Prosthetic heart valve implant

Abstract

A monitoring apparatus is provided for monitoring physiological information of a heart of a patient. The monitoring apparatus includes a heart valve prosthesis implanted into a first valve of the heart. At least one passive sensor is attached to the heart valve prosthesis and obtains physiological information adjacent to the first valve of the heart. A first wireless power component is electrically coupled to the at least one passive sensor. An electronic implant is implanted within the patient. The electronic implant includes a power source including a second wireless power component that wirelessly communicates with the first wireless power component. The wireless communication between the first wireless power component and the second wireless power component powers the at least one passive sensor. Methods of monitoring physiological information of a heart of a patient are provided.

Description

PROSTHETIC HEART VALVE IMPLANTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 570,710, filed March 27, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to a heart valve prosthesis comprising at least one sensor.BACKGROUND

[0003] It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient. The heart valve prosthesis can be moved from a radially-contracted position to a radially-expanded position. However, monitoring the function of the heart after the implantation of the heart valve prosthesis can be difficult.SUMMARY

[0004] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0005] In aspects, a monitoring apparatus for monitoring physiological information of a heart of a patient is provided. The monitoring apparatus comprises a heart valve prosthesis configured to be implanted into a first valve of the heart. The monitoring apparatus comprises at least one passive sensor attached to the heart valve prosthesis and configured to obtain physiological information adjacent to the first valve of the heart. The monitoring apparatus comprises a first wireless power component electrically coupled to the at least one passive sensor. The monitoring apparatus comprises an electronic implant configured to be implanted within the patient. The electronic implant comprises a power source comprising a second wireless power component configured to wirelessly communicate with the first wireless power component. The wireless communication between the first wireless power component and the second wireless power component is configured to power the at least one passive sensor.

[0006] In aspects, the first valve of the heart is the aortic valve, and the electronic implant is implanted into the right atrium of the patient.

[0007] In aspects, the first wireless component comprises a first inductive coil, the second wireless power component comprises a second inductive coil, and the power source comprises a battery electrically connected to the second wireless power component. A first electric current is configured to flow between the battery and the second inductive coil to generate an electromagnetic field.

[0008] In aspects, the first inductive coil is positioned within the electromagnetic field to induce a second electric current at the first inductive coil. The second electric current is configured to flow between the at least one passive sensor and the first inductive coil to power the at least one passive sensor.

[0009] In aspects, the first wireless power component and the second wireless power component comprise radio frequency power transmission components.

[0010] In aspects, the at least one passive sensor is attached to an inflow end of the heart valve prosthesis.

[0011] In aspects, the at least one passive sensor is attached to one of a central location of the heart valve prosthesis, wherein the central location is located between an inflow end and an outflow end of the heart valve prosthesis, or an outflow end of the heart valve prosthesis.

[0012] In aspects, the electronic implant is in a chamber of the heart not directly connected to the first valve, and power is transmitted across a wall of the heart to the first wireless power component.

[0013] In aspects, a monitoring apparatus for monitoring physiological information of a heart of a patient is provided. The monitoring apparatus comprises a heart valve prosthesis configured to be implanted into a first valve of the heart. The monitoring apparatus comprises at least one passive sensor attached to the heart valve prosthesis and configured to obtain physiological information adjacent to the first valve of the heart. The monitoring apparatus comprises a first wireless power component coupled to the at least one passive sensor. The monitoring apparatus comprises an electronic implant configured to be implanted within the patient. The electronic implant comprises a power source comprising a second wireless power component configured to wirelessly communicate with the first wireless power component. The electronic implant comprises a memory component,wherein the wireless communication between the first wireless power component and the second wireless power component is configured to power the at least one passive sensor. The first wireless power component is configured to wirelessly transmit data related to the physiological information to the memory component. The data is related to the physiological information obtained from the at least one passive sensor.

[0014] In aspects, the first wireless component comprises a first inductive coil, the second wireless power component comprises a second inductive coil, and the power source comprises a battery electrically connected to the second wireless power component. A first electric current is configured to flow between the battery and the second inductive coil to generate an electromagnetic field.

[0015] In aspects, the first inductive coil is positioned within the electromagnetic field to induce a second electric current at the first inductive coil. The second electric current is configured to flow between the at least one passive sensor and the first inductive coil to power the at least one passive sensor.

[0016] In aspects, the first wireless power component and the second wireless power component comprise radio frequency power transmission components.

[0017] In aspects, methods of monitoring physiological information of a heart of a patient comprise delivering a heart valve prosthesis to a first valve of the heart. The heart valve prosthesis comprises at least one passive sensor and a first wireless power component electrically coupled to the at least one passive sensor. Methods comprise implanting an electronic implant within the patient in proximity to the heart valve prosthesis. The electronic implant comprises a power source comprising a second wireless power component. Methods comprise wirelessly communicating between the second wireless power component and the first wireless power component to generate power at the first wireless power component. Methods comprise powering the at least one passive sensor from the first wireless power component such that the at least one passive sensor obtains physiological information adjacent to the first valve of the heart.

[0018] In aspects, wirelessly communicating between the second wireless power component and the first wireless power component comprises generating a first electric current that flows between a battery of the electronic implant and the second wireless power component to generate an electromagnetic field at the second wireless power component, positioning the first wireless power component within the electromagnetic field, andinducing a second electric current at the first wireless power component that flows between the at least one passive sensor and the first wireless power component to power the at least one passive sensor.

[0019] In aspects, the physiological information comprises one or more of blood pressure, heart rate, activity-level of the patient, or arrhythmia.

[0020] In aspects, the electronic implant activates the pressure recording intermittently based on at least one of a preset timing, patient heart rate, or patient activity.

[0021] In aspects, the electronic implant activates the pressure recording continuously.

[0022] In aspects, methods comprise wirelessly transmitting data related to the physiological information to a memory component of the electronic implant.

[0023] In aspects, methods comprise obtaining physiological information by a second sensor of the electronic implant, the second sensor electrically connected to the power source.

[0024] In aspects, the first valve of the heart is the aortic valve and wherein the electronic implant is implanted within the right atrium such that the electronic implant is in proximity to the heart valve prosthesis.

[0025] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0027] FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0028] FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0029] FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0030] FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure;

[0031] FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0032] FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure;

[0033] FIG. 7 schematically illustrates a side view of a transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure;

[0034] FIG. 8 illustrates an example of a transcatheter heart valve prosthesis comprising a sensor in accordance with aspects of the disclosure;

[0035] FIG. 9 illustrates an example of a transcatheter heart valve prosthesis comprising a sensor in accordance with aspects of the disclosure;

[0036] FIG. 10 illustrates an example of a transcatheter heart valve prosthesis comprising a sensor in accordance with aspects of the disclosure; and

[0037] FIG. 11 illustrates an example of an electronic implant in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0038] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0039] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors,rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0040] Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0041] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0042] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0043] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0044] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matteror relevant portions of this disclosure in any manner. It can be appreciated that a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0045] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0046] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0047] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0048] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may beimparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers. The present application is not limited to self-expanding valve embodiments, and, in aspects, other ways of expanding a valve prosthesis are envisioned, such as, for example, balloon-expanding, mechanically-expanding, or the like.

