Transcatheter Heart Valve with Deformable Inductors for Dual Wireless Pressure Monitoring

Abstract

Transcatheter Heart Valve with Deformable Inductors for Dual Wireless Pressure Monitoring The prosthetic valve includes a flexible frame disposed along and deformable about the frame axis. The frame includes a first end, a second end 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 tracing 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

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 387,915, filed December 16, 2022, and entitled "TRANSCATHETER HEART VALVE WITH DEFORMABLE INDUCTOR FOR DUAL WIRELESS PRESSURE MONITORING," the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical implant devices, and in particular to implantable prosthetic valves. [Background technology]

[0003] Patients undergoing heart valve transplants may suffer from postoperative complications. The risk of complications is particularly high within 30 to 60 days of the transplant procedure. However, during this period, the patient may no longer be in the hospital or extended care facility / system; therefore, any complications that arise may require readmission to the care system, adding significant costs to overall patient care. Furthermore, failure to recognize complications until they manifest through perceptible symptoms that the patient interprets as requiring hospital care may increase health risks by delaying the patient's readmission to the hospital. Therefore, systems, devices, and methods for postoperative monitoring of prosthetic heart valve transplant recipients, including in environments outside of the hospital or care facility, are desirable to improve patient outcomes. Summary of the Invention [Means for solving the problem]

[0004] In one embodiment, the prosthetic valve includes a flexible frame disposed along 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 tracing 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 embodiment, a prosthetic valve assembly includes a prosthetic valve having a flexible frame disposed along a frame axis and deformable about the frame axis between a crimped state and an expanded state. 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 tracing 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 prosthetic valve assembly further includes a transmitter in communication with the first sensor.

[0006] In another example, the prosthetic valve includes a flexible frame disposed along a frame axis and deformable about the frame axis between a crimped state and an expanded state. 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 multi-layered sensing assembly is mounted on the frame. The multi-layered sensing assembly includes: a first inductor coil pair having first upper and lower inductor coil portions, the first inductor coil pair disposed on a flexible substrate; a harmonic reduction layer disposed between the frame and the flexible substrate; and a first sensor in electrical communication with the first inductor coil pair. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a schematic diagram of a human patient with a heart. [Figure 2] FIG. 2 is a schematic diagram of a partial cross section of the heart. [Figure 3] FIG. 3 is a block diagram illustrating a monitoring system for monitoring one or more physiological parameters associated with a patient. [Figure 4] FIG. 4 is a perspective view of a first embodiment of a prosthetic heart valve shown in an expanded state. [Figure 5] 5 is a front view of the sensing circuitry of the prosthetic heart valve of FIG. 4 shown separated from the frame. [Figure 6] 6 is a schematic cross-sectional exploded view of the struts and inductor coil of the prosthetic heart valve of FIG. 4, taken transverse to axis A of FIG. [Figure 7] FIG. 7 is a perspective view of a second embodiment of a prosthetic heart valve shown in an expanded state. [Figure 8] FIG. 8 is a schematic front view of a third embodiment of a prosthetic heart valve shown in a crimped state. [Figure 9]FIG. 9 is a schematic plan view comparing the radial dimensions of the frame of a third embodiment of a prosthetic heart valve in an expanded state and a crimped state. [Figure 10] FIG. 10 is a schematic diagram of a fourth embodiment of a prosthetic heart valve shown in an expanded state with a fabric cover over the inductor coil. [Figure 11] FIG. 11 is a schematic cross-sectional view showing a portion of a multi-layer sensing assembly disposed on a flexible frame. DETAILED DESCRIPTION OF THE INVENTION

[0008] 1 is a front view of a human patient 2 having a heart 4. The body of the patient 2 can be generally bisected by any of three planes: the coronal (i.e., xy) plane, the sagittal (i.e., yz) plane, and the horizontal (i.e., xz) plane.

[0009] Figure 2 is a partial cross-sectional schematic diagram of a heart 4. The heart 4 includes four chambers: a left atrium 6, a left ventricle 8, a right ventricle 10, and a right atrium 12. The four chambers are shown in cross-section in Figure 2. The heart 4 further includes four valves to aid in the circulation of blood therein, including a tricuspid valve 14, a pulmonary valve 16, a mitral valve 18, and an aortic valve 20. Figure 2 further shows a pulmonary artery 21, and an aorta 22.

