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WO2025096257A1 - Systèmes pour le maintien d'un contact ultrasonore avec un tissu intraluminal - Google Patents

Systèmes pour le maintien d'un contact ultrasonore avec un tissu intraluminal Download PDF

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Publication number
WO2025096257A1
WO2025096257A1 PCT/US2024/052598 US2024052598W WO2025096257A1 WO 2025096257 A1 WO2025096257 A1 WO 2025096257A1 US 2024052598 W US2024052598 W US 2024052598W WO 2025096257 A1 WO2025096257 A1 WO 2025096257A1
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WO
WIPO (PCT)
Prior art keywords
wire
force
transducer
housing
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/052598
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English (en)
Inventor
Ron GLANDON
Christopher Lee
Michael CICERO
Joey Magno
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Veran Medical Technologies Inc
Original Assignee
Veran Medical Technologies Inc
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Filing date
Publication date
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Publication of WO2025096257A1 publication Critical patent/WO2025096257A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B8/12—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
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • 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
    • 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
    • A61B8/42—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
    • A61B8/429—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by determining or monitoring the contact between the transducer and the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00011—Operational features of endoscopes characterised by signal transmission
    • A61B1/00016—Operational features of endoscopes characterised by signal transmission using wireless means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0638—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements providing two or more wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • 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

Definitions

  • Examples described herein generally relate to ultrasound devices. More specifically, the examples described herein generally relate to techniques for maintaining ultrasonic contact with intraluminal tissue.
  • Conventional endoscopes can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like.
  • fluid delivery e.g., saline or other preparations via a fluid channel
  • passage e.g., via a working channel
  • suction passageways for collecting fluids (e.g., saline or other preparations)
  • Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra), other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.
  • gastrointestinal tract e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like
  • renal area e.g., kidney(s), ureter, bladder, urethra
  • other internal organs e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract
  • the inventors of the present disclosure have recognized the limits of ultrasonic imagingfor intraluminal ultrasound imaging devices (e.g., endobronchial ultrasound (EBUS) endoscopes, sampling devices, or the like) that fail to maintain contact between the intraluminal tissue and the transducer.
  • EBUS endobronchial ultrasound
  • obtaining a high-quality ultrasound (“US”) image is dependent on US energy propagating from a transducer element into the patient’s tissue at least as deep as the tissue structure of interest, which reflects a portion of the US energy back to the transducer element.
  • the transducer element generates signals based on the reflected portion of US energy and these signals are used to generate an image of the tissue structure of interest.
  • Air gaps residing between the US transducer and the tissue structure of interest can create an unwanted sonographic barrier, due to air having an extremely low acoustic impedance relative to body tissues.
  • This “impedance mismatch” results in US waves that strike a tissue-air surface being mostly reflected back. This severely limits penetration of the US waves into the tissue beyond a lumen wall and can result in a poor or even non-existent image of the tissue structure of interest. Maintaining contact between the transducer and the intraluminal tissue can become especially difficult to maintain contact between the transducer and the intraluminal tissue when there is a small ultrasonic device, and the intraluminal tissue has a larger diameter than the small ultrasonic device.
  • the inventors have developed systems for maintaining contact between the transducer and the intraluminal tissue.
  • an ultrasonic sampling device can be configured to be inserted within inner walls defining a lumen of a patient and can include a coupler extending from a proximal portion to a distal portion.
  • the coupler can include a side-exit ramp extending within the coupler from the proximal portion and through a side of the coupler.
  • the side-exit ramp can direct an instrument through the side of the coupler and toward the inner lumen walls.
  • the ultrasonic sampling device can include a housing extending along a central axis from a proximal section to a distal section.
  • the housing can include a mount feature configured to receive a transducer and a force-generating system.
  • the force-generating system can be operable to maintain contact between the inner lumen walls and the transducerto mitigate air gaps between the inner lumen walls and the transducer.
  • a system for taking ultrasonic images of intraluminal tissue of a patient can include a control handle; an insertion tube extendingfrom the control handle.
  • the insertion tube can be configured for insertion within the lumen and can include a working lumen.
  • the system can include an ultrasonic sampling device configured to be inserted within the working lumen such that the ultrasonic sampling device can be extended beyond a distal tip of the insertion tube and into the lumen.
  • the ultrasonic sampling device can include a coupler extendingfrom a proximal portion to a distal portion.
  • the coupler can include a side-exit ramp extending within the coupler from the proximal portion and through a side of the coupler.
  • the side-exit ramp can direct an instrument through the side of the coupler and toward the intraluminal tissue.
  • a housing can extend along a central axis from a proximal section to a distal section.
  • the housing can include a mount feature configured to receive a transducer and a force-generating system operable to maintain contact between the intraluminal tissue and the transducerto mitigate air gaps between the intraluminal tissue and the transducer.
  • an intraluminal ultrasound device configured to be inserted within inner walls defining a lumen of a patient can include a housing extending along a central axis from a proximal section to a distal section.
  • the housing can include a transducer configured to capture ultrasonic images and a mount feature configured to receive the transducer.
  • the intraluminal ultrasound device can also include a forcegenerating system operable to maintain contact between the inner walls and the transducer to mitigate air gaps between the lumen and the transducer.
  • FIG. 1 is a schematic diagram of an example of an endobronchial ultrasound sampling device.
  • FIG. 2 is a schematic diagram of an example of an imaging and control system of an ultrasonic sampling device.
  • FIG. 3 is a cross-sectional view of a portion of an example of an ultrasonic sampling device.
  • FIG. 4 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a retracted configuration.
  • FIG. 5 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in an extended configuration.
  • FIG. 6 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a retracted configuration.
  • FIG. 7 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in an extended configuration.
  • FIG. 8 is a perspective view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system.
  • FIG. 9 is a perspective view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system.
  • FIG. 10 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a deflated configuration.
  • FIG. 11 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a in an expanded configuration.
  • FIG. 12 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a retracted configuration.
  • FIG. 14 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in a retracted configuration.
  • FIG. 15 is a cross-sectional view of a portion of an example of an ultrasonic sampling device with an example pressure-generating system in an extended configuration.
  • FIG. 17 is a cutaway view of a port in an example actuator of an example sampling device.
  • FIG. 18 is a schematic diagram of an exemplary computer- based clinical decision support system (CDSS).
  • CDSS computer- based clinical decision support system
  • FIG. 19 is a block diagram of an example of a machine upon which one or more examples can be implemented.
  • Intraluminal ultrasound (US) imaging can help with real-time imaging of anatomical structures that lie beyond the luminal wall.
  • endobronchial ultrasound (EBUS) devices can enable doctors to obtain a real-time image stream of a tissue structure of interest, such as a Solitary Pulmonary Nodule (SPN) located next to an airway of the patient.
  • SPN Solitary Pulmonary Nodule
  • Obtaining a high-quality US image can require US energy to propagate from a transducer element into the tissue of the patient, at least as deep as the tissue structure of interest.
  • the structure of interest reflects a portion of the US energy to the transducer element.
  • the transducer element generates signals based on the reflected portion of US energy, and these signals can generate an image of the tissue structure of interest.
  • the functional section 128 can include components for treating and diagnosing the anatomy of a patient.
  • the functional section 128 can include an imaging device 144 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensors), an illumination device 146 (e.g., a light emitting diode), and the distal working channel port 112 at a distal face of the functional section 128.
  • CMOS complementary metal oxide semiconductor
  • illumination device 146 e.g., a light emitting diode
  • distal working channel port 112 at a distal face of the functional section 128.
  • medical device 108 can extend from the distal working channel port 112 at the distal face of the functional section 128 of the endoscope 104.
  • the medical device 108 can be configured to be attached to the proximal working channel port 140 (of the endoscope 104) such that the medical device 108 extends through a working channel (e.g., extending through the insertion section 126 to the distal working channel port 112) of the endoscope 104 and out the distal end of the endoscope 104.
