Sensor implant system

Abstract

A sensor implant system includes: a shunt implant comprising a central flow portion configured to maintain an opening through a tissue wall; and a sensor implant device. The sensor implant device includes: a shunt body configured to at least partially fit within the central flow portion of the shunt implant; and a sensor device coupled to the shunt body.

Description

[Technical Field]

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 191,534, filed May 21, 2021, entitled "Implant-Coupled Sensor"; U.S. Provisional Patent Application No. 63 / 224,286, filed July 21, 2021, entitled "Anchoring of Implant Adjacent Sensors"; U.S. Provisional Patent Application No. 63 / 225,039, filed July 23, 2021, entitled "Anchoring of a Diverter Sensor Implant"; U.S. Provisional Patent Application No. 63 / 225,689, filed July 26, 2021, entitled "Embedded Sensor Implant Device"; and U.S. Provisional Patent Application No. 63 / 235,038, filed August 19, 2021, entitled "Anchoring of a Sensor Implant Device," the full disclosure of which is hereby incorporated by reference. Field of the Invention

[0003] This disclosure is primarily concerned with the field of medical implant devices. [Previous Technology]

[0004] Background of the Invention

[0005] Various medical procedures involve implanting medical devices within the anatomical structures of the heart. Certain physiological parameters associated with these anatomy structures, such as fluid pressure, can affect a patient's health prospects. [Summary of the Invention]

[0006] Summary of the Invention

[0007] This document describes one or more methods and / or devices to facilitate the monitoring of (multiple) physiological parameters associated with certain chambers and / or blood vessels of the heart, such as the left atrium, using one or more sensor implantation devices.

[0008] For the purpose of summarizing the contents of this disclosure, certain forms, advantages, and novel morphologies have been described. It should be understood that not all such advantages may be achieved in any particular instance. Therefore, the disclosed instance may be implemented in a manner that achieves or optimizes one or a group of advantages as taught herein without necessarily achieving other advantages as taught or suggested herein.

Implementation Method

[0032] Detailed Description of Preferred Embodiments

[0033] The titles provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0034] Although certain preferred embodiments are disclosed below, the subject matter of the invention extends beyond the specific disclosed embodiments to other alternative embodiments and / or uses, and extends to their modifications and equivalents. Therefore, the scope of the claims that may arise therefrom is not limited to any of the specific embodiments described below. For example, in any method or procedure disclosed herein, the actions or operations of the method or procedure may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as a series of discrete operations in a manner that may aid in understanding certain embodiments; however, the order of description should not be construed as implying that such operations are sequentially dependent. Furthermore, the structures, systems, and / or apparatuses described herein may be embodied as integrated components or individual components. For the purpose of comparing various embodiments, certain aspects and advantages of such embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, one advantage or group of advantages as taught herein may be achieved or optimized without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0035] For convenience, certain reference numerals are repeated across different drawings within the set of drawings disclosed herein for devices, components, systems, forms, and / or modules having forms that are similar in one or more aspects. However, the repetition of common reference numerals in the drawings does not necessarily indicate that such forms, devices, components, or modules are identical or similar to any of the examples disclosed herein. In fact, the use of common reference numerals in the context may suggest the degree of similarity between the referenced subjects to those skilled in the art. The use of a particular reference numeral in the context of the description of a particular drawing may be understood to relate to an identified device, component, form, form, module, or system in that drawing, and not necessarily to any device, component, form, form, module, or system identified by the same reference numeral in another drawing. Furthermore, forms in individual drawings identified using common reference numerals may be interpreted as having shared characteristics or being completely independent of each other.

[0036] Certain standard anatomical terms for location are used herein to refer to anatomical structures in animals, i.e., humans, relative to preferred examples. While certain spatially relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship between one device / element or anatomical structure and another device / element or anatomical structure, it should be understood that these terms are used herein for ease of description to describe the positional relationship between (multiple) elements / (multiple) structures, as illustrated in the diagrams. It should be understood that spatially relative terms are intended to encompass different orientations of (multiple) elements / (multiple) structures in use or operation, in addition to the orientations depicted in the diagrams. For example, an element / structure described as “above” another element / structure may indicate a position relative to the subject patient or an alternative orientation of the element / structure below or beside this other element / structure, and vice versa.

[0037] This disclosure relates to systems, apparatus, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using a sensor-integrated cardiac shunt and / or other medical implant device. In some embodiments, this disclosure relates to a cardiac shunt and / or other cardiac implant device that is associated with or related to a pressure sensor or other sensor device. The term "associated with" is used herein in its broad and general sense. For example, when a first morphology, element, component, device, or member is described as being "associated with" a second morphology, element, component, device, or member, such description should be understood to indicate that the first morphology, element, component, device, or member is physically coupled, attached, or connected to the second morphology, element, component, device, or member; integrated with the second morphology, element, component, device, or member; at least partially embedded within the second morphology, element, component, device, or member; or otherwise associated with the second morphology, element, component, device, or member, whether directly or indirectly. Certain examples are disclosed in the context of cardiac implantable devices herein. However, while some of the principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that sensor implantable devices based on this disclosure can be implanted or configured for implantation in any suitable or desired anatomical structure.

[0038] While the various sensing devices described herein can be integrated with the various medical implant devices described herein, the sensing devices can also be separate from the medical implant devices. For example, the sensing device can form a detachable and / or releasable connection with the medical implant device. Furthermore, the sensing devices described herein can be assembled for separate delivery within a patient's heart (e.g., before and / or after the medical implant device). For example, the sensing device may not be attached to the medical implant device during the delivery procedure of the sensing device and / or the medical implant device (e.g., during catheter delivery) but may be attached / coupled to the medical implant device after delivery to the desired location within the heart (e.g., after catheter removal). Example delivery locations may include the left atrium, left atrial appendage, pulmonary veins, coronary sinus, and / or various tissue walls associated with these locations.

[0039] In some instances, catheters and / or guides used for delivering sensor devices may also be used for delivering medical implant devices. For example, catheters and / or guides may remain in the body after delivery of sensor devices and / or medical implant devices for delivery of (multiple) remaining devices.

[0040] Some of the sensing devices described herein can be assembled for delivery prior to the delivery of the medical implant devices described herein. This can advantageously simplify the delivery of the sensing devices and / or medical implant devices and / or provide simple imaging of the sensing devices and / or medical implant devices. The sensing devices can be adjusted as needed prior to delivery of the medical implant device to maximize the measurements of the sensing devices. Furthermore, the delivery of the medical implant device can be delayed and / or suspended as needed after delivery of the sensing devices.

[0041] Some of the sensing devices described herein can be assembled for delivery after the delivery of the medical implant device described herein. This can advantageously simplify the delivery of the sensing device and / or medical implant device and / or provide simple imaging of the sensing device and / or medical implant device. The sensing device can be adjusted as needed to maximize the measurement values ​​of the sensing device. Furthermore, the sensing device can be effectively secured to the medical implant device with minimal risk of displacement. Cardiac Physiology

[0042] The anatomy of the heart is described below to aid in understanding some of the inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ with four pump chambers, the flow of which is at least partially controlled by various cardiac valves, namely the aortic, mitral (or mitral), tricuspid, and pulmonary valves. The valves can be configured to open and close in response to pressure gradients present during various phases of cardiac circulation (e.g., relaxation and contraction) to at least partially control the flow of blood to specific regions of the heart and / or to blood vessels (e.g., the lungs, aorta, etc.).

[0043] Figure 1 illustrates an example representation of a heart 1 having various morphologies associated with certain embodiments of the present invention. The heart 1 includes four chambers, namely a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 to the pulmonary artery 11 via pulmonary valves 9, which separate the right ventricle 4 from the pulmonary artery 11 and are configured to open during systole to allow blood to be pumped toward the lungs and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 includes the pulmonary trunk and the left pulmonary artery 15 and right pulmonary artery 13 branching from the pulmonary trunk, as shown. Pulmonary veins 23 carry blood from the lungs to the left atrium 2.

[0044] In addition to the pulmonary valve 9, the heart 1 includes three additional valves for assisting blood circulation therein: 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 can generally close during ventricular systole (i.e., contraction) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / lealets 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, when properly functioning, close during systole to prevent blood leakage back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to leave the left ventricle 3 and enter the aorta 12, and to close during diastole to prevent blood from leaking back into the left ventricle 3.

[0045] A heart valve may generally consist of a relatively dense fibrous ring, referred to herein as a ring, and multiple leaflets or apexes attached to the ring. Generally, the size of the leaflets or apexes is such that, when the heart contracts, the resulting increase in blood pressure generated in the corresponding heart chamber forces the leaflets to open at least partially to allow flow from the heart chamber. As the pressure in the heart chamber decays, the pressure in subsequent chambers or vessels can become dominant and push back down on the leaflets. Thus, the leaflets / apexes are juxtaposed with each other, thereby closing the flow pathway. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can cause valvular leakage and / or other health complications.

[0046] The atrioventricular (i.e., mitral and tricuspid) heart valves may further include an assembly of chordae tendineae and papillary muscles (not shown) for securing the leaflets of the individual valves to promote and / or facilitate proper closure of the leaflets and prevent their prolapse. For example, the papillary muscles may generally comprise finger-like projections from the ventricular wall. The leaflets are connected to the papillary muscles by chordae tendineae. A muscular wall called a diaphragm separates the left and right ventricles. Specifically, portion 18 of the atrial septum wall (referred to herein as the "atrial septum," "atrial septum," or "septum") separates the left atrium 2 from the right atrium 5, while portion 17 of the ventricular septum wall (referred herein as the "ventricular septum," "ventricular septum," or "septum") separates the left ventricle 3 from the right ventricle 4. The lower apex 26 of the heart 1 is referred to as the apex and is generally located on or near the midclavicular line in the fifth intercostal space.

[0047] The coronary sinus 16 comprises a collection of veins that join together to form a larger vessel that collects blood from the heart muscle (myocardium). The opening of the coronary sinus, which may be at least partially protected by the valve of Deutsche Cesarean in some patients, opens into the right atrium 5, as shown. The coronary sinus runs along the posterior portion of the left atrium 2 and delivers less oxygenated blood to the right atrium 5. The coronary sinus generally runs transversely in the left atrioventricular groove on the posterior side of the heart.

[0048] Any of the several pathways within the heart 1 may be used to access guides and catheters within and around the heart 1 to deploy the implant and / or device of this application. For example, access may be made superiorly via the subclavian or jugular vein into the superior vena cava (SVC) 19, right atrium 5, and from there into the coronary sinus 16. Alternatively, the pathway may begin in the femoral vein and pass through the inferior vena cava (IVC) 14 into the heart 1. Other pathways may also be used, each utilizing a percutaneous incision through which the guide and catheter are inserted into the vascular structure, typically via a sealed guide, allowing the physician to control the distal end of the device externally. Health conditions associated with cardiac pressure and other parameters.

[0049] As mentioned above, certain physiological conditions or parameters associated with cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with the relatively slow movement of blood through the heart and / or body, which increases the fluid pressure in one or more chambers of the heart. Consequently, the heart does not pump enough oxygen to meet the body's needs. The various chambers of the heart can respond to increased pressure by stretching to allow more blood to be pumped through the body or by becoming relatively rigid and / or thickened. The heart walls can eventually weaken and become inefficient at pumping. In some cases, the kidneys can respond inefficiently to the heart by causing the body to retain fluid. Fluid buildup in the arms, legs, ankles, feet, lungs, and / or other organs can cause congestion, which is called congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality, and therefore, the treatment and / or prevention of congestive heart failure is an important issue in healthcare.

[0050] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As described above, pressure accumulation in one or more chambers or regions of the heart can be associated with congestive heart failure. Without direct or indirect monitoring of cardiac pressure, it may be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or methods that do not involve direct or indirect pressure monitoring may involve measuring or observing other pre-existing physiological conditions in the patient, such as measuring body weight, thoracic impedance, right cardiac catheterization, or the like. In some solutions, pulmonary capillary wedge pressure may be measured as an alternative to 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 an alternative to left atrial pressure. However, compared to catheter-based pressure measurements in the pulmonary artery or certain other chambers or regions of the heart, the use of invasive catheters may be required to maintain such pressure sensors, which may be uncomfortable or difficult to perform. Furthermore, certain lung-related conditions can affect pulmonary artery pressure readings, unnecessarily weakening the correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurement, right ventricular outflow tract pressure measurements can also correlate with left atrial pressure. However, such correlations between pressure readings and left atrial pressure may be insufficient for the diagnosis, prevention, and / or treatment of congestive heart failure.

[0051] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, which is a marker of left ventricular function representing the ratio of peak-rate blood flow due to gravity in early diastole (E-wave) to peak-rate flow in delayed diastole caused by atrial contraction (A-wave), can be used as an alternative for measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques; generally, an abnormal E / A ratio may indicate that the left ventricle is not adequately filled with blood during the intersystolic cycle, which can lead to symptoms of heart failure, as explained above. However, E / A ratio determination generally does not provide an absolute pressure measurement.