[0010] The tricuspid valve 14 separates the right atrium 12 from the right ventricle 10 and may include three coronary cusps, or leaflets. The tricuspid valve 14 can close during ventricular contraction (i.e., systole) and open during ventricular expansion (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 to allow blood to be pumped toward the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery 21 into the heart 4. Like the tricuspid valve 14, the pulmonary valve 16 may have three coronary cusps / leaflets, each resembling a crescent moon. The mitral valve 18 separates the left atrium 8 from the left ventricle 6 and may have two coronary cusps / leaflets. The mitral valve 18 is configured to open during diastole to allow blood from the left atrium 6 to flow into the left ventricle 8 and close during systole to prevent blood from flowing back into the left atrium 6. Aortic valve 20 separates left ventricle 8 from aorta 22. Aortic valve 20 is configured to open during systole to allow blood leaving left ventricle 8 to enter aorta 22 and close during diastole to prevent blood from leaking back into left ventricle 8.

[0011] A heart valve may include multiple valve or coronary cusps attached to the annulus, as well as a relatively dense fibrous ring, referred to herein as the annulus. Some valves may further include a collection of chordae tendineae and papillary muscles that secure the valve cusps. Generally, the size of the valve or coronary cusps may be such that, when the heart contracts, the increased blood pressure within the corresponding heart chamber causes the valve cusps to at least partially open, allowing flow from the heart chamber. When pressure within a heart chamber decreases, pressure within the subsequent heart chamber or blood vessel may prevail and push the valve cusps back. As a result, the valve / coronary cusps appose each other, thereby closing the flow path.

[0012] Heart valve disease describes a condition in which one or more of the valves of the heart 4 does not function properly. Affected heart valves can be classified as stenotic, in which the valve does not open sufficiently to allow proper forward flow of blood through the valve, and / or incompetent, in which the valve does not close completely, causing excessive backflow of blood through the valve when closed. In certain conditions, valve disease can be severely debilitating and, if left untreated, fatal.

[0013] For example, to treat disease of the mitral valve 18, a prosthetic heart valve can be implanted and sutured into the annulus of the mitral valve 18. Such a prosthetic heart valve can be positioned with its opening oriented in the direction of blood flow from the left atrium 6 to the left ventricle 8. The prosthetic heart valve can be configured to operate as an aortic valve 20 to allow unidirectional blood flow from the left atrium 6 to the left ventricle 8 while preventing flow in the reverse direction.

[0014] In a typical heart transplant procedure, the heart may be opened, and in a valve replacement procedure, the defective valve may be removed, leaving behind the desired placement site, which may include the valve annulus. Sutures may be passed through the valve annulus or fibrous tissue at the desired placement site to form a series of stitches. The free ends of the sutures may be individually threaded through the suture-permeable sealing rim of the prosthetic heart valve. Prosthetic heart valves may be used to replace defective or deteriorating native heart valves in patients with heart valve disorders such as aortic stenosis or mitral regurgitation. The valve replacement process generally involves a surgical or transcatheter procedure (e.g., balloon valvotomy) to replace the existing valve with a new prosthetic valve. Because prosthetic valves are foreign bodies, such procedures can involve many different challenges and problems. For example, paravalvular leak (PVL) and / or thickening of the valve leaflets may occur in patients undergoing heart valve replacement surgery. Similarly, rejection of prosthetic surgical heart valves due to thrombus may occur, requiring patients to use anticoagulants for proper valve function.

[0015] Some methods for monitoring valve performance after implantation involve the use of complex bioimaging techniques, such as echocardiography. Such methods can generally only be performed in specialized medical centers and can require significant time and expense. Therefore, such methods are generally only used after symptoms of valve dysfunction are detected. Some prosthetic valves may not offer the ability to detect changes in operation to detect problems early. Furthermore, many patients with valvular disease who require prosthetic valves may also suffer from other cardiovascular disorders, including heart failure. Some prosthetic heart valve systems may not be able to collect data about the valve and / or postoperative patient status in outpatient settings (e.g., cardiologist visits) using existing patient monitoring systems. As the number and diversity of patients increases over time, such systems may not provide routine data collection with sufficient resolution to enable the development of new digital solutions for better patient management.

[0016] Thus, the prosthetic heart valve can be part of a larger system for post-operative patient monitoring, as will be described with reference to FIG.

[0017] 3 is a block diagram illustrating a monitoring system 23 for monitoring one or more physiological parameters associated with a patient (e.g., patient 2 shown in FIG. 1). System 23 includes a prosthetic heart valve 24 that includes a sensing device 26, a control circuit 28, a transmitter 30, and a power source 32. System 23 further includes an external device 34 that includes an antenna 36, ​​a control circuit 38, and a transceiver 40. System 23 also includes a cloud 42 and a remote monitor 44.

