Sensor integration in cardiac implant devices

Abstract

Sensor integration in a cardiac implant device. The sensor retention structure comprises a sensor support post and means for securing the sensor device to the sensor support post. The sensor support arm may be configured to have an at least partially cylindrical sensor device disposed thereon and associated with one or more sensor holding fingers protruding from the sensor support arm and / or a cage structure configured to be secured to the sensor device.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 2020800759203 (PCT / US2020 / 056746), filed on October 22, 2020, entitled “Sensor Integration in Cardiac Implantable Devices”.

[0002] Related applications This application claims priority to U.S. Provisional Application No. 62 / 926,829, filed October 28, 2019, entitled “SENSOR INTEGRATION IN CARDIACIMPLANT DEVICES,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally pertains to the field of medical implantable devices. Background Technology

[0004] Various medical procedures involve implanting medical devices within the anatomical structures of the heart. Certain physiological parameters associated with this anatomy (e.g., fluid pressure) can influence a patient's health prospects. Summary of the Invention

[0005] This document describes one or more methods and / or devices for facilitating the monitoring of one or more physiological parameters associated with the left atrium using one or more sensor implantation devices, said one or more sensor implantation devices being implanted in or into one or more pulmonary veins and / or associated anatomical structures / tissues.

[0006] In some embodiments, this disclosure relates to a sensor holding structure including a sensor support arm and one or more sensor holding fingers, the sensor support arm being configured to have a sensor device that is at least partially cylindrical thereon, and the one or more sensor holding fingers protruding from the sensor support arm and configured to be secured to the sensor device.

[0007] One or more sensor holding fingers may be configured to at least partially wrap around a sensor device disposed on a sensor support arm. In some embodiments, at least one of the one or more sensor holding fingers includes a strap form, and at least one of the one or more sensor holding fingers includes a buckle form extending from opposite sides of the sensor support arm, such that the strap form can be inserted through a portion of the buckle form. In some embodiments, at least one of the one or more sensor holding fingers has a hole therein, the hole being sized to allow adhesive to be disposed therein to secure at least one of the one or more sensor holding fingers to the sensor device. In some embodiments, the one or more sensor holding fingers are positioned in one or more sets of aligned opposing fingers.

[0008] In some embodiments, one or more sensor retaining fingers project distally from the sensor support arm. For example, the one or more sensor retaining fingers include corresponding distal crossbars. In some embodiments, at least two of the one or more sensor retaining fingers are configured to lock together at their distal ends.

[0009] The sensor holding structure may further include a distal stop associated with the distal portion of the sensor support arm. In some embodiments, the sensor holding structure also includes a housing form configured to at least partially rest on the sensor device when the sensor device is mounted on the sensor support arm. For example, the housing form may include one or more cutouts configured to engage at least one of one or more sensor holding fingers. In some embodiments, the one or more sensor holding fingers are part of a removable partial ring form. In some embodiments, the one or more sensor holding fingers have associated corresponding tabs configured to project radially inward.

[0010] In some embodiments, this disclosure relates to a sensor holding structure including a sensor support arm configured to have a sensor device, at least partially cylindrical, and a cage structure associated thereon. The cage structure is configured to at least partially wrap around the circumferential surface of the sensor device.

[0011] In some embodiments, a sensor support arm is attached to a proximal portion of the diverter arm structure, and the sensor support arm is configured to bend away from the diverter arm structure, thereby projecting radially at least partially away from the longitudinal axis of the diverter arm structure. The cage structure may include one or more distal stop tabs. In some embodiments, the cage structure includes a plurality of longitudinal struts. For example, the cage structure may include a plurality of transverse struts connected between two or more of the plurality of longitudinal struts. The sensor holding structure may further include a sleeve disposed around at least a portion of the cage structure, wherein the cage structure is in a sensor holding configuration that is at least partially wrapped around it. In some embodiments, the sensor holding structure further includes a plurality of suture attachment tabs associated with the distal end of the cage structure.

[0012] In some embodiments, this disclosure relates to a sensor holding structure including a sensor support pillar and means for securing a sensor device to the sensor support pillar. The means for securing the sensor device to the support pillar may have any form, shape, composition, and / or configuration of any embodiment shown and / or disclosed herein, or any form, shape, composition, and / or configuration relating to any aspect of any embodiment shown and / or disclosed herein.

[0013] Means for securing a sensor device to a sensor support pillar may include one or more strap features associated with the sensor support pillar. In some embodiments, means for securing a sensor device to a sensor support pillar includes a cloth wrapped around at least a portion of the sensor device and the sensor support pillar. In some embodiments, means for securing a sensor device to a sensor support pillar includes a polymer film disposed around at least a portion of the sensor device and the sensor support pillar. In some embodiments, means for securing a sensor device to a sensor support pillar includes a sensor mold associated with the sensor support pillar, wherein the sensor mold is configured to have a sensor device inserted therein.

[0014] A means for securing a sensor device to a sensor support post may include a proximal sensor attachment structure that at least partially projects orthogonally from the sensor support post. For example, the proximal sensor attachment structure may include a hole sized to allow adhesive to be disposed therein for securing the proximal sensor attachment structure to the sensor device. In some embodiments, the sensor attachment structure includes a suction cup associated with its distal side. In some embodiments, the proximal sensor attachment structure includes an arm angled distally, the arm having a hook feature associated with its distal end.

[0015] In some embodiments, the means for securing a sensor device to a sensor support post includes a housing attachment flange and a sensor housing configured to attach to the housing attachment flange at its proximal end and to house the sensor device. The means for securing the sensor device to the sensor support post may include one or more trapdoor flaps. In some embodiments, the means for securing the sensor device to the sensor support post includes a sheet configured to be wrapped around at least a portion of the sensor device.

[0016] In some embodiments, the means for securing a sensor device to a sensor support post includes one or more clamp forms configured to bend away from the sensor support post and having a sensor device disposed at least partially through an opening in the one or more clamp forms. In some embodiments, the means for securing a sensor device to a sensor support post includes a locking retaining arm and a sensor housing, the locking retaining arm including a plurality of forks, the sensor housing including a plurality of channels associated with its proximal end and configured to receive one or more of the plurality of forks and a distal portion of the sensor support post.

[0017] For the purposes of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all of these advantages can necessarily be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other advantages as taught or suggested herein. Attached Figure Description

[0018] The accompanying drawings depict various embodiments for illustrative purposes and should not in any way be construed as limiting the scope of the invention. Furthermore, various features of the different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondences between reference elements.

[0019] Figure 1 An example representation of a human heart according to one or more embodiments is illustrated.

[0020] Figure 2 The illustration shows example pressure waveforms associated with the various chambers and blood vessels of the heart according to one or more embodiments.

[0021] Figure 3 It is a block diagram representing an implantable device according to one or more embodiments.

[0022] Figure 4 This is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, according to one or more embodiments.

[0023] Figure 5 An example shunt structure according to one or more embodiments is illustrated.

[0024] Figure 6 The illustration depicts a sensor implantation device that is integrated with and / or attached to / fixed to a medical device structure according to one or more embodiments.

[0025] Figure 7 A sensor implantation device for implantation in the atrial septum according to one or more embodiments is shown.

[0026] Figure 8 A sensor implantation device is shown, which is implanted in the tissue wall between the coronary sinus and the left atrium according to one or more embodiments.

[0027] Figure 9 A perspective view of a shunt device in a duct delivery (e.g., at least partially collapsed) configuration according to one or more embodiments is shown.

[0028] Figure 10 A sensor implantation device having a sensor support strut or arm according to one or more embodiments is shown.

[0029] Figure 11A and Figure 11B A perspective view of a medical implantable device according to one or more embodiments is shown, comprising a sensor support strut / arm and a fabric and / or polymer wrapping configured to at least partially secure the sensor device to the sensor support strut / arm.

[0030] Figure 12A and Figure 12B A perspective view of a medical implantable device including a sensor support strut / arm and a film wrapping, according to one or more embodiments, is shown, the film wrapping being configured to at least partially secure a sensor device to the sensor support strut / arm.

[0031] Figure 13A and Figure 13B The illustration shows a perspective view of a sensor implantation device with an integrated sensor featuring fixation to a sock, according to one or more embodiments.

[0032] Figure 14A and Figure 14B A perspective view of a medical implantable device including a sensor support strut / arm and a film wrapping, according to one or more embodiments, is shown, the film wrapping being configured to at least partially secure a sensor device to the sensor support strut / arm.

[0033] Figure 15-1 and Figure 15-2A perspective view of a medical implantable device according to one or more embodiments is shown, comprising a respective sensor support strut / arm and one or more buckle and / or strap components associated therewith.

[0034] Figure 16A and Figure 16B A perspective view of a medical implant device according to one or more embodiments is shown, comprising a sensor support strut / arm and one or more buckle and / or strap components and / or one or more axial holding features associated therewith.

[0035] Figure 16C An illustration is provided according to one or more embodiments. Figure 16A and Figure 16B A side view of a medical implantable device.

[0036] Figures 17A-17C Perspective and end views of at least a portion of a medical implantable device including a sensor support strut / arm and one or more sensor-holding fingers, according to one or more embodiments, are shown respectively.

[0037] Figures 18A-18C A perspective view of a sensor support strut / arm and a sensor holding over-mold support form according to one or more embodiments is shown.

[0038] Figures 19A-19E Perspective, side, and end views of a sensor support strut / arm associated with multiple locking sensor holding fingers according to one or more embodiments are shown.

[0039] Figures 20A-20E Exploded views, side views, cross-sectional views, and end views of the arm structure associated with the housing attachment flange according to one or more embodiments are shown respectively.

[0040] Figure 21A and Figure 21B Exploded views and perspective views of arm structures associated with one or more sets of sensor holding and / or housing connecting fingers, according to one or more embodiments, are shown respectively.

[0041] Figure 22A and Figure 22B A perspective view of a medical implantable device, according to one or more embodiments, includes a sensor support strut / arm associated with a plurality of mechanically locking sensor-secured fingers.

[0042] Figure 23A and Figure 23B A perspective view of a sensor support strut / arm associated with multiple sets of sensor holding fingers according to one or more embodiments is shown.

[0043] Figure 24A and Figure 24B A perspective view of a sensor support structure including a trapdoor sensor holding feature according to one or more embodiments is shown.

[0044] Figures 25A-25C The illustration shows a perspective view of certain portions of a sensor support arm associated with one or more tension-fitting rings according to one or more embodiments.

[0045] Figures 26A-26E The illustration shows a perspective view of a sensor support arm including one or more clamping features according to one or more embodiments.

[0046] Figure 27A and Figure 27B The illustration shows a perspective view of a sensor support arm structure including opposing circumferentially wound fingers according to one or more embodiments.

[0047] Figure 28A and Figure 28B The illustration shows a perspective view of a sensor support structure including one or more forks according to one or more embodiments.

[0048] Figures 29A-29D The illustration shows a perspective view of a sensor support structure / arm including a proximal stop feature according to one or more embodiments.

[0049] Figures 30A-30D Perspective and side views of a sensor holding structure including a sensor support structure / arm and a proximal stop feature capable of suction, according to one or more embodiments, are illustrated.

[0050] Figures 31A-31D The illustrations show perspective and side views of a sensor holding structure according to one or more embodiments, including a stop and / or holding arm / structure that is positioned proximally and angled distally.

[0051] Figure 32A and Figure 32B The illustration shows a perspective view of a sensor holding structure according to one or more embodiments, including a sheet configured to be at least partially wrapped around a sensor device.

[0052] Figure 33A and Figure 33B The illustration shows a perspective view of a sensor holding structure including a sensor support arm structure and one or more sensor holding rings according to one or more embodiments.

[0053] Figures 34A-34D Top view, bottom view and side view of a sensor holding structure according to one or more embodiments are illustrated.

[0054] Figure 35A and Figure 35B The illustration shows a perspective view of a sensor holding structure according to one or more embodiments.

[0055] Figure 36A and Figure 36B The illustrations show a side view and an axial view of a medical implantable device including certain sensor holding features according to one or more embodiments.

[0056] Figure 37A and Figure 37B The illustration shows a perspective view of a sensor holding structure including a sensor holding cage structure according to one or more embodiments.

[0057] Figure 38A and Figure 38B The illustration shows a perspective view of a sensor holding structure configured to bend away from a medical implant device, according to one or more embodiments.

[0058] Figure 38C A planar configuration according to one or more embodiments is shown. Figure 38A and Figure 38B Sensor holding structure.

[0059] Figure 39 The illustration shows a side view of a medical implantable device including an axial sensor support arm according to one or more embodiments, the axial sensor support arm being configured to support the sensor device.

[0060] Figure 40 A side view of an embodiment of a shunt medical implant device according to one or more embodiments is shown, the shunt medical implant device having a sensor device at least partially fixed thereto.

[0061] Figures 41A-41C An embodiment of a shunt medical implant device according to one or more embodiments is illustrated, the shunt medical implant device having a sensor device at least partially fixed thereto.

[0062] Figure 42A and Figure 42B Side and axial views of embodiments of a shunt-type medical implant device including certain sensor holding features according to one or more embodiments are illustrated.

[0063] Figure 43 The illustration shows a perspective view of a sensor holding structure including a sensor holding groove according to one or more embodiments.

[0064] Figure 44 The illustration shows a perspective view of a sensor holding structure including a mesh or the like, according to one or more embodiments, the mesh or the like being configured to secure a sensor device to a sensor support structure.

[0065] Figure 45 The illustration shows a perspective view of a magnetic sensor holding structure according to one or more embodiments.

[0066] Figure 46A and Figure 46B The illustrations show side perspective views of sensor holding structures in relatively shortened and lengthened configurations according to one or more embodiments.

[0067] Figures 47-49 The illustrations show individual embodiments of sensor structures including respective sensor holding features according to one or more aspects of this disclosure.

[0068] Figures 50A-50E Perspective and end views of a sensor holding structure including one or more sensor holding fingers according to one or more embodiments are illustrated.

[0069] Figures 51A-51E The illustration shows a sensor holding structure comprising one or more flow channel-type sensor support pillars according to one or more embodiments.

[0070] Figures 52A-52C The illustration shows a sensor holding structure comprising one or more flow channel-type sensor support pillars according to one or more embodiments.

[0071] Figures 53A-53E Perspective and side views of embodiments of the sensor holding structure according to one or more embodiments are illustrated.

[0072] Figures 54A-54C The illustration shows a perspective view of a sensor holding structure including sensor holding arms with end crosspieces, according to one or more embodiments.

[0073] Figure 55 The illustration shows one or more embodiments. Figures 54A-54C A perspective view of the sensor holding structure with a sleeve installed on it.

[0074] Figures 56A-56D The illustration shows a perspective view of a sensor holding structure including an axially extending arm with end crossbars, according to one or more embodiments.

[0075] Figure 57 The illustration shows one or more embodiments. Figures 56A-56D A perspective view of the sensor holding structure with a sleeve installed on it.

[0076] Figures 58A-58D The illustration shows a perspective view of a sensor holding structure, including a cage configured to hold a sensor device, according to one or more embodiments.

[0077] Figure 59 The illustration shows one or more embodiments. Figures 58A-58D A perspective view of the sensor holding structure with a sleeve installed on it.

[0078] Figures 60A-60D The illustration shows a perspective view of a sensor holding structure including a cage structure according to one or more embodiments.

[0079] Figure 61 The illustration shows one or more embodiments. Figures 60A-60D A perspective view of the sensor holding structure 600 with a sleeve mounted on it.

[0080] Figures 62A-62D The illustration shows a perspective view of a sensor holding structure including a cage structure according to one or more embodiments.

[0081] Figure 63 The illustration shows one or more embodiments. Figures 62A-62D A perspective view of the sensor holding structure 620 with a sleeve mounted thereon.

[0082] Figures 64A-64D The illustration shows a perspective view of a sensor holding structure including a cage structure according to one or more embodiments.

[0083] Figure 65 The illustration shows one or more embodiments. Figures 64A-64D A perspective view of the sensor holding structure with a sleeve installed on it.

[0084] Figure 66A and Figure 66B The illustration shows a perspective view of a sensor holding structure comprising two support pillars and arms of a medical implantable device according to one or more embodiments.

[0085] Figures 67A-67C The illustration shows one or more embodiments. Figures 66A-66B A perspective view of the sensor holding structure with a sleeve installed on it.

[0086] Figures 68A-68C The illustration shows a perspective view of a sensor holding structure including a cage structure according to one or more embodiments.

[0087] Figures 69A-69D The illustration shows a perspective view of a sensor holding structure according to one or more embodiments, including a cage structure configured to hold a sensor device.

[0088] Figures 70A-70D The illustration shows a perspective view of a sensor holding structure including a cage structure and a distal stop ring according to one or more embodiments.

[0089] Figure 71A and Figure 71B The illustration shows a perspective view of a sensor holding structure according to one or more embodiments, the sensor holding structure including a cage structure configured to hold a sensor device and one or more distal and / or proximal stop features.

[0090] Figure 72 The illustration shows a perspective view of a sensor support pillar and an associated sensor cover according to one or more embodiments.

[0091] Figures 73-75 The figures show bottom and perspective views of embodiments of a sensor holding structure including a sensor support column and a housing, according to one or more embodiments.

[0092] Figures 76A-76D Exploded and perspective views of a sensor holding structure according to one or more embodiments are shown, the sensor holding structure including a sensor support arm and a housing configured to mate or engage with the sensor support arm.

[0093] Figure 77 The illustration shows one or more embodiments. Figures 76A-76D A perspective view of the sensor holding structure with a sleeve installed on it.

[0094] Figures 78A-78D Exploded and perspective views of a sensor holding structure according to one or more embodiments are shown, the sensor holding structure including a sensor support arm, a housing configured to mate or engage with the sensor support arm, and one or more sets of opposing fingers and / or one or more axially offset holding fingers.

[0095] Figure 79 The illustration shows one or more embodiments. Figures 78A-78D A perspective view of the sensor holding structure with a sleeve installed on it.

[0096] Figures 80A-80D Exploded and perspective views of a sensor holding structure according to one or more embodiments are shown, the sensor holding structure including a sensor support arm, a housing configured to mate or engage with the sensor support arm, and one or more sets of opposing fingers with end crossbars and / or one or more axially offset holding fingers.

[0097] Figure 81 The illustration shows one or more embodiments. Figures 80A-80D A perspective view of the sensor holding structure with a sleeve installed on it.

[0098] Figure 82 The illustration shows a perspective view of a locking arm according to one or more embodiments.

[0099] Figures 83A-83C The illustration shows a view of a sensor holding structure configured to be fixed to a holding arm structure in a certain way according to one or more embodiments.

[0100] Figures 84A-84C The illustration shows one or more embodiments. Figure 82 A perspective view of at least a portion of the locking and holding arm.

[0101] Figures 85A-85C This indicates that, according to one or more embodiments, it is used for... Figure 82 The locking retaining arm is inserted into Figures 83A-83C The process phase in the proximal part of the holding structure.

[0102] Figures 86A-86D The illustration shows a perspective view of a sensor holding structure configured to hold a sensor device according to one or more embodiments.

[0103] Figure 87 This is an end view of a sensor holding structure including a distal stop bar feature according to one or more embodiments. Detailed Implementation

[0104] The titles provided in this document are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0105] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple discrete operations in a manner that aids in understanding certain embodiments; however, the order of description should not be construed as implying that these operations are order-dependent. Furthermore, the structures, systems, and / or devices described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0106] Regarding preferred embodiments, certain standard anatomically significant positional terms are used herein to refer to anatomical structures of animals, that is, humans. While certain spatially relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe the spatial relationship between one device / element or anatomical structure and another device / element or anatomical structure, it should be understood that these terms are for ease of description in order to describe the positional relationship / structure between the elements / structures(one or more) as shown in the figures. It should be understood that, in addition to the orientations depicted in the figures, spatially relative terms are intended to cover different orientations of the elements / structures(one or more) in use or operation. For example, an element / structure described as “above” another element / structure may indicate a position below or beside such another element / structure relative to the subject / patient or the alternating orientation of the element / structure, and vice versa.

[0107] This disclosure relates to systems, apparatus, and methods for telemetry monitoring of one or more physiological parameters (e.g., blood pressure) in relation to a patient in connection with a cardiac shunt and / or other medical implantable device and / or procedure. Such pressure monitoring can be performed using a cardiac implantable device having an integrated pressure sensor and / or associated components. For example, in some embodiments, this disclosure relates to a cardiac shunt and / or other cardiac implantable device incorporating or associated with a pressure sensor or other sensor device. The term “associated” is used herein in its broad and general sense. For example, where a first feature, element, component, device, or member is described as being “associated” with a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, at least partially embedded in, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member. Certain embodiments are disclosed herein in the context of cardiac implantable devices. However, although some of the principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that the sensor implantation device according to this disclosure can be implanted or configured for implantation in any suitable or desired anatomical structure.

