Vascularly anchored cardiac sensor

Abstract

A method of sensing a physiological parameter involves advancing a delivery catheter to a right atrium of a heart of a patient via a transcatheter access path, advancing the delivery catheter through an atrial septal wall into a left atrium of the heart, deploying a distal anchor of a sensor implant device from the delivery catheter, anchoring the distal anchor of the sensor implant device to a first pulmonary vein, withdrawing the delivery catheter from the first pulmonary vein, thereby exposing at least a portion of a sensor module of the sensor implant device in the left atrium, deploying a proximal anchor of the sensor implant device from the delivery system, anchoring the proximal anchor of the sensor implant device to a second pulmonary vein, and withdrawing the delivery catheter from the heart.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 890,537, filed August 22, 2019, entitled PULMONARY-VEIN-ANCHORED CARDIACSENSOR, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to the field of medical devices and procedures. Background Technology

[0004] Certain physiological parameters related to the heart chambers, such as fluid pressure and blood flow, can influence a patient's health prospects. Specifically, high cardiac fluid pressure can lead to heart failure, embolism, and / or other complications in some patients. Therefore, information related to the physiological conditions (such as pressure) in one or more chambers of the heart can be beneficial. Summary of the Invention

[0005] This article describes one or more methods and / or devices to facilitate the monitoring of one or more physiological parameters (one or more) associated with the left atrium by utilizing one or more sensor implantation devices implanted in or to one or more pulmonary veins and / or associated anatomical structures / tissues.

[0006] In some embodiments, this disclosure relates to a method for sensing physiological parameters. The method includes advancing a delivery catheter via a catheter access path into the right atrium of a patient's heart, advancing the delivery catheter through the interatrial septum into the left atrium of the heart, deploying a distal anchor of a sensor implantation device from the delivery catheter, anchoring the distal anchor of the sensor implantation device to a first pulmonary vein, withdrawing the delivery catheter from the first pulmonary vein, thereby exposing at least a portion of the sensor module of the sensor implantation device to the left atrium, deploying a proximal anchor of the sensor implantation device from a delivery system, anchoring the proximal anchor of the sensor implantation device to a second pulmonary vein, and withdrawing the delivery catheter from the heart.

[0007] The method may further include using sensor elements of the sensor module to sense physiological parameters related to the left atrium. For example, this physiological parameter could be left atrial blood pressure.

[0008] In some embodiments, the sensor implantation device includes a first arm portion that physically connects the sensor module to a distal anchor and a second arm portion that physically connects the sensor module to a proximal anchor. For example, the first and second arm portions may be integral arm structures connected between the distal and proximal anchor devices.

[0009] In some implementations, the sensor module includes an engagement feature configured to attach the sensor module to an arm structure.

[0010] In some embodiments, the sensor module includes a guidewire lumen configured to house a guidewire therein. For example, the method may further include advancing a delivery catheter along a pre-positioned guidewire.

[0011] In some embodiments, the sensor module includes a housing and a sensor element disposed at least partially within the housing. For example, the sensor element may be disposed at least partially within the housing such that when the sensor implantation device is disposed in the left atrium, the transducer surface of the sensor element is at least partially exposed to blood in the left atrium.

[0012] In some implementations, the transducer surface is a pressure transducer diaphragm.

[0013] In some embodiments, anchoring the distal anchor of the sensor implantation device to the first pulmonary vein involves expanding a stent-type anchor within the conduit of the first pulmonary vein.

[0014] In some embodiments, this disclosure relates to a sensor implantation device including a sensor module comprising a housing and sensor elements; a first bracket-type anchor connected to the sensor module via a first arm structure portion; and a second bracket-type anchor connected to the sensor module via a second arm structure portion.

[0015] Each of the first and second bracket-type anchors can be self-expanding.

[0016] In some implementations, the sensor element is configured to generate a signal indicating a physiological parameter. For example, this physiological parameter may be fluid pressure.

[0017] The first and second arm structural portions can be the sections of an integral bridge structure connected between the first and second bracket anchors. For example, the sensor module may include engagement features configured to engage with the bridge structure.

[0018] In some implementations, the engagement feature is associated with the underside of the sensor module housing.

[0019] The sensor module may include channel features configured to receive guidewires therein.

[0020] In some implementations, the sensor element includes a transducer surface that is at least partially exposed outside the housing. For example, the transducer surface may be associated with a pressure transducer membrane layer.

[0021] In some embodiments, this disclosure relates to a delivery system including an outer shaft and a sensor implantation device at least partially disposed within the outer shaft.

[0022] The sensor implantation device includes a first anchoring device, a second bracket-type anchoring device, and a sensor module physically connected to the first anchoring device and the second anchoring device.

[0023] The delivery system also includes a distal inner shaft that is at least partially arranged within the outer shaft and configured to axially abut against a first anchoring device within the outer shaft.

[0024] In some embodiments, the first anchoring device is arranged without a distal inner shaft and is located distal to the inner shaft, and the sensor module is arranged at least partially within the distal inner shaft.

[0025] The delivery system may further include a proximal inner shaft that is at least partially disposed within a distal inner shaft and configured to axially abut a sensor module within the distal inner shaft. For example, in some embodiments, a second anchoring device is at least partially disposed within the proximal inner shaft, the diameter of which is smaller than the diameter of the distal inner shaft. The second anchoring device is disposed within the proximal inner shaft in a configuration that is at least partially compressed, and the diameter of the second anchoring device in the at least partially compressed configuration is smaller than the diameter of the first anchoring device disposed and arranged within the outer shaft.

[0026] The second anchor can be connected to the sensor module via an arm portion that is bent such that the end of the second anchor is oriented distally within the proximal inner shaft.

[0027] The delivery system may further include a pusher device at least partially disposed within the proximal inner shaft and configured to axially abut a second anchoring device within the proximal inner shaft. For example, the pusher device may include a central cavity configured to receive the guidewire therein.

[0028] In some embodiments, this disclosure relates to a sensor implantation device including a bracket-type anchor, a first arm structure coupled to the bracket-type anchor and extending axially beyond the axial end of the bracket-type anchor, and a sensor device fixed to the first arm structure.

[0029] The support anchor can be sized to anchor in an expanded deployment configuration within any one of the pulmonary veins, coronary sinus, and / or superior or inferior vena cava.

[0030] The first arm structure can have shape memory properties, which cause the first arm structure to deflect radially outward relative to the axis of the bracket anchor when the sensor implantation device is deployed.

[0031] The sensor implantation device may further include a second arm structure that is connected to and secured to the sensor device via a bracket-type anchor. For example, the first and second arm structures may be connected to opposite circumferential portions of the bracket-type anchor, and / or the first and second arm structures may be configured to hold the sensor device on the central axis of the bracket-type anchor.

[0032] In some embodiments, this disclosure relates to a sensor implantation device comprising a bracket-type anchor and a sensor device fixed to the inner diameter of the bracket-type anchor.

[0033] In some embodiments, the sensor device includes a housing configured to engage with one or more cells of a grid structure of a bracket-type anchor.

[0034] The sensor device can be fixed to the bracket anchor at the axial end of the bracket anchor.

[0035] In some embodiments, this disclosure relates to a method of implanting a sensor implantation device. The method includes advancing a delivery system via a catheter access path into a patient's first vena cava, advancing the delivery system through at least a portion of the patient's right atrium and into the patient's second vena cava, deploying a distal anchor of the sensor implantation device from the delivery system, anchoring the distal anchor of the sensor implantation device within the second vena cava, withdrawing the delivery system through at least a portion of the right atrium, thereby exposing at least a portion of the sensor device of the sensor implantation device and a first support arm portion connecting the sensor device to the distal anchor to the right atrium in the right atrium, deploying a proximal anchor of the sensor implantation device from the delivery system within the first vena cava, anchoring the proximal anchor of the sensor implantation device within the first vena cava, and withdrawing the delivery system from the patient.

[0036] The sensor device can be connected to the proximal anchor via the second support arm section.

[0037] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all of these advantages can necessarily be achieved according to any particular implementation. Therefore, the disclosed implementations may be carried out in a way that achieves or optimizes one or more advantages taught herein, without necessarily achieving other advantages that may be taught or proposed herein. Attached Figure Description

[0038] Various embodiments are depicted in the drawings for illustrative purposes and should not be construed in any way as limiting the scope of the invention. Furthermore, various features of different disclosed embodiments can be combined to form other embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be used repeatedly to indicate correspondences between reference elements.

[0039] Figure 1 A cross-sectional view of a human heart is shown.

[0040] Figure 2 The diagram shows cross-sectional views of the upper and lower atria of the human heart.

[0041] Figure 3 Examples of pressure waveforms related to various chambers and vessels of the heart according to one or more embodiments are provided.

[0042] Figure 4 An example is shown in a graph illustrating the range of pressure in the left atrium.

[0043] Figure 5 A system for monitoring pressure and / or volume is shown according to one or more embodiments.

[0044] Figure 6 An example is a heart in which a sensor implantation device is implanted, according to one or more embodiments.

[0045] Figure 7 A side view of a sensor implantation device according to one or more embodiments is shown.

[0046] Figure 8 A sensor implantation device comprising anchoring features coupled to a plurality of pulmonary veins is shown according to one or more embodiments.

[0047] Figure 9A and 9B Front and side views of a sensor implantation device in an expanded configuration according to one or more embodiments are shown respectively.

[0048] Figure 10A and 10B Front and side views of a sensor implantation device in a compression configuration according to one or more embodiments are shown respectively.

[0049] Figure 11 A cross-sectional view of a delivery system for a sensor implantation device according to one or more embodiments is shown.

[0050] Figure 12-1 , 12-2 12-3 and 12-4 are flowcharts illustrating a process for implanting a sensor implantation device according to one or more embodiments.

[0051] Figure 13-1 , 13-2 13-3 and 13-4 provide a method for implementing one or more embodiments of the same principle. Figures 12-1 to 12-4 The process of operation corresponds to the cardiac anatomy and cross-sectional images of certain devices and systems.

[0052] Figure 14-1 , 14-2 14-3 and 14-4 provide a method for implementing one or more embodiments of the same principle. Figures 12-1 to 12-4 The process of operation corresponds to the front and side views of various configurations of sensor implantation devices.

[0053] Figure 15 A sensor implantation device anchored in / to the left inferior pulmonary vein and right superior pulmonary vein is shown according to one or more embodiments.

[0054] Figure 16 A sensor implantation device anchored in / to the left and right inferior pulmonary veins is shown according to one or more embodiments.

[0055] Figure 17 A sensor implantation device anchored in / to the left upper pulmonary vein and right lower pulmonary vein according to one or more embodiments is shown.

[0056] Figure 18 A sensor implantation device anchored in / to the right lower pulmonary vein and right upper pulmonary vein according to one or more embodiments is shown.

[0057] Figure 19A A side deployment view of a sensor implantation device anchored in a blood vessel according to one or more embodiments is shown.

[0058] Figure 19B An illustration is shown according to one or more embodiments. Figure 19A An axial view of the sensor implantation device.

[0059] Figure 19C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 19A A side view of the sensor implantation device.

[0060] Figure 20A A side deployment view of a sensor implantation device anchored in a blood vessel according to one or more embodiments is shown.

[0061] Figure 20B An illustration is shown according to one or more embodiments. Figure 20AAn axial view of the sensor implantation device.

[0062] Figure 20C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 20A A side view of the sensor implantation device.

[0063] Figure 21A A side deployment view of a sensor implantation device anchored in a blood vessel according to one or more embodiments is shown.

[0064] Figure 21B An illustration is shown according to one or more embodiments. Figure 21A An axial view of the sensor implantation device.

[0065] Figure 21C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 21A A side view of the sensor implantation device.

[0066] Figure 22A A side deployment view of a sensor implantation device anchored in a blood vessel according to one or more embodiments is shown.

[0067] Figure 22B An illustration is shown according to one or more embodiments. Figure 22A An axial view of the sensor implantation device.

[0068] Figure 22C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 22A A side view of the sensor implantation device.

[0069] Figure 23 A sensor implantation device for implantation in the superior vena cava and inferior vena cava according to one or more embodiments is shown.

[0070] Figure 24A -C respectively show a crimped side view, an enlarged front view, and an axial view of a sensor implantation device according to one or more embodiments.

[0071] Figure 25 A sensor implantation device anchored in the superior vena cava according to one or more embodiments is shown.

