WO2020236594A1 - Devices to access peripheral regions of the lung for direct visualization with tool attachment - Google Patents

Devices to access peripheral regions of the lung for direct visualization with tool attachment Download PDF

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Publication number
WO2020236594A1
WO2020236594A1 PCT/US2020/033143 US2020033143W WO2020236594A1 WO 2020236594 A1 WO2020236594 A1 WO 2020236594A1 US 2020033143 W US2020033143 W US 2020033143W WO 2020236594 A1 WO2020236594 A1 WO 2020236594A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
main body
dual
endoscopic instrument
distal end
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.)
Ceased
Application number
PCT/US2020/033143
Other languages
English (en)
French (fr)
Inventor
Kevin Walsh
Jeremy DITULLIO
Douglas W. GARRITY
Tyler Noyes
Seamus F. O'SHAUGHNESSY
Austin G. Johnson
Colby HARRIS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Scimed Life Systems 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 Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Priority to AU2020278580A priority Critical patent/AU2020278580B2/en
Priority to CA3132326A priority patent/CA3132326C/en
Priority to EP20730855.2A priority patent/EP3968863A1/en
Priority to CN202080035285.6A priority patent/CN113811248B/zh
Priority to JP2021557971A priority patent/JP7271710B2/ja
Publication of WO2020236594A1 publication Critical patent/WO2020236594A1/en
Anticipated expiration legal-status Critical
Priority to JP2023072315A priority patent/JP7664311B2/ja
Priority to AU2023203577A priority patent/AU2023203577A1/en
Ceased legal-status Critical Current

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Classifications

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Definitions

  • the present disclosure relates generally to the field of medical devices.
  • the present disclosure relates to modular assemblies, systems and methods for direct visualization and biopsy of peripheral pulmonary nodules.
  • a modular assembly of the present disclosure may include a dual lumen catheter attached to a distal end of a main body.
  • a first lumen may extend through the main body.
  • the first lumen may be contiguous with a first lumen of the dual-lumen catheter.
  • a second lumen may extend through the main body.
  • the second lumen may be contiguous with a second lumen of the dual-lumen catheter.
  • An attachment member may be formed within the main body at a proximal end of the second lumen.
  • the first lumens of the main body and the dual-lumen catheter may be configured to receive a first endoscopic instrument therethrough.
  • the second lumens of the main body and the dual-lumen catheter may be configured to receive a second endoscopic instrument therethrough.
  • a first support structure may be attached to a proximal end of the main body at a proximal end of the first lumen.
  • a second support structure may be attached to the distal end of the main body at a distal end of the first lumen.
  • the attachment member may be configured to receive a handle assembly of the second endoscopic instrument in a snap-lock configuration.
  • the present disclosure relates to a system comprising a modular assembly.
  • the modular assembly may include a dual-lumen catheter attached to a distal end of a main body.
  • a first lumen may extend through the main body.
  • the first lumen may be contiguous with a first lumen of the dual-lumen catheter.
  • a second lumen may extend through the main body.
  • the second lumen may be contiguous with a second lumen of the dual-lumen catheter.
  • An attachment member may be formed within the main body at a proximal end of the second lumen.
  • a first endoscopic instrument may extend through the first lumens of the main body and the dual-lumen catheter.
  • a second endoscopic instrument may extend through the second lumens of the main body and the dual-lumen catheter.
  • the first endoscopic instrument may include a radial ultrasound probe and the second endoscopic instrument may include a biopsy needle.
  • the second endoscopic instrument may be configured to move laterally between a first and second position within the dual-lumen catheter.
  • the attachment member may be configured to receive a handle assembly of the second endoscopic instrument in a snap-lock configuration.
  • the handle assembly may be configured to move laterally along the main body of the modular assembly.
  • the handle assembly may be configured move from a first position in which a distal end of the second endoscopic instrument may be disposed within the second lumen of the dual lumen catheter, and a second position in which the distal end of the second endoscopic instrument may extend beyond a distal end of the dual-lumen catheter.
