Patent Description:
Native heart valves, such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system. Various valvular diseases can render the valves ineffective and require replacement with artificial valves. Surgical procedures can be performed to repair or replace a heart valve. Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The actuation mechanism usually includes a plurality of actuation/locking assemblies, releasably connected to respective actuation members of the valve delivery system, controlled via the handle for actuating the assemblies to expand the valve to a desired diameter. The assemblies may optionally lock the valve's position to prevent undesired recompression thereof, and disconnection of the delivery system's actuation member from the valve actuation/locking assemblies, to enable retrieval thereof once the valve is properly positioned at the desired site of implantation.

When implanting a prosthetic valve, such as a mechanically expandable valve, it is desirable to expand the valve to a maximum size allowed by the patient's anatomical considerations, in order to avoid paravalvular leakage or other unfavorable hemodynamic phenomena across the valve that may be associated with a mismatch between the valve's expansion diameter and the surrounding tissue, while mitigating the risk of annular rupture that may result from over-expansion. To ensure optimal implantation size, the diameter of the prosthetic valve should be monitored in real-time during the implantation procedure.

<CIT> discloses a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor. <CIT> also discloses an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

The present disclosure is directed toward devices, assemblies and methods for monitoring radial expansion of a prosthetic valve during prosthetic valve implantation procedures. Real-time measurement of the expansion diameter ensures proper implantation of the prosthetic valve within a designated site of implantation, such as the site of malfunctioning native valve.

The claimed invention is defined in independent claim <NUM> and relates to a delivery assembly comprising a prosthetic valve, a delivery apparatus and at least one vibration sensor. Preferred configurations of the claimed invention are defined in dependent claims <NUM> to <NUM>. Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims.

According to one aspect of the disclosure, there is provided a prosthetic valve expansion monitoring system comprising a prosthetic valve, a delivery apparatus and at least one sound sensor. The prosthetic valve comprises a frame movable between a radially compressed configuration and a radially expanded configuration, and at least one expansion and locking assembly. The at least one expansion and locking assembly comprises an outer member coupled to the frame at a first location, and an inner member, coupled to the frame at a second location spaced apart from the first location. The inner member extends at least partially into the outer member, and comprises a plurality of ratcheting teeth.

The delivery apparatus comprises a handle, a delivery shaft extending distally from the handle, and at least one actuation assembly. The at least one actuation assembly comprises an actuator extending from the handle through the delivery shaft, and a sleeve disposed around the corresponding actuator. The actuator is releasably coupled to the corresponding inner member.

The spring biased arm is biased toward the inner member, wherein engagement of the pawl with the ratcheting teeth allows movement in a first direction to allow axial foreshortening and radial expansion of the frame and prevents movement in a second direction to prevent radial compression of the frame.

The sound sensor is configured to generate signals commensurate with click sounds generated during movement of the pawl over the ratcheting teeth.

In some examples, the system further comprises a control unit configured to: receive the signals from the at least one sound sensor; responsive to the received signals, determine the number of click sounds generated during the movement of the pawl; evaluate an expanded diameter of the prosthetic valve; and output an indication of the evaluated expanded diameter.

In some examples, the control unit is further configured to estimate the axial foreshortening of the frame by multiplying the number of click sounds by the length of a single ratcheting tooth, the evaluation of the expanded diameter being responsive to the estimated axial foreshortening.

In some examples, the evaluation of the expanded diameter is based on pre-stored relationships between axial foreshortening and radial expansion of the frame.

In some examples, the prosthetic valve comprises three expansion and locking assemblies, wherein the control unit is further configured to differentiate between click sounds of different expansion and locking assemblies based on identification of the time difference between such click sounds.

In some examples, the sound sensor is disposed between the actuator and the sleeve.

In some examples, the sound sensor is attached to the actuator.

In some examples, the difference between an inner diameter of the sleeve and an outer diameter of the actuator is at least twice as large as the thickness of the sound sensor.

In some examples, the sleeve has a non-uniform inner diameter such that the difference between the inner diameter of the sleeve and an outer diameter of the actuator is at least twice as large as the thickness of the sound sensor at the region at which the sound sensor is positioned, and wherein the sleeve comprises a neck portion tapering distally inward to a narrower inner diameter of the sleeve.

According to the claimed invention defined in independent claim <NUM>, there is provided a delivery assembly comprising a prosthetic valve, a delivery apparatus and at least one vibration sensor. The prosthetic valve comprises a frame movable between a radially compressed configuration and a radially expanded configuration, and at least one expansion and locking assembly. The at least one expansion and locking assembly comprises an outer member coupled to the frame at a first location, and an inner member, coupled to the frame at a second location spaced apart from the first location. The inner member extends at least partially into the outer member, and comprises a plurality of ratcheting teeth.

The at least one vibration sensor is attached to the at least one actuation assembly, and is configured to generate signals commensurate with vibrations generated by the expansion and locking assembly during movement of the pawl over each ratcheting tooth.

In some examples, and as defined in dependent claim <NUM>, the delivery assembly further comprises a control unit configured to: receive the signals from the at least one vibration sensor; responsive to the received signals, count the vibrations generated by the expansion and locking assembly during movement of the pawl over each ratcheting tooth; responsive to an outcome of the count of the vibrations, evaluate an expanded diameter of the prosthetic valve; and output an indication of the expanded diameter.

In some examples, and as defined in dependent claim <NUM>, the control unit is further configured to estimate the axial foreshortening of the frame by multiplying the number of vibrations generated by the expansion and locking assembly during movement of the pawl over each ratcheting tooth, by the length of a single ratcheting tooth, the evaluation of the expanded diameter responsive to the estimated axial foreshortening.

In some examples, and as defined in dependent claim <NUM>, the evaluation of the expanded diameter of the prosthetic valve is based on pre-stored relationships between axial foreshortening and radial expansion of the frame.

In some examples, and as defined in dependent claim <NUM>, the at least one expansion and locking assembly comprises three expansion and locking assemblies, and wherein the actuation assembly comprises three actuation assemblies, each vibration sensor attached to a separate actuation assembly coupled to corresponding expansion and locking assembly, and wherein the control unit is further configured to identify signals acquired within a predefined time period and mathematically manipulate such signals.

In some examples, and as defined in dependent claim <NUM>, the mathematical manipulation comprises averaging the signals received within the predefined time period.

In some examples, and as defined in dependent claim <NUM>, the control unit is further configured to identify a non-uniform expansion of the prosthetic valve, the evaluation of the expanded diameter responsive to the identified non-uniform expansion.

In some examples, and as defined in dependent claim <NUM>, the identification of a non-uniform expansion comprises estimating the extent of axial foreshortening at more than two regions around the circumference of the prosthetic valve.

In some examples, and as defined in dependent claim <NUM>, the identification of a non-uniform expansion comprises estimating the circumferential contour of the expanded prosthetic valve.

In some examples, and as defined in dependent claim <NUM>, the vibration sensor is disposed between the actuator and the sleeve, and/or attached to the actuator, and wherein the difference between an inner diameter of the sleeve and an outer diameter of the actuator is at least twice as large as the thickness of the vibration sensor.

In some examples, and as defined in dependent claim <NUM>, the vibration sensor is disposed between the actuator and the sleeve, and/or attached to the actuator, and wherein the sleeve has a non-uniform inner diameter such that the difference between the inner diameter of the sleeve and an outer diameter of the actuator is at least twice as large as the thickness of the vibration sensor at the region at which the vibration sensor is positioned, and wherein the sleeve comprises a neck portion tapering distally inward to a narrower inner diameter of the sleeve.

Certain examples of the present disclosure may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Aspects and examples of the disclosure are further described in the specification herein below and in the appended claims.

Unless otherwise defined, 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 disclosure pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

The following examples and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, but not limiting in scope. In various examples, one or more of the above-described problems have been reduced or eliminated, while other examples are directed to other advantages or improvements.

Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

<FIG> shows a view in perspective of a delivery assembly <NUM>, according to some examples. The delivery assembly <NUM> can include a prosthetic valve <NUM> and a delivery apparatus <NUM>. The prosthetic valve <NUM> can be on or releasably coupled to the delivery apparatus <NUM>. The delivery apparatus can include a handle <NUM> at a proximal end thereof, a nosecone shaft <NUM> extending distally from the handle <NUM>, a nosecone <NUM> attached to the distal end of the nosecone shaft <NUM>, a delivery shaft <NUM> extending over the nosecone shaft <NUM>, and optionally an outer shaft <NUM> extending over the delivery shaft <NUM>.

The term "proximal", as used herein, generally refers to the side or end of any device or a component of a device, which is closer to the handle <NUM> or an operator of the handle <NUM> when in use.

The term "distal", as used herein, generally refers to the side or end of any device or a component of a device, which is farther from the handle <NUM> or an operator of the handle <NUM> when in use.

The term "prosthetic valve", as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, a prosthetic valve <NUM> can be crimped or retained by a delivery apparatus <NUM> in a compressed state during delivery, and then expanded to the expanded state once the prosthetic valve <NUM> reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.

The term "plurality", as used herein, means more than one.

A prosthetic valve <NUM> of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. While a delivery assembly <NUM> described in the current disclosure, includes a delivery apparatus <NUM> and a prosthetic valve <NUM>, it should be understood that the delivery apparatus <NUM> according to any example of the current disclosure can be used for implantation of other prosthetic devices aside from prosthetic valves, such as stents or grafts.

According to some examples, the prosthetic valve <NUM> is a mechanically expandable valve, and the delivery apparatus <NUM> further comprises a plurality of actuation assemblies <NUM> (shown, for example, in <FIG> and <FIG>) extending from the handle <NUM> through the delivery shaft <NUM>. The actuation assemblies <NUM> can generally include actuators <NUM> (visible, for example, in <FIG>) releasably coupled at their distal ends to respective expansion and locking assemblies <NUM> of the valve <NUM>, and sleeves <NUM> disposed around the respective actuators <NUM>. Each actuator <NUM> may be axially movable relative to the sleeve <NUM> covering it.

The prosthetic valve <NUM> can be delivered to the site of implantation via a delivery assembly <NUM> carrying the valve <NUM> in a radially compressed or crimped state, toward the target site, to be mounted against the native anatomy, by expanding the valve <NUM> via a mechanical expansion mechanism, as will be elaborated below.

The delivery assembly <NUM> can be utilized, for example, to deliver a prosthetic aortic valve for mounting against the aortic annulus, to deliver a prosthetic mitral valve for mounting against the mitral annulus, or to deliver a prosthetic valve for mounting against any other native annulus.

