Sensor integration in cardiac implant devices

Abstract

It is an object to provide one or more methods and / or devices for facilitating the monitoring of physiological parameters associated with the left atrium using one or more sensor implant devices implanted in or into one or more pulmonary veins and / or associated anatomy / tissue.SOLUTION: The sensor retention structure includes a sensor support strut and means for securing the sensor device to the sensor support strut. The sensor support arm may be configured to have an at least partially cylindrical sensor device disposed thereon, and may be associated with one or more sensor retention fingers protruding from the sensor support arm and / or a cage structure configured to be secured to the sensor device.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 62 / 926,829, entitled "SENSOR INTEGRATION IN CARDIAC IMPLANT DEVICES," filed October 28, 2019, the disclosure of which is incorporated herein by reference in its entirety.

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

[0003] Various medical procedures involve the implantation of medical implant devices within cardiac anatomical structures, and certain physiological parameters associated with such anatomical structures (e.g., fluid pressure, etc.) can have an impact on the health outlook of a patient. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,789,294 [Patent Document 2] U.S. Patent Application Publication No. 2017 / 0325976 [Patent Document 3] U.S. Patent Application Publication No. 2010 / 0193999 [Patent Document 4] U.S. Patent No. 9,410,267 Summary of the Invention [Means for solving the problem]

[0005] Described herein are one or more methods and / or devices for facilitating monitoring of physiological parameters associated with the left atrium using one or more sensor implant devices implanted in or on one or more pulmonary veins and / or related anatomical structures / tissues.

[0006] In some implementations, the present disclosure relates to a sensor retention structure that includes a sensor support arm configured to have an at least partially cylindrically shaped sensor device disposed thereon, and one or more sensor retention fingers protruding from the sensor support arm and configured to be secured to the sensor device.

[0007] The one or more sensor retention fingers can be configured to at least partially wrap around a sensor device disposed on the sensor support arm. In some embodiments, at least one of the one or more sensor retention fingers includes a strap configuration, and at least one of the one or more sensor retention fingers includes a buckle configuration, the buckle configuration extending from opposite sides of the sensor support arm such that the strap configuration can be inserted through a portion of the buckle configuration. In some embodiments, at least one of the one or more sensor retention fingers has an aperture therein, the aperture being dimensioned to allow for the deposition of adhesive therein to secure at least one of the one or more sensor retention fingers to the sensor device. In some embodiments, the one or more sensor retention fingers are positioned within one or a set of aligned opposing fingers.

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

[0009] The sensor retention structure can further include a distal stop associated with the distal end portion of the sensor support arm. In some embodiments, the sensor retention structure further includes an encasement form configured to be at least partially disposed over the sensor device when the sensor device is disposed on the sensor support arm. For example, the encasement form can include one or more cutouts configured to fit over at least one of the one or more sensor retention fingers. In some embodiments, the one or more sensor retention fingers are part of a removable partial ring form. In some embodiments, the one or more sensor retention fingers have respective tabs associated therewith configured to protrude radially inward.

[0010] In some implementations, the present disclosure relates to a sensor retention structure that includes a sensor support arm configured to have an at least partially cylindrically shaped sensor device disposed thereon, and a cage structure associated with the sensor support arm, the cage structure configured to at least partially wrap around a circumferential surface of the sensor device.

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

[0012] In some implementations, the present disclosure relates to a sensor retention structure including a sensor support strut and a means for securing a sensor device to the sensor support strut. The means for securing the sensor device to the support strut can have any form, shape, composition, and / or configuration of or relating to any aspect of any of the embodiments illustrated and / or disclosed herein.

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

[0014] The means for securing the sensor device to the sensor support strut can include a proximal sensor mounting structure projecting at least partially orthogonally from the sensor support strut. For example, the proximal sensor mounting structure can include an aperture therein, the aperture being dimensioned to allow placement of an adhesive therein to secure the proximal sensor mounting structure to the sensor device. In some embodiments, the sensor mounting structure includes a suction cup associated with its distal side. In some embodiments, the proximal sensor mounting structure includes a distally angled arm having a hook feature associated with its distal end.

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

[0016] In some embodiments, the means for securing the sensor device to the sensor support strut includes one or more hoop forms bent away from the sensor support strut and configured to have the sensor device at least partially disposed through an opening in the one or more hoop forms. In some embodiments, the means for securing the sensor device to the sensor support strut includes a locking retention arm including a plurality of prongs and a sensor housing including a plurality of channels associated with a proximal end thereof and configured to receive one or more of the plurality of prongs and a distal end portion of the sensor support strut.

[0017] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0018] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 illustrates an exemplary representation of a human heart in accordance with one or more embodiments. [Figure 2] 1A-1C illustrate exemplary pressure waveforms associated with various chambers and vessels of the heart in accordance with one or more embodiments. [Figure 3] FIG. 1 is a block diagram depicting an implant device according to one or more embodiments. [Figure 4] FIG. 1 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. [Figure 5] 1A-1D illustrate exemplary shunt structures according to one or more embodiments. [Figure 6] 1A-1C illustrate a sensor implant device integrated into and / or attached / secured to a medical device structure, according to one or more embodiments. [Figure 7] FIG. 1 illustrates a sensor implant device implanted in the atrial septum, according to one or more embodiments. [Figure 8] 1 illustrates a sensor implant device implanted in the tissue wall between the coronary sinus and the left atrium, according to one or more embodiments. [Figure 9] FIG. 1 is a perspective view of a shunt device in a catheter delivery (eg, at least partially folded) configuration, according to one or more embodiments. [Figure 10] 10A-10C illustrate a sensor implant device having sensor support struts or arms, according to one or more embodiments. [Figure 11A] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a fabric and / or polymer cloth wrap configured to at least partially secure a sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 11B] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a fabric and / or polymer cloth wrap configured to at least partially secure a sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 12A] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a membrane wrap configured to at least partially secure the sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 12B] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a membrane wrap configured to at least partially secure the sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 13A] FIG. 10 is a perspective view of a sensor implant device having an integrated sensor secured to a sock feature, according to one or more embodiments. [Figure 13B] FIG. 10 is a perspective view of a sensor implant device having an integrated sensor secured to a sock feature, according to one or more embodiments. [Figure 14A]FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a membrane wrap configured to at least partially secure the sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 14B] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and a membrane wrap configured to at least partially secure the sensor device to the sensor support strut / arm, according to one or more embodiments. [Figure 15-1] FIG. 1 is a perspective view of a medical implant device including respective sensor support struts / arms and associated buckles and / or strap members according to one or more embodiments. [Figure 15-2] FIG. 1 is a perspective view of a medical implant device including respective sensor support struts / arms and associated buckles and / or strap members according to one or more embodiments. [Figure 16A] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and one or more buckles and / or strap members and / or one or more axial retention features associated therewith, according to one or more embodiments. [Figure 16B] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm and one or more buckles and / or strap members and / or one or more axial retention features associated therewith, according to one or more embodiments. [Figure 16C] 16C is a side view of the medical implant device of FIGS. 16A and 16B according to one or more embodiments. FIG. [Figure 17A]FIG. 1 is a perspective view of at least a portion of a medical implant device including a sensor support strut / arm and one or more sensor retention fingers, according to one or more embodiments. [Figure 17B] FIG. 1 is a perspective view of at least a portion of a medical implant device including a sensor support strut / arm and one or more sensor retention fingers, according to one or more embodiments. [Figure 17C] FIG. 1 illustrates an end view of at least a portion of a medical implant device including a sensor support strut / arm and one or more sensor retention fingers, according to one or more embodiments. [Figure 18A] FIG. 12 is a perspective view of a sensor support strut / arm and sensor retention overmolded support form according to one or more embodiments. [Figure 18B] FIG. 12 is a perspective view of a sensor support strut / arm and sensor retention overmolded support form according to one or more embodiments. [Figure 18C] FIG. 12 is a perspective view of a sensor support strut / arm and sensor retention overmolded support form according to one or more embodiments. [Figure 19A] FIG. 12 is a perspective view of a sensor support strut / arm associated with multiple locking sensor retention fingers according to one or more embodiments. [Figure 19B] FIG. 12 is a perspective view of a sensor support strut / arm associated with multiple locking sensor retention fingers according to one or more embodiments. [Figure 19C] FIG. 12 is an end view of a sensor support strut / arm associated with multiple locking sensor retention fingers according to one or more embodiments. [Figure 19D]FIG. 10 is an end view of a sensor support strut / arm associated with multiple locking sensor retention fingers according to one or more embodiments. [Figure 19E] FIG. 10 is a side view of a sensor support strut / arm associated with multiple locking sensor retention fingers according to one or more embodiments. [Figure 20A] FIG. 10 is an exploded view of an arm structure associated with a housing mounting flange according to one or more embodiments. [Figure 20B] FIG. 10 is a side view of an arm structure associated with a housing mounting flange according to one or more embodiments. [Figure 20C] FIG. 10 is a cross-sectional view of an arm structure associated with a housing mounting flange according to one or more embodiments. [Figure 20D] FIG. 10 is an end view of an arm structure associated with a housing mounting flange according to one or more embodiments. [Figure 20E] FIG. 10 is an end view of an arm structure associated with a housing mounting flange according to one or more embodiments. [Figure 21A] FIG. 10 is an exploded view of an arm structure associated with one or more sets of sensor retention and / or housing connection fingers, according to one or more embodiments. [Figure 21B] FIG. 10 is a perspective view of an arm structure associated with one or more sets of sensor retention and / or housing connection fingers according to one or more embodiments. [Figure 22A] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm associated with multiple mechanically locking sensor retention fingers, according to one or more embodiments. [Figure 22B] FIG. 1 is a perspective view of a medical implant device including a sensor support strut / arm associated with multiple mechanically locking sensor retention fingers, according to one or more embodiments. [Figure 23A] FIG. 10 is a perspective view of a sensor support strut / arm associated with multiple sets of sensor retention fingers according to one or more embodiments. [Figure 23B] FIG. 10 is a perspective view of a sensor support strut / arm associated with multiple sets of sensor retention fingers according to one or more embodiments. [Figure 24A] FIG. 1 is a perspective view of a sensor support structure including a trapdoor sensor retention feature according to one or more embodiments. [Figure 24B] FIG. 1 is a perspective view of a sensor support structure including a trapdoor sensor retention feature according to one or more embodiments. [Figure 25A] FIG. 10 is a perspective view of a particular portion of a sensor support arm associated with one or more tension fit rings, according to one or more embodiments. [Figure 25B] FIG. 10 is a perspective view of a particular portion of a sensor support arm associated with one or more tension fit rings, according to one or more embodiments. [Figure 25C] FIG. 10 is a perspective view of a particular portion of a sensor support arm associated with one or more tension fit rings, according to one or more embodiments. [Figure 26A] FIG. 10 is a perspective view of a sensor support arm including one or more clamping features, according to one or more embodiments. [Figure 26B] FIG. 10 is a perspective view of a sensor support arm including one or more clamping features, according to one or more embodiments. [Figure 26C] FIG. 10 is a perspective view of a sensor support arm including one or more clamping features, according to one or more embodiments. [Figure 26D] FIG. 10 is a perspective view of a sensor support arm including one or more clamping features, according to one or more embodiments. [Figure 26E]FIG. 10 is a perspective view of a sensor support arm including one or more clamping features, according to one or more embodiments. [Figure 27A] FIG. 1 is a perspective view of a sensor support arm structure including opposing circumferentially wrapping fingers according to one or more embodiments. [Figure 27B] FIG. 1 is a perspective view of a sensor support arm structure including opposing circumferentially wrapping fingers according to one or more embodiments. [Figure 28A] FIG. 1 is a perspective view of a sensor support structure including one or more prongs according to one or more embodiments. [Figure 28B] FIG. 1 is a perspective view of a sensor support structure including one or more prongs according to one or more embodiments. [Figure 29A] FIG. 12 is a perspective view of a sensor support structure / arm including a proximal stop feature according to one or more embodiments. [Figure 29B] FIG. 12 is a perspective view of a sensor support structure / arm including a proximal stop feature according to one or more embodiments. [Figure 29C] FIG. 12 is a perspective view of a sensor support structure / arm including a proximal stop feature according to one or more embodiments. [Figure 29D] FIG. 12 is a perspective view of a sensor support structure / arm including a proximal stop feature according to one or more embodiments. [Figure 30A] FIG. 12 is a perspective view of a sensor retention structure including a sensor support structure / arm and a suction-capable proximal stop feature, according to one or more embodiments. [Figure 30B] FIG. 10 is a side view of a sensor retention structure including a sensor support structure / arm and a suction-capable proximal stop feature according to one or more embodiments. [Figure 30C] FIG. 12 is a perspective view of a sensor retention structure including a sensor support structure / arm and a suction-capable proximal stop feature, according to one or more embodiments. [Figure 30D] FIG. 10 is a side view of a sensor retention structure including a sensor support structure / arm and a suction-capable proximal stop feature according to one or more embodiments. [Figure 31A] FIG. 12 is a perspective view of a sensor retention structure including a proximally positioned, distally angled stopper and / or retention arm / structure according to one or more embodiments. [Figure 31B] FIG. 10 is a side view of a sensor retention structure including a proximally positioned, distally angled stop and / or retention arm / structure according to one or more embodiments. [Figure 31C] FIG. 12 is a perspective view of a sensor retention structure including a proximally positioned, distally angled stopper and / or retention arm / structure according to one or more embodiments. [Figure 31D] FIG. 10 is a side view of a sensor retention structure including a proximally positioned, distally angled stop and / or retention arm / structure according to one or more embodiments. [Figure 32A] FIG. 1 is a perspective view of a sensor retention structure including a sheet configured to be at least partially wrapped around a sensor device according to one or more embodiments. [Figure 32B] FIG. 1 is a perspective view of a sensor retention structure including a sheet configured to be at least partially wrapped around a sensor device according to one or more embodiments. [Figure 33A] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm structure and one or more sensor retention rings according to one or more embodiments. [Figure 33B] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm structure and one or more sensor retention rings according to one or more embodiments. [Figure 34A]FIG. 1 is a top view of a sensor retention structure according to one or more embodiments. [Figure 34B] FIG. 1 is a top view of a sensor retention structure according to one or more embodiments. [Figure 34C] FIG. 1 is a side view of a sensor retention structure according to one or more embodiments. [Figure 34D] FIG. 1 illustrates a bottom view of a sensor retention structure according to one or more embodiments. [Figure 35A] FIG. 1 illustrates a perspective view of a sensor retention structure according to one or more embodiments. [Figure 35B] FIG. 1 illustrates a perspective view of a sensor retention structure according to one or more embodiments. [Figure 36A] FIG. 1 illustrates a side view of a medical implant device including a particular sensor retention feature, according to one or more embodiments. [Figure 36B] FIG. 1 illustrates an axial view of a medical implant device including a particular sensor retention feature, according to one or more embodiments. [Figure 37A] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention cage structure according to one or more embodiments. [Figure 37B] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention cage structure according to one or more embodiments. [Figure 38A] FIG. 10 is a perspective view of a sensor retention structure configured to bend away from the arms of a medical implant device according to one or more embodiments. [Figure 38B] FIG. 10 is a perspective view of a sensor retention structure configured to bend away from the arms of a medical implant device according to one or more embodiments. [Figure 38C] FIG. 38C illustrates the sensor retention structure of FIGS. 38A and 38B in a flat configuration, according to one or more embodiments. [Figure 39]FIG. 1 illustrates a side view of a medical implant device including an axial sensor support arm configured to support a sensor device according to one or more embodiments. [Figure 40] FIG. 1 is a side view of an embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 41A] 1A-1C illustrate an embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 41B] 1A-1C illustrate an embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 41C] 1A-1C illustrate an embodiment of a shunt-type medical implant device having a sensor device at least partially secured thereto, according to one or more embodiments. [Figure 42A] FIG. 1 is a side view of an embodiment of a shunt-type medical implant device including a particular sensor retention feature, according to one or more embodiments. [Figure 42B] FIG. 1 illustrates an axial view of an embodiment of a shunt-type medical implant device including a particular sensor retention feature, according to one or more embodiments. [Figure 43] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention trough according to one or more embodiments. [Figure 44] FIG. 1 is a perspective view of a sensor retention structure including a mesh or the like configured to secure a sensor device to a sensor support structure according to one or more embodiments. [Figure 45] FIG. 1 is a perspective view of a magnetic sensor retention structure according to one or more embodiments. [Figure 46A]FIG. 10 is a side perspective view of a sensor retention structure in a relatively shortened configuration according to one or more embodiments. [Figure 46B] FIG. 10 is a side perspective view of a sensor retention structure in a relatively elongated configuration according to one or more embodiments. [Figure 47] 1A-1C illustrate separate embodiments of sensor structures including respective sensor retention features in accordance with one or more aspects of the present disclosure. [Figure 48] 1A-1C illustrate separate embodiments of sensor structures including respective sensor retention features in accordance with one or more aspects of the present disclosure. [Figure 49] 1A-1C illustrate separate embodiments of sensor structures including respective sensor retention features in accordance with one or more aspects of the present disclosure. [Figure 50A] FIG. 1 is a perspective view of a sensor retention structure including one or more sensor retention fingers according to one or more embodiments. [Figure 50B] FIG. 1 is a perspective view of a sensor retention structure including one or more sensor retention fingers according to one or more embodiments. [Figure 50C] FIG. 1 is a perspective view of a sensor retention structure including one or more sensor retention fingers according to one or more embodiments. [Figure 50D] FIG. 1 is a perspective view of a sensor retention structure including one or more sensor retention fingers according to one or more embodiments. [Figure 50E] FIG. 10 is an end view of a sensor retention structure including one or more sensor retention fingers according to one or more embodiments. [Figure 51A] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 51B]FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 51C] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 51D] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 51E] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 52A] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 52B] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 52C] FIG. 10 illustrates a sensor retention structure including one or more runner-type sensor support struts, according to one or more embodiments. [Figure 53A] FIG. 1 is a perspective view of an embodiment of a sensor retention structure according to one or more embodiments. [Figure 53B] FIG. 1 is a perspective view of an embodiment of a sensor retention structure according to one or more embodiments. [Figure 53C] FIG. 1 is a perspective view of an embodiment of a sensor retention structure according to one or more embodiments. [Figure 53D] FIG. 1 is a perspective view of an embodiment of a sensor retention structure according to one or more embodiments. [Figure 53E] FIG. 1 is a side view of an embodiment of a sensor retention structure according to one or more embodiments. [Figure 54A] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention arm with an end crosspiece according to one or more embodiments. [Figure 54B] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention arm with an end crosspiece according to one or more embodiments. [Figure 54C] FIG. 1 is a perspective view of a sensor retention structure including a sensor retention arm with an end crosspiece according to one or more embodiments. [Figure 55] FIG. 54A is a perspective view of the sensor retention structure of FIGS. 54A-54C with a sleeve disposed thereon according to one or more embodiments. [Figure 56A] FIG. 10 is a perspective view of a sensor retention structure including an axially extending arm with an end crosspiece according to one or more embodiments. [Figure 56B] FIG. 10 is a perspective view of a sensor retention structure including an axially extending arm with an end crosspiece according to one or more embodiments. [Figure 56C] FIG. 10 is a perspective view of a sensor retention structure including an axially extending arm with an end crosspiece according to one or more embodiments. [Figure 56D] FIG. 10 is a perspective view of a sensor retention structure including an axially extending arm with an end crosspiece according to one or more embodiments. [Figure 57] FIG. 56A is a perspective view of the sensor retention structure of FIGS. 56A-56D with a sleeve disposed thereon according to one or more embodiments. [Figure 58A] FIG. 1 is a perspective view of a sensor retention structure including a cage configured to hold a sensor device according to one or more embodiments. [Figure 58B] FIG. 1 is a perspective view of a sensor retention structure including a cage configured to hold a sensor device according to one or more embodiments. [Figure 58C] FIG. 1 is a perspective view of a sensor retention structure including a cage configured to hold a sensor device according to one or more embodiments. [Figure 58D] FIG. 1 is a perspective view of a sensor retention structure including a cage configured to hold a sensor device according to one or more embodiments. [Figure 59] FIG. 58A is a perspective view of the sensor retention structure of FIGS. 58A-58D with a sleeve disposed thereon according to one or more embodiments. [Figure 60A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 60B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 60C] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 60D] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 61] FIG. 60A-60D are perspective views of the sensor retention structure 600 of FIGS. 60A-60D with a sleeve disposed thereon, according to one or more embodiments. [Figure 62A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 62B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 62C] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 62D] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 63]FIG. 62A-62D is a perspective view of the sensor retention structure 620 of FIGS. 62A-62D with a sleeve disposed thereon, according to one or more embodiments. [Figure 64A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 64B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 64C] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 64D] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 65] FIG. 64B is a perspective view of the sensor retention structure of FIGS. 64A-64D with a sleeve disposed thereon according to one or more embodiments. [Figure 66A] FIG. 10 is a perspective view of a sensor retention structure including two support struts and an arm of a medical implant device according to one or more embodiments. [Figure 66B] FIG. 10 is a perspective view of a sensor retention structure including two support struts and an arm of a medical implant device according to one or more embodiments. [Figure 67A] FIG. 66C is a perspective view of the sensor retention structure of FIGS. 66A-66B with a sleeve disposed thereon according to one or more embodiments. [Figure 67B] FIG. 66C is a perspective view of the sensor retention structure of FIGS. 66A-66B with a sleeve disposed thereon according to one or more embodiments. [Figure 67C] FIG. 66C is a perspective view of the sensor retention structure of FIGS. 66A-66B with a sleeve disposed thereon according to one or more embodiments. [Figure 68A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 68B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 68C] FIG. 1 is a perspective view of a sensor retention structure including a cage structure according to one or more embodiments. [Figure 69A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device according to one or more embodiments. [Figure 69B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device according to one or more embodiments. [Figure 69C] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device according to one or more embodiments. [Figure 69D] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device according to one or more embodiments. [Figure 70A] FIG. 10 is a perspective view of a sensor retention structure including a cage structure and a distal stopper ring according to one or more embodiments. [Figure 70B] FIG. 10 is a perspective view of a sensor retention structure including a cage structure and a distal stopper ring according to one or more embodiments. [Figure 70C] FIG. 10 is a perspective view of a sensor retention structure including a cage structure and a distal stopper ring according to one or more embodiments. [Figure 70D] FIG. 10 is a perspective view of a sensor retention structure including a cage structure and a distal stopper ring according to one or more embodiments. [Figure 71A] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device and one or more distal and / or proximal stop features according to one or more embodiments. [Figure 71B] FIG. 1 is a perspective view of a sensor retention structure including a cage structure configured to hold a sensor device and one or more distal and / or proximal stop features according to one or more embodiments. [Figure 72] FIG. 10 is a perspective view of a sensor support strut and associated sensor covering according to one or more embodiments. [Figure 73] FIG. 10 is a bottom view of an embodiment of a sensor retention structure including a sensor support strut and an encasement according to one or more embodiments. [Figure 74] FIG. 10 is a bottom view of an embodiment of a sensor retention structure including a sensor support strut and an encasement according to one or more embodiments. [Figure 75] FIG. 10 is a perspective view of an embodiment of a sensor retention structure including a sensor support strut and an encasement according to one or more embodiments. [Figure 76A] FIG. 1 is an exploded view of a sensor retention structure including a sensor support arm and an encasement configured to fit or engage with the sensor support arm, according to one or more embodiments. [Figure 76B] FIG. 1 is an exploded view of a sensor retention structure including a sensor support arm and an encasement configured to fit or engage with the sensor support arm, according to one or more embodiments. [Figure 76C] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm and an encasement configured to fit or engage with the sensor support arm, according to one or more embodiments. [Figure 76D] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm and an encasement configured to fit or engage with the sensor support arm, according to one or more embodiments. [Figure 77] FIG. 76A is a perspective view of the sensor retention structure of FIGS. 76A-76D with a sleeve disposed thereon according to one or more embodiments. [Figure 78A] FIG. 1 is an exploded view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 78B] FIG. 1 is an exploded view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 78C] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 78D] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 79] FIG. 78A is a perspective view of the sensor retention structure of FIGS. 78A-78D with a sleeve disposed thereon according to one or more embodiments. [Figure 80A]FIG. 10 is an exploded view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers with end crosspieces and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 80B] FIG. 10 is an exploded view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers with end crosspieces and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 80C] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers with end crosspieces and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 80D] FIG. 1 is a perspective view of a sensor retention structure including a sensor support arm, an encasement configured to fit or engage with the sensor support arm, and one or more sets of opposing fingers with end crosspieces and / or one or more axially offset retention fingers, according to one or more embodiments. [Figure 81] FIG. 80B is a perspective view of the sensor retention structure of FIGS. 80A-80D with a sleeve disposed thereon according to one or more embodiments. [Figure 82] FIG. 12 illustrates a perspective view of a locking retention arm according to one or more embodiments. [Figure 83A]FIG. 10 illustrates a sensor retention structure configured to be secured in some manner to a retention arm structure according to one or more embodiments. [Figure 83B] FIG. 10 illustrates a sensor retention structure configured to be secured in some manner to a retention arm structure according to one or more embodiments. [Figure 83C] FIG. 10 illustrates a sensor retention structure configured to be secured in some manner to a retention arm structure according to one or more embodiments. [Figure 84A] FIG. 83 is a perspective view of at least a portion of the locking retention arm of FIG. 82 according to one or more embodiments. [Figure 84B] FIG. 83 is a perspective view of at least a portion of the locking retention arm of FIG. 82 according to one or more embodiments. [Figure 84C] FIG. 83 is a perspective view of at least a portion of the locking retention arm of FIG. 82 according to one or more embodiments. [Figure 85A] 83A-83C depict stages in a process for inserting the locking retention arm of FIG. 82 into the proximal end portion of the retention structure of FIGS. 83A-83C, according to one or more embodiments. [Figure 85B] 83A-83C depict stages in a process for inserting the locking retention arm of FIG. 82 into the proximal end portion of the retention structure of FIGS. 83A-83C, according to one or more embodiments. [Figure 85C] 83A-83C depict stages in a process for inserting the locking retention arm of FIG. 82 into the proximal end portion of the retention structure of FIGS. 83A-83C, according to one or more embodiments. [Figure 86A] FIG. 1 is a perspective view of a sensor retention structure configured to hold a sensor device according to one or more embodiments. [Figure 86B] FIG. 1 is a perspective view of a sensor retention structure configured to hold a sensor device according to one or more embodiments. [Figure 86C] FIG. 1 is a perspective view of a sensor retention structure configured to hold a sensor device according to one or more embodiments. [Figure 86D] FIG. 1 is a perspective view of a sensor retention structure configured to hold a sensor device according to one or more embodiments. [Figure 87] FIG. 10 is an end view of a sensor retention structure including a distal stop bar feature according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0020] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0021] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise therefrom is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described sequentially as multiple separate operations, in a manner that may be helpful in understanding a particular embodiment. However, the order of description should not be construed to imply that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.