  • the medical device 108 can include a sheath extension mechanism 148 for advancing or retracting a flexible sheath of the medical device 108 within the working channel to control how far distally from the distal working channel port 112 the distal end of the medical device 108 extends.
  • the medical device 108 can further include an instrument actuator 150 for controllably advancing and retracting a medical instrument (e.g., biopsy needle) within a lumen of the medical device 108, where the lumen extends from the medical device 108 handle through the lumen of the medical device 108 to a side exit ramp at or nearthe distal end.
  • a medical instrument e.g., biopsy needle
  • manipulation of the instrument actuator 150 can control advancement or retraction of a biopsy needle from a side exit port of the medical device 108 while the distal end 110 of the medical device 108 is extended beyond the distal end of the endoscope 104, thereby facilitating treatment or biopsy of target anatomy within a patient beyond the distal end of the endoscope 104.
  • the sheath extension mechanism 148 can be configured to extend the medical device 108 beyond a distal end of the endoscope 104, such as to navigate the medical device 108 to the target area within the patient.
  • the sheath extension mechanism 148 can slide along a housing 152 of the medical device 108.
  • the housing 152 can include indicia, which indicates an amount of extension of the medical device 108 beyond a distal end of the endoscope 104 (e.g., extension beyond the distal working channel port 112 indicated in inches, centimeters, or other suitable linear distance units).
  • the instrument actuator 150 can be configured to extend an instrument from the medical device 108 to obtain a tissue sample from the patient.
  • the side exit port can be located proximal from the transducer 160 and configured to deflect the instrument at an acute angle with respect to a longitudinal axis of the distal end 110 of the medical device 108 such that a tissue sample can be obtained from the patient while the instrument and tissue sample are within the field of view of the transducer.
  • activation of the camera and light source 120 or the illumination device 146 can enable an operator to visualize in real-time the internal anatomy of the patient as the distal end of the endoscope 104 is advanced and can further enable the operatorto visualize the distal end of the medical device 108 being advanced beyond the distal end of the endoscope 104.
  • the outer profile or diameter of the medical device 108 is less than that of the endoscope 104 (e.g., since it fits within a working channel of the endoscope 104)
  • advancement of the medical device 108 beyond the endoscope 104 can enable tissue treatment or sampling in anatomical regions (e.g., airways) that are too small forthe endoscope 104 to be advanced through.
  • the coupler section 134 can be connected to the control unit 114 to connect to the endoscope 104 to multiple features of the control unit 114, such as the image processing unit 202, the treatment generator 204, or the like.
  • the port 138 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 104.
  • Such instruments and devices can be independently connected to the control unit 114via the cable section 132.
  • the proximal working channel port 140 can be used to connect the coupler section 134 to various inputs and outputs, such as video, air, light and electricity.
  • the image processing unit 202, the ultrasound image processing unit 208, and the light source 120 can each interface with the endoscope 104 (e.g., at the functional section 128) or the medical device 108 by wired or wireless electrical connections.
  • the control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 116.
  • the ultrasound image processing unit 208 can be configured to receive ultrasonic signals from eitherthe endoscope 104 orthe medical device 108 (e.g., from the transducer 160, FIG. 1 ), which can be converted into ultrasonic images and transmitted to the display unit 116 or any other component of the endoscopy system 100.
  • the control system 102 can include the light source 120 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, and the like).
  • the control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).
  • the fluid source 122 (shown in FIG. 1) can be in communication with the control unit 114 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like).
  • the control system 102 can also include a drive unit 206, which can include a motorized drive for advancing a distal section of endoscope 104.
  • FIG. 3 illustrates a cross-sectional view of a portion of an example of a sampling device 300.
  • the sampling device 300 can be configured to be inserted within a lumen 290, which can be defined by inner walls 288 of the air passages or airways of the lungs or any other lumen defined by the inner walls or tissue of the patient.
  • the sampling device 300 can be directly inserted into the lumen 290 or can be extended from a mother scope that can guide the sampling device 300 toward a target location within the lumen 290.
  • the sampling device 300 can include a coupler 310 and a housing 330.
  • the coupler 310 can extend from a proximal portion 312 to a distal portion 314.
  • the coupler 310 can include a side-exit ramp 320.
  • the side-exit ramp 320 can extend within the coupler 310 from the proximal portion 312 and through a side of the coupler 310.
  • the side-exit ramp 320 can direct an instrument 322 (e.g., a sampling need, cutting device, light source, liquid source, orthe like) through the side of the coupler 310 and toward the inner walls 288.
  • the force-generating system 340 can be operable to maintain contact between the inner walls 288 and the transducer 341 to mitigate air gaps between the inner walls 288 and the transducer 341 .
  • the inventors of the present disclosure have discovered many potential versions of the force-generating system 340 that can be used to mitigate air gaps between the inner walls 288 and the transducer 341 , some of which, will be discussed herein with reference to FIGS. 4-15. However, the inventors recognize that any elements of any force-generating system 340 can be combined to create different variations of the force-generating system 340. Additionally, other systems that can decrease the air gap between the inner walls 288 and the transducer 341 can be used on the sampling device 300. [0053] FIGS. 4 and 5 will be discussed together.
  • FIG. 4 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 400 with an example pressure-generating system 440 in a retracted configuration 442.
  • FIG. 5 illustrates a cross-sectional view of a portion of an example of the ultrasonic sampling device 400 with an example of the pressure-generating system 440 in an extended configuration 444.
  • the housing 430 of the ultrasonic sampling device 400 can include a slot 450.
  • the slot 450 can be opposite the housing 430 from the mount feature 438.
  • the slot 450 can permit the pressure-generating system 440 to operate between the retracted configuration 442 and the extended configuration 444.
  • the pressure-generating system 440 can include a forcegeneratingwire 446.
  • the force-generating wire 446 can extend between a distal section 448 and a proximal section 449.
  • the distal section 448 can be to the distal section 436 of the housing 430.
  • the proximal section 449 can extend such that a medical professional can manipulate the force-generating wire 446 to expose the force-generating wire 446, either directly or indirectly, with an axial force 445.
  • the proximal section 449 of the forcegeneratingwire 446 can be configured to receive an axial force 445.
  • the axial force 445 can operate the force-generating wire 446 between the retracted configuration 442 and the extended configuration 444.
  • the force-generating wire 446 can include one or more sensors (sensor 447) (e.g., force sensors, capacitance sensors, image sensors, or the like) to detect one or more system characteristic (e.g., force applied to the force-generating wire 446, contact between the forcegenerating wire 446 and the inner walls 288, a linear length of the forcegenerating wire 446 extended from the housing 430, any other property or characteristic of the force-generating wire 446, or the like).
  • sensors e.g., force sensors, capacitance sensors, image sensors, or the like
  • system characteristic e.g., force applied to the force-generating wire 446, contact between the forcegenerating wire 446 and the inner walls 288, a linear length of the forcegenerating wire 446 extended from the housing 430, any other property or characteristic of the force-generating wire 446, or the like.
  • the sensors 447 can help the clinician in the deployment and guidance of the force-generating wire 446 within the lumen 290.
  • the sensors 447 can be in communication with a control system (e.g., the control unit 114 (FIG. 2)) to generate alerts or send controlling signals to any of the systems of the endoscopy system 100 (FIG.1 ) or the sampling device 300.
  • the sensors 447 can sense movement and position of the force-generating wire 446, and as a result, the control system can automatically control the deployment of the forcegeneratingwire 446 within the patient until the force-generating wire 446 is at a pre-determined location.
  • the pre-determined location can be a location that the ultrasonic sampling device 400 can obtain a sample from a target nodule, or any other position within the patient.
  • FIGS. 6 and 7 will be discussed together.
  • FIG. 6 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 600 with an example pressure-generating system 640 in a retracted configuration 642.
