Sensors connected to implants

Abstract

The method includes the steps of delivering a first implant to an orifice of a heart chamber, securing the first implant to the orifice, delivering a sensor device to the orifice, and coupling the sensor device to the first implant.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is a continuation of U.S. Provisional Patent Application No. 63 / 191,534, entitled IMPLANT-COUPLED SENSORS, filed May 21, 2021; U.S. Provisional Patent Application No. 63 / 224,286, entitled IMPLANT-ADJACENT SENSOR ANCHORING, filed July 21, 2021; U.S. Provisional Patent Application No. 63 / 225,039, entitled SHUNT BARREL SENSOR IMPLANT ANCHORING, filed July 23, 2021; U.S. Provisional Patent Application No. 63 / 225,689, entitled EMBEDDED SENSOR IMPLANT DEVICES, filed July 26, 2021; and U.S. Provisional Patent Application No. 63 / 225,689, entitled EMBEDDED SENSOR IMPLANT DEVICES, filed August 19, 2021. This application claims priority from U.S. Provisional Patent Application No. 63 / 235,038, entitled ANCHORING, the complete disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to the field of medical implantable devices. [Background technology]

[0003] Various medical procedures involve the placement of medical implant devices within cardiac anatomical structures. Certain physiological parameters associated with these anatomical structures, such as fluid pressure, can affect the health outlook of a patient. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,789,294 Summary of the Invention [Means for solving the problem]

[0005] Described herein are one or more methods and / or devices for facilitating monitoring of physiological parameters associated with particular chambers and / or blood vessels of the heart, such as the left atrium, using one or more sensor-embedded devices.

[0006] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features are described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0007] Various embodiments are illustrated 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 the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 shows an exemplary representation of the human heart. [Diagram 2] FIG. 2 shows examples of pressure waveforms associated with various chambers and vessels of the heart. [Diagram 3] FIG. 3 illustrates a graph showing left atrial pressure range. [Figure 4] FIG. 4 is a block diagram illustrating an embedding device according to one or more embodiments. [Diagram 5] FIG. 5 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. [Figure 6] FIG. 6 illustrates an example sensor assembly / device that may be a component of a sensor embedding device according to one or more embodiments. [Figure 7]FIG. 7 illustrates an example shunt / anchor structure that may be configured to attach to one or more sensor devices according to one or more embodiments. [Figure 8] FIG. 8 illustrates an example shunt / anchor implant that may be configured to attach to one or more sensor devices according to one or more embodiments. [Figure 9] FIG. 9 illustrates another anchor / shunt implant that may be configured to attach to one or more sensor devices, according to one or more embodiments. [Figure 10] FIG. 10 illustrates another anchor / shunt implant that may be configured to attach to one or more sensor devices according to one or more embodiments. [Figure 11] FIG. 11 illustrates another anchor / stent implant that may be configured to attach to one or more sensor devices, according to one or more embodiments. [Figure 12] FIG. 12 illustrates another shunt / anchor implant that may be configured to attach to one or more sensor devices according to one or more embodiments. [Figure 13] FIG. 13 illustrates a shunt implant / anchor device / structure implanted within the atrial septum, according to one or more embodiments. [Figure 14] FIG. 14 shows a shunt device / structure implanted within the tissue wall between the coronary sinus and the left atrium. [Figure 15] FIG. 15 illustrates an example anchor / shunt implant coupled to a sensor device 1560 according to one or more embodiments. [Figure 16] FIG. 16 illustrates another anchor / shunt implant coupled to a sensor device 1660 in accordance with one or more embodiments. [Figure 17-1] FIG. 17-1 provides a flowchart illustrating a process including one or more steps for delivering one or more implants coupled to one or more sensors, according to one or more embodiments. [Figure 17-2]FIG. 17-2 provides a flowchart illustrating a process including one or more steps for delivering one or more implants coupled to one or more sensors, according to one or more embodiments. [Figure 17-3] FIG. 17-3 provides a flowchart illustrating a process including one or more steps for delivering one or more implants coupled to one or more sensors, according to one or more embodiments. [Figure 18-1] FIG. 18-1 provides images corresponding to the process steps of FIG. [Figure 18-2] FIG. 18-2 provides images corresponding to the process steps of FIG. [Figure 18-3] FIG. 18-3 provides images corresponding to the process steps of FIG. [Figure 19] FIG. 19 illustrates a sensor attachment device configured to secure a sensor device 1960 to one or more implants, which may include various shunt devices and / or other implants described herein in accordance with one or more embodiments. [Figure 20] FIG. 20 illustrates a sensor mounting device attached to a shunt implant 2003, which may be secured to a tissue wall, according to one or more embodiments. [Figure 21A] FIG. 21A illustrates at least a portion of an implant configured to attach to one or more sensor devices and / or sensor mounting devices, according to one or more embodiments. [Figure 21B] FIG. 21B illustrates a sensor device and / or sensor attachment device configured for fastening to an implant and / or for fastening in a form of attachment with an implant. [Figure 21C] FIG. 21C provides a top view of an implant attached to a sensor mounting device, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0010] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be helpful in understanding a particular embodiment, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0011] Certain reference numbers are reused across different figures in the set of figures of the present disclosure as a matter of convenience for devices, components, systems, features, and / or modules that have characteristics that may be similar in one or more respects. However, with respect to any of the embodiments disclosed herein, the reuse of common reference numbers in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art may be informed by the context as to the extent to which the use of common reference numbers may imply similarity between the referenced subject matter. The use of a particular reference number in the context of the description of a particular figure may be understood to relate to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number may be construed as sharing characteristics or being entirely independent of each other.

[0012] Certain standard anatomical terms of location are used herein to refer to animal, i.e., human, anatomical structures with respect to the preferred embodiment. While certain spatially relative terms such as "outer," "inner," "upper," "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 device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationships between the elements / structures illustrated in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the elements / structures during use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or beside such other element / structure with respect to the subject patient or alternative orientations of the element / structure, and vice versa.

[0013] The present disclosure relates to systems, devices, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using a cardiac shunt and / or other medical implant device integrated with a sensor. In some implementations, the disclosure relates to a cardiac shunt and / or other cardiac implant device incorporating or associated with a pressure sensor or other sensor device. The term "associated with" is used herein according to its broad and ordinary meaning. For example, if a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly. Particular examples are disclosed herein in connection with cardiac implant devices. However, it should be understood that while certain principles disclosed herein are particularly applicable to cardiac anatomical structures, a sensor-implantation device according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure.

[0014] The various sensor devices described herein may be integrated with the various medical implant devices described herein, although the sensor device may be a separate device from the medical implant device. For example, the sensor device may form a frangible and / or releasable connection with the medical implant device. Additionally, the sensor devices described herein may be configured to be delivered separately (e.g., before and / or after) the medical implant device into the patient's heart. For example, the sensor device may not be attached to the medical implant device during the delivery process of the sensor device and / or the medical implant device (e.g., during delivery through a catheter), but may be attached / coupled to the medical implant device after delivery to a desired location in the heart (e.g., after removal from the catheter). Exemplary delivery locations may include the left atrium, the left atrial appendage, the pulmonary veins, the coronary sinus, and / or various tissue walls associated with these locations.

[0015] In some examples, the catheter and / or guidewire used to deliver the sensor device may also be used to deliver the medical implant device, for example, the catheter and / or guidewire may remain in the body after delivery of the sensor device and / or medical implant device for delivery of the remaining devices.

[0016] Some sensor devices described herein may be configured to be delivered prior to delivery of a medical implant device described herein. This may advantageously simplify delivery of the sensor device and / or medical implant device and / or provide simple imaging of the sensor device and / or medical implant device. The sensor device may be adjusted as needed to maximize the sensor device measurements prior to delivery of the medical implant device. Additionally, delivery of the medical implant device may be delayed and / or stopped as needed after delivery of the sensor device.

[0017] Some sensor devices described herein may be configured to be delivered after delivery of a medical implant device described herein. This may advantageously simplify delivery of the sensor device and / or medical implant device and / or provide simple imaging of the sensor device and / or medical implant device. The sensor device may be adjusted as necessary to maximize the sensor device measurements. Additionally, the sensor device may be effectively secured to the medical implant device with minimal risk of dislodging the sensor device.

[0018] Cardiac Physiology The anatomical structure of the heart is described below to aid in the understanding of certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, the flow of which is at least partially controlled by various cardiac valves, namely the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to at least partially control the flow of blood to respective regions and / or vessels of the heart (e.g., the pulmonary artery, the aorta, etc.) in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole).

[0019] FIG. 1 illustrates an exemplary representation of a heart 1 having various features associated with certain embodiments of the present disclosure. The heart 1 includes four chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. In terms of blood flow, generally, blood flows from the right ventricle 4 through a pulmonary valve 9 into a pulmonary artery 11, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood can be pumped toward the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. As shown, the pulmonary artery 11 includes a pulmonary trunk and left 15 and right 13 pulmonary arteries that branch off from the pulmonary trunk. A pulmonary vein 23 carries blood from the lungs to the left atrium 2.

[0020] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in the circulation of blood therein, 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 cusps 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 cusps / 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 close during systole to prevent backflow of blood into the left atrium 2, if functioning properly. 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 exiting the left ventricle 3 to enter the aorta 12 and to close during diastole to prevent backflow of blood into the left ventricle 3.

[0021] A heart valve may generally include a relatively dense fibrous ring, referred to herein as an annulus, and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that the resulting increased blood pressure in the corresponding heart chamber when the heart contracts will at least partially open the leaflets and allow flow from the heart chamber. When pressure in a heart chamber decreases, pressure in the subsequent heart chamber or blood vessel may prevail and push back against the leaflets. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0022] Atrioventricular (i.e., mitral and tricuspid) heart valves further include a collection of chordae tendineae and papillary muscles (not shown) that anchor the leaflets of each valve to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. Papillary muscles may generally include, for example, finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae. A muscular wall called the septum separates the left heart chamber from the right heart chamber. In particular, interatrial septal wall portion 18 (referred to herein as the "atrial septum," "interatrial septum," or "septum") separates left atrium 2 from right atrium 5, while interventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates left ventricle 3 from right ventricle 4. The inferior tip 26 of heart 1 is called the apex, and is generally located at or near the midclavicular line, in the fifth intercostal space.

