Delivery assemblies with balloon diameter measurement devices

Abstract

Delivery assemblies herein are configured to provide a diameter indication of an inflatable balloon. In an example, a delivery apparatus comprises an inflatable balloon mounted on a balloon catheter, and a stent positioned in the balloon cavity. In an example, a delivery apparatus of a delivery assembly comprises an inflatable mounted on a balloon catheter, a wire comprising an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon, and a sensor coupled to the wire proximal end. The axial portion of the wire is configured to axially translate in response to change in diameter of the balloon during transition between deflated and inflated states thereof, and the sensor is configured to measure the axial translation of the wire proximal end.

Description

Docket No.: THVMC-13640W001DELIVERY ASSEMBLIES WITH BALLOON DIAMETER MEASUREMENT DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 725,370, filed November 26, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to apparatuses and methods that can be used in the treatment of heart valve disease, including balloon valvuloplasty and the delivery of prosthetic valves.BACKGROUND

[0003] Heart valve disease is a serious problem that involves the malfunction of one or more valves of the heart. The malfunction can manifest itself in a variety of manners. For example, valve stenosis is the calcification or narrowing of a native heart valve. As a result, the native heart valve is not able to completely open and blood flow through the native valve is impeded or restricted. Another example of heart valve disease is valve insufficiency. Valve insufficiency is the failure of a native heart valve to close properly to prevent leaking, or backflow, of blood through the valve.

[0004] Various methods have been developed to treat heart valve disease. Some of these methods require a balloon member that is expanded within the native heart valve. For example, a balloon member can be used in a valvuloplasty procedure where the balloon member is positioned within the native heart valve and expanded to increase the opening size (i.e., flow area) of the native heart valve and thereby improve blood flow. Another procedure that can be performed is a valve replacement, in which a native heart valve is replaced by an artificial heart valve. The implantation of an artificial heart valve in the heart can also involve the expansion of a balloon member in the valve annulus. For example, the balloon member can be used to increase the size of the native valve prior to implantation of the artificial valve and / or it can be used to expand and deploy the artificial valve itself.Docket No.: THVMC-13640W001SUMMARY

[0005] When implanting a prosthetic valve, such as a balloon expandable valve, it is desirable to expand the valve to a maximum size allowed by the subject’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 overexpansion.

[0006] One potential technique for mitigating the risk of mismatch between a prosthetic valve's expansion diameter and the surrounding tissue, such as the diameter of a native annulus, involves measuring, in real-time, the balloon's or valve's expansion diameter, by a wire looped around the balloon, wherein the proximal end of the wire is coupled to an axial displacement sensor configured to measure axial displacement associated with the change in diameter of the loop portion disposed around the balloon during balloon inflation, for example. However, when the balloon is used to expand a prosthetic valve disposed around the balloon, the loop portion of the wire can be forcibly pressed between the balloon and the prosthetic valve, which can interfere with movement of the loop in response to change in balloon diameter.

[0007] In one of its basic configurations, a delivery apparatus comprises a balloon catheter, an inflatable balloon mounted on the balloon catheter, and a wire. This basic configuration can be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, the balloon comprises a balloon wall defining a balloon cavity that is in fluid communication with the balloon catheter.

[0009] In some examples, the wire can optionally extend along the balloon catheter.

[0010] In some examples, the wire can optionally comprise an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon.

[0011] In some examples, the delivery apparatus can comprise a sensor coupled to the wire proximal end.

[0012] In some examples, the balloon is configured to transition between a deflated state and an inflated state.Docket No.: THVMC-13640W001

[0013] In some examples, the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between the deflated state and the inflated state, causing a proportional axial translation of the wire proximal end.

[0014] In some examples, the sensor is configured to measure the axial translation of the wire proximal end.

[0015] In some examples, the wire is coupled to the balloon wall.

[0016] In some examples, the wire comprises a loop continuously extending from the axial portion.

[0017] In some examples, the loop is disposed between an inner layer and an outer layer of the balloon wall.

[0018] In some examples, the wire comprises at least one radial portion extending continuously from the axial portion towards the balloon wall.

[0019] In some examples, the at least one radial portion is attached, at a wire distal end thereof, to the balloon wall.

[0020] In some examples, the at least one radial portion comprises two radial portions.

[0021] In some examples, the two radial portions extend towards diametrically opposing sides of the balloon wall.

[0022] In some examples, each of the two radial portions is attached, at a wire distal end thereof, to the balloon wall.

[0023] In some examples, the wire comprises a circumferentially extending portion coupled to, and extending along, the balloon wall, wherein the circumferentially extending portion continuously extends between the two radial portions.

[0024] In some examples, the wire comprises two circumferentially extending portions, coupled to, and extending along, the balloon wall, wherein each of the two circumferentially extending portions continuously extends a corresponding one of the two radial portions.

[0025] In some examples, the wire comprises a crossing portion continuously extending between the two circumferentially extending portions, wherein the crossing portion diametrically extends across the balloon cavity.

[0026] In some examples, the wire comprises at least one proximal angled portion diagonally extending distally and radially away from a central longitudinal axis of the delivery apparatus.

[0027] In some examples, the wire comprises a distal angled portion continuously extending from the at least one proximal angled portion at a distal and radially inwards oriented direction.Docket No.: THVMC-13640W001

[0028] In some examples, the delivery apparatus comprises a stent disposed inside the balloon cavity and configured to self-expand against and track the balloon wall during transition of the balloon between the deflated state and the inflated state.

[0029] In some examples, the wire is coupled to the stent.

[0030] In some examples, the wire comprises a loop circumscribing the stent.

[0031] In some examples, the wire is attached, at a wire distal end thereof, to the stent.

[0032] In some examples, the wire distal end is affixed to a proximal end portion of the stent.

[0033] In one of its basic configurations, a delivery apparatus comprising a balloon catheter, an inflatable balloon mounted on the balloon catheter, and a stent disposed inside the balloon. This basic configuration can be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0034] In some examples, the balloon catheter comprises a balloon catheter wall defining a balloon catheter lumen.

[0035] In some examples, the balloon comprises a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen.

[0036] In some examples, the balloon is configured to transition between a deflated state and an inflated state.

[0037] In some examples, the stent extends between a proximal end portion and a distal end portion, and is disposed inside the balloon cavity, wherein the stent is configured to self-expand against the balloon wall.

[0038] In some examples, the stent is configured to expand against and track the balloon wall during transition of the balloon between the deflated state and the inflated state.

[0039] In some examples, the stent has an outward radial force that is lower than a force required to transition the balloon from the deflated state to the inflated state.

[0040] In some examples, the outward radial force of the stent is between 0.1N to 5N.

[0041] In some examples, the stent is coupled to an inner shaft axially extending therethrough.

[0042] In some examples, the distal end portion of the stent is affixed to the inner shaft.

[0043] In some examples, the balloon comprises a balloon proximal section attached to the balloon catheter, a balloon intermediate section extending distally from the balloon proximal section, and a balloon distal section extending distally from the balloon intermediate section.Docket No.: THVMC-13640W001

[0044] In some examples, the stent comprises a stent intermediate section which is axially aligned with the balloon intermediate section both in the deflated state and in the inflated state of the balloon.

[0045] In some examples, the delivery apparatus comprises a wire coupled to the stent and comprising an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the stent and a sensor coupled to the wire proximal end.

[0046] In some examples, the axial portion of the wire is configured to axially translate in response to change in diameter of the stent during transition of the balloon between the deflated and inflated state, causing a proportional axial translation of the wire proximal end.

[0047] In some examples, the sensor is configured to measure the axial translation of the wire proximal end.

[0048] In some examples, the wire comprises a loop disposed around the stent.

[0049] In some examples, the wire is attached at a wire distal end thereof, to the stent.

[0050] In some examples, the wire distal end is attached to the proximal end portion of the stent.

[0051] In some examples, the delivery apparatus comprises a biasing member configured to apply an axially oriented pull-force on the axial portion of the wire.

[0052] In some examples, the delivery apparatus comprises a linear displacement sensor disposed inside the balloon and configured to measure axial translation of either the distal end portion or the proximal end portion of the stent.

[0053] In some examples, the linear displacement sensor comprises an axially movable component which is coupled, directly or indirectly, to the proximal end portion of the stent.

[0054] In some examples, the inner shaft comprises at least one reference radiopaque marker, wherein at least one of the proximal end portion or the distal end portion of the stent comprises an indicator radiopaque marker.

[0055] In some examples, the axial position of the indicator radiopaque marker, relative to the at least one reference radiopaque marker, is indicative of a diameter of the stent.

[0056] In some examples, the at least one reference radiopaque marker comprises a plurality of reference radiopaque markers, wherein each reference radiopaque marker is associated with a different diameter of the stent.

[0057] In some examples, alignment of the indicator radiopaque marker with any one of the reference radiopaque markers is indicative of the diameter associated with the respective reference radiopaque marker.Docket No.: THVMC-13640W001

[0058] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0059] 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 Figures:

[0060] Fig. 1 A is a perspective view of an example prosthetic valve.

[0061] Fig. IB is a perspective view of a frame of the prosthetic valve of Fig. 1 A.

[0062] Fig. 2 shows an example delivery assembly comprising a delivery apparatus carrying a prosthetic valve.

[0063] Fig. 3A shows an example delivery apparatus comprising a wire loop extending between layers of a double-walled balloon.

[0064] Fig. 3B shows a distal portion of an example delivery apparatus comprising a wire loop extending between layers of a double-walled balloon.

[0065] Fig. 4 shows a distal portion of an example delivery apparatus comprising a wire extending through a balloon catheter channel.

[0066] Fig. 5 shows a proximal portion of an example delivery apparatus comprising a sensor residing inside the handle.

[0067] Fig. 6 shows a proximal portion of an example delivery apparatus comprising a sensor residing inside a sensor housing extending from a branch of the balloon catheter.

[0068] Fig. 7 shows a proximal portion of an example delivery apparatus comprising a sensor residing inside a balloon catheter hub.

[0069] Figs. 8 A and 8B show an example self-expandable stent in compressed and expanded configurations of the stent, respectively.Docket No.: THVMC-13640W001

[0070] Figs. 9 A and 9B show a distal portion of an example delivery apparatus comprising a wire loop circumscribing a stent disposed inside a balloon, in deflated and inflated states of the balloon, respectively.

[0071] Figs. 10A and 10B show a distal portion of an example delivery apparatus comprising a wire loop extending through a sleeve attached to a stent disposed inside a balloon, in deflated and inflated states of the balloon, respectively.

[0072] Figs. 11 A and 1 IB show a distal portion of an example delivery apparatus comprising a wire attached to a slidable end portion of a stent disposed inside a balloon, in deflated and inflated states of the balloon, respectively.

[0073] Fig. 12 shows a distal portion of an example delivery apparatus comprising a linear displacement sensor attached to a slidable end portion of a stent disposed inside a balloon.

[0074] Fig. 13 shows a distal portion of an example delivery apparatus comprising a stent disposed inside a balloon, having an indicator radiopaque marker over a slidable end portion of the stent, movable relative to one or more reference radiopaque markers.

[0075] Fig. 14 shows a distal portion of an example delivery apparatus comprising two radial wire portions extending from two openings of a single wire shaft.

[0076] Figs. 15A and 15B are cross-sectional view taken along line 15-15 of Fig. 14, in deflated and inflated states of the balloon, respectively.

[0077] Fig. 16A shows the wire shaft of Fig. 14 with both radial portions extending from shaft openings thereof.

[0078] Fig. 16B shows an exemplary arrangement of two separate wire shafts and corresponding radial wire portions extending therefrom.

[0079] Fig. 17 shows a distal portion of an example delivery apparatus comprising two radial wire portions extending from two openings of a nosecone shaft.

[0080] Fig. 18A shows an example of a wire shaft defining a primary lumen and a single wire passage lumen.

[0081] Fig. 18B shows an exemplary arrangement of a single wire shaft radially offset from the nosecone shaft.

[0082] Figs. 19A and 19B are perspective and cross-sectional side views, respectively, of a distal portion of an example delivery apparatus equipped with a wire that defines a circumferentially extending portion between two radial portions.

[0083] Fig. 20 shows a distal portion of an example delivery apparatus comprising proximal and distal angled wire portions.Docket No.: THVMC-13640W001

[0084] Fig. 21 A shows an example balloon catheter hub equipped with a sensor fluidly sealed from a flow path of the inflation fluid.

[0085] Fig. 21B is a cross-sectional view along line 21B-21B of Fig. 21A.

[0086] Fig. 22A is a perspective view of a distal portion of an example delivery apparatus equipped with a wire that defines two circumferentially extending portions and a crossing portion diametrically extending therebetween.

[0087] Fig. 22B shows an isolated view of a distal portion of the wire of Fig. 22A.DETAILED DESCRIPTION

[0088] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only examples and should not be taken as limiting the scope of the disclosed technology.

[0089] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0090] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.Docket No.: THVMC-13640W001

[0091] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or". It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0092] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0093] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0094] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (for example, the end that is inserted into a subject’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to orDocket No.: THVMC-13640W001 oriented towards the distal end of the delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0095] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. Tn particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.

[0096] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0097] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.

[0098] As used herein, terms such as "first", "second", and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0099] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property that differs from the listed value and / or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0100] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a", "b", "c", etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood thatDocket No.: THVMC-13640W001 components sharing like names and / or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0101] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more embodiments or one or more implementations.

[0102] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0103] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0104] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a subject (e.g., living subject (e.g., human, other animal) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person)). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0105] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide) toDocket No.: THVMC-13640W001 ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide).

[0106] 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 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.

[0107] Figs. 1A and IB show perspective views of an exemplary prosthetic valve 100 with and without soft components attached thereto, respectively. Fig. 2 shows a perspective view of an exemplary delivery assembly 200. The delivery assembly 200 can include the prosthetic valve 100 and a delivery apparatus 202. The prosthetic valve 100 can be positioned on and / or releasably coupled to the delivery apparatus 202.

[0108] The term "prosthetic valve", as used herein, refers to any type of an expandable (e.g., balloon expandable) prosthetic valve deliverable to a subject'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 100 can be crimped or retained by a delivery apparatus 202 in a compressed state during delivery, and then expanded to the expanded state once the prosthetic valve 100 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 a radially compressed or crimped state, and a maximum expanded state.

[0109] A prosthetic valve 100 of the current disclosure may include any balloon-expandable 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 200 described in the cunent disclosure, includes a delivery apparatus 202 and a balloon expandable prosthetic device, such as prosthetic valve 100, it should be understood that the delivery apparatus 202 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, and that delivery apparatus 202 can be used to deliver an inflatable balloon 234 that does notDocket No.: THVMC-13640W001 necessarily carry an expandable prosthetic device, for example for medical procedures that can include valvuloplasty, pre-ballooning and post-ballooning.

[0110] A catheter deliverable prosthetic valve 100 can be delivered to the site of implantation via the delivery assembly carrying the valve 100 in a radially compressed or crimped state, toward the target site, to be mounted against the native anatomy, by expanding the prosthetic valve 100. Balloon expandable valves 100 generally involve a procedure of inflating a balloon 234 within a prosthetic valve 100, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is sufficiently expanded, the balloon 234 is deflated and retrieved along with the delivery apparatus 202. The delivery assembly 200 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.

[0111] Figs. 1 A-1B show an example of a balloon expandable prosthetic valve 100, illustrated in an expanded state. The prosthetic valve 100 can comprise an outflow end 102, an inflow end 104, and a central longitudinal axis Ca extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the outflow end 102 is the proximal end of the prosthetic valve 100, and the inflow end 104 is the distal end of the prosthetic valve 100. Nevertheless, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the prosthetic valve, and the inflow end can be the proximal end of the prosthetic valve.

[0112] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.

[0113] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.

[0114] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0115] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "distal to" and "proximal to", respectively. Thus, for example, a lowermost component can refer to a distal-most component, and an uppermost component can similarly refer to a proximal-most component.

[0116] The prosthetic valve 100 comprises an annular frame 106 movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly 120 mounted within the frame 106. The frame 106 can be made of various suitable materials,Docket No.: THVMC-13640W001 including plastically-deformable materials such as, but not limited to, stainless steel, a nickel- based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 106 can be crimped to a radially compressed state on a balloon catheter 210, and then expanded inside a subject by an inflatable balloon 234.

[0117] In the example illustrated in Figs. 1A-1B, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 112. In the current disclosure, the term "stmt" encompasses axial struts, angled stmts, laterally extendable stmts, commissure windows, commissure support stmts, support posts, and any similar stmctures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A stmt 112 may be any elongated member or portion of the frame 106. The frame 106 can include a plurality of stmt mngs that can collectively define one or more rows of cells 132. The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0118] The end portions of the stmts 112 are forming apices 116 at the outflow end 102 and apices 118 at the inflow end 104. The stmts 112 can intersect at additional junctions 114 formed between the outflow apices 116 and the inflow apices 118. The junctions 114 can be equally or unequally spaced apart from each other, and / or from the apices 116, 118, between the outflow end 102 and the inflow end 104.

[0119] At least some of the stmts 112 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 106 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 the like.

[0120] A leaflet assembly 120 of the prosthetic valve 100 can include a plurality of leaflets 122 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 102. While three leaflets 122 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1 A, it will be clear that a prosthetic valve 100 can include any other number of leaflets 122.

[0121] The inflow or cusp edges (concealed from view in Fig. 1A) of the leaflets 122 can be secured to the frame 106 directly or indirectly, such as by being sutured directly to the frame,Docket No.: THVMC-13640W001 being sutured to an inner skirt, and / or via one or more connecting skirts. The cusp portions of the leaflets 122 can collectively define a scalloped line of attachment. Further examples and methods of attaching skirts and seal members to a frame, as well as method and techniques for coupling leaflets 122 to the frame 106, with or without connecting skirts, are disclosed in US Pat. No. 11,096,781, which is incorporated herein by reference.

[0122] Adjacent leaflets 122 can be arranged together to form commissures 130 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing an upper portion (e.g., above the scalloped line) of the leaflet assembly 120 to the frame 106. In some examples, each leaflet 122 can comprise opposing tabs 126. Each tab 126 can be secured to an adjacent tab 126 of an adjacent leaflet 122 to form a commissure 130 that is secured to the frame 106. The tabs 126 can be folded in various manners, for example to form radially extending layers and circumferentially extending layers facing the frame. Radially extending layers can extend radially inward from a location on the frame 106 to free edges 128, also termed coaptation edges, of the leaflets.

