Transcatheter heart valve with deformable inductor for dual wireless pressure monitoring

Abstract

A prosthetic valve includes a flexible frame disposed along a frame axis and deformable about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and a network of interconnected struts defining a plurality of cells. A first circuit is mounted on the frame. The first circuit includes: a first inductor coil attached to and tracking a first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells; and a first sensor in electrical communication with the first inductor coil. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

Description

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 387,915, filed on Dec. 16, 2022, entitled “Transcatheter Heart Valve with Deformable Inductor for Dual Wireless Pressure Monitoring”, the disclosure of which is hereby incorporated by reference in its entirety. Background of the Invention

[0002] The present disclosure relates to medical implant devices and, in particular, to implantable artificial valves.

[0003] Patients receiving heart valve implants may suffer from postoperative complications. The risk of complications is particularly high within thirty or sixty days after the implantation surgery. However, during such time periods, the patient may no longer be in a hospital or extended care facility / system, and thus any emerging complications may require re - entry into the care system, potentially increasing the significant cost of the patient's overall treatment. Additionally, the increased health risk may be due to the patient delaying their return to the hospital due to failure to recognize the complications until they manifest as perceivable symptoms that the patient interprets as requiring hospitalization. Accordingly, there is a need for systems, devices, and methods for postoperative monitoring of artificial heart valve recipients, including in environments outside of a hospital or care institution, to improve patient outcomes. Summary of the Invention

[0004] In one example, an artificial valve includes a flexible frame disposed along and deformable about a frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network defining a plurality of cells. A first circuit is mounted on the frame. The first circuit includes: a first inductor coil attached to and tracking a first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells; and a first sensor in electrical communication with the first inductor coil. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0005] In another example, an artificial valve assembly includes an artificial valve having a flexible frame disposed along a frame axis and deformable between a crimped state and a deployed state about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network defining a plurality of cells. A first circuit is mounted on the frame. The first circuit includes: a first inductor coil attached to and tracking a first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells; and a first sensor in electrical communication with the first inductor coil. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter. The artificial valve assembly further includes a transmitter in communication with the first sensor.

[0006] In another example, an artificial valve includes a flexible frame disposed along a frame axis and deformable between a crimped state and a deployed state about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network defining a plurality of cells. A multilayer sensing assembly is mounted on the frame. The multilayer sensing assembly includes: a first pair of inductor coils including a first upper inductor coil portion and a first lower inductor coil portion, the first pair of inductor coils disposed on a flexible substrate; a detuning mitigation layer disposed between the frame and the flexible substrate; and a first sensor in electrical communication with the first pair of inductor coils. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a schematic illustration of a human patient with a heart.

[0008] Figure 2 is a partial cross-sectional schematic illustration of the heart.

[0009] Figure 3 is a block diagram depicting a monitoring system for monitoring one or more physiological parameters associated with a patient.

[0010] Figure 4 is a perspective view of a first example of an artificial heart valve shown in a deployed state.

[0011] Figure 5 is shown isolated from the frame Figure 4 front view of the sensing circuit of the artificial heart valve.

[0012] Figure 6 is transverse to Figure 4 axis A of Figure 4 schematic cross-sectional exploded view of the struts and inductor coils of the artificial heart valve.

[0013] Figure 7A perspective view of a second example of an artificial heart valve shown in an expanded state.

[0014] Figure 8 A schematic front view of a third example of an artificial heart valve shown in a crimped state.

[0015] Figure 9 A schematic plan view comparing the radial dimensions of the frames of a third example of an artificial heart valve in an expanded state and a crimped state.

[0016] Figure 10 A schematic view of a fourth example of an artificial heart valve shown in an expanded state, having a fabric cover over an inductor coil.

[0017] Figure 11 A schematic cross-sectional view showing a portion of a multi-layer sensing assembly disposed on a flexible frame. Detailed Description

[0018] Figure 1 A front view of a human patient 2 having a heart 4. The body of patient 2 can generally be bisected by any one of three planes: the coronal (i.e., x-y) plane, the sagittal (i.e., y-z) plane, and the transverse (i.e., x-z) plane.

[0019] Figure 2 A partial cross-sectional schematic view of the heart 4. The heart 4 includes four chambers, including the left atrium 6, the left ventricle 8, the right ventricle 10, and the right atrium 12. The four chambers are shown in cross-section. The heart 4 further includes four valves for assisting blood circulation therein, including the tricuspid valve 14, the pulmonary valve 16, the mitral valve 18, and the aortic valve 20. Figure 2 The pulmonary artery 21 and the aorta 22 are further shown. Figure 2

[0020] ​The tricuspid valve 14 separates the right atrium 12 from the right ventricle 10 and may include three cusps or leaflets. The tricuspid valve 14 may close during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The pulmonary valve 16 separates the right ventricle 10 from the pulmonary artery 21 and may be configured to open during systole so that blood can be pumped toward the lungs and close during diastole to prevent blood from leaking back from the pulmonary artery 21 into the heart 4. Similar to the tricuspid valve 14, the pulmonary valve 16 may have three cusps / leaflets, each cusp / leaflet being crescent-shaped. The mitral valve 18 separates the left atrium 6 from the left ventricle 8 and may have two cusps or leaflets. The mitral valve 18 is configured to open during diastole so that blood in the left atrium 6 can flow into the left ventricle 8 and close during systole to prevent blood from leaking back into the left atrium 6. The aortic valve 20 separates the left ventricle 8 from the aorta 22. The aortic valve 20 is configured to open during systole to allow blood leaving the left ventricle 8 to enter the aorta 22 and close during diastole to prevent blood from leaking back into the left ventricle 8.

