Bronchoscope for selective airway occlusion, isolation, and segmental therapy

Abstract

The present disclosure relates generally to pulmonary medical devices and methods for selective lung ventilation and reinflation. More particularly, the present disclosure relates to bronchoscopic systems, including fully integrated bronchoscopes and bronchoscope-based accessories, configured to selectively isolate and reinflate collapsed or under-ventilated lung regions while preserving bronchoscopic visualization and procedural access. The present disclosure additionally encompasses bronchoscopic platforms adaptable for adjacent applications including intraoperative lung isolation, interventional pulmonology procedures, improved access and visualization during lung cancer diagnosis and treatment, management of airway bleeding or air leaks, management of pulmonary strictures, deployment in austere or military environments, and targeted pulmonary drug or biologic delivery enabled by selective airway isolation.

Description

BRONCHOSCOPE FOR SELECTIVE AIRWAY OCCLUSION, ISOLATION, AND SEGMENTAL THERAPYINVENTORS: Whitney Elaine Slightham, Brian Anthony Cripe, Nathan Friedman, Benjamin Michael Trapp, Carlos Manuel MorenoTECHNICAL FIELD

[0001] The present disclosure relates generally to pulmonary medical devices and methods for selective lung ventilation and reinflation. More particularly, the present disclosure relates to bronchoscopic systems, including fully integrated bronchoscopes and bronchoscope-based accessories, configured to selectively isolate and reinflate collapsed or under-ventilated lung regions while preserving bronchoscopic visualization, navigation, and procedural access.BACKGROUND

[0002] Atelectasis, including lobar and segmental lung collapse, is a common and clinically significant problem in critically ill and perioperative patients. It frequently occurs in patients receiving mechanical ventilation, particularly those with pneumonia, acute respiratory distress syndrome, obesity, prolonged immobilization, or following major surgery. Collapsed lung regions often exhibit reduced compliance and resistance to reopening under normal ventilatory pressures.

[0003] Current clinical management of atelectasis relies primarily on global lung recruitment strategies, including increases in positive end-expiratory pressure (PEEP), recruitment maneuvers, or adjustments to tidal volume and inspiratory pressure. While such approaches may improve aeration in compliant lung regions, they often fail to selectively reopen collapsed segments. Instead, increased pressure is preferentially distributed to already open alveoli, increasing the risk of volutrauma, barotrauma, and 181500.00216ventilator-associated lung injury. As a result, collapsed lung regions may remain untreated while non-collapsed regions are exposed to injurious pressures.

[0004] Bronchoscopy is routinely used in intensive care and perioperative settings for airway visualization, suctioning, lavage, and diagnostic procedures. Bronchoscopic access provides direct navigation to lobar and segmental airways and allows identification of collapsed regions, mucus plugging, or obstructive pathology. However, conventional bronchoscopes are not designed to deliver therapeutic reinflation to isolated lung segments. Standard bronchoscopic tools primarily support visualization and limited fluid exchange, rather than controlled, sustained delivery of pressurized gas to reopen collapsed lung tissue.

[0005] Various airway occlusion devices have been used in pulmonary procedures for purposes such as temporary airway isolation, bleeding control, or selective ventilation during surgery. These devices are typically configured as standalone blockers or balloons introduced separately from the bronchoscope or passed through the bronchoscope working channel. Such configurations may interfere with visualization, limit instrument access, require repeated device exchanges, or lack integrated pressure control suitable for therapeutic reinflation. Moreover, many existing occlusion tools are optimized for short-duration isolation rather than sustained, controlled reinflation of collapsed lung regions.

[0006] In addition to atelectasis, clinicians performing bronchoscopic procedures encounter related challenges including airway bleeding during biopsy, difficulty accessing peripheral lung lesions obscured by collapse, and the need to localize or manage air leaks. While bronchoscopy provides access to these regions, existing devices do not provide an integrated platform for selective airway isolation combined with controlled delivery of gas or therapeutics in a manner that preserves281500.00216bronchoscopic workflow and minimizes risk to non-target lung regions.

[0007] Accordingly, there remains a need for bronchoscopic systems that enable selective isolation and targeted reinflation of collapsed lung segments, particularly in intensive care and perioperative environments. There is further a need for such systems to integrate with or can be incorporated into bronchoscopes in a manner that preserves visualization and procedural access, while supporting expanded applications including interventional pulmonology, intraoperative lung isolation, oncologic access, and targeted pulmonary therapy.SUMMARY

[0008] The present disclosure provides bronchoscopic systems and methods for selective airway isolation of bronchopulmonary segments and localized delivery of pulmonary therapies. The present disclosure enables controlled isolation of a target bronchopulmonary region and localized delivery of therapeutic agents — including pressurized gas for reinflation, fluids, drugs, biologies, or combinations thereof — while minimizing exposure of non-target lung tissue. The systems are particularly suited for selective pulmonary reinflation in the treatment of lobar or segmental atelectasis, as well as fora broad range of therapeutic and procedural applications requiring localized airway control.

[0009] For example, an accessory device for a bronchoscope is contemplated by the present disclosure. The accessory may comprise an occluding element configured to be secured proximate to a distal end of a bronchoscope and positionable within a bronchial passage. The accessory may include an occluding element actuator for deploying and contracting the occluding element to form a seal with an inner wall of the bronchial passage and to isolate a selected pulmonary region and a working channel in communication with the pulmonary region. The accessory may further381500.00216include a fluid control manifold coupled to the working channel for controlling the delivery of a pulmonary fluid to the pulmonary region.

[0010] In various embodiments, the present disclosure also contemplates bronchoscopic devices or platforms incorporating one or more occlusive elements positioned on or near a distal portion of a bronchoscope and actuated independently of a bronchoscope working channel. Such systems enable controlled delivery of pressurized gas, fluids, or therapeutic agents to a selected bronchopulmonary segment for targeted reinflation, while reducing pressure exposure to non-target lung regions.

[0011] For example, a bronchoscope in accordance with the present disclosure may comprise a working channel in communication with the pulmonary region, a shaft having a distal end and an occluding element secured proximate to the distal end of the shaft. In some embodiments, the bronchoscope may have a pulmonary fluid lumen that is separate from the working channel and used for the delivery of a pulmonary fluid to the pulmonary region. The bronchoscope may further include an occluding element actuator for deploying and contracting the occluding element to form a seal with an inner wall of the bronchial passage and to isolate a selected pulmonary region. In accordance with various aspects of the present disclosure, the bronchoscope may comprise a pulmonary fluid control mechanism coupled to the working channel for controlling the delivery of a pulmonary fluid to the pulmonary region and a bronchoscope control interface for actuating and terminating the delivery of the pulmonary fluid.

[0012] The present disclosure further relates to methods of using such bronchoscopic systems to treat lobar or segmental atelectasis, particularly in intensive care and perioperative settings, as well as to support adjacent clinical applications481500.00216including intraoperative lung isolation, interventional pulmonology procedures, improved access and visualization for lung cancer diagnosis and treatment, management of airway bleeding or air leaks, management of pulmonary strictures, deployment in austere or military environments, and targeted pulmonary drug or biologic delivery enabled by selective airway isolation.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and together with the description serve to explain the principles of the disclosure, wherein:

[0014] Figure 1 is a perspective view of a modular bronchoscope accessory system in accordance with the present disclosure;

[0015] Figure 2 is another perspective view of a modular bronchoscope accessory system in accordance with the present disclosure;

[0016] Figure 3 is a perspective view of an alternative modular bronchoscope accessory system in accordance with the present disclosure;

[0017] Figures 4A-D are side views of a balloon sleeve assembly carried on a shaft of a bronchoscope used with a removable segmented support sleeve in accordance with the present disclosure;

[0018] Figure 5 is a perspective view of a distal occlusive sleeve in accordance with the present disclosure;

[0019] Figures 6A-D are perspective, side and end views of a distal occlusive sleeve in accordance with the present disclosure;

[0020] Figure 7 is a perspective view of a balloon occlusion mechanism secured to a bronchoscope using an attachment mechanism extending proximally along the581500.00216bronchoscope shaft in accordance with the present disclosure;

[0021] Figure 8 is a perspective view of a balloon occlusion mechanism having an accordion style outer attachment mechanism for placement on a bronchoscope in accordance with the present disclosure;

[0022] Figure 9 is a perspective view of an extended outer attachment mechanism extending down the bronchoscope shaft, with a balloon in an inflated state in accordance with the present disclosure;

[0023] Figure 10 is a perspective view of an occluding device releasably attached utilizing a clip mechanism in accordance with the present disclosure;

[0024] Figure 11 is a perspective view of the occluding device of Figure 10 wherein the occluding device is detached from the bronchoscope during partial inflation of the balloon occlusion mechanism;

[0025] Figure 12 is a perspective view of a “C-shaped” occluding device positioned adjacent to a bronchoscope in a delivered state in accordance with the present disclosure;

[0026] Figure 13 is a cross-sectional view of the C-shaped device of Figure 12;

[0027] Figure 14 is a cross-sectional view of the C-shaped device of Figure 13 in a deployed state;

[0028] Figure 15 is a perspective view of an occluding device detachably attached to a bronchoscope using a knot-based attachment mechanism in accordance with the present disclosure;

[0029] Figure 16 is a perspective view of an occluding device detachably attached to a bronchoscope using a hook-shaped attachment mechanism in accordance with the present disclosure;

[0030] Figure 17 are views of various balloon occlusion devices compatible with681500.00216standard guidewire exchange techniques in accordance with the present disclosure;

[0031] Figure 18 is a perspective view of a balloon occlusion device incorporating a large central lung inflation lumen in accordance with the present disclosure;

[0032] Figure 19 is a perspective view of an integrated bronchoscope with selective isolation and inflation control in accordance with the present disclosure;

[0033] Figure 20 is a perspective view of an alternative embodiment of an integrated bronchoscope with selective isolation and inflation control in accordance with the present disclosure;

[0034] Figure 21 is a block diagram of an inflation control system in accordance with the present disclosure;

[0035] Figures 22A and 22B are side and end views of an inflatable helical balloon sleeve disposed about an elongate shaft in accordance with the present disclosure;

[0036] Figures 23A and 23B are side views of a C-shaped inflatable balloon cuff configured to clip onto the outer circumference of a bronchoscope shaft in accordance with the present disclosure;

[0037] Figures 24A and 24B are side views of a mechanically expandable occlusive structure positioned movable between an elongated delivery state and a radially expanded occluding state in accordance with the present disclosure;

[0038] Figures 25A-B are front views of an alternative embodiment of a mechanically actuated occluder in accordance with the present disclosure;

[0039] Figure 25C is an end view of the occluder of Figure 25B in accordance with the present disclosure;

[0040] Figures 26A-B are front views of a self-expanding umbrella occlusion781500.00216assembly in accordance with the present disclosure;

[0041] Figure 27 is a perspective view of a Y-valve control manifold for selective fluid communication with a bronchoscope working or suction channel in accordance with the present disclosure;

[0042] Figure 28 is a perspective view of a bronchoscope accessory system positioned within a target bronchial branch with an occlusion balloon deployed at or near the branch ostium in accordance with the present disclosure;

[0043] Figure 29 is a block diagram of a portable bronchoscope system where access to conventional hospital infrastructure may be limited or unavailable in accordance with the present disclosure;

[0044] Figure 30 is a perspective view of an intranasally delivered device in accordance with the present disclosure; and

[0045] Figure 31 is a perspective view of a bronchoscope accessory system that is deployed separately from the bronchoscope in accordance with the present disclosure.DETAILED DESCRIPTION

[0046] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and systems configured to perform the intended functions. Stated differently, other methods and systems can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. Finally, although the present disclosure can be described in connection with various principles and beliefs, the present disclosure should not be bound by theory.881500.00216

[0047] In general, the present disclosure relates to pulmonary medical devices, systems and methods for selective lung ventilation and reinflation. More particularly, the present disclosure relates to bronchoscopic systems, including fully integrated bronchoscopes and bronchoscope accessories, configured to selectively isolate and reinflate collapsed or under-ventilated lung regions while preserving bronchoscopic visualization and procedural access and without increasing airway pressure in nonisolated regions of the lung. The present disclosure additionally encompasses bronchoscopic platforms adaptable for adjacent applications including intraoperative lung isolation, interventional pulmonology procedures, improved access and visualization during lung cancer diagnosis and treatment, management of airway bleeding or air leaks, deployment in austere or military environments, and targeted pulmonary drug or biologic delivery enabled by selective airway isolation.Clinical Context and Scope of Selective Pulmonary Isolation and Therapy

[0048] The above being noted, selective airway isolation and pulmonary reinflation as provided for by the present disclosure address a class of pulmonary conditions characterized by partial, segmental, or lobar loss of ventilation in which global ventilation strategies are ineffective, inefficient, or injurious. Lobar and segmental atelectasis represent common and clinically significant manifestations of this problem, particularly in critically ill, perioperative, and mechanically ventilated patients. In such conditions, collapsed or under-ventilated lung regions frequently resist reopening during conventional ventilation, while non-collapsed regions preferentially receive increased pressure, contributing to ventilator-associated lung injury.