[0052] Various methods for identifying and / or treating congestive heart failure involve observing worsening symptoms of congestive heart failure and / or changes in weight. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements can vary significantly (e.g., by up to 9% or more) and may be unreliable in communicating cardiac-related complications. Furthermore, treatment guided by monitoring signs, symptoms, weight, and / or other biomarkers has not been shown to substantially improve clinical outcomes. Additionally, for discharged patients, such treatment may require remote telemedicine systems.

[0053] This disclosure provides systems, apparatus, and methods for guiding drug delivery in relation to the treatment of congestive heart failure, at least in part, by directly monitoring pressure in the left atrium or other chambers or blood vessels, wherein the pressure measurement indicates left atrial pressure and / or pressure levels in one or more other blood vessels / chambers, such as for patients with congestive heart failure, in order to reduce hospital readmissions, morbidity, and / or otherwise improve the patient's health prospects. Cardiac pressure monitoring

[0054] Cardiac pressure monitoring according to examples of this disclosure can provide an active intervention for the prevention or treatment of congestive heart failure and / or other physiological conditions. Generally, an increase in ventricular filling pressure associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators may be present several weeks prior to hospitalization for some patients. Therefore, a pressure monitoring system according to examples of this disclosure can be advantageously implemented to reduce hospitalizations by guiding appropriate or desired titrations and / or medications before the onset of heart failure.

[0055] Dyspnea is a cardiac stress indicator characterized by shortness of breath or the feeling that one cannot breathe adequately. Dyspnea can be caused by elevated atrial pressure, which can lead to pulmonary effusion due to pressure buildup. Pathological dyspnea can occur in congestive heart failure. However, there can be a considerable time between the initial increase in pressure 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 the examples in this disclosure, normal ventricular filling pressure can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0056] As mentioned above, increased pressure in the left atrium, relative to cardiac pressure, can be particularly associated with heart failure. Figure 2 illustrates example pressure waveforms associated with various chambers and vessels of the heart, based on one or more examples. The various waveforms illustrated in Figure 2 can represent waveforms obtained by advancing one or more pressure sensors into the respective illustrated and labeled chambers or vessels of the heart using right cardiac catheterization. As illustrated in Figure 2, waveform 25, representing left atrial pressure, can be considered to provide optimal feedback for the early detection of congestive heart failure. Furthermore, there can be a generally relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0057] Left atrial pressure is generally closely correlated with left ventricular end-diastolic pressure. However, although left atrial pressure can be significantly correlated with end-diastolic pulmonary artery pressure, this correlation may weaken when pulmonary vascular resistance is elevated. That is, in the presence of various acute conditions, such as certain patients with congestive heart failure, pulmonary artery pressure is generally not adequately correlated with left ventricular end-diastolic pressure. For example, pulmonary hypertension affecting approximately 25% to 83% of patients with heart failure can affect the reliability of pulmonary artery pressure measurements used to estimate left ventricular filling pressure. Therefore, the pulmonary artery pressure measurement alone, as represented by waveform 24, may be an inadequate or inaccurate indicator of left ventricular end-diastolic pressure, especially in patients with comorbid conditions such as lung disease and / or thromboembolism. Left atrial pressure may further be at least partially correlated with the presence and / or degree of mitral regurgitation.

[0058] Compared to other pressure waveforms shown in Figure 2, left atrial pressure readings are relatively less likely to be distorted or affected by other conditions, such as respiratory conditions or similar. Generally, left atrial pressure can significantly predict heart failure, such as up to two weeks before the onset of heart failure. For example, increased left atrial pressure and both diastolic and systolic heart failure can occur several weeks before hospitalization, and thus such increases are known to be predictive of congestive heart failure, such as the onset of acute weakness symptoms of congestive heart failure.

[0059] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide guidance for medication administration to treat and / or prevent congestive heart failure. Such treatment can advantageously reduce hospital readmissions and morbidity, and provide other benefits. Implantable pressure sensors according to examples of this disclosure can be used to predict heart failure two weeks or more before the onset of symptoms or signs of heart failure (e.g., dyspnea). When identifying heart failure predictors using examples of cardiac pressure sensors according to this disclosure, certain preventative measures, including pharmacological interventions such as modifications to a patient's medication regimen, can be implemented, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium can advantageously provide an accurate indicator of pressure accumulation that can lead to heart failure or other complications. For example, a trend of increased atrial pressure can be analyzed or used to determine or predict the onset of cardiac dysfunction, where medications or other treatments can be enhanced to reduce pressure and prevent or reduce further complications.

[0060] Figure 3 illustrates a graph 300 showing the range of left atrial pressure, including a normal range 301 of left atrial pressure that is not substantially associated with a risk of postoperative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Examples of this disclosure provide systems, devices, and methods for determining whether a patient's left atrial pressure is within the normal range 301, above the normal range 303, or below the normal range 302 using certain sensor implantation devices. For left atrial pressure detected above the normal range, it may be associated with an increased risk of heart failure, as illustrated in the examples of this disclosure described below, to help reduce left atrial pressure until it is within the normal range 301. Furthermore, for left atrial pressure detected below the normal range 301, it may be associated with an increased risk of acute kidney injury, myocardial injury, and / or other health complications, as illustrated in the examples of this disclosure described below, to help increase left atrial pressure so that the pressure level is within the normal range 301. Implantable devices with integrated sensors

[0061] In some embodiments, this disclosure relates to sensors associated with or integrated with cardiac shunts or other implantable devices. Such integrated devices can be used to provide controlled and / or more effective therapies for treating and preventing heart failure and / or other health complications related to cardiac function. Figure 4 is a block diagram illustrating an implantable device 30 including a shunt (or other type of implant) structure 39. In some instances, 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 instances, the sensor 37 includes a transducer 32, such as a pressure transducer, and certain control circuitry 34, which may be embodied in, for example, an application-specific integrated circuit (ASIC).

[0062] The control circuitry 34 can be configured to process signals received by the transducer 32 and / or wirelessly transmit associated signals via the antenna 38 through biological tissue. The term "control circuitry" is used herein in its broad and general sense and can refer to any combination of: processor, processing circuitry, processing module / unit, chip, die (e.g., a semiconductor die including one or more active and / or passive devices and / or connectivity circuitry), microprocessor, microcontroller, digital signal processor, microcomputer, central processing unit, field-programmable gate array, programmable logic device, state machine (e.g., hardware state machine), logic circuitry, analog circuitry, digital circuitry, and / or any device that manipulates signals (analog and / or digital) based on hard-coded circuitry and / or operating instructions. The control circuitry referenced herein may further include one or more storage devices, which may be embodied in a single memory device, multiple memory devices, and / or embedded circuitry of devices. Such data storage devices may include read-only memory, random access memory, electrically dependent memory, non-electrically dependent memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device storing digital information. It should be noted that in instances where the control circuitry includes hardware and / or software state machines, analog circuitry, digital circuitry, and / or logic circuitry, the data storage devices / registers storing any associated operation instructions may be embedded within or outside the circuitry including the state machine, analog circuitry, digital circuitry, and / or logic circuitry. The transducers 32 and / or antennas 38 may be considered part of the control circuitry 34.

[0063] Antenna 38 may comprise a conductive material, such as copper wire or one or more coils or loops of the like. In some instances, at least a portion of transducer 32, control circuitry 34, and / or antenna 38 is at least partially housed or contained within sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, housing 36 may comprise glass or other rigid materials in some instances, providing mechanical stability and / or protection for the components housed therein. In some instances, housing 36 is at least partially flexible. For example, housing may comprise polymers or other flexible structures / materials that advantageously allow sensor 37 to be folded, bent, or collapsed to allow its delivery via conduits or other introduction components.

[0064] The transducer 32 may include any type of sensor component or mechanism. For example, the transducer 32 may be a pressure sensor of the force harvester type. In some instances, the transducer 32 includes a vibrating diaphragm, piston, Baden tube, bellows, or (a plurality of) other strain or deflection measuring elements to measure strain or deflection applied to its area / surface. The transducer 32 may be associated with the housing 36 such that at least a portion thereof is contained within or attached to the housing 36. The term "associated" with a vascular stent or other implant structure refers to the sensor device / component being physically coupled to, attached to, or connected to, or integrated with the implant structure.

[0065] In some instances, transducer 32 includes or is an assembly of a piezoresistive strain gauge, which can be assembled to detect strain caused by applied pressure using a bonded or formed strain gauge, wherein the resistance increases as the pressure deforms the assembly / material. Transducer 32 may be made of any type of material, including but not limited to silicon (e.g., single crystal), polycrystalline silicon thin film, bonded metal foil, thick film, silicon-on-sapphire, sputtered thin film and / or the like.

[0066] In some instances, transducer 32 includes or is an assembly of a capacitive pressure sensor, comprising a diaphragm and a pressure cavity configured to form a variable capacitor for detecting strain caused by pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor may decrease substantially as the diaphragm deforms under pressure. The diaphragm may comprise any (or multiple) materials, including but not limited to metals, ceramics, silicon, and the like. In some instances, transducer 32 includes or is an assembly of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement by means of changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some instances, transducer 32 includes or is an assembly of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0067] In some instances, transducer 32 includes or is a component of a strain gauge. For example, a strain gauge instance may include a pressure-sensitive element on or associated with the exposed surface of transducer 32. In some instances, a metallic strain gauge is adhered to the surface of a 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 vibrating diaphragm or a metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as optical, potential, resonant, thermal, ionizing, or other types of strain or pressure sensors.

[0068] Figure 5 illustrates a system 40 according to one or more examples for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) in a patient 44. The patient 44 may have a medical implant device 30 implanted, for example, in the heart (not shown) or associated physiology of the patient 44. For example, the implant device 30 may be implanted at least partially in the left atrium and / or coronary sinus of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as one or more microelectromechanical systems (MEMS) devices (e.g., MEMS pressure sensors or other types of sensor transducers).

[0069] In some instances, the monitoring system 40 may include at least two subsystems, including an implantable internal subsystem or device 30 comprising multiple sensor transducers 32, and a control circuitry system 34 comprising one or more microcontrollers, multiple discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further include an external (e.g., non-implantable) subsystem comprising an external reader 42 (e.g., a coil), which may include a wireless transceiver electrically and / or communicatively coupled to some control circuitry system 41. In some instances, both the internal subsystem 30 and the external subsystem 42 include corresponding coil antennas for wireless communication and / or power delivery via patient tissue disposed therein. The sensor implant device 30 may be any type of implant device. For example, in some instances, the implant device 30 includes a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or vascular stent device / structure.

[0070] Certain details of the implant device 30 are illustrated in the enlarged section 30 shown. The implant device 30 may include an implant / anchoring structure 39 as described herein. For example, the implant / anchoring structure 39 may include a percutaneously deliverable shunt device configured to be secured to and / or secured in a tissue wall to provide a flow path between two chambers of the heart and / or blood vessels, as described in detail throughout this disclosure. Although certain components are illustrated as part of the implant device 30 in FIG. 5, it should be understood that the sensor implant device 30 may include only a subset of the illustrated components / modules and may include additional components / modules not illustrated. The implant device may represent an example of the implant device shown in FIG. 4, and vice versa. The implant device 30 may advantageously include one or more sensor transducers 32, which may be configured to provide a response indicative of one or more physiological parameters of the patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducer(s) 32 may include any suitable or desired type of sensor transducer(s) for providing signals related to physiological parameters or conditions associated with the implant device 30 and / or the patient 44.

[0071] The (multiple) sensor transducer 32 may include one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / meters, accelerometers, gyroscopes, diaphragm-based sensors, and / or other types of sensors, which may be positioned in the patient 44 to sense one or more parameters related to the patient's health. The transducer 32 may be a pressure sensor of the force harvester type. In some instances, the transducer 32 includes a diaphragm, piston, Baden tube, bellows, or (multiple) other strain or deflection measuring elements to measure strain or deflection applied to its area / surface. The transducer 32 may be associated with the sensor housing 36 such that at least a portion of it is contained within or attached to the housing 36.

[0072] In some instances, transducer 32 includes or is an assembly of a strain gauge, which can be assembled to detect strain caused by applied pressure using a bonded or formed strain gauge. For example, transducer 32 may include or be an assembly of a piezoresistive strain gauge, wherein the resistance increases as pressure deforms the strain gauge assembly / material. Transducer 32 may be made of any type of material, including but not limited to silicone, polymers, silicon (e.g., single crystal), polycrystalline silicon thin films, bonded metal foils, thick films, silicon-on-sapphire, sputtered thin films, and / or the like. In some instances, a metal strain gauge is adhered to the sensor surface, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a vibrating diaphragm or metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionizing, or other types of strain or pressure sensors.

