Sensor Stabilizer

Abstract

The sensor holding structure includes a sensor support arm configured to hold the sensor device, and a stabilizer structure associated with the sensor support arm and configured to protrude away from the sensor support arm to provide stabilizing support for the sensor support arm.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 060333, filed August 3, 2020, the entire contents of which are incorporated herein in their entirety. [Background technology]

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of medical devices and procedures.

[0003] 2. Description of Related Art Certain physiological parameters associated with the heart chambers, such as fluid pressure and blood flow, can have an impact on a patient's health outlook. In particular, high cardiac fluid pressure can lead to heart failure, embolism, and / or other complications in some patients. Therefore, information about physiological conditions, such as pressure, in one or more heart chambers can be beneficial. Summary of the Invention

[0004] Described herein are one or more methods and / or devices for facilitating monitoring of physiological parameters using particular sensor devices and stabilizer mechanisms that facilitate stabilization of implanted sensor devices.

[0005] In some embodiments, the present disclosure relates to a sensor holding structure comprising: a sensor support arm configured to hold a sensor device; and a stabilizer structure associated with the sensor support arm and projecting away from the sensor support arm so as to provide stabilizing support for the sensor support arm.

[0006] The stabilizer structure may include elongated leg portions, end portions, and a base portion integral with the sensor support arm. The stabilizer structure may be configured to flex at the base portion to cause the end portion of the stabilizer structure to protrude away from the distal end of the sensor support arm. In some embodiments, the stabilizer structure is configured to flex at the base portion to cause the end portion of the stabilizer structure to protrude away from the proximal end of the sensor support arm. The end portion of the stabilizer structure has an atraumatic coating disposed on at least a portion thereof. In some embodiments, the end portion of the stabilizer structure comprises two feet configured to flex in opposite directions. The end portion may comprise a foot portion having a width at one or more portions thereof that is greater than the width of the elongated leg portion. In some embodiments, the end portion comprises a foot portion configured to deflect at an angle relative to the elongated leg portion to provide a tissue contacting surface.

[0007] The stabilizer structure may include a first leg and a second leg. For example, the first leg and the second leg may be oriented relatively parallel. In some embodiments, the first leg and the second leg are angled relative to each other.

[0008] In some embodiments, the present disclosure relates to a method of deploying a sensor implantation device, the method comprising implanting an implantation structure in a tissue wall, the implantation structure including a sensor support member configured to hold the sensor device and cause a distal portion of a stabilizer form associated with the sensor support member to protrude away from the sensor support member and toward the tissue wall.

[0009] The method may further include stabilizing the sensor support member relative to an angle of the sensor support member relative to the surface of the tissue wall. In some embodiments, the method further includes deflecting an end portion of the stabilizer form to provide the tissue contacting structure. In some embodiments, the stabilizer form includes a shape memory material, and protruding a distal portion of the stabilizer form involves deploying the implant structure from the delivery system, and the shape memory material bending the stabilizer form at its base to allow the stabilizer form to deflect away from the sensor support member.

[0010] In some embodiments, the present disclosure relates to a method for retracting a sensor stabilizer, the method including providing a sensor implantation device including a sensor support structure and a stabilizer member including a suture-engagement feature, engaging a suture with the suture-engagement feature, implanting the sensor implantation device into a tissue wall, at least partially deploying the stabilizer member by causing at least a portion of the stabilizer member to protrude away from the sensor support structure, and pulling one or more portions of the suture, thereby pulling the stabilizer member into alignment with the sensor support structure.

[0011] The suture engagement feature may comprise an aperture associated with an end portion of the stabilizer member. In some embodiments, the method further includes pulling suture tails of the suture proximally through a delivery system associated with the sensor implantation device to withdraw the suture from the sensor implantation device. The method may further include advancing a delivery catheter into the tissue wall, the delivery catheter having multiple suture tail portions of the suture disposed therein. In some embodiments, the tissue wall is a wall separating the coronary sinus from the left ventricle of the heart.

[0012] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein. [Brief explanation of the drawings]

[0013] Various embodiments are illustrated in the accompanying drawings for purposes of illustration and should not be construed as limiting the scope of the present invention in any way. Additionally, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements.

[0014] [Figure 1A] 1 shows a cross-sectional view of an exemplary human heart. [Figure 1B] 1 shows a superior atrial cross-section of a human heart. [Figure 2] 1 illustrates exemplary pressure waveforms associated with various heart chambers and blood vessels of the heart, according to one or more embodiments. [Figure 3] 1 illustrates a graph showing left atrial pressure range. [Figure 4] FIG. 1 is a block diagram depicting an implant device according to one or more embodiments. [Figure 5] 1 illustrates a system for monitoring physiological parameters according to one or more embodiments. [Figure 6] 1 illustrates an exemplary shunt-type anchor structure according to one or more embodiments. [Figure 7A] 1 illustrates a sensor implantation device having a sensor support post according to one or more embodiments. [Figure 7B] 1 illustrates a sensor implantation device having a sensor support post according to one or more embodiments. [Figure 8] 1 shows a perspective view of an implanted device including a sensor retention structure in a catheter delivery (e.g., at least partially collapsed) configuration, according to one or more embodiments. [Figure 9] 1 illustrates a side view of a medical implant device including a sensor retention structure and a sensor stabilizer feature, according to one or more embodiments. [Figure 10] 1 shows a side view of a medical implant device including a sensor retention structure and a sensor stabilizer feature implanted in a tissue wall according to one or more embodiments. [Figure 11A] 1 illustrates a perspective view of a sensor holding structure configured to bend away from an arm of a medical implant device, according to one or more embodiments. [Figure 11B] 1 illustrates a side view of a sensor holding structure configured to bend away from an arm of a medical implant device, according to one or more embodiments. [Figure 12A]1 illustrates a perspective view of a medical implant device including a sensor-holding arm structure with a stabilizer, according to one or more embodiments. [Figure 12B] 1 illustrates a side view of a medical implant device including a sensor-holding arm structure with a stabilizer, according to one or more embodiments. [Figure 13A] 1 illustrates an exploded side view of a sensor holding structure having stabilizers protruding from top to bottom, according to one or more embodiments. [Figure 13B] 1 illustrates an unexpanded top view of a sensor holding structure having stabilizers protruding from top to bottom, according to one or more embodiments. [Figure 14AB] 1 illustrates an exploded side view of a sensor holding structure having stabilizers protruding from below to above, according to one or more embodiments. [Figure 14B] 1 illustrates an unexpanded top view of a sensor holding structure having stabilizers protruding from below to above, according to one or more embodiments. [Figure 15A] 1 illustrates a perspective view of a sensor holding structure with a stabilizer according to one or more embodiments. [Figure 15B] 1 illustrates a side view of a sensor holding structure with a stabilizer according to one or more embodiments. [Figure 15C] 1 illustrates an end view of a sensor holding structure with a stabilizer according to one or more embodiments. [Figure 15D] FIG. 10 illustrates an end view of a sensor retention structure having a distal stop feature, according to one or more embodiments. [Figure 16A] 1 illustrates a perspective exploded view of a sensor holding structure having multiple stabilizers according to one or more embodiments. [Figure 16B] 1 illustrates an unexpanded top view of a sensor retention structure having multiple stabilizers according to one or more embodiments. [Figure 17A] 1 illustrates a perspective exploded view of a sensor holding structure having multiple stabilizers according to one or more embodiments. [Figure 17B] 1 illustrates an unexpanded top view of a sensor retention structure having multiple stabilizers according to one or more embodiments. [Figure 18A] 1 illustrates an exploded side view of a sensor holding structure including a sensor stabilizer according to one or more embodiments. [Figure 18B] 1 illustrates an unexpanded top view of a sensor retention structure including a sensor stabilizer according to one or more embodiments. [Figure 19A] 1 illustrates an exploded side view of a sensor holding structure including a sensor stabilizer according to one or more embodiments. [Figure 19B] 1 illustrates an unexpanded top view of a sensor retention structure including a sensor stabilizer according to one or more embodiments. [Figure 20-1] FIG. 10 is a flow diagram illustrating a process for deploying a sensor ballast, according to one or more embodiments. [Figure 20-2] FIG. 10 is a flow diagram illustrating a process for retracting a sensor ballast according to one or more embodiments. [Figure 21-1] 20-1 provides images of cardiac anatomy and specific devices / systems corresponding to the operations associated with the process of FIG. 20-1, according to one or more embodiments. [Figure 21-2] 20-2 provides images of cardiac anatomy and specific devices / systems corresponding to the operations associated with the process of FIG. 20-2, according to one or more embodiments. [Figure 22] 1 illustrates a sensor implantation device implanted in the wall separating the coronary sinus from the left atrium, according to one or more embodiments. [Figure 23A] 1 illustrates a diagram of cardiac anatomy showing a catheter access path to the wall separating the coronary sinus from the left atrium, in accordance with one or more embodiments. [Figure 23B] 1 illustrates a diagram of cardiac anatomy showing a catheter access path to the wall separating the coronary sinus from the left atrium, in accordance with one or more embodiments. [Figure 24] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the wall separating the coronary sinus from the left atrium, according to one or more embodiments. [Figure 25] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the atrial septal wall, according to one or more embodiments. [Figure 26] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the ventricular septal wall, according to one or more embodiments. [Figure 27] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the wall of a cardiac chamber, according to one or more embodiments. [Figure 28] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the apical region of the heart, according to one or more embodiments. [Figure 29] 1 illustrates a sensor implantation device having a sensor stabilizer implanted in the left atrial appendage of a heart, according to one or more embodiments. [Figure 30] 1 illustrates various access routes by which access to the cardiac anatomy may be achieved in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0015] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claims. The present disclosure relates to systems, devices, and methods for stabilizing a sensor device configured to be implanted in a body (e.g., the heart). For such purposes, one or more stabilizers may be implemented to provide stabilizing contact / support between a sensor holder / holding structure and a tissue wall or other anatomical structure.

[0016] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable arrangement and are not necessarily limited to any particular disclosed arrangement. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding particular embodiments, the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated or separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0017] The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and embodiments disclosed herein and is included to provide context for certain aspects of the present disclosure. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, with blood flow between the chambers controlled, at least in part, by various cardiac valves: the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves can be configured to control, at least in part, blood flow to respective regions of the heart and / or associated blood vessels (e.g., lungs, aorta, etc.) in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole).

[0018] 1A and 1B illustrate vertical and horizontal cross-sectional views, respectively, of an exemplary heart 1 having various features / anatomical structures relevant to certain embodiments of the present disclosure. Heart 1 includes four chambers: left ventricle 3, left atrium 2, right ventricle 4, and right atrium 5. A muscular wall, called the septum, separates the left heart chamber from the right heart chamber. In particular, atrial septal wall portion 79 (referred to herein as the "atrial septum," "interatrial septum," or "septum") separates left atrium 2 from right atrium 5, while ventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates left ventricle 3 from right ventricle 4. The lower tip 19 of the heart 1 is called the apex and is generally located in the midclavicular line, in the fifth intercostal space. The apex 19 may be considered part of a larger apical region 39, identified in the drawings.

[0019] The left ventricle 3 is the primary pumping chamber of the heart 1. A healthy left ventricle is generally conical or apical in shape in that it is longer (along a longitudinal axis extending from the aortic valve 7 (not shown in FIG. 1 ) in a direction toward the apex 19) than it is wide (along a transverse axis extending between the opposing walls 25, 26 at the widest point of the left ventricle) and descends with a decreasing cross-sectional diameter and / or circumference from the base 15 to the point or apex 19. Generally, the apical region 39 of the heart is the bottom region of the heart within the left and / or right ventricular region, but distal to the mitral valve 6 and tricuspid valve 8, and disposed toward the apex 19 of the heart.

