Sensor implant device with stable attachment

Abstract

The invention provides a sensor implant device comprising: a sensor body comprising at least a first sensor assembly; one or more anchors coupled to the sensor body and configured to anchor the sensor body within a tissue wall; a detachable tip; and a tether connecting the detachable tip to the sensor body.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 331,963, filed on April 18, 2022, entitled “SENSOR IMPLANT DEVICE WITH STABILIZING APPENDAGE,” the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] The present disclosure relates generally to the field of medical implant devices.

[0004] Various medical procedures involve implanting medical implant devices within the anatomy of the heart. Certain physiological parameters associated with this anatomy, such as fluid pressure, may have an impact on the patient's health outlook. Summary of the invention

[0005] One or more methods and / or devices are described herein to facilitate monitoring physiological parameters associated with certain chambers and / or vessels of the heart, such as the left atrium, using one or more sensor implant devices.

[0006] According to some embodiments of the present disclosure, a sensor implant device includes: a sensor body, which includes at least a first sensor component; one or more anchors, which are coupled to the sensor body and configured to anchor the sensor body within a tissue wall; a detachable tip; and a tether, which connects the detachable tip to the sensor body.

[0007] The tether may be shaped to direct the detachable tip away from the sensor body. In some examples, the tether is configured to direct the detachable tip to a side of the sensor body.

[0008] In some examples, the tether is configured to direct the detachable tip toward a surface of the tissue wall.The tether may be comprised of a shape memory alloy.

[0009] The detachable tip may have a conical shape with a pointed tip. In some instances, the pointed tip is configured to pierce a tissue wall.

[0010] In some examples, the detachable tip has a rounded head.The detachable tip can be configured to provide a leading end for the sensor body during delivery to a tissue wall.

[0011] The removable tip may include a flat base configured to sit flat against the distal end of the sensor body.

[0012] In some examples, the one or more anchors include one or more proximal anchors extending from a proximal end of the sensor body. The one or more proximal anchors can have a semicircular shape that can be concentric with the sensor body.

[0013] The one or more proximal anchors may have a semicircular shape extending along the sensor body toward the distal end of the sensor body. In some examples, the one or more anchors include three proximal anchors.

[0014] In some examples, the one or more anchors include one or more distal anchors extending from a distal end of the sensor body.

[0015] The one or more distal anchors can have a semicircular shape extending along the sensor body toward the proximal end of the sensor body. In some examples, the one or more anchors include three distal anchors.

[0016] In some examples, the one or more anchors include one or more side anchors extending from a middle section of the sensor body. Each of the one or more side anchors may include a free end configured to form an angle of approximately 45 degrees with the sensor body.

[0017] The one or more anchors may include three side anchors.In some examples, the sensor implant device further includes a marker attached to the sensor body.

[0018] In some examples, the sensor body includes an internal lumen configured to receive a guidewire.The detachable tip may include a lumen configured to align with the internal lumen of the sensor body during delivery.

[0019] Some embodiments of the present disclosure are directed to a method comprising delivering a shaft carrying a sensor implant device to a tissue wall. The sensor implant device comprises: a sensor body comprising at least a first sensor component; one or more anchors coupled to the sensor body and configured to anchor the sensor body within the tissue wall; a detachable tip; and a tether connecting the detachable tip to the sensor body. The method also includes retracting the shaft to allow the tether to pull the detachable tip away from the sensor body.

[0020] The tether may be shaped to direct the detachable tip away from the sensor body. In some examples, the tether is configured to direct the detachable tip to a side of the sensor body.

[0021] The tether can be configured to guide the detachable tip toward the surface of the tissue wall.In some examples, the tether is composed of a shape memory alloy.

[0022] In some examples, the removable tip has a conical shape with a pointed tip. The pointed tip can be configured to pierce a tissue wall.

[0023] The removable tip can have a rounded head.In some examples, the removable tip is configured to extend beyond the distal end of the shaft during delivery to the tissue wall.

[0024] In some examples, the detachable tip includes a flat base configured to sit flat against the distal end of the sensor body.The one or more anchors may include one or more proximal anchors extending from the proximal end of the sensor body.

[0025] The one or more proximal anchors can have a semicircular shape that can be concentric with the sensor body. In some examples, the one or more proximal anchors have a semicircular shape extending along the sensor body toward the distal end of the sensor body.

[0026] The one or more anchors may include three proximal anchors.

[0027] In some examples, the one or more anchors include one or more distal anchors extending from a distal end of the sensor body.

[0028] The one or more distal anchors can have a semicircular shape extending along the sensor body toward the proximal end of the sensor body. In some examples, the one or more anchors include three distal anchors.

[0029] In some examples, the one or more anchors include one or more side anchors extending from a middle section of the sensor body. Each of the one or more side anchors may include a free end configured to form an angle of approximately 45 degrees with the sensor body.

[0030] The one or more anchors may include three side anchors.

[0031] In some examples, the sensor implant device further comprises a marker attached to the sensor body.The sensor body may comprise an internal lumen configured to receive a guidewire.

[0032] The removable tip may include a lumen configured to align with the interior lumen of the sensor body during delivery.

[0033] To summarize the present disclosure, certain aspects, advantages and novel features have been described. It should be understood that not all such advantages may be achieved according to any particular example. Therefore, the disclosed examples may be performed in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] For the purpose of illustration, various examples are depicted in the accompanying drawings, and these examples should not be construed as limiting the scope of the present invention. In addition, the various features of the different disclosed examples can be combined to form additional examples as part of the present disclosure. In all the accompanying drawings, reference numerals may be reused to represent the corresponding relationship between the reference elements.

[0035] Figure 1 An example representation of a human heart is shown according to one or more examples.

[0036] Figure 2 Example pressure waveforms associated with various chambers and blood vessels of the heart are shown according to one or more examples.

[0037] Figure 3 A graph showing left atrial pressure range is shown.

[0038] Figure 4 is a block diagram representing an implant device according to one or more examples.

[0039] Figure 5 is a block diagram representing a system for monitoring one or more physiological parameters associated with a patient according to one or more examples.

[0040] Figure 6 Example sensor assemblies / devices are shown that can be components of sensor implant devices according to one or more examples.

[0041] 7A to 7C A sensor implant device according to one or more examples is shown.

[0042] Fig. 8A and Figure 8B Another example sensor implant device according to one or more examples is shown.

[0043] Fig. 9 A perspective view of another example sensor implant device according to one or more examples is provided.

[0044] Fig.10 A delivery system for delivering a sensor implant device according to one or more examples is shown.

[0045] Fig.11 A side view of a sensor implant device implanted and / or anchored within a heart according to one or more examples is provided.

[0046] Figure 12 Figure 12-1 and Figure 12-2 ) provides a flowchart illustrating a process including one or more steps for delivering one or more implants and / or sensors to a target location within the heart according to one or more examples.

[0047] Figure 13 Figure 13-1 and Figure 13-2 ) provides images corresponding to the steps of the process of Figure 12. DETAILED DESCRIPTION

[0048] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0049] Although certain preferred examples and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the resulting claims is not limited to any of the specific examples described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in sequence in a manner that may help understand certain examples; however, the order of description should not be interpreted as implying that these operations are order-dependent. In addition, the structures, systems and / or devices described herein may be embodied as integrated components or separate components. In order to compare various embodiments, certain aspects and advantages of these examples are described. Not all of these aspects or advantages are necessarily achieved by any particular example. Therefore, for example, various examples may be performed in a manner that realizes or optimizes one advantage or a group of advantages taught herein, without necessarily realizing other aspects or advantages that may also be taught or suggested herein.

[0050] For the convenience of devices, components, systems, features and / or modules having similar features in one or more aspects, certain reference numerals are reused in different figures of the group of figures of the present disclosure. However, with respect to any one of the examples disclosed herein, the reuse of common reference numerals in the figures does not necessarily indicate that such features, devices, components or modules are the same or similar. On the contrary, those of ordinary skill in the art can understand through the context that the use of common reference numerals can imply the degree of similarity between the referenced subjects. The use of specific reference numerals in the context of the description of a specific figure can be understood as involving the identified device, component, aspect, feature, module or system in the specific figure, without having to involve any device, component, aspect, feature, module or system identified by the same reference numeral in another figure. In addition, the various aspects of the separate figures identified with common reference numerals can be interpreted as sharing characteristics or being completely independent of each other.

[0051] Some standard anatomical terms of position are used herein to refer to the anatomy of animals (i.e. humans) about preferred examples. Although some spatially relative terms, such as "external", "interior", "upper", "lower", "below", "above", "vertical", "horizontal", "top", "bottom" and similar terms, are used herein to describe the spatial relationship between a device / element or anatomical structure and another device / element or anatomical structure, it should be understood that for ease of description, these terms are used herein to describe the positional relationship between elements / structures, as shown in the figure. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are intended to cover the different orientations of elements / structures in use or operation. For example, an element / structure described as "above" another element / structure can represent a position below or beside such other element / structure relative to an alternative orientation of a subject patient or element / structure, and vice versa.

[0052] 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 sensor-integrated cardiac shunt and / or other medical implant device. In some embodiments, the present disclosure relates to a cardiac shunt and / or other cardiac implant device that is incorporated with a pressure sensor or other sensor device or is associated with a pressure sensor or other sensor device. The term "associated with..." is used herein according to its broad and common meaning. For example, in the case where a first feature, element, component, device or part is described as being associated with a second feature, element, component, device or part, such description should be understood to indicate that the first feature, element, component, device or part is directly or indirectly physically connected, attached or connected, integrated, at least partially embedded therein or otherwise physically related to the second feature, element, component, device or part. Certain examples are disclosed herein in the context of a cardiac implant device. However, although certain principles disclosed herein are particularly applicable to the anatomical structure of the heart, it should be understood that the sensor implant device according to the present disclosure can be implanted or configured to be implanted in any suitable or desired anatomical structure.