  • FIG. 7 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 600 with an example pressuregenerating system 640 in an extended configuration 644.
  • the housing 630 can include a channel 650.
  • the channel 650 can be formed in the housing 630 opposite of the mount feature 638.
  • the channel 650 can be configured to permit the pressure-generating system 640 to operate between the retracted configuration 642 and the extended configuration 644.
  • the pressure-generating system 640 can include a curling wire 656.
  • the curling wire 656 can be operable between the retracted configuration 642 and the extended configuration 644.
  • the curling wire 656 can extend between a distal section 658 and a proximal section 660.
  • the distal section 658 of the curling wire 656 can include a shape memory such that the curling wire 656 the distal section 658 of the curling wire 656 bends as the curling wire 656 is positioned in the extended configuration 644.
  • the distal section 658 of the curling wire 656 can bend such that a portion of the curling wire 656 proximal to a distal tip 659 of the curling wire 656 contacts the inner walls 288 when the curling wire 656 is in the extended configuration 644.
  • the proximal section 660 of the curling wire 656 can extend out of the ultrasonic sampling device 600 toward the controller such that the clinician can control the curling wire 656 by altering a force 662 applied to the curling wire 656.
  • the proximal section 660 of the curling wire 656 can be configured to receive the force 662 applied to the curling wire 656 by the clinician to operate the curling wire 656 between the retracted configuration 642 and the extended configuration 644.
  • the curling wire 656 can extend through the channel 650 of the housing 630 to contact the lumen 290 and press the transducer 641 toward the inner walls 288 opposite the contact between the curling wire 656 and the inner walls 288 to improve contact and mitigate air gaps between the transducer 641 and the inner walls 288.
  • the curling wire 656 can be completely within the housing 630.
  • the curling wire 656 can extend through the channel 650 enough that the shape memory of the curling wire 656 can begin to bend the curling wire 656 such that a portion proximal the distal tip 659 of the curling wire 656 can contact the innerwalls 288 to provide support to help guide the ultrasonic sampling device 600 through the lumen 290 toward the target nodule.
  • the distal tip 659 of the curling wire 656 can include a contact feature 664 (shown in FIG. 7).
  • the contact feature 664 can increase a surface area of the distal tip 659 such as to decrease pressure resulting from the distal tip 659 engagingwith the innerwalls 288.
  • the increased surface area of the distal tip 659 can also help the sensors (e.g., force sensors, capacitance sensors, image sensors, or the like) detect one or more system characteristics (e.g., force applied to the curling wire 656, contact between the curling wire 656 and the inner walls 288, a linear length of the curling wire 656 extendingfrom the housing 630, any other property or characteristic of the curling wire 656, or the like).
  • sensors e.g., force sensors, capacitance sensors, image sensors, or the like
  • system characteristics e.g., force applied to the curling wire 656, contact between the curling wire 656 and the inner walls 288, a linear length of the curling wire 656 extendingfrom the housing 630, any other property or characteristic of the curling wire 656, or the like.
  • the force-generating wire 646 can include one or more sensors (sensor 647) (e.g., force sensors, capacitance sensors, image sensors, or the like) to detect one or more system characteristics (e.g., force applied to the force-generating wire 646, contact between the forcegeneratingwire 646 and the inner walls 288, a linear length of the forcegenerating wire 646 extended from the housing 630, any other property or characteristic of the force-generating wire 646, or the like).
  • the sensors 647 can help the clinician in the deployment and guidance of the force-generating wire 646 within the lumen 290.
  • the sensors 647 can be in communication with a control system (e.g., the control unit 114 (FIG.
  • the sensors 647 can sense movement and position of the force-generating wire 646, and as a result, the control system can automatically control the deployment of the forcegenerating wire 646 within the patient until the force-generating wire 646 is at a pre-determined location.
  • the pre-determined location can be a location that the ultrasonic sampling device 600 can obtain a sample from a target nodule, or any other position within the patient.
  • FIGS. 8 and 9 will be discussed together.
  • FIG. 8 illustrates a perspective view of a portion of an example of an ultrasonic sampling device 800 with an example pressure-generating system 840.
  • FIG. 9 illustrates a perspective view of a portion of an example of the ultrasonic sampling device 800 with of the example pressure-generating system 840.
  • the pressure-generating system 840 can include a suction system 866.
  • the suction system 866 can be fluidically connected to the suction pump 124 (FIG. 1 ) or any other vacuum source to generate a suction force against a portion of inner walls 288 to drawthe inner walls 288 toward the transducer 841 .
  • the suction system 866 can be configured to hold the innerwalls 288 against the transducer 841such as to mitigate air trapped between the innerwalls 288 and the transducer 841 .
  • the suction system 866 can include an inlet 868.
  • the inlet 868 can surround a periphery 839 of the mount feature 838.
  • the inlet 868 can extend from the housing 830 more than the mount feature 838 and the transducer 841 .
  • the inlet 868 can be closer to the innerwalls 288 than the transducer 841 such as to provide a suction force to drawthe innerwalls 288 toward the transducer 841 or to drawthe transducer 841 (and the ultrasonic sampling device 800) toward the inner walls 288.
  • the suction system 866 can include a plurality of suction ports (ports 870).
  • the ports 870 can be formed in the housing 830 surrounding the mount feature 838. There can be one of the ports 870, two of the ports 870, three of the ports 870, four of the ports 870, or any number of the ports 870.
  • the ports 870 can be configured to introduce a suction force to the inner walls 288 to draw the inner walls 288 toward the transducer 841 or to draw the ultrasonic sampling device 800 (or the transducer 841 ) toward the inner walls 288 to prevent airgaps between the inner walls 288 and the transducer 841 to improve the imaging capabilities of the ultrasonic sampling device 800.
  • the suction system 866 can include one or more sensors (sensor 847) (e.g., force sensors, capacitance sensors, image sensors, flow sensors, or the like) to detect one or more system characteristic (e.g., pressure within the suction system 866, contact between the housing 830 and the inner walls 288, a volume of air supplied to the suction system 866, or the like).
  • sensors e.g., force sensors, capacitance sensors, image sensors, flow sensors, or the like
  • system characteristic e.g., pressure within the suction system 866, contact between the housing 830 and the inner walls 288, a volume of air supplied to the suction system 866, or the like.
  • the sensors 847 can help the clinician in the deployment and suction system 866.
  • the sensors 847 can be in communication with a control system (e.g., the control unit 114 (FIG. 2)) to generate alerts or send controlling signals to any of the systems of the endoscopy system 100 (FIG.1) or the ultrasonic sampling device 800.
  • the control system can automatically control (e.g., turn on or adjust the suction power) the suction system 866 during the insertion of the ultrasonic sampling device 800 into the patient.
  • FIGS. 10 and 11 will be discussed together.
  • FIG. 10 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 1000 with an example pressure-generating system 1040 in a deflated configuration 1042.
  • FIG. 11 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 1000 with an example pressure-generating system 1040 in an expanded configuration 1044.
  • the housing 1030 can include an airbag slot 1052 and the pressure-generating system 1040 can include an airbag 1072 connected to a pump 1074 (e.g., the suction pump 124 (FIG. 1 )).
  • the airbag slot 1052 can be opposite the housing 1030 from the mount feature 1038.
  • the pump 1074 can be operable to inflate and deflate the airbag 1072 between the expanded configuration 1044 and the deflated configuration 1042, respectively.
  • the pump 1074 can inflate the airbag 1072 such that the airbag 1072 extends through the airbag slot 1052 to contact the inner walls 288 of the patient and mitigate air gaps between the inner walls 288 and the transducer 1041 .
  • the airbag 1072 can retract through the airbag slot 1052 and into the housing 1030. In the deflated configuration 1042, a portion of the airbag 1072 can extend outside of the housing 1030 beyond the airbag slot 1052.