[0020] Pumping of blood from the left ventricle 3 is accomplished by squeezing and twisting, or twisting, motions. The squeezing action occurs between the lateral wall 14 of the left ventricle 3 and the septum 17. The twisting motion is the result of myocardial fibers that extend in a circular or spiral direction around the heart. As these fibers contract, they generate a gradient of angular displacement of the myocardium from the apex 19 to the base 15 about the longitudinal axis of the heart. The resulting force vector extends at an angle of approximately 30-60 degrees relative to the flow of blood through the aortic valve 7. When viewed from the apex 19, cardiac contraction manifests as a counterclockwise rotation of the apex 19 relative to the base 15. In conjunction with the respective filling volumes of the left atrium 2 and left ventricle 3, cardiac contraction can result in relatively high fluid pressures on the left side of the heart, at least during certain phases of the cardiac cycle, the consequences of which are discussed in detail below.

[0021] Four valves in the heart support the circulation of blood within the heart. 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 advantageously closes during ventricular contraction (i.e., systole) and opens during ventricular expansion (i.e., diastole). The pulmonary valve 9 separates the right ventricle 4 from the pulmonary artery 11 and is generally configured to open during systole to allow blood to be pumped from the right ventricle 4 toward the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery into the right ventricle 4. The pulmonary valve 9 generally has three cusps / leaflets. The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 may be configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3 and close during diastole to prevent blood from flowing back into the left atrium 2. Aortic valve 7 separates left ventricle 3 from aorta 12. Aortic valve 7 is configured to open during systole to allow blood to exit left ventricle 3 and enter aorta 12, and to close during diastole to prevent blood from flowing back into left ventricle 3.

[0022] Atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with subvalvular tissue, including a collection of chordae tendineae and papillary muscles that anchor the respective valve leaflets to promote and / or facilitate proper fusion and prevent prolapse. The papillary muscles, for example, may generally comprise finger-like protrusions from the ventricular wall. Surrounding the ventricles (3, 4) are several arteries 13 that supply oxygenated blood to the myocardium and several veins 15 that return blood from the myocardium to the right atrium 5 via the coronary sinus 16 (see FIG. 1B). The coronary sinus 16 is a relatively large vein that extends generally around the upper portion of the left ventricle 3 and provides a return path for blood returning to the right atrium 5. A muscular 18 wall separates the coronary sinus 16 from the left atrium. The coronary sinus 16 terminates at the coronary ostium 14, through which blood enters the right atrium.

[0023] The primary role of the left atrium 2 is to act as a holding chamber for blood returning from the lungs (not shown) and as a pump to transport blood to other areas of the heart. The left atrium 2 receives oxygenated blood from the lungs via pulmonary veins 12. Oxygenated blood collected from the pulmonary veins 12 of the left atrium 2 enters the left ventricle 3 through the mitral valve 6. In some patients, the wall of the left atrium 2 is slightly thicker than the wall of the right atrium 5. Deoxygenated blood enters the right atrium 5 through the inferior vena cava 29 and superior vena cava 19. The right side of the heart then pumps this deoxygenated blood into the pulmonary arteries around the lungs. There, fresh oxygen enters the bloodstream, and the blood travels to the left side of the heart via the pulmonary vein vascular network, as shown, ultimately terminating in the left atrium 2. The pulmonary vein ostium 12 is generally located at or near the posterior left atrial wall of the left atrium 2.

[0024] Cardiac Pressure Monitoring for the Prevention and Treatment of Heart Failure - Patent application As referenced 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 relatively slow movement of blood through the heart and / or body, which increases fluid pressure in one or more heart chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. Various heart chambers may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the heart's inefficiency by retaining fluid in the body. Fluid accumulation in the arms, legs, ankles, feet, lungs, and / or other organs causes the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality; therefore, treatment and / or prevention of congestive heart failure is a significant medical concern.

[0025] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring one or more chambers or regions of the heart or other anatomical structures, such as monitoring left atrial pressure. As explained above, pressure buildup in one or more heart chambers or regions of the heart may be associated with congestive heart failure. However, without direct or indirect monitoring of cardiac pressure (e.g., left atrial pressure), it may be difficult to estimate, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring body weight, thoracic impedance, right heart catheterization, etc.

[0026] In some solutions, pulmonary artery wedge pressure may be measured as a surrogate for left atrial pressure. For example, a pressure sensor may be placed or implanted in the pulmonary artery, and the associated readings may be used as a surrogate for left atrial pressure. However, catheter-based pressure measurements in the pulmonary artery or certain other heart chambers or regions may require the use of an invasive catheter to maintain such a pressure sensor, which may be inconvenient or difficult to implement. Furthermore, certain lung-related conditions may affect pressure readings in the pulmonary artery, resulting in undesirably weakened correlations between pulmonary artery pressure and left atrial pressure. As a surrogate for pulmonary artery pressure measurements, pressure measurements in the right ventricular outflow tract may be similarly related to left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be utilized in the diagnosis, prevention, and / or treatment of congestive heart failure.

[0027] Additional solutions can be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of the heart's left ventricle's function that represents the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow at end diastole (A wave) caused by atrial contraction, can be used as a surrogate for measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques, and abnormalities in the E / A ratio generally indicate an inability of the left ventricle to properly fill with blood during the period between contractions, which can lead to symptoms of heart failure, as explained above. However, determining the E / A ratio generally does not provide an absolute pressure measurement.

[0028] Various methods for identifying and / or treating congestive heart failure involve monitoring worsening congestive heart failure symptoms and / or changes in weight. However, such indications may be relatively delayed and / or appear relatively unreliable. For example, daily weight measurements can vary significantly (e.g., by up to 9% or more) and may be unreliable in signaling cardiac complications. Furthermore, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. Additionally, for discharged patients, such treatments may require telemedicine systems.

[0029] The present disclosure provides systems, devices, and methods for directing the administration of medications associated with the treatment of congestive heart failure, at least in part, by directly monitoring pressure within the left atrium or other chambers or vessels where pressure measurements are indicative of left atrial pressure, in order to reduce hospital readmissions, morbidity, and / or improve the health outlook of patients at risk for heart failure.

[0030] Cardiac pressure monitoring according to embodiments of the present disclosure may provide a proactive intervention mechanism for preventing or treating congestive heart failure. Generally, increases in ventricular filling pressure associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators may appear for some patients several weeks before hospitalization. Thus, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce hospitalizations by guiding appropriate or desired medication titration and / or administration before the onset of heart failure.

[0031] Dyspnea represents a cardiac pressure indicator characterized by shortness of breath or a feeling of being unable to breathe adequately. Dyspnea can be due to elevated atrial pressure, which can cause fluid accumulation in the lungs due to backflow of pressure. Pathological dyspnea can result from congestive heart failure. However, a significant amount of time can elapse between the initial pressure increase and the onset of dyspnea, and therefore, symptoms of dyspnea may not provide a sufficient early signal of elevated atrial pressure. By directly monitoring pressure in accordance with embodiments of the present disclosure, normal ventricular filling pressures can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0032] As referenced above, with respect to cardiac pressure, elevated left atrial pressure may be particularly correlated with heart failure. FIG. 2 illustrates exemplary pressure waveforms associated with various heart chambers and heart vessels, according to one or more embodiments. The various waveforms illustrated in FIG. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors into the respective illustrated and labeled heart chambers or heart vessels. As illustrated in FIG. 2, a waveform 225 representing left atrial pressure may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, generally, there may be a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0033] Left atrial pressure may generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlation may weaken when pulmonary vascular resistance increases. That is, pulmonary artery pressure generally does not correlate adequately with left ventricular end-diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary retention, which affects approximately 35-83% of heart failure patients, may affect the reliability of pulmonary artery pressure measurements to estimate left-sided filling pressure. Therefore, as represented by waveform 326, pulmonary artery pressure measurements alone may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly for patients with comorbid conditions such as pulmonary disease and / or thromboembolism. Left atrial pressure may further correlate, at least in part, with the presence and / or degree of mitral valve insufficiency.

[0034] Left atrial pressure readings may be less likely to be distorted or affected by other conditions, such as respiratory status, compared to the other pressure waveforms shown in Figure 2. Generally, left atrial pressure may be a significant predictor of heart failure, such as up to two weeks before the onset of heart failure. For example, increases in left atrial pressure and both diastolic and systolic heart failure may occur several weeks before hospitalization, and therefore knowledge of such increases may be used to predict the onset of congestive heart failure.

[0035] Cardiac pressure monitoring, such as left atrial pressure monitoring, may provide a mechanism for guiding the administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce rehospitalizations and morbidity, as well as provide other benefits. Implanted pressure sensors according to embodiments of the present disclosure may be used to predict heart failure two weeks or more before the onset of heart failure symptoms or markers (e.g., dyspnea). When heart failure prediction is recognized using cardiac pressure sensor embodiments according to the present disclosure, specific preventative measures may be implemented, including pharmaceutical interventions such as modifications to a patient's drug regimen, which may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium may advantageously provide an accurate indicator of pressure buildup that may lead to heart failure or other complications. For example, trends in atrial pressure elevation may be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other therapies may be increased to cause a reduction in pressure and prevent or reduce further complications.

[0036] FIG. 3 illustrates a graph 300 showing left atrial pressure ranges, including a normal range 301 of left atrial pressure, that are generally not associated with a substantial risk of post-operative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of the present disclosure provide systems, devices, and methods for determining whether a patient's left atrial pressure is within normal range 301, above normal range 303, or below normal range 302 using readings from a sensor-implanted device including a sensor retention structure and a sensor stabilizer structure. With respect to a left atrial pressure detected above the normal range, which may correlate with an increased risk of heart failure, embodiments of the present disclosure, described in detail below, may report efforts to reduce the left atrial pressure until it is within normal range 301. Furthermore, with respect to a left atrial pressure detected below normal range 301, which may correlate with an increased risk of acute kidney injury, myocardial injury, and / or other health complications, embodiments of the present disclosure, described in detail below, may serve to facilitate efforts to increase the left atrial pressure to bring the pressure level within normal range 301.

[0037] Implantable device having associated sensor and sensor stabilizer In some embodiments, the present disclosure relates to sensors associated with or integrated with cardiac shunts or other implanted devices / structures. Such integrated devices can be used to provide controlled and / or more effective therapy for treating and preventing heart failure and / or other health complications related to cardiac function. FIG. 4 is a block diagram illustrating an implanted device 400 comprising a cardiac implant structure 420, which may comprise a shunt-type structure or any other type of implant structure, as described in detail herein. The cardiac implant structure 420 may include specific anchoring structures 421 for anchoring the implanted device 400 in place at the implantation location / position. For example, the anchoring structure 421 may include one or more arms, barbs, sutures, suture-engaging features, corkscrew-type or other tissue-engaging features, etc.

[0038] In some embodiments, the cardiac implant structure 420 is physically integrated with and / or connected to the sensor device 410. The sensor device 410 may be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 410 includes one or more transducers 412, such as one or more pressure transducers, and specific control circuitry 414, which may be embodied, for example, in an application-specific integrated circuit (ASIC). The sensor device 410 may have a generally cylindrical shape for one or more portions thereof. The sensor device 410 may be secured to the implant structure 420 by a specific sensor retention structure 425, examples of which are disclosed in detail herein. The sensor device 410 and / or the sensor retention structure 425 may be secured / stabilized using a stabilizer 426, which may be integrated with or associated with the sensor retention structure 425 or another component of the sensor implant device 400.

