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WO2025019208A1 - Système pour confirmer un emplacement de gaine à l'intérieur d'une lumière - Google Patents

Système pour confirmer un emplacement de gaine à l'intérieur d'une lumière Download PDF

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Publication number
WO2025019208A1
WO2025019208A1 PCT/US2024/037180 US2024037180W WO2025019208A1 WO 2025019208 A1 WO2025019208 A1 WO 2025019208A1 US 2024037180 W US2024037180 W US 2024037180W WO 2025019208 A1 WO2025019208 A1 WO 2025019208A1
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WO
WIPO (PCT)
Prior art keywords
protective sheath
sampling device
sampling
lumen
distal
Prior art date
Application number
PCT/US2024/037180
Other languages
English (en)
Inventor
Christopher Lee
Ron GLANDON
Original Assignee
Veran Medical Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Veran Medical Technologies, Inc. filed Critical Veran Medical Technologies, Inc.
Publication of WO2025019208A1 publication Critical patent/WO2025019208A1/fr

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Classifications

    • 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
    • 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
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Definitions

  • sampling devices such as, for example, sampling devices including a system to confirm a location of a protective sheath within a lumen.
  • 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
  • Sampling devices can be endoscopes used for 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, within the lungs of a patient.
  • Sampling devices can be used to discover, treat, and sample abnormalities or anomalies within the lungs.
  • Sampling devices can be used to capture samples or biopsies of portions of tissue from within the airways or the lungs of a patient.
  • Intraluminal sampling devices can include an exit port through which a biopsy sampling needle can be extended into targeted tissue for which a biopsy sample is desired.
  • the endobronchial ultrasound (EBUS) sampling device can include a side-exit port through which a flexible biopsy needle can be extended to perform transbronchial needle aspiration (TBNA).
  • TBNA transbronchial needle aspiration
  • a clinician will typically extend a needle sheath at least partially out of the exit port prior to extending a biopsy needle that resides within the needle sheath from the distal end of the needle sheath.
  • EBUS devices include a ramp element that connects a needle lumen running the entire length of a flexible EBUS sheath to a side exit port.
  • a ramp element can be constructed of a plastic material and can be configured to deflect the biopsy needle away from the longitudinal axis of the EBUS device.
  • an attempt by the operating clinician to extend the extremely sharp distal tip of the biopsy needle, sampling device, cutting device, any other medical device or the like, directly out of the ramp element without a needle sheath enshrouding the biopsy needle can result in the distal tip of the needle piercing or otherwise damaging the ramp element of the EBUS device or damage to the medical device. Therefore, the inventors of the present disclosure have created an EBUS sampling device that includes a system to detect a position of a protective sheath within a lumen to verify it is okay to extend the sampling needle, or other medical devices, from a distal tip of the protective sheath and into the tissue of the patient.
  • a sampling device can include an elongated body, a medical instrument, and a sensor.
  • the elongated body can extend longitudinally between a proximal section and a distal section and define a lumen.
  • the medical instrument can be insertable into the elongated body. At least a portion of the medical instrument can be configured to be inserted into the lumen.
  • the medical instrument can include a protective sheath and a sampling portion.
  • the protective sheath can extend longitudinally between a proximal portion and a distal portion and define a working lumen.
  • the sampling portion can be slidingly installed within the working lumen and can be extendable relative to the protective sheath such that the sampling portion can be retracted within the protective sheath and extended distally from the protective sheath.
  • the sensor can be configured to generate a signal indicating that the protective sheath is adjacent an outlet of the lumen.
  • FIG. 1 illustrates a schematic diagram of an example of an endobronchial ultrasound system.
  • FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of an endobronchial ultrasound sampling device.
  • FIG. 3 illustrates a perspective view of a portion of an example distal tip of a sampling device having ultrasound imaging capabilities.
  • FIG. 4 illustrates a perspective view of a portion of an example distal tip of a sampling device having a sampling instrument within a protective sheath and within a working lumen of an elongated member.
  • FIG. 5 illustrates a perspective view of a portion of an example distal tip of a sampling device having a protective sheath adjacent an exit of a working lumen of an elongated member.
  • FIG. 6 illustrates a perspective view of a portion of an example distal tip of a sampling device having a protective sheath adjacent an exit of a working lumen of an elongated member and a sampling device extending from the protective sheath.
  • FIG. 7 illustrates a perspective view of a portion of an example distal tip of a sampling device having a protective sheath adjacent to an exit of a working lumen of an elongated member.
  • FIG. 8 illustrates a perspective view of a portion of an example distal tip of a sampling device having a protective sheath adjacent to an exit of a working lumen of an elongated member.
  • FIG. 9 illustrates a graphical representation of an example graphical user interface of an example of an endobronchial ultrasound system.
  • FIG. 10 is a block diagram illustrating an example of a method for reprocessing a sampling device.
  • FIG. 11 is a block diagram illustrating an example of a machine upon which one or more examples may be implemented.
  • Endobronchial ultrasound (EBUS) sampling devices can be used to sense ultrasound images at a distal tip of the sampling device.
  • the distal tip can also include an imaging sensor (e.g., video camera, light source, or the like), a working channel exit for instruments (e.g., biopsy needle, scalpel, or the like), and in more recent advancements, position or orientation sensors.