[0021] Heart valves may include a relatively dense fibrous ring (referred to herein as an annulus), and a plurality of leaflets or cusps attached to the annulus. Some valves may further include a series of chordae tendineae and papillary muscles that anchor the leaflets. Generally, the size of the leaflets or cusps may be such that when the heart contracts, the resulting increase in blood pressure generated within the corresponding heart chamber forces the leaflets to open at least partially to allow flow out of the chamber. As the pressure in the chamber drops, the pressure in the subsequent chamber or vessel may become dominant and push the leaflets back together. Thus, the leaflets / cusps are juxtaposed against each other, thereby closing the flow channel.

[0022] Heart valve disease represents a condition in which one or more of the valves of the heart 4 do not function properly. Diseased heart valves may be classified as stenotic and / or incompetent. In a stenotic heart valve, the valve does not open sufficiently to allow adequate blood to flow forward through the valve. In an incompetent heart valve, the valve does not close completely when it is closed, such that too much blood flows backward through the valve. In some cases, if left untreated, valve disease can be severely debilitating and even life-threatening.

[0023] For a disease of, for example, the mitral valve 18, an artificial heart valve may be implanted and sutured into the annulus of the mitral valve 18. Such an artificial heart valve may be positioned such that its opening is oriented in the direction of blood flow from the left atrium 6 to the left ventricle 8. The artificial heart valve may be configured to operate as the aortic valve 20 such that it can allow one-way blood flow from the left atrium 6 to the left ventricle 8 while preventing flow in the opposite direction.

[0024] In a typical heart implantation surgery, the heart can be incised, and in a valve replacement surgery, a defective valve can be removed, leaving a desired placement site that may include an annulus. Sutures can be passed through the annulus or the fibrous tissue of the desired placement site to form a suture array. The free ends of the sutures can be individually passed through the suture-permeable sealing edge of an artificial heart valve. The artificial heart valve can be used to replace a defective or degenerated natural heart valve in patients suffering from heart valve diseases, including aortic stenosis, mitral regurgitation, etc. The valve replacement process typically involves a surgical or transcatheter procedure (e.g., balloon valvotomy) to replace the existing valve with a new artificial valve. Since the artificial valve is a foreign body, such surgeries involve many different challenges and problems. For example, paravalvular leakage (PVL) and / or leaflet thickening can occur in patients undergoing heart valve replacement. Similarly, artificial surgical heart valves may be rejected due to thrombosis, and patients need to use anticoagulants to properly perform the valve surgery.

[0025] Some methods for monitoring valve performance after implantation include using complex bioimaging techniques such as echocardiography. This method can typically only be performed in specialized medical institutions and is time-consuming and costly. Therefore, this method is usually only used when symptoms of valve insufficiency are detected. Some artificial valves may not provide the ability to detect changes during the detection operation to detect problems early. In addition, many patients with valve diseases who require artificial valves may also suffer from other cardiovascular diseases, including heart failure. Some artificial heart valve systems may not allow the use of existing patient monitoring systems to collect data on the valve and / or the patient's postoperative condition in an outpatient setting (e.g., when a cardiologist makes rounds in a ward). As the number and diversity of patients increase over time, such systems may not be able to provide routine collection of data with sufficient resolution to enable the development of new digital solutions to better manage patients.

[0026] Therefore, an artificial heart valve can be part of a larger system for postoperative patient monitoring, as will be referenced Figure 3 discussed.

[0027] Figure 3 is a block diagram of a monitoring system 23 for monitoring one or more physiological parameters associated with a patient (e.g., Figure 1 patient 2 as shown). The system 23 includes an artificial heart valve 24, which includes a sensing device 26, a control circuitry 28, a transmitter 30, and a power source 32. The system 23 further includes an external device 34, which includes an antenna 36, a control circuitry 38, and a transceiver 40. The system 23 also includes a cloud 42 and a remote monitor 44.

[0028] The artificial heart valve 24 may include one or more sensing devices 26, a control circuitry 28, a transmitter 30, and a power source 32. The sensing device 28 may include one or more of the following types of sensors / transducers: MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / strain gauges, accelerometers, gyroscopes, and / or other types of sensors, which may be positioned within the patient's body to sense one or more parameters related to the patient's health. The control circuitry 28 may be connected to the sensing device 26 either wired or wirelessly, and may include one or more of an application specific integrated circuit (ASIC), a microcontroller, a chip, a tuning capacitor, etc. The control circuitry 28 may receive signals (e.g., requests for stored or immediately acquired data) from an external device 34, request data from the sensor 26, and coordinate data transmission. The transmitter 30 may be, for example, an antenna for radiating the electrical signals transmitted by the control circuitry 28. The power source 32 may be a suitable power source capable of minimizing interference with the patient's heart or other anatomical structures. In one example, the power source 32 may be a passive component for wirelessly receiving external power (e.g., short-range or near-field wireless power transfer). In another example, the power source 32 may be a battery, or a component for harvesting energy in situ from within the patient's body.

