Real-time measurements of physiological parameters associated with heart valve replacement

Abstract

To provide devices and assemblies equipped with sensors for monitoring physiological parameters prior to, during and subsequent to prosthetic valve implantation procedures, where the sensors can be used with a delivery assembly to provide real-time measurements thereby ensuring proper implantation of a prosthetic valve within a designated site of implantation, such as the site of a malfunctioning native valve.SOLUTION: The present invention relates to devices and methods for measuring physiological parameters, such as flow, pressure, temperature, electric conductivity and / or visual indication of thrombus formation or deposit accumulation, prior to, during and / or subsequent to prosthetic heart valve implantation procedures.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to devices and methods for measuring physiological parameters such as flow, pressure, temperature, electrical conductivity, and / or visual indications of thrombus formation or deposit accumulation before, during, and / or after an artificial heart valve implantation procedure.

Background Art

[0002] Natural heart valves (e.g., aortic valve, pulmonary valve, mitral valve, etc.) function to ensure sufficient directional flow from and to the heart and between heart chambers, and supply blood to the entire cardiovascular system. Various valvular diseases can render the valve ineffective and may require replacement with an artificial valve. Surgical procedures can be performed to repair or replace the heart valve. Surgery is prone to a number of clinical complications, and thus alternative minimally invasive techniques for delivering an artificial heart valve on a catheter and implanting it over a naturally dysfunctional valve have been developed over the years.

[0003] Various types of artificial heart valves are known to date, including balloon-expandable valves, self-expandable valves, and mechanically expandable valves. Also, various methods of delivery and implantation are known, which can vary according to the site of implantation and the type of artificial valve. One exemplary technique is the use of a delivery assembly to deliver an artificial valve in a crimped state from an incision that can be positioned in the patient's femoral artery or iliac artery towards the naturally dysfunctional valve. Once the artificial valve is properly positioned at the desired implantation site, it can be expanded against the surrounding anatomical structure (e.g., the annulus of the natural valve, etc.), and the delivery assembly can then be retrieved.

[0004] Various parameters (e.g., artificial valve size and expansion diameter, orientation, and interaction with surrounding tissue, etc.) can affect various physiological parameters such as the flow pattern and pressure gradient across and / or near the artificial valve, the electrical conductivity in the natural tissue contacted by the artificial valve, and the post-implantation physiological response to the presence of the artificial valve (e.g., inflammation and / or thrombosis, etc.). Therefore, there is a need for improvement in devices, systems, and methods for accurately measuring the physiological parameters associated with the artificial valve before, during, and / or after the implantation procedure to ensure proper artificial valve functionality and long-term durability.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

Patent Document 12

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] The present disclosure is directed to devices and assemblies equipped with sensors for monitoring physiological parameters before, during, and after an artificial valve implantation procedure. The devices and assemblies are primarily intended to monitor physiological parameters in real time, such as pressure, flow, temperature, electrical conductivity, and / or visual indications of thrombus formation or accumulation of deposits in areas important to the functionality of the artificial valve. Sensors that provide real-time measurements are used with a delivery assembly and can ensure proper implantation of the artificial valve within a specified site of implantation (e.g., the site of a natural valve with dysfunction).

MEANS FOR SOLVING THE PROBLEMS

[0007] According to one aspect of the present invention, a delivery assembly is provided that includes an artificial valve and a delivery device. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device includes a handle, a delivery shaft extending distally from the handle, a nose cone shaft extending through the delivery shaft, a nose cone, a first sensor, and a first transmission line. The nose cone shaft includes an outer surface of the nose cone shaft, a nose cone shaft guide wire lumen, and a distal portion of the nose cone shaft. The nose cone is attached to the distal portion of the nose cone shaft and includes a nose cone guide wire lumen and an outer surface of the nose cone. The first sensor is held within the nose cone. The first transmission line is connected to the first sensor and extends proximally from the first sensor toward the handle.

[0008] According to some embodiments, the first sensor is a first pressure sensor.

[0009] According to some embodiments, the first transmission line is a first optical fiber, and the first pressure sensor is a first optical pressure sensor.

[0010] According to some embodiments, the nose cone further includes a nose cone lateral port that terminates at the nose cone port opening, and the first pressure sensor is aligned with the nose cone port opening and positioned within the nose cone lateral port.

[0011] According to some embodiments, the nose cone port opening is formed on the outer surface of the nose cone.

[0012] According to some embodiments, the nose cone port opening is formed between the nose cone lateral port and the nose cone guide wire lumen.

[0013] According to some embodiments, the first pressure sensor is attached to the outer surface of the nose cone shaft.

[0014] According to some embodiments, the nose cone shaft further includes a nose cone shaft sensor lumen and a nose cone shaft side opening, the first pressure sensor is aligned and positioned with the nose cone shaft side opening, and the first transmission line extends through the nose cone shaft sensor lumen.

[0015] According to some embodiments, the delivery device further includes a first sensor shaft extending through the delivery shaft, the first sensor shaft including a first sensor shaft lumen, a first sensor shaft distal portion, and a first sensor shaft side opening in the first sensor shaft distal portion. In such embodiments, the nose cone is attached to the first sensor shaft distal portion, the first pressure sensor is aligned and positioned with the first sensor shaft side opening, and the first transmission line extends through the first sensor shaft lumen.

[0016] According to some embodiments, the delivery device further includes a second pressure sensor positioned proximal to the artificial valve and a second transmission line, the second transmission line being coupled to the second pressure sensor and extending proximally from the second pressure sensor toward the handle.

[0017] According to some embodiments, the second transmission line is a second optical fiber and the second pressure sensor is a second optical pressure sensor.

[0018] According to some embodiments, the second pressure sensor is attached to the outer surface of the nose cone shaft.

[0019] According to some embodiments, the nose cone shaft further includes a first nose cone shaft sensor lumen having a first nose cone shaft side opening and a second nose cone shaft sensor lumen having a second nose cone shaft side opening, the first pressure sensor being aligned and positioned with the first nose cone shaft side opening, and the second pressure sensor being aligned and positioned with the second nose cone shaft side opening.

[0020] According to some embodiments, the nose cone shaft further includes a nose cone shaft sensor lumen, the nose cone shaft sensor lumen includes a first nose cone shaft side opening and a second nose cone shaft side opening, the first pressure sensor is aligned and positioned with the first nose cone shaft side opening, the second pressure sensor is aligned and positioned with the second nose cone shaft side opening, and both the first transmission line and the second transmission line extend through the nose cone shaft sensor lumen.

[0021] According to some embodiments, the delivery device further includes a plurality of actuator arm assemblies, the plurality of actuator arm assemblies extend through the delivery shaft, are releasably coupled to the prosthetic valve, and the second pressure sensor is attached to at least one actuation assembly.

[0022] According to some embodiments, the delivery device further includes a recompression mechanism configured to compress a mechanically expandable prosthetic valve. The recompression mechanism includes a recompression shaft and a recompression member, the second pressure sensor is attached to the recompression shaft. The recompression shaft extends through the delivery shaft and includes a recompression shaft main lumen. The recompression member extends through the recompression shaft main lumen and includes a distal loop. The second pressure sensor is attached to the recompression shaft.

[0023] According to some embodiments, the second pressure sensor is attached to the outer surface of the outer surface of the recompression shaft.

[0024] According to some embodiments, the recompression shaft further includes a recompression shaft sensor lumen and a recompression shaft side opening, the second pressure sensor is aligned and positioned with the recompression shaft side opening, and the second transmission line extends through the recompression shaft sensor lumen.

[0025] According to some embodiments, the second pressure sensor is attached to the delivery shaft.

[0026] According to some embodiments, the second pressure sensor is attached to the outer surface of the delivery shaft.

[0027] According to some embodiments, the delivery shaft further includes a delivery shaft sensor lumen and a delivery shaft side opening, the second pressure sensor is aligned and positioned with the delivery shaft side opening, and the second transmission line extends through the delivery shaft sensor lumen.

[0028] According to some embodiments, the delivery device further includes a sensing catheter including a sensing head, the sensing catheter is axially movable relative to the delivery shaft, and the sensing head includes the second pressure sensor.

[0029] According to some embodiments, the handle further includes an internal control unit, the internal control unit is connected to the first transmission line, and is configured to receive signals from the first pressure sensor and / or transmit signals thereto via the first transmission line.

[0030] According to some embodiments, the handle further includes a proximal communication component, the proximal communication component is operably coupled to the internal control unit, and is configured to receive signals from components and / or devices external to the delivery assembly and / or transmit signals thereto.

[0031] According to some embodiments, the handle further includes a display operably coupled to the internal control unit.

[0032] According to some embodiments, the display includes a digital screen.

[0033] According to some embodiments, the display includes an LED light.

[0034] According to some embodiments, the handle further includes an internal control unit, the internal control unit is connected to a first transmission line and a second transmission line, configured to receive a signal from a first pressure sensor via the first transmission line and / or transmit a signal thereto, and further configured to receive a signal from a second pressure sensor via the second transmission line and / or transmit a signal thereto.

[0035] According to some embodiments, the handle further includes a proximal communication component, the proximal communication component is operably coupled to the internal control unit, and is configured to receive a signal from a component and / or device outside the delivery assembly and / or transmit a signal thereto.

[0036] According to some embodiments, the handle further includes a display operably coupled to the internal control unit.

[0037] According to some embodiments, a system is provided that includes a delivery assembly and a sensing catheter including a sensing head, the sensing head including a second pressure sensor.

[0038] According to some embodiments, the sensing catheter is a pigtail catheter.

[0039] According to some embodiments, a method for obtaining transvalvular pressure measurements includes: (a) providing a delivery assembly; (b) advancing a nose cone over a guide wire to a distal position of a native heart valve; (c) expanding an artificial valve against the native heart valve; and (d) simultaneously obtaining measurement signals from a first pressure sensor and a second pressure sensor.

[0040] According to some embodiments, a method for obtaining transvalvular pressure measurement values, comprising: (a) providing a delivery assembly; (b) advancing a nose cone over a guide wire to a distal position of a native heart valve; (c) expanding an artificial valve against the native heart valve; (d) positioning a sensing head proximal to the artificial valve; and (e) simultaneously obtaining measurement signals from a first pressure sensor and a second pressure sensor.

[0041] According to some embodiments, a method for obtaining transvalvular pressure measurement values, comprising: (a) providing a system; (b) advancing a nose cone over a guide wire to a distal position of a native heart valve; (c) expanding an artificial valve against the native heart valve; (d) positioning a sensing head proximal to the artificial valve; and (e) simultaneously obtaining measurement signals from a first pressure sensor and a second pressure sensor.

[0042] According to some embodiments, the method for obtaining transvalvular pressure measurement values further comprises retracting the guide wire before simultaneously obtaining the measurement signals.

[0043] According to some embodiments, the artificial valve is a non-balloon-expandable artificial valve.

[0044] According to some embodiments, the first sensor is a Doppler sensor.

[0045] According to some embodiments, a method for obtaining transvalvular pressure measurement values, comprising: (a) providing a delivery assembly; (b) advancing a nose cone over a guide wire to a distal position of a native heart valve; (c) expanding an artificial valve against the native heart valve; and (d) using a Doppler sensor to obtain measurement signals from at least two diametrically opposed regions.

[0046] According to some embodiments, the method further includes: (e) orienting the Doppler sensor in one direction towards a first region; (f) using the Doppler sensor to acquire a measurement signal from the first region; (g) rotating the nose cone to orient the Doppler sensor in the diametrically opposite direction towards a second region; and (h) using the Doppler sensor to acquire a measurement signal from the second region.

[0047] According to some embodiments, the first sensor is an ultrasonic distance sensor.

[0048] According to some embodiments, a method of obtaining a transvalvular pressure measurement includes: (a) providing a delivery assembly; (b) advancing a nose cone over a guide wire to a distal position of a native heart valve; (c) expanding an artificial valve relative to the native heart valve; (d) orienting an ultrasonic distance sensor towards a heart chamber wall; and (e) using the ultrasonic distance sensor to measure the distance to the heart chamber wall.

[0049] According to some embodiments, the method further includes using the ultrasonic distance sensor to measure the distance to a side wall of the artificial valve.

[0050] According to another aspect of the present invention, a method for obtaining flow measurement values from at least two diametrically opposed regions, comprising: (a) providing a delivery assembly, the delivery assembly including an artificial valve movable between a radially compressed configuration and a radially expanded configuration, and a delivery device, the delivery device including a handle, a delivery shaft extending distally from the handle, and an ultrasonic measurement catheter extending through the delivery catheter, the delivery catheter including a sensing head, the sensing head including a Doppler sensor; (b) expanding the artificial valve relative to the native heart valve; (c) advancing the ultrasonic measurement catheter distally through the expanded artificial valve; and (d) obtaining measurement signals from at least two diametrically opposed regions using the Doppler sensor.

[0051] According to some embodiments, the step of obtaining measurement signals using the Doppler sensor comprises: (i) orienting the Doppler sensor in one direction towards a first region; (ii) obtaining a measurement signal from the first region using the Doppler sensor; (iii) rotating a nose cone to orient the Doppler sensor in the diametrically opposite direction towards a second region; and (iv) obtaining a measurement signal from the second region using the Doppler sensor.

[0052] According to another aspect of the present invention, a method for obtaining flow measurement values from at least two diametrically opposed regions, comprising: (a) providing a delivery assembly, the delivery assembly including an artificial valve movable between a radially compressed configuration and a radially expanded configuration, and a delivery device, the delivery device including a handle, a delivery shaft extending distally from the handle, and an ultrasonic measurement catheter extending through the delivery catheter, the delivery catheter including a sensing head, the sensing head including an ultrasonic distance sensor; (b) expanding the artificial valve against the natural heart valve; (c) advancing the ultrasonic measurement catheter distally through the expanded artificial valve; (d) orienting the ultrasonic distance sensor towards the heart chamber wall; and (e) using the ultrasonic distance sensor to measure the distance to the heart chamber wall.

[0053] According to some embodiments, the method further includes using the ultrasonic distance sensor to measure the distance to the side wall of the artificial valve.

[0054] According to another aspect of the present invention, a method for measuring flow in a region adjacent to an artificial valve, comprising: (a) providing an artificial valve movable between a radially compressed configuration and a radially expanded configuration, and a delivery device including a handle; (b) providing an ultrasonic measurement catheter including a sensing head, the sensing head including a Doppler sensor; (c) expanding the artificial valve against a first natural valve such that at least a portion of the artificial valve extends into the heart chamber; (d) extending the ultrasonic measurement catheter through a second natural valve such that the sensing head is positioned within the heart chamber; (e) orienting the Doppler sensor towards the artificial valve; and (f) using the Doppler sensor to obtain a measurement signal from at least one region adjacent to the artificial valve.

[0055] According to some embodiments, the step of using a Doppler sensor to acquire a measurement signal from at least one region includes the step of using a Doppler sensor to acquire a measurement signal from at least two diametrically opposed regions adjacent to the prosthetic valve.

[0056] According to another aspect of the present invention, a delivery assembly including a prosthetic valve and a delivery device is provided. The prosthetic valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device includes a handle, a delivery shaft extending distally from the handle, a nose cone shaft extending through the delivery shaft, a nose cone attached to the nose cone shaft, a shaft with a valve extending through the delivery shaft, a first pressure sensor, and a first transmission line. The shaft with a valve includes a shaft with a valve lumen, a proximal portion of the shaft with a valve extending into the handle, a distal portion of the shaft with a valve, and a shaft valve connected to the proximal portion of the shaft with a valve. The shaft valve is movable between an open position and a closed position. The first pressure sensor is attached to the distal portion of the shaft with a valve and disposed within the shaft with a valve lumen. The first transmission line is connected to the first pressure sensor and extends proximally from the first pressure sensor toward the handle. The shaft valve is configured to prevent flow through the shaft with a valve lumen in the closed position and to allow flow through the shaft with a valve lumen in the open position. The shaft with a valve is axially movable relative to the delivery shaft.

[0057] According to some embodiments, the shaft valve includes a leaf valve attached to the proximal portion of the shaft with a valve via a hinge, and the leaf valve is pivotable about the hinge.

[0058] According to some embodiments, the shaft valve includes a stopcock valve.

[0059] According to some embodiments, the first transmission line is a first optical fiber, and the first pressure sensor is a first optical pressure sensor.

[0060] According to some embodiments, the delivery device further includes a second pressure sensor positioned proximal to the prosthetic valve and a second transmission line, the second transmission line being coupled to the second pressure sensor and extending proximally from the second pressure sensor toward the handle.

[0061] According to some embodiments, the second transmission line is a second optical fiber and the second pressure sensor is a second optical pressure sensor.

[0062] According to some embodiments, the second pressure sensor is attached to the nose cone shaft.

[0063] According to some embodiments, the delivery device further includes a plurality of actuator arm assemblies extending through the delivery shaft and releasably coupled to the prosthetic valve, the second pressure sensor being attached to at least one of the actuator assemblies.

[0064] According to some embodiments, the delivery device further includes a recompression mechanism configured to compress a mechanically expandable prosthetic valve. The recompression mechanism includes a recompression shaft and a recompression member. The recompression shaft extends through the delivery shaft and includes a recompression shaft main lumen. The recompression member extends through the recompression shaft main lumen and includes a distal loop. The second pressure sensor is attached to the recompression shaft.

[0065] According to some embodiments, the second pressure sensor is attached to an outer surface of the outer surface of the recompression shaft.

[0066] According to some embodiments, the recompression shaft further includes a recompression shaft sensor lumen and a recompression shaft side opening, the second pressure sensor is aligned and positioned with the recompression shaft side opening, and the second transmission line extends through the recompression shaft sensor lumen.

[0067] According to some embodiments, the second pressure sensor is attached to the delivery shaft.

[0068] According to some embodiments, the second pressure sensor is attached to the outer surface of the delivery shaft.

[0069] According to some embodiments, the delivery shaft further includes a delivery shaft sensor lumen and a delivery shaft side opening, the second pressure sensor is aligned and positioned with the delivery shaft side opening, and the second transmission line extends through the delivery shaft sensor lumen.

[0070] According to some embodiments, the delivery device further includes a second pressure sensor and a second transmission line, the second pressure sensor is attached to the valve shaft and disposed in the valve shaft lumen at a proximal position of the first pressure sensor, the second transmission line is connected to the second pressure sensor and extends proximally from the second pressure sensor towards the handle.

[0071] According to some embodiments, the handle further includes an internal control unit, the internal control unit is connected to the first transmission line and the second transmission line, configured to receive signals from the first pressure sensor via the first transmission line and / or transmit signals thereto, and also configured to receive signals from the second pressure sensor via the second transmission line and / or transmit signals thereto.

[0072] According to some embodiments, the handle further includes a proximal communication component, which is operably coupled to the internal control unit and configured to receive signals from components and / or devices outside the delivery assembly and / or transmit signals thereto.

[0073] According to some embodiments, the handle further includes a display operably coupled to the internal control unit.

[0074] According to some embodiments, the display includes a digital screen.

[0075] According to some embodiments, the display includes LED lights.

[0076] According to some embodiments, a method for obtaining transvalvular pressure measurements includes: (a) providing a delivery assembly; (b) expanding an artificial valve against a native heart valve; (c) advancing a valved shaft through the expanded artificial valve, positioning a first pressure sensor distal to the artificial valve; (d) moving the shaft valve to an open position; and (e) simultaneously obtaining measurement signals from the first sensor and a second sensor.

[0077] According to some embodiments, a method for obtaining transvalvular pressure measurements includes: (a) providing a delivery assembly; (b) expanding an artificial valve against a native heart valve; (c) advancing a valved shaft through the expanded artificial valve, positioning a first pressure sensor distal to the artificial valve; (d) moving the shaft valve to an open position; and (e) simultaneously obtaining measurement signals from the first sensor and a second sensor.

[0078] According to some embodiments, a method for obtaining a transvalvular pressure measurement value includes: (a) providing a delivery assembly; (b) expanding an artificial valve against a natural heart valve; (c) advancing a valve-attached shaft through the expanded artificial valve, positioning a first pressure sensor distal to the artificial valve and a second pressure sensor proximal to the artificial valve; (d) moving the shaft valve to an open position; and (e) simultaneously obtaining measurement signals from the first sensor and the second sensor.

[0079] According to some embodiments, the artificial valve is a non-balloon-expandable artificial valve.

[0080] According to another aspect of the present invention, a delivery assembly including an artificial valve and a delivery device is provided. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device includes a handle, a delivery shaft extending distally from the handle, a nose cone shaft extending through the delivery shaft, a nose cone attached to the nose cone shaft, a valve-attached guide wire extending through the nose cone shaft and the nose cone, a first pressure sensor, a second pressure sensor, a first transmission line, and a second transmission line.

[0081] The valve-attached guide wire includes an inner lumen of the guide wire, an inner surface of the valve-attached guide wire, a proximal portion of the valve-attached guide wire extending into the handle, and a guide wire valve connected to the proximal portion of the valve-attached guide wire. The guide wire valve is movable between an open position and a closed position. The first pressure sensor is attached to the inner surface of the valve-attached guide wire at a distal position of the artificial valve. The second pressure sensor is attached to the inner surface of the valve-attached guide wire at a proximal position of the artificial valve. The first transmission line is connected to the first pressure sensor and extends proximally from the first pressure sensor toward the handle. The second transmission line is connected to the second pressure sensor and extends proximally from the second pressure sensor toward the handle. The guide wire valve is configured to prevent flow through the inner lumen of the guide wire in the closed position and to allow flow through the inner lumen of the guide wire in the open position.

[0082] According to some embodiments, the guide wire valve includes a leaf valve attached to the proximal portion of the valve-attached guide wire via a hinge, and the guide wire valve is pivotable about the hinge.

[0083] According to some embodiments, the guide wire valve includes a stopcock valve.

[0084] According to some embodiments, the first transmission line is a first optical fiber, the first pressure sensor is a first optical pressure sensor, the second transmission line is a second optical fiber, and the second pressure sensor is a second optical pressure sensor.

[0085] According to some embodiments, the handle further includes an internal control unit, the internal control unit is connected to the first transmission line and the second transmission line, configured to receive a signal from the first pressure sensor via the first transmission line and / or transmit a signal thereto, and also configured to receive a signal from the second pressure sensor via the second transmission line and / or transmit a signal thereto.

[0086] According to some embodiments, the handle further includes a proximal communication component, the proximal communication component is operably coupled to the internal control unit, and is configured to receive signals from components and / or devices external to the delivery assembly and / or transmit signals thereto.

[0087] According to some embodiments, the handle further includes a display operably coupled to the internal control unit.

[0088] According to some embodiments, the display includes a digital screen.

[0089] According to some embodiments, the display includes an LED light.

[0090] According to another aspect of the present invention, a delivery assembly is provided that includes an artificial valve, at least one sensor housing coupled to the artificial valve, at least one sensor retained within the sensor housing, and a delivery device. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The artificial valve includes an inflow end portion, an outflow end portion, a frame, and a plurality of valve tips coupled to the frame via a plurality of cross-links. The delivery device includes a handle, a delivery shaft extending distally from the handle, at least one transmission line shaft extending through the delivery shaft, and at least one transmission line extending through the at least one transmission line shaft.

[0091] At least one transmission line shaft is releasably coupled to at least one sensor housing. At least one transmission line is releasably coupled to at least one sensor. When the transmission line shaft is coupled to the sensor housing, the transmission line shaft is configured to seal at least one transmission line and at least one sensor. When at least one transmission line is released from at least one sensor, the at least one transmission line is axially movable relative to at least one transmission line shaft.

[0092] According to some embodiments, when a tensile force is applied to at least one transmission line, the at least one transmission line is released from at least one sensor, and the magnitude of the tensile force exceeds the magnitude of a predetermined threshold.

[0093] According to some embodiments, the sensor housing includes a housing threaded bore, and the transmission shaft includes an external thread configured to engage the housing threaded bore.

[0094] According to some embodiments, at least one sensor is a pressure sensor.

[0095] According to some embodiments, at least one sensor is a flow sensor.

[0096] According to some embodiments, at least one sensor is a temperature sensor.

[0097] According to some embodiments, at least one sensor is an optical fiber sensor configured to acquire optical data.

[0098] According to some embodiments, at least one sensor is an impedance sensor configured to acquire electrical conductivity data.

[0099] According to some embodiments, at least one sensor is oriented radially outward from the artificial valve.

[0100] According to some embodiments, at least one sensor housing includes a first sensor housing and a second sensor housing, at least one sensor includes a first sensor retained within the first sensor housing and a second sensor retained within the second sensor housing, at least one transmission line shaft includes a first transmission line shaft and a second transmission line shaft, the first transmission line shaft is releasably coupled to the first sensor housing, the second transmission line shaft is releasably coupled to the second sensor housing, at least one transmission line includes a first transmission line and a second transmission line, the first transmission line extends through the first transmission line shaft and is releasably coupled to the first sensor, and the second transmission line extends through the second transmission line shaft and is releasably coupled to the second sensor.

[0101] According to some embodiments, the first sensor housing is coupled to the inflow end portion, and the second sensor housing is coupled to the outflow end portion.

[0102] According to some embodiments, the first sensor housing and the second sensor housing are attached to the outflow end portion.

[0103] According to some embodiments, the first sensor housing and the second sensor housing are attached to the outflow end portion at diametrically opposite positions.

[0104] According to some embodiments, the first sensor housing and the second sensor housing are axially spaced from each other and longitudinally aligned along the same circumferential position of the artificial valve.