[0023] The coronary sinus 16 includes a collection of veins that combine to form a relatively large vessel that collects blood from the heart muscle (myocardium). The ostium of the coronary sinus, which may be at least partially protected in some patients by the Thebesian valve, opens into the right atrium 5 as shown. The coronary sinus passes along the posterior aspect of the left atrium 2 and delivers deoxygenated blood to the right atrium 5. The coronary sinus generally extends across the left atrioventricular groove at the posterior side of the heart.

[0024] Any of several access routes within the heart 1 may be utilized to manipulate guidewires and catheters in and around the heart 1 to deploy the implants and / or devices of the present application. For example, access may be from above into the superior vena cava (SVC) 19, right atrium 5, and from there into the coronary sinus 16 via either the subclavian or jugular vein. Alternatively, an access route may begin in the femoral vein and pass into the heart 1 through the inferior vena cava (IVC) 14. Other access routes may also be used, each of which may utilize a percutaneous incision where a guidewire and catheter are inserted into the vascular system, usually through a sealed introducer, from which the physician may control the distal end of the device from outside the body.

[0025] Health Status Associated with Cardiac Pressure and Other Parameters As referenced above, certain physiological conditions or parameters associated with cardiac anatomy may affect the health of a patient. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, which causes an increase in fluid pressure in one or more heart chambers. As a result, the heart does not pump enough oxygen to meet the body's needs. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiff and / or thickened. The walls of the heart may eventually weaken and become unable to pump efficiently. In some cases, the kidneys may respond to the inefficiency of the heart by causing the body to retain fluid. The accumulation of fluid in the arms, legs, ankles, feet, lungs, and / or other organs causes the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and therefore, the treatment and / or prevention of congestive heart failure is of significant medical interest.

[0026] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As explained above, pressure buildup in 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 estimate, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve assessing or observing other current physiological conditions of the patient, such as assessing weight, thoracic impedance, right heart catheterization, etc. In some solutions, pulmonary capillary wedge pressure may be measured as a surrogate for left atrial pressure. For example, a pressure sensor may be placed or implanted in the pulmonary artery and readings associated therewith may be used as a surrogate for left atrial pressure. However, with regard to catheter-based pressure measurements in the pulmonary artery or certain other cardiac chambers or regions, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be inconvenient or difficult to implement. Furthermore, certain lung-related conditions may affect pressure readings in the pulmonary artery, resulting in undesirably weakened correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurements, pressure measurements in the right ventricular outflow tract may be similarly related to left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be utilized in the diagnosis, prevention, and / or treatment of congestive heart failure.

[0027] Additional solutions may be implemented to derive or estimate left atrial pressure. For example, the E / A ratio, a marker of the function of the left ventricle of the heart, representing the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity blood flow in late diastole caused by atrial contraction (A wave), may be used as a proxy to measure left atrial pressure. The E / A ratio may be determined using echocardiography or other imaging techniques, and generally, abnormalities in the E / A ratio may suggest that the left ventricle is unable to properly fill with blood during the period between contractions, which may lead to symptoms of heart failure, as described above. However, determining the E / A ratio generally does not provide a measurement of absolute pressure.

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

[0029] The present disclosure provides systems, devices, and methods for directing administration of medications associated with the treatment of congestive heart failure, at least in part, by directly monitoring pressure in the left atrium, or other chambers or vessels whose pressure measurements are indicative of left atrial pressure and / or pressure levels in one or more other vessels / chambers, for example, to reduce re-hospitalizations, morbidity, and / or improve patient health outlook for patients with congestive heart failure.

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

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

[0032] As referenced above, with respect to cardiac pressure, left atrial pressure elevation may be particularly correlated with heart failure. FIG. 2 shows examples of pressure waveforms associated with various cardiac chambers and vessels, according to one or more embodiments. The various waveforms illustrated in FIG. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors to the illustrated and labeled cardiac chambers or vessels, respectively. As shown in FIG. 2, a waveform 25 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 an increase in left atrial pressure and pulmonary congestion.

[0033] Left atrial pressure may generally correlate well with left ventricular end diastolic pressure. However, while left atrial pressure and end diastolic pulmonary artery pressure may have a significant correlation, such correlation may weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate adequately with left ventricular end diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension, which affects approximately 25%-83% of heart failure patients, may affect the reliability of pulmonary artery pressure measurements to estimate left filling pressure. Thus, as represented by waveform 24, pulmonary artery pressure measurements alone may be an insufficient or inaccurate indicator of left ventricular end diastolic pressure, especially for patients with comorbidities such as pulmonary disease and / or thromboembolism. Left atrial pressure may further correlate, at least in part, with the presence and / or degree of mitral regurgitation.

[0034] Left atrial pressure readings may be less likely to be distorted or affected by other conditions, such as respiratory conditions, compared to the other pressure waveforms shown in Figure 2. In general, left atrial pressure may be significantly predictive of heart failure, such as up to two weeks before the onset of heart failure. For example, increases in left atrial pressure and both diastolic and systolic heart failure may occur several weeks prior to hospitalization, and thus knowledge of such increases may be used to predict the onset of congestive heart failure, such as acute debilitating symptoms of congestive heart failure.

[0035] Cardiac pressure monitoring, such as left atrial pressure monitoring, may provide a mechanism to guide administration of medications to treat and / or prevent congestive heart failure. Such treatment may advantageously reduce re-hospitalization and morbidity rates as well as provide other benefits. An implanted pressure sensor according to an embodiment of the present disclosure may be used to predict heart failure two weeks or more prior to the onset of symptoms or markers of heart failure (e.g., dyspnea). When heart failure predictors are recognized using an embodiment of a cardiac pressure sensor according to the present disclosure, certain preventative measures may be implemented, including drug interventions such as modifications to a patient's drug regimen, that may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurements in the left atrium may advantageously provide an accurate indicator of pressure build-up that may lead to heart failure or other complications. For example, atrial pressure rise trends may be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other therapies may be augmented to cause a reduction in pressure and prevent or reduce further complications.

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

[0037] IMPLANTED DEVICE HAVING INTEGRATED SENSORS - Patent application In some implementations, the present disclosure relates to sensors associated with or integrated with cardiac shunts or other implanted devices. Such integrated devices may be used to provide controlled and / or more effective therapy for treating and preventing heart failure and / or other health complications related to cardiac function. FIG. 4 is a block diagram illustrating an implanted device 30 comprising a shunt (or other type of implant) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 may be, for example, a pressure sensor, or other type of sensor. In some embodiments, the sensor 37 comprises not only a transducer 32, such as a pressure transducer, but also certain control circuitry 34, which may be embodied, for example, in an application specific integrated circuit (ASIC).

[0038] The control circuitry 34 may be configured to process signals received from the transducer 32 and / or to wirelessly communicate signals associated with the transducer through the biological tissue using the antenna 38. The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies containing one or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any devices that manipulate signals (analog and / or digital) based on hard-coding of circuit and / or operational instructions. The control circuitry referred to herein may further comprise one or more storage devices, which may be embodied within a single memory device, multiple memory devices, and / or embedded circuitry of the device. Such data storage may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. Of note, in embodiments where the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage / registers that store any associated operating instructions may be embedded within or external to the circuitry that includes the state machines, analog circuits, digital circuits, and / or logic circuits. The transducer 32 and / or antenna 38 may be considered part of the control circuitry 34.

[0039] The antenna 38 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 32, the control circuitry 34, and / or the antenna 38 are at least partially disposed or contained within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 36 may, in some embodiments, comprise glass or other rigid material, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure / material, which may advantageously allow the sensor 37 to bend, flex, or fold to enable transport through a catheter or other introduction means.

[0040] The transducer 32 may comprise any type of sensor means or mechanism. For example, the transducer 32 may be a force collector type pressure sensor. In some embodiments, the transducer 32 comprises a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component for measuring the applied strain or deflection across its area / surface. The transducer 32 may be associated with the housing 36 such that at least a portion of the transducer 32 is contained within or attached to the housing 36. With respect to a sensor device / component "associated with" a stent or other implant structure, such terms may refer to a sensor device or component that is physically coupled, attached, or connected to the implant structure or is integrated therewith.

[0041] In some embodiments, the transducer 32 may be configured to use bonded or formed strain gauges to detect strain due to applied pressure, comprise piezoresistive strain gauges, or be a component of a piezoresistive strain gauge, where the resistance increases as pressure deforms the component / material. The transducer 32 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0042] In some embodiments, the transducer 32 comprises or is a component of a capacitance pressure sensor including a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitance pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicon, and the like. In some embodiments, the transducer 32 comprises or is a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by a change in inductance, a linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 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 certain materials, such as quartz.

[0043] In some embodiments, the transducer 32 comprises or is a component of a strain gauge. For example, a strain gauge embodiment may comprise a pressure sensitive element on or associated with an exposed surface of the transducer 32. In some embodiments, a metallic strain gauge may be adhered to the surface of the sensor by sputtering or other techniques, or a thin film gauge may be applied onto the sensor. The measuring element or mechanism may include a diaphragm or a metal foil. The transducer 32 may comprise any type of sensor or pressure sensor, such as an optical, potentiometric, resonance, thermal, ionization, or other type of strain or pressure sensor.

[0044] 5 illustrates a system 40 for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) in a patient 44, according to one or more embodiments. The patient 44 may have a medical implant device 30 implanted, for example, in a heart (not shown) or associated physiology of the patient 44. For example, the implant device 30 may be at least partially implanted within the left atrium and / or coronary sinus of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as one or more microelectromechanical systems (MEMS) devices (e.g., MEMS pressure sensors, or other types of sensor transducers).