[0108] Cardiac Physiology The anatomy of the heart is described below to aid in understanding some of the inventive concepts disclosed herein. In humans and other vertebrates, the heart typically comprises a muscular organ with four pumping chambers, where blood flow is controlled at least in part by various cardiac valves (i.e., the aortic valve, the mitral valve, the tricuspid valve, and the pulmonary valve). Valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to corresponding areas and / or vessels of the heart (e.g., the pulmonary vessels, the aorta, etc.). Signals generated by the cardiac electrical system can induce various myocardial contractions, which will be discussed in detail below. Some embodiments disclosed herein relate to cardiac conditions such as atrial fibrillation and / or associated complications or solutions. However, embodiments of this disclosure more generally relate to any health complications related to fluid overload in a patient, such as those that may occur postoperatively following any surgical procedure involving fluid resuscitation. In other words, the detection of atrial stretching as described in this article can be performed to detect / determine fluid overload conditions, which can guide treatment or compensatory actions related to atrial fibrillation and / or any other conditions at least partially caused by fluid overload.

[0109] Figure 1 The illustration shows an example representation of a heart 1 having various features associated with certain embodiments of the invention disclosed herein. The heart 1 includes four chambers: a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery via a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped to the lungs, and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 delivers deoxygenated blood from the right side of the heart to the lungs. As shown, the pulmonary artery 11 includes the pulmonary trunk and branching from it: a left pulmonary artery 15 and a right pulmonary artery 13. In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid blood circulation therein: 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 is normally closed during ventricular systole (i.e., systole) and open during ventricular dilation (i.e., diastole). The mitral valve (6) typically has two cusps / lealets and separates the left atrium (2) from the left ventricle (3). The mitral valve (6) is configured to open during diastole to allow blood in the left atrium (2) to flow into the left ventricle (3), and, when functioning normally, closes during systole to prevent blood from leaking back into the left atrium (2). The aortic valve (7) separates the left ventricle (3) from the aorta (12). The aortic valve (7) is configured to open during systole to allow blood to leave the left ventricle (3) and enter the aorta (12), and close during diastole to prevent blood from leaking back into the left ventricle (3).

[0110] Heart valves typically comprise a relatively dense fibrous ring (referred to herein as the valve annulus) and multiple leaflets or cusps attached to the annulus. Typically, the leaflets or cusps are sized such that, when the heart contracts, the resulting increase in blood pressure within the corresponding heart chamber forces the leaflets to open at least partially to allow flow out of the heart chamber. As the pressure within the heart chamber decreases, the pressure in the adjacent heart chamber or blood vessel may become dominant and press against the leaflet. As a result, the leaflets / cusps align with each other, thus closing the flow passage. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can lead to valvular leakage and / or other health complications.

[0111] Atrioventricular (i.e., mitral and tricuspid) heart valves may further include an assembly of chordae tendineae and papillary muscles (not shown) for securing the leaflets of the respective valves to facilitate and / or ensure proper engagement of the leaflets and prevent their prolapse. For example, papillary muscles may typically include finger-like projections from the ventricular wall. The leaflets are connected to the papillary muscles by chordae tendineae. A muscular wall 17 (called a septum) separates the left atrium 2 and right atrium 5 and separates the left ventricle 3 and right ventricle 4.

[0112] Health conditions associated with cardiac stress and other parameters As mentioned above, certain physiological conditions or parameters associated with cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with a relatively slow movement of blood through the heart and / or body, leading to increased fluid pressure in one or more chambers of the heart. As a result, the heart does not pump enough oxygen to meet the body's needs. The individual chambers of the heart can respond to the increased pressure by stretching to keep more blood pumped through the body or by becoming relatively stiff and / or thickened. The heart walls eventually weaken and become unable to pump efficiently. In some cases, the kidneys can respond to the heart's inefficiency by keeping the body fluid. Fluid buildup in the arms, legs, ankles, feet, lungs, and / or other organs can cause congestion in the body, a condition known as congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality, and therefore, the treatment and / or prevention of congestive heart failure is a significant issue in healthcare.

[0113] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As mentioned 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, treatments or methods that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient, such as measuring weight, chest impedance, right heart catheterization, or the like. In some solutions, pulmonary capillary wedge pressure can be measured as a surrogate indicator of left atrial pressure. For example, a pressure sensor can be placed or implanted in the pulmonary artery, and the associated reading can be used as a surrogate value for left atrial pressure. However, catheter-based pressure measurements of the pulmonary artery or certain other chambers or regions of the heart may require the use of invasive catheters to maintain such pressure sensors, which may be uncomfortable or difficult to perform. Furthermore, certain lung-related conditions may affect pressure readings in the pulmonary artery, thus potentially undesirably weakening the correlation between pulmonary artery pressure and left atrial pressure. As an alternative to pulmonary artery pressure measurement, pressure measurements in the right ventricular outflow tract may also correlate with left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be used for the diagnosis, prevention, and / or treatment of congestive heart failure.

[0114] Additional solutions can be implemented to obtain or infer left atrial pressure. For example, the E / A ratio (a marker of left ventricular function, representing the ratio of peak velocity blood flow due to gravity in early diastole (E wave) to peak velocity flow due to atrial contraction in late diastole (A wave)) can be used as a substitute indicator for measuring left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques; generally, an abnormal E / A ratio may indicate that the left ventricle is not filling properly with blood between systoles, which can lead to symptoms of heart failure, as described above. However, E / A ratio determination typically does not provide an absolute pressure measurement.

[0115] Various methods for identifying and / or treating congestive heart failure involve observing worsening symptoms and / or weight changes. However, such signs may appear relatively late and / or be relatively unreliable. For example, daily weight measurements can vary considerably (e.g., by up to 9% or more) and may be unreliable as a signal of cardiac-related complications. Furthermore, treatment guided by monitoring signs, symptoms, weight, and / or other biomarkers has not shown significant improvements in clinical outcomes. Additionally, for discharged patients, such treatment may require remote telemedicine systems.

[0116] This disclosure provides systems, devices, and methods for guiding the administration of medications related to the treatment of congestive heart failure, at least in part by directly monitoring pressure in the left atrium of a patient or by pressure measurements in other chambers or vessels that indicate left atrial pressure, in order to reduce readmission, morbidity, and / or otherwise improve the patient’s health prospects.

[0117] Cardiac stress monitoring Cardiac pressure monitoring according to embodiments of this disclosure can provide an active intervention mechanism for the prevention or treatment of congestive heart failure. Typically, an increase in ventricular filling pressure associated with diastolic and / or systolic heart failure may occur before the onset of symptoms leading to hospitalization. For example, in some patients, cardiac pressure indicators may appear several weeks prior to hospitalization. Therefore, a pressure monitoring system according to embodiments of this disclosure can be advantageously implemented to reduce hospitalizations by guiding appropriate or desired titration and / or drug administration prior to the onset of heart failure.

[0118] Dyspnea represents a cardiac stress indicator, characterized by shortness of breath or a feeling of difficulty breathing. Dyspnea may be caused by elevated atrial pressure, which can lead to pulmonary effusion due to pressure rebound. Pathological dyspnea can be caused by congestive heart failure. However, a considerable time may pass between the initial pressure rise and the onset of dyspnea, and therefore the symptoms of dyspnea may not provide a sufficiently early signal of elevated atrial pressure. By directly monitoring pressure according to embodiments of this disclosure, normal ventricular filling pressure can be advantageously maintained, thereby preventing or reducing the effects of heart failure (e.g., dyspnea).

[0119] As mentioned above, regarding cardiac pressure, elevated pressure in the left atrium may be particularly associated with heart failure. Figure 2 The illustration shows example pressure waveforms associated with the various chambers and blood vessels of the heart according to one or more embodiments. Figure 2 The various waveforms shown can represent waveforms obtained using right heart catheterization to advance one or more pressure sensors into the corresponding illustrated and labeled chambers or vessels of the heart. For example... Figure 2 As shown, waveform 25, representing left atrial pressure, can be considered to provide the best feedback for the early detection of congestive heart failure. Furthermore, there is usually a relatively strong correlation between increased left atrial pressure and pulmonary congestion.

[0120] Left atrial pressure is typically closely correlated with left ventricular end-diastolic pressure. However, while there is a significant correlation between left atrial pressure and pulmonary artery end-diastolic pressure, this correlation may weaken when pulmonary vascular resistance is elevated. That is, in the presence of various acute conditions, including some patients with congestive heart failure, pulmonary artery pressure often does not adequately correlate with left ventricular end-diastolic pressure. For example, pulmonary hypertension, affecting approximately 25% to 83% of heart failure patients, can affect the reliability of pulmonary artery pressure measurements used to estimate left filling pressure. Therefore, as illustrated in waveform 24, pulmonary artery pressure measurements alone may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly in patients with comorbidities such as lung disease and / or thromboembolism. Left atrial pressure can further be correlated, at least in part, with the presence and / or extent of mitral regurgitation.

[0121] and Figure 2 Compared to other pressure waveforms shown, left atrial pressure readings are relatively less likely to be distorted or affected by other conditions, such as respiratory status or similar conditions. Typically, left atrial pressure can significantly predict heart failure, for example, up to two weeks before the onset of heart failure. For instance, an increase in left atrial pressure, along with both diastolic and systolic heart failure, may occur several weeks before hospitalization, and therefore knowledge of such increases can be used to predict the onset of congestive heart failure (e.g., acute weakness symptoms of congestive heart failure).

[0122] Cardiac pressure monitoring (e.g., left atrial pressure monitoring) can provide a mechanism to guide medication administration for the treatment and / or prevention of congestive heart failure. Such treatment can advantageously reduce hospital readmission rates and morbidity, and provide other benefits. An implantable pressure sensor according to embodiments of this disclosure can be used to predict heart failure two weeks or longer before the onset of symptoms or signs of heart failure (e.g., dyspnea). When identifying a heart failure predictor using cardiac pressure sensor embodiments according to this disclosure, certain preventative measures, including pharmacological interventions such as modifying a patient's medication regimen, can be implemented, which can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement in the left atrium can advantageously provide an accurate indicator of pressure accumulation that may lead to heart failure or other complications. For example, trends in elevated atrial pressure can be analyzed or used to identify or predict the onset of cardiac dysfunction, where medications or other therapies can be intensified to induce pressure reduction and prevent or reduce further complications.

[0123] Implantable devices with integrated sensors In some embodiments, this disclosure relates to sensors associated with or integrated with cardiac shunts or other implantable devices. Such integrated devices can be used to provide controlled and / or more effective therapies for the treatment and prevention of heart failure and / or other health complications related to cardiac function. Figure 3 This is a block diagram illustrating an implantable device 30 including a shunt (or other type of implantation) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. For example, the sensor device 37 may be a pressure sensor or other type of sensor. In some embodiments, the sensor 37 includes a transducer 32 (e.g., a pressure transducer) and some control circuitry 34 that may be embodied in, for example, an application-specific integrated circuit (ASIC).

[0124] Control circuitry 34 may be configured to process signals received from transducer 32 and / or wirelessly transmit associated signals through biological tissue using antenna 38. Antenna 38 may include one or more coils or loops of conductive material, such as copper wire or the like. In some embodiments, at least a portion of transducer 32, control circuitry 34, and / or antenna 38 is at least partially disposed within or contained in sensor housing 36, which may comprise any type of material and may advantageously be at least partially sealed. For example, in some embodiments, housing 36 may comprise glass or other rigid materials, which may provide mechanical stability and / or protection for components housed therein. In some embodiments, housing 36 is at least partially flexible. For example, housing may comprise polymers or other flexible structures / materials that may advantageously allow sensor 37 to be folded, bent, or collapsed to allow its delivery via conduit or other introduction device.

[0125] Transducer 32 may include any type of sensor device or mechanism. For example, transducer 32 may be a force-harvesting type pressure sensor. In some embodiments, transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or one or more other strain or deflection measuring components for measuring strain or deflection applied to its area / surface. Transducer 32 may be associated with housing 36 such that at least a portion of it is contained within or attached to housing 36. The term “associated” is used herein in its broad and general sense. 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.

[0126] In some embodiments, transducer 32 includes a piezoresistive strain gauge or a component of a piezoresistive strain gauge, which can be configured to detect strain caused by applied pressure using an bonded or molded strain gauge, wherein the resistance increases as the pressure deforms the component / material. Transducer 32 can incorporate any type of material, including but not limited to silicon (e.g., monocrystalline silicon), polycrystalline silicon thin films, bonded metal foils, thick films, silicon-on-sapphire, sputtered thin films, and / or the like.

[0127] In some embodiments, transducer 32 includes a capacitive pressure sensor or a component thereof, the capacitive pressure sensor including a diaphragm and a pressure chamber configured to form a variable capacitor to detect strain caused by pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor typically decreases as pressure deforms the diaphragm. The diaphragm may include any (one or more) materials, including but not limited to metals, ceramics, silicon, and the like. In some embodiments, transducer 32 includes an electromagnetic pressure sensor or a component thereof, the electromagnetic pressure sensor being configured to measure diaphragm displacement by means of changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes a piezoelectric strain sensor or a component thereof. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials (e.g., quartz).

[0128] In some embodiments, transducer 32 includes a strain gauge or 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 transducer 32. In some embodiments, a metal strain gauge is adhered to the surface of the sensor, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as an optical sensor, a potential sensor, a resonant sensor, a thermal sensor, an ionization sensor, or other type of strain or pressure sensor.

[0129] Figure 4 A system 40 is illustrated according to one or more embodiments for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) of a patient 44. The patient 44 may have a medical implantable device 30 implanted, for example, in the heart (not shown) or related physiological function of the patient 44. For example, the implantable device 30 may be at least partially implanted in the left atrium of the patient 44's heart. The implantable device 30 may include one or more sensor transducers 32, such as one or more microelectromechanical systems (MEMS) devices (e.g., MEMS pressure sensors) or other types of sensor transducers.

[0130] In some embodiments, the monitoring system 40 may include at least two subsystems, including an implantable internal subsystem or device 30 and control circuitry 34. The internal subsystem or device 30 includes one or more sensor transducers 32, and the control circuitry 34 includes one or more microcontrollers, one or more discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 may further include an external (e.g., non-implantable) subsystem including an external reader 42 (e.g., a coil), which may include a wireless transceiver electrically and / or communicatively coupled to some of the control circuitry. In some embodiments, both the internal and external subsystems include corresponding coil antennas for wireless communication and / or power delivery via patient tissue disposed therebetween. The sensor implantation device 30 may be any type of implantation device. For example, in some embodiments, the implantation device 30 includes a pressure sensor integrated with another functional implant structure, such as a prosthetic shunt or stent device / structure.

[0131] Certain details of the implantable device 30 are shown in the enlarged box 30. The implantable device 30 may include a cardiac implant structure 39 as described herein. For example, the cardiac implant structure 39 may include a percutaneously deliverable shunt device configured to be secured to and / or fixed in a tissue wall to provide a flow path between two chambers of the heart and / or blood vessels, as described in more detail throughout this disclosure. Although some components are... Figure 4 The sensor implantation device 30 is illustrated as part of the implantation device 30; however, it should be understood that the sensor implantation device 30 may include only a subset of the illustrated components / modules and may include additional components / modules not shown. The implantation device may represent... Figure 3 The embodiments of the implantable device shown are, conversely, described below. The implantable device 30 may advantageously include one or more sensor transducers 32, which may be configured to provide a response indicative of one or more physiological parameters (e.g., atrial pressure) of the patient 44. Although a pressure transducer is described, the sensor transducers(s)32 may include any suitable or desired type of sensor transducer(s) for providing signals relating to physiological parameters or conditions associated with the implantable device 30 and / or the patient 44.

[0132] One or more sensor transducers 32 may include one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / strain gauges, accelerometers, gyroscopes, diaphragm-based sensors, and / or other types of sensors, which may be positioned in the patient 44 to sense one or more parameters related to the patient's health. Transducer 32 may be a force-harvesting type pressure sensor. In some embodiments, transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or one or more other strain or deflection measuring components for measuring strain or deflection applied to its area / surface. Transducer 32 may be associated with sensor housing 36 such that at least a portion of it is contained within or attached to housing 36. The term "associated" is used herein in its broad and general sense. For example, when a first feature, element, component, device, or member is described as being "associated" with a second feature, element, component, device, or member, this description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, at least partially embedded in, or otherwise physically associated with, the second feature, element, component, device, or member, whether directly or indirectly. Regarding sensor devices / components "associated" with an implant structure, such terms can refer to sensor devices or components that are physically coupled, attached, or connected to, or integrated with, the implant structure.

[0133] In some embodiments, transducer 32 includes a piezoresistive strain gauge or a component of a piezoresistive strain gauge, which can be configured to detect strain caused by applied pressure using an bonded or molded strain gauge, wherein the resistance increases as the pressure deforms the component / material. Transducer 32 can incorporate any type of material, including but not limited to silicone resins, polymers, silicon (e.g., monocrystalline silicon), polycrystalline silicon thin films, bonded metal foils, thick films, silicon-on-sapphire, sputtered thin films, and / or the like. In some embodiments, transducer 32 includes a strain gauge or a component of a strain gauge. In some embodiments, a metal strain gauge is adhered to the sensor surface, or a thin-film gauge can be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as an optical sensor, a potential sensor, a resonant sensor, a thermal sensor, an ionization sensor, or other type of strain or pressure sensor.

[0134] In some embodiments, transducer 32 includes a capacitive pressure sensor or a component thereof, the capacitive pressure sensor including a diaphragm and a pressure chamber configured to form a variable capacitor to detect strain caused by pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor typically decreases as pressure deforms the diaphragm. The diaphragm may include any (one or more) materials, including but not limited to metals, ceramics, silicon, or other semiconductors and the like. In some embodiments, transducer 32 includes an electromagnetic pressure sensor or a component thereof, the electromagnetic pressure sensor being configured to measure diaphragm displacement by means of changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes a piezoelectric strain sensor or a component thereof. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials (e.g., quartz).

[0135] In some embodiments, one or more transducers 32 are electrically coupled and / or communicatively coupled to control circuitry 34, which may include one or more application-specific integrated circuit (ASIC) microcontrollers or chips. Control circuitry 34 may further include one or more discrete electronic components, such as tuning capacitors, resistors, diodes, inductors, or the like.

[0136] In some embodiments, one or more sensor transducers 32 may be configured to generate electrical signals that can be wirelessly transmitted to a device outside the patient's body, such as the illustrated local external monitoring system 42. For this wireless data transmission, the implantable device 30 may include radio frequency (RF) (or other frequency band) transmission circuitry (e.g., signal processing circuitry) and an antenna 38. The antenna 38 may include an internal antenna coil implanted within the patient's body. The control circuitry 34 may include any type of transceiver circuitry configured to transmit electromagnetic signals, which may be radiated by the antenna 38, which may include one or more wires, coils, plates, or the like. The control circuitry 34 of the implantable device 30 may include, for example, one or more chips or dies configured to perform a certain amount of processing on the signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, in some embodiments, the implantable device 30 may not include independent processing capabilities.

[0137] The wireless signals generated by the implanted device 30 can be received by a local external monitoring device or subsystem 42, which may include a reader / antenna interface circuit module 43 configured to receive wireless signal transmissions from the implanted device 30, which is at least partially located within the patient 44. For example, module 43 may include one or more transceiver devices / circuits.

[0138] The external local monitor 42 can use an external antenna 48 (e.g., a rod-shaped device) to receive wireless signal transmissions and / or provide wireless power. The reader / antenna interface circuitry 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30. Such circuitry may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuitry, phase-locked loop (PLL) circuitry, signal mixers, or the like. The reader / antenna interface circuitry 43 may be further configured to transmit signals to a remote monitoring subsystem or device 46 via a network 49. The RF circuitry of the reader / antenna interface circuitry 43 may further include one or more digital-to-analog converter (DAC) circuits, power amplifiers, low-pass filters, antenna switching modules, antennas, or the like for handling / processing signals transmitted via the network 49 and / or for receiving signals from the implanted device 30. In some embodiments, the local monitor 42 includes control circuitry 41 for processing signals received from the implanted device 30. Local monitor 42 may be configured to communicate with network 49 according to known network protocols (e.g., Ethernet, Wi-Fi, or the like). In some embodiments, local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0139] In some embodiments, the implantable device 30 includes a quantity of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory or the like utilizing a floating-gate transistor array. Control circuitry 34 may utilize the data storage to store sensing data collected over a period of time, wherein the stored data may be periodically transmitted to a local monitor 42 or another external subsystem. In some embodiments, the implantable device 30 does not include any data storage. Control circuitry 34 may be configured to facilitate the wireless transmission of data generated by (or other than) the sensor transducer(s) 32. Control circuitry 34 may be further configured to receive input from one or more external subsystems (e.g., from the local monitor 42) or from a remote monitor 46, for example, via network 49. For example, implantable device 30 may be configured to receive signals that at least partially control the operation of implantable device 30, such as by activating / deactivating one or more components or sensors, or otherwise influencing the operation or performance of implantable device 30.