  • the handle assembly may include a plunger configured to move the second endoscopic instrument between the first and second position.
  • the dual-lumen catheter may be configured to extend through a working channel of a bronchoscope.
  • the second endoscopic instrument may provide columnar support to the dual-lumen catheter.
  • a first support structure may be attached to a proximal end of the main body at a proximal end of the first lumen.
  • a second support structure may be attached to a distal end of the main body at a distal end of the first lumen.
  • the first and second support structures may provide a leak-proof seal for the first lumen.
  • the present disclosure relates to a method that may comprise advancing a bronchoscope into a pulmonary passage of a patient.
  • a dual-lumen catheter may be advanced through a working channel of the bronchoscope such that a distal end of the dual-lumen catheter may extend beyond the distal end of the bronchoscope.
  • a first pulmonary nodule may be visualized with a first endoscopic instrument that may extend through a first lumen of the dual-lumen catheter.
  • a biopsy sample of the first pulmonary nodule may be acquired with a second endoscopic instrument extending through a second lumen of the dual lumen catheter.
  • visualizing the first pulmonary nodule and acquiring the biopsy sample of the first pulmonary nodule may occur without having to exchange the first instrument with another instrument.
  • the method may further include removing the second endoscopic instrument from within the second lumen of the dual-lumen catheter without altering a position of the first endoscopic instrument within the pulmonary passage.
  • the method may further include ejecting the biopsy sample from within the second endoscopic instrument.
  • the method may further include advancing the second endoscopic instrument through the second lumen of the dual-lumen catheter.
  • the method may further include advancing the dual-lumen catheter through the pulmonary passage to visualize a second pulmonary nodule.
  • the method may further include acquiring a biopsy sample of the second pulmonary nodule with the second endoscopic instrument.
  • the first pulmonary nodule may include an eccentric pulmonary nodule.
  • FIGS. 1-3 provide perspective views of a direct visualization and biopsy assembly, according to one embodiment of the present disclosure.
  • FIGS. 4A-4C provide perspective views of a distal portion of a direct visualization and biopsy assembly, according to one embodiment of the present disclosure.
  • FIG.5 provides a schematic illustration of direct visualization and biopsy assembly acquiring a biopsy sample, according to one embodiment of the present disclosure.
  • distal refers to the end farthest away from the medical professional when introducing a device into a patient
  • proximal refers to the end closest to the medical professional when introducing a device into a patient
  • the present disclosure relates generally to a direct visualization and biopsy modular assembly (e.g., modular tool attachment) which may include an ergonomic handle and catheter configured for dual-function use during an endoscopy procedure.
  • the modular assembly may be configured for use within a bronchoscope working channel to provide real-time visualization (e.g., radial ultrasound imaging) and manipulation (e.g., diagnostic biopsy sampling) of solitary pulmonary nodules in peripheral regions of the lung.
  • the modular assembly may be configured to reposition and/or exchange an endoscopic tool/instrument (e.g.
  • the modular assembly may be configured to allow a medical professional to access, lock and/or manipulate an endoscopic tool/instrument attached thereto using a single hand.
  • a modular assembly 100 of the present disclosure may include a flexible dual-lumen catheter 112 (e.g., dual-lumen elongate shaft, etc.) attached to or otherwise extending from a proximal end of a main body 110 (e.g. , housing, ergonomic handle, etc.).
  • First and second lumens 114, 116 may extend through the main body 110 such that the first lumen 114 is contiguous (e.g., coextensive) with a first lumen 115 of the dual-lumen catheter 112, and the second lumen 116 is contiguous with a second lumen 117 of the dual-lumen catheter 112.