  • the airbag 1072 can include one or more sensors (sensor 1047) (e.g., force sensors, capacitance sensors, image sensors, pressure sensors, flow sensors, or the like) to detect one or more system characteristic (e.g., pressure generated by the airbag 1072, contact between the airbag 1072 and the inner walls 288, a volume of air pumped into or out of the airbag 1072, any other property or characteristic of the airbag 1072, or the like).
  • sensor 1047 e.g., force sensors, capacitance sensors, image sensors, pressure sensors, flow sensors, or the like
  • system characteristic e.g., pressure generated by the airbag 1072, contact between the airbag 1072 and the inner walls 288, a volume of air pumped into or out of the airbag 1072, any other property or characteristic of the airbag 1072, or the like.
  • system characteristic e.g., pressure generated by the airbag 1072, contact between the airbag 1072 and the inner walls 288, a volume of air pumped into or out of the airbag 10
  • the sensors 1047 can help the clinician with the deployment of the airbag 1072 and the guidance of the sampling device 300 (FIG. 3) within the lumen 290.
  • the sensors 1047 can be in communication with a control system (e.g., the control unit 114 (FIG. 2)) to generate alerts or send controlling signals to any of the systems of the endoscopy system 100 (FIG.1 ) or the ultrasonic sampling device 1000.
  • the sensors 1047 can sense the movement and position of the ultrasonic sampling device 1000, and as a result, the control system can automatically control the deployment of the airbag 1072 to position the ultrasonic sampling device 1000 at a pre-determined location within the patient.
  • the pre-determined location can be a location where the ultrasonic sampling device 1000 can obtain a sample from a target nodule, the location of which can be determined pre-operatively or intra-operatively.
  • FIGS. 12 and 13 will be discussed together.
  • FIG. 12 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 1200 with an example pressure-generating system 1240 in a retracted configuration 1242.
  • FIG. 13 illustrates a cross-sectional view of a portion of an example of the ultrasonic sampling device 1200 with an example of the pressure-generating system 1240 in an extended configuration 1244.
  • the housing 1230 can include a linear slot 1260.
  • the linear slot 1260 can be formed on the opposite side of the housing 1230 from the mount feature 1238.
  • the pressure-generating system 1240 can include a flexible member 1276.
  • the flexible member 1276 can extend between a proximal portion 1278 and a distal portion 1280.
  • the proximal portion 1278 of the flexible member 1276 can be fixedly attached to the housing 1230.
  • the pressure-generating system 1240 can also include an actuation wire 1282.
  • the actuation wire 1282 can be attached to the distal portion 1280 of the flexible member 1276 such that adding tension to the actuation wire 1282 translates the distal portion 1280 of the flexible member 1276 toward the proximal portion 1278 of the flexible member 1276.
  • the flexible member 1276 bends and extends through the linear slot 1260 of the housing 1230 to contact the inner walls 288 and mitigate airgaps between the transducer 1241 and the inner walls 288.
  • the flexible member 1276 can include shape memory such that when the tension from the actuation wire 1282 is removed, the distal portion 1280 of the flexible member 1276 translates away from the proximal portion 1278 of the flexible member 1276 and the flexible member 1276 retracts back through the linear slot 1260 of the housing 1230 and into the housing 1230.
  • the flexible member 1276 can include one or more sensors (sensor 1247) (e.g., force sensors, capacitance sensors, image sensors, or the like) to detect one or more system characteristic (e.g., force applied to the flexible member 1276, contact between the flexible member 1276 and the inner walls 288, or the like).
  • the sensors 1247 can help the clinician in the deployment and guidance of the ultrasonic sampling device 1200 within the lumen 290.
  • the sensors 1247 can be in communication with a control system (e.g., the control unit 114 (FIG. 2)) to generate alerts or send controlling signals to any of the systems of the endoscopy system 100 (FIG.1 ) or the ultrasonic sampling device 1200.
  • the sensors 1247 can sense movement and position of the ultrasonic sampling device 1200, the flexible member 1276, or the actuation wire 1282, and as a result, the control system can automatically control the deployment of the flexible member 1276 from the ultrasonic sampling device 1200 and into the patient.
  • control system can navigate the ultrasonic sampling device 1200 to a pre-determined location within the patient.
  • the pre-determined location can be a location where the ultrasonic sampling device 1200 can obtain a sample from a target nodule, the location of which can be determined pre-operatively or intra-operatively.
  • FIGS. 14 and 15 will be discussed together.
  • FIG. 14 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 1400 with an example pressure-generating system 1440 in a retracted configuration 1442.
  • FIG. 15 illustrates a cross-sectional view of a portion of an example of the ultrasonic sampling device 1400 with an example pressure-generating system 1440 in an extended configuration 1444.
  • the housing 1430 can include a linear slot 1460.
  • the linear slot 1460 can be formed on the opposite side of the housing 1430 from the mount feature 1438.
  • the pressure-generating system 1440 can include a flexible wire 1476.
  • the flexible wire 1476 can extend between a proximal portion 1478 and a distal portion 1480.
  • the proximal portion 1478 of the flexible wire 1476 can be fixedly attached to the housing 1430.
  • the pressure-generating system 1440 can also include an actuation wire 1482.
  • the actuation wire 1482 can be attached to the distal portion 1480 of the flexible wire 1476 such that adding tension to the actuation wire 1482 translatesl 480 the distal portion 1480 of the flexible wire 1476 toward the proximal portion 1478 of the flexible wire 1476. As the distal portion 1480 of the flexible wire 1476 translates toward the proximal portion 1478 of the flexible wire 1476, the flexible wire 1476 bends and extends through the linear slot 1460 of the housing 1430 to contact the inner walls 288 and mitigate airgaps between the transducer 1441 and the inner walls 288.
  • the flexible wire 1476 can include one or more sensors (sensor 1447) (e.g., force sensors, capacitance sensors, image sensors, or the like) to detect one or more system characteristics (e.g., force applied to the flexible wire 1476, contact between the flexible wire 1476 and the inner walls 288, or the like).
  • sensors e.g., force sensors, capacitance sensors, image sensors, or the like
  • system characteristics e.g., force applied to the flexible wire 1476, contact between the flexible wire 1476 and the inner walls 288, or the like.
  • the sensors 1447 can help the clinician in the deployment and guidance of the ultrasonic sampling device 1400 or the flexible wire 1476 within the patient.
  • the sensors 1447 can be in communication with a control system (e.g., the control unit 114 (FIG. 2)) to generate alerts or send controlling signals to any of the systems of the endoscopy system 100 (FIG.1 ) or the ultrasonic sampling device 1400.
  • the sensors 1447 can sense the movement or position of the ultrasonic sampling device 1400 or the flexible wire 1476 within the patient, and as a result, the control system can automatically control the deployment of the ultrasonic sampling device 1400 or the flexible wire 1476 within the patient.
  • the control system can navigate the ultrasonic sampling device 1400 to a pre-determined location and then deploy the flexible wire 1476 to position the transducer 1441 adjacent to the target nodule of the patient.
  • the endoscopic system e.g., the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG. 8), the ultrasonic sampling device 1000 (FIG. 10), the ultrasonic sampling device 1200 (FIG. 12), and the ultrasonic sampling device 1400 (FIG. 14)
  • the sampling devices e.g., the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG.
  • FIG. 16 is a side view of an example of a sampling device 1600, accordingto at least one example of the present disclosure.
  • the sampling device 1600 can operate in conjunction with an insertion device 1630 (only a portion is shown in FIG. 16), such as an endoscope or a bronchoscope.
  • the insertion device 1630 can include an insertion conduit that is insertable into a body via an orifice or other opening.
  • the insertion device 1630 can receive the elongated instrument 1602 (e.g., the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG. 8), the ultrasonic sampling device 1000 (FIG. 10), the ultrasonic sampling device 1200 (FIG. 12), and the ultrasonic sampling device 1400 (FIG. 14)), and the elongated instrument 1602 can be extended through the insertion conduit to the desired location.
