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WO2025151779A1 - Ensembles de distribution avec capteurs ultrasonores - Google Patents

Ensembles de distribution avec capteurs ultrasonores

Info

Publication number
WO2025151779A1
WO2025151779A1 PCT/US2025/011182 US2025011182W WO2025151779A1 WO 2025151779 A1 WO2025151779 A1 WO 2025151779A1 US 2025011182 W US2025011182 W US 2025011182W WO 2025151779 A1 WO2025151779 A1 WO 2025151779A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
sensor
ultrasound
delivery assembly
examples
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/011182
Other languages
English (en)
Inventor
David Maimon
Elazar Levi SCHWARCZ
Ilan LESHECZ
Halit YAAKOBOVICH
Noa Axelrod Manela
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025151779A1 publication Critical patent/WO2025151779A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics

Definitions

  • 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 transcatheter heart valves.
  • 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.
  • valve stenosis is the calcification or narrowing of a native heart valve.
  • the native heart valve is not able to completely open and blood flow through the native valve is impeded or restricted.
  • valve insufficiency is the failure of a native heart valve to close properly to prevent leaking, or backflow, of blood through the valve.
  • a balloon member that is expanded within the native heart valve.
  • 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.
  • 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.
  • a prosthetic valve such as a balloon expandable valve
  • 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 an ultrasound sensor placed inside the balloon's cavity
  • adding a components such as the ultrasound sensor, inside the balloon, over which the prosthetic valve is crimped may negatively affect the overall crimped profile, making it harder to pass the delivery assembly through narrow portions of the patient's vasculature.
  • a delivery assembly comprising a delivery apparatus.
  • the delivery apparatus comprises: a balloon catheter defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and defining a balloon cavity that is in fluid communication with the balloon catheter lumen.
  • 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.
  • the delivery apparatus comprises at least one ultrasound sensor configured to move between a first position which is axially offset from the balloon intermediate section, and a second position which is axially aligned with the balloon intermediate section inside the balloon cavity.
  • a method comprising: advancing a deliver ⁇ ' assembly that comprises a delivery apparatus comprising a balloon mounted on a balloon catheter and at least one ultrasound sensor, to a target site of treatment, while the at least one ultrasound sensor is in a first position which is axially offset from an intermediate balloon section of the balloon; and inflating the balloon by streaming inflation fluid into a cavity of the balloon.
  • the method comprises axially moving the at least one ultrasound sensor to a second position which is aligned with the intermediate balloon section inside the balloon cavity.
  • the advancing the delivery assembly comprises maintaining a spring attached to the at least one ultrasound sensor in a compressed loaded state configured to distally bias the at least one ultrasound sensor towards the second position.
  • the axially moving the at least one ultrasound sensor comprises injecting the inflation fluid into a sleeve extending proximally from the at least one ultrasound sensor, such that the inflation fluid impinges against a proximal surface of the at least one ultrasound sensor and biases the at least one ultrasound sensor distally towards the second position.
  • the at least one ultrasound sensor further comprises a proximally tapering sensor proximal portion, and wherein the advancing the delivery assembly further comprises wedging the sensor proximal portion against the inflow end of the prosthetic valve.
  • a delivery assembly comprising a delivery apparatus.
  • the delivery apparatus comprises: a balloon catheter defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and defining a balloon cavity that is in fluid communication with the balloon catheter lumen; and at least one ultrasound sensor.
  • the delivery apparatus further comprises a temperature sensor.
  • the sensor data unit is configured, based at least in part on an output of the at least one ultrasound sensor, to determine a diameter indication of the balloon.
  • a method comprising: advancing a delivery assembly that comprises a delivery apparatus comprising a balloon mounted on a balloon catheter and at least one ultrasound sensor, to a target site of treatment; inflating the balloon by streaming inflation fluid into a cavity of the balloon; and measuring a temperature of the inflation fluid.
  • the method comprises, based at least in part on an output of the at least one ultrasound sensor and the measured temperature of the inflation fluid, determining a diameter indication.
  • the determined diameter indication is of one or more of: the balloon; an anatomical wall around the balloon; or a prosthetic valve disposed around the balloon.
  • the method further comprises: measuring a flow velocity of the inflation fluid; and adjusting the measured temperature based at least in part on the measured flow velocity, the determination of the diameter indication based at least in part on the adjusted temperature.
  • the delivery apparatus comprises at least one second ultrasound transducer axially offset from the at least one first ultrasound transducer.
  • the sensor data unit is configured, based at least in part on the detected ultrasound waves, to determine a diameter indication of an anatomical wall around the balloon.
  • the delivery assembly comprises a refractive element comprising a refractive surface positioned between the at least one first ultrasound transducer and the at least one second ultrasound transducer such that a line of sight between the at least one first ultrasound transducer and the at least one second ultrasound transducer is blocked.
  • the method further comprises, based at least in part on the detected ultrasound waves, determining a diameter indication of the balloon.
  • Fig. IB is a perspective view of a frame of the prosthetic valve of Fig. 1A.
  • Fig. 2A shows an exemplary delivery assembly comprising a delivery apparatus carrying a prosthetic valve.
  • Fig. 2B shows the exemplary delivery assembly of Fig. 2A further comprising a fluid passageway coupled to a fluid source.
  • Fig. 3A is a high-level perspective view of an exemplary delivery apparatus equipped with an ultrasound sensor.
  • Fig. 3B is a high-level perspective cut-away view of a portion of the delivery apparatus of Fig. 3A.
  • Fig. 4A is a perspective cut-away view of a distal portion of a delivery apparatus with an exemplary ultrasound sensor disposed inside a balloon thereof.
  • FIG. 6 A is a high-level perspective view of an exemplary delivery apparatus equipped with an axially movable ultrasound sensor positioned proximal to the balloon intermediate section.
  • Fig. 8B shows an exemplary wedge-shaped stopper.
  • Fig. 9B is a cross sectional view across line 9B-9B of Fig. 9A.
  • Fig. 11 A is a cross-sectional view of a distal portion of an exemplary delivery assembly, with a spring disposed between the ultrasound sensor and a sensor shaft, shown in a first position.
  • Fig. 1 IB is a cross-sectional view of the delivery assembly of Fig. 11A with the ultrasound sensor moved to the second position.
  • FIG. 13 A is a cross-sectional view of a distal portion of an exemplary delivery assembly, with a sleeve proximally extending from the ultrasound sensor, shown in a first position.
  • Fig. 13B is a cross-sectional view of the delivery assembly of Fig. 13A with the ultrasound sensor moved to the second position.
