阅读说明：本技术 直接心脏压力监测 (Direct cardiac pressure monitoring ) 是由 G·巴卡-博依胡克 G·T·拉比托 J·瓦伦西亚 J·A·帕斯曼 于 2020-01-28 设计创作，主要内容包括：一种中隔闭合装置包括框架、封堵膜和压力传感器装置,所述框架包括一个或多个组织锚定特征,所述压力传感器装置附接到所述封堵膜。(A septal closure device includes a frame including one or more tissue anchoring features, an occlusion membrane, and a pressure sensor device attached to the occlusion membrane.)

1. A septal closure device comprising:

a frame comprising one or more tissue anchoring features;

a blocking membrane; and

a pressure sensor device attached to the occlusion membrane.

2. The septal closure device of claim 1, wherein the pressure sensor device comprises:

a first portion disposed on a first side of the occlusion membrane; and

a second portion disposed on a second side of the occlusion membrane.

3. The septal closure device of claim 2, wherein the first portion of the pressure sensor device comprises a first pressure sensor element and the second portion of the pressure sensor device comprises a second pressure sensor element.

4. The septum closure device of any of claims 1-3, wherein the occluding membrane comprises a cloth.

5. The septum closure device of any of claims 1-4, wherein the occluding membrane comprises a bio-spun polymer.

6. The septum closure device of any of claims 1-5, wherein the pressure sensor device comprises a rigid cylindrical body.

7. The septal closure device of claim 6, wherein the body of the pressure sensor device has one or more radially protruding features associated therewith.

8. The septal occlusion device of any of claims 1-7, wherein the occlusion membrane comprises a cuff feature configured to retain the sensor device.

9. The septum closure device of claim 8, further comprising a suture collar at least partially wrapped around the cuff feature of the occlusion membrane.

10. An implant device, comprising:

leaflet spacer form;

a first lanyard attached to a first end in the form of the leaflet spacer;

a tissue anchor attached to the first lanyard; and

a first pressure sensor device coupled to the leaflet spacer form.

11. The implant device of claim 10, wherein the leaflet spacer form has a foam filler disposed therein.

12. The implant device of claim 10 or claim 11, wherein the leaflet spacer form has an exterior recess and the first pressure sensor device is at least partially disposed within the recess.

13. The implant device of any of claims 10-12, wherein the first pressure sensor device is at least partially disposed within the leaflet spacer form.

14. The implant device of any of claims 10-13, further comprising:

a second lanyard attached to a second end of the leaflet spacer form;

a second pressure sensor device attached to the second lanyard; and

an anchor attached to the second sensor device;

wherein the anchor is configured to at least partially secure the second sensor device within a blood vessel.

15. The implant device of claim 14, wherein the blood vessel is an inferior vena cava, and the second lanyard is configured to couple the second pressure sensor device to the leaflet spacer form through a right atrium.

16. An edge-to-edge valve leaflet repair device, comprising:

a first fastener member;

a second fastener member;

a spacer disposed between the first and second fastener members, the spacer having a ventricular base portion and an atrial end portion, the ventricular base portion being coupled to the first and second fastener members; and

a pressure sensor device integrated with the spacer.

17. The valve leaflet repair device of claim 16, wherein the pressure sensor device comprises a pressure sensor element protruding from the end portion of the spacer.

18. The valve leaflet repair device of claim 16 or claim 17, further comprising a second pressure sensor element associated with the base portion of the spacer.

19. An implant device, comprising:

a cylindrical elongate sensor device having a proximal portion and a distal portion; and

a tissue anchor coupled to the sensor device, the tissue anchor comprising:

a plurality of curved distal arms that are concave in a proximal direction relative to the sensor device and have respective tissue contacting ends that point in the proximal direction in a deployed configuration; and

a plurality of at least partially straight proximal arms deflected away from the sensor device and projecting in a distal direction relative to the sensor device.

20. The implant device of claim 19, further comprising one or more protruding features associated with the sensor device.

21. The implant device of claim 20, wherein the sensor device comprises a glass cylinder body and the one or more protruding features are attached to the cylinder body by an adhesive.

22. The implant device of any one of claims 19-21, wherein the sensor device comprises a first sensor element associated with the distal end portion and a second sensor element associated with the proximal end portion.

23. An anchor, comprising:

a first coil portion and a second coil portion, the first and second coil portions having a first diameter; and

an intermediate coil portion disposed between the first coil portion and the second coil portion and having a second diameter smaller than the first diameter.

24. The anchor of claim 23, wherein the anchor comprises a memory metal, and

the first and second coil portions are configured to be disposed in a compressed state in a delivery catheter and form a plurality of coils of the first diameter when deployed from the delivery catheter.

25. The anchor of claim 23 or claim 24, further comprising a cylindrical form coupled to one or more coils of the middle coil portion by one or more protruding features associated with the cylindrical form.

26. The anchor of claim 25 wherein the cylindrical form is a pressure sensor device.

Technical Field

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

Background

Various medical procedures involve implanting a medical implant device within the anatomy of the heart. Certain physiological parameters associated with such anatomy (such as fluid pressure) may have an impact on patient health.

Disclosure of Invention

One or more methods and/or devices are described herein that facilitate pressure sensing in cardiac anatomy. In some embodiments, the present disclosure relates to a septal closure device comprising a frame comprising one or more tissue anchoring features, an occlusion membrane, and a pressure sensor device attached to the occlusion membrane.

In some embodiments, the pressure sensor device comprises a first portion disposed on a first side of the occlusion membrane and a second portion disposed on a second side of the occlusion membrane. For example, the first portion of the pressure sensor device comprises a first pressure sensor element and the second portion of the pressure sensor device comprises a second pressure sensor element.

The occlusion membrane may comprise a cloth. The occlusion membrane may comprise a bio-spun polymer. The pressure sensor device may include a rigid cylindrical body. For example, the body of the pressure sensor device may have one or more radially protruding features associated therewith. In some embodiments, the occlusion membrane includes a cuff feature configured to retain the sensor device. For example, the septal closure device may further include a suture loop at least partially wrapped around the cuff feature of the occlusion membrane.

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

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

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

In some embodiments, the present disclosure relates to an implant device comprising a cylindrical elongate sensor device having a proximal end portion and a distal end portion, and a tissue anchor coupled to the sensor device, the tissue anchor may comprise a plurality of curved distal arms that are concave in a proximal direction relative to the sensor device and have respective tissue contacting ends that point in the proximal direction in a deployed configuration, and a plurality of at least partially straight proximal arms that deflect away from the sensor device and protrude in a distal direction relative to the sensor device.

The implant device may further include one or more protruding features associated with the sensor device. For example, the sensor device may comprise a glass cylinder body, and the one or more protruding features may be attached to the cylinder body by an adhesive. In some embodiments, the sensor device comprises a first sensor element associated with the distal portion and a second sensor element associated with the proximal portion.

In some embodiments, the present disclosure relates to an anchor comprising first and second coil portions having a first diameter, and an intermediate coil portion disposed between the first and second coil portions and having a second diameter smaller than the first diameter. In some embodiments, the anchor comprises a memory metal, and the first and second coil portions are configured to be disposed in a compressed state in a delivery catheter and form a plurality of coils of the first diameter when deployed from the delivery catheter. The anchor may further include a cylindrical form coupled to the one or more coils of the middle coil portion by one or more protruding features associated with the cylindrical form. For example, the cylindrical form may be a pressure sensor device.

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

Drawings

Various embodiments are depicted in the drawings for illustrative purposes and should not be construed to limit the scope of the invention in any way. In addition, various features of different disclosed embodiments can be combined to form additional embodiments that are part of the disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between reference elements. It should be understood, however, that the use of like reference numerals in connection with the various drawings does not necessarily imply similarity between the corresponding embodiments with which they are associated. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and their illustrated dimensions are presented for purposes of illustrating the inventive aspects thereof. In general, some of the illustrated features may be relatively smaller than that illustrated in some embodiments or configurations.

Fig. 1 is a cross-sectional view of a human heart.

Fig. 2 illustrates example pressure waveforms associated with various chambers and vessels of a heart in accordance with one or more embodiments.

Fig. 3 illustrates an implanted sensor implant device in accordance with one or more embodiments.

Fig. 4 is a block diagram of an implant device according to one or more embodiments.

Fig. 5 illustrates a perspective view of a sensor implant device in accordance with one or more embodiments.

Fig. 6 illustrates a sensor implant device implanted in a tissue wall in accordance with one or more embodiments.

Fig. 7 is a flow diagram illustrating a process for implanting a sensor implant device according to one or more embodiments of the present disclosure.

Fig. 8 illustrates states of components of a sensor implant device and/or associated delivery system corresponding to various steps of the process of fig. 7, in accordance with one or more embodiments.

Fig. 9 illustrates a system for removing a previously implanted sensor implant device in accordance with one or more embodiments.

Fig. 10 illustrates a sensor implant device in accordance with one or more embodiments.

Fig. 11 illustrates a sensor implant device in accordance with one or more embodiments.

Fig. 12 is a flow diagram illustrating a process for implanting a sensor implant device in accordance with one or more embodiments.

Fig. 13 illustrates states of components of a sensor implant device and/or associated delivery system corresponding to various steps of the process of fig. 12, in accordance with one or more embodiments.

Fig. 14 illustrates a sensor anchor in accordance with one or more embodiments.

Fig. 15 illustrates an anchor implanted in a septal wall according to one or more embodiments.

Fig. 16 illustrates a sensor anchor in accordance with one or more embodiments.

FIG. 17 illustrates a pressure sensor device according to an embodiment of the present invention.

Fig. 18 illustrates a front view of a sensor integrated septum closure device in accordance with one or more embodiments.

Fig. 19 illustrates a perspective view of the sensor-integrated septum closure device of fig. 18 implanted in a tissue wall according to one or more embodiments.

Fig. 20 illustrates a sensor implant device including a sensor integrated with a septum closure device in accordance with one or more embodiments.

Fig. 21 illustrates a process for removing a sensor implant device, according to an embodiment.

Fig. 22 illustrates the sensor implant device and associated removal system and cardiac anatomy in various states corresponding to the process steps of fig. 21.

Fig. 23 illustrates a sensor implant device including a sensor integrated with a heart valve spacer device in accordance with one or more embodiments.

Fig. 24 illustrates a sensor assembly including a sensor integrated spacer implant device and a tethered separate sensor device in accordance with one or more embodiments.

