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WO2024215869A1 - Technologie à ultrasons intravasculaire sans rinçage - Google Patents

Technologie à ultrasons intravasculaire sans rinçage Download PDF

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Publication number
WO2024215869A1
WO2024215869A1 PCT/US2024/024045 US2024024045W WO2024215869A1 WO 2024215869 A1 WO2024215869 A1 WO 2024215869A1 US 2024024045 W US2024024045 W US 2024024045W WO 2024215869 A1 WO2024215869 A1 WO 2024215869A1
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WO
WIPO (PCT)
Prior art keywords
catheter
coupling medium
acoustic coupling
lumen
imaging
Prior art date
Application number
PCT/US2024/024045
Other languages
English (en)
Inventor
Patrick John PHILLIPS
Danielo B. PIAZZA
Rickard Clinton LOFTMAN
Joshua Alexander SPARKS
Christian Thomas TOSTADO
Daniel Jason VELASCO
Nathan Ryan COELHO
Michi E. Garrison
Original Assignee
Evident Vascular, Inc.
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 Evident Vascular, Inc. filed Critical Evident Vascular, Inc.
Publication of WO2024215869A1 publication Critical patent/WO2024215869A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Clinical applications involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • 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
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • 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
    • A61B8/4416—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • 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
    • A61B8/4422—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to hygiene or sterilisation
    • 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
    • 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
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N20/00—Machine learning

Definitions

  • IVUS Intravascular ultrasound
  • Ultrasound transducers including those used for intravascular imaging, employ one or more ultrasound elements to emit and/or receive acoustic signals through an acoustic coupling medium, such as a gel or fluid, in order to image and/or treat tissue.
  • an acoustic coupling medium such as a gel or fluid
  • Some standard IVUS catheters rely on flushing an inner lumen with a fluid to remove or reduce air bubbles surrounding the ultrasound transducer in order to improve clarity for satisfactory imaging.
  • Imaging and diagnosis of intravascular tissue and blood can be critical, for example, in identifying irregularities, disease, and/or injury for medical treatment and can improve patient outcomes. Clarity of imaging can be critical, for example, for proper identification of lesions, plaque (e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, fibro-fatty plaque, substantially non calcified plaque), thrombus, clots, embolisms, calcium build up, dissections, and measurements of these abnormalities. Imaging, such as IVUS imaging, can be useful for planning treatment and guiding selection of therapies for interventional cardiology, vascular surgery, and interventional radiology throughout the body from the heart to the peripheral vasculature.
  • IVUS imaging systems comprise an imaging console (e.g., workstation, computer, processors), a user interface (e.g., tablet, controls), one or more displays, and IVUS imaging catheters which are inserted into the patient vasculature to image the vascular anatomy.
  • the imaging console is a tablet, workstation, computer, display, user interface or other control device that may include a processor and/or software.
  • a catheter interface module optionally connects the catheter to the console or the catheter can optionally connect directly to the console.
  • the technologies described herein, including the IVUS flushless technologies for example are used with other medical imaging systems (such as cardiac catheterization lab systems), to provide an integrated healthcare portfolio for cardiologists.
  • An integrated or otherwise coordinated platform in several embodiments, can improve workflow between various imaging systems, including for example, x-ray systems.
  • stent placement and other procedures e.g., thrombectomy, clot retrieval, balloon placement, etc.
  • IVUS technology described herein are optimized using the IVUS technology described herein together with x-ray, external ultrasound and/or other non-IVUS technology.
  • Imaging procedures may include ultrasound, x-ray, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, fluoroscopy, endoscopy, angiography, optical coherence tomography, intravital microscopy, 2D imaging, 3D imaging, etc.
  • CT computed tomography
  • MRI magnetic resonance imaging
  • PET positron emission tomography
  • PET-CT fluoroscopy
  • endoscopy endoscopy
  • angiography optical coherence tomography
  • intravital microscopy 2D imaging, 3D imaging, etc.
  • Imaging, and/or measurements from two, three or more imaging modalities e.g, ultrasound, X-ray (including radiography, fluoroscopy, angiography, venography, etc.), magnetic resonance, PET scans, optical imaging (e.g, optical coherence tomography, light, laser imaging), etc.
  • imaging modalities e.g, ultrasound, X-ray (including radiography, fluoroscopy, angiography, venography, etc.), magnetic resonance, PET scans, optical imaging (e.g, optical coherence tomography, light, laser imaging), etc.
  • Multi-modality synergies between IVUS and one or more additional imaging systems are achieved in several embodiments, including for example, enhanced visualization and image quality, decreased procedure time, increased precision in stent positioning and vessel measurements, improved workflow and reliability, and other benefits.
  • Multi-modal systems including IVUS may be used, for example, to allow cardiologists to diagnose and/or treat vascular blockages and other defects that should, in turn, offer patients with improved cardiac outcomes, while reducing the overall cost burden to the healthcare system through efficient and effective integration with IVUS.
  • a more robust image of vessel and organ structures can be obtained using various embodiments of the IVUS technologies described herein.
  • a proximal connector hub (i) securely latches into the CIM or to the console, and easily unlatches during removal, (ii) mates and makes electrical connections with the CIM or the console receptacle, (iii) mates with a motor driveshaft in the CIM or the console receptacle and maintains concentric rotation of a spinning shaft, (iv) seals acoustic coupling media inside the catheter lumen distal of the seal, and/or (v) supports a fill port for acoustic coupling media.
  • the driveshaft may optionally comprise a drive cable, a drive coil, a drivetrain, and/or a drive actuator.
  • a rigid proximal connector hub with a seal e.g., a flexible seal, wherein flexible in some embodiments is elastic, malleable, bendable, modifiable, adjustable, accommodating, adaptable, pliable, supple, pliant, and/or resilient
  • a seal e.g., a flexible seal, wherein flexible in some embodiments is elastic, malleable, bendable, modifiable, adjustable, accommodating, adaptable, pliable, supple, pliant, and/or resilient
  • one or more seals are disposed in a rigid connector hub.
  • a seal is not placed in a flexible structure, such as a flexible catheter or flexible lumen.
  • a seal may be placed in a rigid structure.
  • a flexible seal surrounds, in several embodiments, a driveshaft (e.g., drive cable, drive coil, drivetrain, drive actuator) of the rotating imaging core inside a rigid proximal connector hub holding the medium inside the lumen connected to the hub while the core rotates.
  • the seal remains stationary with respect to the driveshaft, the seal remains stationary with respect to a wall of the catheter, and/or does not move with or relative to the driveshaft and the catheter wall (e.g., without translation or linear movement).
  • a seal is distanced from, separate, and does not contact a motor.
  • the circular seal may be compressed onto the driveshaft with sufficient force to prevent leaks while still allowing a motor (e.g, connected to an imaging console) to rotate the inner imaging core at rates to support high imaging frame rates.
  • Example seal materials include elastic polymers like nitrile, ethylene propylene rubber, and fluorocarbons and similar materials.
  • Hub components and features may be arranged to fix the flexible seal between the connector hub and the rotating driveshaft, such as for example a seal housing and/or a seal cap.
  • the inner diameter / surface of the seal housing may be precisely dimensioned to ensure proper compression is applied to the flexible seal allow the driveshaft to rotate without too much friction while also preventing the medium from leaking proximally through the flexible seal.
  • An adhesive may optionally be applied to the outer circumference of the flexible seal to prevent leaks around the flexible seal.
  • the flexible seal may be assembled inside the rigid proximal connector hub to ensure a precise fit. In some embodiments, this is advantageous over placing a seal inside a flexible catheter or similar catheter body/lumen as the flexibility may contribute to medium leaks or air ingress during use.
  • the pressure differential on the two sides of a flexible seal may generally be insignificant so there is little force to push the medium out or to pull air in according to several embodiments.
  • the catheter may be subject to extreme temperature and ambient temperature swings.
  • the coupling medium volume When exposed to extreme drops or rises in temperature, the coupling medium volume may decrease or increase, respectively, and then returning back to a default volume after the extreme temperature exposure. This volume change may typically require some sealing force so air is not pulled into or fluid leak out of the inner imaging lumen in some embodiments. Air that gets into the lumen may migrate to the distal transducer of the spinning imaging core and degrade image quality.
  • the dual seal housings may be preferred in one embodiment for precise assembly and sealing, however a single housing on the proximal side only may also be used.
  • a fill port is included in the rigid proximal connector hub and is sealed after filling the catheter lumen with the medium, according to several embodiments. The fill port may be configured to facilitate the connection to the filling equipment.
  • the fill port may be closed off, for example with a seal, stopper, plug and/or adhesive to prevent any air ingress.
  • the technologies described herein, including the IVUS flush-less technologies comprise a reversable flush port seal that allows for product rework after inspection (e.g., if air bubbles remain, checking quality of imaging, etc.) and before optionally permanently sealed.
  • the filling and/or flushing procedure may be repeated with reversible port seal(s) until a satisfactory result is obtained (e.g., removal of bubbles, etc.).
  • a seal is reversible.
  • a seal is permanent.
  • the fill port may be temporarily sealed to facilitate inspection, and permanently sealed upon confirmation of successful filling process.
  • a temporary seal of the fill port may be removed to facilitate further fluid filling process steps.
  • a fill port in one embodiment, has the inlet most proximal, juxtaposed to the flexible seal to aid in purging all air bubbles during the fill process.
  • a portion of the acoustic coupling medium exits the imaging lumen of the IVUS catheter (e.g., during the filling process) via a distal port (e.g., exit port, exhaust port, vent, hole, aperture, channel, opening).
  • a distal port extends through a catheter wall perpendicular to a catheter longitudinal axis, and the distal port does not extend along a distance in the catheter wall along the longitudinal axis of the catheter.
  • a distal plug is attached to a removable wire in one embodiment.
  • Designs and methods to vent and seal the inner imaging lumen are also provided in several embodiments herein.
  • the distal tip is formed with a plug fused into the distal end of the imaging lumen, sealing the imaging lumen.
  • a removable wire may be positioned next to the plug during the fusing process and then removed, effectively creating a narrow channel for air to vent during the filling process.
  • Removable wires may include, for example, NiTi (nitinol), stainless steel, or other wires.
  • the wire size may be configured to create an effective vent which can be easily sealed after the filling process, e.g. by heat or adhesive.
  • the wire is in the size range 0.005” to 0.010” (e.g., 0.005, 0.006, 0.007, 0.008, 0.009, 0.010 inches and overlapping values and ranges therein).
  • the filling process is completed once all bubbles are removed from the imaging lumen as air is purged from the vent; and upon inspection of no air bubbles, the vent and distal plug are sealed shut either with a heating process that reflows the materials together and/or a small amount of adhesive is inserted into the vent.
  • a distal tip may be formed with a distal plug and a removable wire at the distal end of the imaging lumen in one embodiment.
  • Removable wires include for example NiTi (nitinol), stainless steel, or other materials (e.g., metals, alloys, rigid and/or flexible wires).
  • the wire is fed through the lumen exiting the exit port leaving the distal plug loosely floating in the distal section of the lumen; (ii) the filling process is completed once all bubbles are removed from the lumen as air is purged from the exit port; and (iii) upon inspection of no air bubbles, the distal plug is bonded to the wall of the lumen either with a heating process that reflows the materials together and/or a small amount of adhesive is inserted into the exit port bonding the plug to the luminal walls.
  • the wire may be removed easily from the plug after the distal plug is bonded to the catheter lumen.
  • a colorant may be added to the medium before the filling process starts aiding inspection for leaks and identification of gas bubbles. The colorant may optionally add optical contrast aiding in the identification of the medium and gas bubbles improving the manufacturing process.
  • catheters are optimized for vascular imaging are configured for superior pushability, tracking, and crossing for arterial and venous peripheral vasculature.
  • one or more of the following features are provided:
  • catheters have superior pushability to avoid kinking with sufficient column strength to advance the catheter through tortuous bends and occlusions in vasculatures without buckling, over bending, or collapsing anywhere along the catheter (e.g., proximate or (e.g., ability to cross an occlusion or constriction).
  • Material properties in some embodiments e.g., balance of rigidity and flexibility, durometer in various segments
  • dimensional characteristics e.g., larger dimensions, such a diameter and thickness, increase column strength, account for greater pushability and kink resistance.
  • catheters have superior tracking for the ability of the catheter to follow a guidewire through tortuous bends in vasculature, having sufficient flexibility and strength to move along and advance along a guidewire to target locations within the vasculature.
  • Hydrophilic coatings according to some embodiments help reduce friction with guidewires and the surrounding luminal tissue.
  • hydrophilic coatings are on an external surface and/or an internal surface (e.g., in a lumen, etc.) of the catheter.
  • hydrophilic coatings are not on an external surface of the catheter.
  • hydrophilic coatings are not on an internal surface (e.g., in a lumen, etc.) of the catheter.
  • catheters have superior crossing capabilities to cross occlusions, restrictions and constrictions within the vasculature, such as at sites with tissue blockage (e.g., stenoses, etc.) and/or implant blockages (such as stents, balloons, etc.).
  • crossing ability is enhanced by one or more of the following: (i) design of the distal tip (e.g., pointed enough to navigate occlusions, etc.
  • low durometer near the distal tip is provided for flexibility to navigate tortuous anatomy and obstructions.
  • a region of varying or step wise gradient changes to a higher durometer proximally sufficient to push the catheter while avoiding kinking is provided.
  • a single durometer and/or flexibility can remain constant along a certain or all portions of a device.
  • an IVUS catheter with a proximal connector hub assembly that facilitates an improved process for filling the IVUS catheter with an acoustic coupling medium.
  • an inner lumen of the IVUS catheter is configured as an imaging lumen and contains the imaging transducer.
  • the fill port is designed for acoustic coupling medium encapsulation in the imaging lumen and around the transducer in several embodiments.
  • acoustic coupling medium preparation processes, coupling medium filling equipment and processes, and structural components are configured with design features assisting with air removal from the catheter body.
  • the proximal connector hub assembly may include a proximal connector hub with a fill port, a fill port cap, and a fill port cover.
  • the fill port may receive the fill port cap, which could be an elastomeric seal component or a rigid plastic cap.
  • the fill port cap may mate with a fill adapter of a fill nozzle, which may be used to fill the I VUS catheter with the acoustic coupling medium.
  • the fill nozzle may include a needle which pierces the seal to fill the catheter.
  • the fill nozzle and fill port adapter may be disengaged from the fill port cap, which may draw acoustic coupling medium into the fill port cap and prevent air from entering the inner imaging lumen of the IVUS catheter.
  • an inner lumen is configured as an imaging lumen.
  • an imaging lumen is an inner lumen.
  • the fill nozzle and/or fill port adapter may be disengaged from the fill port cap, which may then be covered by the fill port cover.
  • the proximal connector hub assembly may include a proximal connector hub with a fill port, a fill port valve cap, and a fill port cover. The fill port may receive the fill port valve cap.
  • the fill port valve cap may mate with a fill adapter of a fill nozzle, which may be used to fill the IVUS catheter with the acoustic coupling medium.
  • a fill adapter of a fill nozzle which may be used to fill the IVUS catheter with the acoustic coupling medium.
  • the fill nozzle and fill port adapter may be disengaged from the fill port valve cap, which may draw acoustic coupling medium into the fill port valve cap and prevent air from entering the inner imaging lumen of the IVUS catheter.
  • a catheter connector hub (i) securely latches into the catheter interface module and easily unlatches during removal, (ii) mates and makes electrical connections with catheter interface module receptacle, (iii) mates with a motor driveshaft in the catheter interface module receptacle and maintains concentric rotation of a spinning shaft, (iv) seals acoustic coupling media inside the catheter lumen distal of the seal, and/or (v) supports a fill port for acoustic coupling media.
  • the driveshaft may optionally comprise a drive cable, a drive coil, a drivetrain, and/or a drive actuator.
  • the proximal connector hub may include a strain relief component which may reduce or prevent kinks and excessive local strains in the IVUS catheter.
  • the proximal hub connector may also include a seal, a drive bushing, a drive hub, a drive hub pin, and/or an electronic identification (EID) printed circuit board (PCB).
  • the drive bushing may reduce wobble and/or non-uniform rotational distortion (NURD) and may prevent acoustic coupling medium leaks by maintaining uniform friction around the inner diameter of the seal.
  • NURD non-uniform rotational distortion
  • Several methods described herein provide for the degassing of an acoustic coupling medium and filling of an IVUS catheter with the degassed acoustic coupling medium, which advantageously removes the need for the user to prepare and flush the lumen around the inner imaging core with a fluid in several embodiments. Moreover, the several embodiments of the methods described herein advantageously prevent the introduction of air into the acoustic coupling medium during filling, which improves the quality of images captured by the I VUS catheter and reduces procedure times by eliminating the need to refill or replace an I VUS catheter among other advantages discussed herein.
  • a degassing process comprises subjecting the acoustic fluid to a vacuum or low pressure over a period of time.
  • the degassing process may begin by providing a degassing apparatus.
  • the degassing apparatus may include a vessel, a vacuum pump, a magnetic stirring plate, a hot plate, and/or a syringe.
  • the vessel may be connected to the vacuum pump via tubing and a first valve, e.g., a diverting valve.
  • the vessel may be connected to the syringe via a second valve, e.g., a stopcock valve.
  • An acoustic coupling medium may be placed in the vessel and held for a first time period.
  • the first time period may be a set time period or may last until the acoustic coupling medium reaches an air saturation threshold.
  • the acoustic coupling medium may be held at a vacuum pressure for a second time period.
  • the second time period may be a set time period as described below or may last until the acoustic coupling medium reaches a desaturation threshold.
  • the medium may be transferred to the syringe.
  • the medium may be transferred to the syringe via tubing and the second valve.
  • the magnetic stirring plate is a hot plate, and the degassing process also comprises heating the acoustic coupling medium to reduce the viscosity of the fluid to facilitate the subsequent filling process.
  • An IVUS catheter may be filled with the degassed acoustic coupling medium.
  • a filling process may begin by providing an IVUS catheter filling apparatus, which may include a fluid pump such as a syringe pump apparatus, a catheter heating plate, and/or a microscope.
  • the IVUS catheter may be placed in the catheter heating plate and heated to a catheter target temperature.
  • the catheter heating plate may include a cutout to receive the IVUS catheter.
  • the cutout may be an “S” shape, a spiral, a straight path, etc. and may be shaped based on one or more properties of the IVUS catheter.
  • the syringe pump apparatus may receive a syringe filled with degassed acoustic coupling medium.
  • the syringe pump apparatus may include a syringe pump, a syringe heating component (e.g., a syringe jacket), a pressure gauge, at least one piece of tubing, a pump, and/or a three-way valve.
  • the syringe pump may receive the syringe, and the syringe heating component may be disposed around the syringe and heat the syringe to a target temperature in a range of 35°C - 80°C (e.g., 35°C, 37°C, 40°C, 45°C, 50°C, 55°C, 60°C, 65°C, 70°C, 75°C, 80°C and overlapping ranges and values therein).
  • the syringe pump may expel the acoustic coupling medium from the syringe through the pressure gauge and into the tubing.
  • the syringe pump may expel the acoustic coupling medium at a target delivery rate, e.g., 0.4 mL/min.
  • the delivery rate may be modified based on whether a pressure in the syringe pump apparatus or IVUS catheter exceeds a pressure threshold, e.g, 80 psi.
  • the syringe pump may expel the acoustic coupling medium at a target fill pressure.
  • the acoustic coupling medium may pass through the tubing to the pump via a valve, such as a three-way valve.
  • the pump may be connected to a fill port of a proximal connector hub of the IVUS catheter, either directly or via fill nozzle and/or fill adapter.
  • the pump may pull/push the acoustic coupling medium from the tubing and/or syringe and into a proximal connector hub of the IVUS catheter to fill the catheter imaging lumen.
  • the pump may also push air out of the imaging lumen of the IVUS catheter according to some embodiments, for example with an air vent in the catheter, as described herein.
  • the IVUS catheter may include an imaging core disposed within a catheter jacket.
  • the imaging core may include a cabled transducer coupled with a transducer housing and the transducer housing coupled to a coil via a coupler within an imaging lumen.
  • a driveshaft may be attached proximally to the coil.
  • the transducer, the transducer housing, and/or the coupler may include one or more apertures according to some embodiments.
  • the driveshaft may also include one or more apertures according to some embodiments.
  • the IVUS catheter may include a luminal first gap between the imaging core and the coil, and a second gap between the coil and the catheter jacket.
  • the cross-sectional area of the first gap may be much smaller than the cross-sectional area of the second gap according to some embodiments.
  • the one or more apertures disposed throughout the IVUS catheter and/or the difference in cross-sectional area of the first and second gap may reduce the resistance to medium flow for the removal of air inside the coil within the IVUS catheter, increase improving the speed and efficiency by which the IVUS catheter can be filled, and improve and makes the removal of bubbles more effective. This can optionally improve the overall quality of IVUS images captured by the IVUS catheter.
  • the acoustic coupling medium fill may occur while rotating the inner core at a target speed such as 1000 rpm ⁇ 100 rpm.
  • the target speed may be modified if air is introduced into the system during filling. For example, the target speed may be decreased if air is introduced.
  • an IVUS catheter having a rotating inner imaging core encapsulated with a medium in an imaging lumen, which advantageously removes the need for the user to prepare and flush the lumen around the inner imaging core with a fluid.
  • the IVUS catheter according to various embodiments does not need a telescoping section connected to a motorized unit in order to enable images of vasculature using a rotating imaging core simplifying an I VUS catheter design.
  • the catheter has no telescoping sections that move along a longitudinal axis of the catheter.
  • catheters have no moveable or plunger or no moveable seal.
  • catheter components include a rapid-exchange (RX) guidewire lumen, or an over-the-wire (OTW) guidewire lumen.
  • RX rapid-exchange
  • OW over-the-wire
  • catheter components that incorporate a RX guidewire lumen or an OTW guidewire lumen are provided.
  • the catheter also contains an inner imaging lumen supporting an imaging core with a rotating drive shaft and distally housed-transducer.
  • the imaging lumen may be filled with an acoustically attractive coupling medium (e.g., liquid, fluid, gel, etc.).
  • An appropriate medium is, for example in one embodiment, a liquid as it may be easier to fill a lumen and remove air from the liquid.
  • IVUS catheters in contact with blood may optionally be biocompatible and sterilizable.
  • an acoustically attractive coupling medium may also be biocompatible and sterilizable as there may be some risk of the medium entering the blood if there was a leak in the catheter.
  • acoustically attractive media may have density and speed of sound values that are similar to the catheter jacket material in several embodiments. Increased differences in density or speed of sound values between a medium and the catheter jacket may result in unwanted strong acoustic reflections and refracted sound pulses that degrade image quality.
  • the acoustic coupling medium has a speed of sound value that is configured for improved lateral performance.
  • the geometry of a rotating element catheter may include a focusing lens for ultrasound that is made by a gently convex circular layer of material over the transducer surface that has speed of sounds slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to and sometimes even higher speed than the material being imaged.
  • a design for the rotating catheter geometry with a thin relatively high velocity catheter body and a coupling medium inside of it may be configured with a focusing effect that is fairly favorable.
  • This embodiment may be configured to be unexpected and surprising because a focusing lens for ultrasound is made by a gently, or slightly, convex circular layer of material over the transducer surface that has speed of sound slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to or even higher speed of sound than the material being imaged.
  • media include one of polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and natural oils.
  • the percentage of the non-PEG fraction may be 80 to 20% (e.g., 80%, 70%, 60%, 50%, 40%, 30%, 20% and overlapping values and ranges therein), and in certain embodiments a range of 50 to 30% (e.g., 50%, 45%, 44%, 43%, 42%, 41 %, 40%, 39%, 38%, 37%, 35%, 35%, 30% and overlapping values and ranges therein) as the propensity for dissolved gases is lower for the latter, respectively.
  • the coupling medium comprises one or more fluids.
  • a rigid proximal connector hub with a seal e.g., a flexible seal, wherein flexible in some embodiments is elastic, malleable, bendable, modifiable, adjustable, accommodating, adaptable, pliable, supple, pliant, and/or resilient
  • a seal e.g., a flexible seal, wherein flexible in some embodiments is elastic, malleable, bendable, modifiable, adjustable, accommodating, adaptable, pliable, supple, pliant, and/or resilient
  • a flexible seal surrounds, in several embodiments, a driveshaft (e.g., drive cable, drive coil, drivetrain, drive actuator) of the rotating imaging core inside a rigid proximal connector hub holding the medium inside the lumen connected to the hub while the core rotates.