[0022] Certain standard anatomical location terms are used herein to refer to animal (and, i.e., human) anatomical structures with respect to preferred embodiments. While certain spatially relative terms (e.g., "outer," "inner," "superior," "lower," "upper," "vertical," "horizontal," "top," "bottom," etc.) and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it is understood that these terms are used herein for ease of description to describe the positional relationships between elements / structures as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of elements / structures in use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as being "above" another element / structure may represent a position below or to the side of such other element / structure with respect to a symmetrical patient or alternative orientations of the element / structure, and vice versa.

[0023] The present disclosure relates to systems, devices, and methods for remote monitoring of one or more physiological parameters (e.g., blood pressure) of a patient in connection with cardiac shunts and / or other medical implant devices and / or procedures. Such pressure monitoring may be performed using cardiac implant devices having integrated pressure sensors and / or related components. For example, in some implementations, the present disclosure relates to cardiac shunts and / or other cardiac implant devices that incorporate or are associated with pressure sensors or other sensor devices. The term “associated with” is used herein in accordance with its broad ordinary meaning. For example, when a first feature, element, component, device, or member is described as “associated with” a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled to, attached or connected to, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly. Certain embodiments are disclosed herein in the context of a cardiac implant device. However, while certain principles disclosed herein are particularly applicable to cardiac anatomy, it should be understood that a sensor implant device according to the present disclosure may be implanted in or configured for implantation in any suitable or desired anatomy.

[0024] Cardiac Physiology The anatomical structure of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, the flow of which is controlled at least in part by various cardiac valves (i.e., the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve). The valves are configured to open and close in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole), and can at least in part control the flow of blood to respective regions of the heart and / or to blood vessels (e.g., the pulmonary vessels, the aorta, etc.). Contraction of the various cardiac muscles can be prompted by signals generated by the heart's electrical system, which is discussed in detail below. Certain embodiments disclosed herein relate to cardiac conditions (e.g., atrial fibrillation and / or complications, etc.) or solutions associated therewith. However, embodiments of the present disclosure relate more generally to any health complications related to fluid overload in a patient, such as may result postoperatively following any surgical procedure involving fluid supplementation. That is, detection of atrial stretching as described herein may be implemented to detect / determine a fluid overload condition, which may direct therapeutic or compensatory actions related to atrial fibrillation and / or any other condition caused at least in part by fluid overload.

[0025] FIG. 1 illustrates an exemplary representation of a heart 1 having various features associated with certain embodiments of the present disclosure. Heart 1 includes four chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. From a blood flow perspective, blood generally flows from the right ventricle 4 through pulmonary valve 9 into the pulmonary artery, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped toward the lungs and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 includes, as shown, the pulmonary trunk and the left pulmonary artery 15 and right pulmonary artery 13, which branch off from the pulmonary trunk. In addition to the pulmonary valve 9, heart 1 includes three additional valves (including the tricuspid valve 8, the aortic valve 7, and the mitral valve 6) to aid in the circulation of blood therein. 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 typically capable of closing during ventricular contraction (i.e., systole) and opening during diastole (i.e., diastole). The mitral valve 6 typically has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole, allowing blood in the left atrium 2 to flow into the left ventricle 3, and, when functioning properly, closes during systole, preventing 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, allowing blood leaving the left ventricle 3 to enter the aorta 12, and closes during diastole, preventing blood from leaking back into the left ventricle 3.

[0026] Heart valves generally may include a relatively dense annulus of fibrous tissue (referred to herein as the annulus) and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that, when the heart contracts, the resulting increased blood pressure created in the corresponding heart chamber forces the leaflets to at least partially open, allowing flow from the heart chamber. When pressure in a heart chamber subsides, pressure in a subsequent chamber or vessel may prevail and push the leaflets back. As a result, the leaflets / cusps fall into apposition with each other, thereby closing the flow passageway. Malfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve malfunction) can result in valve leakage and / or other health complications.

[0027] The atrioventricular heart valves (i.e., the mitral and tricuspid valves) further include a collection of chordae tendineae and papillary muscles (not shown) to secure the leaflets of each valve, urging and / or promoting proper coaptation of the leaflets and preventing their prolapse. For example, the papillary muscles may include finger-like protrusions from the ventricular wall. The leaflets are connected to the papillary muscles by the chordae tendineae. A muscular wall 17 (called the septum) separates the left atrium 2 and the right atrium 5, and also separates the left ventricle 3 and the right ventricle 4.

[0028] Health conditions associated with cardiac pressure and other parameters As referenced above, certain physiological conditions or parameters associated with the cardiac anatomy can affect a patient's health. For example, congestive heart failure is a condition associated with relatively slow movement of blood through the heart and / or body, causing 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 various chambers of the heart can respond to the increased pressure by stretching to hold more blood for pumping through the body or by becoming relatively stiff and / or thickened. The walls of the heart can eventually weaken and become unable to pump efficiently. In some cases, the kidneys can respond to the heart's inefficiency by causing the body to retain fluid. Fluid accumulation in the arms, legs, ankles, feet, lungs, and / or other organs can cause the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality and, therefore, the treatment and / or prevention of congestive heart failure is of significant medical interest.

[0029] Treatment and / or prevention of heart failure (e.g., congestive heart failure) may advantageously involve monitoring pressure in one or more chambers or regions of the heart or other anatomical structures. As explained above, elevated pressure in one or more chambers or areas of the heart may be associated with congestive heart failure. Without direct or indirect monitoring of cardiac pressure, it may be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure. For example, treatments or approaches that do not involve direct or indirect pressure monitoring may involve measuring or observing other current physiological conditions of the patient (such as measuring body weight, thoracic impedance, or right heart catheterization). In some solutions, pulmonary capillary wedge pressure may be measured as a surrogate for left atrial pressure. For example, a pressure sensor may be disposed or implanted in the pulmonary artery, and readings associated therewith may be used as a surrogate for left atrial pressure. However, with regard to catheter-based pressure measurements in the pulmonary artery or certain other chambers or regions of the heart, the use of an invasive catheter may be required to maintain such a pressure sensor, which may be uncomfortable or difficult to implement. Moreover, certain pulmonary conditions may affect pressure readings in the pulmonary artery, such that the correlation between pulmonary artery pressure and left atrial pressure may be undesirably attenuated. As an alternative to pulmonary artery pressure measurements, pressure measurements in the right ventricular outflow tract may be similarly related to left atrial pressure. However, the correlation between such pressure readings and left atrial pressure may not be strong enough to be utilized in congestive heart failure diagnosis, prevention, and / or treatment.

[0030] Additional solutions can be implemented to derive or estimate left atrial pressure. For example, the E / A ratio (which represents the ratio of peak velocity blood flow from gravity in early diastole (E wave) to peak velocity flow in late diastole (A wave) caused by atrial contraction, and is a marker of the function of the heart's left ventricle) can be used as a surrogate to measure left atrial pressure. The E / A ratio can be determined using echocardiography or other imaging techniques. Generally, an abnormality in the E / A ratio can indicate that the left ventricle is unable to properly fill with blood during the period between contractions, which can lead to symptoms of heart failure, as explained above. However, E / A ratio determinations generally do not provide an absolute pressure measurement.

[0031] Various methods for identifying and / or treating congestive heart failure involve monitoring worsening congestive heart failure symptoms and / or weight changes. However, such signs may be relatively delayed and / or relatively unreliable. For example, daily weight measurements can vary significantly (e.g., by up to 9% or more) and may be unreliable in signaling cardiac complications. Moreover, treatments guided by monitoring signs, symptoms, weight, and / or other biomarkers have not been shown to substantially improve clinical outcomes. Additionally, for discharged patients, such treatments may require remote telemedicine systems.

[0032] The present disclosure provides systems, devices, and methods for guiding the administration of medications related to the treatment of congestive heart failure by, at least in part, directly monitoring pressure within the left atrium or other chamber or vessel (for which pressure measurements indicate left atrial pressure) of a congestive heart failure patient in order to reduce hospital readmissions, morbidity, and / or otherwise improve the patient's health outlook.

[0033] Cardiac Pressure Monitoring Cardiac pressure monitoring according to embodiments of the present disclosure can provide a preventative intervention mechanism for preventing or treating congestive heart failure. Generally, increases in ventricular filling pressure associated with diastolic and / or systolic heart failure can occur before the onset of symptoms leading to hospitalization. For example, cardiac pressure indicators can be present for some patients several weeks before hospitalization. Thus, pressure monitoring systems according to embodiments of the present disclosure can be advantageously implemented to reduce instances of hospitalization by guiding appropriate or desired titration and / or administration of medications before the onset of heart failure.

[0034] Dyspnea represents a cardiac pressure indicator characterized by shortness of breath or a feeling of not being able to breathe adequately. Dyspnea can result from elevated atrial pressure, which can cause fluid accumulation in the lungs from pressure backup. Pathological dyspnea can result from congestive heart failure. However, a significant amount of time can elapse between the time of the initial pressure rise and the onset of dyspnea, and thus, symptoms of dyspnea may not provide an early enough signal of elevated atrial pressure. By directly monitoring pressure in accordance with embodiments of the present disclosure, normal ventricular filling pressures can be advantageously maintained, thereby preventing or reducing the effects of heart failure (e.g., dyspnea, etc.).

[0035] As referenced above, with respect to cardiac pressure, elevated left atrial pressure may be correlated with heart failure, among other things. FIG. 2 illustrates exemplary pressure waveforms associated with various chambers and vessels of the heart, according to one or more embodiments. The various waveforms illustrated in FIG. 2 may represent waveforms obtained using right heart catheterization to advance one or more pressure sensors to each illustrated and labeled cardiac chamber or vessel. As illustrated in FIG. 2, waveform 25 (which represents left atrial pressure) may be considered to provide the best feedback for early detection of congestive heart failure. Moreover, a relatively strong correlation may exist between increased left atrial pressure and pulmonary congestion.

[0036] Left atrial pressure may generally correlate well with left ventricular end-diastolic pressure. However, while left atrial pressure and end-diastolic pulmonary artery pressure may have a significant correlation, such correlation may be weakened when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally may not correlate well with left ventricular end-diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. For example, pulmonary hypertension (which affects approximately 25% to 83% of patients with heart failure) may affect the reliability of pulmonary artery pressure measurements to estimate left-sided filling pressure. Therefore, pulmonary artery pressure measurements, such as those represented by waveform 24, alone may be an insufficient or inaccurate indicator of left ventricular end-diastolic pressure, particularly for patients with coexisting conditions (e.g., pulmonary disease and / or thromboembolism). Left atrial pressure may further be at least partially correlated with the presence and / or degree of mitral valve regurgitation.

[0037] Left atrial pressure readings may be relatively less likely to be distorted or affected by other conditions (e.g., respiratory conditions, etc.) compared to the other pressure waveforms shown in Figure 2. In general, left atrial pressure can significantly predict heart failure, such as two weeks before the onset of heart failure. For example, increases in left atrial pressure and both diastolic and systolic heart failure can occur several weeks before hospitalization, and thus knowledge of such increases can be used to predict the onset of congestive heart failure (e.g., acute debilitating episodes of congestive heart failure, etc.).

[0038] Cardiac pressure monitoring (e.g., left atrial pressure monitoring, etc.) can provide a mechanism for guiding the administration of medications to treat and / or prevent congestive heart failure. Such treatment can advantageously reduce rehospitalizations and morbidity, and can provide other benefits. Implantable pressure sensors according to embodiments of the present disclosure can be used to predict heart failure up to two weeks or more before the manifestation of heart failure symptoms or markers (e.g., dyspnea). Using cardiac pressure sensor embodiments according to the present disclosure, when heart failure predictors are recognized, specific preventative measures can be implemented (including pharmaceutical interventions (e.g., modifications to a patient's drug regimen)) that can help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurement of the left atrium can advantageously provide an accurate indicator of elevated pressures that may lead to heart failure or other complications. For example, trends in elevated atrial pressure can be analyzed or used to determine or predict the onset of cardiac dysfunction, and drugs or other therapies can be increased to cause a reduction in pressure and prevent or reduce further complications.

[0039] Implantable devices with integrated sensors In some implementations, the present disclosure relates to sensors associated with or integrated with cardiac shunts or other implant devices. Such integrated devices can be used to provide controlled and / or more effective therapy for treating and preventing heart failure and / or other health complications related to cardiac function. FIG. 3 is a block diagram illustrating an implant device 30 including a shunt (or other type of implant) structure 39. In some embodiments, the shunt structure 39 is physically integrated with and / or connected to a sensor device 37. The sensor device 37 can be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 37 includes a transducer 32 (e.g., a pressure transducer, etc.) and specific control circuitry 34, which can be embodied, for example, in an application-specific integrated circuit (ASIC).

[0040] The control circuitry 34 may be configured to process signals received from the transducer 32 and / or wirelessly communicate signals associated therewith through biological tissue using the antenna 38. The antenna 38 may include one or more coils or loops of a conductive material (e.g., copper wire, etc.). In some embodiments, at least a portion of the transducer 32, the control circuitry 34, and / or the antenna 38 are at least partially disposed or contained within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 36, in some embodiments, may comprise glass or other rigid material, which may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure / material, which may advantageously allow the sensor 37 to be folded, bent, or folded, enabling its transport through a catheter or other introduction means.

[0041] The transducer 32 can include any type of sensor means or mechanism. For example, the transducer 32 can be a force-collector-type pressure sensor. In some embodiments, the transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or other strain- or deflection-measuring component to measure strain or deflection applied over its area / surface. The transducer 32 can be associated with a housing 36, at least a portion of which is contained within or attached to the housing 36. The term “associated with” is used herein in accordance with its broad ordinary meaning. With respect to a sensor device / component “associated with” a stent or other implant structure, such terminology can refer to the sensor device or component being physically coupled to, attached to, connected to, or integral with the implant structure.

[0042] In some embodiments, transducer 32 includes or is a piezoresistive strain gauge component, which may be configured to detect strain due to applied pressure using bonded or formed strain gauges, which increase in resistance as pressure deforms the component / material. Transducer 32 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, and / or sputtered thin film.

[0043] In some embodiments, transducer 32 includes or is a component of a capacitive pressure sensor. A capacitive pressure sensor includes a diaphragm and a pressure cavity, which form a variable capacitor and are configured to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor generally decreases when pressure deforms the diaphragm. The diaphragm can include any material, including, but not limited to, metal, ceramic, and silicon. In some embodiments, transducer 32 includes or is a component of an electromagnetic pressure sensor. The electromagnetic pressure sensor can be configured to measure diaphragm displacement through changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors can determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials (e.g., quartz).

[0044] In some embodiments, the transducer 32 includes or is a component of a strain gauge. For example, strain gauge embodiments can include a pressure-sensitive element on or associated with the exposed surface of the transducer 32. In some embodiments, a metal strain gauge is glued to the surface of the sensor, or a thin-film gauge can be applied to the sensor by sputtering or other techniques. The measuring element or mechanism can include a diaphragm or metal foil. The transducer 32 can include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0045] 4 illustrates a system 40 for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) in a patient 44, according to one or more embodiments. The patient 44 may have a medical implant device 30 implanted in, for example, the heart (not shown) (or associated physiology) of the patient 44. For example, the implant device 30 may be at least partially implanted in the left atrium of the patient's heart. The implant device 30 may include one or more sensor transducers 32, such as, for example, one or more microelectromechanical systems (MEMS) devices, such as, for example, MEMS pressure sensors, or other types of sensor transducers.

[0046] In certain embodiments, the monitoring system 40 can include at least two subsystems, including an implantable internal subsystem or device 30, which includes a sensor transducer 32 and a control circuit 34, which includes one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 can further include an external (e.g., non-implantable) subsystem, which includes an external reader 42 (e.g., a coil), which can include a wireless transceiver electrically and / or communicatively coupled to the specific control circuit. In certain embodiments, both the internal and external subsystems include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implant device 30 can be any type of implant device. For example, in some embodiments, the implant device 30 includes a pressure sensor integrated with another functional implant structure (e.g., an artificial shunt or stent device / structure, etc.).

[0047] Certain details of the implant device 30 are illustrated within the enlarged block 30 shown. The implant device 30 can include a cardiac implant structure 39, as described herein. For example, the cardiac implant structure 39 can include a percutaneously deliverable shunt device configured to be secured to and / or within a tissue wall and provide a fluid path between two chambers and / or blood vessels of the heart, as described in more detail throughout this disclosure. While certain components are illustrated in FIG. 4 as part of the implant device 30, it should be understood that the sensor implant device 30 can include only a subset of the illustrated components / modules and can also include additional components / modules not shown. The implant device can represent the embodiment of the implant device shown in FIG. 3, or vice versa. The implant device 30 can advantageously include one or more sensor transducers 32, which can be configured to provide a response indicative of one or more physiological parameters of the patient 44 (e.g., atrial pressure, etc.). Although a pressure transducer is described, the sensor transducer 32 may include any suitable or desirable type of sensor transducer for providing a signal related to a physiological parameter or condition associated with the implant device 30 and / or the patient 44.

[0048] The sensor transducer 32 may include one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, diaphragm-based sensors, and / or other types of sensors that may be positioned within the patient 44 and sense one or more parameters related to the patient's health. The transducer 32 may be a force-collector type pressure sensor. In some embodiments, the transducer 32 includes a diaphragm, piston, Bourdon tube, bellows, or other strain- or deflection-measuring component to measure strain or deflection applied over its area / surface. The transducer 32 may be associated with the sensor housing 36, such that at least a portion of it is contained within or attached to the housing 36. The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, if 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 to, attached or connected to, integrated with, at least partially embedded within, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member. With respect to a sensor device / component being "associated with" an implant structure, such terminology can refer to the sensor device or component being physically coupled to, attached to, connected to, or integrated with the implant structure.

[0049] In some embodiments, the transducer 32 includes or is a component of a piezoresistive strain gauge, which may be configured to detect strain due to applied pressure using bonded or formed strain gauges, which increase in resistance as pressure deforms the component / material. The transducer 32 can incorporate any type of material, including, but not limited to, silicone, polymer, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, and / or sputtered thin film. In some embodiments, the transducer 32 includes or is a component of a strain gauge. In some embodiments, a metal strain gauge is glued to the sensor surface, or a thin film gauge may be applied onto the sensor by sputtering or other techniques. The measuring element or mechanism can include a diaphragm or metal foil. Transducer 32 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionization, or other type of strain or pressure sensor.

[0050] In some embodiments, transducer 32 includes or is a component of a capacitive pressure sensor. A capacitive pressure sensor includes a diaphragm and a pressure cavity, which form a variable capacitor and are configured to detect strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor generally decreases when pressure deforms the diaphragm. The diaphragm can include any material, including, but not limited to, metal, ceramic, silicone, silicon, or other semiconductors. In some embodiments, transducer 32 includes or is a component of an electromagnetic pressure sensor. The electromagnetic pressure sensor can be configured to measure diaphragm displacement through changes in inductance, linear variable displacement transducer (LVDT) functionality, Hall effect, or eddy current sensing. In some embodiments, transducer 32 includes or is a component of a piezoelectric strain sensor. For example, such sensors can determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials (e.g., quartz).

[0051] In some embodiments, the transducer 32 is electrically and / or communicatively coupled to a control circuit 34, which may include one or more application specific integrated circuits (ASIC) microcontrollers or chips. The control circuit 34 may further include one or more individual electronic components (e.g., tuning capacitors, resistors, diodes, inductors, etc.).

[0052] In certain embodiments, the sensor transducer 32 may be configured to generate an electrical signal that may be transmitted wirelessly to a device outside the patient's body (such as the illustrated local external monitor system 42). To implement such wireless data transmission, the implant 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. The control circuitry 34 may include any type of transceiver circuitry configured to transmit electromagnetic signals, which may be radiated by the antenna 38, which may include one or more conductive wires, coils, or plates. The control circuitry 34 of the implant device 30 may include, for example, one or more chips or dies configured to perform some amount of processing on signals generated and / or transmitted using the device 30. However, due to size, cost, and / or other constraints, the implant device 30 may not include independent processing capabilities in some embodiments.