[0105] According to some embodiments, at least one sensor housing includes a plurality of sensor housings, at least one sensor includes a plurality of sensors, the plurality of sensor housings and the plurality of sensors match the number of a plurality of valve tips, each of the plurality of sensor housings is positioned between an inflow end portion and an outflow end portion, each of the plurality of sensors is radially inwardly oriented and faces a corresponding valve tip among the plurality of valve tips.

[0106] According to some embodiments, at least one sensor housing is attached to a junction.

[0107] According to another aspect of the present invention, there is provided an artificial valve including an inflow end portion, an outflow end portion, a plurality of valve tips, and at least two sensors connected to the outflow end portion, the artificial valve being movable between a radially compressed configuration and a radially expanded configuration.

[0108] According to some embodiments, the plurality of sensors are pressure sensors.

[0109] According to some embodiments, the plurality of sensors are flow sensors.

[0110] According to some embodiments, the plurality of sensors are temperature sensors.

[0111] According to some embodiments, the plurality of sensors are circumferentially spaced from each other.

[0112] According to some embodiments, at least two of the plurality of sensors are attached to the outflow end portion at diametrically opposite positions.

[0113] According to some embodiments, at least two of the plurality of sensors are axially spaced from each other and longitudinally aligned along the same circumferential position of the artificial valve.

[0114] According to another aspect of the present invention, a method for identifying cusp thrombosis in a pre - implanted prosthetic valve, comprising: (a) providing an ultrasonic cardiac echo catheter including a sensing head, the sensing head including an ultrasonic cardiac echo sensor; (b) advancing the ultrasonic cardiac echo catheter toward the lumen of the pre - implanted prosthetic valve; (c) orienting the ultrasonic cardiac echo sensor toward at least one cusp of the prosthetic valve; (d) using the ultrasonic cardiac echo sensor to obtain an image of a space confined between at least one cusp and the frame of the prosthetic valve.

[0115] In some embodiments, the method further comprises: (e) orienting the ultrasonic cardiac echo sensor toward at least one other cusp of the prosthetic valve; (f) using the ultrasonic cardiac echo sensor to obtain an image of a space confined between at least one other cusp and the frame.

[0116] According to another aspect of the present invention, a method for identifying cusp thrombosis in a pre - implanted prosthetic valve, comprising: (a) providing an acoustic viscosity catheter including a sensing head, the sensing head including an acoustic viscosity sensor; (b) advancing the acoustic viscosity catheter toward the lumen of the pre - implanted prosthetic valve; (c) orienting the acoustic viscosity sensor toward at least one cusp of the prosthetic valve; (d) using the acoustic viscosity sensor to measure the blood viscosity in a space confined between at least one cusp and the frame of the prosthetic valve.

[0117] In some embodiments, the method further comprises: (e) orienting the acoustic viscosity sensor toward at least one other cusp of the prosthetic valve; (f) using the acoustic viscosity sensor to measure the blood viscosity in a space confined between at least one other cusp and the frame.

[0118] Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may become readily apparent to those skilled in the art from the figures, description, and claims included herein. Aspects and embodiments of the present invention are further described in the following description and the appended claims.

[0119] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification (including definitions) will prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

[0120] The following embodiments and aspects are described and illustrated in relation to systems, tools, and methods, which are intended to be exemplary and illustrative and not limiting in scope. In various embodiments, one or more of the above problems are reduced or eliminated, while other embodiments are directed to other advantages or improvements.

[0121] Some embodiments of the present invention are described herein with reference to the accompanying figures. The description, together with the figures, makes clear to those skilled in the art how some embodiments may be practiced. The figures are for illustrative purposes only and no attempt is made to show structural details of the embodiments in more detail than is necessary for a basic understanding of the invention. For clarity, some of the objects shown in the figures are not to scale.

Brief Description of the Drawings

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[0123] In the following description, various aspects of the present disclosure will be described. For the purposes of the description, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the present disclosure. However, it will also be apparent to those skilled in the art that the present disclosure may be practiced without the specific details presented herein. Moreover, well-known features may have been omitted or simplified in order not to obscure the present disclosure. To avoid excessive clutter from having too many reference numerals and lead lines on a particular drawing, some components will be introduced through one or more drawings and will not be explicitly identified in all subsequent drawings that contain that component.

[0124] FIG. 1 depicts a cross-section of a healthy human heart. The heart has a four-chambered conical structure that includes a left atrium 12, a right atrium 14, a left ventricle 16, and a right ventricle 18. The wall that separates the left and right sides of the heart is referred to as a septum 20. The native mitral valve 30 is positioned between the left atrium 12 and the left ventricle 16. The native aortic valve 40 is positioned between the left ventricle 16 and the aorta 80. The first portion of the aorta 80 that extends from the native aortic valve 40 is the aortic root 82, and the adjacent portion of the left ventricle 16 is the left ventricular outflow tract (LVOT) 22.

[0125] The native mitral valve 30 includes a mitral valve annulus 32 and a pair of mitral valve leaflets 34 extending downwardly from the annulus 32. When operating properly, the leaflets 34 function together to permit blood flow only from the left atrium 12 to the left ventricle 14. Specifically, during diastole, when the muscles of the left atrium 12 and left ventricle 16 expand, oxygenated blood flows from the left atrium 12 through the mitral valve 30 into the left ventricle 16. During systole, when the muscle of the left atrium 12 relaxes and the left ventricle 16 contracts, the blood pressure in the left ventricle 16 rises and urges the two mitral valve leaflets 34 to join, thereby preventing blood flow from the left ventricle 16 from returning to the left atrium 12. A plurality of fibrous cords (referred to as chordae tendineae 36) connect the mitral valve leaflets 34 to the papillary muscles of the left ventricle 16 and prevent them from prolapsing under pressure and being folded back through the mitral valve annulus 32.

[0126] As used herein, the term "plurality" means two or more.

[0127] The native aortic valve 40 includes an aortic valve annulus 42 and three aortic valve leaflets 44 extending upwardly (toward the aortic root 82) from the annulus 42. During systole, blood is ejected from the left ventricle 16 through the aortic valve 40 into the aorta 80. When either the native mitral valve 30 or the native aortic valve 40 cannot function properly, an artificial replacement valve 140 can help restore functionality.

[0128] Figure 2 constitutes a perspective view of a delivery assembly 100 according to some embodiments. The delivery assembly 100 can include an artificial valve 140 and a delivery device 102. The artificial valve 140 can be on top of the delivery device 102 or releasably coupled to the delivery device 102. The delivery device can include a handle 110 at its proximal end, a nose cone shaft (also referred to herein as an NC shaft) 108 extending distally from the handle 110, a nose cone 126 attached to a distal portion of the nose cone shaft (also referred to herein as an NC shaft distal portion) 120, a delivery shaft 106 extending over the NC shaft 118, and optionally, an outer shaft 104 extending over the delivery shaft 106.

[0129] As used herein, the term "proximal" generally refers to the side or end of any device or component of the device that is closer to the handle 110 or the operator of the handle 110 during use.

[0130] As used herein, the term "distal" generally refers to the side or end of any device or component of the device that is farther from the handle 110 or the operator of the handle 110 during use.

[0131] As used herein, the term "artificial valve" refers to any type of artificial valve that can be delivered over a catheter to a target site in a patient and that is radially expandable and compressible between a radially compressed (or crimped) state and a radially expanded state. Thus, the artificial valve 140 can be crimped or held by the delivery device 102 in a compressed state during delivery and then expanded to an expanded state when the artificial valve 140 reaches the implantation site. The expanded state can include a range of diameters within which the valve can expand between the compressed state and the maximum diameter reached in the fully expanded state. Thus, a plurality of partially expanded states can be related to any expanded diameter between the radially compressed or crimped state and the maximally expanded state.

[0132] The artificial valve 140 of the present disclosure can include any artificial valve configured to be implanted within a native aortic valve, a native mitral valve, a native pulmonary valve, and a native tricuspid valve. The delivery assembly 100 described in the present disclosure includes the delivery device 102 and the artificial valve 140, but it should be understood that the delivery device 102 according to any embodiment of the present disclosure can be used for the implantation of other artificial devices (such as stents or grafts, etc.) other than the artificial valve.

[0133] The prosthetic valve 140 is delivered to the implantation site via a delivery assembly 100 that transports the valve 140 in a radially compressed or crimped state toward the target site and can be attached to the native anatomical structure by expanding the valve 140 via various expansion mechanisms. Balloon-expandable valves generally require a procedure of inflating a balloon within the prosthetic valve, thereby expanding the prosthetic valve 140 into the desired implantation site. Once the valve is fully expanded, the balloon is deflated and retrieved with the delivery device 102. Self-expandable valves include a frame that is shaped to automatically expand as soon as an outer retaining capsule (which can also be defined as the distal portion of the outer shaft 104 or the distal portion of the delivery shaft 106) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism typically includes a plurality of actuator assemblies that are releasably coupled to respective actuation arm assemblies of the delivery device 102, and the actuation arm assemblies are controlled via a handle 110 for actuating the actuator assemblies to expand the prosthetic valve to a desired diameter. The actuator assemblies can optionally lock the position of the valve, prevent its undesired recompression, and detachment of the actuation arm assemblies from the actuator assemblies, and enable retrieval of the delivery device 102 once the prosthetic valve is properly positioned at the desired site of implantation.

[0134] For example, the delivery assembly 100 can be utilized to deliver a prosthetic aortic valve for attachment to the aortic valve annulus 42, a prosthetic mitral valve for attachment to the mitral valve annulus 32, or a prosthetic valve for attachment to any other native valve annulus.

[0135] The outer shaft 104 and the delivery shaft 106 can be configured to be axially movable relative to each other, such that movement of the outer shaft 104 oriented proximally relative to the delivery shaft 106, or movement of the delivery shaft 106 oriented distally relative to the outer shaft 104, can expose the prosthetic valve 140 from the outer shaft 104. In an alternative embodiment, the prosthetic valve 140 is not housed within the outer shaft 104 during delivery. Thus, according to some embodiments, the delivery device 102 does not include the outer shaft 104.

[0136] As described above, the NC shaft 118, the delivery shaft 106, components of the actuation arm assembly (in the case of a mechanically expandable valve), and, when present, the proximal end of the outer shaft 104 can be coupled to the handle 110. During delivery of the prosthetic valve 140, the handle 110 is manipulated by an operator (e.g., a clinician or surgeon) to axially advance or retract components of the delivery device 102 (e.g., the nose cone shaft 118, the delivery shaft 106, and / or the outer shaft 104, etc.) through the patient's vasculature, and to expand or contract the mechanically expandable valve 140' by, for example, operating the actuation arm assembly, and to decouple the prosthetic valve 140 from the delivery device 102 by, for example, releasing the actuation arm assembly from the actuator assembly of the mechanically expandable valve, and to retract the delivery device 102 once the prosthetic valve is positioned at the implantation site.

[0137] The term "and / or" is inclusive herein and means "and" as well as "or". For example, "the delivery shaft 106 and / or the outer shaft 104" includes the delivery shaft 106, the outer shaft 104, and the delivery shaft 106 with the outer shaft 104, and such "delivery shaft 106 and / or the outer shaft 104" can similarly include other elements.

[0138] According to some embodiments, the handle 110 can include one or more actuation interfaces (e.g., manipulable or rotatable adjustment knobs, levers, sliders, buttons (not shown), and other actuation mechanisms, etc.), and the one or more actuation interfaces are operably connected to different components of the delivery device 102 and are configured to create axial movement of the delivery device 102 in the proximal and distal directions, and are also configured to expand or contract the prosthetic valve 140 via various adjustment and activation mechanisms.

[0139] According to some embodiments, the handle further includes one or more visual or auditory information elements (e.g., a digital screen 1022 (e.g., an LCD screen), an LED light 1024, and a speaker (not shown), etc.) configured to provide visual or auditory information and / or feedback to the user or operator of the delivery device 102.

[0140] FIG. 3A shows an exemplary prosthetic valve 140 in an expanded state according to some embodiments. The prosthetic valve 140 can include an inflow end portion 144 defining an inflow end 145 and an outflow end portion 142 defining an outflow end 143. The prosthetic valve 140 can define a valve longitudinal axis 141 extending through the inflow end portion 144 and the outflow end portion 142. In some cases, the outflow end 143 is the distal end of the prosthetic valve 140 and the inflow end 145 is the proximal end of the prosthetic valve 140. Alternatively, for example, depending on the delivery approach of the valve, the outflow end can be the proximal end of the prosthetic valve and the inflow end can be the distal end of the prosthetic valve.

[0141] As used herein, the term "outflow" refers to the region of the prosthetic valve through which blood flows from the valve 140, which is, for example, between the valve longitudinal axis 141 and the outflow end 143.

[0142] As used herein, the term "inflow" refers to the region of the prosthetic valve through which blood flows into the valve 140, which is, for example, between the inflow end 145 and the valve longitudinal axis 141.

[0143] Valve 140 includes a frame 146 composed of interconnected struts 148. The frame can be made from a variety of suitable materials including, but not limited to, stainless steel, nickel-based alloys (such as cobalt-chromium or nickel-cobalt-chromium alloys, such as MP35N alloy, etc.), polymers, or combinations thereof, such as plastically expandable materials. When constructed from a plastically expandable material, the frame 146 (and thus the prosthetic valve 140) can be crimped in a radially compressed state on the delivery shaft 106 and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 146 can be made from a self-expanding material, such as, but not limited to, nickel-titanium alloys (such as nitinol). When constructed from a self-expandable material, the frame 146 (and thus the prosthetic valve 140) can be crimped in a radially compressed state and constrained in the compressed state by insertion into the shaft of the delivery device 102 or an equivalent mechanism.

[0144] In the exemplary embodiment shown in FIG. 3A, the end portions of strut 148 form apex 149 at outflow end 143 and apex 151 at inflow end 145. Struts 148 can be interconnected to each other at additional junction 150 formed between outflow apex 149 and inflow apex 151. Junction 150 can be disposed equidistantly or non-equidistantly from each other and / or from apices 149, 151 between outflow end 143 and inflow end 145. Struts 148 collectively define a plurality of open cells 147 of frame 146. According to some embodiments, as shown in the exemplary embodiment of FIG. 3A, struts 148 can be formed with alternating bends that can be welded or otherwise fixed to each other at junction 150.

[0145] Artificial valve 140 further includes one or more valve leaflets 152 (e.g., three valve leaflets), and the one or more valve leaflets 152 are configured to regulate blood flow through artificial valve 140 from inflow end 145 to outflow end 143. Three valve leaflets 152 arranged to fold in a tricuspid valve configuration are shown in the exemplary embodiment illustrated in FIG. 3A, but it will be apparent that artificial valve 140 can include any other number of valve leaflets 152. Valve leaflets 152 are made of a flexible material derived from a biological material (e.g., bovine pericardium or pericardium from another source), a biocompatible synthetic material, or other suitable material. The valve leaflets can be directly, or attached to other structural elements (e.g., commissural posts, etc.) connected to or embedded in frame 146, and can be connected to frame 146 via commissure 154. Further details regarding artificial valves, including the manner in which valve leaflets can be attached to their frames, are described in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,252,202, as well as U.S. Patent Application No. 62 / 614,299, all of which are incorporated herein by reference.

[0146] According to some embodiments, the prosthetic valve 140 can further include at least one skirt or sealing member (e.g., an inner skirt 153 as shown in the exemplary embodiment illustrated in FIG. 3A). The inner skirt 153 can be mounted on the inner surface of the frame 146, which functions, for example, as a sealing member and is configured to prevent or reduce perivalvular leakage. The inner skirt 153 can further function as an anchor fixation region for the valve tip 152 to the frame 146, and / or can function to protect the valve tip 152 against damage that may be caused by contact with the frame 146, for example, during valve crimping or during the operating cycle of the prosthetic valve 140. Additionally or alternatively, the prosthetic valve 140 can include an outer skirt (not shown) mounted on the outer surface of the frame 146, which can be configured to function, for example, as a sealing member maintained between the frame 146 and the tissue surrounding the native valve annulus (to which the prosthetic valve 140 is mounted), thereby reducing the risk of paravalvular leakage through the prosthetic valve 140. Either the inner skirt 153 and / or the outer skirt can be made from various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue).

[0147] Figure 3B illustrates a mechanically expandable valve 140', which is a particular type of prosthetic valve 140 as described above herein, and like parts have a dash symbol. According to some embodiments, struts 148' are arranged in a lattice-type pattern. In the embodiment illustrated in Figure 3B, struts 148' are positioned obliquely or offset at a predetermined angle with respect to the valve longitudinal axis 141' and radially offset from the valve longitudinal axis 141' when the prosthetic valve 140' is in an expanded position. It will be apparent that struts 148' can be offset at angles other than those shown in Figure 3B (e.g., oriented substantially parallel to the valve longitudinal axis 141').

[0148] According to some embodiments, as further shown in Figure 3B, frame 146' can include openings or apertures in the regions of vertices 149', 151' and at joints 150' of struts 148'. Each hinge can be included where the apertures of struts 148' overlap each other via a fastener (e.g., a rivet or pin) extending through the aperture. When frame 146' is radially expanded or compressed, the hinge can enable struts 148' to pivot relative to each other.

[0149] In an alternative embodiment, the struts are not connected to each other via respective hinges but are pivotable or bendable relative to each other in other ways to allow for frame expansion or compression. For example, the frame can be formed from a single piece of material (e.g., a metal tube) via various processes (e.g., but not limited to, laser cutting, electroforming, and / or physical vapor deposition, etc.) while maintaining the ability to fold / expand radially even in the absence of hinges such as.

[0150] According to some embodiments, the mechanically expandable valve 140' includes a plurality of actuator assemblies 156, which are configured to facilitate expansion of the valve 140 and, in some cases, are configured to lock the valve 140' in the expanded state to prevent its unintentional recompression. FIG. 3B illustrates three actuator assemblies 156 that are mounted on the inner surface of the frame 146 and are equally spaced around the inner surface of the frame 146, but it should be clear that a different number of actuator assemblies 156 can be utilized, that the actuator assemblies 156 can be mounted on the frame 146 around its outer surface, and that the circumferential spacing between the actuator assemblies 156 need not be equal.

[0151] Specific examples of the prosthetic valves 140 and 140' are illustrated in FIGS. 3A and 3B, respectively, but it will be understood that the prosthetic valve 140 can take many other forms known in the art. Throughout the present disclosure, references to the prosthetic valve 140 relate to any type of prosthetic valve, including the embodiment of the prosthetic valve 140 illustrated in FIG. 3A and the embodiment of the mechanically expandable valve 140' illustrated in FIG. 3B, unless stated otherwise.

[0152] Figures 4A and 4B constitute a perspective view and a side cross-sectional view of an exemplary conventional nose cone 130 having a nose cone outer surface (also referred to herein as the NC outer surface) 127. The nose cone 126 can be connected to the distal end of the NC shaft 118. A guide wire (GW) 112 (not shown in FIG. 2 but can be seen, for example, in FIG. 12) can extend through a nose cone shaft guide wire lumen (also referred to herein as the NC shaft GW lumen) 122 and a nose cone guide wire lumen (also referred to herein as the NC GW lumen) 134 such that the delivery device 102 can be advanced over the guide wire 112 through the patient's vasculature. According to some embodiments, the nose cone 126 can be made from a low durometer polymer, such as Pebax (e.g., 35-shore Pebax).

[0153] According to some embodiments, the NC shaft 118 includes an NC shaft distal portion 120 that extends into the nose cone 126 through a nose cone proximal opening (also referred to herein as the NC proximal opening) 133. The nose cone 126 can be overmolded onto the NC shaft distal portion 120 or formed as a separate part and coupled thereto. According to some embodiments, a retaining ring (not shown) can be rigidly attached to the NC shaft distal portion 120, and then the nose cone 126 can be overmolded onto the NC shaft distal portion 120 together with the retaining ring to create a retaining channel over the retaining ring, thereby forming a tight fit between the nose cone 126 and the NC shaft distal portion 120, which is configured to prevent spontaneous axial displacement therebetween.

[0154] According to some embodiments, the nose cone shaft distal end (also referred to herein as the NS shaft distal end) 121 is rigidly attached to the proximal surface of the nose cone 126 around the edge of the NC proximal opening 133 (embodiment not shown).

[0155] According to some embodiments, the distal portion 120 of the NC shaft extends at least to the nose cone distal end (also referred to herein as the NC distal end) 138 or extends beyond the NC distal end 138, and the NC GW lumen 134 is adapted to overlap a portion of the outer surface of the distal portion 120 of the NC shaft along its entire length (an embodiment is not shown). The nose cone 126 can define a guide wire lumen longitudinal axis (also referred to herein as the GW lumen longitudinal axis) 135 that extends through the NC proximal opening 133 and the NC distal end 138. In some cases, the GW lumen longitudinal axis 135 and the valve longitudinal axis 141 can coincide.

[0156] According to some embodiments, the nose cone 126 includes a non-traumatic nose cone distal portion (also referred to herein as the NC distal portion) 129 that is tapered distally, which is formed to provide a smooth transition with the guide wire 112 when the guide wire 112 extends therethrough.

[0157] According to some embodiments, the nose cone 126 further includes a nose cone proximal portion (also referred to herein as the NC proximal portion) 128, which can have an outer diameter smaller than the most proximal end of the NC distal portion 129 and is adapted to define a shoulder portion or a nose cone ridge portion (also referred to herein as the NC ridge portion) 132.

[0158] As shown in FIGS. 4A-4B, the NC proximal portion 128 can include a nose cone proximal cylindrical portion (also referred to herein as the NC proximal cylindrical portion) 131 that extends proximally from the NC ridge portion 132, has a uniform outer diameter, and is desirably sized to allow the distal portion of the outer shaft 104 to extend thereon, and is also sized to allow the outer shaft distal lip 105 (e.g., shown in FIGS. 5B-5C) to abut or be pressed against the nose cone ridge portion 132. The NC proximal portion 128 can further include a nose cone proximal inclined portion (also referred to herein as the NC proximal inclined portion) 130 that is tapered from a larger diameter at the most proximal end of the NC proximal cylindrical portion 131 to a smaller diameter at the most proximal end of the nose cone 126. This can assist in retracting the nose cone 126 back into the delivery shaft 106 through the prosthetic valve 140 after the prosthetic valve 140 has been expanded. However, in other embodiments, the NC proximal portion 128 may not include the NC proximal inclined portion 130. Similarly, the NC proximal portion 128 can also be provided with a geometric shape different from that described above.

[0159] Figures 5A-5C show the distal portion of the delivery assembly 100 in different aspects of the artificial valve 140 delivery and expansion procedure. Prior to implantation, the artificial valve 140 can be crimped onto the delivery device 102. This step can include placing the radially compressed valve 140' into the outer shaft 104. The distal end portion of the outer shaft 104 extends over the artificial valve 140 and can contact the nose cone 126 in the delivery configuration of the delivery device 102. Thus, the distal end portion of the outer shaft 104 can serve as a delivery capsule, which contains or houses the artificial valve 140 in a radially compressed or crimped configuration for delivery through the patient's vasculature. Figure 5A shows an exemplary embodiment of the distal portion of the outer shaft 104 extending over the crimped artificial valve (hidden from view), with the outer shaft distal lip 105 pressed against the NC ridge portion 132 (both can be seen in FIGS. 5B-5C). According to some embodiments, the maximum diameter of the NC distal portion 129 is substantially equal to the outer diameter of the outer shaft 104, providing a smooth transition between the nose cone 126 and the outer shaft 104.

[0160] The outer shaft 104 and the delivery shaft 106 can be configured to be axially movable relative to each other, and movement of the outer shaft 104 oriented proximally with respect to the delivery shaft 106, or movement of the delivery shaft 106 oriented distally with respect to the outer shaft 104, can expose the artificial valve 140 from the outer shaft 104 as shown in FIG. 5B. In an alternative embodiment, the artificial valve 140 is not housed within the outer shaft 104 during delivery. Thus, according to some embodiments, the delivery device 102 does not include the outer shaft 104.

[0161] According to some embodiments, the prosthetic valve 140 is a mechanically expandable valve 140', which includes a plurality of actuator assemblies 156. The plurality of actuator assemblies 156 are fixed to the frame 146 and are configured to radially expand and / or compress the frame 146 via a suitable actuation control mechanism operable by the handle 110.

[0162] FIG. 5C shows an exemplary mechanically expandable valve 140' in an expanded state. The delivery device 102 further includes a plurality of actuation arm assemblies 160 that extend from the handle 110 through the delivery shaft 106. The actuation arm assemblies 160 can generally include an actuation member 155 and a support sleeve 157. The actuation members 155 are releasably coupled to their respective actuator assemblies 156 at their distal ends, and the support sleeves 157 are disposed around their respective actuation members 155 (the actuation members 155 and the support sleeves 157 can be seen, for example, in the cross-sectional view of FIG. 9D). Each actuation member 155 can be axially movable relative to the support sleeve 157 that covers it. Unless otherwise stated, the valve tips 132, 132' and the skirts 136, 136' are omitted from the figures throughout for clarity purposes.

[0163] According to some embodiments, each actuator assembly 156 includes an inner member 159, which can partially extend through the lumen of the outer member 158. The inner member can be attached to the frame 146' at one of its ends (such as the inflow apex 151' along the inflow end portion 144' or another junction 150', etc.). The outer member can be attached to the frame 146' at its opposite end (such as the outflow apex 149' along the outflow end portion 142' or another junction 150', etc.).