[0045] In certain embodiments, the monitoring system 40 may comprise at least two subsystems, including an implantable internal subsystem or device 30 including not only the sensor transducer 32 but also a control circuit 34 including one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further include an external (e.g., non-implantable) subsystem including an external reader 42 (e.g., coil), which may include a wireless transceiver electrically and / or communicatively coupled to the specific control circuit 41. In certain embodiments, both the internal 30 and external 42 subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implantation device 30 may be any type of implantation device. For example, in some embodiments, the implantation device 30 comprises a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or stent device / structure.

[0046] Certain details of the implanted device 30 are illustrated within the enlarged block 30 shown. The implanted device 30 can include an implant / anchor structure 39 as described herein. For example, the implant / anchor structure 39 can include a percutaneously deliverable shunt device configured to be anchored to and / or within a tissue wall to provide a flow path between two heart chambers and / or vessels, as described in detail throughout this disclosure. Although certain components are illustrated in FIG. 5 as part of the implanted device 30, it will be appreciated that the sensor implanted device 30 may include only a subset of the illustrated components / modules and may include additional components / modules not illustrated. The implanted device may represent an embodiment of the implanted device shown in FIG. 4, or vice versa. The implanted device 30 can advantageously include one or more sensor transducers 32, which can be configured to provide a response indicative of one or more physiological parameters of the patient 44, such as atrial pressure. Although a pressure transducer is described, the sensor transducer 32 may comprise any suitable or desired type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the implanted device 30 and / or the patient 44.

[0047] The sensor transducer 32 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, diaphragm-based sensors and / or other types of sensors that may be positioned within the patient 44 to sense one or more parameters related to the patient's health. The transducer 32 may be a force collector type pressure sensor. In some embodiments, the transducer 32 comprises a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component for measuring applied strain or deflection across its area / surface. The transducer 32 may be associated with a sensor housing 36 such that at least a portion of it is contained within or attached to the housing 36.

[0048] In some embodiments, the transducer 32 may be configured to use, comprise, or be a component of a strain gauge bonded or formed to detect strain due to applied pressure. For example, the transducer 32 may comprise or be a component of a piezoresistive strain gauge, where the resistance increases as pressure deforms the strain gauge component / material. The transducer 32 may incorporate any type of material, including but not limited to silicone, polymer, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like. In some embodiments, a metal strain gauge may be bonded to the sensor surface by sputtering or other techniques, or a thin film gauge may be affixed onto the sensor. The measuring element or measuring mechanism may include a diaphragm or a metal foil. The transducer 32 may comprise any type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0049] In some embodiments, the transducer 32 comprises or is a component of a capacitance pressure sensor including a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitance pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicone, silicon or other semiconductors, and the like. In some embodiments, the transducer 32 comprises or is a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by changes in inductance, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 32 comprises or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0050] In some embodiments, the converter 32 is electrically and / or communicatively coupled to a control circuit 34, which may comprise one or more application specific integrated circuits (ASIC) microcontrollers or chips. The control circuit 34 may further include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, or the like.

[0051] In certain embodiments, the sensor transducer 32 may be configured to generate electrical signals that may be wirelessly transmitted to a device outside the patient's body, such as the illustrated local external monitor system 42. To effect such wireless data transmission, the implanted device 30 may include signal processing circuitry and radio frequency (RF) (or other frequency band) transmission circuitry, such as an antenna 38. The antenna 38 may include an antenna coil implanted within the patient. The control circuitry 34 may include any type of transceiver circuitry configured to transmit electromagnetic signals, which may be radiated by the antenna 38, which may include one or more conductive wires, coils, plates, or the like. The control circuitry 34 of the implanted device 30 may include, for example, one or more chips or dies configured to perform some amount of processing on signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implanted device 30 may not include independent processing capabilities in some embodiments.

[0052] The wireless signals generated by implanted device 30 may be received by a local external monitoring device or subsystem 42, which may include a reader / antenna interface circuit module 43 configured to receive wireless signal transmissions from implanted device 30, which is located at least partially within the patient 44. For example, module 43 may include a transceiver device / circuitry.

[0053] The external local monitor 42 may receive wireless signal transmissions from the implanted device 30 and / or provide wireless power to the implanted device 30 using an external antenna 48, such as a wand device. The reader / antenna interface circuitry 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30, which may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, and the like. The reader / antenna interface circuitry 43 may further be configured to transmit signals over a network 49 to a remote monitor subsystem or device 46. The RF circuitry of the reader / antenna interface circuitry 43 may further include one or more of a digital-to-analog converter (DAC) circuitry, a power amplifier, a low-pass filter, an antenna switch module, an antenna, or the like, for handling / processing transmitted signals over the network 49 and / or receiving signals from the implanted device 30. In one particular embodiment, local monitor 42 includes control circuitry 41 for performing processing of signals received from embedded device 30. Local monitor 42 may be configured to communicate with network 49 according to known network protocols such as Ethernet, Wi-Fi, or the like. In one particular embodiment, local monitor 42 comprises a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0054] In certain embodiments, the embedded device 30 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may comprise solid-state memory utilizing an array of floating gate transistors or the like. The control circuitry 34 may utilize data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 42 or another external subsystem. In certain embodiments, the embedded device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate wireless transmission of data generated by the sensor transducers 32 or other data associated therewith. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as, for example, from the local monitor 42 or from the remote monitor 46 via a network 49. For example, the embedded device 30 may be configured to receive signals that at least partially control the operation of the embedded device 30, such as by activating / deactivating one or more components or sensors, or by otherwise affecting the operation or performance of the embedded device 30.

[0055] One or more components of the implanted device 30 may be powered by one or more power sources 35. Due to size, cost, and / or electrical complexity concerns, it may be desirable for the power source 35 to be relatively minimalist in nature. For example, high power driving voltages and / or currents within the implanted device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implanted device. In certain embodiments, the power source 35 is at least partially passive in nature, such that power may be received wirelessly from an external power source by passive circuitry of the implanted device 30, such as through the use of short-range or near-field wireless power transfer, or other electromagnetic coupling mechanisms. For example, the local monitor 42 may act as an initiator that actively generates an RF field that can provide power to the implanted device 30, thereby allowing the power circuitry of the implanted device to take on a relatively simple form factor. In certain embodiments, the power source 35 may be configured to obtain energy from an environmental source, such as fluid flow, motion, or the like. Additionally or alternatively, power source 35 may comprise a battery, which may be advantageously configured to provide sufficient power as needed for the monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period).

[0056] In some embodiments, the local monitoring device 42 can act as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 can be a wearable communication device or other device that can be easily placed in close proximity to the patient 44 and the implanted device 30. The local monitoring device 42 can be configured to continuously, periodically, or sporadically query the implanted device 30 to extract or request sensor-based information therefrom. In certain embodiments, the local monitor 42 includes a user interface that allows a user to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0057] The system 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with the monitored cardiac pressure data. In one example, the local monitor 42 may be a wearable device or other device or system configured to be placed in physical proximity to the patient and / or implanted device 30, and the local monitor 42 is designed primarily to receive / send signals to and / or from the implanted device 30 and provide the signals to the secondary local monitor 47 for viewing, processing, and / or manipulation. The external local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implanted device 30, such as a device ID or the like, which may also be provided via a data link from the implanted device 30.

[0058] The remote monitoring subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received over the network 49 from the local monitoring device 42, the secondary local monitor 47, and / or the embedded device 30. For example, the remote monitoring subsystem 46 may be advantageously operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient 44. Although certain embodiments disclosed herein describe communicating with the remote monitoring subsystem 46 indirectly from the embedded device through the local monitoring device 42, in certain embodiments, the embedded device 30 may be equipped with a transmitter capable of communicating with the remote monitoring subsystem 46 over the network 49 without having to relay information through the local monitoring device 42.

[0059] In some embodiments, at least a portion of the transducer 32, the control circuitry 34, the power source 35, and / or the antenna 38 are at least partially disposed or housed within a sensor housing 36, which may comprise any type of material, and may advantageously be at least partially hermetically sealed. For example, the housing 36 may comprise glass or other rigid material, in some embodiments, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure / material, which may advantageously allow the sensor 30 to bend, flex, or fold to enable transport through a catheter or other percutaneous introduction means.

[0060] As referenced above, shunts and other implanted devices / structures may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. A sensor device according to an embodiment of the present disclosure may be integrated with a cardiac shunt structure / device or other implanted device using any suitable or desirable attachment or integration mechanism or configuration. FIG. 6 illustrates an exemplary sensor assembly / device 60, which may be a component of a sensor implantation device. The sensor device 60 may be configured to provide a sensor reading related to one or more physiological parameters associated with a target implantation site.

[0061] The sensor device 60 may be configured to attach to an implanted device. For example, the sensor device 60 may be attached to one or more implants using a coil configuration including one or more wires or other materials or structures formed into one or more coil windings that form a fluid conduit / barrel portion and an axial end flange. A shunt structure may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure may be configured to hold the sensor device 60.

[0062] The sensor device 60 may advantageously be arranged, positioned, secured, oriented, and / or otherwise installed in a configuration in which its sensor transducer components 65 are disposed within a channel area of ​​a shunt structure. The term "channel area" is used herein in accordance with its broad and ordinary meaning and may refer to the three-dimensional space defined by the radial boundaries of a fluid conduit and extending axially from the fluid conduit.

[0063] In some embodiments, the sensor assembly 61 includes a sensor component 65 and an antenna component 69. The sensor component 65 may comprise any type of sensor device, such as those described in detail above. In some embodiments, the sensor 65 may be attached to or integrated with an arm member of the shunt structure.