[0049] Beyond classic lobar collapse, a wide range of pulmonary pathologies and procedural scenarios involve localized loss of ventilation or require temporary981500.00216airway isolation that may benefit from selective reinflation, localized therapy delivery, or controlled airway management applied to discrete bronchopulmonary segments. The ability to selectively isolate a target airway region and deliver pressurized gas, fluids, or therapeutic agents — while limiting exposure of non-target lung tissue — enables a variety of therapeutic and diagnostic interventions not achievable with global ventilation alone.

[0050] Clinically, selective airway isolation and reinflation may be applied to postoperative and prolonged-ventilation atelectasis, where dependent lung regions commonly fail to respond to standard recruitment maneuvers; obstructive or mucus-plug-related collapse, in which isolation and localized pressurization, irrigation, or suction may facilitate clearance and re-expansion; and transplant or donor lung management, where controlled recruitment or stabilization of specific segments can reduce injury during reperfusion or recovery. Selective airway isolation further supports intraoperative lung management during thoracic or cardiac surgery, enabling ventilation, deflation, or stabilization of selected lung regions without requiring complete lung collapse.

[0051] In addition to reinflation, selective airway isolation enables targeted pulmonary therapy, including localized delivery of surfactants, bronchodilators, mucolytics, anti-inflammatory agents, antibiotics, biologies, or other therapeutic compositions, as well as containment or management of airway bleeding during procedural interventions. Controlled isolation and pressure modulation may also be used for diagnostic and functional assessment, including evaluation of segmental compliance, differentiation of reversible collapse from fixed pathology, and improved access and visualization during diagnostic procedures such as lung cancer evaluation.

[0052] Selective airway isolation capabilities further extend to emergency,1081500.00216transport, pediatric, and austere care environments, where compact, bedsidecompatible systems may be used to manage lung collapse, bleeding, or airway instability following trauma, aspiration, or prolonged immobilization. Scaled embodiments may support neonatal or pediatric patients in whom conventional selective ventilation tools are impractical. In research and development contexts, selective segmental isolation and pressure or therapy modulation support lung physiology studies, imaging calibration, and development of computational or data-driven pulmonary models.

[0053] Accordingly, selective airway isolation and targeted pulmonary therapy are not limited to a single disease state or care setting, but represent foundational capabilities applicable across critical care, surgery, interventional pulmonology, oncology, emergency medicine, pediatrics, and research. Systems that enable precise, controlled, and bronchoscopically accessible airway isolation provide a platform for multiple therapeutic, diagnostic, and procedural applications.

[0054] Thus, in the embodiments contemplated herein, the present disclosure comprises a bronchoscope-based platform configured to selectively isolate a target airway region using one or more occlusive elements positioned on or near a distal portion of the bronchoscope. The occlusive element may be inflatable or mechanically expandable and is actuated through a dedicated pathway that is independent of the bronchoscope working channel, thereby preserving visualization, navigation, and instrument access during therapy. Isolation of the target airway enables controlled delivery of pressurized gas for reinflation, controlled insufflation or lavage, delivery of liquid or aerosolized therapies, and containment or management of airway bleeding.

[0055] In certain embodiments, the selective isolation and therapy delivery functionality is fully integrated into the bronchoscope itself, including integrated1181500.00216occlusive elements, actuation pathways, pressure-limiting components, and proximal control interfaces. In other embodiments, the present disclosure comprises modular accessories configured to attach to or interface with existing bronchoscopes, such as distal sleeves or sheaths carrying occlusive elements and proximal manifolds configured to control delivery of gas, fluids, or therapeutic agents. These embodiments allow selective airway isolation and therapy delivery without requiring redesign of the bronchoscope.

[0056] The present disclosure supports targeted pulmonary reinflation for treatment of atelectasis in intensive care and perioperative settings, reducing reliance on global ventilation strategies that expose healthy lung regions to injurious pressures. The same bronchoscopic platform further supports adjacent clinical applications including intraoperative lung isolation, interventional pulmonology procedures, management of airway bleeding during biopsy or cryobiopsy, localization or management of air leaks, improved access and visualization during lung cancer diagnosis and treatment, and localized delivery of therapeutic or biologic agents to pulmonary lesions.

[0057] In additional embodiments, the systems may be configured for portability and manual operation, enabling use in emergency, transport, military, or other austere or resource-limited environments. Optional sensing, pressure-limiting, and control features may be incorporated to support safe, repeatable isolation and therapy delivery across a range of patient populations and clinical settings. Collectively, the present disclosure provides a versatile bronchoscopic platform for selective airway isolation, pulmonary reinflation, and localized pulmonary therapy, including drug delivery and other therapeutic interventions.

[0058] In the context of the above and in accordance with various aspects of1281500.00216the present disclosure, in various embodiments, an accessory device for use in connection with a bronchoscope is contemplated. As will be described in more detail herein, in accordance with various aspects, an occluding element configured to be secured proximate to a distal end of a bronchoscope and positionable within a bronchial passage of a patient (e.g., human, mammal or other animal). An occluding element actuator for deploying and contracting the occluding element to form a seal with an inner wall of the bronchial passage and to isolate a selected pulmonary region.

[0059] In accordance with various aspects, a working channel in communication with the pulmonary region and a fluid control manifold coupled to the working channel are provided for controlling the delivery of a pulmonary fluid to the pulmonary region, for example, for reinflation. In accordance with various aspects of the present disclosure, a control interface for actuating and terminating the delivery of the pulmonary fluid is provided.

[0060] In accordance with various aspects of the present disclosure, the pulmonary fluid may comprise a liquid, a gas or a combination thereof. Examples of pulmonary fluid include ambient air, oxygen-enriched gas, a therapeutic material, a lavage fluid, an irrigation fluid, a hemostatic agent, a surfactant, an antibiotic, a bronchodilator, a mucolytic, a biologic agent, a graft material, and a diagnostic medium. Other pulmonary fluids now known or as yet unknown are likewise contemplated herein.

[0061] In accordance with various aspects of the present disclosure, a pressure-limiting element configured to limit a pressure delivered to the pulmonary region to a predefined threshold, such as when reaching a pressure below a clinically accepted peak inspiratory pressure, may be provided. The pressure-limiting element may be actuated or adjusted by the user or may be independent of user adjustment.1381500.00216For example, the pressure-limiting element may be configured to automatically externally vent before a pulmonary region pressure reaches the predefined pressure threshold. In accordance with some aspects, the pressure-limiting element may be actuated with electronic sensors, active control systems, or software-based regulation.

[0062] In accordance with various aspects of the present disclosure, the occluding element may be attached to the bronchoscope with any suitable device for securing the occluding element, such as, for example, clips, loops, knots, various cinch-structures, hooks, or adhesive interfaces.

[0063] In accordance with some aspects, the occluding element itself may further comprises reinforcement structures such as threads or filaments wrapped around the occluding element, sleeves, coatings and the like, now known or as yet unknown. In accordance with additional or alternative aspects, the occluding element may comprise bioabsorbable materials, radiopaque material (for example, for visibility during a medical procedure), or other suitable materials dependent on the particular application.

[0064] In accordance with various aspects of the present disclosure, the occluding element may comprise one or more sensors for measuring various characteristics of the fluids and / or gases communicated to and from the pulmonary region.

[0065] In accordance with various aspects of the present disclosure, the occluding element at least partially surrounds an area proximate to the distal end of the bronchoscope. In accordance with some aspects, the occluding element may have various shapes and configurations depending upon the particular application or use, such as a helix (or generally helical) shape, circumferential or partially circumferential shapes, among others.1481500.00216

[0066] In accordance with various aspects of the present disclosure, the occluding element comprises an inflatable occlusive element, such as balloon. For example, the inflatable occlusive element may comprise an inflatable sleeve configured to surround a shaft of the bronchoscope proximate to a distal end or portion of the bronchoscope and to expand radially to form a circumferential seal in the bronchial passage. The sleeve thus allows securement without permanent modification of the bronchoscope, for example, when occlusion is not necessary.

[0067] Inflatable occlusive elements may have any number of shapes and fall within the scope of the present disclosure. For example, FIGS. 22A and 22B illustrate a helical balloon sleeve 400 surrounding the shaft of a bronchoscope 300, shown in side and end views. The helical balloon sleeve 400 is arranged in a spiral or helical configuration around the outer circumference of the shaft of a bronchoscope 300, defining one or more circumferentially offset inflatable lobes that wrap around the shaft axis. A microinflation lumen 102 extends proximally within or alongside the shaft and is fluidly coupled to the helical balloon sleeve 400 to deliver inflation media thereto. Upon pressurization through the microinflation lumen 102, the helical balloon sleeve 400 expands radially in the helical pattern shown, enabling circumferential sealing, anchoring, or occlusive engagement while maintaining the central shaft profile.

[0068] In accordance with another embodiment and with reference to FIGS.23A and 23B, a C-shaped balloon cuff 401 configured to clip onto the outer circumference of the shaft of a bronchoscope 300 is shown. The C-shaped balloon cuff 401 is shown in an uninflated low-profile configuration (FIG. 23A) and an inflated expanded configuration (FIG. 23B). Upon delivery of inflation media through a microinflation lumen, the C-shaped balloon cuff 401 expands circumferentially about the shaft of a bronchoscope 300 to provide sealing engagement and occlusion within a1581500.00216target airway while remaining removably mounted to the bronchoscope exterior.

[0069] In inflatable occlusive element embodiments, the occluding element actuator includes an inflation fluid that is delivered or evacuated to and from the inflatable occlusive element via an occluding element actuator lumen to inflate or deflate the occlude. The inflation fluid is at least one of a liquid and a gas and may optionally include a radiopaque occluding element. In accordance with some aspects of the present disclosure, inflation of the inflatable element only requires a low enough inflation volume that is sufficient to deploy the inflatable element but without materially altering the flexibility of the bronchoscope insertion shaft.

[0070] In accordance with various other aspects of the present disclosure, the occluding element comprises a mechanically expandable structure, such as radially deployable struts, arms, braided members, helically wound elements, or umbrella-like frameworks similar to expandable stent grafts, occluding devices, and the like made of various biocompatible materials that expand outward when actuated.

[0071] For example, with reference to FIGS. 24A and 24B, a mechanically expandable occlusive structure positioned at a distal end and movable between an elongated delivery state (FIG. 24A) and a radially expanded occluding state (FIG. 24B) is shown. A finger ring 503 is coupled to an actuator member 501 , and may further include a biasing spring element configured to assist proximal pull actuation and / or automatically return the actuator to the elongated delivery state upon release. Proximal displacement of the finger ring 503 shortens the reinforced braided sleeve 404, causing radial expansion and occlusion of the bronchial passage. The occlusive structure includes an outer polymer or silicone layer over a reinforcing lattice formed from polymer, titanium, nitinol, or other tensile-strength material.

[0072] With reference now to FIGS. 25A-C, an alternative mechanically1681500.00216actuated occluder is illustrated. FIG. 25A-C depict a mechanically actuated, radially expanding umbrella-shaped sealing member 403 deployable from a position proximate to the distal end of the shaft of a bronchoscope 300, shown in collapsed (FIG. 25A) and expanded states (FIG. 25B). A proximal actuator ring 502, which may further comprise a biasing spring element configured to assist proximal pull actuation, is coupled to an actuator member 501, such that axial displacement of the actuator causes the umbrella-shaped sealing member 403 to transition from a low-profile delivery configuration (FIG. 25A) to a radially expanded occluding configuration (FIG.25B and 25C). In the expanded state, the umbrella-shaped sealing member 403 extends circumferentially about the shaft of a bronchoscope 300 to engage the surrounding airway wall and provide segmental lung occlusion. The umbrella sealing member may be formed from a conformable yet shape-retaining polymeric, elastomeric, reinforced silicone, or composite material configured to accommodate airway irregularities while maintaining sufficient radial rigidity to resist collapse and preserve an effective seal.