[0053] Although the various sensor devices described herein may be integrated with the various medical implant devices described herein, the sensor device may be a device separate from the medical implant device. For example, the sensor device may form a disconnectable and / or releasable connection with the medical implant device. In addition, the sensor device described herein may be configured to be delivered separately from the medical implant device (e.g., before the medical implant device and / or after the medical implant device) within 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 by a catheter), but may be attached / coupled to the medical implant device after delivery (e.g., after removal from the catheter) to the desired location within the heart. Example delivery locations may include the left atrium, left atrial appendage, pulmonary veins, coronary sinus, and / or various tissue walls associated with these locations.

[0054] In some examples, the catheter and / or guidewire used to deliver the sensor device can also be used to deliver the medical implant device. For example, after the delivery of the sensor device and / or medical implant device, the catheter and / or guidewire can remain in the body for delivery of one or more remaining devices.

[0055] Examples described herein provide components for stabilizing and / or securely anchoring sensor devices within various anatomical structures. For example, a sensor device may include a detachable and / or detachable front end / tip configured to extend away from a sensor body of the sensor device to provide an arm-like extension against which the sensor body rests and / or is tethered. In some examples, the detachable front end may be configured to limit shaking of the sensor body, and / or may be configured to improve synchronization of movement between the sensor body and the patient's heartbeat when anchored within the heart.

[0056] The terms "sensor device" and "sensor implant device" are used herein according to their plain and ordinary meanings and may refer to any device, implant, member for sensing, and / or other mechanism configured to sense, measure, and / or determine various conditions within a patient's body. For example, a sensor device may be configured to measure blood flow rate and / or pressure through one or more blood vessels and / or within a heart chamber. A sensor device may include a sensor assembly attached to and / or embedded within a sensor body and configured to perform various measurements.

[0057] The detachable front end may be configured to contact the tissue wall and / or at least partially embed into the tissue wall. For example, the detachable front end may include a pointed tip configured to puncture the tissue wall, causing the tissue to grow inward around the detachable front end. In some instances, the detachable front end / tip may include a coating to accelerate the inward growth of tissue around the detachable front end / tip. The detachable tip may be configured to be firmly attached to and / or contact the sensor body of the sensor device. The terms "tip" and / or "front end" are used according to their simple and ordinary meanings and may refer to any member for guiding, a member for stabilizing, a member for expanding, a distal portion and / or a proximal portion, a cap and / or other features configured to be located at or near the distal end of the sensor body. The detachable front end / tip may be configured to expand tissue during delivery into the body and / or the target tissue wall.

[0058] In some instances, the sensor device may include one or more markers including radiopaque markers to facilitate visualization and / or positioning of the sensor device in the patient's body. The marker may be embedded in the sensor body of the device. In some instances, a tether interconnecting a detachable front end / tip to the sensor body may be embedded in the sensor body and / or may be coupled to the marker. A contrast solution may be used to further facilitate visualization of the sensor device. The term "tether" is used herein according to its simple and ordinary meaning, and may refer to any rope, line, wire, member for tethering, and / or other devices configured to form an attachment between a detachable and / or detachable tip and a sensor body. The term "sensor body" is used herein according to its simple and ordinary meaning, and may refer to any part of a sensor device configured to be attached to a component of the sensor device, which may include various anchors, tethers, and / or detachable tips.

[0059] Cardiac Physiology

[0060] The anatomy of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart typically comprises a muscular organ having four pumping chambers, wherein flow is at least partially controlled by various heart valves (i.e., the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve). The valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to corresponding regions and / or vessels of the heart (e.g., the pulmonary artery, the aorta, etc.).

[0061] Figure 1An example representation of a heart 1 having various features relevant to certain examples of the present disclosure is shown. The heart 1 includes four chambers, namely, a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery 11 via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood can be pumped to the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 includes a pulmonary trunk and a left pulmonary artery 15 and a right pulmonary artery 13 that branch from the pulmonary trunk, as shown. The pulmonary vein 23 carries blood from the lungs to the left atrium 2.

[0062] In addition to the pulmonary valve 9, the heart 1 also includes three additional valves that assist blood circulation therein, including the tricuspid valve 8, the aortic valve 7, and the mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 typically has three cusps or leaflets, and can typically close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 typically 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 so that blood in the left atrium 2 can flow into the left ventricle 3, and when functioning normally, close during systole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and to close during diastole to prevent blood from leaking back into the left ventricle 3.

[0063] A heart valve can typically include a relatively dense fibrous ring (referred to herein as an annulus), and a plurality of leaflets or cusps attached to the annulus. Typically, the leaflets or cusps can be sized such that when the heart contracts, the resulting increased blood pressure generated in the corresponding heart chamber forces the leaflets to at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber drops, the pressure in the subsequent chamber or vessel may become dominant and press back on the leaflets. As a result, the leaflets / cusps become juxtaposed to one another, closing the flow channel. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can result in valve leakage and / or other health complications.

[0064] Atrioventricular (i.e., mitral and tricuspid) heart valves may also include a collection of chordae tendineae and papillary muscles (not shown) for fixing the leaflets of the corresponding valves to promote and / or facilitate the correct engagement of the valve leaflets and prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by chordae tendineae. A muscle wall called the septum separates the left chamber from the right chamber. In particular, the septal wall portion 18 (referred to herein as the "atrial septum", "atrial septum" or "septum") separates the left atrium 2 from the right atrium 5, and the septal wall portion 17 (referred to herein as the "ventricular septum", "ventricular septum" or "septum") separates the left ventricle 3 from the right ventricle 4. The lower tip 26 of the heart 1 is called the apex and is generally located on or near the midclavicular line, in the fifth intercostal space.

[0065] The coronary sinus 16 comprises a collection of veins that join together to form a large vessel that collects blood from the heart muscle (myocardium). As shown, the ostium of the coronary sinus, which may be at least partially protected by a coronary sinus valve in some patients, opens to the right atrium 5. The coronary sinus extends along the posterior portion of the left atrium 2 and delivers less oxygenated blood to the right atrium 5. The coronary sinus generally extends laterally in the left atrioventricular groove on the posterior side of the heart.

[0066] Any of several access routes in the heart 1 can be used 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 can be gained from above via the subclavian vein or jugular vein into the superior vena cava (SVC) 19, the right atrium 5, and from there into the coronary sinus 16. Alternatively, the access route can begin at the femoral vein and enter the heart 1 through the inferior vena cava (IVC) 14. Other access routes can also be used, and each access route can utilize a percutaneous incision through which a guidewire and catheter are inserted into the vasculature, typically through a sealed introducer, and from there the physician can control the distal end of the device from outside the body.

[0067] Health conditions associated with heart stress and other parameters

[0068] As mentioned above, certain physiological conditions or parameters associated with cardiac anatomy can affect the health of patients. For example, congestive heart failure is a disease associated with the relatively slow movement of blood through the heart and / or body, which causes the fluid pressure in one or more chambers of the heart to increase. Therefore, the heart cannot pump enough oxygen to meet the needs of the body. The various chambers of the heart can respond to the pressure increase by stretching to keep more blood pumped through the body or by becoming relatively hard and / or thickening. The walls of the heart may eventually weaken and become unable to pump effectively. In some cases, the kidneys may respond to heart function decline by keeping the body with fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs and / or other organs may cause body congestion, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is the main cause of morbidity and mortality, so treatment and / or prevention of congestive heart failure is an important concern in medical care.

[0069] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously include monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As described above, pressure accumulation in one or more chambers or regions of the heart may be associated with congestive heart failure. Without directly or indirectly monitoring heart pressure, it may be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure. For example, a treatment or method that does not involve direct or indirect pressure monitoring may include measuring or observing other current physiological conditions of the patient, such as measuring weight, thoracic impedance, right heart catheterization, etc. In some solutions, pulmonary capillary wedge pressure may be measured as a substitute for left atrial pressure. For example, a pressure sensor may be provided or implanted in the pulmonary artery, and the reading associated therewith may be used as a substitute for left atrial pressure. However, with respect to catheter-based pressure measurements in the pulmonary artery or certain other chambers or regions of the heart, it may be necessary to use an invasive catheter to maintain such a pressure sensor, which may be uncomfortable or difficult to implement. In addition, certain lung-related conditions may affect the pressure readings in the pulmonary artery, so that the correlation between pulmonary artery pressure and left atrial pressure may be undesirably weakened. As an alternative to pulmonary artery pressure measurements, pressure measurements in the right ventricular outflow tract can also be correlated with left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be used for diagnosis, prevention and / or treatment of congestive heart failure.

[0070] Additional solutions may be implemented to derive or infer left atrial pressure. For example, an E / A ratio, which is a marker of the function of the left ventricle of the heart, representing the ratio of the peak velocity blood flow (E wave) caused by gravity in early diastole caused by atrial contraction to the peak velocity blood flow (A wave) in late diastole, may be used as a substitute for measuring left atrial pressure. The E / A ratio may be determined using echocardiography or other imaging techniques; typically, an abnormality in the E / A ratio may indicate that the left ventricle is not properly filled with blood during the period between contractions, which may lead to symptoms of heart failure, as described above. However, the E / A ratio determination does not typically provide an absolute pressure measurement.

[0071] Various methods for identifying and / or treating congestive heart failure include observing worsening congestive heart failure symptoms and / or weight changes. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements may vary greatly (e.g., up to 9% or more) and may be unreliable in signaling heart-related complications. In addition, treatment guided by monitoring signs, symptoms, weight and / or other biomarkers has not been shown to significantly improve clinical outcomes. In addition, for patients who have been discharged from the hospital, such treatment may require a remote telemedicine system.