[0064] The sensor 65 includes a sensor element 67, such as a pressure sensor transducer. As described herein, the sensor assembly 61 may be configured to implement wireless data and / or power transmission. The sensor assembly 61 may include an antenna component 69 for such purposes. The antenna 69 may be at least partially housed within an antenna housing 79, which may further have disposed therein certain control circuitry configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna component 69 includes one or more conductive coils 62, which may facilitate inductive powering and / or data transmission. In embodiments that include conductive coils, such coils may be at least partially wound / disposed around a magnetic core (e.g., ferrite, iron) 63.

[0065] The antenna component 69 may be attached to, integrated with, or otherwise associated with the arm / anchor feature of the shunt structure.

[0066] The sensor assembly 61 may advantageously be biocompatible. For example, the sensor 65 and antenna 69 may comprise a biocompatible housing, such as a housing comprising glass or other biocompatible material. However, at least a portion of the sensor element 67, such as a diaphragm or other component, may be exposed to the external environment in some embodiments to allow for pressure readings or sensing of other parameters to be performed. With respect to the antenna housing 79, the housing 79 may comprise an at least partially rigid cylindrical or tubular form, such as a glass cylinder. In some embodiments, the sensor 65 / 67 components are approximately 3 mm or less in diameter. The antenna 69 may be approximately 20 mm or less in length.

[0067] The sensor assembly 61 may be configured to communicate with an external system when implanted within the heart or other area of ​​the patient's body. For example, the antenna 69 may wirelessly receive power from the external system and / or communicate sensed data or waveforms to and / or from the external system. The sensor assembly 61 may be attached to or integrated with the shunt structure 90 in any suitable or desirable manner. For example, in some implementations, the sensor 65 and / or antenna 69 may be attached to or integrated with the shunt structure using mechanical attachment means. In some examples, the sensor 65 and / or antenna 69 may be housed in a pouch or other receptacle that is attached to the shunt structure.

[0068] The sensor element 67 may comprise a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer that includes a semiconductor diaphragm component. In some embodiments, the transducer may include an at least partially flexible or compressible diaphragm component that may be made from silicone or other flexible material. The diaphragm component may be configured to flex or compress in response to changes in environmental pressure.

[0069] Cardiac implants FIG. 7 illustrates an example shunt / anchor structure 150 that may be configured to attach to one or more sensor devices according to one or more embodiments. The shunt structure 150 may represent an example of a cardiac implant (e.g., the anchor and / or cardiac implant structure associated with FIG. 4 or FIG. 5) that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular opening or an oval shaped opening and / or may form a fluid conduit when positioned within an orifice in a tissue wall. The channel 166 may be configured to hold the sides of the puncture opening and / or other orifice in the tissue wall to form a blood flow pathway between heart chambers or blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be implanted in a wall separating the coronary sinus and the left atrium to form a fluid conduit between the coronary sinus and the left atrium. The central flow channel 166 may be formed in part by a pair of sidewalls 170a, 170b defined by a generally parallel arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, the substantially complete shunt 150 is formed by superelastic struts that are configured to be compressed and fitted into a catheter (not shown) and then expanded and return to a relaxed shape as shown in FIG.

[0070] Forming the shunt 150 using multiple interconnected struts forming cells therebetween may function to at least partially increase the flexibility of the shunt, thereby allowing for its compression and expansion at the implantation site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold tissue at the puncture in an open position. The end walls 172a, 172b of the central flow channel 166 may function to connect the side walls 170a, 170b and extend between the distal and proximal flanges or arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b may together define a tubular lattice as shown. The end walls 172a, 172b may include thin struts 179 that extend at a slight angle from the central flow axis of the shunt 150. The shunt 150 may further comprise distal ends (160a, 164a, 160b, 164b) of the arms 152, 154 which may be closer to each other than the ends connected to the end walls 172a, 172b of the arms 152, 154.

[0071] The illustrated shunt 150 comprises struts that define an open-celled tubular or circular lattice that forms a central flow channel 166, although in some embodiments the structure creating the channel forms a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated embodiment, the angle of the shunt structure 150 may facilitate not only collapsing the shunt into a delivery catheter (not shown), but also expanding the flanges / arms 152, 154 on either side of the target tissue wall. The shunt 150 may comprise a first left arm 152a, a second left arm 154a, a first right arm 152b, and / or a second right arm 154b. The central flow channel 166 may remain essentially unchanged between the collapsed and expanded states of the shunt 150, while the flanges / arms 152, 154 may transition between being aligned and not aligned with the angled flow channel.

[0072] While certain embodiments of shunts disclosed herein include flow channels and / or fluid conduits having a substantially circular cross-section, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond, or elliptical flow channel configurations. For example, relatively elongated side walls compared to the illustrated configuration of Figure 5 may produce rectangular or oval shaped flow channels. Shunt flow channels of such shapes may be desirable for larger punctures while still being configured to collapse into a relatively small delivery profile.

[0073] In some embodiments, each of the distal and proximal flanges / arms 152, 154 curl outwardly from the end walls 172a, 172b and are configured to point generally radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms may function to anchor the shunt 150 to the target tissue wall. Additional aspects and features of shunt, implant, and / or anchor structures that may be integrated with the sensor devices / functionality of the embodiments of the present disclosure are disclosed in U.S. Patent Application Publication No. 2013 / 0133999, issued Oct. 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 5 and described above, it will be understood that a shunt structure or other implanted device integrated with pressure sensor functionality according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether shunting or other purpose or function.

[0074] FIG. 8 illustrates an exemplary shunt / anchor implant 800 (e.g., a shunt body) that may be configured to attach to one or more sensor devices, according to one or more embodiments. The implant 800 may be configured for use as a shunt, as a stent, as an anchor, and / or for any other purpose. The implant 800 may have a generally expandable and / or inelastic form. In some embodiments, the implant 800 may be configured to be expanded through the use of a balloon expander and / or similar device. For example, the implant 800 may be configured for delivery at an opening and / or orifice in a tissue wall. A balloon expander configured to expand and / or widen the opening and / or orifice may simultaneously expand and / or widen the implant 800 at the opening and / or orifice.

[0075] The implant 800 can include a network of struts 802 that form one or more cells 803. The struts 802 may be constructed at least in part from a generally flexible material, which may include Nitinol and / or similar alloys and / or materials. During delivery to a treatment site, the struts 802 may have a generally compressed configuration in which the cells 803 may be compressed and / or one or more struts 802 may be pressed relatively closely together. For example, in response to an expansion force from a balloon expander, one or more struts 802 may be configured to stretch and / or separate to enlarge one or more cells 803 and / or increase the diameter, width, and / or length of the implant 800.

[0076] 8 provides a side view of implant 800. In some embodiments, implant 800 may have a generally cylindrical and / or tubular form, where a network of struts 802 encloses an inner lumen through implant 800. The inner lumen may be configured to form a fluid conduit through at least a portion of implant 800 when implant 800 is positioned within an orifice / opening in a tissue wall. In some embodiments, implant 800 may be configured to be crimped onto a delivery sheath and / or catheter.

[0077] In some embodiments, the implant 800 may be configured to independently secure to an opening / orifice and / or a tissue wall. For example, the implant 800 may be configured for placement within an opening through a tissue wall and / or may be configured to be secured and / or securely attached to a tissue wall. In some embodiments, the implant 800 may have generally curved / non-linear side portions 805 forming an "hourglass" and / or similar shape. For example, the diameter of the implant 800 may be larger at the top portion 807 and / or bottom portion 809 of the implant 800 than at the central / side portion 805 (e.g., mid-section) of the implant 800. In this manner, the top portion 807 and / or bottom portion 809 may be configured to extend out of the opening through the tissue wall and / or at least partially over the tissue wall to prevent the implant 800 from dislodging from the opening in the tissue wall. In some embodiments, the middle section 805 of the structure may be configured to at least partially reside within the opening in the tissue wall. The diameter of the implant 800 at the middle section 805 of the implant 800 may be approximately equal to and / or less than the diameter of the opening through the tissue wall, while the diameter of the implant 800 at the upper portion 807 and / or lower portion 809 may be greater than the diameter of the opening in the tissue wall.

[0078] In some embodiments, the implant 800 may be configured for attachment to one or more sensor devices. The sensor devices may be attached to various portions of the structure. For example, one or more sensor devices may be configured to be attached to the struts 802 at or near the upper portion 807 and / or lower portion 809 of the implant 800 through the use of one or more attachment devices or otherwise. In some embodiments, the sensor devices may be configured to be placed at different portions of the implant 800 to maximize sensor readings at the sensor devices. Additionally, the implant 800 may be configured to be twisted and / or otherwise adjusted at and / or within the opening in the tissue wall to allow the position of the sensor devices to be adjusted by the physician to maximize readings at the sensor devices.

[0079] The implant 800 may be configured to be implemented in combination with other implants. For example, the implant 800 may be configured for use with the shunt 150 described in FIG. 7. In some embodiments, the implant 800 may be configured for delivery prior to delivery of the shunt structure. Alternatively, the shunt 150 may be configured for delivery prior to the implant 800. However, the implant 800 may alternatively be configured for use independent of the other implants.

[0080] Implant 800 may be configured for use independent of additional implants and / or may be configured for use in combination with additional and / or separate implants. For example, the sensor embedding device may comprise a shunt device / body (see, e.g., shunt 150 in FIG. 7) configured to extend at least partially through a barrel portion (i.e., shunt body) of implant 800. The shunt device may comprise one or more fixation arms configured to anchor into one or more tissue walls.

[0081] FIG. 9 provides a flat pattern view of another anchor / shunt implant 900 (e.g., a shunt body) that may be configured for attachment to one or more sensor devices, according to one or more embodiments. The implant 900 may comprise a network of struts 902 that form one or more cells 903 along a barrel portion of the implant 900. The implant 900 may form a fluid conduit through the barrel portion of the implant 900. FIG. 9 provides a flat pattern view of the implant 900. However, the implant 900 may be configured to form a generally circular / tubular / cylindrical shape that may be configured to fit within and / or form a fluid conduit through a generally circular / cylindrical opening and / or orifice in a tissue wall. For example, the left side of the implant 900 shown in FIG. 9 may be configured to couple to the right side of the implant 900.

