Direct cardiac pressure monitoring

Abstract

To provide a method and / or device to facilitate pressure sensing in cardiac anatomy.SOLUTION: A septal closure device includes a frame comprising one or more tissue anchor features, an occluding membrane, and a pressure sensor device attached to the occluding membrane.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 62 / 803,182, entitled "DIRECT CARDIAC PRESSURE MONITORING," filed February 8, 2019, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of medical implant devices. [Background technology]

[0003] Various medical procedures involve implanting medical implant devices within cardiac anatomical structures, and several physiological parameters associated with such anatomical structures, such as fluid pressure, can affect the health of a patient. Summary of the Invention [Means for solving the problem]

[0004] Described herein are one or more methods and / or devices for facilitating pressure sensing in cardiac anatomy. In some implementations, the present disclosure relates to a septal closure device comprising a frame including one or more tissue anchor features, an occluding membrane, and a pressure sensor device attached to the occluding membrane.

[0005] In some embodiments, the pressure sensor device comprises a first portion disposed on a first side of the occluding membrane and a second portion disposed on a second side of the occluding membrane, e.g., the first portion of the pressure sensor device comprises a first pressure sensor element and the second portion of the pressure sensor device comprises a second pressure sensor element.

[0006] The occlusion membrane may be comprised of a fabric. The occlusion membrane may be comprised of a bio-spun polymer. The pressure sensor device may also be comprised of a rigid cylinder. For example, the body of the pressure sensor device may have one or more radially protruding features associated therewith. In some embodiments, the occlusion membrane comprises a cuff feature configured to retain the sensor device. For example, the septal closure device may further comprise a suture collar at least partially wrapped around the cuff feature of the occlusion membrane.

[0007] In some implementations, the present disclosure relates to an implant device comprising a leaflet spacer form, a first tether attached to a first end of the leaflet spacer form, a tissue anchor attached to the first tether, and a first pressure sensor device coupled to the leaflet spacer form. In some embodiments, the leaflet spacer form has a foam filler disposed therein. In some embodiments, the leaflet spacer form has an external recess, and the first pressure sensor device is at least partially disposed within the recess. In some embodiments, the first pressure sensor device is at least partially disposed within the leaflet spacer form.

[0008] The implant device may further include a second tether attached to a second end of the leaflet spacer foam, a second pressure sensor device attached to the second tether, and an anchor attached to the second sensor device. The anchor is configured to secure the second sensor device at least partially within a blood vessel. The blood vessel may be the inferior vena cava, and the second tether is configured to couple the second pressure sensor device to the leaflet spacer foam through the right atrium.

[0009] In some implementations, the present disclosure relates to an edge-to-edge valve leaflet repair device comprising a first clasp member, a second clasp member, a spacer disposed between the first and second clasp members, the spacer having a ventricular base coupled to the first and second clasp members and an atrial end, and a pressure sensor device integrated with the spacer. In some embodiments, the pressure sensor device comprises a pressure sensor element protruding from an end of the spacer. In some embodiments, the valve leaflet repair device further comprises a second pressure sensor element associated with the base of the spacer.

[0010] In some implementations, the present disclosure relates to an implant device comprising: a cylindrical elongated sensor device having a proximal end portion and a distal end portion; and a tissue anchor coupled to the sensor device, the tissue anchor comprising a plurality of curved distal arms, the plurality of distal arms being concave in a proximal direction relative to the sensor device and having respective tissue contacting ends facing proximally in a deployed configuration; and a plurality of at least partially straight proximal arms, the plurality of proximal arms being deflected away from the sensor device and protruding in a distal direction relative to the sensor device.

[0011] The implant device may further include one or more protruding features associated with the sensor device. For example, the sensor device may include a glass cylindrical body, and the one or more protruding features may be attached to the cylindrical body with an adhesive. In some embodiments, the sensor device includes a first sensor element associated with the distal end portion and a second sensor element associated with the proximal end portion.

[0012] In some implementations, the present disclosure relates to an anchor comprising first and second coil portions having a first diameter and an intermediate coil portion disposed between the first and second coil portions and having a second diameter smaller than the first diameter. In some embodiments, the anchor comprises a shape memory alloy, and the first and second coil portions are disposed within a delivery catheter in a compressed state and configured to form multiple coils of the first diameter upon deployment from the delivery catheter. The anchor may further comprise a cylinder form coupled to one or more coils of the intermediate coil portion by one or more protruding features associated with the cylinder form. For example, the cylinder form may be a pressure sensor device.

[0013] Certain aspects, advantages, and novel features have been described herein to provide an overview of the present disclosure. It should be understood that not necessarily all such advantages may be achieved in accordance with a particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0014] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of this disclosure. Reference numbers may be reused throughout the drawings to indicate correspondence between referenced elements. However, it should be understood that the use of like reference numbers in relation to multiple drawings does not necessarily imply similarity between the respective embodiments associated therewith. Furthermore, it should be understood that features in the respective drawings are not necessarily drawn to scale, and that illustrated sizes are presented for the purpose of illustrating inventive aspects thereof. In general, some of the illustrated features may be relatively smaller than those illustrated in some embodiments or configurations. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a cross-sectional view of a human heart. [Figure 2] FIG. 1 illustrates exemplary pressure waveforms associated with various chambers and vessels of the heart in accordance with one or more embodiments. [Figure 3] 1 illustrates an implanted sensor implant device according to one or more embodiments. [Figure 4] FIG. 1 is a block diagram of an implant device according to one or more embodiments. [Figure 5] FIG. 1 is a perspective view illustrating a sensor implant device according to one or more embodiments. [Figure 6] 1 illustrates a sensor implant device implanted in a tissue wall according to one or more embodiments. [Figure 7] 1 is a flow chart illustrating a process for implanting a sensor implant device according to one or more embodiments of the present disclosure. [Figure 8]8A-8C illustrate the state of components of a sensor implant device and / or associated delivery system corresponding to various steps of the process of FIG. 7 according to one or more embodiments. [Figure 9] 1 illustrates a system for removing a previously implanted sensor implant device according to one or more embodiments. [Figure 10] 1 illustrates a sensor implant device according to one or more embodiments. [Figure 11] 1 illustrates a sensor implant device according to one or more embodiments. [Figure 12] 1 is a flow chart illustrating a process for implanting a sensor implant device according to one or more embodiments. [Figure 13] 13A-13C illustrate the state of components of a sensor implant device and / or associated delivery system corresponding to various steps of the process of FIG. 12 according to one or more embodiments. [Figure 14] FIG. 1 illustrates a sensor anchor according to one or more embodiments. [Figure 15] 1 illustrates an anchor implanted in a septal wall according to one or more embodiments. [Figure 16] FIG. 1 illustrates a sensor anchor according to one or more embodiments. [Figure 17] FIG. 1 illustrates a pressure sensor device according to an embodiment of the present disclosure. [Figure 18] FIG. 1 is a front view illustrating a sensor-integrated septal closure device according to one or more embodiments. [Figure 19] FIG. 19 is a perspective view illustrating the sensor-integrated septal closure device of FIG. 18 implanted within a tissue wall according to one or more embodiments. [Figure 20] 1 illustrates a sensor implant device comprising a sensor integrated with a septal closure device according to one or more embodiments. [Figure 21]10A-10C illustrate a process for removing a sensor implant device according to an embodiment. [Figure 22] 22A-22C illustrate a sensor implant device and associated detachment system, as well as cardiac anatomy in various states corresponding to the process steps of FIG. 21. [Figure 23] 1 illustrates a sensor implant device comprising a sensor integrated with a heart valve spacer device according to one or more embodiments. [Figure 24] 1 illustrates a sensor assembly comprising a sensor-integrated spacer implant device and a separate tethered sensor device according to one or more embodiments. [Figure 25] 1 illustrates a sensor-integrated cardiac implant device comprising a sensor integrated with a left atrial appendage occluder implant device according to one or more embodiments. [Figure 26] FIG. 1 is a side view illustrating an integrated sensor valve repair implant configured to provide edge-to-leaflet attachment for mitral valve repair according to one or more embodiments. [Figure 27] FIG. 1 is a top view illustrating an integrated sensor valve repair implant configured to provide edge-to-leaflet attachment for mitral valve repair according to one or more embodiments. [Figure 28] FIG. 10 illustrates another embodiment of a sensor integrated with a mitral valve repair implant to form a valve repair sensor assembly according to one or more embodiments. [Figure 29] FIG. 1 illustrates one embodiment of a sensor integrated with a mitral valve repair implant to form a valve repair sensor assembly according to one or more embodiments. [Figure 30] 1 illustrates an integrated sensor annular reduction implant according to one or more embodiments. [Figure 31]1 illustrates a sensor coupled to a replacement mitral valve implant according to one or more embodiments. [Figure 32] 1 illustrates a valve repair and pressure sensor assembly according to one or more embodiments. [Figure 33] 1 illustrates a sensor device suspended in the left atrium using an anchoring system according to one or more embodiments. [Figure 34A] 1A-1C illustrate exemplary embodiments of a pressure sensor having an associated or integrated tissue anchor according to one or more embodiments. [Figure 34B] 1A-1C illustrate exemplary embodiments of a pressure sensor having an associated or integrated tissue anchor according to one or more embodiments. [Figure 35] 1 illustrates an integrated sensor implant device including a docking device integrated with a sensor according to one or more embodiments. [Figure 36A] 1 illustrates a sensor-integrated cardiac implant device according to one or more embodiments. [Figure 36B] 1 illustrates a sensor-integrated cardiac implant device according to one or more embodiments. [Figure 37] 1A-1C illustrate various access routes by which access to a target cardiac anatomy may be achieved according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0016] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0017] The present disclosure relates to systems, devices, and methods for providing telemetric pressure monitoring in connection with cardiac implants and / or other medical implant devices and / or procedures. Such pressure monitoring may be performed using cardiac implant devices having integrated pressure sensors and / or associated components.

[0018] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited to any of the specific embodiments described below. For example, in any method or process disclosed herein, the activities or operations of the method or process may be performed in any suitable order and are not necessarily limited to the specific order disclosed. Various operations may then be described as multiple discrete operations, in a manner that may aid in the understanding of some embodiments, but the order of description should not be construed to imply that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated or separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. It is not necessarily the case that all such aspects or advantages are achieved by a particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0019] Certain standard anatomical terms relating to location are used herein to refer to animal, i.e., human, anatomical structures with respect to preferred embodiments. While certain spatially relative terms, such as "outer," "inner," "superior," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it is understood that these terms are used herein for ease of description to describe the positional relationships between elements / structures as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or to the side of such other element / structure, and vice versa, with respect to the intended patient or alternative orientations of the element / structure.

[0020] Embodiments of the present disclosure relate to cardiac pressure monitoring solutions that include implant devices integrated with sensor functionality, such as pressure sensor functionality. For example, pressure monitoring solutions according to embodiments of the present disclosure may be applicable to patients suffering from various forms of heart failure, such as acute congestive heart failure. Pressure monitoring solutions as disclosed herein may enable improved diagnosis and / or notification related to cardiac conditions. For example, embodiments of the present disclosure enable cardiac pressure monitoring of patients after surgery, where pressure monitoring may involve tracking and / or notification of pressure trends (or trends associated with one or more other physiological parameters monitored according to the present disclosure) that may result in or be associated with side effects or adverse events. Various embodiments disclosed herein involve sensor-integrated implant devices implanted in various vessels or chambers of the cardiac system. Additionally, various embodiments disclosed herein relate to various types of sensor-integrated implants, including septal closure or occluder devices, leaflet repair spacers, leaflet clip devices, and the like.

[0021] Some embodiments are disclosed herein in the context of a cardiac implant device. However, although some principles disclosed herein are particularly applicable to cardiac anatomy, it should be understood that a sensor implant device according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomy.

[0022] To aid in understanding some of the inventive concepts disclosed herein, the anatomical structure of the heart is described below. In humans and other vertebrates, the heart generally comprises a muscular organ with four pumping chambers, the flow of which is controlled, at least in part, by various heart valves: the aortic valve, the mitral valve (bicuspid valve), the tricuspid valve, and the pulmonary valve. These valves may be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., relaxation and systole) and at least in part control the flow of blood to respective regions and / or vessels of the heart (e.g., the pulmonary trunk, the aorta, etc.). Contraction of the various cardiac muscles may be facilitated by signals generated by the heart's electrical system, which is described in detail below. Some embodiments disclosed herein relate to cardiac conditions, such as atrial fibrillation, and / or associated complications or solutions. However, embodiments of the present disclosure relate more generally to any health complications related to fluid overload in a patient, such as may result postoperatively following any surgical procedure involving fluid replacement. That is, detection of atrial stretching as described herein may be performed to detect / determine a fluid overload condition, which may indicate therapeutic or compensatory action related to atrial fibrillation and / or any other condition caused at least in part by fluid overload.