  • the circular seal may be compressed onto the driveshaft with sufficient force to prevent leaks while still allowing a motor (e.g., connected to an imaging console) to rotate the inner imaging core at rates to support high imaging frame rates.
  • Example seal materials include elastic polymers like nitrile, ethylene propylene rubber, and fluorocarbons and similar materials.
  • Hub components and features may be arranged to fix the flexible seal between the connector hub and the rotating driveshaft, such as for example a seal housing and/or a seal cap.
  • the inner diameter / surface of the seal housing may be precisely dimensioned to ensure proper compression is applied to the flexible seal allow the driveshaft to rotate without too much friction while also preventing the medium from leaking proximally through the flexible seal.
  • An adhesive may optionally be applied to the outer circumference of the flexible seal to prevent leaks around the flexible seal.
  • the flexible seal may be assembled inside the rigid proximal connector hub to ensure a precise fit. In some embodiments, this is advantageous over placing a seal inside a flexible catheter or similar catheter body/lumen as the flexibility may contribute to medium leaks or air ingress during use.
  • the pressure differential on the two sides of a flexible seal may generally be insignificant so there is little force to push the medium out or to pull air in according to several embodiments.
  • the catheter may be subject to extreme temperature and ambient temperature swings. When exposed to extreme drops or rises in temperature, the coupling medium volume may decrease or increase, respectively, and then returning back to a default volume after the extreme temperature exposure. This volume change may typically require some sealing force so air is not pulled into or fluid leak out of the inner imaging lumen in some embodiments. Air that gets into the lumen may migrate to the distal transducer of the spinning imaging core and degrade image quality.
  • a fill port is included in the rigid proximal connector hub and is sealed after filling the catheter lumen with the medium, according to several embodiments.
  • the fill port may be configured to facilitate the connection to the filling equipment. After filling the catheter lumen the fill port may be closed off, for example with a seal, stopper, plug and/or adhesive to prevent any air ingress.
  • a fill port in one embodiment, has the inlet most proximal, juxtaposed to the flexible seal to aid in purging all air bubbles during the fill process.
  • a portion of the acoustic coupling medium exits the imaging lumen of the IVUS catheter (e.g., during the filling process) via a distal port (e.g., exit port, vent, hole, aperture, channel, opening).
  • a distal port e.g., exit port, vent, hole, aperture, channel, opening.
  • Methods to seal the exit port after filling the imaging lumen are also provided in embodiments herein.
  • a distal plug is attached to a removable wire in one embodiment.
  • Designs and methods to vent and seal the inner imaging lumen e.g., vent and seal the exit port and filling port during or after filling the inner imaging lumen are also provided in several embodiments herein.
  • the distal tip is formed with a plug fused into the distal end of the imaging lumen, sealing the imaging lumen.
  • a removable wire may be positioned next to the plug during the fusing process and then removed, effectively creating a narrow channel for air to vent during the filling process.
  • Removable wires may include, for example, NiTi (nitinol), stainless steel, or other wires.
  • the wire size may be configured to create an effective vent which can be easily sealed after the filling process, e.g. by heat or adhesive.
  • the wire is in the size range 0.005” to 0.010” (e.g., 0.005, 0.006, 0.007, 0.008, 0.009, 0.010 inches and overlapping values and ranges therein).
  • the filling process is completed once all bubbles are removed from the imaging lumen as air is purged from the vent; and upon inspection of no air bubbles, the vent and distal plug are sealed shut either with a heating process that reflows the materials together and/or a small amount of adhesive is inserted into the vent.
  • a distal tip may be formed with a distal plug and a removable wire at the distal end of the imaging lumen in one embodiment.
  • Removable wires include for example NiTi (nitinol), stainless steel, or other materials (e.g., metals, alloys, rigid and/or flexible wires).
  • the wire is fed through the lumen exiting the exit port leaving the distal plug loosely floating in the distal section of the lumen; (ii) the filling process is completed once all bubbles are removed from the lumen as air is purged from the exit port; and (iii) upon inspection of no air bubbles, the distal plug is bonded to the wall of the lumen either with a heating process that reflows the materials together and/or a small amount of adhesive is inserted into the exit port bonding the plug to the luminal walls.
  • the wire may be removed easily from the plug after the distal plug is bonded to the catheter lumen.
  • a colorant may be added to the medium before the filling process starts aiding inspection for leaks and identification of gas bubbles. The colorant may optionally add optical contrast aiding in the identification of the medium and gas bubbles improving the manufacturing process.
  • Methods are also provided for encapsulating a medium such as a fluid in the lumen of an IVUS catheter to prevent bubbles from forming or being captured during the filling process in several embodiments.
  • a vacuum pump may be attached to the distal exit port to remove air from the catheter lumen and then an entry port valve can be opened to allow the medium to be pulled into the lumen.
  • a pump can also be used instead of a vacuum pump to push the medium in or in combination with a vacuum pump for pulling the medium in.
  • a pump e.g., peristaltic or other pump
  • a pump is an example of a useful pumping mechanism for pushing.
  • filling the imaging lumen with the medium using a vacuum to pull and/or a pump to push can be supplemented by degassing the medium prior to filling.
  • Non-degassed medium will typically be in a saturated state with dissolved gases in ambient environments and these gases may come out of solution during the filling process or during the shelf-life of the device, creating bubbles during and after the filling process that then interfere with imaging during use. These bubbles may stick to surfaces, especially uneven surfaces, making it difficult to fully clear air from the catheter lumen.
  • Degassing the coupling medium before pulling it and/or pushing it into the lumen in several embodiments. Further minimizing exposure to ambient air before the filling process begins in some embodiments.
  • Degassed liquids can maintain an under-saturated state for some practical period of time (practical filling period), and during this time the catheter lumen can be filled. This can reduce the risk of air coming out of solution during the filling process and further can absorb bubbles if present during the process. Absorption of bubbles using the properly degassed medium may be an effective mitigation as these bubbles will stay in solution and not reemerge later.
  • the pressure inside an existing bubble can optionally force the air inside to dissolve into the medium eliminating captured air bubbles.
  • optionally degassing a medium reduces the number of visible bubbles in the medium.
  • the maximum period may be experimentally determined using an oxygen sensor placed in representative medium to measure the oxygen in the medium compared to the fraction of oxygen in the ambient air.
  • an oxygen sensor placed in representative medium to measure the oxygen in the medium compared to the fraction of oxygen in the ambient air.
  • PEG400 a fluid that has a viscosity of about 100 cP when properly degassed has a practical filling period of less than two hours supporting a manufacturing process that can be used to fill a lumen within a fraction of one hour immediately after the degassing step is completed.
  • Heat may be added to the medium during the medium-filling process, for example by heating the container used to degas the coupling medium and/or to the tubes used to fill the catheter lumen and/or to the catheter itself. Heat may reduce the viscosity decreasing the time to fill the catheter lumen and may further reduce the dissolved gases in the medium. Temperatures above ambient may lower the medium viscosity and the dissolved gases with higher temperature further improving filling results.
  • the coupling medium is heated to a temperature in a range of 60-100 °C (e.g., 60, 65, 70, 75, 80, 85, 90, 95, 100 °C and overlapping values and ranges therein).
  • 60°C is a useful temperature, in one embodiment, as burns can be avoided if someone touches the catheter or equipment. Higher temperatures, such as below 100 °C, can be more helpful with precautions to prevent accidental contact during the filling process.
  • Bubbles can also be present inside other cavities or interfaces inside the imaging lumen of the catheter, for example inside the imaging core, or inside the proximal hub connections to the imaging lumen. These other cavities may be difficult or impossible to inspect for bubbles during and after the filling process. As a result, bubbles may exist after the filling process is complete and go undetected and may emerge later during clinical use.
  • Several processes of degassing the coupling medium and filling the catheter described in embodiments herein can significantly decrease the risk of undetected bubbles emerging and degrading image quality.
  • Agitation of the catheter lumen and movement of the inner imaging core is performed in several embodiments for removing air from the lumen and other inner components during the filling process. Agitation can be from vibration of the catheter and/or rotation of the inner imaging core. In one embodiment, optionally holding the catheter vertical, or at some positive angle above the horizontal, aided by gravity to allow bubbles to migrate upwards out the exit port is performed in several instances to help release bubbles and visualizing an acceptable filling process. [0032] Visual inspection of the distal exit port of the catheter for complete removal of all bubbles can be used to signal stopping the filling process as well as a validated process based on time duration.
  • an IVUS catheter comprises (i) an elongate flexible member with a sealed lumen; (ii) a rigid proximal connector hub attached to the elongate member which connects to a console; (iii) an imaging core that moves inside the imaging lumen that includes a rotating driveshaft and a distal ultrasound transducer; and (iv) a flexible seal in the rigid proximal connector hub that seals a medium inside the imaging lumen between the driveshaft and the flexible member, and wherein the acoustic coupling medium does not leak outside the lumen and air does not enter through the flexible seal and wherein the console activates the transducer and received signals for forming an image.
  • the driveshaft may optionally comprise a drive cable, a drive coil, a drivetrain, and/or a drive actuator.
  • a distal end of the inner imaging lumen may comprise a distal port and a distal plug.
  • methods for medium filling comprise (i) placing a flexible seal in a rigid proximal connector hub sealing with coupling medium inside the elongate flexible member lumen, wherein the coupling medium is biocompatible, sterilizable, and acoustically compatible; (ii) degassing medium (fluid or gel) before filling cavity to remove some dissolved gases from medium; (iii) pulling and/or pushing medium into lumen with vacuum; (iv) sealing an entry port; and (v) sealing an exit port.
  • the medium is polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and/or natural oils.
  • the methods for medium filling include one or more of: pushing medium with a pump, for example a peristaltic, syringe, or displacement pump, pulling medium with a vacuum pump attached to a distal exit port, introducing mechanical agitation to facilitate more effective air removal, vertical or non-horizontal orientation of catheter to support effective gravity-assisted air removal from lumen, heating of medium and/or heating of catheter lumen to facilitate removal of air from the medium while reducing viscosity to speed up filing process, sealing exit port with polymer plug using heat to melt polymer plug into jacket or adhesive to bond interface.
  • a pump for example a peristaltic, syringe, or displacement pump
  • pulling medium with a vacuum pump attached to a distal exit port introducing mechanical agitation to facilitate more effective air removal, vertical or non-horizontal orientation of catheter to support effective gravity-assisted air removal from lumen
  • heating of medium and/or heating of catheter lumen to facilitate removal of air from the medium while reducing viscosity to speed up filing process
  • a flush-less, rotational-imaging core, IVUS catheter is provided that works right out of the package after plugging a rigid proximal connector hub into an imaging console for improved ease-of-use.
  • not using a telescoping catheter body removes any need for an additional motorized uniton the patient table, improving ease-of-use and reduced catheter cost manufacture.
  • a flush-less catheter is provided that, with improved reliability of a sealed coupling medium, avoids leaks and air ingress.
  • intraluminal ultrasound imaging is accomplished with the devices and methods described herein.
  • Imaging and diagnosis of intraluminal e.g., intravascular, cavity, digestive tract, esophagus, stomach, intestine, rectum, pancreas, sinus, ureter, bladder, gynecological, etc.
  • tissue assists in identifying irregularities, disease, and/or injury for medical treatment to improve patient outcomes in several embodiments.
  • a pre-filled I VUS device that comprises one or more seals that help prevent leakage of acoustic coupling medium from the device.
  • the flexible seal can account for pressure differences that are present when filling the lumen or during variable pressure and temperature shipment, handling, and storage conditions.
  • a flush-less I VUS catheter includes an imaging core comprising a rotational ultrasound transducer connected to a distal end of a driveshaft.
  • the driveshaft may optionally include a drive cable, a drive coil, a drivetrain, and/or a drive actuator.
  • the IVUS catheter may include a flexible elongate member comprising a sealed lumen, in which the sealed lumen is designed to receive the rotational ultrasound transducer and an acoustic coupling medium.
  • the sealed lumen may include a proximal end, a distal end, and a flexible wall extending a length between proximal end and the distal end.
  • the proximal end includes a proximal connector.
  • the distal end may include a distal port and a distal plug.
  • the IVUS catheter may include a rigid connector hub with an internal chamber, a medium fill port, a distal interface, a proximal interface, and a flexible seal.
  • the medium fill port may optionally be designed for insertion of the acoustic coupling medium into the rigid connector hub to fill the sealed lumen.
  • the distal interface may be configured for connection to the proximal connector strain relief of the sealed lumen.
  • the proximal interface may be configured for connection to a console that rotates the driveshaft.
  • the imaging console is a tablet, workstation, computer, display, user interface or other control device that may include a processor and/or software.
  • the seal in several embodiments, is distally connected to a seal housing connected to the proximal interface, wherein the seal is proximally connected to the internal chamber of the rigid connector hub; wherein the driveshaft extends distally through the seal, wherein the sealed lumen is in sealed medium communication with the seal, the internal chamber, and the distal plug.
  • an ultrasound catheter includes one or more seals that allow for air to escape while allowing an acoustic coupling medium to completely fill a cavity around an ultrasound transducer to reduce or eliminate bubbles (which thereby provide sharper images because bubbles can interfere with transmission of acoustic waves).
  • a device including but not limited to a flush-less IVUS catheter
  • an ultrasound transducer connected to a driveshaft
  • an elongate member comprising at least one sealed lumen, wherein the sealed lumen is configured to receive the ultrasound transducer and an acoustic coupling medium, wherein the sealed lumen comprises a proximal end, a distal end, and one or more walls extending a length between proximal end and the distal end.
  • the proximal end comprises a proximal connector; wherein the distal end comprises one or more distal ports and one or more distal plugs.
  • the rigid connector hub may optionally include one or more internal chambers, one or more medium fill ports, one or more distal interfaces, one or more proximal interfaces, and one or more seals.
  • the medium fill port may be configured for insertion of the acoustic coupling medium into the rigid connector hub to fill the sealed lumen.
  • the distal interface may be configured for connection to the proximal end of the elongated member and the sealed lumen.
  • the proximal interface may be configured for connection to a console, in one embodiment, wherein the console is configured for actuation of the driveshaft, with the seal being distally connected to a seal housing connected to the proximal interface.
  • the seal may be proximally connected to the internal chamber of the rigid connector hub according to one embodiment, and the driveshaft extends distally through the seal, with the sealed lumen in sealed medium communication with the one or more seals, the one or more internal chambers, and the one or more distal plugs.
  • a catheter includes an ultrasound transducer connected to a drive cable, an elongate member comprising a lumen, wherein the lumen is configured to receive the ultrasound transducer and an acoustic coupling medium, wherein the lumen comprises a proximal end, a distal end, and a wall extending a length between proximal end and the distal end, wherein the proximal end comprises a proximal connector; wherein the distal end comprises a distal port and a distal plug; a rigid connector hub comprising an internal chamber, a distal interface, a proximal interface, and a seal, wherein the distal interface is configured for connection to the proximal connector strain relief of the lumen; wherein the seal is distally connected to a seal housing connected to the proximal interface, wherein the seal is proximally connected to the internal chamber of the rigid connector hub; wherein the drive cable extends distally through the seal, wherein the lumen the lumen comprises a
  • the seal housing is bonded to the connector hub by, for example, via a seal port.
  • the flush-less I VUS catheter can also include a second seal housing, wherein the second seal housing is attached to the proximal interface.
  • the medium fill port is configured for sealing after delivery of the acoustic coupling medium.
  • the distal plug can optionally comprise a removable wire extending through the distal port, can be configured to be inserted into a proximal end of the lumen and drawn to the distal end of the lumen by a removable wire, can be bonded to the distal port, can be bonded to a portion of the flexible wall proximate the distal end, can be configured to be sealed with the distal plug can be bonded via heating and/or adhesive.
  • the distal plug can be a polymer.
  • the coupling medium is selected from the group consisting of one or more of the following: polyethylene glycol (PEG), water, saline, glycerin, and oil (and combinations).
  • the driveshaft can be rotationally actuated by an actuator proximate the proximal interface.
  • the imaging core can be in electrical communication via the driveshaft with a console.
  • the console can include a processor, where the processor is configured to instruct the actuator to rotate the imaging core, to instruct the rotational transducer to generate an ultrasonic signal, to receive a backscatter signal from the rotational transducer, and/or generate an ultrasound image based on the backscatter signal.
  • kits comprising one, several or all of the following one or more catheters, hubs, connectors, as described herein, as well as instructions for use.
  • AI/ML Artificial intelligence and/or machine learning
  • the system is matched for high definition (e.g., HD, UHD, HD+, etc.) image quality using acoustics and signal processing customized for peripheral vascular imaging with enhanced resolution and/or penetration.
  • high definition e.g., HD, UHD, HD+, etc.
  • Several embodiments are configured for intravascular imaging with a platform that is optimized for peripheral and/or coronary vascular procedures that will enable improved image interpretation, intervention guidance, and enhance ease of use and improve overall usability to streamline intraprocedural and clinical workflow.
  • the system improves usability with a contemporary system featuring a simplified user-interface and enhanced total-system capabilities leveraging Al to streamline workflow and image interpretation.
  • the systems described herein leverage Artificial Intelligence (Al) to enable image interpretation, enhance total-system capabilities, and streamline workflows to maximize the clinical value.
  • Al Artificial Intelligence
  • physicians will not need to integrate (e.g., cognitively integrate) imaging data spatially and temporally to fully interpret the clinical condition.
  • systems according to several embodiments described herein can leverage the power of Al with generational advancements to go beyond single image interpretation.
  • the Al-powered engine for example, may include a workstation that enhances image interpretation with a simplified workflow improving overall useability. Machine learning is used in several embodiments.
  • the Al-ready processing power is designed to support real time and on-demand image interpretation.
  • the Al powered workstation can provide high end processing and an Al engine for advanced signal and image processing.
  • the native image data capture provides for superior image interpretation (e.g, border detection, identification and measurement of vessel size, vessel disease, dissection, plaque morphology, etc.).
  • the systems described herein provide simplified measurement via automated border detection (e.g., Al algorithms automatically identify borders of a lumen, vessel, tissue, lesion, plaque, etc.).
  • the system provides simplified measurement via semi-automated border detection (e.g., the user can manually adjust or modify automated Al algorithms that identify borders of a lumen, vessel, tissue, lesion, plaque, etc. with the border selection reconfigured based on user modifications).
  • Al plaque identification utilizes Al algorithms to automatically classify and identify types of plaque within the imaged area to provide user guidance on treatment options (e.g., using color coding, icons or text overlays can be used to indicate what type of condition, such as plaque, may be present for the selected image).
  • the data driven platform is designed to collect data, simplify image interpretation, with Al processing power to support real time and on-demand image interpretation and reduce user cognitive load to help (i) identify lumen size, (ii) visualize dissections, (iii) characterize disease morphology, (iv) locate and quantify stenosis, and/or (v) identify true lumen.
  • image interpretation is used to identify thrombus, thrombosis, clots, embolisms, plaque, calcium, tissue health, stent or balloon apposition, and/or stent or balloon “health” or condition.
  • Image interpretation may involve imaging to evaluate quality and/or position of placement of an existing stent.
  • Image interpretation can involve identifying position relative to lumen walls, determine level of and/or quality of tissue grown into and around the stent or balloon.
  • image interpretation can involve (i) evaluating the amount of dissolving of the stent, (ii) determining if the dissolving of the stent is in accordance with expected decay patterns (e.g., determining whether the level of decay on one side of the stent similar to the other side of the stent, and if not, that may indicate a problem with stent placement, or if the stent is dissolving more rapidly than expected that could indicate the stent will not provide the tissue with the expected structural support).
  • expected decay patterns e.g., determining whether the level of decay on one side of the stent similar to the other side of the stent, and if not, that may indicate a problem with stent placement, or if the stent is dissolving more rapidly than expected that could indicate the stent will not provide the tissue with the expected structural support.
  • High-fidelity ultrasound data is used in one embodiment to drive improved image generation and image interpretation, with the option for leveraging artificial intelligence and/or machine learning.
  • catheters, devices, systems, and methods may be configured for use in performing edge-based machine learning computations associated with an image and/or image analysis using an artificial intelligence algorithm to identify one or more of a tissue border, plaque, calcium, thrombus, dissection, and/or stent apposition.
  • a method for filling an IVUS catheter with an acoustic coupling medium includes: connecting asource of an acoustic coupling medium to catheter, wherein the IVUS catheter comprises a flexible elongate member and a rigid connector hub, wherein the rigid connector hub comprises an entry port and an internal chamber, wherein the flexible elongate member comprises a lumen, an ultrasound imaging core, and an exit port; filling the lumen with the acoustic coupling medium via the entry port; expressing a portion of the acoustic coupling medium via the exit port; sealing the exit port with a plug; and sealing the entry port.
  • a method for filling an IVUS catheter with an acoustic coupling medium includes: connecting a source of an acoustic coupling medium to an IVUS catheter, wherein the IVUS catheter comprises a flexible elongate member and a rigid connector hub, wherein the rigid connector hub comprises an entry port and an internal chamber, wherein the flexible elongate member comprises a lumen, an ultrasound imaging core, and an exit port; filling the lumen with the acoustic coupling medium via the entry port; expressing a portion of the acoustic coupling medium via the exit port; sealing the exit port with a plug; and sealing the entry port.
  • the method can include degassing the acoustic coupling medium.
  • the lumen may be filled with acoustic coupling medium involving pushing the acoustic coupling medium into the lumen with a positive pressure at the entry port, such as, for example, with a peristaltic pump designed to push the acoustic coupling medium into the lumen with the positive pressure at the entry port.
  • the lumen may be filled with acoustic coupling medium that involves pulling the acoustic coupling medium into the lumen with a vacuum pressure at the exit port.
  • the acoustic coupling medium can be biocompatible, sterilizable, and/or acoustically compatible.
  • a method for filling an IVUS catheter with an acoustic coupling medium includes providing an IVUS catheter, wherein the IVUS catheter comprises a flexible elongate member and a rigid connector hub, wherein the rigid connector hub comprises an entry port and an internal chamber, wherein the flexible elongate member comprises an inner lumen, an ultrasound imaging core, and an exit port; filling the inner lumen with an acoustic coupling medium via the entry port; expressing a portion of the acoustic coupling medium via the exit port; sealing the exit port with a plug; and sealing the entry port.
  • a method for filling an IVUS catheter with an acoustic coupling medium includes connecting a source of an acoustic coupling medium to an IVUS catheter, wherein the IVUS catheter comprises a flexible elongate member and a rigid connector hub, wherein the rigid connector hub comprises an entry port and an internal chamber, wherein the flexible elongate member comprises an inner lumen, and an ultrasound imaging core; filling the inner lumen with the acoustic coupling medium via the entry port; and sealing the entry port.
  • a flush-less IVUS catheter imaging core is in mechanical communication with the driveshaft via the catheter interface module.
  • the catheter interface module comprises an actuator configured to rotate the driveshaft and/or a transceiver configured to transmit and receive ultrasound acoustic pulses.
  • the IVUS catheter may include one or more strain relief components configured to prevent kinks and excessive local strains in the IVUS catheter according to some embodiments.
  • the flush-less IVUS catheter may include (i) a fill port cap configured to seal the acoustic coupling medium into the sealed imaging lumen at the acoustic coupling medium fill port, (ii) a fill port valve cap, wherein the fill port valve cap comprises an open configuration for filling the acoustic coupling medium, wherein the fill port valve cap comprises to seal the acoustic coupling medium into the sealed imaging lumen at the acoustic coupling medium fill port, and/or (iii) a fill port cover configured to be inserted into and seal a fill port cap or a fill port valve cap.
  • the rigid connector hub includes a drive bushing disposed around the driveshaft.
  • the driveshaft may include one or more apertures configured to allow the acoustic coupling medium and bubbles to flow through the driveshaft.
  • a flush-less intravascular ultrasound (IVUS) catheter includes (i) an imaging core comprising a rotational ultrasound transducer connected to a driveshaft, (ii) a flexible elongate member comprising a sealed imaging lumen, wherein the sealed imaging lumen is configured to receive the imaging core with the rotational ultrasound transducer and an acoustic coupling medium, wherein the sealed imaging lumen comprises a proximal end, a distal end, and a flexible wall extending a length between the proximal end and the distal end, wherein the distal end comprises a distal port and a distal plug; (iii) a rigid connector hub comprising an internal chamber, an acoustic coupling medium fill port, a distal interface, a proximal interface, and a flexible seal, wherein the acoustic coupling medium fill port is configured for insertion of the acoustic coupling medium into the rigid connector hub to fill the sealed imaging lumen; wherein
  • a method for filling an ultrasound device with an acoustic coupling medium includes (i) connecting a source of an acoustic coupling medium to an ultrasound device, wherein the ultrasound device comprises a flexible elongate member and a rigid connector hub, wherein the rigid connector hub comprises an entry port and an internal chamber, wherein the flexible elongate member comprises an inner lumen, and an ultrasound imaging core; and (ii) filling the inner lumen with the acoustic coupling medium via the entry port; and sealing the entry port.
