Embedded sensor implant devices

Abstract

A sensor implantation device includes a sensor body, at least one first sensor assembly, and one or more anchoring morphologies coupled to the sensor device and configured to anchor within a tissue wall. The one or more anchoring morphologies are configured to present an unexpanded form during delivery and are configured to expand into the tissue wall.

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"; and U.S. Provisional Patent Application No. 63 / 225,689, filed July 26, 2021, entitled "Embedded 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

[0023] Detailed Description of Preferred Embodiments

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

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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. This document discloses certain examples in the context of cardiac implantable devices. However, while some 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. Cardiac Physiology

[0029] 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.).

[0030] 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. The pulmonary vein 23 carries blood from the lungs to the left atrium 2.

[0031] 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.

[0032] 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 decreases, 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.

[0033] 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.

[0034] 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.

[0035] 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, it may be accessed 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.

[0036] 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.

[0037] 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.

[0038] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of left ventricular function representing the ratio of peak velocity blood flow due to gravity during early diastole (E-wave) to peak velocity flow during 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 indicates 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.

[0039] 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.

[0040] 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

[0041] 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.

[0042] 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 may 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.

[0043] 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 early detection of congestive heart failure. Furthermore, there can be a generally relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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 by 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

[0048] 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 implant 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).

[0049] The control circuitry system 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 system" is used herein in its broad and general sense and can refer to any combination of: processor, processing circuitry system, processing module / unit, chip, die (e.g., a semiconductor die including one or more active and / or passive devices and / or connectivity circuitry systems), 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 system, analog circuitry system, digital circuitry system, and / or any device that manipulates signals (analog and / or digital) based on hard-coded circuitry system and / or operating instructions. The control circuitry system referred to 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 systems 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.

[0050] 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.

[0051] Transducer 32 may include any type of sensor component or mechanism. For example, transducer 32 may be a pressure sensor of the force harvester type. In some instances, 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. Transducer 32 may be associated with housing 36 such that at least a portion thereof is contained within or attached to housing 36. The term "associated" with a vascular stent or other implant structure refers to a sensor device / component being physically coupled to, attached to, or connected to, or integrated with an implant structure.

[0052] 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.

[0053] 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 (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.

[0054] 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.

[0055] 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).

[0056] In some instances, the monitoring system 40 may include at least two subsystems, including a sensor transducer(s) 32 and an implantable internal subsystem or device 30 comprising one or more microcontrollers, one or more discrete electronic components, a control circuitry system 34, 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.

[0057] 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. In some instances, the anchoring structure includes one or more anchoring morphologies configured to anchor the implant device 30 within a tissue wall. 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 can be configured to provide responses indicative of one or more physiological parameters of the patient 44, such as atrial pressure. Although a pressure transducer has been described, the sensor transducers 32 may include any suitable or desired type of sensor transducer for providing signals related to physiological parameters or conditions associated with the implant device 30 and / or the patient 44.

[0058] 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.

[0059] 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.

[0060] 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 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.

[0061] In some instances, the transducers 32 are electrically and / or communicatively coupled to a 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.

[0062] 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 implant 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 implant 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 implant device 30 may not include independent processing capabilities in some instances.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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 can 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 other periods).

[0067] 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.

[0068] 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 implanted device 30, wherein local monitor 42 is primarily designed to receive signals from and / or transmit signals to the implanted 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 certain metadata (such as device ID or the like) from the implanted device 30 and / or process certain metadata associated with the implanted device, which may also be provided via data coupling from the implanted device 30.

[0069] 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.

[0070] 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.

[0071] 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 anchoring 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.

[0072] The sensor device 60 can be configured for anchoring to an implant device. For example, a coil form comprising one or more coils wound with one or more wires or other materials or structures, including 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.

[0073] 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.

[0074] 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.

[0075] Sensor 65 includes sensing elements 67, such as pressure sensor transducers. 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.

[0076] The antenna assembly 69 may be attached to, integrated with, or otherwise associated with the arm / anchor body of the shunt structure.

[0077] 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. Relative to the antenna housing 79, the 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.

[0078] The sensor assembly 61 can be configured to communicate with an external system when implanted in the heart or other areas of a patient's body. For example, the antenna 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 anchoring components. In some instances, the sensor 65 and / or antenna 69 can be contained in a bag or other container attached to the shunt structure.

[0079] The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm 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. Sensor implant device

[0080] Figure 7 illustrates a sensor implantation device 700 comprising a sensor body / device 702 and / or one or more anchoring morphologies 704 according to one or more embodiments. The sensor body 702 may be coupled, attached, and / or otherwise releasably and / or permanently fastened to one or more anchoring morphologies 704. The one or more anchoring morphologies may comprise one or more needles, clamps, puncture coils, hooks, arms, cords, pins, grooves, protrusions, studs, spikes, and / or other morphologies assembled for anchoring and / or anchoring to one or more tissue regions within the heart. In some embodiments, one or more anchoring morphologies 704 may be assembled to at least partially anchor the sensor implantation device 700 within a tissue wall.

[0081] The sensor device 702 may include at least one sensor assembly 705. The sensor assembly(s) 705 may include any type of sensor element as described in detail above. The sensor implantation device 700 may be configured to position the sensor assembly(s) 705 at a target location in the body, which may include a cardiac chamber (e.g., the left atrium), an opening into and / or out of the cardiac chamber (e.g., the left atrial appendage), and / or a blood flow pathway (e.g., the coronary sinus).