[0039] The control circuitry 414 may be configured to process signals received from the transducer 412 and / or to communicate signals wirelessly through biological tissue using the antenna 418. The antenna 418 may include one or more coils or loops of conductive material, such as copper wire. In some embodiments, at least a portion of the transducer 412, the control circuitry 414, and / or the antenna 418 are at least partially disposed or housed within a sensor housing 416, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 416 may, in some embodiments, include glass or other rigid material that may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 416 is at least partially flexible. For example, the housing may advantageously include a polymer or other flexible structure / material that may allow the sensor 420 to bend, flex, or collapse to enable transport through a catheter or other introduction means. In some embodiments, the sensor housing 416 is at least partially cylindrical in shape.

[0040] Transducer 412 may comprise any type of sensor means or mechanism. For example, transducer 412 may be a force collector type pressure sensor. In some embodiments, transducer 412 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures applied strain or deflection across its area / surface. Transducer 412 may be associated with housing 46 such that at least a portion of transducer 412 is contained within or attached to housing 46. The term “associated with” is used herein in accordance with its broad and ordinary meaning. With respect to a sensor device / component “associated with” a shunt or other implanted structure, such term may refer to a sensor device or component that is physically coupled, attached, connected, or integrated with the implanted structure. That is, when a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated with, at least partially embedded within, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member.

[0041] In some embodiments, transducer 412 includes or is a piezoresistive strain gauge component that may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, where resistance increases as pressure deforms the component / material. Transducer 412 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0042] In some embodiments, transducer 412 includes or is a component of a capacitive pressure sensor, which includes a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicon, etc. In some embodiments, transducer 412 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement through inductance changes, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, transducer 412 includes or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0043] In some embodiments, transducer 412 includes or is a strain gauge component. For example, strain gauge embodiments may include a pressure-sensitive element on or associated with the exposed surface of transducer 412. In some embodiments, a metal strain gauge may be glued to the surface of the sensor, or a thin film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. Transducer 412 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0044] Sensor implantation system Embodiments of the present disclosure provide systems, devices, and methods for determining and / or monitoring left atrial fluid pressure and / or other physiological parameters or conditions using one or more implantable sensor devices, such as permanently implanted sensor devices. By placing a permanent sensor monitor device directly in the left atrium, embodiments of the present disclosure may advantageously enable physicians and / or technicians to collect real-time cardiac information, including left atrial pressure values ​​and / or other valuable cardiac parameters.

[0045] The disclosed solutions for implanting and maintaining a sensor-implanted device, including certain stabilizer features, may be implemented in connection with a pressure monitoring system. FIG. 5 illustrates a system 500 for monitoring pressure and / or other parameters associated with a patient 515, according to an embodiment of the present disclosure. While the description of FIG. 5 and other embodiments herein are generally presented in the context of pressure monitoring, the descriptions of pressure sensing and pressure sensor stabilization herein are applicable to sensing / stabilizing other types of sensors and sensing other types of physiological parameters, and sensor devices used for such purposes are stabilized using certain stabilizer features.

[0046] A patient 515 may have a pressure sensor implantation device 510 implanted, for example, in the patient's heart (not shown) or associated physiology. For example, the sensor implantation device 510 may be at least partially implanted within the left atrium of the patient's heart. The sensor implantation device 510 may include one or more sensor transducers 512, such as one or more microelectromechanical systems (MEMS) devices, such as MEMS pressure sensors.

[0047] In certain embodiments, the monitoring system 500 may comprise at least two subsystems, including an implantable internal subsystem or device 510 including a sensor transducer 512 (e.g., a MEMS pressure sensor) and a control circuit 514 including one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 518 (e.g., an antenna coil). The monitoring system 500 may further include an external (e.g., non-implantable) subsystem including an external reader 550 (e.g., a coil), which may include a wireless transceiver electrically and / or communicatively coupled to the particular control circuit. In certain embodiments, both the internal and external subsystems include corresponding antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor-implanted device 510 may be any type of implantable device.

[0048] The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies containing one or more active and / or passive devices and / or connecting circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any devices that manipulate signals (analog and / or digital) based on circuitry and / or hard coding of operational instructions. Control circuitry 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 the device's embedded circuitry. Such data storage may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in embodiments in which the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage devices / registers that store any associated operating instructions may be incorporated within or external to the circuitry that includes the state machines, analog circuits, digital circuits, and / or logic circuits.

[0049] Specific details of the sensor implantation device 510 are illustrated in the enlarged block 510 shown. The sensor implantation device 510 may include an implantation / anchor structure 520 as described herein. For example, the implantation structure 520 may include one or more shunt-type implants / anchors for anchoring to a cardiac tissue wall, as described in more detail below. The implantation structure 520 may further include, for example, one or more arm structures that physically hold / anchor the implantation structure 520 to the tissue wall. While certain components are illustrated in FIG. 5 as part of the sensor implantation device 510, it should be understood that the sensor implantation device 510 may include only a subset of the illustrated components / modules and may include additional components / modules not illustrated. The sensor implantation device 510 includes one or more sensor transducers 512 that may be configured to provide a response indicative of one or more physiological parameters of the patient 515, such as atrial pressure and / or volume. Although a pressure transducer is described, the sensor transducer 512 may include any suitable or desirable type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the sensor implant device 510.

[0050] The sensor transducer 512 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, and / or other types of sensors that may be positioned within the patient 515 to sense one or more parameters related to the patient's health. The transducer 512 may be a force collector-type pressure sensor. In some embodiments, the transducer 512 comprises a diaphragm, membrane, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures applied strain or deflection across its area / surface. The transducer 512 may be associated with the housing 516 such that at least a portion of the transducer 512 is contained within or attached to the housing 516.

[0051] In some embodiments, transducer 512 includes or is a piezoresistive strain gauge component that may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, where resistance increases as pressure deforms the component / material. Transducer 512 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0052] In some embodiments, transducer 512 includes or is a component of a capacitive pressure sensor, including a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicon, or other semiconductor. In some embodiments, transducer 512 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement through inductance changes, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, transducer 512 includes or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0053] In some embodiments, transducer 512 includes or is a strain gauge component. For example, strain gauge embodiments may include a pressure-sensitive element on or associated with the exposed surface of transducer 512. In some embodiments, a metal strain gauge may be glued 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 diaphragm or metal foil. Transducer 512 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0054] In some embodiments, the converter 512 is electrically and / or communicatively coupled to a control circuit 514, which may include one or more application specific integrated circuit (ASIC) microcontrollers or chips. The control circuit 514 may further include one or more discrete electronic components, such as tuning capacitors.

[0055] In certain embodiments, the sensor transducer 512 may be configured to generate an electrical signal that can be wirelessly transmitted to a device outside the patient's body 515, such as the illustrated local external monitor system 550. To implement such wireless data transmission, the sensor implanted device 510 may include signal processing circuitry and radio frequency (RF) transmission circuitry, such as an antenna 518. The antenna 518 may include an internal antenna coil or other structure implanted within the patient. The control circuitry 514 may comprise any type of transducer circuit configured to transmit electromagnetic signals, which may be radiated by the antenna 518, which may include one or more conductive wires, coils, plates, etc. The control circuitry 514 of the sensor implanted device 510 may include, for example, one or more chips or dies configured to perform some amount of processing on signals generated and / or transmitted using the device 510. However, due to size, cost, and / or other constraints, the sensor implanted device 510 may not include independent processing capabilities in some embodiments.

[0056] The wireless signals generated by the sensor-implanted device 510 may be received by a local external monitor device or subsystem 550, which may include a transceiver module 553 configured to receive wireless signal transmissions from the sensor-implanted device 510 disposed at least partially within the patient 515. The external local monitor 550 may receive the wireless signal transmissions and / or provide wireless power using an external antenna 555, such as a wand device. The transceiver 553 may include radio frequency (RF) front-end circuitry configured to receive and amplify signals from the sensor-implanted device 510, which may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, etc. The transceiver 553 may be further configured to transmit signals to a remote monitor subsystem or device 560 over a network 575. The RF circuitry of the transceiver 553 may further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc. for processing / processing signals transmitted over the network 575 and / or for receiving signals from the sensor-implanted device 510. In particular embodiments, the local monitor 550 includes control circuitry 551 for performing processing of signals received from the sensor-implanted device 510. The local monitor 550 may be configured to communicate with the network 575 according to known network protocols such as Ethernet, Wi-Fi, etc. In particular embodiments, the local monitor 550 is a smartphone, a laptop computer, or other mobile computing device, or any other type of computing device.

[0057] In certain embodiments, the sensor-implanted device 510 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating-gate transistors or the like. The control circuitry 514 may utilize data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 550 or another external subsystem. In certain embodiments, the sensor-implanted device 510 does not include any data storage. The control circuitry 514 is configured to facilitate wireless transmission of data generated by the sensor transducer 512 or other data associated therewith. The control circuitry 514 may further be configured to receive inputs from one or more external subsystems, such as from the local monitor 550 or from a remote monitor 560 via a network 575. For example, the sensor-implanted device 510 may be configured to receive signals that at least partially control the operation of the sensor-implanted device 510, such as by activating / deactivating one or more components or sensors or otherwise affecting the operation or performance of the sensor-implanted device 510.

[0058] One or more components of the sensor-implanted device 510 may be powered by one or more power sources 540. Due to size, cost, and / or electrical complexity concerns, it may be desirable for the power source 540 to be relatively minimalist in nature. For example, high power driving voltages and / or currents within the sensor-implanted device 510 may adversely affect or interfere with the operation of the heart or other anatomical structures associated with the implanted device. In certain embodiments, the power source 540 is at least partially passive in nature, such that power may be received wirelessly from an external source by passive circuitry in the sensor-implanted device 510. Examples of wireless power transmission techniques that may be implemented include, but are not limited to, short-range or near-range wireless power transmission or other electromagnetic coupling mechanisms. For example, the local monitor 550 may act as an initiator that actively generates an RF field that may provide power to the sensor-implanted device 510, thereby allowing the power circuitry of the implanted device to adopt a relatively simple form factor. In certain embodiments, the power source 540 may be configured to obtain energy from environmental sources, such as fluid flow, motion, or pressure. Additionally or alternatively, power supply 540 may advantageously include a battery, which may be configured to provide sufficient power as needed for the relevant monitoring period.

[0059] In some embodiments, the local monitor device 550 may serve as an intermediate communication device between the sensor-implanted device 510 and the remote monitor 560. The local monitor device 550 may be a dedicated external unit designed to communicate with the sensor-implanted device 510. For example, the local monitor device 550 may be a wearable communication device or other device that may be easily disposed in proximity to the patient 515 and / or the sensor-implanted device 510. The local monitor device 550 may be configured to continuously, periodically, or sporadically poll the sensor-implanted device 510 to extract or request sensor-based information from the sensor-implanted device 510. In certain embodiments, the local monitor 550 includes a user interface that a user may utilize to view sensor data or interact with the local monitor system 550 and / or the sensor-implanted device 510.

[0060] System 500 may include a secondary local monitor 570, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for displaying and / or interacting with monitored cardiac data. In one embodiment, local monitor 550 may be a wearable device or other device or system configured to be disposed in physical proximity to the patient and / or sensor-implanted device 510, with local monitor 550 primarily designed to receive / transmit signals to and / or from sensor-implanted device 510 and provide such signals to secondary local monitor 570 for display, processing, and / or operation thereof. External local monitor system 550 may be configured to receive and / or process certain metadata from or associated with sensor-implanted device 510, such as a device ID, which may also be provided via a data link from sensor-implanted device 510.