[0049] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0050] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0051] FIGS. 1 and 2 illustrate an example transcatheter heart valve prosthesis 10. The delivery assemblies described herein may be used with the transcatheter heart valve prosthesis 10 and / or other transcatheter heart valve prostheses. The transcatheter heart valve prosthesis 10 is illustrated to facilitate description of the disclosure. The following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.

[0052] FIGS. 1 and 2 illustrate a side view and a top / end view, respectively, of the transcatheter heart valve prosthesis 10. The transcatheter heart valve prosthesis 10 includes a radially-expandable frame or stent 15 and a prosthetic valve 20. The frame 15 of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within an interior of the frame 15. In the example transcatheter heart valve prosthesis 10 shown in FIGS. 1 and 2, the frame 15 is self-expandable. However, this is not meant to be limiting, and the frame 15 can be balloon-expandable or mechanically expandable in other embodiments. In some embodiments, the transcatheter heart valve prosthesis 10 may be delivered to and implanted at a treatment site within a patient to replace any of an aortic valve, a pulmonic valve, a mitral valve, and a tricuspid valve. The valve to be replaced may be a native valve or a previously-implanted prosthetic valve, such as a failed surgical replacement valve or a failed transcatheter valve.

[0053] The prosthetic valve 20 includes at least one leaflet 21 disposed within and secured to the frame 15. In the embodiment shown in FIGS. 1 and 2, the prosthetic valve20 includes exactly three leaflets 21, as shown in FIG. 2. However, this is not meant to be limiting, as the prosthetic valve 20 may include more or fewer leaflets 21. The valve leaflets21 open and close to regulate flow through the transcatheter heart valve prosthesis 10.

[0054] As shown in FIG. 1, the transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12. The prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when pressure at the inflow end 11 exceeds pressure at the outflow end 12, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the inflow end 11 to the outflow end 12. When the pressure at the outflow end 12 exceeds pressure at the inflow end 11, the prosthetic leaflets 21 close to prevent blood flow from the outflow end 12 to the inflow end 11. Accordingly, the at least one leaflet (e.g., the prosthetic leaflets 21) can be attached to the plurality of struts 16, for example, by being directly attached to the plurality of struts 16 at the commissures 25, orby being indirectly attached to the plurality of struts 16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., mechanical actuator) that is attached to the plurality of struts 16. In aspects, the heart valve prosthesis 10 can comprise one or more attachment members 24 (e.g., paddles) positioned at an end, for example, the outflow end 12. The attachment members 24 can be received within pockets of a spindle 38 (e.g., illustrated in FIG. 4), such that the spindle 38 and the attachment members 24 can interact to facilitate loading of the transcatheter heart valve prosthesis 10 and, in aspects, allow for possible recapture of the transcatheter heart valve prosthesis 10 during the deployment process.

[0055] The frame 15 of the transcatheter heart valve prosthesis 10 further includes a plurality of struts 16 that are arranged to form a plurality of openings or cells 18 arranged circumferentially around a longitudinal axis LA of the transcatheter heart valve prosthesis 10 and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis 10. For example, the frame 15 can extend along the longitudinal axis LA between the inflow end 11 and the outflow end 12. The frame 15 is configured to secure the prosthetic valve 20 within the central lumen of the frame 15 and to secure the transcatheter heart valve prosthesis 10 in place in the vasculature of the patient. The struts 16 are defined herein as the elongated wire segments of the frame 15. Struts 16 come together to form crowns 17 or nodes 19, as can be seen in FIG. 1. The frame 15 of the heart valve prosthesis 10 includes a plurality of cells 18 defined as the spaces between the plurality of crowns 17, the plurality of nodes 19, and the plurality of struts 16. The frame 15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.

[0056] In the example embodiment shown in FIG. 1, the plurality of cells 18 may be diamond-shaped. In the example embodiment shown, the plurality of cells include a plurality of first cells 18 and, in aspects, access cells (e.g., an access cell 23). In particular, the access cells may be larger than the first cells 18 and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in the patient. FIG. 1 illustrates an example of an access cell 23, with the struts 16 at the access cell 23 illustrated with dashed lines to show that the struts 16 may not be present at the access cell 23, thus allowing for the access cell 23 to be larger than the first cells 18. The access cells can have an enlarged area relative or compared to the first cells 18. In some embodimentsthe transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the stent 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0057] FIGS. 3 and 4 show schematically side views of a transcatheter heart valve delivery assembly 30 (e.g., “delivery assembly”) for delivering and deploying a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) according to embodiments hereof. One skilled in the art will realize that FIGS. 3 and 4 illustrate one example of a delivery assembly 30 and that components illustrated in FIGS. 3 and 4 may be removed and / or additional components may be added. The delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33. The handle 33 enables a physician to manipulate a distal portion of the delivery assembly 30 and includes actuators for moving parts of the delivery assembly 30 relative to other parts. In the delivery assembly 30, an outer shaft 34 is coupled to an actuator 39 of the handle 33 for moving the outer shaft 34 relative to an inner shaft 36.

[0058] A distal portion of the outer shaft 34, referred to as a capsule 35, is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a native heart valve) and is retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands (in self-expanding embodiments). In this way, the capsule 35 is in frictional engagement with the heart valve prosthesis 10. The inner shaft 36 can be coupled to the handle 33 (e.g., by being directly connected and in contact with the handle 33, or by being indirectly connected to the handle 33 with intermediate structures between the inner shaft 36 and the handle 33) and movement of the handle 33 can translate to movement of the inner shaft 36 and a distal tip or nosecone 37 coupled to a distal end of the inner shaft 36. The inner shaft 36 and distal tip or nosecone 37 may also be translated relative to the outer shaft 34 and the handle 33 via a tip retractor. In the embodiment shown, the inner shaft 36 includes a retainer or spindle 38 for receiving the paddles (e.g., attachment members 24) of the transcatheter heart valve prosthesis 10.

[0059] When the actuator 39 is actuated, the actuator 39 moves the outer shaft 34 and the capsule 35 relative to the inner shaft 36, as shown in FIG. 4. As known to those skilled in the art, when the delivery assembly 30 is in position such that the transcatheter heart valveprosthesis 10 is at the desired position at the treatment site in the patient’s vasculature, the actuator 39 is actuated (e.g., rotated) to move the capsule 35 relative to the inner shaft 36 and the transcatheter heart valve prosthesis 10 disposed between the inner shaft 36 and the capsule 35, thereby enabling the transcatheter heart valve prosthesis 10 to deploy via selfexpansion at the treatment site and release from the retainer 38, as shown in FIG. 4 (without showing the transcatheter heart valve prosthesis 10).

[0060] Minimally invasive percutaneous interventional procedures, including endovascular procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously. Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body. With such procedures, access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. This can be problematic, however, if during the procedure the physician discovers a larger device is needed. This leads to a need to upsize the sheath, which is a lengthy procedure and leads to increased risk to the patient. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.

[0061] Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when the device is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath. Embodiments disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma. The expandable introducer sheath is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath may be employed alone or in combination for other medicalprocedures requiring percutaneous access, including but not limited to placement of stents, angioplasty, removal of arterial or venous calcification, and pre-dilatation or post-dilatation.

[0062] Various embodiments disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device. The various embodiments may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, these embodiments can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications.