[0123] During valve cycling, the leaflets 122 can articulate at the inner most edges of the tab layers, which helps space the leaflets away from the frame 106 during normal operation of the prosthetic valve. This is advantageous in cases where the prosthetic valve 100 is not fully expanded to its nominal size when implanted in a subject. As such, the prosthetic valve 100 can be implanted in a wider range of subject annulus sizes. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 122 can be coupled to the frame 106 of the prosthetic valve 100, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, all of which are incorporated herein by reference in their entireties.

[0124] In some examples, the prosthetic valve 100 can comprise at least one skirt or sealing member. In some examples, an inner skirt 140 can be secured to the inner surface of the frame 106, configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. An inner skirt 140 can function as an anchoring region for the leaflets 122 to the frame 106, and / or function to protect the leaflets 122 against damage which may be caused by contact with the frame 106, for example during valve crimping or during working cycles of the prosthetic valve 100. In some examples, the prosthetic valve 100 can comprise an outer skirt 170 mounted on the outer surface of the frame 106, configured to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100.Docket No.: THVMC-13640W001

[0125] Any of the inner skirt 140 and / or outer skirt 170 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). In some examples, the inner skirt 140 can be formed of a single sheet of material that extends continuously around the inner surface of frame 106. In some examples, the outer skirt 170 can be formed of a single sheet of material that extends continuously around the outer surface of frame 106.

[0126] Fig. 2 illustrates a delivery assembly 200 that includes a delivery apparatus 202, optionally adapted to deliver a prosthetic device, which can be the prosthetic valve 100 described above with respect to Figs. 1A-1B, or any other suitable prosthetic device. The delivery apparatus 202 includes a handle 204 and a balloon catheter 210 having an inflatable balloon 234 mounted on its distal end. A balloon expandable prosthetic device, such as balloon expandable prosthetic valve 100, can be carried in a crimped state over the balloon catheter 210.

[0127] In some examples, a delivery apparatus 202 further comprises an outer delivery shaft 208. Optionally, an outer delivery shaft 208 of a delivery apparatus 202 can concentrically extend over at least a portion of the balloon catheter 210.

[0128] The outer delivery shaft 208 and the balloon catheter 210 can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer delivery shaft 208 relative to the balloon catheter 210, or a distally oriented movement of the balloon catheter 210 relative to the outer delivery shaft 208, can expose the prosthetic valve 100 from the outer delivery shaft 208.

[0129] A delivery apparatus 202 can further include a nosecone 224 to facilitate advancement of the delivery apparatus 202 through the subject's vasculature to the site of treatment. A nosecone shaft 218 (shown, for example, in Figs. 3A-3B) can extend proximally from the nosecone 224 through a lumen 212 of the balloon catheter 210. The nosecone 224 can be conical or frustoconical in shape, and can include a nosecone tapering outer surface 230 terminating at a nosecone distal end 226, and a nosecone proximal end portion 228 that can be coupled to the nosecone shaft 218 extending proximally therefrom. Attachment of the nosecone shaft 218 to the nosecone proximal end portion 228 can be achieved by a variety of methods, such as overmolding, radio-frequency welding, through an adhesive, and / or a combination thereof. In some examples (not illustrated), the nosecone shaft 218 can extend through the entire length of the nosecone 224, such that a distal end of the nosecone shaft 218 is aligned with the nosecone distal end 226. In some examples (not illustrated), the nosecone shaft 218 isDocket No.: THVMC-13640W001 coupled to one or more components, such as collars or other connectors, which are in turn attached to the nosecone 224.

[0130] In Fig. 2, a prosthetic valve 100 is mounted on the balloon 234 and is shown in a crimped state, providing prosthetic valve 100 with a reduced diameter for delivery to the heart via the subject’s vasculature. As mentioned above, it should be understood that balloon 234 can be configured for delivery to a treatment location without a prosthetic device (such as a prosthetic valve 100) mounted thereon, either for off-balloon delivery of the prosthetic device to a treatment location or for use of the balloon in a valvuloplasty procedure.

[0131] Although the example illustrated in Fig. 2 shows a prosthetic device (e.g., prosthetic valve 100) as being crimped or mounted on the balloon 234 for delivery to the treatment location, it should be understood that the prosthetic device can be crimped or mounted at a location different from the location of balloon 234 (e.g., proximal to the balloon 234) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic device. This off-balloon delivery allows the prosthetic device to be crimped to a lower profile than would be possible if the prosthetic device was crimped on top of the balloon 234. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic device) through a subject’s vasculature to the treatment location. The lower profile of the crimped prosthetic device can be particularly helpful when navigating through portions of the subject’s vasculature which are particularly narrow, such as the iliac artery.

[0132] The proximal ends of the balloon catheter 210, the outer delivery shaft 208, and / or the nosecone shaft 218, can be coupled to the handle 204. During delivery, the handle 204 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 202, such as the nosecone shaft 218, the outer delivery shaft 208, and / or the balloon catheter 210, through the subject’s vasculature and / or along the target site of implantation, as well as to inflate the balloon 234 mounted on the balloon catheter 210, for example to expand a prosthetic valve 100 mounted on the balloon 234, and to deflate the balloon 234 and retract the delivery apparatus 202, for example once the prosthetic valve 100 is mounted in the implantation site.

[0133] The handle 204 can include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 202. In the illustrated example, the handle 204 includes an adjustment member, such as the illustrated rotatable knob 206a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle 204 through the outer delivery shaft 208 and has a distal endDocket No.: THVMC-13640W001 portion affixed to the outer delivery shaft 208 at or near the distal end of the outer delivery shaft 208. Rotating the knob 206a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 202. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.

[0134] In some examples, the handle 204 can include an adjustment member such as the illustrated rotatable knob 206b, configured to adjust the axial position of the balloon catheter 210 relative to the outer delivery shaft 208, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 202. Further details on the delivery apparatus 202 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0135] A prosthetic valve 100 can be carried by the delivery apparatus 202 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures).

[0136] The balloon 234 can be secured to balloon catheter 210 at the balloon’s proximal end, and to either the balloon catheter 210, the nosecone shaft 218, or the nosecone 224, at its distal end. In some examples, the balloon 234 is secured to a distal end portion of the balloon catheter 210 at its proximal end, while the balloon’s distal end can be coupled, directly or indirectly, to another component of the delivery apparatus 202, such as the nosecone 224 or nosecone shaft 218.

[0137] In the examples illustrated in Figs. 3A-3B, the balloon 234 is shown to be coupled to the nosecone proximal end portion 228. The nosecone proximal end portion 228 can optionally include an outer step configured to accommodate the distal end of the balloon 234, such that the outer surface of the balloon 234 can be flush or otherwise relatively continuous with the outer surface of the nosecone 224. Similarly, in some examples, the distal end portion of the balloon catheter 210 can include an outer step configured to accommodate the proximal end of the balloon 234, such that the outer surface of the balloon 234 can be flush or otherwise relatively continuous with the outer surface of the balloon catheter 210.

[0138] In some examples, such as when the balloon 234 is attached at both ends thereof to the nosecone 224 and balloon catheter 210, both the nosecone 224 with nosecone shaft 218 and the balloon catheter 210 can be configured to move simultaneously in the axial direction, without necessarily being axially movable relative to each other, or while axial movement of one relative to the other is limited. In such examples, the delivery apparatus 202 can beDocket No.: THVMC-13640W001 designed such that axial movement of the balloon catheter 210 causes the nosecone shaft 218 to move therewith, or such that axial movement of the nosecone shaft 218 causes the balloon catheter 210 to move therewith.

[0139] Balloon 234 is configured to transition between a deflated state, shown for example in Fig. 2, and an inflated state, shown for example in Figs. 3A-3B. When reaching the site of implantation, the deflated balloon 234, carrying crimped prosthetic valve 100 thereover, can be advanced to the target site to expand the prosthetic valve. Once the prosthetic valve 100 is expanded to its functional diameter within a native annulus or within a previously implanted prosthetic valve, the balloon 234 can be deflated, and the delivery apparatus 202 can be retrieved from the subject’s body.

[0140] Balloon 234 comprises a balloon proximal section 240, a balloon distal section 244, and a balloon intermediate section 242 extending therebetween. The balloon proximal section 240 extends from a proximal end of the balloon 234, at which it can be attached to the balloon catheter 210, to the balloon intermediate section 242, and can include a portion configured to assume a proximally -tapering configuration in the inflated state of the balloon 234. The balloon distal section 244 extends from the balloon intermediate section 242 to a distal end of the balloon 234, at which it can be attached to the nosecone 224 (or any other distal component of the delivery apparatus 202), and can include a portion configured to assume a distally-tapering configuration in the inflated state of the balloon 234. When a prosthetic valve 100 is mounted on balloon 234, it may be disposed around the balloon intermediate section 242, while the balloon proximal section 240 and balloon distal section 244 can remain uncovered by prosthetic valve 100. When a balloon is inflated without having a prosthetic valve 100 disposed therearound, such as during valvuloplasty procedures, the balloon intermediate section 242 can be defined as a section of the balloon 234 configured to expand to a diameter sufficient to contact the surrounding native anatomy (e.g., native annulus or a blood vessel wall).

[0141] As shown, for example, in Figs. 3A-3B, the balloon catheter 210 can define a balloon catheter lumen 212 through which a guidewire 80 (shown, for example, in Figs. 5-7) and / or one or more additional shafts of the delivery apparatus 202 can extend. The balloon catheter 210 can extend through the handle 204 and be fluidly connectable to a fluid source for inflating the balloon 234.

[0142] In some examples, as further shown in Fig. 2, the balloon catheter 210 can distally extend from a balloon catheter hub 270 which can be disposed proximally to the handle 204. The balloon catheter hub 270 can include a first port 272a configured to receive a guidewire 80 therethrough and a second port 272b configured to receive fluid from a fluid sourceDocket No.: THVMC-13640W001 comprising inflation fluid. The term "inflation fluid", as used herein, means a fluid (e.g., saline, though other liquids or gas can be used) used for inflating the balloon 234. The inflation fluid source (not shown) is in fluid communication with the balloon catheter lumen 212 via second port 272b, such that fluid from the fluid source can flow through the balloon catheter lumen 212 into balloon 234 to inflate it.

[0143] As further shown, for example, in Figs. 3A-3B, the nosecone shaft 218 and the nosecone 224 collectively define a guidewire passage lumen 232 extending along the length of the nosecone shaft 218 and nosecone 224, and continuous with the first port 272a, through which the guidewire 80 can pass, such that the delivery apparatus 202 can be advanced toward the treatment region over the guidewire 80. The outer diameter of the nosecone shaft 218 can be sized such that an annular space is formed within balloon catheter lumen 212 between balloon catheter wall 216 and the nosecone shaft outer surface 220 along the length of balloon catheter 210. This annular space can be in fluid communication with one or more inflation openings 214 exposed to an internal cavity 238 of the balloon 234, which can be in fluid communication with a fluid source (e.g., a syringe or a pump) that can inject an inflation fluid (e.g., saline) into balloon cavity 238. In this way, inflation fluid from the fluid source can flow through the balloon catheter lumen 212 into balloon cavity 238 via inflation opening(s) 214 to inflate the balloon 234, and optionally expand and deploy a prosthetic valve 100 when such a device is disposed thereon.

[0144] For example, the pressure of the fluid within balloon 234 may provide the force that allows the intermediate section 242 of balloon 234 to dilate the prosthetic valve 100 and / or surrounding anatomy. Further, the balloon catheter lumen 212 may be configured to withdraw fluid from the balloon cavity 238 through the opening(s) 214 to deflate the balloon 234. Thus, the balloon catheter lumen 212 may be utilized to inflate the balloon 234 to transition the balloon 234 to the inflated or deployed state, and may be utilized to deflate the balloon 234 to transition the balloon 234 to the deflated or undeployed state.

[0145] Nosecone shaft 218, balloon catheter 210, and optional outer delivery shaft 208, can be formed from, and / or include, any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®). In some examples, balloon catheter 210 and / or optional outer delivery shaft 208 have longitudinal sections formed from, or including, different materials, in order to vary the flexibility of the shafts along their lengths. In some examples, nosecone shaft 218 has an inner liner or layer formed of Teflon®, polytetrafluoroethylene (PTFE), etc. to minimize sliding friction with a guidewire 80. Balloon 234 includes a balloon wall 236 surrounding and defining the balloon cavity 238, which mayDocket No.: THVMC-13640W001 be made of one polymer, or use several layers or a mix of different polymers. Polymers such as Nylon, PEBAX, PET, parylene and / or polyurethane may be used to make the balloon wall 236.

[0146] In some examples, any delivery assembly of the current disclosure can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the delivery assembly can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0147] When inflating a balloon in valvuloplasty procedure, it is desirable to avoid applying excessive force to calcifications present in the artery and / or annulus. Additionally, when implanting a prosthetic device, such as balloon expandable prosthetic valve 100, it is desirable to expand the valve to a maximum size allowed by the subject’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 overexpansion.

[0148] An exemplary delivery apparatus 202 can include, in some examples, at least one sensor 260 (indicated, for example, in Figs. 3A and 5-7) configured to measure a distance that can be indicative, in some examples, of a radius or diameter of the balloon 234. The diameter of the balloon can be further indicative of an expansion diameter of a prosthetic valve 100 disposed around the balloon, and / or a lumen of a native anatomical structure in a subject's body against which the balloon can be inflated.

[0149] In some examples, the delivery apparatus 202 comprises a sensor data unit 254 (indicated, for example, in Figs. 3A and 6-7). The sensor data unit 254 can include, in some examples, 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. In some examples, sensor data unit 254 comprises electrical circuitry.

[0150] In some examples, the sensor 260 is in communication with the sensor data unit 254. In some examples, the sensor 260 is in communication with the sensor data unit 254 via one orDocket No.: THVMC-13640W001 more optional communication lines (not shown). In some examples, the sensor 260 is in wireless communication with the sensor data unit 254.

[0151] In some examples, the sensor 260 is operated by the sensor data unit 254 such that the sensing of sensor 260 is performed in cooperation with the sensor data unit 254. In some examples, the sensor 260 comprises dedicated circuitry for operation and the sensor data unit 254 receives the measured data from the sensor 260.

[0152] In some examples, the delivery apparatus 202 comprises one or more visual or auditory informative elements configured to provide visual or auditory information and / or feedback to a user or operator of delivery apparatus 202, such as a display 256 (indicated, for example, in Figs. 3A and 6-7), LED lights 257, speakers (not shown), etc. and / or a combination thereof. It is to be understood that a sensor data unit 254 and an information element such as a display 256 are schematically shown in Fig. 3A to be comprised in the handle 204 and in Fig. 5 to be comprises in a separate console for illustrative purpose, and that other components of the delivery apparatus 202, such as the balloon catheter hub 270 or a sensor housing 217 (indicated, for example, in Fig. 5), can include an information element such as a display 256 and / or the sensor data unit 254.

[0153] In some examples, responsive to an output of the sensor 260, a diameter indication (e.g., of the balloon 234) is determined and an indication of the determined diameter indication is generated and presented to a user, for example, via the display 256. In some examples, the sensor data unit 254 determines the diameter indication based on output(s) of the sensor 260. The term "diameter indication", as used herein, means a predetermined indication of a diameter. As mentioned above, the diameter indication can comprise the diameter of the balloon 234 and / or of the prosthetic valve 100 (derived, for example, from the balloon's diameter indication). In some examples, the diameter indication is determined based at least in part on a predetermined function of the diameter. In some examples, the diameter indication comprises the amount of a change in the diameter. For example, sensor data unit 254 can determine the rate of change in the diameter of the balloon 234 and / or of the prosthetic valve 100, and / or the amount the diameter has changed between two or more measurements.

[0154] In some examples, upon detection that the diameter is no longer increasing (for example, when the balloon wall 236 and / or a prosthetic valve 100 disposed therearound is pushing against the walls of an anatomical wall at the site of treatment), sensor data unit 254 can output a signal indicating that the diameter is no longer increasing. In such a case, it may be desired to cease the injection of inflation fluid into the balloon 234, so as to reduce risk of damaging the surrounding tissue due to increased pressure applied by the balloon 234 and / orDocket No.: THVMC-13640W001 prosthetic valve 100 thereto. In some examples, sensor data unit 254 is further configured to control a flow controller (not shown) to prevent the flow of any more inflation fluid into the balloon 234 (e.g., based on sensor data and / or an indication that the diameter is no longer increasing).

[0155] In some examples, sensor data unit 254 outputs the determined diameter indication to a user display 256 that can be part of a component of the apparatus 202, such as the handle 204, balloon catheter hub 270, or sensor housing 217. In some examples, sensor data unit 254 outputs the determined diameter indication to an external display or system (an example of which is shown in Fig. 6). In some examples, responsive to the determined diameter indication, sensor data unit 254 outputs an indication of the maximum diameter allowed for expansion within the site of treatment. For example, balloon 234 can be used to determine the size of an anatomical lumen inside a subject, such as the size of the annulus, for purposes of determining the target expansion diameter of a prosthetic valve 100. In some examples, sensor data unit 254 can measure the diameter of a lumen inside the subject, for example during inflation of the balloon 234, thereby identifying the appropriate expansion diameter for a prosthetic valve 100.

[0156] During various medical procedures, such as pre-ballooning, post-ballooning, and / or prosthetic valve implantation, it may be desired to measure expansion diameter within a corresponding native annulus in which the balloon is inflated. One potential technique for measuring, in real-time, the balloon's or valve's expansion diameter, involves a wire looped around the balloon, wherein the proximal end of the wire is coupled to an axial displacement sensor configured to measure axial displacement associated with the change in diameter of the loop portion disposed around the balloon during balloon inflation, for example. However, when the balloon is used to expand a prosthetic valve disposed around the balloon, the loop portion of the wire can be forcibly pressed between the balloon and the prosthetic valve, which can interfere with movement of the loop in response to change in balloon diameter.

[0157] Disclosed herein are delivery assemblies 200 and delivery apparatuses 202 thereof, comprising devices or mechanisms by which a diameter of an inflatable balloon 234 can be estimated in real-time. In some examples, delivery assemblies and delivery apparatuses disclosed herein comprise devices or mechanisms by which a diameter of an inflatable balloon (and / or of a valve, and / or native annulus, etc.) can be estimated in real time, wherein no part of a measurement device or mechanism is disposed over an outer surface of the balloon 234. Some exemplary delivery apparatuses 202 disclosed herein can optionally include a displacement sensor 260. The term "sensor 260" includes "displacement sensor 260" and / or any other sensor(s) configured to measure, obtain and / or provide sensor data relating to aDocket No.: THVMC-13640W001 diameter of a valve, balloon, surrounding area. etc. In some examples, the displacement sensor 260 can optionally be a linear displacement sensor, configured to measure axial displacement of a component of the apparatus, which is axially movable in response to change in diameter of the balloon 234.