  • Imaging sensor e.g., video camera, light source, or the like
  • instruments e.g., biopsy needle, scalpel, or the like
  • Existing EBUS sampling devices can utilize a rigid distal tip structure to house these components.
  • the electronics can be arranged in a distal tip of the distal tip such that the ultrasound sensor (e.g., transducer) is disposed at the distal end of the distal tip.
  • the rest of the components within the distal tip can be disposed proximate to the distal tip.
  • Existing techniques for extending a biopsy needle from the exit port of intraluminal sampling devices includes first extending the needle sheath into a field of view of an imaging device such as a camera of an endoscope or ultrasound transducer. Then, once the extension of the needle sheath has been visually confirmed in a real-time image stream, the clinician will then advance the biopsy needle from the needle sheath into the target tissue.
  • an imaging device such as a camera of an endoscope or ultrasound transducer.
  • the clinician will then advance the biopsy needle from the needle sheath into the target tissue.
  • One drawback of this approach is that, depending on the configuration of the device (e.g., imaging device location relative to the exit port), the extension of the needle sheath into a field of view of the imaging device may require substantial extension from the device resulting in the needle sheath contacting a tissue wall.
  • an EBUS sampling device that includes a system to detect a position of a protective sheath within a lumen to verify it is okay to extend the sampling needle, or other medical devices, from a distal tip of the protective sheath and into the tissue of the patient.
  • the EBUS sampling device will be discussed herein with reference to FIGS. 1-10.
  • FIG. 1 is a schematic diagram of an endoscopy system 100 that can include an imaging and control system 102 and an endobronchial ultrasound sampling arrangement including an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and which includes a distal end 144 that extends from the distal end of the endoscope 104 via a distal working channel port.
  • the system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.
  • the endoscope 104 can be insertable into an anatomical region for imaging or attachment to (e.g., via tethering) one or more sampling devices for biopsies or therapeutic devices for treating a disease state associated with the anatomical region.
  • the endoscope 104 can interface or connect to the imaging and control system 102.
  • the endoscope 104 is described in the present example as a bronchoscope, though other types of endoscopes are contemplated for use with the features and teachings of the present disclosure.
  • the imaging and control system 102 can include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and a suction pump 116.
  • the imaging and control system 102 can include various ports for coupling with the endoscopy system 100.
  • the control unit 106 can include a data input/output port for receiving data from and communicating data to the endoscope 104.
  • the light source 112 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link.
  • the fluid source 114 can include a port for transmitting fluid to the endoscope 104.
  • the fluid source 114 can include, for example, a pump and a fluid tank or can be connected to an external tank, vessel, or storage unit.
  • the suction pump 116 can include a port to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted.
  • the display unit 108 and the input unit 110 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and view the output of the endoscope 104.
  • the control unit 106 can also generate signals or other outputs from treating the anatomical region into which the endoscope 104 is inserted. In examples, the control unit 106 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.
  • the endoscope 104 can include an insertion section 118, a functional section 120, and a handle section 122, which can be coupled to a cable section 124 and a coupler section 126.
  • the insertion section 118 can extend distally from the handle section 122, and the cable section 124 can extend proximally from the handle section 122.
  • the insertion section 118 can be elongated and include a bending section and a distal end to which the functional section 120 can be attached.
  • the bending section can be controllable (e.g., by a steering control 128 on the handle section 122) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like).
  • the insertion section 118 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools of the functional section 120, such as a bronchoscope.
  • the working channel can extend between the handle section 122 and the functional section 120. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 118 (e.g., via suction or irrigation passageways, or the like).
  • a coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.
  • the handle section 122 can include the steering control 128 and the port 130.
  • the steering control 128 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 104 within the patient.
  • the steering control 128 can be connected to a pull wire or other actuation mechanisms, extending through the insertion section 118.
  • the port 130, as well as other ports, such as a port 132 can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 122, such as for coupling with the insertion section 118.
  • the examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.
  • the imaging and control system 102 can be provided on a mobile platform (e.g., a cart 134) with shelves for housing the light source 112, the suction pump 116, an image processing unit 202 (FIG. 2), or the like.
  • a mobile platform e.g., a cart 134 with shelves for housing the light source 112, the suction pump 116, an image processing unit 202 (FIG. 2), or the like.
  • components of the imaging and control system 102, shown in FIG. 1 and FIG. 2 can be provided directly on the endoscope 104 to make the endoscope “self-contained.”
  • the functional section 120 can include components for treating and diagnosing the anatomy of a patient.
  • the functional section 120 can include an imaging device 146 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensors), an illumination device 148 (e.g., a light emitting diode), and a working channel port 150 at a distal face of the functional section 120.
  • CMOS complementary metal oxide semiconductor
  • illumination device 148 e.g., a light emitting diode
  • working channel port 150 at a distal face of the functional section 120.
  • a sampling device 136 can extend from the working channel port 150 at the distal face of the functional section 120 of the endoscope 104.
  • the sampling device 136 can be configured to be attached to the port 132 such that the sampling device 136 extends through a working channel of the endoscope 104 and out the distal end of the endoscope 104.