  • the contiguous first lumens 114, 115 of the main body 110 and dual-lumen catheter 112 may be configured to receive a first endoscopic instrument 140 (e.g. , a radial ultrasound probe) therethrough, e.g. , in a rotatable fashion, and the contiguous second lumens 116, 117 of the main body 110 and dual-lumen catheter 112 may be configured to slidably and/or rotatably receive a second endoscopic instrument 150 (e.g., a biopsy needle) therethrough.
  • An attachment member 118 may be formed within or otherwise attached to the main body 110 at or adjacent to a proximal end of the second lumen 116.
  • the attachment member 118 may be configured to receive/engage a corresponding surface of the second endoscopic instrument 150 (e.g., a handle assembly 154 of the second endoscopic instrument) in a snap-lock configuration such that the second endoscopic instrument 150 may move laterally (e.g., back-and- forth) along/relative to along a longitudinal axis of the main body 110.
  • the second endoscopic instrument 150 e.g., a handle assembly 154 of the second endoscopic instrument
  • the attachment member 118 may be configured to receive/engage a corresponding surface of the second endoscopic instrument 150 (e.g., a handle assembly 154 of the second endoscopic instrument) in a snap-lock configuration such that the second endoscopic instrument 150 may move laterally (e.g., back-and- forth) along/relative to along a longitudinal axis of the main body 110.
  • a first support structure 120 may be attached to or integrally formed with the main body 110 at or near a proximal end of the first lumen 114 and a second support structure 122 may be attached to or integrally formed with the main body 110 at or near the distal end of the first and second lumens 114, 116.
  • the first and second support structures 120, 122 may be configured to eliminate, minimize or reduce bending or kinking of the first endoscopic instrument 140 (e.g., radial ultrasound probe) extending through the contiguous first lumens 114, 115, which may impair or otherwise negatively affect ultrasound image quality.
  • the first and second support structures 120, 122 may limit the extent to which the first endoscopic instrument 140 bends or flexes within the main body 110 and/or the proximal portion of the dual-lumen catheter 112 , e.g., to allow the requisite high-speed rotation of the radial ultrasound probe throughout the full length of the dual-lumen catheter 112.
  • the first and second support structures 120, 122 may provide a dampening or insulating function to prevent, minimize or eliminate outside forces acting on the main body 110, e.g. , contact by other medical devices and/or the hand(s) of a medical professional operating the modular assembly, from propagating through the main body 110 and interfering with or otherwise corrupting the ultrasound signal.
  • first and second support structures 120, 122 may provide a leak-proof seal at the proximal and distal ends of the first lumen 114 of the main body 110 such that fluid flushed through the contiguous first lumens 114, 115 of the main body 110 and dual-lumen catheter 112 (e.g. , to remove air from within the first lumens 114, 115 and/or improve propagation of the ultrasound signal with the pulmonary passageway) does not leak into the patient and/or the contiguous second lumens 116, 117 of the main body 110 and dual-lumen catheter 112.
  • a system 200 of the present disclosure may include a first endoscopic instrument 140 (e.g. , radial ultrasound probe) disposed within the first lumens 114, 115 of the main body 110 and dual-lumen catheter 112 such that an ultrasound transducer 142 disposed at a distal end of the first endoscopic instrument 140 extends beyond a distal end of the dual-lumen catheter 112 (FIG. 4A).
  • a first endoscopic instrument 140 e.g. , radial ultrasound probe
  • a second endoscopic instrument 150 (e.g., elongate biopsy needle) may be slidably disposed within the second lumens 116, 117 of the main body 110 and dual-lumen catheter 112 to move a sharpened distal end 152 of the second endoscopic instrument 150 between a first position, e.g. , proximally retracted, shielded or protected within the second lumen 117 (FIG. 4A), and a second position, e.g., extended distally beyond or exposed from within the second lumen 117 (FIG. 4B).
  • a first position e.g. , proximally retracted, shielded or protected within the second lumen 117 (FIG. 4A
  • a second position e.g., extended distally beyond or exposed from within the second lumen 117
  • a handle assembly 154 (FIG. 3) of the second endoscopic instrument 150 may be engaged with the attachment member 118 of the main body 110 in a snap-lock configuration.