[0158] In some examples, the sensor 260 comprises a linear displacement sensor. In some examples, the linear displacement sensor 260 can be optionally implemented as a linear variable differential transformer (LVDT) sensor, comprising a transformer core 264 within a tube 262, as illustrated in Fig. 3A. In other implementations, sensor 260 can include one or more linear potentiometers. An LVDT sensor can generally have coils (not shown) placed end to end around tube 262 in which transformer core 264, which can be a cylindrical ferromagnetic core, is disposed.

[0159] Fig. 3A schematically shows an exemplary delivery apparatus 202 that includes a wire 280 coupled to the sensor 260. The wire 280 can comprise a loop 285 extending along at least part of a circumference of the balloon wall 236, and an axial portion 284 extending proximally from the loop 285, such as along the balloon catheter 210, wherein the wire 280 can be connected at a proximal end 281 thereof to the sensor 260. The loop 285 can be coupled to the balloon wall 236 such that increase in balloon diameter during inflation and expansion of the balloon 234 will cause enlargement of the loop 285. Increase in loop 285 perimeter will draw a greater portion of the wire 280 from the axial portion 284, causing the axial portion 284 and its proximal end 281 to translate in the distal direction.

[0160] In some examples, such as when the sensor is a linear displacement sensor 260 that can be optionally implemented as an LVDT sensor, the proximal end 281 of wire 280 can be coupled to transformer core 264, such that when the axial portion 284 of wire 280 moves in the proximal or distal direction, the transformer core 264 moves relative to the tube 262 creating voltage differential between the coils, which can be converted by sensor 260 into relative displacement, corresponding to the movement of the wire 280 and change in loop 285 perimeter. Sensor data unit 254 can measure the voltage at the output of linear displacement sensor 260 and responsive thereto determine a diameter indication of balloon 234, optionally the diameter indication being the diameter thereof.

[0161] Although the coupling of the wire proximal end 281 to transformer core 264 is illustrated as being a direct connection, this is not meant to be limiting in any way. In some examples, a cable (not shown) can extend from transformer core 264, and the wire proximal end 281 can be coupled to the cable.Docket No.: THVMC-13640W001

[0162] It should be understood that a displacement sensor 260 is not limited to an LVDT, and that other displacement sensors, including other types of linear displacement sensors, may be utilized. Exemplary displacement sensors 260 can include a potentiometer, an optical linear encoder, an optical sensor, a capacitive sensor, or any combination thereof. Angular displacement sensors may also be utilized in the same manner, for example to measure the angular or rotational movement of pulleys around which a portion of a wire 280 disclosed herein extends, based on known correlations between such rotational movement and the axial displacement of the wire 280.

[0163] Various exemplary implementations for delivery assemblies 200 can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. Unless otherwise indicated, references to structural or functional features of any apparatus, assembly, or component without a superscript are intended to describe features that are generally applicable across the implementations discussed, but not necessarily required in every implementation. Features emphasized with respect to an exemplary implementation of any apparatus, assembly or component, such as delivery assemblies 200 and / or delivery apparatuses 202 thereof, referred to with a superscript, are applicable at least to that implementation and may be optionally shared by some, but not necessarily all, other implementations. For example, delivery apparatus 202ashown in Figs. 3A-3B is an implementation of delivery apparatus 202 that can include any combination of the features described for any delivery apparatus 202 throughout the current disclosure, and delivery apparatus 202aincludes a double-layered balloon 234ahaving a multi-layered balloon wall 236a, wherein the loop 285 of wire 280aextends between the two layers.

[0164] A balloon 234aof delivery apparatus 202acan have a multi-layered balloon wall 236a. While balloon wall 236ais illustrated in Fig. 3A to include two layers, namely an inner layer 246 and an outer layer 248, it is to be understood that a single layer balloon and / or balloons having any other plurality of layers (e.g., 2, 3, 4, 5 layers) is contemplated. The inner layer 246 encloses the balloon cavity 238, and the outer layers 248 is disposed around the inner layer 246, such that when inflation fluid is introduced into the balloon cavity 238, both layers 246, 248 forming the balloon wall 236aare simultaneously expanded. The wire 280acan extend distally from the balloon catheter 210ainto the balloon cavity 238 and towards the balloon wall 236a, wherein the inner layer 246 can optionally have, in some examples, an inner layer opening 250 through which the 280acan extend to form a loop 285 between both layers 246 and 248.

[0165] A portion and / or an entire loop 285 of wire 280acan freely slide between the inner layer 246 and the outer layer 248, such that when the balloon 234ais inflated and the diameter of theDocket No.: THVMC-13640W001 balloon 234a, defined by balloon wall 236a, is increased, the loop 285 can (in whole and / or in part) freely slide between the layers and expand along with the balloon wall 236a, optionally drawing a greater portion of the wire 280acausing its proximal end 281 to be distally moved, which in turn can be sensed by the sensor 260 as described above. The inner layer 246 and the outer layer 248 can be attached to each other along different regions thereof, such as by gluing, fusing, overmolding, and the like. In some examples, regions of attachment between the layers 246, 248 will not include the position of the loop 285 between the layers 246, 248, so as to allow the loop 285 to freely slide between the layers 246, 248 corresponding to change in balloon diameter.

[0166] In some examples, a circumferential channel 252 can be optionally formed between the layers 246, 248, through which the loop 285 extends. The inner layer 246 and the outer layer 248 can be optionally attached to each other proximally and distally to the channel 252, forming a relatively narrow channel sized to accommodate the loop 285. The size of the channel 252, in the axial direction, can be sufficient to allow free slidable movement of the loop 285 therealong, while optionally also being narrow enough to prevent undesired axial displacement of the loop 285, limiting movement thereof to the circumferential direction.

[0167] Although an exemplary loop 285’ is illustrated in Fig. 3A as being loop shaped and surrounding the circumference of the inner layer 246 of balloon 234, this is not meant to be limiting in any way. In some examples, loop 285 can circumferentially surround a portion of the circumference of an inner layer 246 of balloon 234, or the circumference of another component of a delivery apparatus 202 configured to change diameter in response to diameter change of balloon wall 236, such as a loop 285 disposed around a stent 300 as will be described below in greater details with respect to Figs 9A-10B. Fig. 3B illustrates an exemplary implementation of a loop 285" that can extend around at least part of the circumference of inner layer 246, such as within a channel 252, and terminate at a wire distal end 282 that can be optionally affixed to balloon wall 236, optionally to at least one of the layers 246 and / or 248.

[0168] The wire 280 can be implemented as any type of a flexible member which is not configured to significantly elongate when axially tensioned, and can include any suitable type of wire, cable, suture, a combination thereof, etc. In some examples, at least a portion of the wire 280 can optionally extend through a lumen of a wire shaft 292. When present, a wire shaft 292 can extend distally from the handle 204 and cover at least part of the axial portion 284 of the wire 280. In some examples, the wire shaft 292 can further extend into the balloon cavity 238. In the example illustrated in Fig. 3A, a wire shaft 292 is shown to extend inside balloon cavity 238 towards the balloon wall 236, optionally terminating proximate to the balloon wallDocket No.: THVMC-13640W001236 such that the wire 280acan extend out of the shaft distal end 296, through the inner layer opening 250, into the channel 252. A wire shaft 292, when present, can define a lumen through which the wire 280 can freely slide in the axial direction. When present, a wire shaft 292 may remain immovable during balloon inflation or deflation, allowing the wire 280 to axially move therethrough and relative thereto.

[0169] In some examples, the axial portion 284 of the wire 280 can extend, either with or without a wire shaft 292 disposed therearound, through balloon catheter lumen 212, such as between the balloon catheter wall 216 and the nosecone shaft 218. For example, a wire 280 and / or a wire shaft 292 can be sized to optionally extend into the balloon cavity 238 through an inflation opening 214, without blocking the inflation opening 214.

[0170] In some examples, the axial position of the loop 285 and / or channel 252 through which it can extend, can be any suitable location of the balloon intermediate section 242, so as to ensure that the measured diameter is that of the section of the balloon over which the prosthetic valve is disposed, or the portion configured to expand against the surrounding anatomy - such as in valvuloplasty or pre-ballooning procedures.

[0171] While a sensor 260 is schematically illustrated in Fig. 3A to reside inside the handle 204, it is to be understood that this is shown by way of illustration and not limitation, and that a sensor 260 can be positioned in any suitable location described herein, such as within handle 204 as described in greater detail with respect to Fig. 5, proximal to the handle 204, such as within the balloon catheter hub 270 as will be described below with respect to Figs. 7 and 21 A- 2 IB, within a sensor housing 217 that can be optionally in fluid communication with balloon catheter lumen 212 as will be described below with respect to Fig. 6, within balloon 234 as will be described below with respect to Fig. 12, or other appropriate locations. Similarly, a sensor data unit 254 and display 256 are schematically shown to be part of the handle 204 in Fig. 3A by way of illustration and not limitation, and other locations thereof are contemplated as described above.

[0172] Fig. 4 shows a sectional view in perspective of a distal portion of an exemplary delivery apparatus 202b. Delivery apparatus 202bis similar to any example described herein for delivery apparatus 202a, except that the balloon catheter wall 216bof delivery apparatus 202bincludes a balloon catheter channel 211 through which the wire 280bcan extend. While wire 280bis illustrated in Fig. 4 without a wire shaft 292, it is to be understood that a wire shaft 292 can optionally be added and similarly extend around the wire 280bthrough balloon catheter channel 211.Docket No.: THVMC-13640W001

[0173] The axial portion 284 of the wire 280bcan slidably extend through balloon catheter channel 211, optionally further extending in a continuous manner therefrom into a corresponding space or channel between the inner 246 and outer 248 layers of the balloon wall 236b, such as towards a channel 252 along a suitable axial position of the balloon intermediate section 242, at which the wire 280bcircumscribes the inner layer 246 to form a complete or partial loop 285.

[0174] Extension of the wire 280bthrough a channel 211 of the balloon catheter wall 216bcan avoid blockage of at least part of the inflation opening(s) 214. Moreover, when further extending from the channel 211 directly into the balloon wall 236b, between layers 246 and 248, no portion of the wire 280bis exposed to the flow channel of the inflation fluid along the balloon catheter lumen 212 or balloon cavity 238, and no inner layer opening 250 needs to be formed for insertion of the wire 280bthrough the inner layer 246.

[0175] While the wire 280bis shown in Fig. 4 to continuously extend from the balloon catheter channel 211 into a passageway formed between the layers 246, 248, in some examples, the balloon catheter channel 211 can be exposed, at the distal end of balloon catheter wall 216b, to the balloon cavity 238, such that the wire can optionally extend from the channel 211 into balloon cavity 238, and towards an inner layer opening 250 that can be similarly formed, in such examples, in inner layer 246. In some examples, the balloon catheter 210bcan be a multilumen catheter, wherein one lumen thereof is the primary balloon catheter lumen 212 through which the nosecone shaft 218 extends, and another lumen can serve as the channel 211.

[0176] As mentioned above, a sensor 260 can be positioned at various suitable positions of any delivery apparatus 202 disclosed herein. Fig. 5 schematically shows a handle 204cof an exemplary delivery apparatus 202c. Delivery apparatus 202cis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that the handle 204cof delivery apparatus 202ccomprises the sensor 260.

[0177] The balloon catheter 210 extends distally from its hub 270, as shown in Fig. 2, into and through the handle 204, as shown in Fig. 5, to continue distally from the handle 204, optionally through the outer delivery shaft 208. When a sensor 260 is positioned inside of the handle 204, at a position outward from balloon catheter 210, the apparatus 202 may need to be modified to enable the wire 280, which extends through the balloon catheter 210, to connect with a sensor 260 positioned outside the balloon catheter 210. In the example shown in Fig. 5, the balloon catheter 210cincludes a side opening 213 at a position of the balloon catheter wall 216cextending through the handle 204c. The wire 280 can extend from the balloon catheter 210c,Docket No.: THVMC-13640W001 through the side opening 213, out of the balloon catheter 210c, such that the wire proximal end 281 can couple to the sensor 260, such as by being coupled and / or connected to the transformer core 264 in the case of an LVDT sensor.

[0178] It is to be understood that a wire 280 without a wire shaft 292 is shown in Fig. 4 for illustrative purpose, and that in some examples, a wire shaft 292 can be further disposed around the wire, and can be optionally similarly extended through the side opening 213. When the wire 280 extends through balloon catheter lumen 212, such as along an axial portion 284 of the wire280, and as illustrated in Fig. 5, the side opening 213 is a sealed side opening, configured to seal against the wire 280 of wire shaft 292 extending therethrough in a manner that will prevent inflation fluid from spilling into the handle 204. When the wire 280 extends through a balloon catheter channel 211 as described above with respect to Fig. 4, a similar side opening 213 can be formed, wherein the side opening 213 in such a case is exposed to the balloon catheter channel 211 but not to the balloon catheter lumen 212, and thus does not need to be implemented as a sealed opening, as long as the balloon catheter channel 211 is not exposed to the balloon cavity 238 at its distal end.

[0179] In order to increase the accuracy of measurement, it may be desired to maintain the wire in a tensioned state at all times. For example, in the case of a wire 280 that includes a loop 285, while expansion of the balloon 234 and increase of its diameter and perimeter can enlarge the loop 285 and cause a distally oriented movement of the wire proximal end 281, deflation of the balloon will not apply any force against the loop 285, such that the wire proximal end281, in the absence of any other tensioning mechanism, may remain in position without providing an indication of the change in diameter during deflation. Likewise, any slack of wire material prior to balloon expansion may lead to measurement inaccuracy, as the wire will draw from this slack prior to having its proximal end 281 moving.

[0180] Thus, in some examples, a minimal tension magnitude Ts is constantly applied to the wire 280. Such tension is configured to retain the wire 280 in a minimally tensed state, even in the absence of external forces acting to distally move the wire proximal end 281 in response to balloon expansion. For example, the minimal tension magnitude Ts may be applied in a compacted or deflated state of the balloon 234. In the case of a wire 280 defining a loop 285, for example, the minimal tension magnitude Ts can be selected so as to apply sufficient biasing force to keep the loop 285 tensed around the inner layer 246 or other elements as will be described in greater detail below, yet not high enough to resist balloon expansion.

[0181] In some examples, any apparatus 202 disclosed herein can include biasing member 266 configured to apply a predetermined pull-force on the wire 280 or a component of the sensorDocket No.: THVMC-13640W001260 coupled to the wire proximal end 281, such as a transformer core 264 in the case of an LVDT sensor. In the example illustrated in Fig. 5, the biasing member 266 is shown to be implemented as a spring 266 coupled to and / or attached to the transformer core 264. The spring 266 can be optionally coupled to and / or affixed to a support member 268 of the handle 204cat a spring first end 267a, while a spring second end 267b, opposite to the spring first end 267a, can be coupled to the transformer core 264 which is, in turn, connected to the wire 280.

[0182] The biasing member 266 (such as the illustrated spring) is configured to apply an axially oriented pull-force on the wire 280. The magnitude of the force applied by the biasing member 266 is sufficient to apply the minimal tension magnitude Ts to the wire 280, in the absence of other external forces effective to cause a distal pull the wire proximal end 281 in response to balloon expansion.

[0183] Fig. 5 schematically illustrates the interior of the exemplary handle 204c, with a biasing member in the form of a spring 266 schematically illustrated to have its first end 267a affixed to a support member 268 of the handle 204c, at a position proximal to the attachment point between the spring second end 267b and the transformer core 264. In such an exemplary configuration, the biasing member can be optionally implemented as a coil compression spring, having a spring coefficient suitable to pull the wire 280 (for example, via transformer core 264) by a pull force that matches the desired minimal tension magnitude Ts. Advantageously, applying the minimal tension magnitude Ts to the wire 280 allows more accurate measurement of balloon diameter.

[0184] It will be understood that the first end 267a and the second end 267b of a biasing member 266 may be positioned in any number of locations within the handle 204c, which may dictate the type of biasing member utilized in conjunction with wire 280 and sensor 260. For example, if the first end 267a is positioned distal to the second end 267b of the biasing member 266 (configuration not shown), it may be necessary to implement an extension spring instead of a compression spring, such that the spring 266 may extend the wire (directly or via transformer core 264) in a proximally oriented direction, to apply the minimal tension magnitude Ts as described above. Any of the first end 267a and / or second end 267b of the biasing member 266 (e.g., spring) can optionally comprise a hook, an eyelet, a ring and the like, by which it may be coupled to the support member 268 and / or to the transducer core, respectively.

[0185] While a biasing member 266 is illustrated in Fig. 5 as a coil compression spring, it is to be understood that any other type of a biasing member is contemplated, such as a tension spring, a torsion spring, a leaf spring, a stretchable and / or elastic cord, or an elastomeric body (e.g., aDocket No.: THVMC-13640W001 silicone of polyurethane component) which is compressible under external force application, and returns to its original shape when such force is removed.

[0186] In some examples, a sensor 260 can be modified in a manner that allows it to reside inside of the handle 204 without needing to extend the wire 280 out of the balloon catheter 210. For example, the wire proximal end 281 can be attached to a transformer core 264 situated inside of the balloon catheter itself, such as inside balloon catheter lumen 212, at a position of the balloon catheter 210 extending through the handle 204, and the tube 262 of the modified sensor 260 can be disposed around the portion of the balloon catheter that includes the transformer core 264, radially outwards to the balloon catheter wall 216 (example not illustrated).

[0187] Fig. 6 schematically shows a proximal portion of an exemplary delivery apparatus 202d. Delivery apparatus 202dis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that delivery apparatus 202dfurther comprises the sensor 260 housing 217 in which the sensor 260 is disposed.

[0188] A sensor housing 217, which is a separate component from the handle 204 and / or the balloon catheter hub 270, is in fluid communication with the balloon catheter lumen 212 via a branch 215 extending from the balloon catheter 210dof apparatus 202d, as illustrated in Fig. 5. In some examples, the branch 215 extends from a portion of the balloon catheter 210dproximal to the handle 204, optionally between the handle 204 and the balloon catheter hub 270.

[0189] In some examples, the branch 215 is integrally formed with the balloon catheter wall 216d. In some examples, the sensor housing 217 and the branch 215 are integrally formed. In some examples, the sensor housing 217 is defined as a portion of the branch 215 itself. In some examples, as shown in Fig. 6, the wire 280 can extend through balloon catheter lumen 212, optionally proximally from the handle 204, into the branch 215 and sensor housing 217. The sensor 260 resides inside the sensor housing 217, and the wire proximal end 281 can be connected to the sensor 260, such as to the transformer core 264 in the case of an LVDT sensor, without needing to pass through and out of balloon catheter wall 216.