[0082] In some embodiments, one or more anchoring topographic bodies 704 may be configured to extend around the sensor device 702 in multiple directions. One or more anchoring topographic bodies 704 may be configured to extend from the sensor device 702 at approximately a 90° angle relative to each other. Alternatively or additionally, one or more anchoring topographic bodies 704 may extend laterally (i.e., along the diameter of the sensor device 702) from the sensor device 702 in substantially opposite directions. One or more anchoring topographic bodies 704 may extend linearly and / or non-linearly away from and / or along the sensor device 702.

[0083] One or more anchoring topforms 704 may be assembled to form a hinged attachment and / or extension from one or more connectors 706 attached to and / or extending from the sensor device 702. In some instances, each connector 706 may be associated with a corresponding anchoring topform 704 of the sensor implant device 700. In some instances, the connectors 706 may be assembled to allow adjustment of the angle 708 between the anchoring topform 704 and the sensor device 702. For example, one or more anchoring topforms 704 may be assembled to freely and / or manually swing and / or hinge between a collapsed configuration / form (e.g., generally flat / flush and / or parallel to the length and / or surface of the sensor device 702) and / or an expanded configuration / form (e.g., at a generally 45° angle to the surface of the sensor device 702). In some instances, one or more anchoring topography bodies 704 may not expand beyond a given angle 708 (e.g., relative to the surface of the sensor device 702, they may not expand beyond an angle of 45° or 90°). One or more anchoring topography bodies 704 may be configured to expand at an angle to allow one or more anchoring topography bodies 704 to be effectively embedded in the tissue surrounding the sensor implant device 700 and / or to prevent the sensor implant device 700 from self-organizing and dislodging.

[0084] In some instances, one or more anchoring morphologies 704 may be biased in a folded form and / or an expanded form. For example, one or more anchoring morphologies 704 may be biased in an expanded form as shown in FIG. 7. One or more anchoring morphologies 704 may be assembled to bend and / or swing to a compressed form while within a catheter and / or other delivery device and / or may be assembled to naturally present an expanded form after removal from the catheter and / or other delivery device. In some instances, one or more anchoring morphologies 704 may be assembled to expand to an expanded form while within a tissue wall. The expansion of one or more anchoring morphologies 704 may be activated by moving the sensor implant device 700 in the opposite direction to the direction of insertion into the tissue wall.

[0085] Although the sensor implant device 700 is shown in FIG. 7 as comprising four anchoring top features 704, the sensor implant device 700 may comprise any number of anchoring top features 704. In some instances, the sensor implant device 700 may comprise a first set of two anchoring top features 704 on a first side of the sensor device 702 and / or a second set of two anchoring top features 704 on a second side of the sensor device 702.

[0086] In some instances, the sensor body 702 may include one or more tips to facilitate puncture and / or drive the sensor body 702 into the tissue wall. Alternatively or alternatively, the sensor body 702 may be delivered and / or assembled via a catheter and / or similar device with tips to puncture the tissue wall, embed into the tissue wall and / or drive through the tissue wall.

[0087] Although the sensor body 702 includes a single sensor component 705 in FIG. 7, the sensor body 702 may include any number of sensor components 705. For example, the sensor body 702 may include a first sensor component 705 at a first end 710 of the sensor body 702 and / or a second sensor component 705 at a second end 711 of the sensor body 702. In some instances, the sensor body 702 may be separable from the sensor component 705 and / or the sensor body 702 and the sensor component 705 may be interconnected via wiring.

[0088] In some instances, the sensor implant device 700 may be configured for anchoring within a tissue wall between a first cardiac chamber / blood flow path and a second cardiac chamber / blood flow path. For example, the sensor implant device 700 may be configured for anchoring within a tissue wall separating the left atrium from the coronary sinus. The sensor implant device 700 may include a first sensor assembly 705 for acquiring measurements at the left atrium and / or a second sensor assembly 705 for acquiring measurements at the coronary sinus.

[0089] In some embodiments, the sensor device 702 and / or sensor assembly 705 may be formed in a generally cylindrical and / or tubular form with generally linear / straight sides. However, the sensor device 702 may have a non-uniform surface and / or may include one or more studs and / or portions with an increased diameter relative to other portions of the sensor device 702. For example, the sensor assembly 705 may have an increased diameter relative to other portions of the sensor device 702. In this way, it is advantageous to prevent the sensor assembly 705 from becoming embedded in the tissue wall.

[0090] Figures 8A and 8B illustrate a sensor implantation device 800 comprising a sensor body / device 802 and / or one or more anchoring morphologies 804 according to one or more embodiments. In some embodiments, one or more anchoring morphologies 804 may be assembled to fit into and / or extend from a corresponding receiver 809, cavity, and / or recess in the sensor device 802. One or more anchoring morphologies may include one or more needles, clamps, puncture coils, hooks, arms, cords, spikes, protrusions, studs, and / or other morphologies assembled for anchoring and / or anchoring to one or more tissue regions within the heart.