  • the method may include holding the acoustic coupling medium in an ambient environment for a first time period (e.g., in a range of 30 - 300 minutes) and/or until the acoustic coupling medium reaches an air saturation threshold.
  • the method may include holding the acoustic coupling medium in a vacuum environment for a second time period (e.g., between about 30 minutes and about 120 minutes) to form a degassed acoustic coupling medium and/or until the acoustic coupling medium reaches a desaturation threshold.
  • the desaturation threshold is based on an air saturation threshold, is between about 5% or less of the air saturation threshold and about 50% or less of the air saturation threshold, and/or is about 20% or less of the air saturation threshold.
  • a method may include placing the IVUS catheter in a catheter heating plate and heating to a catheter target temperature between 35°C and 80°C and/or placing the acoustic coupling medium in a syringe and inserting the acoustic coupling medium into the inner lumen via a syringe pump apparatus.
  • a syringe pump apparatus may include a syringe pump configured to expel the acoustic coupling medium from the syringe at a target delivery rate, such as between 0.1 mL/min and 1.0 mL/min.
  • the syringe pump apparatus may include a rotating motor configured to (i) rotate an imaging core to agitate and remove air from the sealed inner imaging lumen, (ii) to operate at a target speed (e.g., between 900 - 1100 rpm) that can be based on one or more of: an internal pressure of the syringe pump apparatus and an internal pressure of the sealed inner lumen; and/or the target speed may be adjusted based on one or more of the internal pressure of the syringe pump apparatus exceeding a pressure threshold (e.g., between 50 psi and 150 psi) or the internal pressure of the sealed inner lumen exceeding a threshold.
  • a pressure threshold e.g., between 50 psi and 150 psi
  • a degassing system includes a vessel configured to receive an acoustic coupling medium; a vacuum pump configured to be placed in fluid communication with the vessel; a hot plate configured to heat the vessel; and a container configured to receive a degassed acoustic coupling medium, wherein the acoustic coupling medium is held in the vessel in an ambient environment for a first time period, and wherein the vacuum pump is placed in fluid communication with the vessel and configured to maintain the vessel at a vacuum pressure for a second time period to transform the acoustic coupling medium into the degassed acoustic coupling medium.
  • the first time period is between 30 minutes and 300 minutes, (ii) the first time period lasts until the acoustic coupling medium reaches an air saturation threshold, (iii) the second time period is between 30 minutes and 120 minutes, (iv) the second time period lasts until the acoustic coupling medium reaches a desaturation threshold, (v) the desaturation threshold is based on an air saturation threshold, (vi) the desaturation threshold is between about 5% or less of the air saturation threshold and about 50% or less of the air saturation threshold, (vii) the desaturation threshold is about 20% or less of the air saturation threshold, (viii) the hot plate includes a magnetic stirring mechanism configured to turn a magnetic stir bar, (ix) the magnetic stir bar is placed in the acoustic coupling medium during one or more of the first time period and the second time period, and wherein the magnetic stirring mechanism is configured to create a magnetic field to turn the magnetic stir bar, stirring the acoustic coupling medium, (x) the hot plate is configured
  • a catheter heating apparatus includes an insulting layer; a heating layer disposed above the insulating layer, the heating layer configured to heat an IVUS catheter to a target temperature; a catheter receiving layer disposed above the heating element, the catheter receiving layer comprising a catheter cutout, the catheter cutout configured to receive the IVUS catheter; and a cover layer disposed above the catheter receiving layer.
  • the catheter heating apparatus may optionally include: (i) a target temperature is between at least about 35°C and at least about at least 80°C, (ii) a shape of the catheter cutout is one of an “S” shape, a spiral shape, or a straight shape, (iii) a shape of the catheter cutout is based on one or more properties of the IVUS catheter, (iv) the catheter receiving layer including one of a metal, metal alloy, and a metal composite, (v) the catheter receiving layer including a metal, such as aluminum, and/or (vi) the heating element including one or more heating elements.
  • a flush-less intravascular ultrasound (IVUS) catheter includes (i) an imaging core comprising a rotational ultrasound transducer disposed in a transducer housing, the transducer housing connected to a distal end of a coil and driveshaft via a coupler, (ii) a flexible elongate member comprising a sealed imaging lumen, wherein the sealed imaging lumen is configured to receive the rotational ultrasound transducer and an acoustic coupling medium, wherein the sealed imaging lumen comprises a proximal end, a distal end, and a flexible wall extending a length between proximal end and the distal end, wherein the distal end comprises a distal port and a distal plug; (iii) a rigid connector hub comprising an internal chamber, an acoustic coupling medium fill port, a distal interface, a proximal interface, and a flexible seal, (iv) one or more apertures disposed on one or more of: the transduc
  • an ultrasound transducer adapted for positioning at an intravascular site with a catheter for acoustic imaging.
  • Images and/or measurements of the vascular anatomy at the treatment site may be created by interrogating surrounding blood and tissues with ultrasonic pulses generated by the ultrasound transducer and creating an image of the blood and tissues based on backscatter signals responsive to the ultrasonic pulses.
  • Ultrasonic pulses may be acoustically transmitted through an acoustic coupling medium, a catheter polymer jacket, traveling through blood and tissue and continuously backscattered back to the transducer, then returning through the catheter jacket and the coupling medium and finally received by the transducer.
  • intravascular ultrasound imaging can create cross-sectional, 360° images of the blood and tissue from within the vasculature based on the backscatter acoustic signals responsive to the ultrasonic pulses.
  • the systems and methods described herein are directed towards creating improved intravascular ultrasound imaging. More specifically, in several embodiments, the systems and methods described herein produce an intravascular ultrasound image in which image quality is not degraded by bubbles via the incorporation of an encapsulated acoustic coupling medium.
  • an IVUS catheter reduces or eliminates the need for the user to flush the imaging core with a fluid, which takes precious procedure time to ensure air bubbles are reduced, removed, or eliminated from the lumen of the IVUS catheter.
  • the imaging core is an inner imaging core.
  • the IVUS catheter may be a fixed length and have a rotating imaging core with sealed encapsulated acoustic coupling medium.
  • the coupling medium is a fluid, liquid, and/or gel.
  • a liquid coupling medium is easier to fill a lumen and minimize air bubbles.
  • the IVUS catheter does not need a telescoping section connected to a motorized unit to enable images of vasculature with a rotating imaging core. Methods are also disclosed for reliably filling with a coupling medium that can support imaging without air impeding high quality imaging.
  • an IVUS catheter includes a rotating and/or translating imaging core assembly within a polymer jacket.
  • the transducer may translate and/or rotate within the distal lumen of the catheter jacket, and a coupling medium, such as a liquid or gel, supports the transmission and reception of ultrasound pulses by the transducer in an embodiment. Without the coupling medium, air can exist between the transducer and the catheter jacket inhibiting sufficient energy transfer into the patient’s blood vessels that may result in poor image quality.
  • IVUS uses ultrasound for imaging only (without therapy). In various embodiments, IVUS uses ultrasound for therapy only (without imaging). In various embodiments, IVUS uses ultrasound for both imaging and therapy.
  • one or more imaging technologies as described herein can be combined on the same catheter as one or more therapy elements, such as an integrated ultrasound imaging element located at or near the tip of (or otherwise along) a thrombectomy device.
  • the thrombectomy device can also be a separate device that is delivered before, during or after the imaging device.
  • Thrombectomy devices can be mechanical clot retrieval devices, clot aspiration devices, or a combination of clot retrieval and aspiration.
  • Neurovascular, coronary and pulmonary clots are treated in several embodiments using the ultrasound imaging devices and methods disclosed herein together with (either integrated or separate) clot treatment devices.
  • the clot treatment device can also include for example non-mechanical devices such as lytic or other drug delivery devices and energy delivery devices to disrupt/remove the clot or otherwise restore blood flow.
  • Combinations of two, three or more therapies combined with the IVUS imaging technologies described herein are also provided (for example, ultrasonic or laser clot disruption with a lytic agent).
  • the integrated IVUS and therapy catheter or probe can also be used, according to several embodiments, for restoring blood flow that is not caused by a clot.
  • the IVUS catheter is configured for imaging (alone or in combination with therapy) tissue and/or plaque (e.g., any one or more of hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially non calcified plaque).
  • the IVUS catheter is configured for imaging thrombus.
  • the technologies described herein are used for one or more of the following: identification of thrombus, dissection, calcium severity, vessel measurement, and/or preprocedural and postprocedural planning.
  • the technologies described herein are used to guide the sizing of stents, identify stent placement, apposition and/or expansion, assess lesion morphology, vascular wall thickening, loss of luminal patency, and/or vascular insufficiency, quantify plaque burden, identify complications from procedures, and/or evaluate stent failure with stent thrombosis or in-stent restenosis.
  • the technologies described herein can distinguish between lipids, calcified plaque, and tissue proliferation. In many embodiments, better imaging detail is provided than, for example, angiography.
  • the technology described herein is used in several embodiments with intraluminal image focusing with spinning single element ultrasound transducer via modification of image (e.g., angular diffraction, phase, amplitude, time shift, compositing backscatter reflected images) including the technology described in U.S. Patent Serial No. 63/497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods (and the PCT application claiming priority thereto and filed April 11, 2024); manually assisted pullback for spatial alignment measurements, voice control, position sensors (e.g., encoder) including the technology described in U.S. Patent Serial No.
  • FIG. 1 A is a block diagram of a rotational intravascular ultrasound system according to an embodiment.
  • FIG. 1 B is a block diagram of a rotational intravascular ultrasound system with a catheter interface module according to an embodiment.
  • Fig. 2A illustrates a detail of a distal tip of an imaging catheter with an elongate member that includes a rapid exchange (RX) lumen according to an embodiment.
  • Fig. 2B illustrates a detail of a distal tip of an imaging catheter with an elongate member that includes an over-the-wire (OTW) lumen according to an embodiment.
  • RX rapid exchange
  • OGW over-the-wire
  • FIG. 3A is an isometric view of a connector hub of an IVUS catheter system according to an embodiment.
  • Fig. 3B is a lateral cutaway view of the connector hub shown in Fig. 3A according to an embodiment.
  • Fig. 4 is a lateral cutaway view of a distal end of an elongate member that includes a lumen with a distal port according to an embodiment.
  • FIG. 5 depicts an example process for filling a flush-less intravascular ultrasound catheter according to an embodiment.
  • FIG. 6 illustrates another example process for filling a flush-less intravascular ultrasound catheter according to an embodiment.
  • Fig. 7 depicts an example process for filling a flush-less intravascular ultrasound catheter according to an embodiment.
  • FIG. 8 illustrates an intravascular ultrasound system including a catheter according to an embodiment.
  • FIG. 9 illustrates sub-assemblies of an intravascular ultrasound system including a catheter according to an embodiment.
  • FIG. 10 illustrates an imaging core according to an embodiment.
  • Fig. 11 illustrates a distal tip of a catheter according to an embodiment.
  • Fig. 12 illustrates a photographic depiction of one embodiment of a distal tip.
  • FIG. 13 illustrates an intravascular ultrasound system including a catheter according to an embodiment.
  • Fig. 14 illustrates sub-assemblies of an intravascular ultrasound system including a catheter according to an embodiment.
  • Fig. 15 illustrates a catheter jacket according to an embodiment.
  • Fig. 16 illustrates a distal tip according to an embodiment.
  • Fig. 17 illustrates a cross section view of a catheter jacket depicting a guidewire lumen and an imaging lumen according to an embodiment.
  • Fig. 18 illustrates a mid-shaft hub and proximal jacket according to an embodiment.
  • Fig. 19 illustrates a proximal hub according to an embodiment.
  • Fig. 20 illustrates isometric views of distal tips with an acoustic coupling medium according to various embodiments.
  • Fig. 21 illustrates a proximal hub assembly process according to an embodiment.
  • Fig. 22 illustrates a medium filling process according to an embodiment.
  • Fig. 23A illustrates an exploded view of a proximal hub assembly according to an embodiment.
  • Fig. 23B illustrates a cross sectional view of a proximal hub assembly according to an embodiment.
  • Fig. 24A illustrates a cross sectional view of a proximal hub with a strain relief component according to an embodiment.
  • Fig. 24B illustrates an isometric view of a proximal hub with a strain relief component according to an embodiment.
  • Fig. 24C illustrates an isometric view of a proximal hub with a strain relief component according to an embodiment.
  • Fig. 25A illustrates a cross sectional view of a proximal hub and a fill nozzle according to an embodiment.
  • Fig. 25B illustrates a cross sectional view of a proximal hub and fill nozzle engaged to fill the proximal hub with a coupling medium according to an embodiment.
  • Fig. 26A illustrates a medium fill port of a proximal hub in an open position according to an embodiment.
  • Fig. 26B illustrates a medium fill port of a proximal hub in engaged with a fill nozzle according to an embodiment.
  • Fig. 26C illustrates a medium fill port of a proximal hub in as the proximal hub is disengaged from the fill nozzle according to an embodiment.
  • Fig. 26D illustrates a medium fill port of a proximal hub connector in a closed or sealed position according to an embodiment.
  • Fig. 27 illustrates an apparatus for degassing a coupling medium according to an embodiment.
  • Fig. 28A illustrates an apparatus for heating a coupling medium according to an embodiment.
  • Fig. 28B illustrates a syringe pump apparatus for heating a coupling medium according to an embodiment.
  • Fig. 29A illustrates an isometric view of a catheter heating plate according to an embodiment.
  • Fig. 29B illustrates a lateral view of a catheter heating plate according to an embodiment.
  • Fig. 30 illustrates a lateral view of an imaging core of an IVUS catheter according to an embodiment.
  • Fig. 30A illustrates a cross-sectional view of a proximal section of the transducer housing showing an aperture according to an embodiment shown in Fig. 30.
  • Fig. 31 illustrates a lateral view of a proximal hub of an IVUS catheter according to an embodiment.
  • Fig. 32 shows a cross sectional view of an IVUS catheter shaft according to an embodiment.
  • Fig. 33 illustrates a flow of acoustic coupling media through the imaging lumen of an IVUS catheter according to an embodiment.
  • Fig. 34 is a process for degassing an acoustic coupling medium and filling an IVUS catheter according to one embodiment.
  • an IVUS catheter includes a rotating imaging core within a sealed imaging lumen that encapsulates an acoustic coupling medium, such as a fluid configured for reducing or eliminating the need for the user to flush the imaging core before and during use.
  • an acoustic coupling medium such as a fluid configured for reducing or eliminating the need for the user to flush the imaging core before and during use.
  • methods for reliably filling the lumen of a flush-less catheter with a coupling medium that supports imaging without air in the encapsulated coupling medium are disclosed.
  • Several methods are disclosed for reducing or eliminating air bubbles inside the sealed lumen in one embodiment.
  • the methods disclosed herein may include filling and encapsulating the coupling medium in the lumen to eliminate leaks and ensure air bubbles will not interfere with delivering high quality images.
  • Several embodiments described herein provide an IVUS catheter with a proximal connector hub assembly that facilitates a process for filling the IVUS catheter imaging lumen with an acoustic coupling medium during the catheter manufacturing process.
  • the coupling medium can encapsulate the imaging transducer, thereby creating an imaging pathway unimpeded by air bubbles.
  • the proximal connector hub assembly may include a proximal connector hub with a fill port, a fill port cap, and a fill port cover according to some embodiments.
  • the fill port may receive the fill port cap, which could include an elastomeric seal component or a rigid plastic cap.
  • the fill port cap may mate with a fill adapter of a fill nozzle, which may be used to fill the imaging lumen of the IVUS catheter with the acoustic coupling medium.
  • the fill nozzle may include a needle which pierces the seal to fill the catheter.
  • the fill nozzle and fill port adapter may be disengaged from the fill port cap, which can then be covered by the fill port cover.
  • the fill nozzle and fill port adapter may be disengaged from the fill port cap, which may draw acoustic coupling medium into the fill port cap and prevent air from entering the imaging lumen of the IVUS catheter.
  • the proximal connector hub assembly may include a proximal connector hub with a fill port, a fill port valve cap, and a fill port cover according to some embodiments. The fill port may receive the fill port valve cap.
  • the fill port valve cap may mate with a fill adapter of a fill nozzle, which may be used to fill the IVUS catheter with the acoustic coupling medium.
  • a fill adapter of a fill nozzle which may be used to fill the IVUS catheter with the acoustic coupling medium.
  • the fill nozzle and fill port adapter may be disengaged from the fill port valve cap, which may draw acoustic coupling medium into the fill port valve cap and prevent air from entering the imaging lumen of the IVUS catheter.
  • the proximal connector hub may include a strain relief component which may reduce or prevent kinks and excessive local strains in the IVUS catheter.
  • the proximal hub connector may also include a seal, a drive bushing, a drive hub, a drive hub pin, and/or an electronic identification (EID) printed circuit board (PCB).
  • the drive bushing may reduce wobble and/or non-uniform rotational distortion (NURD) and may prevent acoustic coupling fluid leaks by maintaining uniform friction around the inner diameter of the seal.
  • NURD non-uniform rotational distortion
  • degassing the acoustic coupling medium may provide for the degassing of an acoustic coupling medium and filling of an IVUS catheter with the degassed acoustic coupling medium.
  • Pre-filling the catheter with acoustic coupling medium during manufacture can optionally advantageously remove the need for the user to prepare and flush the lumen around the inner imaging core with a fluid.
  • degassing the acoustic coupling medium has the advantage of reducing the level of dissolved air in the medium, so that any small amounts of air left in the catheter or introduced into the catheter during the manufacturing process or during the shelf life of the device are dissolved or absorbed into the medium.
  • some embodiments of the methods described herein advantageously prevent the introduction of air into the acoustic coupling medium during filling, which improves the quality of images captured by the IVUS catheter and reduces procedure times by eliminating the need to refill or replace an IVUS catheter among other advantages discussed herein.
  • a degassing process comprises subjecting the acoustic coupling medium to a vacuum (or low) pressure over a period of time.
  • the degassing process may begin by providing a degassing apparatus.
  • the degassing apparatus may include a vessel, a vacuum pump, a magnetic stirring hot plate, and a syringe.
  • the vessel may be connected to the vacuum pump via tubing and a first valve, e.g, a diverting valve.
  • the vessel may be connected to the syringe via a second valve, e.g. , a stopcock valve.
  • An acoustic coupling medium may be placed in the vessel for a first time period.
  • the first time period may be a set time period or may last until the acoustic coupling medium reaches an air saturation threshold.
  • the acoustic coupling medium may be exposed to a vacuum pressure for a second time period.
  • the second time period may be a set time period as described below or may last until the acoustic coupling medium reaches a desaturation threshold.
  • the medium may be transferred to the syringe (such as, e.g., via tubing and the second valve).
  • the magnetic stirring plate is a hot plate
  • the degassing process also comprises heating the acoustic coupling medium to reduce the viscosity of the fluid to facilitate the subsequent filling process.
  • the technologies described herein, including the IVUS flush-less technologies for example comprise a reversable flush port seal that allows for product rework after inspection (e.g., if air bubbles remain, checking quality of imaging, etc.) and before optionally permanently sealed.
  • the filling and/or flushing procedure may be repeated with reversible port seal(s) until a satisfactory result is obtained (e.g, removal of bubbles, etc.).
  • a seal is reversible.
  • a seal is permanent.
  • the fill port may be temporarily sealed to facilitate inspection, and permanently sealed upon confirmation of successful filling process.
  • a temporary seal of the fill port may be removed to facilitate further fluid filling process steps.
  • An IVUS catheter may be filled with the degassed acoustic coupling medium.
  • a filling process may begin by providing an IVUS catheter filling apparatus and pressurizing the medium, such as with a syringe pump apparatus or other fluid pump apparatus.
  • the filling apparatus may also include a means to heat the catheter during the filling process, for example with a heating plate, and/or a microscope to monitor the filling process and inspect for air bubbles.
  • the IVUS catheter may be placed in the catheter heating plate and heated to a catheter target temperature.
  • the catheter heating plate may include a cutout to receive the IVUS catheter. The cutout may be an “S” shape, a spiral, a straight path, etc. and may be shaped based on one or more properties of the IVUS catheter.
  • the syringe pump apparatus may receive a syringe filled with degassed acoustic coupling medium.
  • the syringe pump apparatus may include a syringe pump, a syringe heating component (e.g., a syringe jacket), a pressure gauge, at least one piece of tubing, a pump, and/or a three-way valve.
  • the syringe pump may receive the syringe, and the syringe heating component may be disposed around the syringe and heat the syringe to a target temperature, e.g., 60°C.
  • the syringe pump may expel the acoustic coupling medium from the syringe through the pressure gauge and into the tubing.
  • the syringe pump may expel the acoustic coupling medium at a target delivery rate, e.g., 0.4 mL/min.
  • the delivery rate may be modified based on whether a pressure in the syringe pump apparatus or IVUS catheter exceeds a pressure threshold, e.g., 80 psi.
  • the syringe pump may expel the acoustic coupling medium at a target fill pressure.
  • the acoustic coupling medium may pass through the tubing to the pump via a valve, such as a three-way valve.
  • the pump may be connected to a fill port of a proximal connector hub of the IVUS catheter, either directly or via fill nozzle and/or fill adapter.
  • the pump may push the acoustic coupling medium from the tubing and/or syringe and into a proximal connector hub of the IVUS catheter to fill the catheter imaging lumen.
  • the pump may also push air out of the imaging lumen of the IVUS catheter according to some embodiments.
  • the filling process may include spinning the imaging core while the medium is filling the imaging lumen, to facilitate removal of air in and around the imaging core.
  • the spinning speed is 500 - 2000 rpm (e.g., 500, 600, 700, 800, 900, 1000, 1200, 1400, 1600, 1800, 2000 rpm, -V- 100 rpm and overlapping ranges and values therein.
  • the target speed may be configured to minimize residual air in the system during filling. For example, the target speed may be decreased temporarily if air bubbles stick to the inner walls of the imaging lumen at a higher speed helping the bubbles move distally, and then the speed can be increased again thereafter to shorten the overall filling duration in one embodiment.
  • the IVUS catheter may include an imaging core disposed within the imaging lumen of the catheter.
  • the imaging core may include a cabled transducer situated in a transducer housing attached to the distal end of a torque coil according to an embodiment.
  • the proximal end of the torque coil can optionally be attached to a driveshaft in the proximal connector hub.
  • a coax cable may be disposed inside the torque coil connects the transducer to the printed circuit board in the proximal connector hub.
  • a coupler component may connect the transducer housing to the coil.
  • the transducer, the transducer housing, and/or the coupler may include one or more apertures according to some embodiments.
  • the driveshaft may also include one or more apertures according to some embodiments.
  • the I VUS catheter may include a luminal first gap between the coax cable and the torque coil, and a second gap between the torque coil and the inner diameter of the imaging lumen.
  • one or more apertures disposed throughout the IVUS catheter and/or the difference in cross-sectional area of the first and second gap may reduce the resistance to medium flow for the removal of air inside the coil within the IVUS catheter, increase improving the speed and efficiency by which the IVUS catheter can be filled, and makes the removal of bubbles more effective. This can improve the overall quality of IVUS images captured by the IVUS catheter.
  • Clarity of imaging is important for proper identification of lesions, plaque (e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially non calcified plaque, fibro-fatty plaque), thrombus, calcium build up, dissections, and measurements of these abnormalities in several embodiments.
  • IVUS imaging can be useful for planning treatment and guiding selection of therapies for interventional cardiology, vascular surgery, and interventional radiology throughout the body from the heart to the peripheral vasculature, such as for measurements of lesions and for guiding and assessing stent implantation.
  • the IVUS catheter is used in an artery, vein, blood vessel (e.g., carotid, subclavian, pulmonary, artic, renal, iliac, arteriovenous (AV) fistula, femoral, popliteal, tibial, etc.).
  • intraluminal imaging is accomplished with the devices and methods described herein. Imaging and diagnosis of intraluminal (e.g., intravascular, cavity, digestive tract, esophagus, stomach, intestine, rectum, pancreas, sinus, ureter, bladder, gynecological, etc.) tissue can assist in identifying irregularities, disease, and/or injury for medical treatment to improve patient outcomes.
  • endoscopes may be used with several features described herein.
  • Transvaginal and other gynecological ultrasound devices may also include several features described herein.