[0029] An external device 34 located at least partially outside the patient's body may communicate wirelessly with the artificial heart valve 24. The external device 34 includes an antenna 36, a control circuitry 38, and a transceiver 40. The antenna 36 may receive wireless signal transmissions from the artificial heart valve 24. In one example, the antenna 36 may be externally mounted to the external device 34. The control circuitry 38 may be a processor or other suitable component for processing the signals received from the artificial heart valve 24. The transceiver 40 may be configured to receive and amplify signals from the artificial heart valve 24 and transmit the signals to a cloud 42 and a remote monitor 44. Such signals may include, for example, pressure data acquired from the sensor 26. Thus, the transceiver 40 may include one or more of a digital-to-analog converter (DAC) circuitry, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc., for handling and / or processing the transmitted and received signals.

[0030] The external device 34 can act as an intermediate communication device between the artificial heart valve 24 and the remote monitor 44. The external device 34 can be a dedicated external unit designed to communicate with the artificial heart valve 24. For example, the external device 34 can be a wearable communication device or other device that can be easily set near the patient and / or the artificial heart valve 24. The external device 34 can be configured to interrogate the artificial heart valve 24 continuously, periodically, or irregularly in order to extract or request sensor-based information therefrom. In some examples, the external device 34 can include a user interface on which a user (e.g., the patient) can view sensor data, request sensor data, or otherwise interact with the external device 34 and / or the artificial heart valve 24.

[0031] The cloud 42 can be a secure network that communicates with the external device 34 via Ethernet, Wi-Fi, or other network protocols. The cloud 42 can also be configured to implement data storage. In another example, the cloud 42 can alternatively be a secure physical network. The remote monitor 44 can communicate with the external device 34 via the cloud 42. The remote monitor 44 can be any type of computing device or collection of computing devices configured to receive, process, and / or present monitor data received from the external device 34 or the artificial heart valve 24 via the cloud 42. For example, the remote monitor 44 can advantageously be operated and / or controlled by a healthcare entity (e.g., a hospital, a doctor, or other care entity associated with the patient). Although some examples disclosed herein describe communication between the artificial heart valve 24 and the remote monitor 44 indirectly through the external device 34, the artificial heart valve 24 can alternatively include a transmitter (e.g., transmitter 30) capable of communicating with the remote monitor 44 via the cloud 42 without the need to relay information through the device 34.

[0032] Figure 4 is a perspective view of the artificial heart valve 124 shown in an expanded state. Figure 5 is a front view of the sensing circuit of the artificial heart valve 124 shown isolated from the frame. Discussed together Figure 4 and 5 .

[0033] As Figure 4 shown, the structural components of the artificial heart valve 124 include a deformable frame 146 and a post assembly 148 that extends axially away from the frame 146 relative to the valve axis A. When the artificial heart valve 124 is implanted in the heart 4, the axis A can generally be aligned with the direction of blood flow through the artificial heart valve. The frame 146 can be formed of a biocompatible metallic material. As Figure 4 shown, one post assembly 148 is based on Figure 4The orientation extends from each of the top / upper end 150 and the bottom / lower end 152 of the artificial heart valve 124. Each post assembly 148 may include a post 154 and an island 156, and the sensor 126 may be mounted on the island. As Figure 4 shown, the island 156 may have a generally square shape corresponding to the shape of the sensor 126. The frame 146 includes a network of struts 158 that define open cells 160 therebetween. Each cell 160 may include tips / ends 162 that are axially disposed opposite each other.

[0034] The electrical components of the artificial heart valve 124 include one or more sensing circuits 164 for monitoring physiological parameters of the patient 2. Each sensing circuit 164 includes a deformable inductor coil 166 and a sensor 126 that is electrically connected (e.g., via leads / wires) to the inductor coil 166. The sensing circuit 164 may be an inductor-resistor-capacitor (LCR) circuit 168, where the inductor coil 166 forms the inductor (L) and resistor (R) elements of the circuit 168, and the sensor 126 is connected in parallel to form the capacitor (C) element. Each LCR circuit 168 of the artificial heart valve 126 has a different self-resonant frequency. The self-resonant frequency of each circuit can be expressed as , where L is the inductance of the inductor coil 166 and C(p) is the capacitance of the sensor 126 at a given pressure. Generally, the self-resonant frequency of each LCR circuit 168 can be in the range of 5 MHz to 50 MHz, and more specifically, in the range of 10 MHz to 20 MHz.

[0035] The inductor coil 166 may include one or more individual wires formed of a conductive but biocompatible metallic material (e.g., gold). Other examples may include copper or titanium. The inductor coil 166 may be further coated with an insulating coating (shown and labeled in Figure 6 ). In one example, the sensor 126 may be a capacitive pressure sensor, each sensor including a diaphragm and a pressure chamber to form a variable capacitor for detecting strain due to pressure applied to the diaphragm. Generally, the capacitance of the sensor 126 decreases as the diaphragm is deformed by pressure. To manage detuning of the sensing circuit 164, a detuning mitigation layer discussed in more detail below with respect to Figure 6 and 11 may be positioned between the inductor coil 166 and the struts 158 of the frame 146.