[0091] Figure 8A illustrates a folded / compressed form of the sensor implant device 800. In the compressed form, one or more anchoring topforms 804 may be at least partially positioned within the receiver 809 of the sensor body 802 (e.g., at the end 810 of the sensor body 802) to reduce the profile of the sensor implant device 800. The sensor implant device 800 may be assembled to present a compressed form when placed within a catheter and / or (a plurality of) other delivery devices. In some instances, one or more anchoring topforms 804 may be coupled to the sensor body 802 via hinged attachments and / or hinges and / or similar mechanisms to allow one or more anchoring topforms 804 to form a movable attachment with the sensor body 802.

[0092] As shown in FIG8A, in its unexpanded form, one or more anchoring topography bodies 804 may extend generally toward the sensor assembly 805. For example, the anchoring topography bodies 804 may extend generally along the surface of the sensor body 802 and / or along the surface of the end 810 toward the second end of the sensor body 802 and / or toward the sensor assembly 805.

[0093] Figure 8B illustrates an expanded form of the sensor implant device 800. In the expanded form, one or more anchoring morphologies 804 may extend away from the sensor device 802. For example, one or more anchoring morphologies 804 may be substantially perpendicular and / or at a 45° angle relative to at least a portion of the sensor device 802. One or more anchoring morphologies 804 may be assembled to expand relative to the surface of the sensor body 802 by no more than 90°. In some instances, at least partial removal of the sensor implant device 800 from a catheter and / or (a plurality of) other delivery systems may cause activation and / or extension of one or more anchoring morphologies 804.

[0094] In some instances, one or more anchoring topologies 804 (including the anchoring topologies of any of the various sensor implant devices described herein) may be configured to swing freely between an expanded form and a compressed / unexpanded form. Alternatively or additionally, one or more anchoring topologies 804 may be spring-loaded and / or otherwise biased into an expanded form. For example, one or more springs may be positioned within a receiver 809 to press the anchoring topology 804 out of the receiver 809.

[0095] The sensor device 802 may include at least one sensor component 805. The sensor component(s) 805 may include any type of sensor device as described in detail above. The sensor implantation device 800 may be configured to position the sensor component(s) 805 at a target location in the body, which may include a heart chamber (e.g., the left atrium), an opening into and / or out of the heart chamber (e.g., the left atrial appendage), and / or a blood flow pathway (e.g., the coronary sinus).

[0096] In some embodiments, one or more anchoring topography bodies 804 may be assembled to extend around the sensor body 802 in multiple directions. One or more anchoring topography bodies 804 may extend laterally (i.e., along the diameter of the sensor body 802) from the sensor body 802 in substantially opposite directions. One or more anchoring topography bodies 804 may extend linearly and / or non-linearly away from and / or along the sensor body 802.

[0097] One or more anchoring topography bodies 804 may be configured to swing and / or hinge between a collapsed configuration (e.g., a conical surface generally parallel to the end 810 of the sensor body 802) and / or an expanded configuration (e.g., at a generally 45° angle to the conical surface of the end 810 of the sensor body 802). One or more anchoring topography bodies 804 may be expanded at an angle to allow one or more anchoring topography bodies 804 to be effectively embedded in the tissue surrounding the sensor implant device 800 and / or to prevent the sensor implant device 800 from self-organizing and dislodging.

[0098] The sensor implant device 800 may include any number of anchoring top features 804. In some instances, the sensor implant device 800 may include a first set of two anchoring top features 804 on a first side of the sensor device 802, a second set of two anchoring top features 804 on a second side of the sensor device 802, and / or a third set of two anchoring top features 804 on a third side of the sensor device 802.

[0099] In some embodiments, the sensor body 802 may have one or more tips to facilitate driving the sensor device 802 into the tissue wall. For example, the sensor body 802 may include a pointed and / or conical end 810 having a tip. The conical end 810 may be positioned on the opposite side / end of the sensor body 802, relative to a sensor assembly 805 that may be positioned at a second end of the sensor device 802. Alternatively or additionally, the sensor body 802 may be delivered via a conduit and / or similar device having a tip and / or may be assembled to pierce the tissue wall, embed into the tissue wall, and / or drive through the tissue wall. In some embodiments, the sensor device 802 may further include a body portion 807 positioned between the conical end 810 and the sensor assembly 805. At least a portion of one or more anchoring morphologies 804 may be coupled to and / or coupled to the conical end 810 of the sensor device 802.

[0100] Although the sensor device 802 includes a single sensor component 805 in Figures 8A and 8B, the sensor device 802 may include any number of sensor components 805. For example, the sensor device 802 may include a first sensor component 805 at a first end 810 of the sensor device 802 and / or a second sensor component 805 at a second end of the sensor device 802. In some instances, the sensor implant device 800 may be configured for anchoring within a tissue wall between a first cardiac chamber / blood flow path and a second cardiac chamber / blood flow path. For example, the sensor implant device 800 may be configured for anchoring within a tissue wall separating the left atrium from the coronary sinus. The sensor implant device 800 may include a first sensor component 805 that obtains measurements at the left atrium and / or a second sensor component 805 that obtains measurements at the coronary sinus.

[0101] In some embodiments, the sensor device 802 and / or sensor assembly 805 may be formed in a generally cylindrical and / or tubular form with generally linear / straight sides. However, the sensor device 802 may have a non-uniform surface and / or may include one or more studs and / or portions having a larger diameter / width than the various portions of the sensor device 802. For example, the sensor assembly 805 may have a larger diameter / width than the body portion 807 and / or the conical end portion 810 of the sensor device 802. In this way, it is advantageous to prevent the sensor assembly 805 from becoming embedded in the tissue wall.