[0053] The wireless signals generated by the implant device 30 may be received by a local external monitoring device or subsystem 42, which may include a reader / antenna-interface circuit module 43 configured to receive wireless signal transmissions from the implant device 30, which is at least partially disposed within the patient 44. For example, the module 43 may include a transceiver device / circuitry.

[0054] The external local monitor 42 may receive wireless signal transmissions and / or provide wireless power using an external antenna 48 (e.g., a pen-type device, etc.). The reader / antenna-interface circuit 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implant device 30, which may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs), and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, etc. The reader / antenna-interface circuit 43 may further be configured to transmit signals to the remote monitor subsystem or device 46 via a network 49. The RF circuitry of the reader / antenna-interface circuit 43 may further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc. for processing signals transmitted via the network 49 and / or for receiving signals from the implant device 30. In certain embodiments, the local monitor 42 includes control circuitry 41 for performing processing of signals received from the implant device 30. The local monitor 42 may be configured to communicate with the network 49 according to known network protocols (e.g., Ethernet or Wi-Fi, etc.). In certain embodiments, the local monitor 42 includes a smartphone, laptop computer, or other mobile computing device, or any other type of computing device.

[0055] In certain embodiments, the implant device 30 includes some amount of volatile and / or non-volatile data storage. For example, such data storage can include solid-state memory utilizing arrays of floating-gate transistors or the like. The control circuitry 34 can utilize data storage to store sensed data collected over a period of time, which can be periodically transmitted to the local monitor 42 or another external subsystem. In certain embodiments, the implant device 30 does not include data storage. The control circuitry 34 can be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated therewith. The control circuitry 34 can further be 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 a network 49. For example, the implant device 30 can be configured to receive signals that at least partially control the operation of the implant device 30, such as by activating / deactivating one or more components or sensors or otherwise affecting the operation or performance of the implant device 30.

[0056] One or more components of the implant device 30 may be powered by one or more power sources 35. Due to size, cost, and / or electrical complexity concerns, it may be desirable for the power source 35 to be relatively minimal in nature. For example, high power drive voltages and / or currents within the implant device 30 may adversely affect or interfere with the operation of the heart or other body parts associated with the implant device. In certain embodiments, the power source 35 is at least partially passive in nature, such that power can be received wirelessly from an external source by passive circuitry of the implant device 30 (e.g., through short-range or near-range wireless power transmission or the use of other electromagnetic coupling mechanisms). For example, the local monitor 42 can act as an initiator that actively generates an RF field, which can provide power to the implant device 30, thereby allowing the implant device's power circuitry to have a relatively simple form factor. In certain embodiments, the power source 35 can be configured to obtain energy from environmental sources (e.g., fluid flow or motion). Additionally or alternatively, power source 35 may include a battery, which may advantageously be configured to provide sufficient power as needed for the monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period of time).

[0057] In some embodiments, the local monitoring device 42 can serve as an intermediate communication device between the implant device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implant device 30. For example, the local monitoring device 42 can be a wearable communication device or other device that can be easily disposed in proximity to the patient 44 and the implant device 30. The local monitoring device 42 can be configured to continuously, periodically, or sporadically interrogate the implant device 30 to extract or request sensor-based information therefrom. In certain embodiments, the local monitor 42 includes a user interface that a user can utilize to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implant device 30.

[0058] System 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with monitored cardiac pressure data. In one embodiment, local monitor 42 may be a wearable device or other device or system configured to be disposed in close physical proximity to the patient and / or implant device 30, and is primarily designed to receive / transmit signals to and / or from implant device 30 and provide such signals to secondary local monitor 47 for viewing, processing, and / or operating thereon. External local monitoring system 42 may be configured to receive and / or process certain metadata (e.g., device ID, etc.) from or associated with implant device 30, which may also be provided via data coupling from implant device 30.

[0059] 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 over the network 49 from the local monitoring device 42, the secondary local monitor 47, and / or the implant device 30. For example, the remote monitoring subsystem 46 can advantageously be operated and / or controlled by a healthcare entity (e.g., a hospital, doctor, or other care entity associated with the patient 44). While certain embodiments disclosed herein describe communicating with the remote monitoring subsystem 46 indirectly from the implant device through the local monitoring device 42, in certain embodiments, the implant device 30 can include a transmitter capable of communicating with the remote monitoring subsystem 46 over the network 49 without having to relay information through the local monitoring device 42.

[0060] In certain embodiments, the antenna 48 of the external monitor system 42 includes an external coil antenna that is matched and / or tuned to be inductively paired with the antenna 38 of the internal implant 30. In some embodiments, the implant device 30 is configured to receive wireless ultrasonic power charging and / or data communication from the external monitor system 42. As referenced above, the local external monitor 42 can include a pen-type or other handheld reader.

[0061] In some embodiments, at least a portion of the transducer 32, control circuitry 34, power source 35, and / or antenna 38 are at least partially disposed or contained within a sensor housing 36, which can comprise any type of material and can advantageously be at least partially hermetically sealed. For example, the housing 36 can, in some embodiments, comprise glass or other rigid material, which can 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 can comprise a polymer or other flexible structure / material, which can advantageously allow the sensor 30 to be folded, bent, or folded, enabling its transport through a catheter or other percutaneous introduction means.

[0062] Cardiac Shunt Implants FIG. 5 illustrates an exemplary shunt structure 150 according to one or more embodiments. The shunt structure 150 may represent an embodiment of a cardiac implant device that may be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular or oval opening. The channel 166 may be configured to hold the sides of a puncture opening in a tissue wall and form a blood flow path between heart chambers or vessels separated by the 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 formed in part by a pair of side walls 170 a, 170 b, which are defined by a generally parallelogram-shaped arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, the shunt 150 is formed substantially entirely from superelastic struts that are configured to compress and fit into a catheter (not shown) and then expand back to a relaxed shape, as shown in FIG. 5.

[0063] Forming the shunt 150 using multiple interconnected struts (forming cells therebetween) can at least partially increase the shunt's flexibility, thereby allowing for compression and expansion at the implant site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold tissue at the puncture open. End walls 172a, 172b of the central flow channel 166 can connect the side walls 170a, 170b and extend between the distal and proximal flanges (or arms) 152, 154 on each side. The side walls 170a, 170b and end walls 172a, 172b can together define a tubular lattice, as shown. The end walls 172a, 172b can include thin struts 179 extending at a slight angle from the central flow axis of the shunt 150.

[0064] The illustrated shunt 150 includes struts defining an open-cell tubular or circular lattice that forms a central flow channel 166, although in some embodiments, the structures making up the channel form substantially contiguous wall surfaces through at least a portion of the channel 166. In the illustrated embodiment, the angle of the shunt structure 150 can facilitate folding of the shunt into a delivery catheter (not shown) and expansion of the flanges / arms 152, 154 on either side of the target tissue wall. The central flow channel 166 can remain essentially unchanged between the folded and expanded states of the shunt 150, while the flanges / arms 152, 154 can move in and out of alignment with the angled flow channel.

[0065] While certain embodiments of the shunts disclosed herein include flow channels with substantially circular cross-sections, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond-shaped, or elliptical flow channel configurations. For example, relatively elongated sidewalls compared to the illustrated configuration of Figure 5 can create rectangular or oval-shaped flow channels. Such shapes of shunt flow channels may be desirable for larger punctures while still being configured to fold down to a relatively small delivery profile.

[0066] In some embodiments, each of the distal and proximal flanges / arms 152, 154 is configured to curl outward from the end wall portions 172a, 172b and point approximately radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms can serve to anchor the shunt 150 to the target tissue wall. Additional aspects and features of shunt structures that may be integrated with sensor devices / functionality according to embodiments of the present disclosure are disclosed in U.S. Patent No. 9,789,294, entitled "Expandable Cardiac Shunt," filed October 17, 2017, the disclosure of which is expressly incorporated by reference in its entirety. Although certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 5 and described above, it should be understood that a shunt structure or other implant device integrated with pressure sensor functionality according to embodiments of the present disclosure can have any type, form, structure, configuration, and / or can be used or configured to be used for any purpose, whether for shunting or other purposes or functionality.

[0067] Sensor retention structures integrated with shunts and other implant devices Sensor devices according to embodiments of the present disclosure can be integrated with cardiac shunt structures / devices or other implant devices using any suitable or desirable attachment or integration mechanism or configuration. FIG. 6 illustrates a sensor implant device 60 including a shunt structure 69 and an integrated sensor 65 according to one or more embodiments. In some embodiments, the sensor 65 is embedded or fabricated into the shunt structure 69, which can form a unitary structure. In some embodiments, the sensor 65 can be attached to or integrated into an arm member 68 of the shunt structure 69.

[0068] The sensor 65 includes a sensor element 62 (e.g., a pressure sensor transducer, etc.). Relative to the arm members 68 of the shunt structure 69, the transducer element 62 (e.g., a pressure transducer) may be oriented / positioned at a distal end or area 63 or a proximal end or area 61 of the sensor 65. For example, the illustrated embodiment of FIG. 5 includes the transducer 62 disposed at the distal end 63 of the sensor 65. In some embodiments, readings obtained by the sensor may be used to guide the titration of drugs for treatment of a patient in whom the implant device 69 is implanted.

[0069] As described herein, the sensor 65 may be configured to implement wireless data and / or power transmission. The sensor 65 may include an antenna component 67 and control circuitry 64 configured to facilitate wireless data and / or power communication functionality. In some embodiments, the antenna 67 includes one or more conductive coils, which may facilitate inductive power and / or data transmission.

[0070] The sensor 65 can advantageously be biocompatible. For example, the sensor 65 can include a biocompatible housing 66 (e.g., a cylindrical or other shaped housing comprising glass or other biocompatible material). The circuitry 64, the sensor element 62, and / or the antenna 67 can be at least partially contained within the housing 66, which is sealed to prevent exposure of such components to the external environment. However, at least a portion of the sensor element 62 (e.g., a diaphragm or other component) can be exposed to the external environment in some embodiments, allowing pressure readings (or other parameter sensing) to be implemented. The housing 66 can include an at least partially rigid cylindrical or tubular configuration (e.g., a glass cylinder configuration), with the sensing probes 62 disposed at one or both ends 61, 63 of the sensor assembly 65. In some embodiments, the sensor assembly is approximately 3 mm or less in diameter and / or approximately 20 mm or less in length. The sensor element 62 may include a pressure transducer, as described herein.

[0071] The sensor assembly 65 may be configured to communicate with an external system when implanted in the heart or other area of ​​the patient's body. For example, the sensor 65 may be capable of receiving power wirelessly from the external system and / or communicating sensed data or waveforms to and / or from the external system. The sensor assembly 65 may be attached to or integrated with the shunt structure 69 in any suitable or desirable manner. For example, in some implementations, the sensor 65 may be attached to or integrated with the shunt structure 69 using mechanical attachment means. In some embodiments, the sensor assembly 65 may be contained within a pouch or other receptacle that is attached to the shunt structure 69, as described in detail below.

[0072] The sensor element 62 can include a pressure transducer. For example, the pressure transducer can be a microelectromechanical systems (MEMS) transducer including a semiconductor diaphragm component. In some embodiments, the transducer can include an at least partially flexible or compressible diaphragm component, which can be made of silicone or other flexible material. The diaphragm component can be configured to flex or compress in response to changes in environmental pressure. Control circuitry 64 can be configured to process signals generated in response to the flexing / compression and provide a pressure reading. 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). The diaphragm component and / or other components of the pressure transducer 62 can advantageously be fused to or otherwise sealed to the housing 66 to provide hermetic sealing of at least some of the sensor assembly components.

[0073] The control circuitry 64 can include one or more electronic application-specific integrated circuit (ASIC) chips or dies, which can be programmed and / or customized or configured to perform monitoring functionality as described herein and / or to facilitate wireless sensor signal transmission. The antenna 67 can include a ferrite core wrapped with a conductive material in the form of multiple coils (e.g., wire coils). In some embodiments, the coils include copper or other metals. The antenna 67 can advantageously be configured with a coil geometry that does not result in substantial displacement or heating in the presence of magnetic resonance imaging. In some implementations, the sensor implant device 60 can be delivered to the target implant site using a delivery catheter (not shown), which includes a cavity or channel configured to accommodate advancement of the sensor assembly 65 therethrough.

[0074] FIG. 7 illustrates a sensor implant device 73 implanted in the atrial septum 18, according to one or more embodiments. A particular location within the atrial septal wall may be selected or determined to provide a relatively safe anchoring location for the shunt structure 72 and to provide a relatively low risk of thrombosis. Moreover, the sensor implant device 73 may be implanted at a desired location to allow for future recrossing of the septal wall for future interventions. Implantation of the sensor implant device 73 within the atrial septal wall may advantageously enable communication between the left atrium 2 and the right atrium 5. With the device 73 within the atrial septum 18, the sensor 70 of the sensor implant device 73 may advantageously be configured to measure pressure within the right atrium 5, the left atrium 2, or both atria. For example, in some embodiments, the device 73 includes multiple sensors, one sensor disposed within each of the right atrium 5 and the left atrium 2. With pressure sensor functionality for measuring pressure in both atria, the sensor implant device 73 may be advantageously configured to provide a sensor signal that can be used to determine the differential pressure between the atria, which may be useful in monitoring fluid accumulation in the lungs, which may be associated with congestive heart failure.

[0075] An atrial shunt procedure using the sensor implant device 73, which in some embodiments may integrate pressure monitoring functionality, may advantageously be well-suited for patients who are relatively sensitive to increased atrial pressure. For example, when pressure increases in the ventricles and / or atria and is applied to the heart muscle, the heart muscle may generally tend to contract relatively vigorously in response to processing excess blood. Therefore, for patients with impaired ventricular contractility, such patients may be more sensitive to higher pressures in the ventricles and / or atria when the ventricles expand or stretch because the heart may not be able to respond or react appropriately to them. Moreover, increased left atrial pressure may result in respiratory distress, and therefore, reducing left atrial pressure through an atrial shunt procedure may be desirable to reduce respiratory distress and / or reduce the incidence of hospital readmissions. For example, when the ventricles experience dysfunction and are unable to handle increased fluid pressure, such fluid may backflow into the atria, thereby increasing atrial pressure. With respect to heart failure, minimizing left ventricular end-diastolic pressure may be of paramount importance. Because left ventricular end-diastolic pressure may be related to left atrial pressure, backflow of fluid in the atrium may cause backflow of fluid in the lungs, thereby causing undesirable and / or dangerous fluid accumulation in the lungs. An atrial shunt procedure (such as one using a shunt device according to an embodiment of the present disclosure) can divert excess fluid in the left atrium to the right atrium, which may be able to handle the additional fluid due to the relatively high compliance of the right atrium.

[0076] In some situations, atrial shunting may not be fully effective due to the patient being on a drug regimen designed to control their fluid output and / or pressure. For example, diuretics may be used to cause the patient to expel excess fluid. Therefore, the use of an integrated pressure sensor implant according to embodiments of the present disclosure can provide a mechanism for informing a technician or physician / surgeon as to how to titrate such medications to regulate / correct the fluid situation. Thus, embodiments of the present disclosure can advantageously serve to direct drug intervention to reduce or prevent undesired increases in left atrial pressure.

[0077] In some implementations, a sensor-integrated shunt implant device according to an embodiment of the present disclosure can be implanted in the wall separating the coronary sinus from the left atrium. For example, an interatrial shunt procedure can be achieved through the coronary sinus. FIG. 8 shows a sensor implant device 80 implanted in the tissue wall 83 between the coronary sinus 16 and the left atrium 2. FIG. 8, like several subsequent figures, shows a cross-section of the heart from a top-down perspective with the posterior surface oriented toward the top of the page.

[0078] Interatrial shunting through implantation of a shunt device 80 into the wall 83 between the left atrium 2 and the coronary sinus 16 may be preferable to shunting through the interatrial septum 85 in some circumstances. For example, shunting through the coronary sinus 16 may offer a reduced risk of thrombus and embolism. The coronary sinus is less likely to have thrombi / emboli present for several reasons. First, blood draining from the coronary vasculature into the right atrium has just passed through capillaries; therefore, it is essentially filtered blood. Second, the mouth of the coronary sinus in the right atrium is often partially covered by a pseudovalve called the Thebesian valve. The Thebesian valve is not always present, but some studies have shown that it is present in most hearts and can prevent thrombi or other emboli from entering in the event of a sudden rise in right atrial pressure. Third, the pressure gradient between the coronary sinus and the right atrium (into which it drains) is generally relatively low, making it more likely that a thrombus or other embolus in the right atrium will become lodged there. Fourth, when a thrombus / embolus enters the coronary sinus, a much greater gradient exists between the right atrium and the coronary vasculature than between the right atrium and the left atrium. In most cases, the thrombus / embolus will travel further down the coronary vasculature until right atrial pressure returns to normal, and then the embolus will return directly to the right atrium.

[0079] Some additional benefits of positioning the shunt structure 82 between the left atrium and the coronary sinus are that this anatomical structure is generally more stable than the interatrial septum tissue. By diverting left atrial blood into the coronary sinus, sinus pressure can be increased by a small amount. This causes blood in the coronary vasculature to travel more slowly through the heart, increasing perfusion and oxygen transfer, which is more efficient and can help dying heart muscle recover.

[0080] In addition to the benefits described above, implanting the shunt device 80 within the wall of the coronary sinus 83 may prevent damage to the atrial septum 85. Thus, the atrial septum may be preserved for later transseptal access for alternative therapies. Preserving transseptal access may be advantageous for a variety of reasons. For example, heart failure patients often have multiple other comorbidities (e.g., atrial fibrillation and / or mitral regurgitation). Certain therapies to treat these conditions require transseptal access.

[0081] 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 drawbacks may be considered. For example, by shunting blood from the left atrium 2 to the coronary sinus 16, oxygenated blood from the left atrium 2 may be passed to the right atrium 5, and / or deoxygenated blood from the right atrium 5 may be passed to the left atrium 2, both of which may be undesirable with respect to the proper functioning of the heart.

[0082] Access to the target wall 83 and left atrium 2 via the coronary sinus 16 may be achieved using any appropriate or desirable procedure. For example, various access routes may be utilized in maneuvering guidewires and catheters in and around the heart to deploy an expandable shunt integrated with or associated with a pressure sensor according to embodiments of the present disclosure. In some embodiments, access may be achieved through the subclavian or jugular vein, into the superior vena cava (not shown), into the right atrium 5, and from there into the coronary sinus 16. Alternatively, an access route may begin in the femoral vein and through the inferior vena cava (not shown) into the heart. Other access routes may also be used, each of which typically utilizes a percutaneous incision through which a guidewire and catheter are inserted, usually through a sealed introducer, into the vasculature, from which the system may be designed or configured to allow a physician to control the distal end of the device from outside the body.

[0083] In some embodiments of procedures for advancing an implant device according to aspects of the present disclosure, a guidewire is introduced through the subclavian or jugular vein, through the superior vena cava, and into the coronary sinus. Once the guidewire provides a pathway, an introducer sheath can be routed into the patient's vasculature along the guidewire, typically with the use of a dilator. A delivery catheter can be advanced through the superior vena cava into the coronary sinus of the heart, with the introducer sheath providing a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter can function to create and prepare an opening in the wall of the left atrium, and a separate placement or delivery catheter would be used for delivery of the expandable shunt. In other embodiments, the deployment catheter can be used as both a fully functional puncture preparation and implant delivery catheter. In this application, the terms "deployment catheter" or "delivery catheter" are used to refer to a catheter or introducer with one or both of these functions.

[0084] 8, the coronary sinus is generally adjacent to and around the left atrium 2, and therefore there are a variety of possible acceptable placements for the implant device 80 and / or shunt structure 82. The target site selected for placement of the shunt structure 82 may be created in an area of ​​thinner or less dense tissue in a particular patient, as predetermined by a non-invasive diagnostic means (e.g., a CT scan or a radiographic technique such as, for example, fluoroscopy or intravascular coronary echocardiography (IVUS)).

[0085] Additional aspects and features of a process for delivering a shunt structure, which may be integrated with a sensor device / functionality according to embodiments of the present disclosure, for implantation into the wall between the coronary sinus and the left atrium is disclosed in U.S. Patent No. 9,789,294, entitled "Expandable Cardiac Shunt," filed October 17, 2017, the disclosure of which is expressly incorporated by reference in its entirety. Although implant device 80 is shown within the left atrium / coronary sinus wall, implant device 80 may be positioned between other heart chambers (e.g., between the pulmonary artery and the right atrium, etc.).

[0086] Sensor Support / Retention Strut / Structure 9 shows a perspective view of a shunt device 90 in an at least partially folded configuration for delivery through a delivery sheath or catheter (not shown). The shunt device 90 includes a sensor support structure / arm 91 attached to or associated with an arm 92 of the shunt device.

[0087] FIG. 10 illustrates a sensor implant device 90 having an integrated sensor 100 mechanically attached or fastened to a portion of a shunt structure 97. The shunt structure 97 includes a sensor support structure / arm 91, which can be in unitary form with the shunt structure 97. In some embodiments, the support 91 is an extension of (or is 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 desirable attachment means, including adhesive attachment or mechanical engagement. For example, the sensor support 91 can include or be associated with one or more retention features 98, which can include one or more clamps, straps, ties, sutures, collars, clips, tabs, or the like. Such retention features 98 can circumferentially encase or hold the sensor 100 (or a portion thereof). In some embodiments, the sensor 100 can be attached to the sensor support 91 through the application of a mechanical force (either by sliding the sensor 100 through the retention feature 98 or by clipping, locking, or otherwise engaging the sensor 100 with the sensor support 91 by pressing or applying other mechanical force thereto). In some embodiments, the retention feature 98 includes one or more tabs that can be configured to pop up or extend at one or more sides of the sensor support 91 for mechanical fastening. Such tabs can include a shape memory alloy (e.g., nitinol) or other at least partially rigid material. In some embodiments, the sensor support 91 is at least partially non-rigid. For example, the sensor support 91 can include a non-rigid tether configured to float the sensor 100.Such a configuration can advantageously allow the sensor 100 to move with the blood flow.

[0088] In some embodiments, sensor 100 is pre-attached to and / or integrated with sensor support 91 prior to implantation. For example, in some embodiments, sensor support 91 forms at least a portion of the housing of sensor 100, such that sensor support 91 and at least a portion of the housing of sensor 100 are in a unitary configuration.

[0089] In some embodiments, the angle or position of the sensor support 91 and / or sensor 100 relative to the longitudinal axis 99 of the shunt structure 97 is such that the sensor protrudes away from the longitudinal axis 99. For example, when the shunt structure 97 is engaged with biological tissue along the dimension of the longitudinal axis 99, the sensor 100 can advantageously protrude at least partially away from the biological tissue (e.g., into a heart chamber (e.g., the atrium of the heart)). In some embodiments, the sensor support 91 is configured or can be configured at a substantially perpendicular or 90° orientation relative to the axis 99, such that the sensor is substantially perpendicular to the longitudinal axis of the shunt. Such a configuration can advantageously allow the sensor element to be positioned a desired distance away from the shunted flow flowing through the flow channel axis 94.

[0090] The sensor element 102 of the sensor 100 may be disposed or positioned anywhere on the sensor 100. For example, the sensor element 102 may be advantageously disposed at or near the distal portion 107 of the sensor 100. Alternatively or additionally, the sensor element may be disposed or positioned at or near the proximal portion 105 of the sensor 100.