[0023] FIG. 1 illustrates an example representation of a heart 1 having various features associated with certain embodiments of the present disclosure. The heart 1 includes four chambers: a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. From a blood flow perspective, blood generally flows from the right ventricle 4 into the pulmonary artery via a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11. The valve opens during systole to pump blood toward the lungs and closes during diastole to prevent blood from leaking back into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11, as illustrated, includes the pulmonary trunk and the left pulmonary artery 15 and right pulmonary artery 13, which branch off from the pulmonary trunk. In addition to the pulmonary valve 9, the heart 1 includes three additional valves that help blood circulate within it, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. 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 may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two tips / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood in the left atrium 2 to flow into the left ventricle 3 and, when functioning properly, 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. The aortic valve 7 is configured to open during systole to allow blood to exit the left ventricle 3 into the aorta 12 and close during diastole to prevent blood from leaking back into the left ventricle 3.

[0024] Heart valves may generally comprise a relatively dense fibrous ring, referred to herein as an annulus, and multiple leaflets or tips attached to the annulus. Generally, the size of the leaflets or tips may be such that when the heart contracts, the resulting increase in blood pressure within the corresponding heart chamber causes the leaflets to at least partially open, allowing flow from the heart chamber. As pressure within the heart chamber returns to normal levels, subsequent pressure within the chamber or vessel may become dominant and again compress the leaflets. As a result, the leaflets / tips appose each other, thereby closing the flow path. Malfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0025] The atrioventricular heart valves (i.e., the mitral and tricuspid valves) may further include a collection of chordae tendineae and papillary muscles (not shown) to secure the leaflets of each valve, promote and / or smooth their proper coaptation, and prevent their prolapse. The papillary muscles, for example, may generally comprise finger-like projections from the ventricular wall. The leaflets are connected to the papillary muscles by the chordae tendineae. A muscular wall 17, called the septum, separates the left and right atria 2 and 5 from the left and right ventricles 3 and 4.

[0026] As mentioned above, several physiological conditions or parameters related to cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with relatively slow blood movement through the heart and / or body, which can increase fluid pressure within one or more chambers of the heart. As a result, the heart is unable to pump enough oxygenated blood to meet the body's needs. The various chambers of the heart may respond to the increased pressure by stretching or by becoming relatively stiff and / or thickened to hold more blood to pump through the body. The heart's walls eventually weaken and are unable to pump efficiently. In some cases, the kidneys may respond to cardiac inefficiency by causing the body to retain fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs, and / or other organs can cause physical congestion, referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality; therefore, treatment and / or prevention of congestive heart failure is a significant medical concern.

[0027] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure within one or more chambers or regions of the heart or other anatomical structures. As explained above, elevated pressure within one or more chambers or regions of the heart may be associated with congestive heart failure. Without direct or indirect monitoring of cardiac pressure, it may be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring body weight, measuring thoracic impedance, right heart catheterization, or the like.

[0028] Various methods for identifying and / or treating congestive heart failure involve monitoring worsening congestive heart failure symptoms and / or changes in weight. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements can vary significantly (e.g., by up to 9% or more) and may be unreliable as a precursor to cardiac complications. Furthermore, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. Additionally, for discharged patients, such treatments may require remote telemedicine. In some situations, congestive heart failure can result from fluid retention over a period of time, such as two to three weeks. Therefore, detecting and / or determining fluid retention within the first few days or weeks of the condition can help prevent the onset of congestive heart failure from prolonged fluid retention.

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

[0030] Cardiac Pressure Monitoring Cardiac pressure monitoring according to embodiments of the present disclosure may provide a preventative intervention mechanism for preventing or treating congestive heart failure. Elevated ventricular filling pressures associated with diastolic and / or systolic heart failure generally occur before the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators may appear several weeks before hospitalization for some patients. Thus, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce cases of hospitalization by guiding appropriate or desirable titration and / or administration of medications before the onset of heart failure.

[0031] As mentioned above, with respect to cardiac pressure, elevated pressure in the left atrium may be particularly correlated with heart failure. FIG. 2 illustrates exemplary pressure waveforms associated with various chambers and vessels of the heart according to one or more embodiments. The various waveforms illustrated in FIG. 2 may represent waveforms obtained using right heart catheterization to deliver one or more pressure sensors to each illustrated and labeled chamber or vessel of the heart. As illustrated in FIG. 2, a waveform 225 representing left atrial pressure may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, generally, there may be a relatively strong correlation between elevated left atrial pressure and pulmonary congestion.

[0032] Cardiac pressure monitoring, such as left atrial pressure monitoring, can provide a mechanism for guiding the administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce rehospitalizations and morbidity, as well as provide other benefits. Implanted pressure sensors according to embodiments of the present disclosure may be used to predict heart failure up to two weeks or more before symptoms or markers of heart failure (e.g., dyspnea) appear. When heart failure predictors are recognized using cardiac pressure sensor embodiments according to the present disclosure, several preventative measures, including pharmaceutical interventions, such as modifying a patient's medication regimen, may be taken, which may help prevent or mitigate the effects of cardiac dysfunction. Direct pressure measurement within the left atrium can advantageously provide an accurate indicator of elevated pressure that may lead to heart failure or other complications. For example, trends in elevated atrial pressure may be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other treatments may be intensified to cause pressure reduction and prevent or mitigate further complications.

[0033] The sensor-integrated implant devices of the present disclosure can be implemented in various locations in the human anatomy. For example, various cardiac anatomical locations can be used for implanting a sensor-integrated implant device for hemodynamic pressure measurement within the cardiovascular system. The implant devices disclosed herein can include one or more sensors integrated with the implant structure that serve one or more additional purposes in addition to pressure monitoring, such as shunting, tissue closure / occlusion, repair, or otherwise treating certain cardiac anatomical structures and / or conditions. The implant devices according to the present disclosure can be implanted in any cardiac vessel or chamber, including the superior vena cava, inferior vena cava, right atrium, left atrium, right ventricle, left ventricle, pulmonary artery, pulmonary veins, coronary sinus, and / or the like.

[0034] Sensor-integrated implant device Embodiments of the present disclosure may provide a mechanism for guiding the administration of medication to a patient by monitoring a patient's left atrial pressure and / or other physiological conditions sensed by one or more sensor-integrated implant devices. For congestive heart failure patients, such monitoring may help reduce rehospitalization and / or morbidity. In some implementations, the sensor-integrated implant device may be configured to detect physiological parameters or conditions indicative of or predicting heart failure or other conditions, such as dyspnea, one or more weeks before symptoms related to heart failure appear. Thus, embodiments of the present disclosure may advantageously facilitate relatively early modification of medication regimens or other therapies, potentially preventing more serious conditions or symptoms from developing. For example, early detection of elevated pressure in the left atrium may be used to determine a trend toward increased pressure, and when detected or predicted, drug therapy may be increased to reduce left atrial pressure to prevent further complications. With respect to heart failure associated with pulmonary fluid accumulation, such fluid accumulation may typically develop gradually over a period of a week or more, and therefore, early detection of elevated pressures that may lead to such fluid accumulation may allow for relatively early intervention and / or prevention.

[0035] FIG. 3 illustrates a sensor implant device 310 implanted within the atrial septum 18 according to one or more embodiments. A specific location within the atrial septal wall can be selected or determined to provide a relatively safe anchoring position for the implant 310 and a relatively low risk of thrombus formation. Additionally, the sensor implant device 310 can be implanted in a desired location to allow for future recrossing of the septal wall 18 for future interventions. Implanting the sensor implant device 310 within the atrial septal wall 18 can advantageously allow communication between the left atrium 2 and the right atrium 5. With the device 310 within the atrial septum 18, the sensor elements 311, 312 of the sensor implant device 310 can advantageously be configured to measure pressure in the right atrium 5, the left atrium 2, or both atria. While two sensor elements 311, 312 are illustrated, in some embodiments, the sensor implant 310 comprises a single sensor element or three or more sensor elements. With pressure sensor functionality for measuring pressure in both atria, the sensor implant device 310 may be advantageously configured to provide a sensor signal that can be used to determine the differential pressure between the atria, which can be useful in monitoring fluid accumulation in the lungs, which may be associated with congestive heart failure.

[0036] As shown, with the sensor 310 implanted or disposed within the atrial septum 18, pressure may be monitored in either or both the right atrium 5 and the left atrium 2. In sensor embodiments that include pressure sensor transducers disposed within both atria, the implant device 310 may have the ability to measure differential pressure between the atria, which may be useful in monitoring fluid accumulation in the lungs, which is associated with congestive heart failure as described above.

[0037] Generally, the atrial septal wall 18 may provide a good fixed location for the pressure sensor 310. The sensor device 310 may be advantageously fixed in a secure location within the atrial wall 18. Furthermore, it may be desirable for the sensor 310 to be configured and / or fabricated to have a relatively low risk of thrombosis with respect to the portion of the sensor device 310 disposed within the left atrium 2. In some embodiments, the present disclosure provides a sensor-integrated implant device that may be implanted within the atrial septal wall 18, where the implant device provides an access mechanism for re-crossing the septal wall 18 for future medical intervention.

[0038] In some implementations, the present disclosure relates to a pressure sensor associated with or integrated with a cardiac implant device. Such a sensor-integrated cardiac implant device can be used to provide controlled and / or more effective therapy for treating and preventing heart failure. FIG. 4 is a block diagram illustrating an implant device 400 including a cardiac implant structure 420. In some embodiments, the cardiac implant structure 420 is physically integrated with and / or connected to a sensor device 410. The sensor device 410 may be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 410 includes a transducer 412, such as a pressure transducer, as well as specific control circuitry 414, which may be embodied in, for example, an application-specific integrated circuit (ASIC). The control circuitry 414 may be configured to process signals received from the transducer 412 and / or wirelessly communicate signals associated therewith through biological tissue using an antenna 418. The antenna 418 may include one or more coils or loops of conductive material, such as copper wire or the like. In some embodiments, at least a portion of the transducer 412, control circuitry 414, and / or antenna 418 are at least partially disposed or housed within a sensor housing 416, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 416, in some embodiments, may comprise glass or other rigid material, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 416 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure / material, which may advantageously allow the sensor 410 to fold, bend, or collapse to enable its transport through a catheter or other introduction means.

[0039] The transducer 412 may comprise any type of sensor means or mechanism. For example, the transducer 412 may be a force-collector-type pressure sensor. In some embodiments, the transducer 412 comprises a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component to measure strain or deflection applied over its area / surface. The transducer 412 may be associated with the housing 416, at least a portion of which is contained within or attached to the housing 316. The term "associated" is used herein in its broad, ordinary sense. With respect to a sensor device / component being "associated" with a stent or other implant structure, such term may refer to the sensor device or component being physically coupled, attached, or connected to the implant structure, or being integrated with the implant structure.

[0040] In some embodiments, the transducer 412 comprises or is a component of a piezoresistive strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain due to applied pressure, where resistance increases as pressure deforms the component / material. The transducer 412 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, laminated metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0041] In some embodiments, transducer 412 comprises or is a component of a capacitive pressure sensor, which comprises a diaphragm and a pressure cavity configured to form a variable capacitor for detecting strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may comprise any material, including but not limited to metal, ceramic, silicon or other semiconductors, and the like. In some embodiments, transducer 412 comprises or is a component of an electromagnetic pressure sensor, which may be configured to measure diaphragm displacement using inductance changes, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current detection. In some embodiments, transducer 412 comprises or is a component of a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in some materials, such as quartz. This technique is commonly employed for highly dynamic pressure measurements.

[0042] In some embodiments, the transducer 412 comprises or is a component of a strain gauge. For example, strain gauge embodiments may include a pressure-sensitive element on or associated with the exposed surface of the transducer 412. In some embodiments, a metal strain gauge may be attached to the sensor surface, or a thin-film gauge may be applied onto the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. The transducer 412 may include other types of sensors or pressure sensors, such as optical sensors, potentiometric sensors, resonant sensors, thermal sensors, ionization sensors, or other types of strain or pressure sensors.