[0018] The prosthetic heart valve 24 may include one or more sensing devices 26, a control circuit 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 / gauges, accelerometers, gyroscopes, and / or other types of sensors that may be positioned within the patient to sense one or more parameters related to the patient's health. The control circuit 28 may be connected to the sensing device 26 via wires or wirelessly and may include one or more of an application-specific integrated circuit (ASIC), a microcontroller, a chip, tuning capacitors, etc. The control circuit 28 may receive signals (e.g., requests for stored data or immediately retrieved data) from an external device 34, request data from the sensors 26, and coordinate data transmission. The transmitter 30 may be, for example, an antenna for emitting electronic signals transmitted by the control circuit 28. The power source 32 may be any suitable power source that minimizes interference with the patient's heart or other anatomical structures. In one embodiment, power source 32 may be a passive means for wirelessly receiving external power (e.g., short-range or near-field wireless power communication), hi another embodiment, power source 32 may be a battery or a means for locally harvesting energy from within the patient.

[0019] An external device 34, located at least partially outside the patient, can wirelessly communicate with the prosthetic heart valve 24. The external device 34 includes an antenna 36, ​​a control circuit 38, and a transceiver 40. The antenna 36 can receive wireless signal transmissions from the prosthetic heart valve 24. In one embodiment, the antenna 36 can be externally mounted to the external device 34. The control circuit 38 can be a processor or other suitable means for processing signals received from the prosthetic heart valve 24. The transceiver 40 can be configured to receive and amplify signals from the prosthetic heart valve 24 as well as transmit signals to a cloud 42 and a remote monitor 44. Such signals can include, for example, pressure data obtained from the sensor 26. Accordingly, the transceiver 40 can include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc. for processing and / or handling transmitted and received signals.

[0020] The external device 34 can serve as an intermediate communication device between the prosthetic heart valve 24 and the remote monitor 44. The external device 34 can be a dedicated external unit designed to communicate with the prosthetic heart valve 24. For example, the external device 34 can be a wearable communication device or other device that can be easily placed in proximity to the patient and / or the prosthetic heart valve 24. The external device 34 can be configured to continuously, periodically, or sporadically interrogate the prosthetic heart valve 24 to extract or request sensor-based information therefrom. In some examples, the external device 34 can include a user interface that allows a user (e.g., a patient) to view sensor data, request sensor data, or otherwise interact with the external device 34 and / or the prosthetic heart valve 24.

[0021] The cloud 42 may be a secure network that communicates with the external device 34 via Ethernet, Wi-Fi, or other network protocols. The cloud 42 may also be configured to implement data storage. In another example, the cloud 42 may instead be a secure physical network. The remote monitor 44 may communicate with the external device 34 via the cloud 42. The remote monitor 44 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received via the cloud 42 from the external device 34 or the prosthetic heart valve 24. For example, the remote monitor 44 may advantageously be operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient. Although certain embodiments disclosed herein describe communication from the prosthetic heart valve 24 with the remote monitor 44 indirectly through the external device 34, the prosthetic heart valve 24 may alternatively include a transmitter (e.g., transmitter 30) that can communicate with the remote monitor 44 via the cloud 42 without having to relay information through the device 34.

[0022] Figure 4 is a perspective view of the prosthetic heart valve 124, shown in an expanded state. Figure 5 is a front view of the sensing circuitry of the prosthetic heart valve 124, shown separated from the frame. Figures 4 and 5 will be discussed together.

[0023] As shown in FIG. 4 , the structural components of the prosthetic heart valve 124 include a deformable frame 146 and post assemblies 148 extending axially away from the frame 146 relative to a valve axis A. The axis A may be generally aligned with the direction of blood flow through the prosthetic heart valve 124 when implanted in the heart 4. The frame 146 may be formed from a biocompatible metallic material. As shown in FIG. 4 , one post assembly 148 extends from each of the apical / upper end 150 and the bottom / lower end 152 of the prosthetic heart valve 124, based on the orientation of FIG. 4 . Each post assembly 148 may include a post 154 on which a sensor 126 may be mounted, and an island 156. As shown in FIG. 4 , 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 opposed axially arranged pointed tips / ends 162 .

[0024] The electrical components of the prosthetic 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 electrically connected to the inductor coil 166 (e.g., via a lead / wire). The sensing circuits 164 may be inductor-resistor-capacitor (LCR) circuits 168, with the inductor coil 166 forming the inductor (L) and resistor (R) elements of the circuit 168 and the sensor 126 connected in parallel to form the capacitor (C) element. Each LCR circuit 168 of the prosthetic heart valve 126 has a distinct self-resonant frequency. The self-resonant frequency of each circuit may be expressed by the following equation:

[0025]

number

[0026] where L is the inductance of the inductor coil 166 and C(p) is the capacitance of the sensor 126 at a given pressure. Typically, the self-resonant frequency of each LCR circuit 168 can be in the range of 5 MHz to 50 MHz, more specifically, 10 MHz to 20 MHz.