[0102] Figure 9 illustrates a sensor implantation device delivered via catheter 912 according to one or more examples. The sensor implantation device may include a sensor body / device 902 and / or one or more anchoring morphologies 904. The sensor body 902 may be coupled, attached, and / or otherwise releasably and / or permanently secured to one or more anchoring morphologies 904. The one or more anchoring morphologies may include one or more needles, clamps, puncture coils, hooks, arms, cords, protrusions, spikes, studs, and / or other morphologies assembled for anchoring and / or anchoring to one or more tissue regions within the heart.

[0103] In some instances, one or more anchoring morphologies 904 may be assembled to present a compressed and / or unexpanded form when within the conduit 912, as shown in FIG9. In the compressed / unexpanded form, one or more anchoring morphologies 904 may be assembled to be placed flat / flush and / or positioned on the outer surface of the sensor device 902 and / or may be assembled to enter one or more receivers of the sensor device 902.

[0104] The sensor device 902 may include at least one sensor component 905. The sensor component(s) 905 may include any type of sensor element as described in detail above. The sensor implantation device may be assembled to position the sensor component(s) 905 at a target location in the body, which may include a heart chamber (e.g., the left atrium), an opening into and / or out of the heart chamber (e.g., the left atrial appendage), and / or a blood flow pathway (e.g., the coronary sinus).

[0105] In some embodiments, one or more anchoring topographic bodies 904 may be configured to extend around the sensor device 902 in multiple directions. One or more anchoring topographic bodies 904 may be configured to extend from the sensor device 902 at approximately a 90° angle relative to each other. Alternatively or additionally, one or more anchoring topographic bodies 904 may extend laterally (i.e., along the diameter of the sensor device 902) in substantially opposite directions from the sensor device 902. One or more anchoring topographic bodies 904 may extend linearly and / or non-linearly away from and / or along the sensor device 902.

[0106] One or more anchoring topforms 904 may be configured to couple to and / or extend from and from one or more connectors 906 of the sensor device 902. In some instances, each connector 906 may be associated with a corresponding anchoring topform 904 of the sensor implant device. In some instances, the connectors 906 may be configured to allow adjustment of the angle between the anchoring topform 904 and the sensor device 902. For example, one or more anchoring topforms 904 may be configured to swing and / or hinge between a collapsed configuration (e.g., generally parallel to the length of the sensor device 902) and / or an expanded configuration (e.g., at a generally 45° angle to the sensor device 902). One or more anchoring topforms 904 may be expanded at an angle to allow one or more anchoring topforms 904 to be effectively embedded in the tissue surrounding the sensor implant device and / or to prevent the sensor implant device from self-dislodging.

[0107] Although the sensor implant device is shown in FIG. 9 as comprising four anchoring topographic bodies 904, the sensor implant device may comprise any number of anchoring topographic bodies 904. In some instances, the sensor implant device may comprise a first set of two anchoring topographic bodies 904 on a first side of the sensor device 902 and / or a second set of two anchoring topographic bodies 904 on a second side of the sensor device 902.

[0108] In some instances, the sensor device 902 may have one or more tips to facilitate driving the sensor device 902 into the tissue wall. Alternatively or additionally, the sensor device 902 may be delivered and / or assembled via a conduit 912 having a tip 920 and / or a similar device to pierce the tissue wall, embed into the tissue wall and / or drive through the tissue wall.

[0109] Although the sensor device 902 includes a single sensor component 905 in FIG. 9, the sensor device 902 may include any number of sensor components 905. For example, the sensor device 902 may include a first sensor component 905 at a first end 910 of the sensor device 902 and / or a second sensor component 905 at a second end 911 of the sensor device 902. In some instances, the sensor implant device may be configured for anchoring within a tissue wall between a first cardiac chamber / blood flow path and a second cardiac chamber / blood flow path. For example, the sensor implant device may be configured for anchoring within a tissue wall separating the left atrium from the coronary sinus. The sensor implant device may include a first sensor component 905 that obtains measurements at the left atrium and / or a second sensor component 905 that obtains measurements at the coronary sinus.

[0110] In some embodiments, the sensor device 902 and / or sensor assembly 905 may be formed in a generally cylindrical and / or tubular form having generally linear / straight sides. However, the sensor device 902 may have a non-uniform surface and / or may include one or more studs and / or portions having an increased diameter relative to other portions of the sensor device 902. For example, the sensor assembly 905 may have an increased diameter relative to other portions of the sensor device 902. In this way, it is advantageous to prevent the sensor assembly 905 from becoming embedded in the tissue wall.

[0111] As shown in FIG9, in its unexpanded form, one or more anchoring topographic bodies 904 may extend substantially away from the sensor assembly 905. For example, one or more anchoring topographic bodies 904 may be configured to extend along the surface of the sensor body 902 toward the second end 911 of the sensor body 902 and / or the sensor assembly 910 may be positioned at or near the first end 910 of the sensor body 902.