[0043] In some embodiments, the sensor 410 is configured to communicate with an external (e.g., non-implantable) device or system that includes an external reader (e.g., a coil), which may include a wireless transceiver electrically and / or communicatively coupled to specific control circuitry. In some embodiments, the sensor 410 and the external subsystem both include corresponding coil antennas for wireless communication and / or power transmission through patient tissue disposed therebetween when the sensor 410 is implanted in a patient.

[0044] An external reader / monitor (not shown), such as a wand or other handheld reader or device, can receive wireless signal transmissions and / or receive wireless power using an external antenna. The external transceiver can include radio frequency (RF) front-end circuitry configured to receive and amplify signals from the sensor 410, where 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 circuits, phase-locked loop (PLL) circuits, signal mixers, or the like. The external transceiver can further be configured to transmit signals over the network to a remote monitor subsystem or device. The RF circuitry of the external transceiver can further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, or the like for processing / handling transmitted signals over the network and / or for receiving signals from the sensor 410. In some embodiments, the external monitor includes control circuitry for performing processing of signals received from the sensor 410. In some embodiments, the external monitor is a smartphone, laptop computer, or other mobile computing device, or other type of computing device.

[0045] In some embodiments, the sensor 410 includes some volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating-gate transistors, or the like. The control circuitry 414 may utilize data storage to store sensed data collected over a period of time, which may be periodically transmitted to an external monitor or other external subsystem. In some embodiments, the sensor 410 does not include any data storage. The control circuitry 414 is configured to facilitate wireless transmission of data generated by the sensor transducer 412 or other data associated therewith. The control circuitry 414 may further be configured to receive inputs from one or more external subsystems, such as from an external reader (e.g., a wand device) or from a remote monitor over a communications network (e.g., the Internet). For example, the sensor 410 may be configured to receive signals that at least partially control the operation of the sensor 410, such as by activating / deactivating one or more components or sensors or otherwise affecting the operation or performance of the sensor 410.

[0046] One or more components of the sensor 410 may be powered by one or more power sources (not shown). Due to size, cost, and / or electrical system complexity considerations, it may be desirable for such power sources to be relatively minimalist in nature. For example, high power driving voltages and / or currents in the sensor 410 may adversely affect or interfere with the operation of a heart or other body part associated with the implant device 400. In some embodiments, the sensor 410 is configured to receive power from an external source wirelessly by passive circuitry in the sensor 410, such as through the use of short-range or near-field wireless power transfer or other electromagnetic coupling mechanisms. For example, an external device may be used as an initiator to actively generate an RF field capable of supplying power to the sensor 410, thereby allowing the power circuitry of the implant device 400 to assume a relatively simple form factor. In some embodiments, the implant device 400 is configured to harvest energy from environmental sources, such as fluid flow, motion, or the like. Additionally or alternatively, the implant device 400 may include a battery that may be advantageously configured to provide sufficient power as needed for a monitoring period (e.g., 1, 2, 3, 5, 10, 20, 30, 60, or 90 days, or other period).

[0047] In some embodiments, the sensor 410 is configured to operate with a local reader / monitor that comprises a wearable communication device or other device that can be easily disposed in proximity to the patient and the sensor 410. Such an external reader / monitor device / system can be configured to continuously, periodically, or sporadically interrogate the sensor 410 and thereby extract or request sensor-based information. In some embodiments, a user interface is implemented that allows a user to utilize the interface to view sensor data, request sensor data, or otherwise interact with the sensor 410.

[0048] In some embodiments, the external reader / monitor comprises a coil antenna that is matched and / or tuned to inductively pair with the antenna 418 of the internal implant device 410. In some embodiments, the sensor 410 is configured to receive wireless ultrasonic power charging and / or data communication from the external monitoring system.

[0049] 5 illustrates a perspective view of a sensor implant device 500 according to one or more embodiments. The sensor implant device 500 includes a sensor 510, which may have a generally cylindrical configuration for one or more portions thereof. However, while certain embodiments are disclosed herein in the context of a cylindrical sensor device, it should be understood that the principles of the present disclosure relate to sensor implant devices including sensors having any suitable or desirable shape, form, or configuration.

[0050] The sensor device 510 may include one or more sensors 511, 512, such as pressure transducers, which may be associated with one or more distal or proximal end portions of the sensor 510. For example, the sensor 510 may include a first sensor element 512, which may be considered a distal sensor element, and a second sensor element 511, which in some embodiments may be considered a proximal sensor element. The sensor implant device 500 includes an anchor 520, which may include one or more arms 521, 522 for anchoring the sensor implant device 500 to a tissue wall, such as the atrial septal wall. The anchor 520 may include a shape memory alloy or other material and may be secured or attached in some manner to the sensor 510. The anchor arms 521, 522 of the anchor 520 may include one or more distal arms 521 and one or more proximal arms 522, which are described in further detail below. In some embodiments, sensor 510 includes or is associated with one or more protruding features 517, which may include tabs, protrusions, extensions, teeth, grooves, posts, or the like, and may be used to secure sensor 510 to one or more components of a delivery system (not shown) or to one or more features of anchor 520.

[0051] The anchor 520 may allow the sensor implant device 500 to be directly attached or implanted within a septal wall or other tissue. Figure 6 shows the sensor implant device 500 implanted within a tissue wall 18, such as the atrial septal wall. Although several figures and descriptions herein are described in the context of the sensor implant device 500 being implanted within the atrial septal wall, it should be understood that the sensor implant device 500 may be implanted within any biological tissue or tissue wall according to embodiments of the present disclosure.

[0052] In some embodiments, the sensor implant device 500 includes a proximal sensor element 511 and a distal sensor element 512, as shown. In a sensor implant device 500 implanted within the septal wall 18, the proximal and distal sensor elements may each be disposed within a respective atrium. For example, with respect to the orientation of the illustrated embodiment of FIG. 6, the proximal sensor element 511 may be disposed within the right atrium, while the distal sensor element 512 may be disposed within the left atrium 2.

[0053] The anchor 520 may include any number of distal and / or proximal arms. The distal arm 521 may be curved such that its end portion faces at least partially proximally in the deployed configuration. The proximal arm 522 may be at least partially straight and may be at least partially biased away from the longitudinal axis of the sensor device and / or the sensor device itself and protrude at least partially distally. Additionally, the end portion of the proximal arm 522 may be at least partially curved, rounded, or otherwise configured to provide a blunt surface for contact with the tissue wall surface to reduce the risk of tissue damage.

[0054] Anchor 520 is illustrated as having three or more distal arms and three or more proximal arms. In some embodiments, anchor 520 may include four or more proximal arms and four or more distal arms. In some embodiments, sensor implant device 500 has a small enough size that, after implantation, it does not interfere with future crossing of the septal wall for alternative interventions.

[0055] In some embodiments, sensor 510 comprises a rigid housing, which may be made from glass or other at least partially rigid material. Protruding feature 517 may be made from the same material as housing 516 of sensor 510. For example, if housing 516 comprises a cylindrical glass tube, protruding feature 517 may be a protrusion integral with housing 516. Alternatively, protruding feature 517 may be attached or secured to housing 516 in any suitable or desirable manner.

[0056] Generally, when the sensor housing 516 comprises glass, the sensor 510 may have desirable biocompatibility and / or anti-outgassing properties. For example, with certain materials such as those used for the sensor housing 516, outgassing may occur at least in part through the housing 516, such as from the sensor's 510's internally disposed electronics, or the like. The housing 516 advantageously forms a sufficient airtight barrier seal for the sensor 510 and / or its internal circuits or components. In some embodiments, the anchor 520 comprises a shape memory alloy frame, such as Nitinol or the like. The anchor 520 may be secured to the sensor 510 through a friction fit or using other suitable or desired attachment mechanisms, including biocompatible adhesives, welding, or other attachment mechanisms.

[0057] Figure 7 is a flow chart illustrating a process 700 for implanting a sensor implant device according to one or more embodiments of the present disclosure. Figure 8 illustrates the state of components of the sensor implant device and / or associated delivery system corresponding to various steps of process 700 of Figure 7. It should be understood that while Figures 7 and 8 relate to implantation of a sensor implant device within the septal wall, the initial puncture of the septal wall and / or its dilation (e.g., using a balloon or other mechanism) that may be used to form an opening in the septal wall for insertion or implantation of a delivery catheter and / or sensor implant device is not shown or described in detail.

[0058] In connection with the steps of process 700, access to the target implantation location may be achieved in any suitable or desirable manner. For example, access to the right atrium may be via the femoral vein in some implementations. At block 702, process 700 involves introducing a delivery catheter 730 through an opening in the septal wall 18 into the left atrium. At block 704, process 700 involves advancing an internal pusher or ejector component (not shown) of the delivery catheter 730, thereby deploying or ejecting a distal portion of the sensor implant device 700 from the distal end of the delivery catheter 730, as shown at state 802 in FIG. 8 . The sensor implant device 700 may include one or more distal anchor arms 721, which may be similar to the distal arms 521 shown in FIGS. 5 and 6 . Further with respect to block 704, the process 700 may involve ejecting the sensor device 700 from the delivery catheter 730 just enough to expose the distal arm 721, but not enough to eject the proximal arm associated with the sensor implant device from the delivery catheter.

[0059] With the distal arm 721 ejected from the delivery catheter 730, the process 700, in block 706, involves retracting the delivery system to set the distal arm 721 against the septal wall 18, as shown in state 803 of FIG. 8 . For example, the distal end 731 of the delivery catheter 730 may be pulled back into the right atrium 5 to set the distal arm 721 against the left atrial side of the septal wall 18, according to some implementations. Once the distal arm 721 is set against the septal wall, the process 700 may, in block 708, involve further retracting the delivery system 730 to deploy the proximal arm 722 of the anchor 720 associated with the sensor implant device 700 against the right atrial side of the septal wall 18. Retracting the delivery catheter 730 exposes the proximal arm (e.g., a nitinol arm), which may then engage the right side of the septal wall 18 relative to the illustrated orientation of the septal wall. In some implementations, the distal arm 721 and / or the proximal arm 722 can be configured or shaped to provide tension against the septal wall 18 when the sensor implant device is fully deployed, as shown in state 804 of FIG. 8. In some implementations, the distal arm 721 can have a curved configuration or shape, as shown herein, while the proximal arm 722 can comprise an at least partially straight configuration or shape.

[0060] With the sensor implant device 700 implanted, as shown in state 804 in FIG. 8 , the sensor element 712 may be configured to be deployed within the left atrium 2 and provide a pressure or other measurement associated therewith. In some embodiments, an additional sensor element 711 associated with a proximal end or portion of the sensor 710 may be disposed within the right atrium 5 and used to provide a pressure or other physiological parameter measurement associated with the right atrium 5, which may be used for differential pressure and / or other measurements.

[0061] In some embodiments, a sensor implant device according to the present disclosure may be configured, shaped, and / or designed to facilitate recapture or removal of the sensor implant device. FIG. 9 illustrates a system for removing a previously implanted sensor implant device 900 according to one or more embodiments. The system of FIG. 9 includes a delivery / aspiration catheter 930, which may be used to deliver and / or remove or extract the sensor implant device 900. The system further includes a pusher or extraction device 935, which in some embodiments may be movable within the delivery catheter 930.

[0062] As described in detail herein, the sensor device 910 may include one or more protrusions 917 or other engagement features that facilitate engagement of the sensor device 910 for implantation and / or extraction. In some embodiments, the pusher / extraction device 935 includes a protruding engagement feature 937. For example, the pusher / extraction device 935 may have an at least partially hollow cylindrical form configured and dimensioned to fit at least partially around the sensor 910, with gaps 939 in the engagement feature 937 of the pusher / extraction device 935 allowing the pusher / extraction device 935 to be threaded longitudinally through the protruding feature 917, and rotation of the pusher / extraction device 935 allowing the engagement feature (e.g., extension member) 937 to circumferentially overlap the protruding feature 917. When the pusher / extraction device 935 is rotated as shown in FIG. 9 , retracting the pusher / extraction device 935 may pull the sensor implant device 900, or its sensor 910 component, toward the right atrium. Thus, the pusher / extractor device 935 may provide a bayonet-style engagement mechanism that may be selectively engaged with and disengaged from the protruding feature 917. Although a single protruding feature 917 is shown in FIG. 9, it should be understood that the sensor implant device 900 may have any number of protruding features, and further, the pusher / extractor device 935 may have any number of respective protruding engagement features.

