensor devices and / or sensor arms positioned on different radial sides of a shunt structure may refer to opposing sides in the diameter plane P2, as shown in Figure 7-1. For example, if a shunt structure includes a sensor arm on a given axial side of the shunt structure that originates 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 of the shunt structure, such an arm may be considered to be on or originating from different and / or opposing radial sides of the shunt structure.

[0074] The barrel portion 98 of the shunt structure 90 is advantageously self-adjustable with respect to its axial length. For example, the shape / shape of the helical wire coil allows the barrel 98 to expand axially, thereby introducing a gap between adjacent windings 91 of the coil barrel 98. Thus, the shunt structure 90 may be configured to be embedded within a range of anatomical structures and / or tissue walls having various features and / or dimensions. In some embodiments, the barrel coil 98 is biased in an axially compressed configuration, as shown in Figure 7-1, where adjacent windings of the coil are in contact with each other or relatively close. The barrel portion 98 may be considered the main body portion of the shunt structure 90.

[0075] The sensor device 60 is advantageous in that its sensor transducer components 65 are arranged, positioned, fixed, oriented, and / or otherwise positioned in a configuration where they 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 ordinary meaning and may refer to a three-dimensional space defined by the radial boundary of a fluid conduit and extending axially from the fluid conduit. For example, with respect to a given fluid conduit structure such as the fluid conduit / barrel structure 98 of the shunt structure 90, the associated channel region 88 may be considered to be defined according to any of the channel regions 88 illustrated and described in Figures 9-1A, 9-1B, 9-2, 9-3A, and 9-3B.

[0076] The shunt structure 90 may be a radially expandable shunt. When expanded, the central flow channel 96 of the shunt 90 may define a substantially circular or elliptical opening. The channel 96 may be configured to hold the sides of the puncture opening to a tissue wall, forming a blood flow path between cardiac chambers or cardiac blood vessels (or other anatomical structures) separated by the tissue wall. For example, the shunt structure 90 may be configured to be embedded in the wall separating the coronary sinus from the left atrium. The central flow channel 96 may be partially formed by one or more windings 91 of the E. coli-type structure 90. In some embodiments, the substantially entire shunt 90 is formed by a superelastic wire (shape memory alloy, nitinol) which is configured to be compressed, housed in a catheter (not shown), and then expanded to return to a relaxed shape as shown in Figure 7-1.

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

[0078] The formation of the shunt 90 using one or more elongated wires can at least partially increase the flexibility of the shunt, thereby allowing its compression and expansion at the embedded portion. As described above, the coil-shaped shunt structure 90 may include a barrel / body portion 98 and one or more flange portions 94, 95. For example, in some embodiments, the barrel portion 98 may include one or more windings 91 of a coil having a diameter D1, the windings 91 defining a barrel or fluid conduit structure 98 through which fluid can be diverted according to the embodiments of this disclosure. That is, the inside of the barrel 98 and / or coil windings 91 may define a fluid path / conduit. In some embodiments, such conduits 98 are substantially fluid-sealed. For example, the windings 91 may be sufficiently sealed and compressed together in the deployed configuration shown in Figure 7-1 to substantially prevent leakage of fluid (e.g., blood) through the barrel portion 98. In some embodiments, some amount of fluid leakage between the coil windings 91 is acceptable in the embedded / deployed configuration. The diameter D1 of the shunt barrel 98 may have any suitable or desirable dimensions, such as approximately 20 mm or less, for example, approximately 10 mm or less (for example, 7.5 mm). In some embodiments, gaps may exist between the windings 91 of the barrel portion 98 of the shunt structure 90, between at least one adjacent pair of windings 91, and / or between the windings 91 of the barrel portion 98 and one or more of the adjacent flange portions 94, 95.

[0079] The coil windings 91 forming the central flow channel 96 advantageously provide a tube with sufficient rigidity and structure to hold the tissue in an open position at the puncture site. The barrel portion 98 extends axially between the distal 94 and proximal 95 flanges on each side, or between the coil. For example, the flange portions 94, 95 of the coil shape 90 can generally be associated with the proximal and distal axial ends of the shunt structure 90, respectively. In some embodiments, the flange portions 94, 95 are configured to function as tissue anchors that prevent axial movement of the shunt structure 90 or detachment of the shunt structure 90 from the tissue wall in which it is embedded, by holding and / or pinching and / or otherwise holding the tissue wall between them. For example, one or both of the flanges 94, 95 may have a coil shape with a diameter D2 greater than the diameter D1 of the barrel 98, such that when the embedded structure 90 is sufficiently sealed and embedded within the tissue wall and the barrel 98 occupies a region at least partially within / through the tissue wall, the expanded diameter D2 of the flange prevents the barrel 98 and the shunt structure 90 from passing through the opening tissue in one or more directions. The diameter D2 of the flange may have any preferred or desired dimension, such as about 40 mm or less, for example, about 30 mm or less (e.g., 10 mm to 15 mm). Both the proximal 95 and distal 94 flange portions are shown in Figure 7-1 and described in relation to the various embodiments disclosed herein, but it should be understood that in some embodiments, a sensor embedded device having an anchor flange according to the aspects of this disclosure may include a flange only on one axial end of the shunt structure. While the distal and proximal sides / parts of a shunt structure are described to some extent herein, it should be understood that the identified distal part / side, like the identified proximal part / side, 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 with respect to the delivery system / device used to implant the associated sensor implantation device and / or shunt structure.