[0061] Remote monitor subsystem 560 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitor data received over network 575 from local monitor device 550, secondary local monitor 570, and / or sensor-implanted device 510. For example, remote monitor subsystem 560 may advantageously be operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with patient 515.

[0062] In certain embodiments, the antenna 555 of the external monitoring system 550 comprises an external coil antenna that is matched and / or tuned to inductively pair with the antenna 518 of the internal implant 510. In some embodiments, the sensor implanted device 510 is configured to receive wireless ultrasonic power charging and / or data communication from the external monitoring system 550. As referenced above, the local external monitor 550 may include a wand or other handheld reader.

[0063] In some embodiments, at least a portion of the transducer 512, control circuitry 514, power source 540, and / or antenna 518 are at least partially disposed or housed within a sensor housing 516, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 516, in some embodiments, may comprise glass or other rigid material, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 516 is at least partially flexible. For example, the housing may advantageously comprise a polymer or other flexible structure / material that may allow the sensor 510 to bend, flex, or collapse, enabling transport through a catheter or other percutaneous introduction means.

[0064] The sensor housing 516 may be secured to a particular sensor holding structure 525, which may be physically coupled to and / or integrated with the cardiac implant structure 520. For example, in some embodiments, the sensor holding structure 525 is integrated with an arm component of the implant structure 520. The sensor holding structure 525 may be stabilized against the tissue wall using one or more sensor stabilizer features 526, which may be coupled to and / or integrated with the sensor holding structure 525. The stabilizer 526 may thus serve to stabilize the sensor housing 516 when implanted in the patient 515. The sensor stabilizer 526 may be similar in certain respects to one or more of the embodiments disclosed herein with respect to stabilizer features and structure.

[0065] The sensor implantation device 510 may be implanted anywhere within the body of the patient 515. In some embodiments of the present disclosure, the sensor implantation device 510 is advantageously implanted in the heart of the patient 515, such as in or near the left atrium of the heart, as described in detail herein. Placement of the sensor implantation device 510 at least partially within the left atrium may advantageously provide a desirable location for measuring and / or monitoring left atrial pressure, blood viscosity, temperature, and / or other cardiac crammers. A sensor implantation device according to one or more embodiments of the present disclosure may be implanted using a transcatheter procedure or any other percutaneous procedure. Alternatively, a sensor implantation device according to aspects of the present disclosure may be placed during open-heart surgery (e.g., sternotomy), mini-sternotomy, and / or other surgical procedures.

[0066] Cardiac implant devices and structures FIG. 6 illustrates an exemplary shunt structure 150 according to one or more embodiments. The shunt structure 150 may represent an embodiment of a cardiac implant device that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular or oval opening / barrel. The channel / barrel 166 may be configured to hold the sides of the puncture opening against a tissue wall to form a blood flow pathway between heart chambers or blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be implanted in the wall separating the coronary sinus and the left atrium. The central flow channel / barrel 166 may be formed in part by a pair of side walls 170a, 170b defined by a generally parallelogram-shaped arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, substantially the entire shunt 150 is formed by superelastic struts that are configured to be compressed, fit into a catheter (not shown), and then expanded and return to a relaxed shape as shown in FIG. 6.

[0067] Forming the shunt 150 using multiple interconnected struts that form cells between them may serve to at least partially increase the shunt's flexibility, thereby enabling its compression and expansion at the implantation site. The interconnected struts around the central flow channel / barrel 166 advantageously provide a cage with sufficient rigidity and structure to hold punctured tissue in an open position. The end walls 172a, 172b of the central flow channel / barrel 166 may connect the side walls 170a, 170b and serve as distal and proximal flanges, or extending between the arms 152, 154 on each side. The side walls 170a, 170b and end walls 172a, 172b may together define a tubular lattice, as shown. The end walls 172a, 172b may include thin struts 179 that extend at a slight angle from the central flow axis of the shunt 150.

[0068] The illustrated shunt 150 includes struts that define a tubular or circular lattice of open cells that form a central flow channel / barrel 166, although in some embodiments, the structure making up the channel / barrel 166 forms a substantially continuous wall surface over at least a portion thereof. In the illustrated embodiment, the angle of the shunt structure 150 may facilitate collapsing of the shunt into a delivery catheter (not shown) and expansion of the flanges / arms 152, 154 on either side of the target tissue wall. The central flow channel 166 may remain essentially unchanged between the collapsed and expanded states of the shunt 150, whereas the flanges / arms 152, 154 may transition into and out of alignment with the angled flow channel.

[0069] While certain embodiments of the shunts disclosed herein include flow channels / barrels having substantially circular or oval cross sections, in some embodiments, shunt structures according to the present disclosure have flow channel configurations that are rectangular, diamond-shaped, or other shapes. For example, relatively elongated sidewalls compared to the illustrated configuration of Figure 6 may produce rectangular or oval flow channels. Shunt flow channels of such shapes may be desirable for larger punctures, yet still be configured to collapse into a relatively small delivery profile.

[0070] In some embodiments, each of the distal and proximal flanges / arms 152, 154 is configured to curve outward from the end walls 172a, 172b and point generally radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms may serve to anchor the shunt 150 to the target tissue wall. Additional aspects and features of shunt structures that may be integrated with sensor devices / functionality according to embodiments of the present disclosure are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. While certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 6 and described above, it should be understood that a shunt structure or other implantable device integrated with pressure sensor functionality according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether as a shunt or other purpose or function.

[0071] Sensor retention structures integrated with shunts and other implantable devices Sensor devices according to embodiments of the present disclosure may be integrated with a cardiac shunt structure / device or other implanted device using any suitable or desirable attachment or integration mechanism or configuration. Figure 7A illustrates a sensor implantation device 90 including a shunt structure 99 and an integrated sensor 100, according to one or more embodiments. In some embodiments, the sensor 100 may be constructed or manufactured together with and / or within the shunt structure 99 to form a unitary structure. In some embodiments, the sensor 100 may be attached to or integrated with a sensor support post / arm member 95 of the shunt structure 99.

[0072] The sensor 100 includes a sensor element 102, such as a pressure sensor transducer. Relative to the arm members 95 of the shunt structure 99, the transducer element 102 (e.g., a pressure transducer) may be oriented / positioned at a distal 107 or proximal 105 end or region of the sensor 100. For example, the illustrated embodiment of FIG. 7A includes a sensor element / transducer 102 disposed at the distal end 107 of the sensor 100.

[0073] As described herein, the sensor 100 may be configured to implement wireless data and / or power transmission. The sensor 100 may include an antenna component 108 and control circuitry 109 configured to facilitate wireless data and / or power communication functionality. In some embodiments, the antenna 108 includes one or more conductive coils that may facilitate inductive powering and / or data transmission. The coils 108, in some embodiments, may be wound around a magnetic (e.g., ferrite) and / or air core 103.

[0074] The sensor 100 may advantageously be biocompatible. For example, the sensor 100 may include a biocompatible housing 106, such as a cylindrical or other shaped housing comprising glass or other biocompatible material. The circuitry 109, the sensor element 102, and / or the antenna 108 may be at least partially contained within the housing 106, which is sealed to prevent exposure of such components to the external environment. However, at least a portion of the sensor element 102, such as the sensor diaphragm / membrane or other components, may be at least partially exposed to the external environment in some embodiments to enable pressure readings or other parameter sensing to be implemented. The housing 106 may comprise an at least partially rigid cylindrical or tubular form, such as a glass cylinder form, with the sensing probe 102 disposed at one or both ends 105, 107 of the sensor assembly 106. In some embodiments, the sensor assembly is about 3 mm or less in diameter and / or about 20 mm or less in length. The sensor element 102 may include a pressure transducer, as described herein.

[0075] The sensor assembly 100 may be configured to communicate with an external system when implanted in the heart or other area of ​​a patient's body. For example, the sensor 100 may wirelessly receive power from the external system and / or communicate sensed data or waveforms to and / or from the external system. The sensor assembly 106 may be attached to, maintained / held by, and / or integrated with the shunt structure 99 in any suitable or desirable manner. For example, in some embodiments, the sensor 100 may be attached to and / or held by the shunt structure 99 using mechanical attachment means. In some embodiments, the sensor assembly 106 may be housed in a pouch or other receptacle that is attached to the shunt structure 99, as described in detail below.

[0076] The sensor element 102 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical systems (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include an at least partially flexible or compressible diaphragm component, which may be made from silicon or other flexible material. The diaphragm component may be configured to flex or compress in response to changes in environmental pressure. The control circuitry 109 may be configured to process signals generated in response to the flexing / compression to provide a pressure reading. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride). The diaphragm component and / or other components of the pressure transducer 102 may advantageously be fused or otherwise sealed to / with the housing 106 to provide a hermetic seal of at least some of the sensor assembly components.

[0077] The control circuitry 109 may include one or more electronic application-specific integrated circuit (ASIC) chips or dies that may be programmed and / or customized or configured to perform the monitoring functions described herein and / or facilitate wireless transmission of sensor signals. The antenna 108 may include a ferrite core wound with a conductive material in the form of multiple coils (e.g., wire coils). In some embodiments, the coils include copper or other metal. The antenna 108 may advantageously be configured with a coil geometry that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementations, the sensor implantation device 90 may be delivered to the target implantation site using a delivery catheter (not shown), which includes a cavity or channel configured to accommodate advancement of the sensor assembly 106 therethrough. The sensor support strut / structure 95 may be deflected by some amount θ relative to the axis 101 of the tissue wall in which the sensor implantation device 90 is configured to be implanted.

[0078] In some embodiments, the sensor 100 is pre-attached to and / or integrated with the sensor retention structure 95 prior to implantation. For example, in some embodiments, the sensor retention structure 95 forms at least a portion of the housing of the sensor 100, such that the sensor retention structure 95 and at least a portion of the housing of the sensor 100 are in one piece.

[0079] In some embodiments, the angle or position of the sensor retention structure 95 and / or sensor 100 relative to the longitudinal axis 101 of the shunt structure 99 is such that the sensor 100 protrudes away from the longitudinal axis 101. For example, when the shunt structure 99 is engaged with biological tissue along the dimension / plane of the longitudinal axis 101, the sensor 100 may advantageously protrude at least partially away from the biological tissue, such as into a chamber cavity (e.g., the atrium). In some embodiments, the sensor retention structure 95 is or can be configured with a substantially perpendicular or 90° orientation relative to the axis / plane 101 such that the sensor 100 is substantially orthogonal to the longitudinal axis / plane of the shunt. Such a configuration may advantageously allow the sensor element 102 to be positioned a desired distance away from the shunted flow flowing through the flow path axis 94.

[0080] The sensor element 102 of the sensor 100 may be disposed or positioned in any area / location of the sensor 100. For example, the sensor element 102 may be advantageously disposed at or near the distal portion 107 of the sensor 100. Alternatively or additionally, the sensor element may be disposed or positioned at or near the proximal portion 105 of the sensor 100.