[0063] FIGS. 5 and 6 depict one embodiment of an introducer sheath 50 positioned through an incision 60 in the skin 65 of a patient and into a vessel 40 of a patient. The sheath 50 has a tubular shaft 55 and a proximal hub 56 with a hemostatic seal and a luer lock 57. FIG. 5 shows the sheath 50 positioned in the vessel 40 in its normal, unexpanded state, while FIG. 6 shows the sheath 50 positioned in the vessel 40 with a delivery device 75 delivering another device 70 that is being advanced through the sheath 50 such that the tubular shaft 55 expands or deforms at the location where the device 70 is passing through. The shaft 55 expands at expanded region 58 when the device 70 passes through and then retracts or recovers to its original diameter after the device 70 moves past or is removed from the shaft 55. Thus, the tubular shaft 55 is configured to be expandable and retractable.

[0064] In certain embodiments, the expandability of the shaft 55 (and any shaft described according to any embodiment set forth herein) is achieved via the elasticity of the shaft 55, which can result in the shaft 55 being either self-expandable or self-expanding or mechanically expandable or mechanically expanding. For purposes of this application, selfexpandable means that the shaft 55 is configured to expand to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically expandable means that the shaft 55 is configured to expand when a positionable medical device is positioned through the shaft 55. That is, the device itself that is being passed through the shaft 55 causes the expansion of the shaft 55, as depicted in FIG. 6. Alternatively, the expandable characteristics of the shaft 55 can be caused by something other than elasticity.

[0065] After passage of the device, the shaft 55 is configured to be contractable, retractable, or recoverable to its original, unexpanded state as depicted in FIG. 5. Theretractability can be, in certain embodiments, achieved by the elasticity of the shaft 55, which can result in the shaft 55 being either self-retractable or self-retracting, self- recoverable, or self-contractable, or mechanically retractable or mechanically retracting, mechanically recoverable, or mechanically contractable. For purposes of this application, self-retractable means that the shaft 55 is configured to retract to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise). Further, for purposes of this application, mechanically retractable means that the shaft 55 is configured to retract when a device or component is used to cause the shaft 55 to retract or recover. Alternatively, the retractable characteristics of the shaft 55 can be caused by something other than elasticity.

[0066] For purposes of this application, any device that can be positioned through an introducer sheath according to any embodiment disclosed or contemplated herein can be referred to as a positionable medical device or insertable medical device. Such devices include guidewires, dilators, delivery devices (for delivery and / or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices. Other devices can include non-vascular devices such as scopes and other common surgical instruments. Further, the introducer sheath is configured to receive tissues or organs. Thus, as one non-limiting example, the introducer sheath 50 is described as being an expandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.

[0067] FIG. 7 illustrates the heart valve prosthesis 10 at a treatment site 701 within a patient’s vasculature. In aspects, the treatment site 701 can comprise a location of a native aortic annulus (hereinafter “annulus”) 703 of a native heart valve, for example, the annulus of a patient’s left ventricle. The treatment site 701 can comprise one or more native valve leaflets 705 and corresponding native sinuses 707. In some instances, paravalvular leakage can occur when blood travels through a gap 709 around the outside of the transcatheter heart valve prosthesis 10, with the gap 709 formed between the transcatheter heart valve prosthesis 10 and the annulus 703. To avoid paravalvular leakage, the heart valve prosthesis 10 can be radially expanded such that an outer radial surface of the heart valve prosthesis 10 can contact the annulus 703 and / or the native valve leaflets 705, thus reducing oreliminating the gap 709 and causing the blood to flow through the central lumen of the heart valve prosthesis 10. The heart valve prosthesis 10 can comprise the frame 15, which can comprise an asymmetric hourglass shape with a first section 713 at the inflow end 11, a second section 715 at the outflow end 12, and a waist section 717 positioned between the first section 713 and the second section 715. In aspects, the first section 713 can comprise a first diameter 721 and the second section 715 can comprise a second diameter 723, with the second diameter 723 greater than the first diameter 721. Additionally, in some embodiments the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the frame 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.

[0068] FIG. 8 illustrates an example of a monitoring apparatus 801 for monitoring physiological information (e.g., physiological characteristics) of a patient, for example, the patient’s heart. In particular, and as disclosed herein, the monitoring apparatus 801 can monitor pressure(s) or other hemodynamic data from the left and right sides of the patient’s heart, as well as surrounding vasculature, which can provide diagnostic value for managing the patients. The monitoring apparatus 801 can comprise the heart valve prosthesis 10 and at least one passive sensor 803. In aspects, the at least one passive sensor 803 can be attached to the heart valve prosthesis 10 and can obtain the physiological information from the patient, for example, from adjacent to a first valve of the patient’s heart, and / or from a vessel connected thereto (e.g., such as, for example, when the at least one passive sensor 803 lies supra-annular and lies in the aorta). The physiological information can comprise one or more characteristics related to the patient’s functioning. For example, the physiological information can comprise one or more of the blood pressure of the patient, the heart rate of the patient, activity-level (e.g., information related to exercise and / or movement, sleep, etc.) of the patient, or arrhythmia (e.g., irregular heartbeat), other hemodynamic data, etc. In this way, the at least one passive sensor 803 can comprise several different types of sensors that are capable of monitoring and collecting data related to some or all of the aforementioned physiological characteristics. In aspects, the at least one passive sensor 803 can resonate at a predetermined frequency. In a possible example, the at least one passive sensor 803 can comprise a piezoresistive pressure sensor or a piezoelectric pressure sensor that can allow for changes to resonant frequency based on the pressure atthe treatment site 701. In addition, or in the alternative, the at least one passive sensor 803 can comprise a capacitive pressure sensor that comprises a pair of parallel conducting plates separated by a small gap, and configured to measure changes in electrical capacitance due to movement of one of the plates. That is, as the pressure changes, one or both of the plates can move in response to the pressure change, with the electrical capacitance changing as a result of the plate movement (e.g., due to the distance between the plates changing).