[0072] The present disclosure provides systems, devices and methods for guiding the 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, for which pressure measurements are indicative of, for example, left atrial pressure and / or pressure levels in one or more other vessels / chambers for a congestive heart failure patient, in order to reduce rehospitalization, morbidity and / or otherwise improve the patient's health outlook.

[0073] Heart stress monitoring

[0074] Cardiac pressure monitoring according to examples of the present disclosure can provide an active intervention mechanism for preventing or treating congestive heart failure and / or other physiological conditions. Typically, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, for some patients, cardiac pressure indicators may be present several weeks before hospitalization. Therefore, a pressure monitoring system according to examples of the present disclosure can be advantageously implemented to reduce instances of hospitalization by guiding appropriate or desired drug dosing and / or administration before the onset of heart failure.

[0075] Dyspnea is an indicator of cardiac stress characterized by shortness of breath or a feeling of being short of breath. Dyspnea may be caused by elevated atrial pressures, which may result in fluid accumulation in the lungs due to the pressure rebound. Pathological dyspnea may be caused by congestive heart failure. However, a considerable period of time may elapse between the initial pressure increase and the onset of dyspnea, and thus the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to examples of the present disclosure, normal ventricular filling pressures may be advantageously maintained, thereby preventing or reducing the effects of heart failure, such as dyspnea.

[0076] As mentioned above with respect to cardiac pressures, elevated pressure within the left atrium may be particularly relevant to heart failure. Figure 2 Example pressure waveforms associated with various chambers and blood vessels of the heart are shown according to one or more examples. Figure 2 The various waveforms shown may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors into the correspondingly shown and labeled chambers or vessels of the heart. Figure 2 As shown, it can be considered that the waveform 25 representing left atrial pressure provides the best feedback for early detection of congestive heart failure. In addition, there may generally be a relatively strong correlation between increases in left atrial pressure and pulmonary congestion.

[0077] Left atrial pressure is usually well correlated with left ventricular end-diastolic pressure. However, although left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, this correlation may be weakened when pulmonary vascular resistance increases. That is, pulmonary artery pressure is usually not fully correlated with left ventricular end-diastolic pressure in the presence of a variety of acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension, which affects approximately 25% to 83% of heart failure patients, can affect the reliability of pulmonary artery pressure measurements used to estimate left filling pressure. Therefore, as represented by waveform 24, a single pulmonary artery pressure measurement may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly for patients with comorbidities (such as lung disease and / or thromboembolism). Left atrial pressure can also be at least partially related to the presence and / or degree of mitral regurgitation.

[0078] and Figure 2Compared to the other pressure waveforms shown, the left atrial pressure reading may be relatively less likely to be distorted or affected by other conditions, such as respiratory conditions, etc. In general, left atrial pressure can significantly predict heart failure, such as two weeks before the onset of heart failure. For example, an increase in left atrial pressure, as well as diastolic and systolic heart failure, may occur weeks before hospitalization, so knowledge of such an increase can be used to predict the onset of congestive heart failure, such as acute debilitating symptoms of congestive heart failure.

[0079] Cardiac pressure monitoring (e.g., left atrial pressure monitoring) can provide a mechanism to guide drug administration to treat and / or prevent congestive heart failure. Such treatment can advantageously reduce rehospitalization and morbidity, as well as provide other benefits. An implantable pressure sensor according to an example of the present disclosure can be used to predict heart failure two weeks or more before the symptoms or signs of heart failure (e.g., dyspnea) occur. When using the cardiac pressure sensor example according to the present disclosure to identify heart failure predictors, certain preventive measures can be implemented, including drug interventions, such as modifying the patient's drug regimen, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium can advantageously provide an accurate indication of pressure accumulation that may lead to heart failure or other complications. For example, a trend in elevated atrial pressure can be analyzed or used to determine or predict the onset of cardiac dysfunction, where drugs or other treatments can be added to cause pressure reduction and prevent or reduce further complications.

[0080] Figure 3 A graph 300 is shown showing a range of left atrial pressures, including a normal range 301 of left atrial pressures that are not typically associated with a substantial risk of postoperative 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 by using certain sensor implant devices. For detected left atrial pressures above the normal range that may be associated with an increased risk of heart failure, examples of the present disclosure, as described in detail below, may inform efforts to reduce the left atrial pressure until it is within the normal range 301. Additionally, for detected left atrial pressures below the normal range 301 that may be associated with an increased risk of acute kidney injury, myocardial injury, and / or other health complications, examples of the present disclosure, as described in detail below, may be used to facilitate efforts to increase the left atrial pressure to bring the pressure level within the normal range 301.

[0081] Implantable devices with integrated sensors

[0082] In some implementations, the present disclosure relates to sensors associated with or integrated with a cardiac shunt or other implanted device. Such an integrated device can be used to provide controlled and / or more effective treatment for treating and preventing heart failure and / or other health complications related to cardiac function. Figure 4 is a block diagram showing an implant device 30 including a shunt (or other type of implant) structure 39. In some instances, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 can be, for example, a pressure sensor or other type of sensor. In some instances, the sensor 37 includes a transducer 32, such as a pressure transducer, and some control circuitry 34, which can be embodied, for example, in an application specific integrated circuit (ASIC).

[0083] The control circuit 34 may be configured to process signals received from the transducer 32 and / or to wirelessly transmit signals associated therewith through biological tissue using the antenna 38. The term "control circuit" is used herein in accordance with its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, die (e.g., semiconductor die containing one or more active and / or passive devices and / or connecting circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any device that manipulates signals (analog and / or digital) based on hard coding of circuits and / or operating instructions. The control circuit system referred to herein may also include one or more storage devices, which (analog and / or digital) may be implemented in a single storage device, multiple storage devices, and / or embedded circuits 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. It should be noted that in examples where the control circuit system includes a hardware and / or software state machine, analog circuit system, digital circuit system, and / or logic circuit system, the data storage device / register storing any associated operating instructions may be embedded within or external to the circuit system including the state machine, analog circuit system, digital circuit system, and / or logic circuit system. Transducer 32 and / or antenna 38 may be considered part of control circuit 34.

[0084] Antenna 38 may include one or more coils or loops of conductive material, such as copper wire, etc. In some examples, at least a portion of transducer 32, control circuit system 34 and / or antenna 38 is at least partially disposed or contained within sensor housing 36, which may include any type of material and may advantageously be at least partially hermetically sealed. For example, in some instances, housing 36 may include glass or other rigid materials, which may provide mechanical stability and / or protection for the components contained therein. In some examples, housing 36 is at least partially flexible. For example, the housing may include a polymer or other flexible structure / material, which may advantageously allow folding, bending or contraction of sensor 37 to allow it to be delivered through a catheter or other introduction member.

[0085] The transducer 32 may include any type of sensor member or mechanism. For example, the transducer 32 may be a force collector type pressure sensor. In some examples, the transducer 32 includes a diaphragm, a piston, a spring tube, a bellows or other strain or deflection measurement assembly to measure the strain or deflection applied above its area / surface. The transducer 32 may be associated with the housing 36 so that at least a portion thereof is contained within or attached to the housing 36. With respect to a sensor device / component "associated with" a stent or other implanted structure, such terminology may refer to a sensor device or component being physically coupled, attached or connected or integrated with the implanted structure.

[0086] In some examples, transducer 32 includes or is an assembly of piezoresistive strain gauges that can be configured to detect strain due to applied pressure using bonded or formed strain gauges where resistance increases as pressure deforms the assembly / material. Transducer 32 can 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.

[0087] In some examples, the transducer 32 includes a capacitive pressure sensor or a component of a capacitive pressure sensor, the capacitive pressure sensor includes a diaphragm and a pressure chamber, the pressure chamber is configured to form a variable capacitor to detect the strain caused by the pressure applied to the diaphragm. As the pressure deforms the diaphragm, the capacitance of the capacitive pressure sensor generally decreases. The diaphragm can include any material, including but not limited to metal, ceramic, silicon, etc. In some examples, the transducer 32 includes an electromagnetic pressure sensor or a component of an electromagnetic pressure sensor, the electromagnetic pressure sensor can be configured to measure the displacement of the diaphragm by means of inductance changes, linear variable displacement transducer (LVDT) functionality, Hall effect or eddy current sensing. In some examples, the transducer 32 includes a piezoelectric strain sensor or a component of a piezoelectric strain sensor. For example, such a sensor can determine the strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials such as quartz.

[0088] In some examples, transducer 32 includes a strain gauge or is an assembly of a strain gauge. For example, a strain gauge example may include a pressure sensitive element on or associated with an exposed surface of transducer 32. In some examples, a metal strain gauge is adhered to the surface of the sensor, or a thin film strain gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0089] Figure 5 A system 40 for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) of a patient 44 is shown according to one or more examples. 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 micro-electromechanical systems (MEMS) devices (e.g., MEMS pressure sensors or other types of sensor transducers).

[0090] In some examples, the monitoring system 40 may include at least two subsystems, including an implantable internal subsystem or device 30, the implantable internal subsystem or device including a sensor transducer 32, and a control circuit system 34, the control circuit system 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 also include an external (e.g., non-implantable) subsystem, the external subsystem including an external reader 42 (e.g., a coil), which may include a wireless transceiver electrically coupled and / or communicatively coupled to certain control circuits 41. In some instances, both the internal subsystem 30 and the external subsystem 42 include corresponding coil antennas for wireless communication and / or power delivery through patient tissue placed between the internal subsystem and the external subsystem. The sensor implant device 30 may be any type of implant device. For example, in some examples, the implant device 30 includes a pressure sensor integrated with another functional implant structure 39 such as a prosthetic shunt or stent device / structure.