[0081] The embodiment of FIG. 7A illustrates a support / backbone-type sensor retention structure 95 that may be associated with one or more strap-type retention features 98 configured to hold the sensor device 100 to the support 95. FIG. 7B illustrates a sensor color device 790 including a shunt structure 799 and a sensor retention structure 65, where the sensor retention structure 65 has specific curved features associated with features of its rear support 64 and side supports 68, configured to cradle / retain the sensor cylinder 106 thereon. The sensor retention structure 65 further includes one or more retention fingers 63 for holding the sensor cylinder 106 against the structure 65. The sensor retention structure 65 may be attached to or integrated with an arm 793 of the sensor implantation device 799. The sensor retention structure 65 may include a window feature 69 that provides an opening at least partially axially aligned with the antenna 108, thereby reducing interference with signals transmitted to / from the antenna 108. In some embodiments, an additional window 67 is also formed in the structure 65. Further details of the sensor holding structure as shown in FIG. 7B are provided below.

[0082] 8 shows a perspective view of a sensor implantation device 890 in at least a partially collapsed configuration for delivery through a delivery sheath or catheter (not shown). The shunt device 890 includes a sensor retention structure / arm 895 attached to or associated with a shunt device arm 893. After deployment of the sensor implantation device 890, the implant arms may expand radially outward to anchor the implantation device 890 to the target tissue wall.

[0083] Sensor holder stabilizer In general, pressure conditions in the left atrium, or other chambers of the body, in which a sensor-implantation device according to aspects of the present disclosure may be implanted may be such that components of such an implantation device that are not adequately stabilized may experience vibration, dislodgement, movement, and / or other torque or tension conditions. Accordingly, sensor-retaining posts / arms associated with various embodiments of the present disclosure may be subject to mechanical vibration after implantation in some biological environments. Such vibration and / or other pressure-related effects may, in some cases, affect sensor readings. For example, mechanical vibration may affect the ability of the sensor element to desirably acquire / generate a consistent and / or accurate signal. By way of example, with respect to embodiments utilizing compression-based pressure sensing (e.g., capacitive or piezoresistive diaphragm deflection sensors), if the mechanical vibration and / or other pressure-induced movement of the sensor-retaining post / arm is not synchronized with the cardiac rhythm of the heart, constructive and / or destructive interference may corrupt sensor readings, resulting in such pressure sensor readings being inaccurate and / or subject to undesirable signal noise.

[0084] Embodiments of the present disclosure may include certain sensor stabilization features and / or associated systems and processes. For any of the embodiments of the present disclosure, the sensor retention struts / structures and / or associated stabilizers may be positioned on or near the atrial septal wall or the wall separating the left atrium from the coronary sinus, as described in detail herein. Stabilizer features according to aspects of the present disclosure may be attached to and / or integrated with the sensor retention structure, such as integrated with the frame of a stent device or other implant device.

[0085] In some embodiments, the present disclosure relates to a sensor holding structure having one or more stand-type stabilizer components / features associated therewith. Such stabilizer features advantageously serve to anchor the sensor holding structure / holder and / or minimize undesired movement or vibration. In some embodiments, a sensor holding structure with an integrated / associated stabilizer may be configured to be delivered using certain minimally invasive (e.g., percutaneous) procedures.

[0086] Figure 9 illustrates a sensor implantation device 20 configured to hold a sensor 100 that is mechanically attached or secured to a portion of a sensor retention structure 25. The sensor implantation device 20 includes a sensor stabilizer feature 26 configured to stabilize the sensor 100 and / or the sensor retention structure 25 when implanted in a patient. Figure 10 shows a side view of a sensor implantation device 20 including a sensor retention structure 25 and a sensor stabilizer feature 26 implanted in a tissue wall 18, according to one or more embodiments.

[0087] The sensor retention structure / arm 25 may be integral with the arm 22 of the implant structure 20. In some embodiments, the sensor retention structure 25 is an extension of or otherwise associated with the arm member 22. The sensor 100 may be attached to the retention / support structure 25 by any suitable or desirable attachment means, including adhesive attachment or mechanical engagement. For example, the sensor retention structure 25 may include or be associated with one or more retention features 23, which may include one or more clamps, straps, ties, sutures, collars, clips, or tabs. Such retention features 23 may circumferentially receive or retain the sensor 100, or a portion thereof. In some embodiments, the sensor 100 may be attached to the sensor retention structure 25 through application of a mechanical force, through sliding the sensor 100 through the retention features 23, or through clipping, locking, or otherwise engaging the sensor 100 with the sensor retention structure 25 by pressing or applying other mechanical force thereto.

[0088] In some embodiments, the sensor retention structure 25 includes one or more distal and / or proximal stop features 72, 74. The stop features 72, 74 may include one or more tabs that may be configured to protrude or extend onto one or more sides of the sensor retention structure 25 to prevent axial sliding / movement of the sensor 100. Such tabs may include a shape memory alloy (e.g., Nitinol) or other at least partially rigid material.

[0089] In some embodiments, various components of the sensor implantation device, sensor retention structure, and / or stabilizer structure, or portions thereof, may be treated with anticoagulants and / or coated with specific materials designed to reduce the risk of blood clotting associated with implantation of such devices. Stabilizers according to embodiments of the present disclosure may include, for example, a nickel-titanium metal alloy (e.g., Nitinol) or another shape memory material.

[0090] As shown, the sensor retention structure 25 shown in Figures 9 and 10 includes radially protruding stabilizers 26 that are configured or configurable to protrude away from the body 28 of the sensor retention structure 25 to provide contact with the tissue wall 18. For example, Figure 10 shows the sensor implantation device 20 implanted in the tissue wall 18, with the stabilizer components / features 26 shown in a deployed configuration. In the deployed configuration, the stabilizers 26 protrude away from the structure 25 at an angle θ1 relative to a proximal side of the stabilizer 26 and at an angle θ2 relative to a distal side of the stabilizer 26. In general, the angles θ1, θ2 may total 180° and may be any value between about 15° and 165°.

[0091] The sensor retention structure 25 may have any suitable or desirable form, shape, and / or configuration. It should be understood that the illustrated embodiments of Figures 9 and 10 are provided by way of example only, and that stabilization devices / features may be associated with a sensor retention structure having any suitable or desirable size or configuration. An exemplary sensor retention structure may have associated therewith the stabilizer devices / features of the present disclosure, as disclosed in U.S. Provisional Patent Application No. 62 / 926,829, entitled "SENSOR INTEGRATION IN CARDIAC IMPLANT DEVICES," the disclosure of which is incorporated herein by reference in its entirety.

[0092] The sensor holding structure 25 may have one or more sensor holding fingers 23 that may protrude / extend from the body 28 of the sensor holding structure 25 and may serve to hold / retain the sensor device 100 to the sensor holding structure 25. That is, the fingers 23 may inhibit or prevent the sensor cylinder 106 from being pulled away from the body 28 of the sensor holding structure 25 in a radial direction relative to the axis of the sensor holding structure 25.

[0093] In some embodiments, the stabilizer 26 may be coupled to and / or integrated with the rear portion / segment 24 of the sensor retention structure 25. For example, the rear segment 24 may span a circumferential portion of the sensor cylinder 106 and provide support thereto. In some embodiments, the stabilizer 26 may be configured to flex, such as may be caused by a shape-memory property of the stabilizer 26 and / or through manual bending / manipulation thereof, for example, using a surgical instrument. The sensor retention structure 25 may include one or more window features 27, 29, as disclosed in detail above, which may advantageously reduce the bulk of the implanted device and / or reduce interference with the transmit coil 108 of the sensor device 100, which in some embodiments may enable wireless data transmission.

[0094] The sensor retention structure 25 may further include one or more distal and / or proximal axial retention features 72, 74. For example, the illustrated proximal tab 72 may prevent the sensor 100 from sliding proximally on the sensor retention structure 25. Additionally, the distal retention bar 74 may be configured to contact at least a portion of the distal face of the sensor element 102 to prevent its distal sliding on the sensor retention structure 25.

[0095] Implementations of the stabilizer device / feature 26 may help reduce vibration and / or other motion toward and away from the tissue wall 18. In some embodiments, the stabilizer 26 may further reduce lateral motion / vibration (e.g., motion parallel to the tissue wall 18). The stabilizer 26 may further reduce stress on the arms 22 of the sensor implantation device 20 from, for example, repetitive motion during the cardiac cycle.

[0096] 11A and 11B illustrate perspective and side views, respectively, of a sensor retention structure 55 configured to bend away from an arm 52 of a medical implant device according to one or more embodiments. The sensor retention structure 55 may be coupled to one or more outer (or inner) arms 51 provided in addition to the tissue-contacting arm 52 of an associated implant device. The sensor retention structure 55 includes a stabilizer 56, which may be similar in various respects to other sensor stabilizer features / devices disclosed herein.

[0097] As described in detail herein, a sensor retention structure according to aspects of the present disclosure may be integrated with and / or associated with a distal portion of an arm member of an implant device, such as a shunt implant device. By positioning such a sensor retention structure at the distal end of an implant support arm, the implant support arm may be configured to provide stabilization to the implant device. In some embodiments, an implant device may utilize a sensor retention structure in place of one or more implant stabilizing arms. FIGS. 12A and 12B illustrate perspective and side views, respectively, of a medical implant device 70 including a sensor retention arm structure 75 having a stabilizer 76, according to one or more embodiments. As shown in FIGS. 12A and 12B, the sensor retention structure 75 can effectively serve as an implant stabilizing arm without the need for an additional implant support arm in the area of ​​the implant device associated with the retention structure 75.

[0098] As shown in FIGS. 12A and 12B , the sensor retaining structure 75 may be coupled to or otherwise associated with the implant device 70 at or near its base portion 73, which corresponds to where the implant stabilizing arms might otherwise be positioned. For example, the base portion 73 may correspond to the outer portion of the barrel 71 of the shunt implant device, as shown in FIGS. 12A and 12B . The implant device 70 may further include a plurality of additional arms 74 positioned at each of three corners of the implant device 70 with respect to the side view of FIG. 12B , such as at the corners of the barrel 71. Rather than including a similar arm member like the other arm members 74, one of the four corners of the implant device 70 may include a sensor retaining structure 75 having a stabilizer 76 configured to provide mechanical contact with a tissue wall when implanted therein, thereby providing a sensor stabilization / support function similar to that of the arm 74.

[0099] By positioning the sensor retention structure 75 relatively close to the orifice / channel of the barrel 71, the stability of the sensor retention structure 75 may be greater as compared to certain other embodiments in which the sensor retention structure is positioned a greater distance away from the barrel 71. It should be understood that the sensor retention structure according to aspects of the present disclosure may be associated with a sensor stabilizing arm having any desired length, shape, and / or configuration.

[0100] As described in detail herein, sensor stabilizers according to aspects of the present disclosure may be integrated with and / or otherwise associated with a sensor retention structure. For example, such stabilizers may be configured to bend / fold away from a body portion of the sensor retention structure and / or to automatically bend or fold according to shape memory characteristics of the stabilizer and / or associated sensor retention structure. Such bending / folding may generally be away from the distal end of the sensor retention structure or the proximal end of the sensor retention structure, depending on the configuration. Figures 13A and 13B show expanded side and unexpanded top views, respectively, of a sensor retention structure 85 having a stabilizer 86 extending from top to bottom, according to one or more embodiments.

[0101] 13A , sensor hold structure 85 includes a stabilizer 86 that is integral with sensor hold structure 85. For example, as shown in the top view of FIG. 13B , stabilizer 86 may be laser cut or otherwise cut out of the material of body 88 of sensor hold structure 85. In embodiments in which stabilizer 86 is cut or otherwise formed such that base 131 of stabilizer 86 is on a proximal side of stabilizer 86 with respect to the orientation of sensor hold structure 85, stabilizer 86 may be configured to bend / fold downward (i.e., away from the distal end of sensor hold structure 85).