[0027] The inductor coil 166 may include one or more individual wires formed from a conductive yet biocompatible metallic material, such as gold. Other examples may include copper or titanium. The inductor coil 166 may be further coated with an insulating coating (shown and labeled in FIG. 6 ). In one embodiment, the sensors 126 may be capacitive pressure sensors, each including a diaphragm and a pressure cavity forming a variable capacitor for detecting strain due to pressure applied to the diaphragm. Generally, as pressure deforms the diaphragm, the capacitance of the sensor 126 decreases. To manage tuning of the sensing circuit 164, a harmonic reduction layer, discussed in more detail below with respect to FIGS. 6 and 11 , may be positioned between the inductor coil 166 and the struts 158 of the frame 146.

[0028] Inductor coil 166 may be removably attached to frame 146 by sutures 170, shown schematically in FIG. 5 . Suture 170 may be formed from a biocompatible polymer, in one embodiment. More specifically, inductor coil 166 may be attached to frame 146 in a manner that traces a subset of struts 158 and outlines a subset of cells 160. In this regard, inductor coil 166 may have substantially identical geometric attributes to struts 158 and cells 160, e.g., having pointed tips 172 that correspond to pointed tips 162 of cells 160 underlying frame 146. In the embodiment of FIGS. 4 and 5 , inductor coil 166 may be positioned to trace / frame / outline a two-by-three subset of cells 160 of frame 146 (i.e., two axially tall cells and three radially long cells). This may include the top or bottom cells, along with interior cells 160. Other arrangements are contemplated herein. The sutures 170 may be placed at various points along the inductor coil 166 to ensure that the inductor coil 166 is secured to the supporting subset of struts 158 and maintains its shape. The suture points may each include the pointed tips 162 of the cells 160 of the frame 146 and the pointed tips 172 of the inductor coil 166. Additional and / or alternative suture points are contemplated herein.

[0029] Figure 6 is a schematic cross-sectional exploded view of the struts 158 and inductor coil 166 of the prosthetic heart valve of Figure 4, taken transverse to axis A of Figure 4. Figure 6 shows the struts 158, inductor coil 166, ferrite layer 174, insulating layer 176, and adhesive backing layer 178.

[0030] As shown in FIG. 6 , the struts 158 are the innermost layer, and the inductor coil 166 is the outermost layer. A ferrite layer 174 is disposed between the struts 158 and the inductor coil 166. The ferrite layer 174, in one example, may be formed as a strip of soft ferromagnetic material and may mitigate degradation caused by the proximity of the inductor coil 166 to the metal struts 158. The ferrite layer 174 may further 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 prosthetic heart valve 124. The ferrite layer 174 is ideally coextensive with the inductor coil 166 so that no area of ​​the inductor coil 166 is exposed to the underlying metal strut(s) 158. Additionally, the ferrite layer 174 should be sufficiently flexible to allow the prosthetic heart valve 124 to transition between a crimped state and an expanded state and maintain its position between the struts 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 may be in direct physical contact (e.g., as a monolithic layer), or the insulating layer 176 can surround / surround 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 polymer (e.g., parylene or polyimide). In some examples, an adhesive backing layer 178 can be included between the insulating layer 176 and the struts 158. Such an adhesive layer can be both biocompatible and non-conductive.

[0031] FIG. 7 is a perspective view of a prosthetic heart valve 224 in an expanded state. The prosthetic heart valve 224 is substantially similar to the prosthetic heart valve 124 shown in FIG. 4 and includes a deformable frame 246 and a post assembly 248 extending axially spaced from the frame 246 at each of an upper end 250 and a lower end 252. The post assembly 248 includes posts 254 and islands 256 for mounting the sensors 226 thereon. The struts 258 of the frame 246 define cells 260. The cells 260 may include oppositely disposed pointed tips 262. The prosthetic heart valve 224 further includes two sensing circuits 264 configured as LCR circuits 268, each including a sensor 226 and an inductor coil 266 that trace a subset of the struts 258 and delineate a subset of the cells 260. Inductor coils 266 may be formed from one or more conductive (e.g., gold) wires and include an underlying ferrite layer (not shown in FIG. 7). Sutures (not shown in FIG. 7) may secure each inductor coil 266 to frame 246 in the manner described above with respect to FIGS. 4 and 5.

[0032] Unlike the previous embodiments, the prosthetic heart valve 224 includes a biocompatible fabric 280 configured as a skirt and a partially covering frame 246. The fabric 280 may be formed from a polymeric material. In an alternative embodiment, the fabric 280 may completely cover the frame 246 such that the struts 258 are not exposed on the outside of the frame 246. The prosthetic heart valve 224 also includes pericardial tissue 282, which may be formed from a synthetic material or may be derived from a mammalian (e.g., bovine) tissue source.