Figure 25 illustrates a sensor integrated cardiac implant device including a sensor integrated with a left atrial appendage occluder implant device in accordance with one or more embodiments.

Fig. 26 and 27 illustrate side and top views, respectively, of a sensor-integrated valve repair implant configured to provide edge-to-edge leaflet attachment for mitral valve repair, in accordance with one or more embodiments.

Fig. 28 illustrates another embodiment of a sensor integrated with a mitral valve repair implant to form a valve repair sensor assembly in accordance with one or more embodiments.

Fig. 29 illustrates an embodiment of a sensor integrated with a mitral valve repair implant to form a valve repair sensor assembly in accordance with one or more embodiments.

Fig. 30 illustrates a sensor-integrated annular reduction implant in accordance with one or more embodiments.

Fig. 31 illustrates a sensor coupled to a replacement mitral valve implant in accordance with one or more embodiments.

Fig. 32 illustrates a valve repair and pressure sensor assembly in accordance with one or more embodiments.

Fig. 33 illustrates a sensor device suspended in the left atrium using an anchoring system in accordance with one or more embodiments.

Fig. 34A and 34B illustrate an example embodiment of a pressure sensor with an associated or integrated tissue anchor in accordance with one or more embodiments.

Fig. 35 illustrates a sensor-integrated implant device including a docking device integrated with a sensor in accordance with one or more embodiments.

Fig. 36A and 36B illustrate a sensor-integrated cardiac implant device in accordance with one or more embodiments.

Fig. 37 illustrates various access paths that may be implemented to access a target cardiac anatomy in accordance with one or more embodiments.

Detailed Description

Headings are provided herein for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

The present disclosure relates to systems, devices, and methods for telemetry pressure monitoring in connection with cardiac implants and/or other medical implant devices and/or procedures. Such pressure monitoring may be performed using a cardiac implant device with an integrated pressure sensor and/or related components.

Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof. Thus, the scope of claims that may be generated thereby is not limited by any particular embodiment described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding certain embodiments; however, the order of description should not be construed as to imply that these operations are order dependent. In addition, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. Certain aspects and advantages of the embodiments are described for purposes of comparing various embodiments. Not necessarily all such aspects or advantages may be achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.

With respect to the preferred embodiments, certain standard anatomical terms for location are used herein to refer to the anatomy of an animal or, that is, a human. Although certain spatially relative terms, such as "outer", "inner", "upper", "lower", "below", "above", "vertical", "horizontal", "top", "bottom", and the like, are used herein to describe the spatial relationship of one device/element or anatomical structure to 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 the element (s)/structure(s) as shown in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the element (s)/element(s) in use or operation in addition to the orientation depicted in the figures. For example, a description of one element/structure as being "above" another element/structure may refer to a position beneath or beside the other element/structure for a patient object or alternative orientation of the element/structure, and vice versa.

Embodiments of the present disclosure relate to cardiac pressure monitoring solutions including an implant device integrated with sensor functionality, such as pressure sensor functionality. For example, a pressure monitoring solution according to embodiments of the present disclosure may be applicable to patients suffering from various forms of heart failure (such as acute congestive heart failure). The pressure monitoring solution as disclosed herein may allow for improved diagnosis and/or notification related to a cardiac condition. For example, embodiments of the present disclosure allow for post-operative cardiac stress monitoring of a patient, where stress monitoring may involve tracking and/or notifying a stress trend (or trend related to one or more other physiological parameters monitored according to the present disclosure) that may result in or be associated with an adverse effect or event. Various embodiments disclosed herein relate to sensor-integrated implant devices implanted in various vessels or chambers of the cardiac system. Further, various embodiments disclosed herein relate to various types of sensor-integrated implants, including septum closure or occluder devices, leaflet repair spacers, leaflet clip devices, and the like.

Certain embodiments are disclosed herein in the context of a cardiac implant device. However, while certain principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that a sensor implant device according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomy.

The following describes the anatomy of the heart to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart typically includes a muscular organ with four pumping chambers, where its flow is controlled at least in part by various heart valves, namely the aortic, mitral (or mitral), tricuspid, and pulmonary valves. The valve may be configured to open and close in response to pressure gradients existing during various phases (e.g., relaxation and contraction) of the cardiac cycle to at least partially control the flow of blood to respective regions of the heart and/or vessels (e.g., lungs, aorta, etc.). The various myocardial contractions may be facilitated by signals generated by the electrical system of the heart, as will be discussed in detail below. Certain embodiments disclosed herein relate to conditions of the heart, such as atrial fibrillation and/or complications or solutions associated therewith. However, embodiments of the present disclosure are more generally directed to any health complications associated with fluid overload of a patient, such as may arise post-operatively following any procedure involving fluid replenishment. That is, the detection of atrial extension as described herein may be implemented to detect/determine a fluid overload condition, which may guide treatment or compensation measures related to atrial fibrillation and/or any other condition caused at least in part by fluid overload.

Fig. 1 illustrates an example representation of a heart 1 having various features relevant to certain embodiments of the present disclosure. The heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4 and the right atrium 5. In terms of blood flow, blood generally flows from right ventricle 4 into the pulmonary artery via pulmonary valve 9, pulmonary valve 9 separating right ventricle 4 from pulmonary artery 11 and is configured to open during systole such that blood can be pumped toward the lungs and close during diastole to prevent leakage of blood from pulmonary artery 11 back into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. Pulmonary artery 11 includes the pulmonary trunk and left and right pulmonary arteries 15 and 13 branching from the pulmonary trunk as shown. In addition to the pulmonary valve 9, the heart 1 includes three additional valves for assisting blood circulation therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 typically has three cusps or leaflets, and may 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 operating normally, to close during diastole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood exiting the left ventricle 3 to enter the aorta 12, and to close during diastole to prevent blood from leaking back into the left ventricle 3.

Heart valves may generally include a relatively dense fibrous ring (referred to herein as the annulus) and a plurality of leaflets or cusps attached to the annulus. In general, the size of the leaflets or cusps may be such that when the heart contracts, the resulting increased blood pressure generated within the respective 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 against the leaflets. Thus, the leaflets/cusps are juxtaposed to each other, closing the flow channel. Dysfunction of the heart valve and/or associated leaflets (e.g., pulmonary valve dysfunction) can lead to valve leakage and/or other health complications.

The atrioventricular heart valves (i.e., mitral and tricuspid valves) may further include a collection of chordae tendinae and papillary muscles (not shown) for securing the leaflets of the respective valves to facilitate and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. For example, the papillary muscles may typically include finger-like protrusions from the ventricular wall. The valve leaflets are connected to the papillary muscles by chordae tendineae. The wall of the muscle 17, called the septum, separates the left atrium 2 from the right atrium 5 and the left ventricle 3 from the right ventricle 4.

As mentioned above, certain physiological conditions or parameters associated with the cardiac anatomy can affect the health of a patient. For example, congestive heart failure is a condition associated with relatively slow movement of blood through the heart and/or body, which may cause an increase in fluid pressure in one or more chambers of the heart. Thus, the heart cannot pump enough oxygenated blood to meet the body's needs. The various chambers of the heart may respond to pressure increases by stretching to keep more blood pumped through the body or by becoming relatively stiff and/or thicker. The walls of the heart may eventually weaken and become ineffective to pump. In some cases, the kidneys may respond to cardiac inefficiency by allowing the body to retain fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs, and/or other organs can cause the body to become engorged with blood, which is known as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and thus treatment and/or prevention of congestive heart failure is an important issue in medical care.

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 buildup in one or more chambers or regions of the heart may be associated with congestive heart failure. Without direct or indirect monitoring of cardiac pressure, it may be difficult to 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 involve measuring or observing other current physiological conditions of the patient, such as measuring body weight, thoracic impedance, right heart catheterization, and the like.

Various methods of 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 relatively unreliable. For example, daily weight measurements may vary significantly (e.g., up to 9% or more) and may be unreliable in signaling heart related complications. Furthermore, treatment guided by monitoring signs, symptoms, weight, and/or other biomarkers has not been shown to significantly improve clinical outcome. Furthermore, for patients who have been discharged, such treatment may require a telemedicine system. In some cases, congestive heart failure may result from fluid accumulation over a period of time, such as a period of 2-3 weeks. Thus, detecting and/or determining fluid accumulation over the first few days or one week of fluid accumulation may be useful in preventing the development of congestive heart failure due to fluid accumulation over an extended period of time.

The present disclosure provides systems, devices, and methods for guiding drug administration in connection with treatment of congestive heart failure, at least in part by directly monitoring pressure in the left atrium or other chambers or vessels where pressure measurements indicate left atrial pressure, in order to reduce readmission, morbidity, and/or otherwise improve a patient's health prospects.

Cardiac pressure monitoring

Cardiac pressure monitoring according to embodiments of the present invention may provide an active intervention mechanism for preventing or treating congestive heart failure. Generally, an increase in ventricular filling pressure associated with diastolic and/or systolic heart failure may occur before symptoms leading to hospitalization occur. For example, for some patients, cardiac stress indicators may be presented weeks prior to hospitalization. Accordingly, pressure monitoring systems according to embodiments of the present disclosure may be advantageously implemented to reduce hospitalization by directing appropriate or desired drug titrations and/or administration prior to the onset of heart failure.

As mentioned above, with respect to heart pressure, pressure increases in the left atrium may be particularly relevant to heart failure. Fig. 2 illustrates example pressure waveforms associated with various chambers and vessels of a heart in accordance with one or more embodiments. The various waveforms shown in fig. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors into correspondingly delineated and labeled chambers or vessels of the heart. As shown in FIG. 2, a waveform 225 indicative of left atrial pressure may be considered to provide optimal feedback for early detection of congestive heart failure. Furthermore, there may generally be a relatively strong correlation between the increase in left atrial pressure and pulmonary congestion.

Cardiac pressure monitoring (such as left atrial pressure monitoring) may provide a mechanism to guide drug administration to treat and/or prevent congestive heart failure. Such treatment may advantageously reduce readmission and morbidity, as well as provide other benefits. Implanted pressure sensors according to embodiments of the present disclosure may be used to predict heart failure for up to two weeks or more prior to the manifestation of symptoms or signs of heart failure (e.g., dyspnea). When identifying heart failure predictors using cardiac pressure sensor embodiments according to the present disclosure, certain preventative measures, including pharmaceutical interventions, such as modifications to a patient's drug regimen, may be implemented, which may help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium may advantageously provide an accurate indication of pressure buildup that may lead to heart failure or other complications. For example, trends in atrial pressure elevation may be analyzed or used to determine or predict the onset of cardiac dysfunction, where medications or other treatments may be enhanced to cause pressure reduction and prevent or reduce further complications.