[0102] 13A and 13B, upon bending / folding the stabilizer downward, deployment of the stabilizer 86 may leave a window / opening 89 in the sensor retention structure 85, as shown. In some embodiments, the sensor retention structure 85 may further comprise a proximal window / opening 87. Such a window / opening 87, 89 may be desirable in some cases to provide a sensor retention structure with reduced bulk while still providing sufficient sensor support. For example, the sensor retention structure 85 may include one or more sensor retention fingers 83 that can hold a sensor disposed within the sensor retention structure 85 against the body 88 of the structure, such that additional longitudinal support of the sensor is not required to hold the sensor in a desired position. The windows 87, 89 may further provide openings through which wireless signals can propagate, thereby reducing interference with wireless signal transmission to / from a sensor device held by the structure 85. For example, an antenna feature of the sensor may at least partially overlap one or both of the windows 87, 89 axially and / or circumferentially.

[0103] In some embodiments, the stabilizer 86 may be automatically deployed when the sensor retention structure 85 is released from a delivery system (e.g., a delivery catheter) used to deliver the implant device to the target tissue / location. For example, the sensor retention structure 85 and / or the stabilizer 86 may comprise a shape-setting memory alloy, such as Nitinol. In some implementations, a wire may be used in connection with the delivery system, and the wire may be used to manually deploy the stabilizer 86, such as by pushing or pulling one or more features on the stabilizer 86. For example, the stabilizer 86 may include one or more apertures, hooks, or other engaging features that a deployment wire may engage to deploy the stabilizer.

[0104] 14A and 14B show expanded side and unexpanded top views, respectively, of a sensor hold structure 35 having a stabilizer 36 protruding from bottom to top, according to one or more embodiments. In FIG. 14A , the sensor hold structure 35 includes a stabilizer 36 that is integral with the sensor hold structure 35. For example, as shown in the top view of FIG. 14B , the stabilizer 36 may be laser cut or otherwise cut out of the material of the body 38 of the sensor hold structure 35. In embodiments in which the stabilizer 36 is cut out or otherwise formed such that the base 132 of the stabilizer 36 is on the distal side of the stabilizer 36 with respect to the orientation of the sensor hold structure 35, the stabilizer 36 may be configured to bend / fold upward (i.e., away from the proximal end of the sensor hold structure 35).

[0105] 14A and 14B, upon bending / folding the stabilizer upward, deployment of the stabilizer 36 may leave a window / opening 39 in the sensor retention structure 35, as shown. In some embodiments, the sensor retention structure 35 may further comprise a distal window / opening 37. Such a window / opening 37, 39 may be desirable in some cases to provide a sensor retention structure with reduced bulk while still providing sufficient sensor retention and support. For example, the sensor retention structure 35 may include one or more sensor retention fingers 33 that can hold a sensor disposed within the sensor retention structure 35 against the body 38 of the structure, such that additional longitudinal support of the sensor is not required to hold the sensor in a desired position. The windows 37, 39 may further provide openings through which wireless signals can propagate, thereby reducing interference with wireless signal transmission to / from a sensor device held by the structure 35. For example, an antenna feature of the sensor may at least partially overlap one or both of the windows 37, 39 axially and / or circumferentially.

[0106] 13A and 13B, the stabilizers 36 may be automatically and / or manually deployed. Additionally, retraction of the stabilizers 36 may be achieved through manual and / or automatic mechanical movement. For example, in some embodiments, the stabilizers 36 may be bent as shown in FIG. 14A and positioned against the tissue wall 18, which retains the stabilizers 36 in the bent configuration shown in FIG. 14A. In such embodiments, retracting the sensor retaining structure 35 from the tissue wall 18 may allow the stabilizers 36 to automatically retract to occupy the space 39 previously vacated when the stabilizers 36 were bent / folded away from the sensor retaining structure 35.

[0107] 15A-15C show diagrams of a sensor retention structure 605 having a stabilizer 606, according to one or more embodiments. As shown in FIG. 15A, the sensor retention structure 605 can include a distal stop mechanism 604. For example, in some embodiments, the sensor retention structure 605 has a generally curved / concave lateral shape, providing a cradle-type shape onto which a cylindrical sensor 616 can be placed / rested. In some embodiments, the curved distal portion 604 can have a radius of curvature that is less than the radius of curvature of the body portion 608 of the sensor retention structure 605. That is, the distal stop portion 604 can be at least partially flatter than the body portion 608 over one or more arc lengths thereof. Such a configuration of the distal stop bar / portion 604 is clearly shown in the end view of FIG. 15C. With the sensor cylinder 616 disposed within the curvature of the body portion 608 of the sensor holding structure 605, the curvature of the sensor holding structure 605 can generally correspond to the curvature of the sensor 616, and the relatively flat stopper bar / portion 604 can radially overlap the distal surface 614 of the sensor 616 by some amount, thereby preventing distal axial movement beyond the contact point of the sensor surface 614 with the stopper bar / portion 604.

[0108] FIG. 15D shows an alternative embodiment in which the distal stop bar 644 has a similar circumferential length to the corresponding arc segment of the body 648 of the sensor holding structure 645, and the distal bar 644 is pressed radially toward the central axis of the sensor 616, thereby forming a radially penetrating inward protrusion on the face 614 of the sensor 616, as shown, thereby providing an axial obstruction to prevent distal movement of the sensor 616 beyond the stop bar 644.

[0109] In some embodiments, as shown in FIG. 15B , the sensor retention structure 605 includes a proximal trap / stopper 622 that may have a tab-type configuration. In some embodiments, the stopper 622 may be configured to manually and / or automatically fold / flex radially inward relative to an axis defined by the curvature of the sensor retention structure 605. The embodiment of FIGS. 15A and 15B includes a single kickstand-type stabilizer 606, but it should be understood that, as with any other embodiment of the present disclosure, the sensor retention structure 605 may include any suitable or desirable number of stabilizer features. Furthermore, as with any of the other embodiments disclosed herein, the stabilizer 606 shown in FIGS. 15A and 15B is shown as a bottom-up stabilizer design, as described above in connection with FIGS. 14A and 14B , but it should be understood that the stabilizer 606 may be a top-down stabilizer or have any other configuration according to aspects of the present disclosure.

[0110] 16A and 16B show perspective, expanded and unexpanded top views, respectively, of a sensor hold structure 705 having multiple stabilizers 706, according to one or more embodiments. In particular, the illustrated sensor hold structure 705 has a dual kickstand configuration. That is, while certain embodiments are disclosed herein in the context of sensor hold structures including a single stabilizer form / feature, the embodiment shown in FIGS. 16A and 16B includes two stabilizer features 706a, 706b.

[0111] The two stabilizers 706a, 706b may be substantially independent of one another, such that one of the stabilizers can be bent and / or manipulated independently of the other. In some embodiments, as shown in FIG. 16A , the stabilizer features 706a, 706b may extend in a substantially parallel relative orientation. In some embodiments, when the stabilizers 706a, 706b are bent / protruding from the sensor retention structure 705, the stabilizers 706a, 706b may be angled so that they protrude radially outward relative to their distal end portions and somewhat away from one another. That is, in the deployed configuration, the distal ends of each of the sensor stabilizers 706a, 706b may be further apart than their proximal portions.

[0112] 16B, the stabilizers 706a, 706b can be cut (e.g., laser cut) from the form of the body 725 of the sensor hold structure 705. As with other embodiments disclosed herein, deployment of the stabilizers 706a, 706b can occur after deployment of the sensor hold structure 705 based on the shape memory properties of the sensor hold structure 705 and / or the stabilizers 706a, 706b. While the embodiment of FIG. 16B shows the stabilizers 706a, 706b positioned relative to one another such that there is a gap 742 between the stabilizers when in the delivery configuration shown in FIG. 16B, in some embodiments, a form of material of the base 725 of the sensor hold structure 705 can be present between the stabilizers 706a, 706b such that such a form of material separates the stabilizers in addition to any space formed through laser cutting of the stabilizers 706a, 706b.

[0113] 17A and 17B show perspective, expanded, and unexpanded top views, respectively, of a sensor retention structure 805 having multiple stabilizers 806, according to one or more embodiments. The particular configuration of FIGS. 17A and 17B represents an alternative dual-stabilizer embodiment in which stabilizers 806a, 806b are angled relative to one another. By constructing stabilizers 806a, 806b at an angle, as shown in FIGS. 17A and 17B, such stabilizers can provide desirable lateral stability. For example, the angle of incidence of each stabilizer 806a, 806b relative to one another with respect to contact with the tissue wall can be different, thereby providing stability against movement / vibration over a wider range of angles. While the overhead view shown in FIG. 17B shows stabilizers 806a, 806b cut out so that a non-uniform gap is formed between them and / or between the stabilizers and the body 825 of the sensor retention structure 805, in some embodiments, such a gap is not present. That is, the ballasts 806 a, 806 b can be cut out of the sensor retention structure configuration without creating a gap beyond the cut edge around the perimeter of the ballasts 806 A, 806 B. Such may be true for any of the cut-out ballast feature embodiments disclosed herein.

[0114] trauma protection features The stabilizer features disclosed herein, as described in detail above, may provide stabilization to the sensor retention structure or other components of the implanted device through contact with the tissue wall, thereby providing a mechanical coupling between the sensor retention structure and the tissue wall via the stabilizer structure / feature. In consideration of such tissue contact, it may be desirable to design / configure stabilizer features according to aspects of the present disclosure in a manner that reduces the risk of injury and / or other damage to biological tissue through contact with the stabilizer feature. For example, when the sensor retention structure is subjected to certain vibrations and / or other mechanical motions / forces, such forces / motions may result in repeated contact with the tissue wall, thereby disrupting and / or otherwise damaging the biological tissue over time. In some embodiments, the distal end of the stabilizer feature may be relatively sharp, thereby enabling and / or causing penetration of the stabilizer distal end into the associated biological tissue. Therefore, it may be desirable for certain embodiments to incorporate trauma protection features on the distal end portion of the stabilizer feature.

[0115] 18A and 18B show side and upright views, respectively, of a sensor stabilizer 1806 associated with a sensor holding structure 1805, according to one or more embodiments. The stabilizer 1806 may have any configuration according to any of the embodiments disclosed herein. The stabilizer 1806 further comprises an abrasion-protective coating or cover 1830 covering at least a portion of the distal end portion of the stabilizer 1806.

[0116] The coating or material 1830 may serve to prevent and / or protect against tissue trauma resulting from contact between the stabilizer 1806 and biological tissue. Additionally, in some embodiments, the coating / covering 1830 may provide a greater coefficient of friction compared to a stabilizer not including such a coating / covering. Thus, the coating / covering 1830 may advantageously reduce and / or prevent sliding of the stabilizer 1806 on the tissue wall 18. In some embodiments, when the distal end of the stabilizer 1806 is at least partially punctured and / or embedded within the tissue wall 18, the coating 1830 may be configured to facilitate and / or accelerate tissue ingrowth between the tissue wall 18 and the coating 1830, which may serve to provide additional stability for the stabilizer and sensor retaining structure 1805.

[0117] As shown in FIG. 18B , the stabilizer 1806 may include a foot feature 1837, at least a portion of which may be coated with a coating / material 1830 in some embodiments. However, it should be understood that embodiments of the present disclosure may include stabilizers having foot features that do not have an atraumatic coating / covering thereon. The foot feature 1837 may have a width dimension w1 that is greater than a width dimension w2 of the medial and / or base portion of the stabilizer 1806. In some embodiments, the foot feature 1837 is rounded on one or more corners or edges thereof, thereby providing a less traumatic physical contact interface for contacting biological tissue without puncturing or irritating the tissue. While the foot feature 1837 is shown as having an at least partially flat distal end surface, in some embodiments, the distal end of the foot feature 1837 may be rounded and / or circular. Although FIG. 18B shows foot features 1837 associated with stabilizer 1806, in some embodiments, stabilizers that include trauma protective coverings / coatings do not include discernible foot features.