[0073] In some instances, transducer 32 includes or is an assembly of a capacitive pressure sensor, comprising a diaphragm and a pressure cavity configured to form a variable capacitor for detecting strain caused by pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor may decrease substantially as the diaphragm deforms under pressure. The diaphragm may comprise any (or multiple) materials, including but not limited to metals, ceramics, silicone, silicon, or other semiconductors and the like. In some instances, transducer 32 includes or is an assembly of an electromagnetic pressure sensor, which may be configured to measure displacement of the diaphragm by means of changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some instances, transducer 32 includes or is an assembly of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0074] In some instances, the transducers 32 are electrically and / or communicatively coupled to the control circuitry system 34, which may include one or more application-specific integrated circuit (ASIC) microcontrollers or chips. The control circuitry system 34 may further include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, or the like.

[0075] In some instances, multiple sensor transducers 32 may be configured to generate electrical signals that can be wirelessly transmitted to a device outside the patient's body, such as the described local external monitoring system 42. To perform such wireless data transmission, the implantable device 30 may include radio frequency (RF) (or other frequency band) transmission circuitry, such as signal processing circuitry and an antenna 38. The antenna 38 may include an antenna coil implanted within the patient. The control circuitry 34 may include any type of transceiver circuitry configured to transmit electromagnetic signals, wherein the signals may be radiated by the antenna 38, which may include one or more conductive wires, coils, plates, or the like. For example, the control circuitry 34 of the implantable device 30 may include one or more chips or dies configured to perform a certain amount of processing on signals generated and / or transmitted by the device 30. However, due to size, cost, and / or other constraints, the implantable device 30 may not include independent processing capabilities in some instances.

[0076] The wireless signals generated by the implant device 30 can be received by an external monitoring device or subsystem 42. The external monitoring device or subsystem may include a reader / antenna-interface circuit system module 43 configured to receive wireless signal transmissions from the implant device 30. The implant device is at least partially placed within the patient 44. For example, module 43 may include (multiple) transceiver devices / circuit systems.

[0077] The external local monitor 42 may receive wireless signal transmissions from the implant device 30 and / or use an external antenna 48, such as a rod-shaped device, to provide wireless power to the implant device 30. The reader / antenna-interface circuitry system 43 may include a radio frequency (RF) (or other frequency band) front-end circuitry system configured to receive and amplify signals from the implant device 30, wherein such circuitry system 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 circuitry systems, phase-locked loop (PLL) circuitry systems, signal mixers, or the like. The reader / antenna-interface circuitry system 43 may be further configured to transmit signals via network 49 to a remote monitor subsystem or device 46. The RF circuitry of the reader / antenna-interface circuitry system 43 may further include one or more of a digital-to-analog converter (DAC) circuitry system, a power amplifier, a low-pass filter, an antenna switching module, an antenna, or the like for treating / processing transmitted signals via network 49 and / or for receiving signals from the implantable device 30. In some instances, the local monitor 42 includes a control circuitry system 41 for performing processing of signals received from the implantable device 30. The local monitor 42 may be configured to communicate with network 49 according to known network protocols, such as Ethernet, Wi-Fi, or the like. In some instances, the local monitor 42 comprises a smartphone, laptop, or other mobile computing device, or any other type of computing device.

[0078] In some instances, the implantable device 30 includes a number of electrically and / or non-electrically dependent data storage devices. For example, such data storage devices may include solid-state memory utilizing a floating-gate transistor array or the like. The control circuitry system 34 may utilize data storage devices for storing sensed data collected over a period of time, wherein the stored data may be periodically transmitted to the local monitor 42 or another external subsystem. In some instances, the implantable device 30 does not include any data storage devices. The control circuitry system 34 may be configured to facilitate the wireless transmission of data generated by the sensor transducers(s) 32 or other data associated therewith. The control circuitry system 34 may be further configured to receive input from one or more external subsystems, such as from the local monitor 42 or from a remote monitor 46, via, for example, a network 49. For example, the implant device 30 may be configured to receive signals that at least partially control the operation of the implant device 30, such as by activating / deactivating one or more components or sensors or otherwise affecting the operation or performance of the implant device 30.

[0079] One or more components of the implant device 30 may be powered by one or more power sources 35. Due to size, cost, and / or electrical complexity considerations, the power source 35 may need to be relatively simple in nature. For example, high-power drive voltages and / or currents in the implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In some instances, the power source 35 is at least partially passive in nature, allowing power to be received wirelessly from an external source via the passive circuitry of the implant device 30, such as through short-range or near-field wireless power transfer or other electromagnetic coupling mechanisms. For example, the local monitor 42 may be used as an initiator to actively generate an RF field that can provide power to the implant device 30, thereby allowing the power circuitry of the implant device to have a relatively simple form factor. In some instances, the power source 35 may be configured to harvest energy from environmental sources, such as fluid flow, motion, or the like. Alternatively, power supply 35 may include a battery, which may be advantageously configured to provide sufficient power as needed during the monitoring period (e.g., 3, 5, 10, 20, 30, 40 or 90 days, or any other period).

[0080] In some instances, the local monitoring device 42 may serve 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 is easily accessible to the patient 44 and where the implanted device 30 is placed. The local monitoring device 42 may be configured to continuously, periodically, or intermittently query the implanted device 30 to retrieve or request sensor-based information from it. In some instances, the local monitor 42 includes a user interface through which a user can view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0081] System 40 may include an auxiliary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. In one example, local monitor 42 may be a wearable device or other device or system configured to be physically close to the patient and / or implant device 30, wherein local monitor 42 is primarily designed to receive signals from and / or transmit signals to the implant device 30 and provide such signals to auxiliary local monitor 47 for viewing, processing, and / or manipulation. External local monitoring system 42 may be configured to receive and / or process certain metadata from or associated with the implant device 30 (such as device ID or the like), which may also be provided via data coupling from the implant device 30.

[0082] 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 via network 49 from the local monitoring device 42, the auxiliary local monitoring device 47, and / or the implanted device 30. For example, the remote monitoring subsystem 46 may advantageously be operated and / or controlled by a healthcare entity, such as a hospital, physician, or other healthcare entity associated with the patient 44. Although some examples disclosed herein describe communication between the implanted device and the remote monitoring subsystem 46 indirectly via the local monitoring device 42, in some instances, the implanted device 30 may include a transmitter capable of communicating with the remote monitoring subsystem 46 via network 49 without having to relay information through the local monitoring device 42.

[0083] In some instances, at least a portion of the transducer 32, control circuitry 34, power supply 35, and / or antenna 38 is at least partially housed or contained within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, in some instances, housing 36 may comprise glass or other rigid materials that provide mechanical stability and / or protection for the components housed therein. In some instances, housing 36 is at least partially flexible. For example, housing may comprise polymers or other flexible structures / materials that advantageously allow the sensor 37 to be folded, bent, or collapsed to allow its delivery via conduits or other percutaneous insertion components.

[0084] As mentioned above, shunts and other implantable devices / structures can be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or (multiple) other physiological parameters. Sensor devices according to examples of this disclosure can be integrated with cardiac shunt structures / devices or other implantable devices using any suitable or desired attachment or integration mechanism or configuration. Figure 6 illustrates an example sensor assembly / device 60 that may be a component of a sensor implantable device. Sensor device 60 can be configured to provide sensor readings associated with one or more physiological parameters related to a target implantation site.

[0085] The sensor device 60 can be configured for attachment to an implantation device. For example, a coil form comprising one or more coils wound with one or more wires or other materials or structures, including a coil forming a fluid conduit / barrel portion and an axial end flange, can be used to attach the sensor device 60 to one or more implants. A shunt structure can be functionally integrated with a pressure sensor according to certain examples disclosed herein. The shunt structure can be configured to hold the sensor device 60.

[0086] The sensor device 60 may be advantageously disposed, positioned, secured, oriented and / or otherwise positioned in a configuration in which its sensor transducer assembly 65 is disposed within the channel region of the shunt structure. The term "channel region" is used herein in its broad and general sense and may refer to a three-dimensional space defined by the radial boundary of the fluid conduit and extending axially from the fluid conduit.

[0087] In some instances, the sensor assembly 61 includes a sensor component 65 and an antenna component 69. The sensor component 65 may contain any type of sensor device as described in detail above. In some instances, the sensor 65 may be attached to or integrated with an arm member of a shunt structure.

[0088] Sensor 65 includes sensing element 67, such as a pressure sensor transducer. As described herein, sensor assembly 61 can be configured to implement wireless data and / or power transmission. Sensor assembly 61 may include antenna assembly 69 for such purposes. Antenna 69 may be at least partially contained within antenna housing 79, which may further house certain control circuitry configured to facilitate wireless data and / or power communication functionality. In some instances, antenna assembly 69 includes one or more conductive coils 62 that facilitate inductive power supply and / or data transmission. In instances including multiple conductive coils, such coils may be at least partially disposed around / around a magnetic (e.g., ferrite, iron) core 63.

[0089] The antenna assembly 69 may be attached to, integrated with, or otherwise associated with the arm / anchor body of the shunt structure.

[0090] The sensor assembly 61 may advantageously be biocompatible. For example, the sensor 65 and antenna 69 may include a biocompatible housing, such as a housing comprising glass or other biocompatible materials. However, at least a portion of the sensor element 67, such as a diaphragm or other component, may be exposed to the external environment in some instances to allow for pressure readings or other parameter sensing. The housing 79, relative to the antenna housing 79, may comprise a cylindrical or tubular form that is at least partially rigid, such as a glass cylinder. In some instances, the diameter of the sensor 65 / 67 assembly is approximately 3 mm or less. The length of the antenna 69 may be approximately 20 mm or less.

[0091] The sensor assembly 61 can be configured to communicate with external systems when implanted in the heart or other areas of a patient's body. For example, the antenna 69 can wirelessly receive power from and / or transmit sensed data or waveforms to and / or from the external system. The sensor assembly 61 can be attached to or integrated with the shunt structure in any suitable or desirable manner. For example, in some implementations, the sensor 65 and / or antenna 69 can be attached to or integrated with the shunt structure using mechanical attachment components. In some instances, the sensor 65 and / or antenna 69 may be contained in a bag or other container attached to the shunt structure.

[0092] The sensing element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm assembly. In some instances, the transducer may include at least a partially flexible or compressible diaphragm assembly, which may be made of silicone or other flexible materials. The diaphragm assembly may be configured to flex or compress in response to changes in ambient pressure. Cardiac implants

[0093] Figure 7 illustrates an example shunt / anchoring structure 150, which can be assembled for attachment to one or more sensor devices according to one or more embodiments. The shunt structure 150 may represent an example of a cardiac implant (e.g., an anchoring and / or cardiac implant structure associated with Figure 4 or Figure 5) that can be functionally integrated with a pressure sensor according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular or elliptical opening and / or may form a fluid conduit when positioned within an orifice in the tissue wall. The channel 166 may be assembled to hold the sides of the puncture opening and / or other orifices in the tissue wall to form a blood flow path between the chambers or vessels of the heart separated by the tissue wall. For example, the shunt 150 can be assembled and implanted in the wall separating the coronary sinus from the left atrium to form a fluid conduit between the coronary sinus and the left atrium. The central flow channel 166 can be partially formed by a pair of sidewalls 170a, 170b, defined by a generally parallel arrangement of thin struts 179 forming an array of parallelogram units or openings 180. In some instances, the entire shunt 150 is essentially formed by hyperelastic struts assembled, compressed, and fitted into a conduit (not shown) and subsequently expanded back to the relaxed shape shown in Figure 7.

[0094] The use of multiple interconnected struts forming units therebetween to form a shunt 150 can at least partially improve the flexibility of the shunt, thereby allowing for compression and expansion at the implantation site. The interconnected struts surrounding the central flow channel 166 advantageously provide a shell and structure with sufficient rigidity to hold tissue in place at the puncture site in the open position. The end walls 172a, 172b of the central flow channel 166 can be used to connect the side walls 170a, 170b and extend between the distal flange and proximal flange or arm 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b can collectively define a tubular lattice, as shown. The end walls 172a, 172b may include thin struts 179 extending at a small angle from the central flow axis of the shunt 150. The shunt 150 may further include the ends (160a, 164a, 160b, 164b) of the arms 152, 154, which may be closer together than the ends connected to the end walls 172a, 172b of the arms 152, 154.

[0095] Although the illustrated shunt 150 includes struts defining tubular or circular lattices of open units forming a central flow channel 166, in some instances, the structure constituting the channel forms a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated examples, the tilting of the shunt structure 150 may facilitate collapse in the shunt to delivery catheter (not shown) and expansion of the flanges / arms 152, 154 on both sides of the target tissue wall. The shunt 150 may include a first left arm 152a, a second left arm 154a, a first right arm 152b, and / or a second right arm 154b. The central flow channel 166 may remain substantially unchanged between a folded state and an expanded state of the shunt 150, while the flanges / arms 152, 154 may transition into and out of alignment with the angled flow channel.

