Sensor ballast

Abstract

The monitoring of physiological parameters is facilitated by using a stabilization mechanism that facilitates the stabilization of specific sensor devices and implanted sensor devices. [Solution] The sensor holding structure includes a sensor support arm configured to hold a 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 to 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 on August 3, 2020, the entire content of which is incorporated herein by reference in its entirety.

Background Art

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

[0003] Description of related art Certain physiological parameters associated with 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. Thus, information regarding physiological conditions such as pressure in one or more heart chambers can be beneficial.

Summary of the Invention

[0004] One or more methods and / or devices for facilitating the monitoring of physiological parameters are described herein using particular sensor devices and a stabilizer mechanism that facilitates the stabilization of implanted sensor devices.

[0005] In some embodiments, the present disclosure relates to a sensor - holding structure comprising a sensor - supporting arm configured to hold a sensor device, and a stabilizer structure associated with the sensor - supporting arm and configured to project away from the sensor - supporting arm to provide stabilization support for the sensor - supporting arm.

[0006] The ballast structure may include an elongated leg portion, an end portion, and a base portion integrated with a sensor support arm. The ballast structure may be configured to bend at the base portion so that the end portion of the ballast structure protrudes away from the distal end of the sensor support arm. In some embodiments, the ballast structure may be configured to bend at the base portion so that the end portion of the ballast structure protrudes away from the proximal end of the sensor support arm. The end portion of the ballast structure has a non-traumatic coating disposed on at least a portion thereof. In some embodiments, the end portion of the ballast structure comprises two legs configured to bend in opposite directions. The end portion may comprise a leg portion having a width greater than the width of the elongated leg portion in one or more of its portions. In some embodiments, the end portion comprises a leg portion configured to deflect at a certain angle relative to the elongated leg portion to provide a tissue contact surface.

[0007] The ballast structure may comprise a first leg and a second leg. For example, the first leg and the second leg may be oriented in parallel relative to each other. 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 for deploying a sensor implantation device. The method includes implanting an implantation structure in a tissue wall, wherein the implantation structure includes a sensor support member configured to hold a sensor device and to project a distal portion of a stabilizer configuration associated with the sensor support member away from the sensor support member and toward the tissue wall.

[0009] The method may further include stabilizing the sensor support member with respect to the angle of the sensor support member with respect to the surface of the tissue wall. In some embodiments, the method further includes deflecting the end portion of the stabilizer form to provide a tissue contact structure. In some embodiments, the stabilizer form includes a shape memory material, and the distal portion of the stabilizer form protrudes, which involves unfolding the implant structure from the delivery system, and the shape memory material allows the stabilizer form to bend at its base, thereby deflecting the stabilizer form away from the sensor support member.

[0010] In some embodiments, the present disclosure relates to a method for retracting a sensor stabilizer. The method includes providing a sensor implantation device including a sensor support structure and a stabilizer member including a suture engagement feature; engaging the suture engagement feature with a suture; implanting the sensor implantation device into a tissue wall; at least partially unfolding 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 a suture to thereby pull the stabilizer member to align with the sensor support structure.

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

[0012] For the purpose of summarizing this disclosure, specific aspects, advantages, and novel features are described. It should be understood that not all such advantages can necessarily be achieved according to any particular embodiment. Accordingly, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other advantages that can be taught or suggested herein. [Brief explanation of the drawing]

[0013] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the invention. In addition, various features of different disclosed embodiments may be combined to form additional embodiments which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondences between reference elements.

[0014] [Figure 1A] An illustrative cross-sectional view of a human heart is shown. [Figure 1B] This shows a cross-sectional view of the upper atrial region of a human heart. [Figure 2] Exemplary pressure waveforms associated with various cardiac chambers and cardiac blood vessels are illustrated according to one or more embodiments. [Figure 3] An example graph showing the left atrial pressure range is provided. [Figure 4] This is a block diagram representing a portable device according to one or more embodiments. [Figure 5] This document describes a system for monitoring physiological parameters according to one or more embodiments. [Figure 6] Exemplary shunt-type anchor structures according to one or more embodiments are illustrated. [Figure 7A] One or more embodiments of a sensor implantation device having a sensor support column are illustrated. [Figure 7B] One or more embodiments of a sensor implantation device having a sensor support column are illustrated. [Figure 8] The image shows a perspective view of an implantable device, including a sensor holding structure in a catheter delivery configuration (e.g., at least partially folded), according to one or more embodiments. [Figure 9] A side view of a medical implantable device, including a sensor holding structure and a sensor stabilization feature section, according to one or more embodiments, is shown. [Figure 10] The image shows a side view of a medical implantation device, including a sensor holding structure and a sensor stabilizer feature section, implanted in a tissue wall, according to one or more embodiments. [Figure 11A] Perspective views illustrating one or more embodiments of a sensor holding structure configured to bend away from the arm of a medical implant device are shown. [Figure 11B] Side views illustrating one or more embodiments of a sensor holding structure configured to bend away from the arm of a medical implant device are shown. [Figure 12A]Exemplify a perspective view of a medical implant device including a sensor holding arm structure having a stabilizer according to one or more embodiments. [Figure 12B] Exemplify a side view of a medical implant device including a sensor holding arm structure having a stabilizer according to one or more embodiments. [Figure 13A] Show a developed side view of a sensor holding structure having a stabilizer protruding from top to bottom according to one or more embodiments. [Figure 13B] Show an undeveloped top view of a sensor holding structure having a stabilizer protruding from top to bottom according to one or more embodiments. [Figure 14AB] Show a developed side view of a sensor holding structure having a stabilizer protruding from bottom to top according to one or more embodiments. [Figure 14B] Show an undeveloped top view of a sensor holding structure having a stabilizer protruding from bottom to top according to one or more embodiments. [Figure 15A] Show a perspective view of a sensor holding structure having a stabilizer according to one or more embodiments. [Figure 15B] Show a side view of a sensor holding structure having a stabilizer according to one or more embodiments. [Figure 15C] Show an end view of a sensor holding structure having a stabilizer according to one or more embodiments. [Figure 15D] Show an end view of a sensor holding structure having a distal stopper feature according to one or more embodiments. [Figure 16A] Show a perspective developed view of a sensor holding structure having a plurality of stabilizers according to one or more embodiments. [Figure 16B] Show an undeveloped top view of a sensor holding structure having a plurality of stabilizers according to one or more embodiments. [Figure 17A] Show a perspective developed view of a sensor holding structure having a plurality of stabilizers according to one or more embodiments. [Figure 17B] Show an undeveloped top view of a sensor holding structure having a plurality of stabilizers according to one or more embodiments. [Figure 18A] Show a side developed view of a sensor holding structure including a sensor stabilizer according to one or more embodiments. [Figure 18B] The image shows a non-deployed top view of a sensor holding structure including a sensor stabilizer according to one or more embodiments. [Figure 19A] A side view of a sensor holding structure including a sensor ballast, according to one or more embodiments, is shown. [Figure 19B] The image shows a non-deployed top view of a sensor holding structure including a sensor stabilizer according to one or more embodiments. [Figure 20-1] This flowchart illustrates a process for deploying a sensor ballast according to one or more embodiments. [Figure 20-2] This is a flowchart illustrating a process for retracting a sensor ballast according to one or more embodiments. [Figure 21-1] Images of cardiac anatomical structures and specific devices / systems corresponding to the processes and associated operations in Figure 20-1 are provided for one or more embodiments. [Figure 21-2] Images of cardiac anatomical structures and specific devices / systems corresponding to the processes and associated operations in Figure 20-2 are provided for one or more embodiments. [Figure 22] One or more embodiments of a sensor implantation device implanted in the wall separating the left atrium from the coronary sinus are shown. [Figure 23A] A diagram of cardiac anatomical structures showing catheter access routes to the wall separating the left atrium from the coronary sinus is shown in one or more embodiments. [Figure 23B] A diagram of cardiac anatomical structures showing catheter access routes to the wall separating the left atrium from the coronary sinus is shown in one or more embodiments. [Figure 24] One or more embodiments of a sensor implantation device are shown, having a sensor stabilizer implanted in the wall separating the left atrium from the coronary sinus. [Figure 25] One or more embodiments of a sensor implantation device having a sensor stabilizer implanted in the atrial septum are shown. [Figure 26] One or more embodiments of a sensor implantation device having a sensor stabilizer implanted in the interventricular septum are shown. [Figure 27] One or more embodiments of a sensor implantation device having a sensor stabilizer implanted in the ventricular wall are shown. [Figure 28] One or more embodiments of a sensor implantation device having a sensor stabilizer implanted in the apical region of the heart are shown. [Figure 29] One or more embodiments of a sensor implantation device having a sensor stabilizer implanted in the left atrial appendage of the heart are shown. [Figure 30] Various access routes are illustrated, which may be achieved according to one or more embodiments of cardiac anatomical structures. [Modes for carrying out the invention]

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

[0016] While certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred sequence, and not necessarily limited to any specific disclosed sequence. Various operations may be described sequentially as a plurality of distinct operations in a manner that may be useful for understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other embodiments or advantages that may similarly be taught or suggested herein.