[0140] One or more components of the implantable device 30 may be powered by one or more power sources 35. Due to considerations of size, cost, and / or electrical complexity, it may be desirable for the power source 35 to be inherently relatively simple. For example, high-power drive voltages and / or currents in the implantable device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implantable device. In some embodiments, the power source 35 is inherently at least partially passive, allowing power to be wirelessly received from an external source via passive circuitry of the implantable device 30, for example, through the use of short-range or near-field wireless power transmission or other electromagnetic coupling mechanisms. For example, a local monitor 42 may serve as an initiator for actively generating an RF field that can power the implantable device 30, thereby allowing the power circuitry of the implantable device to employ a relatively simple form factor. In some embodiments, the power source 35 may be configured to draw energy from an environmental source, such as fluid flow, motion, or the like. Additionally or alternatively, the power source 35 may include a battery that may be advantageously configured to provide sufficient power as needed during monitoring cycles (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other cycles).

[0141] In some embodiments, the local monitoring device 42 may serve as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 may be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 may be a wearable communication device or another device that can be easily placed near the patient 44 and the implanted device 30. The local monitoring device 42 may be configured to continuously, periodically, or occasionally query the implanted device 30 to extract or request sensor-based information. In some embodiments, the local monitor 42 includes a user interface through which a user can view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0142] System 40 may include an auxiliary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. In one embodiment, local monitor 42 may be a wearable device or other device or system configured to be physically very close to the patient and / or implanted device 30, wherein local monitor 42 is primarily designed to receive signals from and / or send signals to implanted device 30, and to provide such signals to auxiliary local monitor 47 for viewing, processing, and / or manipulation. External local monitoring system 42 may be configured to receive and / or process certain metadata from or associated with implanted device 30, such as device ID or the like, which may also be provided through data coupling from implanted device 30.

[0143] The remote monitoring subsystem 46 can be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received via network 49 from local monitoring device 42, auxiliary local monitor 47, and / or implanted device 30. For example, the remote monitoring subsystem 46 can advantageously be operated and / or controlled by a healthcare entity such as a hospital, physician, or other care entity associated with patient 44. While some embodiments disclosed herein describe communication with the remote monitoring subsystem 46 from the implanted device indirectly via local monitoring device 42, in some embodiments, the implanted device 30 may include a transmitter capable of communicating with the remote monitoring subsystem 46 via network 49 without relaying information via local monitoring device 42.

[0144] In some embodiments, the antenna 48 of the external monitoring system 42 includes an external coil antenna that is matched and / or tuned to inductively pair with the antenna 38 of the internal implant 30. In some embodiments, the implanted device 30 is configured to receive wireless ultrasonic charging and / or data communication from the external monitoring systems 42. As described above, the local external monitor 42 may include a stick-shaped or other handheld reader.

[0145] In some embodiments, at least a portion of the transducer 32, control circuitry 34, power supply 35, and / or antenna 38 are at least partially disposed within or contained in a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, in some embodiments, the housing 36 may comprise glass or other rigid materials, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may comprise polymers or other flexible structures / materials that may advantageously allow the sensor 30 to be folded, bent, or collapsed to allow its delivery via a conduit or other percutaneous introduction device.

[0146] Heart shunt implant Figure 5 An example shunt structure 150 according to one or more embodiments is illustrated. The shunt structure 150 may represent an embodiment of a cardiac implantable device that can be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, a central flow channel 166 of the shunt 150 may define a generally circular or oval opening. The channel 166 may be configured to retain the sides of the puncture opening within a tissue wall to form a blood flow path between one or more chambers or vessels of the heart separated by a tissue wall. For example, the shunt 150 may be configured to be implanted in the wall separating the coronary sinus and the left atrium. The central flow channel 166 may be partially formed by a pair of sidewalls 170a, 170b defined by thin struts 179 arranged in a generally parallelogram shape, forming an array of parallelogram-shaped cells or openings 180. In some embodiments, essentially the entire shunt 150 is formed of hyperelastic struts configured to compress and fit into a conduit (not shown) and then expand back as shown. Figure 5 The relaxed shape shown.

[0147] The use of multiple interconnected struts forming cells therebetween to create a shunt 150 can at least partially increase the flexibility of the shunt, allowing it to compress and expand at the implantation site. The interconnected struts surrounding the central flow channel 166 advantageously provide the rigidity and structure sufficient to hold tissue at the puncture site in an open position, forming a cage. The end walls 172a, 172b of the central flow channel 166 can be used to connect the side walls 170a, 170b and extend on each side between distal and proximal flanges or arms 152, 154. As shown, the side walls 170a, 170b and the end walls 172a, 172b together can define a tubular lattice. The end walls 172a, 172b may include thin struts 179 extending at a small angle from the central flow axis of the shunt 150.

[0148] Although the illustrated diverter 150 includes pillars defining open cells of a tubular or circular lattice forming a central flow channel 166, in some embodiments, the structure constituting the channel forms a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated embodiment, the tilting of the diverter structure 150 can facilitate the diverter collapsing into the delivery conduit (not shown) and facilitate the expansion of the flanges / arms 152, 154 on either side of the target tissue wall. The central flow channel 166 can remain substantially unchanged between the collapsed and expanded states of the diverter 150, while the flanges / arms 152, 154 can be adapted to be aligned with and misaligned with the angled flow channel.

[0149] While some embodiments of the diverters disclosed herein include flow channels with a generally circular cross-section, in some embodiments, the diverter structure according to this disclosure has an elliptical, rectangular, rhomboid, or elliptical flow channel configuration. For example, with Figure 5 Compared to the configuration shown, relatively elongated sidewalls can create rectangular or oval flow channels. Such shaped split flow channels may be desirable for larger perforations, while still being configured to collapse into a relatively small delivery profile.

[0150] In some embodiments, each of the distal and proximal flanges / arms 152, 154 is configured to curl outward from the end walls 172a, 172b and is positioned generally radially away from the central flow channel 166 in the extended configuration. The extended flanges / arms can be used to secure the shunt 150 to the target tissue wall. Additional aspects and features of the shunt structure that can be integrated with sensor devices / functions according to embodiments of this disclosure are disclosed in U.S. Patent No. 9,789,294, entitled “Expandable Cardiac Shunt,” issued October 17, 2017, the disclosure of which is incorporated herein by reference in its entirety. Although some embodiments are related to… Figure 5The disclosure is made in a similar context to the shunt structures shown and described above, but it should be understood that shunt structures or other implantable devices integrated with pressure sensor functionality according to embodiments of this disclosure may have any type, form, structure, configuration and / or be usable or configured for any purpose, whether for shunt or other purpose or function.

[0151] Sensor holding structure integrated with shunt and other implantable devices The sensor device according to embodiments of this disclosure can be integrated with a cardiac shunt structure / device or other implantable device using any suitable or desired attachment or integration mechanism or configuration. Figure 6 The illustration shows a sensor implantation device 60 including a shunt structure 69 and an integrated sensor 65 according to one or more embodiments. In some embodiments, the sensor 65 may be built into or manufactured into the shunt structure 69 to form a single structure. In some embodiments, the sensor 65 may be attached to or integrated with an arm member 68 of the shunt structure 69.

[0152] Sensor 65 includes sensor element 62, such as a pressure sensor transducer. The transducer element 62 (e.g., a pressure transducer) can be oriented / positioned relative to the arm member 68 of the shunt structure 69 in either a distal or distal region 63 or a proximal or proximal region 61 of sensor 65. For example, Figure 5 The illustrated embodiment includes a transducer 62 disposed at the distal end 63 of the sensor 65. In some embodiments, readings acquired by the sensor can be used to guide drug titration for treating a patient with an implanted device 69.

[0153] As described herein, sensor 65 can be configured to enable wireless data and / or power transmission. Sensor 65 may include antenna component 67 and control circuitry 64 configured to facilitate wireless data and / or power communication functions. In some embodiments, antenna 67 includes one or more conductive coils that may facilitate inductive power supply and / or data transmission.

[0154] Sensor 65 may advantageously be biocompatible. For example, sensor 65 may include a biocompatible housing 66, such as a cylindrical or other shaped housing comprising glass or other biocompatible materials. Circuitry 64, sensor element 62, and / or antenna 67 may be at least partially contained within housing 66, wherein housing 66 is sealed to prevent such components from being exposed to the external environment. However, in some embodiments, at least a portion of sensor element 62 (e.g., a diaphragm or other component) may be exposed to the external environment to allow pressure readings or other parameter sensing. Housing 66 may include at least partially rigid cylindrical or tubular forms, such as glass cylinders, wherein sensing probe 62 is disposed at one or both ends 61, 63 of sensor assembly 65. In some embodiments, the diameter of sensor assembly is about 3 mm or less and / or the length is about 20 mm or less. As described herein, sensor element 62 may include a pressure transducer.

[0155] Sensor assembly 65 can be configured to communicate with external systems when implanted in the heart or other areas of a patient's body. For example, sensor 65 can wirelessly receive power from and / or transmit sensed data or waveforms to and / or from external systems. Sensor assembly 65 can be attached to or integrated with shunt structure 69 in any suitable or desired manner. For example, in some embodiments, sensor 65 can be attached to or integrated with shunt structure 69 using a mechanical attachment device. In some embodiments, as described in detail below, sensor assembly 65 may be contained in a bag or other container attached to shunt structure 69.

[0156] Sensor element 62 may include a pressure sensor. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer may include at least a partially flexible or compressible diaphragm component, which may be made of silicone or other flexible materials. The diaphragm component may be configured to flex or compress in response to changes in ambient pressure. Control circuitry 64 may be configured to process signals generated in response to said flexing / compression to provide pressure readings. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride) or the like. The diaphragm component and / or other components of the pressure transducer 62 may advantageously be fused or otherwise sealed to or together with housing 66 to provide an hermetically sealed at least some of the sensor assembly components.

[0157] Control circuitry 64 may include one or more application-specific integrated circuit (ASIC) chips or dies that can be programmed and / or customized or configured to perform monitoring functions as described herein and / or facilitate the wireless transmission of sensor signals. Antenna 67 may include a ferrite core wound with a conductive material in the form of multiple coils (e.g., wire coils). In some embodiments, the coils comprise copper or other metals. Antenna 67 may advantageously be configured with a coil geometry that will not cause significant displacement or heating in the presence of magnetic resonance imaging. In some embodiments, sensor implantation device 60 may be delivered to a target implantation site using a delivery conduit (not shown), wherein the delivery conduit includes a cavity or channel configured to accommodate the sensor assembly 65 through which it advances.

[0158] Figure 7 A sensor implantation device 73, implanted in the atrial septum 18 according to one or more embodiments, is illustrated. A specific location within the atrial septum wall can be selected or determined to provide a relatively fixed anchoring point for the shunt structure 72 and to provide a relatively low risk of thrombosis. Furthermore, the sensor implantation device 73 can be implanted at a desired location considering future re-crossing of the septum wall for future intervention. Implanting the sensor implantation device 73 in the atrial septum wall can advantageously allow communication between the left atrium 2 and the right atrium 5. Utilizing the device 73 in the atrial septum 18, the sensor 70 of the sensor implantation device 73 can be advantageously configured to measure pressure in the right atrium 5, the left atrium 2, or both atria. For example, in some embodiments, the device 73 includes multiple sensors, with one sensor disposed in each of the right atrium 5 and the left atrium 2. Utilizing the pressure sensor function to measure pressure in the two atria, the sensor implantation device 73 can be advantageously configured to provide a sensor signal that can be used to determine the pressure differential between the atria. The determination of the pressure differential can be used to monitor pulmonary effusion that may be associated with congestive heart failure.

[0159] Atrial shunts using the sensor implantation device 73 (which, in some embodiments, may integrate pressure monitoring) can be advantageously suited for patients who are relatively highly sensitive to increases in atrial pressure. For example, when pressure increases in the ventricles and / or atria and is applied to the cardiomyocytes, the heart muscle may typically tend to contract relatively stiffly depending on the amount of blood being processed. Therefore, patients with impaired ventricular contractility may become more sensitive to higher pressures in the ventricles and / or atria as the heart may not be able to adequately respond to or react to them, due to ventricular dilation or stretching. Furthermore, increased left atrial pressure can lead to dyspnea, and therefore, atrial shunts may be intended to reduce left atrial pressure to decrease dyspnea and / or reduce readmission rates. For example, when the ventricles experience dysfunction to the point of being unable to adapt to increased fluid pressure, this fluid may flow back into the atria, increasing atrial pressure. For heart failure, minimizing left ventricular end-diastolic pressure may be of paramount importance. Because left ventricular end-diastolic pressure can be correlated with left atrial pressure, the reflux of fluid in the atria can lead to the reflux of fluid in the lungs, resulting in unwanted and / or dangerous effusion in the lungs. Atrial shunts (e.g., using a shunt device according to embodiments of this disclosure) can divert additional fluid from the left atrium to the right atrium, which may be able to hold the additional fluid due to its relatively high compliance.

[0160] In some cases, atrial shunt surgery may not be effective enough because the patient is undergoing a pharmacological treatment regimen designed to control fluid output and / or pressure. For example, diuretics are used to drain excess fluid from the patient. Therefore, the use of an implant with an integrated pressure sensor according to embodiments of this disclosure can provide a mechanism to inform a technician or physician / surgeon how to titrate such medications to adjust / modify fluid status. Thus, embodiments of this disclosure can be advantageously used to guide pharmacological interventions to reduce or prevent undesirable increases in left atrial pressure.

[0161] In some embodiments, the sensor-integrated shunt implantation device according to embodiments of the present disclosure can be implanted in the wall separating the coronary sinus from the left atrium. For example, atrial shunt can be achieved through the coronary sinus. Figure 8 A sensor implantation device 80 is shown, which is implanted in the tissue wall 83 between the coronary sinus 16 and the left atrium 2. Figure 8 And many subsequent figures show a heart from a top-down perspective, with the back facing the top of the page.

[0162] In some cases, atrial shunts via a shunt device 80 implanted in the wall 83 between the left atrium 2 and the coronary sinus 16 can be superior to shunts via the interatrial septum 85. For example, shunts via the coronary sinus 16 can reduce the risk of thrombosis and embolism. Thrombi / emboli are unlikely to form in the coronary sinus for several reasons. First, blood draining from the coronary vascular system into the right atrium has just passed through capillaries, so it is essentially filtered blood. Second, the right atrial coronary sinus ostium is often partially covered by a pseudovalve known as the thebesian valve. The thebesian valve is not always present, but some studies suggest it is present in most hearts and can prevent thrombi or other emboli from entering in the event of a surge in right atrial pressure. Third, the pressure gradient between the coronary sinus and the right atrium into which blood drains is typically relatively low, making it more likely that thrombi or other emboli in the right atrium will remain there. Fourth, if a thrombus / embolus does enter the coronary sinus, the gradient between the right atrium and the coronary vascular system will be much greater than the gradient between the right atrium and the left atrium. Most likely, the thrombus / embolus will travel down the coronary vascular system until the pressure in the right atrium returns to normal, and then the embolus will return directly to the right atrium.

[0163] Some additional advantages of positioning the shunt structure 82 between the left atrium and the coronary sinus are that this anatomy is generally more stable than the interatrial septum tissue. By diverting blood from the left atrium to the coronary sinus, sinus pressure may increase slightly. This will cause blood in the coronary system to travel more slowly through the heart, thereby increasing perfusion and oxygen transfer, which will be more efficient and may also help recover dying myocardium.

[0164] In addition to the benefits mentioned above, by implanting the shunt device 80 into the wall of the coronary sinus 83, damage to the atrial septum 85 can be prevented. Therefore, the atrial septum can be preserved for later transseptal access for replacement therapy. Preserving the transseptal access may be advantageous for various reasons. For example, patients with heart failure often have many other comorbidities, such as atrial fibrillation and / or mitral regurgitation; some treatments for these conditions require transseptal access.

[0165] It should be noted that, in addition to the various benefits of placing the implant 80 between the coronary sinus 16 and the left atrium 2, certain disadvantages can also be considered. For example, by shunting blood from the left atrium 2 to the coronary sinus 16, oxygenated blood from the left atrium 2 can be diverted to the right atrium 5 and / or anaerobic blood from the right atrium 5 can be diverted to the left atrium 2, both of which may be undesirable for the normal functioning of the heart.

[0166] Access to the target wall 83 and left atrium 2 via the coronary sinus 16 can be achieved using any suitable or desired procedure. For example, according to embodiments of this disclosure, various access routes can be used to manipulate guidewires and catheters in and around the heart to deploy scalable shunts integrated with or associated with pressure sensors. In some embodiments, access to the superior vena cava (not shown), right atrium 5, and from there to the coronary sinus 16 can be achieved via the subclavian or jugular vein. Alternatively, the access route can begin from the femoral vein and proceed through the inferior vena cava (not shown) to the heart. Other access routes may also be used, each typically utilizing a percutaneous incision through which the guidewire and catheter are usually inserted into the vascular system via a sealed guide tube, and from there the system can be designed or configured to allow a physician to control the device distally from outside the body.

[0167] In some embodiments of the procedure for advancing an implantable device according to aspects of this disclosure, a guidewire is introduced through the subclavian or jugular vein, through the superior vena cava, and into the coronary sinus. Once the guidewire has provided a path, typically using a dilator, a guide sheath can be advanced along the guidewire and into the patient's vascular system. The delivery catheter can be advanced through the superior vena cava into the coronary sinus of the heart, where the guide sheath can provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may serve to form and prepare an opening in the wall of the left atrium, and a separate placement or delivery catheter will be used to deliver an expandable shunt. In other embodiments, the deployment catheter may serve as both a puncture preparation and a fully functional implant delivery catheter. In this application, the terms "deployment catheter" or "delivery catheter" are used to refer to a catheter or guide having one or both of these functions.

[0168] like Figure 8 As shown, the coronary sinus is typically continuous around the left atrium 2, and therefore there are a variety of possible acceptable placements for the implanted device 80 and / or shunt structure 82. The target site selected for placement of the shunt structure 82 can be fabricated in areas of less thick or less dense tissue in a particular patient, as predetermined by non-invasive diagnostic means such as CT scans or radiographic techniques (such as fluoroscopy or intravascular coronary echo (IVUS)).

[0169] Additional aspects and features of the process for delivering a shunt structure that can be integrated with sensor devices / functions, according to an embodiment of this disclosure for implantation in the wall between the coronary sinus and the left atrium, are disclosed in U.S. Patent No. 9,789,294, entitled "Expandable Cardiac Shunt," issued October 17, 2017, the disclosure of which is incorporated herein by reference in its entirety. Although the implanted device 80 is shown in the wall of the left atrium / coronary sinus, the implanted device 80 may be positioned between other cardiac chambers, such as between the pulmonary artery and the right atrium.

[0170] Sensor support / holding strut / structure Figure 9 A perspective view of a diversion device 90 is shown, in a configuration at least partially collapsed, for delivery via a delivery sheath or conduit (not shown). The diversion device 90 includes a sensor support structure / arm 91 attached to or associated with an arm 92 of the diversion device.

[0171] Figure 10 The illustration shows a sensor implantation device 90 having an integrated sensor 100 mechanically attached or secured to a portion of a shunt structure 97. The shunt structure 97 includes a sensor support structure / arm 91, which may be integral with the shunt structure 97. In some embodiments, the support 91 is an extension of or otherwise associated with an arm member 92 of the shunt structure 97. The sensor 100 can be attached to the support structure / arm 91 by any suitable or desired attachment means, including adhesive attachment or mechanical engagement. For example, the sensor support 91 may include or be associated with one or more retaining features 98, which may include one or more clamps, straps, ties, sutures, collars, clips, tabs, or the like. Such retaining features 98 may circumferentially enclose or hold the sensor 100 or a portion thereof. In some embodiments, sensor 100 may be attached to sensor support 91 by applying mechanical force, either by sliding sensor 100 through retaining feature 98, or by clamping, locking, or otherwise engaging sensor 100 to sensor support 91 by pressing or applying other mechanical force thereto. In some embodiments, retaining feature 98 includes one or more tabs that may be configured to pop out or extend on one or more sides of sensor support 91 for mechanical fastening. Such tabs may include shape memory metal (e.g., nitinol) or other at least partially rigid materials. In some embodiments, sensor support 91 is at least partially non-rigid. For example, sensor support 91 may include a non-rigid tether configured to allow sensor 100 to float. Such a configuration may advantageously allow sensor 100 to move with blood flow.

[0172] In some embodiments, the sensor 100 is pre-attached to and / or integrated with the sensor support 91 prior to implantation. For example, in some embodiments, the sensor support 91 forms at least a portion of the housing of the sensor 100, such that the sensor support 91 and at least a portion of the housing of the sensor 100 are integral.

[0173] In some embodiments, the angle or position of the sensor support 91 and / or the sensor 100 relative to the longitudinal axis 99 of the shunt structure 97 causes the sensor to protrude away from the longitudinal axis 99. For example, when the shunt structure 97 is dimensioned to engage with biological tissue along the longitudinal axis 99, the sensor 100 may advantageously protrude at least partially away from the biological tissue, such as into a chamber (e.g., the atrium of a heart). In some embodiments, the sensor support 91 is configured, or may be configured, to be substantially perpendicular or 90° oriented relative to the axis 99, such that the sensor is substantially orthogonal to the longitudinal axis of the shunt. Such a configuration may advantageously allow the sensor element to be positioned away from the desired distance of the shunt flow along the flow path axis 94.