[0063] In some embodiments, the shape or configuration of the distal arm 921 of the anchor 920 may allow the arm to be pulled into a straighter configuration / form, allowing the anchor 920 to be pulled or withdrawn through the opening in the septal wall 18. Thus, by further retracting the delivery catheter 930 and / or extraction device 935 in the direction illustrated, the sensor implant device 900 may be removed from its implanted position in the septal wall 18. The shape of the distal arm 921 and proximal arm 922 of the anchor 920 may facilitate recapture of the anchor 920. Recapture / removal of the sensor implant device 900 may be performed between procedures or at a later time, if necessary or desired.

[0064] Although the pusher / extraction device 935 has been described with respect to removing the sensor implant device 900 and / or the sensor component 916, the pusher / extraction device 935 may, in some embodiments, be utilized to implant the sensor implant device 900 and / or the sensor component 916. For example, the pusher 935 may be used to manipulate the implant device 900 as it is deployed. When used for deployment, the pusher device 935 may push the sensor protruding feature 917 to engage the sensor implant device 900 and the septal wall as shown, and then the pusher device 935 may be rotated to disengage the engagement feature 937 from the protruding feature 917, allowing for withdrawal of the pusher device 935 from the sensor implant device 900.

[0065] 5-9 illustrate sensor implant devices having anchors of particular configurations with distal and proximal arms, as described above. FIG. 10 illustrates a sensor implant device 1000 having an anchor 1020 with a different form and / or configuration than those described above. In particular, the anchor 1020 of the sensor implant device 1000 shown in FIG. 10 may enable the sensor 1010 to be implanted within a chamber or vessel associated with the heart or other anatomical structure, such as within the left atrium of the heart, with the entire sensor device 1010 disposed within a single vessel or chamber, but with the arms 1027 of the anchor 1020 remaining solely within the chamber or vessel on the opposite side of a tissue wall separating the sensor 1010 from the anchor arms 1027.

[0066] FIG. 11 shows the sensor implant device 1000 implanted within the septal wall 18. In some embodiments, a cylindrical or other shaped sensor 1010 is used as an anchoring member when implanting the sensor implant device 1000 into a desired tissue wall. When implanted, the anchoring arms 1027 may serve to hold the sensor 1010 against the first side 119 of the septal wall 18, at least in part by applying pressure or force on the opposite side 117 of the septal wall 18. Thus, when implanted, the sensor 1010 may be held relatively close to the septal wall 18. Once the sensor is disposed and secured within the chamber 2 (e.g., the left atrium), its sensor element may be used to detect pressure or another physiological parameter within the chamber 2. While FIG. 11 shows the sensor 1010 disposed within the left atrium 2, in some embodiments, the sensor may be disposed within the right atrium 5, or other blood vessel or chamber, but the anchoring arms 1027 may be disposed exclusively within the left atrium 2. In some embodiments, the implant device 1000 comprises an occlusion membrane or fabric (eg, a polymeric fiber fabric) attached to the frame of the anchor 1020 and covering at least a portion of the opening 115 in the septal wall 18 .

[0067] 10 , the anchor 1020 may comprise a shape memory alloy, such as nitinol, or the like, and / or other at least partially rigid material. In some embodiments, one or more arms or features of the anchor 1020 include one or more tissue or suture attachment features 1025, such as one or more eyelets or the like. For example, after implantation, the eyelets 1025 of the anchor frame 1020 may be sewn into the tissue wall, thereby securing the sensor implant device 1000 in the implanted position. If the anchor 1020 includes multiple eyelets or other attachment features, a suture may be threaded through each respective feature to achieve the desired attachment. Alternatively, the eyelets or other suture engagement features may be used to retrieve, move, and / or retract the anchor frame 1020. For example, prior to its deployment, with the anchor frame 1020 disposed within the delivery catheter in a collapsed state, a suture may be engaged with each of the illustrated eyelet features 1025, with at least one eyelet or other suture engagement feature associated with each respective anchor arm 1027. If, during placement of the sensor implant device 1000, the anchor frame and / or sensor 1010 are poorly positioned in any way, the suture attached to the eyelet or other suture engagement feature 1025 may be pulled through the delivery catheter, thereby causing the arms 1027 to be at least partially collapsed, which may allow for repositioning of the sensor device 1000 and / or retraction of the sensor implant device 1000 and / or anchor 1020 into the delivery catheter.

[0068] The illustrated semicircular shape of the anchor arm 1027 may help secure the anchor arm 1027 with tissue at the target location. For example, the corner features 1029 of the anchor 1020 may provide desirable engagement with and / or embedding within the target tissue. Additionally, the illustrated shape of the anchor arm 1027 may serve to facilitate the anchor being retracted and / or withdrawn into the delivery catheter.

[0069] 11, tissue ingrowth may occur on one or both sides of the septal wall 18 on either or both of the anchor frame arms 1027 and the sensor 1010. In some embodiments, a coating or material may be added or used in connection with the sensor 1010 that serves to inhibit tissue ingrowth thereon. Such a material or coating may advantageously be such that it does not substantially affect the dynamics of the sensor element.

[0070] Figure 12 is a flow chart illustrating a process 1200 for implanting a sensor implant device similar in some respects to the sensor implant device 1000 illustrated in Figures 10 and 11 in accordance with one or more embodiments of the present disclosure. Figure 13 illustrates the implant sensor device 600 and associated delivery system, as well as the target implantation site anatomy, at various states of process 1200.

[0071] At block 1202, the process 1200 involves feeding / introducing a delivery catheter 630 into the left atrium 2. For example, access to the left atrium 2 may be achieved through the inferior vena cava 29, the right atrium 5, and through the septal wall 18 separating the right atrium 5 from the left atrium 2. Access to the inferior vena cava 29 may be achieved through the femoral vein or other access port.

[0072] With the distal end of the delivery catheter 630 disposed within the left atrium 2, the process 1200 involves ejecting the sensor 610 of the sensor implant device 600 from the delivery catheter 630 at block 1204. The process 1200 may advantageously first involve ejecting only the sensor element 610 while at least a portion of the associated anchor foam 620 remains within the delivery catheter 630, as shown in states 602 and 603 of FIG. 13 . In some embodiments, a pusher device 635 may be used to eject the sensor 610 from the delivery catheter 630.

[0073] In block 1206, process 1200 involves turning or pivoting sensor device 610, which may be initially ejected from the delivery catheter in a longitudinally aligned orientation with respect to delivery catheter 630, to assume an orientation that is substantially perpendicular to the longitudinal axis of the distal end of delivery catheter 630, as shown in state 603 of FIG. 13. While this is a perpendicular orientation as shown and described for sensor 610, it should be understood that turning or pivoting sensor 610 may not cause the sensor to assume a perpendicular orientation, but may simply cause sensor 610 to assume an orientation that is more perpendicular than a coaxial orientation with the distal end of the delivery catheter. In some embodiments, anchor frame 620 comprises a shape memory alloy (e.g., nitinol), which may be pre-shaped to pivot / turn sensor 610 as shown. That is, anchor frame 620 may be attached to a portion of sensor 610, and after being ejected from delivery catheter 630, the shape memory properties of the frame allow sensor 610 to pivot or rotate as shown.

[0074] At block 1208, the process 1200 involves retracting the delivery catheter and positioning the sensor (e.g., a pressure sensor) against the septal wall 18. The sensor 610 may thereby serve to self-anchor in a desired position relative to the septal wall on either side thereof.

[0075] At block 1210, the process 1200 entails further retracting the delivery catheter 630 to deploy the anchor arms 627 of the anchor frame 620 on the opposite side of the septal wall 18 relative to the pressure sensor 610. As the arms 627 are deployed from the delivery catheter 630, they may swing outward to contact the septal wall 18, as shown, providing a tensioning force that secures the implant device 600 in a desired position. For example, the frame 620 may be pre-shaped so that the arms 627 flare outward when deployed from the delivery catheter 630. In some embodiments, the anchor arms 627 have a suture-engaging feature, such as an eyelet or the like, for coupling a suture 640 thereto. Such a suture may advantageously allow the frame arms 627 to be pulled back to a relatively straight configuration to re-enter the delivery catheter 630 when it is desired to remove, retract, or reposition the sensor device 600. When the desired implantation location is reached, the suture may be pulled through the suture engagement feature of anchor arms 627, thereby releasing anchor 620 from the delivery system. Although separate sutures are illustrated for each of the anchor arms in Figure 13, in some embodiments, a single suture is coupled to both anchor arms.

[0076] A sensor anchor according to embodiments of the present disclosure may include multiple coil stacks at the proximal and distal ends, with smaller diameter coils in between configured to engage protrusions or projections on a cylindrical sensor to secure the sensor to the coil. FIG. 14 illustrates one embodiment of a sensor anchor 220 according to one or more embodiments of the present disclosure. The anchor 220 includes a wireform having multiple helical portions with different diameters. For example, in some embodiments, the anchor 220 includes two large diameter helical portions, including a proximal large diameter portion 222 and a distal large diameter portion 224, one or more of which may have a diameter d1 as shown. The anchor 220 may further include an intermediate small diameter helical portion 223 having a diameter d2 smaller than diameter d1. The anchor wireform 220 may advantageously include a single, integral wire formed into the illustrated complex helical coil. Alternatively, the wireform 220 may include multiple separate wire components that are joined or integrated to form the anchor 220.

[0077] 15 shows anchor 220 implanted within septal wall 18, where anchor 220 engages sensor device 210, thereby securing and anchoring sensor device 210 in the illustrated implanted position. For example, in some embodiments, anchor 220 can be configured and / or dimensioned such that cylindrical sensor device 210 can be retained and secured within smaller diameter intermediate portion 223 of anchor 220, while distal larger diameter portion 222 and proximal larger diameter portion 224 can hold implant device 200 against septal wall 18. For example, smaller diameter coil portion 223 can advantageously be dimensioned to fit within an opening / perforation in septal wall 18, while larger diameter portions 222, 224 can have a diameter greater than the septal wall opening when in the expanded configuration.

[0078] The anchor 220 can be delivered to the target implantation site in a delivery catheter in a compressed configuration. For example, the wireform 220 can be delivered in a substantially straight or relatively tightly wound configuration, and after deployment from the delivery catheter, the wireform anchor 220 is configured to assume the shape and configuration shown in FIGS. 14 and 15 . In some embodiments, the anchor 220 is delivered in a delivery catheter in a configuration such that it is wound around or attached to the sensor 210. Alternatively, the anchor can be delivered separately from the sensor. For example, the wireform anchor 220 can be implanted in the septal wall 18 as shown, after which the cylindrical sensor 210 can be pushed through the center of one or more coils of the intermediate small diameter helical portion 223 to achieve an interference fit with the small diameter coil portion such that the small diameter coil is wound relatively tightly around the cylindrical sensor body (e.g., a glass cylindrical body).

[0079] In some embodiments, sensor 210 includes one or more engagement features for engaging with and / or securing to small diameter portion 223 of anchor 220. For example, as shown in FIG. 16 , sensor 210 may include one or more protruding features 217, as described above. Such protruding features 217 may be integral with the body of sensor 210 or may be attached thereto using adhesive or other attachment mechanisms. Protruding features 217 may be sized and / or positioned such that when the protruding features intertwine or pass between the coils of small diameter coil portion 223, contact between the protruding features and the wire coil serves to hold or maintain the sensor in position relative to anchor 220. In some embodiments, protruding features 217 are configured such that sensor 210 can be engaged with anchor 220 by rotating or winding sensor 210 through intermediate portion 223. Thus, removal of sensor 210 can be achieved by unwinding sensor 210 to disengage protruding features 217 from small diameter intermediate coil 223. Such removal may allow access to the left atrium through the opening between the small diameter coils 223. Additionally, removal of the sensor 210 may be desirable if the sensor is malfunctioning or otherwise needs to be replaced or removed. In some embodiments, the wireform anchor 220, as illustrated, comprises a shape memory alloy wire preformed into a desired coil shape.