The nosecone <NUM> can be connected to the distal end of the nosecone shaft <NUM>. A guidewire (not shown) can extend through a central lumen of the nosecone shaft <NUM> and an inner lumen of the nosecone <NUM>, so that the delivery apparatus <NUM> can be advanced over the guidewire through the patient's vasculature.

As mentioned above, the proximal ends of the nosecone shaft <NUM>, the delivery shaft <NUM>, components of the actuation assemblies <NUM>, and when present - the outer shaft <NUM>, can be coupled to the handle <NUM>. During delivery of the prosthetic valve <NUM>, the handle <NUM> can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus <NUM>, such as the nosecone shaft <NUM>, the delivery shaft <NUM>, and/or the outer shaft <NUM>, through the patient's vasculature, as well as to expand or contract the prosthetic valve <NUM>, for example by maneuvering the actuation assemblies <NUM>, and to disconnect the prosthetic valve <NUM> from the delivery apparatus <NUM>, for example - by decoupling the actuators <NUM> from the expansion and locking assemblies <NUM> of the valve <NUM>, in order to retract it once the prosthetic valve is mounted in the implantation site.

The term "and/or" is inclusive here, meaning "and" as well as "or". For example, "delivery shaft <NUM> and/or outer shaft <NUM>" encompasses, delivery shaft <NUM>, outer shaft <NUM>, and delivery shaft <NUM> with outer shaft <NUM>; and, such "delivery shaft <NUM> and/or outer shaft <NUM>" may include other elements as well.

According to some examples, the handle <NUM> can include one or more operating interfaces, such as steerable or rotatable adjustment knobs, levers, sliders, buttons (not shown) and other actuating mechanisms, which are operatively connected to different components of the delivery apparatus <NUM> and configured to produce axial movement of the delivery apparatus <NUM> in the proximal and distal directions, as well as to expand or contract the prosthetic valve <NUM> via various adjustment and activation mechanisms.

According to some examples, the handle <NUM> further comprises one or more visual or auditory informative elements (such as display <NUM>) configured to provide visual or auditory information and/or feedback to a user or operator of the delivery apparatus <NUM>, such as a LCD screen 113a, LED lights 113b, speakers (not shown) and the like.

<FIG> shows an example of a mechanically expandable prosthetic valve <NUM> in an expanded state, according to some examples. <FIG> shows the prosthetic valve <NUM> of <FIG> with actuation assemblies <NUM> coupled to the expansion and locking assemblies <NUM>. Soft components, such as leaflets or skirts, are omitted from view in <FIG> to expose the expansion and locking assemblies <NUM>. The prosthetic valve <NUM> can comprise an inflow end portion <NUM> defining an inflow end <NUM>, and an outflow end portion <NUM> defining an outflow end <NUM>. In some instances, the outflow end <NUM> is the distal end of the prosthetic valve <NUM>, and the inflow end <NUM> is the proximal end of the prosthetic valve <NUM>. Alternatively, depending for example 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.

The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the valve <NUM>.

The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the valve <NUM>.

The valve <NUM> comprises a frame <NUM> composed of interconnected struts <NUM>, and may be made of various suitable materials, such as stainless steel, cobalt-chrome alloy (e.g. MP35N alloy), or nickel titanium alloy such as Nitinol. According to some examples, the struts <NUM> are arranged in a lattice-type pattern. In the example illustrated in <FIG>, the struts <NUM> are positioned diagonally, or offset at an angle relative to, and radially offset from, the longitudinal axis of the valve <NUM>, when the valve <NUM> is in an expanded position. It will be clear that the struts <NUM> can be offset by other angles than those shown in <FIG>, such as being oriented substantially parallel to the longitudinal axis of the valve.

According to some examples, the struts <NUM> are pivotably coupled to each other. In the example shown in <FIG>, the end portions of the struts <NUM> are forming apices <NUM> at the outflow end <NUM> and apices <NUM> at the inflow end <NUM>. The struts <NUM> can be coupled to each other at additional junctions <NUM> formed between the outflow apices <NUM> and the inflow apices <NUM>. The junctions <NUM> can be equally spaced apart from each other, and/or from the apices <NUM>, <NUM> along the length of each strut <NUM>. Frame <NUM> may comprise openings or apertures at the regions of apices <NUM>, <NUM> and junctions <NUM> of the struts <NUM>. Respective hinges can be included at locations where the apertures of struts <NUM> overlap each other, via fasteners such as rivets or pins, which extend through the apertures. The hinges can allow the struts <NUM> to pivot relative to one another as the frame <NUM> is radially expanded or compressed.

In alternative examples, the struts are not coupled to each other via respective hinges, but are otherwise pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.

The frame <NUM> further comprises a plurality of cells <NUM>, defined between intersecting portions of struts <NUM>. The shape of each cell <NUM>, and the angle between each portions of struts <NUM> defining its borders, vary during expansion or compression of the prosthetic valve <NUM>.

The prosthetic valve <NUM> further comprises a leaflet assembly <NUM> having one or more leaflets <NUM>, e.g., three leaflets, configured to regulate blood flow through the prosthetic valve <NUM> from the inflow end to the outflow end. While three leaflets <NUM> configured to collapse in a tricuspid arrangement similar to the native aortic valve, are shown in the example illustrated in <FIG>, it will be clear that a prosthetic valve <NUM> can include any other number of leaflets <NUM>, such as two leaflets configured to collapse in a bicuspid arrangement similar to the native mitral valve, or more than three leaflets, depending upon the particular application. The leaflets <NUM> are made of a flexible material, derived from biological materials (e.g., bovine pericardium or pericardium from other sources), bio-compatible synthetic materials, or other suitable materials as known in the art and described, for example, in <CIT>, <CIT> and<CIT>.

The leaflets <NUM> may be coupled to the frame <NUM> via commissures <NUM>, either directly or attached to other structural elements connected to the frame <NUM> or embedded therein, such as commissure posts. Further details regarding prosthetic valves, including the manner in which leaflets may be mounted to their frames, are described in <CIT>, <CIT>, <CIT> and <CIT>, and <CIT>.

According to some examples, the prosthetic valve <NUM> may further comprise at least one skirt or sealing member, such as the inner skirt <NUM> shown in the example illustrated in <FIG>. The inner skirt <NUM> can be mounted on the inner surface of the frame <NUM>, configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. The inner skirt <NUM> can further function as an anchoring region for the leaflets <NUM> to the frame <NUM>, and/or function to protect the leaflets <NUM> against damage which may be caused by contact with the frame <NUM>, for example during valve crimping or during working cycles of the prosthetic valve <NUM>. Additionally, or alternatively, the prosthetic valve <NUM> can comprise an outer skirt (not shown) mounted on the outer surface of the frame <NUM>, configure to function, for example, as a sealing member retained between the frame <NUM> and the surrounding tissue of the native annulus against which the prosthetic valve <NUM> is mounted, thereby reducing risk of paravalvular leakage past the prosthetic valve <NUM>. Any of the inner skirt <NUM> and/or outer skirt can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g. pericardial tissue).

<FIG> show the distal portion of the delivery assembly <NUM> at different stages of a prosthetic valve <NUM> delivery and expansion procedure. Prior to implantation, the prosthetic valve <NUM> can be crimped onto the delivery apparatus <NUM>. This step can include placement of the radially compressed valve <NUM> within the outer shaft <NUM>. A distal end portion of the outer shaft <NUM> can extend over the prosthetic valve <NUM> and contact the nosecone <NUM> in a delivery configuration of the delivery apparatus <NUM>. Thus, the distal end portion of the outer shaft <NUM> can serve as a delivery capsule that contains, or houses, the prosthetic valve <NUM> in a radially compressed or crimped configuration for delivery through the patient's vasculature. <FIG> shows an example of a distal portion of the outer shaft <NUM> extending over a crimped prosthetic valve (hidden from view), having the distal lip of the outer shaft pressed against the nosecone.

The outer shaft <NUM> and the delivery shaft <NUM> can be configured to be axially movable relative to each other, such that a proximally oriented movement of the outer shaft <NUM> relative to the delivery shaft <NUM>, or a distally oriented movement of the delivery shaft <NUM> relative to the outer shaft <NUM>, can expose the prosthetic valve <NUM> from the outer shaft <NUM> as shown in <FIG>. In alternative examples, the prosthetic valve <NUM> is not housed within the outer shaft <NUM> during delivery. Thus, according to some examples, the delivery apparatus <NUM> does not include an outer shaft <NUM>.

<FIG> shows a fully exposed mechanically expandable valve <NUM> in an expanded state, wherein the distal portions of the actuation assemblies <NUM>, extending from the handle <NUM> through the delivery shaft <NUM>, are exposed as well.

<FIG>, <FIG> show an exploded view in perspective, an assembled view in perspective, and a cross-sectional side view, respectively, of an expansion and locking assembly <NUM> according to some examples. The expansion and locking assembly <NUM> may include an outer member <NUM> defining an outer member lumen <NUM>, secured to a component of the valve <NUM>, such as the frame <NUM>, at a first location, and an inner member <NUM> secured to a component of the valve <NUM>, such as the frame <NUM>, at a second location, axially spaced from the first location.

The inner member <NUM> extends between an inner member proximal end portion <NUM> and an inner member distal end portion <NUM>. The inner member <NUM> comprises an inner member coupling extension <NUM> extending from its distal end portion <NUM>, which may be formed as a pin extending radially outward from the distal end portion <NUM>, configured to be received within respective openings or apertures of struts <NUM> intersecting at a junction <NUM> or an apex <NUM>, <NUM>. The inner member <NUM> may further comprise a linear rack having a plurality of ratcheting teeth <NUM> along at least a portion of its length. According to some examples, inner member <NUM> further comprises a plurality of ratcheting teeth <NUM> along a portion of its outer surface.

The outer member <NUM> comprises an outer member proximal end portion <NUM> defining a proximal opening of its lumen <NUM>, and an outer member distal end portion <NUM> defining a distal opening of its lumen <NUM>. The outer member <NUM> can further comprise an outer member coupling extension <NUM> extending from its proximal end portion <NUM>, which may be formed as a pin extending radially outward from the external surface of the proximal end portion <NUM>, configured to be received within respective openings or apertures of struts <NUM> intersecting at a junction <NUM> or an apex <NUM>, <NUM>.

The outer member <NUM> can further comprise a spring biased arm <NUM>, attached to or extending from one sidewall of the outer member <NUM>, and having a tooth or pawl <NUM> at its opposite end, biased inward toward the inner member <NUM> when disposed within the outer member lumen <NUM>.