[0174] The sensor element 102 of the sensor 100 can be disposed or positioned at any location on the sensor 100. For example, the sensor element 102 can be advantageously disposed at or near the distal portion 107 of the sensor 100. Alternatively or additionally, the sensor element can be disposed or positioned at or near the proximal portion 105 of the sensor 100.

[0175] Sensor device 100 may include one or more electrically coupled components 108, which may include, for example, one or more conductive (e.g., metallic) coils. Such coils may be configured to wirelessly couple inductively to an external transmitter / receiver. The one or more electrically coupled components may have a magnetic core (e.g., iron; ferrite) to provide desired permeability and / or conductivity characteristics. Various embodiments disclosed herein provide sensor holding structures configured to hold and / or secure certain sensor devices that may be similar to sensor device 100 in one or more respects. In cases where such sensor holding structures include conductive support arms (e.g., shape memory metal or other metals), when conductive features of the sensor holding structure axially overlap with the one or more electrically coupled components 108, such conductive features may interfere with signals transmitted to or from the one or more electrically coupled components 108. Therefore, it should be understood that the various sensor holding features disclosed in connection with any embodiment of this disclosure may be designed to reduce the degree of axial overlap between their conductive features and the associated sensor device's one or more electrically / wirelessly coupled components. Furthermore, sensor devices used in conjunction with various embodiments of the sensor holding structures disclosed herein can be configured such that their electrically coupled components have a minimum amount of axial overlap with the conductive features of the corresponding sensor holding structure.

[0176] Figure 11A and Figure 11B A perspective view of a medical implantable device is shown, comprising a sensor support strut / arm and a fabric and / or polymer wrap configured to at least partially secure a sensor device to the sensor support strut / arm. The polymer wrap may include a 0.003-inch (") expanded polytetrafluoroethylene (ePTFE) biaxial membrane and / or certain sutures (e.g., PET sutures) above and / or below the membrane. In some embodiments, the wrap 113 is wound circumferentially and / or axially around the sensor support strut 112 on the sensor cylinder.

[0177] The sock or wrap 113 may comprise a polymer and / or fabric material, which may take the form of one or more strips of material extending across the length of the cylinder 114. LAt least a portion of the material is circumferentially wrapped around the cylinder / sensor 114. In some embodiments, the sock / wrap 113 has a sock-like form and is pulled or applied to the cylinder and sensor support pillar / structure 112. For example, sutures or other types of thread or suture may be wrapped around the sock to secure it to the sensor 114 and pillar 112. Such sutures / threads may include ePTFE, PET, or the like. With embodiments incorporating suture / thread reinforcement (e.g., sutures), it may be desirable to protect such features from inward tissue growth. In some embodiments, suture / thread reinforcement is omitted to prevent unwanted inward tissue growth.

[0178] Figure 12A Figures and Figure 12B A perspective view of a medical implantable device including a sensor support structure or assembly 120 is shown. The sensor support structure or assembly 120 includes a sensor support strut / arm and a retaining device or feature 123 of the type of membrane stocking or wrapping, configured to at least partially secure a sensor device to the sensor support strut / arm. The membrane wrapping may include a polytetrafluoroethylene (PTFE) and / or polyurethane (PU) membrane (e.g., electrospun or rotary-jet spun). In some embodiments, the membrane 123 is wound in a strip circumferentially and / or axially around the sensor cylinder and around the sensor support strut 122 and the sensor device 124 supported / held by the sensor support structure 120.

[0179] In some embodiments, the membrane has certain thermal and voltage properties relative to its application process(s) to avoid causing undesirable effects / damage to sensor 124. Wraps, stockings, sleeves, membranes, coatings, or similar types of features described herein in conjunction with various disclosed embodiments can be applied to the sensor holding structure and / or the sensor in any suitable or desired manner. For example, in some embodiments, such materials can be applied using one or more electrospinning processes. Certain methods, apparatus, and systems relating to the electrospinning concept applicable to embodiments of this disclosure are disclosed in U.S. Publication No. 2017 / 0325976, the entire contents of which are incorporated herein by reference. Electrospinning of PTFE is described in U.S. Patent Publication No. 2010 / 0193999, which is incorporated herein by reference. Other processes that can be implemented to apply wraps, stockings, sleeves, membranes, or similar features may include rotary jet spinning. Certain methods, apparatuses, and systems relating to the concept of rotary jet spinning applicable to embodiments of this disclosure are disclosed in U.S. Patent No. 9,410,267, the entire contents of which are incorporated herein by reference.

[0180] Figure 13A and Figure 13BThe illustration shows a perspective view of a sensor implantation device 130 having an integrated sensor 134 attached to a portion of a shunt structure 139, according to one or more embodiments. The sensor 134 is attached to or held within a bag or sock 133, which is attached to or otherwise associated with an arm / support member 132 or another portion of the shunt structure 139 (e.g., anchoring arm 131). For example, the bag 133 may be a stitch-based or fabric-based bag (e.g., fiber and / or polymer fabric), wrap, or other holding material and / or form.

[0181] The bag 133 may include any suitable or desired material, including polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), or similar and / or combinations thereof. In some embodiments, this material may be electrospun onto the sensor 135, or it may be applied using rotary jet spinning.

[0182] In some embodiments, the sensor 134 is configured to be slidably disposed within the bag 133, wherein tension and / or compression of the bag 133 serves to hold the sensor 134 in a fixed position within the bag 133. Although Figure 13A and Figure 13B The illustration shows a bag / wrap that encapsulates at least a portion of sensor 134 in a sock-like / tubular manner; however, in some embodiments, bag 133 includes straps or other non-encapsulated holding devices. In some embodiments, sensor 134 may be sewn or otherwise attached or secured to bag 133. Furthermore, bag 133 may be sewn or otherwise secured or attached to arm member 132 of shunt structure 139. Bag 133 may advantageously be open at one or both of its distal and proximal ends to allow liquid contact with the sensor element / transducer associated with sensor 134. That is, sensor 134 may be exposed through an open portion at the distal or proximal end of support 132 and / or bag 133.

[0183] Figure 14A and Figure 14B A perspective view of a medical implantable device including a sensor support strut / arm and a membrane wrapping configured to at least partially secure the sensor device to the sensor support strut / arm is shown. The membrane wrapping may comprise a polytetrafluoroethylene (PTFE) and / or polyurethane (PU) membrane (e.g., electrospun or spin-jet spun). In some embodiments, the membrane wrapping 143 comprises a carbothane balloon and / or laser welding. In some cases, the use of a carbothane balloon or the like may provide desired manufacturing and biocompatibility benefits.

[0184] Sensor holding structure with sensor holding fingers and other features Figure 15-1 and Figure 15-2 A perspective view of a medical implantable device 150-1, 150-2 is shown, including corresponding sensor support struts / arms 152-1, 152-2 and associated buckles and / or strap components 153-1, 153-2 and 155-1, 155-2. The buckles and / or strap components 153, 155 can be configured to engage with each other to secure a sensor device (not shown) to the sensor support strut / arm 152.

[0185] about Figure 15-1 The strip member 155b-1 (and / or 155a-1) can be formed into an elongated, at least partially rectangular shape, with a width of w 1 The dimensions are designed to be the internal width of the coupling portion / hole 159b-1 (and / or 159a-1) of the buckle member 153b-1 (and / or 153a-1). w 2 The coupling portion / hole 159-1 is designed to slide across the length of the strap member 155b-1 to provide engagement with it. For example, the strap 155-1 can be secured in a locking position within the coupling portion / hole 159-1 by friction fit and / or shape memory fit. Furthermore, when the strap 155-1 is secured in the hole 159-1, the distal crossbar 156-1 can hold the strap 155-1 downward and / or in place.

[0186] about Figure 15-2 The strap component 155b-2 (and / or 155a-2) may include a clasp 154, which is shaped as an elongated, at least partially rectangular shape, with a width of w 3 The dimensions are designed to be the internal width of the coupling portion / hole 159b-2 (and / or 159a-2) of the buckle member 153b-2 (and / or 153a-2). w 4The coupling portion / hole 159-2 is designed to slide across the length of the latch 154 to provide engagement with it. The latch member 154 may typically protrude and / or be rearwardly oriented toward the base 158 of the sensor holding structure 150-2, such that, in order to insert the latch 154 into the hole, the buckle member 153-2 can be brought above (or below) the strap member 155-2 far enough to allow the latch 154 to bend and pass through the hole 159-2. When the buckle and strap are pulled outward after the latch 154 has engaged with the hole 159-2, the rearward protrusion / or orientation of the latch 154 can hold the buckle 153-2 and the strap 155-2 together. For example, the crossbar 156-2 of the buckle 153-2 can remain abutting against the crossbar portion 157-2 of the strap member 155-2 and / or the latch 154. The strap 155-2 can be further secured in a locking position within the coupling portion / hole 159-2 by friction fit and / or shape memory fit.

[0187] Figure 16A and Figure 16B A perspective view of a medical implantable device 160 is shown, including a sensor support strut / arm 162 and one or more buckle and / or strap members 163, 165 and / or one or more axial retention features 166 associated therewith. The buckle and / or strap members 163, 165 can be configured to engage with each other to secure a sensor device (not shown) to the sensor support strut / arm 162. One or more axial retention features can be configured such that when feature 166... Figure 16C The engagement shown prevents the sensor device, which is fixed to the sensor support strut / arm 162, from sliding proximally and / or axially.

[0188] The strap member 163 may include one or more fastening features 167, which are shaped to form tabs, the width of which is... w 5 The dimensions are designed to fit within the corresponding coupling portion / hole 169 of the corresponding relatively oriented buckle member 165. w 6The coupling portion / hole 169 is slidable thereon to provide engagement with the latch 167. The latch member 167 may typically project and / or be rearwardly oriented toward the base 168 of the sensor holding structure 160 and / or the base of the strap member 163, such that, in order to insert the latch 167 into the hole 169, the buckle member 165 can be brought above (or below) the strap member 163 far enough to allow the latch 167 to bend and / or pass through the hole 169. When the buckle and strap are pulled outward after the latch 167 has engaged with the hole 169, the rearward projection / or orientation of the latch 167 can hold the buckle 163 and the strap 165 together. For example, the distal crossbar of the buckle 165 can be held against the distal portion of the strap member 165 and / or the latch 167. The strap 165 can be further secured in a locked position within the coupling portion / hole 169 by friction engagement and / or shape memory engagement.

[0189] Figures 17A to 17C Perspective and end views of at least a portion of a medical implantable device 170 including a sensor holding structure 170 according to one or more embodiments are shown, the sensor holding structure 170 including a sensor support strut / arm 172 and one or more sensor holding fingers 173. The one or more sensor holding fingers 173 may include one or more holes 175 or be configured to facilitate or allow adhesive fixation of the one or more fingers 173 to other features of a sensor device configured to contact and / or be close to the one or more fingers 173. Figure 17B A sensor holding structure 170 is shown with a sensor device 174 thus at least partially held or at least partially held therein, wherein an adhesive material 176 is applied to or through a hole feature 175 to secure one or more fingers 173 to the sensor 174.

[0190] Adhesive 176 can be any suitable type of adhesive. Adhesive 176 is advantageously biocompatible to facilitate implantation of the implantable device into the body. Although four fingers 173 are shown, each with an adhesive engagement hole / feature 175, it should be understood that structure 170 can have any number of fingers and / or adhesive engagement features. Furthermore, although closed holes are shown as… Figure 17A and Figure 17BThe adhesive-bonded feature 175 is described, but it should be understood that the adhesive-bonded feature implemented in any embodiment of this disclosure may be open, closed, and / or have any other suitable or desired shape or form. In some embodiments, adhesive 176 is applied to the finger 173 and the sensor 174 on the outer portion of the finger(s) 173. That is, there may be no adhesive-bonded hole; instead, adhesive may be applied to the finger(s) 173 at or near the contact point between the respective finger(s) 173 and the sensor 174. For example, adhesive 176 may be applied to the underside of the finger(s) 173 such that the adhesive is disposed between the finger(s) 173 and the sensor 174. Additionally or alternatively, adhesive 176 may be applied to the side(s) of the finger(s) 173 and contact the sensor 174.

[0191] Figures 18A to 18C A perspective view of at least a portion of a medical implantable device 180, comprising a sensor support strut / arm 188 and a sensor holding overmolded support form 183, according to one or more embodiments, is shown. The strut / arm 188 may include one or more holes 186 or other features configured to facilitate or allow adhesive fixation of the strut 188 to a sensor device 184 disposed in contact with and / or near the strut 188. In some embodiments, the shape of the holes 186 and / or the arm 188 is advantageous for coupling with the overmolded support form 183. Figure 18B A medical implantable device 180 is shown with a sensor device 184 thus at least partially held in place, wherein the sensor 184 is at least partially nested within an overmolded support form 183.

[0192] The overmolded support form 183 can be rigid or flexible. In some embodiments, the overmolded part is incorporated into the sensor 184 and / or support pillar 188 by heat setting or other processes. The sensor can be inserted into the overmolded support template 183, or the overmolded support form 183 can be applied to the sensor 184 and support pillar 188 after the sensor 184 has been placed on the support pillar. Although a hole 186 is shown, it should be understood that the support pillar may not have such a hole and may have any suitable or desired shape, form, and / or configuration.

[0193] Figures 19A to 19EA portion of a medical implantable device 190 is shown, comprising a sensor support strut / arm 198 associated with a plurality of sensor holding fingers 193, 195. At least two of the plurality of sensor holding fingers 193, 195 are mechanically locking fingers 195 capable of being locked using certain locking features 196, which can be configured to mechanically engage in a certain manner, as shown. The sensor support strut / arm 198 may further include a distal axial holding feature 197 and / or a proximal axial holding feature 192 for further holding a sensor 194 (see Figure 195). Figures 19C-19E It is fixed in the desired position.

[0194] Axial restraint / holding features 197, 192 can have any suitable or desired configuration. In some embodiments, the distal axial holding feature 197 includes a shape-defined, inwardly projecting tab that may have a shape corresponding to at least a partially curved / wavy profile of an inwardly curved circumferential arcuate portion of a cylindrical form. Reference Figure 19C , Figure 19C A distal view is shown of a sensor device 199 held to / held therein by an implanted device 190, wherein an axial holding feature 197 (also referred to as an "eyebrow" feature) may radially overlap at least a portion of the circumferential / peripheral region of the sensor device / transducer component 199. The overlapping portion of the sensor 199 may advantageously not cover the sensing membrane of the sensor device / transducer 199. That is, the radial overlap of the sensor 199 by the axial holding feature(s) 197 may not significantly affect the sensing function of the sensor 194 and / or its sensor element 199.

[0195] The proximal retaining feature 192 may include one or more tabs / fingers configured to bend inward toward the axis of sensor 194 or otherwise deflect or curl inward. The radial overlap of the tabs / fingers 192 can be used to prevent sensor 194 from sliding proximally past the tabs / fingers 192. The shape of the proximal retaining feature 192 may be sized to be smaller than the radius of curvature of the outer cylindrical form of sensor 194 and / or smaller than the radius of curvature of the finger 193 that is at least partially wrapped around the body of sensor 194.

[0196] The intermediate sensor-holding finger is axially positioned between the distal axial holding feature 197 and the proximal axial holding feature 192, and is configured to prevent the sensor 194 from being pulled away from the sensor support strut 198 when at least partially wrapped around the cylindrical body of the sensor 194. The finger 193 may be relatively longer than the finger 192, and in some embodiments may be laser-cut.

[0197] Figures 20A to 20E A portion of a medical implantable device 200 is shown, including an arm structure 201 associated with a housing attachment flange configured to attach to a sensor holding housing 203 configured to hold a sensor device 204. The sensor holding housing 203 may further include a distal slit feature configured to facilitate insertion of the sensor device 204 therein. The flange feature 202 may be shape-set and mechanically locked to the housing 203, which may comprise polyetheretherketone (PEEK) or other thermoplastic resins and / or polymers.

[0198] In some embodiments, PEEK is used for the sensor holding housing 203 because certain properties of it may be desirable for use in the sensor holding embodiments and features disclosed herein. For example, PEEK can be considered a relatively inert material and can inhibit pannus growth thereon. Furthermore, PEEK is relatively easy to process while providing sufficient rigidity and allowing for the fabrication of relatively thin-walled structures, which may be advantageous for sensor holding features because they can be formed without excessively increasing the overall size of the sensor holding device. For example, the walls of some portions of the PEEK sensor holding features disclosed herein can be as thin as 0.005 inches. In some embodiments, the sensor holding housing 203 can be formed by machining processes or by reflow soldering.

[0199] The proximal housing retaining ring / flange 202 can be configured to snap / clamp into a corresponding mating recess / clamp feature 206. In some embodiments, the proximal housing / ring coupling feature 206 of the sensor retaining housing 203 can be engaged with the housing retaining ring 202, wherein after such engagement, the feature 206 can be melted or otherwise wound around the ring 202 to create a mechanical bond / coupling therewith. That is, the material of the housing 203 can be reflow soldered onto the ring 202 to create a bond / coupling therewith.

[0200] The housing 203 may include a distal slot 205 that allows the circumference of the housing 203 to expand outward to receive the sensor device 204 therein. In some embodiments, once the sensor 204 is inserted into the inner cavity / cavity of the housing 203, a distal ridge / shoulder feature 211 of the housing 203 can be used to axially hold the sensor 204 in the housing 203.

[0201] Figure 21A and Figure 21BA portion of a medical implantable device 210 is shown, comprising an arm structure 211 associated with one or more sets of sensor holding and / or housing connecting fingers 215. The fingers 215 are configured to engage and / or assemble with corresponding features 212 of a sensor holding cover / housing 213. A sensor device 219 may advantageously be at least partially contained within the cover 213 and at least partially recessed bracket arm portions 218.

[0202] In some embodiments, sensor device 219 may be attached to arm 218, after which cover 213 may snap / set onto sensor cylinder 219. In some embodiments, sensor 219 may be placed inside cover 213, wherein the combined sensor 219 and cover 213 may then be placed on arm 218. Fingers 215 may advantageously be wrapped only around the circumferential portion of the sensor, such that opposing fingers do not contact each other during implantation, thereby providing a gap between opposing fingers through which sensor 219 can be pressed / inserted.

[0203] The cover 213 may include a distal ridge / shoulder feature 217, which can be used to axially hold the sensor 219 within the cover 213 once the sensor 219 is covered by the cover 213. Fingers 215 may be fitted into an axial / circumferential gap 212 within the cover 213, wherein this engagement between the fingers 215 and the gap 212 prevents axial movement of the cover 213 relative to the arm 218.

[0204] Figure 22A and Figure 22B A portion of a medical implantable device 220 is shown, comprising a sensor support strut / arm 228 associated with a plurality of sensor holding fingers 225, at least two of which are mechanically locking fingers that can be locked using certain locking features 226, 227. The sensor support strut / arm 228 may further include certain mating features (e.g., holes) 223 for mating with corresponding features (not shown) of a sensor device 224 to further secure the sensor device 224.

[0205] The mating feature 223 can be configured and sized to receive, at least partially, a corresponding protrusion associated with the sensor cylinder 224. With the corresponding protrusion / feature of the feature 223 and sensor 224 engaged / mated together, axial movement of the sensor 224 within the retaining finger 225 can be restricted. In some embodiments, an adhesive layer can be applied to the sensor 224 and / or the arm 228 and / or between the sensor 224 and / or the arm 228 to secure the sensor 224 to the arm 228. This adhesive can further at least partially fill the feature 223 of the arm 228. Furthermore, any embodiments herein may include an adhesive between the sensor retaining arm component (e.g., a metal component) and the sensor thereby retained.

[0206] Figure 23A and Figure 23B A portion of a medical implantable device 230 is shown, comprising sensor support struts / arms 238 associated with multiple sets of sensor holding fingers 235, wherein the sets may or may not have different widths. In some embodiments, the implantable device 230 includes one or more axially retaining features, such as one or more stop tabs 236 or the like, at the distal and / or proximal ends of the sensor support struts / arms 238. The sensor support struts / arms 238 may further include certain mating features (e.g., one or more grooves) 233 for mating with corresponding features (not shown) of the sensor device 234 to further secure the sensor device 234. For example, the device 230 may include one or more longitudinally laser-cut grooves that engage and / or lock with one or more corresponding features (e.g., one or more glass protrusions) associated with the sensor device 234.

[0207] The process for securing sensor 234 in sensor holding structure 230 may include inserting a stud / protrusion component of sensor 234 into a longitudinal recess 233 of arm 238. The stud / protrusion may be configured to fit within the recess 233. In some embodiments, the stud / protrusion of the sensor (e.g., a glass or metal protrusion from one or more portions of sensor 234) may be located at or near the distal or proximal end of the sensor. Once the stud / protrusion reaches the circumferential recess 237, the sensor can be rotated to nest the stud / protrusion within the recess to restrict axial movement of sensor 234. Although the recess 237 is in Figure 23A and Figure 23BThe notch 237 is shown at the proximal end of arm 238, but it should be understood that the notch 237 may be at the distal end of arm 238, or at any other point along the length of arm 238. Furthermore, the stop tab 236 may be at the distal end of arm 238, as shown, to prevent the sensor 234 from sliding distally, or at the proximal end of arm 238 to prevent the sensor 234 from sliding proximally. The notch 237 may have a longitudinal hook / bend at its end to allow a stud / protrusion of the sensor 234 to be locked therein.