[0080] Although various embodiments are illustrated and described herein with reference to a sensor implant device implanted within the atrial septal wall, it should be understood that embodiments of the present disclosure are applicable to other implantation sites, including implantation of a sensor implant device within the ventricular septal wall. FIG. 17 illustrates one embodiment of a sensor implant device according to aspects of the present disclosure. FIG. 17 shows a pressure sensor device 1710, or other type of sensor device, within the ventricular septal wall 17. The sensor implant device 1700 includes a sensor 1710 and one or more anchoring features (not shown) configured to secure the sensor 1710 at a desired location within the septal wall 17.

[0081] The sensor implant device 1700 may be configured to provide sensor readings for monitoring pressure within the right ventricle 4 and / or the left ventricle 3. For example, the sensor 1710 may include one or more sensor elements 1711, 1712, each of which may be disposed within a respective ventricle of the heart 1 when implanted, as shown in FIG. 17 . In some embodiments, the sensor 1710 includes only a single sensor element and is configured to provide pressure sensor readings for only one ventricle. Ventricular pressure monitoring may be useful in diagnosing and / or treating certain heart failure patients. As with other embodiments of the sensor implant device disclosed herein, the sensor implant device 1700 may advantageously include wireless transmission capabilities for receiving and / or transmitting wireless data and / or power, as described in detail herein.

[0082] Sensor-integrated tissue closure device In some embodiments, a sensor implant device according to the present disclosure may include a sensor integrated with a septal closure device or other tissue closure device. While some embodiments are disclosed below in the context of a septal closure device, it should be understood that such disclosure is applicable to sensor-integrated implant devices including one or more sensors integrated with other types of tissue closure devices. FIG. 18 illustrates a front view of a sensor-integrated septal closure device according to one or more embodiments of the present disclosure. FIG. 19 illustrates a perspective view of the sensor-integrated septal closure device of FIG. 18 implanted within a tissue wall 18. As shown in FIG. 18, the sensor-integrated septal closure device 100 may include a frame 112 configured to support a blood-occlusive membrane 138. With reference to FIG. 19, the septal closure device 100 may be implanted within the septal wall 18 to close a shunt across the septal wall, which may be congenital or formed during an interventional procedure. In some embodiments, the septal occluder frame and occluding membrane 138 may be first implanted in the septal wall 18, and then the sensor device 110 may be attached to the septal closure device, such as by puncturing the occluding membrane 138 and passing the sensor device 110 therethrough.

[0083] The frame 112 in the illustrated configuration may comprise a generally planar body including a central portion 114 and a plurality of anchoring arms 116 extending radially outward from the central portion 114. For example, as shown in the illustrated embodiment, at least four arms may extend from the central portion 114, although the frame may have more than four arms 116 or fewer than three arms 116 in other embodiments. While arms 116 are shown and described, it should be understood that the septal closure device 100 and / or the frame may comprise any type of tissue anchoring feature.

[0084] The four arms 116 may include a first set of opposing arms 118 and a second set of opposing arms 120 extending from the central portion 114. The closure device desirably (but not necessarily) has the same number of arms in the first and second sets so that the clamping force the arms exert when the device is implanted is evenly distributed against the septum. In the illustrated embodiment, for example, the first set of arms 118 includes exactly two arms extending from opposite sides of the central occlusion membrane 138, and the second set of arms 120 includes exactly two arms extending from opposite sides of the central occlusion membrane 138. In other embodiments, the first or second sets of arms may include only one arm, or four or more arms.

[0085] In the deployed or expanded configuration, the arms 116 can extend radially outward from the central occlusion portion 138. The arms 116 can extend perpendicular or substantially perpendicular to a central axis of the device 100 (a central axis that extends through the center of the sensor device 110 integrated with the septal closure device and is perpendicular to the plane of the page) such that the atrial septum 18 can be compressed or sandwiched between the first set of arms 118 and the second set of arms 120 when the device 100 is implanted within the septal wall 18. In other words, when the device 110 is implanted, the first set of arms 118 is on one side of the septal wall 18, the second set of arms 120 is on the other side of the atrial septum, and the central portion 138 can be disposed within the septal opening or defect.

[0086] The frame 112 in the illustrated embodiment has a relatively thin, flat profile to avoid or minimize thrombus formation. Accordingly, for such purpose, the arms 116 may be attached to a central portion of the frame 114 associated with the periphery of the central occlusion membrane 138 in an angularly spaced apart arrangement, the attachment arrangement intersecting a common plane perpendicular to the central axis; in other words, the arms 116 in the illustrated embodiment may all be attached to the central frame portion 114 along a circumferential path defined by the central frame portion 114.

[0087] In some embodiments, arms 116 and central frame portion 114 may be flush with one another when device 100 is in its fully expanded, undeflected shape; i.e., arms 116 have no portions that extend axially away from central frame portion 114. It should be understood that after implantation, first set of arms 118 and second set of arms 120 may be bent slightly axially away from one another by the thickness of septum 18 and may no longer be flush with one another. Nevertheless, device 110 in some embodiments may be said to have a flat profile with arms that are flush with one another and with central frame portion 114 when the device is in its undeflected state. However, in other embodiments, the arms, or portions thereof, may be heat set or otherwise shaped to extend axially away from one another or from central frame portion 114 in the undeflected state.

[0088] Frame 112 can be radially compressed or contracted into a delivery configuration for delivery to the heart in a delivery catheter / system. For example, in the delivery configuration, frame 112 can be deployed and held in a generally compressed configuration in which a first set of arms 118 are folded toward each other along a central axis of device 100 and a second set of arms 120 are folded toward each other along a central axis of device 100, with the first set of arms 118 and the second set of arms 120, respectively, extending parallel to each other in axial direction 120. When deployed in the delivery configuration, frame 112 can also be radially compressed with respect to the deployed configuration.

[0089] The frame 112 can include eyelets 130 disposed at the distal end of one or more arms for coupling the closure device 100 to a delivery system via one or more attachment sutures, as described further below. The eyelets can project toward or away from the central portion 114, as shown at 18 and 19.

[0090] The frame 112 may be self-expandable and may be formed from a shape-memory material, such as nitinol, so that the frame 112 self-expands from a delivery configuration to a deployed configuration when released from a delivery device or deployed. In an alternative embodiment, the frame 112 may be formed from a plastically expandable material, such as stainless steel or a cobalt-chromium alloy, and configured to be plastically expanded from a delivery configuration to a deployed configuration by an expansion device, such as an inflatable balloon. The frame 112 may be laser cut or otherwise formed from a flat sheet of metal, such as nitinol. Alternatively, the frame 112 may be formed by bending one or more metal wires into the shape shown.

[0091] The occlusion membrane 138 may be configured to block the flow of blood between the right and left atria. In adults, the normal range for right atrial pressure is approximately 2-6 mmHg, and the normal range for left atrial pressure is approximately 4-12 mmHg. Thus, throughout most of the cardiac cycle, the left atrial pressure is greater than the right atrial pressure. In some embodiments, the occlusion membrane 138 may be configured to block the flow of blood from at least the left atrium to the right atrium. In other embodiments, the occlusion membrane 138 may be configured to block the flow of blood between the right and left atria in both directions throughout the cardiac cycle.

[0092] In certain embodiments, the occlusion membrane 138 can include one or more sheets or pieces of material that at least partially block or impede blood flow through the frame 112. For example, the occlusion membrane 138 can include one or more pieces of a bioabsorbable material, film, or fabric that is configured to encourage tissue ingrowth and can degrade over time, leaving only regenerated tissue within the central frame portion 114. For example, the occlusion membrane 138 can include one or more pieces of a bioabsorbable electrospun polymer material, such as polylactide (PLA), polylactide glycolide (PLGA), polycaprolactone (PLC), polyacrylonitrile (PAN), poly(lactide-co-caprolactone) (PLCL), polyglyconate, and polypeptides. Compared to woven fabrics, electrospun polymers promote faster tissue ingrowth, have shorter biodegradation times, are potentially less thrombogenic, and are weaker in shape, and therefore can be more easily punctured with a medical instrument during subsequent recrossing of the closure device.

[0093] In some embodiments, the occlusive membrane 138 may comprise one or more sheets of pieces of non-bioabsorbable material, such as any of a variety of synthetic fibers (e.g., polyethylene terephthalate (PET)) or natural tissue (e.g., pericardium). In some embodiments, the occlusive membrane 138 may be completely or substantially impermeable to blood. In other embodiments, the occlusive membrane 138 may be semi-porous to blood flow (e.g., a porous fabric). The porous material may remain porous or may be selected to become impermeable or non-porous to blood over time. In certain implementations, the occlusive membrane may be made from biospun polyurethane with a fiber size between about 0.05 and 1.5 microns and a porosity between about 50 and 80%. The thickness of the occlusive membrane 138 may be between about 100 and 200 microns. In another implementation, the occlusive membrane may be made from a biospun polymer blend including polyurethane and PET, such as a 70 / 30% blend of polyurethane / PET, with similar fiber size and porosity. In some embodiments, the occlusive membrane 138 can be made from a biocompatible foam, such as polyurethane, PET, silicone, or polyethylene foam.

[0094] The occluding membrane 138 can be configured to form a substantially fluid-tight seal with adjacent tissue of the septum. In some embodiments, the occluding membrane 138 is configured to, at least initially, allow a small amount of blood flow between the atria, resulting in residual shunting. Over time, the occluding membrane 138 can promote tissue ingrowth to substantially completely close the septal opening and prevent residual shunting between the atria. The occluding membrane 138 can completely cover the central frame portion 114, as shown in FIGS. 18 and 19 , or the occluding membrane 138 can cover a portion of the opening in the central frame portion 114. The occluding membrane 138 can be configured so that the opening in the septum 18 can be accessed for re-entry through the defect either before or after degradation of the occluding membrane 138.

[0095] The occlusion membrane 138 may be attached to the frame 112 via heat staking, stitching, molding, adhesive, braiding, and / or other means known to those skilled in the art with the benefit of this disclosure. For example, the outer edges of the occlusion membrane 138 may be folded over the central frame portion 114 and then welded to a more central region of the occlusion membrane 138 to secure the occlusion membrane 138 to the frame 112. The occlusion membrane 138 may extend beyond the periphery of the central frame portion 114, for example, by up to 2 mm. In some embodiments, the occlusion membrane 138 may have a generally circular shape before being attached to the frame 112.

[0096] The occlusion membrane 138 may advantageously comprise a relatively thin fabric that may be penetrated to gain access to the left atrium, should the need arise in connection with a future intervention. Additionally, the frame 112 may advantageously be configured to stretch and open to accommodate a relatively large diameter catheter, allowing access to the left atrium through the frame 112, and particularly through the central frame portion 114.

[0097] 18 and 19 includes a sensor device 110 attached to or otherwise integrated with an occlusion membrane 138. The sensor device 110 may be a pressure sensor including one or more sensor elements, as described herein. For example, the sensor device 110 may have a generally cylindrical shape and may penetrate the occlusion membrane 138 such that distal and proximal end portions of the sensor 110 are exposed on opposite sides of the septal closure device 100.

[0098] Removal of the sensor device 110 after implantation may allow access through the occlusion membrane 138 to access the left atrium. For example, the frame 112 of the septal closure device 100 may include a shape memory alloy or other material that is relatively easily deformed to allow passage of an interventional device. In some implementations, the interventional device may pass through the occlusion membrane 138 with the sensor device 110 remaining disposed therein or integrated therewith. In some implementations, the sensor-integrated implant device 100 may be delivered with the sensor 110 already integrated with the septal closure device.

[0099] 20 illustrates a sensor implant device 2000 including a sensor 2010 integrated with a septal closure device. The septal closure device includes an occlusion fabric or membrane 2038 connected to a frame 2012 including multiple arms, as described in detail herein. To maintain the intended functionality of the sensor-integrated implant device 2000, the embodiments disclosed herein utilize a means for affixing the sensor 2010 to the septal closure implant. In some embodiments, the occlusion membrane 1038 may include a fabric (e.g., a biospun polymer fabric) membrane formed into one or more sleeves / cuffs 2039 shaped to retain the sensor device 2010. For example, with respect to a cylindrical sensor device 2010, the sleeves / cuffs 2039 may be at least partially cylindrical and serve to affix the cylindrical sensor 2010 to the frame 2012. The sleeve / cuff 2039 of the occlusion membrane / cloth 2038 may be secured to the sensor device 2010 using a suture collar 2037, which may be wrapped around the sleeve / cuff 2039 and the sensor device 2010 to secure the sleeve / cuff 2039 to the sensor device 2010.