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

[0081] In some embodiments, the distal and proximal flanges / coils 94, 95 are configured to radiate outward in a helical manner from the periphery 87 of the barrel 98. These helical flange coils / wires 94, 95 are located on the flange plane P in the extended / unfolded configuration shown in Figure 7-1. f They can be shaped to be located internally. The extended flanges / coils 94, 95 can serve to anchor the shunt 90 to the target tissue wall. While specific embodiments are disclosed herein in the context of shunt structures similar to those shown in Figure 7-1, it should be understood that shunt structures or other implantable devices integrated with pressure sensor functions according to embodiments of this disclosure may have any type, form, structure, configuration, and / or be used or configured for any purpose or function, regardless of whether they are shunts or otherwise.

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

[0083] In some embodiments, the sensor arm 92 is positioned on the tissue engagement plane P1 of the shunt structure 90 and / or on the plane P of the flange 94 from which the arm 92 is ejected at an amount / angle θ1. f The sensor arm 92 is deflected axially relative to the tissue engagement plane P1. Figure 7-1 shows a sensor implantation device 70 configured such that the sensor 60 is held in a position closer to the axial direction of the barrel 98 than in other embodiments having a sensor arm deflected axially with respect to the tissue engagement plane P1, as shown in Figure 7-1. f It may be substantially located inside.

[0084] The deflection of the sensor 60 and sensor arm 92 distal to the flange 94 may be important to provide a flow path for the fluid being shunted around the sensor 60 and / or through the fluid conduit 98 of the shunt structure 90. For example, the sensor 92 may be deflected to provide an axial gap G between the sensor 60 and / or the sensor holding portion 93 of the shunt structure 90 and the flange 94 and / or the fluid conduit opening 96. The axial flow gap G can provide an area for blood or other fluids to flow around the sensor arm 92 and within the opening 96 of the fluid conduit 98. The angle θ1 is between the extension portion 75 of the sensor arm 92 and the tissue engagement plane P1 and / or plane P of the flange 94. f It may be any desired angle between θ1 and θ2. In some embodiments, the deflection angle θ1 is about 30° to 60°, such as about 35°, 40°, or 45°. For embodiments in which the arm 92 is deflected by an angle greater than 90°, such implementations may position at least a portion of the sensor device 60 outside the channel region 88. Therefore, it may be desirable to implement a sensor arm deflection angle θ1 of less than 90° in order to keep the sensor device 60 and / or its transducer components 65 within the channel region 88 of the shunt structure 90. Furthermore, by deflecting the sensor arm 92 so that the sensor 60 is positioned at or near the center of the flow channel 88 and / or the axis A1 of the fluid conduit 98, the gap region of the fluid flow can be maximized with respect to a given gap distance G. For example, in such embodiments, substantially equal amounts of blood flow may be allowed from around the periphery 87 of the fluid conduit 98. In some embodiments, the arm 92 may be deflected to position the sensor 60 and sensor arm 92 on one side or region of the fluid conduit 98 in order to allow for a larger area or amount of fluid flow within and / or from a desired direction of the fluid conduit.

[0085] Specifically, Figure 8A shows an axial view corresponding to the axial side of the implantation device 70 associated with the sensor device 60. That is, the sensor component 65 is attached to the arm 92, integrated with the arm 92, or otherwise associated with the arm 92, with its side facing outward from the plane of the paper in Figure 8A. The side facing outward from the plane of the paper in Figure 8A may be the distal or proximal side. Figure 8B shows an axial view corresponding to the axial side of the implantation device 70 on the opposite side of the sensor device 60. The side facing outward from the plane of the paper in Figure 8B may be the distal or proximal side.

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

[0087] The sensor arm 92 may further include a sensor holding portion 93, which may comprise one or more wraps / windings 99 of a coil arm 92 in a configuration relatively tightly wound around the body / housing 69 of the sensor device 60, thereby at least partially restraining / holding the sensor device 60 and holding the sensor device 60 in a desired sensing position. It may be desirable that the coil windings 99 within the holding portion 93 of the sensor arm 92 be sufficiently sealed and / or secured to reduce the risk of the sensor device 60 falling out / escaping in the presence of fluid flow and / or other fluid conditions (e.g., pressure) in the embedded environment. Figure 7-1 shows the sensor holding portion 93 of the sensor arm 92 as including coil-shaped windings 99 wound around the body 69 of the sensor 60, but it should be understood that the sensor device 60 may be coupled to the sensor arm 92 in any suitable or preferred manner. The sensor device 60 may be fixed to the anchor arm 94 using any preferred means or mechanism. For example, suitable fastening / mounting means / mechanisms for attaching the sensor device 60 to the sensor arm of the shunt structure 90 could be any mechanism disclosed in PCT application PCT / US20 / 56746, filed October 22, 2020, entitled “Sensor Integration in Cardiac Implant Devices,” the entirety of which is expressly incorporated herein by reference. For example, the shunt structure 90 and / or its sensor arm may include one or more sensor-holding fingers, clamps, wraps, bands, belts, clips, pouches, housings, casings, and / or similar, configured to fasten the sensor device 60 to the arm and / or other structural features of the shunt structure 90. For example, one or more clips, hooks, adhesives, or other mounting features may be associated with the sensor-holding portion 93 of the sensor arm 92, such features configured to fasten the sensor 60 to the sensor arm 92.