[0118] 19A and 19B show side and upright views, respectively, of a sensor stabilizer 1906 associated with a sensor retention structure 1905, according to one or more embodiments. The stabilizer feature 1906 may be configured according to any of the embodiments disclosed herein. Additionally, the stabilizer 1906 may have certain additional trauma protection and / or stabilization features associated therewith. For example, as shown, the stabilizer 1906 may include one or more splaying foot features 1941, 1942. For example, as shown in the view of FIG. 19B , which shows the stabilizer 1906 in a pre-deployed configuration, the stabilizer 1906 may include a notch 1947 at or near a distal end portion of the stabilizer 1906, such notch 1947 forming separate foot features 1941, 1942 that may splay in opposite directions relative to one another in the deployed configuration to provide the foot stabilizer feature 1940.

[0119] 19A shows foot stabilizer 1940 with foot feature 1942 bent away from the plane of stabilizer 1906. With foot feature 1942 and foot feature 1941 separated, as shown in FIG. 19A , the contact force of stabilizer 1906 on tissue wall 18 may be distributed between foot feature 1941 and foot feature 1942, thereby potentially reducing trauma and / or impact to tissue wall 18 from stabilizer 1906. While angle Θ illustrated in FIG. 19A between foot feature 1942 and foot feature 1941 is shown as being less than about 90°, it should be understood that when deployed, the angle between foot features 1941, 1942 may be any suitable or desirable angle. For example, angle Θ may be about 90°, between about 90° and 135°, between about 135° and 180°, about 180°, or greater than 180°. 19A and 19B show two foot features 1941, 1942 and a notch 1947 separating them, in some embodiments, foot feature 1940 does not include separate foot features. Rather, a distal portion of stabilizer 1906 may bend / bendable away from the plane of stabilizer 1906, thereby presenting a contact surface that is more parallel to tissue surface 18 than an inner portion of stabilizer 1906. For example, with respect to the view of FIG. 19A , such a foot feature may advantageously bend toward the distal end of sensor retaining structure 1905, thereby presenting a tissue contact surface that is more in line with tissue surface 18 than the plane of the inner portion of stabilizer 1906. The various configurations of foot features disclosed herein may, in some embodiments, prevent deep tissue penetration of the stabilizer feature.

[0120] 20-1 and 20-2 provide a flow diagram illustrating a process 2100 for implanting and retracting a sensor stabilizer, according to one or more embodiments. FIGS. 21-1 and 21-2 provide images of cardiac anatomy and devices / systems corresponding to the operations of process 2100 of FIGS. 20-1 and 20-2, according to one or more embodiments. Process 2100 relates to implanting, deploying, positioning, adjusting, and / or retracting a sensor retention structure and / or associated retractable / retrievable stabilizer features.

[0121] Process 2100, at block 2000, involves coupling a suture 2170 with a suture engagement feature 2150 of a sensor stabilizer 2196, as shown in image 2101. For example, stabilizer 2196 may be configured according to any of the stabilizer feature embodiments disclosed herein. Furthermore, while process 2100 is described in the context of a sensor stabilizer, such as a stabilizer associated with a sensor holding structure 2105 configured to hold / support a sensor device 2116, it should be understood that the principles disclosed herein are applicable to stabilizers used to stabilize any type of structure, whether or not associated with a medical implant device.

[0122] As shown in image 2101 of FIG. 21-1 , the stabilizer 2196 may be associated with a sensor retaining structure 2105, which may be coupled to and / or associated with the arm 2192 of the implant device. In connection with the operation of block 2000, the suture 2170 may be threaded through the aperture 2150 or another suture engagement feature of the stabilizer 2196. In some embodiments, the stabilizer 2196 may include an at least partially rounded foot portion 2140, with the suture engagement feature 2150 associated with the foot feature 2140. The suture 2170 may be configured with a temporary suture loop that passes through the suture engagement feature 2150, allowing for recapture or bailout of the stabilizer feature 2196.

[0123] At block 2002, the process 2100 involves implanting a medical implant device 2110 including a sensor holding structure 2105, which may be configured to hold a sensor device 2116, as shown in image 2102 of FIG. 21-1 . The operations associated with block 2002 may further involve deploying a suture-coupled stabilizer 2196, which may have a suture 2170 engaged with its suture engagement mechanism 2150, as described above. With the suture 2170 looped through and / or otherwise engaged with the suture engagement feature 2150 of the stabilizer 2196, a first suture tail 2171 and a second suture tail 2172 may extend from the stabilizer 2196, as shown in image 2102.

[0124] In some embodiments, the sensor implantation device 2110 may be delivered to the target implantation site so that it is disposed at least partially around a delivery catheter or device 2140. The catheter 2140 may access the target anatomical structure, such as the left atrium or other anatomical cavity or channel, by following a guidewire 2160, which may already be disposed along the desired access path. In some embodiments, the suture tails 2171, 2172 may extend generally along the catheter 2140 and / or other delivery system / device. In some embodiments, the catheter 2140 may access the patient's internal anatomical structure through one or more access sheaths.

[0125] At block 2004, the process 2100 involves retracting the stabilizer 2196 using the coupled suture 2170. For example, as shown in image 2103 of FIG. 21-2 , retraction of the stabilizer 2196 may be achieved by pulling one or both of the suture tails 2171, 2172 proximally, thereby pulling the distal end of the stabilizer 2196 associated with the suture engagement feature 2150 in a generally proximal direction and / or toward the body portion 2188 of the sensor holding structure 2105. Pulling the stabilizer 2196 back into the body 2188 of the sensor holding structure 2105 may return the stabilizer 2196 to approximately the delivery configuration illustrated in FIG. 2101. In some embodiments, pulling the stabilizer 2196 using the suture 2170 may not completely retract the stabilizer 2196 into the image 2101 delivery configuration, but may still retract the stabilizer 2196 sufficiently to allow removal, repositioning, and / or adjustment of the sensor holding structure 2105.

[0126] At block 2006, the process 2100 involves removing the suture 2170 from the stabilizer 2196 and / or the implantation device 2110. For example, removal of the suture 2170 may involve pulling on one of the suture tails 2171, thereby retracting and removing the other suture tail 2172 through the suture engagement feature 2150. Although removal of the suture 2170 is shown as being performed with the stabilizer 2196 retracted in the delivery configuration, as shown in image 2104 of FIG. 21-2, it should be understood that suture removal from the suture engagement feature 2150 may occur with the stabilizer 2196 in the deployed configuration, as shown in image 2102, or in the retracted configuration shown in images 2103 and / or 2104.

[0127] Implantation location of implantable device with stabilizer Implant devices incorporating the stabilizer features described in connection with various embodiments disclosed herein may be any type of implant device. That is, while specific shunt-type implant devices are described in detail and shown in the figures of this disclosure, it should be understood that such implant devices may be any type of implant device, including non-shunt implant devices configured to hold / maintain a sensor device. Furthermore, implant devices equipped with / supplied with stabilizers according to aspects of the present disclosure may be implanted in any suitable or desired anatomical structure, examples of which are described in detail below for reference.

[0128] FIG. 22 illustrates a sensor implantation device 2200 implanted in a wall 2218 separating the coronary sinus 16 from the left atrium 2, according to one or more embodiments. FIG. 22 and several following figures show a cross-section of the heart viewed from top to bottom with the posterior surface oriented toward the top of the page. The sensor implantation device 2200 of FIG. 22 includes a sensor retention structure 2205 having a stabilizer feature 2206 associated therewith. The stabilizer 2206 can be any type of stabilizer feature disclosed herein. With the sensor implantation device 2200 implanted in the wall 2218 separating the left atrium 2 from the coronary sinus 16, the stabilizer 2206 can contact an atrial surface 2232 of the wall 2218 separating the left atrium 2 from the coronary sinus 16 when deployed.

[0129] Atrial shunting through implantation of the implant device 2200 in the wall 18 between the left atrium 2 and the coronary sinus 16 may be preferable to shunting through the interatrial septum in some circumstances. For example, shunting through the coronary sinus 16 may offer a reduced risk of thrombus and emboli. The coronary sinus is less likely to have thrombi / emboli present for several reasons. First, blood draining from the coronary vasculature into the right atrium has just passed through capillaries and is essentially filtered blood. Second, the coronary sinus ostium in the right atrium is often partially covered by a false valve called the Thebesian valve. While the Thebesian valve is not always present, several studies have shown that it is present in most hearts and may block the entry of thrombi or other emboli in the event of a spike in right atrial pressure. Third, the pressure gradient between the coronary sinus through which it drains and the right atrium is generally relatively low. As a result, thrombi or other emboli in the right atrium are more likely to remain there. Fourth, in the event that a thrombus / embolus enters the coronary sinus, a much greater gradient exists between the right atrium and the coronary vasculature than between the right and left atria. Presumably, the thrombus / embolus will travel further down the coronary vasculature until right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0130] Some additional advantages of placing the implant device 2200 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the interatrial septum tissue. By shunting left atrial blood into the coronary sinus, sinus pressure may be increased by a small amount. This may cause blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygenation, which may be more efficient and may help dying heart muscle recover.

[0131] In addition to the above benefits, by implanting the implant device 2200 into the wall 2218 of the coronary sinus, damage to the atrial septum may be prevented. Thus, the atrial septum may be preserved for later transseptal access for alternative therapies. Preserving transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have several other comorbidities, such as atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions require transseptal access.

[0132] It is worth noting that in addition to the various advantages of placing a shunt graft between the coronary sinus and the left atrium, certain disadvantages may be considered. For example, by shunting blood from the left atrium to the coronary sinus, oxygenated blood from the left atrium may pass into the right atrium, and / or deoxygenated blood from the right atrium may pass into the left atrium, both of which may be undesirable for the proper functioning of the heart.

[0133] Access to the target wall 2218 via the coronary sinus 16 may be achieved using any suitable or desired procedure. For example, various access routes may be utilized in manipulating guidewires and catheters in and around the heart to deploy an expandable shunt integrated with or associated with a pressure sensor according to embodiments of the present disclosure. Figures 23A and 23B show diagrams of cardiac anatomy illustrating catheter access routes to the coronary sinus 16 according to one or more embodiments.

[0134] In some embodiments, access may be achieved through the subclavian or jugular vein to the superior vena cava 19, right atrium 5, and thence to the coronary sinus 16. Alternatively, the access route may begin in the femoral vein and enter the heart through the inferior vena cava 29. Other access routes may also be used, each of which typically utilizes a percutaneous incision through which a guidewire and catheter are inserted into the vasculature, usually through a sealed introducer, from which the system may be designed or configured to allow the physician to control the distal end of the device from outside the body.

[0135] In some embodiments of a procedure for advancing an implant device according to aspects of the present disclosure, a guidewire is introduced through the subclavian or jugular vein, through the superior vena cava, and into the coronary sinus. Once the guidewire provides a pathway, an introducer sheath can be routed along the guidewire into the patient's vasculature, typically with the use of a dilator. A delivery catheter can be advanced through the superior vena cava to the coronary sinus of the heart, where the introducer sheath can provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter can function to create and prepare an opening in the wall of the left atrium, and a separate placement or delivery catheter will be used to deliver the implant device 2200. In other embodiments, the deployment catheter can be used as both a fully functional puncture preparation and implant delivery catheter. In this application, the terms "deployment catheter" or "delivery catheter" are used to refer to catheters, sheaths, and / or introducers that have one or both of these functions.