[0100] As described above, the occlusive membrane 2038 may comprise a biospun polymer, which may be fabricated in any suitable or desirable geometry, such as a fabric or scaffold geometry. In some embodiments, the occlusive membrane 2038 is configured to gradually integrate with living tissue through progressive tissue ingrowth over time. Such a membrane may advantageously have properties such that the force required to penetrate the membrane is less than the amount of force required to remove the frame 2012 from the implantation location / site, as described in detail herein. In some embodiments, the sensor device 2010 includes one or more protruding features 2017, which may be integral with the body of the sensor 2010 or may be attached or adhered using a biocompatible adhesive or other attachment means.

[0101] To maintain the ability to gain access to the left atrium after implantation of a sensor-integrated septal closure device as described herein, a sensor implant device detachment catheter may be utilized. FIG. 21 illustrates a process 2100 for removing a sensor implant device according to an embodiment of the present disclosure. FIG. 22 illustrates a sensor implant device and associated detachment system, as well as various cardiac anatomical conditions corresponding to the process steps of FIG. 21 . In block 2102, the process 2100 involves introducing a detachment catheter 2103 into the right ventricle and advancing the detachment catheter to the atrial septal wall 18 where the sensor implant device 2200 is implanted. A detachment catheter 2230 may be used to safely detach the cylindrical sensor 2210 from its integrated septal closure device or to remove the entire sensor-integrated septal closure device 2200. The sensor 2210 may advantageously include one or more protrusions or other engagement features 2217 that may be used to detach the sensor 2210. The protruding features 2217 may protrude radially from the outer surface of the sensor body 2210. Although protruding features are described herein, it should be understood that other means of holding or gripping on the sensor 2210 may be implemented in accordance with embodiments of the present disclosure.

[0102] At block 2104, process 2100 involves advancing extraction device 2235 within removal catheter 2230. In some embodiments, pusher / extraction device 2235 includes a protruding engagement feature 2237. For example, at block 2106, process 2100 involves engaging engagement feature 2237 with protruding feature 2217 of sensor 2210, as shown in state 2203 of FIG. 22 . Pusher / extraction device 2235 may have an at least partially hollow cylindrical tubular form configured and dimensioned to fit at least partially around sensor 2210, with gaps 2239 in engagement feature 2237 of pusher / extraction device 2235 allowing pusher / extraction device 2235 to be advanced longitudinally over protruding feature 2217, and rotation of pusher / extraction device 2235 allowing extension / engagement feature 2237 to circumferentially overlap and engage protruding feature 2217.

[0103] At block 2108, the process 2100 involves withdrawing the removal catheter 2230, thereby detaching the sensor 2210 from the septal closure implant 2211. For example, when the pusher / extraction device 2235 is rotated as shown in state 2203 of FIG. 22 , retracting the pusher / extraction device 2235 may pull the sensor 2010 and / or the septal closure implant device 2200 toward the right atrium. Thus, the pusher / extraction device 2235 may provide a bayonet-style engagement mechanism that may be selectively engaged with or disengaged from the protruding feature 2217. While a single protruding feature 2217 is shown in FIG. 22 , it should be understood that the sensor implant device 2200 may have any number of protruding features, and further, the pusher / extraction device 2235 may have any number of respective protruding engagement features. In some embodiments, when the pusher / extraction device 2235 is engaged with the protruding feature 2217, the distal end 2231 of the detachment catheter 2230 can be held against the septal closure device 2200 to prevent the septal closure device 2200 from becoming dislodged when the sensor 2210 is extracted.

[0104] 22 shows the septal closure implant device 2200 with the sensor device 2210 removed therefrom. However, it should be understood that in some embodiments, the entire sensor-integrated septal closure device 2200 can be removed in connection with the process 2100. After the sensor 2210 is removed from the septal closure device 2200, the relatively weak occlusion membrane 2238 (e.g., a biospun polymer) can be relatively easily crossed using a standard device catheter.

[0105] Although the pusher / extraction device 2235 has been described with respect to removing the sensor implant device 2200, the pusher / extraction device 2235 may, in some embodiments, be utilized to implant the sensor implant device 2200. For example, the pusher 2235 may be used to manipulate the implant device 2200 as it is deployed. When used for deployment, the pusher device 2235 may push the sensor protruding feature 2217 to engage the sensor implant device 2200 and the septal wall as shown, and then the pusher device 2235 may be rotated to disengage the engagement feature 2237 from the protruding feature 2217, allowing for withdrawal of the pusher device 2235 from the sensor implant device 2200.

[0106] Additional sensor-integrated cardiac implant devices In some embodiments, the sensor implant device may include a sensor integrated with a heart valve spacer device. As shown in FIG. 23 , a valve spacer device 2300, 2301 may be implanted in the heart 1 to improve the performance of the tricuspid valve 8 or the mitral valve 6. While the following description focuses on a sensor-integrated spacer implant device 2300 implanted in the right ventricle 4 and positioned to fit within the tricuspid valve 8 to improve its performance, it should be understood that the following description is also applicable to a sensor-integrated spacer implant device implanted in any valve and / or the left ventricle. This spacer implant device 2300 may be designed to reduce valve regurgitation by occupying the regurgitant orifice area between the native valve leaflets and providing a surface for leaflet coaptation. The sensor-integrated spacer implant device 2300 consists of a spacer foam 2320 and a tether 2325 that is anchored to the right ventricle 4, such as at or near the ventricular apex 26. The spacer foam 2320 may include an at least partially filled polymer (e.g., foam-filled) balloon configured to passively expand through one or more openings in the spacer chamber. The openings into the spacer foam 2320, in some embodiments, may be positioned at opposite longitudinal ends of the spacer foam. The openings in the spacer foam 2320 may allow the spacer foam 2320 to be compressed for catheter-based deliverability. In some embodiments, the spacer implant 2300 includes one or more radiopaque markers to aid in locating the spacer using fluoroscopy. The spacer foam 2320 may have any suitable or desirable size, such as a diameter of approximately 12 mm or 15 mm, a length of approximately 42 mm, or other dimensional values.

[0107] In some embodiments, the implant device 2300 is secured at its distal end within the right (or left) ventricular muscle using a tissue anchor 2327. The tissue anchor 2327 may have any suitable or desirable form. For example, in some embodiments, the anchor 2327 comprises a pronged metal anchor designed to minimize the risk of epicardial penetration and / or prong exposure within the ventricle. In some embodiments, the implant device 2300 may include an excess device length (not shown) that penetrates the right atrium 5 and into a subcutaneous pocket (not shown). In some embodiments, one or more of the antenna and / or wireless communication chip and / or circuitry may be housed within the subcutaneous pocket. Such antenna and / or circuitry may be configured to wirelessly communicate and / or process data and / or power related to the sensor function of the implant device 2300.

[0108] The filling of the spacer foam 2310, in some embodiments, comprises a resilient foam, which may provide suitable or desirable compression and decompression characteristics. The implant device 2300 includes a sensor 2310, which may be integrated with the spacer foam 2320 in any suitable or desirable manner. For example, in some implementations, the spacer foam 2320 comprises an external slot or recess in the external spacer foam and / or internal foam or chamber. The sensor 2310 may be configured and / or positioned within the implant device 2300 such that the sensor element is positioned to determine pressure readings within the ventricle 4 and / or atrium 5. In embodiments in which the sensor 2310 is disposed within the external balloon foam of the spacer 2320, the pressure sensor diaphragm of the sensor 2310 may at least partially protrude from the spacer foam 2320 such that the pressure sensor diaphragm may be used to determine fluid pressure outside of the spacer foam 2320.

[0109] In some embodiments, the spacer foam 2320 is fluid-filled such that fluid pressure outside the spacer foam 2320 is at least partially transmitted to or somehow converted into fluid pressure within the spacer foam. In some embodiments, the internal pressure of the spacer foam 2320 provides information indicative of how hard the valve leaflets strike the spacer foam during the cardiac cycle. That is, in some embodiments, the sensor 2310 is configured to measure the pressure within one or more chambers of the heart 1 as well as the leaflet contact force exerted on the spacer foam. The leaflet contact force can be measured to determine functional wear of the implant device 2300. In some embodiments, the spacer foam 2320 has one or more openings at one or more longitudinal ends thereof through which a sensor element can be exposed to external fluid pressure.

[0110] In some embodiments, a battery or other power source is maintained within 2320. Additionally, wireless transmission and / or control circuitry may be housed within 2320 and / or sensor 2310, including one or more antennas, chips, conductors, and / or the like. Such components and circuitry may be configured to wirelessly communicate and / or process data and / or power related to sensor functions associated with sensor 2310. In some embodiments, sensor-integrated implant 2300 is configured to provide atrial pressure readings, as well as pressure readings related to pulmonary artery pressure, which may provide information descriptive of both valvular and ventricular performance.

[0111] 24 illustrates a sensor assembly including a sensor-integrated spacer implant device 2400 and a separate tethered sensor device 2415, which may be secured to the inferior vena cava or other vessel or anatomical structure using an anchor 2417. The sensor 2415 may be tethered to the spacer implant device 2400 via a tether 2419, as illustrated. While the spacer implant device 2400 is shown as being integrated with a sensor 2410, in some embodiments, the spacer 2400 does not include a sensor. The spacer implant device 2400 may be secured to the ventricular wall by a tether 2425 and / or tissue anchor 2427.

[0112] The tethered pressure sensor 2415, anchored within the inferior vena cava 29, may advantageously provide a central venous pressure measurement, which may provide a good measure of venous congestion, or other useful measurements. The anchor 2417 may advantageously be configured to center the pressure sensor 2415 within the blood vessel 29, which may provide a desirable pressure measurement location. Additionally, the anchor 2417 and / or the sensor 2415 may advantageously include a material configured and / or operable to limit tissue overgrowth onto the sensor element of the sensor 2415. The anchor 2417 may further provide an additional fixation function for the valve spacer implant 2400, which may further secure the valve spacer implant 2400 in its desired position.

[0113] In some embodiments, pressure sensor 2410 of valve spacer implant device 2400 may measure right ventricular and / or right atrial pressure, while sensor 2415 may provide a measurement of inferior vena cava pressure, which in combination may provide a relatively complete picture of right-sided cardiac performance. Alternatively, sensors within the spacer device may be implanted in a similar manner on the left side of the heart.

[0114] In some embodiments, an implant device according to the present disclosure may include a sensor integrated with the left atrial appendage implant device. FIG. 25 illustrates a sensor-integrated cardiac implant device 2500 including a sensor 2510 integrated with a left atrial appendage occluder implant device 2520. The implant device 2500 may be implanted in the left atrial appendage 49 of the heart. The implant device 2500 may be positioned to measure pressure within the left atrial appendage 49 and / or the left atrium 2. Generally, measuring left atrial pressure may be useful for monitoring pulmonary fluid accumulation associated with congestive heart failure, as described in detail above. The sensor implant device 2510 may be permanently affixed to the left atrial appendage closure implant device 2520 via or using any attachment or integration mechanism, including adhesives, suture wrapping, or other attachment means for securing the sensor 2510 to the implant 2520. The sensor-integrated implant device 2500 may advantageously provide a secure location for securing the atrial pressure monitoring sensor 2510. The sensor 2510 may be advantageously positioned and / or configured to indicate a relatively low risk of a blood clot in the left atrium.

[0115] In some embodiments, an integrated sensor implant device according to the present disclosure comprises a sensor integrated with a valve repair clip or device configured to secure the leaflets together to reduce valve regurgitation. Figures 26 and 27 show side and top views, respectively, of an integrated sensor valve repair implant 2600 configured to provide edge-to-edge leaflet attachment for mitral valve repair according to one or more embodiments of the present disclosure.

[0116] Edge-to-edge leaflet repair implemented using implant device 2600 can advantageously restore valve competence at least in part by securing the free edge of the anterior leaflet 62 of the mitral valve 6 to the corresponding free edge of the posterior leaflet 62, thereby forming a double-orifice valve, as shown in Figure 27. Implant device 2600 is deliverable using a transcatheter approach and, therefore, may be suitable for patients who are high risk for surgical valve repair solutions.