[0036] The inductor coil 166 may be detachably attached to the frame 146 by sutures 170, as shown in Figure 5is schematically shown. In one example, suture 170 can be formed of a biocompatible polymer. More specifically, inductor coil 166 can be attached to frame 146 in such a way as to track a subset of struts 158 and delineate a subset of cells 160. In this regard, inductor coil 166 can have nearly the same geometric properties as struts 158 and cells 160, e.g., having a tip 172 corresponding to the tip 162 of the underlying cells 160 of frame 146. In Figure 4 and 5 example, inductor coil 166 can be arranged to track / construct / delineate a two-by-three subset of cells 160 of frame 146 (i.e., two cells high in the axial direction and three cells long in the radial dimension). This can include the uppermost or lowermost cell as well as the internal cells 160. Other arrangements are envisioned herein. Sutures 170 can be disposed at various points along inductor coil 166 to ensure that inductor coil 166 is fixed to a support subset of struts 158 and maintains the shape of the support subset of struts 158. The suture points can respectively include the tips 162 of cells 160 of frame 146 and the tips 172 of inductor coil 166. Additional and / or alternative suture points are contemplated herein.

[0037] Figure 6 is taken transverse to Figure 4 axis A of Figure 4 a schematic cross-sectional exploded view of struts 158 and inductor coil 166 of an artificial heart valve. Figure 6 shows struts 158, inductor coil 166, ferrite layer 174, insulating layer 176, and adhesive backing layer 178.

[0038] As Figure 6As shown, the strut 158 is the innermost layer, and the inductor coil 166 is the outermost layer. A ferrite layer 174 is disposed between the strut 158 and the inductor coil 166. The ferrite layer 174 can be formed as a strip of soft ferromagnetic material in one example and can mitigate detuning caused by the proximity of the inductor coil 166 to the metal strut 158. The ferrite layer 174 can additionally improve (e.g., increase) the sensing range of the sensing circuit 164 by shielding the inductor coil 166 from magnetic field interference, induced eddy currents, etc., typically caused by the electronic components of the artificial heart valve 124. The ferrite layer 174 ideally coextends with the inductor coil 166 such that the area of the inductor coil 166 is not exposed to the underlying metal strut 158. Additionally, the ferrite layer 174 should have sufficient flexibility to transition between the crimped state and the expanded state of the artificial heart valve 124 and maintain its position between the strut 158 and the inductor coil 166. An insulating layer 176 surrounds the inductor coil 166 and the ferrite layer 174. The ferrite layer 174 and the inductor coil 166 can be in direct physical contact (e.g., as an integrated layer), and the insulating layer 176 can surround / enclose the inductor coil 166 and the ferrite layer 174. In one example, the insulating layer 176 can be a biocompatible elastomer (e.g., silicone) or a polymer (e.g., parylene or polyimide). In some examples, an adhesive backing layer 178 can be included between the insulating layer 176 and the strut 158. Such an adhesive layer can be biocompatible and non-conductive.

[0039] Figure 7 is a perspective view of an artificial heart valve 224 shown in an expanded state. The artificial heart valve 224 is substantially similar to Figure 4 the artificial heart valve 124 shown, having a deformable frame 246 and a column assembly 248 that axially extends away from the frame 246 at each of an upper end 250 and a lower end 252. The column assembly 248 includes columns 254 and islands 256 for mounting sensors 226 thereon. The struts 258 of the frame 246 define units 260. The units 260 can include oppositely disposed tips 262. The artificial heart valve 224 further includes two sensing circuits 264 configured as LCR circuits 268, each sensing circuit including a sensor 226 and an inductor coil 266 that tracks a subset of the struts 258 and outlines a subset of the units 260. The inductor coils 266 can be formed of one or more conductive (e.g., gold) wires and include an underlying ferrite layer ( Figure 7 not shown in Figure 7 . Sutures ( Figure 4 not shown in 5 ) can fix each inductor coil 266 to the frame 246 in the manner discussed above with respect to

[0040] Unlike the foregoing examples, the artificial heart valve 224 includes a biocompatible fabric 280 that is configured as a skirt and that partially covers the frame 246. The fabric 280 may be formed of a polymeric material. In an alternative example, the fabric 280 may completely cover the frame 246 such that no struts 258 are exposed on the outer side of the frame 246. The artificial heart valve 224 further includes pericardial tissue 282, which may be formed of a synthetic material or derived from a mammalian (e.g., bovine) tissue source.

[0041] Figure 8 is a schematic front view of an artificial heart valve 324 shown in a crimped state. The artificial heart valve 324 is substantially similar to Figure 4 the artificial heart valve 124 shown and Figure 7 the artificial heart valve 224 shown, wherein the deformable frame 346 has interconnected struts 358 that define a cell 360. The frame 346 may be formed of a biocompatible metallic material. The post assembly 348 ( Figure 8 only one is shown therein) extends axially away from the upper end 350. The artificial heart valve 324 may further include at least one sensing circuit 364, wherein the flexible inductor coil 366 is in electrical communication with the sensor 326 via a wire 392. In the crimped state, the axial dimension (i.e., along axis A) of the frame 346 is greater than the axial dimension when in the expanded state such that the upper end 350 is further from the lower end 352 in the crimped state. Additionally, in the crimped state, the inductor coil 366 sutured to the frame 346 will deform similarly to the frame 346, thereby maintaining the geometry of the underlying struts 358 and configuring the deformable cell 360 and increasing / elongating in the axial direction. This may occur, for example, due to the relative overall flexibility of the inductor coil material and / or the surrounding layers (e.g., insulation layers and detuning mitigation devices), the thickness of the layers, and the robustness of the attachment member (e.g., suture) used to secure the inductor coil to the underlying struts.