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

Sensor-integrated implant device

Embodiments of the present disclosure may provide mechanisms for guiding administration of a drug to a patient by monitoring left atrial pressure and/or other physiological conditions of the patient sensed by one or more sensor-integrated implant devices. For congestive heart failure patients, such monitoring may help to reduce readmission and/or morbidity. In some embodiments, the sensor-integrated implant device may be configured to detect a physiological parameter or condition indicative or predictive of heart failure or other condition one or more weeks before exhibiting symptoms associated therewith, such as dyspnea. Accordingly, embodiments of the present disclosure may advantageously facilitate relatively early modification of a pharmaceutical regimen or other treatment, potentially preventing the development of more severe conditions or symptoms. For example, early detection of pressure rise in the left atrium may be used to determine a trend of pressure rise, where when medication is detected or predicted, the medication may be enhanced to reduce left atrial pressure to prevent further complications. With respect to heart failure associated with fluid accumulation in the lungs, such fluid accumulation may generally develop gradually over one or more weeks, and thus the initial detection of increased pressure that may lead to such fluid accumulation may allow for relatively early intervention and/or prevention.

FIG. 3 illustrates a sensor implant device 310 implanted in atrial septum 18 in accordance with one or more embodiments. The particular location in the atrial septum wall may be selected or determined to provide a relatively firm anchoring location for the implant 310 and a relatively low risk of thrombosis. Further, the sensor implant device 310 may be implanted at a location desired to allow for future re-penetration of the medial wall 18 for future interventions. Implantation of sensor implant device 310 in atrial septal wall 18 may advantageously allow communication between left atrium 2 and right atrium 5. With device 310 in atrial septum 18, sensor element(s) 311, 312 of sensor implant device 310 may advantageously be configured to measure pressure in right atrium 5, left atrium 2, or both atria. Although two sensor elements 311, 312 are shown, in some embodiments, the sensor implant 310 includes a single sensor element or more than two sensor elements. With the pressure sensor functionality for measuring the pressure in both atria, the sensor implant device 310 may advantageously be configured to provide a sensor signal that may be used to determine the pressure difference between the atria. The pressure differential determination may be useful for monitoring fluid accumulation in the lungs, which may be associated with congestive heart failure.

In the case where sensor 310 is implanted or positioned in atrial septum 18, as shown, pressure in one or both of right atrium 5 and left atrium 2 may be monitored. For sensor embodiments including pressure sensor transducers disposed in both atria, implant device 310 may provide the ability to measure the pressure differential between the atria, which may be useful in monitoring fluid accumulation in the lungs associated with congestive heart failure as described above.

In general, the atrial septal wall 18 may provide a good anchoring location for the pressure sensors 310. The sensor device 310 may advantageously be anchored in a secure position in the atrial wall 18. Furthermore, it may be desirable for sensor 310 to be configured and/or constructed such that it presents a relatively low risk of thrombus relative to the portion of sensor device 310 disposed in left atrium 2. In some embodiments, the present disclosure provides a sensor-integrated implant device that may be implanted in the atrial septal wall 18 such that the implant device provides an access mechanism for re-passing the septal wall 18 for future medical intervention.

In some embodiments, the present disclosure relates to a pressure sensor associated with or integrated with a cardiac implant device. Such sensor-integrated cardiac implant devices may be used to provide controlled and/or more effective therapies for the treatment and prevention of heart failure. Fig. 4 is a block diagram illustrating an implant device 400 including a cardiac implant structure 420. In some embodiments, the cardiac implant structure 420 is physically integrated with the sensor device 410 and/or connected to the sensor device 410. The sensor device 410 may be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 410 includes a transducer 412, such as a pressure transducer, and certain control circuitry 414, which may be embodied, for example, in an Application Specific Integrated Circuit (ASIC). The control circuitry 414 may be configured to process signals received from the transducer 412 using the antenna 418 and/or wirelessly transmit signals associated therewith through biological tissue. The antenna 418 may include one or more coils or loops of conductive material, such as copper wire or the like. In some embodiments, at least a portion of the transducer 412, control circuitry 414, and/or antenna 418 are at least partially disposed or contained within the sensor housing 416, and the sensor housing 416 may comprise any type of material, and may advantageously be at least partially hermetically sealed. For example, in some embodiments, housing 416 may comprise glass or other rigid material that may provide mechanical stability and/or protection to the components housed therein. In some embodiments, the housing 416 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure/material that may advantageously allow folding, bending, or collapsing of the sensor 410 to allow its delivery through a catheter or other introduction device.

The transducer 412 may include any type of sensor device or mechanism. For example, the transducer 412 may be a force collector type pressure sensor. In some embodiments, the transducer 412 includes a diaphragm, piston, bourdon tube, bellows, or other strain or deflection measuring component(s) to measure the strain or deflection imposed on its area/surface. The transducer 412 may be associated with the housing 416 such that at least a portion thereof is contained within the housing 316 or attached to the housing 316. The term "associated with" is used herein in accordance with its broad and ordinary meaning. With respect to a sensor device/component "associated with" a stent or other implant structure, such term may refer to a sensor device or component that is physically coupled, attached, or connected to or integrated with the implant structure.

In some embodiments, the transducer 412 includes or is a component of a piezoresistive strain gauge that may be configured to detect strain due to applied pressure using an adhesive or shaped strain gauge, where the electrical resistance increases as the pressure deforms the component/material. The transducer 412 may comprise 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.

In some embodiments, the transducer 412 comprises or is a component of a capacitive pressure sensor that includes a diaphragm and a pressure chamber configured to form a variable capacitor to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may comprise any material including, but not limited to, metal, ceramic, silicon or other semiconductor, etc. In some embodiments, the transducer 412 comprises or is a component of an electromagnetic pressure sensor that may be configured to measure the displacement of the diaphragm by means of a change in inductance, a Linear Variable Displacement Transducer (LVDT) function, a hall effect, or eddy current sensing. In some embodiments, the transducer 412 comprises or is a component of a piezoelectric strain sensor. For example, such sensors may determine strain (e.g., pressure) on a sensing mechanism based on piezoelectric effects in certain materials, such as quartz. This technique is commonly used to measure high dynamic pressures.

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

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

An external reader/monitor (not shown) may receive wireless signal transmissions and/or provide wireless power using an external antenna, such as a wand device or other handheld reader or device. The external transceiver may include Radio Frequency (RF) front-end circuitry configured to receive and amplify signals from the sensor 410, where such circuitry may include one or more filters (e.g., band pass filters), amplifiers (e.g., low noise amplifiers), analog-to-digital converters (ADCs) and/or digital control interface circuitry, phase-locked loop (PLL) circuitry, signal mixers, and so forth. The external transceiver may be further configured to transmit the signal over a network to a remote monitoring subsystem or device. The RF circuitry of the external transceiver may further include one or more of digital-to-analog converter (DAC) circuitry, power amplifiers, low pass filters, antenna switch modules, antennas, etc., for handling/processing signals transmitted over the network and/or for receiving signals from the sensors 410. In certain embodiments, the external monitor includes control circuitry for performing processing of signals received from the sensor 410. In some embodiments, the external monitor is a smartphone, laptop or other mobile computing device, or any other type of computing device.

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

The one or more components of sensor 410 may be powered by one or more power sources (not shown). Due to size, cost, and/or electrical complexity issues, it may be desirable for such power source(s) to be relatively minimal in nature. For example, high power drive voltages and/or currents in the sensor 410 may adversely affect or interfere with the operation of the heart or other body part associated with the implant device 400. In certain embodiments, the sensor 410 is configured to wirelessly receive power from an external source through the passive circuitry of the sensor 410, such as through the use of short range or near field wireless power transmission or other electromagnetic coupling mechanisms. For example, an external device may serve as an initiator that actively generates an RF field that may provide power to the sensor 410, allowing the power circuitry of the implant device 400 to take a relatively simple form factor. In certain embodiments, the implant device 400 is configured to harvest energy from environmental sources (such as fluid flow, motion, etc.). Additionally or alternatively, the implant device 400 may include a battery, which may advantageously be configured to provide sufficient power as needed during a monitoring period (e.g., 1, 2, 3, 5, 10, 20, 30, 60, or 90 days, or other time period).

In some embodiments, the sensor 410 is configured to operate with a local reader/monitor that includes a wearable communication device or other device that can be easily placed in proximity to the patient and the sensor 410. Such an external reader/monitor device/system is configured to continuously, periodically, or sporadically interrogate the sensors 410 in order to extract or request sensor-based information therefrom. In some embodiments, a user interface may be implemented that allows a user to view sensor data, request sensor data, or otherwise interact with the sensor 410 using the interface.

In certain embodiments, the external reader/monitor includes a coil antenna that is matched and/or tuned to inductively mate with the antenna 418 of the internal implant device 410. In some embodiments, the sensor 410 is configured to receive wireless ultrasound power charging and/or data communication therebetween from an external monitoring system.

Fig. 5 illustrates a perspective view of a sensor implant device 500 in accordance with one or more embodiments. The sensor implant device 500 includes a sensor 510 that may have a generally cylindrical form with respect to one or more portions thereof. However, it should be understood that although certain embodiments are disclosed herein in the context of a cylindrical sensor device, the principles of the present disclosure relate to sensor implant devices that include sensors having any suitable or desired shape, form, or configuration.

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

Anchor 520 may allow sensor implant device 500 to be installed or implanted directly into the septal wall or other tissue. Fig. 6 shows a sensor implant device 500 implanted in a tissue wall 18, such as an atrial septal wall. Although certain figures and descriptions herein are described in the context of a sensor implant device 500 implanted in a septal wall in an atrium, it should be understood that the sensor implant device 500 may be implanted in any biological tissue or tissue wall in accordance with embodiments of the present disclosure.

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

Anchor 520 may include any number of distal and/or proximal arms. The distal arm 521 may be curved such that an end portion thereof at least partially points in a proximal direction in the deployed configuration. The proximal arm 522 may be at least partially straight, and may be at least partially deflected away from the longitudinal axis of the sensor device and/or the sensor device itself, and at least partially protrude in the distal direction. Further, the end portion of the proximal arm 522 may be at least partially curved, rounded, or otherwise configured to provide a blunt surface for contacting the tissue wall surface to reduce the risk of tissue damage.