[0117] The implant device 2600 includes a first clasp member 2621, a second clasp member 2622, and a spacer 2620. The implant 2600, as shown, can be configured to capture the valve leaflet between the clasps 2621, 2622 and the spacer 2620, which may be particularly effective in cases of relatively short posterior leaflets or relatively large leaflet prolapse gaps. The spacer includes a base 2609 and an end 2607. The base 2609 may be disposed within and / or exposed to the ventricle when the implant device 2600 is implanted and therefore may be considered the ventricular or ventricular portion of the spacer. The end 2607 may be disposed within and / or exposed to the atrium when the implant device 2600 is implanted and therefore may be considered the atrial or atrial portion of the spacer.

[0118] The implant 2600 further comprises a sensor 2610, which may be disposed within and / or integrated with the spacer 2620, as shown. For example, in some embodiments, the sensor 2610 has an exposed sensor element positioned and / or configured to generate a pressure reading indicative of left atrial pressure. Additionally, in some embodiments, the implant device 2600 comprises one or more sensor elements positioned and / or configured to provide a pressure sensor reading indicative of left (or right, in the case of tricuspid valve repair) ventricular pressure. For example, such sensor elements may be disposed at or near the ventricular portion of the spacer 2620 and / or the base 2609 of the implant device 2600. In some embodiments, the sensor 2610 is embedded in the spacer 2620.

[0119] The sensor element 2601 (e.g., a pressure sensor element as described herein) may be exposed and / or protrude from the end 2607 of the spacer 2620, thereby enabling the sensor element to generate pressure readings related to the atrial side of the valve 6. In addition to measuring left atrial and / or left ventricular pressure, the sensor 2610 may be used to measure the long-term performance of the repair valve 6. For example, the sensor 2610 may comprise a dual-element sensor configured to measure the gradient across the valve 6 and / or regurgitation into the left atrium.

[0120] FIG. 28 illustrates another embodiment of a sensor 2810 integrated with a mitral valve repair implant 2800 to form a valve repair sensor assembly 2801. The assembly 2801 may provide a mechanism for measuring left atrial pressure by tethering the pressure sensor 2810 to the valve repair implant 2800. The assembly 2801 may provide a simplified implant device for integrating pressure sensor functionality with a mitral valve leaflet repair implant, as compared to embodiments in which the pressure sensor is integrated with a spacer or other component of the repair clip implant. In some embodiments, the sensor-integrated assembly 2801 further comprises a support strut 2805, which may be coupled or attached in some manner to the sensor 2810 and serve to further secure the sensor 2810 at a desired location and / or within a range of locations. In some embodiments, the strut 2805 is at least partially rigid. The distal end 2806 of the strut 2805 may be embedded in tissue to secure the strut and sensor 2810.

[0121] FIG. 29 illustrates yet another embodiment of a sensor 2910 integrated with a mitral valve repair implant 2900 to form a valve repair sensor assembly 2901. In the embodiment of FIG. 29, the sensor 2910 is anchored to the inferior vena cava 29 by an anchor feature 2917. The anchor 2917 may be any suitable or desirable anchor according to embodiments of the present disclosure. In some embodiments, the anchor 2917 includes a shape memory alloy wire frame. The mitral valve repair device 2900 may be implanted using transseptal access to the left atrium 2. In connection with such a procedure, the sensor 2910 may be at least partially anchored within the inferior vena cava or right atrium, and a tether 2905 connecting the sensor 2910 to the valve repair device 2900 penetrates the atrial septal wall 18.

[0122] In some embodiments, an integrated sensor implant device according to the present disclosure includes an annulus reduction implant device having a sensor, such as a pressure sensor, integrated therein, as described in detail herein. Figure 30 illustrates an integrated sensor annulus reduction implant 3000 including an annulus reduction tube 3020 mechanically coupled to a sensor 3010, such as a pressure sensor. In some implementations, the implant device 3000 is configured to be implanted on or adjacent to the native mitral valve annulus.

[0123] The annulus reduction tube 3020 may comprise a woven tube configured to be sutured or otherwise secured to the native valve annulus and tightened to reduce its effective diameter to repair the associated valve. In some embodiments, the integrated sensor implant device 3000 comprises an anchor wire 3005 coupled to the sensor 3010 and configured to further support the sensor 3010 when implanted. For example, the anchor 3005 may comprise a relatively large diameter wire (e.g., a shape memory alloy such as Nitinol) that provides support for the sensor 3010. The anchor 3005 may be attached to the sensor 3010 in any manner or using any attachment mechanism. For example, as illustrated, the anchor wire 3005 may be wrapped around at least a portion of the sensor 3010. The anchor 3005 may be configured to radially expand to provide support within the left atrium or other chamber or vessel. In some embodiments, the anchor wire 3005 is configured to be implanted in tissue or coupled to a tissue anchor element.

[0124] In some embodiments, the distal end of the sensor 3005 is secured by the anchor 3005, while the proximal end of the sensor 3010 is anchored or secured to a sleeve or other attachment feature of the tube 3020. For example, the tube 3020 may include a reducer feature 3001 or other attachment mechanism. The reducer 3001 may allow a suture or other fastening feature to be wrapped around the sensor to tighten the reducer 3001 around the sensor, thereby securing the sensor 3010 to the tube 3020. Generally, incorporating the sensor 3010 with the annulus reduction implant may have a relatively small impact on the procedural steps involved in affixing the annulus reduction implant to the native valve annulus.

[0125] 31 illustrates a sensor 3110 coupled to a replacement mitral valve implant 3120. The combination of the sensor 3110, replacement valve 3120, and coupling structure 3105 can provide a sensor-integrated implant device that can be configured to provide atrial pressure readings as well as valve repair or function. In some embodiments, the replacement valve 3120 is a transcatheter heart valve.

[0126] Generally, a relatively large delivery system may be required to deliver the transcatheter heart valve 3120 illustrated in FIG. 31 . For example, if access to the target implantation site is achieved through the atrial septal wall 18, such access opening or aperture in the septal wall may be between approximately 6 and 18 mm in diameter, or larger. Therefore, it may be desirable to place a septal closure device within the septal wall to at least partially occlude flow through the septal opening. Described in detail herein is a pressure sensor device integrated with a septal closure implant. The illustrated assembly 3101 may advantageously include a septal closure structure 3103 with an integrated sensor device 3110, thereby providing septal closure functionality in addition to pressure monitoring and valve repair or function. Additionally or alternatively, the coupling structure 3105 may serve as a tether incorporated into the frame of the replacement valve 3120 and used as an anchor to secure the pressure sensor 3110 within the atrial septum 18 or at least partially within the left atrium or elsewhere. Although the valve replacement 3120 is described as a mitral valve replacement and the atrium 2 is described as the left atrium, it should be understood that the principles disclosed and illustrated in FIG. 31 apply to other replacement valves, including replacement tricuspid, aortic, and / or pulmonary valves.

[0127] 32 illustrates a valve repair and pressure sensor assembly having an alternative anchoring mechanism for the sensor within the tissue wall 18 (e.g., the septal wall). In some embodiments, anchoring of the sensor 3210 may provide one anchoring point from the frame of the replacement valve 3220 and another anchoring point from the septal wall, as illustrated. The tissue wall anchor 3217 may include a wire shaped into a coil at one end and a hook at the other end. For example, the proximal end 3218 of the wire anchor 3217 may be coiled around the sensor 3210, thereby at least partially anchoring the sensor 3210. A distal end portion 3219 of the anchor 3217 may be embedded in tissue and / or form a larger diameter coil as shown, or may have a free end.

[0128] 32 may utilize the transseptal access necessary to initially place the replacement valve 3220. That is, for the procedure, access, septal crossing, and guidewire may already be established in connection with placement of the replacement valve 3220 such that introduction of a catheter to deliver the sensor 3210 and associated anchor 3217 does not add substantial complexity to the procedure. Additionally, in some embodiments, the anchor 3217 and sensor 3210 may also function as a septal defect closure device.

[0129] In some embodiments, a sensor device, such as a pressure sensor device, may be implanted in an atrium or other chamber of the heart and anchored at least in part using one or more radially expanding anchor features or coils. FIG. 33 illustrates a sensor device 3310 suspended in the left atrium 2 of the heart. While some embodiments are disclosed herein in the context of the left atrium, it should be understood that sensors according to the present disclosure may be implanted in the right atrium or other chambers or vessels of the heart or body. The sensor 3310 is mounted or attached to a relatively large radially expanding anchor system including a radially expanding wire 3305. The wire 3305 may be configured to contact at least a portion of the interior wall of the atrium 2 when expanded. In some embodiments, the wire 3305 is configured to exert an outward radial force on the atrial wall, thereby anchoring or suspending the sensor device 3305 in a central or desired portion of the atrium. Additionally, the wire 3305 may be at least partially flexible and / or elastic to allow it to contract and / or expand in response to the contractions and expansions of the atria associated with the cardiac cycle.

[0130] The sensor 3310, in some embodiments, may be anchored or embedded within atrial tissue. For example, the sensor 3310 may have associated therewith a sensor anchor 3317 configured and dimensioned to be embedded within the tissue of the atrial wall at any suitable or desired location and / or portion thereof. FIGS. 34A and 34B illustrate exemplary embodiments of a pressure sensor having an associated or integrated tissue anchor. For example, as shown in FIG. 34A, the pressure sensor 3410 may be associated with or integrated into a multi-pronged tissue anchor, as illustrated. Additionally, as shown in FIG. 34B, the pressure sensor 3411 may be associated with or integrated into a corkscrew-type anchor 3418. The anchors in FIGS. 34A and 34B may be incorporated into the distal end of each sensor, and a shaped wire (e.g., a shape memory alloy wire) may be attached to the proximal end of each sensor to add stability to the sensor, as illustrated in FIG.

[0131] In some embodiments, a sensor-integrated cardiac implant device according to the present disclosure includes a pressure sensor integrated with a docking device, such as a docking apparatus for docking a replacement heart valve, or other implant device. Various anchors and docking devices, such as coiled anchors or docking devices, can be used in conjunction with transcatheter heart valves at the native valve annulus (e.g., the mitral or tricuspid annulus) to more securely implant and retain the prosthetic valve at the implantation site. Figure 35 illustrates a sensor-integrated implant device 3500 including a docking device 3507 integrated with a sensor 3510, such as a pressure sensor.

[0132] The anchoring / docking device 3507 can provide a more circular and / or stable valve annulus at the implantation site, within which a prosthetic valve having a circular or cylindrically shaped valve frame or stent can be expanded or otherwise implanted. In addition to providing an anchoring site for the prosthetic valve, the anchoring / docking device 3507 can be sized and shaped to clamp or pull the native valve (e.g., mitral valve, tricuspid valve, etc.) anatomical structure radially inward. In this manner, one of the major causes of valve regurgitation (e.g., functional mitral valve regurgitation), specifically, cardiac (e.g., left ventricle) and / or valve annulus hypertrophy and the resulting stretching of the native valve (e.g., mitral valve) annulus, can be at least partially offset or counteracted. In some embodiments, the anchoring / docking device 3507 further comprises shaped and / or modified features to, for example, better retain the position or shape of the docking device during and / or after expansion of the prosthetic valve therein.

[0133] The docking device 3507 includes a coil having multiple turns extending along a central axis of the docking device. The coil may be continuous or may extend in a generally helical manner with sections of various different sizes and shapes. The docking device 3507 shown in FIG. 35 may be configured to fit best in the mitral valve position, but other embodiments may have similar or different shapes to better accommodate other native valve positions.

[0134] The pressure sensor 3510 may be integrated with or attached to the proximal end 3503 of the docking device 3507. When implanting the docking / sensor assembly 3500, the sensor 3510 may be advanced to engage the docking device 3507. Additional fixation features (not shown) may be added to secure the proximal end of the sensor 3510 to the septal wall or other wall of the atrium 2. In some embodiments, the sensor 3510 is fixed to the septal wall and integrated with a septal closure device as described herein. In some embodiments, the docking device 3507 includes one or more proximal coils or loops 3506, which may be configured to assume a shape that can contact one or more portions of the interior wall of the atrium 2, thereby at least partially fixating the sensor 3510 in a desired position. Although a single proximal coil / loop 3506 is shown, the docking device 3507 may have any suitable or desirable number of coils / loops or other shapes and / or configuration features for securing or stabilizing the sensor 3510.