[0017] The following includes a general description of the anatomical structure of the human heart, relating to the features and embodiments of the specific inventions disclosed herein and included to provide context for the specific aspects of this disclosure. In humans and other vertebrates, the heart generally comprises a muscular organ having four pump chambers, and the flow of blood between the pump chambers is at least partially controlled by various heart valves, namely the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. The valves may be configured to at least partially control the flow of blood to the respective regions of the heart and / or associated blood vessels (e.g., lungs, aorta, etc.) in response to the pressure gradients present during the different stages of the cardiac cycle (e.g., relaxation and contraction).

[0018] Figures 1A and 1B illustrate vertical and horizontal cross-sectional views of an exemplary heart 1 having various features / anatomical structures relevant to a particular aspect of the disclosure of the present invention, respectively. The heart 1 comprises four chambers, namely the left ventricle 3, the left atrium 2, the right ventricle 4, and the right atrium 5. Muscular walls called septa separate the left chambers from the right chambers. In particular, the interatrial septal portion 79 (referred herein to as the “atrial septum”, “interatrial septum”, or “septum”) separates the left atrium 2 from the right atrium 5, while the interventricular septal portion 17 (referred herein to as the “ventricular septum”, “interventricular septum”, or “septum”) separates the left ventricle 3 from the right ventricle 4. The lower end 19 of the heart 1 is called the apex and is generally located on the midclavicular line, within the fifth intercostal space. The apex 19 can be considered part of the larger apical region 39 identified in the drawing.

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

[0020] Pumping of blood from the left ventricle 3 is achieved by compression and twisting or torsional motions. Compression occurs between the lateral wall 14 and septum 17 of the left ventricle 3. Twisting motion is a result of myocardial fibers extending in a circular or spiral direction around the heart. When these fibers contract, they generate a gradient of angular displacement of the myocardium from the apex 19 to the base 15 around the long axis of the heart. The resulting force vector extends at an angle of approximately 30–60 degrees relative to the blood flow through the aortic valve 7. When viewed from the apex 19, cardiac contraction appears as a counterclockwise rotation of the apex 19 relative to the base 15. In relation to the respective filling volumes of the left atrium 2 and left ventricle 3, cardiac contraction can result in relatively high fluid pressure on the left side of the heart, at least during certain phases of the cardiac cycle, the consequences of which will be discussed in detail below.

[0021] The four valves of the heart assist in 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 dilation (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 so that blood can be pumped from the right ventricle 4 towards the lungs and to 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 so that blood from the left atrium 2 can flow into the left ventricle 3 and to close during diastole to prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to leave the left ventricle 3 and enter the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0022] The 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 leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. The papillary muscles may generally include, for example, finger-like projections from the ventricular wall. 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 Figure 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 channel for blood returning to the right atrium 5. The wall of muscle 18 separates the coronary sinus 16 from the left atrium. The coronary sinus 16 terminates at the coronary orifice 14, through which blood enters the right atrium.

[0023] The main roles of the left atrium 2 are to act as a retaining chamber for blood returning from the lungs (not shown) and as a pump for transporting blood to other areas of the heart. The left atrium 2 receives oxygenated blood from the lungs via the pulmonary veins 12. The oxygenated blood collected from the pulmonary veins 12 in 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. The 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 surrounding the lungs. There, fresh oxygen enters the bloodstream, and as shown, the blood moves to the left side of the heart via the vascular network of pulmonary veins, finally terminating in the left atrium 2. The pulmonary vein orifice 12 is generally located in or near the posterior left atrial wall of the left atrium 2.

[0024] Cardiac pressure monitoring for the prevention and treatment of heart failure As referenced above, certain physiological conditions or parameters associated with cardiac anatomical structures can affect a patient's health. For example, congestive heart failure is a condition associated with the relatively slow movement of blood through the heart and / or body, which increases fluid pressure in one or more cardiac chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. Various cardiac chambers may respond to the pressure increase by stretching to hold more blood and pump it through the body, or by becoming relatively stiff and / or thickened. The heart walls may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the heart's inefficiency by retaining fluid in the body. Accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs causes congestion in the body, which is called congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and death, and therefore, the treatment and / or prevention of congestive heart failure is a matter of great concern in medicine.

[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 described above, pressure buildup in one or more cardiac 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 development of congestive heart failure. Treatment or approaches without direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring body weight, chest impedance, right heart catheterization, etc.

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

[0027] Additional solutions may be implemented to derive or infer left atrial pressure. For example, the E / A ratio, a marker of left ventricular function of the heart, which represents the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow in end diastole (A wave) caused by abdominal contraction, may be used as an alternative to measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques, and generally, an abnormal E / A ratio may suggest that the left ventricle is unable to adequately fill with blood during the interval between contractions, which can lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide an absolute pressure measurement.

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

[0029] This disclosure provides systems, devices, and methods for inducing the administration of drugs at least partially related to the treatment of congestive heart failure by directly monitoring pressure in the left atrium or in other chambers or vessels where pressure measurements indicate left atrial pressure, in order to reduce readmission, morbidity, and / or improve the health outlook of patients at risk of heart failure.

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

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

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

[0033] Left atrial pressure can generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlations may weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate well with left ventricular end-diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, lung retention, which affects approximately 35–83% of heart failure patients, can affect the reliability of pulmonary artery pressure measurement for estimating left-sided filling pressure. Therefore, as represented by waveform 326, pulmonary artery pressure measurement alone may be an inadequate or inaccurate indicator of left ventricular end-diastolic pressure, especially in patients with comorbidities such as lung disease and / or thromboembolism. Left atrial pressure can further correlate, at least partially, with the presence and / or degree of mitral regurgitation.

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

[0035] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide a mechanism for inducing the administration of medications to treat and / or prevent congestive heart failure. Such treatments may, advantageously, reduce readmission and morbidity, and may also provide other benefits. Implanted pressure sensors according to embodiments of the present disclosure may be used to predict heart failure at least two weeks before the onset of symptoms or markers of heart failure (e.g., dyspnea). When a prediction of heart failure is recognized using the cardiac pressure sensor embodiments of the present disclosure, certain precautionary measures may be implemented, including pharmacological interventions such as modifications to the patient's medication regimen, which may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium may, advantageously, provide an accurate indicator of pressure buildup that may lead to heart failure or other complications. For example, a trend of elevated atrial pressure may be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other therapies may be augmented to cause pressure reduction and prevent or reduce further complications.

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

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

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

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

[0040] The transducer 412 may comprise any type of sensor means or mechanism. For example, the transducer 412 may be a force collector type pressure sensor. In some embodiments, the transducer 412 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied over an area / surface thereof. The transducer 412 may be associated with the housing 46 such that at least a portion of it is housed within or attached to the housing 46. The term “associated with” is used herein in accordance with its broad and ordinary meaning. With respect to sensor devices / components “associated with” a shunt or other implantation structure, such term may refer to a sensor device or component that is physically coupled, attached, connected to, or integrated with the implantation 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, at least partially embedded within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

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

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

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

[0044] Sensor transplantation system Embodiments of the present disclosure provide systems, devices, and methods for determining and / or monitoring fluid pressure and / or other physiological parameters or conditions of the left atrium using one or more implantable sensor devices, such as permanently implanted sensor devices. By directly placing a permanent sensor monitoring device 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 sensor implantation devices including specific ballast features may be implemented in conjunction with a pressure monitoring system. Figure 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 Figure 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 specific ballast features.

[0046] Patient 515 may have a pressure sensor implantation device 510 implanted in, for example, the patient's heart (not shown) or associated physiological function. For example, the sensor implantation device 510 may be at least partially implanted in 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 MEMS devices, such as microelectromechanical systems (MEMS) pressure sensors.

[0047] In certain embodiments, the monitoring system 500 may comprise at least two subsystems, including a portable internal subsystem or device 510 comprising a sensor transducer 512 (e.g., a MEMS pressure sensor) and a control circuit 514 comprising one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 518 (e.g., antenna coils). The monitoring system 500 may further comprise an external (e.g., non-portable) subsystem comprising an external reader 550 (e.g., a coil) which may include a wireless transceiver electrically and / or communicatively coupled to a 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 between them. The sensor implantation device 510 can be any type of implantation device.

