Endobronchial implant for reduction of pulmonary artery pressure
Patent Information
- Application Number
- PCT/IB2025/052253
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-19
- Filing Date
- 2025-03-02
- Publication Date
- 2025-10-02
AI Technical Summary
Pulmonary hypertension causes elevated pulmonary vascular resistance, leading to increased blood pressure in the lungs and strain on the right side of the heart, which can result in heart failure.
An endobronchial implant is used to control airflow in and out of the lung by partially obstructing inhalation and/or exhalation, regulating lung volume to reduce vascular resistance through the use of valves that open or close partially during different phases of the breathing cycle.
The implant effectively reduces pulmonary vascular resistance by controlling airflow, thereby decreasing alveolar expansion and maintaining air pressure in targeted lung regions, thus alleviating the strain on the heart and potentially preventing heart failure.
Smart Images

Figure IB2025052253_02102025_PF_FP_ABST
Abstract
Description
ENDOBRONCHIAL IMPLANT FOR REDUCTION OF PULMONARY ARTERY PRESSURECROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims priority to:Provisional US Patent Application 63 / 561,436 to Taff et al., filed 5 March 2024, and titled "Endobronchial implant for reduction of pulmonary vascular resistance;" andProvisional US Patent Application 63 / 684,493 to Taff et al., filed 19 August 2024, and titled "Endobronchial implant for reduction of pulmonary artery pressure."
[0002] Each of the aforementioned references is incorporated herein by reference.FIELD OF THE INVENTION
[0003] The present application relates to the field of medical devices, particularly devices for reduction of pulmonary hypertension.BACKGROUND
[0004] Pulmonary hypertension is a serious condition where there is abnormally high pressure in the blood vessels of the lungs.
[0005] Oxygen-poor blood is pumped from the right side of the heart through the pulmonary arteries into the lungs. These arteries divide into smaller branches called arterioles, which further branch into capillaries within the lung tissue.
[0006] During gas exchange, oxygen diffuses from the alveoli into the bloodstream through the capillaries surrounding the alveoli, while carbon dioxide diffuses from the bloodstream into the alveoli through these same capillaries.
[0007] Oxygen-rich blood then returns to the left side of the heart from where it is pumped back into the body.
[0008] In patients suffering from pulmonary hypertension, the pulmonary vascular resistance is elevated which makes blood flow through the lungs more difficult, causing the blood pressure in the lungs to rise and the right side of the heart to work harder. Over time, these increased pressures on the right side of the heart can lead to various medical problems, specifically heart failure.SUMMARY OF THE INVENTION
[0009] The vascular resistance is linked with the breathing cycle. Generally speaking, inspiring air increases lung volume and compresses the intra-alveolar vessels which in turn results in an increase in intra-alveolar vessels resistance. On the other hand, increased lung volume induces a decrease in extra-alveolar vessels resistance from residual volume to total lung capacity. Thus, the total pulmonary vascular resistances may be described as a “U” shape with a nadir corresponding to a lung volume equal to the relaxation volume or functional residual capacity. Controlling the lung volume by means of regulating the airflow in and out may therefore allow the regulation of the vascular resistance (and in turn the pulmonary pressures).
[0010] In healthy subjects, the lung is not symmetrical, especially in the upright position, with most of the blood pooled in the lower regions of it. For patients suffering from pulmonary hypertension it may be advantageous to partially obstruct air flow to or from the lower lobes.
[0011] In general, some implementations of the present disclosure include an apparatus configured for endobronchial implantation in a patient’s airway to control the air passage in and out of the lung in order to reduce the vascular bed resistance.
[0012] In some implementations (e.g. for some subjects, and / or for some conditions) it may be beneficial to partially obstruct inflow / inhalation of air into a region of the lung (e.g. a lower lobe). In some such implementations, this may be achieved with a lesser degree of obstruction of outflow / exhalation from that region - e.g. without material obstruction of outflow / exhalation of air from that region. This may advantageously decrease alveolar expansion (e.g. peak alveolar volume) of that region of the lung.
[0013] In some implementations (e.g. for some subjects, and / or for some conditions) it may be beneficial to partially obstruct outflow / exhalation of air from a region of the lung (e.g. a lower lobe). In some such implementations, this may be achieved with a lesser degree of obstruction of inflow / inhalation into that region - e.g. without material obstruction of inflow / inhalation of air into that region. This may advantageously increase or maintain air pressure (e.g. peak air pressure) in the bronchioles and / or alveolae of that region of the lung.
[0014] In some implementations, the apparatus may be in the form of a valve that may be completely or almost completely open when exhaling and partially closed when inhaling.
[0015] In some implementations, the valve may be with a variable opening limiting the intake of air, such that it may collapse as the lung volume increases.
[0016] In some implementations, the apparatus may be in the form of a valve that is completely or almost completely open when inspiring and partially closed when exhaling.
[0017] In some implementations, the valve is configured to open when exhaling and partially close when inhaling in order to limit the maximal lung volume and reduce the intra-alveolar vessels resistance. In some implementations, the valve is configured to open when inspiring and partially close when exhaling in order to reduce the extra-alveolar vessels resistance. In some implementations, a combination of both options may be used in order to set the lung volume around an optimal level in terms of overall vascular resistance.
[0018] In some implementations, the valve may be with a variable opening limiting the outtake of air, such that it may collapse as the lung volume decreases.
[0019] In some implementations, the valve may have a variable opening limiting the inflow and / or outflow of air, such that it may collapse as a function of air volume passing through it.
[0020] Some implementations of the present disclosure include a method for reducing the vascular resistance by controlling the airflow in and out of the lung.
[0021] In some implementations, the method may include endobronchial implantation of a valve in a patient’s airway configured to limit the amount of air inhaled during the breathing cycle.
[0022] In some implementations, the method may include endobronchial implantation of a valve in a patients airway configured to limit the amount of air exhaled during the breathing cycle.
[0023] In some implementations, the target airway may be the one leading to the lower lobe of the lung.
[0024] In some implementations, multiple valves may be positioned in the same airway. Alternatively, or additionally, multiple valves may be positioned in different airways.
[0025] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.
[0026] Any of the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., human, other mammal, etc.) or on a non-living simulation such as a cadaver, a cadaver heart, an anthropomorphic ghost, and / or a simulator device (which may include computerized and / or physical representations of body parts, tissue, etc.).
[0027] There is provided, in accordance with some implementations, a system for use with a respiratory system of a real or simulated subject, the system including an implant that includes an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the lung.
[0028] In some implementations, the obstructor is shaped to obstruct inhalation to the same extent as exhalation.
[0029] In some implementations, the system further includes a transbronchial retrieval tool adapted to transbronchially retrieve the implant from the bronchus.
[0030] In some implementations, the implant is configured to maintain the obstructor stationary during inhalation and exhalation.
[0031] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0032] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0033] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0034] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0035] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0036] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0037] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 20 percent of a cross-sectional area of the bronchus.
[0038] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0039] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0040] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 70 percent of a cross- sectional area of the bronchus.
[0041] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 40 percent of a cross- sectional area of the bronchus.
[0042] In some implementations, the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 20 percent of a cross- sectional area of the bronchus.
[0043] In some implementations, the obstructor includes a valve that: partially obstructs the inflow of air by closing responsively to inhalation by the subject, and / or facilitates outflow of air past the obstructor by opening responsively to exhalation by the subject.
[0044] In some implementations, the implant is configured such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0045] In some implementations, the valve partially obstructs the inflow of air by closing incompletely responsively to inhalation by the subject.
[0046] In some implementations: (a) the valve facilitates outflow of air past the obstructor by, responsively to exhalation by the subject, opening such that the valve defines an orifice therethrough having a cross-sectional area, and / or (b) the valve partially obstructs the inflowof air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 20 percent.
[0047] In some implementations, the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 40 percent.
[0048] In some implementations, the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 70 percent.
[0049] In some implementations: (i) the valve facilitates outflow of air past the obstructor by, responsively to exhalation by the subject, opening such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 70 percent.
[0050] In some implementations, the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 40 percent.
[0051] In some implementations, the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 20 percent.
[0052] In some implementations, the valve is a duckbill valve.
[0053] In some implementations, the valve includes multiple leaflets.
[0054] In some implementations, the valve is a bileaflet valve.
[0055] In some implementations, the valve is a trileaflet valve.
[0056] In some implementations, the valve is a diaphragm valve.
[0057] In some implementations, the valve is a butterfly valve.
[0058] In some implementations, the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (a) inflow of air past the obstructor flows peripherally past the valve, and / or (b) outflow of air past the obstructor flows both (i) peripherally past the valve and (ii) through the valve.
[0059] In some implementations, the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (i) inflow of air past the obstructor flows through the valve, and / or (ii) outflow of air past the obstructor flows through the valve.
[0060] In some implementations, the implant is configured to seal against a bronchial wall of the bronchus such that any inflow of air past the obstructor passes through the valve.
[0061] In some implementations, the valve is a linear check valve.
[0062] In some implementations, the valve is a piston check valve.
[0063] In some implementations, the linear check valve is spring loaded.
[0064] In some implementations, the linear check valve includes a disk.
[0065] In some implementations, the obstructor is shaped to obstruct inhalation to a greater extent than exhalation.
[0066] In some implementations, the obstructor does not move responsively to inhalation or exhalation.