  • a proximal portion of the second endoscopic instrument 150 may extend through the handle assembly 154 such that a proximal end of the second endoscopic instrument 150 is attached to a plunger 156 extending beyond a proximal end of the handle assembly 154.
  • a spring 158 may be disposed around an outer circumference of a portion of the second endoscopic instrument 150 such that the plunger 156 may move between a first position (e.g., non-depressed, non-deployed) and second position (e.g., depressed, deployed, etc.).
  • the handle assembly 154 may move laterally (e.g., slide back-and-forth) along a longitudinal axis of the main body 110 of the modular assembly 100 between a proximally retracted position with the sharpened distal end 152 of the second endoscopic instrument 150 in the first position (FIG. 4A) and a distally extended position with the sharpened distal end 152 of the second endoscopic instrument in the second position (FIG. 4B).
  • the plunger 156 may be moved from the first position to the second position to further distally advance the sharpened distal end 152 of the second endoscopic instrument 150 relative to the ultrasound transducer 142 (FIG. 4C).
  • a bronchoscope (not shown) may be advanced into a pulmonary passage of a patient (e.g., through the esophagus).
  • a dual lumen catheter 112 of the modular assembly 100 may then be introduced into a working channel of the bronchoscope and distally advanced through the working channel, e.g., by a medical professional holding the main body 110 of the modular assembly 100.
  • the dual-lumen catheter 112 may be distally advanced beyond the distal end of the bronchoscope and into a peripheral region of the lung (e.g., where early cancerous pulmonary nodules tend to form) under radial ultrasound direct imaging guidance provided by the ultrasound transducer 142 extending beyond the distal end of the dual-lumen catheter 112 to identify a first pulmonary nodule 160.
  • the handle assembly 154 of the second endoscopic instrument 150 may then be moved laterally along a longitudinal axis of the main body 110 of the modular assembly 100 from a proximally retracted position to a distally extended position to expose the sharpened distal end 152 of the second endoscopic instrument 150 from within the second lumen 117 of the dual-lumen catheter 112.
  • the sharpened distal end 152 of the second endoscopic instrument 150 may be substantially adjacent to or extend slightly distally beyond the ultrasound transducer 142 such that the pulmonary nodule 160 and sharpened distal end 152 may be imaged simultaneously.
  • the main body 110 of the modular assembly 100 may be rotated and/or distally advanced to position/align the sharpened distal end 152 of the second endoscopic instrument 150 with the pulmonary nodule 160.
  • the plunger 156 may then be repeatedly moved between the first and second positions to extend/advance the sharpened distal end 152 of the second endoscopic instrument 150 into the pulmonary nodule 160.
  • the plunger 156 may be depressed multiple (e.g., 12-15) times to ensure that sufficient volume and location of biopsy sample of the pulmonary nodule 160 is acquired within the lumen of the sharpened distal end 152 of the second endoscopic instrument 150 for diagnostic analysis.
  • the handle assembly 154 may then be detached from the attachment member 118 of the main body 110 and the second endoscopic instrument 150 withdrawn/retracted through the contiguous second lumens 116, 117 of the main body 110 and dual-lumen catheter 112 while the dual-lumen catheter 112 remains disposed within the working channel of the bronchoscope.
  • the biopsy sample may then be ejected from within the lumen of the second endoscopic instrument 150 for diagnostic analysis and a second endoscopic instrument 150 (e.g. , the same second endoscopic instrument or a different/second endoscopic instrument) reinserted/inserted through the contiguous second lumens 116, 117 such that the sharpened distal end 152 returns to the first position (FIG.
  • an additional biopsy sample may be acquired from the first pulmonary nodule 160 by repeating the steps outlined above.
  • the dual-lumen catheter 112 may be repositioned within the peripheral region of the lung (e.g., advanced to a more distal peripheral region or a different peripheral branch) to visualize a second pulmonary nodule (not shown).