  • EUS endoscopic ultrasound
  • IVUS intraluminal imaging or imaging of other body cavities or organs
  • the features described herein for “IVUS” or “catheters” should be understood to apply to intraluminal (or other cavity/organ) catheters, probes, tubes, scopes and other such devices.
  • the technologies described herein, in some embodiments, are used with other medical imaging systems (such as cardiac catheterization lab systems), to provide a precision healthcare portfolio for physicians, such as cardiologists.
  • a partnered platform improves workflow between IVUS and one or more other imaging systems (e.g., x-ray systems).
  • imaging systems e.g., x-ray systems.
  • stent placement and other procedures are optimized using the IVUS technology described herein together with x-ray, external ultrasound and/or other non-IVUS technology.
  • Imaging and diagnosis of intravascular or extravascular tissue is accomplished herein in several embodiments, including identification of irregularities.
  • irregularities as used herein may be given its ordinary meaning and shall also include vascular or other malformations, constrictions, occlusions, dilations, disease, and injury.
  • Irregularities may also include lesions, thrombus, aneurysm, dissection, plaque (e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially noncalcified plaque, fibro-fatty plaque), thrombus, fistulas, tumors, neoplasia, gallstones, kidney stones, polyps, cysts, etc., and measuring morphology assessment wherein such irregularities are within vessels, other bodily lumens or other target sites.
  • plaque e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially noncalcified plaque, fibro-fatty plaque
  • thrombus e.g., fistulas, tumors, neoplasia, gallstones, kidney stones, polyps, cysts, etc.
  • measuring morphology assessment wherein such irregularities are within vessels, other bodily lumens or other target sites.
  • irregularities may also include stent or balloon malapposition, dissection (e.g., post atherectomy, post balloon angioplasty, etc.), determining etiology of compression, under-expansion of a stent or other device, and issues with IVUS-guided sizing and grading of severity of an irregularity or under expansion of a stent, such as an iliac vein stent.
  • IVUS-guided sizing and grading of severity of an irregularity or under expansion of a stent such as an iliac vein stent.
  • Irregularities in the esophagus, stomach, and small intestine may be viewed using several embodiments described herein (e.g., through endoscopic ultrasound imaging).
  • the IVUS system is configured for optimized peripheral vascular procedures. In several embodiments, the IVUS system is configured for optimized peripheral vascular procedures and is not configured for coronary vascular procedures. In several embodiments, the IVUS system is configured for coronary procedures.
  • the IVUS system is configured for neurovascular procedures (including but not limited to cerebral vessels).
  • the IVUS system is configured for intravascular ultrasound-guided thrombectomy, including but not limited to mechanical thrombectomy.
  • the IVUS system is configured for ultrasound-guided pulmonary embolectomy.
  • simultaneous, real-time IVUS guidance is provided for procedures such as thrombectomy/embolectomy, stent placement, clot aspiration, other coronary or neurovascular procedures, etc.
  • the technology described herein are also used for intraluminal imaging (other than intravascular).
  • several embodiments are used for imaging, diagnosing, and/or providing an image-guided intervention in the digestive tract, esophagus, stomach, intestine, rectum, sinus, ureter, bladder, uterus, fallopian tubes, lungs, brain, etc.
  • the systems and methods described herein may be used in conjunction with an endoscope rather than an IVUS catheter and support identification and diagnoses of gastrointestinal tumors, such as tumors in the intestines and/or biliary ducts.
  • the systems and methods described herein may be used to image a sinus cavity using IVUS.
  • Figs. 1A and 1 B illustrate an intravascular ultrasound (IVUS) system 100 according to one embodiment.
  • the system 100 is flush-less.
  • the system 100 includes reusable and/or disposable components.
  • the disposable component is one or more of a family of imaging catheters 101, such as one or more peripheral imaging catheters.
  • the imaging catheter 101 may include a catheter body 102, a catheter shaft 110, an imaging core 104, a transducer 105, and a proximal connector hub 116.
  • the imaging catheter 101 may include a catheter body 102, a catheter shaft 110, an imaging core 104, a transducer 105, and a proximal connector that is attachable to an interface to a proximal connector hub 116.
  • a reusable component is a console 118, and the catheter body 102 attaches directly to the console, such as by the proximal connector hub 116.
  • the console 118 may include one or more processors 112, one or more transceivers 113, and/or an actuator 114. In one embodiment, such as the embodiments shown in Fig.
  • the reusable components of system 100 can include a catheter interface module (CIM) 115 that may be disposed between the console 118 and the catheter 101.
  • the transceiver 113 and actuator 114 may be part of the CIM 115, and the CIM can be remote from and attached to the console 118 via a cable. Parts of the transceiver 113 and actuator 114 may be distributed between the console 118 and CIM 115 according to some embodiments.
  • the CIM 115 may be placed in electronic communication with the console 118.
  • the CIM 115 may be connected to the console 118 with a cable, and the proximal connector hub 116 of catheter 101 may be connected to the CIM 115.
  • the intravascular ultrasound system 100 may include a catheter 101 with a catheter body 102, console 118, and display 120.
  • the display 120 may be part of the console 118.
  • the catheter body 102 of catheter 101 can be a flexible, elongate member.
  • the catheter body 102 may be split into a working length section which is insertable into the patient, and a proximal extension section connecting the working length to the proximal connector hub 116.
  • the working length section may be a fixed length which allows placement of the distal catheter imaging portion from a vessel access site to a treatment site.
  • the catheter 101 has a proximal extension length configured to attach the proximal connector 116 to a catheter interface module 115 outside of the sterile field.
  • the working length of catheter body 102 may be at least 90 cm, at least 120 cm, at least 150 cm, at least 180 cm, at least 210 cm, at least 240 cm, at least 270 cm, at least 300 cm, at least 330 cm, or at least 360 cm in length (e.g., 90, 100, 110, 125, 150, 175, 200, 230, 250, 280, 310, 350, 370, or 400 cm in length including values therein).
  • the catheter body 102 including both the working length and proximal extension may be at least 3 feet (ft), at least 4 ft, at least 5 ft, at least 6 ft, at least 7 ft, at least 8 ft, at least 9 ft, at least 10 ft, at least 11 ft, at least 12 ft, or at least 13 ft in length.
  • the catheter body 102 is a fixed length, and may not include any telescoping sections.
  • one or more radiopaque (RO) markers are spaced along a portion of the length of the catheter body 102.
  • the catheter body 102 may be comprised of one, two, or more housings, lumens, coils, mediums, connectors, sensors, and/or measurement devices.
  • the catheter body 102 includes an imaging lumen 108 containing an imaging core 104.
  • the annular space between the imaging lumen 108 and imaging core 104 with distal transducer 105 may be filled with an acoustic coupling medium 109.
  • the catheter body 102 may include one, two, or more material layers to refract ultrasonic signals and/or limit backscatter signals in an intended manner.
  • the catheter body 102 may have one, two, or more connecting elements, such as sections with varying materials and flexibility.
  • the catheter body 102 has a proximal end and a distal end.
  • the distal end may include a distal tip.
  • the catheter body 102 includes a guidewire lumen to enable the catheter to be advanced over a guidewire to a target site.
  • the guidewire lumen extends over the length of the distal tip in a rapid-exchange (RX) tip design, with the guidewire exit port at the proximal end of the distal tip.
  • the distal tip includes a distal plug as discussed in greater detail in conjunction with Fig. 4.
  • the guidewire lumen extends over the working length of the catheter body 102, as depicted in Fig. 2B.
  • the imaging core 104 comprises a drive shaft and a distal transducer 105 in several embodiments.
  • the transducer 105 may be a single-element transducer or a multi-element array of transducers in various embodiments.
  • a single ultrasound transducer e.g. , with only a single element, without multiple elements, without a plurality of elements, and/or without an array of elements
  • a multielement array may be a 2, 8, 10, 12, 16, 24, 32, 50, 64, 100, 128 element array.
  • the transducer is rotated by an actuator while the one, two, or more receiving transducers may remain static.
  • the catheter body 102 optionally has a flexible wall extending along the length of the catheter from a proximal end to a distal end.
  • the catheter body 102 can also include one or more lumens, such as an imaging lumen 108.
  • the catheter body 102 may include two or more lumens, such as a guidewire lumen and an imaging lumen.
  • the imaging lumen 108 may extend from the proximal end to the distal tip of the catheter body 102, terminating before the distal end of the tip.
  • the imaging lumen 108 may extend from a proximal end to a distal portion of the catheter body 102.
  • the imaging lumen 108 may be defined by a wall of the catheter body 102.
  • the wall of the catheter body is flexible.
  • the imaging lumen 108 may be defined by a wall of a member inserted into the catheter body 102.
  • the catheter body 102 may include two or more lumens.
  • the imaging lumen 108 may be sealable and comprise a proximal opening and a distal opening.
  • the imaging lumen 108 may be sealable and comprise a proximal port and a distal port.
  • the proximal opening of the imaging lumen may be connected to a fill port, for example a fill port in proximal connector 116.
  • the distal opening may be disposed at or near a distal end of the imaging lumen 108, and comprise a small opening which vents air during the filling process and which is then sealed off.
  • the proximal opening and the distal opening may be sealed as discussed below in conjunction with Figs. 3A-3B, 4, and 5.
  • the imaging lumen 108 may be sealable and comprise a proximal port and a distal port.
  • the proximal port may be disposed at or near a proximal end of the imaging lumen 108, and the distal port may be disposed at or near a distal end of the imaging lumen 108.
  • a lumen may be an inner lumen (e.g., an imaging lumen).
  • a wall may be an inner wall or an outer wall.
  • a transducer may be an inner transducer.
  • an imaging core 104 may be an inner imaging core 104.
  • the imaging catheter 101 of system 100 includes a catheter body 102, an imaging core 104 with a rotational transducer 105 disposed inside an imaging lumen 108, and a proximal connector hub 116.
  • the rotational transducer 105 is a component of the imaging core 104.
  • the rotational transducer 105 may be disposed at the distal section of the imaging lumen 108 of the catheter body 102 and generate a plurality of ultrasonic signals 106.
  • the rotational transducer 105 may be oriented such that ultrasonic signals propagate perpendicular to the catheter body 102.
  • the rotational transducer 105 may be oriented such that ultrasonic signals propagate with a circular shape perpendicular to the catheter body 102. In several embodiments, the ultrasound signals propagate away from the perpendicular to the catheter body wall forming a conical shape relative to the catheter wall. The rotational transducer 105 may be oriented such that ultrasonic signals propagate perpendicular to an axis.
  • a device such as a catheter 101 may include an imaging core 104 comprising a rotational ultrasound transducer 105 connected to a distal end of driveshaft 110.
  • the catheter body 102 of catheter 101 may include a flexible elongate member comprising a sealed imaging lumen 108, wherein the sealed lumen is configured to receive the ultrasound imaging core 104 and an acoustic coupling medium 109, wherein the sealed lumen comprises a proximal end, a distal end, and a flexible wall extending a length between proximal end and the distal end, wherein the proximal end is connected to a fill port of a proximal connector 116, and wherein the distal end comprises a distal seal such as a distal plug.
  • a device may include a rigid connector hub comprising an internal chamber, a medium fill port, a distal interface, a proximal interface, and a flexible seal, wherein the medium fill port is configured for insertion of the acoustic coupling medium into the rigid connector hub to fill the sealed lumen, wherein the distal interface is configured for connection to the proximal end of catheter body 102, wherein the proximal interface is configured for connection to a console, wherein the console is configured for rotational actuation of the driveshaft, wherein the flexible seal is distally connected to a seal housing connected to the proximal interface, wherein the flexible seal is proximally connected to the chamber of the rigid connector hub, wherein the driveshaft extends distally through the flexible seal, wherein the sealed lumen is in sealed medium communication with the flexible seal, the chamber, and the distal plug of the catheter body 102.
  • a strain relief may be positioned over the proximal end of catheter body 102 and the distal interface of proximal connector hub 116 to prevent kinking or over-bending of the flexible catheter body where it attaches to the rigid proximal connector hub 116.
  • the rotational transducer 105 may also detect a plurality of backscatter signals.
  • the catheter 101 of system 100 may include one, two, or more generating transducers and one, two, or more receiving transducers.
  • the imaging lumen 108 is configured to receive imaging core 104, comprising a rotational transducer 105 and a driveshaft 110.
  • the driveshaft 110 optionally mechanically couples the rotational transducer 105 to a component in the proximal hub 116, which in turn is connected to the actuator 114 when the catheter is connect to the Cl M 115 or console 118.
  • the imaging lumen 108 may be configured to receive a coupling medium 109.
  • the coupling medium is biocompatible, sterilizable, and/or acoustically compatible.
  • the coupling medium may be polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and/or oil (e.g., natural, mineral, etc.), or a combination thereof.
  • the coupling medium does not include PEG, water, saline, glycerin, or oil.
  • the coupling medium is degassed prior to insertion into the imaging lumen 108.
  • the coupling medium has a viscosity greater than water that reduces or eliminates non-uniform rotational distortion (NURD).
  • NURD non-uniform rotational distortion
  • the acoustic coupling medium may include a colorant to facilitate visual monitoring of the filling process during manufacture of catheter 101 to confirm elimination or reduction (e.g., reduction by 5%, 10%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100%) of potential air bubbles.
  • a colorant to facilitate visual monitoring of the filling process during manufacture of catheter 101 to confirm elimination or reduction (e.g., reduction by 5%, 10%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100%) of potential air bubbles.
  • the proximal connector hub 116 of imaging catheter 101 of system 100 is configured to connect to an actuator 114.
  • the actuator 114 can comprise a component or connection that is configured to couple a catheter component such as a driveshaft, to a motor in the console or CIM, to cause relative motion (e.g., rotational motion and/or translation motion, rotational motion without translational motion, and/or translational motion without rotation) between two or more components (e.g., a motion between the rotational transducer 105 and the catheter body 102).
  • Actuator 114 can comprise one, two, or more of, or a combination of, e.g., a hub, seal, valve, adhesive, bearing, hinge, pin, ball and pinion, axle, rotational joint, clutch, disc, gear, belt, motor, linear slide, linear actuator, track, groove, slot, cam, vibrational table, etc.
  • the proximal connector hub 116 may include features which couple to features in the actuator 114 such that rotation of actuator 114 translates torque forces to a drive hub 2316, causing rotation of drive hub 2316 and thereby to drive shaft 110 of imaging core 104.
  • an actuator is not necessarily coupled to an electronic, motorized, or otherwise automatic system, and that embodiments of the actuator(s) described herein can be configured to be moved manually, semi-automatically, and/or automatically.
  • the actuator 114 may be a drivetrain or a driveshaft.
  • the actuator 114 may rotate the rotational transducer 105 within the catheter body 102 in an azimuthal direction.
  • the catheter 101 may be connected to the one, two, or more processors 112 in a console or a CIM, via a connector hub 116, 300, which is shown in greater detail in Figs. 3A and 3B.
  • the connector hub 116 may include rigid and/or flexible elements.
  • the connector hub 116 may include one, two, or more seals that enclose the acoustic coupling medium in the imaging lumen 108.
  • the connector hub 116 may also include a medium fill port to insert the acoustic coupling medium into the imaging lumen 108.
  • the connector hub 116 may include mechanical and electrical connections to the actuator 114 and the processors 112, which may be housed in a console 118 or CIM 115. There may be one, two or more processors according to alternate embodiments.
  • the connector hub 116 may also provide for proximal rotation of the imaging core 104.
  • a keyed mechanical connection from the connector hub 116 to the console 118 or CIM 115 provides a tight connection to rotational forces that are transferred efficiently from the rotating motor actuator 114 to the driveshaft 110 of the imaging core 104 in the catheter 101.
  • the connector hub 116 may maximize torque control of a coil of the driveshaft 110 in the catheter body 102.
  • the connector hub 116 may connect the catheter body 102 to the console 118 that contains the processors 112 and other components.
  • the console 118 may include the actuator 114, an intravascular ultrasound transceiver 113 (that transmits and receives ultrasound acoustic pulses), an upgradable catheter-specific electrical matching network, and or a microphone to provide for a voice control interface.
  • the actuator and ultrasound transceiver may be placed in the CIM that may be connected to the console through a cable.
  • the console 118 may include a user interface and/or display comprising a wireless medical-grade tablet that may be docked and charged between procedures. The tablet may include a microphone or microphones to provide a voice control interface.
  • the distal end of the catheter 101 may be inserted into the patient.
  • the processors 112 may control various elements of the system 100 to generate an ultrasound image, which may be provided on a display device 120.
  • the distal end of the catheter 101 may be inserted into a vessel of a patient.
  • the processors 112 may control various elements of the system 100 to generate an ultrasound image of the vessel walls, blood flow, and surrounding tissue, which may be provided on a display device 120.
  • the processors 112 may control the actuator 114 and the rotation of the rotational transducer 105 at the distal end of the imaging core 104 of catheter 101.
  • the actuator 114 may rotate the rotational transducer 105 at a fixed rate.
  • the actuator 114 may rotate the rotational transducer 105 at one or more variable rates.
  • the processors 112 may instruct the rotational transducer 105 to generate ultrasonic signals and detect backscatter signals generated by the blood and tissue surrounding the catheter 101 in response to the ultrasonic signals. In some embodiments, the processors 112 may cycle the rotational transducer 105 between generating ultrasonic signals and detecting backscatter signals. For example, the processors 112 may generate an electrical pulse that causes the rotational transducer to emit an ultrasonic signal 106.
  • the plurality of ultrasonic signals may include ultrasonic signals with varying frequencies and/or amplitudes.
  • an imaging device such as an I VUS catheter has an imaging frequency (such as, for example, in the range of 1 - 90 MHz (e.g., 1-10, 10-15, 10-20, 10-25, 10-30, 10-40, 15-35, 20- 30, 30-40, 40-50, 20 -25, 20-30, 20-40, 20-45, 20-50, 25-35, 25-40, 25-45, 25-50, 30-45, 30-50, 40-45, 45- 50 MHz and any values and ranges therein).
  • the rotational transducer 105 may detect a backscatter signal generated by the blood and/or tissue surrounding the catheter body in response to the ultrasonic signal 106.
  • the processors 112 may receive backscatter signals from the rotational transducer 105 and generate an ultrasound image. In some embodiments, the processors 112 may process the backscatter signals by filtering, beamforming, adjusting, and/or transforming the backscatter signals. The processors 112 may provide the ultrasound image to be displayed on the display device 120.
  • the display device 120 may be any device suitable for providing a visual output including a television, a monitor, a mobile device, a tablet, a smart watch, projector screen, or the like.
  • the processors 112 may execute an imaging software platform.
  • the imaging software platform may provide a user interface for the control of the system 100.
  • the processors 112 may generate the user interface on the display device 120.
  • the imaging software platform may provide a multiple client interface and an image data platform.
  • the imaging software may allow a user to hand draw a border for an ultrasound image. For example, a physician during a procedure may draw a border around a vessel shown on a touch-input display, such a medical grade tablet.
  • the system 100 may provide an updated image only within the border.
  • the imaging software may provide a 3D visualization approach and/or a pullback summary.
  • the distal end of catheter 101 houses the imaging transducer 105.
  • Fig. 2A illustrates a distal end of an elongate member 200 of catheter 101 that includes an imaging lumen 202 and a rapid exchange (RX) guidewire lumen 204 according to one embodiment.
  • the elongate member 200 comprises one or more housing layers 206.
  • the imaging lumen 202 of the elongate member 200 may receive a rotating transducer 208 that is mechanically connected to a driveshaft 210.
  • the lumen 202 may also receive an acoustic coupling medium.
  • the coupling medium may be a liquid or a gel.
  • the coupling medium may be polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, natural oils, or a combination thereof.
  • the coupling medium has a density and speed of sound value that are similar to the catheter jacket material to prevent or reduce unwanted reflections from the medium/jacket interface and prevent or reduce refraction of the acoustic beam.
  • the acoustic coupling medium has a speed of sound value that is configured for improved lateral imaging performance.
  • the acoustic coupling medium has a speed of sound value that is configured for improved lateral performance.
  • the geometry of a rotating element catheter may include a focusing lens for ultrasound that is made by a gently convex circular layer of material over the transducer surface that has speed of sounds slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to and sometimes even higher speed than the material being imaged.
  • a design for the rotating catheter geometry with a thin relatively high velocity catheter body and a coupling medium inside of it may be configured with a focusing effect that is fairly favorable.
  • This embodiment may be configured to be unexpected and surprising because a focusing lens for ultrasound is made by a gently convex circular layer of material over the transducer surface that has speed of sounds slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to or even higher speed of sound than the material being imaged.
  • PEG may be provided in a range of 5-90% (e.g., 5-10%, 10-25%, 20-50%, 40-80%, and overlapping ranges therein).
  • PEG may be provided in various low molecular weight grades of polyethylene glycol.
  • PEG may be provided in various medium molecular weight grades of polyethylene glycol.
  • PEG may be provided in various high molecular weight grades of polyethylene glycol.
  • Fig. 2B illustrates a distal end of an elongate member 212 of a catheter 101 that includes multiple lumens 214, 218 according to one embodiment.
  • one of the lumens 218 may be an over-the-wire (OTW) guidewire lumen.
  • the catheter may include a guidewire lumen 218.
  • the elongate member 212 may include a distal tip 216.
  • the elongate member 212 may include a second guidewire lumen 218.
  • the imaging lumen 214 may receive a rotating transducer 208 that is mechanically connected to a driveshaft 210.
  • the imaging lumen 214 may also receive an acoustic coupling medium.
  • the guidewire lumen 218 may receive a guidewire where the guidewire lumen 218 extends to the end of the distal tip 216.
  • the guidewire lumen 218 does not include the acoustic coupling medium.
  • the luminal space around the transducer 208 contains an acoustic coupling medium that is encapsulated inside the imaging lumen 214.
  • Fig. 3A is an isometric view and Fig. 3B is a cross sectional view of a proximal connector hub 300 of one embodiment of an IVUS catheter 101.
  • the connector hub 300 is a rigid material with one or more flexible seals 304 such as is illustrated in Fig.
  • the flexible seal 304 surrounds the driveshaft 210 (extending though flexible seal and distally through the connector hub and into the lumen of the catheter body 102) inside a rigid connector hub holding the medium inside the lumen while the imaging core 104 rotates.
  • the flexible seal 304 is a circular (e.g., an O-ring) seal that is compressed onto the imaging core 104 of the connector hub 300 with sufficient force to prevent leaks while still allowing a motor or actuator in an imaging console to rotate the imaging core 104 at rates to support high imaging frame rates.
  • the flexible seal 304 is made of nitrile, nitrile rubber, nitrile butadiene rubber, Buna- N, acrylonitrile butadiene rubber, ethylene propylene rubber, ethylene propylene diene monomer rubber, fluorocarbons, fluoroelastomer, fluorine rubber, synthetic rubber polymer (such as Viton and others), silicone rubber, rubber derived from acrylonitrile, and similar materials.
  • the connector hub 300 can be connected to a proximal connector strain relief 302 of an IVUS catheter 101.
  • a drive hub component of the connector hub 300 is connected to the driveshaft of an imaging core 104.
  • the connector hub 300 is integrated with the catheter body such that the connector hub 300 forms the proximal end of the catheter body.
  • the connector hub 300 is separate and distinct from the catheter body such that the connector hub 300 is adjacent to, or near, a proximal end of the catheter body.
  • Fig. 3B is a lateral cutaway view of the connector hub 300 shown in the embodiment of Fig. 3A.
  • the housing portion of the connector hub 300 is rigid.
  • the connector hub 300 comprises an internal chamber 305.
  • the connector hub 300 comprises an internal chamber 305 in medium communication with a distal interface 303, a proximal interface 308, and/or a medium fill port 312.
  • the connector hub 300 comprises a distal interface 303 configured to connect to the proximal end of catheter body 102.
  • a driveshaft 210 extends through the distal interface 303 (portion illustrated at Fig. 3B).
  • the connector hub 300 comprises a proximal interface 308 configured to connect to a connector to console.
  • the connector in mechanical and/or electrical connection to the console includes a flexible seal.
  • a driveshaft 210 extends through the connector and is rigidly attached to a drive hub in the proximal interface 308. The drive hub interfaces with the actuator 114 when the catheter 101 is connected to the CIM 115 or Console 118 such that spinning of the actuator 114 spins the drive hub, which in turn spins the drive shaft and imaging core.
  • the connector hub 300 includes one or more sealing ports 310.
  • the proximal interface 308 may comprise one or more sealing ports 310.
  • the proximal interface 308 may be proximally adjacent and connected or otherwise coupled to the sealing ports 310.
  • the sealing ports 310 may be apertures in the body of the connector hub 300 and disposed radially above the seal housings 306.