[0073] With reference now to FIG. 26A and 26B, a self-expanding umbrella occlusion assembly deployable from the distal end of the shaft of a bronchoscope 300 is shown in constrained (FIG. 26A) and deployed (FIG. 26B) states. A proximal actuator ring 502 is coupled to an actuator member 501, which is operatively connected to a retractable outer sleeve 405 positioned over a resilient umbrella sealing structure 406. The actuator ring 502 may comprise a biasing spring mechanism. In the constrained configuration (FIG. 26A), the retractable outer sleeve 405 maintains the umbrella sealing structure 406 in a low-profile collapsed state for delivery. Upon proximal retraction of the actuator ring 502, the retractable outer sleeve 405 is withdrawn, allowing the umbrella sealing structure 406 to self-expand radially to its1781500.00216biased open configuration (FIG. 26B) and engage the surrounding airway wall. The umbrella sealing structure 406 may be formed from a shape-memory polymer, nitinol-reinforced elastomer, spring polymer, or other resilient, conformable material configured to naturally assume the expanded occluding geometry when unconstrained, thereby providing reliable segmental lung occlusion.

[0074] In accordance with various other aspects of the present disclosure, mechanical expansion may be achieved through proximal actuation mechanisms such as guide wires, pull wires, push rods, sliding sheaths, or rotational elements. The mechanically expandable structure may be covered with or coupled to a flexible occlusive membrane to enhance sealing and reduce air or fluid leakage. Mechanically expandable occlusive structures may provide predictable expansion geometry and may be advantageous in airways where inflation-based occlusion is undesirable or impractical.

[0075] As noted above, in accordance with various aspects of the present disclosure, a bronchoscope may include an integrated occluding element built directly into the bronchoscope.

[0076] As will be described in more detail herein, a bronchoscope in accordance with the present disclosure, comprises a shaft having a distal end and an occluding element secured proximate to the distal end of the shaft. The bronchoscope may further comprise an occluding element actuator for deploying and contracting the occluding element to form a seal with an inner wall of the bronchial passage and to isolate a selected pulmonary region and a working channel in communication with the pulmonary region. In accordance with various aspects, a pulmonary fluid control mechanism coupled to the working channel for controlling the delivery of a pulmonary fluid to the pulmonary region and a control interface for actuating and terminating the1881500.00216delivery of the pulmonary fluid may be provided. The bronchoscope may further comprise a dedicated working channel and separate lumen for the delivery of pulmonary fluid.

[0077] In accordance with various aspects of the present disclosure, a pressure sensor located proximate to the distal tip of the bronchoscope itself enables the measurement and display of a regional pulmonary flow, pressure, and derived volume distal to the occlusive mechanism.

[0078] The occluding element may be generally similar to the accessory embodiments described herein, for example, comprising reinforcement structures, bioabsorbable materials, radiopaque materials, coatings and the like. Similarly, the occluding element may include one or more sensors for measuring characteristics of various gases communicated to and from the pulmonary region.

[0079] In accordance with various aspects of the present disclosure, as with the accessories described above, the integrated occluding element may at least partially surround an area proximate to the distal end of the bronchoscope. In accordance with some aspects, the occluding element may have various shapes and configurations depending upon the particular application or use, such as helix and circumferential and partially circumferential shapes, among others.

[0080] In accordance with various aspects of the present disclosure, the integrated occluding element may comprise an inflatable occlusive element, such as a balloon. For example, the inflatable occlusive element may comprise an inflatable sleeve configured to surround a shaft of the bronchoscope proximate to a distal tip and to expand radially to form a circumferential seal in the bronchial passage.

[0081] In inflatable occlusive element embodiments, the occluding element actuator includes an inflation fluid that is delivered or evacuated to and from the1981500.00216inflatable occlusive element via an occluding element actuator lumen to inflate or deflate the occlude. The inflation fluid is at least one of a liquid and a gas and may optionally include a radiopaque occluding element. In accordance with various aspects of the present disclosure, inflation of the inflatable element require a low enough inflation volume that is sufficient to deploy the inflatable element but without materially altering the flexibility of the bronchoscope shaft.

[0082] In accordance with various other aspects of the present disclosure, the occluding element comprises a mechanically expandable structure, such as radially deployable struts, arms, braided members, helically wound elements, or umbrella-like frameworks similar to expandable stent grafts, occluding devices, and the like made of various biocompatible materials that expand outward when actuated.

[0083] In accordance with various other aspects of the present disclosure, mechanical expansion may be achieved through proximal actuation mechanisms such as guide wires, pull wires, push rods, sliding sheaths, or rotational elements. The mechanically expandable structure may be covered with or coupled to a flexible occlusive membrane to enhance sealing and reduce air or fluid leakage. Mechanically expandable occlusive structures may provide predictable expansion geometry and may be advantageous in airways where inflation-based occlusion is undesirable or impractical.

[0084] The above being noted, non-limiting exemplary embodiments of devices and systems contemplated herein are discussed in detail with reference to the Figures.Modular Bronchoscope Accessory Systems

[0085] As noted above, in some embodiments in accordance with the present disclosure, a modular accessory device for use in connection with a bronchoscope is contemplated. These embodiments enable selective reinflation, pressure-mediated2081500.00216therapy, and segmental airway management without requiring structural modification of the bronchoscope itself, thereby preserving compatibility with existing clinical workflows and instrumentation.

[0086] The system includes a distal accessory assembly configured to be positioned on or along a distal portion of a bronchoscope insertion shaft. For example, in one embodiment, the distal accessory assembly comprises a sleeve or sheath carrying an occlusive element positioned at a predetermined axial location relative to the distal tip of the bronchoscope. The sleeve may be elastomeric and configured to be rolled, unrolled, cinched, adhered, or otherwise secured to the bronchoscope shaft such that the occlusive element maintains a fixed positional relationship with the bronchoscope during navigation, deployment, and therapy.

[0087] The occlusive element may comprise an inflatable balloon, a reinforced balloon, a mechanically expandable structure, or a hybrid configuration, and is configured to selectively isolate a target bronchopulmonary segment when deployed. An actuation pathway for the occlusive element extends proximally along the sleeve and terminates at a proximal control interface. The actuation pathway may be fluidic, mechanical, or electromechanical, depending on the occlusive element design. The accessory assembly may be provided as a disposable component, a reusable component, or part of a sterile procedural kit.

[0088] The system further comprises a proximal inflation and therapy control manifold configured to fluidly couple to the bronchoscope and the distal accessory assembly. The control manifold is configured to deliver controlled pressurization to an isolated airway segment and includes one or more standard connectors compatible with clinical oxygen tubing, ventilator circuits, manual resuscitation bags, or regulated gas sources. The manifold includes an adjustable flow control interface enabling the2181500.00216clinician to regulate delivered flow and pressure.

[0089] The control manifold further includes a passive pressure relief mechanism configured to automatically vent excess pressure upon reaching a predetermined maximum pressure threshold, thereby limiting peak airway pressure independent of clinician response or electronic control. In certain embodiments, the manifold further includes optional ports for manometry, PEEP control, suction, or sensing. Delivery of pressurization may be initiated and terminated instantaneously by the clinician, including via existing bronchoscope suction or control interfaces, enabling momentary and repeatable reinflation maneuvers with immediate cessation of flow.

[0090] During use, the bronchoscope retains full functionality for visualization, suction, irrigation, and delivery of medical instruments through its working channel. The modular system enables selective reinflation to restore access to atelectatic regions, manage bleeding, deliver therapeutic agents, or improve visualization for diagnostic and interventional procedures while maintaining standard bronchoscopic operation.

[0091] For example, FIG. 1 illustrates a modular bronchoscope accessory system according to one embodiment of the present disclosure and FIG. 28 illustrates a bronchoscope accessory system positioned within a target bronchial branch with an occlusive balloon sleeve assembly 101 deployed at or near the branch ostium. A microinflation lumen 102 extends along the airway wall to provide inflation media to the occlusive balloon sleeve assembly 101, enabling selective sealing and isolation of the targeted pulmonary segment.

[0092] FIG.1 shows a distal portion of a bronchoscope insertion shaft carrying a conformable occlusive sleeve positioned proximate (near) the distal tip. The2281500.00216occlusive sleeve includes an expandable balloon configured to assume a substantially rounded, circumferential geometry when inflated, enabling atraumatic sealing within a narrow or curved bronchial branch. The occlusive sleeve is secured to the bronchoscope shaft such that the balloon maintains a fixed axial position relative to the distal end during navigation and deployment. In this embodiment, the inflation pathway for the balloon is integrated into the sleeve structure and is not externally visible in the rendering. The configuration shown is representative of a low-profile delivery state and an expanded occlusive state suitable for selective airway isolation and localized therapy delivery.

[0093] With reference to FIG. 2, an embodiment of a modular selective airway isolation and therapy delivery system comprising a bronchoscope 300, a distal occlusive balloon sleeve assembly 101, and a handheld inflation control manifold 200 are illustrated. The system is configured to enable selective isolation of a target airway segment while preserving full bronchoscope functionality, including visualization, suction, irrigation, and instrument delivery, and to permit controlled, pressure-limited delivery of gas or other therapies to the isolated segment.

[0094] With brief reference now to FIG. 21, a functional block diagram of an inflation control system according to various aspects of the present disclosure is shown. As illustrated, a gas or therapy source provides pressurized gas or therapeutic media to an inflation control manifold. The inflation control manifold comprises a flow control element configured to regulate delivered flow and a passive pressure relief valve configured to limit maximum delivered pressure to a predefined safe threshold. In some embodiments, the pressure relief valve is set to vent automatically at a pressure below clinically accepted peak inspiratory and plateau pressures, thereby preventing over-pressurization of an isolated airway segment.2381500.00216

[0095] With reference back to FIG. 2, the inflation control manifold 200 may further include one or more optional monitoring or access ports configured for pressure measurement, manual verification, or auxiliary connections. Downstream of the inflation control manifold, a bronchoscope interface couples the controlled flow to a bronchoscope working channel or dedicated delivery pathway. Gas or therapy is then delivered to a distal airway segment that has been isolated by an occlusive balloon sleeve assembly 101, enabling targeted reinflation, ventilation, irrigation, suction, or therapeutic delivery.

[0096] The bronchoscope 300 is a flexible or rigid bronchoscope configured for navigation within the tracheobronchial tree and for performing diagnostic and therapeutic pulmonary procedures. The bronchoscope includes a suction channel 303 having a user-actuated on-off control valve that permits selective delivery of gas or fluid and enables immediate cessation of flow when released, thereby sealing the channel and preserving access to the working channel during use. The bronchoscope further includes a working channel access port 302 configured to receive medical instruments, irrigation, or therapeutic delivery tools. A distal tip navigation control 301 enables controlled extension, flexion, or steering of the distal flexible tip of the bronchoscope, and an eyepiece or camera head provides real-time visualization of the airway during navigation, isolation, and therapy delivery.

[0097] The inflation control manifold 200 is a compact, handheld device configured to regulate delivery of pressurized gas or therapeutic flow to the bronchoscope while providing passive pressure-limiting safety. The manifold includes a gas or therapy source inlet, such as a Luer lock or oxygen tubing fitting, configured to interface with wall oxygen, ventilator outlets, portable oxygen sources, or other regulated gas or therapy supplies using standard clinical connectors. The manifold2481500.00216further includes a passive pressure relief valve 201 that may incorporate an adjustable dial that allows a clinician to select a maximum allowable delivery pressure within a safe physiological range appropriate for selective lobar or segmental inflation. In preferred embodiments, the pressure relief valve is configured to automatically vent excess pressure at a threshold below conventional peak inspiratory pressure limits and below clinically accepted plateau pressure thresholds, thereby enabling effective reinflation of an isolated lung segment while substantially reducing the risk of barotrauma or volutrauma. By way of non-limiting example, the pressure relief valve may be configured to vent at acceptable peak and plateau pressures, or within a comparable safety margin, permitting safe recruitment of a lung lobe without exceeding lung-protective ventilation parameters. The pressure relief valve operates passively and independently of electronic sensors or active feedback control, immediately venting excess pressure when the selected threshold is reached. In some embodiments, the inflation control manifold 200 may also comprise at least one of a pressure regulator, needle valve, precision metering valve, flow meter, pressure gauge, adjustable pressure relief valve, selector valve, and a fixed flow restrictor to precisely control the pressure and flow rate of the pulmonary fluid.