[0067] In some implementations, the obstructor includes a baffle, configured to favor outflow of air more than inflow of air.
[0068] In some implementations, the obstructor is streamlined in a manner which favors outflow of air more than inflow of air.
[0069] In some implementations, the obstructor has an aerodynamic face and a draginducing face, and the implant is configured to be implanted with the aerodynamic face pointing toward a deeper part of the bronchus and the drag-inducing face pointing to a shallower part of the bronchus.
[0070] In some implementations, the obstructor is mounted in a mount, the mount being securable to a bronchial wall of the bronchus.
[0071] In some implementations, the mount includes a self-expanding frame.
[0072] In some implementations, the mount includes a balloon-expandable frame.
[0073] In some implementations, the mount is securable to the bronchial wall by the mount exerting an outwards radial force against the bronchial wall.
[0074] In some implementations, the mount defines at least one grip that is adapted to grip the bronchial wall.
[0075] In some implementations, the mount includes a frame and a covering that covers the frame.
[0076] In some implementations, the mount is configured to seal against the bronchial wall.
[0077] In some implementations, the mount includes an open frame configured to allow airflow between the obstructor and the bronchial wall.
[0078] In some implementations, the obstructor partially obstructs inflow of air past the obstructor by allowing airflow between the obstructor and the bronchial wall, but not through the obstructor.
[0079] In some implementations, the implant is deliverable into the bronchus while the mount is in a collapsed state, and expandable within the bronchus towards an expanded state in which the mount presses radially outwards against the bronchial wall.
[0080] In some implementations, the mount defines two expandable portions, the obstructor being disposed axially between the expandable portions.
[0081] In some implementations, in the expanded state of the frame, the frame has an hourglass form defined by two bulbs connected by a neck, the obstructor being disposed at the neck.
[0082] In some implementations, one of the bulbs defines an inlet for inflow of air and the other of the bulbs defines an outlet for inflow of air.
[0083] In some implementations, at least one of the expandable portions is articulatable with respect to the obstructor.
[0084] In some implementations, at least one of the expandable portions is articulatable with respect to the other expandable portion.
[0085] In some implementations, the system further includes a transbronchial delivery device for implanting the implant within the bronchus.
[0086] In some implementations, the transbronchial delivery device includes a bronchoscope.
[0087] In some implementations, the transbronchial delivery device is adapted to retrieve the implant out of the bronchus.
[0088] There is further provided, in accordance with some implementations, a method including: (a) identifying a real or simulated subject as having pulmonary hypertension, and / or (b) responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that, during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0089] In some implementations: (i) the lung is a first lung, and / or (ii) implanting the obstructor within the bronchus of the lung includes implanting the obstructor within the bronchus of the first lung without implanting an obstructor within a second lung of the subject.
[0090] In some implementations, the bronchus is a bronchus of an inferior lobe of the lung, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the inferior lobe of the lung.
[0091] In some implementations, the bronchus is an inferior lobar bronchus of the lung, and implanting the obstructor within the bronchus includes implanting the obstructor within the inferior lobar bronchus of the lung.
[0092] In some implementations, the lung is a left lung of the subject, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the left lung.
[0093] In some implementations, the lung is a right lung of the subject, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the right lung.
[0094] In some implementations: the bronchus is a secondary bronchus, and / or implanting the implant within the bronchus includes implanting the implant within the secondary bronchus.
[0095] In some implementations: (i) the bronchus is a primary bronchus, and / or (ii) implanting the implant within the bronchus includes implanting the implant within the primary bronchus.
[0096] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to left heart disease (PH-LHD).
[0097] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary arterial hypertension.
[0098] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to lung disease.
[0099] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to chronic obstructive pulmonary disease.
[0100] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to chronic blood clots in the lungs.
[0101] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having idiopathic pulmonary hypertension.
[0102] In some implementations: (a) the obstructor is shaped to obstruct inhalation to the same extent as exhalation, and / or (b) implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0103] In some implementations, the method further includes transbronchially retrieving the obstructor from the bronchus.
[0104] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor remains stationary during each inhalation and exhalation by the subject.
[0105] In some implementations, the method further includes transbronchially delivering the obstructor to the bronchus via the airways of the subject.
[0106] In some implementations: (i) the obstructor is a first obstructor, (ii) the bronchus is a first bronchus, and / or (iii) the method further includes implanting a second obstructor within a second bronchus of the lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, and the second obstructor partially obstructs inhaled air from flowing past the second obstructor.
[0107] In some implementations, the method further includes implanting a third obstructor in a third bronchus of the lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, the second obstructor partially obstructs inhaled air from flowing past the second obstructor, and the third obstructor partially obstructs inhaled air from flowing past the third obstructor.
[0108] In some implementations: (i) the obstructor is a first obstructor, (ii) bronchus is a first bronchus of a first lung, and / or (iii) the method further includes implanting a second obstructor within a second bronchus of the second lung of the subject such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor and the second obstructor partially obstructs inhaled air from flowing past the second obstructor.
[0109] In some implementations, the method further including implanting a third obstructor in another bronchus of the second lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, thesecond obstructor partially obstructs inhaled air from flowing past the second obstructor, and the third obstructor partially obstructs inhaled air from flowing past the third obstructor.
[0110] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0111] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0112] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0113] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0114] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0115] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0116] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 20 percent of the cross-sectional area of the bronchus.
[0117] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0118] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0119] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0120] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs no more than 40 percent of the cross-sectional area of the bronchus.
[0121] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs no more than 20 percent of the cross-sectional area of the bronchus.
[0122] In some implementations: (i) the obstructor includes a valve, (ii) implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that: (a) during each inhalation by the subject, the valve partially obstructs the inflow of air by closing responsively to the inhalation, and / or (b) during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation.
[0123] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0124] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the valve partially obstructs the inflow of air by closing incompletely responsively to inhalation by the subject.
[0125] In some implementations: during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 20 percent.
[0126] In some implementations, during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 40 percent.
[0127] In some implementations, the valve partially obstructs the inflow of air, responsively to inhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by at least 70 percent.
[0128] In some implementations: (a) during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or (b) duringeach inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 70 percent.
[0129] In some implementations, during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 40 percent.
[0130] In some implementations, the valve partially obstructs the inflow of air, responsively to inhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by no more than 20 percent.
[0131] In some implementations: the obstructor is shaped to obstruct inhalation to a greater extent than exhalation, and / or implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor allows exhaled air to flow past the obstructor.
[0132] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor does not move responsively to inhalation or exhalation.
[0133] In some implementations, the obstructor includes a baffle, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the baffle favors outflow of air due to exhalation of the subject more than inflow of air due to inhalation of the subject.
[0134] In some implementations, the obstructor is streamlined, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor favors outflow of air due to exhalation of the subject more than inflow of air due to inhalation of the subject.
[0135] In some implementations, the obstructor has an aerodynamic face and a draginducing face, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the aerodynamic face points toward a deeper part of the bronchus and the drag-inducing face points toward a shallower part of the bronchus.
[0136] In some implementations, the obstructor is mounted in a mount, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus by securing the mount to a bronchial wall of the bronchus.
[0137] In some implementations, the mount includes a self-expanding frame, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchusby securing the mount to the bronchial wall includes allowing the frame to self -expand within the bronchus such that the mount becomes secured to the bronchial wall.
[0138] In some implementations: (i) the mount includes a balloon-expandable frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes using a balloon to expand the frame within the bronchus.
[0139] In some implementations, implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus by positioning the mount against the bronchial wall such that the mount exerts an outwards radial force against the bronchial wall.
[0140] In some implementations, the mount defines at least one grip that is adapted to grip the bronchial wall, and implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes inserting the grip into the bronchial wall .
[0141] In some implementations, implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus such that the mount seals against the bronchial wall.
[0142] In some implementations: (i) the mount includes an open frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus by securing the frame to the bronchial wall in a manner that allows airflow between the obstructor and the bronchial wall.
[0143] In some implementations, the method further includes: (i) delivering the obstructor to the bronchus while the mount is in a collapsed state, and / or (ii) expanding the mount within the bronchus such that the mount presses radially outwards against the bronchial wall.
[0144] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a real or simulated subject, the system including an implant that includes a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate exhaled air being exhaled past the implant, and (ii) closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
[0145] There is further provided, in accordance with some implementations, a method including: identifying a real or simulated subject as having pulmonary hypertension, and / or responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each exhalation by the subject, the valve opens to facilitate exhaled airbeing exhaled past the implant, and (ii) during each inhalation by the subject, the valve closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
[0146] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a real or simulated subject, the system including: an implant that includes an obstructor, and / or a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0147] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a real or simulated subject, the system including an implant that includes an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from being inhaled beyond the obstructor.
[0148] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a real or simulated subject, the system including an implant that includes an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the respiratory system.
[0149] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including an implant that includes an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs outflow of air past the obstructor.
[0150] In some implementations, the obstructor is shaped to obstruct inhalation to the same extent as exhalation.
[0151] In some implementations, the system further includes a transbronchial retrieval tool adapted to transbronchially retrieve the implant from the bronchus.
[0152] In some implementations, the implant is configured to maintain the obstructor stationary during inhalation and exhalation.
[0153] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 20 percent.
[0154] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 40 percent.