  • the handle assembly 154 and plunger 156 may then be actuated, and the sharpened distal end 152 of the second endoscopic instrument 150
  • a first advantage may be provided by the second endoscopic instrument 150 extending through the second lumen 117 of the dual-lumen catheter 112, which may provide columnar support to the dual-lumen catheter 112 to protect the first endoscopic instrument 140 from excessive bending, twisting or kinking within the narrow and tortuous pulmonary passages.
  • a second advantage may be provided by the sharpened distal end 152 of the second endoscopic instrument 150 being maintained within the dual-lumen catheter 112 as a pulmonary nodule is imaged, thereby allowing a biopsy sample to be acquired upon imaging without requiring a device exchange.
  • a third advantage may be provided by the plunger and spring of the handle assembly, which may allow a medical professional to actuate the second endoscopic instrument using a single hand, e.g., to obtain a sufficient biopsy sample from the pulmonary nodule.
  • a fourth advantage may be provided by the side-by-side configuration of the first and second lumens 115, 117 of the dual-lumen catheter 112, which may allow a medical professional to rotate the main body 110 of the modular assembly 100 to align the sharpened distal end 152 of the second endoscopic instrument 150 with an eccentric pulmonary nodule while maintaining visualization of the pulmonary nodule (e.g., as the second endoscopic instrument 150 rotates around/relative to an axis of the first endoscopic instrument 140).
  • a fourth advantage may be provided by the main body 110 of the modular assembly 100 being configured for single-user control or multiple-user control.
  • multiple-user control may allow a first medical professional (e.g., a physician) to position the first endoscopic instrument 140 adjacent to a target pulmonary nodule and a second medical professional (e.g., a medical assistant) to manipulate the second endoscopic instrument 150 (e.g., acquire the biopsy sample and remove the second endoscopic instrument through the working channel) at the instruction of the first medical professional.
  • a first medical professional e.g., a physician
  • a second medical professional e.g., a medical assistant
  • single-user control may allow a medical professional to manipulate the first endoscopic instrument 140 with one hand and manipulate the second endoscopic instrument 150 with the other hand.
  • the second endoscopic instrument 150 of the present disclosure is not limited to a biopsy needle, but may include a variety of medical instmments configured to manipulate a target tissue within a body passage, including, for example, electrocautery knives, clips, brushes, scissors, graspers, forceps, laser ablative elements, etc.
  • Other peripheral pulmonary nodule visualization and/or biopsy techniques, features, and/or components that may be used herein are disclosed in U.S. Non- Pro visional Patent Application titled“Apparatus to Provide an Adjustable Mechanism for Radial Ultrasound Port and Flush Port”, attorney docket number 8150.0600, filed even date herewith, the entirety of which is incorporated herein by reference and/or U.S. Non-Provisional Patent Application titled“Medical Imaging Devices, Systems, and Methods”, attorney docket number 8150.0746, filed even date herewith, the entirety of which is incorporated herein by reference.

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AU2020278580A AU2020278580B2 (en) 2019-05-17 2020-05-15 Devices to access peripheral regions of the lung for direct visualization with tool attachment
CA3132326A CA3132326C (en) 2019-05-17 2020-05-15 Devices to access peripheral regions of the lung for direct visualization with tool attachment
EP20730855.2A EP3968863A1 (en) 2019-05-17 2020-05-15 Devices to access peripheral regions of the lung for direct visualization with tool attachment
CN202080035285.6A CN113811248B (zh) 2019-05-17 2020-05-15 利用工具附接件以进入肺的外周区域进行直接可视化的装置
JP2021557971A JP7271710B2 (ja) 2019-05-17 2020-05-15 ツールを装着して直接視覚化するために肺の末梢領域にアクセスする装置
JP2023072315A JP7664311B2 (ja) 2019-05-17 2023-04-26 ツールを装着して直接視覚化するために肺の末梢領域にアクセスする装置
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