At least one of the inner or outer member <NUM> or <NUM>, respectively, is axially movable relative to its counterpart. The expansion and locking assembly <NUM> in the illustrated example, comprises a ratchet mechanism or a ratchet assembly, wherein the pawl <NUM> is configured to engage with the teeth <NUM> of the inner member <NUM>. The spring-biased arm <NUM> can comprise an elongate body terminating in a pawl <NUM> in the form of a locking tooth, configured to engage the ratcheting teeth <NUM> of the inner member <NUM>. As shown in <FIG>, the pawl <NUM> can have a shape that is complimentary to the shape of the teeth <NUM>, such that the pawl <NUM> allows sliding movement of the inner member <NUM> in one direction relative to the spring-biased arm <NUM> (proximal direction in the illustrated example, as shown by arrow <NUM>) and resists sliding movement of the inner member <NUM> in the opposite direction (distal direction in the illustrated example) when the pawl <NUM> is in engagement with one of the teeth <NUM>.

Referring again to <FIG>, the arm <NUM> can be biased inwardly such that the pawl <NUM> is resiliently retained in a position engaging one of the teeth <NUM> of the inner member <NUM> (which can be referred to as the engaged position of the pawl <NUM>). In the illustrated example, the spring-biased arm <NUM> is implemented as a leaf spring. In some examples, the spring-biased arm <NUM> can be integrally formed with the outer member <NUM>, in other examples, the spring-biased arm <NUM> can be separately formed and subsequently coupled to the outer member <NUM>. The biased configuration of the arm <NUM> ensures that under normal operation, the pawl <NUM> stays engaged with the teeth <NUM> of the inner member <NUM>.

The spring biased arm <NUM> can be formed of a flexible or resilient portion of the outer member <NUM> that extends over and contacts, via its pawl <NUM>, an opposing side of the outer surface of the inner member <NUM>. According to some examples, the spring biased arm <NUM> can be formed from a shape-memory material (e.g., Nitinol) pre-treated (for example, by implementing heat-treatment processes) to assume a biased configuration.

A mechanically expandable prosthetic valve <NUM> may be releasably attachable to at least one actuation assembly <NUM>, and preferably a plurality of actuation assemblies <NUM>, matching the number of expansion and locking assemblies <NUM>. In some examples, the prosthetic valve <NUM> comprises three expansion and locking assemblies <NUM>, and the delivery apparatus comprises three actuation assemblies <NUM>. The actuator <NUM> and the sleeve <NUM> can be movable longitudinally relative to each other in a telescoping manner to radially expand and contract the frame <NUM>, as further described in <CIT>, <CIT> and <CIT>. The actuators <NUM> can be, for example, wires, cables, rods, or tubes. The sleeves <NUM> can be, for example, tubes or sheaths having sufficient rigidity such that they can apply a distally directed force to the frame <NUM> or the outer member <NUM> without bending or buckling.

The inner member proximal end portion <NUM> further comprises an inner member threaded bore <NUM>, configured to receive and threadedly engage with a threaded portion of a distal end portion <NUM> (shown for example in <FIG>) of a corresponding actuator <NUM>. <FIG> shows a view in perspective of a valve <NUM> in an expanded state, having its expansion and locking assemblies <NUM> connected to actuators <NUM> (hidden from view within the sleeves <NUM>) of a delivery apparatus <NUM>. When actuators <NUM> are threaded into the inner members <NUM>, axial movement of the actuators <NUM> causes axial movement of the inner members <NUM> in the same direction.

According to some examples, the actuation assemblies <NUM> are configured to releasably couple to the prosthetic valve <NUM>, and to move the prosthetic valve <NUM> between the radially compressed and the radially expanded configurations. <FIG> illustrate a non-binding configuration representing actuation of the expansion and locking assemblies <NUM> via the actuation assemblies <NUM> to expand the prosthetic valve <NUM> from a radially compressed configuration to a radially expanded configuration.

<FIG> shows an expansion and locking assembly <NUM>, having an outer member <NUM>, secured to the frame <NUM> at a first location, and an inner member <NUM> secured to the frame <NUM> at a second location. According to some examples, the first location can be positioned at or adjacent to the outflow end portion <NUM>, and the second location can be positioned at or adjacent to the inflow end portion <NUM>. In the illustrated example, the outer member <NUM> is secured to a proximal-most non-apical junction 124a which is distal to the outflow apices <NUM> or the outflow end <NUM>, via outer member coupling extension <NUM>, and the inner member <NUM> is secured to a distal-most non-apical junction 124c which is proximal to the inflow apices <NUM> or the inflow end <NUM>, via inner member coupling extension <NUM>. A proximal portion of the inner member <NUM> extends, through the distal opening of the outer member distal end <NUM>, into the outer member lumen <NUM>.

It is to be understood that while the illustrated examples are for an expansion and locking assembly <NUM> secured to a proximal-most non-apical junction 124a serving as the first location, and to a distal-most non-apical junction 124c serving as the second location, in other implementations, the expansion and locking assembly <NUM> can be secured to other junctions, including apices of the valve. For example, the expansion and locking assembly can be secured to an outflow apex <NUM> via the outer member coupling extension <NUM>, serving as the first location, and to an opposing inflow apex <NUM> along the same column of cells, via the inner member coupling extension <NUM>, serving as the second location.

The expansion and locking assembly <NUM> is shown in <FIG> in a radially compressed state of the valve <NUM>, wherein the outflow and inflow apices <NUM> and <NUM>, respectively, are relatively distanced apart from each other along the axial direction, and the inner member proximal end portion <NUM> is positioned distal to the outer member proximal end portion <NUM>.

As further shown in <FIG>, the actuator distal end portion <NUM> is threadedly engaged with the inner member threaded bore <NUM>. According to some examples, as shown in <FIG>, the actuator distal end portion <NUM> includes external threads, configured to engage with internal threads of the inner member threaded bore <NUM>. According to alternative examples, an inner member may include a proximal extension provided with external threads, configured to be received in and engage with internal threads of a distal bore formed within the actuator (examples not shown).

The sleeve <NUM> surrounds the actuator <NUM> and may be connected to the handle <NUM> of a delivery apparatus <NUM>. The sleeve <NUM> and the outer member <NUM> are sized such that the distal lip <NUM> of the sleeve <NUM> can abut or engage the outer member proximal end <NUM>, such that the outer member <NUM> is prevented from moving proximally beyond the sleeve <NUM>.

In order to radially expand the frame <NUM>, and therefore the valve <NUM>, the sleeve <NUM> can be held firmly against the outer member <NUM>. The actuator <NUM> can then be pulled in a proximally oriented direction <NUM>, as shown in <FIG>. Because the sleeve <NUM> is being held against the outer member <NUM>, which is connected to the frame <NUM> at the first location, the outflow end <NUM> of the frame <NUM> is prevented from moving relative to the sleeve <NUM>. As such, movement of the actuator <NUM> in a proximally oriented direction <NUM> can cause movement of the inner member <NUM> in the same direction, thereby causing the frame <NUM> to foreshorten axially and expand radially.

More specifically, as shown for example in <FIG>, the inner member coupling extension <NUM> extends through apertures in two struts <NUM> interconnected at a distal non-apical junction 124c, while the outer member coupling extension <NUM> extends through aperture in two struts <NUM> interconnected at a proximal non-apical junction 124a. As such, when the inner member <NUM> is moved axially, for example in a proximally oriented direction <NUM>, within the outer member lumen <NUM>, the inner member coupling extension <NUM> moves along with the inner member <NUM>, thereby causing the portion to which the inner member coupling extension <NUM> is attached to move axially as well, which in turn causes the frame <NUM> to foreshorten axially and expand radially.

The struts <NUM> to which the inner member coupling extension <NUM> is connected are free to pivot relative to the coupling extension <NUM> and to one another as the frame <NUM> is expanded or compressed. In this manner, the inner member coupling extension <NUM> serves as a fastener that forms a pivotable connection between those struts <NUM>. Similarly, struts <NUM> to which the outer member coupling extension <NUM> is connected are also free to pivot relative to the coupling extension <NUM> and to one another as the frame <NUM> is expanded or compressed. In this manner, the outer coupling extension <NUM> also serves as a fastener that forms a pivotable connection between those struts <NUM>.

As mentioned above, when the pawl <NUM> of the spring biased arm <NUM> is engaged with the ratcheting teeth <NUM>, the inner member <NUM> can move in one axial direction, such as the proximally oriented direction <NUM>, but cannot move in the opposite axial direction. This ensures that while the pawl <NUM> is engaged with the ratcheting teeth <NUM>, the frame <NUM> can radially expand but cannot be radially compressed. Thus, after the prosthetic valve <NUM> is implanted in the patient, the frame <NUM> can be expanded to a desired diameter by pulling the actuator <NUM>. In this manner, the actuation mechanism also serves as a locking mechanism of the prosthetic valve <NUM>.

Once the desired diameter of the prosthetic valve <NUM> is reached, the actuator <NUM> may be rotated, for example in rotation direction <NUM>, to unscrew the actuator <NUM> from the inner member <NUM>, as shown in <FIG>. This rotation serves to disengage the distal threaded portion <NUM> of the actuator <NUM> from the inner member threaded bore <NUM>, enabling the actuation assemblies <NUM> to be pulled away, and retracted, together with the delivery apparatus <NUM>, from the patient's body, leaving the prosthetic valve <NUM> implanted in the patient. The patient's native anatomy, such as the native aortic annulus in the case of transcatheter aortic valve implantation, may exert radial forces against the prosthetic valve <NUM> that would strive to compress it. However, the engagement between the pawl <NUM> of the spring biased arm <NUM> and the ratcheting teeth <NUM> of the inner member <NUM> prevents such forces from compressing the frame <NUM>, thereby ensuring that the frame <NUM> remains locked in the desired radially expanded state.

Thus, the prosthetic valve <NUM> is radially expandable from the radially compressed state shown in <FIG> to the radially expanded state shown in <FIG> upon actuating the expansion and locking assemblies <NUM>, wherein such actuation includes approximating the second locations to the first locations of the valve <NUM>. The prosthetic valve <NUM> is further releasable from the delivery apparatus <NUM> by decoupling each of the actuation assemblies <NUM> from each of the corresponding expansion and locking assemblies <NUM> that were attached thereto.