  • the sampling device 136 can include an actuator 138 for advancing or retracting the insertion section 118 within the working channel so as to control how far distally from the working channel port 150 the distal end of the sampling device 136 extends, an instrument actuator 142 (e.g., for actuating a biopsy needle from a side exit port of the sampling device 136), and a distal end 144.
  • the actuator 138 can be configured to extend the sampling device 136 beyond a distal end of the endoscope 104, such as to navigate the sampling device 136 to the target area within the patient.
  • the actuator can slide along a housing 140 of the sampling device 136.
  • the housing 140 can include indicia, which can indicate an amount of extension of the sampling device 136 beyond a distal end of the endoscope 104.
  • the instrument actuator 142 can be configured to extend an instrument from the sampling device 136 to obtain a tissue sample from the patient.
  • a distal end 144 of the sampling device 136 can include a transducer (or other imaging device) and a side exit port located proximal from the transducer for directing an instrument configured to obtain a tissue sample from the patient into the field of view of the transducer.
  • the sampling device 136 will be discussed in more detail herein.
  • FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 including the imaging and control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope and a sampling device 136 extendable via a distal working channel port of the endoscope.
  • FIG. 2 schematically illustrates components of the imaging and control system 102 coupled to the endoscope 104.
  • the imaging and control system 102 can include the control unit 106, which can include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208, as well as the light source 112, the input unit 110, and the display unit 108.
  • the control unit 106 can include, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) can view target tissue via the inclusion of optically enhanced materials and components.
  • imaging equipment e.g., a camera
  • the control unit 106 can be configured to activate a camera to view target tissues distal of the endoscopy system.
  • control unit 106 can be configured to activate the light source 112 to shine a light on the surgical instrument, which can include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.
  • the coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the image processing unit 202, the treatment generator 206, or the like.
  • the port 130 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 106 via the cable section 124.
  • the port 132 can be used to connect the coupler section 126 to various inputs and outputs, such as video, air, light and electric.
  • the image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can each interface with the endoscope 104 (e.g., at the functional section 120) or the sampling device 136 by wired or wireless electrical connections.
  • the imaging and 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 108.
  • the ultrasound image processing unit 204 can be configured to receive ultrasonic signals from either of the endoscope 104 or the sampling device 136, which can be converted into ultrasonic images and transmitted to the display unit 108 or any other component of the endoscopy system 100.
  • the imaging and control system 102 can include the light source 112 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like).
  • the imaging and 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 114 (shown in FIG. 1) can be in communication with control unit 106 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 imaging and control system 102 can also include a drive unit 208, which can include a motorized drive for advancing a distal section of endoscope 104.
  • FIG. 3 illustrates a perspective view of a portion of an example distal tip 302 of a sampling device 300.
  • the sampling device 300 e.g., the sampling device 136 shown in FIGS. 1 and 2
  • EBUS endobronchial ultrasound
  • the sampling device 300 can be an EBUS sampling device that facilitates performance of real-time ultrasound imaging of a target tissue such as, for example, a solitary pulmonary nodule (SPN) while a procedure is being performed on the target tissue.
  • a target tissue such as, for example, a solitary pulmonary nodule (SPN)
  • SPN solitary pulmonary nodule
  • Exemplary such procedures include obtaining biopsy samples of the target tissue (e.g., for removal and pathology analysis), performing ablation on the target tissue, injecting medicine into the target tissue, and so on.
  • the distal tip 302 can be connected to the insertion section 28 (FIG. 1 and 2) of the sampling device 300 to be inserted within the lungs of the patient.
  • the distal tip 302 can be connected to the insertion section 28 by a rigid connection that helps maintain the distal tip 302 in the direction that the insertion section 28 is being steered within the patient.
  • the distal tip 302 can also be attached to the insertion section 28 by a rotatable connection (which can rotate about one or more axes) that enables a medical professional to influence further or steer the distal tip 302 as it extends into the patient.
  • the distal tip 302 can perform tasks during the bronchoscopy procedure.
  • the distal tip 302 can capture images (e.g., digital images, ultrasound images, or the like) of the lungs of the patient, capture samples (e.g., using a biopsy needle extending from any of the components of the distal tip 302), or remove one or more objects (e.g., using scalpels, forceps, or the like).
  • the distal tip 302 can include a coupler 304 and a housing 312.
  • the coupler 304 can extend along a longitudinal axis LA from a proximal portion 306 to a distal portion 308.
  • the distal portion 308 of the coupler 304 can be coupled to the proximal section 314 of the housing 312.
  • the coupler 304 can include a lumen 309 and a side-exit ramp 310.
  • the lumen 309 and the side-exit ramp 310 can extend within the coupler.
  • the lumen 309 can extend from the proximal portion 306 to the side-exit ramp 310, and the side-exit ramp 310 can extend from the lumen 309 through a side of the coupler 304.
  • the lumen 309 can be substantially circular and can mate with a flexible needle lumen embedded within a flexible sheath of the EBUS endoscope.
  • an instrument e.g., a biopsy (or sampling) needle, scalpel, forceps, a laser cut TBNA needle, an ablation device, or the like
  • the side-exit ramp 310 can be configured to direct the instrument 311 through the side of the coupler 304 and toward a tissue of a patient.
  • the housing 312 can extend along a central axis CA from a proximal section 314 to a distal section 316.
  • the housing 312 can include a mount feature 318, which can be configured to receive a transducer 320.