[0048] The term “control circuit” is used herein in accordance with its broad and ordinary meaning and may include processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including coming or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any group of any devices that operate signals (analog and / or digital) based on a hard coating of circuits and / or operation instructions. Control circuits as referred herein may further include one or more storage devices that can be embodied in a single memory device, a plurality of memory devices, and / or embedded circuits of a device. Such data storage units may include read-only memory, random-access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. In embodiments in which the control circuit includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, it should be noted that data storage devices / registers for storing any associated operation instructions may be incorporated within or outside the circuit including the state machine, analog circuits, digital circuits, and / or logic circuits.

[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 comprise one or more arm structures for physically holding / fixing the implantation structure 520 to the tissue wall. While certain components are illustrated in Figure 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 may include one or more sensor transducers 512 configured to provide responses indicating one or more physiological parameters of a 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 signals related to physiological parameters or states associated with the sensor implantation 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 can 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 includes a diaphragm, membrane, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied over an area / surface thereof. The transducer 512 may be associated with the housing 516 such that at least a portion of it is housed within or attached to the housing 516.

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

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

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

[0054] In some embodiments, the transducer 512 is electrically and / or communically 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 regulating 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 monitoring system 550. To carry out such wireless data transmission, the sensor implantation device 510 may include a signal processing circuit and a radio frequency (RF) transmitting circuit, such as an antenna 518. The antenna 518 may include an internal antenna coil or other structure implanted within the patient. The control circuit 514 may comprise any type of transducer circuit configured to transmit an electromagnetic signal, which may be radiated by the antenna 518, which may include one or more conductive wires, coils, plates, etc. The control circuit 514 of the sensor implantation device 510 may include, for example, one or more chips or dies configured to perform some amount of processing on the signal generated and / or transmitted using the device 510. However, due to size, cost, and / or other constraints, the sensor implantation device 510 may not include independent processing capabilities in some embodiments.

[0056] The radio signal generated by the sensor implantation device 510 may be received by a local external monitoring device or subsystem 550, which may include a transceiver module 553 configured to receive radio signal transmissions from the sensor implantation device 510, which is at least partially located within the patient 515. The external local monitor 550 may receive the radio signal transmissions and / or provide radio power using an external antenna 555, such as a wand device. The transceiver 553 may include a radio frequency (RF) front-end circuit configured to receive and amplify the signal from the sensor implantation device 510, such a circuit may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, and the like. The transceiver 553 may be further configured to transmit the signal to a remote monitoring subsystem or device 560 via a network 575. The RF circuit of the transceiver 553 may further include one or more of the following for processing / handling signals transmitted over the network 575 and / or for receiving signals from the sensor implantation device 510: a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc. In certain embodiments, the local monitor 550 includes a control circuit 551 for performing processing of signals received from the sensor implantation device 510. The local monitor 550 may be configured to communicate with the network 575 according to a known network protocol such as Ethernet or Wi-Fi. In certain 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 implantation 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. The control circuit 514 may utilize the data storage to store sensed data collected over a period of time, and the stored data may be periodically transmitted to the local monitor 550 or another external subsystem. In certain embodiments, the sensor implantation device 510 does not include any data storage. The control circuit 514 is configured to facilitate the wireless transmission of data generated by the sensor transducer 512, or other data associated therewith. The control circuit 514 may be further configured to receive input from the local monitor 550 or from one or more external subsystems, such as from a remote monitor 560 via the network 575. For example, the sensor implantation device 510 may be configured to receive signals that at least partially control the operation of the sensor implantation device 510, such as by activating / deactivating one or more components or sensors, or by otherwise affecting the operation or performance of the sensor implantation device 510.

[0058] One or more components of the sensor implantation device 510 may be powered by one or more power supplies 540. Due to concerns about size, cost, and / or electrical complexity, it may be desirable that the power supplies 540 be relatively minimal in nature. For example, high-power drive voltages and / or currents within the sensor implantation device 510 may adversely affect or interfere with the operation of the heart or other anatomical structures associated with the implantation device. In certain embodiments, the power supplies 540 are at least partially passive in nature, and as a result, power may be received wirelessly from an external source by the passive circuitry of the sensor implantation 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, a local monitor 550 may act as an initiator that actively generates an RF field that can power the sensor implantation device 510, thereby allowing the power circuitry of the implantation device to adopt a relatively simple form factor. In certain embodiments, the power supplies 540 may be configured to obtain energy from an environmental source such as fluid flow, motion, or pressure. Additionally or alternatively, the power supply 540 may include a battery, which may be advantageously configured to provide sufficient power as needed over the relevant monitoring period.

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

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

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

[0062] In certain embodiments, the antenna 555 of the external monitoring system 550 comprises an external coil antenna matched and / or tuned to inductively pair with the antenna 518 of the internal implant 510. In some embodiments, the sensor implant device 510 is configured to receive wireless ultrasonic power charging and / or data communication between it and 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 circuit 514, power supply 540, and / or antenna 518 is at least partially disposed or housed within a sensor housing 516, which may comprise any type of material and, advantageously, may be at least partially sealed. For example, in some embodiments, the housing 516 may include glass or other rigid material that can provide mechanical stability and / or protection to the components housed therein. In some embodiments, the housing 516 is at least partially flexible. For example, the housing may include a polymer or other flexible structure / material that can advantageously allow the sensor 510 to be bent, flexed, or folded to enable transport through a catheter or other percutaneous delivery means.

[0064] The sensor housing 516 may be fixed to a specific sensor holding structure 525 that is 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 a tissue wall using one or more sensor stabilizer features 526 that are coupled to and / or integrated with the sensor holding structure 525. Thus, the stabilizer 526 may play a role in stabilizing the sensor housing 516 when implanted in the patient 515. The sensor stabilizer 526 may be similar in certain respects to one or more embodiments disclosed herein with respect to stabilizer features and structure.

[0065] The sensor implantation device 510 can be implanted at any location 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 can advantageously provide a desirable location for measuring and / or monitoring left atrial pressure, blood viscosity, temperature, and / or other cardiac crammers. Sensor implantation devices according to one or more embodiments of the present disclosure may be implanted using a transcatheter procedure or any other percutaneous procedure. Alternatively, sensor implantation devices according to embodiments of the present disclosure may be placed during open-heart surgery (e.g., sternotomy), minor sternotomy, and / or other surgical procedures.

[0066] Heart transplant devices and structures Figure 6 illustrates exemplary shunt structures 150 according to one or more embodiments. The shunt structure 150 may represent embodiments of a cardiac implantation device that can be integrated with a pressure sensor function 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 substantially circular or elliptical opening / barrel. The channel / barrel 166 may be configured to hold the sides of the puncture opening to a tissue wall, thereby forming a blood flow pathway between cardiac chambers or cardiac blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be implanted in a wall separating the coronary sinus from the left atrium. The central flow channel / barrel 166 may be partially formed by a pair of side walls 170a, 170b defined by a substantially parallelogram arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, the substantially entire shunt 150 is formed by a hyperelastic support configured to be compressed, housed in a catheter (not shown), and then expanded to return to a relaxed shape as shown in Figure 6.

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

[0068] The illustrated shunt 150 includes supports defining a tubular or circular grid of open cells forming a central flow channel / barrel 166, although in some embodiments, the structures constituting the channel / barrel 166 form a substantially continuous wall surface over at least a portion thereof. In the illustrated embodiments, the inclination of the shunt structure 150 can facilitate the folding of the shunt into a delivery catheter (not shown) and the expansion of the flanges / arms 152, 154 on both sides of the target tissue wall. The central flow channel 166 may remain essentially unchanged between the folded and expanded states of the shunt 150, whereas the flanges / arms 152, 154 can transition between alignment and misalignment with the angled flow channel.

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

[0070] In some embodiments, the distal and proximal flanges / arms 152, 154, respectively, curve outward from the end walls 172a, 172b and are configured to point substantially radially away from the central flow channel 166 in an expanded configuration. The expanded flanges / arms may serve to anchor the shunt 150 to the target tissue wall. Additional embodiments and features of shunt structures that can be integrated with sensor devices / functions 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 in its entirety by reference. While certain embodiments are disclosed herein in the context of shunt structures similar to those shown in Figure 6 and described above, it should be understood that shunt structures or other implantation devices integrated with pressure sensor functions according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured for any purpose or function, whether shunt or otherwise.

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

[0072] The sensor 100 includes a sensor element 102, such as a pressure sensor transducer. With respect to the arm member 95 of the shunt structure 99, the transducer element 102 (e.g., a pressure transducer) may be oriented / positioned at the distal 107 or proximal 105 end or region of the sensor 100. For example, the embodiment illustrated in Figure 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 a control circuit 109 configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna 108 includes one or more conductive coils that can facilitate inductive power feeding and / or data transmission. In some embodiments, the coils 108 may be wound around a magnetic (e.g., ferrite) and / or air core 103.