  • the sealing ports 310 may provide access to the seal housings 306 and flexible seals 304.
  • sealing ports 310 may allow the connector hub 300 to be attached, bonded, and/or adhered to the one or more seal housings 306.
  • an adhesive may be applied to the seal housing(s) 306 and the flexible seal 304 via sealing ports 310.
  • One, two, three or more sealing ports 310, flexible seals 304, and seal housings 306 are used in several embodiments.
  • the connector hub 300 comprises a medium fill port 312.
  • the medium fill port 312 is configured to connect to a source or reservoir of an acoustic coupling medium 109.
  • the medium fill port 312 may be configured for inserting the acoustic coupling medium through the connector hub 300 and into the imaging lumen of the elongate member of the IVUS catheter.
  • the medium fill port 312 may be sealed after filling the imaging lumen with the medium.
  • the medium fill port 312 may be shaped to accommodate different connector geometries.
  • the medium fill port 312 may be disposed proximal to the distal interface 303 and is distal to a flexible seal 304 and the proximal interface 308.
  • the position of the medium fill port 312 may aid in purging all air bubbles during the fill process.
  • the medium fill port 312 may be sealed with an adhesive and/or with a plug similar to the method described below in conjunction with Fig. 4.
  • the fill port 312 has the inlet most proximal, juxtaposed to the flexible seal 304 to aid in purging all air bubbles during the fill process.
  • the hub may also include a fill port cap, and a fill port cover according to some embodiments.
  • the fill port may receive the fill port cap, which could be either an elastomeric seal component or a rigid plastic cap.
  • the fill port cap may mate with a fill adapter of a fill nozzle, which may be used to fill the IVUS catheter with the acoustic coupling medium.
  • the fill nozzle may include a needle which pierces the seal to fill the catheter.
  • the connector hub 300 includes one or more flexible seals 304.
  • the flexible seal 304 may surround the driveshaft 210 inside a connector hub 300 and seal a coupling medium inside a lumen of a catheter body while the core 104 rotates.
  • the flexible seal 304 may be compressed onto the core 104 with sufficient force to prevent leaks while still allowing an actuator of the console via the proximal interface 308 to rotate the imaging core 104 at rates to support high imaging frame rates.
  • the flexible seal 304 may be assembled inside the connector hub 300 to ensure a precise fit.
  • the connector hub 300 may include one, two, three or more flexible seals 304.
  • the flexible seal 304 may have a round cross section or may have an “X” cross section as illustrated in Fig. 3B.
  • the connector hub 300 may also include one or more seal housing components 306.
  • the seal housing 306 is a round, circular, oval, triangular, square, rectangular, and/or polyhedral shape.
  • two seal housing components 306 may arranged to house and capture the flexible seal 304 the connector hub 300 and the proximal interface 308.
  • the inner diameter of the seal housing 306 may be closely and precisely mated to ensure proper pressure is applied to the flexible seal 304.
  • the proper pressure may allow the imaging core 104 to rotate without too much friction and to prevent the acoustic coupling medium from leaking through the flexible seal 304.
  • an adhesive applied to the outer circumference of the flexible seal 304 prevents leaks around the flexible seal 304.
  • the pressure differential on the two sides of the flexible seal 304 can be generally insignificant so there is practically no force to push the medium out or pull air in.
  • the catheter may be subject to extreme temperature and/or atmospheric pressure swings, which could introduce air to the medium or cause the seal 304 to burst.
  • extreme rise or drops in temperature of the acoustic coupling medium may cause the acoustic coupling medium to expand or contract or even change from a liquid to a solid, either increasing or decreasing the encapsulated volume in turn causing an increase or decrease in fluid pressure, and then returning back to a default volume after the extreme exposure.
  • This volume and/or pressure change may be addressed by the flexibility and/or compressive force of the seal 304 so that air bubbles are not pulled into the lumen (in the case of a pressure drop) or fluid leaking out (in the case of a pressure increase). Air that gets into the lumen may migrate to the distal transducer and degrade image quality.
  • the dual seal housings in some embodiments, provide for precise assembly and sealing. In one embodiment, a single housing on the proximal side only may also be used.
  • Fig. 4 is a lateral cutaway view of a section of the distal end of an elongate member 400 of catheter 101.
  • the distal end may comprise an exit port configured for sealing after filling the imaging lumen of catheter body with an acoustic coupling medium according to one embodiment.
  • the elongate member 400 may include a lumen 402, which includes a distal port 404.
  • the lumen 402 may be filled with a coupling medium, and the distal port 404 may be sealed to reduce or eliminate air bubbles from the lumen, and to reduce or eliminate the need to flush the catheter lumen.
  • a distal plug 406 may be attached to a removable wire 408.
  • the distal plug 406 is a polymer material.
  • the distal plug 406 may be made of Pebax (polyether block amide), nylon or other polymer materials such that bonding and/or thermally fusing the plug with the catheter body is effective.
  • the distal plug 406 may be shaped to conform with the geometry of the distal port 404 and distal section of the imaging lumen 402.
  • the removable wire 408 may be NiTi (nitinol), stainless steel, or another flexible material.
  • the wire 408 may be fed through the lumen 402 from a proximal port at the proximal end towards the distal port 404.
  • the wire 408 is configured, in one embodiment, to exit the distal port 404, leaving the distal plug 406 in the distal section of the lumen 402.
  • the distal plug 406 may be bonded or adhered to the wall of the lumen 402.
  • the distal plug 406 may be drawn to the distal port 404 by the wire 408 such that the distal plug 406 seals the distal port 404.
  • heat may be applied to the distal end of the elongate member 400, causing the distal plug 406 to melt with and/or adhere to the wall of the lumen 402.
  • an adhesive may be inserted into the distal port 404, bonding the plug 406 to the walls of the lumen 402.
  • the wire 408 may be removed from the plug 406 after the distal plug is bonded to the lumen 402.
  • the wire 408 may be fed through the imaging lumen 402 starting from a proximal port at the proximal end of the catheter towards the distal port 404.
  • the wire 408 is configured, in one embodiment, to exit the distal port 404, leaving the distal plug 406 in the distal section of the imaging lumen 402.
  • the wire 408 may be removed before the filling process starts.
  • the air channel left in the distal plug 406 can create an effective vent that provides a path for the coupling medium to exit through the distal port 404 during the medium filling process.
  • space between the distal plug 406 and the imaging lumen 402 further provides a path for coupling medium to exit.
  • the distal port 404 can be closed, sealing the imaging lumen 402.
  • heat may be applied to the distal end of the elongate member 400 around the distal plug 406 for the closing process, causing the distal plug 406 to melt with and/or adhere to the wall of the imaging lumen 402. The heat can also close the vent created by the channel from the removed wire.
  • an adhesive may be inserted into the distal port 404, bonding the plug 406 to the walls of the lumen 402 creating an effective seal of the imaging lumen 402.
  • the wire 408 in the distal plug 406 remains in place until the medium filling process halts and the distal plug is secured to the imaging lumen 402.
  • the space around the outside of the distal plug may be an effective vent that provides an exit out the distal port 404 for the moving coupling medium.
  • heat may be applied to fuse the distal plug to the imaging lumen, then the wire is removed. Either further heat or adhesive can be applied to close the channel formed from removing the wire.
  • the wire 408 is removed after filling is complete. Heat can then applied to fuse the distal plug to the imaging lumen closing the channel formed from removing the wire.
  • an optional additional rapid exchange guidewire lumen 410 is shown in Fig. 4.
  • a distal plug 406 is used without a rapid exchange lumen 410.
  • Fig. 5 illustrates a process 500 for encapsulating a coupling medium in the lumen of an IVUS catheter according to an embodiment.
  • the process 500 prevents, reduces, and/or eliminates bubbles from forming or being trapped in the lumen during the filling process, thereby allowing for higher quality ultrasound images to be created.
  • the process 500 shown in Fig. 5 is an example process.
  • the process 500 may include more or fewer steps.
  • one or more of the steps of process 500 may be performed in a different order or simultaneously with respect to one or more of the other steps of process 500.
  • a degassing process comprises subjecting the acoustic fluid to a vacuum pressure over a period of time.
  • the degassing process may begin by providing a degassing apparatus.
  • the degassing apparatus may include a vessel, a vacuum pump, a magnetic stirring hot plate, and a syringe.
  • the vessel may be connected to the vacuum pump via tubing and a first valve, e.g, a diverting valve.
  • the vessel may be connected to the syringe via a second valve, e.g., a stopcock valve.
  • An acoustic coupling medium may be placed in the vessel and held for a first time period.
  • the first time period may be a set time period or may last until the acoustic coupling medium reaches an air saturation threshold.
  • the acoustic coupling medium may be held at a vacuum pressure for a second time period.
  • the second time period may be a set time period as described below or may last until the acoustic coupling medium reaches a desaturation threshold.
  • the medium may be transferred to the syringe via tubing and the second valve.
  • the magnetic stirring plate is a hot plate
  • the degassing process also comprises heating the acoustic coupling fluid medium to reduce the viscosity of the fluid to facilitate the subsequent filling process.
  • IVUS catheter may be filled with the degassed acoustic coupling medium.
  • a filling process may begin by providing an IVUS catheter filling apparatus, which may include a fluid pump such as a syringe pump apparatus, a catheter heating plate, and/or a microscope.
  • the IVUS catheter may be placed in the catheter heating plate and heated to a catheter target temperature.
  • the catheter heating plate may include a cutout to receive the IVUS catheter.
  • the cutout may be an “S” shape, a spiral, a straight path, etc. and may be shaped based on one or more properties of the IVUS catheter.
  • a vacuum pump is attached to the distal exit port to remove air from the catheter imaging lumen and then the entry port is opened (e.g., via a valve) to allow the medium to be pulled into the lumen.
  • a positive pressure pump can also be used instead of or in addition to the vacuum pump to push the medium into the imaging lumen.
  • a peristaltic pump is a useful pumping mechanism for pushing the medium.
  • the process 500 may include a step 502 in which the acoustic coupling medium is degassed.
  • the coupling medium may be degassed by vacuum degassing, sonication, sparging, or a combination thereof.
  • vacuum degassing is used in light of its simplicity and effectiveness.
  • degassing the coupling medium prevents, reduces, or eliminates formation of air bubbles in the coupling medium during transporter during a procedure.
  • Non-degassed medium will typically be in a saturated state with dissolved gases in ambient environments, and these gases may come out of solution during the filling process, creating bubbles during and after the filling process.
  • Bubbles may stick to surfaces, especially uneven surfaces, making it difficult to fully clear air from the catheter lumen.
  • the coupling medium can maintain an under-saturated state for some practical period of time, e.g, a practical filling period. During the practical filling period, the catheter lumen can be filled. Degassing the coupling medium minimizes the risk of air coming out of solution during the filling process and can dissolve bubbles if present.
  • the process may move to step 504 in which the coupling medium is heated. Heating the coupling medium may further remove dissolved gases in the coupling medium and may reduce the medium’s viscosity, decreasing the time it takes to fill the catheter lumen.
  • the coupling medium may be heated by conduction, convection, radiation, or a combination thereof.
  • the coupling medium may be heated in a container used to degas the coupling medium.
  • heat may also be applied to the tubes used to fill the catheter lumen and/or the catheter itself thereby heating the interfacing surrounding the coupling medium.
  • the process 500 moves to step 506 where the coupling medium is inserted into the lumen of an elongate member.
  • the coupling medium may be inserted by applying a positive pressure to a proximal fill port connected to the lumen, pushing the coupling medium into the lumen.
  • tubes may be attached to the proximal port of the elongate member and lumen, and a positive pressure pump may be used to push the coupling medium through the tubes and into the lumen.
  • the positive pressure pump could be a syringe pump, displacement pump, or other pump capable of applying adequate controlled pressure to fill the imaging lumen.
  • a peristaltic pump may be used to apply a constant positive pressure.
  • the coupling medium may be inserted by applying a negative pressure, or vacuum pressure, to the distal port of the elongate member.
  • a vacuum pump may be attached to the distal port to remove air from the lumen, and then a proximal valve can be opened, allowing the coupling medium to be pulled into the lumen.
  • a combination of positive pressure and vacuum pressure may be employed to insert the coupling medium into the lumen.
  • a vacuum pump may be attached to the distal port to remove air from the lumen; a proximal port valve may be opened; and a pump may apply a positive pressure to the coupling medium, pushing the medium into the lumen.
  • the coupling medium is inserted into the lumen during a practical filling period.
  • the practical filling period may be defined as a set period of time that the coupling medium remains unsaturated with air after a degassing process.
  • the practical filling period can depend on the medium type.
  • the practical filling period may be calculated by placing an oxygen sensor in the coupling medium to measure the oxygen in the medium compared to the fraction of oxygen in the ambient air. For example, measuring the oxygen content in the coupling medium as a function of time can be executed to quantify how quickly ambient air is absorbed into the medium. Setting the practical filling period to ensure that only an insignificant ambient air is absorbed into the medium is provided in some embodiments to support an effective degassing method.
  • PEG400 a fluid that has a viscosity of about 100 cP when property degassed, can have a practical filling period of less than two hours supporting a manufacturing process that can be used to fill a lumen within a fraction of one hour immediately after the optional degassing step is completed.
  • the process 500 may move to step 508 where the coupling medium may be agitated by shaking or vibrating one or more of the surrounding catheter components.
  • the coupling medium may be agitated by moving the imaging core 104 within the coupling medium.
  • the coupling medium may be agitated using a vibration of the catheter, by rotating of the imaging core 104, and/or moving the core longitudinally within the lumen.
  • the catheter is agitated on a vibration surface and/or subjected to ultrasound energy.
  • the process may optionally move to step 510 where the catheter body may be oriented at an angle (e.g., at an angle between 0 - 90 degrees between horizontally (e.g., 0 degrees) and vertically (e.g., 90 degrees) oriented, e.g., orienting the catheter body to a positive angle above horizontal).
  • the catheter is optionally placed at an angle above horizontal and up to a vertical orientation that may be executed before the coupling medium is inserted.
  • the catheter body may be oriented between horizontal to vertically such that the distal end of the elongate member is above a proximal end of the catheter body.
  • any positive angle catheter orientation above horizontal may be used to help any bubbles leave the catheter lumen.
  • Orienting the catheter to a positive angle may allow bubbles to migrate upwards out the distal port to help release bubbles and visualize an acceptable filling process in one embodiment.
  • the catheter body may be oriented vertically such that the distal port is the highest point of the lumen.
  • the shaft of the catheter is oriented at an angle above horizontal and less than vertical where vertical is ninety degrees.
  • any positive angle above horizontal can facilitate air removal with an angle based on the medium type and processes parameters described in Fig. 5.
  • no angle an angle of zero, may be implemented if air bubbles are effectively removed without this step 510 for a selected coupling medium and other process parameters.
  • the process 500 may move to step 512 where insertion of the coupling medium is ceased. Insertion of the coupling medium may cease when the lumen is sufficiently filled with the coupling medium. In some embodiments, insertion of the coupling medium may cease upon visual inspection that the imaging lumen is full and coupling medium is devoid of air bubbles. Visual inspection may include, in several embodiments, a microscope with at least 10x magnification. Magnification of 10x, 30x, 50x, and up to 10Ox can help identify when bubbles are no longer in the filled medium. The distal end of the catheter may be visually inspected for complete removal of all bubbles. Bubble sizes initially present in the medium may be dependent on the geometry of the inner components in contact with the medium.
  • At least bubbles larger than 10-20um in diameter are removed.
  • microbubbles smaller than 10-20um in diameter are less likely to significantly impact imaging performance for IVUS if the quantity of bubbles is less than 10-20% of the active surface area of the transducer or transducers.
  • insertion of the coupling medium may cease after a set time period has elapsed.
  • a set time period may be 5 - 30 minutes (e.g., 5, 10, 15, 20, 25, and 30 minutes and any ranges or values therein) in duration.
  • both the volume of the lumen to be filled as well as the viscosity of the selected medium can affect the filling time period.
  • a longer catheter may take longer to fill for the same luminal diameter.
  • the process 500 may move to step 514 where the inner lumen is sealed.
  • the distal port may be sealed with a plug.
  • a plug may be attached to a flexible wire.
  • the wire may be fed through the inner lumen from a proximal port towards the distal port.
  • the wire may exit the distal port, leaving the distal plug in the distal section of the lumen.
  • the wire and the distal plug may be inserted into the lumen prior to the lumen being filled with a coupling medium (step 506).
  • the distal plug may be drawn to the distal port by the wire such that the distal plug seals the distal port.
  • the distal plug may be bonded to the wall of the inner lumen.
  • Heat may be applied to the distal end of the elongate member, causing the distal plug to adhere and/or fuse with the wall of the inner lumen.
  • adhesive may be inserted into the distal port, bonding the plug to the inner and/or outer walls of the inner lumen.
  • the wire may be removed from the plug after the distal plug is bonded to the inner lumen.
  • the medium entry port e.g., a fluid fill port
  • the adhesive is a single component, one part, two part, or multiple part, is an epoxy, acrylic-based, cyanoacrylate, ethyl cyanoacrylate adhesive.
  • the adhesive may be cured, e.g., with a chemical, light, ultraviolet light.
  • the adhesive maintains bonding properties with sufficient adhesive strength after sterilization process(es) such as steam, autoclave, gamma, and/or electron beam (e- beam) sterilization.
  • sterilization process(es) such as steam, autoclave, gamma, and/or electron beam (e- beam) sterilization.
  • adhesives include options from Loctite such as 3311, 3922, 4310, 4311 , EA-M-21 HP, and EA-M-31 CL. These examples have good bonding properties and maintain sufficient adhesive strength even after gamma and/or e-beam sterilization.
  • the fill port may be self-sealing, i.e. removing the fill nozzle automatically ensures the port is sealed.
  • steps 502 may occur simultaneously.
  • steps 504, 506, 508, and/or 510 may occur simultaneously.
  • the process 500 significantly decreases the risk of undetected bubbles emerging and degrading image quality according to several embodiments.
  • the spaces inside and around the driveshaft and along the full length of the catheter are spaces where air may not be fully purged easily so a degassed coupling medium will help clear air from hidden cavities.
  • Bubbles can also be present inside other cavities or interfaces inside the main lumen of the catheter. These other cavities can often difficult to inspect and might be impossible to inspect for bubbles during and after the filling process. Bubbles may exist after the filling, go undetected, and emerge later during clinical use.
  • the process 500 allows the inner lumen to be filled with an acoustic coupling medium minimizing captured air during a single setup procedure according to several embodiments.
  • the process 500 may represent a series of steps within a manufacturing process and allow a catheter to be shipped in “ready to use” state such that the catheter can be plugged into a console quickly. Because the coupling medium does not have any bubbles or insignificant quantities of microbubbles and will not generate bubbles during a procedure, high quality ultrasound images can be captured without flushing the catheter with saline. In turn, procedure times are reduced, higher quality diagnostic images are captured, and patient outcomes are improved in several embodiments.
  • Fig. 6 illustrate an example process 600 for encapsulating a coupling medium in the inner lumen of an IVUS catheter.
  • the process 600 shown in Fig. 6 is an example process.
  • the process 600 may include more or fewer steps.
  • one or more of the steps of process 600 may be performed in a different order or simultaneously with respect to one or more of the other steps of process 600.
  • the process 600 may begin at step 602 where a coupling medium is degassed. Step 602 may be similar to step 502 described above. Next, the process 600 may move to step 604 where the coupling medium may be pushed into the lumen of a catheter via a proximal entry port and/or pulled into the lumen by a vacuum pump disposed at a distal exit port of the catheter. The coupling medium may be heated. The process 600 may move to step 606 where filling of the inner lumen of the catheter with the coupling medium may be stopped when all air is removed from the inner lumen. Step 606 may be similar to step 512. Next, the process 600 may move to steps 608 and 610 where the distal exit port and the proximal entry port may be sealed, respectively. Step 608 may include the processes for sealing the distal port described above in conjunction with step 514. Step 610 may include the processes for sealing the proximal port described above in conjunction with step 514.
  • Fig. 7 is an example process for illustrating a process 700 for encapsulating a coupling medium in the inner lumen of an IVUS catheter.
  • the process 700 shown in Fig. 7 is an example process.
  • the process 700 may include more or fewer steps.
  • one or more of the steps of process 700 may be performed in a different order or simultaneously with respect to one or more of the other steps of process 700.
  • the process 700 may begin at step 702 where a coupling medium is degassed.
  • the coupling medium is a coupling fluid.
  • Step 702 may be similar to steps 502 and 602 described above.
  • a filling apparatus such as a motor or pump may be attached to a fill port of imaging catheter proximal hub.
  • the process 700 may move to step 704 where the coupling medium may be pushed into the lumen of a catheter via a proximal entry port and/or pulled into the lumen by a vacuum pump disposed at a distal exit port of the catheter.
  • the coupling medium may be heated.
  • the process 700 may move to step 706 where the inner imaging core 104 may be moved to dislodge air.
  • Step 706 may be similar to step 508 where the coupling medium may be agitated using a vibration of the catheter, by rotating of the inner imaging core 104, and/or moving the imaging core 104 longitudinally within the inner lumen.
  • the process 700 may move to step 708 where filling of the inner lumen of the catheter with the coupling medium may be stopped when all air is removed from the inner lumen.
  • Step 708 may be similar to steps 512 and 606.
  • the process 700 may move to steps 710 and 712 where the distal exit port may be sealed and the proximal entry port may be sealed, respectively.
  • Step 710 may include the processes for sealing the distal port described above in conjunction with steps 514 and 608.
  • Step 712 may include the processes for sealing the proximal port described above in conjunction with steps 514 and 610.
  • Fig. 8 illustrates an embodiment of a catheter 101 of IVUS system 100.
  • the catheter 101 may include a catheter body 102, an imaging core 104, a proximal connector hub 870 with a fill port 860.
  • the imaging core 104 (with transducer 105) can be positioned in an imaging lumen of catheter body 102,
  • the catheter body 102 can comprise a distal tip 810, an acoustic window 820, a catheter working length section 835 (e.g., 100 - 200 cm), a hydrophilic coating 830 (e.g., distal 20 - 80 cm), a mid-shaft hub 840, a proximal extension section 850 (e.g., 100 - 150 cm)), and a proximal strain relief 855, and may be connectable to a proximal connector hub 870 with a fill port 860.
  • a catheter working length section 835 e.g., 100 - 200 cm
  • hydrophilic coatings are on an external surface and/or an internal surface (e.g., in a lumen, etc.) of the catheter. In some embodiments, hydrophilic coatings are not on an external surface of the catheter. In some embodiments, hydrophilic coatings are not on an internal surface (e.g., in a lumen, etc.) of the catheter.
  • Fig. 9 illustrates embodiments of an IVUS system 100 with various sub-assemblies for the IVUS catheter 101, including the catheter body 102, such as an imaging core 104, a distal catheter jacket along a catheter working length 835, a proximal extension 850, and including a proximal hub connector 870.
  • the catheter body 102 such as an imaging core 104, a distal catheter jacket along a catheter working length 835, a proximal extension 850, and including a proximal hub connector 870.
  • Fig. 10 illustrates an embodiment of an imaging core 104 sub-assembly with a transducer 105 and transducer housing 103, a coaxial electrical connector cable 1000 and a coil 1010.
  • the coil 1010 e.g., torque coil, driveshaft, drive cable, drive coil, drivetrain, drive actuator, etc.
  • the imaging core 104 can be configured to minimize bubbles at or around the transducer 105.
  • an imaging core 104 sub-assembly may include one or more apertures or holes to improve a filling process.
  • Fig. 11 illustrates a distal tip 810 of an RX embodiment of catheter 101 of an IVUS system 100 according to an embodiment.
  • the distal tip 810 may be flexible, atraumatic, robust (with the ability to cross occlusions without deformation) and may include a radiopaque marker 812 at the tip.
  • the distal tip includes an acoustic window 820 over the transducer imaging plane. The distal tip can be configured to seal the coupling medium in the catheter.
  • the distal tip includes a plug 406 to close a bleed or vent hole/port at the distal end of the imaging lumen 402.
  • the distal tip and plug assembly may be formed with a small wire which is then removed, to form a vent or exit port so air may escape during the fluid fill process. Once the fluid fill is complete, the vent or exit port can be closed off.
  • the distal tip 810 includes a plug 406 that reinforces the RX guidewire lumen 204.
  • the RX port includes a lumen 204 is of length 1 - 3 cm (e.g., 1 .0, 1 .5, 2.0, 2.5, 3.0 cm) and supports insertion of a guidewire into the lumen that is durable and kink resistant.
  • the distal tip is durable with a tapered distal tip.