[0096] Although some examples of the diverters disclosed herein include flow channels and / or fluid conduits with substantially circular cross-sections, in some instances, the diverter structures according to this disclosure have elliptical, rectangular, rhomboid, or elliptical flow channel configurations. For example, relatively elongated sidewalls can create rectangular or elliptical flow channels compared to the configuration illustrated in Figure 7. Such shapes of the diverter flow channels can be desirable for larger punctures while still being assembled to collapse downwards into a relatively small delivery profile.

[0097] In some instances, each of the distal and proximal flanges / arms 152, 154 is configured to be rolled outward from the end walls 172a, 172b and positioned substantially radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms can be used to secure the shunt 150 to the target tissue wall. Additional forms and morphologies of shunts, implants, and / or anchoring structures that can be integrated with the sensor devices / functionalities of examples of this disclosure are disclosed in U.S. Patent No. 9,789,294 entitled "Expandable Cardiac Shunt," published October 17, 2017, the contents of which are hereby expressly incorporated herein by reference in their entirety. Although certain examples are disclosed herein in a context similar to the shunt structures shown in Figure 7 and described above, it should be understood that shunt structures or other implantable devices functionally integrated with pressure sensors according to examples of this disclosure may have any type, form, structure, configuration and / or be used or assembled for any purpose, whether for shunt or other purposes or functionality.

[0098] Figure 8 illustrates a shunt implant / anchoring device / structure 73 implanted in the atrial septum 18 according to one or more examples. Although the shunt implant is depicted in Figure 8, the implant 73 can be any of the various implants described herein. Specific locations within the atrial septum wall 18 can be selected or determined to provide a relatively secure anchoring location for the shunt structure 73. Furthermore, the shunt device / structure 73 can be implanted at a location where future recrossing of the septum wall 18 for future intervention is desirable. Implanting the shunt device / structure 73 in the atrial septum wall 18 advantageously allows fluid flow between the left atrium 2 and the right atrium 5.

[0099] Atrial shunt using shunt device / structure 73 may be well-suited for patients who are relatively highly sensitive to increases in atrial pressure. For example, when pressure increases in the ventricles and / or atria and is applied against the myocardial cells, the heart muscle can generally contract easily, making it relatively difficult to handle excess blood. Therefore, patients with impaired ventricular contractility may become more sensitive to higher pressures in the ventricles and / or atria when the ventricles dilate or stretch, as the heart may not be able to respond adequately. Furthermore, increased left atrial pressure can lead to dyspnea, and therefore, reducing left atrial pressure to decrease dyspnea and / or hospital readmissions via atrial shunt may be desirable. For example, when the ventricles experience dysfunction that prevents them from accommodating the accumulation of fluid pressure, this fluid can be diverted into the atria, thereby increasing atrial pressure. Minimizing left ventricular end-diastolic pressure may be paramount relative to heart failure. Because left ventricular end-diastolic pressure can be correlated with left atrial pressure, a backfill of fluid in the atria can cause a backfill of fluid in the lungs, resulting in unwanted and / or dangerous effusion in the lungs. Atrial shunting, such as that using a shunt device according to an example of this disclosure, can divert additional fluid from the left atrium to the right atrium, which may be able to accommodate the additional fluid due to the relatively higher compliance of the right atrium.

[0100] In some implementations, the shunt device / structure according to examples of this disclosure may be implanted in the wall separating the coronary sinus from the left atrium, allowing atrial shunting to be achieved via the coronary sinus. Figure 9 shows a shunt device / structure 83 implanted in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. Although the shunt implant is depicted in Figure 9, implant 83 may be any of the various implants described herein. Figure 9 and several of the following figures show segments of the heart from a superior top-down view, with the posterior orientation at the top of the page.

[0101] In some cases, for shunts via the atrial septum, a left-to-right shunt via implanting a shunt device 83 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable. For example, shunts via the coronary sinus 16 can reduce the risk of thrombi and embolisms. Thrombi / embolisms are unlikely to be present in the coronary sinus for several reasons. First, blood draining from the coronary artery structures into the right atrium 5 passes only through capillaries, so it is essentially filtered blood. Second, the opening 14 of the coronary sinus in the right atrium is often partially covered by a pseudovalve called the Deutsche valve (not shown). The Deutsche valve is not always present, but some studies have shown that it is present in most of the heart and can prevent thrombi or other emboli from entering even when there are spikes in the right atrial pressure. Third, the pressure gradient between the coronary sinus and the draining right atrium is generally relatively low, making it possible for thrombi or other embolisms in the right atrium to remain there. Fourth, if a thrombus / embolism does indeed enter the coronary sinus, the gradient between the right atrium and the coronary artery structures is much greater than the gradient between the right atrium and the left atrium. It is highly likely that the thrombus / embolism will continue to travel downwards along the coronary artery structures until the right atrial pressure returns to normal and the embolism returns directly to the right atrium.

[0102] Some additional advantages of positioning the shunt structure 83 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the atrial septum tissue. By diverting blood from the left atrium into the coronary sinus, sinus pressure can be increased slightly. This allows blood in the coronary artery structures to travel more slowly through the heart, thereby increasing perfusion and oxygen delivery, which can be more efficient and also help the dying heart muscle recover. In addition, by implanting the shunt device / structure 83 into the wall of the coronary sinus, damage to the atrial septum 18 can be prevented. Therefore, for replacement therapy, the atrial septum 18 can be kept for subsequent transseptal access. Keeping it transseptal access can be advantageous for various reasons. For example, patients with heart failure often have a number of other comorbidities, such as atrial fibrillation and / or mitral regurgitation; some therapies used to treat these conditions require transseptal access.

[0103] It should be noted that, in addition to the various benefits of placing the implant / structure 83 between the coronary sinus 16 and the left atrium 2, certain drawbacks 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 can be delivered to the right atrium 5 and / or deoxygenated blood from the right atrium 5 can be delivered to the left atrium 2, both of which may be undesirable for proper cardiac function. Sensor implant device

[0104] Figures 10A and 10B illustrate an example sensor implant device 1000 according to one or more embodiments of this disclosure. Figure 10A provides a top view of an example sensor implant device 1000 including a sensor 1004 coupled to at least a portion of the implant 1000 (e.g., shunt body 1007 and / or barrel portion). The term "shunt body" is used herein in its common and general sense and may refer to the body portion of the sensor implant device 1000 and / or a portion of the sensor implant device 1000 configured for at least partial placement within a shunt opening (i.e., an opening) and / or orifice through a tissue wall. In some embodiments, the various shunt bodies 1007 described herein may be configured to maintain the shunt opening (e.g., by preventing growth within the opening). The shunt body 1007 may have a generally tubular and / or cylindrical form and / or a partially tubular and / or partially cylindrical form. Figure 10B provides a side view of an example sensor implant device 1000. The sensor 1004 described herein can be coupled to the shunt body 1007 in any of a variety of ways. For example, an arm 1005, which may include one or more ropes, wires, chains, and / or similar devices, may extend from and / or be coupled between the shunt body 1007 and / or the sensor device 1004. In some instances, the arm 1005 may be coupled to and / or extend into one or more coils 1013, which are configured to at least partially surround at least a portion of the sensor device 1004 to form a secure attachment between the arm 1005 and the sensor device 1004. For example, the arm 1005 may include a rope configured to extend between the sensor 1004 and the shunt body 1007 and / or configured to at least partially surround the sensor 1004 to form a secure attachment to the sensor 1004. In some instances, the sensor 1004 may be coupled to the shunt body 1007 via one or more arms 1005.

[0105] In some instances, the sensor implant device 1000 and / or shunt body 1007 described herein can be configured to provide a fluid conduit passing through an opening and / or orifice in the tissue wall within the heart. For example, the shunt body 1007 can be configured for placement at least partially within an opening in the tissue wall between the coronary sinus and the left atrium of the heart. The opening can be formed via a tissue puncture procedure. In some instances, the shunt body 1007 can be configured to maintain the opening and / or prevent tissue growth across the opening. This allows blood flow between the left atrium and the coronary sinus to flow through at least a portion of the shunt body 1007 and / or through the opening.

[0106] The sensor device 1004 can be configured to collect any of a variety of measurements related to blood flow at or near the sensor implant device 1000. As shown in Figures 10A and 10B, the sensor device 1004 can be configured to be at least partially positioned above the cavity 1015 of the shunt body 1007. For example, the shunt body 1007 may have at least a partially cylindrical shape. The sensor device 1004 can be at least partially positioned above the shunt body 1007 such that blood flow through the shunt body 1007 can be transmitted along the sensor device 1004 and / or the sensor device 1004 can be positioned to collect measurements related to blood flow through the shunt body 1007 and / or the cavity 1015 of the sensor implant device 1000. In some instances, the arm 1005 of the sensor implant device 1000 may be at least partially adjustable to allow for adjustment of the placement of the sensor device 1004 when the sensor device 1004 is at least indirectly coupled to the shunt body 1007.

[0107] Figures 11A and 11B illustrate an example sensor implant device 1100 according to one or more embodiments of this disclosure. Figure 11A provides a top view of an example sensor implant device 1100 including a sensor 1104 coupled to at least a portion of the implant 1100 (e.g., the shunt body 1107). Figure 11B provides a side view of the example sensor implant device 1100. The sensor 1104 described herein may be coupled to the shunt body 1107 in any of a variety of ways. For example, an arm 1105, which may include one or more ropes, wires, chains, and / or similar devices, may extend from and / or be coupled between the shunt body 1107 and the sensor device 1104. In some instances, the arm 1105 may be coupled to and / or extend into one or more coils 1113, which are configured to at least partially surround at least a portion of the sensor device 1104 to form a secure attachment between the arm 1105 and the sensor device 1104. For example, the arm 1105 may include a cord configured to extend between the sensor 1104 and the shunt body 1107 and / or configured to at least partially surround the sensor 1104 to form a secure attachment to the sensor 1104.

[0108] In some instances, the sensor implant device 1100 and / or shunt body 1107 described herein can be configured to provide a fluid conduit passing through an opening and / or orifice in the tissue wall within the heart. For example, the shunt body 1107 can be configured for placement at least partially within an opening in the tissue wall between the coronary sinus and the left atrium of the heart. The opening can be formed via tissue puncture. In some instances, the shunt body 1107 can be configured to maintain the opening and / or prevent tissue growth across the opening. This allows blood flow between the left atrium and the coronary sinus to pass through at least a portion of the shunt body 1107.

[0109] The sensor device 1104 can be configured to collect any of a variety of measurements related to blood flow at or near the sensor implant device 1100. As shown in Figures 11A and 11B, the sensor device 1104 can be configured to be at least partially offset from the lumen 1115 and / or shunt body 1007 of the sensor implant device 1100. For example, the sensor device 1004 may be at least partially outside the path of blood flow through the lumen 1115 and / or shunt body 1007 of the sensor implant device 1100 and / or may not be completely positioned above the lumen 1115. The measurements collected by the sensor device 1004 may reflect the blood flow characteristics within one of the chambers of the heart and / or may not directly indicate blood flow through the sensor implant device 1100. In some instances, the arm 1105 of the sensor implant device 1100 may be at least partially adjustable to allow for adjustment of the placement of the sensor device 1104 when the sensor device 1104 is at least indirectly coupled to the shunt body 1007 (e.g., via one or more arms 1105).

[0110] Figures 12A and 12B illustrate a sensor implant device 1200 comprising a sensor 1204 coupled to and / or extending from a shunt body 1203, according to one or more embodiments. The shunt body 1203 may be configured to position the sensor 1204 at a desired location and / or securely hold the sensor 1204 in place. In some embodiments, the shunt body 1203 may include a wire loop having a wire loop configured to be coupled to and / or attached to a first end 1226 of the sensor 1204 at a first point and / or attached to a second end 1227 of the sensor 1204 at a second point. In some instances, the shunt body 1203 may have a "mushroom" shape, wherein a first portion 1207 of the shunt body 1203 has a first width and / or diameter and / or wherein a second portion 1209 of the shunt body 1203 expands to a second width and / or diameter greater than the first width and / or diameter. Although the shunt body 1203 is shown in Figures 12A and 12B as comprising a single line, the shunt body 1203 may comprise any number of lines and / or may comprise a network of lines forming the mushroom shape depicted in Figures 12A and 12B. For example, the shunt body 1203 may comprise multiple lines that may overlap and / or intersect at various points and / or expand relative to the sensor 1204 in different planes. In some instances, the shunt body 1203 may form a coil 1213 around at least a portion of the sensor 1204.

[0111] In some instances, the shunt body 1203 may be at least partially constructed of one or more shape memory alloys (e.g., nickel-titanium alloys) and / or may be configured to naturally present the form shown in FIG. 12A after removal from the catheter and / or other delivery device. For example, the shunt body 1203 may include one or more wire shapes configured as a loop. The wire loop may be configured to present a compressed form when delivered via the catheter and / or other delivery system. Furthermore, the wire loop may be configured to present a first width at a first portion 1207 (e.g., within the opening 1214 of the tissue wall 1221 and / or the central flow portion 1217 of the shunt device 1202) and / or may be configured to expand to a second width at a second portion 1209 (e.g., beyond the opening 1214 of the tissue wall 1221 and / or the second side 1223 and / or beyond the central flow portion 1217).