  • the elongated instrument 1602 can be inserted through a working channel of a bronchoscope and extended from a port on the distal end of the bronchoscope.
  • the elongated instrument 1602 can be extended further into a bronchial structure than the bronchoscope due to the elongated instrument 1602 having a smaller outer diameter than the bronchoscope.
  • the elongated instrument 1602 can be a sampling probe that can include an imaging probe (which can be integrated into a distal tip of the elongated instrument) and a sampling needle within a flexible lumened catheter.
  • the elongated instrument 1602 can be insertable via the insertion device 1630 to procure a tissue sample at a desired location within a body.
  • the elongated instrument 1602 also can include a stylet that can be removably insertable into or through the needle, as further described below.
  • the sampling device 1600 herein described can be coupled to the insertion device 1630 using a coupling 1606 at a distal end 1608 of the sampling device 1600.
  • the elongated instrument 1602 which can be manipulated by the sampling device 1600, can extend through the coupling 1606 and can be inserted into the insertion conduit of the insertion device 1630.
  • the elongated instrument 1602 can be secured to an actuator 1612 that is movably coupled to a housing 1614.
  • the actuator 1612 can be moved alongthe housing 1614 between a proximal end 1610 and the distal end 1608 of the sampling device 1600 (which corresponds with proximal and distal ends of the housing 1614) to extend and retract the elongated instrument 1602 relative to the insertion device 1630.
  • Movement of the actuator 1612 along the housing 1614 in distal and proximal directions can cause the elongated instrument 1602 to be extended distally from a port at the distal end of the insertion device 1630 or retracted into the port, respectively.
  • Anti-buckling devices can be received within the housing 1614 to provide lateral support to the elongated instrument 1602 as the actuator 1612 moves the elongated instrument 1602 through the housing 1614.
  • the flexible lumened catheter of the elongated instrument 1602 can be secured to the actuator 1612 while the needle can be received into the flexible lumened catheter via the actuator 1612.
  • a proximal port 1616 can be configured to receive and secure an imaging probe such as, for example, a radial Endobronchial Ultrasound (EBUS) probe configured to generate real-time ultrasound images of tissue surrounding the distal end of the elongated instrument 1602.
  • EBUS radial Endobronchial Ultrasound
  • a needle inlet guide tube 1618 can be configured to receive and engage a needle actuator 1620 to which the sampling needle can be secured.
  • the needle inlet guide tube 1618 and the needle actuator 1620 can be movably coupled at an orientation interface 1622.
  • the orientation interface 1622 can be configured to maintain an orientation of the needle actuator 1620 relative to the needle inlet guide tube 1618 to control an orientation of the sampling needle, as further described below.
  • the needle actuator 1620 can removably receive an end cap 1624 that can be coupled with the stylet and used to releasably secure the stylet within the sampling needle.
  • the stylet can be used to prevent the sampling needle from collecting non-targeted tissue. For example, in a scenario in which the operator is targeting tissue several millimeters or centimeters beyond an airway wall, the operator can leave the stylet fully inserted in the sampling needle while the sampling needle is advance through non-target tissue.
  • the needle actuator also can include a release mechanism 1626 that an operator can positively engage to permit advancing the sampling needle into a sampling position, as also further described below.
  • FIG. 17 is a cutawayview of the port 1616 in the actuator 1612 of the sampling device 1600, according to at least one example of the present disclosure.
  • the sampling device 1600 can include an imaging probe 1648.
  • the proximal port 1616 of the actuator 1612 can be configured to receive the imaging probe 1648 and direct the imaging probe 1648 into a first lumen 1644 of a flexible lumened catheter 1640.
  • the flexible lumened catheter 1640 can include a proximal end 1642 that can be coupled to the actuator 1612.
  • the flexible lumened catheter 1640 can define a second lumen 1646 configured to receive a sampling needle 1650.
  • the second lumen 1646 of the flexible lumened catheter 1640 can extend into the first lumen 1644 and can be configured to keep the sampling needle 1650 away from the imaging probe 1648.
  • the flexible lumened catheter 1640 can define only a single lumen configured to receive the sampling needle 1650 and a distal end of the elongated instrument 1602, which can include an imaging element (e.g., linear ultrasound transducer) integrated into the distal tip thereof adjacent to a ramp (of a side exit port) that can be configured to direct the sampling needle 1650 into a field of view of the imaging element.
  • the sampling needle 1650 as further described below, can be coupled with and controlled by the needle actuator 1620.
  • the sampling needle 1650 can extend between a base 1652 (FIG. 16) and a tip 1654.
  • the sampling needle 1650 can also include a lumen 1651 .
  • the lumen 1651 can be used to extract a sample from the patient.
  • the needle actuator 1620 can be slidably mounted on the needle inlet guide tube 1618 (which can be also further described below).
  • the sampling needle 1650 can extend from the needle actuator 1620 through the needle inlet guide tube 1618 and into the second lumen 1646 of the flexible lumened catheter 1640, through which the sampling needle 1650 can be extended into a body to collect a sample.
  • the needle inlet guide tube 1618 can also be joined with the actuator 1612.
  • FIG. 18 illustrates a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 1800 that can be configured to control one or more aspects of the endoscopic system (e.g., the endoscopy system 100 (FIG. 1), the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG. 8), the ultrasonic sampling device 1000 (FIG. 10), the ultrasonic sampling device 1200 (FIG. 12), and the ultrasonic sampling device 1400 (FIG.
  • CDSS computer-based clinical decision support system
  • the CDSS 1800 can include an input interface 1802 through which medical information, such as, age, weight, sex, or any other information specific to a patient, or procedure-specific information, such as location of the anomaly, planned path for the procedure, planned steps of the procedure, orthe like, can be provided as input features to an artificial intelligence (Al) model 1804.
  • medical information such as, age, weight, sex, or any other information specific to a patient, or procedure-specific information, such as location of the anomaly, planned path for the procedure, planned steps of the procedure, orthe like, can be provided as input features to an artificial intelligence (Al) model 1804.
  • Al artificial intelligence
  • a processor 1806 e.g., the control unit 114 (FIG. 1 ) or the hardware processor 1902 (FIG. 19)
  • a processor 1806 can perform an inference operation in which the input from any one of the components of the endoscopic system, signals from any of the sensors, medical information, procedure-specific information, or the like, are applied to the Al model to generate a suggested medical procedure, automatically complete the medical procedure, of the like.
  • a user interface (Ul) can be used to communicate (with a clinician) the suggested medical procedure, proposed changes to the medical procedure, orthresholds instilled based at least in part on any of the inputs to the CDSS 1800.
  • the input interface 1802 can be a direct data link between the CDSS 1800 and one or more medical devices (e.g., the endoscopy system 100 (FIG. 1), the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG. 8), the ultrasonic sampling device 1000 (FIG. 10), the ultrasonic sampling device 1200 (FIG. 12), and the ultrasonic sampling device 1400 (FIG. 14), orthe like), that can generate at least some of the input features.
  • medical devices e.g., the endoscopy system 100 (FIG. 1), the sampling device 300 (FIG. 3), the ultrasonic sampling device 400 (FIG. 4), the ultrasonic sampling device 600 (FIG. 6), the ultrasonic sampling device 800 (FIG. 8), the ultrasonic sampling device 1000 (FIG. 10), the ultrasonic sampling device 1200 (FIG. 12), and the ultrasonic sampling device
  • the input interface 1802 can transmit input from any one of the components of the endoscopic system, medical information, procedure-specific information, or the like, directly to the CDSS 1800 during a therapeutic and/or diagnostic medical procedure.
  • the input interface 1802 can be a classical user interface that facilitates interaction between a user and the CDSS 1800.