[0042] Figure 9 is a schematic plan view comparing the radial dimensions of the frame 346 of the artificial heart valve 324 in the expanded and crimped states. The frame 346 is the Figure 8 frame of the artificial heart valve 324 shown. The frame 346 in the expanded state is represented by a solid line, while the frame 346 in the crimped state is represented by a dashed line. As Figure 9 shown, in the expanded state, the frame 346 has a radius R1, while in the crimped state, the frame has a radius R2. R1 is greater than R2. Thus, in the expanded state, the axial dimension of the frame 346 is less than the axial dimension of the frame 346 in the crimped state. In the expanded state, the radial dimension (i.e., radius R1) of the frame 346 is greater than the radial dimension (i.e., radius R2) of the frame 346 in the crimped state.

[0043] Figure 10 A schematic perspective view of an artificial heart valve 424 shown in an expanded state, with a fabric cover 484 over an inductor coil 466. For simplicity, the artificial heart valve 424 is shown without a post assembly and sensors. The artificial heart valve 424 is substantially similar to Figure 4 the artificial heart valve 124 shown Figure 7 the artificial heart valve 224 shown Figure 8 and the artificial heart valve 324 shown. The artificial heart valve 424 has: a biocompatible metal frame 446 having interconnecting struts defining cells ( Figure 10 not shown in), an upper end 450, and a lower end 452. The artificial heart valve 424 further includes a sensing circuit 464 (only one shown), the sensing circuit including an inductor coil 466 and a sensor (not shown). The inductor coil 466 can be formed of one or more wires of a conductive material (e.g., gold). Sutures 470 can secure the inductor coil 466 to the struts of the frame 446.

[0044] The artificial heart valve 424 differs from the previous examples in that it includes a cover 484 disposed over the inductor coil 466 and sutures 470. Thus, the hidden components are represented by dashed lines. The cover 484 can be a biocompatible fabric substantially similar to Figure 7 the fabric 280. The cover 484 can be stitched and / or woven to the frame 446 in one example to secure it in place, while in another example, the cover 484 can be arranged as a sleeve surrounding the frame 446. The cover 484 can protect the hidden components from ingrowth of autologous tissue after implantation of the artificial heart valve 424. The cover 484 can further protect the surrounding tissue from getting caught on / directly contacting the hidden components.

[0045] Figure 11 is a schematic cross-sectional view of a portion of a multi-layer sensing assembly 586 disposed on a flexible frame 546. The multi-layer sensing assembly 586 incorporates a plurality of inductor coils 566 stacked / layered in a radial direction relative to the axis of the surrounding artificial heart valve, and can be used with any of the artificial heart valves disclosed herein.

[0046] As Figure 11As shown, a multi-layer sensing assembly 586 is disposed on a metal support 558, which may be formed of a biocompatible metal material. The multi-layer sensing assembly 586 includes a first pair of inductor coils 566A and a second pair of inductor coils 566B, each pair of inductor coils including an upper coil portion and a lower coil portion printed on a flexible substrate 588. The flexible substrate 588 may be formed of a polymeric material such as polyimide and may have a thickness in the range of 2 millimeters to 3 millimeters in one example. Each pair of inductor coils 566A and 566B may be printed on the flexible substrate 588 and may be formed of gold in one example, or formed of copper or titanium in an alternative example. Each pair of inductor coils 566A and 566B may be electrically connected to Figure 11 the corresponding sensors 526 schematically shown in Figure 4 and 5 to form a sensing circuit 564. The sensors 526 may be substantially similar to Figure 7 the sensor 126 shown in Figure 8 and / or Figures 4 to 6 the sensor 226 shown in Figure 7 and / or Figure 8 the sensor 326 shown in Figure 10 . Each upper coil portion in the pairs of inductor coils 566A and 566B may be further electrically connected (e.g., via a conductive via) to the corresponding lower coil portion. The pairs of inductor coils 566A and 566B may be arranged to follow the support 558 and the cells (not shown), having a pattern similar to

[0047] the inductor coil 166 shown in Figure 6 , the inductor coil 266 shown in Figure 11In the example shown, the ferrite layer 574 can be printed onto the flexible substrate 588. In one example, the ferrite layer 574 can have a thickness in the range of 0.25 millimeters to 0.35 millimeters. The soft magnetic layers 590A and 590B are further disposed between the upper coil portions and the lower coil portions of the respective inductor coil pairs 566A and 566B, and can be formed of a frequency-dependent soft magnetic material. More specifically, the soft magnetic layer 590A can respond to and be tuned to the frequency at which the inductor coil pair 566A operates. Similarly, the soft magnetic layer 590B can respond to and be tuned to the frequency at which the inductor coil pair 566B operates. Thus, the soft magnetic layers 590A and 590B isolate two different frequencies of their respective inductor coil pairs, thereby minimizing interference and crosstalk between the inductor coil pairs 566A and 566B. The ferrite layer 574, the flexible substrate 588, and the various layers disposed therein can be encapsulated by an insulating layer 576, which can be biocompatible silicone, parylene, or polyimide, like the Figure 6 insulating layer 176 shown. In one example, the insulating layer can have a thickness in the range of 50 micrometers to 100 micrometers.