[0069] In aspects, the at least one passive sensor 803 can be attached to the heart valve prosthesis 10 at several different locations. For example, FIG. 8 illustrates two possible locations (e.g., a first sensor location 807 and a second sensor location 809) at which the at least one passive sensor 803 can be attached to the heart valve prosthesis 10. In aspects, the first sensor location 807 is at an end of the heart valve prosthesis 10, for example, the inflow end 11, such that the at least one passive sensor 803 may be attached to the inflow end 11. The first sensor location 807 may be sub-annular to allow for pressure measurements in an area adjacent to the first sensor location 807 (e.g., the left ventricle or LVOT for a TAVR device). In aspects, when the at least one passive sensor 803 is attached to the inflow end 11, the frame 15 can comprise an extension portion that extends from the inflow end 11, with the at least one passive sensor 803 attached to the extension portion. For example, the extension portion may extend from at least one proximal crown of the frame 15, such as from two adjacent proximal crowns as shown in FIG. 8. In other aspects, the passive sensor 803 may be embedded within a cell of the frame 15 at the inflow end 11, such as attached to an inner or outer skirt or sandwiched therebetween. The second sensor location 809 is at a central location of the heart valve prosthesis 10 located between the inflow end 11 and the outflow end 12. As such, the at least one passive sensor 803 may be attached to the central location of the heart valve prosthesis 10, such that the at least one passive sensor 803 may be spaced a distance apart from the inflow end 11 and the outflow end 12. The second sensor location 809 may therefore allow for pressure measurements in an area adjacent to the second sensor location, such as intra-valvular pressure or pressure in the outflow chamber or vessel (e.g., the aorta for a TAVR device). The passive sensor 803 may be attached to a strut of the frame 15 and may be disposed within a cell of the frame 15. While two locations 807, 809 for attachment of the at least one passive sensor 803 to the heart valve prosthesis 10 are illustrated in FIG. 8, these locations are merely exemplary and not intended to be limiting. Rather, in aspects, the at least one passive sensor 803 can beattached at additional locations that are different than the illustrated locations 807, 809. For example, in yet another possible location, the at least one passive sensor 803 can be attached to the outflow end 12 of the heart valve prosthesis 10 in a similar or identical manner as the attachment of the sensor 803 to the inflow end 11. In a possible example, when the at least one passive sensor 803 is not positioned at the first sensor location 807, a pacing electrode can be positioned at the first sensor location 807 and attached to the inflow end 11, with the pacing electrode in electrical communication with the at least one passive sensor 803.

[0070] The at least one passive sensor 803 can be attached to the heart valve prosthesis 10 while not interfering with or hampering the function of the heart valve prosthesis 10. For example, in aspects, the at least one passive sensor 803 can be attached to the frame 15 of the heart valve prosthesis 10 while not interfering with the movement and function of the prosthetic valve 20. In this way, the at least one passive sensor 803 can function to monitor and collect the physiological information while allowing the heart valve prosthesis 10 to function. In addition, the at least one passive sensor 803 can be attached to the heart valve prosthesis 10 in such a way that the at least one passive sensor 803 (e.g., and first wireless power component 813 discussed below) are misaligned from coronary arteries (e.g., illustrated in FIG. 7) of the heart. That is, by being misaligned, the sensor 803 and first wireless power component 813 do not interfere with, obstruct, or block the adjacent coronary arteries. In particular, the at least one passive sensor 803 and first wireless power component 813 can be rotationally aligned (e.g., relative to the heart valve prosthesis 10 and the coronary arteries) and / or longitudinally positioned (e.g., along the longitudinal axis LA of the heart valve prosthesis 10) such that the at least one passive sensor 803 and first wireless power component 813 do not obstruct the coronary arteries, allowing for subsequent access to the coronary arteries after implantation of the heart valve prosthesis 10. In one aspect and method, the heart valve prosthesis may be configured such that the passive sensor 803 and associated components (e.g., wireless power component) are aligned with the non-coronary cusp (NCC) of the native aortic valve when deployed. In aspects, the at least one passive sensor 803 can be positioned within one of the cells 18 of the heart valve prosthesis 10, or embedded into the tissue or fabric covering of the heart valve prosthesis 10.

[0071] In aspects, the at least one passive sensor 803 can comprise a single sensor that is attached to the heart valve prosthesis 10, with the single sensor capable of monitoring andcollecting data related to one or more of the aforementioned physiological characteristics. Alternatively, the at least one passive sensor 803 can comprise a plurality of sensors that are attached to the heart valve prosthesis 10 at one or more of the locations 807, 809, etc. In this way, the plurality of sensors can monitor and collect physiological data at different locations of the heart valve prosthesis 10. For example, a first sensor can monitor and collect information related to a first physiological characteristic, while a second sensor can monitor and collect information related to a second physiological characteristic that is different than the first physiological characteristic. In this way, one location (e.g., the first sensor location 807, for example) may be better suited for monitoring information related to the first physiological characteristic, such that the first sensor can be positioned at the first sensor location 807, and another location (e.g., the second sensor location 809, for example) may be better suited for monitoring information related to the second physiological characteristic, such that the second sensor can be positioned at the second sensor location 809. Furthermore, a first sensor can monitor and collect information related to a first physiological characteristic, while a second sensor can monitor and collect information related to the first physiological characteristic, and the difference, ratio, etc. between that first physiological characteristic of the first sensor and second sensor can be calculated (e.g. pressure gradient across the valve).

[0072] To power the at least one passive sensor 803, the monitoring apparatus 801 can comprise a first wireless power component 813 that is electrically coupled to the at least one passive sensor 803. As used herein, the term ‘wireless’ means that the first wireless power component 813 may be electrically connected to a power source without wires as a physical link. In this way, the first wireless power component 813 can be powered via wireless power transfer, electromagnetic power transfer, or similar. For example, an electrically powered transmitter component (e.g., a second wireless power component described below) can generate an electromagnetic field (e.g., time varying electric fields, magnetic fields, radio waves, microwaves, infrared or visible light waves, etc.) that transmits power across a space to a receiver component (e.g,, the first wireless power component 813), with the receiver component extracting power from the electromagnetic field and supplying the power to an electrical load, for example, the at least one passive sensor 803. Accordingly, the first wireless power component 813 and the second wireless power component can function as a wireless power system such that, in aspects, a power source may not be directly connectedto the at least one passive sensor, and the power source may not be attached to or supported by the heart valve prosthesis 10. Rather, the power source may be housed or positioned at a location that is separate from the heart valve prosthesis 10. By having the power source be located separate from, and remote from, the heart valve prosthesis 10, the footprint (e.g., area occupied by) of the heart valve prosthesis 10 may be maintained at a desirable size, as well as the profde of the transcatheter heart valve delivery assembly 30 may be maintained at a desirable size.

[0073] In aspects, the first wireless power component 813 can be electrically coupled to the at least one passive sensor 803 by one or more wires (e.g., electrically-conductive wires through which an electrical current can flow between the first wireless power component 813 and the at least one passive sensor 803), which, for example, could be directed along the frame struts and / or span across the frame cells. In aspects, the first wireless power component 813 can be electrically connected in series to the at least one passive sensor 803, with resonant frequency changes based on the treatment site 701. The first wireless power component 813 can be attached to the frame 15 of the heart valve prosthesis 10 while not interfering with the movement and function of the prosthetic valve 20. While FIG. 8 illustrates one possible location at which the first wireless power component 813 can be attached to the frame 15, this location is merely exemplary, and other possible locations are envisioned. In general, the first wireless power component 813 can be affixed to the frame 15 with an electrically-conductive wire extending between the first wireless power component 813 and the at least one passive sensor 803, such that the first wireless power component 813 can electrically power the at least one passive sensor 803. In aspects, the first wireless power component 813 can be positioned within one of the cells 18 of the heart valve prosthesis 10, or embedded into the tissue or fabric covering of the heart valve prosthesis 10.