[0164] According to some embodiments, the actuating arm assembly 160 is configured to releasably couple to the prosthetic valve 140', and is further configured to move the prosthetic valve 140' between a radially compressed state and a radially expanded state. For example, the actuating member 155 of the actuating arm assembly 160 can be threadedly attached at its distal end to a threaded bore in the proximal end of the inner member 159. The distal edge of the support sleeve 157 covering the actuating member 155 can abut or engage the proximal end of the outer member 158, and is configured to prevent the outer member 158 from moving proximally beyond the support sleeve 157.

[0165] To radially expand the frame 146' (and thus the prosthetic valve 140'), the support sleeve 157 can be held firmly against the outer member 158. The actuating member 155 can then be pulled in a proximally oriented direction. Since the support sleeve 157 is held against the outer member 158 and the outer member 158 is connected to the outflow apex 149', the outflow end 143' of the frame 146' is prevented from moving relative to the support sleeve 157. As such, movement of the actuating member 155 in the proximally oriented direction causes movement of the inner member 159 in the same direction, thereby enabling the frame 146' to be axially shortened and radially expanded. More specifically, when the inner member 159 is axially moved (e.g., in a proximally oriented direction) through the outer member 158, the junction 150' to which the inner member 159 is attached moves in the same direction along the outer member 158 toward the opposite junction to which the outer member 158 is attached. And this axially shortens and radially expands the frame 146'.

[0166] When the desired diameter of the prosthetic valve 140' is reached, the actuating member 155 can be rotated to turn it away from the inner member 159. This rotation serves to disengage between the distal threaded portion of the actuating member 155 and the threaded bore of an inner member (not shown), enabling the actuating arm assembly 160 to be pulled away and retracted with the delivery device 102 from the patient's body, leaving the prosthetic valve 140' implanted in the patient.

[0167] Radial expansion of the frame 146' can be achieved by axially moving the inner member 159 relative to the outer member 158 in a proximally oriented direction, although it will be understood that a similar frame expansion can be achieved by axially pushing the outer member 158 relative to the inner member 159 in a distally oriented direction. Moreover, the illustrated embodiment of FIG. 5C shows an outer member 158 secured to the outflow end portion 142' of the frame 146' and an inner member 159 secured to the inflow end portion 144' of the frame 146', although in alternative embodiments, the outer member 158 can be secured to the inflow end portion 144' of the frame 146' while the inner member 159 can be secured to the outflow end portion 142' of the frame 146'.

[0168] According to some embodiments, the handle 110 can include a control mechanism, which can include operable or rotatable knobs, levers, buttons, etc., which can be manually controlled by an operator to create axial and / or rotatable movement of different components of the delivery device 102. For example, the handle 110 can include one or more manual control knobs (such as a manually rotatable control knob effective to pull the actuating member 155 of the actuating arm assembly 160 when rotated by an operator).

[0169] According to other embodiments, the control mechanisms within the handle 110 and / or other components of the delivery device 102 can be controlled electrically, pneumatically, and / or hydraulically. According to some embodiments, the handle 110 can house one or more electric motors, and the one or more electric motors can be actuated by an operator, for example, by pressing a button or switch on the handle 110, to create movement of the components of the delivery device 102. For example, the handle 110 can include one or more motors operable to create linear movement of components of the actuating arm assembly 160 and / or one or more motors operable to create rotational movement of the actuating member 155 to disengage the actuating member 155 from the inner member 159. According to some embodiments, one or more manual or electrical control mechanisms are configured to create all simultaneous linear and / or rotational movement of the actuating member 155.

[0170] While specific actuation mechanisms have been described above, other mechanisms can be used, for example, to drive relative movement between the inner and outer members of the actuation assembly via screw-type or other engagement mechanisms. Further details regarding the structure and operation of mechanically expandable valves and their delivery systems are described in U.S. Patent No. 9,827,093, U.S. Patent Application Publication No. 2019 / 0060057, U.S. Patent Application Publication No. 2018 / 0153689, and U.S. Patent Application Publication No. 2018 / 0344456, as well as U.S. Patent Application No. 62 / 870,372 and U.S. Patent Application No. 62 / 776,348, all of which are incorporated herein by reference.

[0171] In some cases, for example, it may be desirable to recompress the expanded prosthetic valve 140 at the site in order to enable a repositioning procedure or a re-crossing procedure to be performed and / or to enable readjustment of the expanded prosthetic valve diameter. According to some embodiments, the delivery device 102 further includes a recompression mechanism configured to facilitate recompression of the prosthetic valve 140 that is partially or fully expanded. FIG. 5C shows an exemplary recompression mechanism configured to compress a mechanically expandable prosthetic valve 140', but the mechanism may be similarly applicable to other types of prosthetic valves 140.

[0172] According to some embodiments, the recompression mechanism includes a flexible recompression member 166 that extends through a recompression shaft main lumen 163 (similar to the main lumen 263 shown in FIG. 9F). The recompression shaft 162 extends through the lumen of the delivery shaft 106. The recompression member 166 can be formed from a flexible wire, cable, suture, and the like. The flexible recompression member 166 is configured to extend distally through an opening formed at the distal end of the recompression shaft 162, forming a distal loop 167 that can surround the prosthetic valve 140' or extend around and / or between the actuation arm assemblies 160 attached to the prosthetic valve 140'.

[0173] In the exemplary embodiment of FIG. 5C, the distal loop 167 is coupled to the actuating arm assembly 160 and extends between the actuating arm assemblies 160. According to some embodiments, each actuating arm assembly 160 includes a loop attachment member 161. For example, the support sleeve 157 of each actuating arm assembly 160 can include the loop attachment member 161 at its distal portion, proximate to the prosthetic valve 140' when the actuating arm assembly 160 is attached to the prosthetic valve 140'. The loop attachment member 161 can be provided in the form of an eyelet, hook, ring, clip, aperture in the support sleeve 157, or any other structural element configured to maintain and enable the extension of the distal loop 167 therebetween. In the particular embodiment illustrated in FIG. 5C, the distal loop 167 extends through a loop attachment member 161 in the form of an eyelet.

[0174] According to some embodiments, the axial relative movement between the recompression member 166 and the recompression shaft 162 is effective to tighten the distal loop 167 connected to the actuating arm assembly 160 and extending between the actuating arm assemblies 160, thereby radially compressing the prosthetic valve 140'. For example, the handle 110 can be operated to pull the recompression member 166 and is adapted to apply an inwardly directed force to the actuating arm assembly 160. As long as the actuating arm assembly 160 is attached to the actuator assembly 156, the frame 146' of the valve 140' is also proportionally radially compressed.

[0175] In an alternative embodiment, the distal loop 167 can directly compress the prosthetic valve 140' while tightening it, instead of passing through the actuating arm assembly 160 (not shown).

[0176] As described above, the recompression mechanism may alternatively be utilized with other types of artificial valves 140 (e.g., self-expanding valves (not shown), etc.). A self-expanding valve includes a flexible frame, and the valve is configured to expand to its expanded free state when the flexible frame is released from a delivery capsule that holds the artificial valve in a crimped state during delivery. In such an embodiment, the distal loop 167 can surround a self-expanding valve instead of a mechanically expandable valve, and it is configured to compress the self-expanding valve when the recompression member 166 is pulled via the handle 110. Valve re-expansion may be permitted when the recompression member 166 is released from a tensioned state (not shown).

[0177] According to some embodiments, the delivery device 102 further includes a first sensor 180a, which is held within the nose cone and is configured to be exposed to the ambient environment of the nose cone through a nose cone side opening, i.e., to the blood flow around the nose cone through the nose cone guide wire lumen. The first sensor 180a is configured to measure characteristics of physiological flow relationships (e.g., blood pressure and / or blood flow, etc.).

[0178] FIG. 6 constitutes a perspective view of a nose cone 226 configured to hold therein a first sensor 180a (e.g., as shown in FIG. 7A). The nose cone 226 is similar in structure and function to the nose cone 126, except that it further includes a nose cone lateral port (also referred to herein as the NC lateral port) 236 (e.g., as shown in FIG. 7A) for providing lateral access to the first sensor 180a (which can be held within the nose cone 226). The first sensor 180a is aligned with the NC lateral port 236 and positioned within the nose cone. As shown in FIG. 6, the NC lateral port 236 can terminate at its end at a nose cone port opening (also referred to herein as the NC port opening) 237, and the first sensor 180a is aligned with the NC port opening 237 and positioned within the NC lateral port 236. According to some embodiments, the NC port opening 237 is formed on the NC outer surface 227 such that the first sensor 180a can be aligned and positioned with the NC port opening 237. Other elements of the nose cone 226 are essentially similar to the elements of the nose cone 126, and like reference numerals refer to like parts throughout the figures and will therefore not be described further.

[0179] The term “held within the nose cone” with respect to a sensor such as the first sensor 180a refers to the sensor being positioned within a volume defined by a boundary between the outer surface of the nose cone and the nose cone longitudinal axis. For example, the first sensor 180a being held within the nose cone 226 refers to the first sensor 180a being positioned between the NC outer surface 227 and the GW lumen longitudinal axis 235. According to some embodiments, the first sensor 180a is defined as being held within the nose cone 226 when no portion of the first sensor 180a radially protrudes away from the NC outer surface 227.

[0180] Advantageously, the configuration in which the first sensor 180a is held within the nose cone 226 ensures that the NC outer surface 227 remains smooth, enabling it to easily navigate through the patient's vasculature.

[0181] According to some embodiments, the NC distal portion 229 includes an NC lateral port 236, and the NC port opening 237 is configured to be formed on the outer surface of the NC distal portion 229 as shown in FIG. 6.

[0182] FIGS. 7A-7G show different configurations of the nose cone and the NC shaft of the delivery device 102 including the first sensor 180a held within the nose cone. FIG. 7A shows an exemplary configuration of the first sensor 180a held within the nose cone 226. According to some embodiments, as shown in FIG. 7A, the first sensor 180a is attached to the outer surface of the NC shaft distal portion 120, and more specifically, is positioned such that the first sensor 180a is aligned and positioned within the NC lateral port 236, and more specifically, is aligned and positioned with the NC port opening 237. According to some embodiments, the NC lateral port 236 is substantially orthogonal to the NC GW lumen 234 as shown in FIG. 7A.

[0183] According to some embodiments, the sensor includes an active face and a passive face. For example, the first sensor 180a includes a first active face 186a and an opposing first passive face 187a, where the first active face 186a is defined as the side or surface of the first sensor 180a oriented towards the measurement region, and the first passive face 187a can be the side or surface of the first sensor 180a facing and / or attached to a component of the delivery assembly 100. In the exemplary embodiment of FIG. 7A, the first sensor 180a is attached to the outer surface of the NC shaft distal portion 120 at its first passive face 187a.

[0184] According to some embodiments, the first sensor 180a is held within the nose cone 226 and is oriented such that the first passive face 187a is oriented toward the GW lumen longitudinal axis 235, while the first active face 186a is oriented toward the NC port opening 237 and optionally is in the same plane as the NC port opening 237.

[0185] According to some embodiments, the length of the NC lateral port 236 is greater than the height of the first sensor 180a, and the first active face 186a is positioned radially inwardly with respect to the NC outer surface 127 (as shown, for example, in FIG. 7A). According to an alternative embodiment, the length of the NC lateral port 236 is substantially equal to the height of the first sensor 180a, and the first active face 186a is in the same plane as the NC outer surface 127 (as shown, for example, in FIG. 7C). The height of the first sensor 180a is defined as the distance between the first passive face 187a and the first active face 186a.

[0186] According to some embodiments, the first transmission line 168a is coupled to the first sensor 180a and extends proximally therefrom toward the handle 110. According to some embodiments, the first transmission line 168a is configured to deliver power to the first sensor 180a. According to some embodiments, the first transmission line 168a is connected to a proximal power source (such as within the handle 110), and the proximal power source is configured to provide power and operate the first sensor 180a.

[0187] According to some embodiments, the first transmission line 168a is configured to deliver signals (e.g., electrical and / or optical signals) from and / or to the first sensor 180a. According to some embodiments, the first transmission line 168a is connected to an internal control unit 1010 (e.g., schematically shown in FIG. 16A) that includes a processor. The internal control unit 1010 may be embedded within the handle 110 and is configured to receive signals from and / or transmit signals to the first sensor 180a.

[0188] According to some embodiments, the first transmission line 168a is connected directly or indirectly (e.g., via the internal control unit 1010) to a proximal communication component 1030 (e.g., schematically shown in FIG. 16A). The proximal communication component 1030 may be operably coupled to the internal control unit 1010. The proximal communication component 1030 can include a transmitter, a receiver, a transceiver, and / or a data communication socket, which is embedded within the handle 110 and is configured to receive signals from and / or transmit signals to components and / or devices external to the delivery assembly 100.

[0189] According to some embodiments, the first transmission line 168a is attached to the outer surface of the nose cone shaft (also referred to herein as the NC shaft outer surface) 125 or, for example, wound therearound in a helical pattern (not shown), extending from the first sensor 180a to the handle 110 and optionally further into the handle 110.

[0190] According to some embodiments, as shown in FIG. 7A, the NC proximal opening 233 is shaped and dimensioned to allow both the NC shaft 118 and the first transmission line 168a to extend therethrough.

[0191] According to some embodiments, the NC shaft is a multi-lumen shaft and includes at least one nose cone shaft guide wire lumen and at least one nose cone shaft sensor lumen.

[0192] FIG. 7B shows another exemplary configuration of the first sensor 180a retained within the nose cone 226. In the embodiment of FIG. 7B, the nose cone 226 is attached to the NC shaft distal portion 220 of the NC shaft 218. The NC shaft 218 is similar to the NC shaft 118 in structure and function, except that it is provided as a multi-lumen shaft. The multi-lumen shaft includes, in addition to the NC shaft GW lumen 222, a nose cone shaft sensor lumen (also referred to herein as the NC shaft sensor lumen) 223. Also, at the NC shaft distal portion 220, the nose cone shaft side opening (also referred to herein as the NC shaft side opening) 224 is included. The NC shaft side opening 224 extends radially outward from the NC shaft sensor lumen 223. The NC shaft side opening 224 may be adjacent to the nose cone shaft distal end (also referred to herein as the NC shaft distal end) 221 or may be spaced axially away from the nose cone shaft distal end 221. Other elements of the NC shaft 218 are essentially the same as the elements of the NC shaft 118, and like reference numerals refer to like parts throughout the figures and will thus not be described further. According to some embodiments, the NC shaft sensor lumen 223 is closed-ended at the NC shaft distal end 221 as shown in FIG. 7B.

[0193] According to some embodiments, the first sensor 180a is aligned with the NC shaft side opening 224 and positioned within the NC shaft sensor lumen 223. According to some embodiments, the first sensor 180a is attached to the inner surface of the NC shaft sensor lumen 223. According to some embodiments, the first sensor 180a is attached to the inner surface of the NC shaft sensor lumen 223 at its first passive surface 187a, while the first active surface 186a is oriented towards the NC shaft side opening 224 and optionally lies in the same plane as the NC shaft side opening 224.

[0194] The NC shaft side opening 224 is aligned with the NC lateral port 236 and in fluid communication therewith, forming together a continuous channel or port configured to expose the first sensor 180a (notably the first active surface 186a) to the blood flow adjacent to the NC port opening 237 during use.

[0195] According to some embodiments, the first transmission line 168a extends axially through the NC shaft sensor lumen 223 from the first sensor 180a towards the handle 110. According to some embodiments, the first transmission line 168a is attached to the inner surface of the NC shaft sensor lumen 223. According to some embodiments, the NC proximal opening 233 is shaped and dimensioned to allow the multi-lumen NC shaft 218 to extend therethrough.

[0196] According to some embodiments, the delivery device 102 further includes at least one sensor shaft 318, the at least one sensor shaft 318 extends distally from the handle 110 and is configured to carry at least one sensor mounted therein (or retained therein). The at least one sensor can be attached to the distal portion 320 of the sensor shaft. According to some embodiments, the at least one sensor shaft is a first sensor shaft 318a, the first sensor shaft 318a includes a first sensor shaft distal portion 320a and defines a first sensor shaft lumen 322a. According to some embodiments, the first sensor shaft 318a extends axially through the lumen of the delivery shaft 108. According to some embodiments, the first sensor shaft distal portion 320a is attached to the nose cone.

[0197] FIG. 7C shows an exemplary configuration of a first sensor 180a retained within the nose cone 326, the first sensor 180a being attached to the first sensor shaft distal portion 320a. The nose cone 326 is similar in structure and function to the nose cone 226, except that the nose cone 326 is attached to both the NC shaft 118 (via the NC shaft distal portion 120) and the first sensor shaft 318a (via the first sensor shaft distal portion 320a). Specifically, the NC shaft 118 and the first sensor shaft 318a extend into the nose cone 326 through a first nose cone proximal opening 333a and a second nose cone proximal opening 333b, respectively. The other elements of the nose cone 326 are essentially the same as the elements of the nose cone 226, and like reference numerals refer to like parts throughout the figures and will therefore not be described further.

[0198] According to some embodiments, the first sensor shaft 318a includes a first sensor shaft side opening 324a at the distal portion 320a of the first sensor shaft. The first sensor shaft side opening 324a may be adjacent to the distal end 321a of the first sensor shaft or may be spaced axially away from the distal end 321a of the first sensor shaft. According to some embodiments, the first sensor shaft lumen 322a is closed at the distal end 321a of the first sensor shaft as shown in FIG. 7C. Alternatively, the first sensor shaft 318a can include a distal axial opening (not shown), for example, a distal axial opening through which the first sensor 180a can extend.

[0199] The first sensor 180a shown in FIG. 7C is aligned with the first sensor shaft side opening 324a and positioned within the first sensor shaft lumen 322a. According to some embodiments, the first sensor 180a is attached to the inner surface of the first sensor shaft lumen 322a. According to some embodiments, the first sensor 180a is attached to the inner surface of the first sensor shaft lumen 322a at its first passive surface 187a, while the first active surface 186a is oriented towards the first sensor shaft side opening 324a. In the embodiment illustrated in FIG. 7C, the first active surface 186a is substantially coplanar with the NC outer surface 327.

[0200] The first sensor shaft side opening 324a is aligned with the NC lateral port 236 and is configured to form a fluid connection therebetween, together forming a continuous channel or port configured to expose the first sensor 180a to the blood flow adjacent to the NC port opening 237 during use.

[0201] According to some embodiments, the first transmission line 168a extends axially from the first sensor 180a towards the handle 110 through the first sensor shuttle lumen 322a. According to some embodiments, the first transmission line 182a is attached to the inner surface of the first sensor shuttle lumen 322a. According to some embodiments, the second nose cone proximal opening 333b is shaped and dimensioned to allow the first sensor shaft 318a to extend therethrough.

[0202] According to some embodiments, the first sensor 180a is retained within the nose cone such that it may be exposed to either the ambient environment around the NC outer surface, the NC GW lumen, or both.

[0203] FIG. 7D shows an exemplary configuration of the first sensor 180a, which is retained within the nose cone 426 such that the first sensor 180a may be exposed to either the ambient environment around the NC outer surface 427, the NC GW lumen 434, or both. In the embodiment of FIG. 7D, the nose cone 426 is attached to the NC shaft distal portion 420 of the NC shaft 418. The NC shaft 418 is a multi-lumen shaft that is similar in structure and function to the multi-lumen NC shaft 218 except that the NC shaft sensor lumen 423 is an open end at the NC shaft distal end 421. The NC shaft 418 may or may not include an NC shaft side opening. In the exemplary embodiment of FIG. 7D, the NC shaft 418 lacks an NC shaft side opening. Other elements of the NC shaft 418 are essentially similar to the elements of the NC shaft 218, and like reference numerals refer to like parts throughout the figure and will therefore not be described further.

[0204] The nose cone 426 is similar to the nose cone 226 in terms of structure and function, except that the NC lateral port 436 extends radially from the NC GW lumen 434 to the NC outer surface 427. The NC shaft 418 can terminate at or proximal to the NC lateral port 436 without protruding into the NC lateral port 436. For example, the distal end 421 of the NC shaft can be coplanar with the proximal edge of the NC lateral port 436. Other elements of the nose cone 426 are essentially the same as the elements of the nose cone 226, and like reference numerals refer to like parts throughout the figures and will not be described further.

[0205] According to some embodiments, the first sensor 180a can be positioned within the NC lateral port 436. For example, the first transmission line 168a can extend through the NC shaft sensor lumen 423 such that the first sensor 180a can extend distally beyond the distal end 421 of the NC shaft.

[0206] The first sensor 180a positioned within the NC lateral port 436 can be exposed to the ambient environment around the NC outer surface 427, the NC GW lumen 434, or both. According to some embodiments, as illustrated in FIG. 7D, the first active face 186a is oriented towards the NC outer surface 427, while the first passive face 187a is oriented towards the NC GW lumen 434. According to some embodiments, the first active face 186a is oriented towards the NC GW lumen 434, while the first passive face 187a is oriented towards the NC outer surface 427. According to some embodiments, the first sensor 180a includes at least two diametrically opposed first active faces, with one active face being oriented towards the NC GW lumen 434 and the opposite active face being oriented towards the NC GW lumen 434. According to some embodiments, the first sensor 180a can be rotated about its axis of symmetry via, for example, a first transmission line 186 operable by a handle 110, such that the orientation of the first active face 186a can be switched between the NC outer surface 427 and the NC GW lumen 434.

[0207] According to some embodiments, neither the first transmission line 168a nor the first sensor 180a is rigidly attached to the nose cone shaft 418. Rather, these elements are configured to be axially movable relative to the nose cone shaft 418. Such embodiments can enable, for example, the insertion and retraction of the first sensor 180a through the NC shaft sensor lumen 423 when removal or replacement of the first sensor 180a is required.

[0208] According to some embodiments, the delivery device 102 includes a first sensor 180a, which is retained within the nose cone, such that the first sensor 180a is exposed to the NC GW lumen and not to the NC outer surface. The term "NC GW lumen" refers to the entire length of such a lumen extending from the NC distal end to the NC proximal opening, which will be apparent to be capable of coinciding with a portion of the NC shaft GW lumen along at least a portion of the distal portion of the NC shaft attached to the nose cone.

[0209] FIG. 7E shows an exemplary configuration of the first sensor 180a, which is retained within the nose cone 126 such that the first sensor 180a is exposed to the NC GW lumen 134. In the exemplary configuration shown in FIG. 7E, the nose cone 126 is attached to the distal portion 520 of the NC shaft of the multi-lumen NC shaft 518. The NC shaft 518 is similar to the nose cone shaft 218 in terms of structure and function, except that the NC shaft side opening 524 extends radially inwards from the NC shaft sensor lumen 523 towards the NC GW lumen 134. The other elements of the NC shaft 518 are essentially similar to the elements of the NC shaft 218, and like reference numerals refer to like parts throughout the figures and will thus not be described further.

[0210] According to some embodiments, the first sensor 180a is aligned with the NC shaft side opening 524 and positioned within the NC shaft sensor lumen 523. According to some embodiments, the first sensor 180a is attached to the inner surface of the NC shaft sensor lumen 523. According to some embodiments, the first sensor 180a is attached to the inner surface of the NC shaft sensor lumen 523 at its first passive surface 187a, while on the other hand, the first active surface 186a is oriented towards the NC shaft side opening 524 and optionally lies in the same plane as the NC shaft side opening 524. More specifically, the first active surface 186a is oriented towards the NC GW lumen 134.

[0211] According to some embodiments, the first sensor 180a is held within the nose cone 126 such that the first active surface 186a is oriented towards the GW lumen longitudinal axis 135, while on the other hand, the first passive surface 187a is oriented towards the NC outer surface 127.

[0212] According to some embodiments, the first transmission line 168a extends axially through the NC shaft sensor lumen 523 from the first sensor 180a towards the handle 110. According to some embodiments, the first transmission line 168a is attached to the inner surface of the NC shaft sensor lumen 523. According to some embodiments, the NC proximal opening 133 is shaped and dimensioned to allow the multi-lumen NC shaft 518 to extend therethrough.

[0213] FIG. 7F shows another exemplary configuration of the first sensor 180a retained within the nose cone 526. In the embodiment of FIG. 7F, the nose cone 526 is attached to the NC shaft distal portion 420 of the NC shaft 418. The nose cone 526 is similar in structure and function to the nose cone 426, except that the NC lateral port 536 extends radially from the NC GW lumen 534 toward the NC outer surface 527 but does not extend to the NC outer surface 527. Thus, the NC lateral port 536 is in fluid communication with the NC GW lumen 534 at the NC port opening 537, which is formed therebetween. The other elements of the nose cone 526 are essentially the same as the elements of the nose cone 426, and like reference numerals refer to like parts throughout the figures and will thus not be described further.

[0214] According to some embodiments, the first sensor 180a can be positioned within the NC lateral port 536. The first sensor 180a positioned within the NC lateral port 536 can be exposed to the NC GW lumen 534.

[0215] FIG. 7G shows an additional exemplary configuration of the first sensor 180a retained within the nose cone 626. As shown in FIG. 7G, the nose cone 626 is attached to both the NC shaft 118 (via the NC shaft distal portion 120) and the first sensor shaft 318a (via the first sensor shaft distal portion 320a). The nose cone 626 is similar in structure and function to the nose cone 326, except that the NC lateral port 636 extends from the first sensor shaft distal portion 320a to the NC GW lumen 634. The other elements of the nose cone 626 are essentially the same as the elements of the nose cone 326, and like reference numerals refer to like parts throughout the figures and will thus not be described further.