[0048] Implanting any of the artificial heart valves discussed herein into a patient (e.g., Figure 1 patient 2 shown) can include the following steps. First, the sterilized artificial heart valve is crimped from its assembled expanded state using an appropriate crimping tool so that the artificial heart valve can be inserted into a delivery medium (e.g., an expandable catheter). The crimped artificial heart valve can be inserted into a delivery site (e.g., Figure 2 the mitral valve 18 shown), and once properly positioned, can be re-expanded and sutured to the surrounding tissue. In one example, the artificial heart valve can be oriented such that one sensor circuit is oriented along the coronal plane and faces outward from the chest. Alternatively, the sensing circuit can be positioned along the sagittal plane such that it faces the patient's left armpit. In one example, the dimensions of the pre-crimped (i.e., assembled) expanded state and the final (i.e., re-expanded) expanded state of the artificial heart valve can be substantially similar. In alternative examples, the final expanded state of the artificial heart valve can be different from (e.g., smaller than) the pre-crimped expanded state. Additionally, the deformable nature of the inductor coils in various examples allows for the crimping and re-expansion of the artificial heart valve with little change in self-resonance and no observed degradation in circuit performance.

[0049] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods herein can include sterilizing the associated systems, devices, apparatuses, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0050] The treatment techniques, methods, steps, etc. described or proposed herein or in the references incorporated herein can be carried out on live animals or on non-living analogs, such as on cadavers, cadaver hearts, anthropomorphic dummies, phantoms (e.g., having body parts, tissues, etc. being simulated), etc.

[0051] Discussion of possible examples The following is a non-exclusive description of possible examples of the present invention.

[0052] The artificial valve includes a flexible frame that is disposed along a frame axis and is deformable between a crimped state and an expanded state about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network that defines a plurality of cells. The artificial valve further includes a first circuit mounted on the frame. The first circuit includes: a first inductor coil that is attached to a first subset of the struts and tracks the first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells; and a first sensor that is in electrical communication with the first inductor coil. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0053] The artificial valve of the previous paragraph may optionally include any one or more of the following additional and / or alternative features, configurations, and / or additional components: The artificial valve further includes a second circuit mounted on the frame. The second circuit includes: a second inductor coil that is attached to a second subset of the struts and tracks the second subset of the struts such that the second inductor coil outlines a second subset of the plurality of cells; and a second sensor that is in electrical communication with the second inductor coil. The second sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0054] The artificial valve further includes at least a first post assembly that extends axially away from the first end and at least a second post assembly that extends axially away from the second end. The first sensor is mounted on the first post assembly, and the second sensor is mounted on the second post assembly.

[0055] The first post assembly includes a first post and a first island, the second post assembly includes a second post and a second island, the first sensor is mounted on the first island, and the second sensor is mounted on the second island.

[0056] The artificial valve further includes a first detuning mitigation layer disposed between the first inductor coil and the frame and a second detuning mitigation layer disposed between the second inductor coil and the frame.

[0057] Each of the first and second detuning mitigation layers includes ferrite.

[0058] The artificial valve further includes a first insulating layer surrounding the first detuning mitigation layer and the first inductor coil, and a second insulating layer surrounding the second detuning mitigation layer and the second inductor coil.

[0059] The first and second insulating layers include one of silicone, parylene, and polyimide.

[0060] Each of the plurality of units has a tip.

[0061] The first inductor coil is attached to a first subset of struts at the tip of each of the first subset of the plurality of units.

[0062] The first inductor coil is detachably attached to the pointing tip of each of the first subset of the plurality of units by a plurality of sutures.

[0063] Each of the plurality of sutures is formed of a biocompatible polymer material.

[0064] The second inductor coil is attached to a second subset of struts at the tip of each of the second subset of the plurality of units.

[0065] The second inductor coil is detachably attached to the pointing tip of each of the second subset of the plurality of units by a plurality of sutures.

[0066] Each of the plurality of sutures is formed of a biocompatible polymer material.

[0067] The first subset of the plurality of units outlined by the first inductor coil includes two units in the axial direction and three units in the radial dimension.

[0068] The second subset of the plurality of units outlined by the second inductor coil includes two units in the axial direction and three units in the radial dimension.

[0069] The frame is formed of a biocompatible metal material.

[0070] Each of the first and second inductor coils is formed of gold.

[0071] Each of the first and second sensors is a capacitive pressure sensor, and the sensed physical parameter is pressure.

[0072] The first circuit has a first self-resonant frequency in the range of 5 MHz to 50 MHz.

[0073] The second circuit has a second self-resonant frequency in the range of 5 MHz to 50 MHz, and the second self-resonant frequency is different from the first self-resonant frequency.

[0074] The first circuit has a first self-resonant frequency in the range of 10 MHz to 20 MHz.

[0075] The second circuit has a second self-resonant frequency in the range of 10 MHz to 20 MHz, and the second self-resonant frequency is different from the first self-resonant frequency.