[0091] Certain details of the implant device 30 are shown in the enlarged box 30 shown. The implant device 30 may include an implant / anchor structure 39 as described herein. For example, the implant / anchor structure 39 may include a percutaneously deliverable shunt device configured to be fixed to and / or in a tissue wall to provide a flow path between two chambers of the heart and / or blood vessels, as described in detail throughout this disclosure. Although certain components are not shown in FIG. Figure 5 30, but it should be understood that the sensor implant device 30 may include only a subset of the components / modules shown, and may include additional components / modules not shown. Figure 4 , and vice versa. Implant device 30 may advantageously include one or more sensor transducers 32 that may be configured to provide a response indicative of one or more physiological parameters (e.g., atrial pressure) of patient 44. Although a pressure transducer is described, sensor transducer 32 may include any suitable or desired type of sensor transducer for providing a signal related to a physiological parameter or condition associated with implant device 30 and / or patient 44.

[0092] The sensor transducer 32 may include one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / strain 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 associated with the patient's health. The transducer 32 may be a force collector type pressure sensor. In some examples, the transducer 32 includes a diaphragm, piston, spring tube, bellows, or other strain or deflection measurement assembly to measure strain or deflection applied over its area / surface. The transducer 32 may be associated with a sensor housing 36 such that at least a portion thereof is contained within or attached to the housing 36.

[0093] In some examples, the transducer 32 includes a strain gauge or a component of a strain gauge that can be configured to detect strain due to applied pressure using a bonded or formed strain gauge. For example, the transducer 32 can include or be a component of a piezoresistive strain gauge, where resistance increases as pressure deforms the component / material of the strain gauge. The transducer 32 can be combined with any type of material, including but not limited to silicone, polymer, silicon (e.g., single crystal), polycrystalline silicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered film, and / or the like. In some examples, a metal strain gauge is adhered to the sensor surface, or a thin film strain gauge can be applied to the sensor by sputtering or other techniques. The measuring element or mechanism can include a diaphragm or a metal foil. The transducer 32 can include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0094] In some examples, the transducer 32 includes a capacitive pressure sensor or a component of a capacitive pressure sensor, the capacitive pressure sensor includes a diaphragm and a pressure chamber, the pressure chamber is configured to form a variable capacitor to detect the strain caused by the pressure applied to the diaphragm. As the pressure deforms the diaphragm, the capacitance of the capacitive pressure sensor usually decreases. The diaphragm can include any material, including but not limited to metal, ceramic, silicone, silicon or other semiconductors. In some instances, the transducer 32 includes an electromagnetic pressure sensor or a component of an electromagnetic pressure sensor, the electromagnetic pressure sensor can be configured to measure the displacement of the diaphragm by means of inductance changes, linear variable displacement transducer (LVDT) functionality, Hall effect or eddy current sensing. In some examples, the transducer 32 includes a piezoelectric strain sensor or a component of a piezoelectric strain sensor. For example, such a sensor can determine the strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials such as quartz.

[0095] In some examples, transducer 32 is electrically and / or communicatively coupled to control circuitry 34, which may include one or more application specific integrated circuits (ASICs) microcontrollers or chips. Control circuitry 34 may also include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, etc.

[0096] In some instances, one or more sensor transducers 32 may be configured to generate electrical signals that can be wirelessly transmitted to a device outside the patient's body, such as the local external monitoring system 42 shown. To perform such wireless data transmission, the implant device 30 may include radio frequency (RF) (or other frequency band) transmission circuitry, such as signal processing circuitry and an antenna 38. The antenna 38 may include an antenna coil implanted in the patient's body. The control circuit 34 may include any type of transceiver circuitry configured to transmit electromagnetic signals, where the signals may be radiated by the antenna 38, which may include one or more wires, coils, plates, etc. The control circuit 34 of the implant device 30 may include, for example, one or more chips or dies that are configured to perform a certain amount of processing on signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implant device 30 may not include independent processing capabilities in some instances.

[0097] The wireless signals generated by implant 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 implant device 30 disposed at least partially within a patient 44. For example, module 43 may include a transceiver device / circuitry.

[0098] The external local monitor 42 may receive wireless signal transmissions from the implant device 30 and / or provide wireless power to the implant device 30 using an external antenna 48, such as a wand device. The reader / antenna interface circuit system 43 may include a radio frequency (RF) (or other frequency band) front-end circuit system configured to receive signals from the implant device 30 and amplify the signals, wherein such circuit system 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 circuit systems, phase-locked loop (PLL) circuit systems, signal mixers, etc. The reader / antenna interface circuit system 43 may also be configured to transmit signals to a remote monitoring subsystem or device 46 via a network 49. The RF circuit system of the reader / antenna interface circuit system 43 may also include one or more of a digital-to-analog converter (DAC) circuit system, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc., for processing / processing signals transmitted via the network 49 and / or for receiving signals from the implant device 30. In some examples, local monitor 42 includes control circuitry 41 for performing processing of signals received from implant device 30. Local monitor 42 can be configured to communicate with network 49 according to known network protocols such as Ethernet, Wi-Fi, etc. In some examples, local monitor 42 includes a smartphone, a laptop computer or other mobile computing device, or any other type of computing device.

[0099] In some examples, the implant device 30 includes a certain amount of volatile and / or non-volatile data storage devices. For example, such data storage devices may include solid-state memory using a floating gate transistor array, etc. The control circuit 34 may utilize a data storage device to store sensing data collected over a period of time, wherein the stored data may be periodically transmitted to a local monitor 42 or another external subsystem. In some examples, the implant device 30 does not include any data storage device. The control circuit 34 may be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuit 34 may also be configured to receive input from one or more external subsystems (e.g., from a local monitor 42 or from a remote monitor 46) via, for example, a network 49. For example, the implant device 30 may be configured to receive a signal that at least partially controls the operation of the implant device 30, such as by starting / deactivating one or more components or sensors, or otherwise affecting the operation or performance of the implant device 30.

[0100] One or more components of the implant device 30 may be powered by one or more power sources 35. Due to size, cost and / or electrical complexity considerations, it may be desirable that the power source 35 is relatively minimized in nature. For example, high power drive voltages and / or currents in the implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In some examples, the power source 35 is at least partially passive in nature, so that power can be wirelessly received from an external source by the passive circuit of the implant device 30, such as by using short-range or near-field wireless power transmission or other electromagnetic coupling mechanisms. For example, the local monitor 42 can act as a starter for actively generating an RF field, which can provide power to the implant device 30, thereby allowing the power circuit of the implant device to take a relatively simple form factor. In some examples, the power source 35 can be configured to obtain energy from an environmental source such as fluid flow, motion, etc. Additionally or alternatively, the power source 35 may include a battery, which can be advantageously configured to provide sufficient power as needed within a monitoring cycle (e.g., 3, 5, 10, 20, 30, 40 or 90 days, or other time periods).

[0101] In some examples, the local monitoring device 42 can act as an intermediate communication device between the implant device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implant device 30. For example, the local monitoring device 42 can be a wearable communication device, or other device that can be easily set near the patient 44 and the sensor implant device 30. The local monitoring device 42 can be configured to continuously, periodically or irregularly query the implant device 30 to extract or request sensor-based information therefrom. In some examples, the local monitor 42 includes a user interface, wherein the user can utilize the interface to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implant device 30.

[0102] 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 monitored cardiac pressure data. In an example, the local monitor 42 may be a wearable device or other device or system configured to be physically located close to the patient and / or implant device 30, wherein the local monitor 42 is primarily designed to receive signals from and / or transmit signals to the implant device 30, and provide these signals to the secondary local monitor 47 for viewing, processing and / or manipulation thereof. The external local monitor system 42 may be configured to receive and / or process certain metadata from or associated with the implant device 30, such as a device ID, etc., which metadata may also be provided via data coupling from the implant device 30.

[0103] The remote monitor subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received from the local monitoring device 42, the secondary local monitor 47, and / or the implant device 30 via the network 49. For example, the remote monitor subsystem 46 may advantageously be operated and / or controlled by a health care entity, such as a hospital, a physician, or other care entity associated with the patient 44. Although certain examples disclosed herein describe communicating with the remote monitor subsystem 46 indirectly from the implant device via the local monitor device 42, in certain examples, the implant device 30 may include a transmitter capable of communicating with the remote monitor subsystem 46 via the network 49 without relaying the information via the local monitor device 42.

[0104] In some instances, at least a portion of the transducer 32, control circuit system 34, power supply 35, and / or antenna 38 are at least partially housed or contained within a sensor housing 36, which may include any type of material and may advantageously be at least partially hermetically sealed. For example, in some instances, the housing 36 may include glass or other rigid materials, which may provide mechanical stability and / or protection for the components housed therein. In some examples, the housing 36 is at least partially flexible. For example, the housing may include a polymer or other flexible structure / material that may advantageously allow folding, bending, or contraction of the sensor 37 to allow it to be delivered through a catheter or other percutaneous guide member.

[0105] As described above, shunts and other implanted devices / structures can be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. Sensor devices according to examples of the present disclosure can be integrated with cardiac shunt structures / devices or other implanted devices using any suitable or desired attachment or integration mechanism or configuration. Figure 6An example sensor assembly / device 60 is shown that may be a component of a sensor implant device. The sensor device 60 may be configured to provide sensor readings regarding one or more physiological parameters associated with a target implant site.

[0106] The sensor device 60 can be configured for attachment to an implant device. For example, a coil type can be used to attach the sensor device 60 to one or more implants, the coil type including one or more wires or other materials or structures shaped into one or more coil windings forming a fluid conduit / barrel portion and an axial end flange. According to certain examples disclosed herein, a shunt structure can be functionally integrated with a pressure sensor. The shunt structure can be configured to hold the sensor device 60.