[0088] In some embodiments, the sensor holding portion 93 of the sensor arm 92 includes a plurality of coil windings 99 separated by a gap 71. A bridge wire portion 97 may connect the coils 99 that straddle the gap 71. In some embodiments, such a gap does not exist between adjacent sensor holding coil windings 99.

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

[0090] The sensor transducer components 65 include a sensor element 67 such as a pressure sensor transducer / membrane. As described herein, the sensor device 60 may be configured to implement wireless data and / or power 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 / windings 67 that can facilitate inductive power feeding and / or data transmission. In embodiments including conductive coils, such coils may be at least partially wrapped / arranged around a magnetic (e.g., ferrite, iron) core 79.

[0091] The sensor device 60 may, advantageously, be biocompatible. For example, the housing 69 may, advantageously, be biocompatible, such as a housing 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.

[0092] The sensor device 60 may be configured to communicate with an external system when implanted in the heart or other areas of a patient's body. For example, the antenna 61 may wirelessly receive power from and / or communicate to and / or sensed data or waveforms from the external system. The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include 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 components and / or other components of the pressure transducer 67 may, advantageously, be fused to / with the housing 69 of the sensor device 60 or otherwise sealed in order to provide hermetically sealed at least some of the components of the sensor.

[0093] 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 / windings 63 (e.g., wire coils). In some embodiments, the coils / windings include copper or other metals. The antenna 61 may be advantageously configured with a coil geometric shape that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementations, the sensor implantation device 70 may be delivered to a target implantation site using a delivery catheter (not shown), the delivery catheter including a cavity or channel configured to adapt to the advancement of the sensor device 60 through it.

[0094] As described above, some embodiments of the present disclosure include a shunt structure having a sensor arm configured to hold a sensor in a channel region of the shunt structure, which is advantageous as it facilitates the sensing of hydrodynamics related to the flow of fluid through the shunt structure. Figures 9-1A, 9-1B, 9-2, 9-3A, and 9-3B show exemplary channel regions 88 associated with a fluid conduit 98 of each shunt body according to one or more embodiments. In particular, Figures 9-1A, 9-2, and 9-3A show side views of the fluid conduit and associated channel region, while Figures 9-1B and 9-3B show axial and / or top-down views of the respective fluid conduit and channel region.

[0095] Figures 9-1A and 9-1B show exemplary fluid conduits 98 formed by one or more outer walls 93, the fluid conduits 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 conduits 98. For example, the fluid conduits 98 may represent the conduit structure of the shunt implantation device described herein (e.g., formed by multiple windings in the form of coiled wire). In the particular embodiments of Figures 9-1A and 9-1B, the fluid conduits 98 have an axis A1 that is substantially orthogonal, perpendicular, and / or normal to the tissue plane P1. In such embodiments / configurations, the channel region 88 associated with the fluid conduits 98 can be considered, as illustrated, a three-dimensional projection / extension of the region of the fluid conduits around axis A1, enclosed by walls 93. Therefore, 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 the axis A1 of the fluid conduit 98. The sensor transducers positioned within the channel region 88 of the fluid conduit 98 shown in Figures 9-1A and 9-1B can be considered to be positioned within a region defined by the radial boundary of the fluid conduit 98 around the axis A1 of the fluid conduit 98. Furthermore, the sensor transducers may be positioned within the axially outer channel region 88 of the fluid conduit structure 98, similar to the illustrated sensor embedding device 70 shown in Figure 7-1, and the sensor transducer 65 is positioned within the axially outer channel region 88 of the shunt barrel structure 98.

[0096] Figure 9-2 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 9-2 may be configured to be embedded within a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the fluid conduit 98 is angled 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 9-2, 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 in the figure.

[0097] Figures 9-3A and 9-3B show another exemplary fluid conduit 98 formed by one or more outer walls 93, the fluid conduit 98 being associated with a tissue plane P1, which may be defined / represented in the manner detailed above. The fluid conduit 98 in the embodiments of Figures 9-3A and 9-3B may be configured to be embedded in a tissue wall (e.g., a tissue wall coplanar with the tissue plane P1), and the axis A1 of the conduit 98 is angled 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 9-1A, 9-1B, 9-2, 9-3A, and 9-3B, 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 identical). Therefore, the channel region 88 in Figures 9-3A and 9-3B may not be coaxial with the conduit 98, but rather may be defined on one end by the radial boundary of the opening 96 of the conduit 98, 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 Figures 9-3A and 9-3B. The channel region 88 identified in Figures 9-3A and 9-3B may correspond to the primary orientation / path of a true flow channel of fluid that can flow through the fluid conduit 98 when the conduit 98 is embedded in the tissue wall between two blood vessels / chambers. That is, the fluid may flow through the opening 96 of the fluid conduit 98, in some cases, primarily in a direction perpendicular to the tissue plane P1.