[0091] The sensor device 100 can include an electrical coupling component 108, which can include, for example, one or more conductive (e.g., metal) coils. Such coils can be configured to wirelessly and inductively couple to an external transmitter / receiver. The electrical coupling component can have a magnetic core (e.g., iron; ferrite) to provide desirable magnetic permeability and / or electrical conductivity characteristics. Various embodiments disclosed herein provide sensor retention structures configured to hold and / or retain particular sensor devices, which can be similar in one or more respects to the sensor device 100. If such a sensor retention structure includes conductive support arms (e.g., shape memory alloys or other metals), such conductive features can cause interference with signals transmitted to / from the electrical coupling component 108 when the conductive features of the sensor retention structure axially overlap the electrical coupling component 108. Thus, it should be understood that the various sensor retention features disclosed in association with any of the embodiments of the present disclosure may be designed to reduce the extent to which their conductive features axially overlap with the electrical / wireless coupling components of the associated sensor device. Moreover, sensor devices used in association with the various embodiments of the sensor retention structures disclosed herein may be configured such that their electrical coupling components have a minimal amount of axial overlap with the conductive features of the respective sensor retention structure.

[0092] 11A and 11B show perspective views of a medical implant device including a sensor support strut / arm and a fabric and / or polymer cloth wrap configured to at least partially secure the sensor device to the sensor support strut / arm. The polymer cloth wrap can include a 0.003" ePTFE biaxial membrane and / or specific stitching (e.g., PET stitching) above and / or below the membrane. In some embodiments, the wrap 113 is wrapped in strips circumferentially and / or axially over the sensor cylinder and around the sensor support strut 112.

[0093] The sock or wrap 113 can comprise a polymer and / or fabric material and can take the form of one or more strips of material wrapped around the cylinder / sensor 114 in a circumferential manner across at least a portion of the length L of the cylinder 114. In some embodiments, the sock / wrap 113 has a sock-like configuration that is pulled or applied over the cylinder and sensor support struts / structures 112. For example, sutures or other types of lines or stitching can be wrapped around the sock to secure it to the sensor 114 and struts 112. Such sutures / lines can comprise ePTFE, PET, or the like. For embodiments incorporating suture / line reinforcement (e.g., stitching), it can be desirable to protect such features from tissue ingrowth. In some embodiments, suture / line reinforcement is omitted to protect against unwanted tissue ingrowth.

[0094] 12A and 12B show perspective views of a medical implant device including a sensor support structure or assembly 120 including a sensor support strut / arm and a membrane sock- or wrap-type retention means or feature 123 configured to at least partially secure a sensor device to the sensor support strut / arm. The membrane wrap can include polytetrafluoroethylene (PTFE) and / or polyurethane (PU) (e.g., electrospun or rotary jet spun) membrane. In some embodiments, the membrane 123 is wrapped in strips circumferentially and / or axially over the sensor cylinder and around the sensor support struts 122 and sensor device 124 supported / retained by the sensor support structure 120.

[0095] In some embodiments, the membrane has specific thermal and voltage characteristics for its application process such that it does not result in undesirable effects / damage to the sensor 124. The wraps, socks, sleeves, membranes, coatings, or similar types of features described herein in connection with various disclosed embodiments may be applied to the sensor retention structure and / or sensor in any suitable or desirable manner. For example, such materials may, in some implementations, be applied using an electrospinning process. Particular methods, devices, and systems relating to electrospinning concepts that may be applicable to embodiments of the present disclosure are disclosed in U.S. Patent Application Publication No. 2017 / 0325976, the disclosure of which is incorporated herein by reference in its entirety. Electrospun PTFE is described in U.S. Patent Application Publication No. 2010 / 0193999, the disclosure of which is incorporated herein by reference. Other processes that may be implemented to apply wraps, socks, sleeves, membranes, or similar features may include rotary jet spinning. Certain methods, devices, and systems relating to rotary jet spinning concepts that may be applicable to embodiments of the present disclosure are disclosed in U.S. Pat. No. 9,410,267, the disclosure of which is incorporated herein by reference in its entirety.

[0096] 13A and 13B illustrate perspective views of a sensor implant 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 pouch or sock 133, which is attached to or otherwise associated with the arm / strut member 132 or another portion of the shunt structure 139 (e.g., anchor arm 131). For example, the pouch 133 can be a suture-based or fabric-based (e.g., fibrous and / or polymeric fabric) pouch, wrapping, or other retention material and / or form.

[0097] The pouch 133 can comprise any suitable or desirable material, including polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or polyurethane (PU), and / or combinations of similar materials. In some implementations, such materials can be electrospun onto the sensor 135 or applied using rotary jet spinning.

[0098] In some embodiments, the sensor 134 is configured to be slidably disposed within the pouch 133, with tension and / or compression of the pouch 133 serving to hold the sensor 134 in a fixed position within the pouch 133. While a pouch / wrap encasing at least a portion of the sensor 134 in a sock-like / tube-like fashion is illustrated in FIGS. 13A and 13B , in some embodiments, the pouch 133 includes a band or other non-enveloping retention means. In some embodiments, the sensor 134 may be sewn or otherwise attached or secured to the pouch 133. Additionally, the pouch 133 may be sewn or otherwise secured or attached to the arm members 132 of the shunt structure 139. The pouch 133 may advantageously be open at one or both of its distal and proximal ends to allow fluid contact with the sensor element / transducer associated with the sensor 134. That is, the sensor 134 may be exposed through an opening at the distal or proximal end of the strut 132 and / or pouch 133 .

[0099] 14A and 14B show perspective views of a medical implant device including a sensor support strut / arm and a membrane wrap configured to at least partially secure the sensor device to the sensor support strut / arm. The membrane wrap can include polytetrafluoroethylene (PTFE) and / or polyurethane (PU) (e.g., electrospun or rotary jet spun) membrane. In some embodiments, the membrane wrap 143 includes a carton balloon and / or laser bonding. In some cases, the use of a carton balloon or the like can provide desirable manufacturing and biocompatibility benefits.

[0100] Sensor retention structure with sensor retention fingers and other features - Patents.com 15-1 and 15-2 show perspective views of medical implant devices 150-1, 150-2, each including a respective sensor support strut / arm 152-1, 152-2 and associated buckle and / or strap members 153-1, 153-2 and 155-1, 155-2. The buckles and / or strap members 153, 155 may be configured to engage with one another and secure a sensor device (not shown) to the sensor support strut / arm 152.

[0101] With reference to FIG. 15-1 , strap member 155b-1 (and / or 155a-1) may be shaped in an elongated, at least partially rectangular form having a width w1 dimensioned to fit within an interior width w2 of coupling portion / aperture 159b-1 (and / or 159a-1) of buckle member 153b-1 (and / or 153a-1), such that coupling portion / aperture 159-1 can slide along the length of strap member 155-1 and provide engagement therewith. For example, strap 155-1 may be secured in a locked position within coupling portion / aperture 159-1 by a friction fit and / or a shape-memory fit. Additionally, distal crossbar 156-1 may depress and / or hold strap 155-1 in place when strap 155-1 is secured within aperture 159-1.

[0102] With reference to FIG. 15-2, strap member 155b-2 (and / or 155a-2) can include clasp 154, which is shaped in an elongated, at least partially rectangular form having a width w3 dimensioned to fit within an interior width w4 of coupling portion / aperture 159b-2 (and / or 159a-2) of buckle member 153b-2 (and / or 153a-2), such that coupling portion / aperture 159-2 can slide over the length of clasp 154 ​​and provide engagement therewith. The clasp member 154 may generally protrude and / or be oriented rearwardly toward the base 158 of the sensor retention structure 150-2 so that the buckle member 153-2 can be brought above (or below) the strap member 155-2 far enough to allow the clasp 154 ​​to be bent and threaded into the aperture 159-2 to insert the clasp 154 ​​into the aperture. The rearward protrusion / orientation of the clasp 154 ​​can hold the buckle 153-2 and strap 155-2 together when the buckle and strap are pulled outward after engagement of the clasp 154 ​​with the aperture 159-2. For example, the crossbar 156-2 of the buckle 153-2 may be held against the strap member 155-2 and / or the crossbar portion 157-2 of the clasp 154. Strap 155-2 may be further secured in a locked position within coupling portion / aperture 159-2 by a friction fit and / or a shape memory fit.

[0103] 16A and 16B show perspective views of a medical implant device 160 including a sensor support strut / arm 162 and associated therewith one or more buckles and / or strap members 163, 165 and / or one or more axial retention features 166. The buckles and / or strap members 163, 165 may be configured to engage with one another and secure a sensor device (not shown) to the sensor support strut / arm 162. The one or more axial retention features may be configured to prevent a sensor device secured to the sensor support strut / arm 162 from sliding proximally and / or axially when feature 166 is engaged as shown in FIG.

[0104] Strap member 163 can include one or more clasp features 167 shaped to form a tab-type configuration having a width w5 dimensioned to fit within an interior width w6 of a corresponding coupling portion / aperture 169 of a respective oppositely oriented buckle member 165 such that coupling portion / aperture 169 can slide over and provide engagement with clasp 167. Clasp member 167 can generally protrude and / or be oriented rearwardly toward base 168 of sensor retention structure 160 and / or the base of strap member 163 such that buckle member 165 can be brought above (or below) strap member 163 far enough to allow clasp 167 to be bent and / or threaded into aperture 169 for insertion into aperture 169. The rearward projection / orientation of clasp 167 can hold buckle 165 and strap 163 together when the buckle and strap are pulled outward after engagement of clasp 167 with aperture 169. For example, a distal crossbar of buckle 165 can be held against a distal portion of strap member 163 and / or clasp 167. Strap 163 can be further secured in a locked position within coupling portion / aperture 169 by a friction fit and / or a shape memory fit.

[0105] 17A-17C show perspective and end views, respectively, of at least a portion of a medical implant device 170 including a sensor retention structure 170, including a sensor support strut / arm 172 and one or more sensor retention fingers 173, according to one or more embodiments. One or more sensor retention fingers 173 can include an aperture 175 or other feature configured to facilitate or enable adhesive fixation of the finger 173 to a sensor device disposed in contact with and / or proximity to the finger 173. FIG. 17B shows the sensor retention structure 170 with a sensor device 174 at least partially retained therein and an adhesive material 176 applied to / through the aperture feature 175 to secure the finger 173 to the sensor 174.

[0106] The adhesive 176 can be any suitable type of adhesive. The adhesive 176 is advantageously biocompatible, facilitating implantation of the implant device into the body. While four fingers 173 are shown, each with an adhesive-engagement aperture / feature 175, it should be understood that the structure 170 can have any number of fingers and / or adhesive-engagement features. Moreover, while closed apertures are shown as the adhesive-engagement features 175 in FIGS. 17A and 17B , it should be understood that the adhesive-engagement features implemented in connection with any of the embodiments of the present disclosure can be open, closed, and / or have any other suitable or desirable shape or form. In some implementations, the adhesive 176 is applied to the fingers 173 and to the sensor 174 on outer portions of the fingers 173. That is, an adhesive-engagement aperture may not be present. Rather, the adhesive may be applied on the fingers 173 at or near the contact point between the respective fingers and the sensor 174. For example, adhesive 176 may be applied to the underside of finger 173 such that the adhesive is disposed between finger 173 and sensor 174. Additionally or alternatively, adhesive 176 can be applied to the side of finger 173 and contacting sensor 174.

[0107] 18A-18C show perspective views of at least a portion of a medical implant device 180 including a sensor support strut / arm 188 and a sensor retention overmolded support form 183, according to one or more embodiments. The strut / arm 188 can include apertures 186 or other features configured to facilitate or enable adhesive fixation of the strut 188 to a sensor device 184 disposed in contact with and / or proximity to the strut 188. In some embodiments, the shape of the apertures 186 and / or arms 188 facilitates coupling with the overmolded support form 183. FIG. 18B shows the medical implant device 180 with the sensor device 184 at least partially retained thereby, with the sensor 184 at least partially nested within the overmolded support form 183.

[0108] Overmolded support form 183 can be rigid or flexible. In some embodiments, the overmolded support form is bonded to sensor 184 and / or support struts 188 through heat setting or other processes. The sensor can be inserted into overmolded support form 183, or overmolded support form 183 can be applied over sensor 184 and support struts 188 after placement of sensor 184 on the support struts. While shown with aperture 186, it should be understood that the support struts need not have such apertures and can have any suitable or desirable shape, configuration, and / or configuration.

[0109] 19A-19E illustrate at least a portion of a medical implant device 190 including a sensor support strut / arm 198 associated with a plurality of sensor retention fingers 193, 195, at least two of which are mechanically locking fingers 195 that may be locked using particular locking features 196, which may be configured to mechanically interlock in some manner, as shown. The sensor support strut / arm 198 may further include a distal axial retention feature 197 and / or a proximal axial retention feature 192 to further secure a sensor 194 (see FIGS. 19C-19E) in a desired position.

[0110] The axial restraint / retention features 197, 192 can have any suitable or desirable configuration. In some embodiments, the distal axial retention feature 197 includes a shaped, inwardly protruding tab that can have at least a partially curved / contoured shape corresponding to an inwardly curved circumferential arc portion of a cylindrical form. Referring to FIG. 19C (which shows a distal end view of the implant device 190 with a sensor device 199 retained thereon / therein), the axial retention feature 197 (also referred to as an “eyebrow” feature) can radially overlap at least a portion of the circumferential / peripheral region of the sensor device / transducer component 199. The overlapped 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 retention feature 197 may not substantially affect the sensing functionality of that sensor 194 and / or sensor element 199 .

[0111] The proximal retention feature 192 can include one or more tabs / fingers that are configured to bend or otherwise deflect or curl inward toward the axis of the sensor 194. The radial overlap of the tabs / fingers 192 can serve to prevent the sensor 194 from sliding proximally past the tabs / fingers 192. The proximal retention feature 192 can be sized with a radius of curvature that is smaller than the radius of curvature of the outer cylindrical form of the sensor 194 and / or the radius of curvature of the fingers 193 that are at least partially wrapped around the body of the sensor 194.

[0112] The intermediate sensor retention finger is axially positioned between the distal axial retention feature 197 and the proximal axial retention 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 can be relatively long compared to the finger 192 and, in some embodiments, can be laser cut.

[0113] 20A-20E illustrate at least a portion of a medical implant device 200 including an arm structure 201 associated with a housing mounting flange configured to be attached to a sensor retention housing 203, which is configured to hold a sensor device 204. The sensor retention housing 203 can further include a distal slit feature configured to facilitate insertion of the sensor device 204 therein. The flange feature 202 can be shape-set and mechanically locked to the housing 203, which can include polyetheretherketone (PEEK) or other thermoplastic and / or polymer.

[0114] In some embodiments, PEEK is used for the sensor retention housing 203 due to certain properties thereof that may be desirable for use in the sensor retention embodiments and features disclosed herein. For example, PEEK may be considered a relatively inert material and may inhibit the growth of pannus thereon. Moreover, PEEK is relatively easy to machine while providing sufficient rigidity and structural integrity to allow for the manufacture of relatively thin walls, which may be advantageous for sensor retention features due to the ability to form such structures without unduly increasing the profile of the sensor retention device. For example, the walls of portions of the PEEK sensor retention features disclosed herein may be as thin as 0.005". In some implementations, the sensor retention housing 203 may be formed through a machining process or may be reflowed.

[0115] The proximal housing retention ring / flange 202 can be configured to snap / clip into a corresponding mating recess / clip feature 206. In some embodiments, the proximal housing / ring coupling feature 206 of the sensor retention housing 203 can be engaged with the housing retention ring 202, and after such engagement, the feature 206 can be melted or otherwise wrapped onto the ring 202 to create a mechanical bond / coupling therewith. That is, the material of the housing 203 can be reflowed onto the ring 202 to create a bond / coupling therewith.

[0116] The housing 203 can include a distal slot 205 that allows the perimeter of the housing 203 to expand outward to receive the sensor device 204 therein. In some embodiments, a distal ridge / shoulder feature 211 of the housing 203 can serve to retain the sensor 204 axially within the housing 203 when the sensor 204 is inserted into the lumen / cavity of the housing 203.

[0117] 21A and 21B illustrate at least a portion of a medical implant device 210 including an arm structure 211 associated with one or more sets of sensor retention and / or housing connection fingers 215. The fingers 215 are configured to engage and / or fit with corresponding features 212 of a sensor retention cover / housing 213. A sensor device 219 may advantageously be at least partially contained within the cover 213 and an at least partially concave cradle arm portion 218.

[0118] In some embodiments, the sensor device 219 may be attached to the arm 218, after which the cover 213 may be snapped / placed onto the sensor cylinder 219. In some embodiments, the sensor 219 may be placed into the cover 213, and then the combined sensor 219 and cover 213 may be placed onto the arm 218. The fingers 215 may advantageously wrap around only a circumferential portion of the sensor, such that opposing fingers do not touch when implanted, thereby providing a gap between the opposing fingers through which the sensor 219 may be pressed / inserted.

[0119] The cover 213 may include a distal ridge / shoulder feature 217 that may serve to retain the sensor 219 axially within the cover 213 when the sensor 219 is covered by the cover 213. The fingers 215 may fit between axial / circumferential gaps 212 in the cover 213, and such engagement between the fingers 215 and the gaps 212 may prevent axial movement of the cover 213 relative to the arms 218.

[0120] 22A and 22B illustrate at least a portion of a medical implant device 220 including a sensor support strut / arm 228 associated with a plurality of sensor retention fingers 225, at least two of which are mechanically locking fingers that can be locked using specific locking features 226, 227. The sensor support strut / arm 228 further includes specific mating features (e.g., holes) 223 for mating with corresponding features (not shown) of the sensor device 224 to further secure the sensor device 224.

[0121] The mating feature 223 may be configured and dimensioned to at least partially receive therein a corresponding protrusion associated with the sensor cylinder 224. The engagement / mating of the feature 223 and the corresponding protrusion / feature of the sensor 224 together may thereby restrain axial movement of the sensor 224 within the retention finger 225. In some embodiments, an adhesive layer may be applied to and / or between the sensor 224 and / or the arm 228 to secure the sensor 224 to the arm 228. Such adhesive may also at least partially fill the feature 223 of the arm 228. Additionally, any of the embodiments herein may include an adhesive between the sensor retention arm component (e.g., a metal component) and the sensor retained thereby.

[0122] 23A and 23B show at least a portion of a medical implant device 230 including a sensor support strut / arm 238 associated with multiple sets of sensor retention fingers 235, the various sets may or may not have different widths. In some embodiments, the implant device 230 includes one or more axial retention features, such as one or more stop tabs 236, at the distal and / or proximal ends of the sensor support strut / arm 238. The sensor support strut / arm 238 may further include specific mating features (e.g., 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 longitudinal laser-cut grooves that key into and / or lock with one or more corresponding features (e.g., glass protrusions) associated with the sensor device 234.

[0123] The process for securing the sensor 234 within the sensor retention structure 230 can involve inserting a peg / protrusion component of the sensor 234 into a longitudinal groove 233 in the arm 238. The peg / protrusion can be configured to fit within the groove 233. In some embodiments, the sensor's peg / protrusion (e.g., a glass or metal protrusion from one or more portions of the sensor 234) can be disposed at or near the distal or proximal end of the sensor. When the peg / protrusion reaches the circumferential notch 237, the sensor can be rotated to nest the peg / protrusion into the notch and constrain axial movement of the sensor 234. While the notch 237 is shown in FIGS. 23A and 23B as being at the proximal end of the arm 238, it should be understood that the notch 237 can be at the distal end of the arm 238 or at any other point along the length of the arm 238. Additionally, stop tab 236 can be at the distal end of arm 238 as shown, thereby preventing sensor 234 from sliding distally, or stop tab 236 can be at the proximal end of arm 238, thereby preventing sensor 234 from sliding proximally. Notch 237 can have a longitudinal hook / turn at its end, allowing the peg / protrusion of sensor 234 to be locked in place therein.

[0124] The placement of tab 236 at the distal end may be undesirable because it may come into contact with sensor membrane 239, thereby potentially corrupting the sensor signal and / or damaging the sensor element. Accordingly, embodiments of the present disclosure including such a distal stop tab may advantageously be sized and / or configured to present a sensor contact surface that is relatively small and / or positioned to have a reduced impact on the structure / integrity and / or function of sensor element 239. Finger 235b may be shaped and may or may not have any locking / mating features associated therewith.

[0125] 24A and 24B show perspective views of at least a portion of a medical implant device 240 including a sensor support structure 248 and a trapdoor sensor retention feature including one or more flaps or other similar components 242 a. In some implementations, the sensor device 244 can be at least partially secured within the sensor retention arm 240 by passing or dropping the sensor 244 through a gap 247 (e.g., between flaps 242 a and 242 b) in the trapdoor feature (which can allow it to open inward toward the arm structure 248), while once passed through, the flaps 242 a, 242 b can at least partially prevent the sensor 244 from passing back through the trapdoor feature.

[0126] The sensor support structure 248 can include a ring 245, and the flap 242 can be secured to the ring 245 in some manner. For example, the flap 242 can be rotatably coupled to the ring 245. In some embodiments, a peg or other feature of the flap / door 242 is present / formed on its side portion that contacts the respective ring 245. Such a feature can allow hinged movement of the flap 242. For example, the peg / feature of the flap 242 can fit into a corresponding hole or groove in the ring 245 that is positioned at the portion where the flap 242 contacts the ring 245.

[0127] 25A-25C illustrate perspective views of a medical implant device 250 including a sensor support arm 258 and one or more tension-fit rings 255. The ring 255 can be interrupted and / or can include a gap 226 associated therewith, which can advantageously allow for the insertion and / or tensioning / securing of a sensor device within the ring 255. In some embodiments, the ring 255 can be secured or attached to the arm 258 by sliding, attaching, securing, clipping, or otherwise associating the arm 258 with a slot-type feature 257 of the ring 255.

[0128] Ring 255 can be positioned at any desired spot along arm 258. In some embodiments, arm 258 includes features (e.g., recesses, pedestals, or ridges) that hold ring 255 in place. In some embodiments, ring 255 may be able to slide relatively freely along arm 258. A tension fit between slot-type feature 257 and arm 258 can hold ring 255 in place as ring 255 is slid / moved along the length of arm 258 to a desired position. In some embodiments, shape-setting ring 255 (e.g., a shape memory alloy ring) can introduce a force against arm 258, which serves to hold the ring in place.

[0129] 26A-26E illustrate perspective views of a medical implant device 260 including a sensor support arm 268 and one or more clamping features 265. In some embodiments, the clamping features 265 include inwardly biasing retention tabs 266 configured to exert tension and / or pressure on a sensor device disposed therein.

[0130] The retention tabs 266 can have any suitable or desirable form and can be laser cut or otherwise cut from the barrel or sheet that forms the clamping feature 265. The tabs 266 can provide compressive friction retention functionality for the sensor 264. The inward deflection of the tabs 266 can be achieved using a shape memory setting in some implementations. While the clamping features 266 are shown as having gaps 269 present between them when in the sensor retention configuration shown in FIGS. 26A-26E, in some embodiments, the edges of the clamping features 266 can touch each other or be closer together than shown. The clamping features 266 can advantageously wrap around most of the circumferential area of ​​the sensor cylinder 264, thereby preventing movement of the sensor 264 away from the base 268 of the retention structure 260.