While the frame <NUM> is shown above to expand radially outward by axially moving the inner member <NUM> in a proximally oriented direction <NUM>, relative to the outer member <NUM>, it will be understood that similar frame expansion may be achieved by axially pushing an outer member <NUM> in a distally oriented direction <NUM>, relative to an inner member <NUM>.

While a threaded engagement is illustrated and described in the above examples, serving as an optional reversible-attachment mechanism between the actuation assemblies <NUM> and the inner members <NUM>, it is to be understood that in alternative implementations, other reversible attachment mechanisms may be utilized, configured to enable the inner member <NUM> to be pulled or pushed by the actuation assemblies <NUM>, while enabling disconnection therebetween in any suitable manner, so as to allow retraction of the delivery apparatus from the patient's body at the end of the implantation procedure. For example, the distal end portion of the actuator can include a magnet, and the inner member bore can include a correspondingly magnetic material into which the distal end portion of the actuator can extend.

While a specific actuation mechanism is described above, utilizing a ratcheting mechanism between inner and the outer members of expansion and locking assemblies <NUM> that are attachable, for example via corresponding coupling extensions, to the frame, other actuation mechanisms may be employed to promote relative movement between inner and outer members of actuation assemblies, for example, based on a ratcheting interaction between other components of the prosthetic valve, such as ratcheting engagement between portions of specific struts of the frame, or between other, potentially integrally formed components, of the frame itself.

Referring again to <FIG>, the axial length L of a tooth <NUM> defines the axial distance by which the inner member moves when the pawl <NUM> slides between the troughs on both ends of the tooth <NUM>, such that the number of teeth N, multiplied by the tooth length L, corresponds to the range of expansion diameters to which the valve <NUM> can be expanded, and remain locked in the expanded state by having the pawl <NUM> engaged with the teeth <NUM>.

Referring again to <FIG>, the inner member <NUM> can comprise a toothless portion extending from a proximal end <NUM> to the plurality of teeth <NUM>. The toothless portion can be a flat portion of the inner member. The toothless portion is configured to allow bidirectional axial movement (in the distal and proximal directions) of the inner member <NUM> relative to the outer member <NUM>. This allows the frame <NUM> to expand and/or contract prior to the engagement of the pawl <NUM> with the plurality of teeth <NUM>. <FIG> shows an initial state in which the pawl <NUM> is pressed against the toothless portion of the inner member <NUM>, proximal to the teeth <NUM>.

When the inner member <NUM> is pulled in a proximal direction <NUM>, the pawl <NUM> slides over the toothless portion of the inner member <NUM> until it engages the teeth <NUM>. The first, proximal-most trough defined by the teeth <NUM> represents the minimal expansion diameter at which the valve <NUM> can be retained in a locked state, without being spontaneously recompressed. <FIG> shows an intermediate state wherein the pawl has been slid over two teeth <NUM>, which is indicative of an axial distance <NUM> along which the frame <NUM> foreshortened, beyond the minimal expansion diameter at which the valve may be locked, also termed minimal expansion diameter. <FIG> shows an optional final position of the pawl <NUM>, locked against the teeth <NUM> pas the fifth tooth, which is indicative of an axial distance <NUM> along which the frame <NUM> foreshortened beyond the minimal expansion diameter, to the final expansion diameter, at which point the actuation assemblies <NUM> can be disengaged from the valve <NUM>.

The number of teeth is selected to cover the desired range of expansion diameters for the valve <NUM>, ranging from a minimal expansion diameter defined by the first (e.g., proximal-most) tooth, to a maximal expansion diameter that may be defined by engagement of the pawl <NUM> with the teeth <NUM> past the last (e.g., distal-most) tooth. This range of expansion diameters corresponds to possible expansion diameters allowable by the ratcheting teeth <NUM>, which may be equal to, or greater than, the range of target diameters of the valve <NUM>, wherein the target diameters refer to a range of desired expansion diameters of the valve <NUM> within a patient's body, ranging from a minimal target diameter to a maximal target diameter.

In some cases, the target range of diameters is narrower than the range of expansion diameters allowable by the ratcheting mechanism, such that the minimal expansion diameter, at which the pawl <NUM> is engaged with, or proximal to, the first (e.g., proximal-most) tooth <NUM>, is not greater than the minimal target diameter of the valve <NUM>. Similarly, the maximal expansion diameter, at which the pawl <NUM> is engaged with, or distal to, the last (e.g., distal-most) tooth <NUM>, is at least as great as the maximal target diameter. For example, while a range of expansion diameters, defined by the number of teeth <NUM> and the relative position between the pawl <NUM> and the teeth <NUM>, may be in a range such as <NUM> to <NUM>, it may be that the target diameters are in the range of <NUM> to <NUM>.

In the illustrated examples, the plurality of ratcheting teeth <NUM> extend along a portion of the length of the inner member <NUM> adjacent the inner member proximal end portion <NUM>. In other examples, the plurality of ratcheting teeth <NUM> can extend substantially the entire length of the inner member <NUM>. In still other examples, the plurality of ratcheting teeth <NUM> can extend a portion of the length of the inner member adjacent the inner member distal end portion <NUM>. The length of each tooth L dictates the resolution of discrete expansion diameters.

The movement of the pawl <NUM> over the ratcheting teeth <NUM> generates click sounds as the pawl <NUM> slides over each tooth <NUM>. Each click sound may be representative of the pawl <NUM> sliding over a single tooth <NUM> having a tooth length L, such that several consecutive click sounds generated during the movement of a pawl <NUM> over ratcheting teeth <NUM> of a corresponding inner member <NUM> may be indicative of a relative movement between the inner member <NUM> relative to the outer member <NUM> along a distance that can be substantially equal to L multiplied by the number of clicks.

According to some examples, there is provided a prosthetic valve expansion monitoring system <NUM>, comprising a delivery assembly <NUM> and at least one sound sensor <NUM>, wherein the at least one sound sensor <NUM> is configured to detect clicking sounds produced by a ratcheting mechanism of an expansion and locking assembly <NUM> of the prosthetic valve <NUM> during expansion thereof.

According to some examples, the at least one sound sensor <NUM> of the monitoring system includes at least one extracorporeal sound sensor <NUM>a. Reference is now made to <FIG>, showing a schematic example of a prosthetic valve expansion monitoring system <NUM>a comprising an extracorporeal sound sensor <NUM>a, that can be placed in contact with or in close proximity to the patient's body. According to some examples, the extracorporeal sound sensor <NUM>a is configured to be placed externally at or in the vicinity of the skin surface of a subject (i.e., a patient), and to externally measure sounds produced within the body of the subject. The extracorporeal sound sensor <NUM>a can be placed over the patient's chest, as shown in <FIG>, prior to or during a prosthetic valve implantation procedure.

According to some examples, the at least one sound sensor <NUM> is comprised within a sensor housing <NUM>. According to some examples, an extracorporeal sound sensor <NUM>a is comprised within an extracorporeal sensor housing <NUM>a, that can be placed on or attached to the patient's body. In some examples, the extracorporeal sensor housing <NUM>a can be provided in the form of a patch. In some examples, the extracorporeal sensor housing <NUM>a is provided in the form of a precordial patch, configured to be placed on or attached to a portion of the patient's body that includes the anterior surface of the lower thorax.

In use, when a prosthetic valve <NUM> carried by a delivery apparatus <NUM> is expanded at the implantation site, for example by pulling the actuators <NUM> in a proximal direction so as to facilitate a relative telescoping movement between the inner members <NUM> and the outer members <NUM> of the expansion and locking assemblies <NUM>, a sound sensor <NUM>, such as the extracorporeal sound sensor <NUM>a, is configured to detect click sounds generated during the movement of the pawls <NUM> over ratcheting teeth <NUM> of inner members <NUM> of respective expansion and locking assemblies <NUM>, and to generate signals (e.g., electric signals) commensurate with such click sounds.

According to some examples, the sensor is characterized by having at least one of a high signal-to-noise ratio, high sensitivity, suitable ambient noise shrouding capability, and the ability to measure low frequency signals, in order to overcome various possible disturbances such as background noise or the relatively low amplitude of the vibrations or sounds that are generated by heart activity, lung activity, and/or blood flow.

According to some example, the monitoring system <NUM> further comprises an ambient noise sensor (not shown) configured to acquire environment noise and/or speech. The ambient noise sensor can be used to remove environmental noise from measured signals. Alternately, any other method of noise removal may additionally or alternatively be used.

According to some examples, the prosthetic valve expansion monitoring system further comprises a control unit <NUM> configured to receive signals detected by the at least one sound sensor <NUM>. In one example, control unit <NUM> comprises a processor. In another example, control unit <NUM> comprises a central processing unit (CPU), a microprocessor, a microcomputer, a programmable logic controller, an application-specific integrated circuit (ASIC) and/or a field-programmable gate array (FPGA), without limitation.

The at least one sound sensor <NUM> can generate electric signals commensurate with click sounds generated by at least one expansion and locking assembly <NUM> of the prosthetic valve <NUM>, and to transmit such signals, via wireless or wired communication appliances, for example to a control unit. Wireless communication can include a radio frequency (RF) link, an infrared link, a Bluetooth link, or any other known wireless communication methods. Wired communication can include a communication line <NUM>, attached to the at least one sound sensor <NUM> at one end, and to a control unit (<NUM>) at the other end.

For example, an extracorporeal sound sensor <NUM>a can be attached to a communication line <NUM>a configured to transmit signals generated thereby to another extracorporeal component, such as an extracorporeal control unit <NUM>a, wherein the extracorporeal control unit can be coupled to, or in communication with, additional devices or components such as a display module <NUM> (e.g., extracorporeal display module <NUM>a shown in <FIG>) and/or a communication component <NUM> (e.g., extracorporeal communication component <NUM>a shown in <FIG>).

According to some examples, extracorporeal sound sensor <NUM>a can be configured to detect heart sounds as well as click sounds, and to generate signals that can be distinguished, for example by the control unit <NUM>a. Signals of heart sounds and click sounds can be distinguished from each other due to having, for example, different amplitudes, waveforms and/or frequencies. Heart sound sensors are conventionally utilized for detection of sounds generated by heart activity, which include the opening and closing of the native heart valves and blood flow. The human heart sounds include a first major sound ("S1") and second major sound ("S2"). The first major sound usually includes a mitral valve sound ("M1") and a tricuspid valve sound ("T1"), while the second major sound usually includes an aortic valve sound ("A2") and a pulmonary valve sound ("P2").