[0082] The implant 900 may comprise a series of diamond and / or spade shaped cells 903 (e.g., a series in a row) that may be interconnected on both sides with adjacent cells 903. For example, each cell 903 may have variable widths and / or extend longer above its widest point than below its widest point, as shown in FIG.

[0083] The implant 900 may be configured for use independent of additional implants and / or may be configured for use in combination with additional and / or separate implants. For example, the sensor embedding device may comprise a shunt device / body (see, e.g., shunt 150 in FIG. 7) configured to extend at least partially through a barrel portion (i.e., shunt body) of the implant 900. The shunt device may comprise one or more fixation arms configured to anchor into one or more tissue walls.

[0084] FIG. 10 illustrates another anchor / shunt implant 1000 (e.g., a shunt body) that may be configured to attach to one or more sensor devices, according to one or more embodiments. The implant 1000 may comprise a network of struts 1002 that form one or more cells 1003 along a barrel portion of the implant 1000. The barrel portion may form a fluid conduit through an inner lumen of the implant 1000. FIG. 10 provides a flat pattern view of the implant 1000. However, the implant 1000 may be configured to form a generally circular / tubular / cylindrical shape that may be configured to fit within a generally circular / cylindrical opening and / or orifice in a tissue wall. For example, the left side of the implant 1000 shown in FIG. 10 may be configured to couple to the right side of the implant 1000.

[0085] The implant 1000 may comprise a network of generally diamond-shaped cells 1003. For example, the implant 1000 may comprise pairs of stacked diamond-shaped cells 1003. The space between the pairs of stacked diamond-shaped cells 1003 may be generally diamond-shaped as well. In some embodiments, the lower cell 1003 of the stack of two cells 1003 may be shorter than the upper cell 1003 of the stack of two cells 1003. For example, as shown in FIG. 10, the lower cell 1003 may be generally spade-shaped.

[0086] The implant 1000 may be configured for use independent of additional implants and / or may be configured for use in combination with additional and / or separate implants. For example, the sensor embedding device may comprise a shunt device / body (see, e.g., shunt 150 in FIG. 7) configured to extend at least partially through a barrel portion (i.e., shunt body) of the implant 1000. The shunt device may comprise one or more fixation arms configured to anchor into one or more tissue walls.

[0087] FIG. 11 illustrates another anchor / stent implant 1100 (e.g., a shunt body) that may be configured to attach to one or more sensor devices, according to one or more embodiments. The implant 1100 may include a barrel portion 1102 configured to form a fluid conduit through the implant 1100. In some embodiments, the barrel portion 1102 may be configured to at least partially fit within an opening and / or orifice in a tissue wall. The barrel portion 1102 may be comprised of a network of struts and / or wires forming an interwoven and / or mesh pattern that may be expandable from a compressed configuration to an expanded configuration. Additionally or alternatively, the barrel portion 1102 may include one or more sheets of material. For example, the barrel portion 1102 may comprise one or more woven sheets that may be implemented independently and / or may be configured to cover a wire structure that forms the barrel portion 1102. In some embodiments, the implant 1100 may have generally curved / non-linear side portions 1105 (e.g., forming an “hourglass” shape).

[0088] In some embodiments, the implant 1100 may comprise one or more rings 1107. For example, the implant 1100 may comprise a first ring 1107a at an upper portion (i.e., a first end portion) of the implant 1100 and / or a second ring 1107b at a lower portion (i.e., a second end portion) of the implant 1100. In some embodiments, the one or more rings 1107 may be at least partially constructed from a generally flexible and / or inelastic material, which may include Nitinol and / or other shape memory alloys. The first ring 1107a may comprise a first end portion and / or the second ring 1107b may comprise a second end portion, which may be configured to grip over and / or otherwise form a secure attachment to at least a portion of a tissue wall, while at least a portion of the implant 1100 (e.g., the barrel portion 1102) is at least partially located within an opening and / or orifice through and / or within the tissue wall. In some examples, the implant 1100 may have a variable diameter and / or a diameter of the implant 1100 at the first ring 1107a and / or the second ring 1107b and / or the second ring 1107b may be larger than the diameter of the implant 1100 in at least a portion of the barrel portion 1102. For example, the first ring 1107a and / or the second ring 1107b may have a first diameter and / or the barrel portion 1102 may extend between the first ring 1107a and the second ring 1107b and / or the barrel portion 1102 may have an hourglass shape that may gradually decrease and / or increase in diameter along the length of the barrel portion 1102.

[0089] The implant 1100 may be configured for use independent of additional implants and / or may be configured for use in combination with additional and / or separate implants. For example, the sensor embedding device may comprise a shunt device / body (see, e.g., shunt 150 in FIG. 7) configured to extend at least partially through the barrel portion 1102 (i.e., the shunt body) of the implant 1100. The shunt device may comprise one or more fixation arms configured to anchor into one or more tissue walls.

[0090] FIG. 12 illustrates another shunt / anchor implant 1200 that may be configured to attach to one or more sensor devices, according to one or more embodiments. In some embodiments, the implant 1200 may be configured to be anchored to the left atrial appendage and / or other orifices and / or areas within a human heart. Anchoring the structure within the left atrial appendage may advantageously minimize effects on blood characteristics (e.g., flow, pressure, etc.) due to the implant 1200 and / or associated sensor device. In some embodiments, the implant 1200 may comprise a barrel portion 1202 that may be comprised of a network of struts and / or wires forming one or more cells to allow expansion of the implant 1200. The implant 1200 may further comprise an outer skirt 1208. In some embodiments, the outer skirt 1208 may be at least partially comprised of fabric and / or a generally flexible material. The barrel portion 1202 may have a generally cylindrical configuration with openings at an upper portion and / or a lower portion of the barrel portion 1202. The outer skirt 1208 can be configured to at least partially cover openings in the upper and / or lower portions of the barrel 1202. In some embodiments, the implant 1200 can be configured for use as an occlusion device.

[0091] The implant 1200 is shown in an expanded configuration in Figure 12. However, the implant 1200 may be configured to be compressed into a smaller profile for delivery via one or more catheters.

[0092] FIG. 13 illustrates a shunt implant / anchor device / structure 73 implanted within the atrial septum 18, according to one or more embodiments. Although a shunt implant is depicted in FIG. 13, the implant 73 may be any of the various implants described herein. A particular location within the atrial septal wall 18 may be selected or determined to provide a relatively secure anchor location for the shunt structure 73. Moreover, the shunt device / structure 73 may be implanted at a desired location to allow for future recrossing of the septal wall 18 for future interventions. Implantation of the shunt device / structure 73 in the atrial septal wall 18 may advantageously allow for fluid communication between the left atrium 2 and the right atrium 5.

[0093] Interatrial shunting using the shunt device / structure 73 may be well suited for patients who are relatively sensitive to increased atrial pressure. For example, when pressure increases in the ventricles and / or atria and pressure is applied against the myocardial cells, the heart muscle may generally tend to contract and may have a harder time processing the excess blood. Thus, for patients with impaired ventricular contractility, as the ventricles expand or stretch, such patients may be more sensitive to higher pressures in the ventricles and / or atria, as the heart may not be able to respond or react appropriately thereto. Moreover, increased left atrial pressure may result in dyspnea, and therefore, through interatrial shunting, it may be desirable to reduce left atrial pressure to reduce dyspnea and / or the incidence of rehospitalization. For example, if the ventricles experience dysfunction such that they cannot accommodate increased fluid pressure, such fluid may pool in the atria, thereby increasing atrial pressure. With respect to heart failure, minimizing left ventricular end-diastolic pressure may be paramount. Because left ventricular end-diastolic pressure can be related to left atrial pressure, fluid retention in the atrium can cause fluid retention in the lungs, thereby causing undesirable and / or dangerous fluid accumulation in the lungs. Inter-atrial shunting, such as using a shunt device according to embodiments of the present disclosure, can divert excess fluid in the left atrium to the right atrium, which may be able to accommodate additional fluid due to the relatively high compliance in the right atrium.

[0094] In some implementations, a shunt device / structure according to embodiments of the present disclosure may be implanted in the wall separating the coronary sinus from the left atrium, such that interatrial shunting may be achieved through the coronary sinus. Figure 14 shows a shunt device / structure 83 implanted in the tissue wall 21 between the coronary sinus 16 and the left atrium 2. Although a shunt implant is depicted in Figure 14, the implant 83 may be any of the various implants described herein. Figure 14, as well as several of the following figures, show a cross-section of the heart from top to bottom, with the posterior surface oriented toward the top of the page.

[0095] In some cases, left-to-right shunting through implantation of a shunt device 83 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable to shunting through the interatrial septum. For example, shunting through the coronary sinus 16 may provide a reduced risk of thrombus and emboli. The coronary sinus is less likely to have the presence of thrombus / emboli for several reasons. First, the blood draining from the coronary vasculature into the right atrium 5 has just passed through the capillaries and is therefore essentially filtered blood. Second, the ostium 14 of the coronary sinus in the right atrium is often partially covered by a false valve (not shown) called the Thebesius valve. The Thebesius valve is not always present, but some studies indicate that it is present in most hearts and can block the entry of thrombi or other emboli in the event of a spike in right atrial pressure. Third, the pressure gradient between the coronary sinus and the right atrium into which it drains is generally relatively low, which makes thrombi or other emboli in the right atrium more likely to remain lodged there. Fourth, if a thrombus / embolus enters the coronary sinus, there will be a much greater gradient between the right atrium and the coronary vasculature than between the right atrium and the left atrium. The thrombus / embolus will most likely travel further down the coronary vasculature until right atrial pressure returns to normal and the embolus then returns directly to the right atrium.