[0155] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 70 percent.
[0156] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 70 percent.
[0157] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 40 percent.
[0158] In some implementations, the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 20 percent.
[0159] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 20 percent of a cross-sectional area of the bronchus.
[0160] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0161] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0162] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 70 percent of a cross- sectional area of the bronchus.
[0163] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 40 percent of a cross- sectional area of the bronchus.
[0164] In some implementations, the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 20 percent of a cross- sectional area of the bronchus.
[0165] In some implementations, the obstructor includes a valve that: partially obstructs the outflow of air by closing responsively to exhalation by the subject, and / or facilitates inflow of air past the obstructor by opening responsively to inhalation by the subject.
[0166] In some implementations, the implant is configured such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0167] In some implementations, the valve partially obstructs the outflow of air by closing incompletely responsively to exhalation by the subject.
[0168] In some implementations: the valve facilitates inflow of air past the obstructor by, responsively to inhalation by the subject, opening such that the valve defines an orifice therethrough having a cross- sectional area, and / or the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 20 percent.
[0169] In some implementations, the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 40 percent.
[0170] In some implementations, the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 70 percent.
[0171] In some implementations: the valve facilitates inflow of air past the obstructor by, responsively to inhalation by the subject, opening such that the valve defines an orifice therethrough having a cross- sectional area, and / or the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 70 percent.
[0172] In some implementations, the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 40 percent.
[0173] In some implementations, the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 20 percent.
[0174] In some implementations, the valve is a duckbill valve.
[0175] In some implementations, the valve includes multiple leaflets.
[0176] In some implementations, the valve is a bileaflet valve.
[0177] In some implementations, the valve is a trileaflet valve.
[0178] In some implementations, the valve is a diaphragm valve.
[0179] In some implementations, the valve is a butterfly valve.
[0180] In some implementations, the valve is mounted within the implant such that, when the implant is implanted within the bronchus: outflow of air past the obstructor flows peripherally past the valve, and / or inflow of air past the obstructor flows both (i) peripherally past the valve and(ii) through the valve.
[0181] In some implementations, the valve is mounted within the implant such that, when the implant is implanted within the bronchus: outflow of air past the obstructor flows through the valve, and / or inflow of air past the obstructor flows through the valve.
[0182] In some implementations, the implant is configured to seal against a bronchial wall of the bronchus such that any outflow of air past the obstructor passes through the valve.
[0183] In some implementations, the valve is a linear check valve.
[0184] In some implementations, the valve is a piston check valve.
[0185] In some implementations, the linear check valve is spring loaded.
[0186] In some implementations, the linear check valve includes a disk.
[0187] In some implementations, the obstructor is shaped to obstruct exhalation to a greater extent than inhalation.
[0188] In some implementations, the obstructor does not move responsively to inhalation or exhalation.
[0189] In some implementations, the obstructor includes a baffle, configured to favor inflow of air more than outflow of air.
[0190] In some implementations, the obstructor is streamlined in a manner which favors inflow of air more than outflow of air.
[0191] In some implementations, the obstructor has an aerodynamic face and a draginducing face, and the implant is configured to be implanted with the aerodynamic face pointing toward a shallower part of the bronchus and the drag-inducing face pointing to a deeper part of the bronchus.
[0192] In some implementations, the obstructor is mounted in a mount, the mount being securable to a bronchial wall of the bronchus.
[0193] In some implementations, the mount includes a self-expanding frame.
[0194] In some implementations, the mount includes a balloon-expandable frame.
[0195] In some implementations, the mount is securable to the bronchial wall by the mount exerting an outwards radial force against the bronchial wall.
[0196] In some implementations, the mount defines at least one grip that is adapted to grip the bronchial wall.
[0197] In some implementations, the mount includes a frame and a covering that covers the frame.
[0198] In some implementations, the mount is configured to seal against the bronchial wall.
[0199] In some implementations, the mount includes an open frame configured to allow airflow between the obstructor and the bronchial wall.
[0200] In some implementations, the obstructor partially obstructs inflow of air past the obstructor by allowing airflow between the obstructor and the bronchial wall, but not through the obstructor.
[0201] In some implementations, the implant is deliverable into the bronchus while the mount is in a collapsed state, and expandable within the bronchus towards an expanded state in which the mount presses radially outwards against the bronchial wall.
[0202] In some implementations, the mount defines two expandable portions, the obstructor being disposed axially between the expandable portions.
[0203] In some implementations, in the expanded state of the frame, the frame has an hourglass form defined by two bulbs connected by a neck, the obstructor being disposed at the neck.
[0204] In some implementations, one of the bulbs defines an inlet for outflow of air and the other of the bulbs defines an outlet for outflow of air.
[0205] In some implementations, at least one of the expandable portions is articulatable with respect to the obstructor.
[0206] In some implementations, at least one of the expandable portions is articulatable with respect to the other expandable portion.
[0207] In some implementations, the system further includes a transbronchial delivery device for implanting the implant within the bronchus.
[0208] In some implementations, the transbronchial delivery device includes a bronchoscope.
[0209] In some implementations, the transbronchial delivery device is adapted to retrieve the implant out of the bronchus.
[0210] There is further provided, in accordance with some implementations, a method including: identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that, during each exhalation by the subject, the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0211] In some implementations: the lung is a first lung, and / or implanting the obstructor within the bronchus of the lung includes implanting the obstructor within the bronchus of the first lung without implanting an obstructor within a second lung of the subject.
[0212] In some implementations, the bronchus is a bronchus of an inferior lobe of the lung, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the inferior lobe of the lung.
[0213] In some implementations, the bronchus is an inferior lobar bronchus of the lung, and implanting the obstructor within the bronchus includes implanting the obstructor within the inferior lobar bronchus of the lung.
[0214] In some implementations, the lung is a left lung of the subject, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the left lung.
[0215] In some implementations, the lung is a right lung of the subject, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus of the right lung.
[0216] In some implementations: the bronchus is a secondary bronchus, and / or implanting the implant within the bronchus includes implanting the implant within the secondary bronchus.
[0217] In some implementations: the bronchus is a primary bronchus, and / or implanting the implant within the bronchus includes implanting the implant within the primary bronchus.
[0218] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to left heart disease (PH-LHD).
[0219] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary arterial hypertension.
[0220] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to lung disease.
[0221] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to chronic obstructive pulmonary disease.
[0222] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having pulmonary hypertension due to chronic blood clots in the lungs.
[0223] In some implementations, identifying the subject as having pulmonary hypertension includes identifying the subject as having idiopathic pulmonary hypertension.
[0224] In some implementations: the obstructor is shaped to obstruct inhalation to the same extent as exhalation, and / orimplanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0225] In some implementations, the method further includes transbronchially retrieving the obstructor from the bronchus.
[0226] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor remains stationary during each inhalation and exhalation by the subject.
[0227] In some implementations, the method further includes transbronchially delivering the obstructor to the bronchus via the airways of the subject.
[0228] In some implementations: the obstructor is a first obstructor, the bronchus is a first bronchus, and / or the method further includes implanting a second obstructor within a second bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
[0229] In some implementations, the method further includes implanting a third obstructor in a third bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, the second obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
[0230] In some implementations: the obstructor is a first obstructor, the bronchus is a first bronchus of a first lung, and / or the method further includes implanting a second obstructor within a second bronchus of a second lung of the subject such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
[0231] In some implementations, the method further includes implanting a third obstructor in another bronchus of the second lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, thesecond obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
[0232] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0233] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0234] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0235] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0236] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0237] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0238] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 20 percent of the cross-sectional area of the bronchus.
[0239] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0240] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0241] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0242] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 40 percent of the cross-sectional area of the bronchus.
[0243] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 20 percent of the cross-sectional area of the bronchus.
[0244] In some implementations: the obstructor includes a valve, and / or implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that: during each exhalation by the subject, the valve partially obstructs the outflow of air by closing responsively to the exhalation, and / or during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation.
[0245] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0246] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the valve partially obstructs the outflow of air by closing incompletely responsively to exhalation by the subject.
[0247] In some implementations: during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 20 percent.
[0248] In some implementations, during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 40 percent.
[0249] In some implementations, the valve partially obstructs the outflow of air, responsively to exhalation by the subject, by closing incompletely to reduce the cross- sectional area of the orifice by at least 70 percent.
[0250] In some implementations: during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 70 percent.
[0251] In some implementations, during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 40 percent.
[0252] In some implementations, the valve partially obstructs the outflow of air, responsively to exhalation by the subject, by closing incompletely to reduce the cross- sectional area of the orifice by no more than 20 percent.
[0253] In some implementations: the obstructor is shaped to obstruct exhalation to a greater extent than inhalation, and / or implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor allows inhaled air to flow past the obstructor.
[0254] In some implementations, implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor does not move responsively to inhalation or exhalation.
[0255] In some implementations, the obstructor includes a baffle, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the baffle favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
[0256] In some implementations, the obstructor is streamlined, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the obstructor favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
[0257] In some implementations, the obstructor has an aerodynamic face and a draginducing face, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus such that the aerodynamic face points toward a shallower part of the bronchus and the drag-inducing face points toward a deeper part of the bronchus.
[0258] In some implementations, the obstructor is mounted in a mount, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus by securing the mount to a bronchial wall of the bronchus.