Heart sounds, such as S1 and S2, are repetitive sounds generated by the ongoing cycling heart activity, while click sounds of expansion and locking assemblies are non-repetitive sounds that occur only during sliding of a pawl <NUM> over corresponding ratcheting teeth <NUM>, and will have different amplitudes, waveforms and/or frequencies than those of heart sounds due to being generated by prosthetic, optionally metallic, components interacting with each other.

In some examples, a sound sensor <NUM>, such as extracorporeal sound sensor <NUM>a, is configured to simultaneously measure both heart sounds and click sounds. Electric signals can be transmitted, for example via wireless communication, or via wired communication such as a communication line <NUM>, to control unit <NUM>, which can distinguish between the heart sounds and the click sounds, according to amplitudes, wavelengths and/or frequencies associated with signals of the different types of sounds, as well as according to identification of repetitive vs. non-repetitive sounds. In some examples, extracorporeal sound sensor <NUM>a is a phonocardiogram sensor.

In some examples, heart sounds monitoring is not required during valve expansion, such that the heart sounds are actually part of background sounds that should be filtered in order to isolate only click sounds.

In some examples, an extracorporeal prosthetic valve expansion monitoring system <NUM>a further comprises additional sensors, such as ECG sensors (not shown). Such systems can be utilized for measuring, potentially in a simultaneous manner, click sounds and ECG signals, with or without heart sounds. ECG sensors can be embedded within an extracorporeal sensor housing <NUM>a, a precordial patch, or provided as additional sensors that can be placed on or attached to the patient's body.

According to some examples, the delivery assembly <NUM> comprises the at least one sound sensor, and in particular examples, the at least one sound sensor <NUM> can be attached to a component of the delivery apparatus <NUM>. Reference is now made to <FIG>, showing various configurations of prosthetic valve expansion monitoring systems <NUM>, that may include sound sensors <NUM> comprised within the delivery assembly <NUM> and/or attached to components of the delivery apparatus <NUM>.

As mentioned hereinabove, the at least one sound sensor <NUM> can be, in some examples, accommodated within a sensor housing <NUM>. According to some examples, sensor housing <NUM> can be attached to a component of the delivery apparatus <NUM> (see <FIG>). According to still further examples, the sensor housing <NUM>b comprises at least one biocompatible material. According to still further examples, the sensor housing <NUM>b is characterized by having a shape and dimensions configured to fit into the delivery apparatus <NUM>.

The biocompatible material can be a biocompatible polymer material selected from but not limited to, poly(dimethyl siloxane) (PDMS), polycaprolactone (PCL), methyl-vinyl siloxane, ethylene/vinyl acetate copolymers, polyethylene, polypropylene, ethylene/propylene copolymers, acrylic acid polymers, ethylene/ethyl acrylate copolymers, polytetrafluoroethylene (PTFE), polyurethanes, thermoplastic polyurethanes and polyurethane elastomers, polybutadiene, polyisoprene, poly(methacrylate), polymethyl methacrylate, styrene-butadiene-styrene block copolymers, poly(hydroxyethyl-methacrylate) (pHEMA), polyvinyl chloride, polyvinyl acetate, polyethers, polyacrylo-nitriles, polyethylene glycol (PEG), polymethylpentene, polybutadiene, polyhydroxy alkanoates, poly(lactic acid) (PLA), poly(glycolic acid) (PGA), polyanhydrides, polyorthoesters, and copolymers and combinations thereof.

According to some examples, the at least one sound sensor <NUM> can be attached to the nosecone shaft <NUM>, the nosecone <NUM>, the delivery shaft <NUM>, the outer shaft <NUM>, the at least one actuation assembly <NUM> (including attachment to any one of actuator <NUM> and/or a sleeve <NUM>). According to some examples, the delivery assembly can include a sensor shaft <NUM> to which the at least one sound sensor <NUM> is attached. According to some examples, the at least one sound sensor <NUM> can be attached to an independent catheter <NUM> that can be advanced toward the implantation site independently of the delivery apparatus. Attachment of the at least one sound sensor <NUM> to any one of the nosecone shaft <NUM>, the nosecone <NUM>, the delivery shaft <NUM>, the outer shaft <NUM>, the at least one actuation assembly <NUM>, the sensor shaft <NUM> and/or the independent catheter <NUM>, can be achieved by suturing, screwing, clamping, gluing with bio-compatible adhesives, fastening, welding, or any other suitable technique.

According to some examples, the at least one sound sensor <NUM> comprises a microphone, that can be any of a piezoelectric, a piezoresistive, or a capacitive-type microphone. A piezoelectric microphone may be made from any piezoelectric material, including piezocomposites, piezoceramics, piezoplastics and the like. According to some examples, the least one sound sensor <NUM> comprises a piezoelectric film, such as polyvinylidine fluoride (PVDF), which takes the form of a thin plastic polymer sheet and may have a thin electrically conductive nickel copper alloy deposited on each side. The sound sensor <NUM> may act as a strain gage that generates an electrical signal when a diaphragm included therein vibrates in response to sounds. According to some examples, the least one sound sensor <NUM> is a micro-electrical mechanical system (MEMS) microphone.

<FIG> shows an example of a prosthetic valve expansion monitoring system <NUM>b wherein sound sensor <NUM>b is attached to the nosecone shaft <NUM>. Preferably, the sound sensor <NUM>b is attached to a portion of the nosecone shaft <NUM> that is in the vicinity of the expansion and locking assemblies <NUM>. As shown in <FIG>, the sound sensor <NUM>b can be attached to an outer surface of the nosecone shaft <NUM> at a position that is proximal to the prosthetic valve <NUM> during valve expansion. However, the sound sensor <NUM>b can be similarly attached to the outer surface of the nosecone shaft <NUM> at a position that is either within the internal lumen defined by the prosthetic valve <NUM>, or distal to the prosthetic valve <NUM>, during valve expansion.

It is to be understood that any reference to a sensor, such as any sound sensor <NUM> or vibration sensor <NUM>, being attached to any component, may refer to the sensor being embedded within a sensor housing <NUM> that is attached to the corresponding component.

According to some examples, the sound sensor <NUM>b is attached to a distal portion of the nosecone shaft <NUM> such that the maximal distance between the sound sensor <NUM>b and at least one expansion and locking assembly <NUM>, during valve expansion, is not greater than <NUM> centimeters. According to some examples, the sound sensor <NUM>b is attached to a distal portion of the nosecone shaft <NUM> such that the maximal distance between the sound sensor <NUM>b and at least one expansion and locking assembly <NUM>, during valve expansion, is not greater than <NUM> centimeters. According to some examples, the sound sensor <NUM>b is attached to a distal portion of the nosecone shaft <NUM> such that the maximal distance between the sound sensor <NUM>b and at least one expansion and locking assembly <NUM>, during valve expansion, is not greater than <NUM> centimeters.

It is to be understood that the distance between sound sensor <NUM> and at least one expansion and locking assembly <NUM> can be measured between a central point of the sound sensor <NUM> and the pawl <NUM>. In the case of a prosthetic valve <NUM> provided with a plurality of expansion and locking assemblies <NUM>, this distance can be measured between the sound sensor <NUM> and the closest pawl <NUM>.

As mentioned above, the sound sensor <NUM> can be attached to other components of the delivery apparatus <NUM>, besides the nosecone shaft, as will be further elaborated hereinbelow. According to some examples, the sound sensor <NUM> is attached to a component of the delivery apparatus <NUM> such that the distance between the sound sensor <NUM> and the pawl <NUM> (e.g., the closest pawl in case of a plurality of expansion and locking assemblies), during valve expansion, is not greater than <NUM> centimeters. According to some examples, the sound sensor <NUM> is attached to a component of the delivery apparatus <NUM> such that the distance between the sound sensor <NUM> and the pawl <NUM> (e.g., the closest pawl in case of a plurality of expansion and locking assemblies), during valve expansion, is not greater than <NUM> centimeters. According to some examples, the sound sensor <NUM> is attached to a component of the delivery apparatus <NUM> such that the distance between the sound sensor <NUM> and the pawl <NUM> (e.g., the closest pawl in case of a plurality of expansion and locking assemblies), during valve expansion, is not greater than <NUM> centimeters.

If the sound sensor <NUM> is attached to a component that may move relative to the pawl <NUM> during valve expansion, such as being attached to an actuator <NUM> that may be pulled proximally to pull the inner member <NUM> during valve expansion, the distance between the sound sensor <NUM> and the pawl <NUM> may change during valve expansion. In such cases, the distance should not exceed the above-mentioned values in a state of maximal valve expansion, i.e., when the prosthetic valve <NUM> is expanded to a maximal desired expansion diameter thereof.

As mentioned hereinabove, the prosthetic valve expansion monitoring system <NUM> can further comprise a control unit <NUM>, that can receive signals generated by the at least one sound sensor <NUM>, for example via a communication line <NUM> attached at one end (e.g., the distal end) to the at least one sound sensor <NUM>, and at the opposite end (e.g., the proximal end) to the control unit <NUM>. The communication line <NUM> can be configured to deliver measurement signals from the at least one sound sensor <NUM> to the control unit <NUM>, and/or to deliver power to the at least one sound sensor <NUM>.

According to some examples, the at least one sound sensor <NUM> includes a plurality of sound sensors <NUM>, wherein a matching plurality of communication lines <NUM> are attached to the sound sensors <NUM>, configured to deliver measurement signals from the sound sensors <NUM>, for example to a control unit <NUM>, and/or to deliver power to the sound sensors <NUM>.

According to some examples, each communication line <NUM> may include various electrically conductive materials, such as copper, aluminum, silver, gold, and various alloys such as tentalum/platinum, MP35N and the like. An insulator (not shown) can surround each communication line <NUM>. The insulator can include various electrically insulating materials, such as electrically insulating polymers.

The sound sensor <NUM>, according to any example disclosed herein, is configured to generate electric signals representative of sounds detected thereby. Specifically, the sound sensor <NUM>, according to any example disclosed herein, is configured to generate electric signals commensurate with click sounds generated during movement of the pawl <NUM> of at least one expansion and locking assembly <NUM> over the ratcheting teeth <NUM> of the corresponding inner member <NUM>. The communication line <NUM> is configured to deliver the electric signals to the control unit <NUM>.

According to some examples, the delivery assembly includes the control unit <NUM>b. According to some examples, the control unit <NUM>b may be embedded within the handle <NUM>, as schematically illustrated for example in <FIG>. According to some examples, the communication line <NUM> is connected to a power source, for example within the handle <NUM>, configured to provide power to operate the sound sensor <NUM>.