  • the distal tip includes a radiopaque (RO) marker 812 at or near the distal end.
  • the distal catheter jacket 835 has a flexible distal region and a stiffer pushable proximal region.
  • the distal catheter jacket 835 has RO markers along the shaft.
  • the tip and shaft RO markers maybe made of radiopaque polymer material such as Pebax and/or nylon with Tungsten to improve visibility and/or opacity of the distal tip and/or provide measurement markings during the clinical procedure.
  • the RO marker(s) may also be platinum, gold, iridium, or alloy thereof and may be glued, swaged, encapsulated, or otherwise secured to the distal tip and/or catheter body 102 in various embodiments.
  • Fig. 12 illustrates a depiction of an embodiment of a distal tip 810 of an IVUS system 100 with 1 mm separated graticules of a measurement ruler positioned next to the distal section of the catheter.
  • Fig. 13 illustrates an over-the-wire OTC embodiment of catheter 101 of an intravascular ultrasound system 100
  • the catheter 101 includes catheter body 102, imaging core 104 (with transducer 105), configured for connection to a proximal connector hub 870 with a fill port 860.
  • the catheter body can include a distal tip 810, an acoustic window 820, a catheter working length of a distal catheter jacket 835 (e.g., 90 - 130 cm), a hydrophilic coating 830 (e.g., distal 20 - 60 cm), a mid-shaft hub 840 , a guidewire exit port 845, a proximal extension 850 (e.g., 120 - 160 cm) and a proximal strain relief 855 configured for connection to a proximal connector hub 870 with a fill port 860.
  • hydrophilic coatings are on an external surface and/or an internal surface (e.g., in a lumen, etc.) of the catheter. In some embodiments, hydrophilic coatings are not on an external surface of the catheter. In some embodiments, hydrophilic coatings are not on an internal surface (e.g., in a lumen, etc.) of the catheter.
  • Fig. 14 illustrates embodiments of various sub-assemblies for the IVUS catheter 101 , such as an imaging core 104, a distal jacket along a catheter working length 835, a proximal extension 850, and a proximal hub 870.
  • Fig. 15 illustrates a distal catheter jacket section 835 of the catheter body 102 of Fig. 14, according to an embodiment.
  • the distal catheter jacket 835 includes a guidewire lumen 847 and an imaging lumen 218, and has a flexible distal region 860, and a stiffer pushable proximal region 870, one or more radiopaque (RO) markers 900 at the distal end and along the shaft.
  • the imaging lumen 218 can house the imaging core 104 and acoustic coupling medium.
  • Fig. 16 illustrates a distal tip 810 according to an embodiment with an acoustic window 820, a plug 406, a guidewire lumen 847, and an imaging lumen 218.
  • the distal tip may be flexible, atraumatic, robust (with sufficient rigidity to cross occlusions without bending or collapsing) and may include one or more radiopaque markers, such as a radiopaque tip marker.
  • the distal tip includes an acoustic window over the transducer imaging plane. The distal tip is configured to seal the coupling medium in the catheter.
  • the distal tip includes a plug to close a bleed or vent hole/port, such an exit port which is sealed after the fluid filling step.
  • the distal tip is durable with a tapered distal tip.
  • the distal tip includes Pebax with one or more durometers with an optional Tungsten distal marking band loading to provide visibility of the distal tip under fluoroscopy.
  • Fig. 17 illustrates a cross section of catheter shaft (comprising a jacket section) 835 of the catheter body 102 according to an embodiment of a catheter 101 of Figs. 13-16, depicting guidewire lumen 847 and an imaging lumen 218.
  • the cross section is shown in a figure “8” configuration with a uniform wall thickness around the transducer section of the catheter shaft, and in a more robust oval cross section for the remainder of shaft, according to an embodiment.
  • a portion of the catheter comprises a substantially uniform polymer thickness in the acoustic window of catheter 101 around the transducer section that is configured for more consistent imaging.
  • Fig. 18 illustrates a mid portion of catheter body 102, comprising a mid-shaft hub 840 connecting the distal shaft working length 835 and the proximal extension 850 of the imaging catheter 101, such a depicted in Fig. 13, according to an embodiment.
  • the proximal extension may optionally connect the distal working length 835 to the proximal connector/hub 870.
  • the proximal extension 850 has a single imaging lumen which is contiguous with the imaging lumen 218 of distal working length section 835. As such, it houses the proximal half of the imaging core 104, and acoustic coupling media.
  • the proximal extension section is configured for a 2 - 5 inch (e.g., 2, 2.5, 3, 3.5, 4, 4.5, 5 inch and values therein) bend radius.
  • the mid-shaft hub includes a guidewire exit port, which is continuous with the guidewire lumen 847 of distal shaft working length 835.
  • the mid-shaft hub is coupled to the two lumens of catheter shaft distal working length 835 via a mid-shaft Y - hub.
  • a skive in the dual lumen extrusion can connect a guidewire lumen 847 to the guidewire exit port 845.
  • the materials of the mid shaft hub may include Pebax, polycarbonate, polycarbonate/ABS, nylon, clear/transparent materials as well as adhesives such as cyanoacrylate or other suitable adhesives.
  • Fig. 19 illustrates a proximal hub 870 of catheter 101 , according to an embodiment.
  • the proximal hub 870 connects: (i) the catheter shaft to a CIM latching mechanism, (ii) the imaging core 104 to the CIM motor, (iii) an electrical connection between the coax to the CIM, (iv) electrical ID (EID) 910 to the catheter interface module, and/or (v) supports a acoustic coupling medium fill process that seals an acoustic medium in the device.
  • the catheter jacket is bonded to the proximal housing, the proximal strain relief 855 provides a transition to the CIM connection 308.
  • the proximal hub housing contains one or more seal housing/seals 304, PCB board 912, fill ports 860, and latch features.
  • the imaging core 104 driveshaft couples to the drive hub 920, which couples to a motor in the catheter interface module.
  • internal PCBs enable the electrical connections.
  • the materials may include Pebax, polycarbonate, polycarbonate/ABS, nylon, clear/transparent materials.
  • Fig. 20 illustrates the distal end of catheter 101 according to various embodiments.
  • the acoustic coupling medium 109 of catheter 101 has similar acoustic properties to blood, is biocompatible, and is configured for filling the imaging lumen without (or by minimizing) bubbles within the imaging plane of an acoustic window to reduce or eliminate bubbles that might interfere with imaging.
  • the acoustic coupling medium volume may be as low as 0.5 mL or as high as to 4 mL within the catheter (e.g., up to 4, 3.9, 3.7, 3.5, 3.3, 3.1 , 3.0, 2.8, 2.6, 2.4, 2.1, 1.9, 1.7, 1.5, 1.0, 0.5 mL and additional volumes therein).
  • the acoustic coupling medium is colored for ease of monitoring fill process and inspection for bubbles. Acoustically attractive media have density and speed of sound values that are similar to the catheter jacket material in several embodiments.
  • the acoustic coupling medium has a speed of sound value that is configured for improved lateral imaging performance. In some embodiments, the acoustic coupling medium has a speed of sound value that is configured for improved lateral performance.
  • the geometry of a rotating element catheter may include a focusing lens for ultrasound that is made by a gently convex circular layer of material over the transducer surface that has speed of sounds slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to and sometimes even higher speed than the material being imaged.
  • a design for the rotating catheter geometry with a thin relatively high velocity catheter body and a coupling medium inside of it may be configured with a focusing effect that is fairly favorable. This embodiment may be configured to be unexpected and surprising because a focusing lens for ultrasound is made by a gently convex circular layer of material over the transducer surface that has speed of sounds slightly lower than the material being imaged.
  • a tightly curved shell of high speed of sound (the catheter body) and the material inside (the coupling medium) can be selected with a speed of sound close to or even higher speed of sound than the material being imaged.
  • media include one of polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and natural oils.
  • the percentage of the non-PEG fraction may be 80 to 20% (e.g., 80%, 70%, 60%, 50%, 40%, 30%, 20% and overlapping values and ranges therein), and in certain embodiments a range of 50 to 30% (e.g., 50%, 45%, 44%, 43%, 42%, 41%, 40%, 39%, 38%, 37%, 35%, 35%, 30% and overlapping values and ranges therein) as the propensity for dissolved gases is lower for the latter, respectively.
  • a range of 50 to 30% e.g., 50%, 45%, 44%, 43%, 42%, 41%, 40%, 39%, 38%, 37%, 35%, 35%, 30% and overlapping values and ranges therein
  • Fig. 21 illustrates an assembly process of proximal hub 870, according to an embodiment.
  • steps may include: installing a seal and/or seal housing, electronic ID and a ultrasound signal PCB for electrical coax connections into the proximal hub housing and bonding; sliding ultrasound signal PCB onto a driveshaft of the imaging core 104; soldering coax to the ultrasound signal PCB; bonding PCB to the drive shaft with a conductive epoxy, installing a driveshaft/PCB into the drive hub; securing using adhesive; assembling a driveshaft/imaging core 104 with the hub housing/seal; applying a vacuum grease around the seal area; place imaging core 104 into the catheter jacket; bonding the jacket to the proximal hub housing; installing and bonding the strain relief; and/or attaching a one-way valve to the fill port.
  • Fig. 22 illustrates a acoustic coupling medium filling process according to an embodiment.
  • steps may include de-gassing the medium in a vacuum chamber; filing the catheter via the proximal fill port; sealing vent hole (e.g, exit port) at the distal tip (e.g, with heat seal, shrink tubing, adhesive, etc.); capping off fill port (e.g, entry port); inspecting for complete fill with no or minimal bubbles, no leaks.
  • De-gassing procedure can be time sensitive.
  • a closed container is used to limit re-gassing and contamination of fluid during handling and fill process.
  • the fluid fill process can take 5 - 60 minutes (e.g, 5-20, 20-40, 30-50, 40-60 minutes, and overlapping ranges therein) at, for example, a pressure of 40 - 100 psi (e.g, 40-60, 60-80, 70-100 psi and overlapping ranges therein).
  • Fig. 23A illustrates an exploded view of a catheter connector hub 2300 of catheter 101 according to an embodiment.
  • the connector hub 2300 includes a fill port cap 2302, and a fill port cover 2304.
  • the connector hub 2300 may be similar to the connector hub 300 shown in Figures 3A, 3B, and 19 according to some embodiments.
  • the connector hub 2300 may mate with a CIM.
  • the connector hub 2300 may include one or more components of the connector hub 300 according to some embodiments.
  • a catheter connector hub 2300 (i) securely latches into the CIM 115 or console 118 and easily unlatches during removal, (ii) mates and makes electrical connections with CIM receptacle, (ii) mates with a motor driveshaft in the CIM receptacle and maintains concentric rotation of a spinning shaft, (iv) seals acoustic coupling media 109 inside the imaging lumen of catheter 101 distal of a seal, and/or (v) supports a fill port for acoustic coupling media.
  • the connector hub 2300 may be disposed on the proximal end of an IVUS catheter that includes an imaging core 2306 attached to a driveshaft 2308.
  • the imaging core 2306 and the driveshaft 2308 may be disposed within an imaging lumen of the catheter body 2303 of IVUS catheter 101 .
  • the driveshaft 2308 may be a stainless steel hypotube and be secured to the imaging core 2306.
  • the IVUS catheter may include a strain relief component 2310. As shown most clearly in Fig. 24A, 24B, and 24C, the strain relief component may be disposed concentrically around the distal end of connector hub 2300 and proximal end of catheter body 2303. In some embodiments, the strain relief component 2310 may be a component of the connector hub 2300. The strain relief component 2310 may reduce or prevent kinks and excessive local strains in the proximal portion of IVUS catheter.
  • the strain relief component 2310 may reduce or prevent kinks while a physician handles the IVUS catheter before, during, or after an IVUS procedure.
  • strain relief provides mechanical strength such that the catheter body 2303 can bend about a rigid proximal connector hub housing without inhibiting proper rotation of the imaging core 2306.
  • the distal end of strain relief 2310 is tapered to provide a gradual stiffness transition to the proximal catheter body 2303.
  • the strain relief extends about 5-10 (7-9 cm) distal to the connector hub 2300, to allow a user to firmly hold the strain relief portion over the shaft while connecting the connector hub 2300 into the CIM 115 or console 118 without kinking the IVUS catheter.
  • the connector hub 2300 may include a hub housing 2301 , seal 2312, a drive bushing 2314, a drive hub 2316, a drive hub pin 2318, and/or an electronic identification (EID) printed circuit board (PCB) 2320.
  • EID electronic identification
  • PCB printed circuit board
  • an electronic identification PCB provides catheter identification and two- way communication to/from the catheter to the console of an IVUS system.
  • the seal 2312 may seal the acoustic coupling medium within the imaging lumen of the IVUS catheter.
  • the drive bushing 2314 may be disposed concentrically around the driveshaft 2308 and adhered to an interior surface of the hub housing 2301 of connector hub 2300. In some embodiments, the drive bushing may be injected molded and/or machined.
  • the drive bushing 2314 is a single part secured with adhesive to the hub housing 2301 and configured to prevent coupling medium leaks. In one embodiment, the drive bushing 2314 is configured to capture the seal 2312 within a seal housing or receptacle in hub housing 2301 when assembled to prevent coupling medium leaks. The drive bushing 2314 may center and align the driveshaft 2308 within the hub housing 2301 of the connector hub 2300. According to some embodiments, the drive bushing may hold or retain the seal 2312 in position at the proximal end of the IVUS catheter. The drive bushing may maintain the position of the driveshaft 2308 concentric to the IVUS catheter.
  • the drive bushing may reduce wobble about the central driveshaft axis and/or non-uniform rotational distortion (NURD), and may prevent acoustic coupling medium leaks by maintaining uniform friction around the inner diameter of the seal 2312.
  • NURD non-uniform rotational distortion
  • an adhesive sealant is applied inside a driveshaft hypotube to prevent coupling medium from leaking proximally through the driveshaft hypotube between the coax cable 2305 of the imaging core 2306 and hypotube inside diameter.
  • the connector hub 2300 may include a drive hub 2316.
  • the drive hub 2316 may be coupled to the proximal end of the driveshaft 2308.
  • the drive hub 2316 may include a ultrasound signal PCB 2322.
  • the ultrasound signal PCB 2322 may provide electronic communication between the transducer 105 of an IVUS catheter and an imaging console.
  • the cable 2305 of the imaging core 2306 is electrically connected at the distal end of the imaging core to an ultrasound transducer 105.
  • the cable 2306 extends out the proximal end of the imaging core 2306 and electrically connected to ultrasound signal PCB 2322.
  • the signal PCB 2322 may include one or more electrodes, e.g., two, three, four, or more electrodes.
  • the cable 2305 is a coax cable with a metal inner conductor and an outer metal shield, with insulation material between the inner conductor and outer shield, and around the outer shield.
  • Electrically connecting the coax cable to the ultrasound signal PCB comprises separating the inner conductor and outer shield and connecting the inner conductor to one electrode of the PCB and connecting the shield to a separate electrode of the PCB.
  • the one or more electrodes may be coaxial electrical contacts that mate with corresponding pogo-pins of a CIM.
  • the pogo-pins may be a component of a receptacle of the CIM, which may mate with the connector hub 2300. In this manner, the ultrasound transducer of IVUS catheter 101 is electrically connected to the console 118 of IVUS system 100.
  • the drive hub 2316 may be held in position by a drive hub pin 2318.
  • a drive hub pin is a drive hub retainment pin.
  • a drive hub pin ensures alignment of a drive hub with a mating receptacle on a catheter interface module and prevents axial movement of driveshaft 2308 and drive hub 2316 inside the housing.
  • the drive hub pin 2318 may project through an aperture in the housing 2301 of the connector hub 2300 and mate with the drive hub 2316. For example, as shown in Fig. 23A, the drive hub pin 2318 projects through a hole in the side of the housing 2301 and mates with a groove of the drive hub 2316.
  • the drive hub pin 2318 may maintain the position of the drive hub 2316 relative to the connector hub 2300 and/or a mating component of a CIM that mates with the drive hub 2316 when the catheter is connected to the CIM.
  • the drive hub pin 2318 may prevent axial movement of the driveshaft 2308 according to some embodiments.
  • the connector hub 2300 may include an EID PCB 2320 to provide catheter identification and information, such as catheter model number and calibration information.
  • the EID PCB 2320 may provide electronic communication between the IVUS catheter and a console.
  • the connector hub 2300 may include a fill port 2324 that provides access to an imaging lumen of the IVUS catheter.
  • the fill port 2324 is integral to hub housing 2301 of the connector hub.
  • the fill port is configured to enable easy connection and disconnection from a filling nozzle of manufacturing fill equipment while reducing or eliminating introduction of air pockets or bubbles into the IVUS system, and is configured to seal against filling pressure.
  • the fill port 2324 may be a low-profile design according to some embodiments. The fill port 2324 may reduce the risk that air is introduced into the lumen of the IVUS catheter and/or the acoustic coupling medium during a filling procedure.
  • the fill port 2324 may include a fill port seal 2326 disposed on a bottom surface of the fill port 2324.
  • Fig. 23B illustrates a cross sectional view of a proximal hub 2300 according to an embodiment.
  • the fill port 2324 may be sealed by inserting a fill port cap 2302 and a fill port cover 2304 into the fill port 2324 as shown in Fig. 23B.
  • the fill port cap 2302 and fill port 2324 may include threaded components.
  • the fill port 2324 may be threaded, and the fill port cap 2302 may be screwed into the fill port 2324.
  • the fill port cap 2302 and the fill port 2324 may be connected using other mechanical means such as a snap fit and/or an adhesive.
  • the fill port cap 2302 may engage the fill port seal 2326 once inserted into the fill port 2324.
  • the fill port cap 2302 may include a recess disposed on its top side.
  • the fill port cover 2304 may be inserted into the recess on the top of the fill port cap 2302.
  • the fill port cover 2304 may be secured to the fill port cap 2302 using an adhesive.
  • the fill port cover 2304 may be secured to the fill port 2324 using a screw fit, snap fit, and/or adhesive to capture the fill port cap 2302.
  • the fill port cap 2302 is a seal which is opened when a filling nozzle is attached during the filling process, but which is then sealed when the filling nozzle is removed and/or when the fill port cover 2304 is secured over the seal 2302.
  • Fig. 24A illustrates a lateral cross-sectional view of connector hub 2300 with a strain relief component 2310 according to an embodiment.
  • the connector hub 2300 may include a hub latch 2402.
  • the hub latch 2402 may secure the connector hub 2300 to a catheter interface module.
  • the connector hub 2300 may include a fill port 2324 as discussed herein.
  • the strain relief component 2310 may fit over a distal portion of the connector hub 2300 as well as a proximal portion of catheter body 2301 .
  • the strain relief component 2310 may fit over the fill port 2324, hiding the fill port 2324.
  • the fill port has a low profile and can be conveniently covered, or hidden, with housing outer shell or strain relief, and does not garner attention by the user when it is not needed during catheter use.
  • the strain relief component 2310 may secure and/or a fill port cover in the fill port 2324.
  • Fig. 24B illustrates a distal isometric view of a connector hub 2300 with a strain relief component 2310 according to an embodiment.
  • Fig. 24C illustrates a proximal isometric view of a connector hub 2300 with a strain relief component 2310 according to an embodiment.
  • the strain relief component 2310 is snap fit, compression fit, and/or adhesive bonded to the connector hub 2300
  • the fill port and/or fill port cap has features to mate with a fill nozzle tip to secure fill nozzle port to counteract filling pressure.
  • the fill port and fill tip have mating threaded features.
  • Fig. 25A illustrates a lateral view of a proximal hub 2502 and a fill nozzle 2504 according to an embodiment.
  • the proximal hub 2502 may include a fill port 2506 to receive an acoustic coupling medium via the fill nozzle 2504.
  • the fill port 2506 may connect to the fill nozzle 2504.
  • the fill port 2506 may include a seal 2508.
  • the seal 2508 may prevent the introduction of air into the imaging lumen of the IVUS catheter and/or maintain a filling pressure.
  • the fill nozzle 2504 may include a proximal end 2510 and a distal end 2512.
  • the fill port 2506 may connect to the distal end 2512.
  • the proximal end 2510 may include a handle or grip component that allows a person to hold the fill nozzle 2504.
  • the proximal end 2510 may include at least one port.
  • the port(s) may be connected to a filling apparatus configured to dispense acoustic coupling medium, and the acoustic coupling medium may pass through the fill nozzle 2504 and into the IVUS catheter imaging lumen while expelling air from the lumen.
  • the distal end 2512 of the fill nozzle 2504 may mate with the fill port 2506.
  • the distal end 2512 may have a threaded component that mates with a threaded portion of the fill port 2506. Other mating features are also possible.
  • the distal end 2512 may receive a fill adapter 2514.
  • the fill adapter 2514 may be mechanically coupled or adhered to the distal end 2512.
  • the fill adapter 2514 may mate with the fill port 2506.
  • the fill adapter 2514 may be a threaded member and mate will a threaded component of the fill port 2506 according to some embodiments.
  • the fill adapter 2514 may be integrated with the distal end 2512.
  • Fig. 25B illustrates a lateral view of a proximal hub 2502 and fill nozzle 2504 engaged to fill the proximal hub 2502 with a coupling medium according to an embodiment.
  • the fill adapter 2514 and/or the distal end 2512 of the fill nozzle 2504 may be engaged with the fill port 2506 of the proximal hub, and the acoustic coupling medium may be pushed or pulled into the imaging lumen of the IVUS catheter.
  • the acoustic coupling medium may pass from the fill port 2506, through the imaging lumen, and exit a distal port of the IVUS catheter.
  • the distal port as discussed, may be sealed as part of a filling process.
  • the fill nozzle 2504 and the fill adapter 2514 may be disengaged from the fill port 2506.
  • the fill port cap 2302 may be threaded into the fill port 2506 pressing on the seal 2508 ensuring bubbles are not present. With pressure on the seal some coupling medium may begin to fill the port.
  • the fill port cover 2304 may be inserted and bonded into the fill port cap 2302 to reduce or eliminate bubbles from the port.
  • Fig. 26A illustrates a fill port 2324 of a connector hub 2300 in an open position according to an embodiment.
  • the fill port 2324 may include a seal 2602.
  • the fill port 2324 may receive a fill port valve cap 2604.
  • the fill port valve cap 2604 acts as a dynamic valve that can be closed to seal the acoustic coupling medium within the IVUS catheter to reduce exposure to air.
  • a pushing filling method may be employed to reduce exposure of the IVUS catheter lumen to ambient air.
  • the fill port valve cap 2604 may include a conical distal tip 2606 with one or more apertures.
  • the one or more apertures may permit the acoustic coupling medium to pass through the fill port valve cap 2604, through the seal 2602, and into the inner imaging lumen of the I VUS catheter.
  • the fill port 2324 may initially retain the fill port valve cap 2604 in an open position. In the open position the fill port valve cap 2604 may be disengaged relative to the seal 2602 and the inner imaging lumen of the IVUS catheter. This open position may enable the coupling medium to be pulled or pushed into the imaging lumen according to several embodiments.
  • the fill port valve cap 2604 fill port valve cap 2604 may include a recess to receive a distal end 2512 of a fill nozzle 2504.
  • the fill port valve cap 2604 may include a threaded portion, e.g., a threaded recess disposed on a top, or proximal side of the fill port valve cap 2604.
  • the distal end 2512 may include, be mechanically coupled with, or adhered to a fill adapter 2514.
  • the fill adapter 2514 may be engaged with and mated to the fill port valve cap 2604.
  • the fill port valve cap 2604 may include a threaded portion in a central recess.
  • the fill adapter 2514 may also include a threaded component that may be screwed into, i.e. engaged with, the threaded portion of the fill port valve cap 2604.
  • a threaded component that may be screwed into, i.e. engaged with, the threaded portion of the fill port valve cap 2604.
  • other releasable connection mechanisms may be implemented. For example, a spring-loaded clasp or clip, a rubber gasket, etc.
  • Fig. 26B illustrates a fill port 2324 of a connector hub 2300 in engaged with a fill nozzle 2504 according to an embodiment.
  • the fill port adapter 2514 may be engaged with a recess of the fill port valve cap 2604.
  • the engagement of the fill port adapter 2514 with the fill port valve cap 2604 initiates the flow of the acoustic coupling medium from the fill nozzle 2504 into the inner imaging lumen of the IVUS catheter.
  • Pressure may be applied to the IVUS catheter to cause the acoustic coupling medium to flow into the imaging lumen.
  • a positive pressure may be applied to the fill nozzle 2504.