[0033] FIG. 8 is a schematic front view of a prosthetic heart valve 324 shown in a crimped state. The prosthetic heart valve 324 is substantially similar to the prosthetic heart valve 124 shown in FIG. 4 and the prosthetic heart valve 224 shown in FIG. 7, with a deformable frame 346 having interconnected struts 358 defining cells 360. The frame 346 may be formed from a biocompatible metallic material. Post assemblies 348 (only one shown in FIG. 8) extend axially spaced from an upper end 350. The prosthetic heart valve 324 may further include at least one sensing circuit 364 having a flexible inductor coil 366 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 when in the expanded state, such that the upper end 350 is spaced further from the lower end 352 in the crimped state. Furthermore, in the crimped state, the inductor coil 366, which is stitched to the frame 346, deforms in the same manner as the frame 346, maintaining the shape of the underlying posts 358 and framing the deformed cell 360 and increasing / stretching axially. This may occur, for example, due to the relative overall flexibility of the inductor coil material and / or surrounding layers (e.g., insulating layers and harmonic reduction means), the thickness of the layers, and the robustness of the attachment means (e.g., sutures) for securing the inductor coil to the underlying posts.

[0034] FIG. 9 is a schematic plan view comparing the radial dimensions of the frame 346 of the prosthetic heart valve 324 in the expanded and crimped states. The frame 346 is the frame of the prosthetic heart valve 324 shown in FIG. 8. The frame 346 in the expanded state is represented by a solid line, and the frame 346 in the crimped state is represented by a dashed line. As shown in FIG. 9, in the expanded state, the frame 346 has a radius R1, and 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 smaller than the axial dimension of the frame 346 in the crimped state. In the expanded state, the radial dimension of the frame 346 (i.e., radius R1) is greater than the radial dimension of the frame 346 in the crimped state (i.e., radius R2).

[0035] FIG. 10 is a schematic perspective view of a prosthetic heart valve 424 shown in an expanded state with a fabric cover 484 over the inductor coil 466. For simplicity, the prosthetic heart valve 424 is shown without the post assembly and sensor. The prosthetic heart valve 424 is substantially similar to the prosthetic heart valve 124 shown in FIG. 4, the prosthetic heart valve 224 shown in FIG. 7, and the prosthetic heart valve 324 shown in FIG. 8. The prosthetic heart valve 424 has a biocompatible metal frame 446 with interconnected struts, upper ends 450, and lower ends 452 that define cells (not shown in FIG. 10). The prosthetic heart valve 424 further includes a sensing circuit 464 (only one shown) comprising an inductor coil 466 and a sensor (not shown). The inductor coil 466 may 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.

[0036] The prosthetic heart valve 424 differs from the previous embodiments in that it includes a cover 484 disposed over the inductor coil 466 and the sutures 470. Accordingly, the hidden components are represented by dashed lines. The cover 484 may be a biocompatible fabric substantially similar to the fabric 280 of FIG. 7. The cover 484 may be sewn and / or woven to the frame 446 to secure it in place in one embodiment, while in another embodiment, the cover 484 may be positioned as a sleeve around the frame 446. The cover 484 may protect the hidden components from natural tissue ingrowth after implantation of the prosthetic heart valve 424. The cover 484 may further protect surrounding tissue from catching on / directly contacting the hidden components.

[0037] 11 is a schematic cross-sectional view of a portion of a multi-layered sensing assembly 586 disposed on a flexible frame 546. The multi-layered sensing assembly 586 incorporates multiple inductor coils 566 stacked / layered radially relative to the axis of the containing prosthetic heart valve and may be used with any of the prosthetic heart valves disclosed herein.

[0038] As shown in FIG. 11 , multi-layer sensing assembly 586 is disposed on metal post 558, which may be formed from a biocompatible metallic material. Multi-layer sensing assembly 586 includes a first inductor coil pair 566A and a second inductor coil pair 566B, each including an upper coil portion and a lower coil portion printed on flexible substrate 588. Flexible substrate 588 may be formed from a polymer material, such as polyimide, and in one example, may have a thickness in the range of 2 millimeters to 3 millimeters. Each inductor coil pair 566A and 566B may be printed on flexible substrate 588 and may be formed from gold in one example, or from copper or titanium in alternative examples. Each inductor coil pair 566A and 566B may be electrically connected to a respective sensor 526 to form sensing circuit 564, which is schematically represented in FIG. 11 . Sensor 526 may be substantially similar to sensor 126 shown in FIGS. 4 and 5, sensor 226 shown in FIG. 7, and / or sensor 326 shown in FIG. 8. Each upper coil portion of inductor coil pair 566A and 566B may be further electrically connected to its respective lower coil portion (e.g., through conductive vias). Inductor coil pair 566A and 566B may have a pattern similar to inductor coil 166 shown in FIGS. 4-6, inductor coil 266 shown in FIG. 7, inductor coil 366 shown in FIG. 8, and inductor coil 466 shown in FIG. 10, and may be arranged along strut 558 and cells (not shown). Alternatively, inductor coil pair 566A and 566B may be arranged as a rounded or square spiral in another embodiment.