[0074] Referring to FIG. 9, the monitoring apparatus 801 can comprise an electronic implant 901 that may be implanted within the patient. In aspects, possible locations at which the heart valve prosthesis 10 can be implanted may include the mitral valve, tricuspid valve, aortic valve, or pulmonary valve. In aspects, possible locations at which the electronic implant 901 may be implanted may include one of the upper chambers, such as the right atrium or left atrium, one of the lower chambers, such as the right ventricle or left ventricle, the pericardial cavity, or in an area that is adjacent to the heart valve prosthesis 10, e.g. theaorta, pulmonary artery, or vena cava. The area at which the electronic implant 901 is implanted can be selected such that the area is relatively easily accessible by the electronic implant 901, the area is in close proximity to the heart valve prosthesis 10, and the area is at a reduced risk of thrombus and / or embolic stroke risk after implantation of the electronic implant 901. As used herein, the term ‘close proximity’ can comprise distances that are less than about 5 centimeters, or less than about 1 centimeter. Accordingly, when the heart valve prosthesis 10 and the electronic implant 901 are implanted within the patient, the electronic implant 901 may be in relatively close proximity to the heart valve prosthesis 10 due to both structures being positioned within regions of the patient’s heart, while possibly being separated by a wall or septum (e.g., wall 1019 in FIG. 10) of the heart. In this way, in aspects, the electronic implant 901 may be implanted into a chamber of the heart not directly connected to the first valve, such that power can be transmitted across the wall 1019 of the heart to the first wireless power component 813.

[0075] A benefit of being in close proximity is that the power requirements for wirelessly powering the passive sensor 803 can be reduced as compared to larger distances between the passive sensor 803 and the electronic implant 901. It will be appreciated that FIG. 9 illustrates one possible location of the heart valve prosthesis 10 implanted at the aortic valve and the electronic implant 901 implanted at the septum of the right atrium, and that other possible locations, such as those listed above, are envisioned. As shown in FIG. 9, the heart valve prosthesis is located in the aortic valve and the electronic implant 901 is located in the right atrium (attached to the right atrial septum).

[0076] FIG. 10 is a schematic illustration of the electronic implant 901 positioned relative to the heart valve prosthesis 10. The electronic implant 901 can comprise several structures such as, for example, a housing defining a sealed cavity within which one or more electronic components can be stored. The electronic implant 901 can comprise a power source 1001. The power source 1001 can comprise an electric battery, which is a source of electric power and comprises one or more electrochemical cells. In aspects, the power source 1001 can comprise a lithium / iodine battery, a lithium / CO2 battery, or the like. The electronic implant 901 can comprise a second wireless power component 1003, wherein the power source 1001 (e.g., the battery) may be electrically connected to the second wireless power component 1003. In aspects, the power source 1001 can be electrically connected to the second wireless power component 1003 by one or more electrically-conductive wires.

[0077] The second wireless power component 1003 can wirelessly communicate with the first wireless power component 813, wherein the wireless communication between the first wireless power component 813 and the second wireless power component 1003 is configured to power the at least one passive sensor 803. For example, the second wireless power component 1003 can comprise an electrically powered transmitter component that can generate an electromagnetic field (e.g., time varying electric fields, electromagnetic fields, radio waves, microwaves, infrared or visible light waves, etc.). The electronic implant 901 can be positioned in proximity to the heart valve prosthesis 10 such that the first wireless power component 813 is within the electromagnetic field.

[0078] In aspects, the first wireless power component 813 and the second wireless power component 1003 can wirelessly communicate by transmitting / receiving power via inductive coupling. For example, the first wireless power component 813 can comprise a first inductive coil and the second wireless power component 1003 can comprise a second inductive coil. As used herein, an inductive coil can comprise an electrically conductive wire that is wound into the shape of a coil, such as a spiral or helix. As an electric current passes through one inductive coil, an electromagnetic field is generated, which can induce an electromotive force (EMF) voltage in the other inductive coil. As illustrated in FIG. 10, the power source 1001 (e.g., battery) is electrically connected to the second wireless power component 1003, such that a first electric current can flow between the battery and the second inductive coil to generate an electromagnetic field 1007 (e.g., illustrated schematically in FIG. 10). The electronic implant 901 may be positioned in proximity to the first wireless power component 813, such that the first wireless power component 813 can be within the electromagnetic field 1007. When the first wireless power component 813 comprises the first inductive coil, the electromagnetic field 1007 can induce the EMF voltage in the first inductive coil. As such, a second electric current can be induced at the first inductive coil, with the second electric current flowing between the at least one passive sensor 803 and the first inductive coil to power the at least one passive sensor 803. In this way, the second wireless power component 1003 can wirelessly communicate with the first wireless power component 813, such that the wireless communication between the two wireless power components 813, 1003 can power the at least one passive sensor 803. In aspects, to further improve communication between the first wireless power component 813 and the second wireless power component 1003 when the wireless power components 813,1003 comprise inductive coils, the second wireless power component 1003 can be positioned at a distal end of the electronic implant 901 such that the two inductive coils can be positioned parallel to one another. That is, an axis along which the first inductive coil is wound can be positioned parallel to an axis along which the second inductive coil is wound.

[0079] The wireless power components 813, 1003 are not limited to comprising inductive power coupling components. Rather, in aspects, the wireless power components 813, 1003 can comprise radio frequency power transmission components. For example, the second wireless power component 1003 can comprise an antenna that converts power (e.g., from the power source 1001) to an oscillating electromagnetic field. The antenna of the second wireless power component 1003 can comprise, for example, one of an antenna that transmits radio waves, or, alternatively, a coil of wire that generates an electromagnetic field, a metal plate that generates the electromagnetic field, etc. The first wireless power component 813 can comprise a similar antenna as the second wireless power component 1003, with the first wireless power component 813 converting the oscillating electromagnetic field to an electric current. This electric current can be used to power the at least one passive sensor 803.

[0080] In aspects, the electronic implant 901 can comprise a processor 1009 that can control the power source 1001, the second wireless power component 1003, and other components of the electronic implant 901. The processor 1009 can be coupled with a memory component 1011 of the electronic implant 901. The processor 1009 can be configured with executable instructions stored in the memory component 1011 to enable operations of the power source 1001, the second wireless power component 1003, other components, etc. The processor 1009 may be one of any form of general -purpose computer processors that can be used in a healthcare setting for controlling various components. The memory component 1011 may be in the form of a computer-readable medium and may be one or more of readily available memory such as random -access memory (RAM), read only memory (ROM), or any other form of digital storage, local or remote. Support circuits (not shown) may be coupled to the processor 1009 for supporting the processor in a conventional manner. These support circuits can include cache, power supplies, clock circuits, input / output circuitry and subsystems, and the like.

[0081] In aspects, the memory component 1011 can store information and data related to the physiological information obtained by the at least one passive sensor 803. Forexample, the first wireless power component 813 can wirelessly transmit data related to the physiological information to the memory component 1011, with the data (e.g., data related to the physiological information) obtained from the at least one passive sensor 803. In this example, the at least one passive sensor 803 can transmit data to the electronic implant 901 via resonant frequency changes through the first wireless power component 813, or alternatively, the electronic implant 901 can comprise a receiver and the at least one passive sensor 803 can comprise a transmitter, such that the physiological information can be transmitted from the at least one passive sensor 803 to the memory component 1011. As such, the physiological information can be stored by the memory component 1011. In aspects, with the at least one passive sensor 803 resonating at the predetermined frequency, changes in the heart’s pressure can cause a shift in frequency in the communication from the at least one passive sensor 803 to the electronic implant 901.