[0074] The sensor 100 may be advantageously biocompatible. For example, the sensor 100 may comprise a biocompatible housing 106, such as a cylindrical or other shaped housing containing glass or other biocompatible material. The circuit 109, sensor element 102, and / or antenna 108 may be at least partially housed within the housing 106, which is sealed to prevent such components from being exposed to the external environment. However, at least a portion of the sensor element 102, such as a sensor diaphragm / membrane or other components, may be at least partially exposed to the external environment in some embodiments to allow for the implementation of pressure reading or other parameter sensing. The housing 106 may include at least partially rigid cylindrical or tubular forms, such as a glass cylinder form, and the sensing probe 102 is disposed at one or both ends 105, 107 of the sensor assembly 106. In some embodiments, the sensor assembly is about 3 mm in diameter and / or about 20 mm 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 ​​the patient's body. For example, the sensor 100 may receive power wirelessly from an external system and / or communicate data or waveforms sensed by 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 preferred 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 mounting means. In some embodiments, as described in detail below, the sensor assembly 106 may be housed in a pouch or other receptacle attached to the shunt structure 99.

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

[0077] The control circuit 109 may include one or more electronically specific integrated circuit (ASIC) chips or dies that can be programmed and / or customized or configured to perform the monitoring functions described herein and / or to facilitate 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 metals. The antenna 108 may be advantageously configured with a coil geometric shape that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some embodiments, the sensor implantation device 90 may be delivered to a target implantation site using a delivery catheter (not shown), the delivery catheter including a cavity or channel configured to adapt to the advancement of the sensor assembly 106 through it. The sensor support column / structure 95 may be deflected by some amount θ with respect to the axis 101 of the tissue wall through which the sensor implantation device 90 is configured to be implanted.

[0078] In some embodiments, the sensor 100 is pre-mounted to the sensor holding structure 95 and / or integrated with it before transplantation. For example, in some embodiments, the sensor holding structure 95 forms at least a portion of the housing of the sensor 100, thereby the sensor holding structure 95 and at least a portion of the housing of the sensor 100 are integrally formed.

[0079] In some embodiments, the angle or position of the sensor retaining structure 95 and / or sensor 100 with respect 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, if the shunt structure 99 engages 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 within a chamber cavity (e.g., an atrium). In some embodiments, the sensor retaining structure 95 is configured, or may be configured, to be oriented substantially perpendicular or 90° with respect to the axis / plane 101, such that the sensor 100 is substantially perpendicular to the longitudinal axis / plane of the shunt. Such a configuration may, advantageously, allow the sensor element 102 to be positioned at a desired distance away from the shunted flow flowing through the flow path axis 94.

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

[0081] An embodiment in Figure 7A shows a strut / backbone type sensor retaining structure 95, which may be associated with one or more strap-type retaining features 98 configured to hold the sensor device 100 on a strut 95. Figure 7B shows a sensor color device 790 including a shunt structure 799 and a sensor retaining structure 65, the sensor retaining structure 65 having a specific curved feature associated with features of a rear support 64 and a side support 68, such a curved feature configured to embrace / hold a sensor cylinder 106 on it. The sensor retaining structure 65 further includes one or more retaining fingers 63 for holding the sensor cylinder 106 against the structure 65. The sensor retaining structure 65 may be attached to or integrated with the arm 793 of the sensor implantation device 799. The sensor retaining 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 and from the antenna 108. In some embodiments, an additional window 67 is also formed within the structure 65. Further details of the sensor holding structure, as shown in Figure 7B, are provided below.

[0082] Figure 8 shows a perspective view of the sensor implantation device 890 in at least a partially folded configuration for delivery through a delivery sheath or catheter (not shown). The shunt device 890 includes a sensor retaining structure / arm 895 attached to or associated with the shunt device arm 893. After deployment of the sensor implantation device 890, the arms of the graft can extend radially outward to secure the implantation device 890 to the target tissue wall.

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

[0084] Embodiments of the present disclosure may include specific sensor stabilization features and / or systems and processes associated therewith. With respect to any embodiment of the present disclosure, the sensor retaining column / structure and / or associated stabilizer may be located in or near the atrial septum or the wall separating the left atrium from the coronary sinus, as described in detail herein. Stabilizer features according to embodiments of the present disclosure may be attached to and / or integrated with the sensor retaining structure, such as being integrated with the frame of a stent device or other implantable device.

[0085] In some embodiments, the disclosure relates to a sensor holding structure, which associates with one or more stand-type ballast components / features. Such ballast components advantageously serve to fix the sensor holding structure / holder and / or minimize undesirable movement or vibration. In some embodiments, a sensor holding structure having an integrated / associated ballast 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 to or fixed to a portion of a sensor holding structure 25. The sensor implantation device 20 includes a sensor stabilizer feature 26 configured to stabilize the sensor 100 and / or the sensor holding structure 25 when implanted in a patient. Figure 10 shows a side view of a sensor implantation device 20, including the sensor holding structure 25 and the sensor stabilizer feature 26, implanted in a tissue wall 18, according to one or more embodiments.

[0087] The sensor holding structure / arm 25 may be integral with the arm 22 of the implantation structure 20. In some embodiments, the sensor holding structure 25 is an extension of the arm member 22 or otherwise associated therewith. The sensor 100 can be attached to the holding / support structure 25 by any suitable or desirable mounting means, including adhesive mounting or mechanical engagement. For example, the sensor holding structure 25 may include or be associated with one or more holding features 23, which may include one or more clamps, straps, ties, sutures, collars, clips, or tabs. Such holding features 23 can accommodate or hold the sensor 100, or a portion thereof, in the circumferential direction. In some embodiments, the sensor 100 can be attached to the sensor holding structure 25 by clipping, locking, or otherwise engaging the sensor 100 with the sensor holding structure 25 by applying mechanical force, sliding the sensor 100 through the holding mechanism 23, or by pressing or applying other mechanical force to it.

[0088] In some embodiments, the sensor holding structure 25 includes one or more distal and / or proximal stopper features 72, 74. The stopper features 72, 74 may include one or more tabs that can be configured to protrude or extend onto one or more sides of the sensor holding 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 hard material.

[0089] In some embodiments, various components of the sensor implantation device, sensor holding structure, and / or stabilization structure, or parts thereof, may be treated with an anticoagulant and / or coated with a specific material designed to reduce the risk of blood clotting associated with the implantation of such a device. 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 holding structure 25 shown in Figures 9 and 10 includes a radially projecting ballast 26, which is configured or may be configured to project away from the body 28 of the sensor holding structure 25 to provide contact with the tissue wall 18. For example, Figure 10 shows a sensor implantation device 20 implanted in the tissue wall 18, and the ballast component / feature 26 is shown in an unfolded configuration. In the unfolded configuration, the ballast 26 projects away from the structure 25 at an angle θ1 with respect to the proximal side of the ballast 26 and at an angle θ2 with respect to the distal side of the ballast 26. Generally, the angles θ1 and θ2 can be any value between approximately 15° and 165°, and may total 180°.

[0091] The sensor holding structure 25 may have any preferred or desirable form, shape, and / or configuration. It should be understood that the exemplary embodiments shown in Figures 9 and 10 are provided only as examples, and the stabilization device / feature may be associated with a sensor holding structure having any preferred or desirable size or configuration. An exemplary sensor holding structure may have the stabilization device / feature of the present disclosure associated therewith, disclosed in U.S. Provisional Patent Application No. 62 / 926,829, entitled "SENSOR INTEGRATION IN CARDIAC IMPLANT DEVICES," 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 protrude / extend from the main body 28 of the sensor holding structure 25 and serve to hold / maintain the sensor device 100 in the sensor holding structure 25. That is, the fingers 23 can prevent or inhibit the sensor cylinder 106 from being pulled away from the main body 28 of the sensor holding structure 25 in a radial direction with respect to the axis of the sensor holding structure 25.

[0093] In some embodiments, the ballast 26 may be coupled to and / or integrated with a rear portion / segment 24 of the sensor holding structure 25. For example, the rear segment 24 may extend to the circumferential portion of the sensor cylinder 106 and provide support therein. In some embodiments, the ballast 26 may be configured to bend, for example, by the shape memory properties of the ballast 26 and / or through its manual bending / manipulation using surgical instruments. The sensor holding structure 25 may include one or more window features 27, 29 that can advantageously reduce the bulk of the implanted device and / or reduce interference with the transmitting coil 108 of the sensor device 100, which may enable wireless data transmission in some embodiments.