  • a negative pressure e.g., a vacuum pressure
  • the acoustic coupling medium may flow through the fill nozzle 2504, through the fill port adapter 2514, through the fill port valve cap 2604, through the seal 2602, and into the inner imaging lumen of the IVUS catheter.
  • Fig. 26C illustrates a fill port 2324 of a connector hub 2300 in as the connector hub 2300 is disengaged from the fill nozzle according to an embodiment.
  • the fill port 2324 may seal the inner imaging lumen of the IVUS catheter.
  • the fill port valve cap 2604 may be sealed with the fill port 2324. Sealing the fill port valve cap 2604 and the fill port 2324 may trap acoustic medium in the fill port 2324, preventing air from entering the fill port 2324.
  • sealing the fill port valve cap 2604 and the fill port 2324 may place the fill port assembly in a “closed” position. In the closed position, the conical distal tip 2606 may be engaged with the seal 2602.
  • the engagement of the conical distal tip 2606 may prevent air from entering the imaging lumen.
  • the fill adapter 2514 may be disengaged.
  • the fill adapter 2514 may be unscrewed from the fill port valve cap 2604.
  • the fill adapter 2514 may be disengaged without introducing air to the fill port 2324 or the inner imaging lumen of the IVUS catheter.
  • Fig. 26D illustrates a fill port 2324 of a connector hub 2300 in a closed or sealed position according to an embodiment.
  • Fig. 26D shows the fill port 2324 and fill port valve cap 2604 in the closed position after the fill adapter 2514 has been disengaged from the fill port valve cap 2604 according to one embodiment.
  • the removal of the fill adapter 2514 may apply a nominal pressure to the fill port 2324, drawing acoustic coupling medium into the fill port 2324 and preventing air from entering the fill port 2324.
  • a fill port cover e.g., the fill port cover 2304, may be placed in the recess of the fill port valve cap 2604.
  • the fill port cover 2304 may be mechanically coupled to or adhered to the recess.
  • the fill port cover 2304 may be coupled to the fill port valve cap 2604 in an airtight manner.
  • Fig. 27 illustrates an apparatus 2700 for preparing a coupling medium according to an embodiment.
  • the acoustic coupling medium is (i) de-gassed to reduce a level of dissolved gas in the medium and provide for absorbing air bubbles into medium if bubbles are inadvertently introduced during manufacturing, and/or (ii) heated before filling catheter to reduce the coupling medium viscosity and speed up the filling process for an IVUS catheter.
  • the apparatus 2700 may include a vessel 2702, a vacuum pump 2704, a magnetic stirring hot plate 2706, and a syringe 2708.
  • the vessel 2702 may be connected to the vacuum pump 2704 via tubing and a diverting valve 2710.
  • the vessel 2702 may be connected to the syringe 2708 via a valve 2712, e.g., a stopcock valve.
  • the vessel 2702 may receive and retain an acoustic coupling medium 2714.
  • a magnetic stir bar 2716 may be placed in the vessel 2702 according to some embodiments.
  • the magnetic stirring hot plate 2706 may be used to heat and/or stir, via the magnetic stir bar 2716, the acoustic coupling medium 2714 according to some embodiments.
  • apparatus 2700 may also include a vacuum gauge, a sensor for measuring the oxygen content of the medium, and/or a thermal sensor for measuring the temperature of the medium (not shown) to monitor and control the preparation process.
  • the apparatus 2700 may be used to prepare the acoustic coupling medium 2714 for filling the IVUS catheter.
  • the process may begin by providing the vessel 2702.
  • acoustic coupling medium 2714 includes one of polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and natural oils.
  • the acoustic coupling medium 2714 is PEG400.
  • the acoustic coupling medium 2714 may sit for a time period, e.g., for 30 minutes, 60 minutes, 90 minutes, 120 minutes. The time period may be of sufficient length to allow the acoustic coupling medium 2714 to reach an air saturated state.
  • PEG400 may sit in an Ambient environment for at least 30, 45, 60, 75, 80, 90, 100, 120, 150 180 minutes (and any ranges and values therein).
  • the acoustic coupling medium 2714 sits for at least 0.5 - 2 hours.
  • the time period may last until the acoustic coupling medium 2714 reaches an air saturation threshold.
  • the air saturation threshold may be measured as a deoxygenation percentage (DO%).
  • DO% may be reduced by 10%, 15%, 20%, 25% 30%, 35% 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or greater.
  • magnetic stirring and vacuuming is applied until degassed to DO% of 80% or greater.
  • measurements are taken of a saturated medium (e.g., 231.0) and a degassed medium (e.g., 33.9) for a DO% rejection of -85%.
  • the air saturation of the acoustic coupling medium 2714 may be detected by a sensor, e.g., a deoxygenation meter probe. The sitting time period may last until the deoxygenation meter probe detects that the acoustic coupling medium has reached the air saturation threshold.
  • the process may continue, and the vessel 2702 may be filled, either partially or wholly, with the acoustic coupling medium 2714.
  • the vessel 2702 may be sealed and placed in fluid connection with the vacuum pump 2704 via tubing and the diverting valve 2710.
  • a rubber stopper with fluid connectors may be placed on a top opening of the vessel 2702.
  • the rubber stopper may be connected to the diverting valve 2710 which in turn may be placed in fluid communication with the tubing, and the vacuum pump 2704.
  • the vacuum pump 2704 may be turned on to remove air from the vessel 2702 and subject the medium to a negative pressure. In some embodiments, the vacuum pump 2704 may run for a degassing period.
  • the degassing period may be 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, etc.
  • the degassing period may be based on the acoustic coupling medium 2714 and its properties, a volume of the acoustic coupling medium 2714 placed in the vessel 2702, and/or a size of the vessel 2702. The degassing period may last until the acoustic coupling medium 2714 reaches a desaturation threshold.
  • the desaturation threshold may be a percentage of the air saturation threshold.
  • the desaturation threshold may be equal to 5% or less, 10% or less, 15% or less, 20% or less, 25% or less, 30% or less, 35% or less, 40% or less, 45% or less, or 50% or less of the air saturation threshold.
  • the desaturation threshold may be about 20% of the air saturation threshold.
  • the magnetic stirring hot plate 2706 may heat the acoustic coupling fluid to or above a degassing temperature.
  • the degassing temperature may be selected based on one or more properties of the acoustic coupling medium 2714.
  • the degassing temperature may be 40 degrees Celsius (°C) for PEG400.
  • the magnetic stirring hot plate 2706 may stir the acoustic coupling medium 2714 via the magnetic stir bar 2716.
  • the vessel 2702 may include a port 2718.
  • the port 2718 may be disposed at the bottom of the vessel 2702 and may be used to extract the acoustic coupling medium 2714 from the vessel.
  • the valve 2712 may be attached to the port 2718.
  • the syringe 2708 may be attached to the valve 2712.
  • the valve 2712 e.g., a stopcock valve
  • the valve 2710 may include a thermocouple and/or a monitoring cable.
  • the thermocouple and cable may be embedded into the valve 2710.
  • the thermocouple may be placed near the bottom of the vessel 2702 within the coupling medium 2714.
  • the cable may extend from the thermocouple and the valve 2710 and connect to a monitoring unit.
  • the monitoring unit may measure temperature.
  • the thermocouple and its cable may extend through a second valve, such as a stopcock valve similar to the stopcock valve 2712 according to some embodiments.
  • the second stopcock valve may be provided in addition to the first stopcock valve 2712.
  • the second stopcock valve may provide an additional way to measure the temperature of the acoustic coupling medium.
  • the vacuum pump 2704 may be stopped.
  • the magnetic stirring hot plate 2706 may also stop heating and/or stirring the acoustic coupling medium.
  • the diverting valve 2710 may be opened at an opening rate (which can be a slow rate). The opening rate may allow ambient air to enter the vessel 2702 without disturbing the medium 2714.
  • the degassed medium 2714 may be removed from the vessel 2702 via the syringe 2708.
  • the plunger of the syringe 2708 may be pulled to draw the acoustic coupling medium 2714 from the vessel 2702.
  • the deoxygenation percentage of the medium 2714 may be detected. If the deoxygenation percentage does not satisfy the desaturation threshold, the vacuum pump 2704 and/or magnetic stirring hot plate 2706 may be restarted, and the process may be continued until the medium 2714 reaches the desaturation threshold.
  • the vessel 2702 may be repressurized to atmospheric pressure. Then, the syringe 2708 may be used to draw the acoustic coupling medium 2714 from the vessel 2702.
  • the syringe 2708 may be one of a plurality of syringes. If the first syringe 2708 is filled, it may be detached from the vessel 2702 and the valve 2712. Another syringe may be attached and used to draw the medium 2714 from the vessel 2702.
  • the valve 2712 may be one of a plurality of valves in parallel. The plurality of valves in parallel may be used to fill a plurality of syringes, including the syringe 2708, at once.
  • Fig. 28A illustrates an apparatus 2800 for filling and heating an acoustic coupling medium and/or the catheter during the filling step, according to an embodiment.
  • the apparatus 2800 may include a syringe pump apparatus 2802 and a catheter heating plate 2804.
  • the apparatus 2800 may also include a microscope 2806.
  • an IVUS catheter 2808 may be placed in the catheter heating plate 2804.
  • the catheter heating plate 2804 may heat the IVUS catheter 2808 to a catheter target temperature.
  • the catheter target temperature may be at least 35°C, at least 37°C, at least 40°C, at least 45°C, at least 50°C, at least 55°C, at least 60°C, at least 65°C, at least 70°C, at least 75°C, at least 80°C, etc.
  • the catheter target temperature may be based on one or more properties of the acoustic coupling medium and/or one or more properties of the IVUS catheter 2808.
  • Fig. 28B illustrates a syringe pump apparatus 2802 for heating a coupling medium according to an embodiment.
  • the syringe pump apparatus 2802 may include a syringe pump 2810, a syringe heating component 2812, a pressure gauge 2814, at least one piece of tubing 2816, a rotational motor 2818, and/or a three-way valve 2820.
  • the syringe pump 2810 may receive one or more syringes, e.g., the syringe 2708, that are filled or partially filled with acoustic coupling medium.
  • the syringe pump 2810 may have one or more syringe retainers.
  • the syringe retainers may be disposed on a top or side of the syringe pump 2810.
  • the syringe retainers may releasably secure the one or more syringes to the syringe pump 2810.
  • the syringe retainers may include a rubber, U-shaped surface that receives the body of the syringe 2708.
  • the syringe pump 2810 may include an actuating surface.
  • the actuating surface may be driven by a motor of the syringe pump and apply a pressure to the piston of the syringe 2708.
  • the actuating surface may cause the contents of the syringe 2708 to be expelled at a delivery rate.
  • the delivery rate may be 0.1 mL/min, 0.2 mL/min, 0.3 mL/min, 0.4 mL/min, 0.5 mL/min, 0.6 mL/min, 0.7 mL/min, 0.8 mL/min, 0.9 mL/min, 1 .0 mL/min, etc.
  • the delivery rate may be based on one or more properties of the acoustic coupling medium being used to fill the IVUS catheter.
  • the delivery rate for PEG400 may be 0.4 mL/min according to some embodiments.
  • the syringe heating components 2812 may be a syringe jacket that fits over a body of the syringe 2708 and heats the syringe 2708.
  • the syringe heating component 2812 may be wrapped around the body of the syringe 2708.
  • the syringe heating component(s) 2812 may include one or more heating elements.
  • the syringe heating component 2812 may heat the syringe to a target temperature.
  • the target temperature may be based on one or more properties of the acoustic coupling medium.
  • the target temperature may be 35°C, 37°C, 40°C, 45°C, 50°C, 55°C, 60°C, 65°C, 70°C, 75°C, 80°C, etc.
  • the target temperature may be 60°C.
  • the target temperature may match the catheter target temperature of the catheter heating plate 2804.
  • the syringe heating component 2812 may heat the syringe to the target temperature for a heating period.
  • the heating period may be 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, etc.
  • the syringe heating component 2812 may heat the syringe 2708 before and/or while an IVUS catheter is filled.
  • the syringe jacket 2812 may be a component of the syringe pump 2810 according to some embodiments.
  • the syringe pump 2810 may include a syringe heating components 2812 within the syringe retainers.
  • the syringe apparatus 2802 may include at least one piece of tubing 2816.
  • the tubing 2816 may be connected to a syringe 2708 at a proximal end.
  • the tubing 2816 may be connected to the syringe 2708 via an air removal filter.
  • the tubing 2816 may be connected to the syringe 2708 via the pressure gauge 2814.
  • the pressure gauge 2814 may provide a pressure at a tip of the syringe 2708 and/or within the tubing 2816 to the syringe pump 2810 according to some embodiments.
  • the syringe pump 2810 may determine a delivery rate of the contents of the syringe 2708 based on the pressure provided by the pressure gauge 2814.
  • the pressure gauge 2814 may be monitored to ensure the pressure in the syringe apparatus 2802 and/or IVUS catheter does not exceed a pressure threshold.
  • the pressure threshold may be 40 psi, 45 psi, 50 psi, 55psi, 60 psi, 65 psi, 70 psi, 75 psi, 80 psi, 85 psi, 90 psi, 95 psi, 100 psi, 105 psi, 110 psi, 115 psi, 120 psi, etc.
  • the pressure threshold for filling an IVUS catheter may be 80 psi according to some embodiments. If the pressure in the syringe apparatus 2802 or the IVUS catheter exceeds the pressure threshold, the syringe pump 2810 may be stopped, and the pressure within the apparatus 2802 may dissipate. In some embodiments, the pressure threshold may be modified if the pressure within the syringe apparatus 2802 exceeds the pressure threshold one time or more, two times or more, three times or more, four times or more, five times or more, etc. In another embodiment the pressure gauge may be removed if the filling process has been designed to satisfactorily fill the catheter bubble-free.
  • the tubing 2816 may be connected to a connector hub 2300 of catheter 2808 for filling the imaging lumen of the catheter.
  • the proximal connector hub can further be attached the rotational motor 2818 for rotating the imaging core during filling.
  • the tubing 2816 may be attached to the connector hub 2300 and, the proximal connector hub may be further attached to the rotational motor 2818.
  • the distal end of the tubing 2816 may be connected to the connector hub 2300 via the three- way valve 2820.
  • a fill adapter 2514 may be disposed on the distal end of the tubing 2816 according to some embodiments.
  • the fill adapter 2514 may be mechanically coupled to and or adhered to the distal end of the tubing 2816.
  • the fill adapter 2514 may mate with a fill port of the connector hub 2300.
  • the tubing 2816 may be a part of the fill nozzle 2504 according to some embodiments.
  • the syringe apparatus 2802 may include a rotational motor 2818.
  • the rotational motor 2818 may rotate the imaging core during filling procedure.
  • the rotational motor 2818 may be operated at a target speed.
  • the target speed may rotate the imaging core to help remove air bubbles during the filling process. Agitating the coupling medium 2714 during the filling process may help bubbles move distally and be vented.
  • the target speed may be 1000 rpm ⁇ 100 rpm. Other target speeds may be selected depending on the coupling medium and viscosity of the selected medium.
  • the target speed may be between 100 rpm and 1500 rpm.
  • the target speed may be 100, 200, 300, 400, 500 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, or 1500 rpm.
  • the target speed may be reduced if air bubbles are present in the imaging lumen. For example, if the bubbles are stuck and not moving distally toward a distal port of the imaging lumen.
  • the rotation is steady state. In other embodiments, the rotation is pulsatile.
  • an acoustic coupling medium e.g., PEG400
  • syringe(s) 2708 may be degassed and placed in one or more syringe(s) 2708.
  • the catheter heating plate 2804 may be heated to the catheter target temperature.
  • a syringe 2708 may be placed in a retaining component of the syringe pump 2810.
  • a syringe heating component 2812 e.g., a syringe jacket may be wrapped around the syringe 2812 and heat the syringe to a target temperature, e.g., 60 °C.
  • the tubing 2816 may be connected to the syringe 2708 at a first end and may be connected, at a second end, to the fill nozzle, which is connected to a fill port on a connector hub 2300.
  • the syringe pump 2810 may be activated and may expel the acoustic coupling medium from the syringe 2708 and into the tubing 2816.
  • the syringe pump 2810 may expel the acoustic coupling medium from the syringe 2708 at a target flow rate, e.g., 0.4 mL/min.
  • a rotational motor 2818 may be activated to facilitate movement of the acoustic coupling medium into the IVUS catheter 2808 and/or assists with removal of air from the acoustic coupling medium.
  • the rotational motor may be operated at 1000 rpm ⁇ 100 rpm according to some embodiments.
  • the pressure gauge 2814 may monitor the pressure within the tubing 2816 and/or the syringe apparatus to ensure the pressure does not exceed a pressure threshold, e.g., 80 psi. The process may continue until the imaging lumen of the IVUS catheter 2808 is filled with the acoustic coupling medium.
  • the IVUS catheter 2808 may be sealed as discussed herein and subsequently be used in an IVUS imaging procedure.
  • Fig. 29A illustrates an isometric view of a catheter heating plate 2804 according to an embodiment.
  • Fig. 29B illustrates a lateral view of a catheter heating plate 2804 according to an embodiment.
  • the catheter heating plate 2804 may heat the IVUS catheter 2808 to a catheter target temperature.
  • the catheter heating plate 2804 may include two or more layers.
  • the catheter heating plate 2804 may include an insulating layer 2902, a heating element 2904, a catheter receiving layer 2906, and a cover layer 2908.
  • the catheter receiving layer 2906 may be made of a metal, metal alloy, or metal composite.
  • the catheter receiving layer 2906 may be made of aluminum.
  • the catheter receiving layer may include a cutout 2910 to receive an IVUS catheter.
  • the cutout may be different shapes, such as the “S” shape shown in Fig. 29A or a “spiral” shape shown in Fig. 28A or a straight cutout.
  • the cutout shape may be based on the type of imaging core of the IVUS catheter placed therein.
  • the heating element 2904 may include one or more individual heating elements.
  • the heating element 2904 may be a heater blanket that is controlled by the controller 2912.
  • the acoustic media preparation apparatus 2700 and the filling apparatus 2800 is the same apparatus.
  • the chamber 2702 which is connected to a vacuum source to degas the media may also be connected to a pressure source.
  • the pressure or vacuum in the chamber may be controlled by a three-way valve between the pressure source, a vacuum source, and the chamber.
  • the valve is a four-way valve which can also expose the chamber to ambient pressure.
  • the media is first exposed to vacuum during a degassing step, and then exposed to pressure during a catheter filling step. The media can be heated during the degassing and/or the filling step.
  • the chamber 2702 is connected to a filling syringe as shown in Fig. 27, but the valve 2712 is a three-way valve which can be configured in one position to fill the syringe from the chamber 2702, and then configured in a second position to connect the filled syringe to the filling nozzle.
  • the filling apparatus is connected to multiple filling nozzles via a tubing configuration and/or manifold component, to be able to fill more than one catheter at a time.
  • Fig. 30 illustrates a lateral view of a distal section of an IVUS catheter 3000 with an imaging core 104 contained within a catheter jacket 3206 according to an embodiment.
  • the imaging core 104 may be placed within an imaging lumen of the IVUS catheter 3000.
  • the IVUS catheter 3000 may include a catheter jacket 3206 as discussed herein.
  • the imaging core 104 may include a cabled transducer 105 within a transducer housing 3008.
  • the transducer housing 3008 may include an opening to allow ultrasound signals to be transmitted and received by the transducer 105.
  • the transducer housing 3008 includes an opening over the transducer 105.
  • the transducer housing 3008 may include one or more housing apertures 3009.
  • an aperture 3009 is an opening that extends through the inside of the transducer housing 3008.
  • the one or more apertures 3009 may be (i) in the proximal end of the coil 3004 and/or (ii) along an outer surface (e.g., longitudinal, circumferential, or a portion thereof) of the transducer housing 3008, with each aperture 3009 making a fluid/air connection to the inside of the coil 3004.
  • the one or more apertures 3009 may allow coupling medium during the medium filling process to fill the inside of the coil 3004 more efficiently (e.g., as compared to the lack of an aperture 3009). This helps reduce or eliminate air bubbles from the catheter 3000.
  • one or more apertures 3009 may run longitudinally, such as along an outer surface of the transducer housing 3008 and allow fluid/air to move distally within the coil 3004 and exit the housing during the medium filling process.
  • Fig. 30A illustrates an example cross-section through a proximal section of the transducer housing 3008 showing an aperture 3009 connecting the inside of the coil 3004 to the top, open, surface of the transducer 105.
  • the cabled transducer 105 and the transducer housing 3008 may be coupled to a driveshaft containing a coil 3004 by a coupler 3010.
  • the coupler 3010 supports a secure mechanical connection between the transducer housing 3008 and the coil 3004. This coupler may be laser welded or bonded with an adhesive to the juxtaposed components.
  • the coupler 3010 may include one or more apertures 3009.
  • Fig. 31 illustrates a lateral view of a proximal hub 3102 of an IVUS catheter 3100 according to an embodiment.
  • the IVUS catheter 3100 may include a proximal driveshaft, for example a hypotube 3104.
  • the driveshaft 3104 may include one or more apertures 3106.
  • the one or more apertures 3106 may allow acoustic coupling medium to enter the driveshaft and move more easily through the coil 3004.
  • the one or more apertures 3106 may allow air to exit the imaging core from within the coil 3004.
  • Fig. 32 shows a cross section of an IVUS catheter 3200.
  • the IVUS catheter 3200 may include an imaging core 104 and a catheter jacket 3206.
  • the imaging core 104 may include the coil 3204, and an electrical coax cable 3202, both disposed within an inner imaging lumen 108 of the IVUS catheter 3200 formed by the catheter jacket 3206 according to some embodiments.
  • the cross-sectional area of the first gap 3208 may be much smaller than the cross-sectional area of the second gap 3210.
  • a coil 3204 may have an inside diameter of -0.005” - 0.030” (e.g, 0.005, 0.008, 0.010, 0.012, 0.015, 0.018, 0.020, 0.022, 0.024, 0.027, 0.030 inches and overlapping values and ranges therein) and an outside diameter of -0.015” - 0.045” (e.g., 0.015, 0.018, 0.020, 0.023, 0.025, 0.028, 0.030, 0.032, 0.035, 0.038, 0.040, 0.042, 0.045 inches and overlapping values and ranges therein).
  • an inside diameter of -0.005” - 0.030 e.g, 0.005, 0.008, 0.010, 0.012, 0.015, 0.018, 0.020, 0.022, 0.024, 0.027, 0.030 inches and overlapping values and ranges therein
  • an outside diameter of -0.015” - 0.045 e.
  • the jacket 3206 may have an inside diameter of 0.020” - 0.050” (e.g., 0.020, 0.023, 0.025, 0.028, 0.030, 0.033, 0.035, 0.038, 0.040, 0.042, 0.045, 0.048, 0.050 inches and overlapping values and ranges therein).
  • the coax cable 3202 may have an outside diameter of 0.002” - 0.025” (e.g., 0.002, 0.005, 0.008, 0.010, 0.012, 0.014, 0.018, 0.020, 0.022, 0.025 inches and overlapping values and ranges therein).
  • the area outside the coil 3204 is in a range of 1.5 - 3.0 (e.g., 1.5, 1.8, 2.0, 2.2, 2.4, 2.6, 2.8, 3.0) times larger than the area between the coax cable 3202 and the coil 3204.
  • the smaller area can create more resistance to medium filling than the larger area.
  • Other inside and outside diameters may be used depending on the selected dimensions of the IVUS catheter 3200 and the differences between the two areas may be different.
  • the apertures described in Figs. 30, 30A, and 31 reduce the resistance to medium flow for the removal of air inside the coil 3204 compared to the medium flow outside the coil 3204 improving the speed and efficiency of a filling process and/or removing air effectively during a filling process.
  • Fig. 33 illustrates a flow of acoustic coupling media through the imaging lumen of the IVUS catheter 3300 during a filling process according to some embodiments.
  • the acoustic coupling medium may flow through the apertures of the driveshaft 3104, the coupler 3010, and/or the transducer housing 3008.
  • the one or more apertures 3106 can allow for air to exit the coil 3004 of the imaging core, driveshaft, and/or other internal components of the IVUS catheter 3300 while maintaining the structural integrity and functionality of the device.
  • IVUS catheters may have small diameters to fit into human vessels. This may result in spinning imaging cores optionally having smaller diameters to fit inside an outer catheter polymer jacket.
  • Fig. 34 is a process 3400 for degassing an acoustic coupling medium and filling an IVUS catheter according to one embodiment.
  • the process 3400 may begin at step 3402 where a degassing apparatus, such as the apparatus 2700, is provided.
  • the degassing apparatus may include one or more of the components of the apparatus 2700.