  • the mount feature 318 can be tapered toward, to, or past, the central axis CA as the housing 312 extends from the proximal section 314 toward the distal section 316.
  • the mount feature 318 can converge toward the central axis CA near the distal-most tip of the distal section 316 and this convergent nature of the mount feature 318 can result in the transducer 320 leaning forward the distal-most tip of the distal section 316.
  • the taper of the mount feature 318 can shift forward a distal most boundary of a field of view 322 of the transducer such that the field of view 322 of the transducer 320 captures the instrument 311 at greater depths as the instrument 311 extends from the side-exit ramp 310 and into the tissue of the patient.
  • the forward leaning nature of the linear transducer results in the field of view that is generated by the linear transducer to lean forward in relation to the side exit port, which increases the depth at which target nodules may be biopsied while remaining within the field of view.
  • sampling device pierces deeper into the tissue (e.g., farther from the transducer) the further the sampling device progresses from the proximal end of the FOV to the distal end of the FOV. Once the sampling device extends beyond the distal end of the FOV, the distal tip of the sampling device (e.g., biopsy needle) is no longer imaged.
  • the linear transducer is in line with (e.g., parallel to) the longitudinal axis of the device (e.g., such as the device depicted in FIG. 2A of U.S. Pat. Pub.
  • the forward-leaning nature of the linear transducer increases the distance that the needle can be extended distally from the exit ramp while remaining within the FOV - thereby enabling deeper sampling during real-time visualization of the sampling device within the US image.
  • the angle 324 can be an angle along the taper of the housing 312 or the mount feature 318 and the field of view 322 of the transducer 320.
  • the angle 324 can be an acute angle (i.e., less than 90 degrees, such that the field of view 322 extends beyond the distal edge 321 of the transducer 320.
  • Angle 326 can be the angle between the coupler 304 and the taper of the housing 312 or the mount feature 318.
  • the angle 326 can be obtuse (i.e., greater than 90 degrees).
  • the transducer 320 leans toward the distal section 316 of the housing 312 such that the field of view 322 of the transducer 320 extends beyond the distal edge 321 of the transducer 320.
  • the taper of the housing 312 and the mount feature 318 can help the transducer 320 engage with the tissue of the airways of the lungs to help prevent air gaps between the transducer 320 and the inner walls of the airways of the lungs to help improve the ultrasonic images captured by the transducer 320.
  • the taper of the housing 312 and the mount feature 318 can help the distal tip 302 navigate through the airways and lungs of the patient because the housing 312 has a smaller diameter on the distal portion of the distal tip 302, which can be easier to navigate into new airways and areas of the lungs of the patient than a distal tip with a consistent diameter from a proximal end to a distal end.
  • the transducer 320 can be a linear array transducer.
  • the transducer 320 can extend from the proximal edge 331 to the distal edge 321.
  • the transducer 320 can be configured to capture an ultrasonic image of the tissue of the patient during the sampling of the target tissue of the patient via the instrument 311.
  • the transducer 320 will be discussed in more detail herein.
  • An intraluminal sampling device that is configured to sense the extension of a needle sheath from an exit port and to provide a notification to a clinician when the needle sheath has been suitably extended from the exit port.
  • the proposed system confirms to the healthcare provider when a needle sheath has been appropriately positioned such that a biopsy needle can be extended without damaging the device.
  • the proposed intraluminal sampling device can include some form of sensor integrated into the sampling device or on the needle sheath, or both, which provides a feedback signal when the needle sheath has been extended a predetermined amount from the exit port of a working channel or has otherwise reached a predetermined location within the working channel.
  • FIG. 4 illustrates a perspective view of a portion of an example distal tip of a sampling device 400 (e.g., the sampling device 136 (FIG. 1) or the sampling device 300 (FIG. 3)) having a sampling instrument within a protective sheath and within a working lumen of an elongated member.
  • the sampling device 400 can be insertable into a patient to obtain one or more samples, biopsies, or the like, from tissue of the patient.
  • the sampling device 400 can include an elongated member 402, a medical instrument 420, and one or more sensors (e.g., sensor 440).
  • the elongated member 402 (e.g., the insertion section 28 (FIG. 1) or the distal tip 302 (FIG. 3)) can extend longitudinally between a proximal section 404 and a distal section 406.
  • the elongated member 402 can be made from a flexible material, for example, polymer, rubber, any other biocompatible material, any combination thereof, or the like.
  • the elongated member 402 can define a lumen 408 that extends from the proximal section 404 to the distal section 406.
  • the lumen 408 (e.g., the lumen 309 (FIG. 3)) can be configured to permit one or more of tools, implements, fluids, debris, tissues, or the like from the distal section 406 and out of the sampling device 400.
  • the lumen 408 can include an inlet port 410 (shown in FIG. 2) formed on the proximal section 404 of the elongated member 402 and an outlet port 412 formed on the distal section 406 of the elongated member 402.
  • the outlet port 412 can define an exit of the lumen 408.
  • the medical instrument 420 (e.g., the instrument 311 (FIG. 3)) can be insertable into the elongated member 402.
  • at least a portion of the medical instrument 420 can be configured to be inserted into the lumen 408 via the inlet port 410 and guided out of the lumen 408 and toward the tissue of a patient via the outlet port 412.