[0082] In aspects, the electronic implant 901 can comprise at least one second sensor 1015 electrically connected to the power source 1001 and configured to obtain physiological information from an area 1017 within which the electronic implant 901 is implanted. In aspects, the area 1017 can comprise the right atrium of the patient, such that the first valve of the heart is the aortic valve, and the electronic implant 901 is implanted into the right atrium of the patient such that the electronic implant 901 is in proximity to the heart valve prosthesis 10. The second sensor 1015 can be similar to the at least one passive sensor 803. For example, the second sensor 1015 can obtain physiological information comprising one or more characteristics related to the patient’s functioning. For example, the physiological information can comprise one or more of the blood pressure of the patient, the heart rate of the patient, activity-level (e.g., information related to exercise and / or movement, sleep, etc.) of the patient, or arrhythmia (e.g., irregular heartbeat), other hemodynamic data, etc. In this way, the second sensor 1015 can comprise several different types of sensors that are capable of monitoring and collecting data related to some or all of the aforementioned physiological characteristics. The second sensor 1015 may be positioned partially or completely outside of the housing of the electronic implant 901, such that the second sensor 1015 can collect information related to the area 1017 within which the electronic implant 901 is positioned. In aspects, the electronic implant 901 can comprise a single second sensor 1015 capable of monitoring and collecting data related to one or more of the aforementioned physiological characteristics, or a plurality of second sensors 1015 monitoring different types ofphysiological characteristics. As illustrated in FIG. 10, an external device 1021 can be positioned relative to the electronic implant 901 to form a wireless communication line 1023 with the electronic implant 901. As used herein, a wireless communication line comprises the transfer of data / information between two points (e.g., the electronic implant 901 and the external device 1021) without the use of a wire or other continuous guided medium. The wireless communication line 1023 can comprise data transfer via radio waves (e.g., Bluetooth or the like), though other methods are possible. In aspects, the external device 1021 can be positioned outside of the patient’s body such that the electronic implant 901 can transmit and / or receive data to / from the external device 1021 along the wireless communication line 1023 while the electronic implant 901 is implanted within the patient’s body and while the external device 1021 is outside of the patient’s body. As an example, the electronic implant 901 can transmit data (e.g., stored in the memory component 1011) to the external device 1021, whereupon the data can be downloaded and analyzed. In aspects, the wireless communication line 1023 can be similar to the electromagnetic field 1007, with the wireless communication line 1023 representing data transfer from the electronic implant 901 to the external device 1021.

[0083] Methods of monitoring physiological information of a heart of a patient can therefore comprise delivering the heart valve prosthesis 10 to the treatment site 701 between chambers of the heart (e.g., a mitral or tricuspid valve) or between a chamber and a vessel extending therefrom (e.g., an aortic or pulmonic valve), and implanting the electronic implant 901 within the patient in proximity to the heart valve prosthesis 10. Methods can comprise wirelessly communicating between the wireless power components 813, 1003 to generate power at the first wireless power component 813. Methods can further comprise powering the at least one passive sensor 803 from the first wireless power component 813 such that the at least one passive sensor 803 obtains physiological information from adjacent to the first valve of the heart or vessel extending therefrom. The wireless communication between the wireless power components 813, 1003 can comprise generating the first electric current that flows between the power source 1001 (e.g., battery) of the electronic implant 901 and the second wireless power component 1003 to generate the electromagnetic field 1007 at the second wireless power component 1003. Methods can further comprise positioning the first wireless power component 813 within the electromagnetic field 1007, and inducing the second electric current at the first wireless power component 813, withthe second electric current flowing between the at least one passive sensor 803 and the first wireless power component 813 to power the at least one passive sensor 803. Methods can further comprise wirelessly transmitting data related to the physiological information from the first wireless power component 813 to the memory component 1011 of the electronic implant 901. In aspects, methods can also comprise obtaining physiological information by the second sensor 1015 of the electronic implant 901, with the second sensor 1015 electrically connected to the power source 1001.

[0084] FIG. 11 illustrates a perspective view of an example of the electronic implant 901. As illustrated, the electronic implant 901 can comprise a housing 1101 with one or more walls that surrounds a chamber or cavity. One or more of the components of the electronic implant 901 may be positioned within the chamber or cavity of the housing 1101. The electronic implant 901 can comprise the second wireless power component 1003, which may be positioned at one end (e .g . , a distal end) of the electronic implant 901, and the second sensor 1015, which may be positioned at an opposing end (e.g., proximal end) of the electronic implant 901. The power source 1001 (e.g., obstructed from view in FIG. 11 but illustrated in FIG. 10) is electrically connected to the second wireless power component 1003. Positioning the second wireless power component 1003 at the distal end of the housing 1101 may be beneficial because after the electronic implant 901 is positioned in the area 1017 adjacent to the heart valve prosthesis 10 (e.g., illustrated in FIGS. 9-10), the second wireless power component 1003 is oriented parallel to the first wireless power component 813. That is, the first wireless power component 813 and the second wireless power component 1003 can each comprise an oscillation coil, with the oscillation coils in a parallel position when the electronic implant 901 is implanted, thus facilitating wireless power transfer. In this way the oscillation coil of the second wireless power component 1003 can allow for oscillation to determine resonate frequency that corresponds to the pressure acting on the sensor(s).

[0085] In aspects, the electronic implant 901 can comprise one or more attachment features 1103. While FIG. 11 is illustrated as comprising four attachment features 1103, any number (e.g., one or more) of attachment features are possible. The attachment features 1103 can be attached to, and extend from, an end (e.g., the distal end) of the housing 1101 of the electronic implant 901. The attachment features 1103 can comprise, for example, hooks, tines, or other structures that can assist in engaging the heart tissue and anchoringthe electronic implant 901 in place after being implanted into the heart. In aspects, the attachment features 1103 can comprise a shape memory material (e.g., such as, for example, Nitinol), that can undergo a shape change to the shape shown in FIG. 11. That is, during the delivery and implant of the electronic implant 901, the shape memory material of the attachment features 1103 can be in a first shape that is amenable to delivery and movement within the patient, but after reaching the area 1017, the attachment features 1103 can undergo the shape change (e.g., to the shape illustrated in FIG. 11) to facilitate engagement with the surrounding heart tissue, thus allowing the electronic implant 901 to be anchored. While the electronic implant 901 is illustrated as comprising the attachment features 1103, other mechanisms of anchoring are possible, such that after being implanted, the electronic implant 901 is limited from inadvertently moving to an undesirable position.

[0086] The monitoring apparatus 801 disclosed herein can comprise several benefits. For example, by not attaching a power source to the heart valve prosthesis 10, the footprint (e.g., area occupied by) of the heart valve prosthesis 10 may not increase beyond a desired amount. The passive sensor 803 and the first wireless power component 813 may be small enough to not impede the delivery, implantation, and function of the heart valve prosthesis 10 while also not increasing the footprint of the heart valve prosthesis 10. The passive sensor 803 can, instead, be powered by a power source that is remotely located, and separate from, the heart valve prosthesis 10, such that the passive sensor 803 can collect data and physiological information related to the patient.