[0098] An outlet connector couples the inflation control manifold to the bronchoscope suction channel 303, enabling controlled delivery of gas or therapy while maintaining compatibility with existing clinical workflows and standard oxygen delivery infrastructure. A separate connector for suction is incorporated into the inflation control manifold 200, with integrated switch to allow changing from suction to insufflation. A working channel entry port 302 is preserved, enabling distal insufflation and simultaneous use of the working channel. In some circumstances, the inflation control manifold may be coupled to the main working channel port 302.2581500.00216

[0099] The distal occlusive balloon sleeve assembly 101 is configured to be positioned along a distal portion of the bronchoscope insertion shaft and to maintain a fixed axial relationship with the bronchoscope distal tip during navigation and deployment. The occlusive balloon sleeve assembly 101 carries a conformable balloon that is expandable to form a circumferential seal against an airway wall when inflated, thereby isolating a target bronchial segment for selective reinflation or localized therapy delivery. In some embodiments, the balloon may be nonconformable. A microinflation lumen 102 extends proximally from the occlusive balloon and is constructed from a non-kinkable, semi-rigid micro-lumen material. The microinflation channel is dimensioned to deliver very small inflation volumes, typically on the order of approximately one to two cubic centimeters, sufficient to fully deploy the occlusive balloon while minimizing bulk and interference with bronchoscope maneuverability. A pilot balloon 103 is fluidly coupled to the occlusive balloon to provide visual and tactile confirmation of inflation status, and an inflation port 104, such as a Luer lock fitting, is configured to receive a small syringe or inflation device for controlled inflation and deflation of the occlusive balloon.[000100] In use, the occlusive sleeve assembly enables selective isolation of a target airway segment without obstructing the bronchoscope working channel. The inflation control manifold delivers regulated gas or therapy through the bronchoscope suction and inflation channel while the passive pressure relief valve limits peak pressure to a clinician-selected safe threshold. This configuration allows targeted reinflation, irrigation, suction, or therapeutic delivery to an isolated airway segment while preserving visualization, instrument access, and immediate manual control of airflow.[000101] With reference to FIG. 3, an alternative embodiment of a modular2681500.00216bronchoscope accessory is illustrated. FIG. 3 shows an assembly of a bronchoscope 300 having a distal occlusive balloon sleeve assembly 101 fluidly coupled to a dedicated microinflation lumen 102 extending externally or alongside the bronchoscope insertion tube. The microinflation lumen may include a small clip to temporarily secure it to the proximal end of the bronchoscope’s shaft during deployment. A pilot balloon 103 is fluidly coupled to the occlusive balloon to provide visual and tactile confirmation of inflation status, and an inflation port 104, such as a Luer lock fitting, is configured to receive a small syringe or inflation device for controlled inflation and deflation of the occlusive balloon.[000102] A proximal control manifold mounted near the handle includes a channel selection control valve 204, a first suction channel connector 202, a second pulmonary fluid channel connector 203 configured for insufflation, and a pressure relief valve 201 to regulate safe pressure delivery of fluid. The bronchoscope’s suction channel 303 may have a standard luer lock or oxygen tube fitting that connects to the inflation manifold proximal to the channel selection control valve 204 ensuring a tight seal. Working channel access port 302 enables the passage of medical devices or fluids through the bronchoscope. A navigation control 301 is provided for articulation of the bronchoscope's distal tip.[000103] With reference to FIGS. 4A-D, an occlusive balloon sleeve assembly 101 carried on a shaft of bronchoscope 300 and used with a removable segmented support sleeve 600 positioned radially outward of the shaft during loading and placement is illustrated. The removable segmented support sleeve 600 has a generally tapered or enlarged profile that temporarily maintains the occlusive balloon sleeve assembly 101 at a diameter greater than the outer diameter of the shaft of a bronchoscope 300 to facilitate mounting and positioning. A microinflation lumen 102 extends proximally to2781500.00216provide inflation media to the occlusive balloon sleeve assembly 101 after the support sleeve has been removed. A withdrawal member or guide 601 may be coupled to the segmented support sleeve 600 to assist in removal.[000104] In this embodiment, the support sleeve 600 is formed from a breakable low-friction structure comprising a plurality of circumferential segments, such as at least four separable plastic segments, arranged beneath the occlusive balloon sleeve assembly 101. After the occlusive balloon sleeve assembly 101 is positioned on the shaft of a bronchoscope 300, the removable segmented support sleeve 600 is fractured or separated into individual pieces and sequentially withdrawn from beneath the balloon sleeve, as shown in FIG. 4B. Removal of the segmented support sleeve permits the occlusive balloon sleeve assembly 101 to relax onto the shaft of a bronchoscope 300 without prolonged stretching or deformation. The removable segmented support sleeve 600 may be formed from a sufficiently rigid yet frangible sheath comprised of a polymeric material having a low-friction outer surface to reduce abrasion, tearing, or distortion of the balloon sleeve during segment removal. After removal of the removable segmented support sleeve 600, the occlusive balloon sleeve assembly 101 may be inflated with an inflation fluid through a microinflation lumen 102 to assume the expanded occluding configuration shown in FIG. 4D.[000105] With reference now to FIG. 5, a distal occlusive sleeve according to another embodiment of the present disclosure is illustrated. Fig. 5 shows a sleeve configured to be positioned over a distal portion of a bronchoscope insertion shaft. The sleeve carries an expandable occlusive balloon arranged circumferentially around the shaft and configured to transition between a low-profile delivery state and an expanded occlusive state. In the expanded state shown, the balloon assumes a substantially rounded, radially symmetric geometry adapted to conform to the inner2881500.00216wall of a bronchial passage, including narrow or curved airway segments. The sleeve defines a central lumen aligned with the bronchoscope working channel, permitting continued airflow, visualization, suction, irrigation, or instrument passage distal to the occluding element. An inflation pathway for the balloon is integrated into the sleeve structure and is shown entering the balloon region laterally, enabling controlled expansion without protruding beyond the sleeve profile. The distal occlusive sleeve is configured to remain axially fixed relative to the bronchoscope during navigation and deployment, thereby enabling selective airway isolation and localized therapy delivery.[000106] With reference now to FIGS. 6A-D, various views of a distal occlusive sleeve and balloon assembly according to an embodiment of the present disclosure are illustrated. FIG. 6A is a perspective view of the sleeve in an uninflated or low-profile configuration. The sleeve is generally cylindrical and defines a central longitudinal lumen configured to receive and surround a distal portion of a bronchoscope insertion shaft. The outer surface of the sleeve is smooth and continuous to permit atraumatic advancement through the airway.[000107] FIGS. 6B-C are front and rear views showing longitudinal cross-sections of the sleeve in an inflated configuration, illustrating two representative internal diameter configurations suitable for different airway sizes. In the inflated state, the occlusive balloon expands radially outward from the sleeve to form a substantially rounded, bulbous geometry with smooth transitions at its proximal and distal ends. This rounded geometry is configured to conform circumferentially to the inner wall of a bronchial passage, including narrow or curved airway segments, to achieve effective occlusion while minimizing localized pressure points.[000108] FIG. 6D is an end view showing a transverse cross-section through a midline of the inflated occlusive balloon illustrating the concentric relationship between2981500.00216the central lumen, which remains open to permit airflow, visualization, suction, irrigation, or instrument passage, and the surrounding balloon wall. The balloon wall has a substantially uniform thickness and expands symmetrically around the central lumen to provide circumferential sealing.[000109] The illustrated sleeve and balloon assembly is configured to transition between the low-profile and inflated states without axial displacement relative to the bronchoscope, enabling selective airway isolation and localized therapy delivery while preserving access through the bronchoscope working channel.[000110] With reference now to FIGS. 7-18, in accordance with various aspects of the present disclosure, various embodiments, configurations and functionalities of bronchoscope accessories are illustrated. For example, FIG. 7 shows a device with a balloon occlusion mechanism secured to a bronchoscope using an attachment mechanism extending proximally along the bronchoscope shaft. FIG. 8 illustrates a device featuring an accordion style or “scrunched” outer attachment mechanism for placement on a bronchoscope. FIG. 9 illustrates a device with an extended outer attachment mechanism extending down the bronchoscope shaft, with the balloon in an inflated state.[000111] FIG. 10 illustrates a bronchoscope with a device releasably attached utilizing a clip mechanism and FIG. 11 shows the clip mechanism detached from the bronchoscope during partial inflation of the balloon occlusion mechanism.[000112] FIG. 12 illustrates a “C-shaped” device positioned adjacent to a bronchoscope in a delivered state, FIG. 13 provides a cross-sectional view of the C-shaped device in the delivered state, and FIG. 14 shows a cross-sectional view of the device in a deployed state, illustrating the inflated occlusion balloon and expanded central lumen for the delivery of pulmonary fluid.3081500.00216[000113] FIG. 15 illustrates a device detachably attached to a bronchoscope utilizing a knot-based attachment mechanism, while FIG. 16 shows a device detachably attached using a hook-shaped attachment mechanism.[000114] FIG. 17 illustrate various balloon occlusion devices compatible with standard guidewire exchange techniques, and FIG. 18 illustrates a balloon occlusion device incorporating a large central lung inflation lumen.[000115] With reference now to FIG. 31, in accordance with various aspects of the present disclosure, an embodiment of the bronchoscope accessory is shown. This device may be placed into position under bronchoscopic visualization or guidewire. A dual-lumen elongated body 900 has a distal inflatable balloon 901 enabling the isolation of a pulmonary region, with a large lumen for the delivery of pulmonary fluid and a micro-lumen 902 for the inflation of the distal occlusive balloon 901. A pilot balloon 103 provides tactile confirmation of distal balloon deployment. The occlusive balloon 901 is inflated via a syringe or fluid source that attaches to a standard port 904, such as a Luer lock, connected to the pilot balloon 103. An inflation manifold is coupled with the main lumen of the dual-lumen elongated body 900 for the delivery of pulmonary fluid. A standard fitting, such as a Luer lock connects the dual-lumen elongated body 900 to the inflation manifold, which comprises a pressure relief valve 201, and a second standard fitting 907 that may be coupled with a fluid source, such as wall oxygen or ventilation tubing. In this embodiment, the system may be temporarily attached to a bronchoscope via a clip, hook, adhesion, or other mechanisms. Alternatively, a guide wire may be delivered through the main lumen of 900, enabling positioning within the bronchopulmonary region.Integrated Bronchoscope Embodiment[000116] As noted above, in some embodiments in accordance with the present3181500.00216disclosure, a bronchoscope configured for standard pulmonary diagnostic and interventional procedures integrates a selectively deployable occlusive element at or near a distal portion of the bronchoscope. The occlusive element may comprise an inflatable balloon or a mechanically expandable structure and is configured to isolate a target bronchopulmonary segment once a desired location within the airway is reached.[000117] Standard features of the bronchoscope may include, without limitation, a working channel, an imaging sensor, an illumination source, and a steering mechanism. The working channel may be used for suction, irrigation, lavage, delivery of fluids, delivery of medical instruments, and performance of interventional procedures including biopsy, ablation, sampling, or placement of therapeutic devices. The working channel remains fully functional for these purposes independent of the selective isolation and reinflation functions described herein. In some embodiments, the delivery of pulmonary fluid may be through its own dedicated lumen, enabling simultaneous insufflation and the passage of medical devices through the working channel of the bronchoscope.[000118] The occlusive element may be positioned proximate to the distal end of the bronchoscope and, when deployed, forms a conformable circumferential seal with the airway wall to isolate a target lung segment. Inflation or deployment of the occlusive element may be monitored via pressure feedback, tactile indicators, visual indicators, or combinations thereof.[000119] Once bronchopulmonary isolation is achieved, controlled insufflation of the isolated lung segment may be performed using a dedicated gas delivery pathway that may be separate from routine suction and irrigation pathways of the working channel. Pressurization may be used to deliver air, oxygen, mixed gases, fluids,3281500.00216aerosols, diagnostic agents, or therapeutic substances to the isolated segment. In some embodiments, limited pressurization may also be delivered through the working channel while maintaining its availability for suction, irrigation, and instrument passage.[000120] The bronchoscope embodiment further includes an integrated gas inlet, internal flow regulation pathways, and a passive pressure relief mechanism functionally equivalent to an external inflation manifold. The pressure relief mechanism may be configured to automatically vent excess pressure upon reaching a predetermined maximum pressure threshold, thereby limiting peak airway pressure without requiring electronic control or clinician intervention. In other embodiments, the pressure relief mechanism may be directly controlled by the clinician to achieve various flow and pressure rates. Flow rate may be adjusted via a user-actuated control, and delivery may be initiated and terminated instantaneously by the clinician, enabling momentary and repeatable reinflation maneuvers.[000121] In certain embodiments, optional ports for pressure monitoring, PEEP control, or manometry may be integrated into the bronchoscope handle or housing. The integrated system provides the same safety, workflow compatibility, and pressurelimiting functionality as external manifold embodiments while eliminating the need for separate attachments and enabling a fully self-contained bronchoscope platform suitable for intensive care, interventional pulmonology, surgical, transport, and austere environments.[000122] For example, FIG. 19 illustrates an embodiment of an integrated bronchoscope system in accordance with the present disclosure, in which airway isolation and controlled therapy delivery functionality are incorporated directly into the bronchoscope structure. As illustrated, the assembly of an integrated bronchoscope3381500.00216300 includes an elongated insertion shaft terminating at a distal end that carries a conformable or non-conformable occlusive element 100. The occlusive element 100 is integrated with or mounted circumferentially around the distal portion of the insertion shaft and is configured to transition between a low-profile delivery state and an expanded occlusive state. In the expanded state, the occlusive element forms a rounded, circumferential seal adapted to conform to the inner wall of a bronchial passage, enabling selective isolation of a target airway segment distal to the balloon.[000123] An inflation pathway for the distal occlusive element 100 may extend proximally from the balloon through a micro-inflation lumen embedded within the wall of the bronchoscope insertion shaft and proximal flexible section. The micro- inflation lumen has an outer diameter of less than approximately 1 mm and is configured to deliver a small inflation volume sufficient to expand the balloon without materially affecting shaft flexibility. The micro-inflation lumen terminates proximally in a pilot balloon 103 and Luer lock connector assembly 108, enabling manual inflation and deflation using a small syringe. In other embodiments, the occlusive element is mechanically actuated into its expanded state.[000124] The bronchoscope handle may include an integrated passive pressure relief valve 201 configured to limit maximum pressure delivered through the bronchoscope to a predefined safe threshold. In certain embodiments, the pressure relief valve is configured to vent automatically at a pressure below clinically accepted peak inspiratory and plateau pressures, thereby reducing the risk of overpressurization of an isolated airway segment during targeted reinflation or therapy delivery.