  • the medical instrument can include a protective sheath 422.
  • the protective sheath 422 can extend longitudinally between a proximal portion 424 and a distal portion 426.
  • the protective sheath 422 can be configured to protect the medical instrument 420 while it is inserted into the inlet port 410 and is extended through the lumen 408.
  • the protective sheath 422 can be flexible such that the protective sheath 422 can be directed through the lumen 408 and toward the outlet port 412.
  • the protective sheath 422 can include a working lumen 428 (shown in phantom).
  • the working lumen 428 can be configured to permit movement of one or more tools, implements, instruments, or the like at least partially through the medical instrument 420.
  • the working lumen 428 can extend between the proximal portion 424 and the distal portion 426 of the protective sheath 422.
  • a sampling portion 430 of the medical instrument 420 can be slidingly installed within the working lumen 428 such that a distal tip 432 of the sampling portion 430 can be extended beyond or retracted within the distal portion 426 of the protective sheath 422.
  • the sampling portion 430 can be a sampling needle, a scalpel, or the like.
  • the sensor 440 can be configured to determine when the medical instrument 420 and, more specifically, the protective sheath 422 are in a position in which the sampling portion 430 can be extended without damaging the lumen 408 or the sampling portion 430.
  • the sensor 440 will be discussed herein with reference to FIG. 5.
  • FIG. 5 illustrates a perspective view of a portion of an example of the sampling device 400 with the protective sheath 422 adjacent to the outlet port 412 of the lumen 408 of the elongated member 402.
  • the sampling device 400 can include the sensor 440.
  • the sensor 440 can be an electrical, mechanical, or magnetic proximity sensor, an optical sensor, or any other sensor that can detect the protective sheath 422 within the lumen 408, or the like.
  • the sensor 440 can be installed adjacent the outlet port 412.
  • the sensor 440 can be a capacitive sensor configured to detect a capacitive change that occurs as a result of the needle sheath (e.g., the protective sheath 422) contacting the sensor location.
  • the needle sheath shown in blue
  • the needle sheath includes a capacitive element disposed at an outer surface that provides a notable capacitive change upon contacting the capacitive sensor.
  • the protective sheath 422 can be extended such that the distal portion 426 of the protective sheath 422 can be adjacent to the outlet port 412.
  • the distal portion 426 of the protective sheath 422 can include a capacitive ring 434 and the sensor 440 can be configured to detect the presence of the capacitive ring 434 near the outlet port 412.
  • the capacitive ring 434 can be configured to generate a notable capacitive change upon contacting or being near the sensor 440.
  • the sensor 440 can detect when the capacitive ring 434 of the protective sheath 422 is adjacent to the outlet port 412 and can generate a signal 442 to indicate that the protective sheath 422 is adjacent to the outlet port 412. As shown in FIG. 5, the signal 442 can be sent to the control unit 106, which can, in return, generate an alert, signal, alarm, other indicators, or the like, to alert the clinician that the protective sheath 422 is adjacent to the outlet port 412.
  • the signal 442 may be transmitted to the control unit 106 to cause the display unit 108 to generate one or more graphical user interface (GUI) elements which indicate that the protective sheath 422 is currently aligned at a predetermined alignment within the working channel.
  • GUI graphical user interface
  • An exemplary such predetermined alignment within the working channel may be selected such that the distal most end of the protective sheath 422 is aligned within a side exit ramp adjacent an outlet port 412 such that the protective sheath barely (if at all) extends from the side exit port while residing sufficiently within the side exit ramp to assist with imparting curvature into a biopsy needle residing within the protective sheath 422.
  • the generation of the signal 442 assist a user with positioning the protective sheath 422 at a precise location within the working channel such that the needle is prevented from damaging the side exit ramp while the protective sheath 422 is also not extended beyond the side exit port and into the patient’s tissue (which could cause some degree of trauma - particularly in narrow passageways such as peripheral lung regions).
  • the signal 442 can indicate that the distal tip 432 of the sampling portion 430 can extend beyond the distal portion 426 of the protective sheath 422 without damaging the sampling device 400. In other examples, the signal 442 can indicate that the distal portion 426 of the protective sheath 422 is aligned with the lumen exit (e.g., the outlet port 412). As shown in FIG. 5, the sensor 440 can be installed within the sampling device 400 such that the sensor 440 is adjacent to the outlet port 412 of the lumen 408. In another example, the sensor 440 can be installed within the distal portion 426 of the protective sheath 422.
  • FIG. 6 illustrates a perspective view of a portion of an example distal tip of a sampling device 400 when the protective sheath 422 is adjacent to the outlet port 412 of the lumen 408 of the elongated member 402 and the sampling portion 430 extending from the protective sheath 422.
  • the health care professional can extend the sampling portion 430 beyond the distal portion 426 of the protective sheath 422.
  • the sampling portion 430 can be extended into the tissue of the patient, and into the field of view 322 (discussed in FIG. 3) of the transducer 320 (discussed in FIG. 3).
  • the transducer 320 can help guide the sampling portion 430 toward a target tissue area of the patient.
  • the position of the protective sheath 422 being adjacent the outlet port 412 signifies that the sampling portion 430 can be extended beyond the distal portion 426 of the protective sheath 422 without causing damage to the sampling portion 430, or the lumen 408 of the elongated member 402.