Anchor 520 is illustrated as having three or more distal arms and three or more proximal arms. In some embodiments, anchor 520 may include four or more proximal arms and four or more distal arms. In some embodiments, the sensor implant device 500 is of a sufficiently small size so as not to preclude future passage through the septal wall for alternative interventions once implanted.

In some embodiments, sensor 510 includes a rigid housing, which may be made of glass or other at least partially rigid material. The protruding feature(s) 517 may be made of the same material as the housing 516 of the sensor 510. For example, where the housing 516 includes a cylindrical glass tube, the protruding feature 517 may be a protrusion that is integral with the housing 516. Alternatively, the protruding feature(s) 517 may be attached or secured to the housing 516 in any suitable or desired manner.

Generally, where sensor housing 516 includes glass, sensor 510 may have desirable biocompatibility and/or outgassing prevention characteristics. For example, with respect to certain materials used for sensor housing 516, outgassing may occur at least partially through housing 516, such as from electronics disposed within sensor 510. The housing 516 advantageously provides an adequate hermetic barrier seal for the sensor 510 and/or internal circuitry or components thereof. In some embodiments, anchor 520 comprises a memory metal frame, such as nitinol or the like. Anchor 520 may be secured to sensor 510 by a friction fit or using any other suitable or desired attachment mechanism, including a biocompatible adhesive, welding, or other attachment mechanism.

Fig. 7 is a flow diagram illustrating a process 700 for implanting a sensor implant device according to one or more embodiments of the present disclosure. Fig. 8 illustrates states of components of a sensor implant device and/or associated delivery system corresponding to various steps of process 700 of fig. 7. Although fig. 7 and 8 refer to the implantation of a sensor implant device in a septal wall, it should be understood that the initial puncture of the septal wall and/or expansion thereof (e.g., using a balloon or other mechanism) is not shown or described in detail, which may be used to create an orifice in the septal wall for the insertion or implantation of a delivery catheter and/or sensor implant device.

Access to the target implant site, in conjunction with the steps of process 700, may be achieved in any suitable or desired manner. For example, in some embodiments, access to the right atrium may be made via the femoral vein. At block 702, the process 700 involves introducing a delivery catheter 730 into the left atrium through an orifice in the septal wall 18. At block 704, the process 700 involves advancing an internal pusher or ejector component (not shown) of the delivery catheter 730 to deploy or eject a distal portion of the sensor implant device 700 from the distal end of the delivery catheter 730, as shown in state 802 of fig. 8. The sensor implant device 700 can include one or more distal anchoring arms 721, which can be similar to the distal arms 521 shown in fig. 5 and 6. Further in connection with block 704, the process 700 may involve ejecting the sensor device 700 from the delivery catheter 730 just enough to expose the distal arm 721, but not enough to eject from the delivery catheter proximal arm associated with the sensor implant device.

With the distal arm 721 ejected from the delivery catheter 730, the process 700 involves retracting the delivery system at block 706 to set the distal arm 721 against the septal wall 18, as shown at state 803 of fig. 8. For example, according to some embodiments, the distal end 731 of the delivery catheter 730 may be pulled back into the right atrium 5 to position the distal arm 721 against the left atrial side of the septal wall 18. Once the distal arm 721 has been disposed against the septal wall, the process 700 may involve further retracting the delivery system 730 to deploy the proximal arm 722 of the anchor 720 associated with the sensor implant device 700 against the right atrial side of the septal wall 18 at block 708. The delivery catheter 730 is retracted to expose the proximal arm (e.g., nitinol arm), which may thereafter engage the right side of the medial septum wall 18 in the illustrated orientation relative to the medial septum wall. In some embodiments, the distal arm 721 and/or the proximal arm 722 may be configured or formed to provide tension against the medial wall 18 when the sensor implant device is fully deployed as shown in state 804 of fig. 8. In some embodiments, the distal arm 721 may have a curved form or shape, as shown herein, while the proximal arm 722 may comprise an at least partially straight form or shape.

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

In some embodiments, a sensor implant device according to the present disclosure may be configured, shaped, and/or designed to facilitate recapturing or removing the sensor implant device. Fig. 9 illustrates a system for removing a previously implanted sensor implant device 900 in accordance with one or more embodiments. The system of fig. 9 includes a delivery/retrieval catheter 930 that may be used to deliver and/or remove or retrieve the sensor implant device 900. The system also includes a pusher or retrieval device 935, which pusher or retrieval device 935 may move within the delivery conduit 930 in some embodiments.

As described in detail herein, the sensor device 910 may include one or more protrusions 917 or other engagement features to facilitate engagement of the sensor device 910 for implantation and/or retrieval. In some embodiments, the pusher/extractor 935 includes a protruding engagement feature 937. For example, the pusher/extraction device 935 may have an at least partially hollow cylindrical form configured and dimensioned to fit at least partially around the sensor 910, wherein a gap 939 of an engagement feature 937 of the pusher/extraction device 935 allows the pusher/extraction device 935 to pass longitudinally through the protrusion feature 917, wherein rotation of the pusher/extraction device 35 allows the engagement feature (e.g., extension member) 937 to circumferentially overlap the protrusion feature 917. In the event that the pusher/retrieval device 935 is rotated as shown in fig. 9, retraction of the pusher/retrieval device 935 may cause the sensor implant device 900 or sensor 910 component thereof to be pulled toward the right atrium. Thus, the pusher/takeout device 935 can provide a plug-in engagement mechanism that can be selectively engaged with and released from the raised feature 917. Although a single protrusion feature 917 is shown in fig. 9, it should be understood that the sensor implant device 900 can have any number of protrusion features, and further, the pusher/retrieval device 935 can have any number of corresponding protrusion engagement features.

In some embodiments, the shape or form of the distal arms 921 of the anchor 920 can allow the arms to be pulled into a more straight configuration/form to allow the anchor 920 to be pulled or dragged through the hole in the medial septum wall 18. Thus, sensor implant device 900 can be removed from its implantation position in septal wall 18 by further retracting delivery catheter 930 and/or retrieval device 935 in the orientation shown. The distal arm 921 and proximal arm 922 of the anchor 920 can be shaped to facilitate recapture of the anchor 920. Recapture/removal of the sensor implant device 900 can be performed at a procedural or later time, if needed or desired.

Although the pusher/retrieval device 935 is described with respect to removal of the sensor implant device 900 and/or the sensor component 916, in some embodiments, the pusher/retrieval device 935 may be used to implant the sensor implant device 900 and/or the sensor component 916. For example, the pusher 935 may be used to manipulate the implant device 900 as the implant device 900 is deployed. When used for deployment, the pusher device 935 may push the sensor protrusion feature 917 to engage the sensor implant device 900 and the medial septal wall as shown, after which the pusher device 935 may be rotated to disengage the engagement feature 937 from the protrusion feature 917, thereby allowing the pusher device 935 to be withdrawn away from the sensor implant device 900.

Fig. 5-9 illustrate a sensor implant device having an anchor with a particular configuration including a distal arm and a proximal arm as described above. Fig. 10 illustrates a sensor implant device 1000 having an anchor 1020, the anchor 1020 having a different form and/or configuration than described above. In particular, anchor 1020 of sensor implant device 1000 shown in fig. 10 may allow for implantation of sensor 1010 in a chamber or vessel associated with the heart or other anatomical structure, such as within the left atrium of the heart, where the entire sensor device 1010 is disposed in a single vessel or chamber, while arms 1027 of anchor 1020 remain primarily in the chamber or vessel opposite the tissue wall separating sensor 1010 from anchoring arms 1027.

Figure 11 shows a sensor implant device 1000 implanted in the septal wall 18. In some embodiments, a cylindrical or other shaped sensor 1010 is used as an anchoring member when the sensor implant device 1000 is implanted into a desired tissue wall. When implanted, anchoring arms 1027 may be used to hold sensor 1010 against first side 119 of medial septum wall 18 at least in part by applying pressure or force on opposing sides 117 of medial septum wall 18. Thus, when implanted, sensor 1010 may remain relatively close to medial wall 18. In case the sensor is arranged and fixed in the chamber 2, e.g. in the left atrium, its sensor element may be used for detecting the pressure or another physiological parameter in the chamber 2. Although fig. 11 shows sensor 1010 disposed in left atrium 2, in some embodiments, the sensor may be disposed in right atrium 5 or other vessel or chamber, while anchoring arm 1027 may be disposed primarily within left atrium 2. In some embodiments, the implant device 1000 includes an occluding film or cloth (e.g., a polymer fiber cloth) attached to the frame of the anchor 1020 and covering at least a portion of the opening 115 in the septal wall 18.

With further reference to fig. 10, the anchor 1020 may comprise a memory metal, such as nitinol or the like, and/or other at least partially rigid material. In some embodiments, one or more arms or features of anchor 1020 include tissue or suture attachment features 1025, such as one or more eyelets or the like. For example, once implanted, eyelet(s) 1025 of anchor frame 1020 may be sutured to the tissue wall, thereby securing sensor implant device 1000 in the implanted position. Where anchor 1020 includes multiple eyelets or other attachment features, a suture may be advanced through each respective feature to provide the desired attachment. Alternatively, eyelets or other suture engagement features may be used for retrieval, movement, and/or retraction of the anchor frame 1020. For example, prior to deployment thereof, with the anchor frame 1020 disposed within the delivery catheter in a collapsed state, a suture may be engaged with each eyelet feature 1025 shown, with at least one eyelet or another suture engagement feature associated with each respective anchor arm 1027. If the position of the anchor frame and/or sensor 1010 is not sufficient to some extent during deployment of sensor implant device 1000, sutures attached to eyelet(s) or other suture engagement feature(s) 1025 may be pulled through the delivery catheter, thereby bringing arms 1027 into an at least partially collapsed state, which may allow repositioning of sensor device 1000 and/or withdrawal of sensor implant device 1000 and/or anchor 1020 into the delivery catheter.

The illustrated semi-circular shape of anchor arm 1027 can help secure anchor arm 1027 with tissue at a target site. For example, corner features 1029 of anchor 1020 may provide a desired engagement with and/or embedding in a target tissue. Further, the illustrated shape of anchor arms 1027 can be used to allow the anchor to be easily retracted and/or withdrawn into the delivery catheter.