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

[0099] As referenced, the sensor implantation device 170 includes a seal or cover 150 which may include any suitable or desired material and / or structure / shape, such as fabric / cloth, polymer, or mesh, formed from any type of material. The cover 150 may be positioned over one or more portions or areas of the shunt structure 190. For example, as shown in Figure 10, the cover 150 may be positioned over and / or inside the barrel portion 198 of the shunt structure 190. Although the cover 150 is illustrated as being positioned around the outside of the barrel 198, embodiments of the present disclosure should be understood to include a cover positioned inside the barrel portion of the shunt structure.

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

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

[0102] The sensor embedding device 50 may further include a second sensor arm 27, which may be configured to fix and / or hold the sensor device 60 at least partially, such as in the area of ​​the sensor holding portion 23 of the sensor arms 22, 27. In some embodiments, the second sensor arm 27 may be similar to the first sensor arm 22 and may extend from the opposing side and / or circumferential region of the flange 24 and / or shunt structure 20, which can advantageously provide a desired degree of stability for sensor holding. For example, in a single-arm embodiment as shown in Figure 7-1, such a sensor arm may be prone to post-embedding deflection of the arm caused by certain fluid dynamics (e.g., flow, pressure, etc.) at the embedding site, which may affect the sensor reading and / or impair the structural integrity of the shunt structure. Thus, embodiments having multiple sensor arms, such as those shown in Figures 11A and 11B, can provide improved stability. Such embodiments can prevent and / or reduce post-embedding movement or deflection of the sensor 60 and / or associated support arms.

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

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

[0105] In some embodiments, two sensor arms 22, 27 are associated with opposing ends of the same wire. For example, such a wire may be wound around the sensor 60 of the sensor holding portion 23 of sensor arm 22, cross the distal flange 24, barrel 28, proximal flange 25, and rearward, and terminate at the sensor holding region / portion 23 at the end of sensor arm 27. In some embodiments, the end of the wire is in another region of the shunt structure 20, such as at or near the proximal flange 25, rather than in the region of sensor arms 22, 27 (e.g., the sensor holding region / portion 23). For example, the wire may start at the proximal end / flange 25, cross through the barrel 98, flange 24, and sensor arm 22 to the sensor holding portion 23, and the wire may be wound around the sensor 60 of the sensor holding region 23, and travel / cross proximal to the proximal end 25 via sensor arm 27, flange 24, and barrel 28. Naturally, the shunt structure 20 may include any number of wires, which can be wound to form a proximal flange 25, barrel 28, distal flange 24, and sensor arms 22, 27, including the sensor holding form / structure 23, in any suitable or desirable manner.

[0106] In some implementations, the shunt device / structure according to the embodiments of this disclosure may be embedded in the wall separating the coronary sinus from the left atrium, and as a result, the interatrial shunt may be achieved through the coronary sinus. Figures 12A and 12B show a shunt-type sensor implantation device 80 embedded in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. Figure 12, and some of the following figures, show a cross-section of the heart viewed from above, covering everything, with the posterior surface oriented towards the top of the page.

[0107] In some cases, a left-to-right shunt through the implantation of a shunt device 80 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable to a shunt through the atrial septum 18. For example, a shunt through the coronary sinus 16 may offer a reduced risk of thrombosis and embolism. Generally, the coronary sinus may be less likely to have the presence of thrombi / embolus for several reasons. Firstly, the drainage of blood from the coronary vascular system to the right atrium 5 is filtered blood, having just passed through capillaries. Secondly, the opening 14 of the coronary sinus in the right atrium is often partially covered by a false valve (not shown) called the Thebesius valve. Thebesius valve is not always present, but some studies have shown that it is present in most hearts and can block the entry of thrombi or other embolisms in events of spikes in right atrial pressure. Thirdly, the pressure gradient between the coronary sinus and the right atrium from which it is expelled is generally relatively low, and as a result, the thrombus or other embolus in the right atrium is likely to remain there. Fourthly, in events in which a thrombus / embolus enters the coronary sinus, there is typically a much larger gradient between the right atrium and the coronary vascular system than between the right and left atria. The thrombus / embolus will likely travel further down the coronary vascular system until the right atrial pressure returns to normal and the embolus returns directly to the right atrium.

[0108] Several additional advantages of placing the sensor implantation device 80 within the wall between the left atrium and the coronary sinus relate to the consideration that such anatomical structures are generally more stable than the atrial septal tissue. By diverting left atrial blood to the coronary sinus, sinus pressure may increase by a small amount. This may allow the blood of the coronary vascular system to move more slowly through the heart, increasing perfusion and oxygen delivery, which may be more efficient and may also help the dying myocardium recover. Furthermore, by implanting the shunt device / structure 83 in the wall of the coronary sinus, damage to the atrial septum 18 can be prevented. Thus, the atrial septum 18 can be preserved for later transseptal access for other therapies. Preserving transseptal access may 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.