[0107] The sensor device 60 may be advantageously positioned, located, fixed, oriented and / or otherwise located in a configuration in which its sensor transducer assembly 65 is disposed within a channel region of a flow-dividing structure. The term "channel region" is used herein according to its broad and ordinary meaning and may refer to a three-dimensional space defined by the radial boundaries of a fluid conduit and extending axially from the fluid conduit.

[0108] In some examples, sensor assembly 61 includes sensor component 65 and antenna component 69. Sensor component 65 may include any type of sensor device as described in detail above. In some examples, sensor 65 may be attached to or integrated with an arm component of a flow diverting structure.

[0109] The sensor 65 includes a sensor element 67, such as a pressure sensor transducer. As described herein, the sensor assembly 61 can be configured to implement wireless data and / or power transmission. The sensor assembly 61 can include an antenna component 69 for this purpose. The antenna 69 can be at least partially contained in an antenna housing 79, which can also be provided with certain control circuits configured to facilitate wireless data and / or power communication functions. In some instances, the antenna assembly 69 includes one or more conductive coils 62, which can facilitate inductive power supply and / or data transmission. In instances including one or more conductive coils, such one or more coils can be at least partially wound / arranged around a magnetic (e.g., ferrite, iron) core 63.

[0110] The antenna assembly 69 may be attached to, integrated with, or otherwise associated with the arm / anchor feature of the shunt structure.

[0111] The sensor assembly 61 can advantageously be biocompatible. For example, the sensor 65 and antenna 69 can include a biocompatible housing, such as a housing including glass or other biocompatible materials. However, in some instances, at least a portion of the sensor element 67 (e.g., a diaphragm or other component) can be exposed to the external environment to allow pressure readings or other parameter sensing to be implemented. Relative to the antenna housing 79, the housing 79 can include a cylindrical or tubular form that is at least partially rigid, such as a glass cylindrical form. In some instances, the diameter of the sensor 65 / 67 assembly is about 3 mm or less. The length of the antenna 69 can be about 20 mm or less.

[0112] The sensor assembly 61 can be configured to communicate with an external system when implanted in the heart or other areas of the patient's body. For example, the antenna 69 can wirelessly receive power from the external system, and / or transmit sensed data or waveforms to the external system and / or transmit sensed data or waveforms from the external system. The sensor assembly 61 can be attached to the shunt structure or integrated with the shunt structure in any suitable or desirable manner. For example, in some embodiments, the sensor 65 and / or antenna 69 can be attached or integrated with the shunt structure using a mechanical attachment member. In some instances, the sensor 65 and / or antenna 69 may be included in a bag or other container attached to the shunt structure.

[0113] The sensor element 67 may include a pressure transducer. For example, the pressure transducer may be a micro-electromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some examples, the transducer may include an at least partially flexible or compressible diaphragm assembly, which may be made of silicone or other flexible materials. The diaphragm component may be configured to bend or compress in response to changes in ambient pressure.

[0114] Sensor implant device

[0115] 7A to 7C A sensor implant device 700 is shown according to one or more examples. Fig. 7A A side view of the device 700 in a compressed and / or delivered form is provided, Figure 7B A bottom view of the device 700 in a compressed and / or delivered form is provided, and Figure 7C A side view of a device 700 in an expanded and / or anchored form is provided. The sensor implant device 700 may include a sensor body 702 coupled, attached, and / or otherwise releasably and / or permanently secured to one or more anchoring features. The term "anchoring feature" is used herein according to its simple and ordinary meaning and may refer to any member for anchoring, which may include one or more clips, coils, piercing coils, hooks, arms, strings, spikes, needles, and / or other features configured for anchoring and / or attachment at one or more tissue regions within the heart.

[0116] In some examples, the device 700 can include multiple types of anchoring features, which can include one or more end anchors 704 and / or one or more side anchors 705. The end anchors 704 can have the form of a coiled and / or bent wire and / or rope. In some examples, the end anchors 704 can have a generally helical form and / or can extend laterally and / or longitudinally away from the sensor body 702. The end anchors 704 can be configured to bend around the longitudinal axis of the sensor body 702. In some examples, the device 700 can include multiple end anchors 704, such as 7A to 7C . For example, the device 700 may include two end anchors 704. In some instances, the end anchors 704 may be configured to extend from substantially opposite sides of the sensor body 702 to maximize the coverage of the end anchors 704 around the circumference of the sensor body 702. In some instances, the end anchors 704 may have a substantially semicircular shape. For example, one or more end anchors 704 may have a semicircular shape that may be substantially concentric with the sensor body 702 and / or each other. One or more end anchors 704 may be configured to increase the transverse profile (i.e., width) of the sensor device 700, and / or press against and / or contact the surface of the tissue wall to prevent the sensor device 700 from further extending into and / or outside the tissue wall. In some instances, one or more end anchors 704 may be configured to compress against the sensor body 702 during the delivery of the device 700 (e.g., via a catheter) and / or be in line with the sensor body 702.

[0117] The device 700 may additionally or alternatively include one or more side anchors 705 configured to extend from a middle section of the sensor body 702. The side anchors 705 may be configured to embed into and / or press against tissue within an opening through a tissue wall. For example, the one or more side anchors 705 may include spikes and / or needles configured to pierce and / or penetrate a tissue wall. In some instances, the one or more side anchors 705 may be configured to compress against the sensor body 702 during delivery of the device 700 (e.g., via a catheter), and / or may be configured to extend (e.g., naturally and / or by default) to the sensor body 702. 7A to 7C. One or more side anchors 705 may be attached to the sensor body 702 at a first side, and / or may be configured to swing freely (e.g., attached via a hinge at a first side) away from the sensor body 702. In some examples, one or more side anchors 705 may be configured to extend outward at an acute angle 707 (e.g., approximately 45 degrees and / or less than 90 degrees) relative to the sensor body 702. One or more side anchors 705 may be configured to anchor to the tissue wall when the sensor device 700 is at least partially pulled back and / or retracted into the tissue wall. For example, the device 700 may extend into the tissue wall while the one or more side anchors 705 remain compressed against the sensor body 702. After at least a portion of the sensor device 700 (e.g., the front end 706 and / or the distal portion 708) is fully extended through the tissue wall, the device 700 may be at least partially retracted so that the side anchors 705 extend away from the sensor body 702 and / or embed into the tissue.

[0118] In some examples, one or more side anchors 705 can be configured to extend in multiple directions around the sensor body 702, and / or can extend laterally (i.e., along a diameter of the sensor body 702) from the sensor body 702 in substantially opposite directions. One or more side anchors 705 can extend linearly and / or non-linearly away from the sensor body 702 and / or along the sensor body 702. In some examples, one or more side anchors 705 extend longitudinally (i.e., along the axis of the sensor body 702) along the sensor body 702.

[0119] The sensor device 700 may include at least one sensor assembly. In some examples, the sensor assembly may be located at or near the distal portion 708 of the sensor body 702. The one or more sensor assemblies may include one or more sensor devices of any type as described in detail above. The sensor implant device 700 may be configured to position the one or more sensor assemblies at a target location in the body, which may include a heart chamber (e.g., left atrium), an opening into and / or out of a heart chamber (e.g., left atrial appendage), and / or a blood flow path (e.g., coronary sinus).

[0120] In some examples, the device 700 may include a detachable and / or detachable tip 706 and / or front end. Although the detachable tip 706 is shown as having a conical and / or pointed form, the detachable tip 706 may have any suitable shape and / or size. In some examples, the detachable tip 706 may be configured to provide a front end and / or expanded end of the device 700 during delivery. For example, the detachable tip 706 may be located at or near the distal portion 708 of the device 700 during delivery of the device 700, and / or may be configured to pierce, puncture and / or expand one or more blood vessels and / or tissue walls. The detachable tip 706 may include a substantially flat base and / or side configured to contact the distal end of the sensor body 702 and / or rest flatly and / or place against the distal end.

[0121] like Figure 7C , the detachable tip 706 can be configured to be disconnected from the sensor body 702 and / or can be tethered to the sensor body 702 via a tether 709, which can include a wire, a rope, and / or the like. In some examples, the tether 709 can be at least partially comprised of nitinol and / or other shape memory alloys, and / or can otherwise have shape memory characteristics. For example, the shape of the tether 709 can be configured to be Figure 7C In the form shown in , the tether 709 can be configured to naturally pull the detachable tip 706 away from the sensor body 702. The detachable tip 706 can be configured to be detached from the sensor body 702 once the detachable tip 706 passes through and / or leaves the tissue wall.

[0122] In some examples, the device 700 can include one or more markers 711 (eg, radiopaque markers) configured to facilitate delivery and / or tracking of the device 700. The markers 711 can be positioned along the sensor body 702.

[0123] The sensor body 702 may include an internal lumen 713 extending at least partially through the sensor body 702. The internal lumen 713 may be configured to receive one or more guidewires and / or facilitate the delivery of one or more guidewires. In some examples, the detachable tip 706 may include a lumen 715 configured to align with the internal lumen 713 of the sensor body 702.

[0124] Fig. 8A and Figure 8B Another example sensor implant device 800 is shown according to one or more examples. Fig. 8A A side view of the device 800 is provided in a compressed and / or delivered form, Figure 8BFIG. 8C provides a perspective view of the device 800 in a compressed and / or delivery form, and FIG. 8C provides a side view of the device 800 in an expanded and / or anchored form. The sensor implant device 800 may include a sensor body 802 coupled, attached, and / or otherwise releasably and / or permanently secured to one or more anchoring features. The term "anchoring feature" is used herein according to its simple and ordinary meaning and may refer to any member for anchoring, which may include one or more clips, coils, piercing coils, hooks, arms, strings, spikes, needles, and / or other features configured for anchoring and / or attachment at one or more tissue regions within the heart.