[0112] Figure 10 illustrates a delivery procedure, according to one or more embodiments, for delivering a sensor implantation device via catheter 1012 to the tissue wall of the left atrium 2. The sensor implantation device may include a sensor body / device 1002 and / or one or more anchoring morphologies 1004. The sensor device 1002 may be coupled, attached, and / or otherwise releasably and / or permanently secured to one or more anchoring morphologies 1004. One or more anchoring morphologies may include one or more needles, clamps, puncture coils, hooks, arms, cords, and / or other morphologies assembled for anchoring and / or anchoring to one or more tissue regions within the heart.

[0113] The sensor device 1002 may include at least one sensor component. The sensor component(s) may include any type of sensor element as described in detail above. The sensor implantation device may be assembled to position the sensor component(s) in a target location within the body, which may include a cardiac chamber (e.g., the left atrium), an opening into and / or out of the cardiac chamber (e.g., the left atrial appendage), and / or a blood flow pathway (e.g., the coronary sinus).

[0114] In some embodiments, one or more anchoring topographic bodies 1004 may be configured to extend around the sensor device 1002 in multiple directions. One or more anchoring topographic bodies 1004 may be configured to extend along the outer surface of the sensor device 1002 at approximately a 90° angle relative to each other. Alternatively or additionally, one or more anchoring topographic bodies 1004 may extend laterally from the sensor device 1002 in substantially opposite directions (i.e., along the diameter of the sensor device 1002). One or more anchoring topographic bodies 1004 may extend linearly and / or non-linearly away from and / or along the sensor device 1002.

[0115] One or more anchoring topforms 1004 may be configured to couple to and / or extend from and to one or more connectors attached to and / or from the sensor device 1002. In some instances, each connector may be associated with a corresponding anchoring topform 1004 of the sensor implant device. In some instances, the connectors may be configured to allow adjustment of the angle between the anchoring topform 1004 and the sensor device 1002. For example, one or more anchoring topforms 1004 may be configured to swing and / or hinge between a collapsed configuration (e.g., generally parallel to the length of the sensor device 1002) and / or an expanded configuration (e.g., at a generally 45° angle to the sensor device 1002). One or more anchoring topography bodies 1004 can be expanded and configured at an angle to allow one or more anchoring topography bodies 1004 to be effectively embedded in the tissue surrounding the sensor implant device and / or to prevent the sensor implant device from dislodging from the tissue.

[0116] Although the sensor implant device is shown in FIG. 10 as comprising four anchoring topographic bodies 1004, the sensor implant device may comprise any number of anchoring topographic bodies 1004. In some instances, the sensor implant device may comprise a first set of two anchoring topographic bodies 1004 on a first side of the sensor device 1002 and / or a second set of two anchoring topographic bodies 1004 on a second side of the sensor device 1002.

[0117] In some instances, the sensor device 1002 may include one or more tips to facilitate driving the sensor device 1002 into the tissue wall. Alternatively or additionally, the sensor device 1002 may be delivered and / or assembled via a catheter 1012 with a tip and / or a similar device to pierce the tissue wall, embed into the tissue wall and / or drive through the tissue wall.

[0118] Although the sensor device 1002 includes a single sensor component 1005 in FIG. 10, the sensor device 1002 may include any number of sensor components 1005. For example, the sensor device 1002 may include a first sensor component 1005 at a first end 1010 of the sensor device 1002 and / or a second sensor component 1005 at a second end 1011 of the sensor device 1002. In some instances, the sensor implant device may be configured for anchoring within a tissue wall between a first cardiac chamber / blood flow path and a second cardiac chamber / blood flow path. For example, the sensor implant device may be configured for anchoring within a tissue wall separating the left atrium from the coronary sinus. The sensor implant device may include a first sensor component 1005 that obtains measurements at the left atrium and / or a second sensor component 1005 that obtains measurements at the coronary sinus.

[0119] In some instances, the sensor device 1002 and / or sensor assembly 1005 may be formed in a generally cylindrical and / or tubular form with generally linear / straight sides. However, the sensor device 1002 may have a non-uniform surface and / or may include one or more studs and / or portions with an increased diameter relative to other portions of the sensor device 1002. For example, the sensor assembly 1005 may have an increased diameter relative to other portions of the sensor device 1002. In this way, it is advantageous to prevent the sensor assembly 1005 from becoming embedded in the tissue wall.

[0120] Figure 11 illustrates a delivery procedure, according to one or more embodiments, for delivering a sensor implantation device via catheter 1012 to the tissue wall of the coronary sinus 16. The sensor implantation device may include a sensor body / device 1102 and / or one or more anchoring morphologies 1104. The sensor device 1102 may be coupled, attached, and / or otherwise releasably and / or permanently secured to one or more anchoring morphologies 1104. One or more anchoring morphologies may include one or more needles, clamps, puncture coils, hooks, arms, cords, protrusions, spikes, emboli, and / or other morphologies assembled for anchoring and / or anchoring to one or more tissue regions within the heart.

[0121] The sensor device 1102 may include at least one sensor component. The sensor component(s) may include any type of sensor element as described in detail above. The sensor implantation device may be assembled to position the sensor component(s) in a target location within the body, which may include a cardiac chamber (e.g., the left atrium), an opening into and / or out of the cardiac chamber (e.g., the left atrial appendage), and / or a blood flow pathway (e.g., the coronary sinus).