[0072] Figure 26 A sensor implantation device anchored in the inferior vena cava according to one or more embodiments is shown.

[0073] Figure 27 A sensor implantation device anchored in the superior vena cava according to one or more embodiments is shown.

[0074] Figure 28 A sensor implantation device anchored in the inferior vena cava according to one or more embodiments is shown.

[0075] Figure 29 A sensor implantation device anchored in the coronary sinus is shown according to one or more embodiments.

[0076] Figure 30 A sensor implantation device anchored in the coronary sinus is shown according to one or more embodiments.

[0077] Figure 31 A sensor implantation device anchored in the coronary sinus is shown according to one or more embodiments.

[0078] Figure 32 Various access paths that can enable access to target cardiac anatomy structures are illustrated according to one or more embodiments. Detailed Implementation

[0079] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter. This disclosure relates to systems, apparatus, and methods for implanting and utilizing sensor implantation devices configured to be implanted in the heart, such as at least partially within the left atrium, and / or anchored to one or more pulmonary veins in fluid communication therewith.

[0080] Although 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 variations and equivalents. Therefore, the scope of the claims that may arise therefrom is not limited to any specific embodiment described below. For example, in any method or process disclosed herein, the behavior or operation of the method or process can be performed in any suitable order and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a plurality of discrete operations in a manner that aids in understanding certain embodiments; however, the order of description should not be construed as implying that these operations are sequentially dependent. Furthermore, the structures, systems, and / or apparatuses described herein may be implemented as integrated components or as separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily implemented in any specific embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0081] The following includes a general description of the human heart anatomy in relation to certain inventive features and embodiments disclosed herein, and is included to provide background for certain aspects of this disclosure. In humans and other vertebrates, the heart generally comprises a muscular organ with four pumping chambers, wherein blood flow between the chambers is at least partially controlled by various cardiac valves, namely the aortic valve, mitral valve (or bicuspid), tricuspid valve, and pulmonary valve. Valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control blood flow to corresponding regions of the heart and / or associated vessels (e.g., the lungs, aorta, etc.).

[0082] Figure 1 and 2 Vertical and horizontal cross-sectional views of an example heart 1 having various features / anatomical structures related to certain aspects of the present invention are illustrated. The heart 1 comprises four chambers: the left ventricle 3, the left atrium 2, the right ventricle 4, and the right atrium 5. Muscular walls, referred to as septums, separate the left and right chambers. Specifically, a portion 18 of the atrial septum wall (referred herein to as the “atrial septum,” “interventricular septum,” or “septum”) separates the left atrium 2 from the right atrium 5, while a portion 17 of the ventricular septum wall (referred herein to as the “ventricular septum,” “ventricular septum,” or “septum”) separates the left ventricle 3 from the right ventricle 4. The lower distal end 19 of the heart 1 is referred to as the apex and is generally located in the fifth intercostal space along the midclavicular line. The apex can be considered as part of the larger apical region 39 identified in the figures.

[0083] The third ventricle of the left heart is the main pumping chamber of the heart. A healthy left ventricle is generally conical or pointed in shape because of its length (along the axis from the aortic valve 7...). Figure 1 The longitudinal axis (not shown) extending towards the apex of the heart is longer than its width (the transverse axis extending between the opposing walls 28 and 29 at the widest point of the left ventricle) and decreases from the base 15 to that point or apex with a decreasing cross-sectional diameter and / or circumference. Generally, the apical region 39 of the heart is located in the left ventricular region and / or right ventricular region, but distal to the mitral valve 6 and tricuspid valve 8 and near the cardiac appendage 19, in the basal region of the heart.

[0084] The pumping of blood from the left ventricle 3 is accomplished through squeezing and twisting or torsional movements. Squeezing occurs between the lateral walls 14 and septum 17 of the left ventricle 3. Twisting is a result of the myocardial fibers extending in a circular or spiral direction around the heart. When these fibers contract, they create an angular displacement gradient of the myocardium from the apex to the base 15 around the longitudinal axis of the heart. The resulting force vector extends at an angle of approximately 30–60 degrees to the blood flow through the aortic valve 7. When viewed from the apex, the contraction of the heart appears as a counterclockwise rotation of the apex relative to the base 15. The contraction of the heart, in conjunction with the filling volume of the left atrium 2 and left ventricle 3, can result in relatively high fluid pressure on the left side of the heart, at least during certain phases (one or more) of the cardiac cycle, the consequences of which will be discussed in detail below.

[0085] The heart's four valves facilitate blood circulation. The tricuspid valve (8) separates the right atrium (5) from the right ventricle (4). The tricuspid valve (8) generally has three tips or leaflets and is advantageously closed during ventricular contraction (i.e., systole) and opened 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 to allow blood to be pumped from the right ventricle (4) towards the lungs, and to close during diastole to prevent blood from leaking back into the right ventricle (4) from the pulmonary artery. The pulmonary valve (9) generally has three tips / leaflets. The mitral valve (6) generally has two tips / leaflets and separates the left atrium (2) from the left ventricle (3). The mitral valve (6) can generally be configured to open during diastole to allow blood to flow from the left atrium (2) into the left ventricle (3), and to close during diastole to prevent blood from leaking back into the left atrium (2). The aortic valve (7) separates the left ventricle (3) from the aorta (12). Aortic valve 7 is configured to open during systole to allow blood leaving left ventricle 3 into aorta 12, and to close during diastole to prevent blood from leaking back into left ventricle 3.

[0086] The atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with a subvalvular apparatus (not shown), comprising a collection of chordae tendineae and papillary muscles that anchor the leaflets of the respective valves to facilitate and / or enable proper occlusion of the leaflets and prevent their prolapse. The papillary muscles may, for example, generally consist of finger-like projections from the ventricular wall. Surrounding the ventricles (3, 4) are multiple arteries 22 supplying oxygenated blood to the myocardium and multiple veins 28 returning blood from the myocardium to the right atrium 5 via the coronary sinus 16 (see...). Figure 2 The coronary sinus 16 is a relatively large vein that generally extends around the upper part of the left ventricle 3 and provides a return channel for blood to return to the right atrium 5. The coronary sinus 16 terminates at the coronary ostium 14, through which blood enters the right atrium.

[0087] The primary function of the left atrium 2 is to act as a reservoir for blood returning from the lungs (not shown) and as a pump to deliver blood to other parts of the heart. The left atrium 2 receives oxygenated blood from the lungs via pulmonary veins 23 and 26. The oxygenated blood collected in the left atrium from pulmonary veins 23 and 26 enters the left ventricle 3 through the mitral valve 6. In some patients, the wall of the left atrium 2 is slightly thicker than the wall of the right atrium 5. Deoxygenated blood enters the right atrium 5 via the inferior vena cava 29 and superior vena cava 19. This deoxygenated blood is then pumped to the pulmonary arteries surrounding the lungs. Here, fresh oxygen enters the bloodstream, and the blood moves to the left side of the heart via the network of pulmonary veins that ultimately terminate in the left atrium 2, as shown.

[0088] The pulmonary veins 23 and 26 are generally located on or near the posterior wall of the left atrium (atrium 2). The right pulmonary veins 21 and 23 carry blood from the right lung to the left atrium, where it is distributed to the rest of the circulatory system, as described in detail herein. The right pulmonary veins include the right inferior pulmonary vein 21 and the right superior pulmonary vein 23, as shown. Meanwhile, the left pulmonary veins 25 and 27 generally include the left inferior pulmonary vein 25 and the left superior pulmonary vein 27. The left pulmonary veins generally carry blood from the left lung to the left atrium (atrium 2), where it continues to flow to other parts of the body.

[0089] Heart failure

[0090] As mentioned above, certain physiological conditions or parameters related to cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, leading to increased fluid pressure in one or more chambers of the heart. As a result, the heart is unable to pump enough oxygen to meet the body's needs. The various chambers of the heart respond to increased pressure by stretching to accommodate more blood to pump through the body or by becoming relatively stiff and / or thickened. The heart walls eventually weaken and become unable to pump effectively. In some cases, the kidneys can respond to cardiac inefficiency by causing the body to retain fluid. Fluid buildup in the arms, legs, ankles, feet, lungs, and / or other organs can lead to congestion in the body, a condition known as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and death, therefore, the treatment and / or prevention of congestive heart failure is a major concern in medical care.

[0091] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures, such as monitoring left atrial pressure. As mentioned above, pressure buildup in one or more chambers or regions of the heart can 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 infer, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or methods that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring weight, chest impedance, right cardiac catheterization, etc.

[0092] In some solutions, pulmonary capillary wedge pressure can be measured as an alternative to left atrial pressure. For example, a pressure sensor can be placed or implanted in the pulmonary artery, and its associated readings can be used as a substitute for left atrial pressure. However, catheter-based pressure measurements in the pulmonary artery or certain other chambers or regions of the heart may require the use of invasive catheters to maintain such pressure sensors, which can be uncomfortable or difficult to implement. Furthermore, certain lung-related conditions can affect pressure readings in the pulmonary artery, causing the correlation between pulmonary artery pressure and left atrial pressure to be undesirably weakened. As an alternative form of pulmonary artery pressure measurement, pressure measurements in the right ventricular outflow tract can also be correlated with left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough for the diagnosis, prevention, and / or treatment of congestive heart failure.

[0093] Other methods can be employed to obtain or infer left atrial pressure. For example, the E / A ratio can be used as an alternative for measuring left atrial pressure. The E / A ratio is an indicator of left ventricular function, representing the ratio of peak velocity blood flow due to gravity during early diastole (E wave) to peak velocity blood flow due to atrial contraction during late diastole (A wave). The E / A ratio can be determined using echocardiography or other imaging techniques; generally, an abnormal E / A ratio may indicate inadequate left ventricular filling during the intersystolic phase, which can lead to symptoms of heart failure, as described above. However, the E / A ratio determination generally does not provide an absolute pressure measurement.

[0094] Various methods for diagnosing and / or treating congestive heart failure involve observing worsening symptoms and / or weight changes. However, these signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements may vary significantly (e.g., up to 9% or higher) and may be unreliable in signaling of cardiac-related complications. Furthermore, treatment guided by monitoring signs, symptoms, weight, and / or other biomarkers has not shown substantial improvement in clinical outcomes. Additionally, for discharged patients, such treatment may require telemedicine systems.

[0095] This disclosure provides systems, devices, and methods for guiding drug administration in connection with the treatment of congestive heart failure by at least in part directly monitoring pressure in the left atrium or other chambers or blood vessels (whose pressure measurements indicate left atrial pressure), in order to reduce readmissions, morbidity, and / or otherwise improve the health prospects of patients at risk of heart failure.

[0096] Cardiac stress monitoring

[0097] Cardiac pressure monitoring according to embodiments of this disclosure can provide a proactive intervention mechanism for the prevention or treatment of congestive heart failure. Generally, an increase in ventricular filling pressure associated with diastolic and / or systolic heart failure can occur before the onset of symptoms leading to hospitalization. For example, in some patients, cardiac pressure indicators may appear several weeks prior to hospitalization. Therefore, the pressure monitoring system according to embodiments of this disclosure can be advantageously implemented to reduce hospitalizations by guiding the appropriate or desired titration and / or administration of medications prior to the onset of heart failure.

[0098] Dyspnea represents a cardiac stress indicator, characterized by shortness of breath or a feeling of inadequacy. Dyspnea may be caused by elevated atrial pressure, which can lead to fluid buildup in the lungs due to pressure back-up. Pathological dyspnea can be caused by congestive heart failure. However, a significant time can pass between the initial pressure rise and the onset of dyspnea, so the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to embodiments of this disclosure, normal ventricular filling pressure can be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0099] As mentioned above, regarding cardiac pressure, elevated pressure in the left atrium may be particularly associated with heart failure. Figure 3 Examples of pressure waveforms associated with various chambers and vessels of the heart, according to one or more embodiments, are provided. Figure 3The various waveforms in the examples can represent waveforms obtained by using right cardiac catheterization to advance one or more pressure sensors into the corresponding, illustrative, and labeled chambers or vessels of the heart. For example... Figure 3 The example waveform 325, representing left atrial pressure, can be considered the best feedback for early detection of congestive heart failure. Furthermore, there is generally a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0100] Left atrial pressure generally correlates well with left ventricular end-diastolic pressure. However, while a significant correlation can exist between left atrial pressure and pulmonary artery end-diastolic pressure, this correlation weakens when pulmonary vascular resistance is elevated. That is, in the presence of various acute conditions (including some patients with congestive heart failure), pulmonary artery pressure is generally not sufficiently correlated with left ventricular end-diastolic pressure. For example, pulmonary hypertension, which affects approximately 35–83% of patients with heart failure, can influence the reliability of pulmonary artery pressure measurements used to estimate left filling pressure. Therefore, pulmonary artery pressure measurements alone, as shown in waveform 326, may be an inadequate or inaccurate indicator of left ventricular end-diastolic pressure, particularly 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.