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

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

[0096] Figures 11A and 11B illustrate perspective and side views, respectively, of a sensor retaining structure 55 configured to bend away from the arm 52 of a medical implant device according to one or more embodiments. The sensor retaining structure 55 may be coupled to one or more outer (or inner) arms 51 provided in addition to the tissue contact arm 52 of the associated implant device. The sensor retaining 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, sensor holding structures according to embodiments of this disclosure may be integrated with and / or associated with the distal portion of an arm member of an implantation device, such as a shunt implantation device. By positioning such a sensor holding structure at the distal end of an implantation support arm, the implantation support arm may be configured to provide stabilization to the implantation device. In some embodiments, the implantation device may utilize the sensor holding structure instead of one or more implantation stabilization arms. Figures 12A and 12B illustrate perspective and side views, respectively, of a medical implantation device 70 including a sensor holding arm structure 75 having a stabilizer 76, according to one or more embodiments. As shown in Figures 12A and 12B, the sensor holding structure 75 may effectively function as an implantation stabilization arm without the need for an additional implantation support arm in the area of ​​the implantation device associated with the holding structure 75.

[0098] As shown in Figures 12A and 12B, the sensor holding structure 75 may be coupled to or otherwise associated with the implantation device 70 at or near its base portion 73, which corresponds to a location where the implantation stabilization arm may be positioned otherwise. For example, the base portion 73 may correspond to the outer portion of the barrel 71 of the shunt implantation device, as shown in Figures 12A and 12B. The implantation device 70 may further comprise a number of additional arms 74 positioned at each of the three corner portions of the implantation device 70 with respect to the side view in Figure 12B, such as the corner portions of the barrel 71. One of the four corner portions of the implantation device 70 may comprise a sensor holding structure 75 having a stabilizer 76 configured to provide mechanical contact with the tissue wall when implanted inside it, rather than comprising a similar arm member like the other arm members 74, thereby providing a sensor stabilization / support function similar to that of the arms 74.

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

[0100] As described in detail herein, sensor ballasts according to embodiments of this disclosure may be integrated with and / or otherwise associated with a sensor holding structure. For example, such a ballast may be configured to bend / fold away from the main body portion of the sensor holding structure and / or to bend or fold automatically, according to the shape memory properties of the ballast and / or associated sensor holding structure. Such bending / folding may generally be away from the distal end or the proximal end of the sensor holding structure, depending on the configuration. Figures 13A and 13B show an unfolded side view and an unfolded top view, respectively, of a sensor holding structure 85 having a ballast 86 extending from top to bottom, according to one or more embodiments.

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

[0102] As shown in Figures 13A and 13B, with respect to bending / folding the ballast downward, the unfolding of the ballast 86 may leave a window / opening 89 within the sensor holding structure 85, as shown. In some embodiments, the sensor holding structure 85 may further comprise a proximal window / opening 87. Such windows / openings 87, 89 may be desirable in some cases to provide a sensor holding structure with reduced bulk while still providing sufficient sensor support. For example, the sensor holding structure 85 may include one or more sensor holding fingers 83 capable of holding a sensor disposed within the sensor holding structure 85 against the body 88 of the structure, thereby eliminating the need for additional longitudinal supports of the sensor to hold the sensor in a desired position. The windows 87, 89 may further provide openings through which radio signals can propagate, thereby reducing interference with radio signal transmission to and from the sensor device held by the structure 85. For example, the antenna feature of the sensor may overlap at least partially with one or both of the windows 87, 89 in the axial and / or circumferential directions.

[0103] In some embodiments, the stabilizer 86 may automatically deploy when the sensor holding structure 85 is released from a delivery system (e.g., a delivery catheter) used to deliver the implantation device to a target tissue / location. For example, the sensor holding structure 85 and / or the stabilizer 86 may include a shape-setting memory alloy such as Nitinol. In some embodiments, a wire may be used in conjunction with the delivery system to manually deploy the stabilizer 86 by pushing or pulling one or more features of the stabilizer 86. For example, the stabilizer 86 may have one or more openings, hooks, or other engageable features that the deployment wire can engage to deploy the stabilizer.

[0104] Figures 14A and 14B show an unfolded side view and an unfolded top view, respectively, of a sensor holding structure 35 having a ballast 36 projecting upward from the bottom, according to one or more embodiments. In Figure 14A, the sensor holding structure 35 includes a ballast 36 integrated with the sensor holding structure 35. For example, as shown in the top view of Figure 14B, the ballast 36 may be cut out by laser cutting or otherwise cutting out the material of the body 38 of the sensor holding structure 35. In embodiments in which the ballast 36 is cut out or otherwise formed such that the base 132 of the ballast 36 is on the distal side of the ballast 36 with respect to the orientation of the sensor holding structure 35, the ballast 36 may be configured to bend / fold upward (i.e., away from the proximal end of the sensor holding structure 35).

[0105] As shown in Figures 14A and 14B, with respect to bending / folding the ballast upward, the unfolding of the ballast 36 may leave a window / opening 39 within the sensor holding structure 35, as shown. In some embodiments, the sensor holding structure 35 may further comprise a distal window / opening 37. Such windows / openings 37, 39 may be desirable in some cases to provide a sensor holding structure with reduced bulk while still providing sufficient sensor holding and support. For example, the sensor holding structure 35 may include one or more sensor holding fingers 33 capable of holding a sensor disposed within the sensor holding structure 35 against the body 38 of the structure, thereby eliminating the need for additional longitudinal supports of the sensor to hold the sensor in a desired position. The windows 37, 39 may further provide openings through which radio signals can propagate, thereby reducing interference with radio signal transmission to and from the sensor device held by the structure 35. For example, the antenna feature of the sensor may overlap at least partially with one or both of the windows 37, 39 in the axial and / or circumferential directions.

[0106] As described above in relation to Figures 13A and 13B, the ballast 36 can be deployed automatically and / or manually. Furthermore, the retraction of the ballast 36 can be achieved through manual and / or automatic mechanical movement. For example, in some embodiments, the ballast 36 may be bent and positioned against a tissue wall 18 as shown in Figure 14A, and the tissue wall 18 holds the ballast 36 in the bent configuration shown in Figure 14A. In such embodiments, pulling the sensor holding structure 35 away from the tissue wall 18 may allow the ballast to retract automatically so as to occupy the previously vacant space 39 when the ballast 36 is bent / folded away from the sensor holding structure 35.

[0107] Figures 15A to 15C show diagrams of a sensor holding structure 605 having a ballast 606 according to one or more embodiments. As shown in Figure 15A, the sensor holding structure 605 may include a distal stopper mechanism 604. For example, in some embodiments, the sensor holding structure 605 has a substantially curved / concave lateral shape and provides a cradle-type shape on which a cylindrical sensor 616 can be arranged / mounted. In some embodiments, the curved distal portion 604 may have a radius of curvature less than the radius of curvature of the main body portion 608 of the sensor holding structure 605. That is, the distal stopper portion 604 may be at least partially flatter than the main body portion 608 with respect to one or more arc lengths. Such configurations of the distal stopper bar / portion 604 are clearly shown in the end view of Figure 15C. According to the sensor cylinder 616 disposed within the curve of the main 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 / part 604 can overlap radially with 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 / part 604.

[0108] Figure 15D shows an alternative embodiment in which the distal stopper bar 644 has a similar circumference to the corresponding arc segment of the main body 648 of the sensor holding structure 645, and the distal bar 644 is pushed radially toward the central axis of the sensor 616, thereby forming an inward projection that radially penetrates the surface 614 of the sensor 616, as shown, thereby providing an axial obstruction to prevent distal movement of the sensor 616 beyond the stopper bar 644.

[0109] In some embodiments, as shown in Figure 15B, the sensor holding structure 605 includes a proximal trap / stopper 622 which may have a tab-type configuration. In some embodiments, the stopper 622 may be configured to bend / flex manually and / or automatically radially inward with respect to an axis defined by the curvature of the sensor holding structure 605. While the embodiments in Figures 15A and 15B include a single kickstand-type ballast 606, it should be understood that, as with any other embodiments of this disclosure, the sensor holding structure 605 may include any preferred or desired number of ballast features. Furthermore, as with any other embodiments disclosed herein, the ballast 606 shown in Figures 15A and 15B is shown as a bottom-up ballast design as described above in relation to Figures 14A and 14B, but it should be understood that the ballast 606 may be a top-down ballast or may have any other configuration according to the embodiments of this disclosure.

[0110] Figures 16A and 16B show a perspective exploded view and a non-exploded top view, respectively, of a sensor holding structure 705 having a plurality of ballasts 706 according to one or more embodiments. In particular, the illustrated sensor holding structure 705 has a double kickstand configuration. That is, while certain embodiments are disclosed herein in the context of sensor holding structures including a single ballast form / feature, the embodiments shown in Figures 16A and 16B include two ballast features 706a and 706b.