  • Fig. 15 A is a cross-sectional view of a distal portion of an exemplary delivery assembly, with an ultrasound sensor attached to a pull-wire, shown in a first position.
  • Fig. 16A is a cross-sectional view of a distal portion of an exemplary delivery assembly, with an ultrasound sensor residing, in a first position, inside a funnel-shaped portion of a nosecone proximal extension.
  • Fig. 17A is a cross-sectional view of a distal portion of an exemplary delivery assembly, with an ultrasound sensor attached to a sensor shaft, shown in a first position.
  • Fig. 18A is a perspective cut-away view of a distal portion of an exemplary deliver ⁇ ' assembly with an exemplary ultrasound sensor and temperature sensor disposed inside a balloon thereof.
  • Fig. 18B is an enlarged perspective view of the ultrasound sensor and temperature sensor of Fig. 18A.
  • Fig. 19 is a perspective cut-away view of a distal portion of a delivery apparatus with an exemplary ultrasound sensor and temperature sensor extending from a dedicated shaft.
  • Fig. 20 is a perspective view of a delivery apparatus with an exemplary temperature sensor at a proximal portion thereof.
  • Fig. 21 is a perspective view of an exemplary delivery apparatus equipped with a pair of ultrasound sensors within a balloon thereof.
  • Fig. 22 is a perspective cut-away view of a distal portion of a delivery apparatus with an exemplary pair ultrasound sensors disposed around carriers.
  • 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.
  • axial direction has 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.
  • directions parallel to the specified direction as well as minor deviations therefrom are included.
  • 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.
  • 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.
  • 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.
  • a reference numeral that includes an alphabetic label 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 that 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.
  • FIGs. 1 A and IB show perspective views of an exemplary prosthetic valve 100 with and without soft components attached thereto, respectively.
  • FIG. 2A 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 on or releasably coupled to the delivery apparatus 202.
  • inflow refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.
  • the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively.
  • the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.
  • a lowermost component can refer to a distal-most component
  • an uppermost component can similarly refer to a proximal-most component
  • 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, 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.
  • the frame 106 can be crimped to a radially compressed state on a balloon catheter 210, for example by using a crimping device 300 (see Fig. 12), and then expanded inside a patient by an inflatable balloon 234.
  • 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.
  • the end portions of the struts 112 are forming apices 116 at the outflow end 102 and apices 118 at the inflow end 104.
  • the struts 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.
  • the struts 112 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression.
  • 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.
  • 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, 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.
  • 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).
  • the inner skirt 140 can be formed of a single sheet of material that extends continuously around the inner surface of frame 106.
  • the outer skirt 170 can be formed of a single sheet of material that extends continuously around the outer surface of frame 106.
  • the illustrated examples discussed herein refer to the 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 handle 204 can include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 202.
  • 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 end 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.
  • 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.
  • 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.
  • 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).
  • the balloon catheter 210 can define a balloon catheter lumen 212 having a balloon catheter lumen diameter DBI, through which a guidewire (not shown) and 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.
  • the balloon catheter 210 can extend through the handle 204 and a proximal portion 249 which can be disposed proximally to the handle 204.
  • the proximal portion 249 can be formed with a fluid passageway 250 that is fluidly connectable to a fluid source 251 for inflating the balloon.
  • the fluid source 251 comprises an inflation fluid.
  • the fluid source 251 comprises an inflation fluid.
  • inflation fluid means a fluid (e.g., saline, though other liquids or gas can be used) used for inflating the balloon 234.
  • the inflation fluid source 251 is in fluid communication with the balloon catheter lumen 212, such that fluid from the fluid source 251 can flow through the balloon catheter lumen 212 into balloon 234 to inflate it.
  • 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, through which the guidewire can pass, such that the delivery apparatus 202 can be advanced toward the treatment region over the guidewire.
  • 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 inner surface 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.
  • a fluid source e.g., a syringe or a pump
  • an inflation fluid e.g., saline
  • 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.
  • 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.
  • 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.
  • 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.
  • Nosecone shaft 218, balloon catheter 210, and optional outer delivery shaft 208 can be formed from, or include, any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®).
  • 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.
  • nosecone shaft 218 has an inner liner or layer formed of Teflon® to minimize sliding friction with a guidewire.
  • Balloon 234 includes a balloon wall 236 surrounding and defining the balloon cavity 238, which may be made of one polymer, or use several layers or a mix of different polymers.
  • 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.
  • the leaflets of the prosthetic valve typically made from bovine pericardium tissue or other natural or synthetic tissues
  • the leaflets of the prosthetic valve 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.
  • An exemplary delivery apparatus 202 can include, in some examples, at least one ultrasound sensor configured to measure a distance that can be indicative, in some examples, or a radius or diameter or any one of: a balloon 234, a prosthetic valve 100, and/or a lumen of a native anatomical structure in a patient’s body.
  • Fig. 3 A illustrates a high-level perspective view of an exemplary delivery apparatus 202 equipped with an ultrasound sensor 260.
  • Fig. 3B illustrates a high-level perspective cut-away view of a portion of the delivery apparatus 202 of Fig. 3A.
  • FIG. 4A shows a perspective cut-away view of a distal portion of a delivery apparatus 202 with an exemplary ultrasound sensor 260 disposed inside the balloon cavity 238.
  • Fig. 4B shows an enlarged perspective view of the ultrasound sensor 260 of Fig. 4A.
  • Fig. 4C shows a cross sectional view across line 4C-4C of Fig. 4B.
  • Fig. 5A illustrates a high-level perspective view of an exemplary delivery assembly 200 comprising a prosthetic valve 100 crimped over a deflated balloon 234 of the delivery apparatus 202 of Fig. 3A.
  • Fig. 5B illustrates a high-level perspective view of the delivery assembly 200 of Fig. 5 A with the prosthetic valve 100 shown in the expanded state over the inflated balloon 234.
  • the delivery apparatus 202 comprises a sensor data unit 254.
  • 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.
  • sensor data unit 254 comprises electrical circuitry.
  • the ultrasound sensor 260 is in communication with the sensor data unit 254. In some examples, the ultrasound sensor 260 is in communication with the sensor data unit 254 via one or more optional communication line(s) 274. In some examples, the ultrasound sensor 260 is in wireless communication with the sensor data unit 254. In some examples, the one or more ultrasound sensor 260 can include a plurality of ultrasound sensors 260, wherein each of the sensors 260 can be in communication with the sensor data unit 254 via one or more respective communication line(s) 274. In some examples, an ultrasound sensor 260 can include a plurality of ultrasound transducers 262, wherein each ultrasound transducers 262 can be in communication with the sensor data unit 254 via a respective communication line 274.