[0101] and Figure 3 Compared to other pressure waveforms shown, left atrial pressure readings are relatively less likely to be distorted or affected by other conditions, such as respiratory status. Overall, left atrial pressure can significantly predict heart failure, up to two weeks before the onset of heart failure. For example, an increase in left atrial pressure, and in both diastolic and systolic heart failure, may occur several weeks before hospitalization; therefore, awareness of this increase can be used to predict the onset of congestive heart failure.

[0102] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide a mechanism to guide medication administration for the treatment and / or prevention of congestive heart failure. Such treatment can advantageously reduce readmissions and morbidity, as well as provide other benefits. Implantable pressure sensors according to embodiments of this disclosure can be used to predict heart failure up to two weeks or more before the onset of symptoms or signs of heart failure (e.g., dyspnea). When predictive indicators of heart failure are identified using cardiac pressure sensor embodiments according to this disclosure, certain preventative measures, including pharmacological interventions such as modifying a patient's medication regimen, can be implemented, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium can advantageously provide an accurate indication of pressure buildup that can lead to heart failure or other complications. For example, trends in elevated atrial pressure can be analyzed or utilized to identify or predict the onset of cardiac dysfunction, where medications or other therapies can be added to result in pressure reduction and prevention or reduction of further complications.

[0103] Figure 4 Figure 300 is illustrated, showing the range of left atrial pressure, including a normal range 301 of left atrial pressure that is not generally associated with a significant risk of postoperative atrial fibrillation, acute kidney injury, myocardial injury, heart failure, and / or other health conditions. Embodiments of this disclosure provide systems, apparatus, and methods for determining whether a patient's left atrial pressure is within the normal range 301, above the normal range 303, or below the normal range 302. For detecting left atrial pressure above the normal range—which may be associated with an increased risk of heart failure—implementations of this disclosure, as described in detail below, can inform efforts to reduce left atrial pressure until it reaches within the normal range 301. Furthermore, for detecting left atrial pressure below the normal range 301—which may be associated with an increased risk of acute kidney injury, myocardial injury, and / or other health complications—implementations of this disclosure, as described in detail below, can facilitate efforts to increase left atrial pressure to bring the pressure level within the normal range 301.

[0104] Cardiac implant sensor system

[0105] Embodiments of this disclosure provide systems, apparatus, and methods for determining and / or monitoring fluid pressure and / or other physiological parameters or conditions in the left atrium using one or more implantable sensor devices (such as permanently implantable sensor devices). By placing the permanent sensor monitoring device directly in the left atrium, embodiments of this disclosure can advantageously allow physicians and / or technicians to collect real-time cardiac information, including left atrial pressure values ​​and / or other valuable cardiac parameters.

[0106] For the purpose of reducing the risk of heart failure and / or other health complications, publicly available protocols for monitoring and / or controlling cardiac pressure and / or compliance within one or more atrial chambers may be implemented in conjunction with a pressure monitoring system. Figure 5 A system 500 for monitoring pressure and / or other parameters (one or more) according to an embodiment of this disclosure is illustrated. Although this document... Figure 5 The descriptions of other implementation methods are generally presented in the context of pressure monitoring, but it should be understood that the descriptions of pressure monitoring herein can be applied to the monitoring of other physiological parameters.

[0107] Figure 5 A system 500 for monitoring pressure (e.g., left atrial pressure) within a patient 515 is illustrated according to one or more embodiments. The patient 515 may have a pressure sensor implantation device 510 implanted, for example, in the patient's heart (not shown) or a related physiological structure. 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 microelectromechanical systems (MEMS) devices, such as MEMS pressure sensors, etc.

[0108] In some embodiments, the monitoring system 500 may include at least two subsystems, including an implantable internal subsystem or device 510 comprising sensor transducers (one or more) 512 (e.g., MEMS pressure sensors (one or more)) and control circuitry 514 comprising one or more microcontrollers, discrete electronic components (one or more), and one or more power and / or data transmitters 518 (e.g., antenna coils). The monitoring system 500 may further include an external (e.g., non-implantable) subsystem comprising an external reader 550 (e.g., a coil) that may include a wireless transceiver electrically and / or communicatively coupled to a control circuit. In some embodiments, both the internal and external subsystems include corresponding antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implantation device 510 may be any type of implantation device.

[0109] Certain details of the sensor implantation device 510 are illustrated in the enlarged block 510 shown. The sensor implantation device 510 may include an anchoring structure 520, as described herein. For example, the anchoring structure 520 may include one or more stent-type anchors for anchoring in one or more pulmonary veins, as described in more detail below. The anchoring structure may further include one or more arm / bridge structures that physically attach the sensor housing 516 to one or more stents or other tissue and / or vascular anchors. Although some components are... Figure 5 The components are exemplified as part of sensor implantation device 510, but it should be understood that sensor implantation device 510 may include only a subset of the illustrated components / modules and may include additional components / modules not illustrated. Sensor implantation device 510 includes one or more sensor transducers 512, which can be configured to provide a response indicative of one or more physiological parameters of the patient 515, such as atrial pressure and / or volume. Although a pressure transducer is described, sensor transducers (one or more) 512 may include any suitable or desired type of sensor transducer (one or more) to provide signals regarding physiological parameters or conditions associated with sensor implantation device 510.

[0110] Sensor transducers (one or more) 512 may include one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / strain gauges, accelerometers, gyroscopes, and / or other types of sensors, which may be positioned within the patient 515 to sense one or more parameters related to the patient's health status. Transducer 512 may be a force-harvesting type pressure sensor. In some embodiments, transducer 512 includes a diaphragm, piston, Bolden tube, bellows, or other strain or deflection measurement assembly (one or more) to measure strain or deflection applied to its area / surface. Transducer 512 may be associated with sensor housing 516 such that at least a portion of it is contained within or attached to housing 516. The term "associated with" is used herein in its broad and conventional sense. Regarding the "associated" sensor device / assembly with an anchor or other implant structure, this term may refer to the sensor device or assembly being physically connected, attached, connected, or integrated with the anchor or other implant structure.

[0111] In some embodiments, transducer 512 includes or is an assembly of a piezoresistive strain gauge, which can be configured to detect strain caused by applied pressure using a bonded or formed strain gauge, wherein the resistance increases as the pressure deforms the assembly / material. Transducer 512 can include any type of material, including but not limited to silicon (e.g., single crystal), polycrystalline silicon thin films, bonded metal foils, thick films, silicon-on-sapphire, sputtered thin films, etc.

[0112] In some embodiments, transducer 512 includes or is an assembly of a capacitive pressure sensor, which includes a membrane and a pressure chamber configured to form a variable capacitor to detect strain caused by pressure applied to the membrane. The capacitance of the capacitive pressure sensor may decrease generally as pressure deforms the membrane. The membrane may include any material (one or more), including but not limited to metals, ceramics, silicon, or other semiconductors. In some embodiments, transducer 512 includes or is an assembly of an electromagnetic pressure sensor, which may be configured to measure displacement of the membrane by means of changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 512 includes or is an assembly 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).

[0113] In some embodiments, transducer 512 includes or is an assembly of a strain gauge. For example, a strain gauge embodiment may include a pressure-sensitive element on or associated with the exposed surface of transducer 512. In some embodiments, a metal strain gauge is adhered to the sensor surface, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a film or metal foil. Transducer 512 may include any other type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionizing, or other types of strain or pressure sensors.

[0114] In some embodiments, transducers(one or more) 512 are electrically and / or communicatively coupled to control circuitry 514, which may include one or more application-specific integrated circuit (ASIC) microcontrollers or chips. Control circuitry 514 may further include one or more discrete electronic components, such as tuning capacitors.

[0115] In some embodiments, sensor transducers (one or more) 512 may be configured to generate electrical signals that can be wirelessly transmitted to a device outside the patient's body, such as the illustrated local external monitoring system 550. For such wireless data transmission, the sensor implantation device 510 may include radio frequency (RF) transmission circuitry, such as signal processing circuitry, and an antenna 518. The antenna 518 may include an internal antenna coil or other structure implanted within the patient's body. Control circuitry 514 may include any type of transducer circuitry configured to transmit electromagnetic signals, wherein the signals may be radiated by the antenna 518, which may include one or more conductive filaments, coils, plates, etc. Control circuitry 514 of the sensor implantation device 510 may include, for example, one or more chips or dies configured to perform a certain amount of processing on the signals generated and / or transmitted using the device 510. However, due to size, cost, and / or other limitations, the sensor implantation device 510 may not include independent processing capabilities in some embodiments.

[0116] The wireless signals generated by the sensor implantation device 510 can be received by a local external monitoring device or subsystem 550, which may include a transceiver module 553 configured to receive wireless signal transmissions from the sensor implantation device 510, which is at least partially disposed within the patient 515. The external local monitor 550 may utilize an external antenna 555 (such as a wand-type device) to receive wireless signal transmissions and / or provide wireless power. The transceiver 553 may include radio frequency (RF) front-end circuitry configured to receive and amplify signals from the sensor implantation device 510, wherein such circuitry may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuitry, phase-locked loop (PLL) circuitry, signal mixers, etc. The transceiver 553 may be further configured to transmit signals to a remote monitoring subsystem or device 560 via a network 575. The RF circuitry of transceiver 553 may further include one or more of the following: digital-to-analog converter (DAC) circuitry, power amplifier, low-pass filter, antenna switch module, antenna, etc., to process / manipulate signals transmitted via network 575 and / or receive signals from sensor implantation device 510. In some embodiments, local monitor 550 includes control circuitry 551 for processing signals received from sensor implantation device 510. Local monitor 550 may be configured to communicate with network 575 according to known network protocols such as Ethernet, Wi-Fi, etc. In some embodiments, local monitor 550 is a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0117] In some embodiments, the sensor implantation device 510 includes a quantity of volatile and / or non-volatile data memory. For example, such data memory may include solid-state memory utilizing an array of floating-gate transistors. Control circuitry 514 may utilize the data memory to store sensing data collected over a period of time, wherein the stored data may be periodically transmitted to a local monitor 550 or other external subsystems. In some embodiments, the sensor implantation device 510 does not include any data memory. Control circuitry 514 is configured to facilitate the wireless transmission of data generated by the sensor transducer(s) 512 or other data associated therewith. Control circuitry 514 may be further configured to receive input from one or more external subsystems (such as from a local monitor 550, or from a remote monitor 560 via, for example, a network 575). For example, sensor implantation device 510 may be configured to receive signals that at least partially control the operation of sensor implantation device 510—such as by activating / deactivating one or more components or sensors, or otherwise influencing the operation or performance of sensor implantation device 510.

[0118] The one or more components of the sensor implantation device 510 may be powered by one or more power sources 540. Due to considerations of size, cost, and / or electrical complexity, the power source 540 is expected to be relatively simple in nature. For example, driving high-power voltages and / or currents in 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 some embodiments, the power source 540 is at least partially passive, allowing power to be received wirelessly from an external (electrical) source via the passive circuitry of the sensor implantation device 510. Examples of wireless power transfer technologies that can be implemented include, but are not limited to, short-range or near-field wireless power transfer, or other electromagnetic coupling mechanisms (one or more). For example, a local monitor 550 may act as an initiator of an actively generated RF field that can provide power to the sensor implantation device 510, thereby allowing the power circuitry of the implantation device to employ a relatively simple form factor. In some embodiments, the power source 540 may be configured to harvest energy from environmental sources such as fluid flow, motion, pressure, etc. Alternatively or additionally, the power supply 540 may include a battery, which may be advantageously configured to provide sufficient power as needed during relevant monitoring.