[0111] The two ballasts 706a and 706b may be substantially independent of each other, so that one of the ballasts can be bent and / or operated independently of the other. In some embodiments, as shown in Figure 16A, the ballast features 706a and 706b may extend in a substantially parallel relative orientation. In some embodiments, when the ballasts 706a and 706b are bent / projecting from the sensor holding structure 705, the ballasts 706a and 706b may be inclined to project radially outward with respect to their distal end portions and at a distance from each other. That is, in the deployed configuration, the distal ends of the sensor ballasts 706a and 706b may be further apart than their proximal portions.

[0112] As shown in Figure 16B, the ballasts 706a, 706b can be cut (e.g., laser cut) from the form of the body 725 of the sensor holding structure 705. As with other embodiments disclosed herein, the deployment of the ballasts 706a, 706b may occur after the deployment of the sensor holding structure 705, based on the shape memory properties of the sensor holding structure 705 and / or the ballasts 706a, 706b. The embodiment in Figure 16B shows the ballasts 706a, 706b positioned relative to each other such that a gap 742 exists between the ballasts when in the delivery configuration shown in Figure 16B, but in some embodiments, the form of the material of the base 725 of the sensor holding structure 705 may exist between the ballasts 706a, 706b to separate the ballasts, in addition to any space formed through the laser cutting of the ballasts 706a, 706b.

[0113] Figures 17A and 17B show a perspective unfolded view and a non-unfolded top view of a sensor holding structure 805 having multiple ballasts 806 according to one or more embodiments, respectively. The particular configurations in Figures 17A and 17B represent an alternative double ballast embodiment in which the ballasts 806a, 806b are angled relative to each other. As shown in Figures 17A and 17B, by constructing the ballasts 806a, 806b at certain angles, such ballasts can provide desirable lateral stability. For example, the incidence angles of each ballast 806a, 806b to contact with the tissue wall may differ relative to each other, thereby providing stability against motion / vibration over a wider range of angles. The overhead view shown in Figure 17B shows ballasts 806a, 806b cut out so that non-uniform gaps are formed between the ballasts 806a, 806b and / or between the ballasts and the body 825 of the sensor holding structure 805, although in some embodiments such gaps do not exist. In other words, ballasts 806a and 806b can be cut out from the sensor holding structure configuration without creating a gap beyond the cut edge around ballasts 806A and 806B. This may apply to any embodiment of the cut-out ballast feature disclosed herein.

[0114] Trauma protection features The stabilizer features disclosed herein, as described in detail above, may provide stabilization to the sensor holding structure or other components of the implantable device through contact with a tissue wall, thereby providing a mechanical bond between the sensor holding structure and the tissue wall via the stabilizer structure / feature. Given such tissue contact, it may be desirable to design / configure the stabilizer features according to embodiments of this disclosure in a manner that reduces the risk of injury and / or other damage to biological tissue through contact with the stabilizer features. For example, if the sensor holding 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 causing and / or damaging the biological tissue over time. In some embodiments, the distal end of the stabilizer feature may be relatively sharp, thereby allowing and / or causing penetration of the distal end of the stabilizer into the relevant biological tissue. Therefore, it may be desirable in certain embodiments to incorporate a trauma-protective feature for the distal end portion of the stabilizer feature.

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

[0116] The coating or material 1830 may play a role in preventing and / or protecting against tissue trauma resulting from contact between the stabilizer 1806 and biological tissue. Furthermore, in some embodiments, the coating / cover 1830 may provide a higher coefficient of friction compared to a stabilizer without such coating / cover. Thus, the coating / cover 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 play a role in providing additional stability for the stabilizer and sensor holding structure 1805, and may be configured to facilitate and / or accelerate intratissue growth between the tissue wall 18 and the coating 1830.

[0117] As shown in Figure 18B, the stabilizer 1806 may include a foot feature 1837, at least a portion of which may be covered by a coating / material 1830 in some embodiments. However, it should be understood that embodiments of the present disclosure may include stabilizers having a foot feature that does not have a trauma-protective coating / covering on it. The foot feature 1837 may have a width dimension w1 that is greater than the width dimension w2 of the inner and / or base portion of the stabilizer 1806. In some embodiments, the foot feature 1837 is rounded with respect to one or more of its corners or edges, thereby providing a low-traumatic physical contact interface for contacting biological tissue without puncturing or irritating biological tissue. The foot feature 1837 is shown having at least a partially flat distal end surface, but in some embodiments, the distal end of the foot feature 1837 may be rounded and / or circular. Figure 18B shows a foot feature 1837 associated with a ballast 1806, although in some embodiments, the ballast, including a trauma-protective cover / coating, does not include an identifiable foot feature.

[0118] Figures 19A and 19B show side and upright views, respectively, of a sensor stabilizer 1906 associated with a sensor holding structure 1905, according to one or more embodiments. The stabilizer feature 1906 may be configured according to any of the embodiments disclosed herein. In addition, the stabilizer 1906 may include certain additional trauma protection and / or stabilization feature parts associated with it. For example, as shown, the stabilizer 1906 may include one or more spreading foot feature parts 1941, 1942. For example, as shown in the diagram of Figure 19B showing the stabilizer 1906 in a pre-deployed configuration, the stabilizer 1906 may include a notch 1947 in or near the distal end portion of the stabilizer 1906, such notch 1947 forming separate foot feature parts 1941, 1942 that can spread in opposite directions relative to each other in a deployed configuration to provide a foot stabilizer feature part 1940.

[0119] Figure 19A shows the foot stabilizer 1940 with the foot feature portion 1942 bent away from the plane of the stabilizer 1906. With the foot feature portions 1942 and 1941 separated, as shown in Figure 19A, the contact force of the stabilizer 1906 on the tissue wall 18 can be distributed between the foot feature portions 1941 and 1942, thereby potentially reducing trauma and / or impact to the tissue wall 18 from the stabilizer 1906. The angle Θ exemplified in Figure 19A between the foot feature portions 1942 and 1941 is shown as less than about 90°, but it should be understood that when unfolded, the angle between the foot feature portions 1941 and 1942 can be any preferred or desired angle. For example, angle theta may be about 90°, about 90° to 135°, about 135° to 180°, about 180°, or greater than 180°. Furthermore, while Figures 19A and 19B show two foot features 1941, 1942 and a notch 1947 separating them, in some embodiments the foot feature 1940 does not include a separate foot feature. Rather, the distal portion of the ballast 1906 is bent / bendable away from the plane of the ballast 1906, thereby providing a contact surface that is more parallel to the tissue surface 18 than the inner portion of the ballast 1906. For example, with respect to the diagram in Figure 19A, such a foot feature may advantageously bend toward the distal end of the sensor holding structure 1905, thereby presenting a tissue contact surface that is more linear with the tissue surface 18 than the plane of the inner portion of the ballast 1906. Various configurations of the foot features disclosed herein can, in some embodiments, prevent deep tissue penetration of the ballast feature.

[0120] Figures 20-1 and 20-2 provide flowcharts illustrating a process 2100 for implanting and retracting a sensor ballast according to one or more embodiments. Figures 21-1 and 21-2 provide images of cardiac anatomical structures and devices / systems corresponding to the operation of process 2100 in Figures 20-1 and 20-2 according to one or more embodiments. Process 2100 relates to the implantation, deployment, positioning, adjustment, and / or retraction of a retractable / recoverable ballast feature associated with a sensor holding structure and / or.

[0121] Process 2100, in block 2000, involves coupling the suture 2170 with the suture engagement feature 2150 of the sensor stabilizer 2196, as shown in Figure 2101. For example, the stabilizer 2196 may be configured according to any embodiment of the stabilizer feature disclosed herein. Furthermore, although process 2100 is described in the context of sensor stabilizers, 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 they are associated with medical implantation devices.

[0122] As shown in image 2101 of Figure 21-1, the stabilizer 2196 may be associated with a sensor holding structure 2105, which is coupled to and / or associated with the arm 2192 of the implantation device. In connection with the operation of block 2000, the suture 2170 may be screwed in through the opening 2150 or another suture engagement feature of the stabilizer 2196. In some embodiments, the stabilizer 2196 may include at least a partially rounded foot portion 2140, and the suture engagement feature 2150 may be associated with the foot portion 2140. The suture 2170 may consist of a temporary suture loop passing through the suture engagement feature 2150, allowing the stabilizer feature 2196 to be recaptured or bailed out.