[0109] It is worth noting that, in addition to the various advantages of placing the sensor implantation device 80 between the coronary sinus 16 and the left atrium 2, certain disadvantages may 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 be passed to the right atrium 5, and / or unoxygenated blood from the right atrium 5 may be passed to the left atrium 2, both of which may be undesirable in terms of proper cardiac function.

[0110] As further referenced in Figures 12A and 12B, the coronary sinus 16 is substantially continuous with the left atrium 2, and therefore, a variety of possible and acceptable placements for the implantable device 80 exist. The target site selected for placement of the implantable device 80 may be within an area where the tissue of a particular patient is thin or low-density, as predetermined by non-invasive diagnostic means such as fluoroscopy or intravascular ultrasound (IVUS), such as CT scan or radiography.

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

[0112] Figure 13 shows a sensor implantation device 80 embedded 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 anchoring position for the shunt structure 81 of the sensor implantation device 80. Furthermore, the implantation device 80 may be implanted in a desirable location, taking into account future re-crossing of the septum 18 for future interventions. Implantation of the sensor implantation device 80 in the atrial septum 18 may advantageously enable fluid communication between the left atrium 2 and the right atrium 5.

[0113] An interatrial shunt using a sensor implantation device 80 may be suitable for patients who are relatively sensitive to increased atrial pressure. For example, when pressure rises in the ventricles and / or atria and myocardial cells are subjected to pressure, the heart muscle generally tends to contract and may have relative difficulty processing the excess blood. Therefore, in patients with impaired ventricular contractility, such patients may be more sensitive to higher pressures in the ventricles and / or atria, as the heart may not be able to adequately respond to or react to the ventricles as they expand or contract. Furthermore, increased left atrial pressure can cause dyspnea, and therefore, it may be desirable to reduce left atrial pressure through an interatrial shunt to alleviate dyspnea and / or reduce the incidence of readmission. For example, if the ventricles experience dysfunction that prevents them from adapting to the accumulation of fluid pressure, such fluid can stagnate in the atria, thereby increasing atrial pressure. In the case of heart failure, minimizing left ventricular end-diastolic pressure may be of paramount importance. Since left ventricular end-diastolic pressure may be related to left atrial pressure, fluid stagnation in the atrium can lead to fluid stagnation in the lungs, thereby potentially causing an undesirable and / or dangerous accumulation of fluid in the lungs. An interatrial shunt, such as using a shunt device according to 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, may be able to accommodate the additional fluid.

[0114] As in other embodiments, the sensor implantation device 80 shown in Figure 13 includes a sensor device 60 comprising a sensor transducer component 65 and a cylindrical (or other shaped) housing 69. The sensor device is positioned, mounted, and / or otherwise fixed or associated with a sensor arm 82, such that the sensor transducer 65 is positioned in a channel region associated with a barrel / conduit portion 78 of a shunt structure 81, and the associated channel region is within the left atrium. The sensor arm 82 and its sensor retaining portion 83 may have any of the sensor arms and associated sensor retaining portions disclosed herein in relation to any embodiment of the present disclosure.

[0115] Figure 14 shows a sensor implantation device 80 embedded in the atrial septum 18, having a sensor 60 of the device exposed in the right atrium 5, according to one or more embodiments. As in other embodiments, the sensor implantation device 80 shown in Figure 14 includes a sensor device 60 comprising a sensor transducer component 65 and a cylindrical (or other shaped) housing 69. The sensor device 60 is positioned, mounted, and / or otherwise fixed or associated with a sensor arm 82 of the shunt structure 81 of the implantation device 80, such that the sensor transducer 65 is positioned in a channel region associated with a barrel / conduit portion 78 of the shunt structure 81, and the associated channel region is within the right atrium 5.

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

[0117] Figure 15 shows a sensor implantation device 220 embedded in the atrial septum 18 such that a first sensor 260 and its associated sensor transducer 265 are exposed in the left atrium 2, while a second sensor 262 and its associated sensor transducer 267 are exposed in the right atrium 5. In some embodiments of dual-sensor implantation devices that may be similar in certain respects to implantation device 220, both sensors may be exposed in either the left atrium 2 or the right atrium 5. With respect to multi-sensor shunt implantation 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 15 shows two sensor devices 260, 262 associated with retaining arms 292, 297 extending from opposing axial sides / ends of a fluid conduit / barrel structure 298, resulting in the sensor devices being exposed on opposing sides of the tissue wall 18, it should be understood that a dual sensor shunt implantation device according to an aspect of the present disclosure may have sensor devices associated with any sensor arm / feature. For example, as an alternative to the particular illustrated embodiment in Figure 15, a sensor implantation device 220 may include sensor devices associated with sensor arms that are associated with and / or extend from a common axial side of the conduit / barrel structure 298 and / or a common anchor flange, such that both sensors are exposed on a common side of the tissue wall in which the sensor implantation device 220 is embedded.