[0125] In some examples, the device 800 can include multiple types of anchoring features, which can include one or more end anchors 804 and / or one or more side anchors 805. The end anchors 804 can have the form of a curled and / or bent wire and / or hook. In some examples, one or more end anchors 804 can have a generally curved form and / or can extend laterally away from the sensor body 802 and / or extend longitudinally along the sensor body 802. In some examples, the device 800 can include multiple end anchors 804, such as Fig. 8A and Figure 8B . For example, the device 800 may include three end anchors 804. In some instances, the end anchors 804 may be configured to extend from substantially opposite sides of the sensor body 802 to maximize the coverage of the end anchors 804 around the circumference of the sensor body 802. In some instances, the end anchors 804 may have a substantially semicircular shape. One or more end anchors 804 may be configured to increase the transverse profile (i.e., width) of the sensor device 800, and / or press against and / or contact the surface of the tissue wall to prevent the sensor device 800 from further extending into and / or outside the tissue wall. In some instances, one or more end anchors 804 may be configured to compress against the sensor body 802 and / or be in line with the sensor body 802 during the delivery of the device 800 (e.g., via a catheter).

[0126] The device 800 may additionally or alternatively include one or more side anchors 805 configured to extend from the middle section of the sensor body 802. The side anchors 805 may be configured to embed into and / or press against tissue within the opening through the tissue wall. For example, the one or more side anchors 805 may include spikes and / or needles configured to pierce and / or penetrate the tissue wall. In some examples, the one or more side anchors 805 may be configured to compress against the sensor body 802 during delivery of the device 800 (e.g., via a catheter), and / or may be configured to extend (e.g., naturally and / or by default) to the sensor body 802. Fig. 8A and Figure 8B. One or more side anchors 805 may be attached to the sensor body 802 at a first side, and / or may be configured to swing freely (e.g., attached via a hinge at a first side) away from the sensor body 802. In some instances, one or more side anchors 805 may be configured to extend outward at an acute angle (e.g., approximately 45 degrees and / or less than 90 degrees) relative to the sensor body 802. One or more side anchors 805 may be configured to anchor to the tissue wall when the sensor device 800 is at least partially pulled back and / or retracted into the tissue wall. For example, the device 800 may extend into the tissue wall while the one or more side anchors 805 remain compressed against the sensor body 802. After at least a portion of the sensor device 800 (e.g., the front end 806 and / or the distal portion 808) is fully extended through the tissue wall, the device 800 may be at least partially retracted so that the side anchors 805 extend away from the sensor body 802 and / or embed into the tissue.

[0127] In some examples, one or more side anchors 805 can be configured to extend in multiple directions around the sensor body 802, and / or can extend transversely (i.e., along a diameter of the sensor body 802) from the sensor body 802 in substantially opposite directions. One or more side anchors 805 can extend linearly and / or non-linearly away from the sensor body 802 and / or along the sensor body 802. In some examples, one or more side anchors 805 extend longitudinally (i.e., along the axis of the sensor body 802) along the sensor body 802.

[0128] The sensor device 800 may include at least one sensor assembly. In some examples, the sensor assembly may be located at or near the distal portion 808 of the sensor body 802. The one or more sensor assemblies may include one or more sensor devices of any type as described in detail above. The sensor implant device 800 may be configured to position the one or more sensor assemblies at a target location in the body, which may include a heart chamber (e.g., left atrium), an opening into and / or out of a heart chamber (e.g., left atrial appendage), and / or a blood flow path (e.g., coronary sinus).

[0129] In some examples, the device 800 can include a detachable and / or detachable tip 806 and / or a leading end. Although the detachable tip 806 is shown as having a conical and / or pointed form, the detachable tip 806 can have any suitable shape and / or size. In some examples, the detachable tip 806 can be configured to provide a leading end and / or an expanded end of the device 800 during delivery. For example, the detachable tip 806 can be located at or near the distal portion 808 of the device 800 during delivery of the device 800, and / or can be configured to pierce, puncture and / or expand one or more blood vessels and / or tissue walls.

[0130] The detachable tip 806 can be configured to be disconnected from the sensor body 802, and / or can be tethered to the sensor body 802 via a tether 809, which can include a wire, a rope, and / or the like. In some examples, the tether 809 can be at least partially comprised of nitinol and / or other shape memory alloys, and / or can otherwise have shape memory characteristics. For example, the shape of the tether 809 can be configured so that the tether 809 can be configured to naturally pull the detachable tip 806 away from the sensor body 802. The detachable tip 806 can be configured to be detached from the sensor body 802 once the detachable tip 806 passes through and / or exits the tissue wall.

[0131] In some examples, the device 800 can include one or more markers 811 (e.g., radiopaque markers) configured to facilitate delivery and / or tracking of the device 800. The markers 811 can be positioned along the sensor body 802. In some examples, the markers 811 can include an annular structure that fits around a circumferential region of the sensor body 802.

[0132] Fig. 9 A perspective view of another example sensor implant device 900 according to one or more examples is provided. The sensor implant device 800 may include a sensor body 802 coupled, attached and / or otherwise releasably and / or permanently secured to one or more anchoring features. The term "anchoring feature" is used herein according to its simple and ordinary meaning and may refer to any member for anchoring, which may include one or more clips, coils, piercing coils, hooks, arms, strings, spikes, needles and / or other features configured for anchoring and / or attachment at one or more tissue regions within the heart.

[0133] In some examples, the device 900 may include multiple types of anchoring features, which may include one or more proximal anchors 904 and / or one or more distal anchors 905. Although the device 900 is not shown including side anchors as shown in Figures 7 and 8, the device 900 may additionally or alternatively include side anchors.

[0134] The proximal anchor 904 and / or the distal anchor 905 may have the form of a curved wire and / or hook. In some examples, one or more proximal anchors 904 and / or distal anchors 905 may have a generally curved form and / or may extend laterally away from the sensor body 902 and / or longitudinally along the sensor body 902. The proximal anchor 904 may extend toward the distal anchor 905 and / or the distal anchor 905 may extend toward the proximal anchor 904. In some examples, the device 900 may include a plurality of proximal anchors 904 and / or distal anchors 905, such as Fig. 9. For example, the device 900 may include three or four proximal anchors 904 and / or three or four distal anchors 905. In some instances, the proximal anchors 904 and / or the distal anchors 905 may be configured to extend from substantially opposite sides of the sensor body 902 to maximize the coverage of the proximal anchors 904 and / or the distal anchors 905 around the circumference of the sensor body 902. In some instances, the proximal anchors 904 and / or the distal anchors 905 may have a substantially semicircular shape. One or more proximal anchors 904 and / or the distal anchors 905 may be configured to increase the transverse profile (i.e., width) of the sensor device 900, and / or to press against and / or contact the surface of the tissue wall to prevent the sensor device 900 from further extending into and / or outside the tissue wall. In some instances, one or more proximal anchors 904 and / or distal anchors 905 can be configured to be compressed against and / or aligned with sensor body 902 during delivery of device 900 (eg, via a catheter).

[0135] In some examples, the device 900 may include a detachable and / or detachable tip 906 and / or a front end. Although the detachable tip 906 is shown as having a dome, a circular and / or a hemispherical form, the detachable tip 906 may have any suitable shape and / or size. In some examples, the detachable tip 906 may be configured to provide a front end and / or an expanded end of the device 900 during delivery. For example, the detachable tip 906 may be located at or near the distal portion 908 of the device 900 during delivery of the device 900, and / or may be configured to pierce, puncture and / or expand one or more blood vessels and / or tissue walls. In some examples, the rounded head of the detachable tip 906 may be configured to prevent damage to surrounding tissue.

[0136] The device 900 may include a detachable tip 906 that is configured to be disconnected and / or detached from the sensor body 902 and / or tethered to the sensor body 902 via a tether 909, which may include a wire, a rope, and / or the like. In some examples, the tether 909 may be at least partially comprised of nitinol and / or other shape memory alloys, and / or may otherwise have shape memory characteristics. For example, the shape of the tether 909 may be configured to Fig. 9 In the form shown in , the tether 909 can be configured to naturally pull the detachable tip 906 away from the sensor body 902. The detachable tip 906 can be configured to be detached from the sensor body 902 once the detachable tip 906 passes through and / or leaves the tissue wall.

[0137] In some examples, the device 900 can include one or more markers 911 (eg, radiopaque markers) configured to facilitate delivery and / or tracking of the device 900. The markers 911 can be positioned along the sensor body 902.

[0138] The sensor body 902 may include an internal lumen 913 extending at least partially through the sensor body 902. The internal lumen 913 may be configured to receive one or more guidewires and / or facilitate the delivery of one or more guidewires. In some examples, the detachable tip 906 may include a lumen 915 configured to align with the internal lumen 913 of the sensor body 902.

[0139] Fig.10 A delivery system for delivering a sensor implant device according to one or more examples is shown. The sensor implant device may include a sensor body 1002 coupled, attached and / or otherwise releasably and / or permanently secured to one or more anchors 1004 (eg, a proximal anchor).

[0140] Although the device is not shown with side anchors for illustrative purposes, the device may include one or more side anchors extending from the sensor body 1002. The end anchor 1004 may have the form of a coiled and / or bent wire and / or rope. In some examples, the end anchor 1004 may have a generally helical form and / or may extend laterally and / or longitudinally away from the sensor body 1002. The end anchor 1004 may be configured to bend around the longitudinal axis of the sensor body 1002. In some examples, the device may include multiple end anchors 1004, such as Fig.10 . For example, the device may include two end anchors 1004. In some examples, the end anchors 1004 may be configured to extend from substantially opposite sides of the sensor body 1002 to maximize the coverage of the end anchors 1004 around the circumference of the sensor body 1002. In some examples, the end anchors 1004 may have a substantially semicircular shape. One or more end anchors 1004 may be configured to increase the transverse profile (i.e., width) of the sensor device, and / or press against and / or contact the surface of the tissue wall to prevent the sensor device from extending further into and / or outside the tissue wall.