  • the signal 442 (FIG. 4) can help reduce damage to the sampling device 400, or more specifically, the lumen 408 and the sampling portion 430, and help increase predictability of the procedure without having to visually confirm that the protective sheath 422 is extended distally beyond the outlet port 412.
  • the visual inspection can have multiple pitfalls, which can be avoided by utilizing the sampling device 400 including the sensor 440 to generate the signal 442 when the protective sheath 422 is extended adjacent to the outlet port 412.
  • FIG. 7 illustrates a perspective view of a portion of an example of the sampling device 400.
  • the sensor 440 can be incorporated into the protective sheath 422, for example, the sensor 440 can be adjacent the distal portion 426 of the protective sheath 422.
  • the sensor 440 can be any style of sensor that can detect a change in capacitance, or that can detect the protective sheath 422 extending from the outlet port 412.
  • the sensor 440 can be a proximity sensor, optical sensor, magnetic, electrical, any other sensor that can detect the extension of the protective sheath 422 at or beyond the outlet port 412, or the like.
  • FIG. 8 illustrates a perspective view of a portion of an example sampling device 400.
  • the sensor 440 can be incorporated into the elongated member 402, for example, the sensor 440 can be disposed adjacent the outlet port 412 of the lumen 408.
  • the sensor 440 can be configured to detect the presence of the protective sheath 422 without another sensor, capacitive ring, or like, disposed on the protective sheath 422 of the medical instrument 420.
  • the sensor 440 can be a proximity sensor, optical sensor, magnetic or electrical, or any other sensors that can detect the presence of the protective sheath 422, or the like.
  • the protective sheath 422 can include echogenic distance markers disposed at different portions of the protective sheath 422, which can reflect ultrasonic waves when the protective sheath 422 is inserted into the field of view of an ultrasound transducer (e.g., the sensor 440).
  • an ultrasound transducer e.g., the sensor 440
  • FIG. 9 illustrates a graphical representation of an example graphical user interface 900 of an example of an endobronchial ultrasound system.
  • the graphical user interface 900 can be displayed on the display unit 108 for viewing by one or more medical professionals.
  • the graphical user interface 900 can include patient information 910, live imaging 920, and alerts 930.
  • the patient information 910 can include patient-specific information (e.g., age, weight, height, blood type, or the like) relating to the patient on which the procedure is being performed.
  • the live imaging 920 can include medical imaging received from one or more of an imaging and control system or transducer (e.g., the imaging and control system 102 or the imaging device 146, see FIG. 1, or the image processing unit 202, see FIG.
  • the alerts 930 can be any alerts triggered by the endoscopy system 100 (FIG. 1), the sampling device 300 (FIG. 3), the sampling device 400 (FIG. 4), or the like, to communicate with the users (e.g., medical professionals) of the devices.
  • the alerts 930 can include an indication that it is safe to deploy the instrument (e.g., sampling needle) because the protective sheath is adjacent to the outlet port.
  • FIG. 10 illustrates a schematic view of an example method 1000.
  • the method 1000 can be a method of reprocessing a sampling device (e.g., the sampling device 136, see FIG. 1, the sampling device 300, see FIG. 3, or the like). More specific examples of the method 1000 are discussed below. The steps or operations of the method 1000 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations.
  • the method 1000 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 1000 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.
  • the reprocessing method 1000 for the above-described treatment instrument (e.g., the sampling device 136, see FIG. 1 or the sampling device 300, see FIG. 3) will be described with reference to FIG. 10.
  • the treatment instrument above can be disposed of after one use, or can be repeatedly used, for example, a plurality of times. In the case of a configuration that is repeatedly used a plurality of times, for example, the reprocessing method 1000 shown in FIG. 10 can be relevant.
  • Step SI An operator can collect the used treatment instrument after it has been used for treatment and transport it to a factory or the like (Step SI). At this time, the used treatment instrument (e.g., the endoscope 104, the sampling device 136, or the sampling device 300) can be transported in a dedicated container to prevent contamination from the treatment instrument (e.g., instrument 311, see FIG. 3).
  • the used treatment instrument e.g., the endoscope 104, the sampling device 136, or the sampling device 300
  • a dedicated container to prevent contamination from the treatment instrument (e.g., instrument 311, see FIG. 3).
  • the operator can clean and sterilize the collected and transported used treatment instrument (Step S2). Specifically, in cleaning the treatment instrument, deposits adhering to the exterior of the distal tip 302 (e.g., the coupler 304 or the housing 312) can be removed by using a brush or the like. After that, to remove pathogenic microorganisms and the like derived from blood, body fluid, etc., the distal tip 302 can be cleaned using a cleaning solution of isopropanol-containing cleaning agent, proteolytic enzyme detergent, and alcohol.
  • the cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used.
  • any of high-pressure steam sterilization, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide and hydrogen peroxide low-temperature sterilization can be used.
  • the part distal tip 302, and specifically, the coupler 304 (FIG. 3) and the housing 312 (FIG. 3) can be disassembled by actuating the clips or securing features to decouple the coupler 304 and the housing 312.
  • the operator can perform an acceptance check of the used treatment instrument (Step S3).