[0119] In some embodiments, the local monitor device 550 may act as an intermediate communication device between the sensor implantation device 510 and the remote monitor 560. The local monitor device 550 may be a dedicated external unit designed to communicate with the sensor implantation device 510. For example, the local monitor device 550 may be a wearable communication device or other devices that can be easily positioned near the patient 515 and / or the sensor implantation device 510. The local monitor device 550 may be configured to continuously, periodically, or occasionally query the sensor implantation device 510 to extract or request sensor-based information. In some embodiments, the local monitor 550 includes a user interface through which a user can view sensor data, request sensor data, or otherwise interact with the local monitoring system 550 and / or the sensor implantation device 510.

[0120] System 500 may include an auxiliary local monitor 570, which may be, for example, a desktop computer or other computing device—configured to provide a monitoring station or interface for viewing and / or interacting with the monitored cardiac data. In one embodiment, local monitor 550 may be a wearable device or other device or system—configured to be positioned physically very close to the patient and / or sensor implantation device 510, wherein local monitor 550 is primarily designed to receive / transmit signals to and / or from sensor implantation device 510 and provide such signals to auxiliary local monitor 570 for its viewing, processing, and / or manipulation. External local monitoring system 550 may be configured to receive and / or process some metadata, such as a device ID, from or associated with sensor implantation device 510, which may also be provided via data coupling from sensor implantation device 510.

[0121] The remote monitoring subsystem 560 can be any type of computing device or set of computing devices configured to receive, process, and / or display monitoring data received via network 575 from local monitoring device 550, auxiliary local monitoring device 570, and / or sensor implantation device 510. For example, the remote monitoring subsystem 560 can advantageously be operated and / or controlled by a healthcare entity such as a hospital, physician, or other care entity associated with patient 515.

[0122] In some embodiments, the antenna 555 of the external monitoring system 550 includes an external coil antenna, which is matched and / or tuned to inductively pair with the antenna 518 of the internal implant 510. In some embodiments, the sensor implantation device 510 is configured to receive wireless ultrasonic charging from and / or communicate data with the external monitoring system 550. As described above, the local external monitor 550 may include a stick-type or other handheld reader.

[0123] In some embodiments, at least a portion of the transducer 512, control circuitry 514, power supply 540, and / or antenna 518 is at least partially arranged or contained within a sensor housing 516, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, in some embodiments, the housing 516 may comprise glass or other rigid materials that can provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 516 is at least partially flexible. For example, the housing may comprise polymers or other flexible structures / materials that may advantageously allow the sensor 510 to be folded, bent, or crumpled to allow its transport via a conduit or other percutaneous delivery device.

[0124] The sensor implantation device 510 can be implanted at any location on the body of the patient 515. In some embodiments of this 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. Arranging the sensor implantation device 510 at least partially within the left atrium can advantageously provide the desired location for measuring and / or monitoring left atrial pressure, blood viscosity, temperature, and / or other cardiac parameters (one or more). The sensor implantation device according to one or more embodiments of this disclosure can be implanted using a transcatheter procedure or any other percutaneous procedure. Alternatively, the sensor implantation device according to aspects of this disclosure can be positioned during open-heart surgery (e.g., sternotomy), microsternotomy, and / or other surgical procedures.

[0125] The various embodiments illustrated in the accompanying drawings and described herein include a variety of features. It should be understood that a given embodiment may not include all features exemplified or described in connection with that embodiment, and may include one or more other features shown or described in connection with one or more other embodiments. That is, features of the exemplary and / or described embodiments of this disclosure may be combined in any desired combination within the scope of this disclosure.

[0126] In some of the accompanying drawings of this disclosure, for convenience, specific reference numerals may be reused for devices and modules that have similar features in one or more aspects. However, the reuse of common reference numerals in the drawings does not necessarily indicate that such features, devices, components, or modules are identical.

[0127] Sensor implantation device and method

[0128] Figure 6The figure illustrates a sensor implantation device 610, which is at least partially implanted within the left atrium 2, such that its sensor assembly 616 can be advantageously positioned and / or arranged to determine or acquire sensor signals indicative of one or more physiological parameters associated with the sensor device 610 and / or the left atrium 2. In some embodiments, the sensor implantation device 610 may be advantageously anchored to one or more anatomical features / locations associated with the left atrium 2. For example, the sensor implantation device 610 may include one or more anchors and / or other features configured to be anchored at, within, or near one or more locations in the left pulmonary vein 26 and / or the right pulmonary vein 23. With the sensor assembly 616 (which may advantageously include or be associated with a sensor transducer / element 612) at least partially exposed within the left atrium 2, the sensor assembly 616 may be able to measure a variety of cardiac parameters (one or more), including but not limited to left atrial pressure, blood viscosity, temperature, and / or others.

[0129] In some embodiments, the sensor implantation device 610 includes a first anchor 622, which may be a scaffold-type anchor—configured to expand to provide friction in the ostium and / or vessel associated with the first pulmonary vein, as shown. The sensor implantation device 610 may further include a second anchor 624, which may be configured and / or designed to be implanted into the ostium or vessel associated with the second pulmonary vein, as shown. For example, the anchor 624 may include a scaffold-type anchor, or a barbed or other type of anchor, configured to be at least partially embedded in biological tissue at or near the target implantation site.

[0130] The sensor implantation device 610 further includes one or more arms or support structures for positioning the sensor assembly 616 at a desired implantation location and / or securing the sensor assembly 616 to one or more anchoring features of the sensor implantation device 610. For example, as shown, arm portion 633 may advantageously secure the sensor assembly 616 to a first anchor 622, while arm portion 631 may support or secure the sensor assembly 616 to a second anchoring feature 624.

[0131] Figure 7A sensor implantation device 710 is illustrated, which is implanted in one or more vessels 701, 702 of a patient's anatomical structure (such as cardiac anatomy), as described in detail herein. The sensor implantation device 710 advantageously includes sensor elements, units, and / or modules 716, which may be associated with sensor transducer elements 712. For example, the sensor transducer element 712 may be advantageously arranged and / or attached to the outward-facing surface of the sensor module 716, such that exposure of physiological parameters associated with the environment exposed to the outward-facing surface of the sensor module 716 can be determined by the sensor transducer 712 and / or converted into a form that can be interpreted and / or indicate one or more physiological parameters associated with the implantation site of the sensor implantation device 710. The sensor module 716 may be anchored or implanted / secured in any suitable or desired manner. For example, in some embodiments of this disclosure, the sensor element is physically and mechanically coupled to one or more anchoring devices via one or more arm or bridge features 730. For example, the illustrated implantation device 710 includes a first arm member portion 731 and a second arm or member portion 733, each of which can be coupled to a corresponding anchoring device, as shown. In some embodiments, the arm member portions 731, 733 are integral in form or part of a structure. That is, the sensor module 716 can advantageously be mechanically or physically coupled to the bridge structure 730, wherein the portion of such bridge structure on the corresponding side of the sensor module 716 is... Figure 7 These are referred to as arm component parts 731 and 733, respectively.

[0132] The implantable device 710 described above may advantageously include one or more anchoring devices configured to be anchored in or to a vasculature or conduit such as a blood vessel or associated orifice. Certain embodiments of this disclosure are described in the context of stent-type anchoring devices, which... Figure 7 Other example figures related to this disclosure are illustrated as example conduit anchors. As described in detail herein, in some embodiments, the sensor implantation device 710 may be anchored to one or more pulmonary veins and / or other cardiac vessels and / or therein to advantageously secure the sensor module 716 in a location at least partially exposed to the left atrium and / or other chambers of the heart. For example, conduit 701 may represent a first pulmonary vein, while conduit 702 may represent a second pulmonary vein. In some embodiments, a first anchoring device associated with the sensor implantation device may be implanted or anchored to a pulmonary vein, while a second anchoring device associated with the sensor implantation device may be implanted or anchored in another manner / configuration (such as by embedding into tissue, etc.).

[0133] While some embodiments disclosed herein describe stent-type anchor devices (one or more), it should be understood that any type / configuration of anchor device can be implemented according to embodiments of this disclosure. For example, in some embodiments, other expandable anchoring forms or devices, such as preformed wireforms, struts, clamps, and / or other anchor devices (one or more), can be implemented. As described in detail herein, the use of stent-type anchors can advantageously allow blood flow through the anchor (one or more) within the pulmonary veins (one or more) to the left atrium, such that the functionality / flow of the pulmonary veins (one or more) is substantially unaffected or unobstructed. In some embodiments, relative clamps or arms—configured to present outward and / or inward radial forces relative to each other—can be used to secure a sensor implantation device according to embodiments of this disclosure at a desired location. For example, the illustrated anchor devices 722, 724 may each provide an outward radial force relative to the central axis of the respective anchor device to secure the respective implantation device within its target blood vessel. Furthermore, each of the arm portions 731, 733 may be further pre-shaped and / or otherwise configured to present outward and / or inward radial forces to further secure the implantation device 710 in the desired position when fixed to the blood vessels 701, 702.

[0134] One or both of the anchor devices 722, 724 may advantageously be at least partially self-expanding, which provides a relatively simple deployment process for the respective anchoring element. Additionally or alternatively, one or both of the anchoring element devices 722, 724 may be balloon-expandable and / or expandable using other devices or mechanisms. Although in Figure 7 Two anchoring devices are shown in certain other figures related to this disclosure; however, it should be understood that in some embodiments, the sensor implantation device 710 is associated with one or more anchoring devices. For example, in some important notations, the sensor implantation device 710 has three or more anchoring devices, each associated with a separate arm / component portion that is attached to the sensor module 716, either indirectly or directly, in any suitable or desired manner.

[0135] Figure 8 A top-down view of the left atrium 2 is shown, in which a sensor implantation device 810 according to one or more embodiments of the present disclosure is implanted. Figure 8 The sensor implantation device 810 shown includes various features that can be incorporated into any of the disclosed embodiments. For example, the sensor implantation device 810 may include a sensor assembly 816, an arm member(s) / structure(s) / structure(s) 830 and / or anchors 822, 824, as described in detail herein.

[0136] As described in detail herein, the tissue anchoring component or portion of a sensor implantation device according to embodiments of this disclosure may include any suitable or desired form or mechanism, including any known tissue anchoring device or mechanism. Figure 8 In the illustrated embodiment, the sensor implantation device 810 advantageously includes expandable anchors 822, 824 associated with the proximal and distal portions of the sensor implantation device 810. One or both of the anchors 822, 824 may be tension / resistance type anchors, such as stents or similar structures or devices. For example, one or both of the anchors 822, 824 may be expanded within the corresponding pulmonary veins 825, 827, as shown.

[0137] In embodiments where the sensor implantation device 810 is anchored to more than one pulmonary vein, such as... Figure 8 In this configuration, bridge / arm components (one or more) / structures (one or more) 830 may be configured to span the distance between pulmonary veins (e.g., adjacent pulmonary veins 822, 824) and / or their orifices, as shown. Bridge / arm components (one or more) / structures (one or more) 830 may be configured to provide an inward radial force relative to the axis of one or both of the anchors 822, 824, thereby providing additional anchoring of the sensor implantation device 810 to the pulmonary vein.

[0138] exist Figure 8 In this embodiment, a first anchoring stent 822 is deployed in a first pulmonary vein 827, wherein, according to embodiments of the present disclosure, the stent 822 is associated with and / or connected to an end of a bridge / arm structure 830. The first anchor 822 is coupled to a second anchor 824, which is deployed within an adjacent pulmonary vein 824, wherein the first anchor 822 and the second anchor 824 are connected to each other via a bridge or arm member (one or more) 830, which may be at least partially rigid and / or flexible. In some embodiments, the bridge / arm member (one or more) 830 has shape memory and / or elastic characteristics, which introduce opposing forces to the anchors 822, 824. Any one or both of the anchors 822, 824 may be self-expanding stents. The use of two anchors can act to provide improved anchoring for a sensor implantation device according to embodiments of the present disclosure.

[0139] Figure 9A and 9B A front view and a side view of a sensor implantation device 910 according to one or more embodiments of the present disclosure are shown respectively. Figure 9A and 9BIn the illustrated configuration, the anchoring devices 922, 924 associated with the implantation device 910 are in an expanded state or configuration, wherein the anchoring devices can be configured to be secured within a target implanted blood vessel, such as a pulmonary vein, by means of a force applied by the respective anchoring device in the illustrated expanded configuration. For example, the anchoring devices 922, 924 may advantageously have an expanded configuration, wherein the diameter or other dimension D is set to be approximately equal to or slightly larger than the diameter of the pulmonary vein lumen at one or more of its longitudinal portions.