[000125] A gas or therapeutic pulmonary fluid channel connector 203 may be integrated into the handle and configured to couple to standard oxygen tubing or other3481500.00216gas or therapy sources via a Luer lock or equivalent connector. The inlet port may be fluidly coupled to an internal delivery pathway that communicates with the bronchoscope working channel and / or a dedicated therapy lumen.[000126] The integrated bronchoscope may further include a distal tip navigation control 301 operable by a control input on the handle to deflect the distal tip during navigation. An optical system 306, which may include an eyepiece or camera head, can provide visualization of the airway during insertion and use. A suction channel connector 202 communicates with the distal end to permit removal of fluids or gases. A working channel entry port 302 provides access to an internal working lumen for delivery of air, fluids, irrigation, suction, or medical instruments such as forceps, baskets, or other therapeutic devices.[000127] A proximal flexible or rigid section or articulation arm 305, also referred to herein as a flexible neck or proximal flexible shaft or bronchoscope shaft, connects the handle to the insertion shaft and houses internal lumens, wiring, and control pathways while permitting ergonomic manipulation and positioning of the bronchoscope during use.[000128] With reference now to FIG. 20, another embodiment of an integrated bronchoscope system in accordance with the present disclosure is shown. FIG. 20 shows the assembly of a bronchoscope 300 having a distal occlusive element 100 positioned near the distal insertion portion and fluidly coupled to an inflation lumen or actuator lumen extending proximally through or along the bronchoscope body. A proximal control manifold is mounted near the handle region and includes a channel activation button 701 with a first suction channel connector 202 configured for suction and a second pulmonary fluid channel connector 203 configured for insufflation. A pressure relief valve 201 maintains a predetermined maximum insufflation pressure3581500.00216within the system. A proximal control actuator 700 is positioned on the bronchoscope body to selectively actuate deployment of the occlusive element 100. A navigation control 301 is configured to control distal tip articulation of the bronchoscope, and an additional working channel access port 302 enables passage of medical devices, sensors, or fluid through the bronchoscope.[000129] In this integrated embodiment, selective airway isolation, controlled reinflation, suction, irrigation, visualization, and therapeutic delivery are achieved without the need for external accessory attachments, while preserving compatibility with standard clinical workflows and gas delivery infrastructure.Inflation Delivery Manifold[000130] In accordance with various aspects of the present disclosure, the inflation manifold may comprise a compact, self-contained assembly configured to connect proximally to a pressurized gas source and distally to a bronchoscope. The manifold may be provided as a standalone accessory attachable to an external bronchoscope or may be fully integrated into an integrated bronchoscope embodiment. In accordance with various aspects of the present disclosure, the manifold includes one or more internal lumens forming a controlled flow path between the gas source and the bronchoscope working channel or dedicated therapy channel.[000131] In accordance with various aspects of the present disclosure, the manifold may include one or more standard fittings compatible with commonly used clinical gas interfaces, including wall oxygen outlets, ventilator circuits, portable oxygen cylinders, or other regulated gas sources. Such fittings may include standard oxygen tubing connectors or ISO-compatible fittings commonly used in respiratory care environments. This configuration allows the manifold to be incorporated into existing ICU, operating room, and interventional pulmonology workflows without3681500.00216requiring specialized or proprietary gas delivery equipment.[000132] In accordance with various aspects of the present disclosure, the manifold may include a user-adjustable flow control mechanism, such as a rotary dial, valve, or restrictor, configured to regulate the rate of gas delivery through the manifold. The flow control mechanism allows the clinician to adjust delivery in a simple, intuitive manner while maintaining continuous tactile control. The flow control may be purely mechanical, requiring no electronic control or external power, thereby enhancing reliability and suitability for use in transport or austere environments.[000133] In accordance with various aspects of the present disclosure, the inflation manifold may comprise a passive pressure relief valve configured to automatically vent gas when pressure within the system exceeds a predetermined maximum threshold. The pressure relief valve is designed to limit peak inspiratory pressure delivered to the isolated airway segment. The pressure relief valve may be calibrated to a fixed pressure or may be adjustable within a safe clinical range. The valve operates mechanically and does not require sensors, electronics, or user intervention to function. Upon reaching the maximum pressure threshold, the valve releases excess gas to atmosphere, thereby preventing over-pressurization of the airway. This passive safety feature provides inherent protection against barotrauma and allows the manifold to be safely used in conjunction with manual or regulated gas sources.[000134] In accordance with various aspects of the present disclosure, the manifold may be configured to connect to the bronchoscope such that gas delivery is controlled by the bronchoscope’s existing suction or working channel control mechanism. For example, in one exemplary, non-limiting configuration, the manifold interfaces with the bronchoscope working channel such that activation of a suction3781500.00216toggle, valve, or button on the bronchoscope initiates gas delivery. Release of the control immediately terminates gas flow, allowing the clinician to use the bronchoscope control as a “deadman switch.” This configuration enables instantaneous cessation of therapy without requiring manipulation of the manifold itself, enhancing procedural safety and ease of use.[000135] In accordance with various aspects of the present disclosure, the manifold further may include one or more auxiliary ports, such as:• a manometry port for connection to a pressure gauge or pressure sensor, and / or• a PEEP port configured to maintain a minimum expiratory pressure during therapy delivery.[000136] These ports may be optional and selectively included depending on the intended clinical use or level of monitoring required.[000137] In accordance with various aspects of the present disclosure, the manifold may be configured to be miniaturized and lightweight, allowing it to be mounted on, adjacent to, or integrated within the bronchoscope without significantly increasing procedural complexity or obstructing clinician movement. The manifold’s design may be compatible with various now known or as yet unknown bronchoscopy workflows, allowing clinicians to deliver localized therapy using familiar controls and interfaces.[000138] In accordance with various aspects of the present disclosure, in connection with integrated bronchoscope embodiments, the functionality of the inflation manifold — including flow regulation, a passive pressure relief valve, and optional monitoring ports — may be incorporated directly into the bronchoscope housing or handle. In such embodiments, the bronchoscope may comprise an 3881500.00216integrated gas inlet, internal flow control pathways, and a passive pressure relief mechanism functionally equivalent to the external manifold. The integrated system provides the same safety and workflow advantages while eliminating the need for external attachment.[000139] With reference now to FIG. 27, an exemplary Y-valve control manifold configured for selective fluid communication with a bronchoscope working or suction channel is illustrated. The manifold includes a female connector 205 configured for attachment to a bronchoscope suction port or working channel port, a first barbed suction channel connector 202 configured for connection to a wall suction source, and a second barbed pulmonary fluid channel connector 203 configured for connection to an insufflation fluid or therapeutic agent source. A user-actuatable channel selection control valve 204 is provided at the junction of the manifold to selectively place the bronchoscope channel in fluid communication with either the suction source or the insufflation source. A pressure relief valve 201 regulates the pressure of the pulmonary fluid to the pulmonary region.Detachable Bronchoscope-Delivered Occlusion and Therapy[000140] In accordance with various aspects of the present disclosure, a selective airway isolation and therapy device may be configured to be delivered to a target bronchopulmonary location with the assistance of a bronchoscope and to subsequently operate independently of the bronchoscope after placement.[000141] In these embodiments, the bronchoscope is used to navigate the device through the airway to a target location. Once the device is positioned, the bronchoscope may be partially or fully withdrawn from the patient while the device remains in place. Removal of the bronchoscope from the airway may increase available cross-sectional area within an endotracheal tube or airway conduit, thereby3981500.00216improving airflow to non-target lung regions during therapy delivery.[000142] The device includes an occlusive mechanism configured to isolate a target airway segment and at least one lumen configured to deliver gas or other therapy distal to the occlusive mechanism. Following delivery, the device may be operated independently of the bronchoscope to perform selective reinflation or localized therapy while normal ventilation continues elsewhere in the lung.[000143] In some embodiments, the device has an overall profile smaller than that of the bronchoscope, allowing reinflation pressure to be maintained for extended durations without significantly interfering with mechanical ventilation or spontaneous breathing.[000144] The device may be configured to remain at the target location after completion of an initial therapy cycle, with the occlusive mechanism deflated or disengaged. This configuration allows confirmation of therapeutic success or subsequent re-treatment without requiring repeat bronchoscopic navigation.[000145] In accordance with various aspects of the present disclosure, the device may be detachably coupled to a bronchoscope during navigation and subsequently released. Detachable attachment mechanisms may include, but are not limited to, by way of example:• a clip mechanism configured to secure the device to the bronchoscope during navigation and to disengage upon partial deployment of the occlusive mechanism;• a loop, knot, or cinch structure configured to tighten around a distal portion of the bronchoscope and to be released by actuation of a secondary pull element;a hook-shaped or alignment feature configured to engage a working 4081500.00216lumen or distal opening of the bronchoscope to maintain alignment during delivery;• an adhesive interface configured to temporarily retain the device along the bronchoscope shaft and to release upon deployment of the occlusive element.[000146] In accordance with various aspects of the present disclosure, the attachment mechanism may be defeated intentionally by the clinician or automatically upon actuation of the occlusive mechanism, allowing the bronchoscope to be withdrawn while the device remains deployed.[000147] In accordance with various aspects of the present disclosure, the accessory device or bronchoscope may include one or more lumens, including: a lumen for actuation of the occlusive mechanism and a lumen for delivery of gas or other therapeutic media distal to the occlusion. In accordance with some aspects, the device has a non-circular or asymmetric cross-sectional profile, such as a semicircular or C-shaped profile, to reduce overall diameter during navigation alongside a bronchoscope. In certain embodiments, one or more lumens are collapsible during delivery and expand upon deployment of the occlusive mechanism to increase therapy delivery capacity. The occlusive mechanism may comprise an inflatable structure, a mechanically expanding structure, or other occlusion configurations described elsewhere herein. In some embodiments, the device includes only a single therapy lumen in addition to a mechanical occlusion mechanism.[000148] In accordance with various aspects of the present disclosure, the device may be delivered over a guidewire previously positioned at the target location using a bronchoscope. The guidewire may be delivered through a working channel of the bronchoscope and left in place while the bronchoscope is withdrawn. The device may 4181500.00216then be advanced over the guidewire using known exchange techniques. One or more lumens of the device may be configured to accommodate commonly used pulmonary or cardiovascular guidewires. The guidewire may include a marker or indicator corresponding to the distal end of the device to assist in positioning prior to deployment. The device may further include a steerable or deflectable distal portion to facilitate navigation, with or without a guidewire.Occlusive Element Designs[000149] As previously noted, selective airway isolation systems described herein may employ one or more occlusive elements configured to form a circumferential seal within an airway lumen. The occlusive element enables isolation of a target bronchopulmonary segment distal to the occlusion, thereby permitting localized delivery of therapy while limiting exposure of non-target lung regions. The occlusive element may be positioned on or near a distal portion of a bronchoscope insertion shaft or on a modular accessory coupled thereto. The occlusive elements described herein and illustrated in the Figures, as well as other not depicted herein, may be used interchangeably across integrated bronchoscope embodiments and modular accessory embodiments. Selection of a particular occlusive element configuration may depend on airway size, anatomy, duration of isolation, type of therapy delivered, or procedural requirements. In certain embodiments, the occlusive element may be elongated to occlude or dilate a larger section of the bronchopulmonary region, such as during the treatment of a stricture.Inflatable Occlusive Elements[000150] In accordance with various aspects of the present disclosure, the occlusive element may comprise an inflatable structure configured to expand radially when inflated to contact an airway wall and form a substantially airtight seal. The4281500.00216inflatable structure may be formed from a compliant or semi-compliant elastomeric material selected to conform to irregular airway geometry.[000151] In accordance with various aspects of the present disclosure, the inflatable occlusive elements may be actuated via a fluidic inflation pathway extending from a proximal control interface to the distal occlusive element. Inflation media may include air, oxygen, saline, or other medically acceptable fluids, including radioopaque contrasts for visualization. The inflatable occlusive element may be inflated to a pressure sufficient to achieve sealing without causing excessive localized stress to airway tissue.[000152] In some embodiments, the inflatable occlusive element is positioned circumferentially around the bronchoscope shaft. In other embodiments, the inflatable occlusive element may be positioned at a location spaced proximally from the distal tip of the bronchoscope to accommodate visualization, instrumentation, or therapy delivery distal to the occlusion.Constrained and Reinforced Balloon Structures[000153] In accordance with various aspects of the present disclosure, the inflatable occlusive element may be constrained or reinforced to limit radial expansion and improve safety. The inflatable structure may be surrounded by, embedded within, or otherwise bonded to a reinforcing mesh, braid, or lattice structure. The reinforcing structure may be formed from polymeric filaments, metallic filaments, shape-memory materials, or combinations thereof.[000154] Constrained balloon structures may distribute radial force more evenly along the airway wall, reduce the risk of over-expansion, and improve sealing reliability across variable airway diameters. In some embodiments, the reinforcing structure defines a maximum expanded diameter of the occlusive element. Such constrained4381500.00216occlusive elements are particularly suitable for prolonged isolation, higher-pressure therapies, or applications involving fragile or diseased airway tissue.[000155] For example, a balloon sleeve may include a multi-layer composite wall construction having an inner silicone lining and an outer reinforced balloon layer configured to provide semi-conformable expansion and enhanced durability. The inner silicone layer may form a compliant sealing surface adapted to contact airway tissue and accommodate minor irregularities in luminal geometry. Surrounding the silicone lining is a reinforcement layer formed from one or more polymeric materials, including, by way of example, PTFE, silicone, nylon, Silastic, elastomeric composites, woven fibers, or other suitable reinforcement structures. The reinforced outer layer limits overexpansion, improves puncture and tear resistance, and imparts controlled semi-conformable behavior such that the balloon expands sufficiently to achieve circumferential sealing while maintaining dimensional stability under repeated inflation and deflation cycles.Hybrid Balloon-Mechanical Occluders[000156] In accordance with various aspects of the present disclosure, the occlusive element may comprise a hybrid configuration combining inflatable and mechanical features. For example, an inflatable balloon may be enclosed within a mechanically expandable frame or mesh that constrains expansion and provides structural support.