[0039] The multi-layer sensing assembly 586 further includes a flexible ferrite layer 574 disposed between the support post 558 and the inductor coil pair 566A and 566B. The ferrite layer 574 may be substantially similar to the ferrite layer 174 shown in FIG. 6 in that it prevents magnetic field interference and reduces degradation of the sensing circuit 564. An exemplary material for the ferrite layer 574 may include manganese zinc (MnZn) ferrite or nickel zinc (NiZn) ferrite. In the embodiment shown in FIG. 11, the ferrite layer 574 may be printed on the flexible substrate 588. The ferrite layer 574 may have a thickness in the range of 0.25 millimeters to 0.35 millimeters in one embodiment. Soft magnetic layers 590A and 590B may be further disposed between the upper and lower coil portions of each inductor coil pair 566A and 566B and may be formed from a frequency-dependent soft magnetic material. More specifically, soft magnetic layer 590A can be responsive and adjusted to the frequency at which inductor coil pair 566A is operating. Similarly, soft magnetic layer 590B can be responsive and adjusted to the frequency at which inductor coil pair 566B is operating. Thus, soft magnetic layers 590A and 590B separate the two different frequencies of their respective inductor coil pairs, minimizing interference and crosstalk between inductor coil pairs 566A and 566B. Ferrite layer 574, flexible substrate 588, and the various layers disposed therein can be encapsulated by insulating layer 576, which can be biocompatible silicone, parylene, or polyimide, similar to insulating layer 176 shown in FIG. 6 . The insulating layer, in one embodiment, can have a thickness ranging from 50 microns to 100 microns.

[0040] Implantation of any of the prosthetic heart valves discussed herein in a patient (e.g., patient 2 shown in FIG. 1 ) may include the following steps: First, a sterilized prosthetic heart valve is crimped from an assembled, expanded state using an appropriate crimping tool so that the prosthetic heart valve can be inserted into a delivery vehicle (e.g., an expandable catheter). The crimped prosthetic heart valve may be inserted into a delivery site (e.g., mitral valve 18 shown in FIG. 2 ) and, once properly positioned, may be re-expanded and sutured to surrounding tissue. In one example, the prosthetic heart valve may be oriented such that one sensor circuit is oriented outward from the chest along the coronal plane. Alternatively, the sensing circuit may be oriented along the sagittal plane so that it faces the patient's left axilla. The dimensions of the prosthetic heart valve in its pre-crimped (i.e., assembled) expanded state and its final (i.e., re-expanded) expanded state may, in one example, be substantially similar. In alternative embodiments, the final expanded state of the prosthetic heart valve can be different (e.g., smaller) than the pre-crimped expanded state. Furthermore, the deformable nature of the inductor coil of various embodiments allows for the prosthetic heart valve to be crimped and re-expanded with little or no change in self-resonance and no observed degradation in circuit performance.

[0041] Any of the various systems, devices, apparatus, etc. in the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use on patients, and the methods herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0042] The treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the documents incorporated herein, may be performed on live animals or on non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., in which body parts, tissues, etc. are simulated), etc.

[0043] Description of Possible Implementations The following is a non-exclusive description of possible embodiments of the present invention.

[0044] The prosthetic valve includes a flexible frame disposed along a frame axis and deformable about the frame axis between a crimped state and an expanded state. The frame includes a first end, a second end opposite the first end, and a network of interconnected struts 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 tracing 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.

[0045] The prosthetic valve of the preceding paragraph may optionally, additionally, and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0046] The prosthetic valve further includes a second circuit mounted on the frame, the second circuit including a second inductor coil attached to and tracing a 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, the second sensor configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0047] The prosthetic valve further includes 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 the second sensor is mounted on the second post assembly.

[0048] 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 attached to the first island, and the second sensor is attached to the second island.

[0049] The prosthetic valve further includes a first harmonic reduction layer disposed between the first inductor coil and the frame, and a second harmonic reduction layer disposed between the second inductor coil and the frame.

[0050] The first and second harmonic reduction layers each include ferrite.

[0051] The prosthetic valve further includes a first insulating layer surrounding the first harmonic reduction layer and the first inductor coil, and a second insulating layer surrounding the second harmonic reduction layer and the second inductor coil.

[0052] The first and second insulating layers include one of silicone, parylene, and polyimide.

[0053] Each of the plurality of cells has a pointed tip.

[0054] A first inductor coil is attached to the first subset of posts at the pointed tip of each of the first subset of the plurality of cells.

[0055] A first inductor coil is removably attached to the pointed tip of each of the first subset of the plurality of cells by a plurality of sutures.

[0056] Each of the plurality of sutures is formed from a biocompatible polymeric material.