[0140] Anchoring devices 922, 924 can advantageously be self-expanding, or balloon-expandable, or otherwise configurable or expandable for fixation within a blood vessel such as the pulmonary vein. Similar to other embodiments exemplified and described herein, anchoring devices 922, 924 can each be physically / mechanically coupled to sensor module 916 using any suitable or desired direct and / or indirect attachment mechanism. Figure 9A and 9B In the example embodiments, the anchoring devices are at least partially secured to the sensor module 916 (e.g., the housing of the sensor transducer element 912) via one or more arm portions / components 931, 933, respectively. As with any other embodiment disclosed herein, the arm portions 931, 933 of the various examples and annotations may be part of a single bridge / arm structure to which the sensor module 916 is directly and / or indirectly secured.

[0141] Sensor module 916 may include a housing for sensor transducer element 912. For example, sensor transducer element 912 may be nested, secured to, or otherwise attached or coupled to one or more portions of bridge structure 930. In some embodiments, sensor module 916 has associated channels, recesses, and / or paths 938 configured and / or sized to hold or otherwise engage guidewires or other delivery system components therein. For example, in some embodiments, a guidewire may be extended or advanced through channels or other paths or features associated with module 916, such that sensor implantation device 910 may be advanced along a path defined by a pre-arranged guidewire according to procedures associated with aspects of this disclosure. Additionally or alternatively, module 916 may include one or more features configured and / or designed to allow module 916 to engage with one or more portions of bridge structure 930. Although bracket-type anchor devices 922, 924 are shown—which can be understood to represent self-expanding bracket-type anchor devices—in some embodiments, anchor devices 922, 924 can be any type of anchor device described herein.

[0142] Figure 10A and 10B Examples were given respectively. Figure 9A and9B The front and side views of the sensor implantation device 910 shown indicate that one or more components of the sensor implantation device 910 are configured in a wrinkled or folded state, which can be implemented to facilitate delivery of the implantation device 910 using a catheter-based delivery system, as described in more detail below. Specifically, Figure 10A and 10B The illustrated embodiments show bracket-type anchoring devices 922, 924 in at least a partially wrinkled / creased state. For example, bracket-type anchoring devices or other types of anchoring devices may include wireframes or other wire-type and / or mesh structures that may exhibit a wrinkled and / or reduced diameter state—through compression and / or elongation of the structure. For example, such compression can be achieved by radially, axially, and / or circumferentially compressing or expanding the expandable strut feature of the anchoring element (one or more). In some embodiments, this compression / expansion of the strut can result in at least partial elongation of the bracket structure relative to its central axis. The compressed anchoring elements 922, 924 may have a compression diameter d, which is smaller than the expansion diameter D.

[0143] Figure 11 A partial cross-sectional view of a delivery system 100 for a sensor implantation device 110 according to one or more embodiments of the present disclosure is shown. In some embodiments, the delivery system 100 includes one or more catheters or sheaths for advancing and / or implanting the sensor implantation device 110, which may be at least partially disposed within the delivery system 100 during the associated delivery process. The implanted sensor device 110 may be positioned within the delivery system 100 with its first end (i.e., distal anchor 122) disposed distally relative to a sensor module 116, and a second / proximal anchor 124 disposed at least partially proximal relative to the sensor module 116. The distal anchor device 122 and the proximal anchor device 124 may be coupled to the sensor module 116 via one of the fixation arm portions 131, 133, respectively.

[0144] In some embodiments, the delivery system 100 includes an external catheter or shaft 140 for delivering the sensor implantation device 110 to a target implantation site. Specifically, the sensor implantation device 110 can be advanced at least partially within the lumen of the external shaft 140 to the target implantation site, such that the sensor implantation device 110 is at least partially held and / or secured within the distal portion of the external shaft 140. In some embodiments, the delivery system 100 includes a tapering nasal cone feature 148 that facilitates advancement of the distal end of the delivery system 100 through the patient's tortuous anatomy and / or using an external delivery sheath or other conduit / pathway. The nasal cone 148 can be a separate component from the external shaft 140 or can be integrated with the external shaft 140. In some embodiments, the nasal cone 148 is adjacent to and / or integrated with the distal end of the external shaft 140. In some embodiments, for example, the nasal cone tapers distally into an overall conical shape and may include and / or be formed of multiple flap-type forms that can be pushed open / spread out as the sensor implantation device 110 and / or any part thereof, inner shaft or device is advanced through it.

[0145] The delivery system 100 may be further configured to have a guide wire 150 arranged at least partially within and / or connected to the delivery system 100 in a manner that allows the delivery system 100 to follow a path defined by the guide wire 150. The distal anchoring device 122 may be included in and / or secured to the outer shaft 140, such as... Figure 11 Example.

[0146] The delivery system 100 may further include a distal inner shaft 142, which is at least partially disposed within the outer shaft 140 and proximal to the distal anchoring device 122, such that the distal inner shaft 142 can provide support for the distal anchoring device 122. Furthermore, the distal inner shaft 142 may be configured to push / advance the distal anchoring device 122 and the remaining components of the implantation device 110 coupled thereto relative to the outer shaft 140. Thus, by advancing the distal inner shaft 142 distally relative to the outer shaft 140, the distal anchoring device 122 and the sensor implantation device 110 can be advanced and / or deployed distally through the distal opening in the outer shaft 140. Although the distal anchoring device 122 is disposed at least partially without the distal inner shaft 142 and / or distal thereto, one or more other components of the sensor implantation device 110 may be at least partially maintained, contained, and / or disposed within the inner shaft 142 during one or more stages of the delivery process, such as... Figure 11 Example. For example, sensor module 116 (which may have an associated sensor transducer element 112, as described in detail herein), and one or more portions of bridge / arm structures 131, 133 and / or proximal anchor 124 may be at least partially contained within distal inner shaft 142.

[0147] The delivery system 100 may further include a proximal inner shaft 144, which is at least partially disposed within the distal inner shaft 142 and the outer shaft 140 and proximal to the sensor module 116, such that the proximal inner shaft 144 can provide support for the sensor module 116. Furthermore, the proximal inner shaft 144 may be configured to push / advance the sensor module 116 and / or other components of the associated sensor implantation device 110 relative to the distal inner shaft 142 and / or the outer shaft 140. Although the sensor module 116 is disposed at least partially without the proximal inner shaft 144 and / or distal to it, one or more other components of the sensor implantation device 110 may be at least partially contained within or disposed within the proximal inner shaft 144 during one or more periods of the delivery process, such as... Figure 11 Example. For instance, the proximal portion 133 of the bridge / arm structure 130 and the proximal anchoring device 124 may be at least partially contained within the proximal inner shaft 144. In some embodiments, the proximal portion 133 of the bridge / arm structure 130 may be configured in a at least partially curved configuration within the proximal inner shaft 144 and / or other components (one or more) of the delivery system 100, such that the proximal anchoring device 124 is held in a cramped / shrunken state within the proximal inner shaft 144 and / or in a position such that the end of the proximal anchoring device 124 faces distally and in a similar orientation to the distal anchoring device 122.

[0148] The delivery system 100 may further include a proximal anchor actuator device 146 configured to be arranged to abut and / or contact the proximal anchor 124 and / or associated structures (e.g., arm portion 133 directly or indirectly coupled to the proximal anchor device 124) to allow pushing and / or controlling / manipulating the proximal anchor device 124. For example, the proximal anchor actuator device 146 may include a tubular form in which a cavity is defined, such as... Figure 11 Example. Optionally, in some embodiments, the proximal anchor pusher support 124 may not include an internal axial cavity, but may instead provide a different type of support. Figure 11 The examples are essentially solid forms and / or other shapes or configurations.

[0149] The proximal anchor pusher support 146 may be at least partially arranged and / or included within one or more of the outer shaft 140, the distal inner shaft 142, and / or the proximal inner shaft 144, and may further arrange one or more components of the sensor implantation device 110 and / or delivery system 100 within its cavity during various stages of the relevant implantation procedure. For example, in some embodiments, during one or more stages of the medical procedure for implanting the sensor implantation device 110, the guidewire 150 may be at least partially arranged within the proximal anchor pusher support 146. For example, the delivery system 100 may be configured to be axially advanced along the guidewire 150 during the medical procedure, wherein the guidewire 150 may initially be arranged along a path leading to the target implantation site such that the delivery system can pass over the guidewire 150. In such a procedure(s), the guidewire 150 may be arranged within the proximal anchor pusher support (and / or the proximal inner shaft 144, the distal inner shaft 142, and / or the outer shaft 140).

[0150] Figure 12 is a flowchart illustrating a process 200 for implanting a sensor implantation device at or within a patient's target anatomical structure, such as one or more cardiac chambers or blood vessels in the patient's heart. Figure 13 illustrates images of cardiac anatomy and the delivery system and sensor implantation device components, corresponding to the various operations described in the flowchart of Figure 12. For example, Figure 13 illustrates an implementation of the delivery system and sensor implantation device, which could be... Figure 11 The delivery system 100 and sensor implantation device 110 shown and described in detail above are exemplary embodiments, and therefore similar reference numerals are used for convenience. FIG14 illustrates front and side views of the sensor implantation device 110 in various configurations corresponding to the corresponding operations of process 200 of FIG12.

[0151] Process 200 involves one or more medical procedures that at least partially implant a sensor implantation device 110 into the left atrium 2 of a patient's heart using a suitable delivery system 100. In some embodiments, process 200 may be performed in conjunction with a mitral valve replacement or repair procedure, or other surgical or transcatheter medical procedures requiring access to the left atrium. Therefore, although certain procedures (one or more) for accessing the left atrium have been described, it should be understood that left atrial access using the delivery system according to embodiments of this disclosure can be performed in any suitable or desired manner. For example, such access may be performed using a minimally invasive procedure or a surgical procedure that incorporates access to the heart through the chest wall (e.g., according to an open-chest procedure).

[0152] In block 202, procedure 200 involves advancing the delivery system / catheter 100 into the right atrium 5 of a patient's heart using a percutaneous / transcatheter access pathway or procedure. For example, as shown in image 302 of FIG13, access to the right atrium 5 can be made via the superior vena cava 19 or the inferior vena cava 16, wherein access to the venous system can be made by the subclavian vein, femoral vein, or any other venous (or arterial) vessel. As shown in FIG14, when the delivery system 100 is advanced into the right atrium 5, the sensor implantation device 110 can be in a configuration that is at least partially wrinkled / folded within the delivery system 100. In some embodiments, as described in detail herein, one or more of the distal anchor device 122 and / or the proximal anchor device 124 can be axially folded inward toward the axial center of the sensor implantation device 110, as shown in image 111 with respect to the proximal anchor 124.

[0153] In block 204, process 200 involves advancing delivery system 100 through interatrial septum 18—which separates the right atrium 5 from the left atrium 2—so that the delivery system can enter the left atrium 2, as shown in image 102 of FIG13. As described herein, such access to the left atrium 2 can be made via other access routes, and image 102 illustrates one specific access route for illustrative and simplification purposes. Operation block 204 can be performed while the sensor implantation device 110 remains in at least a partially compressed configuration as shown in image 113.

[0154] In block 206, process 200 involves advancing the delivery system 100 into, and within, and / or near the pulmonary vein 26, which is fluidly connected to the left atrium 2, as described in detail above. Although image 103 shows the delivery system 100 being advanced into the left superior pulmonary vein 26, it should be understood that such a vein is presented in image 103 for illustrative purposes only, and any other pulmonary vein or other cavity or vessel may be engaged by the delivery system 100 according to embodiments of this disclosure.

[0155] In block 208, process 200 involves deploying the distal anchoring device 122 of the sensor implantation device 110 into and / or into the target pulmonary vein 26 and / or its associated tissue. For example, with respect to stent-type or other expandable tissue anchoring devices, as shown in image 104, the operation associated with block 208 may involve expanding the tissue anchoring device 122 within the conduit / lumen of the pulmonary vein 26. However, alternative anchoring mechanisms or techniques may be implemented, such as anchoring one or more tissue-embedded anchoring devices into the interior of the pulmonary vein conduit, or into the left atrial tissue proximal to the pulmonary vein 26 and / or its orifice.