[0141] The device is shown at least partially within the catheter 1010 and / or shaft. In some examples, one or more end anchors 1004 can be configured to be compressed against and / or aligned with the sensor body 1002 during delivery of the device (e.g., via the catheter 1010). For example, the catheter 1010 can be configured to at least partially enclose the device and / or prevent maximum expansion of one or more anchors 1004.

[0142] The device may additionally or alternatively include one or more side anchors configured to extend from a middle section of the sensor body 1002. The side anchors may be configured to embed into and / or press against tissue within an opening through a tissue wall. For example, one or more side anchors may include spikes and / or needles configured to pierce and / or penetrate a tissue wall. In some instances, one or more side anchors may be configured to compress against the sensor body 1002 during delivery of the device (e.g., via a catheter), and / or may be configured to extend (e.g., naturally) to the sensor body 1002. Fig.10 . One or more side anchors may be attached to the sensor body 1002 at a first side, and / or may be configured to swing freely (e.g., attached via a hinge at a first side) away from the sensor body 1002. In some instances, one or more side anchors may be configured to extend outward at an acute angle (e.g., about 45 degrees and / or less than 90 degrees) relative to the sensor body 1002. One or more side anchors may be configured to anchor to the tissue wall when the sensor device is at least partially pulled back and / or retracted into the tissue wall. For example, the device may extend into the tissue wall while one or more side anchors remain compressed against the sensor body 1002. After at least a portion of the sensor device (e.g., the front end 1006 and / or the distal portion 1008) is fully extended through the tissue wall, the device may be at least partially retracted to extend the side anchor away from the sensor body 1002 and / or embed into the tissue.

[0143] In some examples, one or more side anchors can be configured to extend in multiple directions around the sensor body 1002, and / or can extend laterally (i.e., along a diameter of the sensor body 1002) from the sensor body 1002 in substantially opposite directions. One or more side anchors can extend linearly and / or non-linearly away from the sensor body 1002 and / or along the sensor body 1002. In some examples, one or more side anchors extend longitudinally (i.e., along the axis of the sensor body 1002) along the sensor body 1002.

[0144] The sensor device may include at least one sensor assembly. In some examples, the sensor assembly may be located at or near the distal portion 1008 of the sensor body 1002. The one or more sensor assemblies may include one or more sensor devices of any type as described in detail above. The sensor implant device may be configured to position the one or more sensor assemblies at a target location in the body, which may include a heart chamber (e.g., left atrium), an opening into and / or out of a heart chamber (e.g., left atrial appendage), and / or a blood flow path (e.g., coronary sinus).

[0145] In some instances, the device may include a removable and / or detachable tip 1006 and / or leading end. Although the removable tip 1006 is shown as having a conical and / or pointed form, the removable tip 1006 may have any suitable shape and / or size. In some instances, the removable tip 1006 may be configured to provide a leading and / or expanded end of the device during delivery. For example, the removable tip 1006 may be located at or near the distal portion 1008 of the device during delivery of the device, and / or may be configured to pierce, perforate, and / or expand one or more blood vessels and / or tissue walls. The removable tip 1006 may be configured to extend at least partially beyond the distal end of the catheter 1010 during delivery into and / or through the body and / or tissue walls of a patient, such as Fig.10 As shown in .

[0146] The detachable tip 1006 can be configured to be disconnected from the sensor body 1002, and / or can be tethered to the sensor body 1002 via a tether 1009, which can include a wire, a rope, and / or the like. In some examples, the tether 1009 can be at least partially comprised of nitinol and / or other shape memory alloys, and / or can otherwise have shape memory characteristics. For example, the shape of the tether 1009 can be configured so that the tether 1009 can be configured to naturally pull the detachable tip 1006 away from the sensor body 1002. The detachable tip 1006 can be configured to be detached from the sensor body 1002 once the detachable tip 1006 passes through and / or exits the tissue wall.

[0147] In some examples, the device can include one or more markers 1011 (eg, radiopaque markers) configured to facilitate delivery and / or tracking of the device. The markers 1011 can be positioned along the sensor body 1002 .

[0148] The sensor body 1002 can include an internal lumen 1015 extending at least partially through the sensor body 1002. The internal lumen 1015 can be configured to receive and / or facilitate delivery of one or more guidewires 1013. In some examples, the detachable tip 1006 can include a lumen 1015 configured to align with the internal lumen 1015 of the sensor body 1002.

[0149] In some examples, the guidewire 1013 can be configured to hold the detachable tip 1006 in place and / or in contact with the sensor body 1002. The sensor body 1002 and / or the detachable tip 1006 can additionally or alternatively include various features (e.g., hooks, clasps, pins, notches, handles, fasteners, grooves, glue, magnets, etc.) configured to maintain contact between the sensor body 1002 and the detachable tip 1006 during the delivery process.

[0150] In some examples, the pusher 1016 and / or shaft can be used to press the sensor device out of the catheter 1010 and / or beyond the distal end of the catheter 1010. The pusher 1016 can be configured to press against the proximal end of the sensor body 1002, such as Fig.10 As shown in .

[0151] Fig.11 An example sensor device is shown at least partially embedded in a tissue wall 10 (e.g., a wall of the right atrium 2) according to one or more examples. The sensor device may include a sensor body 1102, one or more proximal anchors 1104, one or more side anchors 1105, a detachable tip 1106, and / or a distal portion 1108. The sensor device may include one or more sensor components, which may be housed at, for example, the distal portion 1108.

[0152] The proximal anchor 1104 can be configured to anchor the sensor device to the proximal surface 12 of the tissue wall 10. For example, one or more proximal anchors 1104 can extend from the proximal end of the sensor body 1102 and / or can increase the width and / or transverse profile of the sensor device at the proximal end. In some examples, the proximal anchor 1104 can be configured to prevent the sensor body 1102 from moving from the tissue wall 10 and / or navigating upward into the right atrium 2.

[0153] The side anchor 1105 can extend from a middle section of the sensor body 1102 and / or can be configured to be embedded in the tissue wall 10 (e.g., between the distal surface 11 and the proximal surface 12). The side anchor 1105 can include a free end configured to extend away from the sensor body 1102 and / or to form an approximately 45 degree angle with the sensor body 1102. The side anchor 1105 can be configured to prevent the sensor body 1102 from moving from the tissue wall 10.

[0154] The detachable tip 1106 can be configured to be detachable from the sensor body 1102, such as Fig.11 1109 can interconnect the detachable tip 1106 with the sensor body 1102. In some examples, the tether 1109 can be at least partially comprised of one or more shape memory alloys (e.g., Nitinol) and / or can be configured to naturally appear as Fig.111109. For example, the tether 1109 may be configured to guide the detachable tip 1106 away from the sensor body 1102 and / or toward the distal surface 11 of the tissue wall 10. The tether 1109 may be configured to apply a lateral force to the detachable tip 1106, so that the detachable tip 1106 and / or the tether 1109 extend substantially vertically from the sensor body 1102, and / or so that the tip of the detachable tip 1106 is guided to contact the distal surface 11 of the tissue wall 10. In some examples, the tether 1109 may be configured to drive the tip of the detachable tip 1106 into the distal surface 11 of the tissue wall 10 so that the tip pierces the distal surface 11.

[0155] The sensor device can be at least partially embedded in the tissue wall 10, and / or at least a portion of the sensor device can extend beyond the tissue wall 10. For example, at least the distal portion 1108 can extend beyond the distal surface 11 of the tissue wall 10. In some examples, a marker 1111 of the sensor device can be aligned with the distal surface 11 of the tissue wall 10, such as Fig.11 As shown in .

[0156] Figure 12 Figure 12-1 and Figure 12-2 ) provides a flow chart illustrating a process 1200 including one or more steps for delivering one or more implants and / or sensors to a target location within the heart according to one or more examples. FIG. 13 ( Figure 13-1 and Figure 13-2 ) provides images corresponding to steps of process 1200 of Figure 12.

[0157] At step 1202, process 1200 involves delivering a guide wire 1313 through a tissue wall 10 (eg, the right atrium 2 wall), such as Figure 13-1 As shown in image 1300a of . For example, tissue wall 10 may separate right atrium 2 from coronary sinus 16. Guidewire 1313 may be delivered prior to delivery of one or more sensor devices, and / or may be delivered in conjunction with one or more sensor devices.

[0158] At step 1204, process 1200 involves delivering the sensor device along guidewire 1313 and / or at least partially within tissue wall 10, as shown in image 1300b of FIG. 13. In some examples, the sensor device may be delivered via catheter 1310 and / or other shaft. Pusher 1316 and / or internal shaft may be used to press the sensor device toward the distal end of catheter 1310.

[0159] The sensor device may include a sensor body 1302, a detachable tip 1306, one or more anchors 1304, and / or a marker 1311. The sensor device may also include at least one sensor assembly, which may be located at a distal portion 1308 of the sensor body 1302 and / or elsewhere. The one or more anchors 1304 may be configured to assume a straightened and / or compressed form when within the catheter 1310. For example, the catheter 1310 may prevent the anchor 1304 from extending away from and / or toward the sensor body 1302. Similarly, the catheter 1310 may prevent the detachable tip 1306 from being detached from the sensor body 1302.

[0160] The sensor device can extend through the tissue wall 10 until at least a portion of the sensor device extends beyond the distal side of the tissue wall 10 (e.g., into the right atrium 2). For example, at least the detachable tip 1306 and / or the distal portion 1308 of the sensor body 1302 can be at least partially located within the right atrium 2 and / or beyond the tissue wall 10.