[0208] Placing the tab 236 at the distal end may be undesirable because it may come into contact with the sensor membrane 239, potentially disrupting the sensor signal and / or damaging the sensor element. Therefore, embodiments of this disclosure including such a distal stop tab can be advantageously sized to and / or configured to present a relatively small sensor contact surface, and / or positioned to have a reduced impact on the structure / integrity and / or function of the sensor element 239. The finger 235b may be shape-set / defined and may or may not have any locking / engaging features associated with it.

[0209] Figure 24A and Figure 24B A perspective view of at least a portion of a medical implantable device 240 including a sensor support structure 248 and a trapdoor sensor holding feature, the trapdoor sensor holding feature including one or more flaps or other similar components 242a. In some embodiments, the sensor device 244 can be at least partially secured in the sensor holding arm 240 by allowing the sensor 244 to pass through or fall through a gap 247 in the trapdoor feature (e.g., between flaps 242a, 242b), which allows inward opening in the direction of the arm structure 248, while once through, the flaps 242a, 242b can at least partially prevent the sensor 244 from returning through the trapdoor feature.

[0210] The sensor support structure 248 may include a ring 245 to which the flip valve 242 may be secured in some way. For example, the flip valve 242 may be rotatably coupled to the ring 245. In some embodiments, a stud or other feature of the flip valve / gate 242 is present or formed at its side portion that contacts the corresponding ring 245. Such a feature allows for hinged movement of the flip valve 242. For example, the stud / feature of the flip valve 242 may fit into a corresponding hole or recess in the ring 245, the hole or recess being positioned at the portion of the ring 245 where the flip valve 242 contacts the ring 245.

[0211] Figures 25A to 25CThe illustration shows a perspective view of a medical implantable device 250 including a sensor support arm 258 and one or more tension-fitting rings 255. The rings 255 may be broken and / or include associated gaps 226, whereby such gaps can advantageously allow insertion and / or tensioning / secured of a sensor device within the rings 255. In some embodiments, the rings 255 may be secured or attached to the arm 258 by sliding, attaching, securing, clamping, or otherwise associating the arm 258 with or with a slotted feature 257 of the ring 255.

[0212] The ring 255 can be positioned at any desired location along the arm 258. In some embodiments, the arm 258 includes features such as a recess, base, ridge, or the like to hold the ring 255 in place. In some embodiments, the ring 255 can slide relatively freely along the arm 258. Once the ring 255 has slid / moved to the desired position along the length of the arm 258, a tension fit between the slotted feature 257 and the arm 258 can hold the ring 255 in place. In some embodiments, the shape setting of the ring 255 (e.g., a shape memory ring) can introduce forces on the arm 258 for holding the ring in place.

[0213] Figures 26A to 26E The illustration shows a perspective view of a medical implantable device 260 including a sensor support arm 268 and one or more clamping features 265. In some embodiments, the clamping features 265 include an inwardly deflected retaining tab 266 configured to apply tension and / or pressure to a sensor device disposed therein.

[0214] The retaining tab 266 can have any suitable or desired form and can be laser-cut or otherwise cut from the cylinder or sheet forming the clamp feature 265. One or more tabs 266 can provide compressive frictional retaining functionality relative to the sensor 264. In some embodiments, shape memory settings can be used to achieve inward deflection of the tab 266. Although when in… Figures 26A-26E In the illustrated sensor holding configuration, the clamp features 266 are shown with a gap 269 between them; however, in some embodiments, the edges of the clamp features 266 may contact each other, or be closer than shown. The clamp features 266 advantageously wrap around a large portion of the circumferential region of the sensor cylinder 264, thereby preventing movement of the sensor 264 in a direction away from the base 268 of the holding structure 260.

[0215] In the deflection configuration shown, the tab may have an axially flat sensor contact portion 266a and a deflection portion 266b. The sensor contact portion may provide a surface contact area to provide frictional retention with the sensor 264, wherein the deflection portion 266b provides an inward force on the sensor contact portion 266b to maintain surface contact and increase friction between the sensor contact portion 266a and the sensor 264.

[0216] Figure 27A and Figure 27B The illustration shows a perspective view of at least a portion of a medical implantable device 270, including a sensor support arm structure 278 and one or more opposing circumferentially wound fingers 273. The one or more opposing circumferentially wound fingers 273 may be used to provide tension fit and / or encapsulation fit to secure the sensor device 274 therein, such as... Figure 27B As shown. The fingers 273 can be offset axially / longitudinally from each other. For example, when the fingers 273 are in a wound / sensor-holding configuration, the fingers on one side of the sensor support arm 278 can interleave / alternate with the fingers originating from the other / opposite side of the sensor support arm 278, as shown.

[0217] One or more retaining fingers 273 may be radially compressed against the outer surface of the sensor cylinder 274. The compression shape and force of the one or more fingers 273 may be provided by shape memory settings. Although five fingers 273 are shown, it should be understood that the sensor retaining structure 270 may include any suitable or desired number of retaining fingers. Furthermore, although the fingers are shown to originate from both longitudinal sides of the support arm / pillar 278, in some embodiments, one or more fingers may originate from only one side of the support arm 278.

[0218] Figure 28A and Figure 28B The illustration shows a perspective view of at least a portion of a medical implantable device 280 including one or more forks 283 connected to a sensor support arm / structure 288. In some embodiments, the sensor device 284 may be positioned between, adjacent to, near, or otherwise opposite to the forks 283, wherein a cannula 285 or other circumferential support feature may be placed, wrapped around, and / or positioned around the sensor 284 and the forks 283, thereby securing the sensor device 284 to the forks 283 and / or the sensor support arm / structure 288. In some contexts, the forks 283 may be considered and / or described as struts. As shown, the forks / struts 283 may project generally distally. For example, the struts / forks 283 may project generally longitudinally / axially.L As shown in the figure.

[0219] The fork 283 and sleeve 285 may comprise ethane or any other material, whether rigid or flexible. In some embodiments, the sleeve / material 285 may be formed / positioned on at least a portion of the length of the sensor 284, wherein the fork 283 may subsequently slide between the sleeve / material 285. The sleeve material may then be reflow soldered and heat-shrinked over the sensor 284, sleeve 285, and / or fork 283 to enhance the retention properties of the sleeve 285. The fork 283 may have certain bending features to prevent the fork 283 from sliding directly out from under the sleeve 285. The length of the fork 283 may extend beyond the sleeve 285 relative to the length of the sensor 284 and / or fork 283.

[0220] Proximal sensor attachment feature Figures 29A to 29D The illustration shows a perspective view of at least a portion of a medical implantable device 290 including a sensor support structure / arm 298, which includes a proximal stop feature 293. The proximal stop feature may include a hole, aperture, or similar feature 296, wherein a sensor device 294 may be disposed on the sensor support structure 298 such that its proximal end 297 is positioned near the proximal stop 293 and / or the hole 296. In some embodiments, an adhesive 292 may be at least partially disposed within the hole 296 to at least partially secure the sensor device 294 and / or its proximal end 297 to the stop 293, the hole 296, and / or the sensor support arm 298. The structure / form 293 may typically project radially and / or orthogonally relative to the axis (e.g., longitudinal axis) of the sensor support arm / arm 298. According to some embodiments, the structure / form 293 may be considered a sensor attachment structure because it can be used to attach to a sensor device, thereby providing a retention function. For example, sensor attachment structure 293 can be configured to attach / fix to the proximal portion of a sensor device (e.g., a cylindrical sensor device). The illustrated proximal sensor attachment structure 293... Figure 29A The structure is shown as a tabular structure with at least a portion of orthogonally protruding holes.

[0221] Hole 296 is shown as circular, but may have any suitable or desired shape or size. In some embodiments, hole 296 is not closed. For example, the top portion of hole 296 (relative to...) Figure 29B The orientation shown is open, so that the proximal stop feature 293 has a forked tip / fork-shaped form.

[0222] Figures 30A to 30DThe illustration shows a perspective view of at least a portion of a medical device including a sensor holding structure 300, which includes a sensor support structure / arm 308 and a proximal stop feature 303 capable of aspiration. The proximal stop may include one or more suction cups 305, wherein such suction cups(s) are configured such that a sensor device 304 and / or its proximal surface / part 307 can engage with the suction cups(s)305, thereby aspirating the sensor device 304 and / or its proximal end 307 to the proximal stop 303 and / or the sensor support structure / arm 308. In some embodiments, an adhesive may be used to hold the suction cups(s)305 against the proximal end of the sensor 304. Although the suction cups 305 are shown at the proximal end of the support arm 308, in some embodiments, one or more suction cups may be positioned on the support arm 308 (e.g., relative to...). Figure 30B The orientation shown is upward.

[0223] Figures 31A to 31D The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor retention structure 310, which includes proximal positioning and distally angled stops and / or retention arms / structures 315. The sensor retention structure 310 may further include one or more circumferential sensor retention straps, such as the distal retention strap 313 illustrated. A sensor support structure 318 may be further positioned and / or configured to provide support for a longitudinal portion of a sensor device 314. The proximal arm structure 315 may be configured to engage with the side and / or proximal portion of the sensor device 314. For example, the arm structure 315 may be attached to the proximal end of the sensor device 314 using a hook feature 312 associated with the distal end of the arm 315. In some embodiments, the arm structure 315 is configured to apply spring tension to the sensor device 314.

[0224] The proximal retaining arm 315 may be at least partially flexible, allowing it to adapt to and / or permit changes in the size / length and / or position of a sensor device that can be mounted on the arm 318. That is, the angle of the proximal retaining arm 315 relative to the arm / support structure 318... θ It can be adjustable to fit a specific sensor set on arm 318.

[0225] The proximal retaining arm 315 can push the sensor 314 to a certain extent in the direction toward the arm 318 and in the distal direction. Therefore, it may be desirable for the distal retaining band 313 to include shoulder / ridge features, as described herein in conjunction with various other embodiments and figures, to prevent the sensor 314 from sliding axially distally.

[0226] Sensor support arm with holding characteristics Figure 32A and Figure 32B The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor holding structure 320 comprising a sheet or other structure 323, which may be at least partially flat and / or curved at one or more points during manufacturing, delivery, and / or implantation, and is configured to at least partially wrap around a sensor device 324 to provide a tension / compression fit with the sensor device 324, thereby securing the sensor device 324 to the sensor holding structure 320 and / or the associated medical implantable device. The radial compressive force applied by the sheet 323 can effectively hold the sensor 324 in place and can prevent one or both of axial movement of the sensor 324 on / within the sheet 323 and movement of the sensor 324 away from the base 322 of the sheet arm. The sheet 323 may be wound into an at least partially cylindrical or curved configuration before the sensor 324 is inserted, or it may be wound around the sensor 324 after the sensor 324 has been placed thereon.

[0227] Sheet 323 allows for a certain amount of expansion and is therefore adaptable to sensor devices with various diameters or other sizes. In some embodiments, the edges 325 of sheet 323 do not contact each other in a winding configuration, but rather form a “C” shape around sensor 324 and / or form a “C” shape in which sensor 324 can be placed. Sheet 323 can be a flexible form of laser-cut metal or plastic. As with any embodiment of this disclosure, the holding form of sensor holding structure 320 (e.g., the winding configuration of sheet 323) can be achieved through shape memory of one or more of its components. For example, sheet 323 can be shaped into a winding shape and can automatically assume this shape when deployed from a delivery system or freed from any type of constraint used with it.

[0228] Figure 33A and Figure 33B The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor retention structure 330, which includes a sensor support arm structure 338 and one or more sensor retention rings 333. In some embodiments, the sensor support arm includes one or more holes 336 and / or other features configured to allow portions of the sensor retention rings 333 to be snapped, hooked, clamped, and / or otherwise attached or secured thereto or within them. For example, the sensor retention rings 333 may include hook features 335 or the like, configured to at least partially insert into the holes 336 or other similar features of the sensor support arm 338 and become hooked / clamped therein. For example, the hook features 335 may be configured to hook onto the peripheral band / portion 332 of the sensor support arm 338.

[0229] The sensor support arm / support 338 can provide mechanical support for the dock to which the sensor 334 and sensor retaining ring 333 can be anchored. In some embodiments, the bending shape of (one or more) rings 333 is achieved at least partially using shape memory settings. Furthermore, the outward bending tendency of the rings 333 can advantageously provide retaining force to the outer / peripheral band / section 332, and this outward bending tendency can derive from the shape memory characteristics of the rings 333 when bent into... Figure 33A and Figure 33B When configured in a bent shape, this can generate tension in ring 333. That is, when... Figure 33A and Figure 33B As shown in the compression / bending diagram, the ring can exhibit an outward spring-like force, causing it to tend to expand and straighten to some extent. Although in Figure 33A and Figure 33B Three sensor holding rings are shown, but it should be understood that the sensor holding structure 330 may include any suitable or desired number of rings and / or ring mating features, including embodiments containing a single sensor holding ring.

[0230] Figures 34A to 34D The illustration shows a top view, a bottom view, and a side view of at least a portion of a medical implantable device including a sensor holding structure 340. The sensor holding structure 340 advantageously includes a sensor support arm structure 348 having one or more holding clamps 343 associated therewith. The sensor holding clamps 343 can be advantageously configured to protrude away from the sensor support structure 348 to allow one or more portions of a sensor device 344 to be at least partially inserted therein.

[0231] The retaining clamp / eyelet 343 can apply a downward force on the sensor 344 toward the sensor support arm / structure 348 to hold the sensor 344 on the support arm / structure 348 and / or prevent the sensor 344 from sliding axially. Ideally, the downward force of the clamp 343 on the distal and proximal ends of the sensor 344 is insufficient to damage or break the sensor 344. In some embodiments, as with any other embodiment disclosed herein, one or more portions of the sensor retaining structure 340 (e.g., one or more portions of the clamp 343) can be immersed in or coated with a relatively viscous polymer / rubber, such as ethane or the like. This coating can increase the friction between the sensor retaining structure 340 and the sensor 344.

[0232] Figure 35A and Figure 35BThe illustration shows a perspective view of at least a portion of a medical implantable device including a sensor retention structure 350. The sensor retention structure 350 advantageously includes a sensor support arm structure 358 having one or more retention clamps 353 associated therewith. The sensor retention clamps 353 may be advantageously configured to protrude away from the sensor support structure 358 to allow at least partial insertion of one or more portions of a sensor device 354 therein. In some embodiments, the sensor retention structure 350 may further include a distal stop 357, which may be bent or otherwise configured to prevent distal movement of the sensor 354 past the distal stop 357.

[0233] In some embodiments, the shape memory properties of one or more sensor retaining hoops 353 may cause the hoops to tend to push downward toward the sensor support structure 358. This tension may press the hoops 353 onto the sensor 354 to help hold the sensor 354 and / or generate friction between the hoops 353 and the sensor 354 to prevent axial slippage of the sensor 354; radial movement of the sensor 354 may generally be limited by wrapping the hoops around the circumference of the sensor 354.

[0234] Figure 36A and Figure 36B The illustrations show side and axial views of a medical implantable device 360 ​​including certain sensor holding features. For example, the medical implantable device 360 ​​may be a shunt device or any other type of medical implantable device including one or more arms 361, 362. The medical implantable device 360 ​​includes a plurality of arms 361, 362 configured to project axially relative to a shunt tube 367 of the medical implantable device 360. The arms 361, 362 may be arranged together, wherein a sensor device 364 may be at least partially secured by the arms 361, 362 and / or by one or more straps or other sensor holding features 363 at least partially disposed or attached therebetween. Thus, the arms 361, 362 and the sensor holding straps 363 can provide a sensor retainer structure, as shown.

[0235] Figure 36A and Figure 36B The illustration shows implantable arms 361, 362 protruding away from the tissue wall 366 to hold the sensor 364. However, in some embodiments, additional arms may be used to secure the implantable device 360 ​​to the tissue wall 366 in addition to any arm structure extending away from the wall 366. That is, the implantable device may include a sensor holding arm / structure and an implant fixation arm structure on the side of the implantable device 360 ​​where the sensor 364 is held.

[0236] Figure 37A and Figure 37BThe illustration shows a perspective view of at least a portion of a medical implantable device including a sensor retention structure 370. The sensor retention structure 370 may advantageously include a distal sensor retention cage structure 375, which may be attached to or otherwise associated with a sensor support arm 378. The sensor support arm 378 may further include or have one or more opposing fingers 373 associated therewith, which may be configured to provide retention and / or support functionality for the sensor device 374. The sensor support structure 370 may further include one or more distal stop tabs 372, which may be attached to and / or otherwise associated with the distal retention cage 375, as shown in the figure.

[0237] The cage structure 375 can provide an adjustable sensor holding structure. For example, the distal stop tab 372 can be bent inward by bending the coupled post 377 at a desired point on the post 377, resulting in a desired length of the cage suitable for a particular sensor device. The distal tab 372 and / or the post 377 can be shaped according to their shape memory characteristics to bend inward to the extent required to constrain the sensor 374. The distal tab 372 may have a hole 376 or other features therein. Such features may have sutures or other features engaged therein to further secure the tab 372 in place and / or provide axial holding for the sensor 374.

[0238] The sensor holding structure 375 may include a proximal stop feature 3771, such as a tab or the like. The tab 3771 may be foldable and / or tend to fold due to its shape memory properties, protruding away from the arm 378 and providing a surface on which the proximal end of the sensor 374 can rest or be pressed, thereby constraining axial movement of the sensor 374 in the proximal direction. It should be understood that any embodiment disclosed herein may have proximal and / or distal stop tabs that may be shaped to take positions protruding into the axial path of the held sensor to constrain its axial movement.

[0239] Figure 38A and Figure 38B The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor holding structure 380. Figure 38CA flattened configuration of a sensor holding structure 380 according to one or more embodiments is shown. The sensor holding structure 380 includes a cage structure 386 comprising one or more longitudinal struts 383, 388 and / or circumferential struts 385, as shown. The sensor holding structure 380 may further include one or more distal stop tabs 387, which may be flexible, foldable and / or otherwise configured to at least partially prevent or reduce distal movement of the sensor 384 when the sensor 384 is at least partially enclosed within the cage structure 386 of the sensor holding structure 380.

[0240] In some embodiments, the sensor holding structure 380 is integrated with or coupled to an auxiliary sensor support arm 382, ​​which is associated with the sensor holding structure 380 of the implantable device and provides an auxiliary sensor support arm 382 in addition to the tissue-engagement implantable support arm 381. It should be understood that any embodiment of the sensor holding arm / structure disclosed herein may be coupled, attached, integrated with, or otherwise associated with a dedicated / auxiliary sensor support arm rather than with an arm used for tissue engagement to achieve implantable device stability. Such a dedicated and / or auxiliary sensor support arm may have similar characteristics to... Figure 38A and Figure 38B The claw-like configuration is shown. For example, in some cases, the auxiliary sensor support arm may include a first arm 382a and a second arm 382b, which are connected at or near the base of the tissue-attaching arm 381 and integrated with a cage-like or other sensor-holding structure, such as... Figure 38A and Figure 38B As shown. For including auxiliary sensor support arms (e.g., in one or more aspects such as Figure 38A and Figure 38B In any embodiment of the implantable device shown, this auxiliary sensor support arm may protrude away from the tissue wall in a deployment configuration, where the implantable device is implanted to a greater extent / angle than the associated tissue engagement arm of the implantable device when the auxiliary arm is positioned on the same side / region as the implantable device. Those skilled in the art will understand that arm component 382 or similar auxiliary arm support / components may be coupled to various other embodiments of this disclosure.

[0241] Sensor support arm associated with the shunt structure Figure 39The illustration shows a side view of a medical implant device 390 including an axial sensor support arm 393 configured to at least partially hold a sensor device 394 within the axial path of a shunt tube 396 associated with the medical implant device 390. In some embodiments, a strap or other feature 395 may at least partially secure the sensor device 394 to the sensor support arm 393.

[0242] For illustrative purposes, the following will be Figure 39 The medical implantable device 390 is described as a shunt structure. However, it should be understood that the medical implantable device 390 can be any suitable or desired type of medical implantable device. Figure 39 In the illustrated embodiments, the sensor element 399 is attached to or integrated with the arm member 393, which typically extends along the longitudinal dimension or axis of the flow divider 390. However, in some embodiments, the arm 393 extends along a dimension parallel and / or at an angle relative to the flow path, but outside the cylinder. Figure 39 In the illustrated embodiment, sensor 394 is attached to or otherwise integrated with the flow path cylinder or pipe portion of the flow splitting structure 396, such that sensor 394 is positioned within or near the flow path channel associated with cylinder / pipe 396.

[0243] Figure 40 A side view of another embodiment of a shunt-type medical implantable device 400 having a sensor device 404 at least partially fixed thereto is shown. Specifically, the sensor device 404 may be at least partially disposed within a shunt tube 406 of the implantable device 400. For example, the sensor device 404 may be fixed to the tube structure in some way. In some embodiments, a liner (e.g., a shape memory metal and / or polymer mesh or cannula) may be at least partially disposed within the tube 406, such that the sensor 404 is at least partially fixed by frictional forces and / or pressure between the mesh / cannula 45 and the tube structure. The mesh / cannula 405 may be fixed / attached to the tube structure 406 in some way, for example by using sutures, hooks, adhesives, and / or other attachment devices.