[0156] As described in detail herein, the distal anchoring device 122 may be coupled or associated with the arm member / part 131—which may be deployed at least partially from the delivery system 100 in conjunction with operations associated with block 208 (and / or block 210, as described below). In conjunction with the deployment of the distal anchoring device 122 in the target pulmonary vein 26, the arm member / part 131 may be at least partially bent or configured to accommodate the distal anchoring device 122, such that the remainder of the sensor implantation device 110 may be oriented in a generally orthogonal / perpendicular direction relative to the axis of the distal anchoring device 122, as shown in accompanying image 117 of FIG14. For example, as shown in image 117, in the case where the distal anchoring device 122 is deployed from the delivery system 100, a portion 114 of the sensor implantation device 110 may be retained and / or maintained within the delivery system 100 after the deployment of the distal anchoring device 122 during the phase of process 200 associated with block 208 (and / or block 210).

[0157] At block 210, process 200 involves withdrawing the delivery system 100 from the pulmonary vein 26 a certain axial distance to move the delivery system 100 and / or its distal end to a second target pulmonary vein 23, within the second target pulmonary vein 23, and / or proximal to the second target pulmonary vein 23. This can thus act to deploy one or more components or portions of the sensor implantation device 110 from the delivery system 100, such as one or more portions or components of the bridge / arm structure (e.g., portion 131) and / or the sensor module 116, as shown in figure 105. With the delivery catheter moved or proximate to the second target pulmonary vein 23, the portion 118 of the sensor implantation device 110 retained within the delivery system may include a proximal anchoring device 124, and / or one or more portions 133 of the bridge / arm structure of the sensor implantation device 110. That is, at the stage associated with the operation of block 210, the sensor implantation device 110 may be in a position / configuration in which the sensor module 116 is deployed from the delivery system 100.

[0158] In block 212, process 200 involves deploying a proximal anchoring device 124 in the second target pulmonary vein 23. For example, the proximal anchoring device 124 may be deployed in and / or engaged with the second target pulmonary vein 23 in any suitable or desired manner, as described in detail herein. For example, the proximal anchoring device 124 may include any suitable or desired type of tissue anchoring or fixation device (one or more), whether expansion-type or tissue embedding / suture-type anchoring device (one or more), and whether anchored to the inner wall of the pulmonary vein 23 and / or to left atrial tissue at or near the ostium of the pulmonary vein 23. When deploying the proximal anchoring device 124 and the pulmonary vein 23, the arm portion 133 of the proximal tissue anchoring device 124, which connects to the remainder of the sensor implantation device 110, may be straight, or otherwise oriented or bent to allow the anchoring device 124 to be substantially coaxial with the pulmonary vein 23, while allowing the remainder of the bridging structure 130 of the sensor implantation device 110 to bridge between the first target pulmonary vein 26 and the second target pulmonary vein 23. Although the second target pulmonary vein 23 is exemplified as corresponding to the right superior pulmonary vein, it should be understood that the second target pulmonary vein can be any suitable or desired pulmonary vein, as described below regarding... Figure 15 , 16 17 and / or 18 are described in detail.

[0159] In box 214, process 200 involves withdrawing the delivery catheter from the patient's heart and / or body, thereby leaving or retaining the sensor implantation device 110 implanted in and / or otherwise engaged with the target pulmonary veins 26, 23, as described above. Therefore, the sensor implantation device 110 can maintain a shape or configuration similar to that shown in image 123 of FIG. 14 after its implantation.

[0160] The above detailed description Figure 6 Examples 1 and 13 illustrate a reference sensor implantation device implanted between the left superior pulmonary vein (distal to the sensor implantation device) and the right superior pulmonary vein (proximal to the sensor implantation device). Furthermore, Figure 8 An example of a sensor implantation device is shown, which is implanted between the left superior pulmonary vein and the left inferior pulmonary vein. However, it should be understood that this particular embodiment is shown for illustrative purposes only, and the sensor implantation device according to embodiments of this disclosure can be implanted between any two pulmonary veins (or other blood vessels), and / or can be implanted and / or fixed to a single pulmonary vein, or three or more pulmonary veins.

[0161] Figure 15 An example is shown of the left atrium 2 and associated anatomical structures, including the pulmonary veins, wherein the sensor implantation device 310 is implanted between the left inferior pulmonary vein 25 and the right superior pulmonary vein 23. Regarding the combination... Figure 15In the implantation procedure, the left lower pulmonary vein 25 or the right upper pulmonary vein 23 can be considered as the distal or proximal end of the sensor implantation device 310. For example... Figure 15 The implantation orientation of the sensor implantation device 310 can be implemented in conjunction with any embodiment of this disclosure, such as any other examples and / or alternative forms of orientation described in relation to the corresponding embodiment.

[0162] Figure 16 An example is shown of the left atrium 2 and associated anatomical structures, including the pulmonary veins, wherein the sensor implantation device 311 is implanted between the left inferior pulmonary vein 25 and the right inferior pulmonary vein 21. Regarding the combination... Figure 16 In the implantation procedure, the left lower pulmonary vein 25 or the right lower pulmonary vein 21 can be considered as the distal or proximal end of the sensor implantation device 311. For example... Figure 16 The implantation orientation of the sensor implantation device 311 can be implemented in conjunction with any embodiment of this disclosure, such as any other examples and / or alternative forms of orientation described in relation to the corresponding embodiment.

[0163] Figure 17 An example is shown of the left atrium 2 and associated anatomical structures, including the pulmonary veins, wherein the sensor implantation device 312 is implanted between the left superior pulmonary vein 27 and the right inferior pulmonary vein 21. Regarding the combination... Figure 17 In the implantation procedure, the left superior pulmonary vein 27 or 7 and the right inferior pulmonary vein 21 can be considered as the distal or proximal end of the sensor implantation device 312. For example... Figure 17 The implantation orientation of the sensor implantation device 312 can be implemented in conjunction with any embodiment of this disclosure, such as any other examples and / or alternative forms of orientation described in relation to the corresponding embodiment.

[0164] Figure 18 An example is shown of the left atrium 2 and associated anatomical structures, including the pulmonary veins, wherein the sensor implantation device 313 is implanted between the right inferior pulmonary vein 21 and the right superior pulmonary vein 23. Regarding the combination... Figure 18 In the implantation procedure, the right lower pulmonary vein 21 or the right upper pulmonary vein 23 can be considered as the distal or proximal end of the sensor implantation device 313. For example... Figure 18 The implantation orientation of the sensor implantation device 313 can be implemented in conjunction with any embodiment of this disclosure, such as any other examples and / or alternative forms of orientation described in relation to the corresponding embodiment.

[0165] Although the various embodiments of this disclosure are described in the context of sensor implantation devices anchored using multiple bracket-type anchors or other types of anchors, it should be understood that sensor devices according to embodiments of this disclosure may be supported and / or anchored by a single bracket-type anchor or other type of anchor. Figure 19AA side deployment view of a sensor implantation device 40 anchored in a blood vessel 35 according to one or more embodiments is shown. Figure 19B An illustration is shown according to one or more embodiments. Figure 19A Axial view of the sensor implantation device 40. Figure 19C An illustration is shown according to one or more embodiments. Figure 19A Side view of the sensor implantation device 40.

[0166] Figures 19A-19C The sensor implantation device 40 shown includes a single scaffold-type anchor 41 to which the sensor device 43 is physically coupled in some way. For example, in some embodiments, a support arm 44 may be attached to and / or integrated with the scaffold frame 41, and the sensor device 43 may be mechanically coupled to the anchor frame 41. In this configuration, the sensor device 43 may extend axially from one end of the anchor frame 41 and may extend into a chamber or blood vessel to which the blood vessel 35 leads, wherein the constituents of blood or other fluids present in such chamber / vessel are sensed by the sensor device 43, such as blood / fluid pressure.

[0167] In some embodiments, the anchor 41 can be anchored within a cardiac blood vessel, such as in the pulmonary vein and / or its orifice, as described in detail herein. In such a configuration, the sensor device 43 can be exposed to blood / fluid within the left atrium, the benefits of which are described in detail above.

[0168] Regarding combination Figure 6-18 Any embodiment shown and described, such as the sensor support arm / support feature in any embodiment of Figures 19-31, may include separate rod-shaped features that are fixed to corresponding bracket-type anchors (or other types of anchors), or they may be integrated with the frame / form of the corresponding anchors. It should be understood that, in conjunction with... Figure 6-18 Any feature of the disclosed sensor implantation device can be implemented in any sensor implantation device disclosed in conjunction with Figures 19-31, and any feature of the sensor implantation device disclosed in conjunction with Figures 19-31 can be implemented in conjunction with... Figure 6-18 Implemented in any publicly disclosed sensor implantation device.

[0169] like Figure 19AAs shown, the sensor device 43 and / or support arm 44 can be radially outwardly deflected relative to the axis of the anchor frame 41, such that the sensor device 43 is substantially parallel to the tissue wall 31 outside the anchoring vessel 35 (e.g., the inner wall of the left atrium), or at an acute angle to the tissue wall 31. The outward deflection of the sensor device 43 and / or support arm 44 can be achieved by manual bending of the support arm, or by autonomous movement / deflection of the sensor support arm 44 caused by the shape memory characteristics / features of the arm 44. In some embodiments, the sensor support arm 44 can be integrally formed with the anchor frame 41. For example, the support arm 44 can extend from one or more pillars or extension features of the support frame 41. Such features can be laser-cut from a sheet of metal / form to form an expandable support frame and a sensor support arm / extension extending from that frame—an extension / feature integral thereto.

[0170] Figure 19B An axial view of the sensor implantation device 40 is shown, wherein the sensor device 43 and / or the sensor support arm 44 are radially outwardly deflected. When implanted, the sensor transducer element / part 45 of the sensor device 43 can be exposed outwardly (i.e., regarding...). Figure 19B (Example orientation, facing outwards from the page). When the sensor device 43 is deflected away from the cylinder 46 of the anchor frame 41, the readings of the sensor device 43 may not be directly correlated with the flow through the cylinder 46, but may instead indicate parameters of the blood in the chamber to which the vasculature 35 leads.

[0171] Figure 19C A side view of the sensor implantation device 40 in a compressed state is shown, wherein the stent frame 41 is radially compressed to fit within, for example, a delivery catheter or other delivery system device / assembly. Figure 19C In the delivery configuration shown, the sensor support arm 44 can be configured in a substantially straight position, such that the sensor device 43 is not as... Figure 19A and 19BThe sensor device 43 is radially outwardly deflected as in other deployment configurations. This straight configuration facilitates placement within cylindrical delivery conduits or other delivery components / devices. As with any other embodiment disclosed herein relating to a sensor device supported by a sensor support arm / support associated with a vascular anchor, the sensor device 43 can be attached or coupled to the support arm / support 44 in any suitable or desired manner. For example, the sensor device 43 can be secured to the support arm 44 using adhesives or other means. In some embodiments, a mechanical connection is implemented between the sensor device 43 and the arm 44. For example, the sensor device 43 may be situated in a recess or other feature configured to engage the sensor housing around at least a portion of its circumference. In some embodiments, the support arm 44 may include hooks, latches, clamps, or other locking / engaging features configured to engage with holes or other openings in the sensor housing, or vice versa.

[0172] Figure 20A A side deployment view of a sensor implantation device 50 anchored in a blood vessel 35 (such as a pulmonary vein and / or pulmonary vein orifice) according to one or more embodiments is shown. Figure 20B An illustration is shown according to one or more embodiments. Figure 20A Axial view of the sensor implantation device 50. Figure 20C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 20A A side view of the sensor implantation device 50. (Compared to...) Figures 19A-19C (It exemplifies a sensor implantation device 40, including a sensor 43 supported by an arm / support feature 44 that extends axially from one end of a support-type anchor frame 41.) This differs from... Figures 20A-20C The illustrated embodiment of the sensor implantation device 50 includes a sensor device 53, which is secured to the anchor frame 51 by direct attachment to the inner diameter of the anchor frame 51. That is, the sensor device 53 can be embedded and / or secured in / to the support frame 51 in some way without the need for / using an axially extending support arm / post.