[0057] A second inductor coil is attached to the second subset of posts at the pointed tip of each of the second subset of the plurality of cells.

[0058] A second inductor coil is removably attached to the pointed tip of each of a second subset of the plurality of cells by a plurality of sutures.

[0059] Each of the plurality of sutures is formed from a biocompatible polymeric material.

[0060] A first subset of the plurality of cells defined by the first inductor coil includes two cells in the axial dimension and three cells in the radial dimension.

[0061] A second subset of the plurality of cells defined by the second inductor coil includes two cells in the axial dimension and three cells in the radial dimension.

[0062] The frame is formed from a biocompatible metallic material.

[0063] Each of the first and second inductor coils is formed from gold.

[0064] Each of the first and second sensors is a capacitive pressure sensor, and the physical parameter sensed is pressure.

[0065] The first circuit has a first self-resonant frequency in the range of 5 MHz to 50 MHz.

[0066] 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.

[0067] The first circuit has a first self-resonant frequency in the range of 10 MHz to 20 MHz.

[0068] The second circuit has a second self-resonant frequency in the range of 10 MHz to 20 MHz, the second self-resonant frequency being different from the first self-resonant frequency.

[0069] In the crimped state, the frame has a first axial dimension and a first radial dimension, and in the expanded state, the frame has a second axial dimension and a second radial dimension.

[0070] The first axial dimension is greater than the second axial dimension, and the first radial dimension is less than the second radial dimension.

[0071] The frame is at least partially covered with a first biocompatible fabric, the first biocompatible fabric being disposed between at least a portion of the first inductor coil or the second inductor coil and the frame.

[0072] A second biocompatible textile covers at least one of the first inductor coil or the second inductor coil.

[0073] The prosthetic valve is implantable into the patient's mitral valve.

[0074] When the prosthetic valve is implanted, the frame axis is aligned with the flow of blood through the prosthetic valve.

[0075] The prosthetic valve can be delivered to the patient's mitral valve via an expandable catheter.

[0076] The prosthetic valve is sterilized.

[0077] A method of implanting a prosthetic valve includes transitioning the prosthetic valve from an expanded state to a crimped state, delivering the prosthetic valve into the organ via an expandable catheter while in the crimped state, and returning the prosthetic valve to the expanded state once inside the patient's organ.

[0078] The method of the preceding paragraphs may optionally, additionally, and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0079] In the crimped state, the frame has a first axial dimension and a first radial dimension.

[0080] In the expanded state, the frame has a second axial dimension and a second radial dimension.

[0081] The first axial dimension is greater than the second axial dimension, and the first radial dimension is less than the second radial dimension.

[0082] The organ is the heart.

[0083] The method further includes sterilizing the prosthetic valve before delivering it to the organ.

[0084] The prosthetic valve assembly includes a prosthetic valve including a flexible frame disposed along a frame axis and deformable about the frame axis between a crimped state and an expanded state. 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. The prosthetic valve further includes a first circuit mounted on the frame. The first circuit includes a first inductor coil attached to and tracing 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 prosthetic valve assembly further includes a transmitter in communication with the first sensor.

[0085] The prosthetic valve assembly of the preceding paragraph may optionally, additionally, and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0086] The prosthetic valve further includes a second circuit mounted on the frame, the second circuit including a second inductor coil attached to and tracing a 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, the second sensor configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0087] The prosthetic valve further includes 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 the second sensor is mounted on the second post assembly.

[0088] The transmitter is in communication with the second sensor.

[0089] The prosthetic valve assembly further includes a power source in wired or wireless communication with the prosthetic valve assembly.

[0090] The monitoring system includes a prosthetic valve assembly and an external device in communication with the prosthetic valve assembly.

[0091] The monitoring system of the preceding paragraph may optionally, additionally, and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0092] The external device includes a transceiver that wirelessly communicates with the prosthetic heart valve assembly.

[0093] The monitoring system further includes a remote monitor that communicates with the prosthetic heart valve assembly via the external device.

[0094] The prosthetic valve includes a flexible frame disposed along a frame axis and deformable about the frame axis between a crimped state and an expanded state. 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. The prosthetic valve further includes a multi-layered sensing assembly mounted on the frame. The multi-layered sensing assembly includes a first inductor coil pair having first upper and lower inductor coil portions, the first inductor coil pair disposed on a flexible substrate, a harmonic reduction layer disposed between the frame and the flexible substrate, and a first sensor in electrical communication with the first inductor coil pair. The first sensor is configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0095] The prosthetic valve of the preceding paragraph may optionally, additionally, and / or alternatively include one or more of the following features, configurations, and / or additional components.

[0096] The multi-layer sensing assembly further includes a second inductor coil pair having second upper and lower inductor coil portions, the second inductor coil pair being disposed on the flexible substrate, and a second sensor in electrical communication with the second inductor coil pair, the second sensor being configured to sense a physical parameter and generate a signal representative of the physical parameter.