[0131] In the deflected configuration shown, the tab can have an axially flat sensor contact portion 266a and a deflected portion 266b. The sensor contact portion can provide a surface contact area to provide frictional retention with the sensor 264, and the deflected portion 266b provides an inward force to the sensor contact portion 266b to maintain surface contact and increase friction between the sensor contact portion 266a and the sensor 264.

[0132] 27A and 27B illustrate perspective views of at least a portion of a medical implant device 270 including a sensor support arm structure 278 and one or more opposing circumferentially wrapping fingers 273 that can be used to provide a tension fit and / or enclosure fit and secure a sensor device 274 therein, as shown in FIG. 27B. The fingers 273 can be axially / longitudinally offset from one another, as shown in FIG. 27A. For example, when the fingers 273 are in the wrapped / sensor retention configuration as shown, the fingers on one side of the sensor support arm 278 can be interleaved / alternated with fingers originating from the other / opposite side of the sensor support arm 278.

[0133] The retention fingers 273 are capable of radial compression against the outer surface of the sensor cylinder 274. The compression shape and force of the fingers 273 may be provided through a shape memory setting. While five fingers 273 are shown, it should be understood that the sensor retention structure 270 may include any suitable or desirable number of retention fingers. Moreover, while fingers are shown as originating from both longitudinal sides of the support arm / strut 278, in some embodiments, fingers originate from only one side of the support arm 278.

[0134] 28A and 28B illustrate perspective views of at least a portion of a medical implant device 280 including one or more prongs 283 connected to a sensor support arm / structure 288. In some implementations, a sensor device 284 may be disposed between, adjacent to, proximate to, and / or otherwise relative to the prongs 283, and a sleeve 285 or other circumferential support feature may be placed, wrapped, and / or disposed around the sensor 284 and prongs 283 to secure the sensor device 284 to the prongs 283 and / or sensor support arm / structure 288. In some contexts, the prongs 283 may be considered and / or described as struts. As shown, the prongs / struts 283 may generally protrude distally. For example, the struts / prongs 283 may protrude generally longitudinally / axially over a length L as shown.

[0135] The prongs 283 and sleeve 285 can comprise cartons or any other material, whether rigid or flexible. In some implementations, the sleeve / material 285 can be formed / disposed over the sensor 284 over at least a portion of its length, and the prongs 283 can then be slid between the sleeve / material 285. The sleeve material can then be reflowed over the sensor 284, sleeve 285, and / or prongs 283 and heat shrunk to enhance the retention characteristics of the sleeve 285. The prongs 283 can have specific bending characteristics that prevent them from sliding straight out from under the sleeve 285. The prongs 283 can have a length that protrudes beyond the sleeve 285 relative to the length of the sensor 284 and / or prongs 283.

[0136] Proximal Sensor Mounting Features 29A-29D illustrate perspective views of at least a portion of a medical implant device 290 including a sensor support structure / arm 298 that includes a proximal stop feature 293. The proximal stop feature can include an aperture or hole 296 or the like, and a sensor device 294 can be disposed on the sensor support structure 298 such that its proximal end 297 is positioned proximate to the proximal stop 293 and / or aperture 296. In some implementations, an adhesive 292 can be at least partially disposed within the aperture 296, thereby at least partially securing the sensor device 294 and / or its proximal end 297 to the stop 293, the aperture 296, and / or the sensor support arm 298. The structure / form 293 can generally project radially and / or orthogonally with respect to an axis (e.g., a longitudinal axis) of the sensor support arm / strut 298. According to some embodiments, structure / form 293 may be considered a sensor mounting structure, i.e., structure 293 may be used to attach to a sensor device, thereby providing retention functionality. For example, sensor mounting structure 293 may be configured to be attached / secured to a proximal end portion of a sensor device (e.g., a cylindrically shaped sensor device). The illustrated proximal sensor mounting structure 293 is shown as an at least partially orthogonally protruding tab structure with an aperture therein in FIG. 29A .

[0137] Aperture 296 is shown as circular in shape, but can have any suitable or desirable shape or size. In some embodiments, aperture 296 is not closed. For example, the top portion of aperture 296 is open (with respect to the orientation shown in FIG. 29B ), such that proximal stop feature 293 has a prong / fork type configuration.

[0138] 30A through 30D illustrate perspective views of at least a portion of a medical device including a sensor retention structure 300, including a sensor support structure / arm 308 and a suction-capable proximal stop feature 303. The proximal stop can include one or more suction cups 305 configured such that the sensor device 304 and / or its proximal surface / portion 307 can be engaged with the suction cup 305, thereby sucking the sensor device 304 and / or its proximal end 307 to the proximal stop 303 and / or sensor support structure / arm 308. In some embodiments, an adhesive can be used to hold the suction cup 305 against the proximal end of the sensor 304. While the suction cup 305 is shown at the proximal end of the support arm 308, in some embodiments, the one or more suction cups can be positioned on the support arm 308 (e.g., facing upward with respect to the orientation shown in FIG. 30B ).

[0139] 31A-31D illustrate perspective views of at least a portion of a medical implant device including a sensor retention structure 310 including a proximally positioned, distally angled stop and / or retention arm / structure 315. The sensor retention structure 310 can further include one or more circumferential sensor retention bands (such as the depicted distal retention band 313). The sensor support structure 318 can be further positioned and / or configured to provide support for a longitudinal portion of the sensor device 314. The proximal arm structure 315 can be configured to engage a side and / or proximal end portion of the sensor device 314. For example, the arm structure 315 can 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 present a spring tension force to the sensor device 314.

[0140] The proximal retention arm 315 can be at least partially flexible such that it can accommodate and / or allow for variations in size / length and / or position of a sensor device that may be disposed on the arm 318. That is, the angle θ of the proximal retention arm 315 relative to the arm / support structure 318 can be adjustable to fit over a particular sensor that is disposed on the arm 318.

[0141] The proximal retention arm 315 may urge the sensor 314 to some extent both toward and distal to the arm 318. Therefore, as described herein in connection with various other embodiments and figures, it may be desirable for the distal retention band 313 to include a shoulder / ridge feature to prevent the sensor 314 from sliding axially distally.

[0142] Sensor support arm with retention feature 32A and 32B illustrate perspective views of at least a portion of a medical implant device including a sensor retention structure 320 that includes a sheet or other structure 323 that may be at least partially flattened and / or curved at one or more points in the manufacturing, delivery, and / or implantation process and that is configured to be at least partially wrapped around a sensor device 324 to provide a tension / pressure fit with the sensor device 324, thereby securing the sensor device 324 to the sensor retention structure 320 and / or associated medical implant device. The radial compressive force imposed by the sheet 323 may effectively hold the sensor 324 in place and may prevent axial movement of the sensor 324 on / in the sheet 323 and / or movement of the sensor 324 away from the base 322 of the seat arm 323. The sheet 323 may be rolled into an at least partially cylindrical or curved configuration prior to insertion of the sensor 324, or may be wrapped around the sensor 324 after the sensor 324 has been placed thereon.

[0143] The sheet 323 can allow for some amount of expansion and thus can be suitable for sensor devices having various diameters or other dimensions. In some implementations, the edges 325 of the sheet 323 form a “C” shape around the sensor 324 rather than being brought into contact with each other in the rolled configuration, and / or the sensor 324 can be placed therein. The sheet 323 can be a laser-cut metal or plastic bendable form. As with any of the embodiments of the present disclosure, the retention configuration of the sensor retention structure 320 (e.g., the rolled configuration of the sheet 323) can be achieved through shape memory of one or more components thereof. For example, the sheet 323 can be shape-set into a rolled shape and automatically assume such shape when deployed from a delivery system or released from any type of restraint used therewith.

[0144] 33A and 33B illustrate perspective views of at least a portion of a medical implant 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 apertures 336 and / or other features configured to allow a portion of the sensor retention ring 333 to be snapped, hooked, clipped, and / or otherwise attached or secured thereto. For example, the sensor retention ring 333 can include a hook feature 335, etc., that is configured to be at least partially inserted into the aperture 336 or other similar feature of the sensor support arm 338 and hooked / clamped therein. For example, the hook feature 335 can be configured to hook onto the peripheral band / portion 332 of the sensor support arm 338.

[0145] The sensor support arms / struts 338 can provide mechanical support for the sensor 334 and a dock to which the sensor retention ring 333 can be anchored. In some embodiments, the curved shape of the ring 333 is achieved (at least in part) using a shape memory setting. Additionally, the tendency of the ring 333 to flex outward (which can advantageously provide a retention force against the outer / perimeter band / portion 332) can come from the shape memory properties of the ring 333, which can create tension in the ring 333 when it is bent into the curved configuration of FIGS. 33A and 33B. That is, when the ring is compressed / curved as shown in FIGS. 33A and 33B, it can have an outward spring-type force that causes the ring to want to expand and straighten to some extent. Although three sensor retention rings are shown in Figures 33A and 33B, it should be understood that the sensor retention structure 330 can include any suitable or desirable number of rings and / or ring docking features, including embodiments including a single sensor retention ring.

[0146] 34A-34D illustrate top, bottom, and side views of at least a portion of a medical implant device including a sensor retention structure 340. The sensor retention structure 340 advantageously includes a sensor support arm structure 348 having one or more retention hoops 343 associated therewith. The sensor retention hoop 343 advantageously protrudes away from the sensor support structure 348 and may be configured to allow one or more portions of a sensor device 344 to be at least partially inserted therein.

[0147] The retention hoop / eyelet 343 can exert a downward force on the sensor 344 toward the sensor support arm / structure 348, holding the sensor 344 relative to the support arm / structure 348 and / or preventing the sensor 344 from sliding axially. The downward force of the hoop 343 on the distal and proximal ends of the sensor 344 is ideally not sufficient to damage / destroy the sensor 344. In some embodiments, as with any of the other embodiments disclosed herein, one or more portions of the sensor retention structure 340 (e.g., portions of the hoop 343) can be dipped or coated in a relatively tacky polymer / rubber (e.g., car button). Such a coating can increase friction between the sensor retention structure 340 and the sensor 344.

[0148] 35A and 35B illustrate perspective views of at least a portion of a medical implant 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 hoops 353 associated therewith. The sensor retention hoop 353 advantageously protrudes away from the sensor support structure 358 and may be configured to allow one or more portions of a sensor device 354 to be at least partially inserted therein. The sensor retention structure 350, in some embodiments, may further include a distal stopper 357, which may be bent or otherwise configured to prevent the sensor 354 from moving distally past the distal stopper 357.

[0149] In some embodiments, the shape memory properties of the sensor retention hoop 353 can cause the hoop to have a tendency to press downward toward the sensor support structure 358. Such a tensile force can press the hoop 353 against the sensor 354, helping to retain the sensor 354 and / or create friction between the hoop 353 and the sensor 354, preventing the sensor 354 from sliding axially. Radial movement of the sensor 354 can generally be restrained by wrapping the hoop around the periphery of the sensor 354.

[0150] 36A and 36B illustrate side and axial views, respectively, of a medical implant device 360 ​​including a particular sensor retention feature. For example, the medical implant device 360 ​​can be a shunt-type device or any other type of medical implant device including one or more arms 361, 362. The medical implant device 360 ​​includes multiple arms 361, 362 configured to be oriented to protrude axially relative to a shunt barrel 367 of the medical implant device 360. The arms 361, 362 can be grouped together, and the sensor device 364 can be at least partially secured by the arms 361, 362 and / or by one or more bands or other sensor retention features 363 at least partially disposed between or attached thereto. Thus, the arms 361, 362 and sensor retention bands 363 can provide a sensor holder structure, as shown.

[0151] 36A and 36B show implant arms 361, 362 projecting away from the tissue wall 366 to hold the sensor 364. However, in some embodiments, in addition to any arm structure extending away from the wall 366, additional arms may be used to secure the implant device 360 ​​to the tissue wall 366. That is, the implant device may include a sensor retaining arm / structure and an implant securement arm structure on the side of the implant device 360 ​​where the sensor 364 is held.

[0152] 37A and 37B illustrate perspective views of at least a portion of a medical implant 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 configurable 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.

[0153] The cage structure 375 can provide an adjustable sensor retention structure. For example, the distal stop tabs 372 can be bent inward at a desired point on the struts 377 by bending the struts 377 to which they are connected, resulting in a cage of a desired length to fit a particular sensor device. The distal tabs 372 and / or struts 377 can be configured according to their shape memory properties to bend inward to a desired degree to constrain the sensor 374. The distal tabs 372 can have apertures 376 or other features therein. Such features can have sutures or other features engaged therein to further secure the tabs 372 in place and / or provide axial retention for the sensor 374.

[0154] The sensor retention structure 375 can include a proximal stop feature 3771 (e.g., in the form of a tab, etc.). The tab 3771 can be foldable and / or tilted to fold due to its shape memory properties, thereby protruding away from the arm 378 and providing a surface against which the proximal end of the sensor 374 can rest or press, constraining axial movement of the sensor in the proximal direction. It should be understood that any of the embodiments disclosed herein can have a proximal stop tab and / or a distal stop tab that can be shaped to assume a position that protrudes into the axial path of the retained sensor, constraining its axial movement.

[0155] 38A and 38B illustrate perspective views of at least a portion of a medical implant device including a sensor retention structure 380. FIG. 38C shows a flattened configuration of the sensor retention structure 380 according to one or more embodiments. The sensor retention structure 380 includes a cage structure 386, which includes one or more longitudinal struts 383, 388 and / or circumferential struts 385, as shown. The sensor retention structure 380 can further include one or more distal stop tabs 387, which may be bendable, foldable, and / or otherwise configurable 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 retention structure 380.

[0156] In some embodiments, the sensor retention structure 380 is integrated with or coupled to an auxiliary sensor support arm 382, ​​which is associated with the sensor retention structure 380 of the implant device and is provided in addition to the tissue-engaging implant support arm 381. It should be understood that any of the sensor retention arm / structure embodiments disclosed herein may be coupled, attached, integrated, or otherwise associated with a dedicated / auxiliary sensor support arm other than the arm used for tissue engagement for implant device stabilization purposes. Such dedicated and / or auxiliary sensor support arms may have a jaw-type configuration, such as that shown in FIGS. 38A and 38B. For example, in some cases, the auxiliary sensor support arm may include a first arm 382a and a second arm 382b, which connect at or near the base of the tissue-engaging arm 381 and are integrated with a cage-like or other sensor retention structure, as shown in FIGS. 38A and 38B. For any embodiment of an implant device that includes an auxiliary sensor support arm (such as, for example, in one or more aspects, shown in FIGS. 38A and 38B ), such auxiliary sensor support arm can, in the deployed configuration, project away from the tissue wall into which the implant device is implanted to a greater extent / angle than the associated tissue engaging arm when the implant device and the auxiliary arm are disposed on the same side / area of ​​the implant device. Those skilled in the art should understand that arm component 382, ​​or a similar auxiliary arm strut / component, can be coupled to various other embodiments of the present disclosure.

[0157] Sensor support arm associated with shunt structure 39 illustrates a side view of a medical implant device 390 including an axial sensor support arm 393 configured to at least partially retain a sensor device 394 within the axial path of a shunt barrel 396 associated with the medical implant device 390. In some embodiments, a band or other feature 395 can at least partially secure the sensor device 394 to the sensor support arm 393.

[0158] For illustrative purposes, the following text describes the medical implant device 390 of FIG. 39 as a shunt structure. However, it should be understood that the medical implant device 390 can be any suitable or desirable type of medical implant device. In the illustrated embodiment of FIG. 39 , the sensor element 399 is attached to or integral with an arm member 393, which generally extends along the longitudinal dimension or axis of the shunt structure 390. However, in certain embodiments, the arm 393 extends along a dimension parallel and / or angled to the fluid path, but extends outside the barrel. In the embodiment illustrated in FIG. 39 , the sensor 394 is attached to or otherwise integrated with the fluid path barrel or conduit portion of the shunt structure 396 such that the sensor 394 is disposed in or near the fluid path channel associated with the barrel / conduit 396.

[0159] 40 shows a side view of another embodiment of a shunt-type medical implant device 400 having a sensor device 404 at least partially secured thereto. Notably, the sensor device 404 may be at least partially disposed within the shunt barrel 406 of the implant device 400. For example, the sensor device 404 may be secured to the barrel structure in some manner. In some embodiments, an inner lining (e.g., a shape memory alloy and / or a polymer mesh or sleeve) may be at least partially disposed within the barrel 406 such that the sensor 404 is secured at least partially through friction and / or pressure forces between the mesh / sleeve 405 and the barrel structure. The mesh / sleeve 405 may be secured / attached to the barrel structure 406 in some manner, such as through the use of sutures, hooks, adhesives, and / or other attachment means.

[0160] 41A-41C illustrate another embodiment of a shunt-type medical implant device 1600 having a sensor device 1610 at least partially secured thereto. FIG. 41A is a perspective view of the sensor implant device 1600. In the embodiment illustrated in FIG. 41A, the sensor 1610 has an elongated cylindrical shape, similar to certain other embodiments disclosed herein. However, it should be understood that sensors according to embodiments of the present disclosure can have any form, shape, configuration, and / or orientation.

[0161] In some embodiments, the sensor 1610 includes a first sensor element 1612 at a first end of the sensor 1610 that is disposed in a first side 1616 of the tissue wall 1601 and the shunt structure 1620 when implanted in a patient (e.g., such as in a wall separating the coronary sinus from the left atrium). For example, the sensor 1612 may be positioned to be exposed in the left atrium, which may be represented by the side or region 1616 in the illustrated diagram. The sensor 1610 may further include a second sensor 1613 that is disposed on an opposite side of the sensor 1610. For example, the sensor 1613 may be configured and positioned to be exposed in a room or area associated with the tissue wall 1601 and / or the opposite side of the shunt structure 1620 (e.g., such as in the coronary sinus). For an inter-atrial shunt procedure, a sensor element 1612, 1613 may be disposed or positioned in each atrium, 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. The use of two sensor elements, as shown in FIG. 41A, can allow for measurement of a differential pressure drop across the shunt structure 1620.

[0162] By disposing or attaching the sensor 1610 in or near the flow channel of the shunt structure 1620, the sensor 1610 can be configured to provide sensor readings that can be used to indirectly measure flow across or through the shunt structure 1620 based at least in part on fluid momentum associated with the fluid in contact with the sensor element. Moreover, the sensor can generate readings related to the velocity of flow through the shunt, and such readings can be used to determine or indicate undesired blockage or occlusion of the shunt flow path. In certain embodiments, pressure waveforms generated using the sensor can be used to generate and / or maintain a waveform profile related to the pressure readings. Changes in the pressure reading profile can indicate health complications and, therefore, can be used to trigger alerts or notifications, which can be relied upon to modify medication or other therapy. In some embodiments, pressure readings from the sensor are analyzed to determine average, diastolic, and / or systolic pressure data points.

[0163] In the embodiment of Figures 41A through 41C, the sensor 1610 is mounted or attached at or near an orifice or channel of the shunt structure 1620, rather than to one or more arm members, as described above. The sensor 1610 may be embedded into or otherwise integrated with, or otherwise attached or associated with, the shunt structure 1620. While Figures 41A through 41C illustrate the sensor 1610 attached to or integrated with the outer surface of the barrel / conduit portion 1622 of the shunt structure 1620, it should be understood that in some embodiments, the sensor 1610 may be disposed on, attached to, or otherwise integrated with the inner surface of the barrel / conduit portion 1622. For the embodiment shown, the sensor 1610 may fit within a pocket / receptacle feature 1625 of the barrel / conduit 1622. In some embodiments, the sensor 1610 includes or is associated with one or more protrusions 1627 that are configured or designed to hold or secure the sensor 1610 to the shunt structure 1620.

[0164] Figure 41B shows a front view of a sensor implant device 1600 according to one or more embodiments. Figure 41B shows a sensor 1610 nested within a pocket / receptacle feature 1625 associated with the barrel portion 1622 of the shunt structure 1620. Figure 41C shows a side view of the sensor implant device 1600, showing the sensor 1610 disposed within the flow path 1603 of the shunt structure. In some embodiments, the sensor 1610 is sutured to the shunt structure. In some embodiments, the sensor 1610 is held within a sock or pouch that is sutured or otherwise attached to the shunt structure 1620.

[0165] 42A and 42B illustrate side and axial views, respectively, of another embodiment of a shunt-type medical implant device 420 including a particular sensor retention feature. The medical implant device 420 can be configured to at least partially secure a sensor device 424 in a position at least partially outside of a barrel structure 427 of the implant device 420 and / or generally parallel to a flow axis / pathway associated with the shunt barrel 427. The sensor retention feature of the medical implant device 420 can include one or more sensor retention hoops, rings, or arms / fingers 423, 425, etc., as shown, which can be configurable to secure the sensor 425 using pressure and / or compression forces. Although features 423, 425 are shown as projecting away from their respective arms 421, 422, in some embodiments, retention features 423, 425 are substantially aligned with or biased inward relative to their respective arms 421, 422. Additionally, while two retention features 421, 425 are included, in some embodiments, only a single sensor retention hoop / feature is included.

[0166] Additional Sensor Retention Structure 43 illustrates a perspective view of at least a portion of a medical implant device including a sensor retention structure 430. The sensor retention structure 430 includes a plurality of sensor support struts, including one or more side struts 433 and one or more radially projecting posterior support struts 438. The sensor support struts 433, 438 may generally form a trough-type support form within which a sensor device 434 may be at least partially disposed and / or secured.

[0167] Contact between the sensor retention structure 430 and the sensor membrane (e.g., the distal surface of the sensor element 439) may advantageously be minimized to reduce interference with the function of the sensor element 439. For example, the struts 432 connecting the posterior support struts 438 to the distal crossbar struts 437 are angled axially outward with respect to the sensor orientation shown, preventing the majority of the length of the connecting struts 432 from contacting the sensor element 439. In some embodiments, one or both of the connecting struts 432 and the crossbar struts 437 are omitted to reduce contact with the sensor element 439. For example, the side struts 433 and the posterior struts 438 can be prongs that are not connected at their distal ends. In such embodiments, the struts 433, 438 can have connecting struts between them at one or more locations along their lengths to provide mechanical stability.

[0168] 44 illustrates a perspective view of at least a portion of a medical implant device including a sensor retention structure 440. The sensor retention structure 440 includes a sensor support arm 447 that includes one or more sensor support struts 443, 448. In some embodiments, the sensor support arm 447 includes one or more lateral support struts 443 and a central spinal support strut 448, as shown. A braid, net, mesh, fabric, film, or the like can be draped or otherwise disposed over the sensor device 444 to secure the sensor 444 to the sensor support arm 447.

[0169] While Figure 44 shows the sensor 444 sitting on the central support strut 448 (which is shown as lying in a common plane with the outer support struts), it should be understood that in some embodiments, the central support strut 448 sits at least partially below the plane of the outer struts 443. For example, the central strut 448 may provide trough-like support similar to the support strut 438 shown in Figure 43. Such a configuration may provide additional support for the sensor 444 on its sides and may further allow the distal and proximal ends of the support structure to axially constrain the sensor 444.

[0170] 45 illustrates a perspective view of at least a portion of a medical implant device including a sensor retention structure 450 that includes one or more magnets 453, which may be associated with an arm 451 of the medical implant device. The one or more magnets 453 may be configured to function as sensor retention magnets such that corresponding magnetic elements 455 associated with a sensor device 454 are attracted to the one or more magnets 453, thereby at least partially securing and / or positioning the sensor device 454 when the magnets of the structure 450 and the corresponding magnets of the sensor 454 are disposed in proximity to one another, as shown.