According to some examples, the communication line <NUM> is connected, directly or indirectly (e.g., via the internal control unit <NUM>) to a communication component <NUM> (schematically shown, for example, in <FIG>). The communication component <NUM> may be operatively coupled to the control unit <NUM>. The communication component <NUM> can comprise a transmitter, a receiver, a transceiver, and/or a data communication socket. In some examples, as schematically shown in <FIG>, communication component <NUM>b is embedded within the handle <NUM>, and may be configured to receive signals from, and/or transmit signals to, components and/or devices external to the delivery assembly <NUM>.

Measurement signals acquired by the at least one sound sensor <NUM>, commensurate with click sounds of the expansion and locking assemblies <NUM> during valve expansion, may provide real-time feedback regarding the valve expansion diameter during an implantation procedure. Such data may be displayed graphically, for example on an LCD screen 113a or LED lights 113b provided on the handle <NUM>. According to some examples, the control unit <NUM> is operatively coupled to a display module <NUM>, configured to relay visual representation of the measurement signals, or other signals or data derived from the measurement signals. In some examples, as schematically shown in <FIG>, display module <NUM>a is configured to relay data or information to be visually displayed via LCD screen 113a or LED lights 113b.

According to some examples, the communication line <NUM>b is attached to the nosecone shaft <NUM>, for example to an outer surface of the nosecone shaft <NUM>, or wrapped there-around, for example in a helical pattern (not shown). According to some examples, communication line <NUM>, such as communication line <NUM>b, extends from the sound sensor <NUM> (e.g., from sound sensor <NUM>b as illustrated in <FIG>) to the handle <NUM>, and optionally further extending into the handle <NUM>.

While not illustrated separately, the sound sensor <NUM>b can be attached to the nosecone <NUM> and operate in the same manner described hereinabove for any of the examples of the sound sensor <NUM>b attached to the nosecone shaft <NUM>, having the communication line <NUM>b extending therefrom, optionally along a portion of the nosecone <NUM>, and further attached to the nosecone shaft <NUM>, extending from the sound sensor <NUM>b to the handle <NUM>, and optionally further extending into the handle <NUM>.

According to some examples, the delivery apparatus <NUM> further comprises a sensor shaft <NUM> extending from the handle <NUM> through the delivery shaft <NUM>. <FIG> shows a distal region of the delivery assembly <NUM> of prosthetic valve expansion monitoring system <NUM>c, wherein the sensor shaft <NUM> comprises a sensing head <NUM>, which is illustrated extending distally from the delivery shaft <NUM>.

The sensor shaft <NUM> may be axially movable relative to the delivery shaft <NUM>. The movement of the sensor shaft <NUM> may be controlled by the handle <NUM>. The sensing head <NUM> may comprise sound sensor <NUM>c. The sensor shaft <NUM> may further comprise communication line <NUM>c extending from the sensing head <NUM> toward the handle <NUM>.

<FIG> shows a distal region of a prosthetic valve expansion monitoring system <NUM>d that comprises, according to some examples, a delivery assembly <NUM> and an independent catheter <NUM>, which may be similar in structure and function to the sensor shaft <NUM>, except that the independent catheter <NUM> is provided as a separate component which is not part of the delivery apparatus <NUM>.

The independent catheter <NUM> may be axially movable relative to any component of the delivery assembly <NUM>. The independent catheter <NUM> comprises a sensing head <NUM>, which may comprise sound sensor <NUM>d. According to some examples, the independent catheter <NUM> may be provided in the form of a pigtail catheter, as illustrated in <FIG>.

Sound sensor <NUM>d can be embedded within sensing head <NUM>, or attached to an external surface of sensing head <NUM> which is a distal end portion of the independent catheter <NUM>. The independent catheter <NUM> may further comprise communication line <NUM>d extending from the sound sensor <NUM>d, either through a lumen of the independent catheter <NUM>, or over the external surface of the independent catheter <NUM> as illustrated for example in <FIG>.

According to some examples, sound sensor <NUM>e is attached to the delivery shaft <NUM>. In the example of prosthetic valve expansion monitoring system <NUM>e shown in <FIG>, the sound sensor <NUM>e is attached to the outer surface of the delivery shaft <NUM>. Alternatively, the sound sensor <NUM>e can be attached to the inner surface of the delivery shaft <NUM>.

According to some examples, communication line <NUM>e is attached to the outer surface of the delivery shaft <NUM>, or wrapped there-around, for example in a helical pattern (not shown), extending from the sound sensor <NUM>e to the handle <NUM>, and optionally further extending into the handle <NUM>. Alternatively or additionally, the communication line <NUM>e can be attached to the inner surface of the delivery shaft <NUM>.

While not illustrated separately, the sound sensor <NUM>e can be attached to any other shaft of the delivery apparatus <NUM>, such as the outer shaft <NUM>, configured to operate in the same manner described hereinabove for any of the examples of the sound sensor <NUM>e attached to the delivery shaft <NUM>, having the communication line <NUM>e extending therefrom to the handle <NUM>, and optionally further extending into the handle <NUM>.

According to some examples, sound sensor <NUM>f is attached to a component of an actuation assembly <NUM>. In the example of <FIG> the sound sensor <NUM>f is attached to the outer surface of one of the plurality of actuation assemblies <NUM>. As mentioned, each actuation assembly <NUM> can include an actuator <NUM> releasably coupled at its distal end to a respective expansion and locking assembly <NUM>, and a sleeve <NUM> disposed around the actuator <NUM>. According to some examples, the sound sensor <NUM>f is attached to the outer surface of a sleeve <NUM>.

According to some examples, communication line <NUM>f is attached to the outer surface of one of the plurality of actuation assemblies <NUM>, or wrapped there-around, for example in a helical pattern (not shown), from the sound sensor <NUM>f to the handle <NUM>, and optionally further extending into the handle <NUM>. According to some examples, the communication line <NUM>f is attached to the outer surface of a sleeve <NUM>.

According to some examples, the delivery apparatus <NUM> includes a plurality of actuation assemblies, and at least one sound sensor <NUM>f attached to at least one of the plurality of actuation assemblies. <FIG> shows an example of a delivery apparatus <NUM> that includes three actuation assemblies 170a, 170b and 170c, coupled to three expansion and locking assemblies 138a, 138b and 138c, and a single sound sensor <NUM>f attached to one of the expansion and locking assemblies, such as to the outer surface of expansion and locking assembly 138a.

It is to be understood that any reference to "the sound sensor" or "the at least one sound sensor" throughout the specification and the claims, refers to each one of the sound sensor in case of configurations that include a plurality of sound sensors.

According to some examples, the delivery apparatus <NUM> includes a plurality of sound sensors <NUM>f, attached to a plurality of actuation assemblies <NUM>. The number of sound sensors <NUM>f can match the number of actuation assemblies <NUM>, which in turn matches the number of expansion and locking assemblies <NUM>. <FIG> shows an example of a delivery apparatus <NUM> that includes three actuation assemblies 170a, 170b and 170c, coupled to three expansion and locking assemblies 138a, 138b and 138c, and three sound sensors <NUM>fa, <NUM>fb and <NUM>fc attached to the actuation assemblies 170a, 170b and 170c, respectively. Three corresponding communication lines <NUM>fa, <NUM>fb and <NUM>fc can extend proximally from the sound sensors <NUM>fa, <NUM>fb and <NUM>fc, respectively.

According to some examples, there is provided a delivery assembly <NUM> comprising at least one vibration sensor <NUM> attached to at least one expansion and locking assembly <NUM>, wherein the at least one vibration sensor <NUM> is configured to detect vibrations of the at least one expansion and locking assembly <NUM>, which are transmitted to the corresponding actuation assembly <NUM> coupled thereto.

When the pawl <NUM> slides over each ratcheting tooth <NUM> of the inner member <NUM>, as described hereinabove with respect to <FIG>, the pawl <NUM> hits the throughs between consecutive teeth <NUM> in a manner that is sufficient to vibrate the inner member <NUM> to some extent. The amplitude of such a vibration may be maximal as the pawl <NUM> slides over a tooth <NUM> to hit against the through between the teeth <NUM>, such that each vibration, detected and identified to be indicative of the pawl <NUM> being slid over a tooth <NUM>, may be indicative of a relative axial movement between the inner member <NUM> and the outer member <NUM> along a distance L, which is the length of a single ratcheting tooth <NUM>. The pawl <NUM> of the outer member <NUM> may similarly experience a similar vibration from the same reason, though the amplitude and waveform of the vibration wave of the outer member <NUM> may be different than that of the inner member <NUM>.

Thus, detection of vibration of a component of the expansion and locking assembly <NUM>, such as the inner member <NUM> and/or the outer member <NUM>, can be indicative of relative axial movement between the inner member <NUM> and the outer member <NUM> along a distance L.

The actuation assemblies <NUM> are releasably coupled to the expansion and locking assemblies <NUM> during valve expansion procedures, such that vibration of a component of each expansion and locking assembly <NUM> can be advanced through a component of the respective actuation assembly <NUM> coupled thereto. For example, since both the inner member <NUM> and the actuator <NUM> coupled thereto are rigid components (e.g., metallic components), vibration of the inner member <NUM> can be axially advanced and cause the actuator <NUM> to vibrate therealong. The sleeve <NUM> covering the actuator <NUM> can also vibrate, either if it is tightly disposed over the actuator <NUM> in a manner that enables vibrations of the actuator <NUM> to vibrate the sleeve <NUM> as well, or due to close contact with the outer member <NUM> as the distal lip <NUM> is pushed against the outer member proximal end portion <NUM>.

According to some examples, a vibration sensor <NUM> can be an accelerometer, or any other type of a biocompatible motion sensor that is biocompatible and configured to detect vibrations generated by components of expansion and locking assemblies <NUM> transmitted to components of actuation assemblies <NUM> coupled thereto. The vibration sensor <NUM>, according to any example disclosed herein, is configured to generate electric signals representative of vibrations sensed thereby. Specifically, the vibration sensor <NUM> is configured to generate signals commensurate with vibrations generated by the corresponding expansion and locking assembly <NUM> (i.e., the expansion and locking assembly that is releasable coupled to the actuation assembly the vibration sensor is attached to) during movement of the pawl <NUM> over each ratcheting tooth <NUM>.