[0122] In some embodiments, one or more anchoring topographic features 1104 may be configured to extend around the sensor device 1102 in multiple directions. One or more anchoring topographic features 1104 may be configured to extend from the sensor device 1102 at approximately a 90° angle relative to each other. Alternatively or additionally, one or more anchoring topographic features 1104 may extend laterally (i.e., along the diameter of the sensor device 1102) in substantially opposite directions from the sensor device 1102. One or more anchoring topographic features 1104 may extend linearly and / or non-linearly away from and / or along the sensor device 1102.

[0123] One or more anchoring topforms 1104 may be configured to couple to and / or extend from and to one or more connectors attached to and / or from the sensor device 1102. In some instances, each connector may be associated with a corresponding anchoring topform 1104 of the sensor implant device. In some instances, the connectors may be configured to allow adjustment of the angle between the anchoring topform 1104 and the sensor device 1102. For example, one or more anchoring topforms 1104 may be configured to swing and / or hinge between a collapsed configuration (e.g., generally parallel to the length of the sensor device 1102) and / or an expanded configuration (e.g., at a generally 45° angle to the sensor device 1102). One or more anchoring topography bodies 1104 can be expanded and configured at an angle to allow one or more anchoring topography bodies 1104 to be effectively embedded in the tissue surrounding the sensor implant device and / or to prevent the sensor implant device from dislodging from the tissue.

[0124] Although the sensor implant device is shown in FIG11 as comprising four anchoring topforms 1104, the sensor implant device may comprise any number of anchoring topforms 1104. In some instances, the sensor implant device may comprise a first set of two anchoring topforms 1104 on a first side of the sensor device 1102 and / or a second set of two anchoring topforms 1104 on a second side of the sensor device 1102.

[0125] In some instances, the sensor device 1102 may include one or more tips to facilitate driving the sensor device 1102 into the tissue wall. Alternatively or additionally, the sensor device 1102 may be delivered and / or assembled via a catheter 1112 with a tip and / or a similar device to pierce the tissue wall, embed into the tissue wall and / or drive through the tissue wall.

[0126] Although the sensor device 1102 includes a single sensor component 1105 in FIG. 11, the sensor device 1102 may include any number of sensor components 1105. For example, the sensor device 1102 may include a first sensor component 1105 at a first end 1110 of the sensor device 1102 and / or a second sensor component 1105 at a second end 1111 of the sensor device 1102. In some instances, the sensor implant device may be configured for anchoring within a tissue wall between a first cardiac chamber / blood flow path and a second cardiac chamber / blood flow path. For example, the sensor implant device may be configured for anchoring within a tissue wall separating the left atrium from the coronary sinus. The sensor implant device may include a first sensor component 1105 that obtains measurements at the left atrium and / or a second sensor component 1105 that obtains measurements at the coronary sinus.

[0127] In some embodiments, the sensor device 1102 and / or sensor assembly 1105 may be formed in a generally cylindrical and / or tubular form having generally linear / straight sides. However, the sensor device 1102 may have a non-uniform surface and / or may include one or more studs and / or portions having an increased diameter relative to other portions of the sensor device 1102. For example, the sensor assembly 1105 may have an increased diameter relative to other portions of the sensor device 1102. In this way, it is advantageous to prevent the sensor assembly 1105 from becoming embedded in the tissue wall.

[0128] Figure 12 provides a flowchart of an example procedure 1200 for percutaneous delivery and / or use of one or more of the various sensor implant devices described herein. The steps of procedure 1200 may be performed in any order and / or may be repeated. For example, although procedure 1200 describes the delivery of only a single sensor implant device, multiple sensor implant devices may be delivered via one or more delivery systems.

[0129] At step 1202, procedure 1200 involves percutaneously delivering a sensor implant device to a target tissue wall of the heart. The tissue wall may be, for example, the left atrial wall separating the left atrium from the coronary sinus. In this example, the sensor implant device may be delivered to the left atrial side of the tissue wall and / or the coronary sinus side of the tissue wall. For example, the sensor implant device may be delivered via the atrial septal wall between the left and right atria and / or via the coronary sinus and delivered through an opening in the tissue wall to enter the left atrium. In another example, the sensor implant device may be delivered via the coronary sinus to the coronary sinus side of the tissue wall.

[0130] The sensor implantation device may include a sensor body / device and / or one or more anchoring topologies. The sensor device may include at least one sensor component configured to obtain measurements related to blood flow characteristics at or near the sensor implantation device. In some instances, the sensor device may include a first sensor component at or near a first end of the sensor device and / or may include a second sensor component at or near a second end of the sensor device. For example, the sensor implantation device may be configured such that a first end of the sensor device extends into and / or is adjacent to a first cardiac chamber and / or blood flow path (e.g., the left atrium), and / or a second end of the sensor device extends into and / or is adjacent to a second cardiac chamber and / or blood flow path (e.g., the coronary sinus).

[0131] In some instances, the sensor implant device may be delivered via a catheter and / or shaft. The sensor implant device may include an anchoring morphology that is configured to expand and / or expand after removal from the catheter and / or shaft. In some instances, the sensor implant device may be configured to present a compressed and / or unexpanded form while within the catheter and / or shaft, which may advantageously minimize the delivery profile of the catheter, shaft, and / or sensor implant device. In some instances, the catheter and / or shaft may include a tip and / or other morphology that is configured to facilitate puncture and / or advance the catheter, shaft, and / or sensor implant device into the tissue wall.