[0259] In some implementations, the mount includes a self-expanding frame, and implanting the obstructor within the bronchus includes implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes allowing the frame to self-expand within the bronchus such that the mount becomes secured to the bronchial wall.
[0260] In some implementations: the mount includes a balloon-expandable frame, and / or implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes using a balloon to expand the frame within the bronchus.
[0261] In some implementations, implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus by positioning the mount against the bronchial wall such that the mount exerts an outwards radial force against the bronchial wall.
[0262] In some implementations, the mount defines at least one grip that is adapted to grip the bronchial wall, and implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes inserting the grip into the bronchial wall .
[0263] In some implementations, implanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus such that the mount seals against the bronchial wall.
[0264] In some implementations: the mount includes an open frame, and / orimplanting the obstructor within the bronchus by securing the mount to the bronchial wall includes implanting the obstructor within the bronchus by securing the frame to the bronchial wall in a manner that allows airflow between the obstructor and the bronchial wall.
[0265] In some implementations, the method further includes: delivering the obstructor to the bronchus while the mount is in a collapsed state, and / or expanding the mount within the bronchus such that the mount presses radially outwards against the bronchial wall.
[0266] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including an implant that includes a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate inhaled air being inhaled past the implant, and (ii) closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
[0267] There is further provided, in accordance with some implementations, a method including: identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each inhalation by the subject, the valve opens to facilitate inhaled air being inhaled past the implant, and (ii) during each exhalation by the subject, the valve closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
[0268] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including: an implant that includes an obstructor, and / or a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0269] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including an implant that includes an obstructor, the implant being configured to beimplanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from being exhaled beyond the obstructor.
[0270] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including an implant that includes an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such that the obstructor partially obstructs outflow of air past the obstructor outwardly with respect to the respiratory system.
[0271] There is further provided, in accordance with some implementations, a system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system including an implant that includes: a mount, configured to secure the implant within a bronchus of a lung of the respiratory system; and / or a valve, secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) opens to facilitate air flowing through the bronchus past the implant in a first direction, and (ii) closes incompletely to partially obstruct air from flowing through the bronchus past the implant in a second, opposite direction.
[0272] In some implementations, the valve is secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) responsively to exhalation, opens to facilitate exhaled air to flow through the bronchus past the implant, and (ii) responsively to inhalation, closes incompletely to partially obstruct inhaled air from flowing through the bronchus past the implant.
[0273] In some implementations, the valve is secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) responsively to inhalation, opens to facilitate inhaled air to flow through the bronchus past the implant, and (ii) responsively to exhalation, closes incompletely to partially obstruct exhaled air from flowing through the bronchus past the implant.
[0274] In some implementations, any of the obstructors mentioned herein are sterilized.
[0275] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).
[0276] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS
[0277] Figs. 1A-B, 2A-B, 3A-B, 4A-B, 5A-B, 6A-B, 7A-B, 8, 9A-B, and 10A-B are schematic illustrations of implants that are implantable in an airway (e.g., in a bronchus) of a lung of a subject, in accordance with some applications.DETAILED DESCRIPTION OF IMPLEMENTATIONS
[0278] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein may include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (i.e. any other variant of the element) having the same reference numeral, independent of any suffix.
[0279] In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements are introduced via one or more drawings and not explicitly identified in every other drawing that contains that element.
[0280] Reference is now made to Figs. 1A-B, 2A-B, 3A-B, 4A-B, 5A-B, 6A-B, 7A-B, and 8, which are schematic illustrations of an implant 100, and variants thereof, that are implantable in an airway (e.g., a bronchus 16) of a lung 15 of a subject 10, in accordance with some applications. Implant 100 comprises an obstructor 110 that is configured to partially obstruct inhaled air from flowing past (e.g. through and / or around) the implant and deeper into the lung. Figs. 1A-B illustrate implant 100 having been implanted in bronchus 16, and Figs. 2A-8 show more close-up schematic views of variants of implant 100. It is to be understood that although the figures describe an implant being implanted in a bronchusof a lung, any of the implants described herein could similarly be implanted in a trachea of a subject.
[0281] Implant 100 may be implanted in order to treat pulmonary hypertension. For example, the partial obstruction of inflow past the implant provided by obstructor 110 (e.g., as illustrated in Fig. 1A by small arrow 20) may reduce the rate and / or extent of inflation of a region 17 of lung 15 supplied by bronchus 16, and or reduce variation (e.g. peaks) in alveolar air pressure in region 17. This, in turn, may advantageously reduce blood flow resistance through the capillary bed of the alveoli in region 17 - e.g. by reducing pressure exerted by the sac of the alveoli on the capillaries of the alveoli. Such reduction of resistance is hypothesized to advantageously reduce blood pressure in the pulmonary artery upstream of the alveolar capillaries.
[0282] Despite the advantage of obstructing inflow of air past the implant, limiting the obstruction to be merely partial obstruction allows region 17 to continue providing gas exchange - i.e. to continue its lung function. That is, there is a trade-off between reducing pulmonary blood pressure and maintaining lung function.
[0283] In some implementations, obstructor 110 is adapted to reduce the inflow of air past implant 100 (e.g., during inhalation by the subject) by up to (i.e. no more than) 70 percent (e.g. by up to 40 percent, such as by up to 20 percent). That is, for such implementations, the obstructor is adapted to allow at least 30 percent (e.g. at least 60 percent, such as at least 80 percent) of inflow of air therethrough.
[0284] In some implementations, obstructor 110 obstructs up to (i.e. no more than) 70 percent (e.g. up to 40 percent, such as up to 20 percent) of a cross-sectional area of bronchus 16 during inhalation by the subject. That is, for such implementations, at least 30 percent (e.g. at least 60 percent, such as at least 80 percent) of the cross-sectional area of the bronchus remains open, allowing inflow of air past the implant 100 and into region 17 of the lung.
[0285] In some implementations, obstructor 110 is adapted to reduce the inflow of air past implant 100 (e.g., during inhalation by the subject) by at least 20 percent (e.g. by at least 40 percent, such as by at least 70 percent). That is, for such implementations, the obstructor is adapted to allow no more than 80 percent (e.g. no more than 60 percent, such as no more than 30 percent) of inflow of air past the implant 100 and into region 17 of the lung.
[0286] In some implementations, obstructor 110 obstructs at least 20 percent (e.g. at least 40 percent, such as at least 70 percent) of a cross-sectional area of bronchus 16 during inhalation by the subject. That is, for such implementations, no more than 80 percent (e.g.no more than 60 percent, such as no more than 30 percent) of the cross-sectional area of the bronchus remains functional (e.g., open), i.e., allowing inflow of air past the implant 100 and into region 17 of the lung.
[0287] In some implementations, implant 100 is configured not to materially obstruct outflow (i.e. exhaled air) from flowing past the implant - e.g., as illustrated in Fig. IB by continuous arrow 22.
[0288] In some implementations, implant 100 is configured to also partially obstruct outflow (i.e. exhaled air) from flowing past the implant. In some such implementations, implant 100 is configured such that this partial obstruction of outflow is to the same extent as the partial obstruction of inflow (e.g., as illustrated in Figs. 7A-B). In some implementations, implant 100 is configured such that the partial obstruction of outflow is to a lesser extent than the partial obstruction of inflow. Such configurations may be provided by the shape, size, movement, and / or mounting of obstructor 110 - e.g. with respect to other parts of implant 100. In some implementations, and as described in more detail hereinbelow, obstructor 110 may be static (e.g. non-responsive to the breathing cycle of the subject). In some implementations, and as described in more detail hereinbelow, obstructor 110 may be dynamic (e.g. responsive to the breathing cycle of the subject).
[0289] In some implementations, and as illustrated in Figs. 1A-B, implant 100 is implanted in a bronchus of, or that supplies, an inferior (i.e. lower) lobe of the lung, e.g., in an inferior lobar bronchus of the lung. In some implementations, implant 100 is implanted within a single lung of the subject (e.g., without implanting an implant in the subject's other lung). Alternatively, in some implementations, an implant 100 is implanted in each lung of the subject, e.g., in a bronchus of each inferior lobe of the subject. In some implementations, multiple implants 100 are implanted within a single lung, or within both lungs, of the subject, such that during each inhalation by the subject, the obstructors of each of the implants each partially obstruct inhaled air from flowing past the respective implants. In some implementations, implants 100 can be implanted in various locations within the lung e.g., within any of the superior lobe(s), the middle lobe and / or the inferior lobe(s) of the lung(s). In some implementations, implant(s) 100 is implanted within the left lung of the subject. In some implementations, implant(s) 100 is implanted within the right lung of the subject.
[0290] In some implementations, implant(s) 100 is implanted within a secondary bronchus of the lung. In some implementations, implant(s) 100 is implanted within a primary bronchus of the lung.
[0291] In some implementations, implant 100 is implantable into bronchus 16 using a delivery tool (not shown). The delivery tool may include a bronchoscope. In some implementations, implant 100 is transbronchially retrievable from the bronchus, e.g., using the delivery tool, or using a separate tool (not shown).
[0292] Various types and / or causes of pulmonary hypertension exist, and can be grouped into categories such as pulmonary arterial hypertension (Group 1), pulmonary hypertension due to left heart disease (PH-LHD; Group 2), pulmonary hypertension due to lung disease such as chronic obstructive pulmonary disease (Group 3), pulmonary hypertension due to chronic blood clots in the lungs (Group 4), and / or idiopathic pulmonary hypertension (Group 5).