[0123] In block 2002, process 2100 involves implanting a medical implantation device 2110, which includes a sensor holding structure 2105 that may be configured to hold a sensor device 2116, as shown in image 2102 of Figure 21-1. The operation associated with block 2002 may further involve deploying a suture-bound stabilizer 2196, which may have a suture 2170 engaged with its suture engagement mechanism 2150, as described above. With the suture 2170 looped through the suture engagement feature portion 2150 of the stabilizer 2196 and / or otherwise engaged, the first suture tail 2171 and the 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 as to be positioned at least partially around a delivery catheter or device 2140. The catheter 2140 may access a target anatomical structure, such as the left atrium or other anatomical cavities or channels, by following a guidewire 2160 that may already be positioned along the desired access route. In some embodiments, suture tails 2171, 2172 may generally extend along the catheter 2140 and / or other delivery systems / devices. In some embodiments, the catheter 2140 may access the patient's internal anatomical structures through one or more access sheaths.

[0125] In block 2004, process 2100 involves retracting the stabilizer 2196 using the joined suture 2170. For example, as shown in image 2103 of Figure 21-2, retraction of the stabilizer 2196 can be achieved by pulling one or both of the suture tails 2171, 2172 proximal, thereby pulling the distal end of the stabilizer 2196 associated with the suture engagement feature 2150 substantially proximal and / or toward the body portion 2188 of the sensor holding structure 2105. Pulling the stabilizer 2196 back toward the body 2188 of the sensor holding structure 2105 can return the stabilizer 2196 to the delivery configuration illustrated substantially in Figure 2101. In some embodiments, pulling the ballast 2196 using the suture 2170 does not require the ballast 2196 to be fully retracted into the delivery configuration of image 2101, but it can still be retracted to a degree sufficient to allow removal, repositioning, and / or adjustment of the sensor holding structure 2105.

[0126] In block 2006, 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 one of the suture tails 2171, thereby drawing in the other suture tail 2172 through the suture engagement mechanism 2150 and removing it therefrom. Although the removal of the suture 2170 is shown as being performed with the stabilizer 2196 retracted into the delivery configuration, as shown in image 2104 of Figure 21-2, it should be understood that the removal of the suture from the suture engagement feature 2150 may be performed with the stabilizer 2196 in an unfolded configuration, as shown in image 2102, or in a retracted configuration, as shown in images 2103 and / or 2104.

[0127] Location of implantation device equipped with a ballast An implantable device incorporating the stabilizer features described in relation to the various embodiments disclosed herein may be any type of implantable device. That is, while certain shunt-type implantable devices are described in detail and shown in the figures of this disclosure, it should be understood that such implantable devices may be any type of implantable device, including non-shunt implantable devices configured to hold / maintain a sensor device. Furthermore, an implantable device equipped with / supplied with a stabilizer according to an aspect of this disclosure may be implanted in any suitable or desired anatomical structure, examples of which are described in detail below for reference.

[0128] Figure 22 shows a sensor implantation device 2200 implanted in the wall 2218 separating the left atrium 2 from the coronary sinus 16, according to one or more embodiments. Figure 22, and some of the following figures, show a cross-section of the heart viewed from top to bottom with the rear surface oriented on the page. The sensor implantation device 2200 of Figure 22 includes a sensor holding structure 2205, the sensor holding structure 2205 having an associated stabilizer feature 2206. The stabilizer 2206 may be any type of stabilizer feature disclosed herein. According to the sensor implantation device 2200 implanted in the wall 2218 separating the left atrium 2 from the coronary sinus 16, the stabilizer 2206, when deployed, may contact the atrial surface 2232 of the wall 2218 separating the left atrium 2 from the coronary sinus 16.

[0129] While an atrial shunt via implantation of a device 2200 in the wall 18 between the left atrium 2 and the coronary sinus 16 may be preferable to a shunt via the atrial septum in some situations, a shunt via the interatrial septum may be preferable. For example, a shunt via the coronary sinus 16 may offer a reduced risk of thrombosis and embolism. The coronary sinus is less likely to have the presence of thrombi / embolus for several reasons. Firstly, the drainage of blood from the coronary vascular system into the right atrium is filtered blood, having just passed through capillaries. Secondly, the coronary sinus orifice in the right atrium is often partially covered by a false valve called the Thebesius valve. While the Thebesius valve is not always present, some studies have shown that it is present in most hearts and can block the entry of thrombi or other embolisms in the event of a spike in right atrial pressure. Thirdly, the pressure gradient between the coronary sinus and the right atrium through which it is drained is generally relatively low, and as a result, thrombi or other embolisms in the right atrium are more likely to remain there. Fourthly, in the event of a thrombus / embolus entering the coronary sinus, there is a much greater gradient between the right atrium and the coronary vascular system than between the right and left atria. Presumably, the thrombus / embolus will then travel further down the coronary vascular system until the right atrial pressure returns to normal and the embolus returns directly to the right atrium.

[0130] Some additional advantages of placing the implantable device 2200 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the atrial septal tissue. By diverting left atrial blood to the coronary sinus, sinus pressure can increase by a small amount. This allows blood in the coronary vascular system to move more slowly through the heart, increasing perfusion and oxygen delivery, which may be more efficient and may also help in the recovery of dying myocardium.

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

[0132] It is important to note that, in addition to the various advantages of placing a shunt implant between the coronary sinus and the left atrium, certain disadvantages may also need to be considered. For example, by shunting blood from the left atrium to the coronary sinus, oxygenated blood from the left atrium may be passed to the right atrium, and / or unoxygenated blood from the right atrium may be passed to the left atrium, both of which may be undesirable in terms of proper cardiac function.

[0133] Access to the target wall 2218 via the coronary sinus 16 can be achieved using any preferred or desired procedure. For example, various access routes may be used when manipulating guidewires and catheters within and around the heart to deploy expandable shunts integrated with or associated with pressure sensors, according to embodiments of the present disclosure. Figures 23A and 23B show diagrams of cardiac anatomical structures illustrating catheter access routes to the coronary sinus 16 according to one or more embodiments.

[0134] In some embodiments, access to the superior vena cava 19, right atrium 5, and from there to the coronary sinus 16 may be achieved via the subclavian or jugular vein. Alternatively, the access route may begin in the femoral vein and enter the heart via the inferior vena cava 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 vascular system, usually through a sealed introducer, from which the system may be designed or configured to allow a physician to control the distal end of the device from outside the body.

[0135] In some embodiments of the procedure for advancing an implantation device according to aspects of this 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 route, the introducer sheath can be routed along the guidewire into the patient's vascular system, typically by the use of a dilator. The delivery catheter can be advanced through the superior vena cava to the coronary sinus of the heart, and the introducer sheath can provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to form and prepare an opening in the wall of the left atrium, and a separate arrangement or delivery catheter will be used for the delivery of the implantation device 2200. In other embodiments, the deployment catheter may be used as both a fully functional puncture preparation and implantation delivery catheter. In this application, the terms “deployment catheter” or “delivery catheter” are used to describe a catheter, sheath, and / or introducer having one or both of these functions.

[0136] As shown in Figures 23A and 23B, the coronary sinus 16 is generally continuous with the left atrium 2, and therefore, a variety of possible and acceptable placements exist for the implantable device 2200. The target site selected for placement of the implantable device 2200 may be within an area where the tissue of a particular patient is thin or low-density, as predetermined by non-invasive diagnostic means such as fluoroscopy or intravascular ultrasound (IVUS), such as CT scan or radiography.

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

[0138] Figure 24 shows a sensor implantation device 2410 having a sensor stabilizer 2406 implanted in the wall 18 separating the atrium 2 from the coronary sinus 16, according to one or more embodiments. In contrast to the orientation of each sensor implantation device in Figures 22, 23A, and 23B, which generally show the sensor retaining structure associated with each implantation device oriented toward the coronary sinus orifice 14, the sensor implantation device 2410 is shown in Figure 24 such that the associated sensor retaining structure 2405 is generally oriented away from the coronary sinus orifice 14 and toward the direction of the narrowing of the coronary sinus 16. However, it should be understood that a sensor implantation device implanted in the wall 18 separating the left atrium 2 from the coronary sinus 16 may have any preferred or desired orientation. For example, the arm and / or sensor retaining structure associated with the sensor implantation device may be oriented substantially perpendicular to the axis of the heart, rather than horizontally, as shown in Figures 22 and 24.

[0139] Figure 25 shows a sensor implantation device 2510 having a sensor stabilizer 2505 implanted in the atrial septum 79, according to one or more embodiments. With the sensor implantation device 2510 implanted in the atrial septum 79, the sensor retaining structure 2505 and associated sensor 2516 may be advantageously 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 retaining structure 2505 may be disposed within the right atrium 5. In any configuration, the stabilizer 2506 may generally be positioned in contact with the atrial septum 79, either on its left atrial side or its right atrial side, depending on the orientation / configuration of the implantation device 2510.