  • the input interface 1802 can facilitate a user interface through which the user can manually enter medical information, procedure specific information, or the like.
  • the input interface 1802 can provide the CDSS 1800 with access to an electronic patient record from which one or more input features can be extracted. Such electronic patient records can be stored on a database 1801 .
  • the input interface 1802 can be configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 1800 is used to assess the safest and most efficient procedure to complete a planned medical procedure.
  • the processor 1806 can perform an inference operation using the Al model 1804 to generate the safest and most efficient medical procedure to perform the medical task.
  • input interface 1802 can deliver any of the medical information, medical procedure information, outputs from any one of the components of the endoscopic system, or signals from any of the sensors into an input layer of the Al model 1604 which propagates these input features through the Al model 1804 to an output layer.
  • the Al model 1804 can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data.
  • the Al model 1804 explores the study and construction of algorithms (e.g., machine-learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.
  • ML machine learning
  • Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs.
  • the goal of supervised ML is to learn a function that, given training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs.
  • Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled and allowingthe algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.
  • supervised ML Common tasks for supervised ML are classification problems and regression problems.
  • Classification problems also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?).
  • Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input).
  • Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM).
  • LR Logistic Regression
  • RF Random Forest
  • N neural networks
  • DNN deep neural networks
  • SVM Support Vector Machines
  • Some common tasks for unsupervised ML include clustering, representation learning, and density estimation.
  • Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and autoencoders.
  • federated learning also known as collaborative learning
  • This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed.
  • Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address issues such as data privacy, data security, data access rights and access to heterogeneous data.
  • the Al model can be trained continuously or periodically prior to performance of the inference operation by the processor 1806. Then, during the inference operation, the patient specific input features provided to the Al model can be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the suggested medical procedure.
  • the processor 1806 can suggest a smaller version of the endoscope, suggest a different path that can improve imaging and sampling efforts, or implement thresholds for energy, speed, ortechniques used for any cutting, ablation, removal procedures, or any other parameters of the sampling device .
  • the output interface 1808 can transmit any of the safest and most efficient medical procedure can be communicated to the user via the user interface (Ul) and/or automatically cause any component of the endoscopic system for performing a desired action.
  • the processor 1806 can transmit a signal to the light source 120 to alter the brightness, color, saturation, or any other light parameter, of the light transmitted, send a controlling signal to the fluid source 122 (FIG. 1 ) to change a fluid supplied to the suction pump 124 (FIG. 1 ), send a signal to the suction pump 124 to alter a velocity or volume of fluid supplied to the imaging site, send a signal to the suction pump 124 to increase or decrease an amount of suction provided to the imaging site.
  • These are exemplary actions that can be taken by the CDSS 1800 to aid in the instruction and procedure of the medical procedure.
  • the inventors of the present application have contemplated how the CDSS 1800 can help with any aspect of the medical procedure, such as, planning preoperatively, performing intraoperatively, or analyzing the procedure postoperatively, or the like.
  • FIG. 19 illustrates a block diagram of an example machine 1900 upon which any one or more of the techniques (e.g., methodologies) discussed herein can perform.
  • Examples, as described herein, can include, or can operate by, logic or a number of components, or mechanisms in the machine 1900.
  • Circuitry e.g., processing circuitry
  • Circuitry membership can be flexible over time. Circuitries include members that may, alone or in combination, perform specified operations when operating.
  • hardware of the circuitry can be immutably designed to carry out a specific operation (e.g., hardwired).
  • the hardware of the circuitry can include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a machine readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation.
  • a machine readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation.
  • the instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation.
  • the machine readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating.
  • any of the physical components can be used in more than one member of more than one circuitry.
  • execution units can be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 1900 follow.
  • the machine 1900 can operate as a standalone device or can be connected (e.g., networked) to other machines. In a networked deployment, the machine 1900 can operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1900 can act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment.
  • the machine 1900 can be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine.
  • machine shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.
  • cloud computing software as a service
  • SaaS software as a service
  • the machine 1900 can include a hardware processor 1902 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1904, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1906, and mass storage 1908 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which can communicate with each othervia an interlink (e.g., bus) 1930.
  • a hardware processor 1902 e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof
  • main memory 1904 e.g., a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1906
  • the machine 1900 can further include a display unit 1910, an alphanumeric input device 1912 (e.g., a keyboard), and a user interface (Ul) navigation device 1914 (e.g., a mouse).
  • the display unit 1910, input device 1912 and Ul navigation device 1914 can be a touch screen display.
  • the machine 1900 can additionally include a storage device (e.g., drive unit) 1908, a signal generation device 1918 (e.g., a speaker), a network interface device 1920, and one or more sensors 1916, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor.
  • GPS global positioning system
  • the machine 1900 can include an output controller 1928, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
  • a serial e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
  • USB universal serial bus
  • IR infrared
  • NFC near field communication
  • Registers of the processor 1902, the main memory 1904, the static memory 1906, or the mass storage 1908 can be, or include, a machine readable medium 1922 on which is stored one or more sets of data structures or instructions 1924 (e.g., software) embodying or utilized by any one or more of the techniques orfunctions described herein.
  • the instructions 1924 can also reside, completely or at least partially, within any of registers of the processor 1902, the main memory 1904, the static memory 1906, or the mass storage 1908 during execution thereof by the machine 1900.
  • one or any combination of the hardware processor 1902, the main memory 1904, the static memory 1906, or the mass storage 1908 can constitute the machine readable media 1922.
  • machine readable medium 1922 is illustrated as a single medium, the term “machine readable medium” can include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) configured to store the one or more instructions 1924.
  • the term “machine readable medium” can include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1900 and that cause the machine 1900 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions.
  • Non-limiting machine readable medium examples can include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon based signals, sound signals, etc.).
  • a non-transitory machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine readable media that do not include transitory propagating signals.
  • non-transitory machine readable media can include: nonvolatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magnetooptical disks; and CD-ROM and DVD-ROM disks.
  • nonvolatile memory such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices
  • EPROM Electrically Programmable Read-Only Memory
  • EEPROM Electrically Erasable Programmable Read-Only Memory
  • flash memory devices e.g., electrically Erasable Programmable Read-Only Memory (EEPROM)
  • EPROM Electrically Programmable Read-Only Memory
  • EEPROM Electrically Erasable Programmable Read-Only Memory
  • flash memory devices e.g., electrically
  • information stored or otherwise provided on the machine readable medium 1922 can be representative of the instructions 1924, such as instructions 1924 themselves or a format from which the instructions 1924 can be derived.
  • This format from which the instructions 1924 can be derived can include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), orthe like.
  • the information representative of the instructions 1924 in the machine readable medium 1922 can be processed by processing circuitry into the instructions to implement any of the operations discussed herein.
  • the instructions 1924 can be further transmitted or received over a communications network 1926 using a transmission medium via the network interface device 1920 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.).
  • transfer protocols e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.
  • Example communication networks can include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa/LoRaWAN, or satellite communication networks, mobile telephone networks (e.g., cellular networks such as those complying with 3G, 4G LTE/LTE-A, or 5G standards), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 502.11 family of standards known as Wi-Fi®, IEEE 502.15.4 family of standards, peer-to-peer (P2P) networks, among others.
  • LAN local area network
  • WAN wide area network
  • a packet data network e.g., the Internet
  • LoRa/LoRaWAN e.g., the Internet
  • LoRa/LoRaWAN e.g., the Internet
  • LoRa/LoRaWAN e.g., the Internet
  • LoRa/LoRaWAN e.
  • the network interface device 1920 can include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1926.
  • the network interface device 1920 can include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input singleoutput (MISO) techniques.
  • SIMO single-input multiple-output
  • MIMO multiple-input multiple-output
  • MISO multiple-input singleoutput
  • transmission medium shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1900, and can include digital or analog communications signals or other intangible medium to facilitate communication of such software.