[000157] Hybrid occluders may offer advantages of both inflatable and mechanical systems, including improved sealing, reduced inflation pressure, and enhanced resistance to migration or deformation. These configurations may be particularly useful in anatomically complex or irregular airways.Biodegradable and Therapeutic-Carrying Occlusive Elements4481500.00216[000158] In accordance with various aspects of the present disclosure, the occlusive element or a portion thereof may be formed from biodegradable or bioresorbable materials. Such materials may be configured to degrade or dissolve over a predetermined period following deployment, reducing the need for retrieval or removal in selected applications.[000159] In accordance with various aspects of the present disclosure, the occlusive element is configured to carry or deliver therapeutic materials. The occlusive element may include a surface coating, embedded matrix, or attached substrate carrying one or more therapeutic agents. Therapeutic agents may include, by way of non-limiting example, drugs, biologies, growth factors, hemostatic agents, or cellular or acellular graft materials.[000160] For example, in one exemplary embodiment, a biodegradable mesh or membrane associated with the occlusive element may carry an allogeneic or synthetic graft material configured for localized deposition within an isolated airway segment. Upon deployment and subsequent degradation or release, the therapeutic material may be deposited onto airway or parenchymal tissue adjacent to a lesion or target site.[000161] Therapeutic-carrying occlusive elements may be used in conjunction with reinflation therapy, bleeding control, oncologic interventions, or regenerative treatments.Therapy Delivery Modalities[000162] In accordance with various aspects of the present disclosure, following isolation of a target bronchopulmonary segment using one or more occlusive elements, the systems described herein enable localized delivery of one or more therapeutic modalities distal to the isolated region. Therapy delivery may occur4581500.00216through a bronchoscope working channel, a dedicated therapy lumen integrated into the bronchoscope or accessory system, or a combination thereof. Therapy delivery pathways are configured to operate independently of the occlusive element actuation pathway.[000163] The type, duration, and sequencing of therapy delivery may be selected based on the clinical indication, target anatomy, and procedural context.Gas Delivery for Reinflation and Pressure Modulation[000164] In accordance with various aspects of the present disclosure, therapy delivery comprises delivery of pressurized gas to the isolated airway region. Gas delivery may be used to promote reinflation of collapsed or under-ventilated lung tissue, to maintain airway patency, or to modulate local airway pressure for diagnostic or therapeutic purposes.[000165] Gas delivery may be continuous, intermittent, pulsed, or delivered according to a predefined pressure-time or volume-time profile. Delivered gases may include ambient air, oxygen-enriched air, oxygen, or other medically acceptable gas mixtures.[000166] Selective delivery of gas distal to the occlusive element enables localized reinflation without exposing non-target lung regions to elevated pressures. Pressure modulation may further be used to assess segmental compliance, confirm airway isolation, or facilitate subsequent therapy delivery.Fluid Delivery, Lavage, and Suction[000167] In accordance with various aspects of the present disclosure, therapy delivery comprises delivery of fluids to the isolated airway region. Fluids may include sterile saline, lavage solutions, contrast agents, or other medically acceptable liquids.[000168] Fluid delivery may be used for lavage, irrigation, mucus clearance, or4681500.00216preparation of tissue for subsequent therapy. In some embodiments, fluid delivery is combined with suction to remove secretions, blood, or debris from the isolated segment while maintaining isolation.[000169] Isolation of the airway segment enables more effective lavage and suction by preventing dilution or redistribution of fluids into adjacent lung regions. Drug and Biologic Delivery[000170] In accordance with various aspects of the present disclosure, the systems may be configured for targeted delivery of drugs, biologies, or other therapeutic compositions to an isolated airway segment. Therapeutic agents may include, byway of non-limiting example, bronchodilators, surfactants, mucolytics, antiinflammatory agents, antibiotics, antifibrotic agents, chemotherapeutic agents, immunotherapies, gene therapies, or combinations thereof.[000171] Delivery may occur in liquid, aerosolized, particulate, or gel form. Isolation of the airway segment enables high local concentration of therapeutic agents while reducing systemic exposure and off-target effects.[000172] In some embodiments, drug or biologic delivery is coordinated with gas delivery, pressure modulation, or mechanical expansion to enhance tissue penetration or distribution within the target region.Hemostatic and Bleeding Management Therapies[000173] In accordance with various aspects of the present disclosure, therapy delivery includes the management or containment of airway bleeding. Isolation of a target airway segment enables localized containment of bleeding associated with biopsy, cryobiopsy, tumor debulking, or other interventional pulmonology procedures.[000174] Hemostatic therapies may include delivery of fluids, foams, gels, powders, or biologic agents configured to promote coagulation or tissue sealing. In4781500.00216some embodiments, the occlusive element itself carries or deploys hemostatic material at the site of isolation.[000175] Selective airway isolation may be maintained during repeated therapeutic or diagnostic interventions, allowing sequential procedures to be performed within the same isolated segment while reducing risk of blood contamination of adjacent airways.Diagnostic and Functional Assessment Therapies[000176] In accordance with various aspects of the present disclosure, therapy delivery includes diagnostic or functional assessment modalities. Controlled delivery of gas or fluid to an isolated airway segment may be used to evaluate segmental compliance, airway patency, leak presence, or response to pressure modulation.[000177] Diagnostic agents such as contrast media, imaging tracers, or marker substances may be delivered to the isolated segment to facilitate imaging, localization of lesions, or assessment of treatment response.[000178] Selective isolation further improves visualization during bronchoscopic evaluation by reducing airway collapse, bleeding obscuration, or secretion migration from adjacent lung regions.Control, Safety, and Feedback Systems[000179] The bronchoscopic systems described herein may incorporate one or more control, safety, and feedback features configured to regulate airway isolation and therapy delivery. These features are intended to promote safe, repeatable operation across a range of clinical environments, patient populations, and therapeutic applications.[000180] Control and safety features may be implemented mechanically, pneumatically, electronically, or through combinations thereof, and may be integrated4881500.00216into the bronchoscope, an accessory system, or a proximal control manifold.Pressure Limiting and Overpressure Protection[000181] In accordance with various aspects of the present disclosure, the system may include one or more pressure-limiting mechanisms configured to prevent excessive pressure within an isolated airway segment or within an occlusive element. Pressure limiting may be applied independently to occlusive element actuation and to therapy delivery.[000182] Pressure-limiting mechanisms may include mechanical relief valves, compliant reservoirs, pressure-regulated valves, burst-limiting structures, or electronic pressure regulators. Such mechanisms may be configured to vent, restrict, or otherwise limit pressure above a predetermined threshold.[000183] Pressure limiting is particularly beneficial during delivery of pressurized gas for reinflation, during prolonged airway isolation, or when therapy delivery involves fragile or diseased airway tissue.Manual, Regulated, and Automated Therapy Sources[000184] Therapy delivery may be driven by a variety of sources, including manual, regulated, or automated systems. Manual sources may include user-actuated devices suitable for bedside, emergency, transport, or austere environments. Regulated sources may include hospital gas supplies, portable cylinders, or fluid delivery systems with built-in pressure regulation.[000185] In more some embodiments, therapy delivery may be controlled by automated systems incorporating electronically actuated valves or regulators. Automated systems may be configured to deliver predefined pressure, flow, volume, or timing profiles according to a selected therapy protocol.[000186] The system may be configured to interface with multiple therapy sources4981500.00216interchangeably, allowing clinicians to select an appropriate delivery mode based on clinical context.Sensor Integration and Feedback[000187] In accordance with various aspects of the present disclosure, the system incorporates one or more sensors configured to provide feedback regarding airway isolation or therapy delivery. Sensors may be positioned proximally, distally, or at intermediate locations along the therapy pathway.[000188] Sensor types may include pressure sensors, flow sensors, volume sensors, gas composition sensors, temperature sensors, or combinations thereof. Sensor output may be used to inform the clinician of current conditions within the isolated airway segment or to verify effective isolation.[000189] For example, a distal balloon assembly may comprise an integrated airflow sensing module configured to measure regional pulmonary flow, pressure, and derived volume distal to the occlusive balloon. The sensor may be embedded within the distal balloon region or catheter tip and include a miniature differential pressure sensor and a Microelectromechanical (MEMS) or thermal flow sensor positioned within a protected distal flow path or bypass channel that communicates with the isolated pulmonary segment.[000190] A microchannel within the shaft may transmit distal airway pressure to a pressure sensor, while the flow sensor detects inspiratory and expiratory gas movement within the targeted pulmonary region. A processor coupled to the airflow sensing module may derive instantaneous flow, regional delivered volume, exhaled volume, and pressure trends, with volume determined by integration of measured flow over time. Lung expansion may be assessed by a characteristic increase in measured volume accompanied by a momentary decrease in distal pressure, reflecting5081500.00216increased local compliance and regional expansion.[000191] Sensor output may be communicated to a digital display interface or integrated directly into an existing ventilator monitor, where the measured parameters are displayed in both numerical and graphical forms, including flow, pressure, and volume waveforms overtime, providing real-time visualization of distal lung expansion and pulmonary mechanics.[000192] Feedback may be provided through visual indicators, numerical displays, alarms, or tactile cues. In some embodiments, feedback is communicated to an external monitoring system or display.Closed-Loop and Algorithmic Control Embodiments[000193] In accordance with various aspects of the present disclosure, the system incorporates closed-loop control functionality in which sensor feedback is used to automatically adjust therapy delivery or occlusive element actuation. Closed-loop control may be implemented using a microcontroller, processor, or other control unit.[000194] Control algorithms may regulate delivered pressure, flow, volume, or duration based on sensed parameters, such as airway compliance, pressure response, or leak detection. Automated control may terminate or modify therapy delivery upon detection of predefined conditions, such as achievement of a target pressure profile or detection of excessive resistance.[000195] Closed-loop embodiments may be particularly useful for repeatable reinflation therapy, standardized diagnostic assessments, or integration with data logging, decision support, or remote monitoring systems.Clinical Use Case Embodiments[000196] Bronchoscopic systems described herein may be used across a variety of clinical scenarios in which selective airway isolation and localized pulmonary5181500.00216therapy are beneficial. The following use case embodiments are illustrative and not limiting.Intensive Care Unit Atelectasis Management[000197] In accordance with various aspects of the present disclosure, the system may be used to treat lobar or segmental atelectasis in critically ill patients, including patients receiving mechanical ventilation. Under bronchoscopic visualization, the bronchoscope is navigated to an airway supplying a collapsed or under-ventilated lung region. An occlusive element is deployed to isolate the target bronchopulmonary segment.[000198] Following isolation, pressurized gas is delivered distal to the occlusive element to promote selective reinflation of the collapsed lung tissue. Because therapy is localized, reinflation may be achieved without increasing global airway pressures applied to non-target lung regions, thereby reducing the risk of ventilator-associated lung injury.[000199] The occlusive element may be maintained in an expanded state during sustained or repeated therapy delivery and subsequently released once adequate reexpansion is achieved. The procedure may be repeated for additional lung segments as clinically indicated.Intraoperative Lung Isolation and Ventilation[000200] In accordance with various aspects of the present disclosure, the system may be used during surgical procedures requiring selective lung isolation or segmental ventilation, such as thoracic or cardiac surgery. The bronchoscope is positioned intraoperatively to isolate one or more airway segments using the occlusive element.[000201] Selective isolation allows ventilation, deflation, or stabilization of targeted lung regions while preserving ventilation in adjacent regions. This approach5281500.00216may improve surgical visualization, reduce the need for complete lung collapse, and allow intraoperative adjustment of lung management based on procedural requirements.Interventional Pulmonology Procedures[000202] In accordance with various aspects of the present disclosure, in interventional pulmonology applications, the system may be used to facilitate diagnostic or therapeutic procedures, including biopsy, cryobiopsy, tumor debulking, ablation, or airway intervention. Prior to or during the procedure, the occlusive element may be deployed to isolate the target airway segment.[000203] Isolation may be used to contain bleeding, prevent migration of blood or debris into adjacent airways, and maintain visualization during the procedure. The occlusive element may remain deployed during repeated instrument passes or sequential interventions within the same airway segment.[000204] In some embodiments, localized therapy delivery — such as lavage, drug administration, or hemostatic treatment — is performed through the isolated airway segment in conjunction with the interventional procedure.Lung Cancer Access, Visualization, and Therapy[000205] In accordance with various aspects of the present disclosure, the system may be used to improve access and visualization for lung cancer diagnosis and treatment. Atelectasis or airway collapse may obscure lesions or limit bronchoscopic access to peripheral lung regions. Selective isolation and localized reinflation may be used to reopen collapsed segments and improve visualization of target lesions.[000206] Following isolation, diagnostic agents, contrast media, or therapeutic compositions may be delivered locally to the lesion site. In some embodiments, the occlusive element or associated therapeutic carriers may be used to deposit drugs,5381500.00216biologies, or graft materials adjacent to or within the target lesion.Air Leak Localization and Bronchopleural Fistula Management[000207] In accordance with various aspects of the present disclosure, the system may be used to localize or manage air leaks, including bronchopleural fistulas. The bronchoscope is navigated to progressively isolate airway segments while monitoring air leak response through external indicators, such as chest drainage systems.[000208] Selective isolation allows identification of the airway segment contributing to the air leak and may be used to temporarily reduce or eliminate airflow to the affected region. Localized therapy, such as sealant or biologic delivery, may be performed within the isolated segment to promote closure or stabilization.Bronchopulmonary Stricture Management[000209] In accordance with various aspects of the present disclosure, the system may be used to treat bronchopulmonary strictures. The bronchoscope is navigated to the location of the stricture and a non-conformable occlusive mechanism is deployed at the point of the stricture to re-expand the bronchopulmonary region, restoring airflow.Portable and Austere Environment Embodiments[000210] In accordance with various aspects of the present disclosure, the bronchoscopic systems described herein are configured for use in portable, emergency, transport, or austere environments where access to conventional hospital infrastructure may be limited or unavailable. Such embodiments are particularly suited for military, disaster response, remote care, transport medicine, and low-resource clinical settings.