In the implanted configuration of fig. 11, tissue ingrowth can develop on either or both of anchor frame arms 1027 and sensor 1010 on one or both sides of septal wall 18. In some embodiments, a coating or material for inhibiting tissue ingrowth thereon may be added to or used in conjunction with sensor 1010. Such a material or coating may advantageously, for example, not substantially affect the dynamics of the sensor element(s).

Fig. 12 is a flow diagram illustrating a process 1200 for implanting a sensor implant device similar in some respects to the sensor implant device 1000 shown in fig. 10 and 11, in accordance with one or more embodiments of the present disclosure. Fig. 13 illustrates the implant sensor device 600 and associated delivery system and target implant site anatomy in various states of the process 1200.

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

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

At block 1206, the process 1200 involves causing the sensor device 610 to rotate or pivot to assume an orientation substantially perpendicular to a longitudinal axis of the distal end of the delivery catheter 630, as shown at state 603 of fig. 13, the sensor device 610 may initially be ejected from the delivery catheter in a longitudinally aligned orientation relative to the delivery catheter 630. Although a perpendicular orientation is shown and described with respect to sensor 610, it should be understood that the step of causing sensor 610 to rotate or pivot may not bring the sensor into a perpendicular orientation, but may merely cause sensor 610 to assume a more perpendicular orientation than a coaxial orientation with the distal end of the delivery catheter. In some embodiments, the anchor frame 620 comprises a memory metal (e.g., nitinol) that can be pre-shaped to cause the sensor 610 to pivot/rotate as shown. That is, the anchor frame 620 may be attached to a portion of the sensor 610, wherein upon ejection from the delivery catheter 630, the shape memory properties of the frame cause the sensor 610 to pivot or rotate as shown.

At block 1208, the process 1200 involves retracting the delivery catheter to position a sensor (e.g., a pressure sensor) against the septal wall 18. Thus, the sensor 610 may be used to anchor itself in a desired position against the septal wall on one side thereof.

At block 1210, the process 1200 involves further retracting the delivery catheter 630 to deploy the anchor arms 627 of the anchor frame 620 on the opposite side of the medial wall 18 relative to the pressure sensor 610. When the arms 627 have been deployed from the delivery catheter 630, they may be swung outward as shown to contact the septal wall 18 and provide tension to secure the implant device 600 in the desired position. For example, the frame 620 can be pre-shaped such that the arms 627 splay outward when deployed from the delivery catheter 630. In some embodiments, anchoring arm 627 has suture-engaging features, such as eyelets or the like, for coupling suture(s) 640 thereto. Such suture(s) may advantageously allow frame arm 627 to be pulled back into a relatively straightened form to re-enter delivery catheter 630 if it is desired to remove, retract, or reposition sensor device 600. When the desired implant location is reached, the suture(s) may be withdrawn through the suture-engaging features of the anchor arms 627, thereby releasing the anchor 620 from the delivery system. Although a separate suture is shown in fig. 13 for each anchoring arm, in some embodiments a single suture is coupled to both anchoring arms.

A sensor anchor according to embodiments of the present disclosure may include a plurality of coil stacks at the proximal and distal ends with a smaller diameter coil therebetween configured to engage a protrusion or protuberance on a cylindrical sensor to secure the sensor to the coil. Fig. 14 illustrates an embodiment of a sensor anchor 220 in accordance with one or more embodiments of the present disclosure. The anchor 220 includes a helical portion having a plurality of wire forms with different diameters. For example, in some embodiments, anchor 220 comprises two large diameter helical portions, including a proximal large diameter portion 222 and a distal large diameter portion 224, one or more of which may have a diameter d1, as shown. Anchor 220 may further include an intermediate smaller diameter helical portion 223 having a diameter d2 that is less than diameter d 1. Anchor wire form 220 may advantageously comprise a single unitary wire formed into the complex helical coil shown. Alternatively, the wire form 220 may include a plurality of separate wire components coupled or integrated to form the anchor 220.

Fig. 15 shows anchor 220 implanted in septal wall 18, wherein anchor 220 is engaged with sensor device 210 such that anchor 220 secures and anchors sensor device 210 in the illustrated implantation position. For example, in some embodiments, anchor 220 can be configured and/or dimensioned such that cylindrical sensor device 210 can be retained and secured within smaller diameter intermediate portion 223 of anchor 220, while distal and proximal larger diameter portions 222, 224 can retain implant device 200 against septal wall 18. For example, the smaller diameter coil portion 223 may advantageously be sized to fit within an aperture/opening in the medial wall 18, while the larger diameter portions 222, 224 have a larger diameter than the medial wall opening when in the expanded form.

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

In some embodiments, the sensor 210 includes one or more engagement features for engaging with and/or securing to the smaller diameter portion 223 of the anchor 220, e.g., as shown in fig. 16, the sensor 210 may include one or more protruding features 217, as described above. Such raised features 217 may be integral with the body of the sensor 210, or may be attached to the body of the sensor 210 using an adhesive or other attachment mechanism. The size and/or location of the protrusion(s) 217 can be designed such that as the protrusion is tangled or passed between the coils of the smaller diameter coil portion 223, contact between the protrusion and the coils acts to hold or maintain the sensor in a relative position to the anchor 220. In some embodiments, protrusion(s) 217 are configured such that sensor 210 can be engaged with anchor 220 by rotating or wrapping the sensor through intermediate portion 223. Thus, removal of the sensor 210 may be accomplished by deploying the sensor 210 to disengage the raised feature 217 from the smaller diameter mid-coil 223. Such removal may allow access to the left atrium through the openings between the smaller diameter coils 223. Further, it may be desirable to remove the sensor 210 if the sensor fails or otherwise needs to be replaced or removed. In some embodiments, the wire form anchor 220 comprises a memory metal wire pre-formed into the desired coil shape, as shown.

Although various embodiments are illustrated herein in connection with a sensor implant device implanted in a septal wall in an atrium, it should be understood that embodiments of the present disclosure may be applied to other implantation sites, including implantation of a sensor implant device in a septal wall in a ventricle. Fig. 17 illustrates an embodiment of a sensor implant device according to aspects of the present disclosure. Fig. 17 shows a pressure sensor device 1710 or other type of sensor device in the septal wall 17 in the ventricle. The sensor implant assembly 1700 includes a sensor 1710 and one or more anchoring features (not shown) configured to secure the sensor 1710 in a desired position in the septal wall 17.

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

Sensor integrated tissue closure device

In certain embodiments, a sensor implant device according to the present disclosure may include a sensor integrated with a septal closure device or other tissue closure device. While certain embodiments are disclosed below in the context of a septum closure device, it should be understood that such disclosure is applicable to sensor-integrated implant devices that include one or more sensors integrated with other types of tissue closure devices. Fig. 18 illustrates a front view of a sensor integrated septum closure device according to one or more embodiments of the present disclosure. Fig. 19 illustrates a perspective view of the sensor-integrated septum closure device of fig. 18 implanted in a tissue wall 18. As shown in fig. 18, the sensor-integrated septal closure device 100 may include a frame 112 configured to support a blood occlusion membrane 138. With respect to fig. 19, the septal closure device 100 may be implanted in the septal wall 18 to close a shunt passing through the septal wall, which may be congenital or created during an interventional procedure. In some embodiments, the septum occluder frame and occluding membrane 138 may be implanted first in the septal wall 18, after which the sensor device 110 may be attached to the septum closure device, such as by piercing the occluding membrane 138 and passing the sensor device 110 therethrough.

In the illustrated construction, the frame 112 may include a generally planar body including a central portion 114 and a plurality of anchor arms 116 extending radially outward from the central portion 114. For example, at least four arms may extend from the central portion 114, as shown in the illustrated embodiment, but in other embodiments the frame may have more than four arms 116 or less than three arms 116. Although the arms 116 are shown and described, it should be understood that the septal closure device 100 and/or the frame may include any type of tissue anchoring feature(s).

The four arms 116 may include a first set of opposing arms 118 and a second set of opposing arms 120 extending from the central portion 114. The closure device desirably (although not necessarily) has the same number of arms in the first and second sets so that when the device is implanted, the clamping force exerted by the arms is evenly distributed over the space. In the illustrated embodiment, for example, the first set of arms 118 includes exactly two arms extending from opposite sides of the central occluding membrane 138, and the second set of arms 120 includes exactly two arms extending from opposite sides of the central occluding portion 138. In other embodiments, the first set of arms or the second set of arms may include only one arm or more than three arms.

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

In the illustrated embodiment, the frame 112 has a relatively thin and flat profile to avoid or minimize thrombus. Thus, to this end, the arms 116 may be attached to a central portion of the frame 114 associated with the outer perimeter of the central occlusion membrane 138 at angularly spaced locations, wherein the attachment locations intersect a common plane perpendicular to the central axis; in other words, in the illustrated embodiment, all of the arms 116 may be attached to the central frame portion 114 along a circumferential path defined by the central frame portion 114.

In certain embodiments, the arms 116 and the central frame portion 114 may be coplanar with one another when the device 100 is in its fully expanded, non-deflected shape; that is, the arms 116 do not have any portion that extends axially away from the central frame portion 114. It should be appreciated that, once implanted, the first set of arms 118 and the second set of arms 120 may flex slightly axially away from each other due to the thickness of the space 18 and may no longer be coplanar. Nonetheless, in certain embodiments, the device 110 can be considered to have a flat profile with arms that are coplanar with each other and the central frame portion 114 when the device is in a non-deflected state. However, in other embodiments, the arms or portions thereof may be heat set or otherwise shaped to extend axially away from each other or the central frame portion 114 in a non-deflected state.

The frame 112 may be radially compressed or collapsed into a delivery configuration for delivery to the heart in a delivery catheter/system. For example, in the delivery configuration, the frame 112 may be placed and held in a generally compressed configuration in which the first set of arms 118 are folded toward each other along a central axis of the device 100 and the second set of arms 120 are folded toward each other along the central axis of the device 100 such that the first set of arms 118 and the second set of arms 120 each extend axially 120 and are parallel to each other. When placed in the delivery configuration, the frame 112 may also be radially compressed relative to the deployed configuration.

The frame 112 may include an eyelet 130 disposed at a distal end of one or more arms to couple the closure device 100 to a delivery system via one or more attachment sutures, as further described below. The aperture may protrude toward the central portion 114, as shown in fig. 18 and 19, or it may protrude away from the central portion 114.