[0136] 23A and 23B, the coronary sinus 16 is generally continuous around the left atrium 2, and therefore there are a variety of possible acceptable placements for the implantation device 2200. The target site selected for placement of the implantation device 2200 may be within an area of ​​thin or sparse tissue in a particular patient, as previously determined by non-invasive diagnostic means, such as CT scan or radiography, fluoroscopy, or intravascular coronary ultrasound (IVUS).

[0137] Additional aspects and features of processes for delivering an implant device that may be integrated with a sensor device / function according to embodiments of the present disclosure for implantation in the wall between the coronary sinus and the left atrium are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although the implant device 2200 is shown within the left atrium / coronary sinus wall 2218, the implant device 2200 may be positioned between other heart chambers, such as between the pulmonary artery and the right atrium.

[0138] FIG. 24 illustrates a sensor implantation device 2410 having a sensor stabilizer 2406 implanted in a wall 18 separating the coronary sinus 16 from the atrium 2, in accordance with one or more embodiments. In contrast to the orientation of the sensor implantation device in each of FIGS. 22 , 23A , and 23B , which shows the sensor retention structures associated with each implantation device oriented generally toward the coronary sinus ostium 14, the sensor implantation devices 2410 are shown in FIG. 24 as oriented such that the sensor retention structures 2405 associated with them are oriented generally away from the coronary sinus ostium 14 and in the direction of the narrowing of the coronary sinus 16. However, it should be understood that a sensor implantation device implanted in a wall 18 separating the left atrium 2 from the coronary sinus 16 may have any suitable or desirable orientation. For example, the arms and / or sensor retention structures associated with the sensor implantation device may be oriented generally perpendicular to the axis of the heart, rather than horizontally, as shown in FIGS. 22 and 24 .

[0139] 25 illustrates a sensor implantation device 2510 having a sensor stabilizer 2505 implanted in the atrial septal wall 79, according to one or more embodiments. With the sensor implantation device 2510 implanted in the atrial septum 79, the sensor retention structure 2505 and associated sensor 2516 may advantageously be disposed within the left atrium 2 as shown, thereby enabling the sensor device 2516 to detect pressure levels within the left atrium 2. However, it should be understood that in some embodiments, the sensor retention structure 2505 may be disposed in the right atrium 5. In either configuration, the stabilizer 2506 may generally be positioned in contact with the atrial septum 79 on either its left atrial side or its right atrial side, depending on the orientation / configuration of the implantation device 2510.

[0140] A particular location within the atrial septal wall may be selected or determined to provide a relatively safe anchor location for the implantation device 2510 and a relatively low risk of thrombus. Furthermore, the sensor implantation device 2510 may be implanted in a desirable location to allow for future recrossing of the septal wall 79 for future interventions. Implantation of the sensor implantation device 2510 in the atrial septal wall may advantageously allow fluid communication between the left atrium 2 and the right atrium 5. With the device 2510 within the atrial septum 79, the sensor 2516 of the sensor implantation device 2510 may advantageously be configured to measure pressure in the right atrium 5, the left atrium 2, or both atria. For example, in some embodiments, the device 2510 includes multiple sensors, one sensor disposed in each of the right atrium 5 and the left atrium 2. With pressure sensor functionality for measuring pressure in both atria, the sensor implantation device 2510 may advantageously be configured to provide a sensor signal that may be used to determine a differential pressure between the atria. Determining the differential pressure can be useful in monitoring fluid accumulation in the lungs, which may be associated with congestive heart failure.

[0141] 26 illustrates a sensor implantation device 2610 having a sensor stabilizer 2606 implanted in the wall of the ventricular septum 17, according to one or more embodiments. With the sensor implantation device 2610 implanted in the ventricular septum 17, the sensor retention structure 2605 and associated sensor 2616 may advantageously be disposed within the left ventricle 3 as shown, thereby enabling the sensor device 2616 to detect pressure levels within the left ventricle 3. However, it should be understood that in some embodiments, the sensor retention structure 2605 may be disposed in the right ventricle 4. In either configuration, the stabilizer 2606 may generally be positioned in contact with the septum 17 on either its left ventricular side or its right ventricle side, depending on the orientation / configuration of the implantation device 2510.

[0142] FIG. 27 illustrates a sensor implantation device 2710 having a sensor stabilizer 2706 implanted in a wall 2701 of a cardiac chamber (e.g., left ventricle 3) according to one or more embodiments. The wall 2701 may generally be in the area of ​​the outer wall of the ventricle. While the implantation device 2710 is shown implanted in the outer left ventricular wall, it should be understood that an implantation device according to aspects of the present disclosure may be implanted in the outer wall of the right ventricle 4. The sensor implantation device 2710 may have any suitable or desirable form and / or anchoring configuration. For example, a cork-screw or other type of tissue anchor may be used to embed the proximal portion of the sensor implantation device 2710 in the tissue wall 2701. Other types of tissue anchors, such as barb-type, hook-type, and / or other anchor types, may be implemented in addition to or instead of those shown in FIG. 27 . With the sensor implantation device 2710 implanted in the outer ventricular wall 2701, the stabilizer 2706 may be deployed in a configuration that contacts the tissue wall 2701 and provides stability to the sensor retention structure 2705. While illustrated as being oriented generally vertically upward in the view of Figure 27, it should be understood that the sensor retention structure 2705 may be oriented in any suitable or desirable direction within the ventricle.

[0143] 28 shows a sensor implantation device 2810 having a sensor stabilizer 2806 implanted in the apical region 26 of the heart 1, according to one or more embodiments. The sensor implantation device 2010 may be embedded in tissue 2801 at or near the apex 26 of the heart 1. While illustrated in the apical area of ​​the left ventricle 3, it should be understood that a sensor implantation device according to aspects of the present disclosure may be implanted in the apical region within the right atrium 4.

[0144] 29 shows a sensor implantation device 2910 having a sensor stabilizer 2906 implanted in the left atrial appendage 249 of the heart 1, in accordance with one or more embodiments. For example, the sensor implantation device 2910 may incorporate a left atrial appendage occluder component 2909. With the sensor implantation device 2910 implanted as shown in FIG. 29 , the stabilizer 2906 may be oriented so as to physically contact the lateral wall of the left atrium 2.

[0145] The implantation device 2910 may be positioned to measure pressure in the left atrial appendage 249 and / or left atrium 2. Generally, measuring left atrial pressure may be useful for monitoring fluid accumulation in the lungs associated with congestive heart failure, as described in detail above. The sensor implantation device 2910 may be permanently secured to the left atrial appendage closure implantation device 2909 via or using any attachment or integration mechanism, including bonding, suture wrapping, or other attachment means, for securing the sensor 2916 and / or sensor retention structure 22905 to the implant 2909. The sensor-integrated implantation device 2910 may advantageously provide a secure location for anchoring the atrial pressure monitoring sensor 2916. The sensor 2916 may advantageously be positioned and / or configured to present a relatively low risk of thrombus formation in the left atrium.

[0146] A sensor implantation device according to one or more embodiments of the present disclosure may be advanced to the left atrium using any suitable or desired procedure. For example, while access to the left atrium is illustrated and described in connection with certain embodiments as via the right atrium and / or inferior vena cava, such as through a transfemoral or other transcatheter procedure, other access routes / methods may be implemented in accordance with embodiments of the present disclosure, as described / shown in connection with FIG. 30 . For example, FIG. 30 illustrates various access routes by which access to the left ventricle may be achieved, including transseptal access 401 a, 401 b, which may be made from the right atrium 5, through the inferior vena cava 29 or superior vena cava 19, through the septal wall (not shown), and into the left atrium 2, as shown, respectively. For transaortic access 402, a delivery catheter may pass through the descending aorta, the aortic arch 12, the ascending aorta, and the aortic valve 7, and through the mitral valve 6 into the left atrium 2. For transapical access 403, access may be through the apex of the heart into the left ventricle 3 and directly through the mitral valve 6 into the left atrium 2. Other access routes than those shown in FIG. 30 are also possible.

[0147] Additional Embodiments Depending on the embodiment, certain acts, events, or functions of any of the processes described herein may be performed in a different order, added, combined, or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0148] Certain standard location anatomical terms are used herein with respect to preferred embodiments. While certain spatially relative terms such as "outer," "inner," "upper," "lower," "lower," "above," "vertical," "horizontal," "top," "bottom," and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it is understood that these terms are used herein for ease of description to describe the positional relationships between elements / structures illustrated in the drawings. Spatially relative terms are intended to encompass different orientations of elements / structures during use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or to the side of such other element / structure, and vice versa, with respect to the intended patient or alternative orientations of the element / structure.

[0149] In particular, conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, unless specifically stated otherwise or understood otherwise within the context of use, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without authorial input or prompting. Terms such as "comprise," "include," "have," and the like are synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (and not its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, conjunctive language such as "at least one of X, Y, and Z" is understood with context as used to generally convey that an item, term, element, etc., can be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z are each present. As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0150] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements of structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish the element from other elements having a similar or identical name (other than the use of sequential terms). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0151] Although a particular order of operations or steps is illustrated and / or described with respect to the various methods and processes disclosed herein, it should be understood that the various steps and operations shown and described may be performed in any suitable or desirable temporal order. Further, any of the operations or steps illustrated and / or described may be omitted from any given method or process, and the illustrated / described methods and processes may include additional operations or steps not explicitly illustrated or described.

[0152] In the description of the above embodiments, various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Accordingly, it is intended that the scope of the invention(s) herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

Claims

1. a sensor holding structure associated with the implanted structure, a sensor support arm configured to hold a sensor device; a stabilizer structure associated with the sensor support arm and configured to project away from the sensor support arm to provide a stabilizing support for the sensor support arm, the sensor support arm includes a proximal end associated with the implanted structure, a distal end opposite the proximal end, and a body portion located between the proximal end and the distal end; The sensor retention structure, wherein the stabilizer structure is configured to be associated with the body portion and to project away from the body portion.

2. the ballast structure: With long, slender legs, The end portion and The sensor holding structure of claim 1 , further comprising: a base portion integral with the sensor support arm.

3. The sensor holding structure of claim 2 , wherein the stabilizer structure is configured to bend at the base portion to cause the end portion of the stabilizer structure to project away from the distal end of the sensor support arm.

4. The sensor holding structure of claim 2 or 3, wherein the stabilizer structure is configured to bend at the base portion to cause the end portion of the stabilizer structure to project away from the proximal end of the sensor support arm.

5. The sensor holding structure of any one of claims 2 to 4, wherein the end portion of the ballast structure has an atraumatic coating disposed on at least a portion thereof.

6. The sensor holding structure of any one of claims 2 to 5, wherein the end portion of the stabilizer structure comprises two legs configured to flex in opposite directions.

7. A sensor holding structure according to any one of claims 2 to 6, wherein the end portion comprises a foot portion having a width at one or more portions thereof that is greater than a width of the elongated leg portion.

8. A sensor holding structure according to any one of claims 2 to 7, wherein the end portion comprises a foot portion configured to be deflected at an angle relative to the elongated leg portion to provide a tissue contacting surface.

9. The sensor holding structure of any preceding claim, wherein the stabilizer structure comprises a first leg and a second leg.

10. The sensor retention structure of claim 9 , wherein the first leg and the second leg are oriented relatively parallel.

11. 11. The sensor holding structure of claim 9 or 10, wherein the first leg and the second leg are angled relative to each other.

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