[0173] With the sensor device 53 fixed to the inner diameter / surface of the anchor frame 51, the sensor transducer feature / element 55 can generally be exposed within the inner cylinder 56 of the device 50. Therefore, when the anchor frame 51 is anchored within a blood vessel 35, such as a pulmonary vein, the sensor transducer 55 can be configured to sense blood flow characteristics through the blood vessel 35 and the stent frame 51. In some cases, the fluid pressure within the pulmonary vein or other blood vessel 35 may differ from the fluid pressure in a chamber outside the blood vessel 35 (e.g., the left atrium). Therefore, this position of the sensor device 53 within the inner diameter of the stent frame 51 allows sensing of fluid characteristics that may differ from corresponding characteristics of the fluid present outside the blood vessel 35, such as flow rate, pressure, and / or other sensing characteristics.

[0174] As shown, the sensor device 53 can be located at or near the distal end of the frame 51 (i.e., along the...). Figure 20A The sensor device 53 is attached to the frame 51 (with the left side of the frame 51 in the example orientation). In some embodiments, the sensor device 53 may be secured to the inner diameter of the frame 51 by adhesives, welding, and / or other permanent or temporary fastening means. For example, in some embodiments, the housing of the sensor 53 may be configured to be gripped, hooked, clamped, snapped, and / or otherwise engaged by the frame 51, such as within one or more cells of the frame grid, to provide a mechanical attachment / locking connection between the sensor 53 (and / or the sensor housing) and the frame.

[0175] like Figure 20B (As shown in the axial view of the sensor implantation device 50), the sensor device 53 can be configured to fit within the cylinder 56 of the device 50, wherein the sensor transducer element / feature 55 of the sensor device 53 is generally radially inwardly oriented. In some embodiments, the sensor transducer 55 may be generally axially oriented such that its (surface) faces or opposes the fluid flow through the cylinder 56.

[0176] Figure 20C A sensor implantation device 50 in a compressed delivery configuration is shown. For example, the anchor frame 51 may be radially folded / compressed to allow for a smaller diameter profile for placement within a delivery conduit or other delivery device. The sensor device 53 may advantageously be small enough that the radial folding of the anchor frame 51 is not obstructed by the presence of the sensor device 53 within the cylinder 56 of the anchor frame 51.

[0177] Figure 21A A side deployment view of a sensor implantation device 60 anchored in a blood vessel 35 according to one or more embodiments is shown. Figure 21B An illustration is shown according to one or more embodiments. Figure 21A Axial view of the sensor implantation device 60. Figure 21CThe following is illustrated in a delivery configuration according to one or more embodiments. Figure 21A Side view of the sensor implantation device 60.

[0178] Figures 21A-21C The illustrated sensor implantation device 60 is similar to in several aspects Figures 19A-19C The sensor implantation device shown is similar to the one described above, 40. However, it differs from... Figure 19A The sensor implantation device 40 shown is shown. Figure 21A The sensor implantation device 60 shown in the deployment configuration may not be radially deflected during deployment. For example, as shown, the sensor support arm / support 64 can be extended from one end of the support frame 61 (i.e., along...). Figure 21A The example orientation (the leftmost end of frame 61) extends axially in a generally straight configuration. Figure 21A In the straight configuration shown, the sensor transducer 65 can generally be oriented radially inward relative to the axis of the anchor frame 61. However, it should be understood that in some embodiments, the sensor transducer 65 can be oriented radially outward and / or distally or proximally relative to the orientation axis of the anchor frame 61.

[0179] about Figure 21B The axial view shows the radially inward orientation of the sensor device 63 and / or the sensor transducer 65, wherein the sensor transducer 65 is located within the radius of the cylinder 56 of the frame 61, although at a position extending axially beyond the end of the frame 61. In the delivery configuration, as... Figure 21C As shown, the sensor device 63 can be supported by a generally straight support strut / arm 64 during its delivery.

[0180] Figure 22A A side deployment view of a sensor implantation device 70 anchored in a blood vessel 35 according to one or more embodiments is shown. Figure 22B An illustration is shown according to one or more embodiments. Figure 22A Axial view of the sensor implantation device 70. Figure 22C The following is illustrated in a delivery configuration according to one or more embodiments. Figure 22A Side view of the sensor implantation device 70.

[0181] exist Figures 22A-22C In some embodiments, the sensor device 73 is supported by a plurality of support arms 74a, 74b. For example, the sensor device 73 may be held at or near the axial center of the cylinder 76 of the anchor frame 71, which may be deployed / implanted within a blood vessel 35 such as a pulmonary vein. In some embodiments, the arms 74a, 74b may hold the sensor device 73 axially beyond the end 78 of the anchor frame 71 (i.e., regarding...). Figure 22AThe example orientation (the leftmost end of frame 71) is such that the sensor device 73 is positioned in front of the anchor frame 71 and / or the port of blood vessel 35 (i.e., regarding the example orientation, the leftmost end of frame 71), so that the sensor device 73 is positioned in front of the anchor frame 71 and / or the port of blood vessel 35 (i.e., regarding the example orientation, the leftmost end of frame 71). Figure 22A At a certain distance (on the left). In some embodiments, the support arms / pillars 74a, 74b keep the sensor device 73 within the axial boundary of the support frame 71. That is, with Figure 22A The illustrated implementation differs from the others; in some implementations, the sensor device 73 may be axially held within the anchor frame 71.

[0182] Figure 22B A sensor device 73 is shown, held within the radius of the cylinder 76 of the anchor frame 71 by support arms 74a, 74b, although axially extending beyond the ends of the frame 71. The sensor device 73 may include one or more sensor transducer features / elements 75, 77. For example, sensor transducer 77 is shown facing the fluid flow through the anchor frame 71 and can therefore be configured and / or arranged at a location that senses parameters related to such fluid flow impacting the face of the transducer 77. In some embodiments, the sensor device 73 includes a sensor transducer 75 that is axially outward relative to the orientation of the anchor frame 71. With an outwardly oriented transducer 75, the sensor 73 can be configured to sense parameters of fluid within a chamber outside the blood vessel 35 (e.g., the left atrium), less affected by flow through the anchor frame 71—compared to axially inward-oriented sensor transducers (such as transducer 77 in the example). Although in Figure 22A and 22C Two sensor transducers are shown, but it should be understood that any number of such transducers, including a single such transducer, can be combined. Figures 22A-22C The implementation method is as follows.

[0183] Arms 74a and 74b can be attached to the housing / structure of sensor 73 in any suitable or desired manner. In some embodiments, the arms are configured to hook or otherwise engage with eyelets / hole features of the sensor housing to establish a mechanical connection. In some embodiments, arms 74a and 74b form or are associated with / integrated with circumferential sensor retaining straps or cup features in which sensor device 73 can be arranged / secured. Sensor device 73 can be secured to arms 74a and 74b and / or their associated sensor retaining features by tension adapters or other mechanical attachment mechanisms. Figure 22C In the delivery configuration shown, the support arms 74a and 74b can be curved, wherein the angle of this curvature is greater than that of the support arms 74a and 74b. Figure 22AIn the deployment configuration shown, the arms 74a and 74b have sharper bends. In the delivery configuration, the sensor device 73 can be coupled to the support arms 74a and 74b, so that the sensor device 73 does not need to be attached to the support arms 74a and 74b during deployment.

[0184] Figure 23 A sensor implantation device 80, implanted in the superior vena cava and inferior vena cava according to one or more embodiments, is illustrated. The sensor implantation device 80 includes a sensor 83 coupled to one or more stent-like anchors 81a, 81b configured to be anchored within the superior vena cava 19 and inferior vena cava 16, respectively. For example, the sensor 83 may be coupled to the stent-like anchors via one or more arms / connectors 84. For example, a first arm portion 84a may physically extend between the sensor 83 and the stent-like anchor 81a, while an arm portion 84b may extend between the sensor 83 and the stent-like anchor 81b. The arm(s) 84 may include a single rod extending between the stent-like anchors 81a and 81b, wherein the sensor 83 is secured to the rod 84 in some manner. In some embodiments, portions 84a, 84b represent physically separate arm segments extending from the sensor 83. The sensor 83 can be coupled to the arm(one or more) 84 in any suitable or desired manner, such as by utilizing one or more adhesives, clamps, adapters and / or other coupling features.

[0185] In such Figure 23 When the sensor 83 is coupled to one or more support anchors 81, the sensor 83 can be generally positioned and exposed within the right atrium 5 of the heart. The application of sensors such as pressure sensors within the right atrium can provide readings indicating central venous pressure (CBP) or other parameters related to central venous blood flow.

[0186] In some embodiments, one or more of the anchors 31 may include certain valve features 88. For example, such valve features may be one-way valves that allow fluid to flow from the inferior vena cava and / or the superior vena cava into the right atrium while impeding or preventing blood from flowing from the right atrium 5 into the superior vena cava 19 and / or the inferior vena cava. In embodiments where one or more anchors 81 include a one-way valve that allows outflow into the right atrium, such valve(s) may prevent or reduce backflow into the vein, thereby reducing the risk and / or occurrence of edema, swelling, and / or other medical conditions. Although embodiments of this disclosure are described herein that include one or more stent-type anchors having valve features anchored in one or more of the superior and inferior vena cava, wherein such anchor(s) are coupled to a sensor at least partially exposed within the right atrium, in some embodiments, a stent-type anchor with a valve may be implanted / placed within the vena cava without an associated / coupled sensor device. That is, with or without the associated sensor functionality / features (one or more), the anchor can be used for the purpose of preventing blood from flowing back into the vein.

[0187] In embodiments that do not include sensor devices, any physical connection 84 between the anchors 81 that may exist can serve as a docking structure for any type of implanted device. Furthermore, even in embodiments that include sensor devices, such as Figure 23 As shown, the connecting arm 84 can also be used to dock one or more other implantable devices or components, such as septal devices, replacement valves, etc. For example, in some embodiments, a replacement valve device, such as a replacement tricuspid valve, can be implanted within the annulus of the tricuspid valve 8 and further secured or docked to the arm structure 84 and / or one or more vascular anchors 81. In some embodiments, a tricuspid valve septal device can be anchored to the connecting arm 84 and / or one or more stent-type anchors 81. Optional valve features 88 may include two, three, or other numbers of leaflets, which may be formed of biological and / or synthetic materials (one or more).

[0188] The sensor implantation device 80 can be implanted in any suitable or desired manner. For example, implanting the sensor implantation device 80 may involve advancing a delivery system (which may include one or more delivery catheters) via a catheter access pathway into the patient's first vena cava (superior vena cava 19 or inferior vena cava 16), as in combination with Figure 32The method may further involve advancing the delivery system through at least a portion of the patient's right atrium 5 and into the patient's second vena cava (i.e., the other of the superior vena cava 19 and inferior vena cava 16), deploying a distal anchor of the sensor implantation device (i.e., the first of anchors 81a, 81b, depending on which vena cava the anchor is deployed in) from the delivery system, and anchoring the distal anchor of the sensor implantation device within the second vena cava. The delivery system may then be withdrawn through said at least a portion of the right atrium 5, thereby exposing at least a portion of the sensor device 83 of the sensor implantation device and a first support arm portion (i.e., 84a or 84b, or both) of the sensor device to the distal anchor in the right atrium 5. The process may further involve deploying a proximal anchor of the sensor implantation device (i.e., the second of anchors 81a, 81b, depending on which vena cava the anchor is deployed in) from the delivery system within the first vena cava, and anchoring the proximal anchor of the sensor implantation device within the first vena cava. The delivery system may then be withdrawn from the patient.

[0189] Figure 24A -C respectively show a crease side view, an expanded front view, and an axial view of a sensor implantation device according to one or more embodiments. Specifically, Figure 24A The image shows a delivery configuration that is at least partially creased / compressed. Figure 23 The heart implant device 80. Figure 24A In the delivery configuration shown, one or more support-type anchors 81 can be radially compressed such that their cross-sectional profile is small enough to fit within the delivery conduit or other delivery device or system component. It should be understood that the connecting arm segment 84 can have any suitable or desired length.

[0190] Figure 24B A front view of the device 80 is shown, in which the sensor transducer 85 is illustrated. Figure 24B In the configuration, the sensor implantation device 80 is in a deployment configuration, wherein the stent-type anchor 81 is at least partially expanded to contact the respective vessel walls of the superior vena cava and the inferior vena cava. Figure 24A and 24B The images illustrate optional valve features 88a and 88b associated with anchors 81a and 81b, respectively. The example implementation includes one or more tricuspid valves. However, it should be understood that the valve features associated with the anchors disclosed herein have any number of leaflets and / or other valve components or features.