[0293] Implant 100, and the implantation thereof, may be particularly advantageous for treating Group 2 pulmonary hypertension. However, implant 100 may also be used to treat subjects having any of, or any combination of, the above categories of pulmonary hypertension.
[0294] Figs. 2A-8 illustrate various more close-up schematic views of variants of implant 100. Implants 100a (Figs. 2A-B), 100b (Figs. 3A-B), and 100c (Figs. 4A-B) are examples of implants that comprise dynamic obstructors - e.g. obstructors that are responsive to the breathing cycle of the subject, such as by moving and / or changing conformation. Implant lOOd (Figs. 5A-B), implant lOOf (Figs. 6A-B), and implant 100g (Figs. 7A-B) are examples of implants that comprises a static obstructor - e.g. an obstructor that is not responsive to the breathing cycle of the subject.
[0295] Figs. 2A-B illustrate an implant 100a comprising an obstructor 110a that comprises a valve (e.g. check valve) 112a. Once implant 100a is implanted within bronchus 16, valve 112a partially obstructs the inflow of air past the implant (and into region 17 of the lung) by closing responsively to inhalation by the subject (Fig. 2A), and facilitates outflow of air (from region 17 of the lung) past the implant by opening responsively to exhalation by the subject (Fig. 2B). Unlike a typical valve, valve 112a is configured such that, in its "closed" state, it is incompletely closed. That is, valve 112a closes incompletely in response to inhalation by the subject, i.e. the valve obstructs inflow of air, but not entirely thereby allowing lung function in region 17, as described hereinabove.
[0296] In the example shown, valve 112a defines multiple leaflets 113a that, during exhalation by the subject, move away from each other to define an orifice 19 therethrough(Fig. 2B), and move towards each other during inhalation by the subject to reduce the size of, but without completely closing, the orifice (Fig. 2A).
[0297] In some implementations, during each inhalation by the subject, the partial closing of valve 112a reduces the cross-sectional area of orifice 19 by at least 20 percent (e.g., by at least 40 percent, such as by at least 70 percent).
[0298] In some implementations, during each inhalation by the subject, the partial closing of valve 112a reduces the cross-sectional area of orifice 19 by up to (e.g., by no more than) 70 percent (e.g., by up to 40 percent, such as by up to 20 percent).
[0299] It is to be noted that although valve 112a is shown as a trileaflet valve, it is to be understood that valve 112a could be a bileaflet or duckbill valve, configured to close incompletely. Furthermore, other types of check valve, configured to close incompletely, may also be used. For example, a ball check valve, a diaphragm valve, a swing or butterfly valve, or an in-line / linear check valve (e.g., a piston check valve) may be used, albeit configured to close incompletely.
[0300] In some implementations, valve 112a occupies at least 90 percent of the cross- sectional area of the bronchus.
[0301] In some implementations, and as illustrated in Figs. 2A-B, obstructor 110a is mounted in a mount 120a that is securable to a bronchial wall of bronchus 16. In some implementations, mount 120a is securable to the bronchial wall by the mount exerting a radial force against the bronchial wall.
[0302] In the example shown, mount 120a has a slight hourglass shape (i.e., defined by two bulbs connected by a neck with obstructor 110a being disposed at the neck). However, it is to be understood that other mount shapes may be used. For example, mount 120a may be substantially cylindrical, or may be frustoconical.
[0303] In some implementations, mount 120a comprises a frame 122a, and implant 100a is deliverable into bronchus 16 while mount 120a (e.g., frame 122a thereof) is in a collapsed (e.g. crimped or compressed) state, and the implant is expandable within the bronchus (e.g., by expanding the frame) such that the mount presses radially outwards against the bronchial wall. In some implementations, frame 122a is self-expanding, e.g., the mount is securable to the bronchial wall by releasing the implant from a constrained state within a delivery tool such that the frame automatically expands within the bronchus. In some implementations, frame 122a is expanded by plastic deformation - e.g. is balloon-expandable.
[0304] In some implementations, mount 120a defines at least one grip (not shown) that is adapted to grip (e.g., penetrate) the bronchial wall, such that implant 100a is implantable into bronchus 16 by inserting the grip into the bronchial wall. In some implementations, such a grip can anchor to the bronchial wall by extending all the way through the bronchial wall to an exterior of the wall. In some implementations, mount 120a comprises at least one barb, adapted to penetrate the bronchial wall, without extending all the way through to the exterior of the bronchial wall. In some implementations, the outer surface of mount 120a may be knurled, e.g., without penetrating the bronchial wall.
[0305] As shown, mount 120a may comprise a cover 124a that covers frame 122a such that air cannot flow between struts of the frame. Cover 124a may thereby direct airflow through valve 112a. Cover 124a may additionally facilitate sealing of implant 100a against the bronchial wall. In some implementations, cover 124a directs inflow and outflow of air through valve 112a, and not peripherally around the valve.
[0306] In some implementations, cover 124a is semi-permeable to airflow, e.g., some airflow flows peripherally around the valve by flowing through the cover, while most of the airflow is directed through the valve. In other implementations, cover 124a is impermeable to airflow, e.g., all inflow and outflow is directed through valve 112a.
[0307] In some implementations, mount 120a does not comprise a cover, e.g., the mount comprises an open frame 122a that allows airflow therethrough. In such implementations, during inhalation of the subject, inflow of air is partially obstructed by valve 112a closing incompletely, such that the air flows both peripherally around obstructor 110a (e.g., through the open frame), and also through the incompletely closed valve (e.g., to a limited extent). During exhalation, valve 112a opens, such that the air flows both peripherally around obstructor 110a (e.g., through frame 122a), and also through the open valve.
[0308] Frame 122a may be formed from a metal (e.g. Nitinol, stainless steel, or cobalt chrome), and / or from a resilient polymer. In some implementations, rather than mount 120a comprising a frame and a covering, the mount may be formed (e.g. entirely) from a resilient polymer that serves both to secure the implant in the airway and to direct airflow through the valve. Furthermore, obstructor 110a may also be made from a polymer or other nonmetallic material - e.g. the implant may be substantially free of metal. In some implementations, implant 100a (including mount 120a and obstructor 110a) can be formed entirely as a unitary structure (e.g. from a single piece of stock material). The formation of implant 100a entirely from non-metallic materials may be advantageous to the subject beingtreated - e.g. by the implant being compatible with later procedures such as, but not limited to, MRI imaging. Each of the other implants herein may similarly be formed from nonmetallic materials and / or as a unitary structure, mutatis mutandis.
[0309] It is to be noted that the outflow-favoring and incomplete inflow obstruction by implant 100a is provided by incomplete closure of its valve-based obstructor - e.g. despite the possibility that all airflow through the implant flows through the valve. In contrast, the outflow-favoring and incomplete inflow obstruction by implants 100b, 100c, and lOOd is provided by the mounting of the respective obstructor within the implant - e.g. such that airflow through the implant may bypass the obstructor.
[0310] Figs 3A-B illustrate an implant 100b, that comprises an obstructor 110b that comprises a valve (e.g. check valve) 112b. Valve 112b is mounted in an open frame 122b, such that the implant is implantable within the bronchus in a manner that allows airflow between obstructor 110b and the bronchial wall - e.g. peripherally around the obstructor. During inhalation valve 112b closes to partially obstruct inflow of air (Fig. 3A), and during exhalation the valve opens to facilitate outflow of air.
[0311] As shown, valve 112b may be configured to close completely during inhalation, such that all inflow of air past the valve occurs peripherally past the valve (e.g. past obstructor 110b) (Fig. 3A). It is to be understood that although valve 112b is shown as closing completely during inhalation, it is to be understood that an incompletely -closing valve would have a similar advantage of limiting inflow of air therethrough. In contrast, during exhalation outflow of air can flow past the valve both peripherally and through the valve (Fig. 3B). That is, the valve is mounted within the implant such that, when the implant is implanted within the bronchus, inflow of air past the obstructor flows peripherally past the valve, and outflow of air past the obstructor flows both (i) peripherally past the valve and (ii) through the valve.
[0312] It is to be noted that although valve 112b is illustrated as being in the form of a liftcheck or in-line valve, it is to be understood that any other valves could be used instead.
[0313] Similarly, Figs. 4A-B illustrate an implant 100c, that comprises an obstructor 110c that comprises a valve 112c, which is mounted in an open frame (e.g., in open frame 122b), such that the implant is implantable within the bronchus in a manner that allows airflow between the obstructor and the bronchial wall.
[0314] As described with reference to implant 120b, valve 112c may be configured to close completely, or partially, during inhalation, such that all, or a significant portion of, inflow of air past the valve occurs peripherally past the valve (e.g. past obstructor 110c) (Fig. 4A). Incontrast, during exhalation outflow of air can flow past the valve both peripherally and through the valve (Fig. 4B). That is, when the implant is implanted within the bronchus, inflow of air past the obstructor flows peripherally past the valve, and outflow of air past the obstructor flows both (i) peripherally past the valve and (ii) through the valve.