[0216] The first sensor 180a shown in FIG. 7G is aligned with the first sensor shaft side opening 324a and positioned within the first sensor shaft lumen 322a, and the first active surface 186a is oriented toward the NC GW lumen 634.

[0217] The first sensor shaft side opening 324a is aligned with the NC lateral port 636 and is configured to form a fluid connection therebetween, together forming a continuous channel or port configured to expose the first sensor 180a to the blood flow adjacent to the NC port opening 637 during use.

[0218] Although several configurations relating to the nose cone with respective nose cone shafts and / or the first sensor shaft are illustrated and described in connection with FIGS. 7A - 7G, it will be apparent that other additional embodiments or configurations having the first sensor 180a are contemplated that are retained within the nose cone and exposed to either the ambient environment around the NC outer surface or the NC GW lumen.

[0219] As used herein (including the specification and claims), the terms "including" and / or "having" are defined as "comprising" (i.e., open - ended language).

[0220] According to some embodiments, the delivery device 102 includes a nose cone 1226, which is configured to hold a first sensor 180a such that the first sensor 180a is exposed at a side opening on the outer surface of the NC. The nose cone 1226 can take any form of the nose cones 226, 326, or 426. According to some embodiments, the delivery device 102 includes a nose cone 1326, which is configured to hold a first sensor 180a such that the first sensor 180a is exposed in the NC GW lumen. The nose cone 1326 can take any form of the nose cones 126, 426, 526, or 626. According to some embodiments, the delivery device 102 includes a nose cone 1126, which is configured to hold the first sensor 180a therein. The nose cone 1126 can take any form of either the nose cone 1226 or 1326. According to some embodiments, the delivery device includes an NC shaft 1118 attached to the nose cone 1126. The NC shaft 1118 can take any form of the NC shafts 118, 218, 318, 418, or 518. According to some embodiments, the delivery device 102 further includes a first sensor shaft 318a connected to the first sensor 180a.

[0221] According to some embodiments, the delivery device 102 further includes a second sensor 180b positioned proximal to the first sensor 180a. According to some embodiments, the second sensor 180b is positioned proximal to the nose cone 1126. According to some embodiments, the second sensor 180b is positioned proximal to the artificial valve 140. According to some embodiments, the artificial valve 140 of the delivery assembly 100 equipped with the first sensor 180a and the second sensor 180b is a non-balloon-expandable valve, and the second sensor 180b is positioned proximal to the non-balloon-expandable valve.

[0222] The term "non-balloon-expandable valve" refers to either a self-expandable prosthetic valve or a mechanically expandable prosthetic valve, but not a balloon-expandable prosthetic valve.

[0223] The second sensor 180b can be coupled to any one of the NC shaft 1118, the delivery shaft, the actuation arm assembly 160 (when present), the recompression shaft (when present), and / or the sensor shaft (when present).

[0224] FIG. 8 constitutes a perspective view of the distal region of an exemplary delivery assembly 100, which is provided with a first sensor 180a and a second sensor 180b. The first sensor 180a is held within the nose cone 1126 (the first sensor 180a is hidden from view in FIG. 8). The nose cone 1126 is positioned distally of the mechanically expandable valve 140'. The second sensor 180b is positioned proximally of the mechanically expandable valve 140'. In the exemplary embodiment shown in FIG. 8, the second sensor 180b is attached to the outer surface 1125 of the NC shaft at a position proximal to the mechanically expandable valve 140'.

[0225] The first sensor 180a and the second sensor 180b can each sense and / or measure physiological parameters (including real-time blood pressure and / or blood flow velocity), and generate a signal (e.g., an electrical signal or an optical signal) representing the physiological parameter. According to some embodiments, the first sensor 180a and the second sensor 180b are each a flow sensor. According to some embodiments, the first sensor 180a and the second sensor 180b are each a pressure sensor, which is configured to provide time-resolved blood pressure data that can be correlated to the parameter of interest based on known empirical correlations known in the art. The measurement ranges for the first sensor 180a and the second sensor 180b are each sufficient to measure normal and elevated physiological pressures and / or flow rates in the cardiovascular system, from which differential values can be calculated.

[0226] Similar to the first sensor 180a, the second sensor 180b can include a second active surface 186b and an opposite second passive surface 187b, where the second active surface 186b is defined as the side or surface of the second sensor 180b directed towards the measurement region, and the second passive surface 187b can be the side or surface of the second sensor 180b attached to a component of the delivery assembly 100.

[0227] Figures 9A-9G show cross-sectional views of various configurations of the delivery device 100, which includes a first sensor 180a held within the nose cone 1126 and a second sensor 180b positioned proximal to the prosthetic valve 140. A mechanically expandable valve 140' is illustrated in FIGS. 9A-9G, and it will be apparent that the configurations of these figures are applicable to other types of prosthetic valves 140 in a similar manner. Moreover, the first sensor 180a is shown as being held within the nose cone 226 and attached to an NC shaft (e.g., NC shaft 218, etc.) with a configuration similar to that shown in FIG. 7B throughout FIGS. 9A-9G. However, this configuration is shown as merely an exemplary representation of the position of the first sensor 180a within the nose cone 1126, and any of the configurations of the first sensor 180a held within the nose cone as shown and described above can be implemented in combination with the configurations shown and described with respect to the second sensor 180b in relation to FIGS. 9A-9G. Similarly, the NC shaft 218 is shown in FIGS. 9A and 9D-9G for illustrative purposes only, and any NC shaft 1118 can be implemented in combination with the configurations shown and described with respect to the second sensor 180b in relation to FIGS. 9A and 9D-9G.

[0228] Figure 9A shows one exemplary configuration of the second sensor 180b positioned proximal to the prosthetic valve 140'. According to some embodiments, the second sensor 180b is attached to the outer surface 1125 of the NC shaft at a position proximal to the prosthetic valve 140. In FIG. 9A, the second sensor 180b is shown as being attached to the outer surface 225 of the NC shaft at a position proximal to the prosthetic valve 140'. As further illustrated in the exemplary embodiment of FIG. 9A, the second sensor 180b can be attached to the outer surface 225 of the NC shaft at its second passive surface 187b.

[0229] According to some embodiments, the second transmission line 168b is coupled to the second sensor 180b and extends proximally toward the handle 110. According to some embodiments, the second transmission line 168b is configured to deliver power to the second sensor 180b. According to some embodiments, the second transmission line 168b is connected to a proximal power source (e.g., within the handle 110), and the proximal power source is configured to provide power and operate the second sensor 180b.

[0230] According to some embodiments, the second transmission line 168b is configured to deliver signals (e.g., electrical and / or optical signals) from and / or to the second sensor 180b. According to some embodiments, the second transmission line 168b is connected to the internal control unit 1010. The internal control unit 1010 may be configured to receive signals from and / or transmit signals to the second sensor 180a.

[0231] According to some embodiments, the second transmission line 168b is connected to the proximal communication component 1030, either directly or indirectly (e.g., via the internal control unit 1010).

[0232] According to some embodiments, the second transmission line 168b is attached to the NC shaft outer surface 1125 (e.g., the NC shaft outer surface 225 shown in FIG. 9A) or wound around it in, for example, a helical pattern (not shown), extending from the second sensor 180b toward the handle 110 and optionally further into the handle 110.

[0233] Figure 9B shows another exemplary configuration of a second sensor 180b positioned proximal to the prosthetic valve 140'. According to some embodiments, the nose cone 1126 is attached to the NC shaft distal portion 620 of the multi-lumen NC shaft 618. The multi-lumen NC shaft 618 is similar to the multi-lumen NC shaft 218 in structure and function except that it includes at least two NC shaft sensor lumens 623a and 623b. The first NC shaft sensor lumen 623a is similar to the NC shaft sensor lumen 223 and provides a first NC shaft side opening 624a, which is structured and positioned in the same manner as any of the embodiments disclosed with respect to the NC shaft side opening 224. The NC shaft 618 further includes a second NC shaft side opening 624b that extends radially outward from the second NC shaft sensor lumen 623b. The second NC shaft side opening 624b is positioned proximal to the prosthetic valve 140 (shown as prosthetic valve 140' in FIG. 9B). Other elements of the NC shaft 618 are essentially the same as the elements of the NC shaft 218, and like reference numerals refer to like parts throughout the figures and will not be described further.

[0234] According to some embodiments, the second sensor 180b is aligned with the second NC shaft side opening 624b and positioned within the second NC shaft sensor lumen 623b. According to some embodiments, the second sensor 180b is attached to the inner surface of the second NC shaft sensor lumen 623b. According to some embodiments, the second sensor 180b is attached to the inner surface of the second NC shaft sensor lumen 623b at its second passive surface 187b, while the second active surface 186b is oriented toward the second NC shaft side opening 624b and optionally lies in the same plane as the second NC shaft side opening 624b.

[0235] According to some embodiments, the second transmission line 168b extends axially from the second sensor 180b toward the handle 110 through the second NC shaft sensor lumen 623b. According to some embodiments, the second transmission line 168b is attached to the inner surface of the second NC shaft sensor lumen 623b.

[0236] Although not explicitly shown, it will be clear that the second sensor 180b and the second transmission line 168b can be similarly retained within the second NC shaft sensor lumen of the NC shaft that is open-ended at its NC distal end, regardless of the presence or absence of an NC shaft side opening extending from the first NC shaft sensor lumen. For example, the NC shaft is similar to the NC shaft 418 described and illustrated in connection with FIGS. 7D and 7F with respect to structure and function, and includes a second NC shaft sensor lumen similar to the second NC shaft sensor lumen 623b described above herein. Similarly, the second sensor 180b and the second transmission line 168b can be retained within the second NC shaft sensor lumen of an NC shaft having a first NC shaft side opening that opens into the NC GW lumen (such as the NC shaft 518 described and illustrated in connection with FIG. 7E).

[0237] Figure 9C shows another exemplary configuration of the second sensor 180b positioned proximal to the prosthetic valve 140'. According to some embodiments, the nose cone 1126 is attached to the NC shaft distal portion 720 of the multi-lumen NC shaft 718. The multi-lumen NC shaft 718 is similar in structure and function to the multi-lumen NC shaft 218, except that it includes at least two NC shaft side openings 724a and 724b (extending radially outward from the same NC shaft sensor lumen 723 at different axial positions). The first NC shaft side opening 724a is structured and positioned in the same manner as any of the embodiments disclosed with respect to the NC shaft side opening 224. The second NC shaft side opening 724b is positioned proximal to the prosthetic valve 140 (shown as prosthetic valve 140' in FIG. 9C). The other elements of the NC shaft 718 are essentially the same as the elements of the NC shaft 218, and like reference numerals refer to like parts throughout the figures and will therefore not be described further.

[0238] According to some embodiments, both the first sensor 180a and the second sensor 180b are positioned within the NC shaft sensor lumen 723, with the first sensor 180a positioned in alignment with the first NC shaft side opening 724a and the second sensor 180b positioned in alignment with the second NC shaft side opening 724b.

[0239] According to some embodiments, the second sensor 180b is attached to the inner surface of the NC shaft sensor lumen 723. According to some embodiments, the second sensor 180b is attached to the inner surface of the NC shaft sensor lumen 723 at its second passive surface 187b, while the second active surface 186b is oriented towards the second NC shaft side opening 724b and optionally lies in the same plane as the second NC shaft side opening 724b.

[0240] According to some embodiments, the second transmission line 168b extends axially from the second sensor 180b towards the handle 110 through the second NC shaft sensor lumen 723. According to some embodiments, the second transmission line 168b is attached to the inner surface of the NC shaft sensor lumen 723.

[0241] According to some embodiments, the NC shaft sensor lumen 723 is dimensioned to accommodate both the first transmission line 168a and the second transmission line 168b along a portion of the NC shaft sensor lumen 723 that extends proximally from at least the second NC shaft side opening 724b.

[0242] Although not explicitly shown, it will be clear that the second sensor 180b and the second transmission line 168b can be similarly retained within the NC shaft sensor lumen of the NC shaft that is open-ended at its NC distal end, regardless of the presence or absence of an NC shaft side opening extending from the first NC shaft sensor lumen. For example, the NC shaft is similar to the NC shaft 418 described and illustrated in connection with FIGS. 7D and 7F with respect to structure and function, and includes a second NC shaft side opening similar to the second NC shaft side opening 624b described above herein. Similarly, the second sensor 180b and the second transmission line 168b can be retained within the NC shaft sensor lumen of an NC shaft having a first NC shaft side opening that opens into the NC GW lumen (such as the NC shaft 518 described and illustrated in connection with FIG. 7E).

[0243] FIG. 9D shows yet another exemplary configuration of a second sensor 180b positioned proximal to a mechanically expandable valve 140' for a delivery device 102 that includes a plurality of actuation arm assemblies 160. In the embodiment of FIG. 9D, the second sensor 180b is attached to an outer surface of one of the plurality of actuation arm assemblies 160. As described, each actuation arm assembly 160 can include an actuation member 155 and a support sleeve 157, the actuation member 155 being releasably coupled at its distal end to a respective actuator assembly 156, and the support sleeve 157 being disposed about the actuation member 155. According to some embodiments, the second sensor 180b is attached to an outer surface of the support sleeve 157.

[0244] According to some embodiments, the second transmission line 168b is attached to an outer surface of one of the plurality of actuation arm assemblies 160 or wound thereabout, for example, in a helical pattern (not shown), extending from the second sensor 180b to the handle 110 and optionally further into the handle 110. According to some embodiments, the second transmission line 168b is attached to an outer surface of the support sleeve 157.

[0245] FIG. 9E shows another exemplary configuration of a second sensor 180b positioned proximal to an artificial valve 140' for a delivery device 102 that includes a recompression mechanism. In the embodiment of FIG. 9E, the second sensor 180b is attached to an outer surface of the recompression shaft 162.

[0246] According to some embodiments, the second transmission line 168b is attached to an outer surface of the recompression shaft 162 or wound thereabout, for example, in a helical pattern (not shown), extending from the second sensor 180b to the handle 110 and optionally further into the handle 110.

[0247] FIG. 9F shows yet another exemplary configuration of a second sensor 180b positioned proximal to an artificial valve 140' for a delivery device 102 that includes a recompression mechanism. The recompression mechanism shown in FIG. 9F includes a recompression shaft 262 that is similar in structure and function to recompression shaft 162, except that it is a multi-lumen recompression shaft, and the multi-lumen recompression shaft includes a recompression shaft sensor lumen 264 in addition to a recompression shaft main lumen 263. The recompression shaft 262 further includes a recompression shaft side opening 265 that extends radially outward from the recompression shaft sensor lumen 264. The recompression shaft side opening 265 is positioned proximal to an artificial valve 140 (shown as artificial valve 140' in FIG. 9F). Other elements of the recompression shaft 262 are essentially similar to the elements of the recompression shaft 162, and like reference numerals refer to like parts throughout the figures and will not be described further herein.

[0248] According to some embodiments, the second sensor 180b is aligned with the recompression shaft side opening 265 and positioned within the recompression shaft sensor lumen 264. According to some embodiments, the second sensor 180b is attached to the inner surface of the recompression shaft sensor lumen 264. According to some embodiments, the second sensor 180b is attached to the inner surface of the recompression shaft sensor lumen 264 at its second passive face 187b, while its second active face 186b is oriented toward the recompression shaft side opening 265 and optionally lies in the same plane as the recompression shaft side opening 265.

[0249] According to some embodiments, the second transmission line 168b extends axially through the recompression shaft sensor lumen 264 from the second sensor 180b toward the handle 110. According to some embodiments, the second transmission line 168b is attached to the inner surface of the recompression shaft sensor lumen 264.

[0250] Figure 9G shows another exemplary configuration of a second sensor 180b positioned proximal to the artificial valve 140'. According to some embodiments, the second sensor 180b is attached to the delivery shaft 106. In the embodiment shown in Figure 9G, the second sensor 180b is attached to the outer surface of the delivery shaft 106. Specifically, the second sensor 180b can be attached to the outer surface of the delivery shaft 106 at its second passive surface 187b. Alternatively, the second sensor 180b can be attached to the inner surface of the delivery shaft 106.

[0251] According to some embodiments, the second transmission line 168b is attached to the outer surface of the delivery shaft 106 or wound around it, for example, in a helical pattern (not shown), extending from the second sensor 180b to the handle 110 and optionally further into the handle 110. Alternatively or additionally, the second transmission line 168b can be attached to the inner surface of the delivery shaft 106.

[0252] FIG. 9H shows an additional exemplary configuration of a second sensor 180b positioned proximal to the prosthetic valve 140'. In the embodiment of FIG. 9H, the second sensor 180b is attached to a delivery shaft 206, which is similar in structure and function to the delivery shaft 106 except that the delivery shaft 206 is a multi-lumen shaft, and at least one of the lumens is a delivery shaft sensor lumen 208. The delivery shaft 206 further includes a delivery shaft side opening 209 that extends radially outward from the delivery shaft sensor lumen 208. In use, the delivery shaft 206 is positioned proximal to the prosthetic valve 140 prior to valve expansion such that the delivery shaft side opening 209 is positioned proximal to the prosthetic valve 140 (shown as prosthetic valve 140' in FIG. 9H). The other elements of the delivery shaft 206 are essentially the same as the elements of the delivery shaft 106, and like reference numerals refer to like parts throughout the figures and will not be described further herein.

[0253] According to some embodiments, the second sensor 180b is aligned with the delivery shaft side opening 209 and positioned within the delivery shaft sensor lumen 208. According to some embodiments, the second sensor 180b is attached to the inner surface of the delivery shaft sensor lumen 208. According to some embodiments, the second sensor 180b is attached to the inner surface of the delivery shaft sensor lumen 208 at its second passive surface 187b, while the second active surface 186b is oriented towards the delivery shaft side opening 209 and optionally lies in the same plane as the delivery shaft side opening 209. According to some embodiments, the delivery shaft side opening 209 is positioned on the outer surface of the delivery shaft 206. Alternatively, the delivery shaft side opening 209 can be oriented towards the GW lumen longitudinal axis 135.

[0254] According to some embodiments, the second transmission line 168b extends axially from the second sensor 180b towards the handle 110 through the delivery shaft sensor lumen 208. According to some embodiments, the second transmission line 168b is attached to the inner surface of the delivery shaft sensor lumen 208.

[0255] Although not explicitly shown, other configurations of the second sensor 180b attached to any component of the delivery device 102 at a position proximal to the prosthetic valve 140 are also contemplated. According to some embodiments, the second sensor 180b may be attached to the first sensor shaft 318a, and the first sensor shaft 318a is attached to the nose cone 1126 as shown and described in connection with FIGS. 7C and 7G. According to some embodiments, the second sensor 180b is attached to the outer surface of the outer surface of the first sensor shaft 325 at a position proximal to the prosthetic valve 140 in a similar manner as described with respect to the attachment of the second sensor 180b to the outer surface of the NC shaft 225 in connection with FIG. 9A. In such embodiments, the second transmission line 168b may be attached to the outer surface of the first sensor shaft 325 or wound around the outer surface of the first sensor shaft 325 and extend from the second sensor 180b to the handle 110 (embodiments are not shown).

[0256] According to some embodiments, the first sensor shaft (e.g., the first sensor shaft 318a, etc.) can include two sensor shaft lumens, and the two sensor shaft lumens each have a side opening that extends radially outward therefrom. The second sensor 180b can be aligned with the second sensor shaft side opening and positioned within the second sensor shaft lumen at a proximal position of the valve 140 in a similar manner as described with respect to the positioning of the second sensor 180b within the second NC shaft sensor lumen 623b in connection with FIG. 9B. In such an embodiment, the second transmission line 168b can extend axially through the second sensor shaft lumen from the second sensor 180b toward the handle 110 (embodiment not shown).

[0257] According to some embodiments, the first sensor shaft (e.g., the first sensor shaft 318a, etc.) can include two sensor shaft side openings that extend radially outward from the same sensor shaft lumen at different axial positions. The second sensor 180b can be aligned with the second sensor shaft side opening and positioned within the sensor shaft lumen in a similar manner as described with respect to the positioning of the second sensor 180b within the NC shaft sensor lumen 723 in connection with FIG. 9C. In such an embodiment, the second transmission line 168b can extend axially through the sensor shaft lumen from the second sensor 180b toward the handle 110 (embodiment not shown).

[0258] According to some embodiments, the delivery device 102 can further include a second sensor shaft 318b, which can be identical to the first sensor shaft 318a except that the second sensor shaft 318b is not attached to the nose cone 1126 and is optionally axially translatable within the delivery shaft 106. The elements of the second sensor shaft 318b are essentially similar to the elements of the first sensor shaft 318a, and like reference numerals refer to like parts throughout the figures and will thus not be further described. The second sensor 180b can be attached to the second sensor shaft 318b in a similar manner as described for the attachment of the first sensor 180a to the first sensor shaft 318a with respect to FIG. 7C. However, in use, the second sensor shaft 318b is positioned such that the second sensor shaft side opening 324b, and the second sensor 180b aligned therewith, are proximal to the prosthetic valve 140. The second transmission line 168b can extend axially from the second sensor 180b towards the handle 110 through the second sensor shaft lumen 322b (not shown in the embodiments).

[0259] Although not dealt with in complete detail, the first sensor 180a held within the nose cone 1126 according to any of the configurations described above herein can be used in combination with a second sensor 180b according to any of the configurations described above herein, and it should be readily understood that the second sensor 180b is positioned and / or disposed within the delivery device 102 at a proximal location of the prosthetic valve 140.

[0260] According to some embodiments, either the first sensor 180a or the second sensor 180b can each be a piezoresistive pressure sensor (e.g., a MEMS piezoresistive pressure sensor, etc.). According to other embodiments, either the first sensor 180a or the second sensor 180b can each be a capacitive pressure sensor (e.g., a MEMS capacitive pressure sensor, etc.). In such embodiments, the transmission lines 168a and 168b can include a conductive medium (e.g., one or more conductive wires, etc.).

[0261] According to some embodiments, the first sensor 180a and the second sensor 180b are each an optical fiber pressure sensor (e.g., Fabry - Perot type pressure sensors 280a and 280b, etc.), and the respective transmission lines 182a and 182b are each an optical fiber 268a and 268b. The use of optical fiber sensors can be advantageous due to their light weight, small size, low power consumption, high sensitivity, environmental durability, and low cost.

[0262] FIG. 10A shows an exemplary nose cone 226 attached to the multi - lumen NC shaft 218, similar to the configuration described and illustrated in relation to FIG. 7B, where the transmission line is the optical fiber 268a and the first sensor is the first optical pressure sensor 280a. FIG. 10B is an enlarged view of region 10B in FIG. 10A. In the embodiments illustrated in FIGS. 10A - 10B, the first optical fiber 268a includes an optical core 270 surrounded by a cladding 271. According to some embodiments, the first optical fiber 268a can further include a polymer buffer coating (not shown) surrounding the cladding 271, which serves as a protective buffer from the surrounding environment.

[0263] According to some embodiments, the first optical pressure sensor 280a is a Fabry - Perot cavity - based sensing head. Fabry - Perot sensors are attractive due to their small size and the low cost of their sensing elements. Fabry - Perot sensors detect the pressure applied to a diaphragm in a direction perpendicular to the surface of the diaphragm. The Fabry - Perot sensor 280a can include a housing 282 attached to the optical fiber distal end 274, and a diaphragm 286 is attached to the housing 282. The pressure can be monitored by detecting and measuring the deflection of the housing 282 to which the pressure is applied.

[0264] According to some embodiments, the first optical pressure sensor 280a is a cross - axial pressure sensor, and the cross - axial pressure sensor is configured to measure the pressure applied to it in a direction substantially orthogonal to the core axis 273. As shown in FIGS. 10A - 10B, the optical core 270 terminates at an inclined surface 272, and the inclined surface 272 is angled with respect to the core axis 273. An optical side cavity 284 extends through the cladding 271 and the housing 282 (overlapped by the diaphragm 286). According to some embodiments, the first optical sensor 280a lacks the housing 282, and the optical side cavity 284 is configured to extend through the cladding 271, and the diaphragm 286 is attached to the outer surface of the cladding 271 or, if present, to any protective layer surrounding the cladding 271 (embodiments are not shown).

[0265] The inclined surface 272 is preferably angled to provide a critical angle of incidence for the light beam passing along the optical core 270 in order to ensure total reflection from the inclined surface 272. Preferably, the inclined surface 272 is angled at an angle of 45° with respect to the core axis 273. However, it should be understood that other angles between the inclined surface 272 and the core axis 273 may be applicable as long as a critical angle of incidence is provided for the light beam passing through the optical core 270.

[0266] As further shown in FIG. 10B, since the inclined surface 272 is angled with respect to the core axis 273, the light beam passing through the optical core 270 is redirected by 90° with respect to the core axis 273. When the redirected light beam impinges on the diaphragm 286, it is reflected and redirected back to the inclined surface 272 and through the optical fiber 268a, for example, back towards the internal control unit 1010 within the handle 110. In other words, the diaphragm 286 and the optical side cavity 284 are axially aligned with the core axis 273 in a cross - axial direction.

[0267] When pressure is applied to the diaphragm 286, the diaphragm 286 bends into the optical side cavity 284, thereby changing the path of the light beam, which changes the phase of the reflected signal.

[0268] FIGS. 10A - 10B illustrate the structural components of the first sensor 180a and the first transmission line 168a (implemented as the cross - axial optical pressure sensor 280a and the optical fiber 286a), but it will be clear that the same functional and structural principles are equally applicable to the second sensor 180b and the second transmission line 168b, respectively.