[0132] At step 1204, procedure 1200 involves pressing the sensor implant into a tissue wall to at least partially embed the sensor implant device within the tissue wall. In some instances, the sensor implant device may include a tip and / or other morphological features configured to facilitate puncture and / or advance the sensor implant device into the tissue wall. For example, the tip of the sensor implant device may extend into a catheter to allow the tip of the sensor implant device to contact and / or puncture the surface of the tissue wall.

[0133] In some instances, the sensor implantation device can be configured to allow a physician to push the sensor implantation device into the tissue wall. For example, one or more pushers and / or similar devices may extend behind the sensor implantation device within the catheter and / or sheath and / or be used to press the sensor implantation device out of the catheter and / or sheath and / or press it into contact with the tissue wall.

[0134] At step 1206, procedure 1200 involves activating and / or engaging one or more anchoring morphologies of the sensor implantation device to anchor the sensor implantation device within the tissue wall and / or prevent the sensor implantation device from dislodging from the tissue wall. In some instances, one or more anchoring morphologies may include arms and / or hooks, which are configured to extend from the sensor implantation device and / or form an angle of approximately 45° with the sensor device.

[0135] In some instances, one or more anchoring morphologies may be configured to be positioned against and / or within the sensor device of the sensor implantation device during delivery to and / or into the tissue wall. One or more anchoring morphologies may be configured to extend manually and / or naturally away from the sensor device after delivery to the catheter and / or other delivery system. For example, one or more pull wires may be attached to and / or configured to activate one or more anchoring morphologies by pulling them away from the sensor device. In another instance, one or more anchoring morphologies may be configured to expand naturally while within the tissue wall.

[0136] One or more anchoring morphologies may be angled such that they do not restrict the advance of the sensor implant device through the tissue wall. For example, one or more anchoring morphologies may be configured to expand and / or extend in the direction of advance through the tissue wall. Thus, when the sensor implant device is pressed into the tissue wall, movement of the sensor implant device may cause one or more anchoring morphologies to press against and / or be pressed into the sensor implant device. In some instances, one or more anchoring morphologies may be configured to extend at approximately 135° relative to the front end of the sensor implant device and / or at approximately 45° relative to the rear end of the sensor implant device. After the sensor implant device has advanced through the tissue wall, the sensor implant device may retract at least partially into the tissue wall to cause activation and / or expansion of one or more anchoring morphologies. For example, the retraction direction of the sensor implant can be opposite to the expansion direction of one or more anchor bodies, so that the retracted sensor implant can exert a force on one or more anchor bodies, thereby pulling one or more anchor bodies away from the sensor device.

[0137] At step 1208, procedure 1200 may involve removing one or more catheters, sheaths, actuators, ties and / or other delivery systems while embedding the sensor implantation device into the tissue wall.

[0138] Some embodiments of this disclosure relate to a sensor implantation device, comprising: a sensor body including a first sensor component; and one or more anchoring morphologies coupled to the sensor device and assembled to anchor within a tissue wall. The one or more anchoring morphologies are assembled to be in an unexpanded form during delivery and assembled to expand to anchor within the tissue wall.

[0139] One or more anchoring topographic bodies are assembled to lie flat on the surface of the sensor body in an unexpanded form. In some instances, the sensor body includes one or more receivers. One or more anchoring topographic bodies may be assembled to enter one or more receivers in an unexpanded form.

[0140] In some instances, one or more receivers are located at the end of the sensor body. The end may have a conical shape.

[0141] The end may be pointed. In some instances, each of the receivers includes one or more springs.

[0142] In some instances, one or more receivers include recesses in the sensor body. One or more anchoring topographic bodies may be coupled to the sensor device via hinge joints.

[0143] One or more anchoring topographic bodies may be assembled to expand in an expansion manner relative to the surface of the sensor body at an angle of approximately 45°. In some instances, one or more anchoring topographic bodies are assembled to expand in an expansion manner relative to the surface of the sensor body at an angle not exceeding 90°.

[0144] In some instances, one or more anchored topographic bodies are assembled to swing freely between an uninflated form and an inflated form. One or more anchored topographic bodies may be biased in an inflated form.

[0145] One or more anchoring morphologies may be spring-loaded. In some instances, the sensor body includes a tip configured to pierce the tissue wall.

[0146] In some instances, the tip is located at the conical end of the sensor body. One or more anchoring topographic bodies may be coupled to the conical end of the sensor body.

[0147] The first sensor component may have a larger width than the sensor body. In some instances, the first sensor component is located at a first end of the sensor body.

[0148] One or more anchoring topographic features may extend from the second end of the sensor body. In some instances, the sensor implant device further includes a second sensor component positioned at the second end of the sensor body.

[0149] In some instances, one or more anchoring topographic features extend from the middle section of the sensor body. The one or more anchoring topographic features may include pointed arms.

[0150] One or more anchored topographic bodies may extend toward the first sensor assembly in an unexpanded form. In some instances, one or more anchored topographic bodies extend away from the first sensor assembly in an unexpanded form.

[0151] In some instances, one or more anchored topographic features may contain four anchored topographic features. One or more anchored topographic features may contain eight anchored topographic features.