[0096] Some additional benefits of locating the shunt structure 83 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the atrial septal tissue. By diverting the left atrial blood to the coronary sinus, sinus pressure may be increased slightly. This will cause the coronary vasculature blood to move more slowly through the heart, increasing perfusion and oxygenation, which may be more efficient and may help the dying myocardium recover. Additionally, by implanting the shunt device / structure 83 within the wall of the coronary sinus, damage to the atrial septum 18 may be prevented. Thus, the atrial septum 18 may be preserved for later transseptal access for alternative therapies. Preservation of transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have several other comorbidities, such as atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions require transseptal access.

[0097] It should be noted that in addition to the various advantages of placing an implant / structure 83 between the coronary sinus 16 and the left atrium 2, certain disadvantages may be considered. For example, by shunting blood from the left atrium 2 to the coronary sinus 16, oxygenated blood from the left atrium 2 may be passed to the right atrium 5 and / or deoxygenated blood from the right atrium 5 may be passed to the left atrium 2, both of which may be undesirable with respect to proper functioning of the heart.

[0098] Sensor-Linked Implant Device 15 illustrates an example anchor / shunt implant 1501 coupled to a sensor device 1560, according to one or more embodiments. The sensor device 1560 may be configured to be attached to and / or extend from an outer skirt 1508 of the implant 1501. The outer skirt 1508 may be configured to at least partially cover an opening through the implant 1501. The sensor device 1560 may be configured for attachment at any portion of the implant 1501 and / or skirt 1508. As shown in FIG. 15, the sensor device 1560 may be configured for attachment at a central portion of the skirt 1508. For example, the sensor device 1560 may be positioned across a central lumen of the implant 1501.

[0099] The implant 1501 may be configured for placement and / or fixation in the left atrial appendage 29 and / or other portions of the cardiac anatomy. The sensor device 1560 may be configured to extend at least partially beyond the left atrial appendage 29 and / or into the left atrium, such that the sensor device 1560 may be configured to measure pressure and / or other characteristics of the left atrium 2. For example, the implant 1501 may be positioned at the left atrial appendage, into the left atrium, such that the skirt 1508 is positioned at the opening of the former left atrial appendage. The sensor device 1560 may be configured to extend from the skirt 1508 such that the sensor device 1560 extends beyond the opening of the left atrial appendage 29. Fixing the structure within the left atrial appendage 29 may advantageously minimize effects on blood characteristics (e.g., flow, pressure, etc.) within the left atrium 2 by the implant 1501 and / or the sensor device 1560, while advantageously allowing the sensor device 1560 to obtain accurate measurements associated with the left atrium. Additionally, fixing the implant 1501 to the left atrial appendage 29 may advantageously allow for sealing blood flow to the left atrial appendage 29, thereby reducing the risk of blood clot formation, which may lead to stroke and / or various cardiac conditions.

[0100] Delivery of the implant 1501 and / or the sensor device 1560 may be performed by any suitable means, possibly including a transseptal procedure. In some embodiments, the implant 1501 may be configured to be delivered separately from the sensor device 1560. For example, the implant 1501 may be delivered during a first procedure, and the sensor device 1560 may be delivered and attached to the implant 1501 at a later time during a separate procedure.

[0101] In some examples, the implant 1501 and / or sensor device 1560 can be delivered via an iatrogenic puncture created in the tissue wall between the coronary sinus and the left atrium 2. By delivering via the coronary sinus, damage to the atrial septum and / or other areas of tissue may be prevented and / or such areas of tissue may be preserved for later alternative therapies that may require transseptal access. Preservation of transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have several other comorbidities, which may include atrial fibrillation and / or mitral regurgitation, and certain therapies to treat these conditions may require transseptal access.

[0102] Blood flow characteristics (e.g., pressure) may be different within the left atrial appendage 29 than in other portions of the left atrium 2. As a result, the sensor device 1560 may be configured to extend at least partially outside the left atrial appendage 29, while the implant 1501 may be located at least partially within the left atrial appendage 29, which may minimize the effect of the implant 1501 on the blood flow characteristics of the left atrium 2.

[0103] In some embodiments, the sensor device 1560 may be configured to provide an adjustable attachment to the implant 1501. For example, an adjustable latch may be used to couple the sensor device 1560 to the implant 1501. The adjustable latch may be configured to allow adjustment to the angle of the sensor device 1560 relative to the implant 1501 while the sensor device 1560 remains coupled to the implant 1501. Additionally, the sensor device 1560 may be configured to attach to any portion of the implant 1501. For example, although the sensor device 1560 is shown attached to a skirt portion of the implant 1501, the sensor device 1560 may alternatively be coupled to a strut portion of the implant 1501. The sensor device 1560 may be adjusted through fixation and / or angle adjustment to a position that may maximize measurements of the left atrium 2 and / or other portions of the heart.

[0104] 16 illustrates another anchor / shunt implant 1601 coupled to a sensor device 1660, according to one or more embodiments. The implant 1601 may include a barrel portion made up of a network of struts 1602 forming one or more cells 1603. In some embodiments, the implant 1601 may have generally curved / non-straight side portions 1605.

[0105] The sensor device 1660 may be configured to attach to any portion of the implant 1601. Additionally, the sensor device 1660 may be configured to attach to the implant 1601 in any suitable manner. For example, a tether 1611, which may include a cord, wire, suture, and / or similar device, may be configured to extend between the implant 1601 and the sensor device 1660. In some embodiments, the tether 1611 may be configured to extend from and / or be attached to an upper and / or lower portion of the implant 1601. The implant 1601 may be configured to be twisted and / or otherwise adjusted to adjust the position of the sensor device 1660 as desired. In some embodiments, the tether 1611 may have a generally flexible structure and / or may be at least partially constructed from a generally flexible material. The tether 1611 and / or the sensor device 1660 may similarly be configured to couple to any implanted device described herein.

[0106] FIG 17 (FIGS. 17-1, 17-2, and 17-3) provides a flowchart illustrating a process 1700 including one or more steps for delivering one or more implants coupled to one or more sensors, according to one or more embodiments. FIG 18 (FIGS. 18-1, 18-2, and 18-3) provides images corresponding to the steps of process 1700 of FIG 17.

[0107] In step 1702, the process 1700 involves delivering a first implant 1801 coupled to one or more sensors 1860 through a tissue wall 1809 to an opening 1818, as illustrated in image 1802 of FIG. 18. In some embodiments, the first implant 1801 and / or the sensor 1860 may be configured for delivery via a catheter 1807. A dilator 1848 and / or an atraumatic tip may be utilized in combination with the catheter 1807 for delivery via one or more pathways through the heart. The tissue wall 1809 may include the atrial septum, the coronary sinus wall, and / or other tissue walls within the heart. The opening 1818 may be formed as part of the process 1700 and / or may be formed during a previous process. In some embodiments, a guidewire 1815 and / or similar device may be introduced through the opening 1818 to guide the dilator 1848 and / or the catheter 1807 to the opening 1818.

[0108] In some examples, the first implant 1801 and / or the sensor device 1860 may be configured to be delivered along an inner sheath 1824, which may be configured to extend along with the first implant 1801 and / or the sensor device 1860 through an inner lumen of the catheter 1807 and / or beyond an opening in the catheter 1807. The inner sheath 1824 may be configured to carry a balloon dilator and / or similar device configured to cause expansion of the first implant 1801 and / or the opening 1818.

[0109] At step 1704, the process 1700 involves placing a first implant 1801 within the opening 1818 of the tissue wall 1809, as illustrated in image 1804 of FIG. 18. The first implant 1801 and / or the sensor device 1860 may be configured to extend along the inner sheath 1824 and / or over the catheter 1807 to position the first implant 1801 at least partially within the opening 1818. The sensor device 1860 may be configured to extend from the first implant 1801 distal to the tissue wall 1809 and / or to a distal heart chamber, e.g., the left atrium 2. The first implant 1801 may be in a generally compressed configuration during delivery and / or placement in the opening 1818 of the tissue wall 1809. As a result, the diameter of the first implant 1801 upon delivery at the opening 1818 may be smaller than the diameter of the opening 1818 to allow the first implant 1801 to be twisted and or otherwise adjusted within the opening 1818. In this manner, the placement of the sensor device 1860 may be similarly adjusted in response to adjustments of the first implant 1801. The first implant 1801 may be configured to be twisted about the inner sheath 1824.

[0110] In step 1706, the process 1700 involves expanding the first implant 1801 and / or the opening 1818 by inflating and / or otherwise engaging an expansion balloon 1805 and / or similar device, as shown in image 1806 of FIG. 18. The expansion balloon 1805 may be configured to extend from the inner sheath 1824 and / or may be configured to expand and / or be expanded to expand the first implant 1801 in multiple and / or all directions. The expansion balloon 1805 may be configured to increase the diameter of the opening 1818 and / or simultaneously apply a pushing force to an inner portion of the first implant 1801 to press the first implant 1801 against the tissue portion of the opening 1818.

[0111] In step 1708, the process 1700 involves compressing the expandable balloon 1805 and / or otherwise disengaging the expandable balloon 1805 and / or similar devices to remove the expansion pressure from the first implant 1801, as shown in image 1808 of FIG. 18. The first implant 1801 may have a generally inelastic configuration such that the first implant 1801 may be configured to maintain its expanded configuration after compression of the expansion balloon 1805 and / or removal of the expansion force on the first implant 1801. The first implant 1801 may have a generally cylindrical configuration and / or may have generally curved and / or non-linear side portions to prevent the first implant 1801 from slipping out of the opening 1818 in the tissue wall 1809. In other words, the side portions of the first implant 1801 may be configured to grip onto the opening 1818 in the tissue wall 1809.