[0097] The harmonic reduction layer includes ferrite.

[0098] The prosthetic valve further includes an insulating layer encapsulating the harmonic reduction layer and the flexible substrate.

[0099] The insulating layer includes one of silicone, parylene, and polyimide.

[0100] The thickness of the insulating layer is in the range of 50 microns to 100 microns.

[0101] The flexible substrate includes a polyimide.

[0102] The thickness of the flexible substrate ranges from 2 millimeters to 3 millimeters.

[0103] The thickness of the harmonic reduction layer ranges from 0.25 millimeters to 0.35 millimeters.

[0104] The prosthetic valve further includes a first soft magnetic layer disposed on the flexible substrate between the first upper inductor coil portion and the lower inductor coil portion, and a second soft magnetic layer disposed on the flexible substrate between the second upper inductor coil portion and the lower inductor coil portion.

[0105] The frame is formed from a biocompatible metallic material.

[0106] Each of the first and second inductor coil pairs is formed from one of gold, copper, and titanium.

[0107] Each of the first and second sensors is a capacitive pressure sensor, and the physical parameter sensed is pressure.

[0108] The prosthetic valve is implantable into the patient's mitral valve.

[0109] The prosthetic valve can be delivered to the patient's mitral valve via an expandable catheter.

[0110] The prosthetic valve is sterilized.

[0111] While the invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its essential scope. Therefore, it is not intended that the invention be limited to the particular embodiments disclosed, but rather that the invention will include all embodiments falling within the scope of the appended claims.

Claims

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

2. a second circuit mounted on the frame, the second circuit comprising: a second inductor coil attached to and tracing a second subset of the posts such that the second inductor coil outlines a second subset of the plurality of cells; a second sensor in electrical communication with the second inductor coil; The prosthetic valve of claim 1 , wherein the second sensor is configured to sense the physical parameter and generate a signal representative of the physical parameter.

3. at least a first post assembly extending axially spaced from the first end; at least a second post assembly extending axially away from the second end; the first sensor is mounted on the first post assembly; The prosthetic valve of claim 2 , wherein the second sensor is mounted on the second post assembly.

4. the first post assembly comprising a first post and a first island; the second post assembly comprises a second post and a second island; the first sensor is attached to the first island; The prosthetic valve of claim 3 , wherein the second sensor is attached to the second island.

5. a first harmonic reduction layer disposed between the first inductor coil and the frame; 3. The prosthetic valve of claim 2, further comprising a second harmonic reduction layer disposed between the second inductor coil and the frame.

6. 6. The prosthetic heart valve of claim 5, wherein the first and second harmonic reduction layers each comprise ferrite.

7. a first insulating layer surrounding the first harmonic reduction layer and the first inductor coil; 7. The prosthetic heart valve of claim 6, further comprising a second insulating layer surrounding the second harmonic reduction layer and the second inductor coil.

8. 8. The prosthetic heart valve of claim 7, wherein the first and second insulating layers comprise one of silicone, parylene, and polyimide.

9. the first inductor coil is attached to the first subset of posts at a pointed tip of each of the first subset of cells; the first inductor coil is removably attached to the pointed 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 posts at the pointed tip of each of the second subset of cells; The prosthetic valve of claim 2 , wherein the second inductor coil is removably attached to the pointed tip of each of the second subset of the plurality of cells by a second plurality of sutures.

10. The prosthetic valve of claim 2 , wherein the frame is formed from a biocompatible metallic material.

11. The prosthetic valve of claim 2 , wherein each of the first and second inductor coils is formed from gold.

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

13. 3. The prosthetic valve of claim 2, wherein the first circuit has a first self-resonant frequency in the range of 5 MHz to 50 MHz, and 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. 3. The prosthetic valve of claim 2, wherein the frame is at least partially covered with a first biocompatible fabric, the first biocompatible fabric being disposed between at least a portion of the first inductor coil or the second inductor coil and the frame.

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

16. The prosthetic valve of claim 2 , wherein the prosthetic valve is sterilized.

17. 1. A monitoring system comprising:

1. A prosthetic valve assembly comprising: The artificial valve of claim 2; a prosthetic valve assembly comprising: a transmitter in communication with the first sensor and the second sensor; an external device in communication with the prosthetic valve assembly; The external device includes a transceiver for wireless communication with the prosthetic heart valve assembly.

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

19. 20. The prosthetic valve of claim 18, further comprising an insulating layer encapsulating the harmonic reduction layer and the flexible substrate.

20. 20. The prosthetic valve of claim 18, further comprising a first soft magnetic layer disposed on the flexible substrate between the first upper inductor coil portion and the first lower inductor coil portion.

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