  • an ultrasound sensor 260 comprises a plurality of ultrasound transducers 262
  • the operation of the ultrasound sensor(s) 260 and/or the ultrasound transducer(s) 262 can be multiplexed such that only one respective ultrasound sensor 260 and/or only one respective ultrasound transducer 262 outputs data each time.
  • any reference to an "ultrasound sensor 260" throughout the disclosure, in the singular form, may similarly refer to a plurality of ultrasound sensors 260, unless stated otherwise.
  • any reference to a "communication line 274" throughout the disclosure, in the singular form, may similarly refer to a plurality of communication lines 274, unless stated otherwise.
  • communication line 274 is configured to allow: electrical communication via a conductive material, such as a wire; and/or optical communication, e.g., via an optical fiber.
  • the communication line 274 can include an electrically insulated cover.
  • the ultrasound sensor 260 is operated by the sensor data unit 254 such that the sensing of ultrasound sensor 260 is performed in cooperation with the sensor data unit 254.
  • the ultrasound sensor 260 comprises dedicated circuitry for operation and the sensor data unit 254 receives the measured data from the ultrasound sensor 260.
  • each ultrasound transducer 262 is attached to a PCB component 264.
  • the ultrasound sensor 260 is in wireless communication with an external computing device (not shown).
  • 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, LED lights 257, speakers (not shown) and the like.
  • a display 256 and LED lights 257 are shown together in some of the drawings, such as, for example, Fig. 3A, for illustrative purpose, and that a handle can include a display 256 without LED lights 257, can include LED lights 257 without a display 256, and can include any other visual or auditory feedback means or combinations thereof.
  • an ultrasound sensor 260 comprises one or more ultrasound transducer(s) 262 attached to a separator 266.
  • the separator can optionally include a non-conductive material, such as a polymeric material.
  • a plurality of ultrasound transducers 262 are provided, they can reside inside depressions 272 formed in the separator 266, and circumferentially spaced from each other by spacer portions 268 of the separator 266.
  • the separator 266 can include a separator distal portion 270 defining a ring-like structure distal to the ultrasound transducer(s) 262. As further shown in Figs.
  • each ultrasound transducer 262 can be attached to a PCB component 264 extending proximally therefrom, with a communication line 274 extending proximally from each respective PCB component 264.
  • a communication line 274 extending proximally from each respective PCB component 264.
  • the plurality of communication lines 274 can be separated from each other along the path extending from the ultrasound sensor 260 towards the sensor data unit 254, can be grouped together.
  • an ultrasound sensor 260 including six ultrasound transducers 262 is illustrated in Figs. 4A-4C, it is to be understood that any other number, including a single ultrasound transducer, two to five ultrasound transducers, or more than six ultrasound transducers, is contemplated.
  • an ultrasound sensor 260 comprises at least two ultrasound transducers 262, the orientation of a first ultrasound transducer 262 opposing the orientation of the second ultrasound transducer 262.
  • diametrically opposite ultrasound transducer 262 can measure the radial distance to each side, such that the total diameter can be estimated based on both radial distances.
  • a first ultrasound transducer 262 of two diametrically ultrasound transducers 262 can be oriented to cover a predetermined 180 degrees of the circumference of the balloon wall 236, and the second ultrasound transducer 262 can be oriented to cover the other 180 degrees of the circumference of the balloon wall 236.
  • more than two ultrasound transducers are provided, such as the six ultrasound transducers 262 shown in Figs. 4A-4C.
  • an array of ultrasound transducers can span circumferentially (e.g., around separator 266), configured to cover 360- degree scanning. More than six ultrasound transducers 262 can be provided in some examples to increase the resolution of the measurements.
  • a plurality of ultrasound transducers 262 can be equally or not equally spaced from each other around the circumference of the separator 266.
  • the ultrasound sensor 260 defines a sensor outer diameter Dso, indicated, for example, in Fig. 4C.
  • the sensor outer diameter Dso is smaller than the balloon catheter inner diameter LBI, to allow passage of the sensor 260 through the balloon catheter lumen 212.
  • an ultrasound sensor 260 can be positioned inside the balloon cavity 238, as shown, for example, in Figs. 3A-4A, such that one or more ultrasound transducer(s) 262 thereof faces an inner surface of balloon wall 236.
  • the radial diameter comprises a sum of: the distance between a first ultrasound transducer 262 and the balloon wall 236 and/or the prosthetic valve 100; the distance between a second ultrasound transducer 262 and the balloon wall 236 and/or the prosthetic valve 100, respectively, wherein the orientation of the second ultrasound transducer 262 generally opposes the orientation of the first ultrasound transducer 262; and the sensor outer diameter Dso, in order to include the space between the two ultrasound transducers 262.
  • 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/or 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.
  • the stopper 252 is positioned at a distal end portion of the balloon intermediate section 242, or a proximal portion of the balloon distal section 244, in a manner that can result in the sensor 260 being axially closer to the inflow end 104 of the prosthetic valve 100 than the outflow end 102, in the second position.
  • This can align the sensor, during a prosthetic valve implantation procedure, with the annulus in which the prosthetic valve 100 is to be implanted. It is to be understood that other axial positions of the stopper 252 are contemplated, so as to position the sensor 260 at any desired axial position along the balloon intermediate section 242 when moved to the second position.
  • each of the plurality of ultrasound sensors 260 can include one or more radiopaque markers 278. While two ultrasound sensors 260 are shown in the illustrated example, it is to be understood that any other number of ultrasound sensors 260 is contemplated, including a series of more than two sensors 260.
  • Inclusion of a plurality of ultrasound sensors 260 which are axially spaced from each other, can advantageously increase the resolution of the acquired data by enabling measurement of diameter at more than one axial position along the length of the balloon intermediate section 242 and/or along the length of the prosthetic valve 100.
  • Fig. 11 A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 c with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 1 IB is a cross-sectional view of the delivery assembly 200 c with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • Delivery assembly 200 c is similar to any example described herein for delivery assemblies 200 a or 200 b , except that delivery apparatus 202 c of delivery assembly 200 c comprises a sensor shaft 286 and may be devoid of a pull-wire 288.
  • the sensor shaft 286 extends through the balloon catheter lumen 212, optionally around the nosecone shaft 218, and is axially movable relative to the balloon catheter 210 and/or nosecone shaft 218.
  • the distal end 294 of the spring 290 is attached to the sensor 260, such as by direct attachment or by being indirectly attached to a carrier 284 of the sensor 260.