[0191] Figure 24CAn axial view of the device 80 is shown, illustrating the sensor 83 and valve feature 88b. As shown, the sensor transducer 85 can be arranged within the radius / diameter of the anchor 81 and / or radially inward relative to the radius / diameter of the anchor 81. Thus, blood flow through the anchor valve 88 can generally be directed along the direction of the sensor device 53, with some flow passing over the sensor transducer 85.

[0192] Figure 25 A sensor implantation device 90 anchored in the superior vena cava 19 according to one or more embodiments is shown. The sensor implantation device 90 includes a sensor device 93 mechanically coupled and / or otherwise associated with the inner diameter of a stent-type anchor 91. That is, the sensor 93 may not be as described above. Figure 23 The sensor 93 is connected to the anchor 91 via an extended arm feature, or it can be arranged at least partially within the inner diameter of the stent-type anchor 91. The stent-type anchor 91 is arranged in the superior vena cava 19, so the sensor 93 can be configured to determine certain parameters associated with blood flow from the superior vena cava 19 into the right atrium 5.

[0193] Figure 26 A sensor implantation device 96 anchored in the inferior vena cava 16 according to one or more embodiments is shown. The sensor implantation device 96 includes a sensor device 94 mechanically coupled and / or otherwise associated with the inner diameter of a stent-type anchor 92. That is, the sensor 94 may not be as described above. Figure 23 The sensor 94 is connected to the anchor 92 via an extended arm feature, or it can be arranged at least partially within the inner diameter of the stent-type anchor 92. The stent-type anchor 92 is arranged in the inferior vena cava 16, so that the sensor 94 can be configured to determine certain parameters associated with blood flow from the inferior vena cava 19 into the right atrium 5.

[0194] Figure 27A sensor implantation device 270 anchored in the superior vena cava 19 according to one or more embodiments is shown. The sensor implantation device 270 includes a sensor device 275 mechanically coupled to a stent-type anchor 271 via a connecting arm 274, which may in some respects be similar to any other connecting arm features disclosed in conjunction with various embodiments of this disclosure. The connecting arm 274 may have any suitable or desired length. For example, the length of the connecting arm 274 may be selected such that the sensor device 273 extends a desired distance into the right atrium 5. Although the sensor transducer 275 is exemplified as being oriented inward and / or toward the axis of the anchor 271, as in any other embodiment disclosed herein, it should be understood that the sensor device 273 may have one or more sensor transducers configured and / or oriented in any suitable or desired manner. Furthermore, although the connecting arm 274 is shown as generally straight, it should be understood that the arm 274 may have any length, shape, and / or configuration. For example, in some embodiments, arm 274 may be deflected toward the center of the right atrium 5, thereby providing sensor device 273 with a more central position of the right atrium 5.

[0195] Figure 28 A sensor implantation device 280 anchored in the inferior vena cava 16 according to one or more embodiments is shown. The sensor implantation device 280 includes a sensor 283 mechanically coupled to a stent-type anchor 281 via a connecting arm 284, which may in some respects be similar to any other connecting arm features disclosed in conjunction with various embodiments of this disclosure. The connecting arm 284 may have any suitable or desired length. For example, the length of the connecting arm 284 may be selected such that the sensor device 283 extends a desired distance into the right atrium 5. Although the sensor transducer 285 is exemplified as being oriented inward and / or toward the axis of the anchor 281, as in any other embodiment disclosed herein, it should be understood that the sensor device 283 may have one or more sensor transducers configured and / or oriented in any suitable or desired manner. Furthermore, although the connecting arm 284 is shown as generally straight, it should be understood that the arm may have any length, shape, and / or configuration. For example, in some embodiments, arm 284 may be deflected toward the center of the right atrium 5, thereby providing sensor device 283 with a more central position of the right atrium 5.

[0196] Figure 29A sensor implantation device 290 is shown, at least partially anchored within the coronary sinus 16 and / or its orifice 14. The sensor implantation device 290 includes a sensor device 293, which may be similar in some respects to various other embodiments disclosed herein. As with other embodiments disclosed herein, the sensor device 293 is coupled to the anchor 291 via a connecting arm 294. In some embodiments, the implantation device 290 does not include a sensor and / or a sensor connecting arm, but instead includes valve features or other features associated with the stent-type anchor 291.

[0197] Anchoring the sensor implantation device at least partially within the coronary sinus allows for the placement of associated sensors within and / or near the right atrium, enabling the measurement of central venous blood pressure and / or other parameters (one or more) associated with central venous flow and / or the right atrium. For example, sensors associated with an implantation device anchored to / within the coronary sinus can be used to sense / determine various hemodynamic parameters such as central venous pressure, blood viscosity, pulmonary artery pressure, and / or other parameters (one or more). Like any other stent-type anchoring embodiment disclosed herein, this anchor can be self-expanding or balloon-expandable. For example, a delivery catheter can be used to deliver and / or implant the anchoring device 291. Positioning the sensor anchor 291 at or near the coronary sinus ostium 14 can be used for attachment of biodegradable or drug-eluting devices and / or can be used as an anchor for various medical device implants, including valve replacement devices, valvular septal devices, etc.

[0198] Although support-type anchors are generally described and exemplified in conjunction with this disclosure, it should be understood that such anchors can have any suitable form, shape, and / or configuration. For example, in some embodiments, other types of anchor features are implemented, including spiral wire anchors, barbs, and / or other types of tissue anchors.

[0199] The sensor connecting arm 294 can have any suitable or desired length, wherein such length can be designed to allow the sensor 293 to extend a desired distance into the right atrium 5 and / or the coronary sinus ostium 14. Figure 30 An example implantation device 305 is shown, wherein its associated sensor device 308 is coupled to an associated bracket-type anchor 306 via a relatively short connecting strut or arm 309, such that the sensor 308 extends only a short distance beyond the axial end of the anchor 306. For example, the sensor 308 may simply be clamped or secured to the strut feature of one or more units of the bracket 306 without utilizing the extension arm feature extending from the grid of the bracket.

[0200] Figure 31A sensor implantation device 320 is shown, disposed / deployed within the coronary sinus 16 and / or the coronary sinus ostium 14, wherein the device 320 includes a sensor device 323, which is at least partially disposed within the inner diameter of the anchor 321 of the device 320. For example, the sensor device 323 can be secured or attached to one or more units of the support-type grid of the anchor 321 by any type of attachment means, including one or more clamps, books, straps, collars and / or any other type of mechanical and / or tension fit.

[0201] The sensor implantation device according to one or more embodiments of this disclosure can be advanced into the left atrium using any suitable or desired procedure. For example, although access to the left atrium is exemplified and described via the right atrium and / or inferior vena cava, such as via the femoral or other transcatheter procedures, other access routes / methods can be implemented according to embodiments of this disclosure, such as those combined with… Figure 32 As shown / explained. For example... Figure 32 Examples of various access pathways for accessing the left ventricle are illustrated, including transseptal access 401a and 401b, which can be performed via the inferior vena cava 16 or superior vena cava 32, as shown respectively, starting from the right atrium 5, passing through the septal wall (not shown), and entering the left atrium 2. For transaortic access 402, the delivery catheter can pass through the descending aorta, aortic arch 12, ascending aorta, and aortic valve 7, and enter the left atrium 2 via the mitral valve 6. For transapical access 403, access can be performed directly through the apex of the heart into the left ventricle 3, and then through the mitral valve 6 into the left atrium 2. Figure 32 Other access paths besides those shown are also possible.

[0202] Other implementation methods

[0203] According to any implementation of the process described herein, certain actions, events, or functions may be performed in a different order, or may be added, combined, or omitted entirely. Therefore, in some implementations, not all described actions or events are necessary for the practice of the process.

[0204] Regarding preferred embodiments, certain standard anatomical location terms are used herein. While certain spatial relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it should be understood that these terms are for descriptive convenience and are used herein to describe the positional relationship between elements(one or more) / structures(one or more), as illustrated in the figures. Spatial relative terms are intended to cover different orientations of elements(one or more) / structures(one or more) in application or operation, in addition to the orientations depicted in the figures. For example, regarding alternative orientations of the object patient or element / structure, describing an element / structure as “above” another element / structure can indicate a position below or beside that other element / structure, and vice versa.

[0205] Unless otherwise expressly stated or understood in the context of application, the conditional language used herein, such as “may,” “can,” “may,” “can,” “for example,” etc., is intended in its conventional sense and generally to convey that certain embodiments include certain features, elements, and / or steps, while others do not. Therefore, this conditional language is not intended in general to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments necessarily include logic for determining, with or without author input or prompting, whether such features, elements, and / or steps are included or will be performed in any particular embodiment. The terms “comprising,” “including,” “having,” etc., are synonymous, used in their conventional sense, and used with an open-ended inclusiveness, and do not exclude other elements, features, behaviors, or operations. And so on. Furthermore, the term "or" is used in its inclusive (rather than exclusive) sense, and thus, when used, for example, to connect enumerated elements, the term "or" means one, some, or all of the elements in the enumeration. Unless otherwise explicitly stated, connective language such as the phrase "at least one of X, Y, and Z" is understood in context to generally convey that an item, term, element, etc., can be X, Y, or Z. Therefore, such connective language is not generally intended to imply that some implementation requires at least one of X, at least one of Y, and at least one of Z to be present. As used herein, the term "and / or" used between the last two elements in an enumeration 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."

[0206] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements such as structure, component, operation, etc. (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of an element relative to any other element, but rather serve to distinguish that element generally from another element with a similar or identical name (except for the use of the ordinal term). Additionally, as used herein, indefinite articles (“a” and “an”) may mean “a / one or more / ones” rather than “a / one”. Furthermore, an operation “based on” a condition or event may also be based on one or more other conditions or events not explicitly stated.

[0207] Regarding the various methods and processes disclosed herein, although certain sequences of operations or steps are exemplified and / or described, it should be understood that the various steps and operations shown and described can be performed in any suitable or desired chronological order. Furthermore, any exemplified and / or described operations or steps may be omitted from any given method or process, and exemplified / described methods and processes may include other operations or steps not explicitly exemplified or described.

[0208] It should be understood that in the above description of the embodiments, various features are sometimes grouped together in their individual embodiments, drawings, or descriptions for the purpose of concise disclosure and to aid in understanding one or more of the various inventive aspects. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than expressly stated in that claim. Furthermore, any component, feature, or step exemplified and / or described in one specific embodiment herein may be applied to or combined with any other embodiment(s). Moreover, no component, feature, step, or grouping of components, features, or steps is necessary or indispensable for every embodiment. Therefore, the scope of the invention intended to be disclosed herein and claimed in the appended claims should not be limited by the above specific embodiments, but should be determined only through a reasonable interpretation of the appended claims.

Claims

1. Delivery systems, including: outer shaft; A sensor implantation device, the sensor implantation device being at least partially disposed within the outer shaft, the sensor implantation device comprising: A first anchoring device is disposed within the outer shaft in a at least partially compressed configuration having a first diameter; Second bracket-type anchoring device; and The sensor module is physically connected to the first anchoring device and the second bracket-type anchoring device via corresponding connecting arm segments; A distal inner shaft, which is at least partially disposed within the outer shaft and configured to axially abut the proximal portion of the first anchoring device within the outer shaft; and A proximal inner shaft, which is at least partially disposed within the distal inner shaft and configured to axially abut the proximal portion of the sensor module within the distal inner shaft, and a second bracket-type anchoring device disposed within the proximal inner shaft in another at least partially compressed configuration having a second diameter smaller than the first diameter.

2. The delivery system of claim 1, wherein the first anchoring device is disposed on the distal side of the distal end of the distal inner shaft, and the sensor module is disposed at least partially within the distal inner shaft.

3. The delivery system of claim 1, wherein the second bracket-type anchoring device is coupled to the sensor module via a connecting arm portion, the connecting arm portion being bent such that the end of the second bracket-type anchoring device is oriented distally within the proximal inner shaft.

4. The delivery system of claim 1, further comprising a pusher device at least partially disposed within the proximal inner shaft and configured to axially abut against the second bracket-type anchoring device within the proximal inner shaft.

5. The delivery system of claim 4, wherein the pusher device includes a central cavity configured to receive a guidewire therein.

Images