[0112] At step 1710, the process 1700 involves extending a catheter 1807 and / or otherwise delivering at least one or more distal arms of a second implant 1803 at an opening 1818 in a tissue wall 1809, as shown in image 1810 of FIG. 18. Although the second implant 1803 is shown as a shunt implant, other types of implants may be used. In some embodiments, an inner catheter 1813 may be used in the delivery of the second implant 1803. For example, the second implant 1803 may extend through the catheter 1807 while a shunt device is crimped onto an outer surface of the inner catheter 1813. Although the second implant 1803 is shown delivered after placement of the first implant 1801, the second implant 1803 and the first implant 1801 may be delivered simultaneously and / or the second implant 1803 may be delivered prior to delivery of the first implant 1801.

[0113] In some examples, the second implant 1803 may be configured to pass at least partially through an inner lumen of the first implant 1801 and / or may include one or more fixation arms configured to extend across at least a portion of the structure to anchor and / or otherwise form an attachment to the tissue wall 1809. For example, one or more arm portions of the second implant 1803 may be configured to extend beyond a portion of the first implant 1801 and grip onto the tissue wall 1809. The second implant 1803 may include a barrel portion configured to fit and / or remain within the opening / orifice 1818 in the tissue wall 1809. The barrel portion may be configured to fit at least partially within the inner lumen of the first implant 1801. Alternatively, the first implant 1801 may be configured to extend at least partially through the inner lumen and / or barrel portion of the second implant 1803.

[0114] The guidewire 1815 may be advantageously configured to guide the delivery of the first implant 1801 and / or the second implant 1803. For example, after delivery of the first implant 1801, the guidewire 1815 may remain within the body and / or extend through an opening 1818 in the tissue wall 1809. The second implant 1803 and / or the inner catheter 1813 may be configured to extend along the guidewire 1815.

[0115] In step 1712, the process 1700 involves securing the second implant 1803 to the tissue wall 1809, as shown in image 1812 of FIG. 18. Securing the second implant 1803 may involve extending a proximal arm of the second implant 1803 out of the catheter 1807 and / or into contact with the tissue wall 1809. After delivery of the second implant 1803, the catheter 1807 may be removed from the body, while the second implant 1803 and / or the first implant 1801 remain secured to the tissue wall 1809.

[0116] 19 illustrates a sensor mounting device / implant 1911 configured to couple to a sensor device and / or secure the sensor device 1960 to one or more additional implants, which may include various shunt devices and / or other implants described herein according to one or more embodiments. In some embodiments, the sensor mounting device 1911 may have a generally curved (e.g., C-shaped) structure including a first end portion 1912 and / or a second end portion 1913. The first end portion 1912 and / or the second end portion 1913 may be configured to act as a hook to allow the sensor mounting device 1911 to hook onto and / or otherwise form an attachment with one or more implants. For example, the first end portion 1912 and / or the second end portion 1913 may be configured to mate with a corresponding attachment feature, e.g., a receptor, on the implant.

[0117] The sensor device 1960 may be configured to extend from and / or be attached to the sensor mounting apparatus 1911. In some embodiments, the sensor device 1960 may be configured to attach to the sensor mounting apparatus 1911 via a network of coils 1961 extending from the sensor mounting apparatus 1911. The coils 1961 may be configured to be at least partially wrapped around at least a portion of the sensor device 1960 to hold the sensor device 1960 in place relative to the sensor mounting apparatus 1911. The sensor device 1960 is attached at or near a first end portion 1912 of the sensor mounting apparatus 1911 as shown, although the sensor device 1960 may be directly coupled to and / or extend from any portion of the sensor mounting apparatus 1911.

[0118] In some examples, the sensor device 1960 may be configured to form an adjustable attachment to the sensor mounting device 1911. For example, the sensor device 1960 may be configured to be attached to the sensor mounting device 1911 via a hinged and / or bendable attachment. In some examples, the coil 1961 may be at least partially flexible and / or configured to allow the sensor 1960 to be adjusted relative to the sensor mounting device 1911 while maintaining a connection between the sensor device 1960 and the sensor mounting device 1911. In this manner, the position of the sensor device 1960 may be adjustable to establish an optimal position for obtaining various measurements within the patient's body.

[0119] In some examples, the sensor attachment device 1911 may be configured to secure to an orifice into and / or through a tissue wall independent of other implantation devices. For example, the first end portion 1912 and / or the second end portion 1913 may be configured to clip and / or otherwise secure onto opposing sides of a tissue wall, with at least a portion of the sensor attachment device 1911 extending through an orifice through the tissue wall. The sensor 1960 may be configured to be attached / coupled to the sensor attachment device 1911 after the sensor attachment device 1911 is delivered to the orifice in the tissue wall and / or may be configured to be attached to the sensor attachment device 1911 before the sensor attachment device 1911 is delivered to the orifice and / or into the body.

[0120] FIG. 20 illustrates a sensor attachment device 2011 attached to a shunt implant 2003, which may be secured to a tissue wall 2009, according to one or more embodiments. As shown in FIG. 20, the sensor attachment device 2011 may be configured to secure and / or clip onto one or more arm portions 2005 of the shunt implant 2003. In some embodiments, the curvature of the sensor attachment device 2011 may be configured to approximate and / or match the curvature of at least a portion of the shunt implant 2003. In this manner, the sensor attachment device 2011 may be configured to extend along at least a portion of the shunt implant 2003 to provide minimal obstruction of the flow path through the shunt implant 2003 without significantly increasing and / or adding to the profile of the shunt implant 2003. In some embodiments, the sensor attachment device 2011 may have a generally curved configuration with a first end portion 2012 and / or a second end portion 2013.

[0121] One or more sensor devices 2060 may be configured to be attached to and / or extend from the sensor mounting device 2011. The sensor mounting device 2011 may be configured to be attached to the shunt implant 2003 in a manner such that the sensor device 2060 may extend at least partially over a flow path through the shunt implant 2003. For example, the shunt implant 2003 may include a barrel portion configured to maintain a blood flow path through the opening 2018 and the tissue wall 2009. The sensor device 2060 may be configured to extend from the sensor mounting device 2011 and / or from the shunt implant 2003 in a manner such that the sensor device 2060 extends at least partially over the opening 2018 to enable the sensor device 2060 to obtain measurements related to blood flow through and / or near the opening 2018. The position of the sensor device 2060 relative to the opening 2018, the sensor mounting device 2011, and / or the shunt implant 2003 may be adjustable due at least in part to an adjustable attachment between the sensor device 2060 and the sensor mounting device 2011.

[0122] FIG. 21A illustrates at least a portion of an implant 2103 (e.g., a first implant and / or an implant barrel portion) configured for attachment to one or more sensor devices 2160 and / or sensor mounting devices / implants 2130 (e.g., a second implant portion) according to one or more embodiments. In some embodiments, the implant 2103 may comprise at least a portion of a shunt implant and / or other implants described herein. The implant 2103 may include one or more anchor arm portions 2105 configured to form an attachment with either side of a tissue wall. The implant 2103 may further comprise at least a partial barrel 2107 (e.g., a first barrel portion) having a semicircular shape and / or configured to maintain and / or define a blood flow pathway and / or a fluid conduit through an opening in the tissue wall. The implant 2003 may comprise one or more attachment features 2120 configured to mate with corresponding attachment features of the sensor device and / or sensor mounting device 2130.

[0123] In some embodiments, the implant 2103 may comprise approximately half of the shunt implant 150 described in FIG. 7. For example, the implant 2103 may comprise only a first set of arms 2105 configured to form an attachment with a tissue wall, as opposed to two sets of fixation arms of the various shunt implants described herein. In some embodiments, the barrel portion may be configured to form a partial and / or semi-cylindrical form configured for placement within an opening in a tissue wall. In some embodiments, one or more attachment features 2120 may be configured to extend from the barrel portion 2107 into a lumen created by the barrel portion 2107. However, the attachment features 2120 may be configured to extend from any suitable portion of the implant 2103.

[0124] The sensor mounting device 2130 may have a "horseshoe", semi-circular, and / or "C-shaped" configuration and / or may include a second partial barrel portion. When the sensor mounting device 2130 is coupled to the implant 2103, the sensor mounting device 2130 and the barrel portion 2107 of the implant 2103 may be configured to form a generally oval shaped (e.g., circular) barrel portion.

[0125] 21B illustrates at least a portion of a sensor embedding device comprising a sensor device 2160 directly coupled to a sensor mounting device 2130 (e.g., second barrel portion) having a semicircular shape and / or configured to be removably secured to and / or form a releasable attachment with the implant 2103. In some examples, the sensor mounting device 2130 may have a generally curved configuration to form an extension of the barrel portion 2107 of the implant 2103. For example, the sensor mounting device 2130 and the barrel portion 2107 when attached together may form a generally full oval (e.g., circular) shaped barrel configured to approximate the shape of an opening through a tissue wall.

[0126] The sensor mounting device 2130 may comprise one or more mounting features 2121 (e.g., arms, prongs, protrusions, notches, clasps, clips, and / or similar mechanisms) configured to removably mate with corresponding mounting features (e.g., notches, cavities, openings, and / or similar mechanisms) of the implant 2103. In some examples, the one or more mounting features 2121 of the sensor mounting device may be configured to extend in a downward direction and / or generally in the opposite direction of the sensor device 2160. The sensor device 2160 may be configured to extend in an upward direction. For example, when the sensor mounting device 2130 is attached to the implant 2103 and positioned within an opening in a tissue wall, the sensor device 2160 may be configured to extend from the mounting device 2130 toward a first anatomical chamber (e.g., the left atrium), while the one or more mounting features 2120 of one of the sensor mounting devices 2130 may be configured to extend toward a second anatomical chamber (e.g., the coronary sinus).