[0076] In the crimped state, the frame has a first axial dimension and a first radial dimension, and wherein in the expanded state, the frame has a second axial dimension and a second radial dimension.

[0077] The first axial dimension is greater than the second axial dimension, and the first radial dimension is less than the second radial dimension.

[0078] The frame is at least partially covered with a first biocompatible fabric, and the first biocompatible fabric is disposed between at least a portion of the first inductor coil or the second inductor coil and the frame.

[0079] A second biocompatible fabric covers at least one of the first inductor coil or the second inductor coil.

[0080] The artificial valve can be implanted into the mitral valve of a patient.

[0081] In the implanted state of the artificial valve, the frame axis is aligned with the blood flow through the artificial valve.

[0082] The artificial valve can be delivered to the mitral valve of a patient via an expandable catheter.

[0083] The artificial valve is sterilized.

[0084] A method of implanting an artificial valve includes: transitioning the artificial valve from an expanded state to a crimped state; delivering the artificial valve via an expandable catheter into an organ while in the crimped state; and returning the artificial valve to the expanded state once within the patient's organ.

[0085] The method of the previous paragraph may optionally include any one or more of the following features, configurations, and / or additional components: In the crimped state, the frame has a first axial dimension and a first radial dimension.

[0086] In the expanded state, the frame has a second axial dimension and a second radial dimension.

[0087] The first axial dimension is greater than the second axial dimension, and the first radial dimension is less than the second radial dimension.

[0088] The organ is the heart.

[0089] The method further includes sterilizing the artificial valve before delivering the artificial valve to the organ.

[0090] The prosthetic valve assembly includes a prosthetic valve, the prosthetic valve including a flexible frame disposed along a frame axis and deformable between a crimped state and a deployed state about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network defining a plurality of cells. The prosthetic valve further includes a first circuit mounted on the frame. The first circuit includes: a first inductor coil attached to and tracking a first subset of struts such that the first inductor coil outlines a first subset of the plurality of cells; and a first sensor in electrical communication with the first inductor coil. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter. The prosthetic valve assembly further includes a transmitter in communication with the first sensor.

[0091] The prosthetic valve assembly of the previous paragraph may optionally include any one or more of the following features, configurations, and / or additional components additionally and / or alternatively: The prosthetic valve further includes a second circuit mounted on the frame. The second circuit includes: a second inductor coil attached to and tracking a second subset of struts such that the second inductor coil outlines a second subset of the plurality of cells; and a second sensor in electrical communication with the second inductor coil. The second sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0092] The prosthetic valve further includes at least a first post assembly axially extending away from the first end and at least a second post assembly axially extending away from the second end. The first sensor is mounted on the first post assembly, and the second sensor is mounted on the second post assembly.

[0093] The transmitter is in communication with the second sensor.

[0094] The prosthetic valve assembly further includes a power source in wired or wireless communication with the prosthetic valve assembly.

[0095] The monitoring system includes a prosthetic valve assembly and an external device in communication with the prosthetic valve assembly.

[0096] The monitoring system of the previous paragraph may optionally include any one or more of the following features, configurations, and / or additional components additionally and / or alternatively: The external device includes a transceiver in wireless communication with the prosthetic heart valve assembly.

[0097] The monitoring system further includes a remote monitor in communication with the prosthetic heart valve assembly via the external device.

[0098] The prosthetic valve includes a flexible frame that is disposed along a frame axis and is deformable between a crimped state and a deployed state about the frame axis. The frame includes a first end, a second end disposed opposite the first end, and an interconnected strut network that defines a plurality of cells. The prosthetic valve further includes a multi-layer sensing assembly mounted on the frame. The multi-layer sensing assembly includes: a first pair of inductor coils that includes a first upper inductor coil portion and a first lower inductor coil portion, the first pair of inductor coils being disposed on a flexible substrate; a detuning mitigation layer disposed between the frame and the flexible substrate; and a first sensor in electrical communication with the first pair of inductor coils. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0099] The prosthetic valve of the preceding paragraph may optionally include any one or more of the following additional and / or alternative features, configurations, and / or additional components: The multi-layer sensing assembly further includes: a second pair of inductor coils that includes a second upper inductor coil portion and a second lower inductor coil portion, the second pair of inductor coils being disposed on a flexible substrate; and a second sensor in electrical communication with the second pair of inductor coils. The second sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0100] The detuning mitigation layer includes ferrite.

[0101] The prosthetic valve further includes an insulating layer that encapsulates the detuning mitigation layer and the flexible substrate.

[0102] The insulating layer includes one of silicone, parylene, and polyimide.

[0103] The thickness of the insulating layer is in the range of 50 microns to 100 microns.

[0104] The flexible substrate includes polyimide.

[0105] The thickness of the flexible substrate is in the range of 2 millimeters to 3 millimeters.

[0106] The thickness of the detuning mitigation layer is in the range of 0.25 millimeters to 0.35 millimeters.

[0107] The prosthetic valve further includes: a first soft magnetic layer disposed on the flexible substrate between the first upper inductor coil portion and the first lower inductor coil portion; and a second soft magnetic layer disposed on the flexible substrate between the second upper inductor coil portion and the second lower inductor coil portion.