[0190] In some examples, the sensor housing 217 can further accommodate a biasing member 266 that can be implemented according to any of the examples described above with respect to Fig. 5, mutatis mutandis. While a sensor data unit 254 and display 256 are illustrated in Fig. 5 to reside in a separate console out of the sensor housing 217, it is to be understood that any of these components can be included in the sensor housing 217. Moreover, any of the sensor dataDocket No.: THVMC-13640W001 unit 254 and display 256 can be connected to the sensor 260 either via wire communication line(s), as illustrated in Fig. 5 for example, or wirelessly.

[0191] Fig. 7 schematically shows a proximal portion of an exemplary delivery apparatus 202e. Delivery apparatus 202eis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that the balloon catheter hub 270eof delivery apparatus 202ecomprises the sensor 260. While not illustrated in Fig. 7, it is to be understood that the balloon catheter hub 270ecan further accommodate a biasing member 266 that can be implemented according to any of the examples described above with respect to Fig. 5, mutatis mutandis.

[0192] Figs. 8A and 8B show an exemplary self-expandable stent 300 in a compressed and an expanded configuration thereof. The stent 300, which can be also referred to as a mesh-stent, comprises a plurality of struts 302 or wires that can be optionally intersect, interconnect and / or be weaved with each other, forming a mesh-like structure. The stent 300 can be formed of a shape memory material, such as Nitinol, configured to radially self-expand against an outer enclosure disposed therearound. In some examples, the stent 300 is designed or chosen to have a relatively low radial force configured to facilitate expansion thereof.

[0193] The stent 300 can define a stent proximal section 304, a stent distal section 308, and a stent intermediate section 306 extending therebetween. The stent proximal section 304 extends from a proximal end portion 310 of the stent 300 to the stent intermediate section 306. The stent distal section 308 extends from the stent intermediate section 306 to a distal end portion 312 of the stent 300, and can be configured to assume a distally-tapering configuration in the inflated or expanded state of the stent 300.

[0194] At least one of the proximal end portion 310 and / or distal end portion 312 of the stent 300 is coupled to an inner shaft extending axially through the stent 300, such as by being either affixed to the inner shaft or axially slidable along the inner shaft, optionally by a corresponding slider that can be at the proximal 310 and / or distal 312 end portion.

[0195] Figs. 9A and 9B show a distal portion of an exemplary delivery apparatus 202fin inflated and deflated states of the balloon 234, respectively. Delivery apparatus 202eis an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that the wire 280fincludes a loop 285 that circumscribes a stent 300fdisposed inside the balloon cavity 238.

[0196] In the example shown in Figs. 9A-9B, the stent 300 is disposed inside the balloon 234, optionally around an inner shaft of the delivery apparatus 202, and is configured to self-expand against the inner surface of the balloon wall 236. The stent 300 can be designed to self-expand,Docket No.: THVMC-13640W001 in a free state thereof (e.g., a state in which it is not bound inside the balloon 234), to a diameter that can be greater than the maximal expanded diameter of the balloon 234.

[0197] In some examples, the inner shaft extending through the stent 300 is the nosecone shaft 218, as illustrated, for example, in Figs. 9A-13, though it is to be understood that the nosecone shaft 218 is shown to serve as the inner shaft by way of illustration and not limitation, and that in some examples, an inner shaft may be any other shaft extending through the balloon 234, such as a separate inner shaft that can extend around the nosecone shaft 218.

[0198] As mentioned above, the stent 300 may be a relatively low radial force stent or support structure, having an outward radial force which is sufficient to strive and expand the stent 300 against the balloon wall 236. yet lower than the force required to expand the balloon 234. This allows the stent 300 to expand against the balloon wall 236 in a manner that constantly biases the stent intermediate section 306 towards and against the balloon wall 236, such that when the balloon is deflated and compressed, the stent 300 is compressed while being pressed thereagainst, as shown in Fig. 9A, without being able to expand the balloon 234 itself, and when the balloon is inflated and expanded, the stent 300 is allowed to expand therewith, such that the stent intermediate section 306 constantly follows the balloon intermediate section 242. In this manner, the diameter of the stent 300 (e.g., along the stent intermediate section 306) is always increased or decreased along with the diameter of the balloon 234 (e.g., along the balloon intermediate section 242).

[0199] In some examples, the stent may be configured to expand radially with an outward radial force of between about 0.1 N to about 5 N (e.g., between about 0.1 N to about 4 N, between about 0.1 N to about 3 N, between about 0.1 N to about 2.5 N, between about 0.1 N to about 2 N, between about 0.1 N to about 1.5 N, 0.1 N or greater, 0.2 N or greater, 0.5 N or greater, 0.75 N or greater, 1 N or greater, 1.1 N or greater, etc.). Thus, in some examples, the outward radial force provided by the stent 300 is designed to not significantly change the shape of the balloon 234, since it provides a relatively low radial force. That is, the stent 300 does not provide sufficient radial force to expand, bend or reshape the balloon wall 236 against which it is pressed.

[0200] An exemplary stent 300fis shown in Figs. 8A-8B and 9A-9B to include a stent proximal section 304fconfigured to assume a proximally-tapering configuration in the expanded state of the stent 300f, and a stent distal section 308fconfigured to assume a distally-tapering configuration in the expanded state of the stent 300f. The proximal end portion 310fand the distal end portions 312fof exemplary stent 300fcan be relatively rigid non-expandable endportions, such as ring-like members, that can have a relatively small size (e.g., greater than, yetDocket No.: THVMC-13640W001 comparable to, the diameter of the nosecone shaft), and can be optionally disposed around the nosecone shaft 218. Since the stent 300 can foreshorten during expansion, at least one of the end portions 310, 312 can be implemented as a slider 320, that can axially slide over the nosecone shaft 218.

[0201] In some examples, as shown in Figs. 9A-9B, both the proximal end portion 310fand the distal end portions 312fcomprise sliders 320 that can axially slide towards each other, over the nosecone shaft 218, when the stent 300 expands, and away from each other, when the stent 300 is compressed. In this manner, the stent intermediate section 306 can optionally maintain axial position, generally aligned with the balloon intermediate section 242, while the proximal end portion 310fand the distal end portions 312fcan axially slide towards or away from each other during expansion and compression of the stent 300. In some examples, one end portion of the stent 300fcan be affixed to a component of the delivery apparatus 202, in a manner similar to that described in greater detail below with respect to Figs. 10A-10B, while the opposite end portion can be axially movable relative thereto.

[0202] The wire 280fcan extend through a wire shaft 292 that extends through the balloon catheter lumen 212 into the balloon cavity 238. The wire shaft 292 can further extend inside the balloon cavity 238, between the stent 300 and the balloon wall 236, and terminate at a desired position along the stent intermediate section 306. The wire 280fthen exits the shaft distal end 296 and forms a loop 285 circumscribing the stent intermediate section 306. The wire can be disposed around the stent 300 between the stent intermediate section 306 and the balloon wall 236, configured to change in diameter in response to a change in diameter of the stent 300, which is proportional to the change in diameter of balloon 234.

[0203] Figs. 10A and 10B show a distal portion of an exemplary delivery apparatus 202gin inflated and deflated states of the balloon 234, respectively. Delivery apparatus 202sis similar to any example described herein for delivery apparatus 202r, except that the stent 300sof delivery apparatus 202gdoes not include a proximally tapered stent proximal section. Instead, the stent 300gcan be optionally funnel-shaped, having a stent distal section 308gthat can distally taper towards a smaller-sized distal end portion 312g, while the proximal end portion 310gcan define a maximal diameter of the stent 300sin its expanded configuration.

[0204] In some examples, one of the end portions of the stent 300 can be affixed to another component of the delivery apparatus 202, such as to the nosecone shaft 218. In the example illustrated in Figs. 10A-10B, the distal end portion 312gis affixed to the nosecone shaft 218, though it is to be understood that it can be affixed to other components, such as the nosecone proximal end portions 228 or other intermediate connectors (not shown).Docket No.: THVMC-13640W001

[0205] In some examples, the delivery apparatus 202 can further comprise a sleeve 316 disposed around, and coupled to, the stent 300. Exemplary delivery apparatus 202sis shown in Figs. 10A- 10B to include a sleeve 316 circumscribing a portion of the stent 300gconfigured to have the greatest diameter of the 300gin the expanded configuration, which can be at or proximate to the proximal end portion 310gfor exemplary stent 300gas shown in Figs. 10A- 10B, or can be along an intermediate section of the stent, distal to the proximal end portion 310g. The wire 280 can extend into the sleeve 316 through a sleeve opening 318, such that the loop 285 can slide inside of the sleeve 316. It is to be understood that a delivery apparatus 202fdescribed above with respect to Figs. 9A-9B can also optionally include a similar sleeve 316 disposed around the stent intermediate section 306. The sleeve 316 can be formed with inner surfaces smooth enough to facilitate slidability of the loop 285 therein.

[0206] In some examples, a sleeve can be replaced with other means for guiding the loop 285 circumferentially around the stent 300, such as suture loops or eyelets (not shown) disposed around the frame stent 300 (e.g., around stmts 302 of junctions thereof), through which the loop 285 may slide. While delivery apparatus 202gis illustrated in Figs. 10A-10B to include a sleeve 316, it is to be understood that any delivery apparatus 202 equipped with a stent 300, including delivery apparatus 202g, can be provided without a sleeve 316. For example, the loop 285 can be optionally disposed around the stent 300 or weaved between stmts 302 of the stent 300.

[0207] Figs. 11A and 11B show a distal portion of an exemplary delivery apparatus 202hin inflated and deflated states of the balloon 234, respectively. Delivery apparatus 202his similar to any example described herein for delivery apparatus 202f, except that instead of forming a loop around the stent, the wire 280his affixed directly or indirectly, at a distal end 282 thereof, to a slidable proximal end portion 310 of the stent 300. The stent 300 of delivery apparatus 20211can be generally similar to that of delivery apparatus 202f, except for having its distal end portion necessarily affixed, such as according to any of the examples described above with respect to stent 300g, while the proximal end portion 310 is axially movable relative thereto, such as by including a slider 320 configured to slide along the nosecone shaft 218.

[0208] The wire distal end 282 can be affixed to the stent's proximal end portion 310 or a slider 320 thereof, directly or via intermediate connectors. When the balloon is inflated and expanded, and the stent expands therewith, foreshortening of the stent, as shown in the transition from Fig. 11A to Fig. 1 IB, will cause the proximal end portion 310 of the stent 300 to slide distally. Since the distal end portion 312 is axially affixed in position, foreshortening will be translated to axial movement of the proximal end portion 310 which is repeatable andDocket No.: THVMC-13640W001 proportional to the stent's expansion. Foreshortening will drag the wire 280 in the distal direction, along with the stent's proximal end portion 310, distally moving the transformer core (e.g., in the case of an LVDT sensor) attached to the wire proximal end 281 therewith.

[0209] Fig. 12 shows a distal portion of an exemplary delivery apparatus 2021in an inflated state of the balloon 234. Delivery apparatus 2021is similar to any example described herein for delivery apparatus 202h, except that the sensor 260 is positioned inside of the balloon 234, such as at or proximal to the proximal end portion 3101of the stent 3001. In some examples, a delivery apparatus 2021can be devoid of a wire 280. For example, the proximal end portion 3101or a slider 320 thereof can be attached or affixed to the transformer core 264 (e.g., in the case of an LVDT sensor), either directly or via one or more intermediate connectors.

[0210] In some examples, the sensor 260 can be optionally coupled to, or otherwise disposed around, the nosecone shaft 218. The distal end portion 312 can be axially affixed, as described above with respect to delivery apparatus 202h, while the proximal end portion 3101is axially movable. Thus, expansion of the stent 3001during expansion of the balloon 234 will cause the stent 3001to foreshorten, distally moving the proximal end portion 3101of the stent, along with the transformer core 264 attached thereto, relative to the tube 262, while compression of the balloon 234 and the stent 3001will lead to elongation of the stent 3001, moving the proximal end portion 3101of the stent, along with the transformer core 264 attached thereto in an opposite proximal direction.

[0211] While not illustrated in Fig. 12, the delivery apparatus 2021can further include, in some examples, one or more signal-delivery wires configured to extend from a sensor (e.g., sensor 260), optionally through the balloon catheter (e.g., balloon catheter 210), towards a sensor data unit (e.g., sensor data unit 254). In some examples, the sensor can include a transducer configured to wirelessly communicate with a sensor data unit.

[0212] Fig. 13 shows a distal portion of an exemplary delivery apparatus 202Jin an inflated state of the balloon 234. Delivery apparatus 202' is similar to any example described herein for delivery apparatus 20211, except that delivery apparatus 202' comprises at least one indicator radiopaque marker 322 configured to axially move along with the proximal end portion 310' of the stent 3001. and at least one reference radiopaque marker 298 configured to maintain an affixed axial position relative to an affixed end of the stent 3(0, such as its distal end portion 312k

[0213] In some examples, one or more reference radiopaque markers 298 can be marked over, or disposed around, the nosecone shaft 218, optionally along a portion of the nosecone shaft 218 which is proximate to the proximal end portion 310* of the stent 300'. In some examples.Docket No.: THVMC-13640W001 the proximal end portion 31 O’ of the stent SOO’, or a slider 320 thereof, can comprise the indicator radiopaque marker 322 marked or disposed over or around an outer surface thereof. In some examples, the proximal end portion 31 O’ of the stent 300' , or a slider 320 thereof, can be affixed to a rigid component (not shown) extending therefrom, which can comprise the indicator radiopaque marker 322 marked or disposed over or around an outer surface thereof.

[0214] A radiopaque marker 322, 298 comprises a radiopaque material, understood to be capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique, during the balloon inflation procedure. Radiopaque materials can include, but are not limited to, gold, platinum, tantalum, tungsten alloy, platinum iridium alloy, palladium, and the like. In some examples, any of radiopaque markers 322 and / or 298 can be formed by means of radiopaque inks and adhesives, and applied on at least a portion of the corresponding stent's proximal end portion 310 or slider 320 (for radiopaque marker 322) or nosecone shaft 218 (for radiopaque markers 298), such as screen printing, high speed roller printing, coating, dipping, etc. In some examples, the markers can be provided as separately formed components, such as annular rings or C-shaped bands that are mounted on the corresponding stent's proximal end portion 310 or slider 320 (for radiopaque marker 322) or nosecone shaft 218 (for radiopaque markers 298). In some examples, the indicator radiopaque marker 322 is configured to be visually distinguishable from the one or more reference radiopaque marker(s) 298, for example by having different dimensions.

[0215] The distal end portion 312 can be axially affixed, as described above with respect to delivery apparatus 202h, while the proximal end portion 31 O' can be axially movable. Thus, in some examples, expansion of the stent 30C during expansion of the balloon 234 will cause the stent 300' to foreshorten, distally moving the proximal end portion 31 O’ of the stent, along with the indicator radiopaque marker 322, relative to the position of the reference radiopaque markers 298 along nosecone shaft 218, while compression of the balloon 234 and the stent 300’ will lead to elongation of the stent 300, moving the proximal end portion 310' of the stent, along with the indicator radiopaque marker 322, in an opposite proximal direction.

[0216] Thus, the one or more reference radiopaque markers 298 may serve as a "scale", and the indicator radiopaque marker 322 can serve as a "dial" relative to the "scale", indicative of the diameter of the stent 300 and balloon 234. Accordingly, real-time measurement of balloon diameter during expansion or compression thereof can be accomplished, based on the alignment of the indicator radiopaque marker 322 relative to reference radiopaque markers 298 under fluoroscopy. In other words, the axial position of the indicator radiopaque marker 322Docket No.: THVMC-13640W001 relative to the reference radiopaque markers 298 is indicative of the diameter of the balloon 234.

[0217] Fig. 13 illustrates an example of three reference radiopaque markers 298, each corresponding to a specific diameter of the balloon 234. Alignment of the indicator radiopaque marker 322 with any of the reference radiopaque markers 298 may be indicative of the balloon diameter associated with the reference radiopaque marker 298. Positioning of the indicator radiopaque marker 322 between any couple of reference radiopaque markers 298 may be indicative of a balloon diameter between the two diameters associated with the respective reference radiopaque markers 298. Similarly, an indicator radiopaque marker 322 positioned distal to the most distal reference radiopaque marker 298 may indicate an expansion diameter exceeding a maximal value.

[0218] While three reference radiopaque markers 298 are shown in the example illustrated in Fig. 13, it will be clear that any other number of reference radiopaque markers 298 is contemplated. For example, more than three reference radiopaque markers 298 may be utilized to provide a higher resolution of the "scale" provided thereby. In some examples, a single reference radiopaque marker 298 may be provided, for example to serve only as a maximal threshold value, such that if the indicator radiopaque marker 322 translates distally to the single reference radiopaque marker 298, it may be indicative of an expansion diameter that exceeds a maximal threshold value (example not shown).

[0219] In some examples, a delivery apparatus 202 can include a wire 280 having at least one radially diverging portion that continuously extends from the axial portion 284 of the wire 280, wherein the radially diverging portion of the wire extends, within the balloon cavity 238, radially away from a central longitudinal axis of the delivery apparatus towards the balloon wall, optionally towards the inner surface of the balloon intermediate section 242. In some examples, the radially diverging portion can be a radial portion 290 that extends at a right angle relative to the central longitudinal axis Cx, as illustrated and described in greater detail, for example, with respect to Figs. 14-19B. In some examples, the radially diverging portion can be a proximal angled portion 287 that extends diagonally relative to the central longitudinal axis Cx, as illustrated and described in greater detail, for example, with respect to Fig. 20. It should be appreciated that the term “extends diagonally”, as used herein, includes components (e.g., portion 287) that extend with a curvature, as shown in Fig. 20.

[0220] Fig. 14 shows a distal portion of an exemplary delivery apparatus 202kin an inflated state of the balloon 234. Figs. 15A and 15B are cross-sectional view taken along line 15-15 of Fig. 14, in deflated and inflated states of the balloon 234, respectively. Delivery apparatus 202kDocket No.: THVMC-13640W001 is an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that delivery apparatus 202kcomprises two wire radial portions 290a, 290b extending from corresponding shaft openings 295a, 295b of an exemplary wire shaft 292k, towards diametrically opposing sides of the balloon wall 236.