  • the proximal end 292 of the spring 290 is attached to the sensor shaft 286, optionally to a distal end of the sensor shaft 286.
  • the distance between the sensor shaft 286 and the sensor 260 is shown to be short enough to compress the spring 290, while the sensor 260 is prevented from moving distally by the outflow end 102 of the crimped valve 100.
  • the delivery apparatus 202 c can include a plurality of ultrasound sensors 260, which can be coupled to a carrier 284 and implemented in a manner similar to that described with respect to Figs. 10A-10B, mutatis mutandis.
  • a crimping device 300 Prior to insertion into the patient's body, a crimping device 300, as shown in Fig. 12, can be used to crimp the prosthetic valve 100 to the compressed configuration, which can be then stored in this configuration up to utilization thereof for implantation into the patient's body.
  • the prosthetic valve 100 can be inserted into a receiving opening of a crimping device 300 while the valve is placed over the deflated balloon 234.
  • a crimping device 300 can be designed to translate a rotational movement of its housing to convergence of a plurality of plates thereof around the inner receiving opening into which the prosthetic valve 100 is inserted, thereby crimping the prosthetic valve 100 onto the balloon 234.
  • the crimping device 300 can include twelve plates configured to converge to crimp a prosthetic valve 100. Nevertheless, any other type of a crimping device 300 known in the art can be utilized for compressing the prosthetic valve 100.
  • preloading the spring 290 of a delivery assembly 200 a or 200 b and placing the ultrasound sensor(s) 260 in the first position can be accomplished by pulling on the pull-wire 288 to pull the sensor(s) 260 against the spring 290, thereby compressing the spring 290, prior to crimping the valve 100.
  • the valve 100 With the sensor(s) 260 maintained in a position proximal to the prosthetic valve 100, the valve 100 can be crimped over the balloon 234 inside the crimping device 300, after which the pull-wire 288 can be released, relying on the outflow end 102 of the crimped valve 100 being aligned against the sensor distal portion 282 to keep the sensor(s) 260 in the first position.
  • Fig. 13A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 d with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 10B is a cross-sectional view of the delivery assembly 200 d with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • Delivery assembly 200 d is an exemplary implementation of delivery assembly 200, and thus can include any of the features described for delivery assembly 200 throughout the current disclosure, except that while delivery assembly 200 comprises a deliver ⁇ ' apparatus 202 having one or more ultrasound sensor(s) 260 that can be actively or passively moved between the first and second positions according to various movement mechanisms, delivery assembly 200 d includes a delivery apparatus 202 d comprising a sleeve 296 extending proximally from the ultrasound sensor 260, configured to facilitate passive advancement of the sensor 260 by inflation fluid pushing the sensor 260 from the first to the second position during balloon inflation, as described in greater detail below.
  • the sleeve 296 can be attached to the ultrasound sensor 260, such as to the sensor proximal portion 280, and extend therefrom to terminate at a sleeve proximal end 298, defining a lumen between the sensor proximal portion 280 and the sleeve proximal end 298 which is exposed to the balloon catheter lumen 212 in the first position, as shown in Fig. 13 A.
  • the sleeve 296 in the first position of the sensor 260, can extend into the balloon catheter lumen 212 such that the sleeve proximal end 298 may be positioned in close proximity to, or proximal to, the inflation opening(s) 214 at the distal end of the balloon catheter 210.
  • the sleeve defines a sleeve inner diameter DSLI and a sleeve outer diameter DSLO, wherein the sleeve outer diameter DSLO can be smaller than the balloon catheter inner diameter DBI, to allow extension of the sleeve into the balloon catheter 210.
  • the sleeve 296 can comprise a rigid material that will prevent buckling or folding thereof, and will maintain constant values of its diameters DSLI and DSLO at all times.
  • the ultrasound sensor 260 defines an inner diameter that is smaller than the sleeve inner diameter DSLI, such that the sensor 260 has a sensor proximal end surface 276 oriented proximally, facing the balloon catheter lumen 212 in the first position.
  • the injected fluid Upon injection of inflation fluid via the balloon catheter 210 towards the balloon cavity 238, the injected fluid enters into the sleeve 296 and impinges against the sensor proximal end surface 276, thus applying a distally-oriented force striving to move the sensor 260 in the distal direction.
  • a portion of the inflation fluid is also configured to flow past the sleeve 296 and the sensor 260 to fill the balloon cavity 238.
  • a gap may exist between the sensor distal portion 282 and the balloon wall 236 in the first position of the sensor 260, as illustrated in Fig. 13 A, allowing inflation fluid to flow through this gap into the balloon cavity 238, thereby inflating the balloon 234 and optionally expanding the prosthetic valve 100.
  • the sensor 260 may be moved, due to the inflation fluid impinging against its proximal end surface 276, in the distal direction 20 to the second position, optionally until it contacts and is stopped by the stopper 252, as shown in Fig. 13B.
  • a total length of the sensor and sleeve Ls can be defined between the sensor distal portion 282 and the sleeve proximal end 298, which can be smaller, in some examples, than the length LBI of the balloon intermediate section 242, so as to place the sleeve proximal end 298 distal to the inflation opening(s) 214 of the balloon catheter 210 in the second position, which will allow for continued undisturbed filling of the balloon cavity 238 by the inflation fluid, as well as suction of the inflation fluid when balloon deflation is required. It is to be understood that while a single sensor 260 is illustrated in Figs.
  • the delivery apparatus 202 d can include a plurality of ultrasound sensors 260, which can be coupled to a carrier 284 and implemented in a manner similar to that described with respect to Figs. 10A-10B, mutatis mutandis.
  • the sleeve 296 will proximally extend from the proximal-most sensor 260, the sensor proximal end surface 276 against which the fluid impinges will be defined by the proximal-most sensor 260, and the total length Ls will be defined between the sensor distal portion 282 of the distal-most sensor 260 and the sleeve proximal end 298.
  • a pull-wire which can be similar to pull-wire 288 described with respect to delivery apparatus 202 a , can be attached to the sleeve 296 and extend proximally therefrom towards the handle 204, which can assist in repositioning the sensor 260 back towards the first position by pulling the pull-wire, and allow positioning of the sensor 260 proximal to the outflow end 102 of the valve 100 prior to crimping the valve, in a manner similar to that described with respect to Fig. 12, mutatis mutandis.
  • the sensor distal portion 282 tapers in the distal direction to a smaller diameter.
  • Fig. 14A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 e with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 14B is a cross-sectional view of the delivery assembly 200 e with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • Delivery assembly 200 e is similar to any example described herein for delivery assembly 200 d , except that the sensor 260 of delivery apparatus 202 e comprises a tapering sensor distal portion 282, as illustrated in Fig. 14A.