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

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

In particular embodiments, the occlusion membrane 138 may comprise one or more sheets or pieces of material that at least partially block or impede blood flow through the frame 112. For example, the occlusion membrane 138 may include a material that may include one or more pieces, films, or cloths that are configured to promote tissue ingrowth and may degrade over time, leaving only regenerated tissue within the central frame portion 114. For example, the occlusion membrane 138 can include one or more pieces of a bioabsorbable electrospun polymer material, such as Polylactide (PLA), polylactide glycolide (PLGA), Polycaprolactone (PLC), Polyacrylonitrile (PAN), poly (lactide-co-caprolactone) (PLCL), polygluconate, and polypeptides. Compared to woven fabrics, electrospun polymers promote faster tissue ingrowth, have faster biodegradation times, are potentially less thrombogenic, and can be made weaker and therefore can be easily pierced with a medical device during subsequent re-penetration of the closure device.

In some embodiments, the occluding membrane 138 may comprise one or more sheets of non-bioabsorbable material, such as any of a variety of synthetic fabrics (e.g., polyethylene terephthalate (PET)) or natural tissues (e.g., pericardium). In some embodiments, the occlusion membrane 138 may be completely or substantially impermeable to blood. In other embodiments, the occlusion membrane 138 may be semi-porous to blood flow (e.g., a porous fabric). The porous material may be selected to remain porous or closed over time and become impermeable or non-porous to blood. In particular embodiments, the occluding membrane may be fabricated from a biowoven polyurethane having a fiber size between about 0.05-1.5 microns and a porosity between about 50-80%. The thickness of the blocking membrane 138 may be between about 100 and 200 microns. In another embodiment, the occluding membrane may be made from a bio-spun polymer blend comprising polyurethane and PET (such as 70/30% polyurethane/PET blend) with similar fiber size and porosity. In some embodiments, the occluding membrane 38 may be fabricated from a biocompatible foam, such as polyurethane, PET, silicone, or polyethylene foam.

The occlusion membrane 138 may be configured to form a substantially fluid-tight seal with the spaced adjacent tissue. In some embodiments, the occlusion membrane 138 is at least initially configured to allow a small amount of blood flow between the atria to provide residual shunting. Over time, the occluding membrane 138 may promote tissue ingrowth and substantially completely close the opening in the septum and prevent residual shunting between the atria. The blocking film 138 may completely cover the central frame portion 114, as shown in fig. 18 and 19, or the blocking film 138 may cover a portion of the opening in the central frame portion 114. The occluding membrane 38 may be configured such that the opening in the septum 18 may be accessed for re-entry through the defect either before or after degradation of the occluding membrane 138.

The blocking membrane 138 may be attached to the frame 112 via heat staking, sewing, molding, adhesive, weaving, and/or other means known to those skilled in the art having the benefit of this disclosure. For example, the outer edge of the occluding membrane 138 may be folded over the central frame portion 114 and then welded to a more central area of the occluding membrane 138 to secure the occluding membrane 138 to the frame 112. The occluding membrane 138 may extend beyond the perimeter of the central frame portion 114, e.g., up to 2 mm. In some embodiments, the occlusion membrane 138 may have a generally circular shape prior to attachment to the frame 112.

The occlusion membrane 138 may advantageously comprise a relatively thin cloth that may be penetrated to access the left atrium, if needed in connection with future interventions. Furthermore, frame 112 may advantageously be configured to stretch open to accommodate relatively large diameter catheters, such that access to the left atrium may be achieved through frame 112 and, in particular, through central frame portion 114.

As described above, the implant device 100 of fig. 18 and 19 includes the sensor device 110, the sensor device 110 being attached to the occlusion membrane 138 or otherwise integrated with the occlusion membrane 138. Sensor device 110 may be a pressure sensor including one or more sensor elements, as described herein. For example, the sensor device 110 may have a generally cylindrical shape and may penetrate through the occlusion membrane 138 such that distal and proximal portions of the sensor 110 are exposed on opposite sides of the septum closure device 100.

Removal of the sensor device 110 after implantation may allow access through the occlusion membrane 138 to access the left atrium. For example, the frame 112 of the septal closure device 100 may comprise a memory metal or other material that is relatively easily deformable to allow passage of an interventional device. In some embodiments, the interventional device may pass through the occlusion membrane 138 with the sensor device 110 remaining disposed in the occlusion membrane 138 or integrated with the occlusion membrane 138. In some embodiments, the sensor-integrated implant device 100 may be delivered with the sensor 110 already integrated with the septum closure device.

Fig. 20 illustrates a sensor implant device 2000 including a sensor 2010 integrated with a septal closure device. The septal closure device includes a blocking cloth or membrane 2038 connected to a frame 2012 that includes a plurality of arms, as described in detail herein. To maintain the intended functionality of the sensor-integrated implant device 2000, embodiments disclosed herein utilize a means for attaching the sensor 2010 to the septal closure implant. In some embodiments, the occlusion membrane 1038 may include a cloth (e.g., a bio-spun polymer cloth) film formed into one or more sleeves/cuffs 2039, the sleeves/cuffs 2039 being shaped to hold the sensor devices 2010. For example, with respect to the cylindrical sensor device 2010, the sleeve/cuff 2039 may be at least partially cylindrical and may be used to secure the cylindrical sensor 2010 to the frame 2012. The sleeve/cuff 2039 of the occluding film/cloth 2038 may be secured to the sensor device 2010 using a suture loop 2037, the suture loop 2037 may be wrapped around the sleeve/cuff 2039 and the sensor device 2010 to secure the sleeve/cuff 2039 to the sensor device 2010.

As described above, the occluding film 2038 may comprise a bio-spun polymer that may be fabricated in any suitable or desired geometry (e.g., a fabric or scaffold geometry). In some embodiments, the occluding film 2038 is configured to gradually integrate with biological tissue over time through tissue ingrowth. Such a film may advantageously have properties such that: the force required to penetrate the membrane is less than the amount of force required to displace the frame 2012 from the implantation site. In some embodiments, as described in detail herein, sensor device 2010 includes one or more raised features 2017, which may be integrally formed with the body of sensor 2010, or may be attached or adhered using a biocompatible adhesive or other attachment means.

To maintain the ability to access the left atrium after implantation of a sensor-integrated septum closure device as described herein, a sensor implant device may be used to remove the catheter. Fig. 21 illustrates a process 2100 for removing a sensor implant device according to an embodiment of the disclosure. Fig. 22 illustrates the sensor implant device and associated removal system and cardiac anatomy in various states corresponding to the process steps of fig. 21. At block 2102, process 2100 involves introducing a removal catheter 2103 into the right ventricle and advancing the removal catheter into the atrial septal wall 18, with the sensor implant device 2200 implanted in the atrial septal wall 18. The removal catheter 2230 may be used to safely remove the cylindrical sensor 2210 from the septum closure device with which it is integrated, or to remove the entire sensor-integrated septum closure device 2200. The sensor 2210 may advantageously include one or more protrusions or other engagement features 2217 that may be used to remove the sensor 2210. The protruding feature(s) 2217 may protrude radially from the outer surface of the sensor body 2210. While a protrusion feature is described herein, it should be understood that other means of implementing a hold or clamp to the sensor 2210 may be implemented in accordance with embodiments of the present disclosure.

At block 2104, process 2100 includes advancing an retrieval device 2235 within the retrieval catheter 2230. In some embodiments, pusher/extractor device 2235 includes a protrusion engagement feature 2237. For example, at block 2106, the process 2100 involves engaging the engagement feature 2237 with a protruding feature 2217 of the sensor 2210, as shown in state 2203 of fig. 22. Pusher/extraction device 2235 may have an at least partially hollow cylindrical tube form configured and dimensioned to fit at least partially around sensor 2210, with a gap 2239 of engagement feature 2237 of pusher/extraction device 2235 allowing pusher/extraction device 2235 to pass through protrusion feature 2217 in a longitudinal direction, with rotation of pusher/extraction device 2235 allowing extension/engagement feature 2237 to circumferentially overlap protrusion feature 2217 to provide engagement therewith.

At block 2108, the process 2100 includes withdrawing the retrieval catheter 2230, thereby removing the sensor 2210 from the septal closure implant 2211. For example, where pusher/retrieval device 2235 is rotated as shown in state 2203 of fig. 22, retraction of pusher/retrieval device 2235 may cause sensor 2010 and/or septal closure implant device 2200 to be pulled in the direction of the right atrium. Thus, pusher/extractor 2235 can provide a plug-in engagement mechanism that can be selectively engaged with or released from protruding feature 2217. Although a single protruding feature 2217 is shown in fig. 22, it should be understood that the sensor implant device 2200 may have any number of protruding features, and further, the pusher/retrieval device 2235 may have any number of corresponding protruding engagement features. In some embodiments, when the pusher/retrieval device 2235 is engaged with the raised feature 2217, the distal end 2231 of the removal catheter 2230 may be held against the septum closure device 2200 to prevent the septum closure device 2200 from dislodging during retrieval of the sensor 2210.

State 2204 of fig. 22 shows the septum-occluding implant device 2200 with the sensor device 2210 removed therefrom. However, it should be understood that in certain embodiments, the entire sensor-integrated septum closure device 2200 may be removed in connection with the process 2100. Once the sensor 2210 is removed from the septal closure device 2200, it can be relatively easily passed through a relatively weak occluding membrane 2238 (e.g., a bio-spun polymer) using standard device catheters.

Although pusher/retrieval device 2235 is described with respect to removal of sensor implant device 2200, in some embodiments pusher/retrieval device 2235 may be used to implant sensor implant device 2200. For example, pusher 2235 may be used to manipulate implant device 2200 as it is deployed. When used for deployment, pusher device 2235 may push on sensor protrusion feature 2217 to engage sensor implant device 2200 and the medial septum wall as shown, after which pusher device 2235 may be rotated to disengage engagement feature 2237 from protrusion feature 2217, allowing pusher device 2235 to be withdrawn away from sensor implant device 2200.