[0315] Valve 112c is illustrated as being a duckbill valve, e.g., having a pair of flexible lips that form the shape of a duckbill to inhibit (e.g., prevent, or minimize) inflow therethrough (Fig. 4A) yet to allow outflow therethrough (Fig. 4B).
[0316] Figs. 5A-B illustrate an implant lOOd comprising an obstructor 112d that is mounted in an open frame 122d such that when the implant is implanted within bronchus 16, the implant partially obstructs inflow of air past the implant by allowing airflow between the obstructor and the bronchial wall, but not through the obstructor. Frame 122d may be a variant of, or substantially identical to, frame 122b, e.g., frame 122d is configured to allow for inflow and outflow of air peripherally between the implant and the bronchial wall.
[0317] Obstructor HOd is a static obstructor, which is not responsive to (e.g. remains stationary during) each inhalation and exhalation by the subject. Being static, obstructor 1 lOd also partially obstructs outflow (i.e. exhaled air) from flowing past the implant. In some implementations, an implant 100 comprising a static obstructor is configured such that this partial obstruction of outflow is approximately equal to the partial obstruction of inflow. However, at least in the example shown, implant lOOd is configured such that the partial obstruction of outflow is less than the partial obstruction of inflow - i.e. such that the implant favors exhalation more than inhalation.
[0318] Such exhalation-favoring configurations may be provided by the shape, size, movement, and / or mounting of obstructor HOd - e.g. with respect to frame 122d. For example, this may be achieved by obstructor 1 lOd being streamlined to favor outflow of air. In the example shown, obstructor HOd has an aerodynamic (e.g. convex) face 116 and a drag-inducing (e.g. flat or concave) face 118, the obstructor being implantable within the bronchus such that the aerodynamic face points toward a deeper part of the bronchus (e.g., towards region 17) and the drag-inducing face points toward a shallower part of the bronchus (e.g. towards the trachea). Alternatively and / or additionally, obstructor HOd may comprise one or more baffles or fins (not shown) that favor outflow of air.
[0319] Figs. 6A-B illustrate an implant lOOf that is static, i.e., that does not move responsively to inhalation or exhalation of the subject, yet is streamlined to favor outflow of air. For example, an obstructor I lOf of the implant may simply be defined by a part of theimplant that has a "bottleneck" form (e.g., that tapers inwardly), the bottleneck defining an aperture that has a smaller cross-sectional area than the rest of the implant, such that implanting the implant in bronchus 16 such that the narrow obstructor faces a shallower part of the bronchus (e.g., a trachea-facing part of the bronchus), and a wider end of the implant faces a deeper part of the lung (e.g., faces region 17 of the lung) restricts the amount of inflow (Fig. 6A) reaching a deeper region of the lung (e.g., region 17), while allowing for a larger proportion of outflow of air to leave the lung via the implant (Fig. 6B).
[0320] In some implementations, implant lOOf comprises a mount 120f. Mount 120f can comprise a frame 122f that is covered with a lining 124f, e.g., the lining inhibits, or prevents, airflow from flowing peripherally around the obstructor and through the mount.
[0321] Figs. 7A-B illustrate an implant 100g that defines an obstructor 110g that obstructs inflow (Fig. 7 A) and outflow (Fig. 7B) of air to an equal extent. For example, implant 100g can be symmetric on either side of obstructor 110g. In some implementations, obstructor 110g does not comprise a dynamic valve (i.e., is static), but may simply obstruct airflow in both directions by having a narrower cross-section than the rest of the implant. In some such implementations, implant 100g comprises a mount 120g that is hourglass shaped, defined by two bulbs connected by a neck, with obstructor 110g being defined by, or mounted at, the neck. Mount 120g can comprise a frame 122g that is covered with a lining 124g. Alternatively, frame 122g may not be covered, and may be open.
[0322] Reference is again made to Figs. 1A-5B, and 7A-B. In some implementations, any of frames 122a, 122b, 122c and / or 122d can be an expandable stent, e.g., defined by interconnected struts. In some implementations, any of the aforementioned frames can define two expandable portions (e.g. bulbs), with the obstructor being disposed axially between the expandable portions. For example, any of the aforementioned frames can have an hourglass shape, defined by two bulbs 126, 128 connected by a neck 127, with the obstructor being disposed at the neck (e.g., as marked in Fig. 5B, but illustrated throughout Figs. 2A-B, 3A- B, 4A-B, and 5A-B). One of the bulbs can therefore defines an inlet for inflow of air (i.e. an inlet through which inhaled air enters the implant on its way to region 17), and the other of the bulbs can define an outlet for inflow of air (i.e. an outlet through which inhaled air exits the implant on its way to region 17).
[0323] Fig. 8 illustrates an implant lOOe, that can be identical to any of the implants described hereinabove, except that the frame 122e of implant lOOe is articulatable. For example, and as shown, the neck and / or the obstructor may be flexible. Alternatively oradditionally, the mount may define a flexure or hinge that articulatably couples one of the expandable portions (e.g. bulbs) to the neck. In some such implementations, such articulation of the implant may advantageously allow implant lOOe to fit conformably with a curved shape of bronchus 16. That is, implant lOOe may be positionable within bronchus 16 such that the frame articulates to conform to the structure of the bronchus.
[0324] Reference is now made to Figs. 9A-B and 10A-B, which are schematic illustrations of an implant 200 that is implantable in an airway (e.g., a bronchus 16 or a trachea) of a lung 15 of a subject 10, in accordance with some applications. Figs. 9A-B illustrate implant 200 having been implanted in bronchus 16, and Figs. 10A-B show more close-up schematic views of implant 200. Implant 200 comprises an obstructor 210 that is configured to partially obstruct air from flowing past (e.g. through and / or around) the implant and out of lung 15 during exhalation - e.g. as illustrated in Fig. 9B by small arrow 40. In some implementations, implant 200 (e.g. obstructor 210 thereof) is configured not to materially obstruct inflow (i.e. inhaled air) from flowing past the implant - e.g., as illustrated in Fig. 9A by continuous arrow 42.
[0325] Implant 200 may be implanted in order to treat pulmonary hypertension. For example, the partial obstruction of outflow past the implant provided by obstructor 210 may reduce the rate and / or extent of deflation of a region 17 of lung 15 supplied by bronchus 16, and or reduce variation in alveolar air pressure in region 17. Purely for example, this may be advantageous in situations in which it is desired to reduce compression of extra-alveolar vessels during exhalation, and / or to maintain positive pressure to oppose lung collapse.
[0326] Despite the advantage of obstructing outflow of air past the implant, limiting the obstruction to be merely partial obstruction allows region 17 to continue providing gas exchange - i.e. to continue its lung function. That is, there is a trade-off between reducing pulmonary blood pressure and maintaining lung function.
[0327] Implant 200 may be considered to be a variant of implant 100 in which its obstructor is inverted, or which is configured to be implanted the other way around - i.e. inverted with respect to as described for implant 100.
[0328] In some implementations, and as illustrated in Figs. 10A-B, obstructor 210 is mounted in a mount 220 that is securable to a bronchial wall of bronchus 16. In some implementations, mount 220 is securable to the bronchial wall by the mount exerting a radial force against the bronchial wall.
[0329] In the example shown, mount 220 has a funnel or conical shape - e.g. with its wide end pointing into the lung and its narrow end pointing out of the lung. However, it is to be understood that other mount shapes may be used. For example, mount 220 may be substantially cylindrical or hourglass-shaped.
[0330] In some implementations, mount 220 comprises a frame 222. In some such implementations, implant 200 is deliverable into bronchus 16 while mount 220 (e.g., frame 222 thereof) is in a collapsed (e.g. crimped or compressed) state, and expandable within the bronchus (e.g., by expanding the frame) such that the mount presses radially outwards against the bronchial wall. In some implementations, frame 222 is self-expanding, e.g., the mount is securable to the bronchial wall by releasing the implant from a constrained state within a delivery tool such that the frame automatically expands within the bronchus. In some implementations, frame 222 is expanded by plastic deformation - e.g. is balloonexpandable.
[0331] In some implementations, mount 220 defines at least one grip (not shown) that is adapted to grip (e.g., penetrate) the bronchial wall, such that implant 200 is implantable into bronchus 16 by inserting the grip into the bronchial wall. In some implementations, such a grip can anchor to the bronchial wall by extending all the way through the bronchial wall to an exterior of the wall. In some implementations, mount 220 comprises at least one barb, adapted to penetrate the bronchial wall, without extending all the way through to the exterior of the bronchial wall. In some implementations, the outer surface of mount 220 may be knurled, e.g., without penetrating the bronchial wall.
[0332] In the example shown, obstructor 210 is a dynamic obstructor, similar to a checkvalve but one that only partially obstructs flow. Obstructor 210 may resemble a duckbill valve but, whereas the dynamic end of a duckbill valve closes by becoming narrow, the dynamic end of obstructor 210 - the lower end in Figs. 10A-B - expands / flares / billows to (partially) close. Obstructor 210 is mounted in mount 220 such that, when open (Fig. 10A; e.g. during inhalation), air can flow both through and around the obstructor - e.g. similarly to as described for implants 100b and 100c (but inverted). However, when obstructor 210 is (partially) closed (Fig. 10B; e.g. during exhalation), air is directed through the obstructor, the expanded / flared / billowed dynamic end obstructing air from flowing around the obstructor (i.e. between the obstructor and the bronchial wall). That is, whereas implants 100b and 100c provide a medial obstruction when (partially) closed, implant 200 provides a lateral / circumferential obstruction when (partially) closed.