[0127] The sensor device 2160 may be configured to be attached to the sensor mounting device 2130 in any suitable manner. For example, one or more coils 2161 and / or similar features may be configured to extend from the sensor mounting device 2130 and / or the sensor device 2160 to form an attachment between the sensor device 2160 and the sensor mounting device 2130. For example, the one or more coils 2161 extending from the sensor mounting device 2130 may be configured to be at least partially wound around at least a portion of the sensor device 2160. In some examples, the sensor device 2160 may be configured to form an adjustable attachment to the sensor mounting device 2130 such that the position of the sensor device 2160 relative to the sensor mounting device 2130 and / or the implant 2103 may be adjustable during and / or after placement within the body of the sensor device.

[0128] 21C provides a top view of an implant 2103 attached to a sensor mounting device 2130, according to one or more embodiments. The sensor mounting device 2130 may be configured to be attached to and / or extend into a sensor device 2160 configured to obtain various measurements related to blood flow at or near the shunt implant 3. One or more mounting features 2120 extending from the implant 2103 may be configured to mate with corresponding mounting features 2121 of the mounting device 2130. The sensor mounting device 2130 may be configured to form an extension of the barrel portion 2107 of the implant 2103. Additionally, the sensor device 2160 may be configured to lie generally opposite one or more fixation arms 2105 of the implant 2103 across an inner lumen formed by the barrel portion 2107 and the sensor mounting device 2130.

[0129] Some implementations of the present disclosure relate to a method that includes delivering a first implant to an orifice of a heart chamber, securing the first implant to the orifice, delivering a sensor device to the orifice, and coupling the sensor device to the first implant.

[0130] The heart chamber may be the left atrium and the orifice is associated with the left atrial appendage. In some embodiments, the heart chamber is the left atrium and the orifice is an opening in a tissue wall between the left atrium and the coronary sinus. The orifice may be an opening in the septum between the left atrium and the right atrium.

[0131] In some embodiments, the sensor device is coupled to the first implant prior to delivery of the first implant to the orifice. The sensor device may be coupled to the first implant after delivery of the first implant to the orifice.

[0132] The sensor device may be coupled to the first implant via a flexible cord. In some embodiments, the method further includes delivering a dilatation balloon to the orifice and inflating the dilatation balloon to expand the first implant from the compressed configuration to the expanded configuration.

[0133] In some embodiments, the method further includes delivering a second implant to the orifice. The second implant may be configured to fit at least partially within the inner lumen of the first implant. In some embodiments, the second implant includes one or more fixation arms extending at least partially over the first implant and configured to fixate with the tissue wall.

[0134] The method may further include delivering a second implant to the orifice and attaching the first implant to the second implant. The second implant can have a barrel portion configured to form a fluid conduit.

[0135] In some embodiments, the first implant is C-shaped and includes a first end portion and a second end portion, each of the first end portion and the second end portion may be configured to attach to the second implant.

[0136] The first implant may comprise a first implant portion and a second implant portion. The first implant portion and the second implant portion may be configured to be coupled together. In some embodiments, the sensor device is configured to be coupled to the first implant portion.

[0137] In some embodiments, the first implant portion comprises a first barrel portion and the second implant portion comprises a second barrel portion, the first barrel portion and the second barrel portion together may form an oval shaped barrel configured to fit at least partially within the orifice when the first implant portion is coupled to the second implant portion.

[0138] Some implementations of the present disclosure relate to a sensor implantation device that includes a first shunt body that includes a barrel portion that forms a fluid conduit, and a sensor device configured to couple to the first shunt body.

[0139] The first shunt body may be balloon expandable. In some embodiments, the first shunt body has an hourglass shape, with the end portions of the first shunt body having a larger diameter than the mid-section of the first shunt body and the mid-section configured to lie at least partially within an orifice through the tissue wall while the end portions grip over the tissue wall.

[0140] In some embodiments, the first shunt body comprises a network of struts that form diamond shaped cells. The first shunt body may comprise a network of struts that form stacked pairs of diamond shaped or spade shaped cells.

[0141] The first shunt body may comprise a network of struts forming a series of aligned cells, hi some embodiments, the first shunt body comprises a network of interwoven cords.

[0142] In some embodiments, the end portion comprises a first ring and a second ring, and the network of interwoven cords extends between the first ring and the second ring. The sensor device may be tethered to the first shunt body via a flexible tether.

[0143] The first shunt body may comprise a cylindrical stent and a skirt extending across a lumen of the cylindrical stent, the sensor device being coupled to the skirt, hi some embodiments, the sensor device extending through an opening in the skirt.

[0144] In some examples, the sensor implantation device further comprises a second shunt body separate from the first shunt body and configured to extend at least partially through the barrel portion of the first shunt body. The second shunt body may comprise one or more fixation arms configured to anchor to a tissue wall.

[0145] The first shunt body may comprise a first barrel portion and a second barrel portion, the first barrel portion configured to be removably attached to the second barrel portion, hi some embodiments, the first barrel portion and the second barrel portion when attached together form an oval shaped barrel.

[0146] In some embodiments, the first barrel portion has a semi-circular shape.The second barrel portion may include one or more anchoring arms configured to anchor into a tissue wall.

[0147] The first barrel portion may include a first protrusion at a first end of the first barrel portion and a second protrusion at a second end of the first barrel portion, the first protrusion and the second protrusion may be configured to mate with the second barrel portion.

[0148] In some embodiments, the sensor device is configured to couple to the first barrel portion between the first end and the second end. The sensor embedding device may further include a second shunt body directly coupled to the sensor device. The second shunt body may have a curved shape and one or more end portions configured to couple to the first shunt body.

[0149] The curvature of the second shunt body may approximate the curvature of one or more fixation arms of the first shunt body, hi some embodiments, the end portions of the second shunt body curve inwardly.

[0150] Additional Examples Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a differing order, may be added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0151] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context of use, and is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without author input or prompting. Terms such as "comprising," "including," "having," and the like, have the same meaning and are used in their ordinary sense and in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. The term "or" is also used in its inclusive sense (and not its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Conjunctive language such as "at least one of X, Y, and Z" is understood to be used in the context as used to generally convey that an item, term, element, etc. may be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z are each present.

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

[0153] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements, such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element with respect to any other elements, but rather may generally distinguish an element from another element having a similar or identical name (other than the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0154] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiment belongs. Furthermore, 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 art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined as such in this specification.

[0155] The spatial relationship terms "outside," "inside," "up," "down," "below," "up," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. It should be understood that the spatial relationship terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device shown in the drawings is inverted, a device that is positioned "below" or "below" another device may be placed "above" another device. As a result, the exemplary term "below" may include both a below position and an above position. The device may also be oriented in other directions, and therefore the spatial relationship terms may be interpreted differently depending on the orientation.

[0156] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass the concept of equivalence. For example, "less" can mean not only "less than" in the strict mathematical sense, but also "less than or equal to."

Claims

1. A sensor-implanting device, comprising: a first shunt body having a barrel portion forming a fluid conduit; and a sensor device configured to be connected to the first shunt body.

2. The sensor-implanting device according to claim 1, wherein the first shunt body is balloon-expandable.

3. The sensor-implanting device according to claim 2, wherein the first shunt body has an hourglass shape, and in the hourglass shape, an end portion of the first shunt body has a diameter larger than that of an intermediate section of the first shunt body, and while the end portion grips over a tissue wall, the intermediate section is configured to be at least partially located within an orifice passing through the tissue wall.

4. The sensor-implanting device according to claim 3, wherein the first shunt body comprises a network of struts forming diamond-shaped cells.

5. The sensor-implanting device according to claim 3 or 4, wherein the first shunt body comprises a network of struts forming a stack of pairs of diamond-shaped or spade-shaped cells.

6. The sensor-implanting device according to any one of claims 3 to 5, wherein the first shunt body comprises a network of struts forming a series of cells in a row.

7. The sensor-implanting device according to any one of claims 3 to 6, wherein the first shunt body comprises a network of woven cords.

8. The sensor-implanting device according to claim 7, wherein the end portion comprises a first ring and a second ring, and the network of woven cords extends between the first ring and the second ring.

9. The sensor-implanting device according to any one of claims 3 to 8, wherein the sensor device is tethered to the first shunt body via a flexible tether.

10. The sensor-implanting device according to any one of claims 1 to 9, wherein the first shunt body comprises a cylindrical stent and a skirt extending across a lumen of the cylindrical stent, and the sensor device is connected to the skirt.

11. The sensor-implanting device according to claim 10, wherein the sensor device extends through an opening of the skirt.

12. The sensor-implanting device according to claim 1, further comprising a second shunt body separated from the first shunt body and configured to at least partially extend through the barrel portion of the first shunt body, wherein the second shunt body includes one or more fixing arms configured to be fixed to a tissue wall.

13. The sensor-implanting device according to claim 1, wherein the first shunt body includes a first barrel portion and a second barrel portion, the first barrel portion is configured to be removably attached to the second barrel portion, and when the first barrel portion and the second barrel portion are attached together, they form an elliptical barrel.

14. The sensor-implanting device according to claim 13, wherein the first barrel portion has a semi-circular shape and the second barrel portion includes one or more fixing arms configured to be fixed to a tissue wall.

15. The sensor-implanting device according to claim 14, wherein the first barrel portion includes a first protrusion at a first end of the first barrel portion and a second protrusion at a second end of the first barrel portion, and the first protrusion and the second protrusion are configured to fit with the second barrel portion.

16. The sensor-implanting device according to claim 15, wherein the sensor device is configured to be connected to the first barrel portion between the first end and the second end.

17. The sensor-implanting device according to claim 1, further comprising a second shunt body directly connected to the sensor device, wherein the second shunt body has a curved shape and one or more end portions configured to be connected to the first shunt body.

18. The sensor-implanting device according to claim 17, wherein the curvature of the second shunt body approximates the curvature of one or more fixing arms of the first shunt body.

19. The sensor-implanting device according to claim 17 or claim 18, wherein the end portion of the second shunt body curves inward.

Images