Additional sensor integrated cardiac implant device

In certain embodiments, the sensor implant device may comprise a sensor integrated with the heart valve spacer device. As shown in fig. 23, valve spacer devices 2300, 2301 may be implanted in the heart 1 to improve the ability of the tricuspid valve 8 or the mitral valve 6. While the following description focuses on the sensor-integrated spacer implant device 2300 implanted in the right ventricle 4 and positioned to fit within the tricuspid valve 8 to improve its ability, it should be understood that the following description also applies to sensor-integrated spacer implant devices implanted in any valve and/or in the left ventricle. The spacer implant device 2300 can be designed to reduce valve regurgitation by occupying the regurgitation orifice area between the native valve leaflets and providing a surface for leaflet coaptation. The sensor-integrated spacer implant device 2300 is comprised of a spacer form 2320 and a lanyard 2325 anchored in the right ventricle 4 (such as at or near the ventricular apex 26). Spacer form 2320 may include an at least partially filled polymer (e.g., foam filled) balloon configured to passively expand via one or more openings in the spacer chamber. In some embodiments, the openings into the spacer form 2320 may be positioned at opposite longitudinal ends of the spacer form 2320. The opening in the spacer form 2320 may allow the spacer form 2320 to be compressed for catheter-based delivery. In some embodiments, the spacer implant 2300 includes one or more radiopaque markers to aid in positioning the spacer using fluoroscopy. The spacer form 2320 may have any suitable or desired size, such as a diameter of about 12mm or 15mm, have a length of about 42mm, or any other size value.

In some embodiments, the implant device 2300 is secured at a distal end in the right (or left) ventricular myocardium using a tissue anchor 2327. The tissue anchor 2327 may have any suitable or desired form. For example, in some embodiments, anchor 2327 comprises a pointed metal anchor designed to minimize the risk of penetration of the epicardial surface and/or exposure of the point within the ventricle. In some embodiments, implant device 2300 may include an excess device length (not shown) that extends through right atrium 5 and into a subcutaneous pocket (not shown). In some embodiments, one or more of the antennas and/or wireless communication chips and/or circuits may be contained within a subcutaneous pocket. Such antennas and/or circuitry can be configured to wirelessly communicate and/or process data and/or power related to sensor functions of implant device 2300.

In some embodiments, the filler of the spacer form 2310 may include an elastomeric foam that may provide suitable or desired compression and decompression characteristics. The implant device 2300 includes a sensor 2310 that may be integrated with the spacer form 2320 in any suitable or desired manner. For example, in some embodiments, the spacer form 2320 includes an external slot or recess in the external spacer form and/or the internal foam or chamber. The sensor 2310 may be configured and/or positioned within the implant device 2300 such that the sensor element is positioned to determine pressure readings in the ventricle 4 and/or atrium 5. In embodiments where sensor 2310 is disposed within the outer balloon form of spacer 2320, the pressure sensor diaphragm of sensor 2010 may at least partially protrude from spacer form 2320 such that the pressure sensor diaphragm may be used to determine the fluid pressure outside of spacer form 2320.

In some embodiments, the spacer form 2320 is fluid-filled such that fluid pressure external to the spacer form 2320 is at least partially displaced or in some manner translated into fluid pressure within the spacer form. In some embodiments, the internal pressure of the spacer form 2320 provides information indicating how hard the valve leaflets impact the spacer form during the cardiac cycle. That is, in some embodiments, the sensor 2310 is configured to measure pressure in one or more chambers of the heart 1 and leaflet contact force on the form of a spacer. The leaflet contact force can be measured to determine the functional wear of the implant device 2300. In some embodiments, the spacer form 2320 has one or more openings at one or more longitudinal ends thereof through which the sensor element may be exposed to external fluid pressure.

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

Fig. 24 illustrates a sensor assembly including a sensor integrated spacer implant device 2400 and a tethered separate sensor device 2415, which sensor device 2415 may be anchored in an inferior vena cava or other vessel or anatomy using an anchor 2417. The sensors 2415 may be tethered to the spacer implant device 2400 via a tether 2419, as shown. Although spacer implant device 2400 is shown as being integrated with sensor 2410, in some embodiments, spacer 2400 does not include a sensor. Spacer implant device 2400 may be anchored to the ventricular wall by a lanyard 2425 and/or tissue anchors 2427.

Tethered pressure sensor 2415 anchored in inferior vena cava 29 may advantageously provide a central venous pressure measurement (which may provide a good measure of venous congestion) or other beneficial measurement. The anchor 2417 may advantageously be configured to center the pressure sensor 2415 in the vessel 29, which may provide a desired pressure measurement location. Further, the anchor 2417 and/or sensor 2415 can advantageously be configured and/or include a material for limiting tissue overgrowth onto the sensing element of the sensor 2415. The anchors 2417 may further provide additional anchoring features to the valve spacer implant 2400, which may further secure the valve spacer implant 2400 in its desired position.

In some embodiments, pressure sensor 2410 of valve spacer implant device 2400 can measure right ventricular and/or right atrial pressure, while sensor 2415 can provide a measure of inferior venous pressure, which in combination can provide a relatively complete picture of right-side heart performance. Alternatively, the sensor in the spacer device may be implanted in a similar manner on the left side of the heart.

In some embodiments, an implant device according to the present invention may include a sensor integrated with the left atrial appendage implant device. Figure 25 illustrates a sensor integrated cardiac implant device 2500 that includes a sensor 2510 integrated with a left atrial appendage occluder implant device 2520. Implant device 2500 may be implanted in left atrial appendage 49 of a heart. Implant device 2500 may be positioned to measure pressure in left atrial appendage 49 and/or left atrium 2. In general, measurement of left atrial pressure may be useful in monitoring fluid accumulation in the lungs associated with congestive heart failure, as described in detail above. Sensor implant device 2510 may be permanently attached to left atrial appendage closure implant device 2520 via or using any attachment or integration mechanism for securing sensor 2510 to implant 2520, including adhesive, suture wrapping, or other attachment means. The sensor-integrated implant device 2500 may advantageously provide a secure location for anchoring the atrial pressure monitoring sensor 2510. Sensor 2510 may advantageously be positioned and/or configured to present a relatively low risk of thrombus in the left atrium.

In some embodiments, a sensor-integrated implant device according to the present disclosure includes a sensor integrated with a valve repair clip or device configured to secure valve leaflets to one another to reduce valve regurgitation. Fig. 26 and 27 illustrate side and top views, respectively, of a sensor-integrated valve repair implant 2600 configured to provide edge-to-edge leaflet attachment for mitral valve repair, according to one or more embodiments of the present disclosure.

Edge-to-edge leaflet repair performed using implant device 2600 can advantageously restore valve capacity, at least in part, by anchoring the free edges of anterior leaflet 62 of mitral valve 6 to the corresponding free edges of posterior leaflet 62, thereby creating a mitral valve, as shown in fig. 27. The implant device 2600 may be deliverable using a transcatheter approach, and thus may be suitable for patients with increased risk of surgical valve repair solutions.

Implant device 2600 includes a first fastener member 2621, a second fastener member 2622, and a spacer 2620. Implant 2600 can be configured to capture the valve leaflets between clasps 2621, 2622 and spacers 2620 as shown, and can be particularly suited for the case of relatively short posterior leaflets or relatively larger leaflet prolapse gaps. The spacer includes a base portion 2609 and an end portion 2607. The base portion 2609 can be considered a ventricle or ventricular portion of the spacer because the base portion 2609 can be disposed within and/or exposed to the ventricle when the implant device 2600 is implanted. The end portion 2607 may be considered an atrial or atrial portion of the spacer because the end portion 2607 may be disposed within and/or exposed to the atrium when the implant device 2600 is implanted.

Implant 2600 further includes a sensor 2610 that may be disposed within spacer 2620 and/or integrated with spacer 2620, as shown. For example, in some embodiments, sensor 2610 has an exposed sensor element positioned and/or configured to generate a pressure reading indicative of left atrial pressure. Further, in some embodiments, implant device 2600 includes one or more sensor elements positioned and/or configured to provide pressure sensor readings indicative of left (or right) ventricular pressure for tricuspid valve repair. For example, such sensor elements can be disposed at or near the spacer 2620 and/or the base 2609 ventricle portion of the implant device 2600. In some embodiments, sensor 2610 is embedded in spacer 2620.

Sensor elements 2601 (e.g., pressure sensor elements as described herein) may be exposed and/or protrude from end portions 2607 of spacers 2620 such that the sensor elements may generate pressure readings associated with the atrial side of valve 6. In addition to measuring left atrial and/or left ventricular pressure, sensor 2610 may be used to measure the long-term performance of prosthetic valve 6. For example, sensor 2610 may include a dual element sensor configured to measure gradient across valve 6 and/or regurgitation into the left atrium.

Fig. 28 illustrates another embodiment of a sensor 2810 integrated with a mitral valve repair implant 2800 to form a valve repair sensor assembly 2801. The assembly 2801 may provide a mechanism for measuring left atrial pressure by tethering the pressure sensor 2810 to the valve repair implant 2800. In contrast to embodiments in which the pressure sensor is integrated with the spacer or other component of the repair clip implant, assembly 2801 may provide a simplified implant device for integrating the pressure sensor function with the mitral leaflet repair implant. In some embodiments, the sensor integration assembly 2801 further includes a support post 2805 that can be coupled or attached to the sensor 2810 in some manner and can be used to further secure the sensor 2810 in a desired location and/or range of locations. In some embodiments, the post 2805 is at least partially rigid. The distal end 2806 of the post 2805 may be embedded in tissue to anchor the post and sensor 2810.

Fig. 29 shows yet another embodiment of a sensor 2910 integrated with a mitral valve repair implant 2900 to form a valve repair sensor assembly 2901. In the embodiment of fig. 29, the sensor 2910 is anchored in the inferior vena cava 29 by an anchoring feature 2917. Anchor 2917 may be any suitable or desired anchor according to embodiments of the present disclosure. In some embodiments, anchor 2917 comprises a memory metal wire frame. The mitral valve repair device 2900 may be implanted using transseptal access to the left atrium 2. In conjunction with such a procedure, sensor 2910 may be at least partially anchored within the inferior vena cava or right atrium, with tether 2905 coupling sensor 2910 to valve repair device 2900 extending through atrial septal wall 18.

In some embodiments, a sensor-integrated implant device according to the present disclosure includes an annular reduction implant device having a sensor (such as a pressure sensor) integrated therewith, as described in detail herein. Fig. 30 illustrates a sensor-integrated annular reduction implant 3000 including an annular reduction tube 3020 mechanically coupled to a sensor 3010 (such as a pressure sensor). In some embodiments, the implant device 3000 is configured to be implanted on or near the native mitral annulus.