[0112] Figure 12B illustrates a sensor implant device 1200 positioned within and / or at least partially within an opening 1214 in the tissue wall 1221. A first portion 1207 of the shunt body 1203 may be assembled to be positioned at least partially within the opening 1214 through the tissue wall 1221. For example, the shunt body 1203 at the first portion 1207 may have a width smaller than the width of the opening 1214 to allow the shunt body 1203 to pass through the opening 1214. The shunt body 1203 at the second portion 1209 may be laterally expanded (e.g., extending parallel and / or approximately parallel to the tissue wall 1221) to have a width exceeding the width of the opening 1214. Thus, the second portion 1209 of the shunt body 1203 may be assembled to prevent the shunt body 1203 from escaping upward through the opening 1214 in the tissue wall 1221. Furthermore, the shunt body 1203 at the second portion 1209 can be configured to extend longitudinally (e.g., perpendicular to the tissue wall 1221) and / or extend away from the sensor 1204 to securely anchor the shunt body 1203 and / or the sensor 1204 in place relative to the opening of the tissue wall 1221. For example, the second portion 1209 of one or more anchoring arms may have a suitable height to press against the superior wall 1223 and / or inferior wall 1224 of the coronary sinus 16 and / or other regions of the heart to secure the second portion 1209 and / or the sensor implant device 1200 in place in the coronary sinus 16 and / or other regions.

[0113] While the sensor implant device 1200 can be used independently of other implant devices in some cases, it can also be used in combination with one or more additional implant devices. For example, as shown in FIG12B, the sensor implant device 1200 can be used in combination with a shunt implant 1202, which can be configured to form and / or maintain a fluid conduit through an opening 1214 in the tissue wall 1221. The shunt implant 1202 may include one or more anchoring arms configured to anchor to a first side 1222 and / or a second side (i.e., the superior wall 1223 of the coronary sinus 16) of the tissue wall 1221. In some instances, the shunt implant 1202 may include a barrel portion 1217 configured for placement within and / or maintenance of the opening 1214. The first portion 1207 of the sensor implant device 1200 can be assembled to pass through and / or at least partially fitted within at least a portion of the barrel portion 1217 of the shunt implant 1202. The sensor 1204 can be assembled to be positioned at any location relative to the opening 1214 and / or the shunt implant 1202. For example, the sensor 1204 can be assembled to be positioned above at least a portion of the barrel portion 1217 of the shunt implant 1202. However, the sensor 1204 can additionally or alternatively be positioned offset from the opening 1214 of the barrel portion 1217 of the shunt implant 1202 and / or at least partially extend above the tissue wall 1221.

[0114] In some instances, the shunt body 1203 may be configured to extend through the tissue wall 1221 and / or to position and / or extend the sensor 1204 beyond the opening 1214 and / or the first side 1222 of the tissue wall 1221. For example, the sensor 1204 may be at least partially and / or completely located in other chambers on the left atrium 2 and / or the first side 1222 of the tissue wall 1221. At least a portion of the shunt body 1203 (e.g., the second portion 1209) may additionally or alternatively be configured to extend beyond the second side 1223 of the tissue wall 1221 and / or anchored in other blood flow pathways and / or chambers on the coronary sinus 16 and / or the second side 1223 of the tissue wall 1221.

[0115] The sensor implant device 1200 may be configured for combined and / or separate delivery with and from the shunt implant 1202. For example, the sensor implant device 1200 and the shunt implant 1202 may be delivered during a single delivery procedure. In some instances, the sensor implant device 1200 may be delivered during a first procedure and the shunt implant 1202 may be delivered during a subsequent procedure. Alternatively, the shunt implant 1202 may be delivered during a first procedure and the sensor implant device 1200 may be delivered during a subsequent procedure.

[0116] Figures 13A to 13D illustrate another sensor implantation device 1300 according to one or more embodiments, comprising a shunt body 1303 (e.g., a coil and / or wound lead) coupled to a sensor 1304 assembled to secure the sensor 1304 at a desired location within the heart. The shunt body 1303 may be assembled to be coupled to the sensor 1304 in any of a variety of ways. For example, the shunt body 1303 may be assembled to form one or more coverings and / or coils 1313 around the sensor implantation for secure attachment to the sensor 1304.

[0117] The shunt body 1303 may include multiple connecting devices (e.g., multiple coils and / or wound wires) or may include a single device (e.g., a single coil and / or wound wire). The shunt body 1303 may have variable shape and / or width and / or diameter. For example, the coil implant may include a first portion 1306, a second portion 1307, and / or a third portion 1308. The first portion 1306 may be configured for placement above an opening in the tissue wall 1321 and / or may be configured to be positioned to at least partially contact a first side 1322 of the tissue wall 1321. The first portion 1306 of the shunt body 1303 may have a first width and / or diameter. The second portion 1307 of the shunt body 1303 may be configured for at least partially placement within an opening in the tissue wall 1321 and / or may have a second width and / or diameter. The third portion 1308 of the shunt body 1303 may have a third width and / or diameter. The second width and / or diameter may be smaller than the first width and / or diameter of the first portion 1306 and / or smaller than the third width and / or diameter of the third portion 1308. The second portion 1307 of the shunt body 1303 may be assembled to be at least partially positioned within an opening in the tissue wall 1321. The second portion 1307 of the shunt body 1303 may have a generally cylindrical shape to approximate the shape of the opening in the tissue wall 1321. The shunt body 1303 may be assembled to expand at the third portion 1308 of the shunt body 1303. The third portion 1308 of the shunt body 1303 may be assembled to be positioned below the opening of the tissue wall and / or may be assembled to be positioned to at least partially contact the second side 1323 of the tissue wall 1321 (e.g., the coronary sinus 16 side of the tissue wall 1321). The third part 1308 of the shunt body 1303 may have any suitable shape, for example, the third part 1308 may be elliptical, as shown in Figures 13A to 13C.

[0118] As shown in FIG13B, the shunt body 1303 may have a generally tubular and / or hollow form surrounding an inner lumen 1315 configured to allow blood flow through the shunt body 1303. In the example shown in FIG13B, the sensor 1304 may be positioned above the inner lumen 1315. Alternatively, as shown in FIG13C, the sensor 1304 may be at least partially offset from the inner lumen 1315.

[0119] In some instances, the shunt body 1303 may be configured to extend through the tissue wall 1321 and / or to position and / or extend the sensor 1304 beyond the opening 1314 and / or the first side 1322 of the tissue wall 1321. For example, the sensor 1304 may be located at least partially and / or completely in other chambers on the left atrium 2 and / or on the first side 1322 of the tissue wall 1321. The shunt body 1303 may additionally or alternatively be configured to extend beyond the second side 1323 of the tissue wall 1321 and / or anchored in other blood flow pathways and / or chambers on the coronary sinus 16 and / or on the second side 1323 of the tissue wall 1321.

[0120] In some instances, the shunt body 1303 may be at least partially made of one or more shape memory alloys. For example, the shunt body 1303 may be assembled to be molded into a generally linear form during delivery via a delivery device (e.g., a catheter). When the shunt body 1303 exits the catheter, the shunt body 1303 may be assembled to naturally form the device shown in Figures 13A to 13D. In some instances, the shunt body 1303 may be assembled for delivery after delivery of the shunt implant 1302.

[0121] While the sensor implant device 1300 can be used independently of other implant devices in some cases, it can also be used in combination with one or more additional implant devices. For example, as shown in FIG13D, the sensor implant device 1300 can be used in combination with a shunt implant 1302, which can be assembled to form a fluid conduit through an opening in the tissue wall 1321. The shunt implant 1302 may include one or more anchoring arms assembled to anchor to a first side 1322 and / or a second side (i.e., the superior wall 1323 of the coronary sinus 16) of the tissue wall 1321. In some instances, the shunt implant 1302 may include a barrel portion 1312 assembled to be placed within an opening 1314 and / or assembled to form a fluid conduit through the opening 1314. The second portion 1307 of the sensor implant device 1300 can be configured to pass through at least a portion of the barrel portion 1312 of the shunt implant 1302. The sensor 1304 can be configured to be positioned at any location relative to the opening and / or the shunt implant 1302. For example, the sensor 1304 can be configured to be positioned above at least a portion of the barrel portion 1312 of the shunt implant 1302. However, the sensor 1304 can additionally or alternatively be positioned offset from the opening of the barrel portion 1312 and / or the tissue wall 1321 of the shunt implant 1302.

[0122] Figures 14 to 17 illustrate at least a portion of a sensor implantation device, according to one or more embodiments, configured to position one or more sensors at or near an opening in a tissue wall. Figure 14 provides a side view of an example shunt body 1400 including a sensor docking member 1405 configured to couple to and / or otherwise mate with one or more sensors. The shunt body 1400 may include a network of one or more wires 1417 and / or supports, which may include cords and / or similar devices. In some embodiments, the shunt body 1400 may be configured to form a barrel portion 1407 with a reduced diameter relative to the end portions 1426, 1427 of the shunt body 1400. One or more end portions 1426, 1427 may be configured to extend beyond and / or out of an opening in the tissue wall and / or the barrel portion 1407 may be configured to be at least partially positioned within the opening. In some instances, the diverter body 1400 may have at least a partially curved form and / or may have an "hourglass" shape such that the diameter of the diverter body 1400 may gradually decrease between the first end portion 1426 and the barrel portion 1407 and / or gradually increase from the barrel portion 1407 to the second end portion 1427. The diameter and / or width of the diverter body 1400 may increase from a first (e.g., minimum) diameter and / or width at the barrel portion 1407 to a second (e.g., maximum) diameter and / or width at the first end portion 1426 and / or the second end portion 1427 that is greater than the first diameter and / or width.

[0123] The shunt body 1400 may have any suitable shape and / or the network of wires forming the shunt body 1400 may have any suitable pattern. In some instances, the shunt body 1400 may be at least partially compressible and / or expandable to allow the shunt body 1400 to be compressed while in the delivery device and / or expand after removal from the delivery device. The shunt body 1400 may be assembled to be retrievable after delivery. In some instances, the shunt body 1400 may be at least partially made of shape memory alloy and / or may be otherwise assembled to be shaped as shown in FIG. 14 such that the shunt body 1400 naturally presents the shape shown in FIG. 14 after removal from the delivery device.

[0124] The shunt body 1400 may include one or more units 1419, which may include gaps and / or openings in the network of wires 1417 forming the shunt body 1400. The one or more units 1419 may have a diamond shape.

[0125] In some instances, the shunt body 1400 may be configured to rotate and / or otherwise adjust after delivery relative to the tissue wall to a desired location. For example, after at least a portion of the shunt body 1400 is placed within an opening through the tissue wall, the shunt body 1400 may be laterally rotated to adjust the position of the sensor dock 1405 and / or the position of one or more sensors coupled to the sensor dock 1405. Thus, one or more sensors coupled to the shunt body 1400 may be rotatably oriented as needed. In some instances, the sensor dock 1405 may be configured to position one or more sensors, which at least partially extend over and / or from the barrel portion 1407 of the shunt body 1400 to an offset position. The sensor dock 1405 may have a generally circular and / or annular form as shown in FIG. 14. However, the sensor docking member 1405 may have any suitable shape and / or may be assembled to provide a platform for placing one or more sensors. In some instances, the sensor docking member 1405 may be assembled away from the barrel portion 1407 and / or coupled to and / or extended to one or more wires 1417 extensions within the sensor docking member 1405. The sensor docking member 1405 may be assembled to extend away from the barrel portion 1407 to prevent obstruction by the barrel portion 1407.

[0126] The diverter body 1400 may include an attachment profile 1409 configured for attachment to one or more delivery devices or delivery systems. For example, the attachment profile 1409 may include a circuit configured for engagement with a hook of the delivery system.

[0127] FIG15 provides a side view of an example shunt body 1500 including a sensor docking member 1505 configured to couple to and / or otherwise mate with one or more sensors. The shunt body 1500 may include a network of one or more wires 1517, which may include ropes and / or similar devices. In some instances, the shunt body 1500 may be configured to form a barrel portion with a reduced diameter relative to the end portions 1526, 1527 of the shunt body 1500. One or more end portions 1526, 1527 may be configured to extend beyond and / or extend out of the tissue wall into an opening and / or the barrel portion may be configured to be at least partially positioned within the opening. In some instances, the diverter body 1500 may have at least a partially curved form and / or may have an hourglass shape such that the diameter of the diverter body 1500 gradually decreases between the first end portion 1526 and the barrel portion and / or gradually increases from the barrel portion to the second end portion 1527. The diverter body 1500 may include an inner cavity 1515 passing through the barrel portion and / or end portions 1526, 1527 of the diverter body 1500.