[0171] In some embodiments, adhesive or other attachment means may be applied to one or more portions of the sensor support structure 450 and / or sensor 454 to assist in securing the sensor 454 to the sensor support structure 450. The sensor magnet 455 may be inside the cylinder (e.g., a glass cylinder) of the sensor 454 or may be disposed outside the cylinder at its proximal end. Although a magnetic coupling is shown as supporting / holding the sensor 454 at its proximal end, magnets may be included along the length / sides of the sensor cylinder coupling the sensor 454 to the sensor support structure 450. The magnet 453 may be coated with a biocompatible coating / material.

[0172] 46A and 46B illustrate side views of a sensor retention structure 460 in a relatively shortened and lengthened configuration, respectively. The sensor retention structure 460 can be a component or portion of a medical implant device. The sensor retention structure 460 can include a cylindrically shaped, helically wound braid, mesh, or the like. For example, the braid can advantageously be a biaxial braid, where lengthening the braid longitudinally / axially results in at least a partial narrowing of the diameter of the braided cylinder in one or more portions of the braided cylinder. In some implementations, a sensor device 464 can be installed with the cylindrically shaped braid 463 in its relatively shortened / shortened configuration, where lengthening the braid 463 results in narrowing and / or tightening the braid 463 around at least a portion of the sensor device 464, thereby at least partially securing the sensor device 464 within and / or to the braid 463. In some implementations, the sensor retention structure 460 can be in the elongated / pinched configuration of FIG. 46B prior to insertion of the sensor 464. In such cases, insertion of the sensor 464 into the structure 463 can result in a friction fit between the structure 463 and the sensor 464.

[0173] 47 through 49 illustrate separate embodiments of sensor structures including respective sensor retention features according to one or more aspects of the present disclosure. With reference to FIG. 47 , the sensor structure 474 can include one or more radial protrusions 475 configured to be engaged by one or more corresponding features or components of a medical implant device, thereby at least partially securing the sensor structure 474 thereto. The protrusions 475 can have a dot-type shape, as shown, and can have substantially rounded and / or straight edges / surfaces. The corresponding engaging feature of the sensor retention structure that engages with the protrusions 475 can include a concave surface that corresponds to the shape of the protrusions 475, allowing the protrusions 475 to fit relatively tightly therein and preventing movement of the sensor 474 relative to the sensor retention structure when the protrusions 475 are engaged / nested within the corresponding recess / concave feature of the sensor retention structure. Although shown as a protrusion, the feature 475 can in some embodiments be a recess / indentation, and the sensor retention structure includes a protrusion configured to fit therein for engagement / retention.

[0174] 48 , the sensor structure 484 includes a recess / trench 485 (e.g., a circumferential recess around at least a portion of a cylindrically shaped housing or body portion of the structure 484). The recess 485 may be configured to be engaged by one or more corresponding features or components of a medical implant device, thereby at least partially securing the sensor structure 484 thereto. The recess 485 may have a neck-type shape, as shown, or may have any other shape. The recess 485 may extend across the entire circumferential section of the sensor 484 or may cover only a portion of the circumferential section of the sensor 484. The corresponding engaging feature of the sensor retention structure that engages with the trench 485 may include an inwardly protruding ring that corresponds to the shape of the trench 485, such that the ring fits relatively tightly within the trench 485 to prevent movement of the sensor 484 relative to the sensor retention structure when the trench 485 is engaged with the corresponding ring / protruding feature of the sensor retention structure. In some embodiments, the corresponding engagement feature of the sensor retention structure is sized and / or configured to snap into trench 485 when pressed into trench 485 over proximal end 481 of sensor 484.

[0175] 49, sensor structure 494 includes an at least partially circumferential protrusion 495 that is integral with and / or associated with or attached to a circumferential portion of a cylindrically shaped housing or body portion of structure 494. Protrusion 495 is configured to be engaged by one or more corresponding features or components of a medical implant device, thereby enabling sensor structure 494 to be at least partially secured thereto.

[0176] The protrusion 495 can have a torus-type shape, as shown, or can have any other shape. The protrusion 495 can span the entire circumferential section of the sensor 494 or can cover only a portion of the circumferential section of the sensor 494. The corresponding engagement feature of the sensor retention structure that engages with the protrusion 495 can include a trench / recess corresponding to the shape of the protrusion 495, such that the protrusion 495 fits relatively tightly within the trench / recess, preventing movement of the sensor 494 relative to the sensor retention structure when the protrusion 495 is engaged with the corresponding trench / recess feature of the sensor retention structure. In some embodiments, the corresponding engagement feature of the sensor retention structure is sized and / or configured to snap over the protrusion 495 when pressed into the protrusion 495 beyond the proximal end 491 of the sensor 494.

[0177] 50A-50E illustrate at least a portion of a medical implant device including a sensor retention structure 500. The sensor retention structure 500 includes a plurality of longitudinal sensor support struts 508, which may be generally longitudinally arranged in parallel on opposite sides of the sensor retention structure 500. The sensor support struts 508 may generally form a trough-type support form within which a sensor device 504 may be at least partially disposed and / or secured.

[0178] The curvature of the sensor retention structure 500 can be designed to fit and / or correspond to the radius of curvature of the outer surface of the sensor cylinder 504, allowing the sensor 504 to effectively seat thereon. Such curvature of the struts 508 can allow the sensor 504 to seat on the struts 508 in a manner such that at least a portion of the sensor 504 falls below the distal cross strut / form 502 and / or the proximal cross strut / form 506 (which can have a smaller (i.e., flatter) curvature than the curvature of the outer struts 508). The relative flatness of the struts / forms 502, 506 can be designed to provide the described axial retention. In some embodiments, the curvature of the distal retention strut 502 is such that only the outer edge / portion of the sensor element 509 is brought into contact with and / or covered by the strut 502, avoiding corrupting the sensor reading and / or causing damage to the sensor element 509.

[0179] 51A through 51E illustrate at least a portion of a medical implant device including a sensor retention structure 510 including one or more runner-type sensor support struts 518. FIG. 51A shows the sensor retention structure 510 in a flattened or straightened configuration, while FIGS. 51B through 51E show perspective views of the sensor retention structure 510 in a sensor-wrapping configuration. The sensor retention structure 510 can include a longitudinal support strut 518 connected between a distal stop ring 517 and a proximal stop ring 513. In some embodiments, the sensor retention structure 510 further includes one or more cross or horizontal struts 516 that are connected between two longitudinal support struts 518 to provide additional mechanical stability for the sensor retention structure 510. The longitudinal support struts 518 can secure a sensor 514 therein in the illustrated wrapped configuration. In the embodiment of Figures 51A to 51E, longitudinal struts 518 may be connected to each stopper ring 513, 517 adjacent to one another on half the circumference of each ring, as shown.

[0180] 51B-51E, the sensor retention structure 510 can be configured in a twisted configuration prior to placement of the sensor 514. In some implementations, the sensor retention structure 510 can be wrapped / twisted around the sensor 514 after placement of the sensor relative to the longitudinal struts 518. The amount of wrapping of the struts 518 and / or the length l1 of the struts 518 can be determined to result in an axial length l2 between the proximal ring 513 and the distal ring 517 that corresponds to the length of the sensor 514.

[0181] 52A-52C illustrate at least a portion of a medical implant device including a sensor retention structure 520 including one or more runner-type sensor support struts 528. FIG. 52A shows the sensor retention structure 520 in a flattened or straightened configuration, while FIGS. 52B and 52C show perspective views of the sensor retention structure 520 in a sensor-wrapped configuration. The sensor retention structure 520 can include longitudinal support struts 528 connected between a distal stop ring 527 and a proximal stop ring 523. In some embodiments, the sensor retention structure 520 further includes one or more cross or horizontal struts (not shown) that are connected between two longitudinal support struts 528 to provide additional mechanical stability for the sensor retention structure 520. The longitudinal support struts 528 can secure a sensor 524 therein in the illustrated rolled configuration. In the embodiment of Figures 52A-52C, longitudinal struts 528 may be connected to respective stopper rings 523, 527 on opposite sides of the rings as shown.

[0182] 53A-53E illustrate perspective views of a sensor retention structure 530 that may be associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 530 includes first and second axially extending prongs 533. A sensor device 534 may be placed against the prongs 533, and a sleeve 535 of any suitable or desirable material may be at least partially wrapped around the sensor 534 and the prongs 533, thereby at least partially securing the sensor 534 to the prongs 533 (and thus to the sensor retention structure).

[0183] With reference to FIG. 53E, in some embodiments, stiffening wire ring 537 can be included inside or outside of sleeve 535 to further secure sleeve 535 to sensor 534 and / or prong 533. It should be understood that any of the embodiments disclosed herein can have stiffening wire ring wrapped around at least a portion of the sensor and / or sensor retention structure (e.g., sensor retention arm or finger). Stiffening wire ring 537 can include mesh, coil, braid, suture, whether metallic or polymeric, or any other material. Stiffening wire ring 537 can be non-metallic suture, in some embodiments.

[0184] 54A-54C illustrate perspective views of a sensor retention structure 540 that may be associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 540 includes first and second axially extending arms 543, each having a distal crosspiece 545 associated therewith. A sensor device 544 may be positioned against the arms 543 and crosspieces 545, thereby at least partially securing the sensor 544 to the sensor retention structure 540.

[0185] 54A-54C, crosspieces 545 are shown as projecting circumferentially on both sides of each arm 543. In some embodiments, the crosspieces project on only one side of each arm. That is, some embodiments may include a "T" shaped sensor retention arm / form, while some embodiments may include an "L" shaped sensor retention arm / form.

[0186] 54A-54C , with a sleeve 555 of any suitable or desirable material at least partially wrapped around the sensor 544, the arm 543, and the crosspiece 545, thereby at least partially securing the sensor 544 to the sensor retention structure 540. The addition of an upper crosspiece 545 can enhance the engagement of the sensor retention structure 540 with the sensor device 544 and / or the sleeve 555. For example, the crosspiece 545 can reduce the risk of the arm 543 slipping out from under the sleeve 555 by increasing the surface and / or surface area that the sensor retention structure 540 engages with the sleeve (e.g., polymer, car button) 555.

[0187] In some implementations, the sleeve 555 is applied around the sensor 544 prior to placing the sensor 544 against the arm 543. After application / placement of the sleeve material around the sensor 544, the material of the sleeve 555 can be reflowed to strengthen the connection between the arm 543 and crosspiece 545 and the sleeve 555. For example, reflowing the sleeve material 555 can involve heating the sleeve material 555 and causing the material to conform to the surfaces of the sensor 544 and the sensor retention structure 540. It should be understood that any of the embodiments disclosed herein can incorporate the application of a polymer sleeve / material to one or more portions thereof, and that such polymer sleeve material can be reflowed during one or more steps of the manufacturing and / or assembly process to promote bonding / engagement of the sleeve material with the associated sensor retention structure components.

[0188] 56A-56D illustrate perspective views of a sensor retention structure 560 that may be associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 560 includes first and second axially extending arms 563, each having a distal crosspiece 565 associated therewith. The crosspieces 565 can provide additional circumferential surface contact between the sensor retention structure 560 and the sensor 564.

[0189] The sensor retention structure 560 further includes a plurality of opposing fingers 562 configured to be at least partially wrapped or otherwise disposed around a cylindrically shaped sensor device 564. The sensor device 564 may be mounted against an arm 563 and a crosspiece 565 and secured to the sensor retention structure 560 by the arm 563 and the fingers 562. The fingers 562 may wrap any arcuate distance around the exterior / periphery of the sensor cylinder 564. While two opposing, axially offset fingers 562 are shown, it should be understood that any number and / or orientation of fingers may be included.

[0190] 57 illustrates a perspective view of the sensor retention structure of FIGS. 56A-56D with a sleeve 575 of any suitable or desirable material at least partially wrapped around sensor 564, arm 563, and crosspiece 565, thereby at least partially securing sensor 564 to sensor retention structure 560. Sensor retention structure 560 can have any of the features and / or attributes of sensor retention structure 540 (including those related to sleeve 555 and sleeve 575).

[0191] Sensor Retention Cage Structure 58A-58D illustrate perspective views of a sensor retention structure 580 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 580 includes a cage 583 configured to hold a sensor device 584 (such as, for example, a cylindrically shaped sensor device according to aspects of the present disclosure). The cage 583 can include a plurality of longitudinal sensor support struts 588, 585 and a proximal stop tab 587 that can be configured to fold or bend inward as shown to prevent proximal movement of the sensor device 584 contained within the cage structure 583 proximally beyond the axial position of the tab 587.

[0192] The circumferential and axial areas between the longitudinal sensor support struts 588, 585 and between the distal circumferential support strut 5801 and the proximal circumferential support strut 5802 form windows 586. Such windows 586 can provide openings 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 retention structure / cage that includes a conductive material, such material can interfere with the transmission of electromagnetic signals. As described in detail above with respect to transmission elements that include conductive coil features, conductive material axially and / or circumferentially overlapping such coils can result in signal noise caused at least in part by the induction of 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. Thus, struts 585, 588, 5801, and 5802 can be configured / designed according to dimensions that provide a window feature that is wide and / or long enough to not substantially interfere with signal transmission to / from transport element 5803. For example, as shown in FIG. 58C , if a transport element (e.g., a coil antenna) has a length w1, in some embodiments, window feature 586 can advantageously have a length dimension w2 that is greater than the dimension w1 of the transport element. Moreover, window feature 586 can be configured to axially overlap transport element 5803 such that when sensor 584 is retained by the sensor retention structure, as in FIG. 58C , the transport element fits axially within window feature 586. In some embodiments, window feature 586 axially overlaps at least 50% of the axial dimension w1 of transport element 5803. In some embodiments, length dimension w2 is at least 50% of the dimension w1 of transport element 5803.

[0193] FIG. 59 illustrates a perspective view of the sensor retention structure 580 of FIGS. 58A to 58D with a sleeve 595 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially wrapped around the sensor 584 and struts 585, 585, thereby at least partially securing the sensor 584 to the sensor retention structure 580.

[0194] 60A-60D illustrate perspective views of a sensor retention structure 600 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 600 includes a cage structure 603 configured to hold a sensor device 604 (such as, for example, a cylindrically shaped sensor device according to aspects of the present disclosure). The cage 603 can include a plurality of longitudinal sensor support struts 608, 605. The cage 603 can be coupled to an arm 601 of a medical implant device (e.g., a shunt implant device as described herein) via one or more of the longitudinal struts 605, with a gap 6006 existing between the medical implant device arm 601 and the cage structure 603, as shown. In some embodiments, one or more proximally disposed, distally angled (with respect to the interface of the struts 602, 607 with the arm 601) support struts 602, 607 can provide mechanical stability for the sensor retention structure 600, as shown.

[0195] The circumferential and axial areas between the longitudinal sensor support struts 608, 605 and between the distal circumferential support strut 6001 and the proximal circumferential support strut 6002 form windows 606. Such windows 606 can provide openings 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 retention structure / cage that includes a conductive material, such material can interfere with the transmission of electromagnetic signals. As described in detail above with respect to transmission elements that include conductive coil features, conductive material axially and / or circumferentially overlapping such coils can result in signal noise caused at least in part by the induction of 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. Thus, struts 605, 608, 6001, and 6002 may be configured / designed according to dimensions that provide a window feature that is wide and / or long enough to not substantially interfere with signal transmission to / from transport element 6003. For example, as shown in FIG. 60C , if a transport element (e.g., a coil antenna) has a length w1, in some embodiments, window feature 606 can advantageously have a length dimension w2 that is greater than the dimension w1 of the transport element. Moreover, window feature 606 may be configured to axially overlap transport element 6003 such that when sensor 604 is retained by the sensor retention structure, as in FIG. 60C , the transport element fits axially within window feature 606. In some embodiments, window feature 606 axially overlaps at least 50% of the axial dimension w1 of transport element 6003. In some embodiments, length dimension w2 is at least 50% of the dimension w1 of transport element 6003.

[0196] FIG. 61 illustrates a perspective view of the sensor retention structure 600 of FIGS. 60A-60D, with a sleeve 615 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially wrapped around the sensor 604 and arms 608, 605, thereby at least partially securing the sensor 604 to the sensor retention structure 600.

[0197] The sensor retention structure 600 includes a hinge point 6001 where the distally angled support strut 607 bends at the intersection of the distally angled support strut 607 and the longitudinal strut 605. The hinge point 6001, as configured in FIGS. 60A through 60D , can serve to guide the outer sheath of a delivery system (in which an implant device associated with the sensor retention structure 600 is delivered to a target location) over other structures of the sensor retention structure 600 (such as structures of the cage 603 distal to the hinge point 6001). Thus, the hinge point 6001 can provide a hinge and prevent overloading of the interface between the sleeve 615 and the sensor retention structure 600, which could otherwise be angled to cause the outer sheath of the delivery system in which the implant device is transported to catch on the sleeve material 615 when installing the sensor retention structure 600 into the delivery system. The angle θ of the support strut 607 at the junction of the strut 607 with the longitudinal strut 605 can advantageously be greater than 90°, as shown, to reduce the risk of the hinge point 6001 getting caught in certain types of delivery system sheaths.

[0198] 62A-62D illustrate perspective views of a sensor retention structure 620 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 620 includes a cage structure 623 configured to hold a sensor device 624 (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The cage 623 can include multiple longitudinal sensor support struts 628, 625. The cage 623 can be coupled to an arm 621 of a medical implant device (e.g., a shunt implant device as described herein) via one or more of the longitudinal struts 625. In some embodiments, the cage includes one or more proximally disposed, proximally angled (with respect to the interface of the strut 627 and the arm 621) support struts 627 that form a generally distally pointing point / arrow, as shown.

[0199] The circumferential and axial areas between the longitudinal sensor support struts 628, 625 and between the distal and proximal circumferential support struts 622 form windows 6203. Such windows 6203 can provide openings 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 dimensions that provide window features that are wide and / or long enough to not substantially interfere with signal transmission to / from the transmission element 6206. For example, as shown in FIG. 62C , if the transmission element (e.g., a coil antenna) has a length w1, in some embodiments, the window feature 6203 can advantageously have a length dimension w2 that is greater than the dimension w1 of the transmission element. Moreover, window feature 6203 can be configured to axially overlap transmission element 6206 such that when sensor 624 is retained by the sensor retention structure, as in FIG. 62C , the transmission element fits axially within window feature 6203. In some embodiments, window feature 6203 axially overlaps at least 50% of axial dimension w1 of transmission element 6206. In some embodiments, length dimension w2 is at least 50% of dimension w1 of transmission element 6206.

[0200] FIG. 63 illustrates a perspective view of the sensor retention structure 620 of FIGS. 62A-62D, with a sleeve 635 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially wrapped around the sensor 624 and struts 628, 625, thereby at least partially securing the sensor 624 to the sensor retention structure 620.

[0201] The sensor retention structure 620 includes a hinge point 6201 where the proximal angled support strut 627 bends at the intersection of the proximal angled support strut 627 and the longitudinal strut 625. The hinge point 6201, as configured in FIGS. 62A through 62D , can serve to guide the outer sheath of a delivery system (in which an implant device associated with the sensor retention structure 620 is delivered to a target location) over other structures of the sensor retention structure 620 (such as structures of the cage 623 distal to the hinge point 6201). Thus, the hinge point 6201 can provide a hinge and prevent overloading of the interface between the sleeve 635 and the sensor retention structure 620, which could otherwise be angled to cause the outer sheath of the delivery system in which the implant device is transported to catch on the sleeve material 635 when installing the sensor retention structure 620 into the delivery system. The angle θ of the support strut 627 at the junction of the strut 627 with the longitudinal strut 625 can advantageously be less than 90° as shown to reduce the risk of the hinge point 6201 getting caught in certain types of delivery system sheaths.

[0202] 64A-64D illustrate perspective views of a sensor retention structure 640 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 640 includes a cage structure 643 configured to hold a sensor device 644 (see FIGS. 64C and 64D ) (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The cage 643 can include multiple longitudinal sensor support struts 643, 645. The cage 643 can also advantageously include a longitudinal support structure 648, which can have a multi-strut and / or loop form / configuration. The cage 643 can be coupled to an arm 641 of a medical implant device (e.g., a shunt implant device as described herein) via one or more of the longitudinal struts 643. In some embodiments, one or more proximally disposed, distally angled support struts 642, 647 can provide mechanical stability for the sensor retention structure 640, as shown.

[0203] The circumferential and axial areas between the longitudinal sensor support struts 643, 645 and between the distal and proximal circumferential support struts 6401 form windows 6403. Such windows 6403 can provide openings through which electromagnetic signals can propagate to and / or from the wireless transmission element 646 of the sensor device 644 and can reduce interference / noise associated therewith. The struts 645, 643, and 6401 can be configured / designed according to dimensions that provide window features that are wide and / or long enough to not substantially interfere with signal transmission to / from the transmission element 646. For example, as shown in FIG. 64C , if the transmission element (e.g., a coil antenna) has a length w1, in some embodiments, the window feature 6403 can advantageously have a length dimension w2 that is greater than the dimension w1 of the transmission element 646. Moreover, the window feature 6403 can be configured to axially overlap the transmission element 646 such that the transmission element fits axially within the window feature 6403 when the sensor 644 is retained by the sensor retention structure, as in FIG. 64C . In some embodiments, the window feature 6403 axially overlaps at least 50% of the axial dimension w1 of the transmission element 646. In some embodiments, the length dimension w2 is at least 50% of the dimension w1 of the transmission element 646.

[0204] 65 illustrates a perspective view of the sensor retention structure 640 of FIGS. 64A-64D with a sleeve 655 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially wrapped around the sensor 644, struts 643, 645, and longitudinal support structure, thereby at least partially securing the sensor 644 to the sensor retention structure 640. In some embodiments, a longitudinal support structure 648 can be disposed over / outside the sleeve 655 to provide sheathability for the sensor retention structure 640.

[0205] In some embodiments, the longitudinal support structure 648 is disposed substantially outside of the sleeve / material 655, while other struts and / or portions of the sensor retention structure 640 are at least partially disposed between the sleeve / material 655 and the sensor cylinder 644. Alternatively, the longitudinal support structure 648 can be sandwiched under the sleeve / material 655, while other struts and / or portions of the sensor retention structure 640 are disposed outside of the sleeve / material 655.

[0206] In some implementations, the longitudinal support structure 648 may be bent (e.g., folded / pulled) away from the axis of the structure 640 while the sleeve / material 655 is being applied to the sensor 644 and sensor retention structure 640 so that the longitudinal support structure 648 is not covered by the sleeve / material 655 (e.g., polymer; carton). After the sleeve / material 655 is applied to the sensor 644 and a portion of the sensor retention structure (e.g., a portion of the strut 643), the longitudinal support structure 648 may be released or otherwise placed over the sleeve / material 655 so that the longitudinal support structure 648 is generally disposed on or near its outer surface. After the longitudinal support structure 648 is placed in contact with the outside of the sleeve / material 655, the material 655 may be reflowed to improve the connection between the sleeve / material 655 and the sensor retention structure 640.