[0269] Moreover, although the optical pressure sensor 280a and the optical fiber 268a are illustrated in connection with the specific configuration of FIGS. 10A - 10B (positioned within the multi - lumen NC shaft 218 attached to the nose cone 226), this configuration is shown for illustrative purposes only, and it will be clear that any one of the sensors 180a, 180b and the transmission lines 168a, 168b illustrated in FIGS. 7A - 9H can be implemented as an optical pressure sensor and an optical fiber (e.g., such as the optical sensor 280a and the optical fiber 268a described herein).

[0270] Throughout the present disclosure, any reference to a sensor (e.g., the first sensor 180a or the second sensor 180b, etc.) relates to any type of sensor, including the embodiments of the optical pressure sensors illustrated in FIGS. 9A - 8B, unless otherwise stated. Similarly, throughout the present disclosure, any reference to a transmission line (e.g., the first transmission line 168a or the second transmission line 168b, etc.) relates to any type of transmission line, including the embodiments of the optical fibers illustrated in FIGS. 10A - 10B, unless otherwise stated.

[0271] According to some embodiments, similar to the optical fiber 268a, a single optical fiber can be a multi - core optical fiber, and each core terminates at an optical pressure sensor. A plurality of optical pressure sensors can be arranged axially spaced from each other, such that a first optical pressure sensor is positioned within the nose cone 1126 corresponding to any of the positions disclosed herein with respect to the first sensor 180a, and a second optical pressure sensor is positioned proximal to the artificial valve 140 corresponding to any of the positions disclosed herein with respect to the second sensor 168a (embodiments are not shown).

[0272] Attaching any of the first sensor 180a, the first transmission line 182a, the second sensor 180b, and / or the second transmission line 182b to any component of the delivery device 102 according to any of the embodiments and configurations illustrated and described herein may be implemented by stitching, screwing, clamping, adhering with a biocompatible adhesive, tightening, welding, or any other suitable technique.

[0273] According to some embodiments, either the first sensor 180a or the second sensor 180b each includes a radiopaque marking, and the radiopaque marking can provide a visible indication of the location of the sensor when viewed under fluoroscopy.

[0274] Note that in some embodiments, the delivery device 102 can be equipped with three or more sensors. For example, delivery devices having a plurality of first sensors 180a and / or a plurality of second sensors 180b are contemplated within the scope of the present invention.

[0275] According to some embodiments, the delivery device 102 further includes a sensing catheter 194 that extends from the handle 110 through the delivery shaft 106. FIG. 11 shows the distal region of the delivery assembly 100, and the sensing catheter 194 is shown to include a sensing head 196 that extends distally from the delivery shaft 106. Although a mechanically expandable valve 140' is illustrated in FIG. 11, it will be apparent that the configurations of these figures apply to other types of prosthetic valves 140 in a similar manner.

[0276] The sensing catheter 194 may be axially movable relative to the delivery shaft 106. The movement of the sensing catheter 194 may be controlled by the handle 110. The sensing head 196 may include a sensor (e.g., the first sensor 180a or the second sensor 180b according to any of the embodiments disclosed herein). The sensing catheter 194 may further include a transmission line (e.g., the first transmission line 168a or the second transmission line 168b according to any of the embodiments disclosed herein) extending from the sensor head towards the handle 100.

[0277] According to some embodiments, the delivery device includes a first sensor 180a retained within the nose cone 1126 and a sensing catheter 194 equipped with a sensing head 196, the sensing head 196 includes a second sensor 180b, and the sensing head 196 may be positioned proximal to the prosthetic valve 140.

[0278] Reference is now made to FIG. 12. By way of example only, for transvalvular pressure measurement, the use of a delivery assembly 100 equipped with a first pressure sensor 180a retained within the nose cone 1226 and a second pressure sensor 180b positioned proximal to a non-balloon-expandable valve will be described with reference to a mechanically expandable aortic valve 140' and with reference to a native aortic valve 40.

[0279] The delivery assembly 100 is utilized according to a conventional trans-catheter valve replacement procedure and is capable of advancing the nose cone 1126 (more specifically, shown as nose cone 1226 in FIG. 12) over the guide wire 112 to a distal position of the native heart valve. For example, the nose cone 1126 is advanced toward the left ventricle 16 and positioned therein within the LVOT 22 as shown in FIG. 12. The non-balloon-expandable aortic valve 140 (e.g., a mechanically expandable valve 140', etc.) is positioned at the aortic valve annulus 42, and the second sensor 180b is arranged to be disposed within the aorta 80 (e.g., within the aortic root 82 or in the vicinity of the aortic root 82).

[0280] At this position, the first pressure sensor 180a and the second pressure sensor 180b are capable of simultaneously measuring the pressures within the left ventricle 16 and the aorta 80. Accordingly, the signals obtained from both the first pressure sensor 180a and the second pressure sensor 180b are used for calculation, thereby providing the pressure difference between the left ventricle 16 and the aorta 80 and making it possible to determine the pressure drop across the non-balloon-expandable aortic valve 140 before, during, and / or after expansion relative to the native aortic valve annulus 42. Such measurements can provide real-time feedback regarding the hemodynamic validity of the valve expansion diameter and valve positioning during the implantation procedure. The measurement results can be graphically displayed, for example, on an LCD screen 1022 or an LED light 1024 provided on the handle 110.

[0281] The proposed assembly and method are primarily applicable to a delivery assembly 100 that includes a non-balloon-expandable prosthetic valve 140. Balloon-expandable valves block blood flow through the prosthetic valve during balloon inflation and thus render it impractical to utilize pressure sensors positioned proximal and distal to the prosthetic valve for pressure drop measurements during such procedures. In contrast, non-balloon-expandable valves (e.g., self-expandable valves or mechanically-expandable valves, etc.) can be expanded without blocking blood flow therethrough.

[0282] According to an alternative embodiment, a delivery assembly 100 equipped with a first sensor 180a retained within a nose cone 1126 and a second sensor 180b positioned proximal to the prosthetic valve is utilized with a balloon-expandable valve and can, for example, provide a measured value of the pressure drop across the expanded valve when the balloon is deflated.

[0283] According to some embodiments, a method of utilizing a delivery assembly 100 equipped with the first pressure sensor 180a and the second pressure sensor 180b described above herein includes partially expanding a non-balloon-expandable aortic valve 140 and deriving real-time pressure values during the expansion procedure, and, if necessary, the non-balloon-expandable aortic valve 140 can be recompressed and repositioned.

[0284] A delivery assembly 100 equipped with the first pressure sensor 180a and the second pressure sensor 180b and further including a recompression mechanism can advantageously be utilized in accordance with the proposed method because the recompression mechanism enables the non-balloon-expandable prosthetic valve 140 to be recompressed to reorient or reposition the non-balloon-expandable prosthetic valve 140 if necessary in light of the real-time pressure measurements received from the first pressure sensor 180a and the second pressure sensor 180b.

[0285] FIG. 12 shows a delivery system for delivering an artificial aortic valve (shown in FIG. 12 as a mechanically expandable valve 140'), but the method can be similarly implemented using a delivery system for delivering an artificial valve for implantation at other locations in the heart (e.g., among the native mitral valve, native pulmonary valve, and native tricuspid valve).

[0286] As shown in FIG. 12, even when the guide wire 112 remains within the NC GW lumen 1234 of any nose cone 1226 (hidden from view in FIG. 12), pressure can be measured by at least the first pressure sensor 180a. The reason is that the active surface 186a of the first pressure sensor 180a is oriented toward the blood flow surrounding the nose cone 1226, for example, through the NC lateral port 1236.

[0287] The same method, described above and shown in relation to FIG. 12, can be implemented with respect to the first sensor 180a retained within the nose cone 1326 by performing a further step of retracting the guide wire 112 from the NC GW lumen 1334. The active surface 186a of the first pressure sensor 180a can be oriented toward the NC GW lumen 1334, and pressure readings cannot be taken as long as the guide wire 112 occupies the space of the NC GW lumen 1334. However, retraction of the guide wire 112 allows blood flow through the NC GW lumen 1334, thereby enabling the first sensor 180a to measure the blood pressure within the NC GW lumen 1334.

[0288] According to some embodiments, a system 200 is provided that includes a delivery assembly 100 equipped with a first sensor 180a retained within a nose cone 1126 and a sensing catheter 294 provided with a sensing head 296.

[0289] FIG. 13 shows the distal region of the system 200, which includes a delivery assembly 100 provided with a valve 140' and a first sensor 180a (the first sensor 180a is hidden from view) held within the nose cone 1126. Although a mechanically expandable valve 140' is illustrated in FIG. 13, it will be apparent that the configuration of this figure applies to other types of prosthetic valves 140 in a similar manner. The system 200 further includes a sensing catheter 294, which can be similar to the sensing catheter 194 in terms of structure and function, except that the sensing catheter 294 is provided as a separate component that is not part of the delivery device 102.

[0290] The sensing catheter 294 can be axially movable relative to any component of the delivery assembly 100. The sensing catheter 294 includes a sensing head 296, and the sensing head 296 can include a sensor (such as a second sensor 180b according to any of the embodiments disclosed herein). According to some embodiments, the sensing catheter 294 can be provided in the form of a pigtail catheter, as illustrated in FIG. 13.

[0291] Reference is now made to FIG. 14. By way of example only, the use of the system 200 will be described with reference to a mechanically expandable aortic valve 140' and with reference to the native aortic valve 40. The delivery assembly 100 is utilized according to a conventional transcatheter valve replacement procedure to advance the nose cone 1126 into the left ventricle 16 and, as shown in FIG. 14, to position it, for example, within the LVOT 22. A non-balloon-expandable aortic valve 140 (such as a mechanically expandable valve 140') is positioned at the aortic valve annulus 42, while the sensing catheter 294 is advanced through the aorta 80 to position the sensing head 296 proximal to the non-balloon-expandable aortic valve 140.

[0292] At this position, the first sensor 180a and the sensing head 296 are capable of simultaneously measuring the pressures in the left ventricle 16 and the aorta 80. Thus, signals from both the first sensor 180a and the sensing head 296 are used to provide the pressure difference between the left ventricle 16 and the aorta 80, and it is possible to determine the pressure drop across the non-balloon-expandable aortic valve 140 before, during, and / or after the expansion relative to the native aortic valve annulus 42. Such measurements can provide real-time feedback regarding the hemodynamic validity of the valve expansion diameter and valve positioning during the implantation procedure. The measurement results can be graphically displayed, for example, on an LCD screen 1022 or an LED light 1024 provided on the handle 110.

[0293] The proposed assembly and method are primarily applicable to a delivery assembly 100 that includes a non-balloon-expandable artificial valve 140, but they can similarly be utilized with balloon-expandable valves, for example, to provide a measured value of the pressure drop across the expanded valve when the balloon is deflated.

[0294] Further steps of the method (including derivation of real-time pressure values during the expansion procedure and / or guidewire 112 retraction) can be implemented in the same manner as described above in relation to FIG. 12.

[0295] According to some embodiments, the delivery device 102 includes a valve shaft that extends from the handle 110 and defines a valve shaft lumen. The valve shaft includes at least one sensor within the valve shaft lumen. The valve shaft further includes a shaft valve that is movable between a closed position and an open position, the closed position blocking fluid flow through the valve shaft lumen and the open position allowing fluid flow (e.g., blood flow) therethrough.

[0296] Figures 15A-15B respectively show a delivery assembly 100 including a shaft valve 188 in a closed state and an open state according to some embodiments. Figures 16A-16B respectively show cross-sectional side views of the shaft valve 188 corresponding to the configuration of the shaft valve 188 in Figures 15A-15B. The shaft valve 188 defines a shaft valve lumen 189 and includes a shaft valve proximal portion 192 and a shaft valve distal portion 190. The shaft valve proximal portion 192 can extend into the handle 110, and the shaft valve distal portion 190 terminates at a shaft valve distal end 191. The shaft valve 188 can extend from the handle 110 through the delivery shaft 106 and can be axially movable relative to the delivery shaft 106. The axial movement of the shaft valve 188 can be controlled by the handle 110.

[0297] According to some embodiments, the shaft valve 188 includes a first sensor 180a attached thereto, and the first sensor 180a is disposed in the shaft valve lumen 189. In the exemplary embodiments shown in Figures 15A-16B, the first sensor 180a is attached to the inner surface 187 of the shaft valve. According to some embodiments, the first sensor 180a is attached to the inner surface of the shaft valve distal portion 190. The shaft valve 188 can further include a first transmission line 168a, and the first transmission line 168a extends from the first sensor 180a towards the handle 110. According to some embodiments, the first transmission line 168a is attached to the inner surface 187 of the shaft valve.

[0298] According to some embodiments, the delivery device 102 includes a first sensor 180a attached to the distal portion 190 of the shaft with valve and a second sensor 180b positioned proximal to the prosthetic valve 140. For illustrative purposes, the second sensor 180b is shown attached to the outer surface 125 of the NC shaft in FIGS. 15A-15B, but it will be clear that the second sensor 180b can be positioned proximal to the prosthetic valve 140 according to any of the configurations described and illustrated in connection with FIGS. 9A-9H.

[0299] The valve shaft 188 further includes a shaft valve coupled to the proximal portion 192 of the shaft, and the shaft valve is schematically shown in FIGS. 15A-16B as a leaf valve disposed within the shaft lumen 189 with valve. The shaft valve 193 can be any type of valve movable between an open position and a closed position, which can be, for example, but not limited to, a gate valve, a butterfly valve, a check valve, and a ball valve. The shaft valve 193 is configured to prevent flow through the shaft lumen 189 with valve in the closed position and to allow flow therethrough in the open position. The shaft valve 193 can be actuated manually or electrically by the user of the delivery assembly 100, for example, by operating a suitable actuation mechanism (not shown) of the handle 110. According to some embodiments, the shaft with valve 188 includes a continuous wall surrounding the shaft lumen 189 with valve, which lacks any cutout, opening, or aperture extending radially outward from the shaft lumen 189 with valve.

[0300] Figure 15A shows the prosthetic valve 140 being carried in a crimped state by the delivery device 102 prior to valve expansion. In this state, the shaft valve 193 is in the closed position as shown in more detail by Figure 16A. The shaft-with-valve distal portion 190 is positioned proximal to the prosthetic valve 140 or can be positioned at any other position relative thereto as shown in Figure 15A in this state. As long as the shaft valve 193 remains in the closed position, blood flow through the shaft-with-valve lumen 189 is blocked.

[0301] Figure 15B shows the prosthetic valve 140 in an expanded state, and the prosthetic valve 140 can be, for example, either partially expanded or fully expanded relative to the native valve annulus. In this state, the valve shaft 188 is advanced distally through the prosthetic valve 140, and for example, by advancing the shaft-with-valve distal portion 190 distally of the prosthetic valve 140, the first sensor 180a can be positioned at a distal position of the prosthetic valve 140. In this position, the shaft valve 193 is moved to the open position. For example, the shaft valve 193, which is hinge-connected to the inner surface of the shaft-with-valve proximal portion 192, can be pivoted about its hinge in the direction of arrow c1 in Figure 16B. However, other types of valves implemented with respect to the shaft valve 193 can be associated with different translational mechanisms from the closed position to the open position. In the open position of the shaft valve 193, blood can flow through the shaft-with-valve lumen 189 in the direction of arrow f1 in Figures 15B and 16B. When blood flow through the shaft-with-valve lumen 189 is permitted, pressure or flow can be easily measured by the first sensor 180a.

[0302] The measurement signal can be transmitted from the first sensor 180a to the internal control unit 1010 via the first transmission line 168a. FIGS. 16A-16B schematically illustrate an exemplary internal control unit 1010, which is embedded in the handle 110 and is operably coupled to a display 1020 (such as the digital screen 1022 or the LED light 1024 shown in FIG. 2) and / or a proximal communication component 1030. Although not explicitly shown in FIGS. 16A-16B, it will be clear that the measurement signal can similarly be transmitted from the second sensor to the internal control unit 1010 via the second transmission line 168b. Thus, the configurations shown in FIGS. 15B and 16B enable the derivation of the proximal pressure measurement value of the prosthetic valve 140 by the second sensor 180b and the derivation of the distal pressure measurement value of the prosthetic valve 140 by the first sensor 180a when the prosthetic valve 140 is expanded and when the shaft valve 193 is in the open position.

[0303] FIGS. 17A-17B show a delivery assembly including a shaft with valve 288 in the closed and open states of the shaft valve 293, respectively, according to some embodiments. FIGS. 18A-18B show cross-sectional side views of the shaft with valve 288 in states corresponding to the states shown in FIGS. 17A-17B, respectively. The shaft with valve 288 is similar in structure and function to the shaft with valve 188, except that the shaft valve is a stopcock valve 293 and the stopcock valve 293 can be switched between a closed position and an open position. Other elements of the shaft with valve 288 are essentially the same as the elements of the shaft with valve 188, and like reference numerals refer to like parts throughout the figures and will thus not be described further.

[0304] Reference is now made to FIGS. 19A-19B. By way of example only, for transvalvular pressure measurement, the use of a delivery assembly 100 equipped with a first pressure sensor 180a maintained within the lumens of valve shafts 188, 288 and a second pressure sensor 180b positioned proximal to the prosthetic valve 140 will be described with reference to a prosthetic aortic valve and with reference to the native aortic valve 40. The delivery assembly 100 is utilized in accordance with a conventional transcatheter valve replacement procedure and is capable of delivering a prosthetic valve toward a desired site of implantation (e.g., the native aortic valve 40, etc.). During the delivery procedure and as long as the prosthetic valve 140 is in the crimped state shown in FIG. 19A, the valve shafts 188, 288 can be positioned such that their distal ends are proximal to the prosthetic valve 140, and the shaft valves 193, 293 (not shown in FIGS. 19A-19B) are in a closed position as illustrated in FIGS. 15A and 16A with respect to shaft valve 193 or as illustrated in FIGS. 17A and 18A with respect to shaft valve 293.

[0305] In FIG. 19B, the prosthetic valve 140 (which can be a non-balloon-expandable aortic valve) is expanded against the aortic valve annulus 42, allowing the valve shafts 188, 288 to advance distally therethrough and positioning the first sensor 180a distal to the prosthetic valve. As shown in FIG. 19B, the valve shafts 188, 288 are advanced toward the left ventricle 16, positioning, for example, the first sensor 180a (hidden from view) within the LVOT 22. In this state, the shaft valves 193, 293 are moved or switched to an open position, allowing blood flow through the valve shafts 188, 288 as illustrated in FIGS. 15B and 16B with respect to shaft valve 193 or as illustrated in FIGS. 17B and 18B with respect to shaft valve 293.

[0306] In this state, the first pressure sensor 180a and the second pressure sensor 180b can simultaneously measure the pressures in the left ventricle 16 and the aorta 80. Accordingly, signals obtained from both the first pressure sensor 180a and the second pressure sensor 180b are used for calculation, thereby providing a pressure difference between the left ventricle 16 and the aorta 80 and making it possible to determine a pressure drop across the non-balloon-expandable aortic valve 140 before, during, and / or after dilation relative to the native aortic valve annulus 42. Such measurements can provide real-time feedback regarding the hemodynamic validity of the valve dilation diameter and valve positioning during the implantation procedure. The measurement results can be graphically displayed, for example, on an LCD screen 1022 or an LED light 1024 provided on the handle 110.

[0307] The proposed assembly and method are primarily applicable to a delivery assembly 100 that includes a non-balloon-expandable artificial valve 140, but they can also be utilized with balloon-expandable valves, for example, to provide a measured value of the pressure drop across the expanded valve when the balloon is deflated. Further steps of the method, including the derivation of real-time pressure values during the dilation procedure, can be implemented in the same manner as described above in connection with FIG. 12.

[0308] Although not explicitly shown, other embodiments of a valve-attached shaft (e.g., valve-attached shaft 188 or 288, etc.) are contemplated, which include a second sensor 180b, and the second sensor 180b is optionally connected to a second transmission line 168b extending therefrom towards the handle 110. The attachment of the second sensor 180b can be implemented according to any of the configurations described and illustrated with respect to the first sensor 180a in connection with FIGS. 15A-18B. A valve-attached shaft including the second sensor 180b within the valve-attached shaft lumen can be used with a delivery device 102 equipped with the first sensor 180a held within the nose cone 1126. In such a case, the valve-attached shaft remains proximal to the prosthetic valve 140 rather than being advanced through the prosthetic valve 140 during its expansion, and is adapted to maintain the second sensor 180b positioned proximal to the prosthetic valve 140. When the prosthetic valve 140 is expanded, the shaft valve can be switched to the open position, enabling the first sensor 180a and the second sensor 180b (which can be pressure sensors) to measure the distal and proximal pressures of the prosthetic valve 140 simultaneously.

[0309] According to some embodiments, the delivery device 102 includes a valve-attached guidewire (also referred to herein as a valve-attached GW) 212 that extends from the handle 110 through the NC shaft GW lumen 122 and the NC GW lumen 134, defining a guidewire internal lumen (also referred to herein as a GW internal lumen) 213. The valve-attached GW includes at least one sensor within the GW internal lumen 213. The valve-attached GW 212 further includes a guidewire valve (also referred to herein as a GW valve) 217 coupled thereto, and the guidewire valve 217 is movable between a closed position that blocks fluid flow through the GW internal lumen 213 and an open position that permits fluid flow (e.g., blood flow) therethrough.

[0310] Figures 20A-20B each show a delivery assembly 100 including a GW with valve 212 in a closed state and an open state, according to some embodiments. Figures 21A-21B each show a side cross-sectional view of the GW with valve 212 corresponding to the states of Figures 20A-20B. The GW with valve 212 includes a valve-attached guide wire proximal portion (also referred to herein as the valve-attached GW proximal portion) 216 and a valve-attached guide wire distal portion (also referred to herein as the valve-attached GW distal portion), and the valve-attached guide wire proximal portion 216 can extend into the handle 110, and the valve-attached guide wire distal portion can extend through and / or distal to the nose cone 126. According to some embodiments, the GW valve 217 is connected to the valve-attached GW proximal portion 216.

[0311] According to some embodiments, the valve-equipped GW212 includes at least two sensors, and the at least two sensors are axially spaced from each other within the GW internal lumen 213. The inner surface of the valve-equipped guide wire (also referred to herein as the inner surface of the valve-equipped GW) 215 is defined around the GW internal lumen 213. According to some embodiments, the valve-equipped GW212 includes a sensor 180a and a second sensor 180b, the sensor 180a is attached to the inner surface 215 of the valve-equipped GW at a distal position of the prosthetic valve 140, and the second sensor 180b is attached to the inner surface 215 of the valve-equipped GW at a proximal position of the prosthetic valve 140. According to some embodiments, the valve-equipped GW212 further includes a first transmission line 168a and a second transmission line 168b, the first transmission line 168a is attached to the first sensor 180a and extends towards the handle 110, and the second transmission line 168b is attached to the second sensor 180b and extends towards the handle 110. According to some embodiments, the first transmission line 168a and / or the second transmission line 168b can be attached to the GW inner surface 215. According to some embodiments, the valve-equipped GW212 includes a continuous GW inner surface 215 that lacks any cuts, openings, or apertures that extend radially outwardly from the GW internal lumen 213 through the GW inner surface 215.

[0312] The proximal portion 216 of the valve-equipped GW includes a GW valve 217 (shown as a stopcock valve in FIGS. 20A - 21B). The GW valve 217 can be any other type of valve movable between an open position and a closed position, which can be, for example, but not limited to, a gate valve, a butterfly valve, a check valve, and a ball valve, etc. The GW valve 217 is configured to prevent flow through the GW internal lumen 213 in the closed position and to allow flow through it in the open position. The GW valve 217 can be actuated manually or electrically by the user of the delivery assembly 100, for example, by operating a suitable actuation mechanism within the handle 110.

[0313] Figure 20A shows the prosthetic valve 140 being transported in a crimped state by the delivery device 102 prior to valve expansion. In this state, the GW valve 217 is in the closed position, as shown in more detail by Figure 21A. As long as the GW valve 217 remains in the closed position, blood flow through the valved GW internal lumen 213 is blocked.

[0314] Figure 20B shows the prosthetic valve 140 in an expanded state, representing a state where transvalvular pressure measurement may be desirable. At this stage, the GW valve 217 is moved or switched to the open position, allowing blood flow through the valved GW internal lumen 213 in the direction of arrow f1 in Figures 20B and 21B. When blood flow through the valved GW internal lumen 213 is permitted, pressure or flow can be easily measured by the first sensor 180a and / or the second sensor 180b. The measurement signal can be transmitted from the first sensor 180a and / or the second sensor 180b to the internal control unit 1010 via the first transmission line 168a and / or the second transmission line 168b.

[0315] Although not explicitly shown, further embodiments of the valved shaft (e.g., valved shaft 188 or 288, etc.) are contemplated, which include both the first sensor 180a and the second sensor 180b within its lumen. The first sensor 180a and the second sensor 180b can be attached to the valved shaft in a manner similar to that disclosed with respect to the valved GW 212, i.e., both are attached to the valved shafts 188, 288 and disposed within the valved shaft lumens 189, 289, with the first sensor 180a being attached to the distal portions 190, 290 of the valved shaft and the second sensor 180b being spaced proximally from the first sensor 180a.