  • the distal-most sensor 260 will have a tapering sensor distal portion 282.
  • the senor 260 can be wedged against the portion of balloon wall 236 covering the outflow end 102 of the crimped prosthetic valve 100 in the first position.
  • the distally-oriented force applied by inflation fluid injected through the balloon catheter 210 and impinging against the sensor proximal end surface 276 may be sufficient to facilitate initial opening of the frame 106 at the outflow end 102 as the arrow-shaped sensor distal portion 282 is pushed there-against, which can assist in initial valve opening and allow for distal advancement of the sensor 260 and filling of the balloon cavity 238 by the inflation fluid, in addition to, or in some examples, even in the absence of, a gap between the sensor 260 and the balloon wall 236.
  • Fig. 15A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 f with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 15B is a cross-sectional view of the delivery assembly 200 f with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • Delivery assembly 200 f is an exemplary implementation of deliver ⁇ ' assembly 200, and thus can include any of the features described for delivery assembly 200 throughout the current disclosure, except that while delivery assembly 200 comprises a deliver ⁇ ' apparatus 202 having one or more ultrasound sensor(s) 260 that can be actively or passively moved between the first and second positions according to various movement mechanisms, delivery assembly 200 f includes a delivery apparatus 202 f comprising an ultrasound sensor 260 configured to be proximally pulled from the first to the second position by a pull-wire 288 attached thereto.
  • the sensor 260 is shown to be positioned distal to the balloon intermediate section 242 in the first position, such as at the balloon distal section 244.
  • the sensor proximal portion 280 can be pressed against the portion of balloon wall 236 covering the inflow end 104 of the prosthetic valve 100, thus preventing proximally-oriented movement of the sensor 260 past the inflow end 104 as long as the prosthetic valve 100 remains crimped over the balloon intermediate section 242.
  • a pull- wire 288 can be attached to the ultrasound sensor 260, such as to the sensor proximal portion 280 and/or to a carrier 284 over which the sensor 260 can be disposed, extending proximally therethrough, such as thorough balloon catheter lumen 212, towards the handle 204.
  • the balloon 234 is inflated, such as to expand the prosthetic valve 100, the sensor 260 is no longer axially blocked, allowing the pull-wire 288 to be proximally pulled, pulling the sensor 260 therewith in the proximal direction 22 to the second position, as shown in Fig. 15B, optionally until the sensor proximal portion 280 engages with a stopper 252 at a desired axial position.
  • the sensor proximal portion 280 can taper in the proximal direction to a narrower diameter. In this manner, the sensor proximal portion 280 can be wedged against the inflow end 104 of the prosthetic valve 100 in the first position, which can facilitate easier movement of the sensor 260 in the proximal direction 22 towards the second position, as the balloon 234 is inflated and the valve 100 is expanded. While the sensor 260 is shown to include a tapering proximal portion 280 in Figs. 15A-15B, it is to be understood that this is merely optional, and that a sensor 260 of delivery apparatus 202 f can have any other shape along its proximal portion 280.
  • the pull- wire 288 can be configured to bias the sensor 260 in a proximal direction, such as by having the pull-wire 288 coupled to a spring which is loaded in the first position, so as to apply a pulling force, via pull-wire 288, on the sensor 260.
  • the delivery apparatus 202 f can include a plurality of ultrasound sensors 260, which can be coupled to a carrier 284 and implemented in a manner similar to that described with respect to Figs. 10A-10B, mutatis mutandis.
  • Fig. 16A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 g with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 16B is a cross-sectional view of the delivery assembly 200 g with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • Delivery assembly 200 g is similar to any example described herein for delivery assembly 200 e , except that the sensor 260 of delivery apparatus 202 g is configured to reside inside a funnel-shaped portion of a proximal extension of the nosecone.
  • the delivery apparatus 202 can further comprise a nosecone proximal extension 246 extending proximally from the nosecone 224, towards balloon distal section 244.
  • the nosecone proximal extension 246 can have funnel-shaped portion 248 at its proximal end, which expands in diameter in the proximal direction, and may terminate at the border between the balloon distal section 244 and the balloon intermediate section 242.
  • the sensor 260 can reside, at least partially, inside the extension funnel portion 248 in the first position, as illustrated in Fig. 16A.
  • the sensor distal portion 282 of a delivery apparatus 202 g can taper in the distal direction, as illustrated in Figs. 14A-14B for example, which can wedge the sensor 260 inside the extension funnel portion 248 in the first position.
  • Fig. 17A is a cross-sectional view of a distal portion of an exemplary delivery assembly 200 h with the ultrasound sensor 260 shown in a first position while the balloon 234 is deflated and the prosthetic valve 100 is crimped thereover.
  • Fig. 17B is a cross-sectional view of the delivery assembly 200 h with the balloon 234 inflated and the ultrasound sensor 260 moved to the second position.
  • the sensor shaft 286 of delivery apparatus 202 h can be similar to the sensor shaft 286 of delivery apparatus 202 c , configured to be axially movable relative to the balloon catheter 210 and/or nosecone shaft 218, with the exception that the sensor shaft 286 of deliver ⁇ ' apparatus 202 h is attached, at a distal end thereof, to the sensor 260, such as to sensor proximal portion 280, and/or to carrier 284 over which the sensor 260 can be disposed.
  • the sensor 260 is shown to be situated in a first position which is proximal to the balloon intermediate section 242, optionally proximal to the outflow end 102 of the crimped prosthetic valve 100.
  • the sensor shaft 286 can be actively pushed in the distal direction 20, thereby pushing the sensor 260 therewith to the second position, optionally until the sensor is engaged with a stopper 252.
  • any sensor 260 of any of the delivery assemblies 200 a , 200 b , 200 c , 200 d , 200 e , 200 f , 200 g , or 200 h can have any desired shapes.
  • the ultrasound sensor 260 can be utilized to acquire measurement signals when positioned in the second position, such as schematically illustrated in Fig. 15B, so as to provide an indication of the diameter of the balloon 234, the prosthetic valve 100, and/or the anatomy surrounding the balloon or prosthetic valve at the axial position of the sensor 260.
  • the ultrasound sensor 260 can be utilized to acquire measurement signals when positioned in the first position as well.
  • measurement signals can be acquired by the ultrasound sensor 260 when positioned in the first position, distal to the balloon intermediate section 242 and/or prosthetic valve 100, optionally even prior to balloon inflation and/or valve expansion.