  • the operator can check whether the used treatment instrument has significant defects or whether the used treatment instrument exceeds a maximum number of reprocessing.
  • Step S4 Can disassemble the distal tip 302 by removing the housing 312 from the coupler 304 and removing all of the components from within the coupler 304 and the housing 312.
  • Step S5 some parts are replaced.
  • any of the components of the distal tip 302, or any of the components within the coupler 304 or the housing 312 can be replaced during step S4.
  • Step S6 can include adding an identifier to indicate the device has been modified from its original condition, such as a adding a label or other marking to designate the device as reprocessed, refurbished or remanufactured.
  • step S6 the operator can inspect and test the newly formed treatment instrument (step S7). Specifically, the operator who remanufactures verifies that the newly formed treatment instrument (e.g., the instrument 311, see FIG. 3) has the same effectiveness and safety as the original product by various functional tests.
  • the newly formed treatment instrument e.g., the instrument 311, see FIG. 3
  • Step S7 the operator sequentially performs a sterilization and storage (Step S8), and shipping (Step S9) of the new treatment instrument (e.g., the instrument 311, see FIG. 3).
  • a sterilization treatment can use a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., the instrument 311, see FIG. 3), and the device is stored in a storage container until use.
  • a sterilization treatment can use a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., the instrument 311, see FIG. 3), and the device is stored in a storage container until use.
  • Steps SI to S9 described above are executed to achieve reprocessing of the treatment instrument (e.g., the instrument 311, see FIG.
  • steps S1-S9 can be completed by one or more parties in any order of the steps.
  • steps S1-S9 are exemplary steps, which are not an all- inclusive list of steps that can be performed by an operator to refurbish, remanufacture, or replenish the medical instrument (e.g., the instrument 311, see FIG. 3).
  • the hardware of the circuitry may 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 underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa.
  • 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 may be used in more than one member of more than one circuitry.
  • execution units may 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 1100 follow.
  • the machine 1100 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1100 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1100 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment.
  • the machine 1100 may 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 1100 may include a hardware processor 1102 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1104, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1106, and mass storage 1108 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which may communicate with each other via an interlink (e.g., bus) 1130.
  • a hardware processor 1102 e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof
  • main memory 1104 e.g., a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1106, and mass storage
  • the machine 1100 may further include a display unit 1110, an alphanumeric input device 1112 (e.g., a keyboard), and a user interface (UI) navigation device 1114 (e.g., a mouse).
  • the display unit 1110, input device 1112 and UI navigation device 1114 may be a touch screen display.
  • the machine 1100 may additionally include a storage device (e.g., drive unit) 1108, a signal generation device 1118 (e.g., a speaker), a network interface device 1120, and one or more sensors 1116, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor.
  • GPS global positioning system
  • the machine 1100 may include an output controller 1128, 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 1102, the main memory 1104, the static memory 1106, or the mass storage 1108 may be, or include, a machine readable medium 1122 on which is stored one or more sets of data structures or instructions 1124 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein.
  • the instructions 1124 may also reside, completely or at least partially, within any of registers of the processor 1102, the main memory 1104, the static memory 1106, or the mass storage 1108 during execution thereof by the machine 1100.
  • one or any combination of the hardware processor 1102, the main memory 1104, the static memory 1106, or the mass storage 1108 may constitute the machine readable media 1122.
  • machine readable medium 1122 is illustrated as a single medium, the term “machine readable medium” may 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 1124.
  • the term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1100 and that cause the machine 1100 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.
  • Nonlimiting machine-readable medium examples may 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 may include: non-volatile 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.
  • non-volatile 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
  • information stored or otherwise provided on the machine readable medium 1122 may be representative of the instructions 1124, such as instructions 1124 themselves or a format from which the instructions 1124 may be derived.
  • This format from which the instructions 1124 may be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), or the like.
  • the information representative of the instructions 1124 in the machine readable medium 1122 may be processed by processing circuitry into the instructions to implement any of the operations discussed herein.
  • deriving the instructions 1124 from the information may include: compiling (e.g., from source code, object code, etc.), interpreting, loading, organizing (e.g., dynamically or statically linking), encoding, decoding, encrypting, unencrypting, packaging, unpackaging, or otherwise manipulating the information into the instructions 1124.
  • the derivation of the instructions 1124 may include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 1124 from some intermediate or preprocessed format provided by the machine readable medium 1122.
  • the information when provided in multiple parts, may be combined, unpacked, and modified to create the instructions 1124.
  • the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or several remote servers.
  • the source code packages may be encrypted when in transit over a network and decrypted, uncompressed, assembled (e.g., linked) if necessary, and compiled or interpreted (e.g., into a library, stand-alone executable etc.) at a local machine, and executed by the local machine.
  • the instructions 1124 may be further transmitted or received over a communications network 1126 using a transmission medium via the network interface device 1120 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 may 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 1120 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1126.
  • the network interface device 1120 may 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 single-output (MISO) techniques.
  • SIMO single-input multiple-output
  • MIMO multiple-input multiple-output
  • MISO multiple-input single-output
  • transmission medium shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1100, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.
  • a transmission medium is a machine-readable medium.