[0152] According to some embodiments of this disclosure, a method includes percutaneously delivering an intracatheter sensor implant device to a tissue wall. The sensor implant device includes one or more anchoring morphologies assembled to present a compressed form when in the catheter. The method further includes puncturing the tissue wall to at least partially embed the sensor implant device within the tissue wall and removing the sensor implant device from the catheter. One or more anchoring morphologies are assembled to present an expanded form after removal from the catheter.

[0153] The catheter may include a tip. In some instances, the tip of the catheter is used to perform puncture of the tissue wall.

[0154] In some instances, the sensor implant device includes a tip. The tip of the sensor implant device can be used to perform tissue wall penetration.

[0155] One or more anchoring morphologies may be assembled to lie flat in a compressed form on the surface of the sensor implant device. In some instances, the sensor implant device includes one or more receivers. One or more anchoring morphologies may be assembled to be inserted into one or more receivers in a compressed form.

[0156] In some instances, one or more anchored topographic bodies are assembled to freely oscillate between compressed and expanded forms. One or more anchored topographic bodies may be biased in an expanded form. Additional Examples

[0157] 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.

[0158] Unless otherwise specifically stated or otherwise 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 "comprising," "including," "having," 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.

[0159] 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 claim. 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.

[0160] 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 element's priority or order 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.

[0161] 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.

[0162] 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, in the case of the device shown in the figures being 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.

[0163] 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 are again 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 a sensor implantation device comprising a sensor assembly / device and / or one or more anchoring topography bodies according to one or more examples.

[0017] Figure 8A illustrates the folding / compression form of a sensor implantation device according to one or more examples.

[0018] Figure 8B illustrates the expansion form of a sensor implantation device according to one or more examples.

[0019] Figure 9 illustrates a sensor implant device delivered via a catheter according to one or more examples.

[0020] Figure 10 illustrates a delivery procedure for delivering a sensor implantation device via a catheter to the tissue wall of the left atrium according to one or more examples.

[0021] Figure 11 illustrates a delivery procedure for delivering a sensor implantation device via a catheter to the tissue wall of the coronary sinus according to one or more examples.

[0022] Figure 12 provides a flowchart of an example procedure for percutaneous delivery and / or use of one or more of the various sensor implantation devices described herein, according to one or more examples.

Claims

1. A sensor implantation device (700, 800) comprising: a sensor body (702, 802) including a first sensor assembly (705, 805), wherein the sensor body is configured for at least partially embedding within a tissue wall, and wherein the first sensor assembly is positioned at a first end (710, 810) of the sensor body; and one or more anchoring morphologies (704, 804) coupled to the sensor body and configured to anchor within the tissue wall, the one or more anchoring morphologies being configured to present an unexpanded form during delivery and configured to expand to anchor into the tissue wall.

2. The sensor implant device of claim 1, wherein the one or more anchoring topographic bodies are assembled to lie flat on one surface of the sensor body in the unexpanded form.

3. The sensor implantation device of claim 1 or claim 2, wherein the sensor body includes one or more receivers (809), and wherein the one or more anchoring morphologies are assembled to enter the one or more receivers in the unexpanded form.

4. The sensor implant device of claim 3, wherein the one or more receivers are located at one end (810) of the sensor body.

5. The sensor implant device as claimed in claim 4, wherein the end has a conical shape.

6. The sensor implant device as claimed in claim 4, wherein the end has a pointed shape.

7. The sensor implant device of claim 4, wherein each of the receivers includes one or more springs.

8. The sensor implantation device of claim 4, wherein the one or more receivers include a recess in the sensor body.

9. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topography bodies are coupled to the sensor body via a hinge joint (706).

10. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topography bodies are assembled to expand in an expansion manner at an angle of approximately 45° relative to one surface of the sensor body.

11. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topography bodies are assembled to expand relative to one surface of the sensor body in an expansion manner at an angle not exceeding one 90°.

12. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring morphologies are assembled to swing freely between the uninflated form and an inflated form.

13. The sensor implantation device of claim 1 or claim 2, wherein the one or more anchoring topographic bodies are biased in an expanded form.

14. The sensor implant device of claim 13, wherein the one or more anchoring top bodies are spring-loaded.

15. The sensor implantation device of claim 1 or claim 2, wherein the sensor body includes a tip configured to pierce the tissue wall.

16. The sensor implantation device of claim 15, wherein the tip is located at a conical end of one of the sensor bodies.

17. The sensor implant device of claim 16, wherein the one or more anchoring topography bodies are coupled to the conical end of the sensor body.

18. The sensor implantation device of claim 1 or claim 2, wherein the first sensor component has a larger width relative to the sensor body.

19. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topography extends from a second end (711) of one of the sensor bodies.

20. The sensor implantation device of claim 1 or claim 2, further comprising a second sensor assembly (705, 805) located at a second end of one of the sensor bodies.

21. The sensor implantation device of claim 1 or claim 2, wherein the one or more anchoring topography extends from the middle section of one of the sensor bodies.

22. The sensor implant device as claimed in claim 1 or claim 2, wherein the one or more anchoring topography bodies include a pointed arm.

23. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topographic bodies extend toward the first sensor assembly in the unexpanded form.

24. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topographic bodies extend away from the first sensor assembly in the unexpanded form.

25. The sensor implant device of claim 1 or claim 2, wherein the one or more anchoring topography includes four anchoring topography.

26. The sensor implantation device of claim 1 or claim 2, wherein the one or more anchoring topography bodies comprise eight anchoring topography bodies.

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