[0087] In addition, in aspects, the heart valve prosthesis 10 comprising the passive sensor 803 can be implanted at different time than the electronic implant 901, or concurrently with the electronic implant 901. For example, when implanting the heart valve prosthesis 10 and the electronic implant 901 at different times, the heart valve prosthesis 10 may be implanted first, with the electronic implant 901 implanted at a later time, such as, for example, days, weeks, months, or years later. In this way, the heart valve prosthesis 10, comprising the passive sensor 803 and the first wireless power component 813, may be implanted without the electronic implant 901, such that the passive sensor 803 may not be powered or in operation until the electronic implant 901 is implanted. At a later time, the electronic implant 901 can be implanted, at which time the electronic implant 901 can wirelessly communicate with the passive sensor 803 and the first wireless power component 813 of the already-implanted heart valve prosthesis 10, for example, by providing power tothe passive sensor 803 and receiving / collecting data from the passive sensor 803. Alternatively, the heart valve prosthesis 10 and the electronic implant 901 can be implanted concurrently, for example, at the same time or within minutes or hours of each other, such that the heart valve prosthesis 10 can be powered and operational almost immediately.

[0088] Another benefit of the monitoring apparatus 801 is that the passive sensor 803 can be configured to monitor / collect information in several ways. For example, the passive sensor 803 can monitor some, or all, of the physiological information continuously and without stopping while the passive sensor 803 is powered. In this way, the electronic implant 901 can activate a continuous pressure recording with the sensor(s). Alternatively, the passive sensor 803 can monitor some, or all, of the physiological information intermittently. For example, during intermittent monitoring, the passive sensor 803 can monitor / collect data at intervals with a time period between intervals at which data may not be collected. In such an example, intermittent data collection can comprise the passive sensor 803 monitoring / collecting data every hour or every twelve hours. In addition or alternatively, the passive sensor 803 can monitor / collect data at intervals when the electronic implant 901 detects activity, such as through increased heart rate or movement detected by a rate response sensor (e.g. accelerometer, piezoelectric crystal, or temperature-responsive) located in the electronic implant 901. In this way, the electronic implant 901 can activate a pressure recording intermittently based on at least one of a preset timing, patient heart rate, or patient activity. The present timing can comprise a set duration of time at which the pressure recording is activated (e.g., every 30 minutes, every hour, every 12 hours, etc.). The patient’ heart rate can comprise a range of heart rates or a heart rate threshold, such that when the patient’s heart rate falls outside of the range and / or outside of a threshold, then the pressure recording can be activated. The patient activity can comprise movement of the patient, such as movement when the patient is exercising. In this way, the pressure can be recorded intermittently (e.g., not continuous, but at intervals). As used herein, the term activate can comprise the electronic implant 901 powering the at least one passive sensor 803 (e.g., as described herein) such that the at least one passive sensor 803 can obtain the physiological information, and / or may comprise the electronic implant 901 receiving data (e.g., from the at least one passive sensor 803) and storing this data in the memory component 1011.

[0089] In any of the aforementioned examples discussed herein, the electronic implant 901 can be interrogated to collect information / data from the memory component 1011. For example, the electronic implant 901 can be interrogated with an external computing device (e.g., external device 1021) located at an exterior of the patient’s body (e.g., via wireless communication line 1023), such that the information / data from the memory component 1011 can be wirelessly transmitted to the external computing device, whereupon the information / data can be analyzed. In aspects, the external device 1021 can comprise a phone or other type of computing device, and the electronic implant 901 can comprise an antenna or other type of data transmission component for transmitting the data to the external device 1021, and / or data may be transmitted via the second wireless power component 1003.

[0090] In an alternative embodiment, the monitoring apparatus 801 acts as a pacing apparatus. This embodiment comprises delivering the heart valve prosthesis 10 to the treatment site 701 within a first valve of the heart (e.g. aortic valve), and implanting the electronic implant 901 within the patient in proximity to the heart valve prosthesis 10 (e.g. right atrium). As noted earlier, the electronic implant 901 is electrically connected to the second wireless power component 1003 to generate power at the first wireless power component 813. As depicted in FIG. 8, the passive sensor 803 could be located in a first sensor location 807 and act as a pacing electrode by being electrically connected to the first wireless power component 813. In one such example, the first sensor location 807 could sit below the aortic annulus within the left ventricular outflow tract and furthermore, could be directed to sit in close proximity to the heart’s native conduction system to provide physiologic ventricular pacing. In order to coordinate the ventricular pacing, the second sensor 1015, which is electrically connected to the power source 1001, could sense the electrical activity in the atrial myocardium and then the processor 1009 can be configured with executable instructions stored in the memory component 1011 to enable operations of the power source 1001, the second wireless power component 1003, other components, etc. to generate the electromagnetic field 1007 at the second wireless power component 1003, thus inducing the second electric current at the first wireless power component 813, with the second electric current flowing between the at least one sensor 803 (acting as a pacing electrode) and the first wireless power component 813 to power the at least one sensor 803 to deliver a pacing pulse (e.g. 0.5 - 5.0V @ 0.2 - 1.5ms). The timing between the sensing in the atrium and pacing in the ventricle could be programmable and could be as short as10ms, or as long as 250ms in order to optimize ventricular filling prior to pacing. In addition to acting as a sensor for atrial myocardial sensing, the second sensor 1015 could also be configured to pace the atrium if it does not detect an atrial activity at a set heart rate (e.g. greater than 40 beats per minute) prior to the processor 1009 triggering pacing of the at least one sensor 803.

[0091] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

[0092] The following examples are illustrative of the techniques described herein.

[0093] Example 1. A monitoring apparatus for monitoring physiological information of a heart of a patient, the monitoring apparatus comprising: a heart valve prosthesis configured to be implanted into a first valve of the heart; at least one passive sensor attached to the heart valve prosthesis and configured to obtain physiological information adjacent to the first valve of the heart; a first wireless power component electrically coupled to the at least one passive sensor; and an electronic implant configured to be implanted within the patient, the electronic implant comprising a power source comprising a second wireless power component configured to wirelessly communicate with the first wireless power component, wherein the wireless communication between the first wireless power component and the second wireless power component is configured to power the at least one passive sensor.

[0094] Example 2. The monitoring apparatus of Example 1, wherein the first valve of the heart is the aortic valve, and the electronic implant is implanted into the right atrium of the patient.

[0095] Example 3. The monitoring apparatus of Example 1, wherein the first wireless component comprises a first inductive coil, the second wireless power component comprises a second inductive coil, and the power source comprises a battery electrically connected to the second wireless power component, a first electric current configured to flow between the battery and the second inductive coil to generate an electromagnetic field.

[0096] Example 4. The monitoring apparatus of Example 3, wherein the first inductive coil is positioned within the electromagnetic field to induce a second electric current at the first inductive coil, the second electric current configured to flow between the at least one passive sensor and the first inductive coil to power the at least one passive sensor.

[0097] Example 5. The monitoring apparatus of Example 1, wherein the first wireless power component and the second wireless power component comprise radio frequency power transmission components.

[0098] Example 6. The monitoring apparatus of Example 1, wherein the at least one passive sensor is attached to an inflow end of the heart valve prosthesis.

[0099] Example 7. The monitoring apparatus of Example 1, wherein the at least one passive sensor is attached to one of: a central location of the heart valve prosthesis, the central location located between an inflow end and an outflow end of the heart valve prosthesis; or an outflow end of the heart valve prosthesis.