[0221] Wire shaft 292k, shown in greater detail in Fig. 16A, can optionally include a primary channel or lumen 291 around which a wire shaft wall 293 is defined. In some examples, a nosecone shaft 218 having a nosecone shaft wall 219 can extend through the primary channel or lumen 291. In some examples, two wire passage lumens 294a and 294b in communication with, and optionally terminating at, corresponding shaft openings 295, can extend through the wire shaft wall 293. The wire shaft 296kcan extend coaxially over the nosecone shaft 218 along a common central longitudinal axis Cx, which can coincide with the central longitudinal axis Ca of the prosthetic valve 100 when a prosthetic valve 100 is disposed around the balloon 234. The wire passage lumens 294 can extend through a wire shaft wall 293 defined around the primary lumen 291.

[0222] The wire passage lumens 294a and 294b can be radially offset from the central longitudinal axis Cx at opposing sides of the wire shaft 292k, optionally terminating at the shaft distal end 296 with corresponding shaft openings 295a and 295b. Wire axial portions 284a and 284 extend through wire passage lumens 294a and 294b, and exit shaft openings 295a and 295b to define radial portions 290a and 290b, respectively, extending in a radial direction towards the inner surface of the balloon wall 236. In some examples, the wire shaft 292kextends axially into balloon cavity 238 past the balloon proximal section 240, so as to position the shaft distal end 296 and / or the shaft opening 295 in axial alignment with the balloon intermediate section 242. Each radial portion 290 of a wire 280kcan optionally extend at a right angle relative to the central longitudinal axis Cx and / or the corresponding axial portion 284.

[0223] In some examples, delivery apparatus 202kcan include a plurality of wires 280k, such as a first wire 280ka defining the first axial portion 284a and a first radial portion 290a, and a second wire 280kb defining the second axial portion 284b and a second radial portion 290b, as indicated for example in Fig. 14. In such examples, each separate wire 280kcan be optionally coupled, at a corresponding wire proximal end 281 thereof, to a separate sensor 260. In some examples, wire proximal ends 281 of two separate wires 280kcan be coupled to the same sensor 260. In some examples, delivery apparatus 202kcan include a single wire 280kdefining both axial portions 284a, 284b and radial portions 290a, 290b, wherein both axial portions 284 ofDocket No.: THVMC-13640W001 the single wire 280kcan be continuous with each other and coupled at a common wire proximal end 281 thereof to a single sensor 260, as will be described in greater detail below, for example, with respect to Figs. 21A-21B.

[0224] In some examples, the diameter of the primary lumen 291, configured to accommodate the nosecone shaft 218, is greater than the diameter of any wire passage lumen 294, configured to accommodate a portion of wire 280. In some examples, the one or more wire passage lumen(s) 294 can be formed inside a wall thickness of the wire shaft 292. In some examples, the wire shaft 292 can be a multidumen shaft, comprising the primary lumen 291 and one or more wire passage lumen(s) 294.

[0225] The radial portions 290a and 290b can terminate at wire distal ends 282a and 282b that can be optionally coupled, directly or indirectly, to the balloon wall 236. In some examples, one or more wall connectors 258 can be used to couple the wire(s) 280 to the balloon wall 236. For example, delivery apparatus 202kis shown in Figs. 14-15B to include two wall connectors 258a and 258b affixed to the balloon wall 236, wherein wire distal ends 282a and 282b are coupled to the wall connectors 258a and 258b, respectively, optionally by being looped around portions of the wall connectors 258. In some examples, a wall connector 258 can be implemented as an adhesive tape or film as illustrated, for example, in Figs. 14-15B, though it is to be understood that a wall connector can be implemented in any other suitable manner. In some examples, a wire 280 and / or a distal end 282 thereof is directly attached to the balloon wall 236, such as by gluing, welding, and the like.

[0226] When the balloon is expanded from the deflated state shown in Fig. 15 A, to the inflated state shown in Fig. 15B, the radial portion 290 elongates, causing the axial portion 284 and its proximal end 281, which is coupled to the sensor 260 (for example, to the transformer core 264 in the case of an LVDT sensor) to translate in the distal direction. Responsive to the measured displacement(s), sensor data unit 254 can determine a diameter indication of the balloon 234 and / or a prosthetic valve 100 disposed around the balloon 234.

[0227] Since the shaft opening 295 from which the radial portion 290 extends may be radially offset inside a balloon cavity 238, for example by being closer to one side of the balloon 234 in the radial direction, during and / or after balloon inflation, diametrically opposite radial portion 290a, 290b can measure the radial distance to each side, such that the total diameter can be estimated based on both radial distances.

[0228] In some examples, more than two radial portions 290 extending from corresponding shaft openings 295 can be provided, angularly offset from each other. A plurality of radialDocket No.: THVMC-13640W001 portions 290 can be equally or not equally spaced from each other around the circumference of the central longitudinal axis Cx.

[0229] In some examples, the diameter indication is representative of a radial diameter of the balloon wall 236 and / or a prosthetic valve 100 disposed therearound. In some examples, the diameter indication comprises lengths of radial portions 290. In some examples, the radial diameter comprises a sum of: the length of a first radial portion 290a the length of a second radial portion 290b, and a distance between the first and second shaft openings 295a and 295b, which can optionally be equal and / or substantially equal to a diameter of the wire shaft 292, wherein the orientation of the second radial portion 290b generally opposes the orientation of the first radial portion 290a.

[0230] As mentioned above, a shaft opening 295 may not be exactly in the radial center of balloon 234, thus the length of a radial portion 290, based on the distance between one shaft opening 295 and the balloon wall 236, may not give an exact radius of the respective balloon 234. Advantageously, using the sum of lengths (or corresponding axial displacements) of two radial portions 290 diametrically opposite to each other provides a value that is more reliably indicative of the diameter of the balloon 234.

[0231] Fig. 16B shows an arrangement of exemplary wire shafts 2921that can be part of an exemplary delivery apparatus 2021. Delivery apparatus 2021is similar to any example described herein for delivery apparatus 202k, except that instead of the two wire passage lumens 294 being comprised in a single wire shaft 292kas shown in Fig. 16A, two separate wire shaft 292’a and 292*b are illustrated in Fig. 16B, each defining the corresponding wire passage lumens 294 that can optionally terminate at shaft openings 295a and 295b, such as at the distal ends 296a and 296b of the wire shafts 2921.

[0232] The wire shafts 292’a, 292'b can be diametrically opposite to each other, each being radially offset from the central longitudinal axis Cx, for example on opposite sides of a nosecone shaft 218 that can extend therebetween. Any of the examples described above with respect to spatial arrangements of the wire passage lumens 294 of wire shaft 292kcan be similarly adopted for wire shafts 2921, including optional inclusion of more than two wire shafts 2921.

[0233] Fig. 17 shows a distal portion of an exemplary delivery apparatus 202mDelivery apparatus 202mis similar to any example described herein for delivery apparatus 202k, except that the axial portions 284a and 284b extend through channels formed in the nosecone shaft 218mand out of side openings of the nosecone shaft 218m, to define the corresponding radial portions 290. In some examples, delivery apparatus 202mcan be devoid of a separate wire shaftDocket No.: THVMC-13640W001292, wherein the nosecone shaft 218mitself can serve the roles described above for a wire shaft 292k

[0234] The exemplary nosecone shaft 218mcan include two nosecone-shaft wire passage channels 222a and 222b, through which the axial portions 284a and 284b can extend. Two corresponding side openings 221a and 221b of the nosecone shaft 218mare exposed to the nosecone-shaft wire passage channels 222a and 222b, respectively, such that each radial portion 290a, 290b can extend radially outwards from the corresponding side opening 221a, 221b. In some examples, each nosecone-shaft wire passage channels 222 can optionally extend through the nosecone shaft wall 219m.

[0235] The nosecone-shaft wire passage channels 222a and 222b can be radially offset from the central longitudinal axis Cx at opposing sides of the nosecone shaft 218m. The side openings 221a, 221b can be in axial alignment with the balloon intermediate section 242. Each radial portion 290 of a wire 280mcan optionally extend at a right angle relative to the central longitudinal axis Cx and / or the corresponding axial portion 284.

[0236] In some examples, delivery apparatus 202mcan include a plurality of wires 280, such as a first wire 280a defining the first axial portion 284a and a first radial portion 290a, and a second wire 280b defining the second axial portion 284b and a second radial portion 290b, as indicated for example in Fig. 17. In such examples and other examples (e.g., with two or more wires), each separate wire 280 can be optionally coupled, at a corresponding wire proximal end 281 thereof, to a separate sensor 260. In some examples, wire proximal ends 281 of two separate wires 280 can be coupled to the same sensor 260. In some examples, delivery apparatus 202mcan include a single wire 280 defining both axial portions 284a, 284b and radial portions 290a, 290b, wherein both axial portions 284 of the single wire 280 can be continuous with each other and coupled at a common wire proximal end 281 thereof to a single sensor 260, as will be described in greater detail below, for example, with respect to Figs. 21A-21B.

[0237] In some examples, the diameter of the guidewire passage lumen 232, configured to accommodate a guidewire 80, is greater than the diameter of any nosecone-shaft wire passage channel 222, configured to accommodate a portion of wire 280. In some examples, the one or more wire passage channel(s) 222 can be formed inside a wall thickness of the nosecone shaft 218m. In some examples, the nosecone shaft 218mcan be a multi-lumen shaft, comprising the guidewire passage lumen 232 and one or more nosecone-shaft wire passage channel(s) 222.

[0238] In some examples, two nosecone-shaft wire passage channels 222a and 222b can be diametrically opposite to each other. In some examples, two side openings 221a and 221b can be diametrically opposite to each other. In some examples, a nosecone shaft 218mcan includeDocket No.: THVMC-13640W001 more than two nosecone-shaft wire passage channels 222 with a correspond! ng plurality of side openings 221.

[0239] In some examples, a delivery apparatus 202 can include a single radial portion 290 extending from a single axial portion 284. Fig. 18 A shows an exemplary wire shaft 292nthat can be part of an exemplary delivery apparatus 202n. Wire shaft 292nis similar to any example described herein for wire shaft 292k, except that it includes a single wire passage lumen 294 through which a single axial portion 284 of a wire 280 can extend towards and out the shaft opening 295, to define a single radial portion 290. Fig. 18B shows an exemplary arrangement that includes a wire shaft 292° that can be part of an exemplary delivery apparatus 202°. Delivery apparatus 202° is similar to any example described herein for delivery apparatus 202g, except that it includes a single wire shaft 292° that can be similar to any example of a wire shaft 292g. A delivery apparatus 202 that includes a single radial portion 290 extending from a single shaft opening 295, as shown, for example, in any of Figs. 18A or 18B, can suffice when total symmetry of balloon expansion around the central longitudinal axis Cx is assumed.

[0240] While arrangements of a single axial portion 284 extending through a single wire passage lumen 294 and out of a single shaft opening 295 of exemplary wire shaft 29211and 292° are illustrated in Figs. 18A and 18B, respectively, it is to be understood that in some examples, a single axial portion 284 can extend through a single nosecone-shaft wire -passage channel 222 and out of a single side opening 221 of a nosecone shaft 218, to similarly define a single radial portion 290.

[0241] Figs. 19A and 19B are perspective and cross-sectional side views, respectively, of a distal portion of an exemplary delivery apparatus 202p. Delivery apparatus 202pis similar to any example described herein for delivery apparatus 202k, except that the wire 280pof delivery apparatus 202pfurther defines a circumferentially extending portion 286 coupled to the inner surface of the balloon wall 236.

[0242] In some examples, a wire shaft 292pcan be similar to any example described above with respect to wire shaft 292k, and can define two wire passage lumens 294a, 294b terminating at respective shaft opening 295a, 295b, optionally on diametrically opposing sides of a primary lumen 291 through which the nosecone shaft 218 extends, as illustrated for example in Figs. 19A-19B.

[0243] Wire 280pdefines a first axial portion 284a extending through the first wire passage lumen 294a, and a first radial portion 290a continuously extending from the first axial portion 284a, out of the first shaft opening 295a, radially towards the balloon wall 236, at which point the wire 280pcan be coupled to the balloon wall 236, optionally by a first wall connector 258a.Docket No.: THVMC-13640W001The wire 280pfurther defines a circumferentially extending portion 286 continuously extending from the first radial portion 290a along the inner surface of the balloon wall 236, and a second radial portion 290b continuously extending from the circumferentially extending portion 286, optionally towards a second wall connector 258b at an outer end of the second radial portion 290b, wherein the second radial portion 290b then extends radially from the balloon wall 236 towards the second shaft opening 295b, entering therethrough to further define a second axial portion 284b continuously extending from the second radial portion 290b, through the second wire passage lumen 294b.

[0244] In some examples, at least one, and optionally a plurality of additional wall connectors 258 can be disposed between the first wall connector 258a and the second wall connector 258b, utilized to couple the circumferentially extending portion 286 to balloon wall 236. When wall connectors 258 are used to couple the circumferentially extending portion 286 to the balloon wall 236 of delivery apparatus 202p, the wall connectors 258 are designed to allow slidable movement of the circumferentially extending portion 286 therealong in the circumferential direction, so as to allow change in length of the circumferentially extending portion 286 when the diameter of the balloon 234 is changed. In some examples, a single elongated wall connector, which can be in the form of a sleeve defining an internal channel, can be used instead of a plurality of discrete shorter wall connectors.

[0245] In some examples, the circumferentially extending portion 286 can span about 180° (for example, between 160° and 200°) around the central longitudinal axis Cx, as illustrated in Figs. 19A-19B, such that the first radial portion 290a and the second radial portion 290b extend in diametrically opposing directions from the respective shaft openings 295a, 295b. In some examples, the circumferentially extending portion 286 can span less than 180°, such that instead of being diametrically opposite to each other, the first radial portion 290a and the second radial portion 290b are correspondingly angularly offset from each other by less than 180°. In some examples, the circumferentially extending portion 286 can span more than 180°, such that the first radial portion 290a and the second radial portion 290b are correspondingly angularly offset from each other by more than 180°.

[0246] While a single wire shaft 292pthat defines two separate wire passage lumen 294a, 294b and shaft openings 295a, 295b is illustrated in Figs. 19A-19B, it is to be understood that two radial portions 290a, 290b of a delivery apparatus 202pcan extend from openings of other shafts disclosed herein. In some examples, two separate wire shafts, such as wire shafts 2921described above with respect to Fig. 16B, can be similarly used in delivery apparatus 202pinstead of a single wire shaft disposed around the nosecone shaft 218, mutatis mutandis. InDocket No.: THVMC-13640W001 some examples, two radial portions 290a, 290b of delivery apparatus 202pcan extend from side openings 221 of a nosecone shaft, similar to nosecone shaft 218mdescribed above with respect to Fig. 17, which can be similarly used in delivery apparatus 202pinstead of a wire shaft 292, mutatis mutandis.

[0247] Compared with the configuration of delivery apparatus 202k, the exemplary delivery apparatus 202pcan advantageously improve sensitivity of measurement as it is further correlated to direct measurement of change of at least a portion of the perimeter of balloon wall 236 instead of solely relying on radial portions 290 that measure change in the radius or diameter of the balloon 234.

[0248] Fig. 20 shows a distal portion of an exemplary delivery apparatus 202q. Delivery apparatus 202qis similar to any example described herein for delivery apparatus 202k, except that instead of a radial portion 290, a wire 280qof delivery apparatus 202qdefines at least one proximal angled portion 287 and at least one distal angled portion 289.

[0249] In some examples, a wire shaft 292qcan be similar to any example described above with respect to wire shaft 292k, and can define two wire passage lumens 294a, 294b terminating at respective shaft opening 295a, 295b, optionally on diametrically opposing sides of a primary lumen 291 through which the nosecone shaft 218 extends, as illustrated for example in Fig. 20. In some examples, the shaft distal end 296 can be optionally positioned proximal to the balloon intermediate section 242. In some examples, the shaft distal end 296 can be optionally axially aligned with the balloon proximal section 240. In some examples, the shaft opening(s) 295 can be optionally positioned proximal to the balloon intermediate section 242. In some examples, the shaft opening(s) 295 can be optionally axially aligned with the balloon proximal section 240.

[0250] In the example illustrated in Fig .20, a first axial portion 284a of wire 280qextends through the first wire passage lumen 294a, and a first proximal angled portion 287a continuously extends from the first axial portion 284a, out of the first shaft opening 295a, at a generally diagonal orientation distally and radially outwards towards the balloon wall 236, such as an inner surface of balloon intermediate section, at which point the wire 280qcan be coupled to the balloon wall 236, optionally by a first wall connector 258a. The wire 280qfurther includes a first distal angled portion 289a continuously extending from the first proximal angled portion 287a, such as from the first wall connector 258a, at a generally diagonal orientation distally and radially inwards towards the central axis Cx, terminating at a first wire distal end 282a coupled to and / or affixed to a portion of the delivery apparatus 202q, optionally at a position that can be distal to the balloon intermediate section 242. In some examples, theDocket No.: THVMC-13640W001 wire distal end 282 of wire 280qcan be coupled and / or affixed, such as by being bonded, glued, sutured and the like, to any of: the balloon distal section 244, the nosecone proximal end portion 228, the nosecone shaft 218, and / or a connector or other component attached to the nosecone proximal end portion 228 or the nosecone shaft 218.

[0251] The exemplary apparatus 202qillustrated in Fig. 20 is further shown to include a second axial portion 284b, a second proximal angled portion 287b diagonally extending from the second axial portion 284b distally and radially outwards towards a second wall connector 258b, and a second distal angled portion 289b diagonally extending from the second wall connector 258b distally and radially inwards, terminating at a second wire distal end 282a that can be similarly affixed to a portion of the delivery apparatus 202q. In some examples, the first proximal angled portion 287a and the second proximal angled portion 287a can diverge in opposite directions, towards diametrically opposing first wall connector 258a and second wall connector 258b.

[0252] In some examples, delivery apparatus 202qcan include a plurality of wires 280q, such as a first wire 280qa defining the first axial portion 284a, the first proximal angled portion 287a and the first distal angled portion 289a, and a second wire 280qb defining the second axial portion 284b, the second proximal angled portion 287b and the second distal angled portion 289b, as indicated for example in Fig. 20. In some examples, each separate wire 280qcan be optionally coupled, at a corresponding wire proximal end 281 thereof, to a separate sensor 260. In some examples, wire proximal ends 281 of two separate wires 280qcan be coupled to the same sensor 260. In some examples, delivery apparatus 202qcan include a single wire 280qdefining both axial portions 284a, 284b, both proximal angled portions 287a, 287b and both distal angled portions 289a, 289b, wherein both axial portions 284 of the single wire 280qcan be continuous with each other and coupled at a common wire proximal end 281 thereof to a single sensor 260, as will be described in greater detail below, for example, with respect to Figs. 21A-21B.