[000211] FIG. 29 is a block diagram illustrating such a system, comprising a handheld, portable, lightweight portable power source, such as a battery pack or miniature5481500.00216solar panel array. The power source enables visualization of the pulmonary regions via the bronchoscope. In this embodiment, the mobile visualization system may be miniaturized, handheld, or configured in a mobile device application. The integrated bronchoscope or bronchoscope accessory coupled on the scope is then directed into the patient in an austere environment. A small hand held inflation manifold with a pressure relief valve couples with the bronchoscope and a fluid source, such as an Ambu bag, or portable oxygen source.Compact and Manual Operation Systems[000212] In accordance with various aspects of the present disclosure, the system may be configured for compact form factor and manual operation. Therapy delivery may be driven by manually actuated pressure or fluid sources, allowing selective airway isolation and localized therapy without reliance on centralized gas supplies, electrical infrastructure, or mechanical ventilators.[000213] Manual operation embodiments may be optimized for rapid deployment, minimal setup, and intuitive operation by trained personnel in emergency or field environments. Components may be packaged as sterile, single-use kits or as reusable systems with replaceable sterile interfaces.Battery-Powered and Solar-Assisted Bronchoscopic Systems[000214] In accordance with various aspects of the present disclosure, the bronchoscope comprises a portable device powered by an internal battery or external battery pack. Battery-powered embodiments may include integrated visualization, illumination, and steering functionality suitable for bedside, transport, or field use.[000215] In accordance with various other aspects of the present disclosure, the system may include solar-assisted charging or hybrid power configurations to extend operational duration in remote environments. Power management features may5581500.00216prioritize essential functions such as visualization and occlusive element actuation while minimizing overall energy consumption.[000216] Portable bronchoscopic systems may be used in combination with modular occlusive element accessories and proximal control manifolds to enable selective airway isolation and therapy delivery in environments lacking fixed infrastructure.Military, Transport, and Field Deployment Configurations[000217] In accordance with various aspects of the present disclosure, in military or field deployment embodiments, the system may be ruggedized to withstand vibration, temperature extremes, moisture, dust, and mechanical shock. Components may be sealed, reinforced, or otherwise protected to maintain functionality in harsh environments.[000218] Such embodiments may be configured for use in battlefield medicine, casualty evacuation, disaster response, or remote clinical settings. Selective airway isolation and localized therapy delivery may be used to manage atelectasis, airway bleeding, aspiration, or lung injury in patients prior to or during transport to higher-level care facilities.[000219] In some embodiments, the system may be configured to operate independently of mechanical ventilation, enabling selective pulmonary therapy in spontaneously breathing patients or patients receiving manual ventilation support. Pediatric, Neonatal, and Specialized Patient Embodiments[000220] In accordance with various aspects of the present disclosure, the bronchoscopic systems described herein may be configured for use in pediatric, neonatal, or other specialized patient populations in which airway size, tissue fragility, or ventilation requirements differ from those of adult patients.5681500.00216[000221] Scaled embodiments may include reduced-diameter bronchoscopes, smaller occlusive bronchoscope accessory elements, and therapy delivery pathways configured for lower volumes and pressures. Occlusive elements may be formed from highly compliant or low-force materials to reduce localized stress on delicate airway tissue. Pressure-limiting and feedback systems may be tuned for lower thresholds appropriate for pediatric or neonatal physiology.[000222] Such embodiments may be used to manage atelectasis, airway obstruction, or localized lung pathology in neonatal intensive care units, pediatric intensive care units, or specialized surgical settings. Selective airway isolation and localized therapy delivery may reduce reliance on global ventilation strategies that pose increased risk in small or fragile patients.[000223] Specialized embodiments may further be configured for use in patients with altered airway anatomy, congenital lung disease, neuromuscular disorders, or other conditions requiring individualized pulmonary management.Research, Diagnostic, and Development Applications[000224] In accordance with various aspects of the present disclosure, the systems described herein may be used in research, diagnostic, or development settings. Selective airway isolation and localized therapy delivery enable controlled modulation of pressure, flow, or therapeutic exposure within discrete bronchopulmonary segments, supporting a variety of investigative and evaluative applications.[000225] Such embodiments may be used in lung physiology research, imaging calibration, validation of diagnostic modalities, or development of computational and data-driven pulmonary models. Controlled isolation and pressure modulation may facilitate assessment of regional lung compliance, ventilation-perfusion relationships,5781500.00216or response to therapeutic interventions.[000226] In diagnostic contexts, selective isolation may be used to improve visualization, localize pathology, or deliver diagnostic agents or markers to targeted airway regions. Data collected through integrated sensors or monitoring systems may be used for analysis, training of machine-learning models, or refinement of clinical decision-support tools.[000227] Research and development embodiments may be implemented using integrated bronchoscopic systems, modular accessory configurations, or benchtop or simulated lung models incorporating components of the present disclosure.Materials, Manufacturing, and Sterilization[000228] The systems, components, and accessories described herein may be fabricated from biocompatible materials suitable for contact with respiratory tissues and compatible with applicable regulatory requirements. Material selection may vary based on intended use, duration of contact, sterilization method, and whether the embodiment is configured for single-use or reuse.Structural and Functional Materials[000229] In accordance with various aspects of the present disclosure, bronchoscopic components, accessory sleeves, occlusive elements, manifolds, and connectors may be formed from medical-grade polymers, elastomers, metals, or composites thereof. Suitable polymeric materials may include, by way of example, silicone, polyurethane, polyether block amide (PEBAX), polyethylene, polypropylene, polycarbonate, polyvinyl chloride (PVC), thermoplastic elastomers, or combinations thereof.[000230] Occlusive elements may employ compliant or semi-compliant elastomeric materials selected to conform to airway geometry while limiting localized5881500.00216tissue stress. Reinforced or constrained occlusive structures may incorporate polymeric meshes, braided filaments, metallic filaments, or shape-memory materials such as nitinol. Hybrid constructions may include multilayer structures combining compliant membranes with reinforcing elements to control expansion and improve durability. Occlusive elements may also employ non-compliant materials to re-expand pulmonary strictures.[000231] Rigid or semi-rigid components, including proximal adapters, control manifolds, or integrated bronchoscope housings, may be formed from engineering plastics or lightweight metals selected for strength, dimensional stability, and resistance to repeated mechanical loading.Manufacturing Techniques[000232] In accordance with various aspects of the present disclosure, components of the system may be manufactured using conventional medical device fabrication techniques, including extrusion, co-extrusion, injection molding, blow molding, dip molding, overmolding, laser cutting, braiding, weaving, additive manufacturing, or combinations thereof.[000233] Occlusive elements may be formed by dip molding, blow molding, or heat-forming techniques, with optional bonding or integration to reinforcing meshes or frames. Sleeve- or sheath-based accessories may be manufactured as thin-wall elastomeric structures configured for roll-on, stretch-fit, or cinch-based attachment to a bronchoscope insertion shaft. One may reflow a micro-elongated lumen into the wall of a single lumen tube with a mandrel in both the single lumen and the micro-elongated lumen. The mandrel in the single lumen may fit the bronchoscope. The single lumen will become eccentric, allowing a flush surface for the balloon bond. If the materials are not compatible for molding or bonding, it may require thermal seals, or a5981500.00216mechanical locking pronged / barbed mechanism to seal and properly inset the inflation channel firmly inside the occlusive balloon chamber with fluid leaks. The distal seal should be done over a mandrel with a slight interference fit over the bronchoscope.[000234] For example, the bronchoscope micro-elongated body may not be bonded to the silicone balloon cuff sleeve, therefore requiring a mechanical locking or pronged / barbed mechanism to seal and inset the inflation channel firmly inside the occlusive balloon chamber without air leaks.[000235] In accordance with various aspects of the present disclosure, integrated bronchoscopic embodiments may be manufactured as monolithic devices or as assemblies of modular subcomponents joined through bonding, welding, mechanical fastening, or overmolding processes.Sterilization and Packaging[000236] Embodiments of the present disclosure may be provided as single-use, disposable devices or as reusable devices with replaceable sterile components. Sterilization methods may include ethylene oxide (EtO), gamma irradiation, electronbeam irradiation, hydrogen peroxide plasma, steam sterilization, or other medically accepted sterilization techniques compatible with the selected materials.[000237] Devices intended for field, transport, or austere environments may be packaged as pre-sterilized kits comprising a portable bronchoscope, occlusive accessory, therapy delivery manifold, and optional manual pressure source. Packaging may be configured to maintain sterility, protect components during transport, and enable rapid deployment.[000238] Reusable embodiments may be designed to withstand repeated sterilization cycles without degradation of mechanical or functional performance. In some embodiments, sterile barrier components such as sleeves or distal occlusive6081500.00216elements may be replaceable while proximal or electronic components are reused.[000239] This embodiment of the device, which includes a tight conformable occlusive balloon cuff sleeve may be packaged with a short plastic single-lumen tube, wider in diameter than the outer diameter of the bronchoscope, enabling the clinician to place the tube over the scope and gently slip the balloon cuff over the distal end of the scope into proper position.Regulatory and Compatibility Considerations[000240] In accordance with various aspects of the present disclosure, materials and manufacturing processes may be selected to comply with applicable biocompatibility standards and with standards governing respiratory gas pathways and bronchoscopic devices. Connectors, interfaces, and adapters may be configured to be compatible with commonly used bronchoscopic, ventilation, and therapy delivery systems.[000241] The system may be configured to meet regulatory requirements applicable to intensive care, interventional pulmonology, surgical, transport, and military use environments.Exemplary Methods of Use[000242] In accordance with various aspects of the present disclosure, methods described herein illustrate representative clinical workflows enabled by the systems described herein. These methods are exemplary and non-limiting, and variations may be employed depending on patient condition, clinical setting, and system configuration.Method for Selective Reinflation of a Collapsed Lung Segment[000243] In accordance with various aspects of the present disclosure, a method for treating atelectasis includes navigating a bronchoscope into an airway supplying a6181500.00216collapsed or under-ventilated lung segment. An occlusive element associated with the bronchoscope or a bronchoscopic accessory is positioned within the airway and actuated to form a seal, thereby isolating the target bronchopulmonary segment from adjacent airways.[000244] Following isolation, pressurized gas is delivered distal to the occlusive element to selectively reinflate the collapsed lung tissue. Pressure may be applied gradually or according to a predefined profile while monitoring pressure response or compliance. Once reinflation is achieved, therapy delivery is reduced or terminated, and the occlusive element is released to restore normal ventilation. The method may be repeated for additional lung segments during the same procedure as clinically indicated.Method for Airway Isolation and Bleeding Control During Bronchoscopic Procedures[000245] In accordance with various aspects of the present disclosure, another method for managing airway bleeding during an interventional pulmonology procedure includes positioning a bronchoscope adjacent to a target airway segment prior to or during tissue manipulation. An occlusive element is deployed to isolate the airway segment associated with the procedure. Isolation limits migration of blood, debris, or fluids into non-target airways and may maintain visualization during repeated instrument passes. The occlusive element may remain deployed during multiple procedural steps and may be deflated or removed once hemostasis is achieved or the procedure is completed.Method for Localized Therapy or Drug Delivery to a Target Lung Region [000246] In accordance with various aspects of the present disclosure, a method includes isolating a target airway segment using an occlusive element and delivering6281500.00216a therapeutic agent distal to the occlusion. Therapeutic agents may include gases, liquids, aerosols, biologies, drugs, or combinations thereof. Delivery may be performed under controlled pressure or flow conditions to promote localized deposition while minimizing exposure to non-target lung regions. In some embodiments, the occlusive element or an associated structure carries or releases a therapeutic composition directly at the target site.Method for Diagnostic Access and Visualization Enhancement[000247] In accordance with various aspects of the present disclosure, another method includes selectively reinflating a collapsed lung segment to improve bronchoscopic access and visualization of a lesion or anatomical region of interest. Following reinflation, diagnostic procedures such as imaging, biopsy, or sampling may be performed through the bronchoscope. Selective isolation may be maintained during diagnostic evaluation to stabilize the airway environment, reduce motion, or localize diagnostic agents.Method for Use in Portable or Austere Environments[000248] In accordance with various aspects of the present disclosure, another method includes deploying a portable bronchoscopic system in an emergency, transport, or austere setting. A battery-powered bronchoscope is navigated to a target airway, and an occlusive element is deployed to isolate a lung segment. Therapy delivery is performed using a manual or portable pressure source. The method enables selective pulmonary therapy independent of fixed infrastructure and may be used prior to or during patient transport.Method for Use in Stricture Management[000249] In accordance with various aspects of the present disclosure, another method includes deploying a bronchoscopic accessory or integrated bronchoscope6381500.00216with an occlusive mechanism to re-expand strictures in a targeted bronchopulmonary region. The bronchoscope is positioned such that the occlusive mechanism may be deployed to radially expand and re-open the stricture.Non-lntubated Patient Applications[000250] The present disclosure may also be adaptable to non-intubated patients via intranasal placement. For example, with reference to FIG. 30, the lung reinflation device is delivered nasally or via a stoma rather than orally. It is positioned either via a miniaturized scope with optical navigation and steering, similar to a bronchoscope, or via a guidewire. The dual lumen elongated body 800 is positioned into the bronchopulmonary region and the occlusive element 801 is deployed via a microinflation lumen within the dual lumen elongated body 800 that couples with a pilot balloon 103 for inflation of the occlusive element. The primary lumen for the delivery of pulmonary fluid couples with an inflation manifold 805 that comprises a pressure relief valve.[000251] Finally, it will be understood by those skilled in the art that the systems and methods described herein are not limited to the specific embodiments disclosed. Various modifications, substitutions, combinations, and rearrangements may be made without departing from the scope of the present disclosure as defined by the claims.[000252] In particular, features described in connection with one embodiment may be incorporated into other embodiments, and individual components may be combined, separated, or reconfigured to suit particular clinical applications or manufacturing constraints. Dimensions, materials, actuation mechanisms, control strategies, and interfaces may be varied according to patient population, clinical setting, or regulatory requirements.[000253] Likewise, numerous characteristics and advantages have been set forth6481500.00216in the preceding description, including various alternatives together with details of the structure and function of the devices and / or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, deposition materials, elements, components, shape, size, and arrangement of parts including combinations within the principles of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.6581500.00216