[0100] Example 8. The monitoring apparatus of Example 1, wherein the electronic implant is in a chamber of the heart not directly connected to the first valve, and wherein power is transmitted across a wall of the heart to the first wireless power component.

[0101] Example 9. A monitoring apparatus for monitoring physiological information of a heart of a patient, the monitoring apparatus comprising: a heart valve prosthesis configured to be implanted into a first valve of the heart; at least one passive sensor attached to the heart valve prosthesis and configured to obtain physiological information adjacent to the first valve of the heart; a first wireless power component coupled to the at least one passive sensor; and an electronic implant configured to be implanted within the patient, the electronic implant comprising: a power source comprising a second wireless power component configured to wirelessly communicate with the first wireless power component; and a memory component, wherein the wireless communication between the first wireless power component and the second wireless power component is configured to power the at least one passive sensor, and wherein the first wireless power component is configured to wirelessly transmit data related to the physiological information to the memory component, the data related to the physiological information obtained from the at least one passive sensor.

[0102] Example 10. The monitoring apparatus of Example 9, wherein the first wireless component comprises a first inductive coil, the second wireless power component comprises a second inductive coil, and the power source comprises a battery electrically connected to the second wireless power component, a first electric current configured to flow between the battery and the second inductive coil to generate an electromagnetic field.

[0103] Example 11. The monitoring apparatus of Example 10, wherein the first inductive coil is positioned within the electromagnetic field to induce a second electric current at the first inductive coil, the second electric current configured to flow between the at least one passive sensor and the first inductive coil to power the at least one passive sensor.

[0104] Example 12. The monitoring apparatus of Example 9, wherein the first wireless power component and the second wireless power component comprise radio frequency power transmission components.

[0105] Example 13. A method of monitoring physiological information of a heart of a patient, the method comprising: delivering a heart valve prosthesis to a first valve of the heart, the heart valve prosthesis comprising at least one passive sensor and a first wireless power component electrically coupled to the at least one passive sensor; implanting an electronic implant within the patient in proximity to the heart valve prosthesis, the electronic implant comprising a power source comprising a second wireless power component; wirelessly communicating between the second wireless power component and the first wireless power component to generate power at the first wireless power component; and powering the at least one passive sensor from the first wireless power component such that the at least one passive sensor obtains physiological information adjacent to the first valve of the heart.

[0106] Example 14. The method of Example 13, wherein the wirelessly communicating between the second wireless power component and the first wireless power component comprises: generating a first electric current that flows between a battery of the electronic implant and the second wireless power component to generate an electromagnetic field at the second wireless power component; positioning the first wireless power component within the electromagnetic field; and inducing a second electric current at the first wireless power component that flows between the at least one passive sensor and the first wireless power component to power the at least one passive sensor.

[0107] Example 15. The method of Example 13, wherein the physiological information comprises one or more of blood pressure, heart rate, activity-level of the patient, or arrhythmia.

[0108] Example 16. The method of Example 13, wherein the electronic implant activates a pressure recording intermittently based on at least one of a preset timing, patient heart rate, or patient activity.

[0109] Example 17. The method of Example 13, wherein the electronic implant activates a pressure recording continuously.

[0110] Example 18. The method of Example 13, further comprising wirelessly transmitting data related to the physiological information to a memory component of the electronic implant.

[0111] Example 19. The method of Example 13, further comprising obtaining physiological information by a second sensor of the electronic implant, the second sensor electrically connected to the power source.

[0112] Example 20. The method of Example 13, wherein the first valve of the heart is the aortic valve and wherein the electronic implant is implanted within the right atrium such that the electronic implant is in proximity to the heart valve prosthesis.

Claims

What is claimed is:

1. A monitoring apparatus for monitoring physiological information of a heart of a patient, the monitoring apparatus comprising: a heart valve prosthesis configured to be implanted into a first valve of the heart; at least one passive sensor attached to the heart valve prosthesis and configured to obtain physiological information adjacent to the first valve of the heart; a first wireless power component electrically coupled to the at least one passive sensor; and an electronic implant configured to be implanted within the patient, the electronic implant comprising a power source comprising a second wireless power component configured to wirelessly communicate with the first wireless power component, wherein the wireless communication between the first wireless power component and the second wireless power component is configured to power the at least one passive sensor.

2. The monitoring apparatus of claim 1, wherein the first valve of the heart is the aortic valve, and the electronic implant is implanted into the right atrium of the patient.

3. The monitoring apparatus of any one of claims 1-2, wherein the first wireless component comprises a first inductive coil, the second wireless power component comprises a second inductive coil, and the power source comprises a battery electrically connected to the second wireless power component, a first electric current configured to flow between the battery and the second inductive coil to generate an electromagnetic field.

4. The monitoring apparatus of claim 3, wherein the first inductive coil is positioned within the electromagnetic field to induce a second electric current at the first inductive coil, the second electric current configured to flow between the at least one passive sensor and the first inductive coil to power the at least one passive sensor.

5. The monitoring apparatus of claim 1, wherein the first wireless power component and the second wireless power component comprise radio frequency power transmission components.

6. The monitoring apparatus of any one of claims 1-5, wherein the at least one passive sensor is attached to an inflow end of the heart valve prosthesis.

7. The monitoring apparatus of any one of claims 1-5, wherein the at least one passive sensor is attached to one of: a central location of the heart valve prosthesis, the central location located between an inflow end and an outflow end of the heart valve prosthesis; or an outflow end of the heart valve prosthesis.

8. The monitoring apparatus of any one of claims 1-7, wherein the electronic implant is in a chamber of the heart not directly connected to the first valve, and wherein power is transmitted across a wall of the heart to the first wireless power component.

9. A method of monitoring physiological information of a heart of a patient, the method comprising: delivering a heart valve prosthesis to a first valve of the heart, the heart valve prosthesis comprising at least one passive sensor and a first wireless power component electrically coupled to the at least one passive sensor; implanting an electronic implant within the patient in proximity to the heart valve prosthesis, the electronic implant comprising a power source comprising a second wireless power component; wirelessly communicating between the second wireless power component and the first wireless power component to generate power at the first wireless power component; and powering the at least one passive sensor from the first wireless power component such that the at least one passive sensor obtains physiological information adjacent to the first valve of the heart.

10. The method of claim 9, wherein the wirelessly communicating between the second wireless power component and the first wireless power component comprises: generating a first electric current that flows between a battery of the electronic implant and the second wireless power component to generate an electromagnetic field at the second wireless power component; positioning the first wireless power component within the electromagnetic field; and inducing a second electric current at the first wireless power component that flows between the at least one passive sensor and the first wireless power component to power the at least one passive sensor.

11. The method of any one of claims 9-10, wherein the physiological information comprises one or more of blood pressure, heart rate, activity-level of the patient, or arrhythmia.

12. The method of any one of claims 9-11, wherein the electronic implant activates the pressure recording intermittently based on at least one of a preset timing, patient heart rate, or patient activity.

13. The method of any one of claims 9-11, wherein the electronic implant activates the pressure recording continuously.

14. The method of any one of claims 9-13, further comprising wirelessly transmitting data related to the physiological information to a memory component of the electronic implant.

15. The method of any one of claims 9-14, further comprising obtaining physiological information by a second sensor of the electronic implant, the second sensor electrically connected to the power source.

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