[0135] 36A and 36B illustrate sensor-integrated cardiac implant devices 3600a, 3600b according to one or more embodiments of the present disclosure. The cardiac implant devices 3600a, 3600b include cardiac implant structures 3620a, 3620b that are implanted and / or anchored within the pulmonary artery 11. The cardiac implant structures may include a pulmonary valve replacement device 3620b and / or a pulmonary stent device 3620a. For example, percutaneous pulmonary valve replacement 3620b may be an effective means for restoring valve function of a defective pulmonary valve. In some cases, the pulmonary artery may be at least partially dilated, so a reducer stent 3620a may desirably be placed within the pulmonary artery prior to percutaneous placement of the replacement valve. Thus, the cardiac implant structure 3620a may comprise a reducer stent, which may include struts configured and designed to secure and position the pressure sensor 3610a so that the sensing element of the pressure sensor 3610a is positioned at or near the center of the pulmonary artery 11. To such end, the cardiac implant structures 3620a, 3620b may include arms or struts 3605a, 3605b, which may have one or more attachment features 3601a, 3601b for attaching the sensors 3610a, 3610b, such as one or more bands, straps, features, locking features, and / or other attachment means. In some embodiments, the struts or arm features 3605 comprise a shape memory alloy shaped to receive and / or secure the sensor 3610. The stent structure 3620 may be sized to retain a valve replacement device therein. Additionally, although a stent is shown in FIG. 36, it should be understood that in some embodiments, the cardiac implant structure 3620 includes a replacement pulmonary valve device.

[0136] Various embodiments disclosed herein relate to sensor-integrated cardiac implant devices that may be implanted in any cardiac chamber or blood vessel. For embodiments involving implant devices implanted in one or more of the left or right atria and / or one or more of the left or right ventricles, or one or more blood vessels accessed through one or more atria or ventricles, such access may be achieved in any suitable or desirable manner. For example, FIG. 37 illustrates various access routes through which access to the target cardiac anatomy may be achieved, including transseptal access 3701, which may proceed from the right atrium 5 through the inferior vena cava 29 or superior vena cava 19, through the septal wall (not shown), and into the left atrium 2. For transaortic access 3702, a delivery catheter may be passed through the descending aorta, the aortic arch 12, the ascending aorta, and the aortic valve 7. For transapical access 3703, access may be made directly through the apex into the left ventricle 3 or right ventricle 4.

[0137] Additional Embodiments Depending on the embodiment, certain activities, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, merged, or omitted entirely. Thus, in some embodiments, not all described activities or events are required to implement a process.

[0138] Conditional phrases used herein, particularly "can," "could," "could," "could," "may," "may," "for example," and similar phrases, are intended in their ordinary sense unless otherwise indicated or should be understood otherwise within the context of their use, and are generally intended to convey that certain features, elements, and / or steps are included in some embodiments but not in other embodiments. Thus, such conditional phrases are not intended to imply that the features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without author input or prompting, whether those features, elements, and / or steps are included in or should be performed in a particular embodiment. The terms "including," "comprising," and "having," and similar phrases, are synonymous and used in their ordinary sense, inclusively, without restriction, and do not exclude additional elements, features, activities, operations, etc. Also, the term "or," for example, when used to connect a list of elements, is used in an inclusive sense (and not an exclusive sense) to mean one, some, or all of the elements in the list. Conjunctive phrases such as "at least one of X, Y, and Z," unless otherwise noted, are generally understood by the context in which they are used to convey that an item, term, element, etc., can be either X, Y, or Z. Thus, such conjunctive phrases are not generally intended to imply that some embodiments require that at least one of X, at least one of Y, and at least one of Z each be present.

[0139] In the foregoing description of embodiments, it will be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof to streamline the disclosure and aid in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that a claim requires more features than are expressly recited in that claim. Moreover, components, features, or steps illustrated and / or described in a particular embodiment herein may be applied to or used in other embodiments. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Accordingly, the scope of the invention(s) disclosed herein and claimed below is not intended to be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0140] It should be understood that some ordinal numbers (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Thus, as used herein, ordinal numbers (e.g., "first," "second," "third," etc.) used to modify an element, such as a structure, component, or operation, do not necessarily indicate a priority or order of the element with respect to other elements, but rather may generally distinguish the element from another element that has a similar or identical name (except for the use of the ordinal number). Additionally, as used herein, the indefinite articles "a" and "an" may indicate "one or more" rather than "one." Furthermore, an operation or action performed "based on" a condition or event may be performed based on one or more other conditions or events not explicitly mentioned.

[0141] Unless otherwise noted, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. Terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0142] Spatial relative terms such as "outside," "inside," "upper," "lower," "below," "vertical," "horizontal," and similar terms are used herein for ease of description and may describe the relationship between one element or component and another, as illustrated in the figures. It will be understood that spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if a device shown in the figures is upside down, a device positioned "below" or "directly beneath" another device may be referred to as being "above" another device. Thus, the exemplary term "below" can include both a lower position and an upper position. Devices may be oriented in other directions, and thus spatial relative terms may be interpreted differently depending on the orientation.

[0143] Unless otherwise specified, comparisons and / or quantitative terms such as "less," "more," "greater than," and similar phrases are intended to encompass equivalent concepts. For example, "less" may mean "less than" in the strict mathematical sense as well as "less than or equal to." [Explanation of symbols]

[0144] 1. Heart 2 left atrium 3 left ventricle 4 Right ventricle 5 Right atrium 6. Mitral valve 7. Aortic valve 8 Tricuspid valve 9 Pulmonary valve 11. Pulmonary artery 12 aorta 13 Right pulmonary artery 15 Left pulmonary artery 17 Muscles 17 Ventricular septal wall 18 Atrial septum 19 Superior vena cava 26 Ventricular apex 29 Inferior vena cava 49 Left atrial appendage 62 Anterior leaflet 62 Posterior cusp 100 Sensor-integrated septal closure device 110 Sensor Devices 112 frames 114 Central part 115 Opening 116 Anchor Arm 117 Side 118 Arm 119 First Aspect 120 Arm 130 eyelets 138 Blood occlusion membrane 210 Cylindrical Sensor Device 217 Protruding Features 220 Anchor 222 Proximal large diameter part 223 Intermediate small diameter spiral part 224 Distal large diameter part 225 waveform 310 Sensor Implant Device 311, 312 Sensor elements 316 Housing 400 implant devices 410 Sensor 412 Transducer 414 Control Circuit 416 Sensor Housing 418 Antenna 420 Cardiac Implant Structure 500 Sensor Implant Device 510 Sensor 511, 512 sensors 516 Housing 517 Protruding Features 520 Anchor 521, 522 Arms 600 Sensor Implant Device 602, 603 status 610 Sensor 620 Anchor Form 627 Anchor Arm 630 Delivery catheter 635 Pusher Device 640 Sutures 700 processes 711 Sensor Elements 712 Sensor Elements 721 Distal Anchor Arm 722 Proximal Arm 730 Delivery Catheter 731 Distal end 802 Status 803 Status 804 Status 900 Sensor Implant Device 910 Sensor Device 916 Sensor Components 917 Protrusion 920 Anchor 921 Distal Arm 922 Proximal Arm 930 Delivery catheter 935 Pusher or Extraction Device 937 Protruding Engagement Features 939 Gap 1000 Sensor Implant Devices 1010 Sensor 1020 Anchor 1025 Tissue or suture attachment features 1025 eyelets 1027 Arm 1029 Corner Features 1038 Occlusion membrane 1200 processes 1700 Sensor Implant Device 1710 Pressure Sensor Device 1711, 1712 Sensor elements 2000 Sensor Implant Device 2010 Sensor 2012 Frame 2017 Prominent Features 2037 Suture Collar 2038 Cloth or membrane 2039 Sleeve / Cuff 2100 Process 2103 Removable catheter 2200 Sensor Implant Device 2203 Status 2204 Status 2210 Cylindrical Sensor 2211 Septal Closure Implant 2217 Engagement feature 2230 Removable catheter 2231 Distal end 2235 Extraction Device 2237 Protruding engagement feature 2238 Occlusion membrane 2239 Gap 2300, 2301 Valve Spacer Device 2300 Sensor-integrated spacer implant device 2310 Spacer Form 2320 Spacer Form 2325 Tether 2327 Tissue Anchor 2400 Sensor-integrated spacer implant device 2410 Sensor 2415 Tethered Separate Sensor Device 2417 Anchor 2419 Tether 2425 Tether 2427 Tissue Anchor 2500 Sensor-integrated cardiac implant device 2510 Sensor 2520 Left atrial appendage occluder implant device 2600 Sensor-Integrated Valve Repair Implant 2601 Sensor Element 2607 End 2609 Base 2610 Sensor 2620 Spacer 2621 First clasp member 2622 Second clasp member 2800 Mitral Valve Repair Implant 2801 Valve Repair Sensor Assembly 2805 Post 2806 Distal end 2810 Sensor 2900 Mitral Valve Repair Implant 2901 Valve Repair Sensor Assembly 2905 Tether 2910 Sensor 2917 Anchor Function 3000 Sensor-Integrated Annulus Reduction Implant 3001 Reducing joint 3005 Anchor Wire 3010 Sensor 3020 Annular reduction tube 3101 Assembly 3103 Septal closed structure 3105 Bonded structure 3110 Sensor 3120 Replacement mitral valve implant 3120 Transcatheter heart valves 3120 Replacement valve 3201 Assembly 3210 Sensor 3217 Tissue wall anchor 3218 Proximal end 3219 Distal end section 3220 Replacement valve 3305 Radially Expanding Wire 3310 Sensor Device 3317 Sensor Anchor 3410 Pressure Sensor 3411 Pressure Sensor 3418 Corkscrew Anchor 3500 Sensor-integrated implant device 3503 Proximal end 3506 Proximal Coil or Loop 3507 Docking Device 3510 Sensor 3600a, 3600b Cardiac Implant Devices 3601a, 3601b Mounting Features 3605 Support or Arm Features 3605a, 3605b Arm or support 3610 Sensor 3620 Stent Structure 3620a, 3620b Cardiac implant structure 3701 Transseptal access 3702 Transaortic access 3703 Transapical access

Claims

1. 1. A device for repairing a heart valve, comprising: a clip device configured to secure native valve leaflets together to reduce valve regurgitation, the clip device comprising a first clasp member, a second clasp member, and a spacer between the first and second clasp members; one or more pressure sensors attached to the clip device; Equipped with the one or more pressure sensors are configured to provide a pressure sensor reading indicative of an atrial pressure and to provide a pressure sensor reading indicative of a ventricular pressure; The one or more pressure sensors comprise one or more transducer elements positioned between the native leaflets of the heart valve and configured to produce the reading indicative of atrial pressure.

2. The apparatus of claim 1 , wherein the clip device is configured to provide edge-to-edge leaflet attachment.

3. The apparatus of claim 1 , wherein the clip device is configured to form a double orifice valve.

4. The apparatus of claim 1 , wherein the clip device is configured to capture the native valve leaflets between the clasp and the spacer.

5. The device of claim 1 , wherein the spacer includes a ventricular portion exposed to the ventricle and an atrial portion exposed to the atrium.

6. 6. The device of claim 5, wherein the one or more pressure sensors comprise a ventricular transducer element disposed in the ventricular portion of the spacer, and wherein the one or more transducer elements configured to generate pressure readings indicative of atrial pressure are disposed in the atrial portion of the spacer.

7. The device of claim 1 , wherein the one or more pressure sensors are disposed within the spacer.

8. The device of claim 1 , wherein the one or more pressure sensors are integrated with the spacer.

9. The apparatus of claim 1 , wherein the one or more pressure sensors include a dual-element sensor.

10. The apparatus of claim 1 , wherein the one or more pressure sensors are configured to measure a gradient across the valve.

11. The device of claim 1 , wherein the one or more pressure sensors are configured to measure retrograde flow into the atrium.

12. The apparatus of claim 1 , wherein the clip device is configured to secure the mitral valve leaflets together.

13. The apparatus of claim 1 , wherein the clip device is configured to secure the tricuspid valve leaflets together.

14. The apparatus of claim 1 , wherein the one or more pressure sensors are configured to measure long-term performance of a repaired valve.

15. A system comprising a device according to any preceding claim coupled to a delivery catheter.

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