[0140] A specific location within the atrial septum may be selected or determined to provide a relatively safe anchoring site for the implanted device 2510 and to provide a relatively low risk of thrombosis. Furthermore, the sensor implanted device 2510 may be implanted in a desirable location considering future re-crossing of the septum 79 for future interventions. Implantation of the sensor implanted device 2510 in the atrial septum may, advantageously, enable fluid communication between the left atrium 2 and the right atrium 5. With the device 2510 in the atrial septum 79, the sensor 2516 of the sensor implanted 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 comprises multiple sensors, one of which is disposed in the right atrium 5 and the left atrium 2, respectively. With pressure sensor functionality for measuring pressure in both atria, the sensor implanted device 2510 may, advantageously, be configured to provide a sensor signal that can be used to determine the differential pressure between the atria. Determining differential pressure may be useful for monitoring intrapulmonary fluid accumulation, which can be associated with congestive heart failure.

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

[0142] Figure 27 shows a sensor implantation device 2710 having a sensor stabilizer 2706 implanted in the wall 2701 of a ventricle (e.g., left ventricle 3) according to one or more embodiments. The wall 2701 can generally be located in the area of ​​the outer wall of the ventricle. Although the implantation device 2710 is shown implanted in the lateral left ventricular wall, it should be understood that the implantation device according to embodiments of this disclosure can be implanted in the lateral wall of the right ventricle 4. The sensor implantation device 2710 may have any preferred or desired form and / or anchor fixation configuration. For example, a corkscrew type or other type of tissue anchor may be used to embed the proximal portion of the sensor implantation device 2710 into 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 alternative to those shown in Figure 27. With the sensor implantation device 2710 implanted in the lateral ventricular wall 2701, the stabilizer 2706 can be deployed in a configuration that contacts the tissue wall 2701 and provides stability to the sensor holding structure 2705. Although illustrated in Figure 27 as being oriented approximately vertically upward, it should be understood that the sensor holding structure 2705 can be oriented in any preferred or desired direction within the ventricle.

[0143] Figure 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 2810 may be implanted in tissue 2801 at or near the apical region 26 of the heart 1. Although illustrated in the apical area of ​​the left ventricle 3, it should be understood that sensor implantation devices according to embodiments of this disclosure may be implanted in the apical region of the right atrium 4.

[0144] Figure 29 shows a sensor implantation device 2910 having a sensor stabilizer 2906 implanted in the left atrial appendage 249 of the heart 1, according to one or more embodiments. For example, the sensor implantation device 2910 may incorporate a left atrial appendage closure component 2909. With the sensor implantation device 2910 implanted as shown in Figure 29, the stabilizer 2906 may be oriented to physically contact the side 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. In general, left atrial pressure measurement 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 fixed to the left atrial appendage closure implantation device 2909 by or using any attachment or integration mechanism, including splices, suture wraps, or other attachment means, for fixing the sensor 2916 and / or sensor retaining structure 22905 to the graft 2909. The sensor integration 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 thrombosis in the left atrium.

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

[0147] Additional Embodiments Depending on the embodiment, any particular action, event, or function of the process described herein may be performed in a different order, added, merged, or completely excluded. Therefore, in a particular embodiment, not all described actions or events are necessary for the practice of the process.

[0148] With respect to preferred embodiments, specific standard anatomical terms are used herein. Certain spatially relative terms and similar terms such as “lateral,” “medial,” “upper,” “lower,” “below,” “up,” “vertical,” “horizontal,” “apex,” and “bottom” are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, but it is understood that these terms are used herein for ease of explanation to describe the positional relationships between elements / structures illustrated in the drawings. Spatially relative terms are intended to encompass different orientations of the element / structure in use or operation, in addition to the orientation illustrated in the drawings. For example, an element / structure described as “above” another element / structure may mean a position below or beside such other element / structure with respect to the patient or alternative orientation of the element / structure in question, and vice versa.

[0149] In particular, conditional statements used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” are intended in their ordinary sense unless otherwise stated or understood differently in the context in which they are used, and are generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in other embodiments. Therefore, such conditional statements are generally not intended to imply that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these features, elements, and / or steps are included or performed in any particular embodiment. Terms such as “equip,” “include,” and “have” are synonymous and are used in their ordinary sense, in a comprehensive, non-restrictive manner, and do not exclude additional elements, features, actions, functions, etc. Furthermore, the term “or” is used in its inclusive sense (and not its exclusive sense), and therefore, for example, when used to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Unless otherwise specified, connecting phrases such as “at least one of X, Y, and Z” are understood in context to be used to generally convey that an item, term, element, etc., may be any of X, Y, or Z. Thus, such connecting phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively. Where used herein, the term “and / or” used between the last two elements in a list means any one or more of the enumerated 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 specific sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, when used herein, sequential terms used to modify elements such as structure, components, and actions (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of an element relative to any other element, but rather may schematically distinguish an element from another element having a similar or identical name (other than the use of sequential terms). In addition, when used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a condition or event may also be performed on the basis of one or more other conditions or events not explicitly listed.

[0151] With respect to the various methods and processes disclosed herein, specific sequences of actions or steps are illustrated and / or described, but it should be understood that the various steps and actions shown and described may be performed in any preferred or desirable time order. Furthermore, any of the actions 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 actions or steps not expressly illustrated or described.

[0152] In the descriptions of the embodiments described above, various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various embodiments of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than are explicitly enumerated in that claim. Furthermore, any component, feature, or step illustrated and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment. Moreover, a component, feature, step, or group of components, features, or steps is not necessarily required or essential to each embodiment. Accordingly, the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

Claims

1. A sensor holding structure, A sensor support arm configured to hold a sensor device, A sensor holding structure comprising: a ballast structure associated with the sensor support arm and configured to protrude away from the sensor support arm to provide stabilizing support to the sensor support arm.

2. The ballast structure described above is The long, slender leg section, The edges and, The sensor holding structure according to claim 1, comprising a base portion integrated with the sensor support arm.

3. The sensor holding structure according to claim 2, wherein the ballast structure is bent at the base portion so that the end portion of the ballast structure protrudes away from the distal end of the sensor support arm.

4. The sensor holding structure according to claim 2 or 3, wherein the ballast structure is bent at the base portion so that the end portion of the ballast structure protrudes away from the proximal end of the sensor support arm.

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

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

7. The sensor holding structure according to any one of claims 2 to 6, wherein the end portion comprises a leg portion having a width greater than the width of the elongated leg portion in one or more of its parts.

8. The 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 a certain angle with respect to the elongated leg portion to provide a tissue contact surface.

9. The sensor holding structure according to any one of claims 1 to 8, wherein the ballast structure comprises a first leg and a second leg.

10. The sensor holding structure according to claim 9, wherein the first leg and the second leg are oriented in relative parallel orientation.

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

12. A method for deploying a sensor implantation device, wherein the method is The implantation involves implanting a transplant structure into a tissue wall, wherein the transplant structure includes a sensor support member configured to hold a sensor device. A method comprising: causing the distal portion of a ballast-like structure associated with the sensor support member to protrude away from the sensor support member and toward the tissue wall.

13. The method according to claim 12, further comprising stabilizing the sensor support member with respect to the angle of the sensor support member with respect to the surface of the tissue wall.

14. The method according to claim 12 or 13, further comprising deflecting the end portion of the ballast form to provide a tissue contact structure.

15. The method according to any one of claims 12 to 14, wherein the ballast form includes a shape memory material, and the distal portion of the ballast form protrudes, thereby unfolding the implantation structure from the delivery system, and the shape memory material allows the ballast form to bend at its base, thereby deflecting the ballast form away from the sensor support member.

16. A method for pulling in a sensor ballast, wherein the method is To provide a sensor implantation device including a sensor support structure and a stabilizer member including a suture engagement feature, The suture-engaging feature portion engages with the suture, The aforementioned sensor implantation device is implanted into the tissue wall, By causing at least a portion of the ballast member to protrude away from the sensor support structure, the ballast member is to be at least partially deployed. A method comprising pulling one or more portions of the suture to thereby pull the ballast member in alignment with the sensor support structure.

17. The method according to claim 16, wherein the suture engagement feature portion comprises an opening associated with the end portion of the stabilizer member.

18. The method according to claim 16 or 17, further comprising pulling the suture tail of the suture proximal through a delivery system associated with the sensor implantation device to pull the suture out of the sensor implantation device.

19. The method according to any one of claims 16 to 18, further comprising advancing a delivery catheter to the tissue wall, wherein the delivery catheter has a plurality of suture tail portions of the suture disposed therein.

20. The method according to any one of claims 16 to 19, wherein the tissue wall is a wall separating the coronary sinus from the left ventricle of the heart.

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