[0244] Figures 41A to 41C Another embodiment of a shunt-type medical implant device 1600 having a sensor device 1610 at least partially fixed thereto is illustrated. Figure 41A This is a perspective view of the sensor implantation device 1600. Figure 41A In the illustrated embodiment, sensor 1610 has an elongated cylindrical shape, as is the case with certain other embodiments disclosed herein. However, it should be understood that sensors according to embodiments of this disclosure can have any form, shape, configuration, and / or orientation.

[0245] In some embodiments, sensor 1610 includes a first sensor element 1612 at a first end of sensor 1610, which, when implanted in a patient, is disposed on a first side 1616 of tissue wall 1601 and shunt structure 1620, such as in the wall separating the coronary sinus from the left atrium. For example, sensor 1612 may be positioned to be exposed within the left atrium, which may be represented by the side or region 1616 in the illustrated figure. Sensor 1610 may further include a second sensor 1613 disposed on the opposite side of sensor 1610. For example, sensor 1613 may be configured and positioned to be exposed in a chamber or region associated with the opposite side of tissue wall 1601 and / or shunt structure 1620, such as within the coronary sinus. Regarding atrial shunt, sensor elements 1612, 1613 may be disposed or positioned in their respective atria, with one sensor element providing a pressure reading associated with the left atrium and the other providing a pressure reading associated with the right atrium, as described in detail above. Figure 41A The two sensor elements shown allow for the measurement of the voltage drop across the shunt structure 1620.

[0246] Because sensor 1610 is disposed or attached in or near the flow path channel of the shunt structure 1620, sensor 1610 can be configured to provide sensor readings that can be used to indirectly measure the flow rate through or through the shunt structure 1620, at least in part, based on the liquid momentum associated with the liquid in contact with the sensor element(s). Furthermore, the sensor(s) can generate readings relating to the flow velocity through the shunt, wherein such readings can be used to identify or indicate undesirable blockages or closures in the shunt flow path. In some embodiments, pressure waveforms generated using the sensor(s) can be used to generate and / or maintain waveform graphs relating to the pressure readings. Changes in the pressure reading graphs may indicate health complications and can therefore be used to trigger alarms or notifications, which may be relied upon to change medications or other therapies. In some embodiments, pressure readings from the sensor(s) are analyzed to determine mean pressure, diastolic pressure, and / or systolic pressure data points.

[0247] exist Figures 41A to 16C In some embodiments, sensor 1610 is mounted or attached at or near an opening or channel of the shunt structure 1620, rather than being mounted or attached to one or more arm members as described above. Sensor 1610 may be built into or otherwise integrated with the shunt structure 1620, or may be otherwise attached to or associated with it. Although Figures 41A to 16CThe illustration shows a sensor 1610 attached to or integrated with a cylinder / pipe portion 1622 of the diversion structure 1620 on the outer surface of the diversion structure 1620. However, it should be understood that in some embodiments, the sensor 1610 may be disposed on, attached to, or otherwise integrated with the cylinder / pipe portion 1622 on the inner surface of the cylinder / pipe portion 1622. Regarding the illustrated embodiment, the sensor 1610 may be fitted within a pocket / container feature 1625 of the cylinder / pipe 1622. In some embodiments, the sensor 1610 includes or is associated with one or more protrusions 1627 configured or designed to hold or secure the sensor 1610 to the diversion structure 1620.

[0248] Figure 41B A front view of a sensor implantation device 1600 according to one or more embodiments is shown. Figure 41B The sensor 1610 is shown nested in a pocket / container feature 1625 associated with the cylindrical portion 1622 of the diversion structure 1620. Figure 41C A side view of the sensor implantation device 1600 is shown, illustrating that the sensor 1610 is disposed in the flow path 1603 of the shunt structure. In some embodiments, the sensor 1610 is sewn to the shunt structure. In some embodiments, the sensor 1610 is held within a sock or bag of the shunt structure 1620 that is sewn or otherwise attached to it.

[0249] Figure 42A and Figure 42B Side and axial views of another embodiment of a shunt-type medical implant device 420 including certain sensor holding features are illustrated. The medical implant device 420 can be configured to at least partially secure a sensor device 424 in a location at least partially outside the cylindrical structure 427 of the implant device 420 and / or generally parallel to the flow axis / path associated with the shunt cylinder 427. As shown, the sensor holding features of the medical implant device 420 may include one or more sensor holding clamps, rings, arms / finger-like structures or the like 423, 425, which may be configured to secure the sensor 425 using productivity and / or pressing force. Although features 423, 425 are shown projecting away from the corresponding arms 421, 422, in some embodiments, the holding features 423, 425 are substantially aligned with or deflected inward relative to the corresponding arms 421, 422. Furthermore, although there are two retaining features 421, 425, in some embodiments only a single sensor retaining hoop / feature is included.

[0250] Additional sensor holding structure Figure 43 The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor holding structure 430. The sensor holding structure 430 includes a plurality of sensor support struts, including one or more side struts 433 and one or more radially projecting rear support struts 438. The sensor support struts 433, 438 may typically be formed in a slotted support configuration, in which the sensor device 434 may be at least partially disposed and / or secured.

[0251] Contact between the sensor holding structure 430 and the sensor membrane (e.g., the distal side of the sensor element 439) can be advantageously minimized to reduce interference with the function of the sensor element 439. For example, the strut 432, which couples the rear support strut 438 to the distal crossbar strut 437, is angled outward relative to the illustrated sensor orientation to prevent a large portion of the length of the connecting strut 432 from contacting the sensor element 439. In some embodiments, one or both of the connecting strut 432 and the crossbar strut 437 are omitted to reduce contact with the sensor element 439. For example, the side struts 433 and the rear strut 438 may be forks that are not coupled at their distal ends. In such embodiments, the struts 433, 438 may have connecting struts at one or more locations along their length to provide mechanical stability.

[0252] Figure 44 The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor holding structure 440. The sensor holding structure 440 includes a sensor support arm 447, which includes one or more sensor support struts 443, 448. In some embodiments, the sensor support arm 447 includes one or more outer support struts 443 and a central skeletal support strut 448, as shown. Woven fabric, mesh, netting, cloth, film, or the like may be draped over or otherwise disposed on the sensor device 444 to secure the sensor 444 to the sensor support arm 447.

[0253] although Figure 44 The sensor 444 is shown mounted on a central support column 448, which is shown to be in the same plane as the outer support column. However, it should be understood that in some embodiments, the central support column 448 is located in a plane that is at least partially lower than the outer support column 443. For example, the central support column 448 may provide a similar... Figure 43 The grooved support member of the strut 438 shown. This configuration can provide additional support for the sensor 444 relative to its sides, and can further allow the distal and proximal ends of the support structure to axially confine the sensor 444.

[0254] Figure 45The illustration shows a perspective view of at least a portion of a medical implantable device including a sensor holding structure 450, wherein the sensor holding structure 450 includes one or more magnets 453 that may be associated with an arm 451 of the medical implantable device. The one or more magnets 453 may be configured to function as sensor holding magnets, wherein a corresponding magnetic element 455 associated with a sensor device 454 may be attracted to the one or more magnets 453, thereby at least partially securing and / or positioning the sensor device 454 when the magnets of structure 450 and the corresponding magnets of sensor 454 are positioned close to each other, as shown.

[0255] In some embodiments, adhesives or other attachment methods may be applied to one or more portions of the sensor support structure 450 and / or the sensor 454 to supplement the fixation of the sensor 454 to the sensor support structure 450. The sensor magnet 455 may be located inside the cylinder (e.g., a glass cylinder) of the sensor 454, or may be disposed on the outer side of the cylinder near its proximal end. Although magnetic coupling is shown as supporting / holding the sensor 454 near its proximal end, it may include a magnet coupling the sensor 454 to the sensor support structure 450 along the length / side of the sensor cylinder. The magnet 453 may be coated with a biocompatible coating / material.

[0256] Figure 46A and Figure 46B Side views of the sensor retaining structure 460 in relatively shortened and extended configurations are illustrated respectively. The sensor retaining structure 460 may be a component or part of a medical implantable device. The sensor retaining structure 460 may include a cylindrical, helically wound braid, mesh, or the like. For example, the braid may advantageously be a biaxial braid, wherein longitudinal / axial elongation of the braid results in at least partial narrowing of the diameter of the braid cylinder at one or more portions of the braid cylinder. In some embodiments, the sensor device 464 may be positioned with a cylindrical braid 463 in its relatively shortened / extended configuration, wherein elongation of the braid 463 results in narrowing and / or tightening of the braid 463 around at least a portion of the sensor device 464, thereby at least partially securing the sensor device 464 in and / or to the braid 463. In some embodiments, the sensor retaining structure 460 may be in a position prior to insertion of the sensor 464. Figure 46B The configuration is elongated / tightened. In this case, inserting the sensor 464 into the structure 463 results in a frictional fit between the structure 463 and the sensor 464. Figures 47 to 49 The illustrations show individual embodiments of sensor structures including respective sensor holding features according to one or more aspects of this disclosure. Regarding... Figure 47 The sensor structure 474 may include one or more radial protrusions 475, which may be configured to engage with one or more corresponding features or components of a medical implantation device to at least partially secure the sensor structure 474 thereto. As shown, the protrusion(s) 475 may have a dotted shape and may have substantially circular and / or straight edges / surfaces. The corresponding engagement feature of the sensor holding structure engaging with the protrusion(s) 475 may include a concave surface corresponding to the shape of the protrusion(s) 475, such that the protrusion(s) 475 is fitted relatively tightly therein to prevent movement of the sensor 474 relative to the sensor holding structure when the protrusion 475 engages / nests in the corresponding concave / recessed feature of the sensor holding structure. Although shown as a protrusion, the feature 475 may be a recess / recess in some embodiments, wherein the sensor holding structure includes the protrusion(s) configured to be fitted therein for engagement / holding.

[0257] about Figure 48 The sensor structure 484 includes a recess / groove 485, such as a circumferential recess surrounding at least a portion of a cylindrical housing or body of the structure 484. The recess 485 can be configured to engage with one or more corresponding features or components of a medical implantable device, thereby at least partially securing the sensor structure 44 to it. As shown, the recess 485 can have a neck-shaped shape, or it can have any other shape. The recess 485 can span the entire circumferential segment of the sensor 484, or it can cover only a portion of the circumferential segment of the sensor 484. Engagement features corresponding to one or more sensor holding structures engaging with the groove 485 may include an inwardly projecting ring corresponding to the shape of the groove 485, such that the ring fits relatively tightly within the groove 485 to prevent movement of the sensor 484 relative to the sensor holding structure when the groove 485 engages with the corresponding ring / protrusion feature of the sensor holding structure. In some embodiments, the engagement features corresponding to one or more of the sensor holding structures are sized and / or configured to engage in the groove 485 when forced past the proximal end 481 of the sensor 484 and into the groove 485.

[0258] about Figure 49 The sensor structure 494 includes at least a partially circumferential protrusion 495 integrated with and / or associated with or attached to a circumferential portion of the cylindrical housing or body of the structure 494. The protrusion 495 may be configured to engage with one or more corresponding features or components of a medical implantable device, thereby securing the sensor structure 494 at least partially to it.

[0259] The protrusion 495 may have an annular shape, as shown, or may have any other shape. The protrusion 495 may span the entire circumferential segment of the sensor 494, or may only cover a portion of the circumferential segment of the sensor 494. Engagement features corresponding to one or more sensor holding structures engaging with the protrusion 495 may include grooves / recesses corresponding to the shape of the protrusion 495, such that the protrusion 495 fits relatively tightly in the grooves / recesses to prevent the sensor 494 from moving relative to the sensor holding structure when the protrusion 495 engages with the corresponding groove / recess features of one or more sensor holding structures. In some embodiments, the engagement features corresponding to one or more sensor holding structures are sized and / or configured to snap onto the protrusion 495 when forced past the proximal end 491 of the sensor 494 and into the protrusion 495.

[0260] Figures 50A to 50E The illustration shows at least a portion of a medical implantable device including a sensor holding structure 500. The sensor holding structure 500 includes a plurality of longitudinal sensor support struts 508, which are generally arranged longitudinally parallel to each other on opposite sides of the sensor holding structure 500. The sensor support struts 508 can typically be formed in the form of a slotted support, in which a sensor device 504 can be at least partially disposed and / or secured.

[0261] The curvature of the sensor holding structure 500 can be designed to fit and / or correspond to the radius of curvature of the outer surface of the sensor cylinder 504 to allow the sensor 504 to be effectively mounted thereon. This curvature of the strut 508 allows the sensor 504 to be mounted on the strut 508 in such a way that at least a portion of the sensor 504 rests below the distal cross strut / form 502 and / or the proximal cross strut / form 506, which may have a smaller curvature (i.e., flatter) than the outer strut 508. The relative flatness of the struts / forms 502, 506 can be designed to provide the aforementioned axial holding. In some embodiments, the curvature of the distal holding strut 502 is such that the strut 502 only contacts and / or covers the outer edge / part of the sensor element 509 to avoid disrupting sensor readings and / or causing damage to the sensor element 509.

[0262] Figures 51A to 51E The illustration shows at least a portion of a medical implantable device including a sensor holding structure 510, which includes one or more slide-type sensor support struts 518. Figure 51A The sensor holding structure 510 is shown in either a flattened or extended configuration, while Figures 51B to 51EA perspective view of a sensor holding structure 510 in a sensor winding configuration is shown. The sensor holding structure 510 may include longitudinal support struts 518 connected between a distal stop ring 517 and a proximal stop ring 513. In some embodiments, the sensor holding structure 510 further includes one or more lateral or horizontal struts 516 connected between two longitudinal support struts 518 to provide further mechanical stability to the sensor holding structure 510. The longitudinal support struts 518 can secure a sensor 514 in the illustrated winding configuration. Figures 51A to 51E In one embodiment, the longitudinal strut 518 may be connected to corresponding stop rings 513 and 517, which are adjacent to each other on half of the circumference of the corresponding ring, as shown in the figure.

[0263] In some embodiments, the sensor holding structure 510 Figure 51B-51E The twisted configuration shown can be configured as a twisted configuration before sensor 514 is placed. In some embodiments, sensor holding structure 510 can be wound / twisted around sensor 514 after sensor is placed against longitudinal strut 518. The amount of winding and / or the length of strut 518(one or more) l 1 It can be determined that this results in the axial length between the proximal ring 513 and the distal ring 517. l 2 The length corresponds to that of sensor 514.

[0264] Figures 52A to 52C The illustration shows at least a portion of a medical implantable device including a sensor holding structure 520, which includes one or more slide-type sensor support struts 528. Figure 52A The sensor holding structure 520 is shown in either a flattened or extended configuration, while Figure 52B and Figure 52C A perspective view of a sensor holding structure 520 in a sensor winding configuration is shown. The sensor holding structure 520 may include longitudinal support struts 528 connected between a distal stop ring 527 and a proximal stop ring 523. In some embodiments, the sensor holding structure 520 further includes one or more lateral or horizontal struts (not shown) connected between the two longitudinal support struts 528 to provide further mechanical stability to the sensor holding structure 520. The longitudinal support struts 528 can secure the sensor 524 in the illustrated winding configuration. Figures 52A to 52C In one embodiment, the longitudinal strut 528 can be connected to corresponding stop rings 523, 527 on opposite sides of the ring, as shown in the figure.

[0265] Figures 53A to 53EThe illustration shows a perspective view of a sensor holding structure 530 that can be associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 530 includes first and second axially extending forks 533. A sensor device 534 can be positioned against the forks 533, wherein a sleeve of any suitable or desired material 535 can be at least partially wrapped around the sensor 534 and the forks 533, thereby at least partially securing the sensor 534 to the forks 533 and thus to the sensor holding structure.

[0266] about Figure 53E In some embodiments, reinforcing wiring 537 may be included inside or outside the sleeve 535 to further secure the sleeve 535 to the sensor 534 and / or the fork 533. It should be understood that any embodiment disclosed herein may have reinforcing wiring wrapped around at least a portion of the sensor and / or sensor holding structure (e.g., a sensor holding arm or finger). Reinforcing wiring 537 may include a mesh, coil, braid, stitch, whether it is metallic or polymeric, or any other material. In some embodiments, reinforcing wiring 537 may be a non-metallic stitch.

[0267] Figures 54A to 54C The illustration shows a perspective view of a sensor holding structure 540 that can be associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 540 includes first and second axially extending arms 543, each arm having a distal crossbar 545 associated therewith. A sensor device 544 can be positioned against the arms 543 and the crossbar 545 to at least partially secure the sensor 544 to the sensor holding structure 540.

[0268] exist Figures 54A to 54C In this embodiment, the crossbar 545 is shown to project circumferentially on both sides of the corresponding arm 543. In some embodiments, the crossbar projects only to one side of the corresponding arm. That is, while some embodiments may include a “T”-shaped sensor holding arm / form, some embodiments may include an “L”-shaped sensor holding arm / form.

[0269] Figure 55 The diagram shows... Figures 54A to 54CA perspective view of the sensor holding structure, wherein a sleeve 555 of any suitable or desired material is at least partially wrapped around the sensor 544, arm 543, and crossbar 545, thereby at least partially securing the sensor 544 to the sensor holding structure 540. Additives on the crossbar 545 may enhance the engagement of the sensor holding structure 540 with the sensor device 544 and / or the sleeve 555. For example, the crossbar 545 may reduce the risk of the arm 543 slipping out from under the sleeve 555 by increasing the surface and / or surface area against which the sensor holding structure 540 abuts the sleeve (e.g., polymer, ethane) 555.

[0270] In some embodiments, a sleeve 555 is applied around the sensor 544 before the sensor 544 is placed against the arm 543. After the sleeve material is applied / placed around the sensor 544, the material of the sleeve 555 may be reflow soldered to enhance the coupling between the arm 543 and the crossbar 545 and the sleeve 555. For example, reflow soldering the sleeve material 555 may include heating the sleeve material 555 to make the material conform to the surfaces of the sensor 544 and the sensor holding structure 540. It should be understood that any embodiment disclosed herein may incorporate a polymer sleeve / material application to one or more of its portions, and such polymer sleeve material may be reflow soldered during one or more steps of the manufacturing and / or assembly process to facilitate bonding / engagement of the sleeve material with one or more components of the associated sensor holding structure.

[0271] Figures 56A to 56D The illustration shows a perspective view of a sensor holding structure 560 that can be associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 560 includes first and second axially extending arms 563, each arm having a distal crossbar 565 associated therewith. The crossbar 565 may provide additional circumferential surface contact between the sensor holding structure 560 and the sensor 564.

[0272] The sensor holding structure 560 further includes a plurality of opposing fingers 562 configured to at least partially wrap around or otherwise position around the cylindrical sensor device 564. The sensor device 564 may be positioned against the arm 563 and crossbar 565 and secured to the sensor holding structure 560 by the arm 563 and the fingers 562. The fingers 562 may wrap around the outer / circumference of the sensor cylinder 564 by any arcuate distance. Although two opposing, axially offset fingers 562 are shown, it should be understood that any number and / or orientation of fingers may be included.

[0273] Figure 57 The diagram shows... Figures 56A to 56DA perspective view of a sensor holding structure, wherein a sleeve 575 of any suitable or desired material is at least partially wrapped around the sensor 564, arm 563, and crossbar 565, thereby at least partially securing the sensor 564 to the sensor holding structure 560. The sensor holding structure 560 may have any features and / or characteristics of the sensor holding structure 540, including features and / or characteristics relating to sleeves 555 and 575.

[0274] Sensor holding cage structure Figures 58A to 58D The illustration shows a perspective view of a sensor holding structure 580 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 580 includes a cage 583 configured to hold a sensor device 584 (e.g., a cylindrical sensor device according to aspects of the present disclosure). The cage 583 may include a plurality of longitudinal sensor support struts 588, 585 and a proximal stop tab 587, which may be configured to fold or bend inward, as shown, to prevent the sensor device 584 contained within the cage structure 583 from moving proximally beyond the axial position of the tab 587.

[0275] The longitudinal sensor support struts 588, 585 form a window 586 in the circumferential and axial regions between the distal circumferential support strut 5801 and the proximal circumferential support strut 5802. Such a window 586 can provide an opening through which electromagnetic signals can propagate to and / or from the wireless transmission element 5803 of the sensor device 584. For example, in embodiments including a sensor holding structure / cage containing conductive material, such material can interfere with the transmission of electromagnetic signals. Regarding transmission elements including conductive coil features, as described in detail above, conductive material overlapping axially and / or circumferentially with such coils can cause signal noise, at least partially induced by the current therein, in the presence of electric and / or magnetic fields associated with wireless data or power transmission between the transmission element 5803 and an external source or receiver. Therefore, struts 585, 588, 5801, and 5802 can be configured / designed according to the dimensions of one or more window features that provide sufficient width and / or sufficient length to substantially not interfere with signal transmission to / from the transmission element 5803. For example, in a transmission element (e.g., a coil antenna) having a length w 1 In such cases, Figure 58C As shown, in some embodiments, window feature(s) 586 may advantageously have a length dimension greater than that of the transmission element. w 1 Length dimension w 2Furthermore, one or more window features 586 can be configured to axially overlap the transmission element 5803, such that when the sensor 584 is held by the sensor holding structure, the transmission element is axially fitted within one or more window features 586, as shown below. Figure 58C As shown. In some embodiments, the axial dimension of the window feature 586 axially overlaps the transmission element 5803. w 1 At least 50% of the length dimension. In some embodiments, the length dimension w 2 The dimensions of the transmission element 5803 w 1 At least 50%.