Each vibration sensor <NUM> can be coupled, for example, to a communication line <NUM>, which may take the form of any example of a communication line <NUM> described hereinabove with respect to the various types of sound sensors, and is configured to transmit the electric signals from the respective vibration sensor <NUM>, and/or deliver power thereto. Similarly, the communication line <NUM> attached to a vibration sensor <NUM> on one end thereof, can be coupled to a control unit, as well as to a communication component <NUM>, a power source, and/or a display module <NUM>, according to any of the examples disclosed hereinabove with respect to delivering electric signals from sound sensors <NUM>, mutatis mutandis. The communication line <NUM> is configured to deliver the electric signals to the control unit <NUM>.

Vibration measurement signals acquired by the at least one vibration sensor <NUM>, commensurate with vibrations of the expansion and locking assemblies <NUM> during valve expansion, may provide real-time feedback regarding the valve expansion diameter during an implantation procedure. Such data may be displayed graphically, for example on an LCD screen 113a or LED lights 113b provided on the handle <NUM>.

According to some examples, the delivery apparatus <NUM> includes a plurality of actuation assemblies, and at least one vibration sensor <NUM> attached to at least one of the plurality of actuation assemblies. <FIG> shows an example of a delivery apparatus <NUM> that includes three actuation assemblies 170a, 170b and 170c, coupled to three expansion and locking assemblies 138a, 138b and 138c, and a single vibration sensor <NUM>a attached to one of the expansion and locking assemblies, such as to the outer surface of expansion and locking assembly 138a. According to some examples, vibration sensor <NUM>a is attached to the outer surface of a sleeve <NUM>, as shown in <FIG> or <FIG>.

According to some examples, communication line <NUM>f is attached to the outer surface of a corresponding actuation assembly <NUM>, or wrapped there-around, for example in a helical pattern (not shown), from the vibration sensor <NUM>a to the handle <NUM>, and optionally further extending into the handle <NUM>. According to some examples, the communication line <NUM>f is attached to the outer surface of a sleeve <NUM>.

According to some examples, the delivery apparatus <NUM> includes a plurality of vibration sensors <NUM>, attached to a plurality of actuation assemblies <NUM>. The number of vibration sensors <NUM> can match the number of actuation assemblies <NUM>, which in turn matches the number of expansion and locking assemblies <NUM>. <FIG> shows an example of a delivery apparatus <NUM> that includes three actuation assemblies 170a, 170b and 170c, coupled to three expansion and locking assemblies 138a, 138b and 138c, and three vibration sensors <NUM>aa, <NUM>ab and <NUM>ac attached to the actuation assemblies 170a, 170b and 170c, respectively. Three corresponding communication lines <NUM>fa, <NUM>fb and <NUM>fc can extend proximally from the vibration sensors <NUM>aa, <NUM>ab and <NUM>ac, respectively.

It is to be understood that any reference to "the vibration sensor" or "the at least one vibration sensor" throughout the specification and the claims, refers to each one of the sound sensor in case of configurations that include a plurality of sound sensors.

Reference is now made to <FIG>, showing various configurations of a sound sensor <NUM> or a vibration sensor <NUM> attached to a component of an actuation assembly <NUM>. <FIG> shows an example of a vibration sensor <NUM>a or a sound sensor <NUM>f attached to an external surface of a sleeve <NUM>.

According to some examples, sleeve <NUM>a is tightly disposed around actuator <NUM>, such that vibrations of the actuator <NUM> are transmitted to the sleeve <NUM>a by contact. Thus, the inner surface of the sleeve <NUM>a may in contact with the outer surface of the actuator <NUM>. Nevertheless, the sleeve <NUM> should preferably allow the actuator <NUM> to be movable axially relative thereto, for example during the pulling of the inner member <NUM> thereby for valve expansion, with as little interference as possible therebetween. Thus, the sleeve <NUM>a can be tightly disposed around actuator <NUM> in a manner that a narrow gap is formed therebetween, sufficient to allow free telescoping movement of the actuator <NUM> with respect to the sleeve <NUM>a, yet narrow enough to allow vibrations of the actuator <NUM> to be transmitted to the sleeve <NUM>a.

According to some examples, a lubricious coating may be provided on an outer surface of the actuator <NUM> and/or the inner surface of the sleeve <NUM>. The lubricious coating can include Teflon, parylene, PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof. Suitable materials for a lubricious coating also include other materials desirably having a coefficient of friction of <NUM> or less. Such coating can allow the sleeve <NUM>a to be tightly disposed around actuator <NUM> in a manner that will allow vibrations to be transmitted from the actuator <NUM> to the sleeve <NUM>a, so as to be easily sensed by a corresponding vibration sensor <NUM>a attached to the sleeve <NUM>a, while allowing the actuator <NUM> and the sleeve <NUM>a to be conveniently movable relative to each other along the axial axis.

According to some examples, a vibration sensor <NUM>b, <NUM>c or a sound sensor <NUM>g, <NUM>h is disposed within the lumen defined by the sleeve <NUM>, between the actuator <NUM> and the sleeve <NUM>. Sleeve <NUM>b can have an inner diameter d2, larger than an outer diameter d1 of the actuator <NUM>. According to some examples, the difference between d2 and d1 is at least twice as large as the thickness Ts of the vibration sensor <NUM>b, <NUM>c or the sound sensor <NUM>g, <NUM>h. According to some examples, the vibration sensor <NUM>b, <NUM>c or the sound sensor <NUM>g, <NUM>h is attached to the outer surface of the inner member <NUM>, as shown in <FIG>. Alternatively, the vibration sensor <NUM>b, <NUM>c or the sound sensor <NUM>g, <NUM>h can be attached to the inner surface of the sleeve <NUM>b.

According to some examples, sleeve <NUM>b has a uniform inner diameter d2, as shown in <FIG>. In other examples, sleeve <NUM>c can have a varying inner diameter, such that the difference between the inner diameter of the sleeve <NUM>c and the outer diameter d1 of the actuator <NUM> is at least as great as twice the thickness Ts, at least at the region at which the vibration sensor <NUM>c or sound sensor <NUM>h is positioned, and potentially along most of the length of the actuation assembly <NUM>, and include a tapering neck portion <NUM> distal to vibration sensor <NUM>c or sound sensor <NUM>h, as shown in <FIG>.

The neck portion <NUM> is tapering from diameter d2 toward the actuator <NUM> in the distal direction, resulting in the distal lip <NUM> having a diameter that is narrower than d2, and closer to d1, which may advantageously allow a vibration sensor <NUM>c or sound sensor <NUM>h to be conveniently accommodated between the actuator <NUM> and the sleeve <NUM>c, while the distal lip <NUM> is dimensioned such that it may contact the outer member proximal end portion <NUM> and provide a counter-force there-against during valve expansion, as described hereinabove with respect to <FIG>.

According to some examples, communication line <NUM>g, <NUM>h is disposed within the lumen defined by the sleeve <NUM>, between the actuator <NUM> and the sleeve <NUM>, extending proximally from the vibration sensor <NUM>b, <NUM>c or the sound sensor <NUM>g, <NUM>h to the handle <NUM>, and optionally further extending into the handle <NUM>. Communication line <NUM>g, <NUM>h can be attached to the outer surface of the actuator <NUM>, or wrapped there-around, for example in a helical pattern (not shown). Alternatively, communication line <NUM>g, <NUM>h can be attached to the inner surface of sleeve <NUM>b, <NUM>c.

While illustrated in the examples to be positioned in the vicinity of the prosthetic valve <NUM>, for example along a distal portion of the actuation assembly <NUM>, it is to be understood that in alternative implementations, the vibration sensors <NUM> can be attached to other portions of the actuation assemblies <NUM>. For example, vibration sensors <NUM> can be attached to proximal portions of the actuation assemblies <NUM>, including configurations of vibration sensors <NUM> attached to proximal portions of the actuators <NUM> situated within the handle <NUM>. Such configurations may be feasible is the actuators <NUM> are provided with rigidity that is sufficient to transmit vibrations from the inner members <NUM> coupled thereto all the way to their proximal portions (e.g., within the handle) in a manner that is sufficient to detect vibrations commensurate with the pawls <NUM> sliding over respective ratcheting teeth <NUM>.

Ambient sounds and noise may be present during the implantation and expansion procedure, including heart sounds, lung sounds, blood flow in the vicinity of the prosthetic valve <NUM> and/or the sound sensor <NUM>, movement of various components such as the leaflets <NUM> of the leaflet assembly <NUM> that may move between open and closed states as the valve is expanded enough to allow blood flow therethrough, and the like. According to some examples, the control unit <NUM> is configured to filter ambient sounds and/or noise, so as to detect and isolate click sounds generated by the expansion and locking assemblies <NUM>.

The amplitude, waveform and frequency of click sounds, generated by the interaction of potentially metallic components, such as the pawl <NUM> and the ratcheting teeth <NUM>, may be distinguishable from that of other ambient sounds and/or noise. Moreover, some ambient sounds may be periodically repeating sounds, related to ongoing repetitive physiological function of the tissues generating such sounds, while the click sounds are discretely generated only during valve expansion.

According to some examples, the control unit <NUM> comprises a processor for processing and interpreting measurement signals received from the at least one sound sensor <NUM> and/or the at least one vibration sensor <NUM>. The control unit <NUM> may include software for interpreting and/or displaying data. A wide variety of algorithms can be used to provide warnings, for example to the clinician, associated with sensed signals interpretations. Thus, an operator of the delivery assembly <NUM> according to any of the examples of the current disclosure, can quickly and easily obtain real-time assessment of the expanded diameter of the prosthetic valve <NUM>.

According to some examples, the control unit <NUM> further comprises a memory member (not shown), such as an internal memory within the control unit <NUM>, configured to store the signals received from any of the sound sensor <NUM> and/or the vibration sensor <NUM>, and/or store interpreted data by the processor. A memory member may include a suitable memory chip or storage medium such as, for example, a PROM, EPROM, EEPROM, ROM, flash memory, solid state memory, or the like. A memory member can be integral with the control unit or may be removably coupled to the control unit.

The terms "signals", "electric signals", and "measurement signals", as used herein, are interchangeable.

According to some examples, the measurement signals may be mathematically manipulated or processed by the control unit <NUM>, in order to derive axial foreshortening and/or valve expansion diameter.

According to some examples, the internal control unit <NUM> is configured to transmit, for example via the communication component <NUM>, raw or interpreted data, including stored data, to an external control unit or any other external device, via either wired or wireless communication protocols.

According to some examples, the control unit <NUM> can be configured to receive electric signals detected by the at least one sound sensor <NUM>, and to filter signals that may follow amplitudes, waveforms and/or frequencies that may be associated with ambient sounds and/or noise, leaving only the signals that may follow amplitudes, waveforms and/or frequencies that may be associated with click sounds.