[0333] Obstructor 210 may be considered to be a flexible and / or collapsible funnel.
[0334] In some implementations, and as shown, implant 200 may comprise a liner 224 that is fixed to (e.g. lines) part of mount 220 and / or frame 222. In some such applications, liner 224 serves as part of obstructor 210 - e.g. serves as a static part of the obstructor, while reference numeral 210 indicates a dynamic part of the obstructor.
[0335] The scope of the present disclosure includes implementations in which any variant of implant 100 is implanted in an inverted manner, mutatis mutandis, such that it partially obstructs outflow / exhalation rather than inflow / inhalation. It is to be further noted that any variant of implant 100 described herein may be modified such that its obstructor is inverted within the implant (e.g. with respect to its mount) such that it partially obstructs outflow / exhalation rather than inflow / inhalation.
[0336] Conversely, implant 200 may be inverted or modified, mutatis mutandis, to provide the functionality described for implant 100. That is, implant 200 may be implanted in an inverted manner, mutatis mutandis, such that it partially obstructs inflow / inhalation rather than outflow / exhalation, and / or may be modified such that obstructor 210 is inverted within the implant (e.g. with respect to mount 220) such that it partially obstructs inflow / inhalation rather than outflow / exhalation.
[0337] An experiment was performed in which pulmonary hypertension was induced in animals (pigs). Pulmonary Arterial Pressure (PAP) was measured, and after stabilization implant 200 was implanted, such that exhalation was partially obstructed but inhalation was materially unobstructed. PAP was continuously monitored, and exhibited a decline from 48.4 mmHg to 43.2 mmHg after implantation - a reduction of approximately 10%.
[0338] Reference is again made to Figs. 1A-10B. The mounts and / or frames of the implants described herein may be formed from metals and / or polymers. For example, self-expanding mounts and / or frames may be formed from an elastic, superelastic, or shape-memory material such as nitinol, spring steel, or a polymer. Plastically-expanded (e.g. balloonexpandable) mounts and / or frames may be formed, for example, from stainless steel, cobalt chrome, or a polymer.
[0339] Reference is again made to Figs. 1A-10B. The obstructors of the implants described herein may be formed from a metal and / or polymer. For example, flexible valve members or other components, such as those of obstructors 110a, 110c, and 210, may be formed from a synthetic polymer such as a silicone, a polyurethane, a polyethylene, or polytetrafluoroethylene .
[0340] Reference is again made to Figs. 1A-10B. The various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or consist of) such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of the present disclosure includes, in some implementations, sterilizing one or more of any of the various systems, devices, apparatuses, obstructors, etc. in this disclosure.
[0341] The techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation, such as a cadaver, cadaver heart, simulator, imaginary person, etc. When performed on a simulation, the body parts, e.g., lungs, tissue, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated lung, simulated tissue, simulated airways, simulated obstructors, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary lung), etc.
[0342] Example Implementations (some non-limiting examples of the concepts herein are recited below):
[0343] Example 1. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the lung.
[0344] Example 2. The system according to example 1, wherein the obstructor is shaped to obstruct inhalation to the same extent as exhalation.
[0345] Example 3. The system according to any one of examples 1-2, further comprising a transbronchial retrieval tool adapted to transbronchially retrieve the implant from the bronchus.
[0346] Example 4. The system according to any one of examples 1-3, wherein the implant is configured to maintain the obstructor stationary during inhalation and exhalation.
[0347] Example 5. The system according to any one of examples 1-4, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0348] Example 6. The system according to example 5, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0349] Example 7. The system according to example 6, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0350] Example 8. The system according to any one of examples 1-7, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0351] Example 9. The system according to example 8, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0352] Example 10. The system according to example 9, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each inhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0353] Example 11. The system according to any one of examples 1-10, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 20 percent of a cross-sectional area of the bronchus.
[0354] Example 12. The system according to example 11, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0355] Example 13. The system according to example 12, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0356] Example 14. The system according to any one of examples 1-13, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0357] Example 15. The system according to example 14, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 40 percent of a cross-sectional area of the bronchus.
[0358] Example 16. The system according to example 15, wherein the implant is configured such that, at least during inhalation by the subject, the obstructor obstructs no more than 20 percent of a cross-sectional area of the bronchus.
[0359] Example 17. The system according to any one of examples 1-16, wherein the obstructor comprises a valve that: (i) partially obstructs the inflow of air by closing responsively to inhalation by the subject, and / or (ii) facilitates outflow of air past the obstructor by opening responsively to exhalation by the subject.
[0360] Example 18. The system according to example 17, wherein the implant is configured such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0361] Example 19. The system according to example 17, wherein the valve partially obstructs the inflow of air by closing incompletely responsively to inhalation by the subject.
[0362] Example 20. The system according to example 19, wherein: (i) the valve facilitates outflow of air past the obstructor by, responsively to exhalation by the subject, opening such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 20 percent.
[0363] Example 21. The system according to example 20, wherein the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 40 percent.
[0364] Example 22. The system according to example 21, wherein the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 70 percent.
[0365] Example 23. The system according to example 19, wherein: (i) the valve facilitates outflow of air past the obstructor by, responsively to exhalation by the subject, opening such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 70 percent.
[0366] Example 24. The system according to example 23, wherein the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 40 percent.
[0367] Example 25. The system according to example 24, wherein the valve partially obstructs the inflow of air by, responsively to inhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 20 percent.
[0368] Example 26. The system according to example 17, wherein the valve is a duckbill valve.
[0369] Example 27. The system according to example 17, wherein the valve comprises multiple leaflets.
[0370] Example 28. The system according to example 27, wherein the valve is a bileaflet valve.
[0371] Example 29. The system according to example 27, wherein the valve is a trileaflet valve.
[0372] Example 30. The system according to example 17, wherein the valve is a diaphragm valve.
[0373] Example 31. The system according to example 17, wherein the valve is a butterfly valve.
[0374] Example 32. The system according to example 17, wherein the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (a) inflow of air past the obstructor flows peripherally past the valve, and / or (b) outflow of air past the obstructor flows both (i) peripherally past the valve and (ii) through the valve.
[0375] Example 33. The system according to example 17, wherein the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (a) inflow of air past the obstructor flows through the valve, and / or (b) outflow of air past the obstructor flows through the valve.
[0376] Example 34. The system according to example 17, wherein the implant is configured to seal against a bronchial wall of the bronchus such that any inflow of air past the obstructor passes through the valve.
[0377] Example 35. The system according to example 17, wherein the valve is a linear check valve.
[0378] Example 36. The system according to example 35, wherein the valve is a piston check valve.
[0379] Example 37. The system according to example 35, wherein the linear check valve is spring loaded.
[0380] Example 38. The system according to example 35, wherein the linear check valve comprises a disk.
[0381] Example 39. The system according to any one of examples 1-38, wherein the obstructor is shaped to obstruct inhalation to a greater extent than exhalation.
[0382] Example 40. The system according to example 39, wherein the obstructor does not move responsively to inhalation or exhalation.
[0383] Example 41. The system according to example 39, wherein the obstructor comprises a baffle, configured to favor outflow of air more than inflow of air.
[0384] Example 42. The system according to example 39, wherein the obstructor is streamlined in a manner which favors outflow of air more than inflow of air.
[0385] Example 43. The system according to example 39, wherein the obstructor has an aerodynamic face and a drag-inducing face, and the implant is configured to be implanted with the aerodynamic face pointing toward a deeper part of the bronchus and the draginducing face pointing to a shallower part of the bronchus.
[0386] Example 44. The system according to any one of examples 1-43, wherein the obstructor is mounted in a mount, the mount being securable to a bronchial wall of the bronchus.
[0387] Example 45. The system according to example 44, wherein the mount comprises a self-expanding frame.
[0388] Example 46. The system according to example 44, wherein the mount comprises a balloon-expandable frame.
[0389] Example 47. The system according to example 44, wherein the mount is securable to the bronchial wall by the mount exerting an outwards radial force against the bronchial wall.
[0390] Example 48. The system according to example 44, wherein the mount defines at least one grip that is adapted to grip the bronchial wall.
[0391] Example 49. The system according to example 44, wherein the mount comprises a frame and a covering that covers the frame.
[0392] Example 50. The system according to example 44, wherein the mount is configured to seal against the bronchial wall.
[0393] Example 51. The system according to example 44, wherein the mount comprises an open frame configured to allow airflow between the obstructor and the bronchial wall.
[0394] Example 52. The system according to example 51, wherein the obstructor partially obstructs inflow of air past the obstructor by allowing airflow between the obstructor and the bronchial wall, but not through the obstructor.
[0395] Example 53. The system according to example 44, wherein the implant is deliverable into the bronchus while the mount is in a collapsed state, and expandable within the bronchus towards an expanded state in which the mount presses radially outwards against the bronchial wall.
[0396] Example 54. The system according to example 53, wherein the mount defines two expandable portions, the obstructor being disposed axially between the expandable portions.
[0397] Example 55. The system according to example 54, wherein, in the expanded state of the frame, the frame has an hourglass form defined by two bulbs connected by a neck, the obstructor being disposed at the neck.