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

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

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

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

[0123] Figures 15 and 16 are described in relation to a sensor implantation device embedded in the atrial septum, but it should be understood that, as with any other embodiments disclosed herein, such sensor implantation devices may be embedded in any tissue wall or anatomical structure. Furthermore, the identified sides 304, 305 of the shunt structure 390 may be embedded on both sides of the atrial septum or other walls.

[0124] Figures 17-1, 17-2, 17-3, 17-4, and 17-5 provide flowcharts illustrating a process 1700 for implanting a sensor implantation device according to one or more embodiments. Figures 18-1, 18-2, 18-3, 18-4, and 18-5 provide images of cardiac anatomical structures and specific devices / systems corresponding to the operation of process 1700 in Figures 17-1, 17-2, 17-3, 17-4, and 17-5 according to one or more embodiments.

[0125] In block 1702, process 1700 includes providing the delivery system 55 with a sensor implantation device 70 to be placed within the delivery configuration, such as a wire-type shunt sensor implantation device as disclosed in detail herein. Image 1802 in Figure 18-1 shows a partial cross-sectional view of the delivery system 55 for the sensor implantation device 70 according to one or more embodiments of the present disclosure. Image 1802 shows the sensor implantation device 70 placed within the outer sheath 51 of the delivery system 55. While specific embodiments of the delivery system are shown in Figure 18-1, it should be understood that sensor implantation devices according to aspects of the present disclosure can be delivered and / or embedded using any suitable or preferred delivery system and / or delivery system components.

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

[0127] In some embodiments, the delivery system 51 may be configured such that a guidewire 54 can be positioned at least partially within it. For example, the guidewire 54 may run within the sheath 51 and / or within the axial region of the inner catheter 52, such as within the inner catheter 52 as shown. The delivery system 55 may be configured to advance along the guidewire 54 to guide the delivery system 55 to the target implantation site.

[0128] Although not shown in Figure 18-1, in some embodiments, the delivery system 55 includes a tapered nose cone feature that may be associated with the sheath 51, catheter 52, and / or the distal end of the delivery system 55. This nose cone feature can be used to expand an opening in the tissue wall through which a sensor implantation device 70 is implanted or through which the delivery system is advanced. Furthermore, the nose cone feature can facilitate the advancement of the distal end of the delivery system 55 through the patient's tortuous anatomical structures and / or through the external delivery sheath or other conduit / pathway. In some embodiments, the delivery system may include a plurality of flap-like forms that are urged / spread apart as the sensor implantation device 70 and / or any part thereof, the internal catheter 55, or other device advances through it, and / or a nose cone feature formed therefrom.

[0129] In some embodiments, the sensor implantation device 70 may be located within a delivery system 55 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 52 includes one or more sensor housing features (not shown), such as one or more cutouts, indentations, recesses, gaps, openings, holes, slits, or other mechanisms configured to accommodate the presence of other features or shapes of the sensor device 60 and / or implantation device 70. Such sensor housing features may be, for example, axial and circumferential cutouts of the inner catheter 52, and may be dimensioned to correspond to the size and / or external shape of the sensor device, and may allow the sensor device to protrude radially into the inner diameter / space of the inner catheter 55. In some embodiments, as shown in Figure 1802, the sensor 60 and sensor holding portion 93 of the sensor arm 92 may be located distal to the distal end of the inner catheter 52 when in a delivery configuration.

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

[0131] The outer sheath 51 may be used to transport the sensor implantation device 70 to the target implantation site. That is, the sensor implantation device 70 can be advanced at least partially within the lumen of the outer sheath 51 to the target implantation site so that the sensor implantation device 70 is at least partially held and / or fixed within the distal portion of the outer sheath 51.

[0132] The delivery system 55 further includes a pusher 53 comprising at least a partially hollow tube configured to slide above the inner catheter 52, and moves the shunt structure 90 above / outside the inner catheter 52 by the pusher 53 advancing distally relative to the inner catheter 52 when the distal end of the pusher 53 is in contact with the proximal end of the shunt structure 90.

[0133] In block 1704, process 1700 includes accessing the right atrium 5 of the patient's heart using a delivery system 55 having a sensor implantation device 70 located therein. In some implementations, accessing cardiac anatomical structures using the delivery system 55 may be carried out by one or more procedures or steps, such as positioning a guidewire 54 to form and / or dilate an opening in the atrial septum 18 (e.g., one located in the region of the fossa ovale 1811), but the details thereof are omitted for convenience and clarity.