[0161] At step 1206, process 1200 involves removing catheter 1310 and / or guidewire 1313 to allow expansion and / or bending of anchor 1304 and / or tether 1309 to connect detachable tip 1306 to sensor body 1302, as shown in image 1300c of FIG. 13. In some examples, tether 1309 may be shaped to direct detachable tip 1306 away from sensor body 1302 and / or to one side of sensor body 1302. For example, tether 1309 may be configured to naturally direct detachable tip 1306 toward distal side 11 of tissue wall 10. Detachable tip 1306 may be configured to contact and / or puncture distal side 11 of tissue wall 10.

[0162] One or more anchors 10 may similarly bend naturally in response to removal of the catheter 1310, and / or may be configured to contact and / or puncture the proximal side of the tissue wall 10. The sensor device may also include a distal anchor (not shown) configured to contact and / or puncture the distal side 11 of the tissue wall 10, and / or a side anchor (not shown) configured to anchor against and / or embed into the tissue wall 10.

[0163] Other Examples

[0164] Depending on the example, some actions, events or functions of any process or algorithm described in this article may be performed in a different order, may be added, combined or omitted entirely. Therefore, in some examples, not all described actions or events are necessary to practice the process.

[0165] Conditional language used herein, such as "may", "can", "could", "might", "for example", etc., unless otherwise expressly stated or otherwise understood in the context of use, is generally intended and generally intended to express that certain instances include certain features, elements and / or steps, while other instances do not include certain features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required for one or more instances in any case, or that one or more instances must include logic for determining whether these features, elements and / or steps are included in any particular instance or will be performed in any particular instance with or without author input or prompting. The terms "include", "comprise", "have", etc. are synonyms, used in their ordinary sense, and are used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in a non-exclusive sense (and is not used in an exclusive sense), so that when, for example, a list of connected elements is used, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is generally understood in context to convey that an item, term, element, etc. can be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain examples require that at least one of X, at least one of Y, and at least one of Z each be present.

[0166] It should be understood that in the above description of examples, various features are sometimes combined in a single example, figure or its specification for the purpose of simplifying the present disclosure and helping to understand one or more of the various inventive aspects. However, this method of the present disclosure should not be interpreted as reflecting the intention that any claim requires more features than the features clearly recorded in the claim. In addition, any parts, features or steps shown and / or described in the specific examples herein can be applied to any other example or used with any other example. In addition, for each example, no component, feature, step or group of components, features or steps is necessary or indispensable. Therefore, it is expected that the scope of the present invention disclosed herein and claimed below should not be limited by the specific examples described above, but should only be determined by clearly reading the attached claims.

[0167] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms (e.g., "first", "second", "third", etc.) used to modify elements (e.g., structures, components, operations, etc.) do not necessarily indicate the priority or order of the elements relative to any other elements, but can generally distinguish the elements from another element with a similar or identical name (but using ordinal terms). In addition, as used herein, indefinite articles ("a" and "an") can indicate "one or more" rather than "one". In addition, operations performed "based on" a condition or event can also be performed based on one or more other conditions or events that are not explicitly stated.

[0168] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the example embodiments belong. It should also be understood that unless explicitly defined as such herein, terms (such as those defined in commonly used dictionaries) should be interpreted as having a meaning consistent with their context in the relevant art and the present invention, and will not be interpreted in an idealized or overly formal sense.

[0169] Spatially relative terms "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," and similar terms may be used herein to describe the relationship between one element or component and another element or component, as shown in the figures. It should be understood that the spatially relative terms are intended to cover different orientations of the device in use or operation in addition to the orientations described in the drawings. For example, in the case where the device shown in the figures is flipped, a device positioned "below" or "below" another device can be placed "above" the other device. Thus, the illustrative term "below" can include a lower position and an upper position. The device can also be oriented in another direction, and thus the spatially relative terms can be interpreted differently depending on the direction.

[0170] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less", "more", "greater", etc. are intended to encompass the concept of equality. For example, "less" may not only mean "less" in the strictest mathematical sense, but also mean "less than or equal to".

Claims

1. A sensor implantation device, comprising: a sensor body including at least a first sensor component; one or more anchors coupled to the sensor body and configured to anchor the sensor body within a tissue wall; Removable tip; as well as A tether connects the detachable tip to the sensor body.

2. The sensor implant device of claim 1, wherein the tether is shaped to direct the detachable tip away from the sensor body.

3. The sensor implant device of claim 2, wherein the tether is configured to guide the detachable tip to a side of the sensor body.

4. The sensor implant device of claim 2 or claim 3, wherein the tether is configured to direct the detachable tip toward the surface of the tissue wall.

5. The sensor implant device according to any one of claims 2 to 4, wherein the tether is composed of a shape memory alloy.

6. The sensor implant device according to any one of claims 1 to 5, wherein the detachable tip has a conical shape with a pointed end.

7. The sensor implant device of claim 6, wherein the tip is configured to pierce the tissue wall.

8. The sensor implant device according to any one of claims 1 to 7, wherein the detachable tip has a rounded head.

9. The sensor implant device according to any one of claims 1 to 8, wherein the detachable tip is configured to provide a leading end for the sensor body during delivery to the tissue wall.

10. The sensor implant device of claim 9, wherein the detachable tip comprises a flat base configured to rest flat against a distal end of the sensor body.

11. The sensor implant device according to any one of claims 1 to 10, wherein the one or more anchors include one or more proximal anchors extending from a proximal end of the sensor body.

12. The sensor implant device of claim 11, wherein the one or more proximal anchors have a semicircular shape concentric with the sensor body.

13. The sensor implant device according to claim 11 or claim 12, wherein the one or more proximal anchors have a semicircular shape extending along the sensor body toward the distal end of the sensor body.

14. The sensor implant device of any one of claims 11 to 13, wherein the one or more anchors include three proximal anchors.

15. The sensor implant device according to any one of claims 1 to 14, wherein the one or more anchors include one or more distal anchors extending from a distal end of the sensor body.

16. The sensor implant device of claim 15, wherein the one or more distal anchors have a semicircular shape extending along the sensor body toward the proximal end of the sensor body.

17. A sensor implant device according to claim 15 or claim 16, wherein the one or more anchors include three distal anchors.

18. The sensor implant device of any one of claims 1 to 17, wherein the one or more anchors include one or more side anchors extending from a middle section of the sensor body.

19. The sensor implant device of claim 18, wherein each of the one or more side anchors comprises a free end configured to form an angle of approximately 45 degrees with the sensor body.

20. The sensor implant device of any one of claims 1 to 19, wherein the one or more anchors include three side anchors.

21. The sensor implant device according to any one of claims 1 to 20, further comprising a marker attached to the sensor body.

22. The sensor implant device of any one of claims 1 to 21, wherein the sensor body comprises an internal lumen configured to receive a guidewire.

23. The sensor implant device of claim 22, wherein the removable tip comprises a lumen configured to align with the internal lumen of the sensor body during delivery.

24. A method comprising: A shaft carrying a sensor implant device is delivered to a tissue wall, the sensor implant device comprising: a sensor body including at least a first sensor component; one or more anchors coupled to the sensor body and configured to anchor the sensor body within a tissue wall; Removable tip; and a tether connecting the detachable tip to the sensor body; and The shaft is retracted to allow the tether to pull the detachable tip away from the sensor body.

25. The method of claim 24, wherein the tether is shaped to direct the detachable tip away from the sensor body.

26. The method of claim 25, wherein the tether is configured to direct the detachable tip to a side of the sensor body.

27. The method of claim 25 or claim 26, wherein the tether is configured to direct the detachable tip toward the surface of the tissue wall.

28. The method of any one of claims 25 to 27, wherein the tether is comprised of a shape memory alloy.

29. The method of any one of claims 24 to 28, wherein the detachable tip has a conical shape with a pointed end.

30. The method of claim 29, wherein the prongs are configured to pierce the tissue wall.

31. The method of any one of claims 24 to 30, wherein the removable tip has a rounded head.

32. The method of any one of claims 24 to 31, wherein the detachable tip is configured to extend beyond the distal end of the shaft during delivery to the tissue wall.

33. The method of any one of claims 24 to 32, wherein the detachable tip comprises a flat base configured to sit flat against a distal end of the sensor body.

34. The method of any one of claims 24 to 33, wherein the one or more anchors include one or more proximal anchors extending from a proximal end of the sensor body.

35. The method of claim 34, wherein the one or more proximal anchors have a semicircular shape concentric with the sensor body.

36. The method of claim 34 or claim 35, wherein the one or more proximal anchors have a semi-circular shape extending along the sensor body toward the distal end of the sensor body.

37. The method of any one of claims 34 to 36, wherein the one or more anchors include three proximal anchors.

38. The method of any one of claims 24 to 37, wherein the one or more anchors include one or more distal anchors extending from a distal end of the sensor body.

39. The method of claim 38, wherein the one or more distal anchors have a semicircular shape extending along the sensor body toward the proximal end of the sensor body.

40. The method of claim 38 or claim 39, wherein the one or more anchors include three distal anchors.

41. The method of any one of claims 24 to 40, wherein the one or more anchors include one or more side anchors extending from a mid-section of the sensor body.

42. The method of claim 41, wherein each of the one or more side anchors comprises a free end configured to form an approximately 45 degree angle with the sensor body.

43. The method of claim 41 or claim 42, wherein the one or more anchors include three side anchors.

44. The method of any one of claims 24 to 43, wherein the sensor implant device further comprises a marker attached to the sensor body.

45. The method of any one of claims 24 to 44, wherein the sensor body comprises an internal lumen configured to receive a guidewire.

46. ​​The method of claim 45, wherein the removable tip comprises a lumen configured to align with the interior lumen of the sensor body during delivery.

Images