  • Fig. 18A shows a perspective cut-away view of a distal portion of an exemplary delivery apparatus 202 1 of an exemplary delivery assembly 200 1 .
  • Delivery assembly 200 1 is an exemplary implementation of delivery assembly 200, and thus can include any of the features described for delivery assembly 200 throughout the current disclosure, except that delivery apparatus 202 1 further comprises a temperature sensor 400. It is noted that although delivery assembly 200 1 is illustrated and described in relation to examples where only a single temperature sensor 400 is provided, this is not meant to be limiting in any way. In some examples (not shown), a plurality of temperature sensors 400 are provided.
  • the temperature sensor 400 is secured to a respective spacer portion 268 of the separator 266. In some examples, the temperature sensor 400 is in communication with the sensor data unit 254 (not shown in Figs. 18A-18B). In some examples, the communication between the temperature sensor 400 and the sensor data unit 254 is wireless. In some examples, the communication between the temperature sensor 400 and the sensor data unit 254 is via one or more wires (not shown).
  • the flow sensor 415 can positioned anywhere within the fluid path of the inflation fluid.
  • the flow sensor 415 is in communication with the sensor data unit 254.
  • the communication is wireless.
  • the communication is via one or more wires (not shown).
  • the flow sensor 415 can be any type of flow sensor, including, but not limited to: a differential pressure flow sensor; or a thermal mass flow sensor.
  • the measured temperature of the inflation fluid is adjusted by a predetermined function, and the adjusted temperature value is used for determining the diameter indication.
  • the predetermined function is determined based on previously performed tests where measurements are performed to determine the change in temperature when flowing from the fluid source 251 to the internal cavity 238 of the balloon 234.
  • the sensor data unit 254 further determines the estimated change in temperature based on the velocity value. For example, for a higher velocity, the change in temperature between the proximal portion 249 and the internal cavity 238 of the balloon 234 will be smaller since there is less time for the inflation fluid to heat up.
  • the use of the temperature sensor 400 is not limited to the examples shown by delivery assemblies 200 1 , 200 1 and 200 k , and the temperature sensor 400 can be used in any of delivery assemblies 200 a - 200 h , or any other similar delivery assemblies.
  • the delivery assembly apparatus 202 1 further comprises a refractive surface 425 on the balloon 234.
  • the refractive surface 425 is positioned between the transducer 420 and the transducer 430.
  • the distance between the refractive surface 425 and the transducer 420 is substantially equal to the distance between the refractive surface 425 and the transducer 430.
  • the distance between the refractive surface 425 and the transducer 420 is different than the distance between the refractive surface 425 and the transducer 430.
  • the sensor data unit 254 determines a diameter indication based on ultrasound signals. In some examples, the sensor data unit 254 controls the transducer 430 to generate ultrasound waves, and the sensor data unit 254 receives the output of the transducer 420. In some examples, each of the transducers 420 and 430 are angled such that at least a significant portion of ultrasound waves transmitted by the transducer 430 are received by the transducer 420.
  • each of the transducers 420 and 430 are angled such that at least a significant portion of ultrasound waves transmitted by the transducer 430 arrive at the refractive surface 425.
  • the refractive surface 425 focuses the ultrasound waves towards the transducer 420.
  • the refractive surface of the refractive element 427 blocks ultrasound waves propagating axially from the transducer 430 to the transducer 420. In some examples, this reduces the noise in the signal received at the transducer 420.
  • the diameter indication is determined as described above, with the exception that the ultrasound waves travel is a generally triangular path, thereby the sensor data unit 254 calculates the height of such a triangle in order to determine the diameter indication.
  • transducers 420 and 430 are illustrated in Fig. 21 at the proximal and distal sections of the balloon 234, this is not meant to be limiting. In some examples, transducers 420 and 430 are axially separated, but not necessarily at both ends.
  • Fig. 22 shows a perspective view of a delivery apparatus 202 m of a delivery assembly 200 m .
  • Delivery assembly 200 m is an exemplary implementation of delivery assembly 200, and thus can include any of the features described for delivery assembly 200 throughout the current disclosure, except that delivery apparatus 202 m comprises a plurality of ultrasound transducers 430 positioned at the balloon proximal section 240 of the balloon 234 and a plurality of ultrasound transducers 420 positioned towards between the balloon proximal section 240 and the balloon distal section 244.
  • ultrasound transducers 420 and 430 are positioned far enough towards the ends of the balloon 234 such that they are positioned distal and proximal, respectively, to a valve 100 when placed over the balloon 234, as described above.
  • an ultrasound grating (not shown) is further provided and positioned between the ultrasound transducers 420 and the ultrasound transducers 430.
  • the ultrasound transducers 420 and 430 are radially arrayed about the nosecone shaft 218, as described above in relation to the ultrasound transducers 262. As further described above, in some examples, the ultrasound transducers 420 and 430 are each in communication with the sensor data unit 254 via respective communication lines 274.
  • a delivery assembly comprising: a delivery apparatus comprising: a balloon catheter defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and defining a balloon cavity that is in fluid communication with the balloon catheter lumen, the balloon comprising: 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 at least one ultrasound sensor configured to move between a first position which is axially offset from the balloon intermediate section, and a second position which is axially aligned with the balloon intermediate section inside the balloon cavity.
  • Example 2 The delivery assembly of any example herein, particularly example 1, wherein the balloon is configured to transition between a deflated state and an inflated state, wherein the ultrasound sensor is configured to be in the first position in the deflated state of the balloon, and to be in the second position in the inflated state of the balloon.
  • Example 3 The delivery assembly of any example herein, particularly example 1 or 2, wherein the delivery apparatus further comprises a nosecone and a nosecone shaft extending proximally from the nosecone through the balloon cavity and through the balloon catheter lumen.
  • Example 4 The delivery assembly of any example herein, particularly example 3, wherein the at least one sensor is configured to axially slide over the nosecone shaft.
  • Example 23 The delivery assembly of any example herein, particularly any one of examples 21 or 22, wherein an outer diameter defined by the sleeve is smaller than an inner diameter defined by the balloon catheter.
  • Example 29 The delivery assembly of any example herein, particularly any one of examples 27 or 28, wherein the pull- wire is configured, when proximally pulled, to proximally pull the at least one ultrasound sensor therewith.
  • Example 30 The delivery assembly of any example herein, particularly any one of examples 26 to 29, wherein the delivery apparatus further comprises a nosecone proximal extension extending proximally from the nosecone, the nosecone proximal extension disposed around the nosecone shaft and comprising an extension funnel portion at a proximal end thereof.