[0276] Figure 59 The diagram shows... Figures 58A to 58D A perspective view of a sensor holding structure 580, wherein a sleeve 595 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially wrapped around the sensor 584 and the posts 585, 585, thereby at least partially securing the sensor 584 to the sensor holding structure 580.

[0277] Figures 60A to 60D The illustration shows a perspective view of a sensor holding structure 600 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 600 includes a cage structure 603 configured to hold a sensor device 604, such as a cylindrical sensor device according to aspects of the present disclosure. The cage 603 may include a plurality of longitudinal sensor support struts 608, 605. The cage 603 may be coupled to an arm 601 of a medical implantable device (e.g., a shunt implantable device described herein) via one or more longitudinal struts 605, wherein a gap 6006 exists between the medical implantable device arm 601 and the cage structure 603, as shown. In some embodiments, one or more proximal-positioned (relative to the interface between struts 602, 607 and arm 601) distally angled support struts 602, 607 may provide mechanical stability to the sensor holding structure 600, as shown. The longitudinal sensor support struts 608, 605 form a window 606 in the circumferential and axial regions between the distal circumferential support strut 6001 and the proximal circumferential support strut 6002. Such a window 606 can provide an opening through which electromagnetic signals can propagate to and / or from the wireless transmission element 6003 of the sensor device 604. For example, in embodiments including a sensor holding structure / cage containing conductive material, such material can interfere with the transmission of electromagnetic signals. Regarding transmission elements including conductive coil features, as described in detail above, conductive material overlapping axially and / or circumferentially with such coils can cause signal noise, at least partially induced by the current therein, in the presence of electric and / or magnetic fields associated with wireless data or power transmission between the transmission element 6003 and an external source or receiver. Therefore, struts 605, 608, 6001, and 6002 can be configured / designed according to the dimensions of one or more window features that provide sufficient width and / or sufficient length to substantially not interfere with signal transmission to / from the transmission element 6003. For example, in a transmission element (e.g., a coil antenna) having a length w 1 In such cases, Figure 60C As shown, in some embodiments, one or more window features 606 may advantageously have a length dimension greater than that of the transmission element. w 1 Length dimension w 2 Furthermore, one or more window features 606 can be configured to axially overlap the transmission element 6003, such that when the sensor 604 is held by the sensor holding structure, the transmission element is axially fitted within one or more window features 606, as shown below. Figure 60C As shown. In some embodiments, the axial dimension of the window feature 606 axially overlaps the transmission element 6003. w 1 At least 50% of the length dimension. In some embodiments, the length dimension w 2 The dimensions of the transmission element 6003 w 1 At least 50%. Figure 61 The diagram shows... Figures 60A to 60D A perspective view of a sensor holding structure 600, wherein a sleeve 615 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially wrapped around the sensor 604 and arms 608, 605, thereby at least partially securing the sensor 604 to the sensor holding structure 600.

[0278] The sensor holding structure 600 includes a hinge point 6001 at which a distally angled support strut 607 bends at the intersection of the distally angled support strut 607 and the longitudinal strut 605. For example... Figures 60A to 60D The configured hinge point 6001 can be used to guide the outer sheath of a delivery system in which the implantation device associated with the sensor holding structure 600 is delivered to a target position on other structures of the sensor holding structure 600 (e.g., the structure of the cage 603 distal to the hinge point 6001). Therefore, the hinge point 6001 can provide a hinge to prevent overloading of the interface between the cannula 615 and the sensor holding structure 600, which would otherwise tilt and cause the outer sheath of the delivery system in which the implantation device is transported to become stuck on the cannula material 615 when the sensor holding structure 600 is placed into the delivery system. The angle of the support strut 607 at the connection between the strut 607 and the longitudinal strut 605. θ It can be advantageously greater than 90°, as shown in the figure, in order to reduce the risk of the hinge point 6001 getting stuck on the sheath of certain types of conveyor systems.

[0279] Figures 62A to 62D The illustration shows a perspective view of a sensor holding structure 620 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 620 includes a cage structure 623 configured to hold a sensor device 624, such as a cylindrical sensor device according to aspects of the present disclosure. The cage 623 may include a plurality of longitudinal sensor support struts 628, 625. The cage 623 may be coupled to an arm 621 of the medical implantable device (e.g., a shunt implantable device described herein) via one or more longitudinal struts 625. In some embodiments, the cage includes one or more proximal-arranged (relative to the interface between struts 627 and arm 621) distally angled support struts 627, the support struts 627 forming generally distally pointing dots / arrows, as shown.

[0280] The longitudinal sensor support struts 628, 625 form a window 6203 in the circumferential and axial regions between the distal and proximal circumferential support struts 622. Such a window 6203 can provide an opening through which electromagnetic signals can propagate to and / or from the wireless transmission element 6206 of the sensor device 624. The struts 625, 628, and 622 can be configured / designed according to the dimensions of one or more window features that provide sufficient width and / or sufficient length to substantially not interfere with signal transmission to / from the transmission element 6206. For example, in the transmission element (e.g., a coil antenna), a length... w 1 In such cases, Figure 62CAs shown, in some embodiments, one or more window features 6203 may advantageously have a length dimension greater than that of the transmission element. w 1 Length dimension w 2 Furthermore, one or more window features 6203 can be configured to axially overlap the transmission element 6206, such that when the sensor 624 is held by the sensor holding structure, the transmission element is axially fitted within one or more window features 6203, as shown below. Figure 62C As shown. In some embodiments, the axial dimension of the window feature 6203 axially overlaps with that of the transmission element 6206. w 1 At least 50% of the length dimension. In some embodiments, the length dimension w 2 The dimensions of the transmission element 6206 w 1 At least 50%.

[0281] Figure 63 The diagram shows... Figures 62A to 62D A perspective view of a sensor holding structure 620, wherein a sleeve 635 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially wrapped around the sensor 624 and the posts 628, 625, thereby securing the sensor 624 at least partially to the sensor holding structure 620.

[0282] The sensor holding structure 620 includes a hinge point 6201 at which a proximal angled support strut 627 bends at the intersection of the proximal angled support strut 627 and the longitudinal strut 625. For example... Figures 62A to 62D The configured hinge point 6201 can be used to guide the outer sheath of a delivery system in which the implantable device associated with the sensor holding structure 620 is delivered to a target position on other structures of the sensor holding structure 620 (e.g., the structure of the cage 6203 distal to the hinge point 6201). Therefore, the hinge point 6201 can provide a hinge to prevent overloading of the interface between the cannula 635 and the sensor holding structure 620, which would otherwise tilt and cause the outer sheath of the delivery system in which the implantable device is transported to become stuck on the cannula material 635 when the sensor holding structure 620 is placed into the delivery system. The angle of the support strut 627 at the connection between the strut 627 and the longitudinal strut 625. θ It can be advantageously greater than 90°, as shown in the figure, in order to reduce the risk of the hinge point 6201 getting stuck in certain types of conveying systems.

[0283] Figures 64A to 64DThe illustration shows a perspective view of a sensor holding structure 640 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 640 includes a cage structure 643 configured to hold a sensor device 644 (see [link to relevant documentation]). Figure 64C and Figure 64D For example, cylindrical sensor devices according to various aspects of this disclosure. Cage 643 may include a plurality of longitudinal sensor support struts 643, 645. Cage 643 may also advantageously include a longitudinal support structure 648, which may have a multi-strut and / or ring form / configuration. Cage 643 may be coupled to an arm 641 of a medical implantable device (e.g., a shunt implantable device described herein) via one or more longitudinal struts 643. In some embodiments, one or more proximal-arranged, distally angled struts 642, 647 may provide mechanical stability to sensor holding structure 640, as shown.

[0284] The longitudinal sensor support struts 643, 645 and the circumferential and axial regions between the distal and proximal circumferential support struts 6401 form a window 6403. Such a window 6403 provides an opening through which electromagnetic signals can propagate to and / or from the wireless transmission element 646 of the sensor device 644, and reduce associated interference / noise. The struts 645, 643, and 6401 can be configured / designed according to the dimensions of one or more window features that provide sufficient width and / or sufficient length to substantially not interfere with signal transmission to / from the transmission element 646. For example, in the case of a transmission element (e.g., a coil antenna) having a length... w 1 In such cases, Figure 64C As shown, in some embodiments, window feature(s)(s)6403 may advantageously have a size larger than that of transmission element 646. w 1 Length dimension w 2 Furthermore, one or more window features 6403 can be configured to axially overlap the transmission element 646, such that when the sensor 644 is held by the sensor holding structure, the transmission element is axially fitted within one or more window features 6403, as shown below. Figure 64C As shown. In some embodiments, the axial dimension of the window feature 6403 axially overlaps with that of the transmission element 646. w 1 At least 50% of the length dimension. In some embodiments, the length dimension w 2 The dimensions of transmission element 646 w 1 At least 50%.

[0285] Figure 65 The diagram shows... Figures 64A to 64D A perspective view of the sensor holding structure 640, wherein a sleeve 655 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially wrapped around the sensor 644, the struts 643, 645, and the longitudinal support structure, thereby at least partially securing the sensor 644 to the sensor holding structure 640. In some embodiments, the longitudinal support structure 648 may be disposed above / outside the sleeve 655 to provide sheathability for the sensor holding structure 640.

[0286] In some embodiments, the longitudinal support structure 648 is substantially disposed on the outside of the sleeve / material 655, while other supports and / or portions of the sensor holding structure 640 are at least partially disposed between the sleeve / material 655 and the sensor cylinder 644. Alternatively, the longitudinal support structure 648 may be inserted below the sleeve / material 655, while other supports and / or portions of the sensor holding structure 640 are disposed on the outside of the sleeve / material 655.

[0287] In some embodiments, the longitudinal support structure 648 may be bent away from the axis of structure 640 (e.g., folded / pulled upwards) while a sleeve / material 655 is applied to sensor 644 and sensor retainer structure 640, such that the longitudinal support structure 648 is not covered by the sleeve / material 655 (e.g., polymer; ethane). After the sleeve / material 655 is applied to portions of sensor 644 and sensor retainer structure (e.g., portions of strut 643), the longitudinal support structure 648 may be released or otherwise placed on the sleeve / material 655, such that the longitudinal support structure 648 is generally disposed on or near its outer surface. After the longitudinal support structure 648 has been positioned to contact the outside of the sleeve / material 655, the material 655 may be reflow soldered to improve the connection between the sleeve / material 655 and sensor retainer structure 640.

[0288] Figure 66A and Figure 66BThe illustration shows a perspective view of a sensor holding structure 660 associated with a medical implantable device according to one or more embodiments of the present disclosure. According to embodiments of the present disclosure, the sensor holding structure 660 includes two support struts 668 extending from an arm 661 of the medical implantable device and providing dorsal sensor support. The support struts 668 extend distally from the arm 661 to the distal end of the structure 660, at which point the struts bend and continue generally around a circumferential support path 662 to the front side of the sensor holding structure 660. A strut 665 may extend further proximally on the front side of the structure 660 and bend again to form a strut portion 667 that is angled / projecting proximally and / or circumferentially. The strut portion 667 may form another bend on a corresponding side portion of the structure 660 and terminate in a distally projecting strut portion 663, as shown.

[0289] Figures 67A to 67C The diagram shows... Figure 66A and Figure 66B A perspective view of a sensor holding structure 660, wherein a sensor device 674 is held therein, wherein a sleeve 675 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially disposed around the sensor device 674, the post 665, and / or the post 667 and / or the post 663. In some embodiments, the sleeve 675 is disposed around the sensor device 674 but within one or more of the posts 667 and / or 663.

[0290] The cannula 675 may comprise ethane or another polymer material. The cannula 675 may be applied to the sensor 674 and / or one or more struts 665, and / or one or more struts 665 may be inserted between portions of the cannula 675 and the sensor 674 in such a way that the cannula 675 is deformed and / or otherwise configured to conform to one or more portions of the struts 665, as shown. As with any embodiment of this disclosure, in some embodiments, the sensor retaining structure 660 may be loaded into the delivery system sheath before delivery to the target implantation site. Upon deployment, the sensor retaining structure 660 may leave the sheath to allow deployment. As shown, the end strut portion 663 may be placed / positioned outside the cannula 675 and may facilitate the sliding of the sensor retaining structure 660 into the delivery sheath or other delivery device. When the support portion 663 is wound around the sleeve 675, the support portion 663 can be pulled out from behind / under the sleeve 675, wherein the shape memory properties of the support portions 667 and 663 allow the support portion 663 to take a position that axially overlaps the sleeve 675 relative to the axis of the sensor 674. For example, the support may comprise nitinol or other materials with superelasticity to allow for such deformation and positioning of various support portions.

[0291] Figures 68A to 68C The illustration shows a perspective view of a sensor holding structure 680 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 680 includes a cage structure configured to hold a sensor device 684 (see [link to relevant documentation]). Figure 68C For example, a cylindrical sensor device according to various aspects of this disclosure. Structure 680 may include a plurality of longitudinal sensor support struts 688, 683 and one or more distal stop tabs 687b and / or one or more proximal stop tabs 687a, which may be configured to fold inward or bend, as shown, to prevent the sensor device 694 contained within the cage structure 680 from moving distally and proximally beyond the respective axial positions of the tabs(one or more) 687, respectively. The illustrated configuration of the tabs 687 may be achieved by the shape memory properties of such features, which may be shaped to bend / protrude toward the axial center of the sensor device 684 and / or the cage structure of the sensor holding structure 680. Structure 680 may further include a plurality of circumferential struts 685, which provide mechanical stability between the rear longitudinal struts 688 and the front longitudinal struts 683. Cage structure 680 may or may not have a polymer sleeve material applied thereto to secure structure 680 to sensor 684.

[0292] The strut 688 connecting the proximal portion / ring 682 to the distal portion / ring 686 facilitates the provision of a sheath for the sensor holding structure 680 and can further aid holding by providing a longitudinal surface area for contact with the sensor device 684 and / or a polymer sleeve material applicable to the structure 680 and / or the sensor device 684. The cage of the sensor holding structure 680 may include struts configured and / or designed to provide a window, as detailed herein, aligned with at least a portion of the transmission element of the sensor 684 to reduce interference / noise regarding wireless data and / or power transmission between the transmission element and an external receiver / transmitter.

[0293] Figures 69A to 69D The illustration shows a perspective view of a sensor holding structure 690 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 690 includes a cage structure configured to hold a sensor device 694 (see [link to relevant documentation]). Figure 69C and Figure 69DFor example, a cylindrical sensor device according to various aspects of this disclosure. Structure 690 may include a plurality of longitudinal sensor support struts 698, 693 and one or more distal stop tabs 697b and / or one or more proximal stop tabs 697a, which may be configured to fold inward or bend, as shown, to prevent the sensor device 694 contained within the cage structure 690 from moving distally and proximally beyond the respective axial positions of the tabs(one or more) 697, respectively. Structure 690 may further include one or more circumferential struts 695 and / or a plurality of intermediate longitudinal struts 696 to provide mechanical stability to structure 690.

[0294] and Figures 68A to 68C Compared to the illustrated embodiment, the cage structure 690 can have one less circumferential ring along its length. For example, the removed ring can typically be located on the proximal half / proximal side of the cage structure 690, which may correspond to the location of the electrically coupled component of the sensor 694. Generally, circumferential overlap of the electrically coupled components (which can typically extend parallel to the coil windings of the electrically coupled components) is more problematic than longitudinal overlap (e.g., orthogonal to the windings / coils of the electrically coupled components), which, like the longitudinal strut 696, replaces... Figures 68A to 68C The circumferential struts 685 of the structure 680 are provided.

[0295] The longitudinal sensor support struts 693, 698 and the circumferential and axial regions between the distal and proximal circumferential support struts 695 form a window 6903. Such a window 6903 provides an opening through which electromagnetic signals can propagate to and / or from the wireless transmission element 6906 of the sensor device 694, and reduce associated interference / noise. The struts 698, 693, and 695 can be configured / designed according to the dimensions of one or more window features that provide sufficient width and / or sufficient length to substantially not interfere with signal transmission to / from the transmission element 6906. For example, in the transmission element (e.g., a coil antenna), the length... w 1 In such cases, Figure 69C As shown, in some embodiments, window feature(s)(s)6903 may advantageously have a size larger than that of transmission element(s)6906. w 1 Length dimension w 2 Furthermore, one or more window features 6903 can be configured to axially overlap the transmission element 6906, such that when the sensor 694 is held by the sensor holding structure, the transmission element is axially fitted within one or more window features 6903, as shown below. Figure 69C As shown. In some embodiments, the axial dimension of the window feature 6903 axially overlaps with that of the transmission element 6906.w 1 At least 50% of the length dimension. In some embodiments, the length dimension w 2 The dimensions of the transmission element 6906 w 1 At least 50%.

[0296] Figures 70A to 70D The illustration shows a perspective view of a sensor holding structure 700 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 700 includes a cage structure configured to hold a sensor device 704 (see [link to relevant documentation]). Figure 70C and Figure 70D For example, a cylindrical sensor device according to various aspects of this disclosure. Structure 700 may include a plurality of longitudinal sensor support struts 708, 703 and one or more distal stop rings 707b and / or one or more proximal stop tabs 707a, which may be configured to fold inward or bend, as shown, to prevent the sensor device 704 contained within the cage structure 700 from moving distally and proximally beyond the respective axial positions of the stop features 707(one or more). Structure 700 may further include a plurality of circumferential struts 705, which provide mechanical stability between the rear longitudinal strut 708 and the front longitudinal strut 703.

[0297] The annular stop 707b can advantageously provide contact with the sensor element 709 only around its periphery. Compared to tabs extending radially inward on the surface of the sensor element (e.g., a hermetically sealed area), this contact can result in a reduced impact on sensor function and / or a lower risk of damage to the sensor element 709.

[0298] The annular stop 707b is shown having a slight curvature corresponding to a curved (e.g., tubular) sheet from which the sensor retaining structure 700 can be cut during manufacturing. In some embodiments, the curvature of the annular stop 707b may be flattened in relation to its shape configuration. Flattening the annular stop 707b can increase the surface contact area of ​​the annular stop 707b on the sensor element 709, thereby potentially dispersing / distributing contact loads thereon. In some embodiments, the annular stop 707b is designed to be similar in size to or slightly larger than the hermetic seal of the sensor element 709, thereby reducing impact on it.

[0299] Figure 71A and Figure 71B The illustration shows a perspective view of a sensor holding structure 710 associated with a medical implantable device according to one or more embodiments of the present disclosure. The sensor holding structure 710 includes a cage structure configured to hold a sensor device 704 (see [link to relevant documentation]). Figure 71B For example, a cylindrical sensor device according to various aspects of this disclosure. Structure 710 may include a plurality of longitudinal sensor support struts 718, 713 and one or more distal stop features 705 and / or proximal stop features 702. For example, the distal stop feature 705 may include a plurality of protrusions and / or holes 705, and a suture 706 or other structure / form may be disposed at least partially through the plurality of protrusions and / or holes 705, wherein the suture (or other structure / form) may intersect at least a portion of the diameter of the sensor device 704, which is at least partially disposed within the cage structure 710, thereby at least partially interfering with or preventing the sensor device 704 from sliding distally toward the distal end of the cage structure 710, the stop feature 705 and / or the suture 706.

[0300] Structure 710 may further include one or more proximal stop tabs 702, which may be configured to fold or bend inward, as shown, to prevent the sensor device 704 contained within the cage structure 710 from moving proximally beyond the axial position of the tabs / stop features 702(s). The term “suture” is used herein according to its simple and general meaning and may refer to any elongated cord, strand, thread, tie, rope, ribbon, strip, or portion thereof, or other type of material used in medical procedures. Those skilled in the art will understand that thread or other similar materials may be used instead of suture. Furthermore, in some contexts herein, the terms “rope” and “suture” are used substantially interchangeably. Additionally, the singular form of any of the suture-related terms listed above (including the terms “suture” and “rope”) may be used to refer to a single suture / rope or a portion thereof.

[0301] It should be understood that, just like Figure 71A and Figure 71B As shown in the examples, the distal (and / or proximal) suture engagement tab 705 can be incorporated into any sensor holding structure disclosed herein. The suture tab 705 and / or (one or more) sutures 706 can be configured to hold the sensor 714 in a substantially immobile axial position, with little or no axial movement / wobbling when implanted in the target environment. This immobile maintenance of the sensor 714 reduces the effects and / or occurrence of forced contact between the sutures 706 and the sensor element 709.