[0134] In block 1706, process 1700 involves advancing the delivery system 55 into the left atrium 2 through the atrial septum 18. Access to the septum 18 and left atrium 2 via the right atrium 5 can be achieved using any preferred or desired procedure. For example, various access routes can be utilized when manipulating the guidewire and catheter within and around the heart to deploy an expandable shunt integrated with or associated with a pressure sensor, according to embodiments of the present disclosure. In some embodiments, access to the superior vena cava (not shown) and from there to the right atrium 5 can be achieved through the subclavian or jugular vein. Alternatively, the access route may begin in the femoral vein and enter the heart through the inferior vena cava (not shown). Other access routes may also be used, each of which typically utilizes a percutaneous incision through which the guidewire and catheter are inserted into the vascular system, usually through a sealed introducer, 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 54 is introduced through the subclavian or jugular vein, through the superior vena cava 19, and into the right atrium 5. In some implementations, the guidewire 54 can be arranged in a spiral configuration within the left atrium 2, which may help to fix the guidewire in place. Once the guidewire 54 provides the route, the introducer sheath can be routed along the guidewire 54 into the patient's vascular structure, for example, by the use of a dilator. The delivery catheter may advance through the superior vena cava to the right atrium 5, and the introducer sheath may provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to form and prepare an opening in the septum 18, and a separate deployment delivery system 55 is used for the delivery of a sensor implantation device 70, as shown. In other embodiments, the delivery system 55 may be used as both a puncture preparation and implantation delivery catheter with full functionality. In this application, the term “delivery system” is used to describe a catheter or introducer having one or both of these functions.

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

[0137] In block 1708, process 1700 involves deploying one or more distal coils of the shunt structure 90 such that the coil expands to form a sensor arm 92 and distal flange 94 of the sensor implantation device 90 on the left atrial side of the septum 18. Deploying the coils of the shunt structure 90 can be carried out at least partially by advancing a pusher or other component of the delivery system 55 against the sheath 51. The anchor arm 92 may have an associated sensor device 60, the sensor transducer 65 of the sensor device 60 being exposed within the left atrium 2 so that the sensor transducer 65 may be used to acquire signals indicating physiological parameters associated with the left atrium, such as pressure.

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

[0139] In block 1712, process 1700 removes the delivery system 55 and leaves the sensor implantation device 70 embedded in the septum 18, thereby allowing blood flow to be short-circuited through the implantation device 70 from the left atrium 2 to the right side of the heart. In some implementations, the implantation device 70 is shown within the atrial septum 18, but the implantation device 70 may be positioned between the wall separating the left atrium 2 from the coronary sinus, or between other cardiac chambers.

[0140] Figure 19 shows various catheters 111 that may be used for implanting a sensor device according to embodiments of the present disclosure. Advantageously, the catheters 111 may have relatively small cross-sectional profiles and be maneuverable to allow for the traversal of various blood vessels and lumens through which they may advance en route to, for example, the right atrium 5, the coronary sinus 16, the left atrium 2, or other anatomical structures or lumens. Catheter access to the right atrium 5, the coronary sinus 16, or the left atrium 2 by a particular transcatheter solution may be 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 involve traversing the atrial septum (e.g., in or near the fossa ovalis).

[0141] Access to the left atrium is exemplified and described in connection with specific embodiments, such as via the right atrium and / or inferior vena cava, including through transfemoral or other transcatheter procedures, but other access routes / methods may be implemented according to embodiments of this disclosure. For example, if septal transposition through the atrial septum is not possible, 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 septum may be undesirable and would result in further injury to the patient. Furthermore, in some patients, the septum may be occupied by one or more implants or other treatments, and transposition through the septum is unacceptable from the standpoint of such treatments. As an alternative to transseptal access, transaortic access may be performed, in which case the delivery catheter 111c may pass through the descending aorta 32, aortic arch 12, ascending aorta, and aortic valve 7 to reach the left atrium 2 through the mitral valve 6. Alternatively, transapical access may be performed to access a target anatomical structure, as indicated by the delivery catheter 111d.

[0142] [Additional Implementations] Depending on the embodiment, any particular action, event, or function of any of the processes or algorithms 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 language used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” is intended in its ordinary sense unless otherwise stated or understood differently in the context in which it is used, and is generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in other embodiments. Therefore, such conditional language is generally not 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 precluding additional elements, features, actions, functions, etc. 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. Unless otherwise specified, 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., could be any of X, Y, or Z. Thus, such connecting phrases are generally not 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 descriptions of the embodiments described above, it should be understood that various features may be grouped together in a single embodiment, drawing, 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 interpreted 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, a component, feature, step, or group of components, features, or steps is not necessarily required or essential to each embodiment. Accordingly, the scope of the invention disclosed and claimed herein is not intended to 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 sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, when used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structure, components, and actions do not necessarily indicate the priority or order of the element relative to any other element, but rather may schematically distinguish the element from other elements having similar or identical names (other than the use of sequential terms). In addition, when used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a condition or event may also be performed on the basis of one or more other conditions or events not explicitly listed.

[0146] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as they are generally understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined 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 spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, if the device shown in the drawing is turned over, a device positioned “below” or “directly below” another device may be positioned “above” the other device. Thus, the illustrative term “below” may include both lower and upper positions. The device may also be oriented in other directions, and therefore, spatially relative terms may have different interpretations depending on the orientation.