  • Example 31 The delivery assembly of any example herein, particularly example 30, wherein at least part of the at least one ultrasound sensor is configured to reside inside the extension funnel portion in the first position.
  • Example 32 The delivery assembly of any example herein, particularly any one of examples 30 or 31, wherein the extension funnel portion is distal to the balloon intermediate section.
  • Example 34 The delivery assembly of any example herein, particularly example 33, wherein the sensor shaft extends through the balloon catheter lumen.
  • Example 35 The delivery assembly of any example herein, particularly any one of examples 33 or 34, wherein the sensor shaft is configured, when axially moved, to axially move the at least one ultrasound sensor therewith.
  • Example 36 The delivery assembly of any example herein, particularly example 3, wherein the delivery apparatus further comprises a stopper disposed around the nosecone shaft inside the balloon cavity.
  • Example 37 The delivery assembly of any example herein, particularly example 36, wherein the stopper is axially positioned between the balloon proximal section and the balloon distal section.
  • Example 38 The delivery assembly of any example herein, particularly any one of examples 36 or 37, wherein the at least one ultrasound sensor is configured to engage with the stopper when moved from the first to the second position, and is prevented from further axial movement in a direction from the first towards the second position by the stopper.
  • Example 39 The delivery assembly of any example herein, particularly any one of examples 36 to 38, wherein the stopper is spherical.
  • Example 40 The delivery assembly of any example herein, particularly any one of examples 36 to 38, wherein the stopper is wedge-shaped.
  • Example 41 The delivery assembly of any example herein, particularly any one of examples 1 to 40, wherein the at least one ultrasound sensor comprises at least one radiopaque marker.
  • Example 42 The delivery assembly of any example herein, particularly any one of examples 1 to 41 , wherein the at least one sensor comprises a tapering sensor proximal portion.
  • Example 43 The delivery assembly of any example herein, particularly any one of examples 1 to 42, wherein the at least one sensor comprises a tapering sensor distal portion.
  • Example 44 The delivery assembly of any example herein, particularly any one of examples 1 to 41, further comprising a prosthetic valve disposed around the balloon intermediate section, the prosthetic valve extending between an inflow end and an outflow end and comprising a frame movable between a crimped state and an expanded state.
  • Example 45 The delivery assembly of any example herein, particularly example 44, wherein the prosthetic valve, when in the crimped state, is axially aligned with the at least one ultrasound sensor in the first position, and wherein the prosthetic valve, when in the expanded state, is axially aligned with the at least one ultrasound sensor in the second position.
  • Example 46 The delivery assembly of any example herein, particularly any one of examples 44 or 45, wherein the at least one ultrasound sensor is proximal to the outflow end of the prosthetic valve in the first position.
  • Example 47 The delivery assembly of any example herein, particularly example 46, wherein, when in the crimped state, the outflow end of the prosthetic valve prevents the at least one ultrasound sensor from axially moving distally towards the second position.
  • Example 48 The delivery assembly of any example herein, particularly any one of examples 46 or 47, wherein the at least one sensor comprises a tapering sensor distal portion configured to wedge against the outflow end of the prosthetic valve in the first position.
  • Example 49 The delivery assembly of any example herein, particularly any one of examples 44 or 45, wherein the at least one ultrasound sensor is distal to the outflow end of the prosthetic valve in the first position.
  • Example 50 The delivery assembly of any example herein, particularly example 49, wherein, when in the crimped state, the inflow end of the prosthetic valve prevents the at least one ultrasound sensor from axially moving proximally towards the second position.
  • Example 51 The delivery assembly of any example herein, particularly any one of examples 49 or 50, wherein the at least one sensor comprises a tapering sensor proximal portion configured to wedge against the inflow end of the prosthetic valve in the first position.
  • Example 52 The delivery assembly of any example herein, particularly any one of examples 44 to 51, wherein the at least one ultrasound sensor is closer to the inflow end of the prosthetic valve than to the outflow end, in the second position of the at least one ultrasound sensor.
  • Example 53 The delivery assembly of any example herein, particularly any one of examples 1 to 52, wherein an inner diameter defined by the balloon catheter is greater than an outer diameter defined by the at least one ultrasound sensor.
  • Example 54 The delivery assembly of any example herein, particularly any one of examples 1 to 43, wherein the delivery apparatus further comprises a sensor data unit in communication with the at least one ultrasound sensor.
  • Example 55 The delivery assembly of any example herein, particularly example 54, wherein the sensor data unit is configured, based at least in part on an output of the at least one ultrasound sensor, to determine a diameter indication of the balloon.
  • Example 56 The delivery assembly of any example herein, particularly example 54, wherein the sensor data unit is configured, based at least in part on an output of the at least one ultrasound sensor, to determine a diameter indication of an anatomical wall around the balloon.
  • Example 57 The delivery assembly of any example herein, particularly example 54, further comprising a prosthetic valve disposed around the balloon intermediate section, wherein the sensor data unit is configured, responsive to an output of the at least one ultrasound sensor, to determine a diameter indication of the prosthetic valve.
  • Example 60 The delivery assembly of any example herein, particularly any one of examples 58 or 59, wherein the plurality of ultrasound transducers comprises at least two ultrasound transducers which are diametrically opposite to each other.
  • Example 96 The delivery assembly of any example herein, particularly example 95, wherein the delivery apparatus further comprises a flow sensor, the determination of the diameter indication of the balloon further based on the output of the flow sensor.
  • Example 107 The delivery assembly of any example herein, particularly any one of examples 92 to 105, wherein the delivery apparatus comprises a handle, the balloon catheter extending distally from the handle, and wherein the temperature sensor is positioned proximal to the handle.
  • Example 108 The delivery assembly of any example herein, particularly any one of examples 92 to 107, wherein the at least one ultrasound sensor comprises a plurality of ultrasound transducers.
  • Example 111 The delivery assembly of any example herein, particularly any one of examples 108 to 110, wherein the at least one sensor further comprises a separator, and wherein the plurality of ultrasound transducers are attached to the separator.
  • Example 112 The delivery assembly of any example herein, particularly example 111, wherein the separator comprises a non-conductive material.
  • Example 113 The delivery assembly of any example herein, particularly any one of examples 111 or 112, wherein the separator comprises a plurality of depressions, and wherein the plurality of ultrasound transducers are situated inside the plurality of depressions.
  • Example 114 The delivery assembly of any example herein, particularly any one of examples 111 to 113, wherein the plurality of ultrasound transducers are circumferentially spaced from each other by spacer portions of the separator.