[0253] While a single wire shaft 292qthat defines two separate wire passage lumen 294a, 294b and shaft openings 295a, 295b is illustrated in Fig. 20, it is to be understood that two proximal angled portions 287a, 287b of a delivery apparatus 202qcan extend from openings of other shafts disclosed herein. In some examples, two separate wire shafts, such as wire shafts 2921described above with respect to Fig. 16B, can be similarly used in delivery apparatus 202qinstead of a single wire shaft disposed around the nosecone shaft 218, mutatis mutandis, wherein the shaft distal ends 296a, 296b can be optionally positioned proximal to the balloon intermediate section 242, so as to axially align the shaft openings 295a, 295b with the balloonDocket No.: THVMC-13640W001 proximal section 240. In some examples, two proximal angled portions 287a, 287b of delivery apparatus 202qcan extend from side openings 221 of a nosecone shaft, similar to nosecone shaft 218mdescribed above with respect to Fig. 17, which can be similarly used in delivery apparatus 202qinstead of a wire shaft 292, mutatis mutandis, wherein the side openings 221 can be optionally formed proximal to the balloon intermediate section 242, such as in axial alignment with the balloon proximal section 240.

[0254] In some examples, more than two proximal angled portions 287 and corresponding distal angled portions 289 extending therefrom can be provided, angularly offset from each other. A plurality of proximal angled portions 287 and corresponding distal angled portions 289 extending therefrom can be equally or not equally spaced from each other around the circumference of the central longitudinal axis Cx.

[0255] In some examples, a single wire 280qof a delivery apparatus 202qcan optionally define a single proximal angled portion 287 and a single distal angled portion 289 extending therefrom. In some examples, a delivery apparatus 202qcan optionally include a wire shaft 292 that defines a primary lumen and a single wire passage lumen 294, similar to wire shaft 292ndescribed above with respect to Fig. 18 A. In some examples, a delivery apparatus 202qcan optionally include a single wire shaft 292 which is radially offset from the nosecone shaft 218, similar to wire shaft 292° described above with respect to Fig. 18B. In some examples, a delivery apparatus 202qcan optionally include a nosecone shaft 218 that includes a single nosecone-shaft wire passage channel 222 leading to a single side opening 221.

[0256] An important design parameter of a delivery assembly 200 is the diameter of the crimped profile. The diameter of the crimped profile is important because it directly influences the physician's ability to advance a prosthetic valve 100, which can be crimped over a deflated balloon 234, through the femoral artery or vein. More particularly, a smaller profile allows for treatment of a wider population of subjects, with enhanced safety.

[0257] A delivery apparatus 202 that includes a wire 280 defining one or more radial portions 290, such as any of the exemplary delivery apparatuses 202 described above with respect to Figs. 14-16B or 18A-19B, may comprise one or more wire shafts 292 configured to be sufficiently advanced into balloon 234 to position the corresponding one or more shaft openings 295 from which the radial portions 290 extend, in alignment with the balloon intermediate section 242. This can result in increase of the crimped profile due to the added wire shaft(s) 292 extending into balloon cavity 238. In contrast, the configuration described herein for exemplary delivery apparatus 202q, which is devoid of radial portions 290 of the wire 280, can be advantageous in that the one or more proximal angled portions 287 areDocket No.: THVMC-13640W001 diagonally extending from the corresponding one or more shaft openings 295, allowing the shaft distal end(s) 296 to be positioned proximal to the balloon intermediate section 242, which means that the wire shaft(s) 292 can axially terminate proximal to the position of the prosthetic valve 100 crimped around the balloon intermediate section 242, without extending further distally into the balloon cavity 238, thereby optionally reducing the overall crimped profile of the delivery apparatus 202q.

[0258] Nevertheless, the measurement sensitivity of a delivery apparatus 202 that includes a wire 280 defining one or more radial portions 290, such as any of the exemplary delivery apparatuses 202 described above with respect to Figs. 14-16B or 18A-19B, can be better than that of the delivery apparatus 202qwhich is devoid of radial portion 290, since the change in axial translation of a wire proximal end 281 and a component of the sensor 260 coupled thereto, in response to change in diameter of the balloon 234, is greater in the case of a wire 280 having a radial portion 290 than for a wire 280qhaving proximal and distal angled portions 287, 289.

[0259] Fig. 21A is a cross-sectional side view of a proximal portion of an exemplary delivery apparatus 202r. Fig. 21B is a cross-sectional view taken along line 21B-21B of Fig. 21A. Delivery apparatus 202ris an exemplary implementation of delivery apparatus 202, and thus can include any of the features described for delivery apparatus 202 throughout the current disclosure, except that the balloon catheter hub 270rof delivery apparatus 202rcomprises the sensor 260 at a position that can seal between the sensor 260 and the flow path of inflation fluid that can be introduced through the second port 272b. The delivery apparatus 202rand balloon catheter hub 270rthereof can be one optional implementation of the more general exemplary delivery apparatus 202eand balloon catheter hub 270ethereof, described herein with respect to Fig. 7.

[0260] The exemplary balloon catheter hub 270rcan include an axially movable plunger 278 connected (e.g., directly or indirectly) on one end thereof to the sensor 260, and on the opposite end to the wire 280. A plunger support mount 274 of the balloon catheter hub 270rsealingly separates between a portion of the hub 270rthat includes the sensor 260 and a portion of the hub 270rwhich is in fluid communication with the second port 272b. The plunger 278 extends through, and is axially movable relative to, an axial bore 273 of the plunger support mount 274. Optionally, the plunger support mount 274 can further define a groove 275 around the bore 273, configured to accommodate a sealing member, such as an O-ring 276, so as to properly seal around the plunger 278 and prevent inflation fluid from flowing across the plunger support mount 274.Docket No.: THVMC-13640W001

[0261] The wire 280 can be coupled to a distal end of the plunger 278 extending distally from the plunger support mount 274. In some examples, two axial portions 284 of the wire 280 can be continuous with each other, forming a common loop at the wire proximal end 281, which can be optionally looped through an aperture 277 formed at the distal end of the plunger 278, or otherwise coupled to the plunger 278, such as by suturing, gluing, and the like.

[0262] The plunger 278 can be connected, at a proximal end thereof, to an axially movable component of the sensor 260, such as to the transformer core 264 in the case of an LVDT sensor. In some examples, the plunger 278 can further define a proximal flange 279 at a proximal end thereof that extends proximally from the plunger support mount 274 (and connected to the sensor 260). A biasing member 266, which can be optionally implemented as a compression spring, can be disposed around the plunger 278 between the plunger support mount 274 and the proximal flange 279, configured to apply the minimal tension magnitude Ts to the wire 280 coupled to the plunger 278, in the absence of other external forces effective to cause a distal pull on the wire proximal end 281 in response to balloon expansion.

[0263] In some examples, the nosecone shaft 218 can extend through the plunger support mount 274, exposing the guidewire passage lumen 232 to the first port 272a, optionally in alignment with the first port 272a. In some examples, the plunger 278 can be radially offset from the guidewire passage lumen 232. In some examples, the bore 273 of the plunger support mount 274 can be radially offset from the guidewire passage lumen 232.

[0264] While Figs. 21A-21B show a single wire 280 defining two axial portions 284 forming a common loop (e.g., doubled over portion) at the wire proximal end 281, which is coupled in turn to the plunger 278, it is to be understood that this is shown by way of illustration and not limitation. In some examples, two separate wires 280, each defining a separate axial portion 284, can be each connected at a corresponding wire proximal end 281 thereof to the plunger 278. In some examples, a single wire 280 can be provided, having a single axial portion 284 attached, at its proximal end 281, to the plunger 278.

[0265] Fig. 22A is a perspective view of a distal portion of an exemplary delivery apparatus 202s, with the balloon shown in transparency to expose internal components disposed therein. Fig. 22B shows an isolated view of a distal portion of a wire 280sof the delivery apparatus 202sof Fig. 22A. Delivery apparatus 202sis similar to any example described herein for delivery apparatus 202p, except that the wire 280sof delivery apparatus 202sfurther defines a crossing portion 288 diametrically extending between two circumferentially extending portions 286a and 286b which are coupled to the inner surface of the balloon wall 236.Docket No.: THVMC-13640W001

[0266] In some examples, a wire shaft 292scan be similar to any example described above with respect to wire shaft 292k, and can define two wire passage lumens 294a, 294b terminating at respective shaft opening 295a, 295b, optionally on diametrically opposing sides of a primary lumen 291 through which the nosecone shaft 218 extends, as illustrated for example in Fig. 22A.

[0267] Wire 280sdefines a first axial portion 284a extending through the first wire passage lumen 294a, and a first radial portion 290a continuously extending from the first axial portion 284a, out of the first shaft opening 295a, radially towards the balloon wall 236, at which point the wire 280scan be coupled to the balloon wall 236, optionally by a first wall connector 258a. The wire 280sfurther defines a first circumferentially extending portion 286a continuously extending from the first radial portion 290a along the inner surface of the balloon wall 236, and a crossing portion 288 extending continuously from the first circumferentially extending portion 286a in a radial direction across the balloon cavity 238, towards a diametrically opposite side of the balloon wall 236. A second circumferentially extending portion 286b continuously extends from the crossing portion 288 along the inner surface of the balloon wall 236, optionally terminating at a second wall connector 258b, from which the wire 280scontinuously extends in a radial direction towards the central longitudinal axis Cx, defining the second radial portion 290b which enters into the second shaft opening 295b, from which point a second axial portion 284b is defined to extend through the second wire passage lumen 294b.

[0268] In some examples, at least one, and optionally a plurality of additional wall connectors 258 can be used to couple each of the first and second circumferentially extending portions 286a, 286b to balloon wall 236. When wall connectors 258 are used to couple the circumferentially extending portions 286a, 286b to the balloon wall 236 of delivery apparatus 2024, the wall connectors 258 are designed to allow slidable movement of the circumferentially extending portions 286a, 286b therealong in the circumferential direction, so as to allow change in lengths of the circumferentially extending portions 286a, 286b when the diameter of the balloon 234 is changed. In some examples, a single elongated wall connector, which can be in the form of a sleeve defining an internal channel, can be used instead of a plurality of discrete shorter wall connectors for each of the circumferentially extending portions 286a, 286b.

[0269] In some examples, each of the circumferentially extending portions 286a, 286b can span less than 180°, as illustrated in Figs. 22A-22B. In some examples, the first radial portion 290a and the second radial portion 290b extend in diametrically opposing directions from theDocket No.: THVMC-13640W001 respective shaft openings 295a, 295b. In some examples, the circumferentially extending portions 286a, 286b are disposed along diametrically opposite sides of the balloon 234. In some examples, the path of the crossing portion 288 is angled relative to, and crosses the path defined collectively by, the first and second radial portions 290a, 290b.

[0270] While a single wire shaft 292sthat defines two separate wire passage lumens 294a, 294b and shaft openings 295a, 295b is illustrated in Fig. 22A, it is to be understood that two radial portions 290a, 290b of a delivery apparatus 202scan extend from openings of other shafts disclosed herein. In some examples, two separate wire shafts, such as wire shafts 2921described above with respect to Fig. 16B, can be similarly used in delivery apparatus 202sinstead of a single wire shaft disposed around the nosecone shaft 218, mutatis mutandis. In some examples, two radial portions 290a, 290b of deliver)' apparatus 202scan extend from side openings 221 of a nosecone shaft, similar to nosecone shaft 218mdescribed above with respect to Fig. 17, which can be similarly used in delivery apparatus 202sinstead of a wire shaft 292, mutatis mutandis.

[0271] Compared with the configuration of delivery apparatus 202k, it is contemplated that the exemplary delivery apparatus 202scan advantageously improve sensitivity of measurement as it is further correlated to direct measurement of change of at least a portion of the perimeter of balloon wall 236 instead of solely relying on radial portions 290 that measure change in the radius or diameter of the balloon 234, as described above with respect to delivery apparatus 202pfor example. It is contemplated that the exemplary configuration of delivery apparatus 202killustrated in Figs. 22A-22B can be advantageous over the exemplary configuration of delivery apparatus 202pillustrated in Figs. 19A-19B in that sensitivity of measurement of delivery apparatus 202pcan be improved by direct measurement of change of a greater total portion of the perimeter of balloon wall 236, wherein the two circumferentially extending portions 286a, 286b of an exemplary wire 280scan optionally span across a greater portion of the perimeter than a single circumferentially extending portion 286 of an exemplary wire 280p. Some Examples of the Disclosed Technology

[0272] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0273] Example 1. A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall thatDocket No.: THVMC-13640W001 comprises: an inner layer defining a balloon cavity that is in fluid communication with the balloon catheter lumen; and an outer layer disposed around the inner layer; and a wire comprising: an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and a loop disposed between the inner layer and the outer layer of the balloon wall; and a sensor coupled to the wire proximal end; wherein the balloon is configured to transition between a deflated state and an inflated state; wherein the size of the loop is configured to change in response to change in diameter of the balloon wall during transition between the deflated and inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

[0274] Example 2. The delivery assembly of any example herein, particularly of example 1, wherein the loop of the wire extends through a circumferential channel defined between the inner layer and the outer layer of the balloon wall.

[0275] Example 3. The delivery assembly of any example herein, particularly of any one of examples 1 and 2, wherein the delivery apparatus further comprises a wire shaft defining a wire passage lumen through which the axial portion of the wire extends.

[0276] Example 4. The delivery assembly of any example herein, particularly of example 3, wherein the wire is axially movable relative to the wire shaft.

[0277] Example 5. The delivery assembly of any example herein, particularly of any one of examples 3 and 4, wherein the wire shaft terminates at a shaft distal end disposed inside the balloon cavity, and wherein the wire extends past the shaft distal end.

[0278] Example 6. The delivery assembly of any example herein, particularly of any one of examples 1-5, wherein the axial portion of the wire extends through the balloon catheter lumen towards the balloon cavity.

[0279] Example 7. The delivery assembly of any example herein, particularly of example 6, wherein the inner layer comprises an inner layer opening through which the wire extends from the balloon cavity to the loop of the wire.

[0280] Example 8. The delivery assembly of any example herein, particularly of any one of examples 1 -3, wherein the axial portion of the wire extends through a balloon catheter channel.

[0281] Example 9. The delivery assembly of any example herein, particularly of example 8, wherein the balloon catheter channel is formed inside a thickness of the balloon catheter wall.

[0282] Example 10. The delivery assembly of any example herein, particularly of any one of examples 8-9, wherein the balloon catheter channel is radially offset from the balloon catheter lumen.Docket No.: THVMC-13640W001

[0283] Example 11. The delivery assembly of any example herein, particularly of any one of examples 8-10, wherein the balloon catheter channel is exposed to a space between the inner layer and the outer layer of the balloon wall.

[0284] Example 12. The delivery assembly of any example herein, particularly of any one of examples 1-11, further comprising a sensor data unit in communication with the sensor.

[0285] Example 13. The delivery assembly of any example herein, particularly of example 12, wherein the sensor data unit is configured, based at least in part on an output of the sensor, to determine a diameter indication of the balloon.

[0286] Example 14. The delivery assembly of any example herein, particularly of example 13, wherein the determined diameter indication comprises a change in a radial diameter of the balloon.

[0287] Example 15. The delivery assembly of any example herein, particularly of any one of examples 12-13, further comprising a display, wherein the sensor data unit is configured to output an indication of the determined diameter indication on the display.

[0288] Example 16. The delivery assembly of any example herein, particularly of any one of examples 1-15, wherein the balloon comprises: a balloon proximal section attached to the balloon catheter; a balloon intermediate section extending distally from the balloon proximal section; and a balloon distal section extending distally from the balloon intermediate section; wherein the loop of the wire is axially aligned with the balloon intermediate section.

[0289] Example 17. The delivery assembly of any example herein, particularly of example 16, further comprising a prosthetic valve disposed around the balloon intermediate section, wherein, when the balloon is inflated, the prosthetic valve is configured to expand.

[0290] Example 18. The delivery assembly of any example herein, particularly of any one of examples 1-17, wherein the sensor comprises a linear displacement sensor.

[0291] Example 19. The delivery assembly of any example herein, particularly of example 18, wherein the linear displacement sensor comprises a linear variable differential transformer (LVDT) sensor.

[0292] Example 20. The delivery assembly of any example herein, particularly of example 19, wherein the LVDT sensor comprises a tube and a transformer core axially movable within the tube, and wherein the wire proximal end is coupled to the transformer core.

[0293] Example 21. The delivery assembly of any example herein, particularly of any one of examples 1-20, wherein the delivery apparatus further comprises a biasing member configured to apply an axially oriented pull-force on the axial portion of the wire.Docket No.: THVMC-13640W001

[0294] Example 22. The delivery assembly of any example herein, particularly of example 21, wherein the biasing member is coupled, directly or indirectly, to the wire proximal end.

[0295] Example 23. The delivery assembly of any example herein, particularly of any one of examples 1-20, wherein the delivery apparatus further comprises a biasing member coupled to the transformer core, and configured to apply an axially oriented pull-force on the axial portion of the wire.

[0296] Example 24. The delivery assembly of any example herein, particularly of any one of examples 21 -23, wherein the pull-force is sufficient to apply a minimal tension magnitude to the wire.

[0297] Example 25. The delivery assembly of any example herein, particularly of any one of examples 21-24, wherein the biasing member comprises a spring.

[0298] Example 26. The delivery assembly of any example herein, particularly of any one of examples 1-25, wherein the delivery apparatus further comprises a balloon catheter hub from which the balloon catheter distally extends, the balloon catheter hub comprising: a first port configured to receive a guidewire therethrough; and a second port in fluid communication with the balloon catheter lumen, the second port configured to receive fluid from a fluid source.

[0299] Example 27. The delivery assembly of any example herein, particularly of example 26, wherein the delivery apparatus further comprises a handle through which the balloon catheter extends, such that the balloon catheter hub is positioned proximal to the handle.

[0300] Example 28. The delivery assembly of any example herein, particularly of example 27, wherein the delivery apparatus further comprises an outer delivery shaft extending distally from the handle and around the balloon catheter.

[0301] Example 29. The delivery assembly of any example herein, particularly of any one of examples 26-28, wherein the balloon catheter hub comprises the sensor.

[0302] Example 30. The delivery assembly of any example herein, particularly of any one of examples 27-28, wherein the delivery apparatus further comprises a branch extending from the balloon catheter and coupled to a sensor housing which comprises the sensor.