[0128] The shunt body 1500 may have any suitable shape and / or the network of wires forming the shunt body 1500 may have any suitable pattern. In some instances, the shunt body 1500 may be at least partially compressible and / or expandable to allow the shunt body 1500 to be compressed while in the delivery device and / or expand after removal from the delivery device. The shunt body 1500 may be assembled to be retrievable after delivery. In some instances, the shunt body 1500 may be at least partially made of shape memory alloy and / or may be otherwise assembled to be shaped as shown in FIG. 15 such that the shunt body 1500 naturally presents the shape shown in FIG. 15 after removal from the delivery device.

[0129] The shunt body 1500 may include one or more units 1519, which may include gaps and / or openings in the network of wires 1517 forming the shunt body 1500. The one or more units 1519 may have a diamond shape.

[0130] In some instances, the shunt body 1500 may be configured to rotate and / or otherwise adjust after delivery relative to the tissue wall to a desired location. For example, after at least a portion of the shunt body 1500 is placed within an opening through the tissue wall, the shunt body 1500 may be laterally rotated to adjust the position of the sensor dock 1505 and / or the position of one or more sensors coupled to the sensor dock 1505. Thus, one or more sensors coupled to the shunt body 1500 may be rotatably oriented as needed. In some instances, the sensor dock 1505 may be configured to position one or more sensors that extend at least partially above and / or from the barrel portion of the shunt body 1500 to an offset position. The sensor dock 1505 may have a generally circular form as shown in FIG. 15. However, the sensor docking member 1505 may have any suitable shape and / or may be assembled to provide a platform for placing one or more sensors. In some instances, the sensor docking member 1505 may be assembled away from the barrel portion and / or coupled to and / or extended to one or more wires 1517 extensions within the sensor docking member 1505. The sensor docking member 1505 may be assembled to extend away from the barrel portion to prevent obstruction by the barrel portion.

[0131] The diverter body 1500 may include attachment features 1509 (e.g., protrusions, hooks, pins, notches, circuits, etc.) configured for attachment to one or more delivery devices or delivery systems. For example, attachment features 1509 may include circuits configured for engagement with hooks of the delivery system.

[0132] FIG. 16 provides a top view of an example shunt body 1600 including a sensor docking member 1605 configured to couple to and / or otherwise mate with one or more sensors. The shunt body 1600 may include a network of one or more wires 1617, which may include ropes and / or similar devices. In some instances, the shunt body 1600 may be configured to form a barrel portion with a reduced diameter relative to the end portions 1626, 1627 of the shunt body 1600. One or more end portions 1626, 1627 may be configured to extend beyond and / or extend out of the tissue wall into an opening and / or the barrel portion may be configured to be at least partially positioned within the opening. In some instances, the diverter body 1600 may have at least a partially curved form and / or may have an hourglass shape such that the diameter of the diverter body 1600 gradually decreases between the first end portion 1626 and the barrel portion and / or gradually increases from the barrel portion to the second end portion 1627. The diverter body 1600 may include an inner cavity 1615 passing through the barrel portion and / or end portions 1626, 1627 of the diverter body 1600.

[0133] The shunt body 1600 may have any suitable shape and / or the network of wires forming the shunt body 1600 may have any suitable pattern. In some instances, the shunt body 1600 may be at least partially compressible and / or expandable to allow the shunt body 1600 to be compressed while in the delivery device and / or expand after removal from the delivery device. The shunt body 1600 may be assembled to be retrievable after delivery. In some instances, the shunt body 1600 may be at least partially made of shape memory alloy and / or may be otherwise assembled to be shaped as shown in FIG. 16 such that the shunt body 1600 naturally presents the shape shown in FIG. 16 after removal from the delivery device.

[0134] The shunt body 1600 may include one or more units 1619, which may include gaps and / or openings in the network of wires 1617 forming the shunt body 1600. The one or more units 1619 may have a diamond shape.

[0135] In some instances, the shunt body 1600 may be configured to rotate and / or otherwise adjust after delivery relative to the tissue wall to a desired location. For example, after at least a portion of the shunt body 1600 is placed within an opening through the tissue wall, the shunt body 1600 may be laterally rotated to adjust the position of the sensor dock 1605 and / or the position of one or more sensors coupled to the sensor dock 1605. Thus, one or more sensors coupled to the shunt body 1600 may be rotatably oriented as needed. In some instances, the sensor dock 1605 may be configured to position one or more sensors that extend at least partially above and / or from the barrel portion of the shunt body 1600 to an offset position. The sensor dock 1605 may have a generally circular form as shown in FIG. 16. However, the sensor docking member 1605 may have any suitable shape and / or may be assembled to provide a platform for placing one or more sensors. In some instances, the sensor docking member 1605 may be assembled away from the barrel portion and / or coupled to and / or extended to one or more wires 1617 extensions within the sensor docking member 1605. The sensor docking member 1605 may be assembled to extend away from the barrel portion to prevent obstruction by the barrel portion.

[0136] The diverter body 1600 may include an attachment profile 1609 configured for attachment to one or more delivery devices or delivery systems. For example, the attachment profile 1609 may include a circuit configured for engagement with a hook of the delivery system.

[0137] Figure 17 illustrates an example sensor implant system including a shunt implant 1702 and a shunt body according to one or more embodiments. The shunt body may include a network of one or more wires, which may include cords and / or similar devices. In some embodiments, the shunt body may be assembled to form a barrel portion with a reduced diameter relative to the end portions 1726, 1727 of the shunt body. One or more end portions 1726, 1727 may be assembled to extend beyond and / or extend out of an opening 1714 of the tissue wall 1721 and / or the barrel portion may be assembled to be at least partially positioned within the opening 1714. In some embodiments, the shunt body may have at least a partially curved form and / or may have an hourglass shape such that the diameter of the shunt body may gradually decrease between the first end portion 1726 and the barrel portion and / or gradually increase from the barrel portion to the second end portion 1727.

[0138] The shunt body may have any suitable shape and / or the network of wires forming the shunt body may have any suitable pattern. In some instances, the shunt body may be at least partially compressible and / or expandable to allow the shunt body to be compressed while in the delivery device and / or expand after removal from the delivery device. The shunt body may be assembled so that it can be retrieved after delivery. In some instances, the shunt body may be at least partially made of shape memory alloy and / or may be otherwise assembled to be shaped as shown in FIG. 17 so that the shunt body naturally presents the shape shown in FIG. 17 after removal from the delivery device.

[0139] In some instances, the shunt body can be configured to rotate and / or otherwise adjust after delivery relative to the tissue wall 1721 to a desired location. For example, after at least a portion of the shunt body is placed within an opening through the tissue wall, the shunt body can be laterally rotated to adjust the position of the sensor dock 1705 and / or the position of one or more sensors coupled to the sensor dock 1705. Thus, one or more sensors 1704 coupled to the shunt body can be rotatably oriented as needed. In some instances, the sensor dock 1705 can be configured to position one or more sensors, which at least partially extend above and / or from the barrel portion of the shunt body to an offset position. The sensor dock 1705 may have a generally circular form as shown in FIG. 17. However, the sensor dock 1705 may have any suitable shape and / or can be configured to provide a platform for placing one or more sensors. In some instances, the sensor docking member 1705 may be configured to extend away from the barrel portion and / or coupled to and / or extend to one or more wire extensions within the sensor docking member 1705. The sensor docking member 1705 may be configured to extend away from the barrel portion to prevent obstruction by the barrel portion. In some instances, one or more coils 1713 may be used to attach one or more sensors 1704 to the sensor docking member 1705.

[0140] While the shunt body can be used independently of other implant devices in some cases, the shunt body can also be used in combination with one or more additional implant devices, either separately or alternatively. For example, the shunt body can be used in combination with a shunt implant 1702, which can be assembled to form a fluid conduit through an opening 1714 in the tissue wall 1721. The shunt implant 1702 may include one or more anchoring arms assembled to anchor to a first side 1722 and / or a second side (i.e., the superior wall 1723 of the coronary sinus 16) of the tissue wall 1721. In some instances, the shunt implant 1702 may include a barrel portion 1712 assembled to be placed within the opening 1714 and / or assembled to form a fluid conduit through the opening 1714. The barrel portion of the shunt body can be assembled to pass through at least a portion of the barrel portion 1712 of the shunt implant 1702. The sensor 1704 can be configured to be positioned at any location relative to the opening 1714 and / or the shunt implant 1702. For example, the sensor 1704 can be configured to be positioned above at least a portion of the barrel portion 1712 of the shunt implant 1702. However, the sensor 1704 can additionally or alternatively be positioned offset from the opening 1714 of the barrel portion 1712 of the shunt implant 1702 and / or the tissue wall 1721.

[0141] Figures 18A and 18B illustrate a sensor implant device 1800 according to one or more embodiments, comprising a sensor 1804 coupled via one or more links 1805 to a shunt body comprising one or more self-expanding anchor arms 1803. The one or more self-expanding anchor arms 1803 may include attachment features 1809 (e.g., hook-shaped ends) configured to couple to and / or otherwise mate with a tissue wall 1821 and / or one or more shunt implant devices 1802. For example, the sensor implant device 1800 may be configured for combined deployment with a shunt implant device 1802, as shown in Figure 18B. The one or more anchor arms 1803 may be configured to hook onto various struts / leads, units, and / or other features of the shunt implant device 1802. For example, one or more attachment features 1809 of the sensor implant device 1800 may include hooks configured to at least partially surround one or more support hooks at the barrel portion 1812 and / or other portions of the shunt implant device 1802. Although the sensor implant device 1800 is shown as including three anchor arms 1803, the sensor implant device 1800 may include any number of anchor arms 1803.

[0142] The tether 1805 that couples one or more anchor arms 1803 to the sensor 1804 may have a rigid or flexible structure. In some instances, the tether 1805 may be configured to maintain a given angle 1831 relative to the axis 1832 of one or more anchor arms 1803. For example, the axis 1832 may be represented by a dashed line passing through the opening 1814 through the tissue wall 1821 and / or through the barrel portion 1812 of the shunt implant 1802. The tether 1805 may be configured to position the sensor 1804 outside and / or offset from the opening 1814 through the tissue wall 1821 and / or the barrel portion 1812 of the shunt implant 1802.

[0143] The shunt implant 1802 can be assembled to form a fluid conduit through an opening 1814 in the tissue wall 1821. The shunt implant 1802 may include one or more anchoring arms assembled to anchor to a first side 1822 and / or a second side (i.e., the superior wall 1823 of the coronary sinus 16) of the tissue wall 1821. In some embodiments, the shunt implant 1802 may include a barrel portion 1812 assembled to be placed within the opening 1814 and / or assembled to form a fluid conduit through the opening 1814. One or more anchoring arms 1803 of the sensor implant device 1800 can be assembled to pass through at least a portion of the barrel portion 1812 of the shunt implant 1802. The sensor 1804 can be assembled to be positioned at any location relative to the opening 1814 and / or the shunt implant 1802. For example, sensor 1804 may be configured to be positioned above at least a portion of the barrel portion 1812 of shunt implant 1802. However, sensor 1804 may additionally or alternatively be positioned offset from the opening 1814 of the barrel portion 1812 and / or tissue wall 1821 of shunt implant 1802.

[0144] Figure 19A illustrates a sensor implant device 1900 comprising a sensor 1904 coupled to a shunt body 1903 via one or more links 1905, according to one or more examples. Figure 19B illustrates a sensor implant system comprising a sensor implant device 1900 and / or a shunt implant device 1902 implanted at an opening 1914 in a tissue wall 1921. The shunt body 1903 may have a generally tubular form and / or may have an hourglass shape. For example, the first implant may have a generally curved form, wherein the barrel portion 1907 (i.e., the middle section) of the shunt body 1903 has a smaller diameter than the shunt body 1903 at a first end 1926 and / or a second end 1927. In some instances, the sensor implant device 1900 can be configured for combined deployment with the shunt implant device 1902, as shown in FIG19B. A first end 1926 and / or a second end 1927 can be configured to extend at least partially over at least a portion of the shunt implant device 1902 and / or the tissue wall 1921. For example, the first end 1926 can be configured to extend over a first side 1922 of the tissue wall 1921 and / or the second end 1927 can be configured to extend over a second side 1923 of the tissue wall 1921.