[0207] 66A and 66B illustrate perspective views of a sensor retention structure 660 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 660 includes two support struts 668 extending from an arm 661 of the medical implant device to provide backside sensor support according to embodiments of the present disclosure. The support struts 668 extend distally from the arm 661 to the distal end of the structure 660, at which point the struts form a bend and continue circumferentially around a circumferential support path 662, generally to the front side of the sensor retention structure 660. The struts 665 may extend further proximally generally at the front side of the structure 660 and bend again to form proximally and / or circumferentially angled / protruding strut portions 667. Strut portions 667 may form another bend on each side portion of structure 660 and terminate in distally projecting strut portions 663 as shown.

[0208] 67A-67C illustrate perspective views of the sensor retention structure 660 of FIGS. 66A and 66B with a sensor device 674 retained therein, and a sleeve 675 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially disposed around sensor device 674, struts 665, and / or struts 667, and / or struts 663. In some embodiments, sleeve 675 is disposed around sensor device 674 but within one or more of struts 667 and / or struts 663.

[0209] The sleeve 675 can comprise carton or another polymeric material. The sleeve 675 can be applied to the sensor 674 and / or struts 665, and / or the struts 665 can be inserted between a portion of the sleeve 675 and the sensor 674 in a manner that results in the sleeve 675 being deformed and / or otherwise configured to conform around one or more portions of the struts 665, as shown. As with any of the embodiments of the present disclosure, in some implementations, the sensor retention structure 660 can be loaded into a delivery system sheath prior to delivery to the target implantation site. When deployed, the sensor retention structure 660 can be unsheathed to allow deployment. The end strut portions 663 can be located / disposed outside the sleeve 675, as shown, to facilitate sliding of the sensor retention structure 660 into a delivery sheath or other delivery device. When wrapping strut portion 663 around the outside of sleeve 675, strut portion 663 can be pulled out from behind / under sleeve 675, and the shape memory properties of strut portions 667, 663 can be such that strut portion 663 assumes a position that axially overlaps sleeve 675 relative to the axis of sensor 674. For example, the struts can include nitinol or other material with superelastic properties that allow for such deformation and positioning of the various strut portions.

[0210] 68A-68C illustrate perspective views of a sensor retention structure 680 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 680 includes a cage structure configured to hold a sensor device 684 (see FIG. 68C ) (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The structure 680 can include a plurality of longitudinal sensor support struts 688, 683 and one or more distal stop tabs 687 b and / or one or more proximal stop tabs 687 a that can be configured to fold or bend inward, as shown, to prevent distal and proximal movement, respectively, of a sensor device 694 contained within the cage structure 680 beyond the axial positions of the tabs 687. The depicted configuration of tabs 687 may be achieved through the shape memory qualities of such features, which may be shaped to bend / protrude toward the axial center of the cage structure of sensor device 684 and / or sensor retention structure 680. Structure 680 may further include a plurality of circumferential struts 685, which provide mechanical stability between backside longitudinal struts 688 and frontside longitudinal struts 683. Cage structure 680 may or may not have a polymer sleeve material applied thereover to secure structure 680 to sensor 684.

[0211] Struts 688 connecting proximal portion / ring 682 to distal portion / ring 686 can facilitate sheathing of sensor retention structure 680 and can further aid in retention by providing a longitudinal surface area for contact with sensor device 684 and / or polymer sleeve material that may be applied to structure 680 and / or sensor device 684. The cage of sensor retention structure 680 can include struts configured and / or dimensioned to provide a window, as described in detail herein, that aligns with at least a portion of the transmission element of sensor 684 and reduces interference / noise with wireless data and / or power transmission between the transmission element and an external receiver / transmitter.

[0212] 69A-69D illustrate perspective views of a sensor retention structure 690 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 690 includes a cage structure configured to hold a sensor device 694 (see FIGS. 69C and 69D ) (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The structure 690 can include a plurality of longitudinal sensor support struts 698, 693 and one or more distal stop tabs 697 b and / or one or more proximal stop tabs 697 a that can be configured to fold or bend inward, as shown, to prevent distal and proximal movement, respectively, of the sensor device 694 contained within the cage structure 690 beyond the axial positions of the tabs 697. The structure 690 may further include one or more circumferential struts 695 and / or more intermediate longitudinal struts 696 , which provide mechanical stability for the structure 690 .

[0213] 68A-68C, the cage structure 690 may have one less circumferential ring along the length of the structure 690. For example, the removed ring may generally be in the proximal half / side of the cage structure 690, which may correspond to the location of the electrical coupling component of the sensor 694. In general, circumferential overlap of the electrical coupling component (which may generally run parallel to the coil windings of the electrical coupling) may be more problematic than longitudinal overlap (e.g., perpendicular to the windings / coils of the electrical coupling component), as may longitudinal struts 696 (which are provided in place of the circumferential struts 685 of the structure 680 in FIGS. 68A-68C).

[0214] The circumferential and axial areas between the longitudinal sensor support struts 693, 698 and between the distal and proximal circumferential support struts 695 form windows 6903. Such windows 6903 can provide openings through which electromagnetic signals can propagate to and / or from the wireless transmission element 6906 of the sensor device 694 and can reduce interference / noise associated therewith. The struts 698, 693, and 695 can be configured / designed according to dimensions that provide window features that are wide and / or long enough to not substantially interfere with signal transmission to / from the transmission element 6906. For example, as shown in FIG. 69C , if the transmission element (e.g., a coil antenna) has a length w1, in some embodiments, the window feature 6903 can advantageously have a length dimension w2 that is greater than the dimension w1 of the transmission element 6906. Moreover, the window feature 6903 can be configured to axially overlap the transmission element 6906 such that the transmission element fits axially within the window feature 6903 when the sensor 694 is retained by the sensor retention structure, as in FIG. 69C. In some embodiments, the window feature 6903 axially overlaps at least 50% of the axial dimension w1 of the transmission element 6906. In some embodiments, the length dimension w2 is at least 50% of the dimension w1 of the transmission element 6906.

[0215] 70A-70D illustrate perspective views of a sensor retention structure 700 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 700 includes a cage structure configured to hold a sensor device 704 (see FIGS. 70C and 70D ) (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The structure 700 can include a plurality of longitudinal sensor support struts 708, 703, as well as one or more distal stop rings 707 b and / or one or more proximal stop tabs 707 a configured to fold or bend inward, as shown, to prevent distal and proximal movement, respectively, of the sensor device 704 contained within the cage structure 700 beyond the axial positions of the respective stop features 707. The structure 700 may further include a plurality of circumferential struts 705 that provide mechanical stability between the backside longitudinal struts 708 and the frontside longitudinal struts 703.

[0216] Ring stopper 707b may advantageously provide contact with sensor element 709 only around its periphery, which may result in reduced impact on sensor function and / or reduced risk of damage to sensor element 709 compared to tabs that project radially inward above the surface of the sensor element (e.g., a hermetic seal).

[0217] The ring stopper 707b is shown as having a slight curvature corresponding to a curved (e.g., tubular) sheet from which the sensor retention structure 700 may be cut during manufacturing. In some implementations, the curvature of the ring stopper 707b may be flattened in relation to its shape setting. Flattening the ring stopper 707b can serve to increase the surface contact area of ​​the ring stopper 707b against the sensor element 709, thereby potentially spreading / distributing the contact load thereon. In some embodiments, the ring stopper 707b is designed to be similar / the same size as or slightly larger than the hermetic seal of the sensor element 709, thereby reducing its effect thereon.

[0218] 71A and 71B illustrate perspective views of a sensor retention structure 710 associated with a medical implant device according to one or more embodiments of the present disclosure. The sensor retention structure 710 includes a cage structure configured to hold a sensor device 704 (see FIG. 71B ) (e.g., a cylindrically shaped sensor device according to aspects of the present disclosure). The structure 710 can include a plurality of longitudinal sensor support struts 718, 713 and one or more distal and / or proximal stop features 705, 702. For example, distal stop feature 705 may include a plurality of protrusions and / or apertures 705 that may have sutures 706 or other structures / forms at least partially disposed therethrough, and the sutures (or other structures / forms) may cross over at least a portion of the diameter of sensor device 704 that is at least partially disposed within cage structure 710, thereby at least partially interfering with or preventing sensor device 704 from sliding distally past the distal end of cage structure 710, stop feature 705, and / or sutures 706.

[0219] The structure 710 may further include one or more proximal stop tabs 702 that may be configured to fold or bend inward, as shown, to prevent proximal movement of a sensor device 704 contained within the cage structure 710 beyond the axial position of the tab / stop feature 702. The term "suture" is used herein according to its plain and ordinary meaning and may refer to any elongated cord, strip, strand, line, tie, string, ribbon, strap, or portion thereof, or other type of material used in medical procedures. Those skilled in the art will understand that wire or other similar materials may be used in place of sutures. Moreover, in some contexts herein, the terms "cord" and "suture" may be used substantially interchangeably. Additionally, use of the singular form of any of the suture-related terms listed above (including the terms "suture" and "cord") may be used to refer to a single suture / cord or to refer to a portion thereof.

[0220] It should be understood that distal (and / or proximal) suture engagement tabs 705, such as those shown in Figures 71A and 71B, can be incorporated into any of the sensor retention structures disclosed herein. The suture tabs 705 and / or sutures 706 can be configured to hold the sensor 714 in a substantially stationary axial position with little or no axial movement / sway when implanted in the target environment. Maintaining the sensor 714 in such a stationary position can reduce the effect and / or occurrence of the sutures 706 and sensor element 709 forcing contact with one another.

[0221] FIG. 72 illustrates a perspective view of a sensor support strut 728, which may be attached to and / or associated with a medical implant device via an arm structure 721, as discussed in connection with various embodiments of the present disclosure. The sensor support strut 728 may be configured to support a sensor device 724 in some manner. For example, as shown in FIG. 72 , the sensor device 724 may have a fabric or other type of covering 723 disposed around at least a portion thereof. For example, the fabric 723 may substantially encase the sensor device 724. The covering 723 may wrap around a side portion of the sensor device 724 while allowing openings therein at the distal and / or proximal sides of the sensor device 724 to allow exposure of the sensor element 729. For example, as shown in FIG. 72 , the distal end of the sensor device 724 may be exposed. In some embodiments, a ridge or other feature 727 may be associated with the sensor device 724 and the fabric / covering 723 may be at least partially wrapped or covered thereover. In some embodiments, the sensor support strut 728 includes multiple apertures 726 through which a suture 725, wire, or other elongated material / device may be passed, with such suture 725 or other material / device being sewn and / or passed at least partially through various portions of the covering 723, thereby securing the sensor device 724 to the sensor support strut 728. Although multiple suture stitches 725 are shown, any number of stitches may be used (including a single stitch).

[0222] In some embodiments, a drawstring type feature may be associated with the distal wrapped portion 727 of the fabric / covering 723, which may allow for cinching / tightening of the fabric / covering 723 around the periphery of the distal surface of the sensor element 729, thereby restricting its axial movement.

[0223] Sensor Retention Encasement / Housing 73-75 illustrate perspective views of embodiments of sensor retention structures 730, 740, including sensor support struts 738, 748 and encasements 733, 743 secured in some manner to the sensor support struts 738, 748 and configured to house or enclose at least a portion of a sensor device therein. The encasements 733, 743 can comprise any suitable or desirable material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)). With reference to FIG. 73, the encasement 733 can include a cutout 735 configured to fit over the sensor support strut 738, as shown in the diagram of FIG. 73. In certain respects, the embodiment of FIG. 74 is similar to the embodiment shown in FIG. 73. 73 , the encasement 743 of FIG. 74 may include a cutout 745 that is shorter in length than the cutout 735 of FIG. 73 . Moreover, the encasement 743 may be secured to the sensor support arm 741 in a manner such that the encasement 743 protrudes, is disposed, and / or is secured axially farther relative to the sensor support strut 738. With respect to both FIG. 73 and FIG. 74 , the encasement 733, 743 may include one or more apertures 732, 742 through which sutures, wires, and / or other materials / devices may be sewn / passed, and such sutures / materials may be further passed / sewn through apertures / features in the sensor support struts 738, 748, as shown, thereby at least partially securing the encasement 733, 743 to the sensor support strut 738.The encasements 733, 743, 753 can have sensor devices disposed therein when the encasements are sutured to the respective sensor support struts 738, 748, 758.

[0224] 76A through 76D illustrate exploded and perspective views, respectively, of a sensor retention structure 760 including a sensor support arm 768 and an encasement 763, according to one or more embodiments of the present disclosure. The encasement 763 is configured to fit or engage with the sensor support arm 768 in some manner to house or enclose at least a portion of a sensor device therein. The sensor support arm 768 can include multiple sets of opposing fingers 765. For example, as shown, the sensor support arm 768 can include a proximal set of sensor retention fingers 765a and a distal set of sensor retention fingers 765b, and the encasement 763 includes corresponding cutouts 766 configured to fit or receive the fingers 765 when the encasement 763 is disposed / placed on the sensor support arm 768, as shown in FIGS. 76C and 76D. Encasement 763 can include any suitable or desirable material, such as, for example, polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)), etc. Cutout 766 can advantageously provide axial retention of encasement 763, and therefore, sensor 764 disposed therein.

[0225] 77 illustrates a perspective view of the sensor retention structure 760 of FIGS. 76A-76D with a sensor device 769 retained therein, with a sleeve 775 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially disposed around the support arm 768, the fingers 765, and / or the encasement 763. The sleeve material 775 may be applied to the encasement 763, the fingers 765, and / or the support arm 768 and may or may not be reflowed after its application, as described herein. The sleeve 775 can advantageously prevent or restrict the fingers 765 from expanding outward, thereby further securing the fingers 765 with the encasement 763 and / or the sensor 769.

[0226] 78A-78D illustrate exploded and perspective views, respectively, of a sensor retention structure 780 including a sensor support arm 788 and an encasement 783, according to one or more embodiments of the present disclosure, where the encasement 783 is configured to fit or engage with the sensor support arm 788 in some manner to house or enclose at least a portion of a sensor device 784 therein (see FIGS. 78C and 78D ). The sensor support arm 788 can include one or more sets of opposing fingers 785 and / or one or more axially offset retention fingers 787. In some embodiments, the offset fingers 787 are longer than the opposing fingers 785 and are configured to at least partially wrap around / on the opposite half of the cylindrically shaped sensor 784 relative to the sensor arm 788 when the sensor 784 is held / disposed therein, as shown in FIGS. 78C and 78D . The encasement 783 can include a cutout 786 configured to fit or receive a finger 785 when the encasement 783 is disposed / placed on the sensor support arm 788, as shown in FIGS. 78C and 78D . The encasement 783 can include any suitable or desirable material, such as polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)). The encasement 783 can be shorter than the encasements associated with the embodiments of FIGS. 76A through 76D . Thus, in some embodiments, the encasement 783 may not cover the entire blank of the sensor 784. The cutout 786 can advantageously provide axial retention of the encasement 783, and therefore, the sensor 784 disposed therein.

[0227] 79 illustrates a perspective view of the sensor retention structure 780 of FIGS. 78A-78D with a sensor device 784 retained therein, with a sleeve 795 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially disposed around the support arm 788, the fingers 785, the fingers 787, the encasement 783, and / or the sensor device 784. The sleeve material 795 may be applied to the encasement 783, the fingers 785, 787, and / or the support arm 788 and may or may not be reflowed after its application, as described herein. The sleeve 795 can advantageously prevent or restrict the fingers 785, 787 from expanding outward, thereby further securing the fingers 785, 787 with the encasement 783 and / or the sensor 784.

[0228] 80A through 80D illustrate exploded and perspective views, respectively, of a sensor retention structure 800 including a sensor support arm 808 and an encasement 802, according to one or more embodiments of the present disclosure, where the encasement 802 is configured to fit or engage with the sensor support arm 808 in some manner and house or surround at least a portion of a sensor device 809 therein (see FIGS. 80C and 80D). The sensor support arm 808 can include one or more sets of opposing fingers 805 and / or one or more axially offset retention fingers 807. The fingers 805 can each have a respective end crosspiece 803 associated therewith. In some embodiments, offset retention finger 807 is longer than opposing finger 805 and is configured to at least partially wrap around / over the opposing half of cylindrical sensor 809 relative to sensor arm 808 when sensor 809 is retained / disposed therein, as shown in FIGS. 80C and 80D . Encasement 802 can include cutout 806, which is configured to fit or receive fingers 805 (including crosspiece 803) when encasement 802 is disposed / placed on sensor support arm 808, as shown in FIGS. 80C and 80D . Encasement 802 can further include cutout 804, which is configured to fit or receive fingers 807 when encasement 802 is disposed / placed on sensor support arm 808. Encasement 802 may comprise any suitable or desirable material, such as, for example, polyetheretherketone (PEEK) or other types of thermoplastic polymers (e.g., other types of polyaryletherketone (PAEK)).

[0229] 81 illustrates a perspective view of the sensor retention structure 800 of FIGS. 80A-80D with a sensor device 809 retained therein, with a sleeve 815 of any suitable or desirable material (e.g., thermoplastic polyurethane (TPU), etc.) at least partially disposed around the support arm 808, the fingers 805, the fingers 807, the encasement 802, and / or the sensor device 809. The crosspiece 803 can serve to increase contact between the fingers 805 and the encasement 802, the sleeve 815, and the sensor 809.

[0230] FIG. 82 illustrates a perspective view of a locking retention arm 810 in accordance with one or more embodiments of the present disclosure. The locking retention arm 810 can include multiple fingers / prongs 812, which may be configured to lock and / or otherwise secure to and / or within a sensor retention structure 820 (e.g., an encasement-type structure, etc.). FIGS. 83A and 83B illustrate views of a sensor retention structure 820 configured to be secured in some manner to a retention arm structure (e.g., to the locking sensor retention arm 810 of FIG. 82). The retention structure 820 advantageously includes a particular feature 827 that is configured to at least partially and / or in some manner engage with a feature of the locking retention arm 810. In some embodiments, such a feature 827 may advantageously be associated with a proximal end of the retention structure 820. FIG. 83C illustrates a side view of a retention structure 820 according to one or more embodiments.

[0231] 84A-84C show perspective views of at least a portion of locking retention arm 810, retention structure 820, and / or sensor device 834, where sensor device 834 is configured to be at least partially disposed within and / or otherwise secured / attached in some manner to retention structure 820. The images in FIGS. 84A-84C each correspond to a different stage of a sensor securement process according to one or more embodiments of the present disclosure.

[0232] 84A illustrates the locking retention arm 810, retention structure 820, and sensor device 834 in a substantially detached or disassociated configuration prior to securing the respective components to one another. As shown in FIG. 84A, the retention structure 820 can have a generally cylindrical shape or form with dimensions configured to allow the generally cylindrical sensor device 834 to be at least partially inserted therein.

[0233] 84B shows the locking retention arm 810 being advanced / inserted into the proximal locking feature 827 of the retention structure 820, which is configured and / or dimensioned to allow the prong 812 of the locking retention arm 810 to be at least partially inserted therethrough. In some implementations, the locking feature 827 of the retention structure 820 includes first and second channels 823 that are sized and configured to receive the prong 812, the channels 823 joining at a common vertical channel 822 such that the trunk feature 817 of the locking retention arm 810 abutting the prong 812 can slide therethrough with the prong 812 at least partially disposed within the retention structure 820. In some embodiments, the retention structure 820 can be considered and / or provide a housing or encasement for at least partially housing / encasing the sensor device 834.

[0234] 84C shows a sensor device 834 being inserted into the retention structure 820. For example, the retention structure 820 can have one or more slots 826 associated with its distal end, which allow for diametric expansion (e.g., outward radial expansion) of the distal end of the retention structure 820, thereby facilitating insertion of the proximal end of the sensor device 834 into the retention structure 820. In some embodiments, the retention structure 820 can include a particular ridge or other lip-type locking / stop feature 828 that protrudes radially inward to some extent at the distal end / edge of the retention structure 820. Such a feature 828 can advantageously serve to prevent the sensor device 834 from sliding distally past the stop feature 828.

[0235] According to some implementations, FIGS. 85A-85C depict a process for inserting a locking retention arm 810 into a proximal end portion of a retention structure 820 and locking or otherwise securing the arm 810 thereto, as shown. As shown in FIG. 85A, the locking retention arm 810 can be inserted into a proximal receiving channel 823, which can be sized and / or configured to receive a prong-type extension of the locking retention arm 810 therein. In FIG. 85B, a unitary form trunk / base 817 is advanced into the channel at the point where the side channel 823 and the vertical channel 822 join. As shown in FIG. 85C, the base / trunk 817 of the locking retention arm 810 is pulled upward through the vertical channel 822, thereby causing the prong 812 to be pulled upward within the retention structure 820 as well. In some implementations, the prongs 812 rest against or rest near the inner wall of the retention structure 820 after sliding the locking retention arm 810 over the vertical channel 822. In some embodiments, the prongs 812 have specific curvature features that correspond to the inner curvature and / or surface of the retention structure 820, allowing the prongs 812 to assume a relatively low / small profile relative to the inner surface of the retention structure 820 when the locking retention arm 810 is engaged with the retention structure 820, as shown in FIG.

[0236] 86A-86D illustrate perspective views of a sensor retention structure 860 configured to hold a sensor device 864 in accordance with one or more embodiments of the present disclosure. The sensor retention structure 860 can include side supports 868 having a specific curvature designed to hold or cradle a cylindrically shaped sensor device 864 therein. For example, the curvature of the side support structures 868 can 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 retention structure 860 and the sensor cylinder 864 is distributed over the area of ​​the support structure 860 facing the sensor cylinder 864. For example, support for holding the sensor device 864 can be provided by the side support structures 868 and intermediate cross supports 865, which can also have a specific curvature corresponding to the curvature of the sensor cylinder 864.

[0237] The sensor retention structure 860 may further include one or more sensor retention fingers 862, which may be configured to clamp and / or hold around a side portion of the sensor cylinder 864. The sensor retention fingers 862 may, in turn, have a particular curvature corresponding to the curvature of the sensor cylinder 864. References herein to the curvature of a particular structural component of the sensor retention structure and / or sensor device may be understood to refer to the radius of curvature of such component relative to an axis (e.g., the central axis of the sensor cylinder 864 when the cylinder 864 is installed / retained within the sensor retention structure 860). In some embodiments, oppositely facing sensor retention fingers 862 may be separated at their distal ends by a distance d that is less than the diameter of the sensor cylinder 864. In such embodiments, the gap between oppositely facing sensor retention fingers 862 may need to be widened somewhat to allow for installation of the sensor cylinder 864 therein. For example, the sensor retention fingers 862 are configured to allow the sensor cylinder 864 to be snapped into place between the sensor retention fingers 862, thereby radially displacing the sensor retention fingers 862 by some amount when snapping the sensor device 864 into place. The sensor retention fingers 862 can have shape memory properties that cause them to return to their unextended position around the sensor cylinder 864 when not currently displaced thereby. Alternatively, in some implementations, the sensor cylinder 864 can be slid into place within the sensor retention fingers 862 from the distal or proximal direction.