  • the process 3400 may move to step 3404 where an acoustic coupling medium is held in an ambient environment for a first time period.
  • the acoustic coupling medium may be placed in a vessel, e.g., the vessel 2702, of the degassing apparatus.
  • the acoustic coupling medium may be held in an ambient environment until the acoustic coupling medium reached an air saturated state, as described above in conjunction with Fig. 27.
  • the first time period may be 30 minutes, 60 minutes, 90 minutes, 120 minute, etc.
  • the first time period may last until the acoustic coupling medium reaches an air saturation threshold.
  • the process 3400 may move to step 3406 where the acoustic coupling medium may be held at a vacuum pressure for a second time period.
  • the acoustic coupling medium may be placed in a vessel 2702, and a vacuum pump 2704 may be turned on and remove gas from the vessel 2702 during at least a portion of the second time period.
  • the second time period may be 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, etc.
  • the second time period may be based on the acoustic coupling medium and its properties, a volume of the acoustic coupling medium placed in the vessel 2702, and/or a size of the vessel 2702.
  • a magnetic stirring hot plate may heat and/or stir the acoustic coupling medium.
  • the process 3400 may move to decision step 3408 where it is determined whether the acoustic coupling medium satisfies a desaturation threshold.
  • the desaturation threshold may be a percentage of the air saturation threshold.
  • the desaturation threshold may be equal to 5% or less, 10% or less, 15% or less, 20% or less, 25% or less, 30% or less, 35% or less, 40% or less, 45% or less, or 50% or less of the air saturation threshold.
  • the desaturation threshold may be about 20% of the air saturation threshold. If the desaturation threshold is not satisfied, the process may return to step 3406, and the acoustic coupling medium may continue to be held at a vacuum pressure until the desaturation threshold is satisfied.
  • the process moves to step 3410 where the acoustic coupling medium is transferred to a syringe, e.g., the syringe 2708.
  • the vessel 2702 may include a valve 2712.
  • the syringe 2708 may be attached to the valve 2712 and may draw the acoustic coupling medium from the vessel 2702 as described above in conjunction with Fig. 27.
  • the acoustic coupling medium may be transferred to a plurality of syringes.
  • the process 3400 may proceed to step 3412 where an I VUS catheter 2808 is heated to a target temperature.
  • the IVUS catheter 2808 may be heated to the target temperature by a catheter heating plate, e.g., the catheter heating plate 2804.
  • the target temperature may be at least 35°C, at least 37°C, at least 40°C, at least 45°C, at least 50°C, at least 55°C, at least 60°C, at least 65°C, at least 70°C, at least 75°C, at least 80°C, etc.
  • the catheter target temperature may be based on one or more properties of the acoustic coupling medium and/or one or more properties of the IVUS catheter 2808.
  • the process 3400 may move to step 3414 where the IVUS catheter 2808 may be filled.
  • the IVUS catheter 2808 may include a proximal connector hub, e.g., the proximal connector hub 300 or 2300.
  • the proximal connector hub may include a fill port, e.g., the fill port 2324.
  • the IVUS catheter 2808 may be filled by placing the syringe filled with acoustic coupling medium in a syringe pump apparatus, e.g., the syringe pump apparatus 2802.
  • the syringe pump apparatus 2802 may be activated as described above and used to fill the IVUS catheter 2808 via a fill port 2324 as described in conjunction with Figs. 23A-23B, 24A, 26A-26D, 28A and 28B.
  • the syringe apparatus 2802 may include a syringe pump 2810 which may expel the acoustic coupling medium from the syringe 2708 at a target flow rate, e.g., 0.4 mL/min.
  • the syringe apparatus 2802 may include a rotational motor 2818 for rotating the imaging core during filling.
  • the target speed may be 1000 rpm ⁇ 100 rpm.
  • the filling process may continue until the imaging lumen of the IVUS catheter 2808 is filled with the acoustic coupling medium.
  • the IVUS catheter 2808 may be agitated using the rotational motor 2818 to remove air from the acoustic coupling medium.
  • the process 3400 may end at step 3416 where the IVUS catheter 2808 is sealed.
  • the distal end of the catheter may be sealed with a distal plug 406.
  • the proximal end of the catheter may be sealed at a proximal connector hub, e.g., via the mechanisms described above in conjunction with Figs. 25A-25B and 26A- 26D.
  • the process 3400 may include more or fewer steps according to some embodiments.
  • the steps of process 3400 may be performed in a different order or simultaneously with respect to one or more of the other steps of process.
  • Endoscopes and other non-vascular imaging may incorporate several features described herein.
  • Transvaginal and other gynecological ultrasound devices may include several features described herein.
  • the figures described above may refer to IVUS catheters, in those embodiments in which endoscopic ultrasound and other intraluminal imaging (or imaging of other bodily cavities or organs) is performed (and such imaging is not in vessel), the features described herein for “IVUS” or “catheters” apply to intraluminal (including EUS, cavities, organs, etc.) catheters, probes, tubes, scopes and the like.
  • IVUS medical imaging systems
  • such systems include one or more improvements beyond conventional IVUS systems, for example, enhanced imaging, image guided therapy, enhanced usability, easier setup, streamlined clinical workflow, reduced operating times, improved clinical efficacy, improved accuracy of diagnostic images, improved accuracy of therapeutic intervention delivery, improved guided interventional therapy, more efficient peripheral interventions, quicker informed treatment decisions, and quicker measurements and reporting.
  • IVUS is a diagnostic image- guided therapy-tool for the treatment of both peripheral arterial and venous disease, enabling 2D and/or 3D intraluminal visualization.
  • a flushless catheter e.g., diameter, stenosis, peripheral interventions, coronary interventions, atherectomy, lithotripsy, intravascular lithotripsy (IVL), balloon placement, stent placement, venous procedures, below the knee (BTK) procedures, AV Fistula, and other procedures are performed with embodiments described herein.
  • Procedures can be performed by interventional cardiologists, radiologists, and/or vascular surgeons in hospitals, physician offices, Office Based Labs (OBL), and/or Ambulatory Surgery Centers (ASC).
  • OBL Office Based Labs
  • ASC Ambulatory Surgery Centers
  • systems described herein can be used efficiently in the hospital and OBL/ASC without specialized clinical support.
  • An intervention may include therapy or other intervention such as peripheral interventions, coronary interventions, atherectomy, IVL, balloon placement, stent placement, venous procedures, BTK procedures, AV Fistula, and other procedures.
  • Imaging can include, for example, IVUS non-coronary peripheral vessels, IVUS in coronary vessels, ultrasound, intraluminal imaging, imaging of body cavities and organs, and other imaging as described herein (and combinations thereof).
  • an IVUS system with a flush-less catheter provides a contemporary IVUS platform and catheter portfolio that provides improved usability with superior image interpretation and streamlined bedside workflow at a competitive cost enabling broader adoption.
  • flush-less catheters are optimized for vascular imaging and configured for superior pushability, tracking, and crossing for arterial and venous vasculature.
  • catheters have superior pushability to avoid kinking with sufficient column strength to advance the catheter through tortuous bends and occlusions in vasculature without buckling, over bending, or collapsing anywhere along the catheter (e.g., ability to cross an occlusion or constriction).
  • catheters have superior tracking for the ability of the catheter to follow a guidewire through tortuous bends in vasculature, having sufficient flexibility and strength to move along and advance along a guidewire to target locations within the vasculature.
  • catheters have superior crossing capabilities to cross occlusions, restrictions and constrictions within the vasculature, such as at sites with tissue blockage (e.g., stenoses, etc.) and/or implant blockages (such as stents, balloons, etc.).
  • tissue blockage e.g., stenoses, etc.
  • implant blockages such as stents, balloons, etc.
  • the systems described herein, such as an IVUS catheter can include a rotational design that is plug and play and for example, can allow the catheter to be taken out of the sterile package and prepared for use without the need to flush the device.
  • the catheter has a single rotational ultrasound element.
  • the catheter includes an encapsulated coupling medium (e.g., coupling medium, medium, liquid, fluid, gel, etc.) that supports the spinning imaging core inside the catheter jackets.
  • the IVUS catheter is a plug and play catheter with a rotational IVUS design flush-less peripheral disposable imaging catheter with a full length of 280 cm with a working length of 150 cm compatible with a 0.014” guidewire and a 5F sheath, allowing the IVUS catheter proximal connector to attach to the CIM outside of the sterile field.
  • the IVUS catheter is a plug and play catheter is a flush-less peripheral disposable imaging catheter with a full length of 250 cm with a working length of 110 cm compatible with a 0.035” guidewire and an 8F sheath, allowing the IVUS catheter proximal connector to attach to the CIM outside of the sterile field. Connecting outside of the sterile field optionally avoids having to drape a cabled motor unit inside of the sterile field.
  • the high definition (e.g., HD, ultra high definition (UHD), UHD, HD+, etc.) imaging uses acoustic pulse echoes with a matched excitation frequency spectrum for optimal penetration, ultra high resolution, and high definition image quality.
  • the system is optimized for peripheral vascular imaging, coronary imaging, or both.
  • the imaging core spins inside the polymer jacket using an inner drive shaft connected through a proximal hub/connector in one embodiment.
  • the hub connector is optionally attached to the CIM after removal from its sterile catheter package.
  • the transducer located at the distal tip of the imaging core can rotate at between 1500 - 4000 rpm and receives echoes for processing into a circular image on the tablet display.
  • the length of the catheter can be 8 to 10 feet long. In various embodiments the catheter can be taken out of the sterile package and prepared for use without the need to flush the device. The lengths can allow the catheter proximal connector to connect to the CIM outside of the sterile field.
  • the catheter can include non-volatile memory that includes unique catheter identification, usage data, and calibration for optimal imaging performance. Calibration may include data related to measurements of electrical impedance versus frequency, acoustic sensitivity versus frequency, and/or beam profile data that is specific to the individual device according to some embodiments.
  • a CIM is a hardware interface between the system cable from a workstation and disposable catheters according to several embodiments.
  • the CIM provides the system (e.g., IVUS system) with a rotational drive and ultrasound signal processing functions.
  • Custom electronics may control the motor that rotates the imaging core inside the catheter.
  • the electronics may also transmit and receive ultrasound signals between the spinning transducer within the distal end of the catheter tip and the custom printed circuit board inside the workstation.
  • the CIM provides an interface to read and write non-volatile memory in, for example, the catheter. Memory can be used to calibrate an ultrasound transducer for each unique catheter.
  • catheter memory may be used to select the appropriate system configuration to achieve the best possible imaging performance.
  • the CIM may transmit ultrasound signals, sensor data, and/or catheter information from a catheter to a workstation and/or at least one user interface device (e.g., tablet, computer, etc.), which may store the transmitted information in a non-volatile memory in one or more locations.
  • the CIM is mounted on a bed rail outside a sterile field.
  • the CIM is embedded or integrated into imaging control equipment, a workstation, a housing, a table, a bed, a pedestal, a platform, and/or a cart.
  • the CIM is located outside a sterile field.
  • One or more ports to allow for seamless connection between IVUS systems and other imaging modalities are provided in several embodiments.
  • an IVUS system provides coregistration data to provide a 1 :1 co-location identification enabling therapeutic precision.
  • several embodiments described herein can work collaboratively with, or independently from, co-registration with another imaging modality such as fluoroscopy, in which a software algorithm tracks radio-opaque (RO) catheter marker(s) or a RO transducer throughout a continuous fluoroscopy recording.
  • Co-registration with angiography may be used, for example, to determine 3D shape of vessel, lumen and lesion, including lesion length, efficient stent selection, efficient location for stent landing zone, in an attempt to shorten procedure time, decrease contrast use, and make practitioners more comfortable with IVUS. Described herein, are several embodiments that accomplish one or more of these benefits with, or without, co-registration.
  • the IVUS system is configured for optimized vascular procedures.
  • Several systems and methods described herein can be used for peripheral, coronary and other intravascular applications.
  • Other embodiments are used in non-vascular intraluminal applications, such as endoscopy.
  • endoscopes may be used with several features described herein.
  • Transvaginal and other gynecological ultrasound devices may also include several features described herein.
  • EUS endoscopic ultrasound
  • IVUS intraluminal imaging or imaging of other body cavities or organs
  • the features described herein for “IVUS” or “catheters” should be understood to apply to intraluminal (or other cavity/organ) catheters, probes, tubes, scopes and other such devices.
  • the systems and methods are configured and optimized for peripheral vascular procedures (and not for coronary vascular procedures).
  • systems and methods configured, designed or adapted solely or primarily for the peripheral vasculature comprise one or more of the following features: flexibility, steerability, length, diameter, material, and/or bending strength for improved pushability, tracking, and crossing (e.g., the ability to cross through obstructions or narrowing) in the lumen. Some of these features may also be incorporated for applications other than peripheral IVUS.
  • the system is configured to image and/or measure tissue before a therapeutic procedure, such as to identify and plan the therapeutic procedure.
  • the system is configured to image and/or measure tissue after a therapeutic procedure, such as to confirm the results and outcome of the therapeutic procedure.
  • the system is configured to image and/or measure tissue during a therapeutic procedure.
  • the systems described herein leverage Al to enable image interpretation, enhance total-system capabilities, and streamline workflows to maximize the clinical value.
  • physicians will not need to integrate (e.g., cognitively integrate) imaging data spatially and temporally to fully interpret the clinical condition.
  • systems according to several embodiments described herein can leverage the power of Al with generational advancements to go beyond single image interpretation.
  • the Al-powered engine for example, may include a workstation that enhances image interpretation with a simplified workflow improving overall useability.
  • Machine learning is used in several embodiments.
  • the Al-ready processing power is designed to support real time and on-demand image interpretation.
  • the Al powered workstation can provide high end processing and an Al engine for advanced signal and image processing.
  • the native image data capture provides for superior image interpretation (e.g., border detection, identification and measurement of vessel size, vessel disease, dissection, plaque morphology, etc.).
  • the systems described herein provide simplified measurement via automated border detection (e.g., Al algorithms automatically identify borders of a lumen, vessel, tissue, lesion, plaque, etc.).
  • the system provides simplified measurement via semi-automated border detection (e.g., the user can manually adjust or modify automated Al algorithms that identify borders of a lumen, vessel, tissue, lesion, plaque, etc. with the border selection reconfigured based on user modifications).
  • Al plaque identification utilizes Al algorithms to automatically classify and identify types of plaque within the imaged area to provide user guidance on treatment options (e.g., using color coding, icons or text overlays can be used to indicate what type of condition, such as plaque, may be present for the selected image).
  • the data driven platform is designed to collect data, simplify image interpretation, with Al processing power to support real time and on-demand image interpretation and reduce user cognitive load to help (i) identify lumen size, (ii) visualize dissections, (iii) characterize disease morphology, (iv) locate and quantify stenosis, and/or (v) identify true lumen.
  • image interpretation is used to identify thrombus, thrombosis, clots, embolisms, plaque, calcium, tissue health, stent or balloon apposition, and/or stent or balloon “health” or condition.
  • Image interpretation may involve imaging to evaluate quality and/or position of placement of an existing stent.
  • Image interpretation can involve identifying position relative to lumen walls, determine level of and/or quality of tissue grown into and around the stent or balloon.
  • image interpretation can involve (i) evaluating the amount of dissolving of the stent, (ii) determining if the dissolving of the stent is in accordance with expected decay patterns (e.g., determining whether the level of decay on one side of the stent similar to the other side of the stent, and if not, that may indicate a problem with stent placement, or if the stent is dissolving more rapidly than expected that could indicate the stent will not provide the tissue with the expected structural support).
  • expected decay patterns e.g., determining whether the level of decay on one side of the stent similar to the other side of the stent, and if not, that may indicate a problem with stent placement, or if the stent is dissolving more rapidly than expected that could indicate the stent will not provide the tissue with the expected structural support.
  • High-fidelity ultrasound data is used in one embodiment to drive improved image generation and image interpretation, with the option for leveraging artificial intelligence and/or machine learning.
  • catheters, devices, systems, and methods may be configured for use in performing edgebased machine learning computations associated with an image or image analysis using an artificial intelligence algorithm to identify a tissue border, plaque, calcium, thrombus, dissection, and/or stent apposition.
  • data, algorithms, Al and/or ML are used to obtain data from one or more sensors and provide feedback on operational aspects (such as imaging parameters) through a feedback loop (e.g., closed feedback loop/automated) or through user directed adjustments.
  • data, algorithms, Al and/or ML are used to obtain data from one or more images and provide feedback on operational aspects (such as imaging parameters and/or therapy) through a feedback loop (e.g., closed feedback loop/automated) or through user directed adjustments.
  • a feedback loop e.g., closed feedback loop/automated
  • imaging as described herein is used to diagnose whether a patient is suitable for a particular intervention or further diagnostics.
  • 2D and/or 3D intraluminal visualization is enabled.
  • 2D imaging includes an image in a single plane.
  • 3D imaging includes a volumetric representation of tissue or a lumen.
  • 3D imaging is reconstructed via algorithms interpolating a series of 2D images across a third dimension, taking a series of individual 2D images and estimating linear progression along the third dimension, and employing artificial intelligence (Al) to produce a 3D volumetric representation of the interpolated 2D images.
  • Al artificial intelligence
  • 3D model generation may involve obtaining 2D cross- sectional images of a vascular object such that a position along the vein or artery (e.g., an insertion length) can be recorded by an encoder or other sensor. Drawing each 2D cross section in 3D at the insertion length at which the cross section was recorded can allow a 3D model of the vascular object to be built.
  • adding an electro-magnetic sensor to the catheter tip can allow the position of the catheter tip to be recorded as the 2D images are obtained, thus allowing a 3D model of the vascular structure to be created.
  • one or more algorithms convert series of IVUS 2D images and signal data into volumetric 3D visualization.
  • 3D visualization is produced via interpolation of linear and/or nonlinear vascular structure geometry and acoustic reflections from a tissue.
  • pixel based interpolation is used to visualize vascular anatomy in three dimensions.
  • a series of cross sectional two dimensional IVUS images and/or signals are generated via pixel based cut view images of a vessel showing acoustic reflection information along a length of a lumen.
  • 3D visualization is produced via algorithms for creating anatomical contour borders via smooth 3D surface rendering.
  • Al is employed to create 3D visualization data and images.
  • devices such as coronary IVUS catheters
  • devices employ smaller diameters, higher rigidity, and modified coronary specific pushability, tracking, and/or crossing characteristics.
  • Catheters for coronary applications may apply different ultrasound frequencies to account for variance in tissue lumen size: for example, the peripheral vasculature may have larger vessel diameters, so lower frequencies can be used for ultrasound imaging to image at farther distances from the IVUS catheter transducer.
  • coronary vessels have smaller diameters, so may use imaging ultrasound frequencies around 60 MHz, while peripheral imaging may use lower frequencies, such as around 40 MHz or less.
  • coronary IVUS catheters need less column strength for pushability or crossing because of the presence of a guide catheter.
  • catheters are optimized for vascular imaging are configured for superior pushability, tracking, and crossing for arterial and venous peripheral vasculature.
  • one or more of the following features are provided:
  • catheters have superior pushability to avoid kinking with sufficient column strength to advance the catheter through tortuous bends and occlusions in vasculatures without buckling, over bending, or collapsing anywhere along the catheter (e.g., proximate or (e.g., ability to cross an occlusion or constriction).
  • Material properties in some embodiments e.g., balance of rigidity and flexibility, durometer in various segments
  • dimensional characteristics e.g., larger dimensions, such a diameter and thickness, increase column strength, account for greater pushability and kink resistance.
  • catheters have superior tracking for the ability of the catheter to follow a guidewire through tortuous bends in vasculature, having sufficient flexibility and strength to move along and advance along a guidewire to target locations within the vasculature.
  • Hydrophilic coatings according to some embodiments help reduce friction with the surrounding luminal tissue.
  • catheters have superior crossing capabilities to cross occlusions, restrictions and constrictions within the vasculature, such as at sites with tissue blockage (e.g., stenoses, etc.) and/or implant blockages (such as stents, balloons, etc.).
  • crossing ability is enhanced by one or more of the following: (i) design of the distal tip (e.g., pointed enough to navigate occlusions, etc.
  • low durometer near the distal tip is provided for flexibility to navigate tortuous anatomy and obstructions.
  • a region of varying or step wise gradient changes to a higher durometer proximally sufficient to push the catheter while avoiding kinking is provided.
  • a single durometer and/or flexibility can remain constant along a certain or all portions of a device.
  • the technology described herein is used in several embodiments with intraluminal image focusing with spinning single element ultrasound transducer via modification of image (e.g., angular diffraction, phase, amplitude, time shift, compositing backscatter reflected images) including the technology described in U.S. Patent Serial No. 63/497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods (and the PCT application claiming priority thereto and filed April 11, 2024); manually assisted pullback for spatial alignment measurements, voice control, position sensors (e.g., encoder) including the technology described in U.S. Patent Serial No.
  • a method for filling an IVUS catheter with an acoustic coupling medium was performed using PEG400 as an acoustic coupling medium to fill an inner imaging lumen/cavity of a catheter prototype.
  • a prototype “014 catheter” was configured for peripheral vascular imaging with an 0.014” CD guidewire.
  • the prototype had an inner rotating core consisting of a coax, dual-layer torque coil drive cable, and a block at the end of the drive cable with a simulated acoustic transducer with dimensions appropriate for high quality imaging.
  • the catheter jacket was consistent with commercially available dimensions for an IVUS catheter.
  • the full length of the catheter was longer than existing commercially available IVUS catheters at 280cm for the 014 catheter.
  • the length of the lumen with encapsulated coupling medium was significantly longer than commercially available catheters purposefully designed to challenge the encapsulation method as longer lumens are more difficult to fill.
  • the catheter prototype was successfully filled with PEG400 with all bubbles purged from the inner imaging lumen.
  • Alternatives to PEG400 may also be used in other embodiments, for example, other low molecular-weight grades of polyethylene glycol as well as other materials.
  • PEG400 was used as an acoustic coupling medium to fill an inner imaging lumen/cavity of a catheter prototype.
  • a prototype “035 catheter” was configured for peripheral vascular imaging with an 0.035” CD guidewire.
  • the prototype had an inner rotating core consisting of a coax, dual-layer torque coil drive cable, and a block at the end of the drive cable attached to a simulated acoustic transducer with dimensions appropriate for high quality imaging.
  • the catheter jacket was consistent with commercially available dimensions for an IVUS catheter. The full length of the catheter was longer than existing commercially available IVUS catheters at 250cm for the 035 catheter.
  • the length of the lumen with encapsulated coupling medium was significantly longer than commercially available catheters purposefully designed to challenge the encapsulation method as longer lumens are more difficult to fill.
  • the catheter prototype was successfully filled with PEG400 with all bubbles purged from the inner imaging lumen.
  • Alternatives to PEG400 may also be used in other embodiments, for example, other low molecular-weight grades of polyethylene glycol as well as other materials.
  • Conditional language used herein such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that some examples include, while other examples do not include, certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular example.
  • the methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any user or third-party instruction of those actions, either expressly or by implication. For example, actions such as “positioning a device” include “instructing positioning of a device.”
  • substantially linear includes “linear.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
  • the phrase “at least one of” is intended to require at least one item from the subsequent listing, not one type of each item from each item in the subsequent listing.
  • “at least one of A, B, and C” can include A; B; C; A and B; A and C; B and C; or A, B, and C.

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Abstract

Selon certains aspects, l'invention concerne des systèmes et des procédés destinés à remplir et sceller un cathéter à ultrasons intravasculaire (IVUS) sans rinçage avec un support de couplage acoustique. Le cathéter IVUS comprend, par exemple, un orifice de remplissage d'entrée de support de couplage acoustique, un orifice de sortie distal, un joint d'étanchéité et un bouchon. Le procédé de remplissage du cathéter IVUS peut avantageusement réduire ou éliminer des bulles de gaz du support de couplage acoustique entourant un noyau d'imagerie à ultrasons mis en rotation à l'intérieur d'une lumière d'imagerie de cathéter. Le procédé peut consister à exercer une pression afin de pousser le support dans la lumière et/ou le vide pour tirer le support de la lumière avec un joint flexible et un bouchon pour encapsuler le support à l'intérieur du cathéter.
PCT/US2024/024045 2023-04-14 2024-04-11 Technologie à ultrasons intravasculaire sans rinçage WO2024215869A1 (fr)

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US7604601B2 (en) * 2005-04-26 2009-10-20 Biosense Webster, Inc. Display of catheter tip with beam direction for ultrasound system
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US9675323B2 (en) * 2013-03-15 2017-06-13 Muffin Incorporated Internal ultrasound assembly with port for fluid injection
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