Claims

CLAIMSWe claim:

1. A bronchoscope, comprising:a shaft having a distal end;an occluding element secured proximate to the distal end of the shaft;an occluding element actuator for deploying and contracting the occluding element to form a seal with an inner wall of a bronchial passage and to isolate a selected pulmonary region;a working channel in communication with the pulmonary region;a pulmonary fluid control manifold coupled to the working channel for controlling the delivery of a pulmonary fluid to the pulmonary region; anda control interface for actuating, controlling, and terminating the delivery of the pulmonary fluid.

2. The bronchoscope of claim 1 , wherein the occluding element further comprises a reinforcement structure.

3. The bronchoscope of claim 1 , wherein the occluding element is bioabsorbable.

4. The bronchoscope of claim 1 , wherein the occluding element further comprises a radiopaque material.

5. The bronchoscope of claim 1 , wherein the occluding element further comprises a coating.

6. The bronchoscope of claim 1, wherein the occluding element comprises a sensor for measuring characteristics of various gases communicated to and from the pulmonary region.

7. The bronchoscope of claim 1, wherein the occluding element at least partially surrounds an area proximate to the distal end of the bronchoscope.6681500.002168. The bronchoscope of claim 1, wherein the occluding element is a helix.

9. The bronchoscope of claim 1 , wherein the occluding element is circumferential.

10. The bronchoscope of claim 1, wherein the occluding element comprises an inflatable occlusive element.

11. The bronchoscope of claim 10, wherein the occluding element actuator is an inflation fluid that is delivered or evacuated to and from the inflatable occlusive element via an occluding element actuator lumen.

12. The bronchoscope of claim 11, wherein the inflation fluid is at least one of a liquid and a gas.

13. The bronchoscope of claim 12, wherein the inflation fluid comprises a radiopaque occluding element.

14. The bronchoscope of claim 1, wherein the occluding element comprises a mechanically expandable structure.

15. The bronchoscope of claim 14, wherein the mechanically expandable structure is delivered to the pulmonary region via guidewire.

16. The bronchoscope of claim 15, wherein the occluding element is deployed and retracted by the guidewire.

17. The bronchoscope of claim 1, wherein the pulmonary fluid comprises at least one of a liquid and a gas.

18. The bronchoscope of claim 1, wherein the pulmonary fluid comprises at least one of ambient air, oxygen-enriched gas, a therapeutic material, a lavage fluid, an irrigation fluid, a hemostatic agent, a surfactant, an antibiotic, a bronchodilator, a mucolytic, a biologic agent, a graft material, and a diagnostic medium.

19. The bronchoscope of claim 1, further comprising a pressure-limiting element configured to limit a pressure delivered to the pulmonary region to a predefined6781500.00216pressure threshold.

20. The bronchoscope of claim 19, wherein the pressure-limiting element is configured to automatically externally vent before a pulmonary region pressure reaches the predefined pressure threshold.

21. The bronchoscope of claim 19, wherein the pressure-limiting element is actuated with electronic sensors, active control systems, or software-based regulation.

22. The bronchoscope of claim 1, wherein the delivery of the pulmonary fluid is controlled using a bronchoscope control interface already used for suction or irrigation.

23. The bronchoscope of claim 1, further comprising a pressure sensor located proximate to the distal end enables the measurement and display of a regional pulmonary flow, pressure, and derived volume distal to the occluding element.

24. The bronchoscope of claim 1, further comprising a hand-held, mobile visualization system.

25. The bronchoscope of claim 24, further comprising a portable power source.

26. The bronchoscope of claim 1, wherein the pulmonary fluid control manifold further comprises at least one of a pressure regulator, needle valve, precision metering valve, flow meter, pressure gauge, adjustable pressure relief valve, selector valve, and a fixed flow restrictor.6881500.00216

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