[0238] The sensor retention structure 860 can further include one or more axial stop features, such as, for example, a distal stop 867 and / or a proximal stop 863. With respect to the distal stop feature 867, such a feature can include a crossbar having a radius of curvature that is smaller than the radius of curvature of the sensor cylinder 864, the sensor retention fingers 862, the side support structures 868, and / or the intermediate cross support 865. The distal stop 867 can reside axially beyond a distal surface 869 of the sensor element / membrane of the sensor device 864 when the sensor 864 is installed in the sensor retention structure 860. Due to the relative flatness of the distal stopper 867 compared to the curvature of the components of the sensor cylinder 864 and / or sensor retention structure 860, the distal stopper bar 867 is able to radially overlap the sensor's distal face 869 by some amount, as shown in FIG. 86D , such that the stopper 867 contacts the sensor's distal end / face 869, thereby preventing its axial movement / sliding beyond the contact between the stopper bar 867 and the sensor's end / face 869. In some embodiments, the distal stopper bar 867 advantageously covers only an outer peripheral portion of the sensor's distal end / face 869, thereby reducing the impact that contact with the stopper bar 867 has on the function of the sensor element. For example, in some embodiments, the outer periphery of the sensor element 869 may include or be associated with a seal ring component, and the inner membrane (which may, for example, act as the diaphragm of a piezoresistive or capacitive pressure sensor device) is not covered by the distal stop bar 867.

[0239] With respect to the proximal stop feature 863, such a feature can include a tab-type structure or form that is configured to protrude radially inward relative to the curvature of the sensor retention structure 860, thereby penetrating into a radial space that overlaps the proximal surface / face of the sensor 864 and obstructing or preventing the sensor 864 from sliding / moving proximally past the proximal stop tab 863. The stop tab 863 can be laser cut or otherwise formed in the shape of the sensor retention structure 860 and can be bent inward / upward through a shape memory action / movement, or manually / mechanically bent or folded into the stop configuration shown in FIG. 86B using a specific tool or through manual manipulation.

[0240] FIG. 87 illustrates an alternative implementation of a distal stop bar. The distal stop bar 877 of FIG. 87 may be implemented in connection with any of the sensor retention structure embodiments disclosed herein. The distal stop bar 877 may be formed from a distal circumferential band of the sensor retention structure (e.g., the sensor retention structure 860 shown in FIGS. 86A-86D ), and the stop bar 877 may be curved radially inward at or near its central portion relative to the axis of a sensor device 879 disposed within the sensor retention structure 870 and / or relative to the axis of curvature of the sensor retention structure 870 (e.g., including particular sensor retention fingers 872 and / or support bands / forms 875 of the sensor retention structure 870). 87, bending the central portion of the stopper band 877 radially inward can cause the stopper bar 877 to radially overlap the face of the sensor device 879, thereby preventing axial sliding / movement of the sensor device 879. Bending of the distal stopper bar 877 can occur substantially automatically in response to the shape memory properties / action of the bar 877, or can be manually bent (e.g., using a specific tool) in vivo or prior to introducing the sensor implant device into the patient's body.

[0241] Additional Embodiments Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different sequence, added, combined, or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0242] Conditional language used herein (e.g., "can," "could," "might," "may," and "for example," among others) is intended to have its ordinary meaning unless specifically stated otherwise or otherwise understood within the context as used, and is intended to generally convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is not intended to generally imply that features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps will be included or performed in any particular embodiment, with or without authorial input or prompting. Terms such as "comprising," "including," and "having" are synonymous and used in their ordinary sense, and are used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (and not its exclusive sense), such as when used to connect a list of elements, so that the term "or" means one, some, or all of the elements in the list. Connecting language such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, will be understood by context as being generally used to convey that an item, term, element, etc., can be either X, Y, or Z. Thus, such connecting language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0243] In the foregoing description of the embodiments, it should be recognized that various features may be grouped together in a single embodiment, figure, or description thereof for purposes of streamlining the disclosure and aiding in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Furthermore, no component, feature, step, or group of components, features, or steps is necessary or essential with respect to each embodiment. Accordingly, it is intended that the scope of the invention as disclosed herein and claimed below should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the claims that follow.

[0244] It should be understood that certain ordinal numbers (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply a physical character or order. Thus, as used herein, ordinal numbers (e.g., "first," "second," "third," etc.) used to modify an element (e.g., a structure, component, operation, etc.) do not necessarily indicate the priority or order of the element relative to any other elements, but may generally distinguish the element from another element that has a similar or identical name (except for the use of the ordinal number). Additionally, as used herein, the indefinite articles ("a" and "an") may mean "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0245] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. It should be further understood that terms (e.g., as defined in commonly used 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 expressly defined as such herein.

[0246] Spatially relative terms such as "outside," "inside," "upper," "lower," "below," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another, as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the drawings. For example, in the case where a device shown in the drawings is turned upside down, a device positioned "below" or "under" another device may be placed "above" another device. Thus, for illustrative purposes, the term "under" can include both a lower position and an upper position. Devices may also be oriented in other directions, and thus spatially relative terms may be interpreted differently depending on the orientation.

[0247] Unless expressly stated otherwise, comparative and / or quantitative terms (e.g., "less than," "more than," and "greater than," etc.) are intended to encompass the concept of equivalence. For example, "less than" not only means "less than" in the strictest mathematical sense, but can also mean "less than or equal to." [Explanation of symbols]

[0248] 1. Heart 2 left atrium 3 left ventricle 4 Right ventricle 5 Right atrium 6. Mitral valve 7. Aortic valve 8 Tricuspid valve 9 Pulmonary valve 11. Pulmonary artery 13 Right pulmonary artery 15 Left pulmonary artery 16 Coronary sinus 17 septum 18 Atrial septum 24 waveform 25 waveform 30 Implant Devices 32 Transducer 34 Control circuit 35 Power supply 36 Sensor housing 37 Sensor Devices 38 Antenna 39 Shunt Structure 40 Monitoring System 41 Control circuit 42 External reader, local monitor 43 Reader / antenna-interface circuit module 44 patients 46 Remote Monitor, Remote Monitor Subsystem 47 Secondary Local Monitor 48 External Antenna 49 Network 60 Sensor Implant Device 61 Proximal end or area 62 Transducer Element 63 Distal end or area 64 Control circuit 65 sensors 66 Biocompatible housing 67 Antenna 68 Arm member 69 Implant Devices 70 sensors 72 Shunt structure 73 Sensor implant device 80 Implant Devices 82 Shunt Structure 83 Wall section 85 Atrial septum 90 Shunt Device 91 Sensor Support Structure / Arm 92 Arm member 94 Flow path axis 97 Shunt Structure 98 Retention Features 99 Longitudinal axis 100 sensors 102 Sensor Element 105 Proximal part 107 Distal portion 108 Electrical Coupling Components 112 Sensor support strut 113 Socks or Wraps 114 Cylinders / Sensors 120 Sensor Support Structure or Assembly 122 Sensor support strut 123 Retention means or features, membranes 124 Sensor Devices 130 Sensor Implant Device 131 Anchor Arm 132 Arm / Strut Member 133 Pouch or Sock 134 Sensors 135 sensors 139 Shunt Structure 143 Membrane Wrap 150 Shunt Structure 150-1, 150-2 Medical implant devices 152 flange / arm 152-1, 152-2 Sensor support strut / arm 153-1, 153-2 Buckle and / or strap members 153a-1, 153b-1 Buckle members 153a-2, 153b-2 Buckle members 154 flange / arm 155-1, 155-2 Buckle and / or strap members 155a-1, 155b-1 Strap members 155a-2, 155b-2 Strap members 156-1, 156-2 Distal crossbar 157-2 Crossbar part 158 base 159-1, 159-2 Coupling part / aperture 159a-1, 159b-1 Coupling part / aperture 159a-2, 159b-2 Coupling part / aperture 160 Medical Implant Devices 162 Sensor Support Strut / Arm 163 Buckles and / or strap members 165 Buckles and / or strap members 166 Central flow channel, features 167 Clasp Features 168 base 169 Aperture 170 Sensor Retention Structure 170a, 170b side wall 172 Sensor Support Strut / Arm 172a, 172b end wall 173 Finger 174 Sensor Devices 175 aperture 176 Adhesive 179 Thin Strut 180 Cells, Openings, Medical Implant Devices 183 Sensor Retention Overmolded Support Form 184 Sensor Devices 186 Aperture 188 Sensor Support Strut / Arm 190 Medical Implant Devices 192 Proximal Axial Retention Features 193 Sensor Retention Finger 194 sensors 195 Sensor Retention Finger 196 Locking Features 197 Distal Axial Retention Features 198 Sensor Support Strut / Arm 199 Sensor Devices / Transducers 200 Medical Implant Devices 201 Arm structure 202 Flange Features 203 Sensor Retention Housing 204 Sensor Devices 205 Distal Slot 206 Proximal Housing / Ring Coupling Features 210 Medical Implant Devices 211 Distal ridge / shoulder features, arm structure 212 Gap 213 Sensor Retention Cover / Housing 215 Finger 217 Distal Ridge / Shoulder Features 218 Arm 219 Sensor Devices 220 Medical Implant Devices 223 Mating Features 224 Sensor Cylinder 225 Sensor Retention Finger 226 Locking Features 227 Locking Features 228 Sensor Support Strut / Arm 230 Medical Implant Devices 233 Mating Features 234 Sensor Devices 235 Sensor Retention Finger 236 Stop Tab 237 Notch 238 Sensor Support Strut / Arm 239 Sensor membranes, sensor elements 240 Medical Implant Devices 242a, 242b flaps 244 Sensors 245 Ring 247 Gap 248 Sensor Support Structure 250 Medical Implant Devices 255 Ring 257 Slot Type Features 258 Sensor Support Arm 260 Medical Implant Devices 264 Sensor 265 Clamp Features 266 Retention Tab 268 Sensor Support Arm 269 ​​Gap 270 Medical Implant Devices 273 Finger 274 Sensor Devices 278 Sensor Support Arm Structure 280 Medical Implant Devices 283 Prong 284 Sensor Devices 285 sleeve 288 Sensor Support Arm / Structure 290 Medical Implant Devices 292 Adhesive 293 Proximal Stopper Features 294 Sensor Devices 296 Aperture 297 Proximal end 298 Sensor Support Structure / Arm 300 Sensor Retention Structure 303 Proximal Stopper Features 304 Sensor Devices 305 Suction Cup 307 Proximal end 308 Sensor Support Structure / Arm 310 Sensor Retention Structure 312 Hook Features 313 Distal Retention Band 314 Sensor Devices 315 Retention Arm / Structure 318 Sensor Support Structure 320 Sensor Retention Structure 322 Base 323 seats 324 Sensors 325 Edge 330 Sensor Retention Structure 332 Peripheral Band / Part 333 Sensor Retention Ring 334 Sensor 335 Hook Features 336 Aperture 338 Sensor Support Arm 340 Sensor Retention Structure 343 Sensor Retention Hoop / Eyelet 344 Sensor Devices 348 Sensor Support Arm Structure 350 Sensor Retention Structure 353 Sensor Retention Hoop 354 Sensor Devices 357 Distal Stopper 358 Sensor Support Arm Structure 360 Medical Implant Devices 361 Arm 362 Arm 363 Sensor Retention Band 364 Sensor Devices 366 Tissue wall 367 Shunt Barrel 370 Sensor Support Structure 372 Distal stopper tab 373 Finger 374 Sensor Devices 375 Distal Retention Cage 376 Aperture 377 Strut 3771 Proximal Stopper Feature, Tab 378 Sensor Support Arm 380 Sensor Retention Structure 381 Tissue-Engaging Implant Support Arm 382 Auxiliary Sensor Support Arm 382a First Arm 382b Second Arm 383 Longitudinal Strut 384 Sensors 385 Circumferential Strut 386 Cage Structure 387 Distal stopper tab 388 Longitudinal Strut 390 Medical Implant Devices 393 Axial Sensor Support Arm 394 Sensor Devices 395 bands 396 Shunt Barrel 399 Sensor Element 400 Medical Implant Devices 404 Sensor Device 405 Mesh / Sleeve 406 Shunt Barrel 420 Medical Implant Devices 421 Arm 422 Arm 423 Sensor Retention Hoop, Ring, or Arm / Finger, Retention Feature 424 Sensor Devices 425 Sensor Retention Hoop, Ring, or Arm / Finger Retention Features 427 Shunt Barrel 430 Sensor Retention Structure 432 Connecting strut 433 Side strut 434 Sensor Devices 437 Distal Crossbar Strut 438 Rear support strut 439 Sensor Element 440 Sensor Retention Structure 443 Outer support strut 444 Sensor 447 Sensor Support Arm 448 Central Support Strut 450 Sensor Retention Structure 451 Arm 453 Magnet 454 Sensor 455 Magnetic Element 460 Sensor Retention Structure 463 Braid 464 Sensor Devices 474 Sensor Structure 475 Radial protrusion 481 Proximal end 484 Sensor Structure 485 Recess / Trench 491 proximal end 494 Sensor Structure 495 Circumferential protrusion 500 Sensor Retention Structure 502 Distal Cross Strut / Morphology 504 Sensor Devices 506 Proximal Cross Strut / Morphology 508 Longitudinal Sensor Support Strut 509 Sensor Element 510 Sensor Retention Structure 513 Proximal stopper ring 514 Sensors 516 Cross strut, horizontal strut 517 Distal stopper ring 518 Longitudinal Support Strut 520 Sensor Retention Structure 523 Proximal stopper ring 524 Sensors 527 Distal Stopper Ring 528 Longitudinal Support Strut 530 Sensor Retention Structure 533 Prong 534 Sensors 535 Sleeve 537 Reinforced Wiring 540 Sensor Retention Structure 543 Arm 544 Sensors 545 Distal Crosspiece 555 sleeve 560 Sensor Retention Structure 562 Finger 563 Arm 564 Sensors 565 Distal Crosspiece 575 sleeve 580 Sensor Retention Structure 5801 Distal Circumferential Support Strut 5802 Proximal Circumferential Support Strut 5803 Wireless Transmission Element 583 Cage 584 Sensor Devices 585 Longitudinal Sensor Support Strut 586 Window 587 Proximal Stopper Tab 588 Longitudinal Sensor Support Strut 595 sleeve 600 Sensor Retention Structure 6001 Distal Circumferential Support Strut 6002 Proximal Circumferential Support Strut 6003 Wireless Transmission Element 6006 Gap 601 Arm 602 Support Strut 603 Cage structure 604 Sensor Devices 605 Longitudinal Sensor Support Strut 606 Window 607 Support Strut 608 Longitudinal Sensor Support Strut 615 Sleeve 620 Sensor Retention Structure 6201 Hinge Point 6203 Window 6206 Transmission Element 621 Arm 622 Circumferential Support Strut 623 Cage Structure 624 Sensor Devices 625 Longitudinal Sensor Support Strut 627 Proximally angled support strut 628 Longitudinal Sensor Support Strut 635 Sleeve 640 Sensor Retention Structure 6401 Circumferential Support Strut 6403 Window Features 641 Arm 642 Distally angled support strut 643 Cage structure, longitudinal sensor support struts 644 Sensor Devices 645 Longitudinal Sensor Support Strut 646 Transmission Element 647 Distally angled support strut 648 Longitudinal Support Structure 655 Sleeve 660 Sensor Retention Structure 661 Arm 662 Circumferential Support Path 663 Strut 665 Strut 667 Strut 668 Support Strut 674 Sensor Devices 675 sleeve 680 Sensor Retention Structure 682 Proximal part / Ring 683 Longitudinal Sensor Support Strut 684 Sensor Devices 685 Circumferential Strut 686 Distal Section / Ring 687a Proximal Stopper Tab 687b Distal Stopper Tab 688 Longitudinal Sensor Support Strut 690 Sensor Retention Structure 6903 Window 6906 Transmission Element 693 Longitudinal Sensor Support Strut 694 Sensor Devices 695 Circumferential Support Strut 696 Longitudinal Strut 697a Proximal Stopper Tab 697b Distal Stopper Tab 698 Longitudinal Sensor Support Strut 700 Sensor Retention Structure 702 Proximal Stopper Features 703 Longitudinal Sensor Support Strut 704 Sensor Devices 705 Distal Stopper Feature, Circumferential Struts, Suture Tabs 706 Sutures 707 Stopper Features 707a Proximal Stopper Tab 707b Distal Stopper Ring 708 Longitudinal Sensor Support Strut 709 Sensor Element 710 Cage structure 713 Longitudinal Sensor Support Strut 714 Sensors 718 Longitudinal Sensor Support Strut 721 Arm structure 723 Coverings, fabrics 724 Sensor Devices 725 Sutures 726 Aperture 727 Ridge 728 Sensor Support Strut 729 Sensor Element 730 Sensor Retention Structure 732 Aperture 733 Encasement 735 Cutout 738 Sensor Support Strut 740 Sensor Retention Structure 741 Sensor Support Arm 742 aperture 743 Encasement 745 Cutout 748 Sensor Support Strut 753 Encasement 758 Sensor Support Strut 760 Sensor Retention Structure 763 Encasement 764 Sensors 765 Finger 765a Proximal Set Sensor Retention Fingers 765b Distal Set Sensor Retention Fingers 766 Cutout 768 Sensor Support Arm 769 Sensor 775 sleeve 780 Sensor Retention Structure 783 Encasement 784 Sensor Devices 785 Finger 786 Cutout 787 Axially Offset Retention Fingers 788 Sensor Support Arm 795 sleeve 800 Sensor Retention Structure 802 Encasement 803 End cross piece 804 Cutout 805 Finger 806 Cutout 807 Retention Finger 808 Sensor Support Arm 809 Sensor Devices 810 Locking Retention Arm 812 Finger / Prong 815 Sleeve 817 Trunk / Base 820 Sensor Retention Structure 822 vertical channels 823 Side Channel 826 Slots 827 Specific features, locking features 828 Locking / Stopping Feature, Stopper Feature 834 Sensor Devices 860 Sensor Retention Structure 862 Sensor Retention Finger 863 Proximal Stopper Features 864 Sensor Devices 865 Intermediate Cross Support 867 Distal Stopper Features 868 Side Support Structure 869 Distal surface 870 Sensor Retention Structure 872 Sensor Retention Finger 875 Support Band / Form 877 Stopper Band 879 Sensor Devices 1600 Medical Implant Devices 1601 Tissue wall 1603 Channel 1610 Sensor 1612 First Sensor Element 1613 Second Sensor Element 1616 First side 1620 Shunt structure 1622 Barrel part 1625 Pocket / Receptacle Features 1627 Protrusion L length l1 length l2 length w1 width, dimensions w2 width, dimensions w3 width w4 width w5 width w6 width θ angle

Claims

1. a sensor support arm configured to have an at least partially cylindrical sensor device disposed thereon; one or more sensor retention fingers projecting from the sensor support arm and configured to be secured to the sensor device; a sensor retention structure including:

2. 10. The sensor retention structure of claim 1, wherein the one or more sensor retention fingers are configured to at least partially wrap around a sensor device disposed on the sensor support arm.

3. 3. The sensor retention structure of claim 1 or 2, wherein at least one of the one or more sensor retention fingers includes a strap form and at least one of the one or more sensor retention fingers includes a buckle form, the buckle forms extending from opposite sides of the sensor support arm such that the strap form can be inserted through a portion of the buckle form.

4. 4. The sensor retention structure of claim 1, wherein at least one of the one or more sensor retention fingers has an aperture therein, the aperture being dimensioned to allow for the placement of an adhesive therein to secure the at least one of the one or more sensor retention fingers to the sensor device.

5. 5. The sensor retention structure of claim 1, wherein the one or more sensor retention fingers are positioned in one or a set of aligned opposing fingers.

6. The sensor retention structure of claim 1 , wherein the one or more sensor retention fingers project distally from the sensor support arm.

7. The sensor retention structure of claim 6 , wherein the one or more sensor retention fingers include a respective distal crosspiece.

8. 8. The sensor retention structure of claim 1, wherein at least two of the one or more sensor retention fingers are configured to lock together at their distal ends.

9. The sensor retention structure of claim 1 , wherein the sensor retention structure further comprises a distal stop associated with a distal end portion of the sensor support arm.

10. 10. The sensor retention structure of claim 1, further comprising an encasement form configured to be at least partially disposed over the sensor device when the sensor device is disposed on the sensor support arm.

11. 11. The sensor retention structure of claim 10, wherein the encasement form includes one or more cutouts configured to fit over at least one of the one or more sensor retention fingers.

12. 12. The sensor retention structure of claim 1, wherein the one or more sensor retention fingers are part of a removable partial ring configuration.

13. 13. The sensor retention structure of claim 1, wherein the one or more sensor retention fingers have a respective tab associated therewith that is configured to project radially inward.

14. a sensor support arm configured to have an at least partially cylindrical sensor device disposed thereon; a cage structure associated with the sensor support arm, the cage structure configured to wrap at least partially around a circumferential surface of the sensor device; a sensor retention structure including:

15. 15. The sensor retention structure of claim 14, wherein the sensor support arm is attached to a proximal portion of the shunt arm structure, and the sensor support arm is configured to bend away from the shunt arm structure, thereby protruding at least partially radially away from a longitudinal axis of the shunt arm structure.

16. 16. The sensor retention structure of claim 14 or 15, wherein the cage structure includes one or more distal stopper tabs.

17. 17. The sensor retention structure of claim 14, wherein the cage structure includes a plurality of longitudinal struts.

18. 20. The sensor retention structure of claim 17, wherein the cage structure includes a plurality of transverse struts connected between two or more of the plurality of longitudinal struts.

19. 19. The sensor retention structure of claim 14, wherein the sensor retention structure further comprises a sleeve disposed around at least a portion of the cage structure, the cage structure being in an at least partially rolled sensor retention configuration.

20. 20. The sensor retention structure of claim 14, further comprising a plurality of suture attachment tabs associated with a distal end of the cage structure.

21. a sensor support strut; means for securing a sensor device to said sensor support strut; a sensor retention structure including:

22. 22. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut comprises one or more strap features associated with the sensor support strut.

23. 23. The sensor retention structure of claim 21 or 22, wherein the means for securing the sensor device to the sensor support strut comprises a fabric wrapped around the sensor device and at least a portion of the sensor support strut.

24. 24. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut comprises a polymer film disposed around the sensor device and at least a portion of the sensor support strut.

25. 25. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut includes a sensor mold associated with the sensor support strut, the sensor mold configured to have the sensor device inserted therein.

26. 24. The sensor retention structure of claim 21, wherein the means for securing a sensor device to the sensor support strut comprises a proximal sensor mounting structure projecting at least partially orthogonally from the sensor support strut.

27. 27. The sensor retention structure of claim 26, wherein the proximal sensor mounting structure includes an aperture therein, the aperture being dimensioned to allow placement of an adhesive therein to secure the proximal sensor mounting structure to the sensor device.

28. 27. The sensor retention structure of claim 26, wherein the proximal sensor mounting structure includes a suction cup associated with a distal side thereof.

29. 27. The sensor retention structure of claim 26, wherein the proximal sensor mounting structure includes a distally angled arm having a hook feature associated with a distal end thereof.

30. The means for securing the sensor device to the sensor support strut comprises: a housing mounting flange; a sensor housing configured to be attached at a proximal end thereof to the housing mounting flange and to house the sensor device; 30. The sensor retention structure of any one of claims 21 to 29, comprising:

31. 31. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut comprises one or more trapdoor flaps.

32. 32. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut comprises a sheet configured to be wrapped around at least a portion of the sensor device.

33. 33. The sensor retention structure of claim 21, wherein the means for securing the sensor device to the sensor support strut comprises one or more hoop forms bent away from the sensor support strut and configured to have the sensor device disposed at least partially through an opening in the one or more hoop forms.

34. The means for securing the sensor device to the sensor support strut comprises: a locking retention arm including a plurality of prongs; a sensor housing including a plurality of channels associated with a proximal end thereof and configured to receive one or more of the plurality of prongs and a distal end portion of the sensor support strut; 33. The sensor retention structure of any one of claims 21 to 32, comprising:

Images