[0303] Example 31. The delivery assembly of any example herein, particularly of example 30, wherein the branch is in fluid communication with the balloon catheter lumen.

[0304] Example 32. The delivery assembly of any example herein, particularly of any one of examples 30-31, wherein the branch is positioned between the handle and the balloon catheter hub.

[0305] Example 33. The delivery assembly of any example herein, particularly of any one of examples 27-28, wherein the handle comprises the sensor.Docket No.: THVMC-13640W001

[0306] Example 34. The delivery assembly of any example herein, particularly of example 33, wherein the balloon catheter wall further comprises a sealed side opening at a portion of the balloon catheter that extends through the handle, and wherein the wire extends from the balloon catheter, through the sealed side opening, towards the sensor.

[0307] Example 35. A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; and a stent disposed inside the balloon cavity and configured to self-expand against the balloon wall, the stent extending between a proximal end portion and a distal end portion; wherein the balloon is configured to transition between a deflated state and an inflated state; and wherein the stent is configured to expand against and track the balloon wall during transition of the balloon between the deflated state and the inflated state.

[0308] Example 36. The delivery assembly of any example herein, particularly of example 35, wherein the stent has an outward radial force that is lower than a force required to transition the balloon from the deflated state to the inflated state.

[0309] Example 37. The delivery assembly of any example herein, particularly of example 36, wherein the outward radial force of the stent is between 0.1N to 5N.

[0310] Example 38. The delivery assembly of any example herein, particularly of any one of examples 35-37, wherein the stent is coupled to an inner shaft axially extending therethrough.

[0311] Example 39. The delivery assembly of any example herein, particularly of any one of examples 35-38, wherein the distal end portion of the stent is affixed to the inner shaft.

[0312] Example 40. The delivery assembly of any example herein, particularly of any one of examples 35-38, wherein the distal end portion of the stent is axially slidable along the inner shaft.

[0313] Example 41. The delivery assembly of any example herein, particularly of any one of examples 35-40, wherein the proximal end portion of the stent is affixed to the inner shaft.

[0314] Example 42. The delivery assembly of any example herein, particularly of any one of examples 35-40, wherein the proximal end portion of the stent is axially slidable along the inner shaft.

[0315] Example 43. The delivery assembly of any example herein, particularly of any one of examples 35-42, wherein the inner shaft is a nosecone shaft of the delivery apparatus.

[0316] Example 44. The delivery assembly of any example herein, particularly of any one of examples 35-43, wherein the balloon comprises: a balloon proximal section attached to theDocket No.: THVMC-13640W001 balloon catheter; a balloon intermediate section extending distally from the balloon proximal section; and a balloon distal section extending distally from the balloon intermediate section; and wherein the stent comprises a stent intermediate section which is axially aligned with the balloon intermediate section both in the deflated state and in the inflated state of the balloon.

[0317] Example 45. The delivery assembly of any example herein, particularly of example 44, wherein the stent further comprises a stent distal section extending from the stent intermediate section to the distal end portion of the stent, and configured to assume a distally-tapering configuration in the inflated state of the balloon.

[0318] Example 46. The delivery assembly of any example herein, particularly of any one of examples 44-45, wherein the stent further comprises a stent proximal section extending from the stent intermediate section to the proximal end portion of the stent, and configured to assume a proximally-tapering configuration in the inflated state of the balloon.

[0319] Example 47. The delivery assembly of any example herein, particularly of any one of examples 44-46, wherein the delivery apparatus further comprises: a wire coupled to the stent and comprising an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the stent; and a sensor coupled to the wire proximal end; wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the stent during transition of the balloon between the deflated and inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

[0320] Example 48. The delivery assembly of any example herein, particularly of example 47, wherein the axial portion of the wire extends through the balloon catheter lumen towards the balloon cavity.

[0321] Example 49. The delivery assembly of any example herein, particularly of any one of examples 47-48, wherein the wire further comprises a loop disposed around the stent.

[0322] Example 50. The delivery assembly of any example herein, particularly of example 49, wherein the loop circumscribes the stent intermediate section.

[0323] Example 51. The delivery assembly of any example herein, particularly of any one of examples 49-50, wherein the size of the loop is configured to change in response to change in diameter of the stent.

[0324] Example 52. The delivery assembly of any example herein, particularly of any one of examples 49-51 , wherein the delivery apparatus further comprises a sleeve disposed around, and coupled to, the stent.Docket No.: THVMC-13640W001

[0325] Example 53. The delivery assembly of any example herein, particularly of example 52, wherein at least part of the loop extends through the sleeve and is slidable relative thereto.

[0326] Example 54. The delivery assembly of any example herein, particularly of any one of examples 47-48, wherein the wire is attached at a wire distal end thereof, to the stent.

[0327] Example 55. The delivery assembly of any example herein, particularly of example 54, wherein the wire distal end is attached to the proximal end portion of the stent.

[0328] Example 56. The delivery assembly of any example herein, particularly of example 55, wherein the stent is configured to axially foreshorten when it expands as the balloon moves from the deflated state to the inflated state.

[0329] Example 57. The delivery assembly of any example herein, particularly of any one of examples 47-57, wherein the delivery apparatus further comprises a wire shaft defining a wire passage lumen through which the axial portion of the wire extends.

[0330] Example 58. The delivery assembly of any example herein, particularly of example 57, wherein the wire is axially movable relative to the wire shaft.

[0331] Example 59. The delivery assembly of any example herein, particularly of any one of examples 57-58, wherein the wire shaft terminates at a shaft distal end disposed inside the balloon cavity, and wherein the wire extends past the shaft distal end.

[0332] Example 60. The delivery assembly of any example herein, particularly of any one of examples 47-59, wherein the delivery apparatus further comprises a biasing member configured to apply an axially oriented pull-force on the axial portion of the wire.

[0333] Example 61. The delivery assembly of any example herein, particularly of example 60, wherein the biasing member is coupled, directly or indirectly, to the wire proximal end.

[0334] Example 62. The delivery assembly of any example herein, particularly of any one of examples 47-59, wherein the wire is attached to an axially movable component of the sensor, and wherein the delivery apparatus further comprises a biasing member coupled to the axially movable component of the sensor and configured to apply an axially oriented pull-force on the axial portion of the wire.

[0335] Example 63. The delivery assembly of any example herein, particularly of any one of examples 60-62, wherein the pull-force is sufficient to apply a minimal tension magnitude to the wire.

[0336] Example 64. The delivery assembly of any example herein, particularly of any one of examples 60-63, wherein the biasing member comprises a spring.

[0337] Example 65. The delivery assembly of any example herein, particularly of any one of examples 47-64, wherein the delivery apparatus further comprises a balloon catheter hub fromDocket No.: THVMC-13640W001 which the balloon catheter distally extends, the balloon catheter hub comprising: a first port configured to receive a guidewire therethrough; and a second port in fluid communication with the balloon catheter lumen, the second port configured to receive fluid from a fluid source.

[0338] Example 66. The delivery assembly of any example herein, particularly of example 65, wherein the delivery apparatus further comprises a handle through which the balloon catheter extends, such that the balloon catheter hub is positioned proximal to the handle.

[0339] Example 67. The delivery assembly of any example herein, particularly of example 66, wherein the delivery apparatus further comprises an outer delivery shaft extending distally from the handle and around the balloon catheter.

[0340] Example 68. The delivery assembly of any example herein, particularly of any one of examples 65-67, wherein the balloon catheter hub comprises the sensor.

[0341] Example 69. The delivery assembly of any example herein, particularly of any one of examples 66-67, wherein the delivery apparatus further comprises a branch extending from the balloon catheter and coupled to a sensor housing which comprises the sensor.

[0342] Example 70. The delivery assembly of any example herein, particularly of example 69, wherein the branch is in fluid communication with the balloon catheter lumen.

[0343] Example 71. The delivery assembly of any example herein, particularly of any one of examples 69-70, wherein the branch is positioned between the handle and the balloon catheter hub.

[0344] Example 72. The delivery assembly of any example herein, particularly of any one of examples 66-67, wherein the handle comprises the sensor.

[0345] Example 73. The delivery assembly of any example herein, particularly of example 72, wherein the balloon catheter wall further comprises a sealed side opening at a portion of the balloon catheter that extends through the handle, and wherein the wire extends from the balloon catheter, through the sealed side opening, towards the sensor.

[0346] Example 74. The delivery assembly of any example herein, particularly of any one of examples 47-73, wherein the sensor comprises a linear displacement sensor.

[0347] Example 75. The delivery assembly of any example herein, particularly of example 74, wherein the linear displacement sensor comprises a linear variable differential transformer (LVDT) sensor.

[0348] Example 76. The delivery assembly of any example herein, particularly of example 75, wherein the LVDT sensor comprises a tube and a transformer core axially movable within the tube, and wherein the wire proximal end is coupled to the transformer core.Docket No.: THVMC-13640W001

[0349] Example 77. The delivery assembly of any example herein, particularly of any one of examples 44-46, wherein the delivery apparatus further comprises a linear displacement sensor disposed inside the balloon and configured to measure axial translation of either the distal end portion or the proximal end portion of the stent.

[0350] Example 78. The delivery assembly of any example herein, particularly of example 77, wherein the linear displacement sensor comprises an axially movable component which is coupled, directly or indirectly, to the proximal end portion of the stent.

[0351] Example 79. The delivery assembly of any example herein, particularly of example 78, wherein the stent is configured to axially foreshorten when it expands.

[0352] Example 80. The delivery assembly of any example herein, particularly of any one of examples 78-79, wherein the proximal end portion of the stent is configured to axially translate in response to change in diameter of the stent during transition of the balloon between the deflated and inflated state.

[0353] Example 81. The delivery assembly of any example herein, particularly of example 80, wherein the sensor is configured to measure axial translation of the proximal end portion of the stent.

[0354] Example 82. The delivery assembly of any example herein, particularly of any one of examples 78-81, wherein the linear displacement sensor comprises a linear variable differential transformer (LVDT) sensor.

[0355] Example 83. The delivery assembly of any example herein, particularly of example 82, wherein the LVDT sensor comprises a tube and a transformer core axially movable within the tube, and wherein the axially movable component of the linear displacement sensor is the transformer core.

[0356] Example 84. The delivery assembly of any example herein, particularly of any one of examples 47-83, further comprising a sensor data unit in communication with the sensor.

[0357] Example 85. The delivery assembly of any example herein, particularly of example 84, wherein the sensor data unit is configured, based at least in part on an output of the sensor, to determine a diameter indication of the balloon.

[0358] Example 86. The delivery assembly of any example herein, particularly of example 85, wherein the determined diameter indication comprises a change in a radial diameter of the balloon.

[0359] Example 87. The delivery assembly of any example herein, particularly of any one of examples 85-86, further comprising a display, wherein the sensor data unit is configured to output an indication of the determined diameter indication on the display.Docket No.: THVMC-13640W001

[0360] Example 88. The delivery assembly of any example herein, particularly of any one of examples 38-46, wherein the inner shaft further comprises at least one reference radiopaque marker, wherein at least one of the proximal end portion or the distal end portion of the stent comprises an indicator radiopaque marker, and wherein the axial position of the indicator radiopaque marker, relative to the at least one reference radiopaque marker, is indicative of a diameter of the stent.

[0361] Example 89. The delivery assembly of any example herein, particularly of example 88, wherein the stent is configured to axially foreshorten when it expands.

[0362] Example 90. The delivery assembly of any example herein, particularly of any one of examples 88-89, wherein the proximal end portion of the stent is configured to axially translate in response to change in diameter of the stent during transition of the balloon between the deflated and inflated state.

[0363] Example 91. The delivery assembly of any example herein, particularly of any one of examples 88-90, wherein the at least one reference radiopaque marker comprises a plurality of reference radiopaque markers, wherein each reference radiopaque marker is associated with a different diameter of the stent.

[0364] Example 92. The delivery assembly of any example herein, particularly of example 91, wherein alignment of the indicator radiopaque marker with any one of the reference radiopaque markers is indicative of the diameter associated with the respective reference radiopaque marker.

[0365] Example 93. The delivery assembly of any example herein, particularly of any one of examples 35-92, further comprising a prosthetic valve disposed around the balloon, wherein, when the balloon is inflated, the prosthetic valve is configured to expand.

[0366] Example 94. A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; a wire comprising: at least one axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and at least one radially diverging portion continuously extending from the axial portion of the wire and extending, inside the balloon cavity, radially away from a central longitudinal axis of the delivery apparatus towards the balloon wall; and a sensor coupled to the wire proximal end; wherein the balloon is configured to transition between a deflated state and an inflated state; wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between theDocket No.: THVMC-13640W001 deflated state and the inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

[0367] Example 95. The delivery assembly of any example herein, particularly of example 94, wherein the at least one axial portion is parallel to, and radially offset relative to, the central longitudinal axis.

[0368] Example 96. The delivery assembly of any example herein, particularly of any one of examples 94-95, wherein the balloon comprises: a balloon proximal section attached to the balloon catheter; a balloon intermediate section extending distally from the balloon proximal section; and a balloon distal section extending distally from the balloon intermediate section; wherein the radially diverging portion of the wire extends towards, and is coupled to, the balloon intermediate section.

[0369] Example 97. The delivery assembly of any example herein, particularly of example 96, wherein the delivery apparatus further comprises a wire shaft defining a primary lumen through which a nosecone shaft of the delivery apparatus extends, and at least one wire passage lumen having a shaft opening which is radially offset from the central longitudinal axis, wherein the axial portion of the wire extends through the wire passage lumen, and wherein the radially diverging portion extends between the shaft opening and the balloon wall.

[0370] Example 98. The delivery assembly of any example herein, particularly of example 96, wherein the delivery apparatus further comprises at least one wire shaft defining a wire passage lumen having a shaft opening, wherein the wire shaft is radially offset from the central longitudinal axis, wherein the axial portion of the wire extends through the wire passage lumen, and wherein the radially diverging portion extends between the shaft opening and the balloon wall.

[0371] Example 99. The delivery assembly of any example herein, particularly of any one of examples 97-98, wherein the shaft opening is at a shaft distal end of the corresponding wire shaft.

[0372] Example 100. The delivery assembly of any example herein, particularly of example 99, wherein the shaft distal end is axially aligned with the balloon intermediate section.

[0373] Example 101. The delivery assembly of any example herein, particularly of any one of examples 97-100, wherein the shaft opening is axially aligned with the balloon intermediate section.

[0374] Example 102. The delivery assembly of any example herein, particularly of example 96, wherein the delivery apparatus further comprises a nosecone shaft comprising a guidewireDocket No.: THVMC-13640W001 passage lumen, at least one nosecone shaft wire-passage channel which is radially offset from the guidewire passage lumen, and at least one side opening exposed to the corresponding nosecone shaft wire-passage channel, wherein the axial portion of the wire extends through the nosecone shaft wire-passage channel, and wherein the radially diverging portion extends between the side opening and the balloon wall.

[0375] Example 103. The delivery assembly of any example herein, particularly of example 102, wherein the side opening is axially aligned with the balloon intermediate section.

[0376] Example 104. The delivery assembly of any example herein, particularly of any one of examples 97-103, wherein the at least one radially diverging portion comprises a radial portion of the wire, the radial portion extending at a right angle relative to the central longitudinal axis.

[0377] Example 105. The delivery assembly of any example herein, particularly of example104, wherein the radial portion terminates at a wire distal end which is attached to the balloon wall.

[0378] Example 106. The delivery assembly of any example herein, particularly of example105, wherein the delivery apparatus further comprises a wall connector configured to attach the wire distal end to the balloon wall.

[0379] Example 107. The delivery assembly of any example herein, particularly of example97, wherein the at least one wire passage lumen comprises two wire passage lumens and the at least one shaft opening comprises two shaft openings, the two shaft openings disposed at different sides of the wire shaft.

[0380] Example 108. The delivery assembly of any example herein, particularly of example98, wherein the at least one wire shaft comprises two wire shafts angularly offset from each other relative to the central longitudinal axis.

[0381] Example 109. The delivery assembly of any example herein, particularly of example 102, wherein the at least one nosecone shaft wire-passage channel comprises two nosecone shaft wire-passage channels and the at least one side opening comprises two side openings, the two side openings disposed at different sides of the nosecone shaft.

[0382] Example 110. The delivery assembly of any example herein, particularly of any one of examples 107-109, wherein the at least one axial portion comprises two axial portions, wherein the at least one radially diverging portion comprises two radially diverging portions, and wherein each radially diverging portion comprises a radial portion extending at a right angle relative to the central longitudinal axis.Docket No.: THVMC-13640W001

[0383] Example 111. The delivery assembly of any example herein, particularly of example110, wherein the two radially diverging portions extend at diametrically opposite directions relative to the central longitudinal axis.

[0384] Example 112. The delivery assembly of any example herein, particularly of example111, wherein each radial portion terminates at a wire distal end which is attached to the balloon wall.

[0385] Example 113. The delivery assembly of any example herein, particularly of example1 12, wherein each wire distal end is attached to the balloon wall by a wall connector of the delivery apparatus.

[0386] Example 114. The delivery assembly of any example herein, particularly of any one of examples 110-111, wherein the wire further comprises a circumferentially extending portion coupled to, and extending along, the balloon wall, wherein the circumferentially extending portion continuously extends between the two radial portions.

[0387] Example 115. The delivery assembly of any example herein, particularly of example 114, wherein the circumferentially extending portion is slidable along the balloon wall.

[0388] Example 116. The delivery assembly of any example herein, particularly of any one of examples 114-115, wherein the circumferentially extending portion is coupled to the balloon wall by one or more wall connectors of the delivery apparatus.

[0389] Example 117. The delivery assembly of any example herein, particularly of any one of examples 114-116, wherein the circumferentially extending portion spans between 160° and 200° around the central longitudinal axis.

[0390] Example 118. The delivery assembly of any example herein, particularly of any one of examples 110-111, wherein the wire further comprises: two circumferentially extending portions, coupled to, and extending along, the balloon wall, wherein each of the two circumferentially extending portions continuously extends a corresponding one of the two radial portions; and a crossing portion continuously extending between the two circumferentially extending portions, wherein the crossing portion diametrically extends across the balloon cavity.

[0391] Example 119. The delivery assembly of any example herein, particularly of example 118, wherein each of the circumferentially extending portions is slidable along the balloon wall.