[0145] The tether 1905 coupling the shunt body 1903 to the sensor 1904 may have a rigid or flexible structure. The shunt implant 1902 may be configured to form and / or maintain a fluid conduit through an opening 1914 in the tissue wall 1921. The shunt implant 1902 may include one or more anchoring arms configured to anchor to a first side 1922 and / or a second side (i.e., the superior wall 1923 of the coronary sinus 16) of the tissue wall 1921. In some embodiments, the shunt implant 1902 may include a barrel portion 1912 configured for placement within the opening 1914 and / or configured to form a fluid conduit through the opening 1914. The shunt body 1903 may be configured to pass through at least a portion of the barrel portion 1912 of the shunt implant 1902. The sensor 1904 can be configured to be positioned at any location relative to the opening 1914 and / or the shunt implant 1902. For example, the sensor 1904 can be configured to be positioned above at least a portion of the barrel portion 1912 of the shunt implant 1902. However, the sensor 1904 can additionally or alternatively be positioned offset from the opening 1914 of the barrel portion 1912 of the shunt implant 1902 and / or the tissue wall 1921.

[0146] Figure 20A illustrates a sensor implant device 2000 comprising a sensor 2004 coupled to a shunt body 2003 via one or more coupling arms 2005, according to one or more embodiments. Figure 20B illustrates a sensor implant system comprising the sensor implant device 2000 and / or a shunt implant 2002 implanted at an opening 2014 in a tissue wall 2021. The shunt body 2003 may have a generally tubular form and / or may have an hourglass shape. In some embodiments, the sensor implant device 2000 may be configured for combined deployment with the shunt implant device 2002, as shown in Figure 20B. In some embodiments, one or more coupling arms 2005 may comprise multiple wires and / or lines forming one or more rhomboid and / or triangular units. For example, the coupling arm 2005 may comprise a network of wires forming two rhomboid units and / or two triangular units.

[0147] One or more coupling arms 2005 that couple the shunt body 2003 to the sensor 2004 may have a rigid or flexible structure. The shunt implant 2002 may be configured to form and / or maintain a fluid conduit through an opening 2014 in the tissue wall 2021. The shunt implant 2002 may include one or more anchoring arms configured to anchor to a first side 2022 and / or a second side (i.e., the superior wall 2023 of the coronary sinus 16) of the tissue wall 2021. In some instances, the shunt implant 2002 may include a barrel portion 2012 configured for placement within the opening 2014 and / or configured to form a fluid conduit through the opening 2014. The shunt body 2003 may be configured to pass through at least a portion of the barrel portion 2012 of the shunt implant 2002. The sensor 2004 can be configured to be positioned at any location relative to the opening 2014 and / or the shunt implant 2002. For example, the sensor 2004 can be configured to be positioned above at least a portion of the barrel portion 2012 of the shunt implant 2002. However, the sensor 2004 can additionally or alternatively be positioned offset from the opening 2014 of the barrel portion 2012 of the shunt implant 2002 and / or the tissue wall 2021.

[0148] Figures 21A to 21C illustrate another sensor implantation device 2100 according to one or more embodiments, including a sensor 2104 coupled to a shunt body 2103 of the sensor implantation device 2100. The shunt body 2103 may be C-shaped and / or may have a partially cylindrical form, having a gap 2128 separating a first end 2126 and a second end 2127 of the shunt body 2103. The shunt body 2103 may include one or more elongated orifices 2129 to allow blood flow through the shunt body 2103.

[0149] In some instances, the sensor 2104 may be coupled to the shunt body 2103 via the use of a sensor docking member 2105 and / or an arm extending from and / or coupled to the shunt body 2103. The sensor docking member 2105 may be configured to position the sensor 2104 at least partially above the shunt body 2103 and / or above the opening 2114 through the tissue wall 2121 and / or may be configured to position the sensor 2104 at an angle relative to the shunt body 2103 and / or at least partially offset from the opening 2114 through the tissue wall 2121.

[0150] The diverter body 2103 may include one or more tabs 2125 extending from the diverter body 2103. In some instances, the tabs 2125 may be assembled for attachment to various delivery systems.

[0151] As shown in FIG21B, the shunt body 2103 may be at least partially compressible and / or expandable. For example, the shunt body 2103 may be configured to reduce its diameter by allowing the first end 2126 and the second end 2127 to at least partially overlap. In some instances, the sensor 2104 may be linearly oriented relative to the shunt body 2103 when it is within the delivery device 2106 (e.g., a conduit) and / or may be configured to be angularly oriented relative to the shunt body 2103 after removal from the delivery device 2106.

[0152] In some instances, the sensor implant device 2100 may be configured for combined deployment with the shunt implant device 2102, as shown in FIG21C. The shunt implant 2102 may be configured to form and / or maintain a fluid conduit through an opening 2114 in the tissue wall 2121. The shunt implant 2102 may include one or more anchoring arms configured to anchor to a first side 2122 and / or a second side (i.e., the superior wall 2123 of the coronary sinus 16) of the tissue wall 2121. In some instances, the shunt implant 2102 may include a barrel portion 2112 configured to be placed within the opening 2114 and / or configured to form a fluid conduit through the opening 2114. The shunt body 2103 may be configured to pass through at least a portion of the barrel portion 2112 of the shunt implant 2102. The sensor 2104 can be configured to be positioned at any location relative to the opening 2114 and / or the shunt implant 2102. For example, the sensor 2104 can be configured to be positioned above at least a portion of the barrel portion 2112 of the shunt implant 2102. However, the sensor 2104 can additionally or alternatively be positioned offset from the opening 2114 of the barrel portion 2112 of the shunt implant 2102 and / or the tissue wall 2121.

[0153] Figure 22 provides a flowchart illustrating the steps of procedure 2200 for delivering one or more sensor implant devices and / or shunt devices described herein, according to one or more examples. Although procedure 2200 is described step by step, some steps of procedure 2200 may be performed simultaneously and / or in a different order.

[0154] At step 2202, procedure 2200 involves percutaneously and / or via a catheter and / or other delivery system delivering a shunt implant to an opening in the tissue wall. For example, the shunt implant may include the shunt / anchoring structure 150 illustrated in FIG. 7. For example, the shunt implant may include a barrel portion configured for at least partial placement within the opening and / or the shunt implant may include one or more anchoring arms configured for anchoring to the tissue wall. The shunt implant may be configured to form and / or maintain a fluid conduit through the opening in the tissue wall. The opening may be created during a puncture procedure performed prior to delivery of the shunt implant.

[0155] At step 2204, procedure 2200 involves delivering a sensor implant device percutaneously and / or via a catheter and / or other delivery system to an opening in the tissue wall. In some instances, the sensor implant device may be delivered together with a shunt implant and / or via the same catheter used for delivering the shunt implant. However, the shunt implant and the sensor implant device may be delivered separately and / or during a separate medical procedure. In some instances, the shunt implant may be delivered prior to the sensor implant device. For example, the shunt implant may be anchored at the opening and the sensor implant device may be subsequently delivered and / or may at least partially pass through the barrel portion of the shunt implant. The sensor implant device may comprise various morphologies, which may include anchoring arms, hooks, expandable shunt bodies, and / or curved ends assembled to anchor to the shunt implant and / or the tissue wall. Alternatively, the sensor implant device may be delivered prior to the delivery of the shunt implant. For example, a sensor implant device may include various morphologies, which may include anchoring arms, hooks, expandable barrel portions, and / or curved ends that are assembled to independently anchor the sensor implant device to a tissue wall and / or at least partially anchor it within an opening. A shunt implant may then be delivered and / or may at least partially pass through the shunt body of the sensor implant device.

[0156] At step 2206, procedure 2200 relates to extending at least a portion of the sensor implant device at least partially through the barrel portion of the shunt device. For example, the shunt implant may include a generally tubular barrel portion forming through the inner cavity of the shunt implant. In some instances, the sensor implant device may include a generally tubular shunt body that is smaller in diameter than the barrel portion of the shunt implant such that the shunt body of the sensor implant device can be assembled to at least partially fit within the barrel portion of the shunt implant.

[0157] Alternatively, the shunt implant may extend at least partially through the shunt body of the sensor implant device. For example, the barrel portion of the shunt implant may be smaller in diameter than the barrel portion of the sensor implant device such that the barrel portion of the shunt implant can be assembled to at least partially fit into the shunt body of the sensor implant device.

[0158] At step 2208, procedure 2200 involves rotating the sensor implantation device as needed to adjust the position of the sensor coupled to the sensor implantation device until the desired position of the sensor is achieved. The sensor may extend above the shunt body of the sensor implantation device, diagonally away from the shunt body of the sensor implantation device, and / or perpendicular to the shunt body of the sensor implantation device. When the sensor implantation device is rotated, the sensor may be moved to be positioned above and / or near different portions of the tissue wall and / or within different portions of the heart chamber.

[0159] At step 2210, procedure 2200 involves the removal of the catheter and / or other delivery system from the body. The shunt and / or sensor implant device may remain in the body.

[0160] Some embodiments of this disclosure relate to a sensor implant system, comprising: a shunt implant having a central flow portion configured to maintain an opening through a tissue wall; and a sensor implant device having a shunt body configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor coupled to the shunt body.

[0161] The sensor may be configured to extend at least partially over an opening through the tissue wall. In some instances, the sensor is configured to extend at least partially over the tissue wall.

[0162] In some instances, the sensor is coupled to the shunt body via an arm extending from the shunt body. The arm may form one or more coils around the sensor.

[0163] The shunt implant may further include one or more anchoring arms. In some instances, the shunt body has a cylindrical shape.

[0164] In some instances, the shunt body includes a guide ring having a proximal portion of a first width assembled to be presented within the central flow portion of the shunt implant and a distal portion assembled to expand to a second width exceeding the central flow portion of the shunt implant. The second width may be greater than the first width.

[0165] The lead loop can be configured to expand to the second width beyond the first side of the tissue wall. In some instances, the sensor is configured to extend beyond the second side of the tissue wall.

[0166] In some instances, the lead loop is at least partially made of one or more shape memory alloys. The proximal portion of the lead loop is assembled to be at least partially positioned within the central flow portion of the shunt implant.

[0167] The wire loop may include a first end and a second end coupled to the sensor. In some instances, the wire loop is assembled to form one or more coils around the sensor.

[0168] In some instances, the shunt body includes a coil having a proximal portion configured to form a first width within the central flow portion of the shunt implant and a distal portion configured to form a second width extending beyond the central flow portion of the shunt implant. The second width may be greater than the first width.

[0169] The shunt body can be configured to form the second width extending beyond the first side of the tissue wall. In some instances, the sensor is configured to extend beyond the second side of the tissue wall.

[0170] In some instances, the coil includes a first end configured to form one or more windings around a sensor. The coil may include a second end at a distal portion.

[0171] The coil may be formed with multiple windings at both the proximal and distal portions. In some instances, the coil is configured to hold the sensor above the proximal portion of the coil.

[0172] In some instances, the coil is configured to hold the sensor at least partially offset from the proximal portion of the coil.

[0173] The splitter body may have an hourglass shape, wherein the middle section of the splitter body has a first diameter and the splitter body expands to a second diameter at the first end and the second end of the splitter body. In some instances, the second diameter is larger than the first diameter.

[0174] In some instances, the shunt body includes a sensor docking point at the first end. The sensor can be assembled to couple to the shunt body at the sensor docking point.

[0175] The shunt body may include a network of supports forming the units. In some instances, at least a portion of the units is rhomboid.

[0176] In some instances, the diverter body includes one or more protrusions at the second end that are configured to mate with one or more delivery devices. The diverter body may have a partially cylindrical form with a gap separating the first end of the diverter body from the second end of the diverter body.

[0177] The splitter body can be assembled to present a compressed form during delivery, wherein the first end at least partially overlaps the second end.

[0178] In some instances, the shunt body includes a plurality of anchor arms assembled to mate with a shunt implant. Each of the anchor arms can be coupled to a chain connecting an interconnecting sensor and the anchor arm.

[0179] The tether can be assembled such that the sensor extends at least partially above the tissue wall. In some instances, the sensor implant system further includes coupling arms that interconnect the sensor and the shunt body. The coupling arms may include a network of struts forming a rhomboid unit.

[0180] Some embodiments of this disclosure relate to a method comprising delivering a shunt implant into an opening in a tissue wall. The shunt implant includes a central flow portion configured to maintain the opening. The method further includes delivering a sensor implant device into the opening in the tissue wall. The sensor implant device includes a shunt body configured to at least partially fit within the central flow portion of the shunt implant and a sensor coupled to the shunt body. The method further includes rotating the sensor implant device to adjust the position of the sensor.

[0181] In some instances, the shunt body includes a coil configured to form a first width within a central flow portion of the shunt implant and configured to form a second width extending beyond the central flow portion of the shunt implant. The second width may be greater than the first width.

[0182] The shunt body can be assembled to form the second width extending beyond the first side of the tissue wall. In some instances, the sensor is assembled to extend beyond the second side of the tissue wall.

[0183] According to some embodiments of the present disclosure, a sensor implantation device includes a shunt body configured to be at least partially fitted within a central flow portion of a shunt implantation and a sensor coupled to the shunt body.

[0184] The splitter body may have an hourglass shape, wherein the middle section of the splitter body has a first diameter and the splitter body expands to a second diameter at the first end and the second end of the splitter body. In some instances, the second diameter is larger than the first diameter.