[0316] The valve-equipped shaft with both the first sensor 180a and the second sensor 180b can be used according to any of the methods described with respect to valve-equipped shaft 188 or 288, such valve-equipped shaft being advanced to a predetermined position through the expanded prosthetic valve 140, with the first sensor 180 being distal to the prosthetic valve 140, while the second sensor 180b is proximal to the prosthetic valve 140.

[0317] According to some embodiments, the delivery assembly 100 includes at least one sensor 380 (preferably, a plurality of sensors 380) attached to the prosthetic valve 140. The sensor 380 is adapted to measure physiological parameters (such as, for example, blood pressure, blood flow velocity, temperature, distance to tissue, deposit accumulation, and / or electrical conductivity, etc.), and to generate a signal representative of the physiological parameter. The at least one sensor 380 can be attached to the inflow end portion 144, to the prosthetic valve outflow end portion 142, or to any other region therebetween. The at least one sensor 380 can be attached to the frame 146, to the commissure 154, to the actuator assembly 156, or to any other structural component of the prosthetic valve 140. According to some embodiments, the at least one sensor 380 can be attached to the prosthetic valve 140 by suturing, screwing, clamping, adhering with a biocompatible adhesive, fastening, welding, or by any other suitable technique.

[0318] The at least one sensor 380 is oriented radially inwards (i.e., towards the valve longitudinal axis 141) and is capable of measuring one or more types of physiological parameters within the prosthetic valve 140, or is oriented radially outwards and is capable of measuring one or more types of physiological data outside of (or in contact with) the outer surface of the prosthetic valve 140.

[0319] According to some embodiments, the prosthetic valve 140 includes a first sensor 380a (attached to the inflow end portion 144) and a second sensor 380b (attached to the outflow end portion 142). Each of the first sensor 380a and the second sensor 380b is configured to measure characteristics of a physiological flow relationship (such as, for example, blood pressure and / or blood flow). According to some embodiments, the first sensor 380a and the second sensor 380b are pressure sensors. According to some embodiments, the first sensor 380a and the second sensor 380b are flow sensors.

[0320] Reference is now made to FIGS. 22A-22B, which illustrate the first sensor 380a and the second sensor 380b attached to a prosthetic valve. FIG. 22A shows an exemplary embodiment of the first sensor 380a and the second sensor 380b, which are attached to a mechanically expandable valve 140', and more specifically, to at least one actuator assembly 156 of the prosthetic valve 140'. In the example shown, both the first sensor 380a and the second sensor 380b are axially spaced apart and attached to the same outer member 158. Alternatively or additionally, each of the first sensor 380a and / or the second sensor 380b may be attached to other components of the actuator assembly 156 (such as, for example, the inner member 159), to different actuator assemblies 156, or to any other component of the prosthetic valve 140'.

[0321] FIG. 22B shows an exemplary embodiment of the first sensor 380a and the second sensor 380b, which are attached to the frame 146 of the artificial valve 140, and more specifically, attached to the junction 150 of the artificial valve 140. In the illustrated example, the first sensor 380a and the second sensor 380b are axially spaced apart and attached to the inflow apex 151 and the outflow apex 149, respectively. Alternatively or additionally, each of the first sensor 380a and / or the second sensor 380b may be attached to other junctions 150 or any other component of the artificial valve 140.

[0322] According to some embodiments, the sensor 380 includes an active surface 386 and a passive surface 387. For example, the first sensor 380a includes a first active surface 386a and a first passive surface 387a, where the first active surface 386a is defined as the side or surface of the first sensor 380a oriented towards the measurement region, and the first passive surface 387a can be the side or surface of the first sensor 380a attached to a component of the artificial valve 140. Similarly, the second sensor 380b includes a second active surface 386b and a second passive surface 387b, where the second passive surface 387b can be the side or surface of the second sensor 380b attached to a component of the artificial valve 140.

[0323] The passive surface 387 can be on the opposite side of the active surface 386 or any other surface, for example, a surface orthogonal to the active surface 386. In the exemplary embodiment illustrated in FIG. 22A, the second active surface 386b is a surface radially outwardly oriented from the frame 146'. In the exemplary embodiment illustrated in FIG. 22A, the second active surface 386b is a surface distally oriented towards the inflow end portion 144'.

[0324] According to some embodiments, either the first sensor 380a or the second sensor 380b can each be a piezoresistive pressure sensor (e.g., a MEMS piezoresistive pressure sensor, etc.). According to other embodiments, either the first sensor 380a or the second sensor 380b can each be a capacitive pressure sensor (e.g., a MEMS capacitive pressure sensor, etc.).

[0325] According to some embodiments, each sensor 380 is coupled to a transmission line 368, and the transmission line 368 extends proximally therefrom toward the handle 110. For example, the first sensor 380a can be coupled to a first transmission line 368a, and the second sensor 380b can be coupled to a second transmission line 368b. According to some embodiments, the transmission line 368 is attached to a component of the delivery device 102. According to some embodiments, the transmission line 368 includes a conductive medium (e.g., one or more conductive wires, etc.).

[0326] According to some embodiments, the transmission line 368 is configured to deliver power to the sensor 380. According to some embodiments, the transmission line 368 is connected to a proximal power source (e.g., within the handle 110), and the proximal power source is configured to provide power and operate the first sensor 380a. According to some embodiments, the transmission line 368 is configured to deliver signals from and / or to the sensor 380. According to some embodiments, the transmission line 368 is connected to the internal control unit 1010. According to some embodiments, the transmission line 368 is directly or indirectly (e.g., via the internal control unit 1010) connected to the proximal communication component 1030.

[0327] According to some embodiments, the transmission line 368 is releasably coupled to the sensor 380. In such embodiments, the transmission line 368 can be coupled to the sensor 380 during delivery of the prosthetic valve 140 to the implantation site and during the implantation procedure, and can be detached or released from the sensor 380 after the implantation procedure is complete, allowing the transmission line 368 to be withdrawn from the patient's body together with the remainder of the delivery device 102. In such embodiments, the prosthetic valve 140 can remain implanted in the patient's body and has at least one sensor 380 attached thereto in a non-operating mode.

[0328] According to some embodiments, the sensor 380 is held within the sensor housing 382 and its active face 386 is oriented towards the desired measurement region. In such embodiments, the sensor 380 is coupled to the prosthetic valve 140 via the sensor housing 382. According to some embodiments, the sensor 380 is attached to the sensor housing 382 via its passive face 386, while the housing is coupled to the prosthetic valve 140. In such embodiments, the transmission line 368 extends through the lumen of the transmission line shaft 376, while the transmission line shaft 376 is releasably coupled to the sensor housing 382. The transmission line 368 further extends into the sensor housing 382 and is releasably coupled to the sensor 380. When the transmission line shaft 376 is coupled to the sensor housing 382, the transmission line shaft 376 is configured to isolate the transmission line 368 extending therethrough and the sensor 380 attached to the transmission line 368 from the surrounding flow (e.g., blood flow).

[0329] The transmission line shaft 376 can extend from the handle 110 through the delivery shaft 106. According to some embodiments, the transmission line shaft 376 is axially movable relative to the artificial valve 140. According to some embodiments, the transmission line shaft 376 is axially movable relative to the delivery shaft 106. The transmission line 368 extends from the handle 100 through the corresponding transmission line shaft 376 and is axially movable relative to the transmission line shaft 376 when released from the corresponding sensor 380.

[0330] Figures 23A - 23C illustrate a non - constrained configuration representing a removable coupling mechanism between a transmission line 368 extending through a transmission shaft lumen 377 and sensors 380 housed within a sensor housing 382. In Figures 23A - 23C, sensors 380a and 380b are respectively hidden from view within corresponding sensor housings 382a and 382b. Figure 23A shows a first sensor housing 382a attached to the inflow end portion 144 and a second sensor 382b attached to the outflow end portion 142.

[0331] According to some embodiments, the transmission line 186 includes a transmission line distal end portion 174, and the transmission line distal end portion 174 is releasably coupled to the sensor 380. Similarly, the transmission line shaft 176 includes a transmission shaft distal end portion 378 (see Figure 23C), and the transmission shaft distal end portion 378 is releasably coupled to the sensor housing 382. According to some embodiments, the sensor housing 382 includes a housing threaded bore 383 (see Figure 23C), the transmission shaft distal end portion 378 includes an external transmission shaft thread 379, and the external transmission shaft thread 379 is configured to threadedly engage the housing threaded bore 383.

[0332] In the state shown in FIG. 23A, the first transmission line distal end 374a and the second transmission line distal end 374b are respectively connected to the first sensor 380a and the second sensor 380b, and the first transmission shaft distal end 378a and the second transmission shaft distal end 378b are respectively connected to the first sensor housing bore 383a and the second sensor housing bore 383b (e.g., connected by screws). In this state, power can be supplied to the sensors 380a and 380b respectively via the transmission lines 368a and 368b, and signals can be transmitted from the sensors 380a and 380b and to the sensors 380a and 380b respectively via the transmission lines 368a and 368b.

[0333] FIG. 23B shows the state during the detachment of the transmission lines 368a and 368b from the sensors 380a and 380b respectively. According to some embodiments, the transmission line 368 can be connected to the sensor 380, and the application of a tensile force in the direction f1 exceeding a predetermined threshold magnitude can detach the transmission line 368 from the sensor 380. According to some embodiments, the force required to detach the transmission line 368 from the sensor 380 can be manually applied. According to some embodiments, the force required to detach the transmission line 368 from the sensor 380 can be applied by a mechanical or electrical actuation mechanism at the handle 110.

[0334] As shown in FIG. 23B, while the transmission line 368 is detached from the sensor 380, the transmission line shaft 376 remains connected to the sensor housing 382, thereby isolating the transmission line 368 from the surrounding environment of the blood flow. This allows the transmission line 368 to be detached from the sensor 380 and pulled while avoiding the risk of exposing the surrounding blood flow or other tissues to its current.

[0335] When the transmission line 368 is released from and then detached from the sensor 380, the transmission line shaft 376 can be rotated, for example, in the direction c2 about its axis of symmetry so as to be released from the sensor housing 382. According to some embodiments, the transmission line 368 is pulled along a sufficient distance before detaching the transmission line shaft 376 from the sensor housing 382 so that when the transmission line shaft 376 is detached, the transmission line 368 cannot be exposed to the blood flow flowing through the transmission shaft lumen 377.

[0336] FIG. 23C shows a more advanced state of detaching the transmission line 368b from the sensor 380b as compared to the state shown in FIG. 23B. The state shown in FIG. 23C is achieved by further pulling the transmission line shaft 376 in the proximal direction f1 away from the sensor housing 382 after being detached from the sensor housing 382. This mechanism allows the transmission line 368 to be detached from the sensor 380 and the sensor housing 382 together with the transmission line shaft 376 and also allows it to be retracted from the patient's body at the end of the implantation procedure without the risk of exposing natural tissue or blood flow to the current flowing through the transmission line 368 during such detachment.

[0337] The delivery assembly 100 including the first pressure sensor 380a and the second pressure sensor 380b respectively attached to the inflow end portion 144 and the outflow end portion 142 of the artificial valve 140 can be utilized to provide pressure readings across the artificial valve 140 during the implantation procedure in the same manner as described above with respect to any of the configurations provided by the first sensor 180a and the second sensor 180b attached to the components of the delivery device 102.

[0338] Alternatively, or in addition to the releasable connection between the sensor 380 and the transmission line 362, the prosthetic valve 140 can be connected to at least one post-treatment sensor 380. The post-treatment sensor 380 is defined as a sensor configured to measure physiological parameters, among other things, after prosthetic valve implantation, without being wired to any component of the delivery device. According to some embodiments, the post-treatment sensor 380 can be removably connected to the transmission line 362, which can receive power from a power source in the handle 110 through the transmission line 362 and communicate with the internal control circuit 1110 and / or the proximal communication component 1130 during the implantation procedure, and can include additional components that enable it to operate when the post-treatment sensor 380 is removed from the transmission line 362. Alternatively, the post-treatment sensor 380 can be configured to operate either during the implantation procedure and / or after the implantation procedure without being connected to the transmission line 362 or any other external power source.

[0339] According to some embodiments, the post-treatment sensor 380 includes or is connected to a transmitter (not shown), and the transmitter is configured to wirelessly transmit a signal (e.g., a measurement signal) obtained by the post-treatment sensor 380. According to some embodiments, the prosthetic valve 140 includes at least one transmitter connected to at least one post-treatment sensor 380. According to some embodiments, the post-treatment sensor 380 can be electromagnetically connected to a transmit / receive antenna (not shown).

[0340] Advantageously, the post-treatment sensor 380 configured to acquire and transmit post-treatment measurement signals enables post-treatment monitoring. For example, prosthetic valve performance can be monitored to detect degradation over time, which can be caused by a reduction in the mobility of the valve leaflets 152 (which can be caused by leaflet thrombosis, leaflet calcification, and / or any other deposits formed thereon).

[0341] Here, FIGS. 24 to 26B are referred to, and FIGS. 24 to 26B illustrate exemplary flow obstacles that may occur during the implantation of the artificial mitral valve 140. The unique anatomical position of the native mitral valve 30 near the LVOT 22 requires careful artificial valve positioning, for example, to avoid hemodynamic obstacles in the LVOT 22.

[0342] FIG. 24 shows the artificial mitral valve 140, which can take any form of the artificial valve 140 (including the mechanically expandable valve 140') described above. The artificial mitral valve 140 shown in FIG. 24 is implanted in the mitral annulus 32. In some cases, as demonstrated in FIG. 24, the placement of the inflow end portion 144 in the left ventricle 16 can form a new LVOT 22' region, which is narrower than the anatomical LVOT 22 (shown in FIG. 1), and may generate an undesirable stenosis region that disturbs the hemodynamic behavior in this region. The new LVOT 22' can be formed, for example, when the inflow end portion 144 is oriented towards the inferior septum 20, pushing the native mitral valve leaflets 34 in the same direction, thereby narrowing the width of the LVOT 22' and suppressing blood flow in the direction of arrow d2 towards the aortic valve 40.

[0343] Therefore, during the artificial valve 140 implantation procedure, it is desirable to provide real-time hemodynamic measurements (such as flow measurements and / or pressure measurements, etc.). Advantageously, real-time detection of flow obstacles in the area of interest (such as the LVOT 22, etc.) can be followed by corrective measures (such as, but not limited to, repositioning the artificial valve 140, reorienting the valve angle with respect to the LVOT 22, or recompressing the artificial valve 140, etc., as long as such operations can be mechanically performed, for example, via a recompression mechanism) to prevent or reduce interference with the LVOT 22.

[0344] Figures 25A - 25B constitute cross - sectional views of the mitral valve prosthesis 140, which is implanted within the mitral annulus 32 such that the mitral inflow d1 is directed towards the apex 26 of the heart. Figures 26A - 26B constitute cross - sectional views of the mitral valve prosthesis 140, which is implanted within the mitral annulus 32 such that the mitral inflow d1 is directed towards the inferior septum 20.

[0345] Figure 25A shows two vortices, namely, a first vortex v1 facing the interventricular septum 20 of the left ventricle 16 and a second vortex v2 formed adjacent to the free wall 24 of the left ventricle 16. As diastole progresses and the left ventricle fills (see Figure 25B), the first vortex v1 grows asymmetrically and captures the momentum transfer that guides blood flow towards the native aortic valve 40 in coordination with left ventricular systole. The vortex structure dissipates as blood is ejected into the aorta 80 and reforms during the next cardiac cycle.

[0346] Figure 26A shows the vortices v1, v2 formed at the start of diastole. In this case, as shown in Figure 26B, the vortex v2 (opposite side of the LVOT 22) grows and redirects blood away from the native aortic valve 40. During systole, the blood flow must cross the incoming vortex path v1 at the LVOT 22 in order to exit through the aortic valve 40.

[0347] Since the vortex structures v1, v2 depend on the orientation and position of the mitral valve prosthesis 140, hemodynamic parameters (such as fluid flow or pressure) should be monitored during mitral valve prosthesis 140 positioning to provide the clinician with real - time feedback regarding the valve implantation configuration. The implantation configuration of the prosthetic valve 140 refers to a set of positioning parameters (such as the depth of the prosthetic valve protrusion into the left ventricle 16 and its angle relative to the plane of the mitral annulus 32).

[0348] According to some embodiments, a delivery assembly is provided that includes an artificial mitral valve 140 and a nose cone 1226, the nose cone 1226 including a first sensor 180a retained therein, the first sensor 180a being a Doppler sensor.

[0349] Referring now to FIG. 27, which illustrates an embodiment of a delivery device 102 that includes a Doppler sensor 180a retained within a nose cone 1126 and that carries an artificial mitral valve 140 for attachment to a native mitral valve annulus 32. The delivery assembly 100 is utilized according to a conventional transcatheter valve replacement procedure and is capable of advancing the artificial valve 140 toward the mitral valve annulus 32 for mitral valve replacement. During such a procedure, the nose cone 1126, which includes the Doppler sensor 180a retained therein, can be advanced toward the left ventricle 16 as shown in FIG. 27.

[0350] The Doppler sensor 180a transmits ultrasonic waves and receives the reflected ultrasonic waves or echoes. The frequency or pitch of the signal is proportional to the blood velocity, creating a unique color pattern. The color pattern indicates the flow pattern in terms of the time-varying velocity. Specifically, determination of the Doppler shift of the echoes provides a means for detecting and evaluating blood flow, thereby providing a means for obtaining information regarding the position and / or orientation of the artificial mitral valve 140. According to some embodiments, the Doppler sensor 180a includes a piezoelectric crystal (not shown) that transmits and receives ultrasonic signals.

[0351] According to some embodiments, the nose cone 1126 can be oriented to direct the Doppler sensor 180a to measure the flow within the LVOT 22. According to some embodiments, the nose cone 1126 can be rotated about its axis, for example, by operating the handle 110, to direct the sensor 180a to different regions of the left ventricle 16. For example, the nose cone 1126 can be rotated 360 degrees about its longitudinal axis to map all transverse flows, or at least rotated between at least two diametrically opposed regions to measure the flow within the LVOT 22 and in the opposite regions of the left ventricle 16, enabling the detection of flow abnormalities (such as undesirable vortex structures v1 and v2, etc.).

[0352] According to some embodiments, a method is disclosed herein for measuring the flow in different regions surrounding the outflow end portion 142 of the prosthetic valve 140 using the delivery assembly 100 equipped with the Doppler sensor 180a retained within the nose cone 1126 as described above. The method includes the steps of partially expanding the mitral valve prosthesis 140, deriving real-time Doppler flow readings during the expansion procedure, and thus, re-compressing and / or repositioning the mitral valve prosthesis 140 if required.

[0353] The Doppler sensor 180a is utilized to obtain flow measurement values from at least two diametrically opposed regions. According to some embodiments, the Doppler sensor 180a is first oriented in one direction towards a first region and utilized to obtain a measurement signal therefrom. Then, the nose cone is rotated and the Doppler sensor 180a is oriented towards a second region in the diametrically opposite direction. The Doppler sensor 180a can then be utilized to obtain a measurement signal from the second region. Alternatively or additionally, the Doppler sensor 180a can be provided with a plurality of ultrasonic transducers, and the plurality of ultrasonic transducers are oriented towards both the first region and the opposing second region.

[0354] The recompression mechanism can advantageously be utilized in combination with a delivery assembly 100 having a Doppler sensor 180a retained within the nose cone 1126, enabling artificial valve recompression to reorient or reposition it if necessary in light of the real-time flow measurement values received from the Doppler sensor 180a.

[0355] In some cases, it may be desirable to evaluate the distance between an artificial valve 140 (e.g., an artificial mitral valve as shown in FIG. 27) and natural tissue (e.g., the septum 20, etc.). The distance between the artificial mitral valve 140 and the septum 20 can provide additional data that can affect the desired artificial valve implantation configuration.

[0356] According to some embodiments, a delivery assembly is provided that is equipped with an artificial mitral valve 140 and a nose cone 1226, the nose cone 1226 including a first sensor 180a retained therein, the first sensor 180a being a distance measurement sensor. According to some embodiments, the first sensor 180a is an ultrasonic distance sensor, which includes at least one ultrasonic transducer for measuring distances within the heart chambers. The delivery assembly 100 shown in FIG. 27 can be equipped with an ultrasonic distance sensor 180a retained within the nose cone 1126, which is oriented towards a region of interest (e.g., the septum 20 or any other wall of the left ventricle 16, etc.), and is capable of measuring the distance from the position of the ultrasonic distance sensor 180a to the septum 20 or any other structure.

[0357] According to some embodiments, a method is disclosed herein for measuring the distance between an artificial valve 140 and a heart chamber wall (e.g., the septum 20, etc.) using an ultrasonic distance sensor 180a retained within a nose cone 1126. According to some embodiments, the method includes positioning the nose cone 1126 such that the ultrasonic distance sensor 180a is positioned at the level of the outflow end portion 142 of the artificial valve 140 and is oriented towards the septum 20, and measuring, through operation of the ultrasonic sensor 180a, the distance to the side wall of the artificial valve 140 (e.g., the side of the frame 146 facing the septum 20, etc.) and the distance to the septum 20, thereby obtaining the distance between the outflow end portion 142 of the artificial valve 140 and the septum 20.

[0358] The ultrasonic distance sensor measures distance based on the pulse-echo method, and the pulse-echo method determines the distance to an object by measuring the flight time of an ultrasonic pulse. This is different from an ultrasonic Doppler sensor, which is based on the pulsed Doppler method according to the principle described above. Nevertheless, according to some embodiments, as illustrated and described in connection with FIG. 27, the first sensor 180a held within the nose cone 1126 is an ultrasonic sensor that can be utilized for both flow measurement (based on the pulsed Doppler method) and distance measurement (based on the pulse-echo method).

[0359] According to some embodiments, a delivery assembly 100 is provided that includes an artificial mitral valve 140 and a delivery device 102, and the delivery device 102 further includes an ultrasonic measurement catheter 394 that extends from a handle 110 through a delivery shaft 106. FIG. 28 shows a distal portion of the delivery assembly 100 that includes the artificial valve 140 carried on the delivery device 102, and the delivery device 102 further includes an ultrasonic measurement catheter 394 having a sensing head 396 equipped with a first sensor 180a, and the first sensor 180a includes at least one ultrasonic transducer and can function as either a Doppler sensor for flow measurement or a distance sensor (as such sensors are described in connection with FIG. 27). A mechanically expandable valve 140' is illustrated in FIG. 28, but it will be apparent that the configuration of this figure applies in a similar manner to other types of artificial valves 140.

[0360] The ultrasonic measurement catheter 394 can further include a transmission line (such as a first transmission line 168a according to any of the embodiments disclosed herein) that extends from the ultrasonic sensor 180a toward the handle 100.

[0361] The ultrasonic measurement catheter 394 can be axially movable relative to the delivery shaft 106. The movement of the ultrasonic measurement catheter 394 can be controlled by the handle 110. The ultrasonic measurement catheter 394 can be axially movable and is adapted to extend through the lumen of the prosthetic valve 140 when it is sufficiently expanded to provide a free passageway therethrough.

[0362] Reference is now made to FIG. 29, which illustrates an embodiment of a delivery device 102 equipped with an ultrasonic measurement catheter 394 that carries a prosthetic mitral valve 140 for attachment to a native mitral annulus 32. The delivery assembly 100 is utilized according to a conventional transcatheter valve replacement procedure and is capable of advancing the prosthetic valve 140 toward the mitral annulus 32 for mitral valve replacement. For example, the delivery assembly 100, as shown in FIG. 29, first punctures the location of the fossa ovalis with a prior pointed device (not shown) (e.g., a needle or wire, etc.), optionally passes a dilator over the prior pointed device, and then retracts the prior pointed device while leaving the dilator in place (the delivery device 102 can be advanced over the dilator) and can be utilized to deliver the crimped prosthetic valve 140 in a transseptal procedure that traverses the upper septum 20 toward the left atrium 12 using conventional techniques.

[0363] When the prosthetic mitral valve 140 is sufficiently expanded to provide a passageway therethrough, the ultrasonic measurement catheter 394 can be distally advanced to a desired position and is adapted to orient the ultrasonic sensor 180a toward a desired region of measurement, as shown in FIG. 29.

[0364] According to some embodiments, the first sensor 180a held within the sensing head 396 is a Doppler sensor. In such embodiments, the ultrasonic measurement catheter 394 can be oriented to direct the Doppler sensor 180a to measure the flow within the LVOT 22. According to some embodiments, the ultrasonic measurement catheter 394 can be rotated about its axis, for example, by operating the handle 110, to direct the Doppler sensor 180a towards different regions of the left ventricle 16. For example, the ultrasonic measurement catheter 394 can be rotated 360 degrees about its longitudinal axis to map all transverse flows or at least rotated to measure the flow within the LVOT 22 and in the opposite regions of the left ventricle 16, enabling the detection of flow abnormalities (such as unwanted vortex structures v1 and v2, etc.).

[0365] According to some embodiments, the Doppler sensor 180a is first oriented in one direction towards a first region and used to acquire a measurement signal therefrom. Then, the nose cone is rotated to orient the Doppler sensor 180a in the diametrically opposite direction towards a second region. The Doppler sensor 180a can then be used to acquire a measurement signal from the second region. Alternatively or additionally, the Doppler sensor 180a includes an array of ultrasonic transducers that extends circumferentially within the sensing head 396, which is configured to provide measurement signals over 360 degrees (i.e., about the longitudinal axis of the sensing head 396).