The annular reduction tube 3020 may comprise a woven tube configured to be sutured or otherwise secured to the native annulus and cinched tight so as to reduce its effective diameter in order to repair the associated valve. In some embodiments, the sensor-integrated implant device 3000 includes an anchor wire 3005, the anchor wire 3005 being coupled to the sensor 3010 and configured to further support the sensor 3010 when implanted. For example, the anchor 3005 may comprise a relatively large diameter wire (e.g., a memory metal such as nitinol) that provides support for the sensor 3010. Anchor 3005 may be attached to sensor 3010 in any manner or using any attachment mechanism. For example, as shown, anchor wire 3005 may be wrapped around at least a portion of sensor 3010. The anchor 35 may be configured to radially expand to provide support within the left atrium or other cavity or vessel. In some embodiments, anchor wire 3005 is configured to be embedded in tissue or coupled to a tissue anchor element.

In some embodiments, the distal end of the sensor 3005 is secured by an anchor 3005, while the proximal end of the sensor 3010 is anchored or secured to a cannula or other attachment feature of the tube 3020. For example, the tube 3020 may include a shrink fit feature 3001 or other attachment mechanism. Reduction fitting 3001 may be wrapped with sutures or other cinching features to cinch reduction fitting 3001 around the sensor to secure sensor 3010 to tube 3020. Generally, by incorporating the sensor 3010 with the annular reduction implant, the impact on procedural steps involved in attaching the annular reduction implant to the native annulus may be relatively minimal.

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

Typically, a relatively large delivery system may be required to deliver the transcatheter heart valve 3120 shown in fig. 31. For example, where access to the target implant site is achieved through the atrial septal wall 18, the diameter of such access openings or orifices in the septal wall may be between about 6-18mm or greater. Accordingly, it may be desirable to place a septum closure device in the septal wall to at least partially occlude flow through the septum opening. Pressure sensor devices integrated with septal closure implants are described in detail herein. The illustrated assembly 3101 may advantageously include a septum closure structure 3103 with the sensor device 3110 integrated with the septum closure structure 3103 to provide a septum closure function in addition to pressure monitoring and valve repair or function. Additionally or alternatively, the coupling structure 3105 may serve as a tether incorporated into the frame of the replacement valve 3120 and may serve as an anchor to secure the pressure sensor 3110 in the atrial septum 18 or other location at least partially within the left atrium. Although the valve replacement 3120 is described as a mitral valve replacement and the atrium 2 is described as a left atrium, it should be understood that the principles disclosed and illustrated in fig. 31 are applicable to other replacement valves, including replacement of the tricuspid, aortic, and/or pulmonary valves.

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

The assembly 3201 of fig. 32 can utilize the transseptal access required for initial placement of the replacement valve 3220. That is, the access port, septal crossing, and guidewire may be pre-established procedurally in conjunction with the placement of the replacement valve 3220 such that the introduction of a catheter for delivery of the sensor 3210 and associated anchor 3217 does not add substantial complexity to the procedure. Further, in some embodiments, the anchors 3217 and sensors 3210 may also function as a septal defect closure device.

In some embodiments, a sensor device (such as a pressure sensor device) may be implanted in the atrium or other chambers of the heart and secured, at least in part, using one or more radially-expanding anchoring features or coils. Fig. 33 illustrates sensor arrangement 3310 suspended in the left atrium 2 of the heart. Although certain embodiments are disclosed herein in the context of the left atrium, it should be understood that sensors according to the present disclosure may be implanted in the right atrium or heart or other chambers or vessels of the body. The sensor 3310 is mounted or attached to a relatively large radially expanding anchor system comprising radially expanding wires 3305. Wire 3305 may be configured to contact at least a portion of the inner wall of atrium 2 when expanded. In some embodiments, the wires 3305 are configured to exert an outward radial force against the walls of the atrium, thereby securing or even suspending the sensor device 3305 in the center or desired portion of the atrium. Additionally, wire 3305 may be at least partially flexible and/or elastic to allow contraction and/or expansion in response to contraction and expansion of the atrium associated with the cardiac cycle.

In some embodiments, sensor 3310 may be anchored or embedded in atrial tissue. For example, the sensor 310 may have a sensor anchor 3317 associated therewith, the sensor anchor 3317 being configured and dimensioned to embed into tissue of the atrial wall at any suitable or desired location and/or portion thereof. Fig. 34A and 34B illustrate an example embodiment of a pressure sensor with an associated or integrated tissue anchor. For example, as shown in fig. 34A, the pressure sensor 3410 may be associated with or integrated with a multi-tipped tissue anchor, as shown. Further, as shown in fig. 34B, pressure sensor 3411 may be associated with or integrated with a screw-type anchor 3418. The anchors of fig. 34A and 34B can be included on the distal end of the respective sensor, where a shaped wire (e.g., a memory metal wire) can be attached to the proximal end of the respective sensor to provide additional stability to the sensor, as shown in fig. 33.

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

The anchoring/docking device 3507 may provide a more rounded and/or stable annulus at the implantation site where a prosthetic valve having a circular or cylindrical valve frame or stent may be expanded or otherwise implanted. In addition to providing an anchoring site for the prosthetic valve, the anchoring/docking device 3507 is sized and shaped to constrict or pull the native valve (e.g., mitral valve, tricuspid valve, etc.) anatomy radially inward. In this way, one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), particularly enlargement of the heart (e.g., left ventricle) and/or annulus and subsequent stretching out of the native annulus (e.g., mitral annulus), may be at least partially compensated or counteracted. In some embodiments, the anchoring/docking device 3507 further includes features shaped and/or modified to better maintain the position or shape of the docking device during and/or after expansion of the prosthetic valve therein, for example.

The docking arrangement 3507 includes a coil having a plurality of turns extending along a central axis of the docking arrangement. The coil may be continuous and may extend generally helically, with various differently sized and shaped portions. The docking device 3507 shown in fig. 35 may be configured to best fit at the mitral valve location, but in other embodiments may also be similarly or differently shaped to better accommodate at other native valve locations.

The pressure sensor 3510 may be integrated with the proximal end 3503 of the docking device 3507 or attached to the proximal end 3503 of the docking device 3507. Upon implantation of the docking/sensor assembly 3500, the sensor 3510 may be advanced to engage with the docking device 3507. Additional anchoring features (not shown) may be added to secure the proximal end of the sensor 3510 to the medial wall or other wall of the atrium 2. In some embodiments, the sensor 3510 is anchored to the septal wall and integrated with the septal closure device as described herein. In some embodiments, the docking device 3507 includes one or more proximal coils or rings 3506, which may be configured to assume a shape that may contact one or more portions of the inner wall of the atrium 2, thereby at least partially securing the sensor 3510 in a desired position. Although a single proximal coil/ring 3506 is shown, the docking arrangement 3507 can have any suitable or desired number of coils/rings, or other shape and/or configuration features for securing or stabilizing the sensor 3510.

Fig. 36A and 36B illustrate sensor-integrated cardiac implant devices 3600a, 3600B according to one or more embodiments of the present invention. The cardiac implant devices 3600a, 3600b include cardiac implant structures 3620a, 3620b implanted and/or secured within the pulmonary artery 11. The cardiac implant structure may include a pulmonary valve replacement device 3620b and/or a pulmonary artery stent device 3620 a. For example, percutaneous pulmonary valve replacement 3620b can be an effective means of restoring valve function to a defective pulmonary valve. In some cases, the pulmonary artery may be at least partially expanded, and thus the reducer stent 3620a may desirably be placed in the pulmonary artery prior to percutaneous placement of the replacement valve. Accordingly, the cardiac implant structure 3620a may include a reducer stent that may include struts configured and designed to anchor and position the pressure sensor 3610a such that the sensing element of the pressure sensor 3610a is positioned at or near the center of the pulmonary artery 11. To this end, the cardiac implant structures 3620a, 3620b may include arms or struts 3605a, 3605b, which arms or struts 3605a, 3605b may have one or more attachment features 3601a, 3601b, such as one or more straps, bands, features, locking features, and/or other attachment devices, for attaching the sensors 3610a, 3610b thereto. In some embodiments, the post or arm feature 3605 includes a memory metal shaped to receive and/or anchor the sensor 3610. The stent structure 3620 may be sized to already have a valve replacement device placed therein. Further, although a stent is shown in fig. 36, it is understood that in some embodiments, the cardiac implant structure 3620 comprises a replacement pulmonary valve device.

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

Additional embodiments

Depending on the embodiment, certain actions, events or functions of any process or algorithm described herein may be performed in a different order, may be added, merged, or omitted altogether. Thus, in some embodiments, not all described acts or events are required for the practice of the processes.

Conditional language, such as "may," "can," "e.g.," as used herein, is intended to be generic and generally intended to convey that certain embodiments include, but not others, certain functions, elements, and/or steps unless specifically stated otherwise or otherwise understood in the context of use. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic to determine that such features, elements, and/or steps are included or are to be performed in any particular embodiment, with or without author input or prompting. The terms "comprising," "including," "having," and the like, are synonymous, used in their ordinary sense, and are used inclusively in an open-ended fashion, and do not exclude other elements, features, acts, operations, and the like. Additionally, the term "or" is used in its inclusive sense (and not its exclusive sense), such that, when used, e.g., to connect listed elements, the term "or" means one, some, or all of the listed elements. Conjunctive language such as the phrase "X, Y and at least one of Z" should be understood in context when used in conjunction, unless otherwise expressly stated, to convey that an item, term, element, etc. may be X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

It should be appreciated that in the foregoing description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Furthermore, any components, features, or steps shown and/or described in particular embodiments herein may be applied to or used with any other embodiment(s). Furthermore, no element, feature, step, or combination of elements, features, or steps is essential or essential to every embodiment. Therefore, the scope of the invention disclosed and claimed herein should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

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 a physical characteristic or order. Thus, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify an element such as a structure, component, operation, etc., do not necessarily denote a priority or order of the element relative to any other element, and may generally distinguish the element from another element having a similar or identical name (but for the ordinal term). In addition, as used herein, the indefinite articles "a" and "an" may mean "one or more" rather than "one". Further, an operation performed "based on" one condition or event may also be performed based on one or more other conditions or events not explicitly recited.

Unless defined otherwise, 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 example embodiments belong. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

For convenience in description, spatially relative terms "outer," "inner," "upper," "lower," "below," "over," "vertical," "horizontal," and the like may be used herein to describe one element or component's relationship to another element or component as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, in the case where the device shown in the drawings is turned over, a device positioned "below" or "beneath" another device may also be positioned "above" the other device. Thus, the illustrative term "below" can include both a lower position and an upper position. The device may also be oriented in another direction and the spatially relative terms may therefore be interpreted differently depending on the orientation.

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