[0185] In some instances, the shunt body includes a sensor docking point at the first end. The sensor can be assembled to couple to the shunt body at the sensor docking point.

[0186] The shunt body may include a network of supports forming the units. In some instances, at least a portion of the units is rhomboid.

[0187] In some instances, the shunt body includes one or more protrusions at the second end that are configured to mate with one or more delivery devices. The sensor may be configured to extend at least partially over an opening through the tissue wall.

[0188] The sensor may be configured to extend at least partially above the tissue wall. In some instances, the sensor is coupled to the shunt body via an arm extending from the shunt body.

[0189] In some instances, the arm forms one or more coils around the sensor. The shunt body may have a cylindrical shape.

[0190] The shunt body may include a guide ring having a proximal portion of a first width configured to be presented within an opening in the tissue wall and a distal portion of a second width configured to expand beyond the opening in the tissue wall. In some instances, the second width is greater than the first width.

[0191] In some instances, the lead loop is configured to expand to a second width beyond the first side of the tissue wall. The sensor may be configured to extend beyond the second side of the tissue wall.

[0192] The lead loop may be at least partially made of one or more shape memory alloys. In some instances, the lead loop includes a first end and a second end coupled to a sensor.

[0193] In some instances, wire loops are assembled to form one or more coils around the sensor.

[0194] The shunt body may include a coil having a proximal portion of a first width configured to form within an opening in the tissue wall and a distal portion of a second width configured to form beyond the opening in the tissue wall. In some instances, the second width is greater than the first width.

[0195] In some instances, the shunt body is configured to form the second width extending beyond the first side of the tissue wall. The sensor may be configured to extend beyond the second side of the tissue wall.

[0196] The coil may include a first end configured to form one or more windings around the sensor. In some instances, the coil includes a second end at a distal portion.

[0197] In some instances, the coil is formed with multiple windings at both the proximal and distal portions. The coil can be assembled to hold the sensor above the proximal portion of the coil.

[0198] The coil can be configured to hold the sensor at least partially offset from the proximal portion of the coil. In some instances, the shunt body has a partially cylindrical form with a gap separating a first end of the shunt body from a second end of the shunt body.

[0199] In some instances, the splitter body is assembled to present a compressed form during delivery, wherein the first end at least partially overlaps the second end.

[0200] The sensor implant device may further include coupling arms that interconnect the sensor and the shunt body. In some instances, the coupling arm includes a network of struts forming a rhomboid unit. Additional Examples

[0201] Depending on the instance, some actions, events, or functions of any of the programs or algorithms described herein may be performed in different sequences, added, combined, or omitted entirely. Therefore, in some instances, not all described actions or events are necessary for the practical program.

[0202] Unless otherwise specifically stated or understood in the context in which they are used, conditional language used herein, such as "can / could / might / may," "for example," and the like, is intended in its general sense and is generally intended to convey that certain instances include certain objects, elements, and / or steps, while others do not. Therefore, such conditional language is not generally intended to imply that an object, element, and / or step is required in any one or more instances, or that one or more instances necessarily include logic for determining, with or without author input or prompting, whether such objects, elements, and / or steps are included in or to be performed in any particular instance. The terms "comprise," "include," "have," and the like are synonymous, used in their general sense, and used inclusively in an open-ended manner, without excluding additional elements, objects, actions, operations, etc. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense) such that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless otherwise specifically stated, connective language such as the phrase "at least one of X, Y, and Z" should be understood, in the context in which it is used, to generally convey that an item, item, element, etc., can be X, Y, or Z. Therefore, this connective language is not generally intended to imply that certain instances require the presence of at least one of X, at least one of Y, and at least one of Z.

[0203] It should be understood that in the above description of the examples, various morphological elements are sometimes grouped together in a single example, drawing, or description for the purpose of simplifying the disclosure and aiding in the understanding of one or more of the various inventive forms. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more morphological elements than expressly listed in the claims. Furthermore, any component, morphological element, or step illustrated and / or described in the specific examples herein may be applied to or used with any other example(s). Moreover, for each example, the component, morphological element, step, or group of components, morphological elements, or steps is not necessary or indispensable. Therefore, the scope of the invention intended to be disclosed herein and claimed below should not be limited to the specific examples described above, but should be determined solely by a proper reading of the appended claims.

[0204] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply entity characteristics or order. Therefore, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate the priority or order of the element with respect to any other element, but rather distinguish the element from another element with a similar or identical name (unless an ordinal term is used). Additionally, as used herein, the indefinite article ("a / an") may indicate "one or more" rather than "one". Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly listed.

[0205] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which such terms pertain. It should be further understood that terms (such as those defined in common dictionaries) shall be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and shall not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0206] For ease of description, the spatial relative terms “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein to describe the relationship between one element or component and another, as illustrated in the figures. It should be understood that the spatial relative terms are intended to cover different orientations of the device in use or operation other than those depicted in the figures. For example, when the device shown in the figures is flipped, a device located “below” or “under” another device may be placed “above” another device. Therefore, the illustrative term “below” may include both lower and upper positions. The device may also be oriented in another direction, and therefore the spatial relative terms may be interpreted differently depending on the orientation.

[0207] Unless otherwise expressly stated, comparative and / or quantitative terms such as “less,” “more,” “larger,” and the like are intended to encompass the concept of equivalence. For example, “less” may mean not only “less” in the strictest mathematical sense, but also “less than or equal to.” [Simplified Explanation of the Diagram]

[0009] Various examples are depicted in the accompanying drawings for illustrative purposes and should not in any way be construed as limiting the scope of the invention. Furthermore, various morphological features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numerals may again be used to indicate the correspondence between reference elements.

[0010] Figure 1 illustrates an example representation of a human heart based on one or more instances.

[0011] Figure 2 illustrates example pressure waveforms associated with various chambers and blood vessels of the heart, based on one or more examples.

[0012] Figure 3 illustrates the curve of the left atrial pressure range.

[0013] Figure 4 is a block diagram representing an implant device according to one or more examples.

[0014] Figure 5 is a block diagram representing a system for monitoring one or more physiological parameters associated with a patient, based on one or more examples.

[0015] Figure 6 illustrates an example of a sensor assembly / device that may be a component of a sensor implantation device according to one or more examples.

[0016] Figure 7 illustrates an example shunt / anchor structure that can be assembled according to one or more examples for attachment to one or more sensor devices.

[0017] Figure 8 illustrates a shunt implant / anchoring device / structure implanted in the atrial septum according to one or more examples.

[0018] Figure 9 shows a shunt device / structure implanted in the tissue wall between the coronary sinus and the left atrium.

[0019] Figures 10A and 10B illustrate an example sensor implantation device according to one or more of the embodiments of this disclosure.

[0020] Figures 11A and 11B illustrate an example sensor implantation device according to one or more of the embodiments of this disclosure.

[0021] Figures 12A and 12B illustrate a sensor implantation device according to one or more examples, comprising a shunt body including one or more wire loops and / or a sensor extending from the shunt body.

[0022] Figures 13A to 13D illustrate another sensor implantation device according to one or more examples, which includes a sensor coupled to a coil shunt body configured to secure the sensor to a desired location within the heart.

[0023] Figure 14 provides a side view of an example sensor implantation device comprising a sensor docking member configured to be coupled to and / or otherwise paired with one or more sensors, according to one or more examples.

[0024] Figure 15 provides a side view of an example sensor implantation device comprising a sensor docking member configured to be coupled to and / or otherwise paired with one or more sensors, according to one or more examples.

[0025] Figure 16 provides a top view of an example sensor implantation device comprising sensor docking parts configured to be coupled to and / or otherwise paired with one or more sensors, according to one or more instances.

[0026] Figure 17 illustrates an instance sensor implant device with a shunt implant according to one or more instances.

[0027] Figures 18A and 18B illustrate a sensor implantation device according to one or more examples, which includes a sensor coupled to one or more self-expanding anchor arms via one or more chains.

[0028] Figures 19A and 19B illustrate a sensor implantation device according to one or more examples, which includes a sensor coupled to a first implantation via one or more chains.

[0029] Figures 20A and 20B illustrate a sensor implantation device according to one or more examples, which includes a sensor coupled to a first implantation via one or more coupling arms.

[0030] Figures 21A to 21C illustrate another sensor implantation device according to one or more examples, which includes a sensor coupled to a barrel portion of a sensor implantation device.

[0031] Figure 22 provides a flowchart illustrating the steps of a procedure for delivering one or more sensor implant devices and / or shunt devices described herein, according to one or more examples.

Claims

1. A sensor implant system comprising: a shunt implant (1202) including a central flow portion configured to maintain an opening (1214) through a tissue wall (1221); and a sensor implant device (1200) including a shunt body (1203) configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor (1204) coupled to the shunt body; wherein the shunt body includes a wire loop having a proximal portion configured to be presented within the central flow portion of the shunt implant at a first width and a distal portion configured to expand to exceed a second width of the central flow portion of the shunt implant, and wherein the second width is greater than the first width.

2. The sensor implant system of claim 1, wherein a portion of the lead loop is configured to secure the sensor implant device relative to an inner wall of the coronary sinus.

3. The sensor implant system of claim 1, wherein the lead loop: a) is configured to expand to the second width beyond a first side (1222) of the tissue wall, and wherein the sensor is configured to extend beyond a second side (1223) of the tissue wall; and / or b) is at least partially composed of one or more shape memory alloys.

4. The sensor implant system of claim 1, wherein the proximal portion of the lead loop is configured to be at least partially positioned within the central flow portion of the shunt implant.

5. The sensor implantation system of claim 1, wherein the lead loop: a) includes a first end (1226) and a second end (1227) coupled to the sensor; and / or b) is assembled to form one or more coils around the sensor.

6. A sensor implant system comprising: a shunt implant (1302) including a central flow portion configured to maintain an opening (1314) through a tissue wall (1321); and a sensor implant device (1300) including a shunt body (1303) configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor (1304) coupled to the shunt body; wherein the shunt body includes a coil having a proximal portion (1307) configured to form a first width within the central flow portion of the shunt implant and a distal portion (1308) configured to form a second width exceeding the central flow portion of the shunt implant, and wherein the second width is greater than the first width.

7. The sensor implantation system of claim 6, wherein the shunt body is configured to form the second width extending beyond a first side (1322) of the tissue wall, and wherein the sensor is configured to extend beyond a second side (1323) of the tissue wall.

8. The sensor implant system of claim 6, wherein the coil: a) includes a first end (1313) assembled to form one or more windings around the sensor; b) includes a second end at the distal portion; and / or c) forms a plurality of windings at the proximal portion and the distal portion.

9. The sensor implantation system of claim 6, wherein the coil is configured to hold the sensor above a) the proximal portion of the coil; and / or b) at least partially offset from the proximal portion of the coil.

10. A sensor implant system comprising: a shunt implant (1702) including a central flow portion configured to maintain an opening (1714) through a tissue wall (1721); and a sensor implant device (1400) including a shunt body configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor (1704) coupled to the shunt body; wherein the shunt body has an hourglass shape, wherein a middle section (1407) of the shunt body has a first diameter and the shunt body expands to a second diameter at a first end (1426) and a second end (1427) of the shunt body, wherein the second diameter is larger than the first diameter.

11. The sensor implantation system of claim 10, wherein the shunt body comprises: a) a sensor docking member (1405) at the first end, wherein the sensor is configured to be coupled to the shunt body at the sensor docking member; b) a network of struts (1417) forming units (1419), optionally wherein at least a portion of the units is rhomboid; and / or c) one or more protrusions (1409) at the second end configured to mate with one or more delivery devices.

12. A sensor implant system comprising: a shunt implant (2102) including a central flow portion configured to maintain an opening (2114) through a tissue wall (2121); and a sensor implant device (2100) including a shunt body configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor (2104) coupled to the shunt body; wherein the shunt body has a partially cylindrical form having a gap separating a first end of the shunt body from a second end of the shunt body; and wherein the shunt body is configured to present a compressed form during delivery, wherein the first end at least partially overlaps the second end.

13. A sensor implant system comprising: a shunt implant (1802) including a central flow portion configured to maintain an opening (1814) through a tissue wall (1821); and a sensor implant device (1800) including a shunt body configured to be at least partially fitted within the central flow portion of the shunt implant and a sensor (1804) coupled to the shunt body; wherein the shunt body includes a plurality of anchor arms configured to mate with the shunt implant.

14. The sensor implantation system of claim 13, wherein each of the anchor arms is coupled to a tether that interconnects the sensor and the anchor arms, optionally the tether being configured such that the sensor extends at least partially over the tissue wall.

15. A sensor implantation system of any one of claims 1 to 14, wherein the sensor is configured to: a) extend at least partially over the opening through the tissue wall; and / or b) extend at least partially over the tissue wall.

16. The sensor implant system of any one of claims 1 to 14, wherein the shunt implant further includes one or more anchor arms (152, 154).

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