[0108] The frame is formed of a biocompatible metallic material.

[0109] Each of the first and second pairs of inductor coils is formed of one of gold, copper, and titanium.

[0110] Each of the first and second sensors is a capacitive pressure sensor, and the physical parameter sensed therein is pressure.

[0111] The artificial valve may be implanted in the mitral valve of a patient.

[0112] The artificial valve may be delivered to the mitral valve of a patient via an expandable catheter.

[0113] The artificial valve is sterilized.

[0114] Although the invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various changes can be made and elements of the invention can be replaced with equivalents without departing from the scope of the invention. Additionally, many modifications can be made to adapt a particular situation or material to the teachings of the invention without departing from the basic scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

1. An artificial valve, comprising: A flexible frame disposed along a frame axis and deformable between a crimped state and a deployed state about the frame axis, the frame comprising: A first end; A second end disposed opposite the first end; and A network of interconnecting struts defining a plurality of cells; A first circuit mounted on the frame, the first circuit comprising: A first inductor coil attached to a first subset of the struts and tracking the first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells; and A first sensor in electrical communication with the first inductor coil; Wherein the first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

2. The artificial valve according to claim 1, further comprising: A second circuit mounted on the frame, the second circuit comprising: A second inductor coil attached to a second subset of the struts and tracking the second subset of the struts such that the second inductor coil outlines a second subset of the plurality of cells; and A second sensor in electrical communication with the second inductor coil; Wherein the second sensor is configured to sense the physical parameter and generate a signal representative of the physical parameter.

3. The artificial valve according to claim 2, further comprising: At least a first post assembly extending axially away from the first end; And At least a second post assembly extending axially away from the second end; Wherein the first sensor is mounted on the first post assembly; and Wherein the second sensor is mounted on the second post assembly.

4. The artificial valve according to claim 3, wherein: The first post assembly includes a first post and a first island; The second post assembly includes a second post and a second island; The first sensor is mounted to the first island; and The second sensor is mounted to the second island.

5. The artificial valve according to claim 2, further comprising: A first detuning mitigation layer disposed between the first inductor coil and the frame; And A second detuning mitigation layer disposed between the second inductor coil and the frame.

6. The artificial heart valve according to claim 5, wherein each of the first and second detuning mitigation layers comprises ferrite.

7. The artificial heart valve according to claim 6, further comprising: A first insulating layer surrounding the first detuning mitigation layer and the first inductor coil; And A second insulating layer surrounding the second detuning mitigation layer and the second inductor coil.

8. The artificial heart valve according to claim 7, wherein the first and second insulating layers include one of silicone, parylene, and polyimide.

9. The artificial valve according to claim 2, wherein: The first inductor coil is attached to the first subset of struts at the tip of each of the first subset of the plurality of cells; The first inductor coil is detachably attached to the tip of each of the first subset of the plurality of cells by a first plurality of sutures; The second inductor coil is attached to the second subset of struts at the tip of each of the second subsets of the plurality of cells; and the second inductor coil is detachably attached to the tip of each of the second subsets of the plurality of cells by a second plurality of sutures.

10. The artificial valve according to claim 2, wherein the frame is formed of a biocompatible metallic material.

11. The artificial valve according to claim 2, wherein each of the first and second inductor coils is formed of gold.

12. The artificial valve according to claim 2, wherein each of the first and second sensors is a capacitive pressure sensor, and wherein the sensed physical parameter is pressure.

13. The artificial valve according to claim 2, wherein the first circuit has a first self-resonant frequency in the range of 5 MHz to 50 MHz, and wherein the second circuit has a second self-resonant frequency in the range of 5 MHz to 50 MHz, the second self-resonant frequency being different from the first self-resonant frequency.

14. The artificial valve according to claim 2, wherein the frame is at least partially covered with a first biocompatible fabric disposed between at least a portion of the first inductor coil or the second inductor coil and the frame.

15. The artificial valve according to claim 14, wherein a second biocompatible fabric covers at least one of the first inductor coil or the second inductor coil.

16. The artificial valve according to claim 2, wherein the artificial valve is sterilized.

17. A monitoring system, comprising: an artificial valve assembly, comprising: the artificial valve according to claim 2; a transmitter in communication with the first sensor and the second sensor; an external device in communication with the artificial valve assembly; wherein the external device includes a transceiver for wireless communication with the artificial heart valve assembly.

18. An artificial valve, comprising: a flexible frame disposed along a frame axis and deformable between a crimped state and a deployed state about the frame axis, the frame comprising: a first end; a second end disposed opposite the first end; a network of interconnecting struts defining a plurality of cells; a multi-layer sensing assembly mounted on the frame, the multi-layer sensing assembly comprising: a first pair of inductor coils including a first upper inductor coil portion and a first lower inductor coil portion, the first pair of inductor coils disposed on a flexible substrate; a detuning mitigation layer disposed between the frame and the flexible substrate; and a first sensor in electrical communication with the first pair of inductor coils; wherein the first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

19. The artificial valve according to claim 18, further comprising: an insulating layer encapsulating the detuning mitigation layer and the flexible substrate.

20. The artificial valve according to claim 18, further comprising: A first soft magnetic layer, which is disposed between the first upper inductor coil portion and the first lower inductor coil portion on the flexible substrate.

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