[0366] According to some embodiments, a method of utilizing a delivery assembly 100 equipped with an ultrasonic measurement catheter 394 having a Doppler sensor 180a is disclosed herein. The method includes the steps of partially expanding the prosthetic mitral valve 140, advancing the ultrasonic measurement catheter 394 through the lumen of the prosthetic mitral valve 140, potentially further expanding the prosthetic mitral valve 140 relative to the mitral annulus 32, deriving real-time Doppler flow readings during the expansion procedure, and thereby, if necessary, recompressing and repositioning the prosthetic mitral valve 140.

[0367] The recompression mechanism can advantageously be utilized in combination with a delivery assembly 100 having an ultrasonic measurement catheter 394 equipped with a Doppler sensor 180a, enabling prosthetic valve recompression to reorient or reposition it if necessary in light of real-time flow measurements received from the Doppler sensor 180a.

[0368] According to some embodiments, the first sensor 180a held within the sensing head 396 is an ultrasonic distance sensor. In such embodiments, a method of using the ultrasonic distance sensor 180a can include advancing the ultrasonic measurement catheter 394 through a partially (or fully) expanded prosthetic valve 140 (e.g., prosthetic mitral valve) such that the ultrasonic sensor 180a is positioned at the level of the outflow end portion 142 of the prosthetic valve 140 and oriented toward the septum 20. The ultrasonic distance sensor 180a can then measure the distance to the side of the frame 146 facing the septum 20 and the distance to the septum 20, from which the distance between the outflow end portion 142 of the prosthetic valve 140 and the septum 20 can be derived.

[0369] Although shown in FIGS. 27 and 29 in connection with a delivery system for carrying an artificial mitral valve, an ultrasonic sensor 180a (kept within the nose cone 1126 or the ultrasonic measurement catheter 394) can be implemented in a similar manner in combination with a delivery system for carrying an artificial valve 140 for implantation at other locations of the heart (e.g., within the native aortic valve, native pulmonary valve, and / or native tricuspid valve, etc.).

[0370] According to some embodiments, a transcatheter Doppler adjustment system is provided that includes a delivery assembly 100 and a separate Doppler catheter 494. The delivery assembly 100 includes, for example, an artificial mitral valve 140 and a conventional delivery device 102 as shown in FIG. 30. The Doppler catheter 494 includes a sensing head 496 equipped with a Doppler sensor 180a. The Doppler catheter is a stand-alone intravascular catheter that is not physically connected to the delivery assembly 100, and each of the delivery assembly 100 and the Doppler catheter 494 can follow different intravascular paths along the patient's vascular system.

[0371] According to some embodiments, a method is provided for measuring flow in a region adjacent to an artificial valve 140, as disclosed herein. The method includes delivering the artificial valve 140 over the delivery device 102 to a first native valve (e.g., native mitral valve 30), expanding the artificial valve 140 relative to the first native valve such that at least a portion of the artificial valve 140 extends into a heart chamber (e.g., left ventricle 16), extending the Doppler catheter 494 through a second native valve (e.g., native aortic valve 40) such that the sensing head 496 is positioned within the heart chamber, orienting the Doppler sensor 180a towards the artificial valve 140, and obtaining measurement signals from at least one region (e.g., LVOT 22) adjacent to the artificial valve 140 and optionally from at least two diametrically opposed regions adjacent to the artificial valve 140 using the Doppler sensor 180a.

[0372] Here, FIG. 30 is referenced, and FIG. 30 illustrates an embodiment of a transcatheter Doppler adjustment system. The delivery assembly 100 is utilized according to a conventional transcatheter valve replacement procedure and is capable of advancing the prosthetic valve 140 toward the mitral annulus 32 for mitral valve replacement. For example, the delivery assembly 100 can be utilized to deliver the prosthetic valve 140 in a crimped state in a transseptal procedure, as shown, for example, in FIG. 30. The Doppler catheter 494 is advanced along either the same path or a different path of the delivery assembly 100 toward a desired flow measurement region, and the desired flow measurement region can be in the vicinity of the prosthetic mitral valve 140.

[0373] According to some embodiments, the Doppler catheter 494 can be advanced through the patient's vasculature prior to utilizing the delivery device 102 such that the sensing head 496 can be disposed within the desired flow measurement region prior to positioning the prosthetic mitral valve 140 within the desired implantation site.

[0374] In the embodiment shown in FIG. 30, the prosthetic mitral valve 140 is expanded relative to the mitral annulus 32, and the distal portion of the Doppler catheter 494 extends through the aorta 80 and the aortic valve 40 and is adapted to position the sensing head 496 within the LVOT 22. Advantageously, such a configuration enables the prosthetic mitral valve 140 to be delivered to the mitral annulus 32 via any delivery approach (e.g., transfemoral, transseptal, transapical, or other percutaneous approaches, etc.) without restricting the measurement region available for the Doppler sensor 180a.

[0375] In comparison, a Doppler sensor 180a retained within a nose cone 1126 (as described and illustrated in connection with FIG. 27), or a Doppler sensor 180a retained within an ultrasonic measurement catheter 394 that can extend through a delivery shaft 106 (as described and illustrated in connection with FIG. 29), can be suitable for a transseptal approach, and the Doppler sensor 180a can be positioned within the lumen of the prosthetic mitral valve 140 or can extend distally therefrom, and is not as suitable for a transapical approach (not shown), and components of the delivery device 102 (such as the delivery shaft 106, etc.) can potentially partially obstruct the ability of the Doppler sensor to measure a specific region within the left ventricle 16. Moreover, having a Doppler catheter 494 provided separately from the delivery device 102 allows a clinician to independently control the Doppler catheter 494 and the delivery assembly 100, if desired.

[0376] According to some embodiments, the Doppler sensor 180a includes an array of ultrasonic transducers that circumferentially extends within the sensing head 496, which is configured to provide a measurement signal that extends 360 degrees across the longitudinal axis of the sensing head 496.

[0377] Here, FIGS. 31A - 31E are referred to, which illustrate various configurations of the artificial valve 140. The artificial valve 140 includes a plurality of sensors 380 attached thereto. The positioning of the sensors 380 is demonstrated in FIGS. 31A - 31E with respect to the artificial mitral valve, which is positioned within the mitral valve annulus 32, with the inflow end portion 144 facing the left atrium 12 and the outflow end portion 142 extending into the left ventricle 16. According to some embodiments, the plurality of sensors 380 shown and described in relation to FIGS. 31A - 31E are configured to measure characteristics of physiological flow relationships (such as blood pressure and / or blood flow, etc.). According to some embodiments, the plurality of sensors 380 are pressure sensors. According to some embodiments, the plurality of sensors 380 are flow sensors.

[0378] According to some embodiments, the artificial valve 140 (such as an artificial mitral valve, etc.) includes a plurality of sensors 380 attached to the outflow end portion 142 as shown in FIG. 31A. According to some embodiments, at least two of the plurality of sensors 380 are circumferentially spaced from each other. According to some embodiments, at least two of the plurality of sensors 380 are arranged at equal circumferential intervals from each other. According to some embodiments, at least two of the plurality of sensors 380 are attached to the outflow end portion 142 at diametrically opposite positions.

[0379] According to some embodiments, at least two of the plurality of sensors 380 are positioned in the same valve horizontal plane, which is defined as any plane substantially orthogonal to the valve longitudinal axis 141.

[0380] Figure 31A shows an embodiment of the artificial mitral valve 140, which is equipped with a first sensor 380a and a second sensor 380b. The first sensor 380a and the second sensor 380b are attached to the outflow end portion 142 at diametrically opposite positions across the same horizontal plane. In this configuration, the first sensor 380a can face the septum 20, while the second sensor 380b can face the free wall 24 of the left ventricle 16.

[0381] Figure 31A can represent an exemplary embodiment of two flow sensors 380a, 380b that can simultaneously measure the flow in two diametrically opposite regions of the artificial valve 140. For example, the first flow sensor 380a can measure the flow near the LVOT 22, while the second flow sensor 380b can measure the flow in the opposite region bounded between the artificial mitral valve 140 and the free wall 24 of the left ventricle 16. According to some embodiments, by comparing the measured values of the first flow sensor 380a and the second flow sensor 380b respectively, abnormal flow patterns can be detected, for example, abnormal vortex formations v1 and v2 during the cardiac cycle can be detected.

[0382] Proper positioning of the first sensor 380a and the second sensor 380b may be required respectively to derive meaningful measurement values from the desired regions of interest. Figure 31B shows an improper circumferential orientation of the artificial valve 140, with both sensors 380a and 380b being disposed at substantially equal distances from the septum 20 and / or the free wall 24 of the left ventricle 16. Such a position is improper if measurements from different regions (such as regions closer to the vortex rings v1 and v2, etc.) are desired.

[0383] According to some embodiments, at least two of the plurality of sensors 380 include radiopaque markings that enable visual detection of their positions during the artificial valve implantation and positioning procedure. The markings can enable a clinician to reposition or reorient the artificial valve 140 (e.g., the artificial mitral valve), and the plurality of sensors 380 are adapted to be positioned and oriented in a region of interest (e.g., the positions of the first sensor 380a and the second sensor 380b shown in FIG. 31A).

[0384] According to some embodiments, the plurality of sensors 380 includes three or more sensors. FIG. 31C shows an exemplary embodiment of three sensors 380a, 380b, and 380c attached to the outflow end portion 142. Advantageously, three or more sensors 380 can provide better resolution by mapping the flow at several points along the outflow end portion 142. Moreover, three or more sensors 380 enable easier circumferential valve orientation and positioning of the sensors 380 in a region of interest.

[0385] According to some embodiments, at least two of the plurality of sensors 380 are axially spaced from each other along the outflow end portion 142. FIG. 31D shows an exemplary embodiment of a first sensor 380a and a second sensor 380b, which are axially spaced from each other and each of the sensors 380a and 380b is adapted to be positioned in a different horizontal plane along the outflow end portion 142.

[0386] In the exemplary embodiment of FIG. 31D, both the first sensor 380a and the second sensor 380b are axially spaced from each other and longitudinally aligned along the same circumferential position of the artificial valve 140, and both are adapted to face the same region of interest in the circumferential direction (which is LVOT22 in FIG. 31D).

[0387] Measurements taken along positions in different axial directions (optionally, aligned longitudinally) can serve to detect flow obstructions (such as stasis or abnormal flow recirculation, etc.).

[0388] FIG. 31D can represent an exemplary embodiment of two pressure sensors 380a and 380b, which are configured to detect the pressure difference between different regions along the trajectory of the flow d2 through the LVOT 22 towards the aortic valve 40. For example, a comparison between the measured pressure in the region of the second sensor 380b and the pressure measured in the region of the first sensor 380a can indicate a flow obstruction in the LVOT 22. Alternatively or additionally, FIG. 31D can represent an exemplary embodiment of two flow sensors 380a and 380b, which are configured to measure the flow in different regions along the trajectory of the flow d2 and derive a flow profile through the LVOT 22.

[0389] FIG. 31E shows an exemplary embodiment of a first sensor 380a attached to the inflow end portion 144 and a second sensor 380b attached to the outflow end portion 142, similar to the configuration illustrated and described in relation to FIGS. 22A-22B. The sensors 380a and 380b spaced apart axially can be either pressure sensors utilized for deriving the pressure drop profile between the inflow end portion 144 and the outflow end portion 142 of the artificial mitral valve 140, or flow sensors utilized for providing a flow profile through the artificial mitral valve 140.

[0390] Although shown in FIGS. 31A-31E in combination with an artificial mitral valve, one or more sensors 380 can similarly be attached to any other type of artificial valve 140 implanted in other locations of the heart (such as within the native aortic valve, native pulmonary valve, and native tricuspid valve, etc.).

[0391] The position of sensor 380 along artificial valve 140 can affect the accuracy of measurements. In particular, in the case of a flow or pressure sensor 380 positioned axially distant, care must be taken to avoid contact between the sensor and native tissue (such as mitral annulus 32 or native mitral leaflet 34, etc.). The reason for this is that such contact can potentially limit the ability to derive meaningful measurement signals. Moreover, sensor 380 pressed against native tissue can induce a physiological response (such as neointimal growth, etc.), which can affect and / or potentially affect the accuracy of long-term and short-term measurements.

[0392] According to some embodiments, one or more sensors 380 are coupled to the luminal surface of artificial valve 460. This configuration can help avoid interference, for example, between one or more sensors 380 and portions of the native anatomical structure that would otherwise contact the sensors 380. Moreover, such a configuration can help ensure that one or more sensors 380 are exposed to the blood passing through artificial valve 140, which in some cases can enable more accurate measurements as compared to sensors facing away from valve longitudinal axis 141.

[0393] Alternatively or additionally, one or more sensors 380 can be coupled to the outer surface of artificial valve 140. This configuration can be useful for measuring physiological parameters in the immediate environment surrounding valve 140. Moreover, such a configuration can help avoid interference, for example, in the case where one or more sensors 380 are coupled to outflow end portion 142, between sensor 380 and leaflet tip 152, which could otherwise contact the luminal surface of frame 146 during phases of the cardiac cycle (such as systole, etc.).

[0394] According to some embodiments, a threshold value for either a flow measurement value or a pressure measurement value is preset, and a measured signal that exceeds the preset threshold value (either exceeds the preset maximum value or is below the preset minimum value) can create a visual or audible warning for the clinician. Alternatively, exceeding a predetermined threshold value can automatically stop the implantation procedure.

[0395] According to some embodiments, a plurality of sensors 380 according to any of the embodiments described and illustrated in connection with FIGS. 31A-31E can be releasably coupled to corresponding transmission lines 368. In such embodiments, any of the sensors 380 can be held within a corresponding sensor housing 382, any of the transmission lines 368 can extend through a transmission line shaft 376, the sensor housing 382 can be attached to an artificial valve 140 according to any of the configurations described and illustrated in connection with FIGS. 31A-31E, and the transmission line shaft 376 can be releasably coupled to the sensor housing 382 in a manner similar to that described and illustrated in connection with FIGS. 23A-23C. Alternatively or additionally, a plurality of sensors 380 according to any one of the embodiments described and illustrated in connection with FIGS. 31A-31E can be post-treatment sensors 380.

[0396] According to some embodiments, the magnitude of the parameter being measured (e.g., maximum or average flow or pressure, etc.) can indicate a particular clinically relevant assessment. For example, a post-treatment measurement signal obtained by a post-treatment sensor 380 can indicate a cardiac output (CO), which may be of high interest to patients having a cardiac resynchronization therapy (CRT) device for monitoring improvement or deterioration of the CO. Such input can assist in making decisions regarding the need to readjust the synchronization parameters of the CRT device.

[0397] Hemodynamic disorders related to prosthetic valves are not limited to flow obstructions that occur during valve implantation procedures, for example, due to sub-optimal valve orientation, dilation, and / or positioning, but can also develop over time after implantation, for example, due to inflammation and other biological processes that may result from valve-tissue or valve-blood flow interactions.

[0398] One such complication is associated with flow stasis in the small anatomical space trapped between the leaflet 152 and the frame 146 of the prosthetic valve 140, which can promote leaflet thrombosis. Even subclinical leaflet thrombosis is associated with reduced leaflet motility, which can thereby reduce prosthetic valve performance. Therefore, it is desirable to provide a means for measuring the flow pattern in such regions of interest to detect whether the flow field around the leaflet 152 is disrupted.

[0399] According to some embodiments, a method is provided that uses a delivery assembly 100 that includes an ultrasonic measurement catheter 394 that carries a prosthetic valve 140 (e.g., a prosthetic aortic valve) and extends through a delivery shaft 106. The method includes deploying the prosthetic valve in a region of interest (e.g., the aortic valve annulus 42, etc.), advancing the ultrasonic measurement catheter 394 to the region of the deployed prosthetic valve 140, and then obtaining a measurement of the flow in the anatomical space trapped between the leaflet 152 and the frame 146.

[0400] According to some embodiments, the ultrasonic measurement catheter 394 includes a Doppler sensor 180a that is configured to provide a flow pattern measurement value, and the flow pattern measurement value is compared to an absolute threshold value to detect, for example, a long residence time that may exceed a pre-set threshold value.

[0401] The ultrasonic measurement catheter 394 can be rotated to direct the Doppler sensor 180a toward a selected region of interest or toward several regions of interest. According to some embodiments, measurements obtained by the Doppler sensor 180a from different regions (such as, for example, an anatomical space confined between each of the valve leaflets 152 and the frame 146) can be compared to each other. Such a comparison can be useful for detecting regions that are susceptible to flow disturbances that indicate a disrupted flow relative to other regions.

[0402] According to some embodiments, the ultrasonic measurement catheter 394 is configured to provide real-time measurement signals during artificial valve deployment. According to some embodiments, the ultrasonic measurement catheter 394 is retracted when the valve deployment procedure is completed.

[0403] In some cases, a thrombus can form in a region that is subject to low flow or stasis (such as, for example, a region bounded between the valve leaflet 152 and the frame 146). According to some embodiments, a method for detecting valve leaflet thrombosis or valve leaflet calcification using an ultrasonic echocardiography catheter 594 is provided. The ultrasonic echocardiography catheter 594 includes a sensing head 596, and the sensing head 596 includes an ultrasonic echocardiography sensor 180a. The ultrasonic echocardiography sensor 180a is utilized to image the valve leaflet 152 and is capable of detecting, for example, valve leaflet thrombosis, valve leaflet calcification, or any other deposits formed thereon.

[0404] Valve leaflet thrombosis typically occurs during the first few days after implantation. Valve leaflet stenosis is typically the result of a longer process. Thus, valve leaflet thrombosis or valve leaflet calcification detection is a post-treatment process.

[0405] Here, reference is made to FIG. 32, which illustrates an embodiment of an ultrasonic cardiac echo catheter 594 that is advanced toward an artificial valve 140' implanted within the aortic valve annulus 42. According to some embodiments, a method of using the ultrasonic cardiac echo catheter 594 to identify leaflet thrombosis within a pre-mounted artificial valve 140 includes introducing the ultrasonic cardiac echo catheter 594 into a patient's body during a follow-up visit rather than during valve deployment, and the sensing head 596 is advanced through an opening defined by the outflow end portion 142' into the lumen of the artificial valve 140' to a position adjacent to the region of interest for imaging. For example, the ultrasonic cardiac echo sensor 180a can be directed at at least one of the leaflets 152', and can be utilized to obtain an image of the anatomical space trapped between the leaflet 152' and the frame 146'.

[0406] According to some embodiments, the ultrasonic cardiac echo sensor 180a includes at least one ultrasonic transducer, and the at least one ultrasonic transducer is configured to provide imaging across a particular lateral region that projects radially outward therefrom. The ultrasonic cardiac echo catheter 594 can be rotated about its longitudinal axis to orient the ultrasonic transducer toward any of the desired regions. For example, the ultrasonic cardiac echo sensor 180a can be directed at one leaflet 152', which is utilized to obtain an image of the anatomical space trapped between this leaflet 152' and the frame 146', and the sensing head 596 can then be rotated to direct the ultrasonic cardiac echo sensor 180a at one other different leaflet 152', which is utilized to obtain an image of the anatomical space trapped between at least one other leaflet 152' and the frame 146', and so on.

[0407] According to some embodiments, the sensing head 596 includes an array of ultrasonic transducers that extends circumferentially therefrom and is configured to provide lateral imaging that extends 360 degrees across the longitudinal axis of the sensing head 596.

[0408] According to some embodiments, a method for measuring a change in blood viscosity is provided that includes the use of an acoustic viscosity catheter 694 that includes a sensing head 696, the sensing head 696 including an acoustic viscosity sensor 180a. The method can be applied, for example, within an anatomical space confined between a valve tip 152 and a frame 146.

[0409] Blood viscosity can change prior to or at an early stage of thrombosis. For example, blood viscosity can be altered due to changes in blood composition, which can include particles such as fibrinogen. FIG. 32 can similarly illustrate an embodiment of an acoustic viscosity catheter 694 advanced toward an artificial valve 140' implanted within the aortic valve annulus 42. According to some embodiments, the method of using the acoustic viscosity catheter 694 includes introducing the acoustic viscosity catheter 694 into a patient's body during a follow-up visit rather than during valve deployment, and the sensing head 696 is advanced through an opening defined by an outflow end portion 142' into the lumen of the artificial valve 140' to a position adjacent to the region of interest to be measured. For example, the acoustic viscosity sensor 180a can be directed toward at least one of the valve tips 152' and utilized to measure the blood viscosity within the anatomical space confined between the valve tip 152' and the frame 146'.

[0410] According to some embodiments, the acoustic viscosity sensor 180a includes an acoustic wave transducer and a piezoelectric transducer, which is configured to measure a modification of the acoustic field quantity of the acoustic wave transducer. The acoustic viscosity catheter 694 can be rotated about its longitudinal axis to orient the acoustic viscosity sensor 180a towards any of the desired circumferential regions. For example, the acoustic viscosity sensor 180a can be directed towards one valve tip 152', which is utilized to measure a modification of the acoustic field quantity of the anatomical space confined between this valve tip 152' and the frame 146'. Next, the sensing head 696 can be rotated to direct the acoustic viscosity sensor 180a towards one other different valve tip 152', which is utilized to measure a modification of the acoustic field quantity of the anatomical space confined between at least one other valve tip 152' and the frame 146', and so on.

[0411] Although shown in FIG. 32 in relation to the mechanically expandable aortic valve 140', either the ultrasonic cardiac echo catheter 594 or the acoustic viscosity catheter 694 can similarly be utilized with any other type of artificial valve 140 positioned within the aortic valve annulus 42 or elsewhere in the heart (such as within the mitral valve annulus 32, the pulmonary valve annulus, and the tricuspid valve annulus, etc.).

[0412] Here, FIGS. 33 - 36 are referred to, which illustrate various configurations of the artificial valve 140 (such as the mechanically expandable valve 140', etc.), which includes a plurality of sensors 380 attached thereto.

[0413] According to some embodiments, the artificial valve 140 includes a plurality of sensors 380, the plurality of sensors 380 are circumferentially spaced from each other, and are attached to the intermediate portion 155 of the artificial valve 140. The intermediate portion 155 is defined as the region between the inflow end portion 144 and the outflow end portion 142.

[0414] FIG. 33 shows an embodiment of an artificial valve 140' equipped with sensors 380a, 380b, and 380c spaced apart circumferentially by three, and the sensors 380a, 380b, and 380c are attached to the intermediate portion 155' across the same horizontal plane. The axial positions of the sensors 380a, 380b, and 380c can be selected to be adjacent to a small anatomical space confined between the valve tip 152' and the frame 146'.

[0415] According to some embodiments, the amount of sensors 380 is equal to the amount of valve tips 152'. According to some embodiments, each sensor 380 is positioned near one of the valve tips 152' and is configured to measure hemodynamic parameters (such as blood flow or pressure, etc.) in the anatomical space confined between the valve tip 152' and the frame 146'. According to some embodiments, each sensor 380 is radially inwardly oriented and faces the corresponding valve tip 152'. Each sensor can be attached to the artificial valve 140 such that its passive surface 387 is oriented towards the frame 146', while its active surface 386 is oriented towards the valve tip 152'.

[0416] According to some embodiments, at least one sensor 380 is a flow sensor, which is configured to provide a flow measurement signal, and the flow measurement signal is compared with an absolute threshold value, and it is possible to detect, for example, a long residence time that may exceed a preset threshold value.

[0417] According to some embodiments, at least one sensor 380 is a pressure sensor, which is configured to provide a pressure measurement signal that may be associated with a flow value and compared to an absolute threshold value, for example, to detect a long residence time that may exceed a preset threshold value. The pressure sensor 380 is capable of sensing pressure fluctuations associated with changes in flow velocity. Without being bound by any theory or mechanism of action, such measurements may be based on Bernoulli's principle (i.e., an increase in the velocity of a fluid can occur simultaneously with a decrease in pressure).

[0418] According to some embodiments, readings from different sensors 380 are compared to each other to detect areas where flow or pressure is disrupted relative to other areas or areas that are susceptible to the effects of such disturbances.

[0419] According to some embodiments, at least one sensor 380, preferably a plurality of sensors (e.g., sensors 380a, 380b, and 380c shown in FIG. 33), is an optical fiber sensor, which is oriented towards the corresponding valve tip 152' and configured to acquire optical data in the region confined between the valve tip 152' and the frame 146'.

[0420] Advantageously, an optical sensor (e.g., sensors 380a, 380b, and 380c) oriented towards the anatomical space confined between the valve tip 152' and the frame 146' may be configured to acquire optical data along the surface of the valve tip 152', which may be used to provide an indication regarding thrombosis, calcification, or other particulate matter accumulated thereon.

[0421] According to some embodiments, at least one sensor 380, preferably a plurality of sensors (e.g., sensors 380a, 380b, and 380c shown in FIG. 33, etc.) is an impedance sensor, which is oriented towards the corresponding valve tip 152' and is configured to obtain electrical conductivity data in the region confined between the valve tip 152' and the frame 146'.

[0422] The conductivity of blood can be affected by changes induced by flow, and it can, for example, affect the orientation of red blood cells and other particles. According to some embodiments, the sensor 380 is configured to detect changes in impedance induced by changes in blood flow in the region confined between the valve tip 152' and the frame 146'.

[0423] According to some embodiments, the measurement signal acquired by the sensor 380 is compared to an absolute threshold value, and it is possible to detect, for example, abnormal impedance values that may indicate a flow obstruction.