According to some examples, the control unit <NUM> be configured to receive electric signals detected by the at least one sound sensor <NUM>, and to filter signals that are present prior to initiation of valve expansion. According to some examples, the control unit <NUM> may be associated with the actuation mechanism within the handle <NUM> that is configured to pull the actuators <NUM>, such that an expansion initiation signal is generated at the onset of pulling the actuators <NUM>, and is sent to the control unit <NUM>, allowing the control unit to filter signals sensed by the at least one sound sensor <NUM> prior to the onset of pulling the actuators <NUM>.

According to some examples, the control unit <NUM> is further configured to detect and count the number of click sounds. According to some examples, the axial foreshortening of the prosthetic valve <NUM>, defined as the axial approximation of the inflow end <NUM> and the outflow end <NUM> toward each other during valve expansion, can be estimated by multiplying the number of detected clicks by the axial length of a ratcheting tooth L. For example, a count of a total of <NUM> clicks can be indicative of a valve foreshortening by a distance of about <NUM>.

Assuming that the relationship between axial foreshortening and radial expansion is known for the specific valve type, the radial expansion can then be derived from the estimated axial foreshortening. Assuming that the diameter of the prosthetic valve <NUM> at which the pawl <NUM> is engaged with the first ratcheting tooth <NUM> to generate the first click sound is known, this initial diameter can serve as the base value to which the additional expansion diameter is added.

Thus, based on the assumptions of such pore-stored known relationships, the at least one sound sensor <NUM> may be utilized to provide an indication, qualitative or quantitative evaluation, or any other feedback regarding the expanded diameter of prosthetic valve <NUM>, in real-time, in-vivo, during a valve <NUM> implantation and expansion procedures.

Since the click sounds are generated at discrete points, once the pawl <NUM> slides over a tooth <NUM> having a length L, the estimated diameter may have an accuracy in the range of L.

The prosthetic valve <NUM> may include a plurality of expansion and locking assemblies <NUM>, such as three expansion and locking assemblies 138a, 138b and 138c in the illustrated examples. In some cases, the distance by which the inner member <NUM> moves relative to the corresponding outer member <NUM> in each of the expansion and locking assemblies <NUM> may slightly differ from each other, and the click sounds generated by each may not necessarily be synchronized with each other.

According to some examples, the control unit is further configured to differentiate between click sounds of different expansion and locking assemblies based on identification of the time difference between such click sounds. For example, unsynchronized click sounds generated by different expansion and locking assemblies, detected at time intervals that are shorter than a predefined threshold, may be indicative of click sounds of two or more expansion and locking assemblies <NUM> actuated simultaneously, while time intervals that are longer than the predefined threshold may be indicative of the pawl of at least one expansion and locking assembly <NUM> sliding over a subsequent tooth <NUM>.

The maximal difference between non-simultaneously moving inner members <NUM> may be in the range of L or <NUM>, and may thus influence the accuracy of diameter estimation, which can be, for example, in the range of a foreshortening of L or <NUM>, respectively. For example, if the length of a single ratcheting tooth L is about <NUM>. , an extreme situation in which all three expansion and locking assemblies <NUM> move asynchronously and may generate three consecutive click sounds that actually represent a valve foreshortening of no more than a length of single tooth, a foreshortening of <NUM>, i.e., of about <NUM>. , might be assumed instead of an actual foreshortening of L, i.e. of about <NUM>. , resulting in an error range of about <NUM> (i.e., <NUM>. ) between the estimated and actual foreshortening. Thus, the length L of ratcheting teeth <NUM> may influence the accuracy of diameter estimation, based on counting click sounds detected by the at least one sound sensor <NUM>.

The relation between axial foreshortening of the valve and diameter expansion can be a non-linear relation, wherein the diameter of the valve can be increased by a value that is either shorter than, equal to, or larger than the axial foreshortening. The accuracy of estimating valve axial foreshortening may influence the accuracy of estimating the expansion diameter based on such relation. For example, a foreshortening of about <NUM>. in a maximal or near maximal expansion diameter of the valve may be translated to an increase in diameter of about <NUM>. , such that an error range of about <NUM> of the estimated foreshortening may result in an error range of about <NUM> of the estimated expansion diameter. While the accuracy of axial foreshortening may be equal along the range of valve foreshortening values, the accuracy of the expansion diameter derived therefrom may change at different diameters for cases in which the relation between axial foreshortening and radial expansion is non-linear.

The ratcheting tooth length L may be selected to provide sufficient accuracy to the estimated axial foreshortening and the expansion diameter derives therefrom. A smaller tooth length L will increase the accuracy of the estimated values and the resolution of intermediate expansion diameters that may be estimated and presented to a user of the delivery assembly <NUM>.

Utilization of vibration sensors <NUM> may be advantageous over sound sensors <NUM> in that vibration sensors <NUM> can be less influenced by ambient sounds and noise. Nevertheless, some ambient sounds and movement of tissues in the vicinity of the prosthetic valve <NUM>, as well as movement of components of the delivery apparatus <NUM> and/or the prosthetic valve <NUM>, may create background vibrations that may be detected by the vibration sensors <NUM>. According to some examples, the control unit <NUM> is configured to filter background vibrations, so as to detect and isolate vibrations generated by the expansion and locking assemblies <NUM> during movement of the pawl <NUM> over each tooth <NUM>.

The amplitude, waveform and frequency of vibrations generated by the expansion and locking assemblies <NUM> during movement of the pawl <NUM> over each tooth <NUM>, may be distinguishable from that of background vibrations.

According to some examples, the control unit <NUM> can be configured to receive electric signals detected by the at least one vibration sensor <NUM>, and to filter signals that may follow amplitudes, waveforms and/or frequencies that may be associated with background vibrations, leaving only the signals that may follow amplitudes, waveforms and/or frequencies that may be associated with vibrations generated by the expansion and locking assemblies <NUM> during movement of the pawl <NUM> over each tooth <NUM>.

According to some examples, the control unit <NUM> be configured to receive electric signals detected by the at least one vibration sensor <NUM>, and to filter signals that are present prior to initiation of valve expansion. According to some examples, the control unit <NUM> may be associated with the actuation mechanism within the handle <NUM> that is configured to pull the actuators <NUM>, such that an expansion initiation signal is generated at the onset of pulling the actuators <NUM>, and is sent to the control unit <NUM>, allowing the control unit to filter signals sensed by the at least one vibration sensor <NUM> prior to the onset of pulling the actuators <NUM>.

According to some examples, the control unit <NUM> is further configured to detect and count the number of vibrations generated by the expansion and locking assemblies <NUM> during movement of the pawl <NUM> over each tooth <NUM>. The axial foreshortening, the derivation of the valve expanded diameter therefrom, and the accuracy of such estimations, may be similar to those described above with respect to the counted click sounds, mutatis mutandis.

Utilization of vibration sensor <NUM> may be advantageous over that of sound sensors <NUM>, as a plurality of vibration sensors <NUM> can be coupled to a corresponding plurality of actuation assemblies <NUM>, as shown for example in <FIG>, allowing the axial movement of each inner member <NUM> relative to a respective outer member <NUM> of each expansion and locking assembly <NUM> to be measured separately by a corresponding different vibration sensor <NUM>. The signals from the plurality of vibration sensors <NUM> can then be transmitted to the control unit <NUM>, which can in turn mathematically manipulate signals acquired within a predefined time period that may be associated with signals that may originate from different expansion and locking assemblies <NUM> but relate to the same range of frame foreshortening. Such mathematical manipulation can include for example averaging the axial translations of the plurality of expansion and locking assemblies <NUM>, so as to improve the accuracy of the valve expanded diameter derived therefrom.

According to some examples, signals from vibration sensors <NUM> attached to different actuation assemblies <NUM>, each indicative of the axial foreshortening of a separate expansion and locking assembly <NUM>, serve to identify non-uniform expansion of the prosthetic valve <NUM>, and to estimate the extent of such non-uniformity that can be displayed to the operator (e.g., clinician) of the delivery assembly <NUM>. Information regarding non-uniformity of valve expansion, that can include data regarding the extent of foreshortening along different regions of the circumference of the prosthetic valve <NUM>, and potentially the resulting, potentially non-circular circumferential contour of valve expansion, may be of high significance and is not easily detectable by a sound sensor <NUM>, as well as by other conventional (e.g., image based) assessments of the expansion diameter of the valve. Such data can be displayed (e.g., via display module <NUM> relaying display data to a display <NUM>) either as textual data that includes numerical values of the various magnitudes of axial foreshortening and locations thereof across the prosthetic valve, as well as graphical representation of such regions and an estimated shape (e.g., non-circular shape) of the expanded prosthetic valve.

It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable subcombination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

Claim 1:
A delivery assembly (<NUM>), comprising:
a prosthetic valve (<NUM>) comprising:
a frame (<NUM>) movable between a radially compressed configuration and a radially expanded configuration, and
at least one expansion and locking assembly (<NUM>), comprising:
an outer member (<NUM>), coupled to the frame (<NUM>) at a first location, and comprising a spring biased arm (<NUM>) with a pawl (<NUM>); and
an inner member (<NUM>), coupled to the frame (<NUM>) at a second location spaced apart from the first location, the inner member (<NUM>) extending at least partially into the outer member (<NUM>), the inner member (<NUM>) comprising a plurality of ratcheting teeth (<NUM>);
a delivery apparatus (<NUM>) comprising:
a handle (<NUM>);
a delivery shaft (<NUM>) extending distally from the handle (<NUM>); and
at least one actuation assembly (<NUM>), comprising:
an actuator (<NUM>) extending from the handle (<NUM>) through the delivery shaft (<NUM>), and releasably coupled to the corresponding inner member (<NUM>); and
a sleeve (<NUM>) disposed around the corresponding actuator (<NUM>),
at least one vibration sensor (<NUM>) attached to the at least one actuation assembly (<NUM>);
wherein the spring biased arm (<NUM>) is biased toward the inner member (<NUM>);
wherein engagement of the pawl (<NUM>) with the ratcheting teeth (<NUM>) allows movement in a first direction to allow axial foreshortening and radial expansion of the frame (<NUM>) and prevents movement in a second direction to prevent radial compression of the frame (<NUM>); and
wherein the vibration sensor (<NUM>) is configured to generate signals commensurate with vibrations generated by the expansion and locking assembly (<NUM>) during movement of the pawl (<NUM>) over each ratcheting tooth (<NUM>).