[0392] Example 120. The delivery assembly of any example herein, particularly of any one of examples 118-119, wherein each of the circumferentially extending portions is coupled to the balloon wall by one or more wall connectors of the delivery apparatus.Docket No.: THVMC-13640W001

[0393] Example 121. The delivery assembly of any example herein, particularly of any one of examples 114-116, wherein each of the circumferentially extending portions spans less than 180° around the central longitudinal axis.

[0394] Example 122. The delivery assembly of any example herein, particularly of any one of examples 97-103, wherein the at least one radially diverging portion comprises a proximal angled portion diagonally extending distally and radially away from the central longitudinal axis, and wherein the wire further comprises a distal angled portion continuously extending from the proximal angled portion at a distal and radially inwards oriented direction.

[0395] Example 123. The delivery assembly of any example herein, particularly of example122, wherein the distal angled portion terminates at a wire distal end which is affixed to a component of the delivery apparatus.

[0396] Example 124. The delivery assembly of any example herein, particularly of example123, wherein the wire distal end is affixed to a nosecone of the delivery apparatus.

[0397] Example 125. The delivery assembly of any example herein, particularly of example 123, wherein the wire distal end is affixed to a nosecone shaft of the delivery apparatus.

[0398] Example 126. The delivery assembly of any example herein, particularly of any one of examples 122-125, wherein the wire is slidably coupled to the balloon wall between the proximal angled portion and the distal angled portion.

[0399] Example 127. The delivery assembly of any example herein, particularly of example107, wherein the two shaft openings are at a distal end of the wire shaft.

[0400] Example 128. The delivery assembly of any example herein, particularly of example 127, wherein the distal end of the wire shaft is proximal to the balloon intermediate section.

[0401] Example 129. The delivery assembly of any example herein, particularly of example108, wherein the shaft opening of each of the two wire shafts is at a distal end of the corresponding wire shaft.

[0402] Example 130. The delivery assembly of any example herein, particularly of example 129, wherein the distal ends of the two wire shafts are proximal to the balloon intermediate section.

[0403] Example 131. The delivery assembly of any example herein, particularly of any one of examples 128 or 130, wherein the at least one axial portion comprises two axial portions, wherein the at least one radially diverging portion comprises two radially diverging portions, wherein each radially diverging portion comprises a proximal angled portion diagonally extending distally and radially away from the central longitudinal axis, and wherein eachDocket No.: THVMC-13640W001 proximal angled portion continuously extends to a distal angled portion that extends at a distal and radially inwards oriented direction.

[0404] Example 132. The delivery assembly of any example herein, particularly of example131, wherein each distal angled portion terminates at a wire distal end which is affixed to a component of the delivery apparatus.

[0405] Example 133. The delivery assembly of any example herein, particularly of example132, wherein each wire distal end is affixed to a nosecone of the delivery apparatus.

[0406] Example 134. The delivery assembly of any example herein, particularly of example 132, wherein each wire distal end is affixed to a nosecone shaft of the delivery apparatus.

[0407] Example 135. The delivery assembly of any example herein, particularly of any one of examples 131-134, wherein the wire is slidably coupled to the balloon wall at each portion thereof defined between one of the proximal angled portions and the corresponding distal angled portion.

[0408] Example 136. The delivery assembly of any example herein, particularly of any one of examples 94-135, further comprising a sensor data unit in communication with the sensor.

[0409] Example 137. The delivery assembly of any example herein, particularly of example136, wherein the sensor data unit is configured, based at least in part on an output of the sensor, to determine a diameter indication of the balloon.

[0410] Example 138. The delivery assembly of any example herein, particularly of example137, wherein the determined diameter indication comprises a change in a radial diameter of the balloon.

[0411] Example 139. The delivery assembly of any example herein, particularly of any one of examples 137-138, further comprising a display, wherein the sensor data unit is configured to output an indication of the determined diameter indication on the display.

[0412] Example 140. The delivery assembly of any example herein, particularly of any one of examples 94-139, further comprising a prosthetic valve disposed around the balloon, wherein, when the balloon is inflated, the prosthetic valve is configured to expand.

[0413] Example 141. The delivery assembly of any example herein, particularly of any one of examples 94-140, wherein the sensor comprises a linear displacement sensor.

[0414] Example 142. The delivery assembly of any example herein, particularly of example 141 , wherein the linear displacement sensor comprises a linear variable differential transformer (LVDT) sensor.Docket No.: THVMC-13640W001

[0415] Example 143. The delivery assembly of any example herein, particularly of example142, wherein the LVDT sensor comprises a tube and a transformer core axially movable within the tube, and wherein the wire proximal end is coupled to the transformer core.

[0416] Example 144. The delivery assembly of any example herein, particularly of example143, wherein the delivery apparatus further comprises a balloon catheter hub from which the balloon catheter distally extends, the balloon catheter hub comprising: a first port configured to receive a guidewire therethrough; and a second port in fluid communication with the balloon catheter lumen, the second port configured to receive fluid from a fluid source.

[0417] Example 145. The delivery assembly of any example herein, particularly of example144, wherein the balloon catheter hub comprises the sensor.

[0418] Example 146. The delivery assembly of any example herein, particularly of example145, wherein the wire proximal end is coupled to a plunger which is attached to the transformer core.

[0419] Example 147. The delivery assembly of any example herein, particularly of example146, wherein the balloon catheter hub further comprises plunger support mount which sealingly separates between a portion of the balloon catheter hub that includes the sensor and a portion of the balloon catheter hub which is in fluid communication with the second port.

[0420] Example 148. The delivery assembly of any example herein, particularly of example147, wherein the plunger extends through, and is axially movable relative to, an axial bore of the plunger support mount.

[0421] Example 149. The delivery assembly of any example herein, particularly of example148, wherein the delivery apparatus further comprises a biasing member disposed around the plunger and configured to apply an axially oriented pull-force on the axial portion of the wire.

[0422] Example 150. The delivery assembly of any example herein, particularly of example149, wherein the pull-force is sufficient to apply a minimal tension magnitude to the wire.

[0423] Example 151. The delivery assembly of any example herein, particularly of any one of examples 149-150, wherein the biasing member comprises a spring.

[0424] Example 152. The delivery assembly of any example herein, particularly of any one of examples 149-151, wherein the biasing member extends between the plunger support mount and a proximal flange of the plunger.

[0425] Example 153. A delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a balloon cavity that is in fluid communication with the balloon catheter; a wire comprising an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and aDocket No.: THVMC-13640W001 sensor coupled to the wire proximal end; wherein the balloon is configured to transition between a deflated state and an inflated state: wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between the deflated state and the inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

[0426] Example 154. The delivery assembly of any example herein, particularly of example 153, wherein the wire is coupled to the balloon wall.

[0427] Example 155. The delivery assembly of any example herein, particularly of any one of examples 153-154. wherein the wire comprises a loop continuously extending from the axial portion.

[0428] Example 156. The delivery assembly of any example herein, particularly of example 155, wherein the loop is disposed between an inner layer and an outer layer of the balloon wall.

[0429] Example 157. The delivery assembly of any example herein, particularly of any one of examples 153-154, wherein the wire comprises at least one radial portion extending continuously from the axial portion towards the balloon wall.

[0430] Example 158. The delivery assembly of any example herein, particularly of example 157, wherein the at least one radial portion is attached, at a wire distal end thereof, to the balloon wall.

[0431] Example 159. The delivery assembly of any example herein, particularly of example 157, wherein the at least one radial portion comprises two radial portions.

[0432] Example 160. The delivery assembly of any example herein, particularly of example 159, wherein the two radial portions extend towards diametrically opposing sides of the balloon wall.

[0433] Example 161. The delivery assembly of any example herein, particularly of any one of examples 159-160, wherein each of the two radial portions is attached, at a wire distal end thereof, to the balloon wall.

[0434] Example 162. The delivery assembly of any example herein, particularly of any one of examples 159-160, wherein the wire further comprises a circumferentially extending portion coupled to, and extending along, the balloon wall, wherein the circumferentially extending portion continuously extends between the two radial portions.

[0435] Example 163. The delivery assembly of any example herein, particularly of any one of examples 159-160, wherein the wire further comprises: two circumferentially extending portions, coupled to, and extending along, the balloon wall, wherein each of the twoDocket No.: THVMC-13640W001 circumferentially extending portions continuously extends a corresponding one of the two radial portions; and a crossing portion continuously extending between the two circumferentially extending portions, wherein the crossing portion diametrically extends across the balloon cavity.

[0436] Example 164. The delivery assembly of any example herein, particularly of any one of examples 153-154, wherein the wire further comprises at least one proximal angled portion diagonally extending distally and radially away from a central longitudinal axis of the delivery apparatus.

[0437] Example 165. The delivery assembly of any example herein, particularly of example 164, wherein the wire further comprises a distal angled portion continuously extending from the at least one proximal angled portion at a distal and radially inwards oriented direction.

[0438] Example 166. The delivery assembly of any example herein, particularly of example 153, further comprising a stent disposed inside the balloon cavity and configured to self-expand against and track the balloon wall during transition of the balloon between the deflated state and the inflated state.

[0439] Example 167. The delivery assembly of any example herein, particularly of example 166, wherein the wire is coupled to the stent.

[0440] Example 168. The delivery assembly of any example herein, particularly of any one of examples 166-167, wherein the wire further comprises a loop circumscribing the stent.

[0441] Example 169. The delivery assembly of any example herein, particularly of any one of examples 166-167, wherein the wire is attached, at a wire distal end thereof, to the stent.

[0442] Example 170. The delivery assembly of any example herein, particularly of example 169, wherein the wire distal end is affixed to a proximal end portion of the stent.

[0443] Example 171. A delivery apparatus comprising: a balloon catheter; an inflatable balloon mounted on and in fluid communication with a lumen of the balloon catheter; and a wire extending along the balloon catheter and comprising a loop, wherein the size of the loop is configured to change in response to change in the size of the balloon.

[0444] Example 172. The delivery assembly of any example herein, particularly of example 171, wherein the loop is disposed between an inner layer and an outer layer of the inflatable balloon.

[0445] Example 173. The delivery assembly of any example herein, particularly of example171, further comprising a sensor coupled to a proximal end of the wire.

[0446] Example 174. The delivery assembly of any example herein, particularly of example172, wherein the change in the size of the loop is configured to cause a proportional axialDocket No.: THVMC-13640W001 translation of the proximal end of the wire, and wherein the sensor is configured to measure the axial translation of the proximal end of the wire.

[0447] Example 175. A delivery apparatus, comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a balloon cavity that is in fluid communication with the balloon catheter lumen; and a stent positioned in the balloon cavity.

[0448] Example 176. A delivery apparatus of any of the examples herein, particularly example175, wherein the stent is configured to self-expand.

[0449] Example 177. A delivery apparatus of any of the examples herein, particularly example176, wherein the stent is configured to self-expand against the balloon wall, and wherein the stent extends between a proximal end portion and a distal end portion.

[0450] Example 178. A delivery apparatus of any of the examples herein, particularly any of examples 175-177, wherein the balloon is configured to transition between a deflated state and an inflated state, and wherein the stent is configured to expand against the balloon wall during transition of the balloon between the deflated state and the inflated state.

[0451] Example 179. A delivery assembly comprising a delivery apparatus of any of the examples herein, particularly any of examples 175-178.

[0452] Example 180. A delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; a wire, comprising: at least one axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and at least one radially diverging portion continuously extending from the axial portion of the wire and extending, inside the balloon cavity, radially away from a central longitudinal axis of the delivery apparatus towards the balloon wall.

[0453] Example 181. A delivery apparatus of any of the examples herein, particularly example180, further comprising a sensor coupled to the wire proximal end, wherein the balloon is configured to transition between a deflated state and an inflated state; and wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between the deflated state and the inflated state.

[0454] Example 182. A delivery apparatus of any of the examples herein, particularly example181, wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between the deflated state and theDocket No.: THVMC-13640W001 inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

[0455] Example 183. A delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; a wire, comprising: at least one axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and at least one portion continuously extending from the axial portion of the wire and extending, inside the balloon cavity.

[0456] Thus, specific examples of devices, assemblies, apparatuses and methods comprising and / or relating to an inflatable device have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the devices and methods disclosed herein. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the devices and methods disclosed herein. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0457] 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 sub-combination 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.

[0458] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons ofDocket No.: THVMC-13640W001 convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0459] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

[0460] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

Docket No.: THVMC-13640W001CLAIMS1. A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; and a stent disposed inside the balloon cavity and configured to self-expand against the balloon wall, the stent extending between a proximal end portion and a distal end portion; wherein the balloon is configured to transition between a deflated state and an inflated state; and wherein the stent is configured to expand against and track the balloon wall during transition of the balloon between the deflated state and the inflated state.

2. The delivery assembly of claim 1, wherein the stent has an outward radial force that is lower than a force required to transition the balloon from the deflated state to the inflated state.

3. The delivery assembly of claim 2, wherein the outward radial force of the stent is between 0.1N to 5N.

4. The delivery assembly of any one of claims 1-3, wherein the balloon comprises: a balloon proximal section attached to the balloon catheter; a balloon intermediate section extending distally from the balloon proximal section; and a balloon distal section extending distally from the balloon intermediate section; and wherein the stent comprises a stent intermediate section which is axially aligned with the balloon intermediate section both in the deflated state and in the inflated state of the balloon.

5. The delivery assembly of claim 4, wherein the delivery apparatus further comprises: a wire coupled to the stent and comprising an axial portion distally extending from a wire proximal end, along the balloon catheter, towards the stent; and a sensor coupled to the wire proximal end; wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the stent during transition of the balloon between the deflatedDocket No.: THVMC-13640W001 and inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

6. The delivery assembly of claim 5, wherein the wire further comprises a loop disposed around the stent.

7. The delivery assembly of claim 5, wherein the wire is attached at a wire distal end thereof, to the stent.

8. The delivery assembly of claim 4, wherein the delivery apparatus further comprises a linear displacement sensor disposed inside the balloon and configured to measure axial translation of either the distal end portion or the proximal end portion of the stent.

9. The delivery assembly of claim 8, wherein the linear displacement sensor comprises an axially movable component which is coupled, directly or indirectly, to the proximal end portion of the stent.

10. The delivery assembly of claim 4, wherein the stent is coupled to an inner shaft axially extending therethrough, wherein the inner shaft comprises at least one reference radiopaque marker, wherein at least one of the proximal end portion or the distal end portion of the stent comprises an indicator radiopaque marker, and wherein the axial position of the indicator radiopaque marker, relative to the at least one reference radiopaque marker, is indicative of a diameter of the stent.

11. The delivery assembly of claim 10, wherein the at least one reference radiopaque marker comprises a plurality of reference radiopaque markers, wherein each reference radiopaque marker is associated with a different diameter of the stent.

12. A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; a wire comprising: at least one axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; andDocket No.: THVMC-13640W001 at least one radially diverging portion continuously extending from the axial portion of the wire and extending, inside the balloon cavity, radially away from a central longitudinal axis of the delivery apparatus towards the balloon wall; and a sensor coupled to the wire proximal end; wherein the balloon is configured to transition between a deflated state and an inflated state; wherein the axial portion of the wire is configured to axially translate in response to change in diameter of the balloon wall during transition between the deflated state and the inflated state, causing a proportional axial translation of the wire proximal end; and wherein the sensor is configured to measure the axial translation of the wire proximal end.

13. The delivery assembly of claim 12, wherein the balloon comprises: a balloon proximal section attached to the balloon catheter; a balloon intermediate section extending distally from the balloon proximal section; and a balloon distal section extending distally from the balloon intermediate section; wherein the radially diverging portion of the wire extends towards, and is coupled to, the balloon intermediate section.

14. The delivery assembly of claim 13, wherein the delivery apparatus further comprises a wire shaft defining a primary lumen through which a nosecone shaft of the delivery apparatus extends, and at least one wire passage lumen having a shaft opening which is radially offset from the central longitudinal axis, wherein the axial portion of the wire extends through the wire passage lumen, and wherein the radially diverging portion extends between the shaft opening and the balloon wall.

15. The delivery assembly of claim 13, wherein the delivery apparatus further comprises at least one wire shaft defining a wire passage lumen having a shaft opening, wherein the wire shaft is radially offset from the central longitudinal axis, wherein the axial portion of the wire extends through the wire passage lumen, and wherein the radially diverging portion extends between the shaft opening and the balloon wall.

16. The delivery assembly of any one of claims 14-15, wherein the at least one radially diverging portion comprises a radial portion of the wire, the radial portion extending at a right angle relative to the central longitudinal axis.Docket No.: THVMC-13640W00117. The delivery assembly of claim 16, wherein the radial portion terminates at a wire distal end which is attached to the balloon wall.

18. The delivery assembly of claim 14, wherein the at least one wire passage lumen comprises two wire passage lumens and the at least one shaft opening comprises two shaft openings, the two shaft openings disposed at different sides of the wire shaft, wherein the at least one axial portion comprises two axial portions, wherein the at least one radially diverging portion comprises two radially diverging portions, and wherein each radially diverging portion comprises a radial portion extending at a right angle relative to the central longitudinal axis.

19. The delivery assembly of claim 18, wherein the two radially diverging portions extend at diametrically opposite directions relative to the central longitudinal axis.

20. The delivery assembly of any one of claims 18-19, wherein the wire further comprises a circumferentially extending portion coupled to, and extending along, the balloon wall, wherein the circumferentially extending portion continuously extends between the two radial portions.

21. The delivery assembly of any one of claims 18-19, wherein the wire further comprises: two circumferentially extending portions, coupled to, and extending along, the balloon wall, wherein each of the two circumferentially extending portions continuously extends a corresponding one of the two radial portions; and a crossing portion continuously extending between the two circumferentially extending portions, wherein the crossing portion diametrically extends across the balloon cavity.

22. The delivery assembly of any one of claims 14-15, wherein the at least one radially diverging portion comprises a proximal angled portion diagonally extending distally and radially away from the central longitudinal axis, and wherein the wire further comprises a distal angled portion continuously extending from the proximal angled portion at a distal and radially inwards oriented direction.

23. The delivery assembly of claim 22, wherein the distal angled portion terminates at a wire distal end which is affixed to a component of the delivery apparatus.

24. A delivery apparatus, comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen;Docket No.: THVMC-13640W001 an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a balloon cavity that is in fluid communication with the balloon catheter lumen; and a stent positioned in the balloon cavity.

25. A delivery apparatus comprising: a balloon catheter comprising a balloon catheter wall defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and comprising a balloon wall defining a cavity that is in fluid communication with the balloon catheter lumen; a wire, comprising: at least one axial portion distally extending from a wire proximal end, along the balloon catheter, towards the balloon; and at least one portion continuously extending from the axial portion of the wire and extending, inside the balloon cavity.

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