  • a transmission medium is a machine-readable medium.
  • Example 2 the subject matter of Example 1 optionally includes wherein the housing comprises a slot opposite the mount feature, and wherein the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force moves the force-generating wire between an extended configuration and a retracted configuration.
  • the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force moves the force-generating wire between an extended configuration and a retracted configuration.
  • Example 3 the subject matter of Example 2 optionally includes wherein in the extended configuration, the force-generating wire extends through the slot of the housing to contact the inner walls defining the lumen of the patient and mitigate air gaps between the inner walls and the ultrasonic sampling device, and wherein in the retracted configuration, the force-generating wire is within the housing.
  • Example 4 the subject matter of any one or more of Examples 1-3 optionally include wherein the housing comprises a channel opposite the mount feature, and wherein the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the extended position, the distal portion of the curling wire bends such that a portion of the curling wire proximal a distal tip of the curling wire contacts the inner walls, the proximal section configured to receive an axial force to move the curling wire between the extended position and the retracted position.
  • the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the extended position
  • Example 5 the subject matter of Example 4 optionally includes wherein in the extended position, the curling wire extends through the channel of the housing to contact the inner walls and mitigate air gaps between the lumen and the transducer, and wherein in the retracted position, the curling wire is within the housing adjacent the channel.
  • Example 6 the subject matter of any one or more of Examples 4-5 optionally include wherein the distal tip of the curling wire comprises a contact feature, the contact feature configured to increase a surface area of the distal tip to decrease a pressure resulting from the distal tip engaging the innerwalls.
  • Example 7 the subject matter of any one or more of Examples 1-6 optionally include wherein the force-generating system comprises: a suction system configured to generate a suction force against a portion of the innerwalls to drawthe innerwalls and the transducer together.
  • the force-generating system comprises: a suction system configured to generate a suction force against a portion of the innerwalls to drawthe innerwalls and the transducer together.
  • Example 8 the subject matter of Example 7 optionally includes wherein the suction system comprises an inlet surrounding a periphery of the mount feature such that the inlet extends above the transducer when the transducer is installed within the mount feature, the inlet introduces the suction force to the lumen to drawthe innerwalls and the transducer together.
  • the suction system comprises an inlet surrounding a periphery of the mount feature such that the inlet extends above the transducer when the transducer is installed within the mount feature, the inlet introduces the suction force to the lumen to drawthe innerwalls and the transducer together.
  • Example 9 the subject matter of any one or more of Examples 7-8 optionally include wherein the suction system comprises a plurality of suction ports formed in the housing surrounding the mount feature, the plurality of suction ports introduces the suction force to the lumen to draw the innerwalls and the transducer together.
  • the suction system comprises a plurality of suction ports formed in the housing surrounding the mount feature, the plurality of suction ports introduces the suction force to the lumen to draw the innerwalls and the transducer together.
  • Example 10 the subject matter of any one or more of Examples 1-9 optionally include wherein the housing comprises an airbag slot opposite the mount feature, and wherein the force-generating system comprises: an airbag fluidically connected to a pump, the pump operable to inflate and deflate the airbag such that as the pump inflates the airbag, the airbag extends through the airbag slot to contact the innerwalls and mitigate air gaps between the innerwalls and the transducer, and as the airbag deflates, the airbag retracts toward the airbag slot.
  • the force-generating system comprises: an airbag fluidically connected to a pump, the pump operable to inflate and deflate the airbag such that as the pump inflates the airbag, the airbag extends through the airbag slot to contact the innerwalls and mitigate air gaps between the innerwalls and the transducer, and as the airbag deflates, the airbag retracts toward the airbag slot.
  • Example 11 the subject matter of any one or more of Examples 1-10 optionally include wherein the housing includes a linear slot opposite the mount feature, and wherein the force-generating system comprises: a flexible member extending between a proximal portion and a distal portion, the proximal portion of the flexible member fixedly attached to the housing; and an actuation wire attached to the distal portion of the flexible member such that adding tension to the actuation wire translates the distal portion of the flexible member toward the proximal portion of the flexible member.
  • Example 13 the subject matter of Example 12 optionally includes wherein the flexible member includes shape memory such that when the tension from the actuation wire is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member and the flexible member retracts backthrough the linear slot and into the housing.
  • Example 14 is a system for taking ultrasonic images of intraluminal tissue of a patient, the intraluminal tissue defines a lumen, the system comprising: a control handle; an insertion tube extendingfrom the control handle and configured for insertion within the lumen, the insertion tube including a working lumen; and an ultrasonic sampling device configured to be inserted within the working lumen such that the ultrasonic sampling device can be extended beyond a distal tip of the insertion tube and into the lumen, the ultrasonic sampling device including: a coupler extendingfrom a proximal portion to a distal portion, the coupler including: a side-exit ramp extending within the coupler from the proximal portion and through a side of the coupler, the side-exit ramp directs an instrument through the side of the coupler and toward the intraluminal tissue; and a housing extending along a central axis from a proximal section to a distal section, the housing including: a mount feature configured to receive a transduc
  • Example 15 the subject matter of Example 14 optionally includes wherein the housing comprises a slot opposite the mount feature, and wherein the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force operates the force-generating wire between an extended configuration and a retracted configuration.
  • the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force operates the force-generating wire between an extended configuration and a retracted configuration.
  • Example 16 the subject matter of Example 15 optionally includes wherein in the extended configuration, the force-generating wire extends through the slot of the housingto contact the intraluminal tissue and mitigate air gaps between the intraluminal tissue and the transducer, and wherein in the retracted configuration, the force-generating wire is within the housing.
  • Example 17 the subject matter of any one or more of Examples 14-16 optionally include wherein the housing comprises a channel opposite the mount feature, and wherein the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the extended position, the distal portion of the curling wire bends such that a portion of the curling wire proximal a distal tip of the curling wire contacts the intraluminal tissue, the proximal section configured to receive an axial force to operate the curling wire between the extended position and the retracted position.
  • the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the
  • Example 18 the subject matter of Example 17 optionally includes wherein in the extended position, the curling wire extends through the channel of the housingto contact the intraluminal tissue and mitigates air gaps between the intraluminal tissue and the transducer, and wherein in the retracted position, the curling wire is within the housing adjacent the channel.
  • Example 19 the subject matter of any one or more of Examples 17-18 optionally include wherein the distal tip of the curling wire comprises a contact feature, the contact feature configured to increase a surface area of the distal tip to decrease a pressure resulting from the distal tip engaging the intraluminal tissue.
  • Example 20 the subject matter of any one or more of Examples 14-19 optionally include wherein the force-generating system comprises: a suction system configured to generate a suction force against a portion of the intraluminal tissue to drawthe intraluminal tissue and the transducertogether and mitigate air gaps between the intraluminal tissue and the transducer.
  • the force-generating system comprises: a suction system configured to generate a suction force against a portion of the intraluminal tissue to drawthe intraluminal tissue and the transducertogether and mitigate air gaps between the intraluminal tissue and the transducer.
  • Example 21 is an intraluminal ultrasound device configured to be inserted within inner walls defining a lumen of a patient, the intraluminal ultrasound device comprising: a housing extending along a central axis from a proximal section to a distal section, the housing including: a transducer configured to capture ultrasonic images; a mount feature configured to receive the transducer; and a force-generating system operable to maintain contact between the inner walls and the transducer to mitigate air gaps between the lumen and the transducer.
  • Example 22 the subject matter of Example 21 optionally includes wherein the housing comprises a slot opposite the mount feature, and wherein the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force moves the force-generating wire between an extended configuration and a retracted configuration.
  • the force-generating system comprises: a force-generating wire extending between a distal section and a proximal section, the distal section of the force-generating wire attached to the distal section of the housing, the proximal section of the force-generating wire configured to receive an axial force, the axial force moves the force-generating wire between an extended configuration and a retracted configuration.