[0424] According to some embodiments, the impedance sensor 380 is a post-treatment sensor, which is configured to wirelessly transmit the impedance measurement signal acquired by the sensor 380, thereby enabling post-treatment monitoring to detect valve performance degradation over time.

[0425] Also, the conductivity of blood can be affected by its composition or viscosity, for example, due to particles such as fibrinogen that affect the composition and viscosity of the blood. Thus, changes in impedance can be analyzed to detect changes in blood composition or viscosity in the region confined between the valve tip 152' and the frame 146'.

[0426] According to some embodiments, each impedance sensor 380 is positioned substantially forward of the distal region of each valve tip 152', in very close proximity to its attachment to the frame 146'. The impedance of blood is different from the impedance of the material (e.g., pericardial tissue) from which the artificial valve tip 152' is made and can depend on the morphological properties of the material. As such, a change in impedance can indicate the presence of a thrombus formed in the region trapped between the valve tip 152' and the frame 146', as well as the presence of calcified debris and / or other large deposits.

[0427] Advantageously, detection of post-treatment valve tip thickening (e.g., obtained by the post-treatment impedance sensor 380) can be followed by appropriate therapy (e.g., oral anticoagulation therapy, etc.). It is preferable to avoid uniform antiplatelet therapy for all patients, regardless of the individual needs of the patient. The reason is that such therapy can also result in an undesirable risk of bleeding. Therefore, it is important to determine appropriate anticoagulation therapy on a case-by-case basis.

[0428] Advantageously, the post-treatment measurements obtained from the post-treatment impedance sensor 380 can provide data regarding patients who develop valve tip thrombosis. Accordingly, the methods and systems disclosed herein enable the design of custom-made anticoagulation therapy for patients who need it. Moreover, it is possible to follow up and obtain impedance measurements during anticoagulation therapy to determine treatment plans and effectiveness.

[0429] According to some embodiments, the prosthetic valve 140 includes at least one sensor 380, and the at least one sensor 380 is coupled thereto in the region of at least one commissure 154. FIG. 34 shows a prosthetic valve 140' including three sensors 380a, 380b, and 380c (sensor 380b is hidden from view), and the three sensors 380a, 380b, and 380c are attached to three corresponding commissures 154. According to some embodiments, the sensor 380 can be attached to a commissure post (such as the outer member 158 of the actuator assembly 156), and more specifically, to the inner surface of such a post.

[0430] The sensor 380 attached to the commissure 154 can be implemented as any of the flow sensors, pressure sensors, optical sensors, and / or impedance sensors described above in connection with FIG. 33. Moreover, the sensor 380 attached to the commissure 154 can be implemented as a post-treatment sensor. Positioning the sensor 380 at the commissure 154 between two adjacent valve leaflets 152 can provide data regarding various parameters (such as deposit accumulation and pannus) focused within or adjacent to the region of the commissure 154.

[0431] The prosthetic aortic valve 140 can be deployed within the aortic valve annulus 42 such that the outflow end portion 142 extends proximally beyond the native aortic valve leaflets 44. In such a case, a gap can be formed between the outflow end portion 142 and the surrounding anatomical structure, allowing for the placement of the sensor 380 oriented radially outwardly from its frame 146 without the risk of the sensor 380 being pressed against the vessel wall.

[0432] FIG. 35 shows an exemplary embodiment of three sensors 380a, 380b, and 380c, which are attached to the outflow end portion 142'. According to some embodiments, each sensor 380 is oriented radially outward from the frame 146', which is configured to measure hemodynamic parameters (e.g., flow or pressure) in the region surrounding the artificial valve 140. For example, the sensors 380a, 380b, and 380c shown in FIG. 35 can measure hemodynamic parameters in a region confined between the outflow end portion 142' and the surrounding anatomical structure (not shown in FIG. 35). Measurement of flow or pressure in that region may be desirable, for example, for detecting the flow pattern of interest near the coronary ostium.

[0433] According to some embodiments, at least one flow or pressure sensor 380, and preferably a plurality of flow or pressure sensors 380, are attached to the artificial valve 140 and are configured to detect a central leak of the artificial valve 140. For example, in the case of an artificial aortic valve 140, aortic valve insufficiency can be detected by the sensor 380 during artificial aortic valve deployment or as an ongoing monitoring process after treatment that utilizes the ongoing measurements derived from the sensor 380 after treatment.

[0434] According to some embodiments, at least one sensor 380, and preferably a plurality of sensors (e.g., sensors 380a, 380b, and 380c shown in FIG. 35, etc.) are temperature sensors, which are oriented radially outward from the frame 146' and are configured to contact the surrounding tissue to measure tissue temperature. An inflamed area can be identified by detecting a temperature above normal body temperature. The elevated temperature typically indicates the metabolic activity of inflammatory cells in the tissue. Specifically, activated inflammatory cells have a slightly higher heat signature than that of connective tissue cells. The sensitivity of the temperature sensor 380 is configured to match the expected temperature variations in order to properly detect inflammation.

[0435] Once the prosthetic aortic valve 360 is positioned at the implantation site, the use of the temperature sensor 380 is feasible as long as the sensor 380 is attached to the outer surface of the prosthetic valve 140 in a manner that the sensor 380 contacts the surrounding tissue. Alternatively, the temperature sensor can be in the immediate vicinity of the surrounding tissue rather than being in complete contact with it. In such a configuration, the blood temperature near the tissue of interest (rather than the tissue temperature) is measured. According to some embodiments, the temperature sensor 380 is a post-treatment temperature sensor 380 intended to detect post-treatment inflammation.

[0436] FIG. 36 shows an exemplary embodiment of three sensors 380a, 380b, and 380c attached to the inflow end portion 144'. According to some embodiments, each sensor 380 is oriented radially outward from the frame 146' and is configured to measure physiological parameters in the region surrounding the prosthetic valve 140'. For example, the sensors 380a, 380b, and 380c can be configured to contact the aortic wall tissue or the aortic valve annulus 42.

[0437] According to some embodiments, at least one sensor 380, and preferably a plurality of sensors (e.g., sensors 380a, 380b, and 380c shown in FIG. 36, etc.) are temperature sensors, which are attached to the inflow end portion 144' and are radially outwardly oriented from the frame 146', and are configured to contact the aortic valve annulus 42 or any other valve annulus or native tissue to measure tissue temperature.

[0438] According to some embodiments, a plurality of temperature sensors 380 are circumferentially spaced from each other as shown in FIGS. 35 - 36. According to some embodiments, at least two temperature sensors 380 are axially spaced from each other, for example, in a configuration as shown in FIGS. 23A - 23B.

[0439] According to some embodiments, temperature measurements from different temperature sensors 380 disposed around different regions of the prosthetic valve 140 are compared to each other to generate a temperature map of the surrounding tissue and to detect whether the area of inflammation is limited to a particular region or if it surrounds the entire prosthetic valve 140.

[0440] According to some embodiments, to monitor the progression of inflammation, the temperature is measured periodically and it is possible to detect a potential increase in the measured temperature values over time.

[0441] Advantageously, the post - treatment readings from the temperature sensor 380 after treatment can assist a clinician in determining the type of anti - inflammatory therapy recommended. Moreover, it is possible to follow up and obtain temperature readings during anti - inflammatory therapy, observe treatment efficacy, and / or determine a desired treatment plan.

[0442] According to some embodiments, at least one sensor 380, and preferably a plurality of sensors (e.g., sensors 380a, 380b, and 380c shown in FIG. 36, etc.) are sensing electrodes, which are oriented radially outward from the inflow end portion 144' and are configured to contact the surrounding tissue (e.g., the aortic valve annulus 42, etc.) to measure the intrinsic electrical activity of the tissue. The sensing electrode 380 utilizes the intrinsic electrical heart activity and detects regions of reduced activity that may be due to scarred and inflamed tissue.

[0443] Once the prosthetic valve 140 is deployed, the sensing electrode 380 can be positioned at any location along the prosthetic valve 140 as long as the sensing electrode 380 can directly contact the surrounding tissue. Examples of suitable locations for attaching the sensing electrode 380 are along the inflow end portion 144', e.g., along the inflow apex 151, where the proximity of the natural rapid conduction pathway may be useful. The number and location of the sensing electrodes 380 can vary, and it will be apparent that in some embodiments, it is possible to include a single sensing electrode 380.

[0444] According to some embodiments, the sensing electrode 380 is attached to the frame 146 or any other component of the prosthetic valve 140, is oriented radially outward therefrom, and is adapted to directly contact the surrounding tissue. According to some embodiments, the sensing electrode 280 is electrically isolated from the frame 146.

[0445] According to some embodiments, the sensing electrode 380 is attached at the location of the prosthetic valve 140 (e.g., a prosthetic aortic valve), and when the prosthetic valve 140 is implanted in the patient's body, it enables contact between the sensing electrode 380 and the proximal portion of the coronary sinus.

[0446] According to some embodiments, the sensing electrode 380 is operable only for sensing purposes and is not operable to provide an electrical pacing signal.

[0447] In some cases, due to the implantation of foreign objects, a time-dependent decay of tissue electrical activity is expected, which results in a loss of expected cell depolarization in the vicinity of the device implantation. The signal acquired by the sensing electrode 380 can be compared to the expected decay or a pre-determined threshold to detect an unexpected decay rate indicating an inflamed area that can justify an appropriate treatment protocol.

[0448] Such mitigation of the inflammatory response can be achieved by using an appropriate drug (e.g., a steroid, etc.). Alternatively or additionally, the surface of the sensing electrode 380 can be coated with an anti-inflammatory drug as a preventive measure. According to some embodiments, the outer surface of the sensing electrode 380 is coated with a nano-level rough material, which is configured to prevent relative movement that may cause certain stimuli.

[0449] According to some embodiments, the sensing electrode 380 is coated with a material configured to reduce electrode polarization. According to some embodiments, the sensing electrode 380 is fractally coated with a coating material (e.g., but not limited to, Irox (iridium oxide) or TiN (titanium nitride), etc.). The surface of the fractal coating is constructed by repeatedly applying a mathematical operation that doubles the electrochemically active surface area. Repeating the doubling step 10 times, for example, can make the ratio between the electrochemically active surface area and the geometric electrode surface area approximately 1,000. Advantageously, the fractally coated electrode 380 is characterized by a very low and nearly constant impedance in the range of 0.1 Hz to 200 Hz, which is the relevant range in which important spectral components of the cardiac signal are located.

[0450] According to some embodiments, the sensing electrode 380 is implemented as a post-treatment sensor. Advantageously, the post-treatment measurements from the post-treatment sensing electrode 380 can assist a clinician in determining the type of anti-inflammatory therapy. Moreover, it is possible to follow up and obtain electrical activity readings, determine the duration of an appropriate therapy, and detect further deterioration of the signal activity.

[0451] According to some embodiments, the sensing electrode 380 is similar to a pacemaker electrode in structure and function and is utilized simultaneously to provide a pacemaker signal when needed, thereby being able to act as both a sensing electrode and a signal delivery electrode. Similarly, the sensing electrode and signal delivery electrode 380 can be utilized to deliver other types of signals (such as defibrillation signals and cardiac contractility modulation, etc.) when needed.

[0452] Alternatively, in cases where the electrode 380 cannot be used to deliver a pacing signal, the signals sensed by the electrode 380 can provide useful information to assist in determining whether a pacemaker / ICD / CCM device should be implanted and / or whether anti-arrhythmic drug therapy should be administered.

[0453] Although shown in FIGS. 33-36 in relation to the mechanically expandable valve 140', one or more sensors 380 can similarly be coupled to any other type of artificial valve 140 configured for implantation at any location in the heart (such as within the aortic valve annulus 42, within the mitral valve annulus 32, within the annulus of the native pulmonary valve, and / or within the annulus of the native tricuspid valve, etc.).

[0454] According to some embodiments, a plurality of sensors 380 (including two or more types of sensors from the sensor types described above herein) are attached to the artificial valve 140.

[0455] According to some embodiments, any one of the first sensors 180a, 280a and / or the second sensors 180b, 280b (attached to components of the delivery device 102), and any sensor 380 attached to the prosthetic valve 140, can transmit the measured signal to a control unit, which can be either an internal control unit 1110 or an external control unit (not shown), the internal control unit 1110 being connected to or housed within a component of the delivery device 102 (such as the handle 110, etc.), and the external control unit (not shown) being provided separately from the delivery assembly 100.

[0456] The control unit can be operably coupled to a communication component (such as the proximal communication component 1130 operably coupled to the internal control unit 1110, etc.). The communication component can include a receiver, and the receiver is operable to receive measurement signals from any one of the first sensors 180a, 280a and / or the second sensors 180b, 280b (attached to components of the delivery device 102), as well as any sensor 380 attached to the prosthetic valve 140.

[0457] According to some embodiments, the external control unit is operably connected to any one of the post-treatment sensors 380 via wireless communication. As described above, the post-treatment sensor 380 can include or be coupled to a transmitter for remote communication (such as with the external control unit). According to some embodiments, the transmitter is a radio frequency transmitter. In one variation of the embodiment, all post-treatment sensors 380 include a transmitter. In another variation of the embodiment, a plurality of post-treatment sensors 380 are coupled to a single transmitter.

[0458] According to some embodiments, the post-treatment sensor 380 includes an internal control circuit (not shown), which is electrically connected to or embedded within the post-treatment sensor 380 or the artificial valve 140. In one variation of the embodiment, all post-treatment sensors 380 include an internal control circuit. In another variation of the embodiment, a plurality of post-treatment sensors 380 are connected to a single internal control circuit.

[0459] According to some embodiments, the post-treatment sensor 380 includes or is coupled to an internal memory, which is electrically connected to or embedded within the post-treatment sensor 380 or the artificial valve 140. In one variation of the embodiment, all post-treatment sensors 380 include an internal memory. In another variation of the embodiment, a plurality of post-treatment sensors 380 are connected to a single internal memory.

[0460] According to some embodiments, the post-treatment sensor 380 can be powered remotely. According to some embodiments, the post-treatment sensor 380 includes an inductive capacitor circuit or any other energy harvesting circuit (not shown), which can be powered using radio frequency (RF) by a transmit / receive antenna. In one variation of the embodiment, the post-treatment sensor 380 includes an energy harvesting circuit. In another variation of the embodiment, a plurality of post-treatment sensors 380 are connected to a single energy harvesting circuit.

[0461] According to some embodiments, the post-treatment sensor 380 can be connected to an RFID reader unit (not shown), and the RFID reader unit is configured to enable power to be provided and / or to enable information to be read from and / or transmitted to the post-treatment sensor 380. In one variation of the embodiment, all post-treatment sensors 380 include an RFID reader unit. In another variation of the embodiment, a plurality of post-treatment sensors 380 are connected to a single RFID reader unit.

[0462] The energy harvesting circuit can be structured to receive RF energy from the RFID reader unit and can also be structured to obtain energy therefrom by converting the RF energy into DC energy (e.g., a DC voltage). The DC energy can be used to power the post-treatment sensor 380 and any other energy-consuming components (e.g., an internal control circuit, an internal memory member, and / or a transmitter, etc.) attached to the post-treatment sensor 380.

[0463] Alternatively or additionally, the prosthetic valve 140 can be provided with a local power source (not shown) (e.g., a battery, etc.) attached thereto to power at least one sensor 380. In such an embodiment, the battery can provide sufficient power to enable sensor operability during the implantation procedure and can consume both the battery and the sensor while remaining non-removably attached to the implanted valve 140 without the need to incorporate an additional complex removal mechanism for the sensor 280 from the valve 140 after the implantation procedure is complete. Alternatively, the battery can be capable of providing sufficient power to enable sensor operability for a limited post-treatment time period.

[0464] According to some embodiments, a control unit (e.g., internal control unit 1110, etc.) includes a processor for processing and interpreting measurement data received from any of the first sensors 180a, 280a and / or the second sensors 180b, 280b (attached to components of the delivery device 102), as well as any sensor 380 attached to the prosthetic valve 140. The control unit can include software for interpreting and / or displaying the data. A variety of algorithms can be used to provide warnings associated with the interpretation of the sensed signals (e.g., to a clinician). Additionally, the control unit can provide a plurality of measurements that will be averaged over several cycles and / or provide cycle-by-cycle variations that will be visualized. Thus, an operator of the delivery assembly 100 according to any of the embodiments of the present disclosure can quickly and easily obtain real-time measurements that can be presented in the form of a transvalvular pressure gradient, a flow pattern across different regions around the prosthetic valve 140, and any other parameter measured by the sensors of the present disclosure.

[0465] According to some embodiments, the control unit further includes a memory member (not shown) (e.g., an internal memory within the internal control unit 1110, etc.), which is configured to store signals received from any of the first sensors 180a, 280a and / or the second sensors 180b, 280b (attached to components of the delivery device 102), as well as and / or data interpreted by the processor. The memory member can include a suitable memory chip or storage medium (e.g., PROM, EPROM, EEPROM, ROM, flash memory, or solid state memory, etc.). The memory member can be integral with the control unit or removably coupled to the control unit.

[0466] According to some embodiments, the measurement signal is stored in a memory member and can be compared to historical values to detect improvement or degradation of the measured parameter.

[0467] According to some embodiments, the measurement signal can be mathematically manipulated or processed by a control unit over the measurement signal to derive known relationships and indices, which may be clinically relevant or may indicate relevant clinical outcomes.

[0468] According to some embodiments, the internal control unit 1110 is configured to transmit raw or interpreted data (including stored data) to an external control unit or any other external device via either a wired or wireless communication protocol, for example, via the proximal communication component 1130.

[0469] Advantageously, the measurement of physiological parameters (e.g., pressure gradients, blood flow, temperature indicative of inflammation, detection of visual deposits, and / or natural electrical activity) obtained by a sensor according to any of the embodiments of the present disclosure can provide accurate quantitative real-time data related to the functional performance of the prosthetic valve 140 during and / or after the implantation procedure.

[0470] It is recognized that certain features of the invention, which are described in the context of separate embodiments for clarity, may also be provided in combination within a single embodiment. Conversely, various features of the invention, which are described in the context of a single embodiment for brevity, may be provided separately, or in any suitable sub-combination, or as appropriate in any other described embodiment of the invention. Features described in the context of an embodiment should not be regarded as essential features of that embodiment unless so expressly specified.

[0471] Although the present invention has been described in connection with its particular embodiments, it will be apparent that numerous alternatives, modifications, and variations are possible to those skilled in the art. It should be understood that the present invention is not necessarily limited to the details of construction and arrangement of the components and / or methods described herein in its application. Other embodiments may be practiced and the embodiments may be implemented in various ways. Accordingly, the present invention encompasses all such alternatives, modifications, and variations that fall within the scope of the appended claims.

Explanation of Signs

[0472] 12 Left atrium 14 Right atrium 16 Left ventricle 18 Right ventricle 20 Septum 22 Left ventricular outflow tract (LVOT) 22' New LVOT 30 Mitral valve 32 Mitral valve annulus 34 Mitral valve leaflet 36 Chordae tendineae 40 Aortic valve 42 Aortic valve annulus 44 Aortic valve leaflet 80 Aorta 82 Aortic root 100 Delivery assembly 102 Delivery device 104 Outer shaft 105 Outer shaft distal lip 106 Delivery shaft 108 Nose cone shaft 110 Handle 112 Guide wire 118 Nose cone shaft 120 Nose cone shaft distal portion 121 Nose cone shaft distal end 122 Nose cone shaft guide wire lumen 125 Nose cone shaft outer surface 126 Nose cone 127 Outer surface of the nose cone 128 Proximal portion of the nose cone 129 Distal portion of the nose cone 130 Nose cone, proximal inclined portion of the nose cone 131 Proximal cylindrical portion of the nose cone 132 Ridge portion of the nose cone 133 Proximal opening of the nose cone 134 Guide wire lumen of the nose cone 135 Longitudinal axis of the guide wire lumen 136 Skirt 136' Skirt 138 Distal end of the nose cone 140 Artificial valve, artificial replacement valve 140' Artificial valve, mechanically expandable valve 141 Valve longitudinal axis 141' Valve longitudinal axis 142 Outflow end portion 142' Outflow end portion 143 Outflow end 143' Outflow end 144 Inflow end portion 144' Inflow end portion 145 Inflow end 145' Inflow end 146 Frame 146' Frame 147 Open cell 147' Open cell 148 Strut 148' Strut 149 Outflow apex 149' Outflow apex 150 Junction 150' Junction 151 Inflow apex 151' Inflow apex 152 Valve tip 152' Valve tip 153 Inner skirt 153' Inner skirt 154 Crosslink 154' Junction 155 Actuating member 155' Intermediate portion 156 Actuator assembly 157 Support sleeve 158 Outer member 159 Inner member 160 Actuating arm assembly 161 Loop attachment member 162 Recompression shaft 163 Recompression shaft main lumen 166 Recompression member 167 Distal loop 168a First transmission line 168b Second transmission line 180a First sensor 180b Second sensor 186a First active surface 186b Second active surface 187a First passive surface 187b Second passive surface 188 Valve shaft 189 Valve shaft lumen 190 Valve shaft distal portion 191 Valve shaft distal end 192 Valve shaft proximal portion 193 Shaft valve 194 Sensing catheter 196 Sensing head 200 System 206 Delivery shaft 208 Delivery shaft sensor lumen 209 Delivery shaft side opening 212 Valve guide wire 213 Guide wire internal lumen 215 Valve guide wire inner surface 216 Valve guide wire proximal portion 217 Guide wire valve 218 Nose cone shaft Distal portion of 220 NC shaft Distal end of 221 nose cone shaft 222 NC shaft GW lumen 223 Nose cone shaft sensor lumen 224 Nose cone shaft side opening 226 Nose cone 227 NC outer surface 229 NC distal portion 233 NC proximal opening 234 NC GW lumen 235 GW lumen longitudinal axis 236 Nose cone transverse port 237 Nose cone port opening 262 Recompression shaft 263 Recompression shaft main lumen 264 Recompression shaft sensor lumen 265 Recompression shaft side opening 268a First optical fiber 268b Optical fiber 270 Optical core 271 Cladding 272 Tapered surface 273 Core axis 274 Optical fiber distal end 280a First optical pressure sensor, Fabry - Perot sensor 280b Second sensor, Fabry - Perot sensor 282 Housing 284 Optical side cavity 286 Diaphragm 288 Shaft with valve 289 Shaft with valve lumen 290 Distal portion of shaft with valve 293 Shaft valve, stopcock valve 294 Sensing catheter 296 Sensing head 318a First sensor shaft 320 Distal portion of sensor shaft 320a First sensor shaft distal portion 321a First sensor shaft distal end 322a First sensor shaft lumen 324a First sensor shaft side opening 326 Nose cone 327 NC outer surface 333a First nose cone proximal opening 333b Second nose cone proximal opening 368 Transmission line 368a First transmission line 368b Second transmission line 374a First transmission line distal end 374b Second transmission line distal end 376 Transmission line shaft 377 Transmission shaft lumen 378 Transmission shaft distal end 378a First transmission shaft distal end 378b Second transmission shaft distal end 379 Transmission shaft external thread 380 Sensor 380a First sensor 380b Second sensor 380c Sensor 382 Sensor housing 382a First sensor housing 382b Second sensor 383 Housing threaded bore 383a First sensor housing bore 383b Second sensor housing bore 386 Active surface 386a First active surface 386b Second active surface 387 Passive surface 387a First passive surface 387b Second passive surface 394 Ultrasonic measurement catheter 396 Sensing head 418 NC shaft 420 Distal portion of NC shaft 421 Distal end of NC shaft 423 Sensor lumen of NC shaft 426 Nose cone 427 NC outer surface 434 NC GW lumen 436 NC lateral port 494 Doppler catheter 496 Sensing head 518 Multilumen NC shaft 520 Distal portion of NC shaft 523 Sensor lumen of NC shaft 524 Lateral opening of NC shaft 526 Nose cone 534 NC GW lumen 536 NC lateral port 537 NC port opening 594 Ultrasonic cardiac echo catheter 596 Sensing head 618 NC shaft 620 Distal portion of NC shaft 623a First sensor lumen of NC shaft 623b Second sensor lumen of NC shaft 624a First lateral opening of NC shaft 624b Second lateral opening of NC shaft 626 Nose cone 634 NC GW lumen 636 NC lateral port 637 NC port opening 694 Acoustic viscosity catheter 696 Sensing head 718 NC shaft 720 Distal portion of NC shaft 723 Sensor lumen of NC shaft 724a First lateral opening of NC shaft 724b Second NC Shaft Side Opening 1010 Internal Control Unit 1020 Display 1022 Digital Screen, LCD Screen 1024 LED Light 1030 Proximal Communication Component 1118 NC Shaft 1125 Outer Surface of NC Shaft 1126 Nose Cone 1226 Nose Cone c1 Arrow c2 Direction d1 Mitral Valve Inflow d2 Flow f1 Proximal Direction v1 First Turbine v2 Second Turbine

Claims

Claim 1 A delivery assembly comprising: an artificial valve movable between a radially compressed configuration and a radially expanded configuration; a delivery device; wherein the delivery device comprises: a handle; a delivery shaft extending distally from the handle; a nose cone shaft extending through the delivery shaft and comprising: an outer surface of the nose cone shaft, a nose cone shaft guide wire lumen, and a distal portion of the nose cone shaft; a nose cone attached to the distal portion of the nose cone shaft and comprising a nose cone guide wire lumen and an outer surface of the nose cone; a first sensor retained within the nose cone; a first transmission line coupled to the first sensor and extending proximally from the first sensor toward the handle. A delivery assembly. ​ ​

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