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

Claims

1. A sensor embedding device (70), A shunt body (90) that forms a fluid conduit (98), A first anchor structure (94) associated with the first axial end of the shunt body (90), A second anchor structure (95) associated with the second axial end of the shunt body (90), A first sensor device (60) coupled to the first anchor structure (94), wherein the first anchor structure (94) is configured to hold the first sensor device (60) in a sensing position across the channel region (88) of the fluid conduit (98), and the first sensor device (60) comprises When in the sensing position, the first sensor device (60) is aligned with the axis (A1) of the fluid conduit (98), A sensor implantation device in which the shunt body includes a helical wire shape.

2. The sensor embedding device according to claim 1, wherein when the first sensor device is in the sensing position, it is coaxial with the fluid conduit.

3. The sensor embedding device according to claim 1 or 2, wherein the first anchor structure comprises a first arm that extends from the shunt body across the channel region and holds the first sensor device.

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

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

6. The sensor embedding device according to claim 5, wherein both the first arm and the second arm surround the body of the first sensor device.

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

8. The sensor embedding device according to claim 1, wherein the first anchor structure comprises a helical arm which is integrated with the helical wire form of the shunt body.

9. The sensor embedding device according to any one of claims 1 to 8, wherein the shunt body further comprises a cover disposed outside at least a portion of the helical wire shape.

10. The sensor embedding device according to any one of claims 1 to 9, wherein the shunt body further comprises a cover disposed within at least a portion of the helical wire shape.

11. The sensor embedding device according to any one of claims 1 to 10, further comprising a second sensor device coupled to the second anchor structure, wherein the second anchor structure is configured to hold the second sensor device on the channel region of the fluid conduit.

12. The sensor embedding device according to claim 11, wherein the sensor converter of the first sensor device and the sensor converter of the second sensor device face in opposite directions.

13. The sensor embedding device according to claim 12, wherein the first sensor device and the second sensor device are coaxial.

14. A sensor embedding device, The shunt body forms a fluid conduit, A first anchor structure associated with the first axial end of the shunt body, A second anchor structure associated with the second axial end of the shunt body, A first sensor device coupled to the first anchor structure, wherein the first anchor structure is configured to hold the first sensor device in a sensing position across the channel region of the fluid conduit, A sensor embedding device comprising: a second sensor device coupled to the second anchor structure, wherein the second anchor structure is configured to hold the second sensor device on the channel region of the fluid conduit.

15. The first sensor device and the second sensor device each comprise a control circuit and one or more transducers, and optionally: a) The one or more transducers are pressure transducers; and / or b) The sensor embedding device according to claim 14, wherein one or more converters are configured to generate an electrical signal that can be transmitted wirelessly to an external reader.

16. The sensor implantation device according to claim 14 or 15, wherein the sensor implantation device is configured to be embedded in the wall separating the atrial septum or the coronary sinus from the left atrium.

17. The sensor embedding device according to any one of claims 14 to 16, further comprising a power supply for supplying power to one or more components of the embedding device.

18. The sensor embedding device according to any one of claims 14 to 17, wherein the first sensor device and / or the second sensor device comprises a cylindrical housing.

19. The sensor implantation device according to any one of claims 15 to 18, wherein when the sensor implantation device is implanted in the atrial septum, the first sensor device and its associated sensor transducer are exposed in the left atrium, and the second sensor device and its associated sensor transducer are exposed in the right atrium.

20. The sensor embedding device according to any one of claims 15 to 19, wherein the sensor converter of the first sensor device and the sensor converter of the second sensor device face opposite directions, and optionally the first sensor device and the second sensor device are coaxial.

21. A sensor embedding device according to any one of claims 14 to 20, wherein when in the sensing position, the first sensor device is aligned with the axis of the fluid conduit, and optionally, when in the sensing position, the first sensor device is coaxial with the fluid conduit.

22. The sensor embedding device according to any one of claims 14 to 21, wherein the first anchor structure is enclosed around the main body of the first sensor device.

23. The sensor embedding device according to any one of claims 14 to 22, wherein the first anchor structure comprises a first sensor arm that extends from the shunt body across the channel region and holds the first sensor device.

24. The sensor embedding device according to claim 23, wherein the first anchor structure further comprises a second sensor arm extending from the shunt body across the channel region and holding the first sensor device, and optionally the first sensor arm and the second sensor arm extend from opposing sides of the shunt body, and optionally both the first sensor arm and the second sensor arm surround the body of the first sensor device.

25. A sensor implantation device according to any one of claims 14 to 24, wherein when the first sensor device is held in the sensing position, an axial blood flow gap exists between the first sensor device and the first axial end of the shunt body.

26. The aforementioned shunt body includes a helical wire shape, optionally: a) The first anchor structure comprises a helical arm which is integrated with the helical wire form of the shunt body; and / or b) The sensor implantation device according to any one of claims 14 to 25, wherein the shunt body further comprises a cover disposed outside at least a portion of the helical wire shape.

27. The sensor embedding device according to claim 26, wherein the shunt body further comprises a cover disposed within at least a portion of the helical wire shape.

28. The sensor embedding device according to claim 24, wherein the shunt body, the first anchor structure, the second anchor structure, the first sensor arm, and the second sensor arm, if present, form a shunt, and substantially the entire shunt is formed of a superelastic wire configured to be radially expandable and compressible.

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