  • Example 23 the subject matter of Example 22 optionally includes wherein in the extended configuration, the force-generating wire extends through the slot of the housing to contact the inner walls defining the lumen of the patient and mitigate air gaps between the inner walls and the intraluminal ultrasound device, and wherein in the retracted configuration, the force-generating wire is within the housing.
  • Example 24 the subject matter of any one or more of Examples 21-23 optionally include wherein the housing comprises a channel opposite the mount feature, and wherein the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the extended position, a distal portion of the curling wire bends such that a portion of the curling wire proximal a distal tip of the curling wire contacts the inner walls, the proximal section configured to receive an axial force to move the curling wire between the extended position and the retracted position.
  • the force-generating system comprises: a curling wire operable between an extended position and a retracted position, the curling wire extending between a distal section and a proximal section, the distal section of the curling wire including a shape memory finish such that as the curling wire is in the
  • Example 25 the subject matter of Example 24 optionally includes wherein in the extended position, the curling wire extends through the channel of the housing to contact the inner walls and mitigate air gaps between the lumen and the transducer, and wherein in the retracted position, the curling wire is within the housing adjacent the channel.
  • Example 26 the subject matter of any one or more of Examples 24-25 optionally include wherein the distal tip of the curling wire comprises a contact feature, the contact feature configured to increase a surface area of the distal tip to decrease a pressure resulting from the distal tip engaging the innerwalls.
  • Example 27 the subject matter of any one or more of Examples 21-26 optionally include wherein the force-generating system comprises: a suction system configured to generate a suction force against a portion of the innerwalls to drawthe innerwalls and the transducer together.
  • the force-generating system comprises: a suction system configured to generate a suction force against a portion of the innerwalls to drawthe innerwalls and the transducer together.
  • Example 28 the subject matter of Example 27 optionally includes wherein the suction system comprises an inlet surrounding a periphery of the mount feature such that the inlet extends above the transducer when the transducer is installed within the mount feature, the inlet introduces the suction force to the lumen to drawthe inner walls and the transducer together.
  • the suction system comprises an inlet surrounding a periphery of the mount feature such that the inlet extends above the transducer when the transducer is installed within the mount feature, the inlet introduces the suction force to the lumen to drawthe inner walls and the transducer together.
  • Example 29 the subject matter of any one or more of Examples 27-28 optionally include wherein the suction system comprises a plurality of suction ports formed in the housing surrounding the mount feature, the plurality of suction ports introduces the suction force to the lumen to draw the inner walls and the transducer together.
  • the suction system comprises a plurality of suction ports formed in the housing surrounding the mount feature, the plurality of suction ports introduces the suction force to the lumen to draw the inner walls and the transducer together.
  • Example 30 the subject matter of any one or more of Examples 21-29 optionally include wherein the housing comprises an airbag slot opposite the mount feature, and wherein the force-generating system comprises: an airbag fluidically connected to a pump, the pump operable to inflate and deflate the airbag such that as the pump inflates the airbag, the airbag extends through the airbag slot to contact the inner walls and mitigate air gaps between the inner walls and the transducer, and as the airbag deflates, the airbag retracts toward the airbag slot.
  • the force-generating system comprises: an airbag fluidically connected to a pump, the pump operable to inflate and deflate the airbag such that as the pump inflates the airbag, the airbag extends through the airbag slot to contact the inner walls and mitigate air gaps between the inner walls and the transducer, and as the airbag deflates, the airbag retracts toward the airbag slot.
  • Example 31 the subject matter of any one or more of Examples 21-30 optionally include wherein the housing includes a linear slot opposite the mount feature, and wherein the force-generating system comprises: a flexible member extending between a proximal portion and a distal portion, the proximal portion of the flexible member fixedly attached to the housing; and an actuation wire attached to the distal portion of the flexible member such that adding tension to the actuation wire translates the distal portion of the flexible member toward the proximal portion of the flexible member.
  • Example 32 the subject matter of Example 31 optionally includes wherein when the actuation wire translates the distal portion of the flexible member toward the proximal portion of the flexible member the flexible member bends and extends through the linear slot of the housingto contact the inner walls to move the transducer and the inner walls together and mitigate air gaps between the inner walls and the transducer.
  • the subject matter of Example 32 optionally includes wherein the flexible member includes shape memory such that when the tension from the actuation wire is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member and the flexible member retracts backthrough the linear slot and into the housing.
  • Example 34 is a device, method, or apparatus including any element of any of Examples 1-33.
  • the term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and belowthe numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%.
  • Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1 -1 .5, 1 .5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1 -4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”
  • the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination.
  • the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
  • a reconditioning facility or by a surgical team immediately prior to a surgical procedure.
  • reassembly Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • the invention described herein will be processed before surgery.
  • a new or used instrument is obtained and, if necessary, cleaned.
  • the instrument can then be sterilized.
  • the instrument is placed in a closed and sealed container, such as a plastic orTYVEK® bag.
  • the container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons.
  • the radiation kills bacteria on the instrument and in the container.
  • the sterilized instrument can then be stored in the sterile container.
  • the sealed container keeps the instrument sterile until it is opened in the medical facility.
  • the device can also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

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Abstract

L'invention concerne un dispositif à ultrasons intraluminal conçu pour être inséré à l'intérieur de parois internes délimitant une lumière d'un patient, pouvant comprendre un boîtier s'étendant le long d'un axe central d'une section proximale à une section distale. Le boîtier peut comprendre un transducteur conçu pour capturer des images ultrasonores et un élément de montage conçu pour recevoir le transducteur. Le dispositif à ultrasons intraluminal peut également comprendre un système de production de force utilisable pour maintenir un contact entre les parois internes et le transducteur pour réduire les espaces d'air entre la lumière et le transducteur.
PCT/US2024/052598 2023-10-31 2024-10-23 Systèmes pour le maintien d'un contact ultrasonore avec un tissu intraluminal Pending WO2025096257A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10162234A1 (de) * 2000-12-19 2002-06-27 Ge Med Sys Global Tech Co Llc Transösophageale Ultraschallsonde mit erweiterbarem Abtastkopf
US20030004439A1 (en) * 1999-02-02 2003-01-02 Transurgical, Inc. Intrabody HIFU applicator
US20070093880A1 (en) * 2005-10-06 2007-04-26 Boston Scientific Scimed, Inc. Adjustable profile probe
US20080039746A1 (en) * 2006-05-25 2008-02-14 Medtronic, Inc. Methods of using high intensity focused ultrasound to form an ablated tissue area containing a plurality of lesions
US20170049415A1 (en) * 2014-10-28 2017-02-23 Olympus Corporation Ultrasound endoscope, suction apparatus for ultrasound endoscope, and ultrasound endoscope system
US20230075251A1 (en) * 2020-06-02 2023-03-09 Noah Medical Corporation Systems and methods for a triple imaging hybrid probe

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030004439A1 (en) * 1999-02-02 2003-01-02 Transurgical, Inc. Intrabody HIFU applicator
DE10162234A1 (de) * 2000-12-19 2002-06-27 Ge Med Sys Global Tech Co Llc Transösophageale Ultraschallsonde mit erweiterbarem Abtastkopf
US20070093880A1 (en) * 2005-10-06 2007-04-26 Boston Scientific Scimed, Inc. Adjustable profile probe
US20080039746A1 (en) * 2006-05-25 2008-02-14 Medtronic, Inc. Methods of using high intensity focused ultrasound to form an ablated tissue area containing a plurality of lesions
US20170049415A1 (en) * 2014-10-28 2017-02-23 Olympus Corporation Ultrasound endoscope, suction apparatus for ultrasound endoscope, and ultrasound endoscope system
US20230075251A1 (en) * 2020-06-02 2023-03-09 Noah Medical Corporation Systems and methods for a triple imaging hybrid probe

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