  • Example 116 The delivery assembly of any example herein, particularly any one of examples 111 to 115, wherein the delivery apparatus further comprises a nosecone and a nosecone shaft extending proximally from the nosecone through the balloon cavity and through the balloon catheter lumen, and wherein the separator is attached to the nosecone shaft.
  • Example 117 The delivery assembly of any example herein, particularly any example herein, particularly any one of examples 92 to 110, wherein the delivery apparatus further comprises a nosecone and a nosecone shaft extending proximally from the nosecone through the balloon cavity and through the balloon catheter lumen, and wherein the temperature sensor is secured to the nosecone shaft.
  • Example 118 The delivery assembly of any example herein, particularly any one of examples 92 to 110, wherein the delivery apparatus further comprises: a nosecone and a nosecone shaft extending proximally from the nosecone through the balloon cavity and through the balloon catheter lumen; and a sensor shaft extending alongside the nosecone shaft, and wherein the temperature sensor is attached to the sensor shaft.
  • Example 119 A method comprising: advancing a delivery assembly that comprises a delivery apparatus comprising a balloon mounted on a balloon catheter and at least one ultrasound sensor, to a target site of treatment; inflating the balloon by streaming inflation fluid into a cavity of the balloon; measuring a temperature of the inflation fluid; and based at least in part on an output of the at least one ultrasound sensor and the measured temperature of the inflation fluid, determining a diameter indication, wherein the determined diameter indication is of one or more of: the balloon; an anatomical wall around the balloon; or a prosthetic valve disposed around the balloon.
  • Example 120 The method of any example herein, particularly example 119, further comprising: measuring a flow velocity of the inflation fluid; and adjusting the measured temperature based at least in part on the measured flow velocity, the determination of the diameter indication based at least in part on the adjusted temperature.
  • Example 121 The method of any example herein, particularly any one of examples 119 or 120, wherein the delivery apparatus comprises a temperature sensor positioned within the cavity of the balloon, wherein the temperature is measured by the temperature sensor.
  • Example 122 The method of any example herein, particularly any one of examples 119 or 120, wherein the delivery apparatus comprises: a handle, the balloon catheter extending distally from the handle; and a temperature sensor positioned proximal to the handle, and wherein the temperature is measured by the temperature sensor.
  • Example 123 The method of any example herein, particularly any one of examples 119 to 122, wherein the at least one ultrasound sensor comprises a plurality of ultrasound transducers.
  • Example 124 The method of any example herein, particularly example 123, wherein each of the plurality of ultrasound transducers is directed towards a balloon wall of the balloon.
  • Example 125 A delivery assembly comprising: a delivery apparatus comprising: a balloon catheter defining a balloon catheter lumen; an inflatable balloon mounted on the balloon catheter and defining a balloon cavity that is in fluid communication with the balloon catheter lumen; at least one first ultrasound transducer; and at least one second ultrasound transducer axially offset from the at least one first ultrasound transducer.
  • Example 126 The delivery assembly of any example herein, particularly example 125, wherein the delivery apparatus further comprises a sensor data unit in communication with the at least one first ultrasound transducer and the at least one second ultrasound transducer.
  • Example 127 The delivery assembly of any example herein, particularly example 126, wherein the sensor data unit is configured to: control the at least one first ultrasound transducer to generate ultrasound waves; and detect the ultrasound waves at the at least one second ultrasound transducer.
  • Example 128 The delivery assembly of any example herein, particularly example 126, wherein the sensor data unit is configured, based at least in part on the detected ultrasound waves, to determine a diameter indication of the balloon.
  • Example 129 The delivery assembly of any example herein, particularly example 126, wherein the sensor data unit is configured, based at least in part on the detected ultrasound waves, to determine a diameter indication of an anatomical wall around the balloon.
  • Example 130 The delivery assembly of any example herein, particularly example 126, further comprising a prosthetic valve disposed around the balloon, wherein the sensor data unit is configured, based at least in part on the detected ultrasound waves, to determine a diameter indication of the prosthetic valve.
  • Example 131 The delivery assembly of any example herein, particularly example 125, wherein a portion of the balloon comprises a refractive surface, the refractive surface of the balloon positioned between the at least one first ultrasound transducer and the at least one second ultrasound transducer.
  • Example 132 The delivery assembly of any example herein, particularly example 131, wherein the at least one first ultrasound transducer is directed towards the refractive surface of the balloon.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Prostheses (AREA)

Abstract

La présente divulgation concerne des ensembles de distribution qui comprennent des capteurs ultrasonores. Dans un exemple, l'ensemble de distribution comprend un cathéter à ballonnet, un ballonnet gonflable monté sur le cathéter à ballonnet, et au moins un capteur ultrasonore conçu pour se déplacer entre une première position qui est axialement décalée par rapport à une section intermédiaire du ballonnet, et une seconde position qui est alignée axialement avec la section intermédiaire à l'intérieur d'une cavité du ballonnet.
PCT/US2025/011182 2024-01-11 2025-01-10 Ensembles de distribution avec capteurs ultrasonores Pending WO2025151779A1 (fr)

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US202463619894P 2024-01-11 2024-01-11
US63/619,894 2024-01-11

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US20110251492A1 (en) * 2006-05-24 2011-10-13 Forster David C Ultrasound assessment of lumens to facilitate repair or replacement
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
WO2014210299A1 (fr) * 2013-06-27 2014-12-31 Bridges Charles R Dispositif, système et procédé d'implantation d'une valve cardiaque prosthétique
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US11096781B2 (en) 2016-08-01 2021-08-24 Edwards Lifesciences Corporation Prosthetic heart valve
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
WO2022046834A1 (fr) * 2020-08-25 2022-03-03 Edwards Lifesciences Corporation Ensemble de détection de ballonnet médical
US20220226114A1 (en) * 2021-01-19 2022-07-21 Boston Scientific Scimed, Inc. Balloon valvuloplasty catheter with ivus

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20110251492A1 (en) * 2006-05-24 2011-10-13 Forster David C Ultrasound assessment of lumens to facilitate repair or replacement
US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
WO2014210299A1 (fr) * 2013-06-27 2014-12-31 Bridges Charles R Dispositif, système et procédé d'implantation d'une valve cardiaque prosthétique
US11096781B2 (en) 2016-08-01 2021-08-24 Edwards Lifesciences Corporation Prosthetic heart valve
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
WO2022046834A1 (fr) * 2020-08-25 2022-03-03 Edwards Lifesciences Corporation Ensemble de détection de ballonnet médical
US20220226114A1 (en) * 2021-01-19 2022-07-21 Boston Scientific Scimed, Inc. Balloon valvuloplasty catheter with ivus

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