  • Example 1 is a sampling device insertable into a patient, the sampling device comprising: an elongated body extending longitudinally between a proximal section and a distal section, the elongated body comprising: a lumen extending longitudinally within the elongated body; an inlet port formed on the proximal section of the elongated body and connected to the lumen; and an outlet port formed on the distal section of the elongated body and connected to the lumen; a medical instrument insertable into the elongated body, at least a portion of the medical instrument configured to be inserted into the lumen via the inlet port and guided out of the lumen and toward tissue of a patient via the outlet port, the medical instrument comprising: a protective sheath extending longitudinally between a proximal portion and a distal portion; and a sensor configured to generate a signal indicating that the protective sheath is adjacent the outlet port.
  • Example 2 the subject matter of Example 1 includes, wherein the protective sheath comprises: a working lumen extending between the proximal portion and the distal portion.
  • Example 3 the subject matter of Example 2 includes, wherein the medical instrument comprises: a sampling portion slidingly installed within the working lumen such that a distal tip of the sampling portion can be extended beyond or retracted within the distal portion of the protective sheath.
  • Example 4 the subject matter of Example 3 includes, wherein the signal indicates the distal tip of the sampling portion can extend beyond the distal portion of the protective sheath without damaging the sampling device.
  • Example 5 the subject matter of Examples 3-4 includes, wherein the medical instrument is an endobronchial ultrasonic sampling device.
  • Example 6 the subject matter of Example 5 includes, wherein the sampling portion is a sampling needle configured to retrieve a sample tissue of the patient.
  • Example 7 the subject matter of Examples 1-6 includes, wherein the outlet port defines a lumen exit.
  • Example 8 the subject matter of Example 7 includes, wherein the signal indicates that the distal portion of the protective sheath is aligned with the lumen exit.
  • Example 9 the subject matter of Examples 7-8 includes, wherein the signal indicates that the distal portion of the protective sheath is adjacent to the lumen exit.
  • Example 10 the subject matter of Examples 1-9 includes, wherein the sensor is adjacent to the outlet port.
  • Example 11 the subject matter of Examples 1-10 includes, wherein the sensor is on the distal portion of the protective sheath.
  • Example 12 the subject matter of Examples 1-11 includes, wherein a first sensor is disposed adjacent to the outlet port and a second sensor is disposed adjacent to the distal portion of the protective sheath.
  • Example 13 is a sampling device insertable into a patient, the sampling device comprising: an elongated body extending longitudinally between a proximal section and a distal section and defining a lumen; a medical instrument insertable into the elongated body, at least a portion of the medical instrument configured to be inserted into the lumen, the medical instrument comprising: a protective sheath extending longitudinally between a proximal portion and a distal portion and defining a working lumen; and a sampling portion slidingly installed within the working lumen, the sampling portion is extendable relative to the protective sheath such that the sampling portion can be retracted within the protective sheath and extended distally from the protective sheath; and a sensor configured to generate a signal indicating that the protective sheath is adjacent an outlet of the lumen.
  • Example 14 the subject matter of Example 13 includes, wherein the protective sheath comprises: a working lumen extending between the proximal portion and the distal portion.
  • the subject matter of Example 14 includes, wherein the signal indicates the sampling portion can be extended beyond the distal portion of the protective sheath without damaging the sampling portion.
  • the subject matter of Examples 13-15 includes, wherein the sensor is disposed adjacent to the outlet of the lumen.
  • Example 17 the subject matter of Examples 13-16 includes, wherein the sensor is disposed adjacent to the distal portion of the protective sheath.
  • Example 18 the subject matter of Examples 13-17 includes, wherein a first sensor is disposed adjacent to the outlet of the lumen and a second sensor is disposed adjacent to the distal portion of the protective sheath.
  • Example 19 is a method for reprocessing a sampling device, the method comprising: obtaining the sampling device of Example 13; sterilizing the sampling device; and storing the sampling device.
  • Example 20 is an apparatus comprising means to implement of any of Examples 1-19.
  • Example 21 is a system to implement of any of Examples 1-19.
  • Example 22 is a method to implement of any of Examples 1-19.
  • Example 23 is an apparatus, system, or method to implement any element of any of Examples 1-19.
  • 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 below the 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).
  • 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. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
  • 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 or TYVEK® 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 may 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 d'échantillonnage qui peut comprendre un corps allongé, un instrument médical et des capteurs. Le corps allongé peut s'étendre longitudinalement entre une section proximale et une section distale et définir une lumière. L'instrument médical peut être inséré dans le corps allongé. Au moins une partie de l'instrument médical peut être conçue pour être insérée dans la lumière. L'instrument médical peut comprendre une gaine de protection et une partie d'échantillonnage. La gaine de protection peut s'étendre longitudinalement entre une partie proximale et une partie distale et définir une lumière de travail. La partie d'échantillonnage peut être installée de manière coulissante à l'intérieur de la lumière de travail et peut être extensible par rapport à la gaine de protection de telle sorte que la partie d'échantillonnage peut être rétractée à l'intérieur de la gaine de protection et étendue de manière distale à partir de la gaine de protection. Le capteur peut être conçu pour générer un signal indiquant que la gaine de protection est adjacente à une sortie de la lumière.
PCT/US2024/037180 2023-07-19 2024-07-09 Système pour confirmer un emplacement de gaine à l'intérieur d'une lumière WO2025019208A1 (fr)

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