[0302] Figure 72 The illustration shows a perspective view of a sensor support strut 728, which, as discussed in conjunction with various embodiments of this disclosure, can be attached to and / or associated with a medical implantable device via an arm structure 721. The sensor support strut 728 can be configured to support a sensor device 724 in a certain way. For example, as... Figure 72 As shown, sensor device 724 may have a cloth or other type of covering 723 disposed around at least a portion thereof. For example, cloth 723 may substantially surround sensor device 724. Covering 723 may be wrapped around one or more side portions of sensor device 724 while allowing openings therein on the distal and / or proximal sides of sensor device 724 to allow exposure of sensor element 729. For example, the distal end of sensor device 724 may be exposed, such as... Figure 72 As shown. In some embodiments, a ridge or other feature 727 may be associated with the sensor device 724, and a fabric / covering 723 may be at least partially wrapped around or covered thereon. In some embodiments, the sensor support post 728 includes a plurality of holes 726 through which stitches 725, threads, or (one or more) other elongated materials / devices may pass, wherein such stitches 725 or (one or more) other materials / devices are stitched and / or at least partially passed through various portions of the covering 723, thereby securing the sensor device 724 to the sensor support post 728. Although multiple stitches 725 are shown, any number of stitches may be used, including a single stitch.

[0303] In some embodiments, a strap-type feature may be associated with the distal winding portion 727 of the fabric / coverage 723, which may allow the fabric / coverage 723 surrounding the periphery of the distal surface of the sensor element 729 to be tightened / gathered, thereby restricting its axial movement.

[0304] Sensor retaining housing / enclosure Figures 73-75 The illustration shows a perspective view of an embodiment of sensor holding structures 730, 740, which include sensor support pillars 738, 748 and housings 733, 743. The housings 733, 743 are configured to be secured to the sensor support pillars 738, 748 in a certain manner and to house or encapsulate at least a portion of a sensor device therein. The housings 733, 743 may comprise any suitable or desired material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletheretherketone (PAEK)). Reference Figure 73 The housing 733 may include a cutout 735 configured to fit the sensor support pillar 738, such as Figure 73 As shown in the figure. Figure 74 The embodiments are in some respects similar to Figure 73 The embodiments shown in some respects are similar. However, with Figure 73 Compared to the 733's outer shell, Figure 74 The housing 743 may include a length ratio of Figure 73The cutout 735 is shorter than the cutout 745. Furthermore, the housing 743 can be secured to the sensor support arm 741 in such a way that the housing 743 protrudes, is positioned, and / or is fixed further axially relative to the sensor support pillar 738. Regarding... Figure 73 and Figure 74 Both housings 733 and 743 may include one or more holes 732 and 742 through which sutures, threads, and / or other materials / devices may be sewn / passed. These sutures / materials may further pass through / sew through holes / features in sensor support pillars 738 and 748, as shown, thereby at least partially securing housings 733 and 743 to sensor support pillars 738. Housings 733, 743, and 753 may have sensor devices disposed therein when the housing is sewn to the respective sensor support pillars 738, 748, and 758.

[0305] Figures 76A to 76D Exploded and perspective views of a sensor holding structure 760 according to one or more embodiments of the present disclosure are illustrated. The sensor holding structure 760 includes a sensor support arm 768 and a housing 763. The housing 763 is configured to engage or cooperate with the sensor support arm 768 in a certain way and to house or encapsulate at least a portion of a sensor device therein. The sensor support arm 768 may include multiple sets of opposing fingers 765. For example, as shown, the sensor support arm 768 may include sensor holding fingers of a proximal group 765a and sensor holding fingers of a distal group 765b, wherein the housing 763 includes corresponding cutouts 766 configured to adapt to or receive the fingers 765 when the housing 763 is set / placed on the sensor support arm 768, such as... Figure 76C and Figure 76D As shown in the diagram. The housing 763 may comprise any suitable or desired material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)). The cutout 766 advantageously provides axial retention of the housing 763, and thus provides axial retention of the sensor 764 disposed therein.

[0306] Figure 77 The diagram shows... Figures 76A to 76DThe diagram shows a perspective view of a sensor holding structure 760 that holds a sensor device 769, wherein a sleeve 775 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially disposed around a support arm 768, one or more fingers 765, and / or a housing 763. The sleeve material 775 may be applied to the housing 763, one or more fingers 765, and / or the support arm 768, and may or may not be reflow soldered as described herein after application. The sleeve 775 may advantageously prevent or constrain the outward expansion of the fingers 765, thereby further securing the fingers 765 to the housing 763 and / or the sensor 769.

[0307] Figures 78A to 78D Exploded and perspective views of a sensor holding structure 780 according to one or more embodiments of the present disclosure are illustrated. The sensor holding structure 780 includes a sensor support arm 788 and a housing 783. The housing 783 is configured to mate or engage with the sensor support arm 788 in a certain way and to house or encapsulate a sensor device 784 therein (see [link to documentation]). Figure 78C and Figure 78D At least a portion of the sensor support arm 788. The sensor support arm 788 may include one or more sets of opposing fingers 785 and / or one or more axially offset retaining fingers 787. In some embodiments, the offset fingers 787 are longer than the opposing fingers 785 and are configured to, when the sensor 784 is... Figure 78C and Figure 78D The housing 783, when held / positioned therein / on it, at least partially wraps around / over the opposite half of the cylindrical sensor 784 relative to the sensor arm 788. The housing 783 may include a cutout 786 configured to adapt to or receive a finger 785 when the housing 783 is positioned / placed on the sensor support arm 788. Figure 78C and Figure 78D As shown in the diagram. The housing 783 may comprise any suitable or desired material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)). The housing 783 may be compared to... Figures 76A to 76D The associated housing in the embodiments is short. Therefore, in some embodiments, the housing 783 may not cover the entire blank of the sensor 784. The notch 786 advantageously provides axial retention of the housing 783, and thus provides axial retention of the sensor 784 disposed therein.

[0308] Figure 79 The diagram shows... Figures 78A to 78DThe diagram shows a perspective view of a sensor holding structure 780 that holds a sensor device 784, wherein a sleeve 785 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially disposed around a support arm 788, one or more fingers 785, a housing 783, and / or a sensor device 784. A sleeve material 795 may be applied to the housing 783, one or more fingers 785, 787, and / or the support arm 788, and may or may not be reflow soldered as described herein after application. The sleeve 795 may advantageously prevent or restrain the outward expansion of the fingers 785, 787, thereby further securing the fingers 785, 787 to the housing 783 and / or the sensor 784.

[0309] Figures 80A to 80D Exploded and perspective views of a sensor holding structure 800 according to one or more embodiments of the present disclosure are illustrated. The sensor holding structure 800 includes a sensor support arm 808 and a housing 802. The housing 802 is configured to mate or engage with the sensor support arm 808 in a certain way and to house or encapsulate a sensor device 809 therein (see [link to documentation]). Figure 80C and Figure 80D At least a portion of the sensor support arm 808. The sensor support arm 808 may include one or more sets of opposing fingers 805 and / or one or more axially offset retaining fingers 807. Each finger 805 may have a corresponding end crossbar 803 associated therewith. In some embodiments, the offset retaining fingers 807 are longer than the opposing fingers 805 and are configured to, when the sensor 809 is... Figure 80C and Figure 80D The housing 802, when held / positioned therein / on it, at least partially wraps around / over the opposite half of the cylindrical sensor 804 relative to the sensor arm 808. The housing 802 may include a cutout 806 configured to adapt to or receive fingers 805, including crossbars 803, when the housing 802 is positioned / placed on the sensor support arm 808. Figure 80C and Figure 80D As shown in the diagram. The housing 802 may further include a notch 804 configured to adapt to or receive a finger 807 when the housing 802 is set / placed on the sensor support arm 808. The housing 802 may comprise any suitable or desired material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)).

[0310] Figure 81 The diagram shows... Figures 80A to 80DThe image shows a perspective view of a sensor holding structure 800 that holds the sensor device 809, wherein a sleeve 815 of any suitable or desired material (e.g., thermoplastic polyurethane (TPU)) is at least partially disposed around the support arm 808, one or more fingers 815, one or more fingers 807, housing 802, and / or sensor device 804. A crossbar 803 may be used to increase contact between the fingers 805 and housing 802, sleeve 815, and sensor 809.

[0311] Figure 82 The illustration shows a perspective view of a locking retaining arm 810 according to one or more embodiments of the present disclosure. The locking retaining arm 810 may include a plurality of fingers / forks 812, which may be configured to lock and / or otherwise secure to and / or secure to a sensor retaining structure 820 (e.g., a housing-type structure, etc.). Figure 83A and Figure 83B The illustration shows a view of a sensor holding structure 820, which is configured to be secured to a holding arm structure in a certain way, for example, to... Figure 82 The locking sensor retaining arm 810. The retaining structure 820 advantageously includes certain features 827 configured to engage at least partially and / or in some way with features of the locking retaining arm 810. In some embodiments, such features 827 may be advantageously associated with the proximal end of the retaining structure 820. Figure 83C A side view shows a retaining structure 820 according to one or more embodiments.

[0312] Figures 84A to 84C The illustration shows a perspective view of at least a portion of the locking retaining arm 810, the retaining structure 820, and / or the sensor device 834, which is configured to be at least partially disposed on the retaining structure 820 and / or fixed / attached thereto in some way. Figures 84A to 84C The images correspond to different stages of the sensor fixing process according to one or more embodiments of this disclosure.

[0313] Figure 84A The illustration shows locking arms 810, 460-degree holding structures 820, and sensor devices 834 in a substantially separate or isolated configuration before the respective components are secured to each other. Figure 84A As shown, the retaining structure 820 may have a generally cylindrical shape or form, and its dimensions are configured to allow a generally cylindrical sensor device 834 to be inserted therein at least partially.

[0314] Figure 84BA locking retaining arm 810 is shown being pushed into / inserted into a proximal locking feature 827 of a retaining structure 820, the proximal locking feature 827 being configured and / or sized such that the fork 812 of the locking retaining arm 810 at least partially passes through it during insertion. In some embodiments, the locking feature 827 of the retaining structure 820 includes first and second channels 823, the first and second channels 823 being sized and configured to receive the fork 812, wherein the channels 823 are connected at a common vertical channel 822 such that a main feature 817 of the locking retaining arm 810 adjacent to the fork 812 can slide therein, wherein the fork 812 is at least partially disposed within the retaining structure 820. In some embodiments, the retaining structure 820 may be contemplated, and / or the retaining structure 820 may provide a housing or enclosure for at least partially receiving / enclosing the sensor device 834.

[0315] Figure 84C The sensor device 834 is shown being inserted into a retaining structure 820. For example, the retaining structure 820 may have one or more slots 826 associated with its distal end, wherein such slots(s) allow for an expansion (e.g., radial outward expansion) of the diameter of the distal end of the retaining structure 820, thereby facilitating proximal insertion of the sensor device 834 into the retaining structure 820. In some embodiments, the retaining structure 820 includes certain ridges or other lip-type locking / stopping features 828 that may project radially inward to a certain extent at the distal / distal edge of the retaining structure 820. Such features 828 can advantageously prevent the sensor device 834 from sliding distally past the stop features 828.

[0316] According to some implementation methods Figures 85A to 85C The process for inserting the locking arm 810 into the proximal portion of the holding structure 820 and locking or otherwise securing the arm 810 thereto is illustrated in the figure. Figure 85A As shown, the locking retaining arm 810 can be inserted into a proximal receiving channel 823, which is designed and / or configured to receive a fork-shaped extension of the locking retaining arm 810 therein. Figure 85B In this configuration, a single-form trunk / base 817 is advanced into the channel at the point where the side channel 823 and the vertical channel 822 connect. For example... Figure 85CAs shown, the base / main trunk 817 of the locking retaining arm 810 is pulled upward across the vertical channel 822, causing the fork 812 to also be pulled upward within the retaining structure 820. In some embodiments, after the locking retaining arm 810 is slid upward along the vertical channel 822, the fork 812 rests against or near the inner wall of the retaining structure 820. In some embodiments, the fork 812 has certain curvature features corresponding to the curvature of the interior and / or surface of the retaining structure 820, such that when the locking retaining arm 810 engages with the retaining structure 820, the fork 812 can present a relatively low / small profile relative to the inner surface of the retaining structure 820, such as... Figure 85C As shown.

[0317] Figures 86A-86D The illustration shows a perspective view of a sensor holding structure 860 configured to hold a sensor device 864 according to one or more embodiments of the present disclosure. The sensor holding structure 860 may include a side support 868 having a curvature designed to hold or support the cylindrical sensor device 864 therein. For example, the curvature of the side support structure 868 may be similar to or match the curvature of the sensor cylinder 864, such that when the sensor 864 is placed on the support structure 868, the contact area between the sensor holding structure 860 and the sensor cylinder 864 is distributed on the region of the support structure 860 facing the sensor cylinder 864. For example, the support for holding the sensor device 864 may be provided by the side support structure 868 and an intermediate lateral support 865, which may also have a curvature corresponding to the curvature of the sensor cylinder 864.

[0318] The sensor holding structure 860 may further include one or more sensor holding fingers 862, which may be configured to clamp and / or hold around a side portion of the sensor cylinder 864. The sensor holding fingers 862 may also have a curvature corresponding to the curvature of the sensor cylinder 864. The curvature of certain structural components of the sensor holding structure and / or sensor device mentioned herein can be understood as referring to the radius of curvature of such components relative to an axis (e.g., the central axis of the sensor cylinder 864 when placed / held in the sensor holding structure 860). In some embodiments, the opposing sensor holding fingers 862 may be spaced apart at their distal ends. d that distance dThe diameter is smaller than that of the sensor cylinder 864. In such an embodiment, the gap between the opposing sensor holding fingers 862 may need to be widened to allow the sensor cylinder 864 to be placed therein. For example, the sensor holding fingers 862 may be configured to allow the sensor cylinder 864 to snap into place between the sensors at the holding fingers 862, thereby causing the sensor at the holding fingers 862 to be radially displaced by a certain amount when the sensor device 864 is snapped into place. The sensor holding fingers 862 may have shape memory properties, allowing them to return to their non-expanded position around the sensor cylinder 864 when they are not currently displaced by the sensor cylinder 864. Alternatively, in some embodiments, the sensor cylinder 864 may slide into the appropriate position within the sensor at the holding fingers 862 from either a distal or proximal direction.

[0319] The sensor holding structure 860 may further include one or more axial stop features, such as a distal stop 867 and / or a proximal stop 863. Regarding the distal stop feature 867, such a feature may include a radius of curvature smaller than that of the sensor cylinder 864, the sensor holding fingers 862, the side support structure 868, and / or the intermediate lateral support 865. When the sensor 864 is placed in the sensor holding structure 860, the distal stop 867 may be axially positioned outside the distal side 869 of the sensor element / film of the sensor device 864. Due to the relative flatness of the distal stop 867 compared to the curvature of the components of the sensor cylinder 864 and / or the sensor holding structure 860, the distal stop 867 may radially overlap the distal side 869 of the sensor by a certain amount, such as... Figure 86D As shown, the stop 867 contacts the distal / distal side 869 of the sensor, thereby preventing its axial movement / sliding beyond the contact between the stop 867 and the sensor end / side 869. In some embodiments, the distal stop 867 advantageously covers only the outer peripheral portion of the distal / distal side 869 of the sensor, thereby reducing the effect of contact with the stop 867 on the action of the sensor element. For example, in some embodiments, the outer periphery of the sensor element 869 may include or be associated with a sealing ring component, wherein the inner diaphragm (e.g., operable according to a piezoresistive or capacitive pressure sensor device that serves as its diaphragm) is not covered by the distal stop 867.

[0320] Regarding the proximal stop feature 863, this feature may include a tab-type structure or form configured to project radially inward relative to the curvature of the sensor retaining structure 860, thereby intruding into the radial space overlapping the proximal surface / proximal side of the sensor 864 and hindering or preventing the sensor 864 from sliding / moving proximally past the proximal stop tab 863. The stop tab 863 may be laser-cut or otherwise formed into the form of the sensor retaining structure 860, and may be bent inward / upward by shape memory action / movement, or may be manually / mechanically bent or folded using one or more tools or by manual manipulation. Figure 86B The stop configuration is shown.

[0321] Figure 87 An alternative implementation of the distal stop bar is shown. Figure 87 The distal stop 877 can be implemented in conjunction with any embodiment of the sensor holding structure disclosed herein. The distal stop 877 can be achieved by the sensor holding structure (e.g., Figures 86A-86D The distal circumferential band of the sensor holding structure 860 shown is formed, wherein the stop bar 877 may be bent radially inward at or near its central portion relative to the axis of the sensor device 879 disposed in the sensor holding structure 870 and / or relative to the axis of curvature of the sensor holding structure 870 (including, for example, certain sensor holding fingers 872 and / or support bands / forms 875 of the sensor holding structure 870). Figure 87 As shown, bending the central portion of the stop band 877 radially inward causes the stop bar 877 to radially overlap with the surface of the sensor device 879, thereby impeding axial sliding / movement of the sensor device 879. The bending of the distal stop bar 877 can occur substantially automatically in response to the shape memory characteristics / action of the bar 877, or it can be bent manually in vivo or before the sensor implantation device is introduced into the patient (e.g., using one or more tools).

[0322] Additional Examples According to embodiments, certain actions, events, or functions of any process or algorithm described herein may be performed in a different order, or may be added, combined, or omitted entirely. Therefore, in some embodiments, not all described actions or events are necessary for the practice of the process.

[0323] Unless otherwise expressly stated, or otherwise understood in the context, the conditional language used herein (e.g., “can,” “may,” “may,” “will,” “for example,” etc.) is intended in its general sense and generally intended to convey that some embodiments include certain features, elements, and / or steps, while other embodiments do not include certain features, elements, and / or steps. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are necessary in any way for one or more embodiments, or that one or more embodiments must include methods for determining, with or without author input or prompting, whether such features, elements, and / or steps are included or will be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonyms, used in their general sense, and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Moreover, the term “or” is used in its inclusive (not exclusive) sense; for example, when used to connect lists of elements, the term “or” indicates one, some, or all of the elements in that list. Unless otherwise explicitly stated, conjunctions such as “at least one of X, Y, and Z” are understood to be generally used to convey that an item, term, element, etc., may be X, Y, or Z. Therefore, such conjunctions are not generally intended to imply that some embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0324] It should be understood that in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, and the accompanying drawings or description are used to simplify the disclosure and aid in understanding one or more of the various inventive aspects. However, the method of this disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in that claim. Furthermore, any component, feature, or step shown and / or described in the specific embodiments herein may be applied to or used with any other embodiment(s). Moreover, for each embodiment, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention disclosed and claimed herein should not be limited to the specific embodiments described above, but should be determined only through a fair reading of the appended claims.

[0325] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements such as structures, components, operations (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of that element relative to any other element, but generally distinguish that element from another element with a similar or identical name (but using ordinal terms). Furthermore, as used herein, indefinite articles ("a" and "an") may mean "one or more" rather than "one." Additionally, operations performed "based on" conditions or events may also be performed based on one or more other conditions or events not explicitly stated.

[0326] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which the example embodiments pertain. It should be further understood that terms (e.g., those defined in common dictionaries) should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless explicitly stated otherwise, unless so defined herein.

[0327] Spatially related terms such as “outside,” “inside,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein to describe the relationship between one element or component and another, as illustrated in the figures. It should be understood that, in addition to the orientations depicted in the figures, spatially relative terms are intended to cover different orientations of the device in use or operation. For example, in the case where the device shown in the figures is flipped, a device located “below” or “below” another device may be placed “above” another device. Therefore, the descriptive term “below” can include both lower and upper positions. The device may also be oriented in another direction, and thus spatially relative terms can be interpreted differently depending on orientation.

[0328] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. A medical device comprising: A shunt configured to redirect blood flow from one region of the cardiovascular system to another region of the cardiovascular system, the shunt comprising: A sensor attachment component configured to be coupled to a sensor system; The sensor system includes: Sensors configured to measure one or more parameters of one region or another region of the cardiovascular system, and A sensor retaining housing is configured to at least partially house the sensor.

2. The medical device of claim 1, wherein the sensor attachment includes reinforcing wiring to further secure the sensor system to the sensor attachment.

3. The medical device of claim 1, wherein the sensor holding housing comprises a thermoplastic polymer.

4. The medical device according to claim 3, wherein the thermoplastic polymer is polyetheretherketone (PEEK) or polyaryletherketone (PAEK).

5. The medical device of claim 1, wherein the sensor holding housing has a cylindrical shape configured to receive the sensor.

6. The medical device of claim 1, wherein one region of the cardiovascular system is the left atrium of the heart, and the other region of the cardiovascular system is the coronary sinus of the heart.

7. The medical device of claim 1, wherein the medical device is delivered via a catheter.

8. The medical device of claim 1, wherein one of the parameters of the one or more regions of the cardiovascular system is a pressure parameter.

9. The medical device of claim 1, wherein at least the shunt comprises shape memory metal.

10. The medical device of claim 1, wherein the shape memory metal is nickel-titanium.

Images