[0398] Example 56. The system according to example 55, wherein one of the bulbs defines an inlet for inflow of air and the other of the bulbs defines an outlet for inflow of air.
[0399] Example 57. The system according to example 54, wherein at least one of the expandable portions is articulatable with respect to the obstructor.
[0400] Example 58. The system according to example 54, wherein at least one of the expandable portions is articulatable with respect to the other expandable portion.
[0401] Example 59. The system according to any one of examples 1-58, wherein the system further comprises a transbronchial delivery device for implanting the implant within the bronchus.
[0402] Example 60. The system according to example 59, wherein the transbronchial delivery device comprises a bronchoscope.
[0403] Example 61. The system according to example 59, wherein the transbronchial delivery device is adapted to retrieve the implant out of the bronchus.
[0404] Example 62. A method comprising: (a) identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or (b) responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that,during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0405] Example 63. The method according to example 62, wherein: (a) the lung is a first lung, and / or (b) implanting the obstructor within the bronchus of the lung comprises implanting the obstructor within the bronchus of the first lung without implanting an obstructor within a second lung of the subject.
[0406] Example 64. The method according to any one of examples 62-63, wherein the bronchus is a bronchus of an inferior lobe of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the inferior lobe of the lung.
[0407] Example 65. The method according to any one of examples 62-64, wherein the bronchus is an inferior lobar bronchus of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the inferior lobar bronchus of the lung.
[0408] Example 66. The method according to any one of examples 62-65, wherein the lung is a left lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the left lung.
[0409] Example 67. The method according to any one of examples 62-66, wherein the lung is a right lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the right lung.
[0410] Example 68. The method according to any one of examples 62-67, wherein: (i) the bronchus is a secondary bronchus, and / or (ii) implanting the implant within the bronchus comprises implanting the implant within the secondary bronchus.
[0411] Example 69. The method according to any one of examples 62-68, wherein: (i) the bronchus is a primary bronchus, and / or (ii) implanting the implant within the bronchus comprises implanting the implant within the primary bronchus.
[0412] Example 70. The method according to any one of examples 62-69, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to left heart disease (PH-LHD).
[0413] Example 71. The method according to any one of examples 62-70, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary arterial hypertension.
[0414] Example 72. The method according to any one of examples 62-71, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to lung disease.
[0415] Example 73. The method according to any one of examples 62-72, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic obstructive pulmonary disease.
[0416] Example 74. The method according to any one of examples 62-73, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic blood clots in the lungs.
[0417] Example 75. The method according to any one of examples 62-74, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having idiopathic pulmonary hypertension.
[0418] Example 76. The method according to any one of examples 62-75, wherein: (i) the obstructor is shaped to obstruct inhalation to the same extent as exhalation, and / or (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0419] Example 77. The method according to any one of examples 62-76, further comprising transbronchially retrieving the obstructor from the bronchus.
[0420] Example 78. The method according to any one of examples 62-77, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor remains stationary during each inhalation and exhalation by the subject.
[0421] Example 79. The method according to any one of examples 62-78, the method further comprising transbronchially delivering the obstructor to the bronchus via the airways of the subject.
[0422] Example 80. The method according to any one of examples 62-79, wherein: (i) the obstructor is a first obstructor, (ii) the bronchus is a first bronchus, and / or (iii) the method further comprises implanting a second obstructor within a second bronchus of the lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, and the second obstructor partially obstructs inhaled air from flowing past the second obstructor.
[0423] Example 81. The method according to example 80, the method further comprising implanting a third obstructor in a third bronchus of the lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, the second obstructor partially obstructs inhaled air from flowing past the second obstructor, and the third obstructor partially obstructs inhaled air from flowing past the third obstructor.
[0424] Example 82. The method according to any one of examples 62-81, wherein: (i) the obstructor is a first obstructor, (ii) the bronchus is a first bronchus of a first lung, and / or (iii) the method further comprises implanting a second obstructor within a second bronchus of a second lung of the subject such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor and the second obstructor partially obstructs inhaled air from flowing past the second obstructor.
[0425] Example 83. The method according to example 82, the method further comprising implanting a third obstructor in another bronchus of the second lung such that, during each inhalation by the subject, the first obstructor partially obstructs inhaled air from flowing past the first obstructor, the second obstructor partially obstructs inhaled air from flowing past the second obstructor, and the third obstructor partially obstructs inhaled air from flowing past the third obstructor.
[0426] Example 84. The method according to any one of examples 62-83, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0427] Example 85. The method according to example 84, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0428] Example 86. The method according to example 85, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0429] Example 87. The method according to any one of examples 62-86, wherein implanting the obstructor within the bronchus comprises implanting the obstructor withinthe bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0430] Example 88. The method according to example 87, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0431] Example 89. The method according to example 88, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0432] Example 90. The method according to any one of examples 62-89, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 20 percent of the cross-sectional area of the bronchus.
[0433] Example 91. The method according to example 90, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0434] Example 92. The method according to example 91, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0435] Example 93. The method according to any one of examples 62-92, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0436] Example 94. The method according to example 93, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor obstructs no more than 40 percent of the cross-sectional area of the bronchus.
[0437] Example 95. The method according to example 94, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus suchthat during each inhalation by the subject, the obstructor obstructs no more than 20 percent of the cross-sectional area of the bronchus.
[0438] Example 96. The method according to any one of examples 62-95, wherein: (i) the obstructor comprises a valve, (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that: (a) during each inhalation by the subject, the valve partially obstructs the inflow of air by closing responsively to the inhalation, and / or (b) during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation.
[0439] Example 97. The method according to example 96, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0440] Example 98. The method according to example 96, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve partially obstructs the inflow of air by closing incompletely responsively to inhalation by the subject.
[0441] Example 99. The method according to example 98, wherein: (i) during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 20 percent.
[0442] Example 100. The method according to example 99, wherein during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 40 percent.
[0443] Example 101. The method according to example 100, wherein the valve partially obstructs the inflow of air, responsively to inhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by at least 70 percent.
[0444] Example 102. The system according to example 98, wherein: (i) during each exhalation by the subject, the valve facilitates outflow of air past the obstructor by opening responsively to the exhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 70 percent.
[0445] Example 103. The method according to example 102, wherein during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 40 percent.
[0446] Example 104. The method according to example 103, wherein the valve partially obstructs the inflow of air, responsively to inhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by no more than 20 percent.
[0447] Example 105. The method according to any one of examples 62-104, wherein: (i) the obstructor is shaped to obstruct inhalation to a greater extent than exhalation, and / or (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor allows exhaled air to flow past the obstructor.
[0448] Example 106. The method according to example 105, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor does not move responsively to inhalation or exhalation.
[0449] Example 107. The method according to example 105, wherein the obstructor comprises a baffle, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the baffle favors outflow of air due to exhalation of the subject more than inflow of air due to inhalation of the subject.
[0450] Example 108. The method according to example 105, wherein the obstructor is streamlined, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor favors outflow of air due to exhalation of the subject more than inflow of air due to inhalation of the subject.
[0451] Example 109. The method according to example 105, wherein the obstructor has an aerodynamic face and a drag-inducing face, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the aerodynamic face points toward a deeper part of the bronchus and the drag-inducing face points toward a shallower part of the bronchus.
[0452] Example 110. The method according to any one of examples 62-109, wherein the obstructor is mounted in a mount, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus by securing the mount to a bronchial wall of the bronchus.
[0453] Example 111. The method according to example 110, wherein the mount comprises a self-expanding frame, and wherein implanting the obstructor within the bronchuscomprises implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises allowing the frame to self-expand within the bronchus such that the mount becomes secured to the bronchial wall.
[0454] Example 112. The method according to example 110, wherein: (i) the mount comprises a balloon-expandable frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises using a balloon to expand the frame within the bronchus.
[0455] Example 113. The method according to example 110, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by positioning the mount against the bronchial wall such that the mount exerts an outwards radial force against the bronchial wall.
[0456] Example 114. The method according to example 110, wherein the mount defines at least one grip that is adapted to grip the bronchial wall, and wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises inserting the grip into the bronchial wall .
[0457] Example 115. The method according to example 110, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus such that the mount seals against the bronchial wall.
[0458] Example 116. The method according to example 110, wherein: (i) the mount comprises an open frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by securing the frame to the bronchial wall in a manner that allows airflow between the obstructor and the bronchial wall.
[0459] Example 117. The method according to example 110, the method further comprising: (i) delivering the obstructor to the bronchus while the mount is in a collapsed state, and / or (ii) expanding the mount within the bronchus such that the mount presses radially outwards against the bronchial wall.
[0460] Example 118. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate exhaled air being exhaled past the implant,and (ii) closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
[0461] Example 119. A method comprising: (a) identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or (b) responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each exhalation by the subject, the valve opens to facilitate exhaled air being exhaled past the implant, and (ii) during each inhalation by the subject, the valve closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
[0462] Example 120. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising: (i) an implant that comprises an obstructor, and / or (ii) a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0463] Example 121. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from being inhaled beyond the obstructor.
[0464] Example 122. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the respiratory system.
[0465] Example 123. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs outflow of air past the obstructor.
[0466] Example 124. The system according to example 123, wherein the obstructor is shaped to obstruct inhalation to the same extent as exhalation.
[0467] Example 125. The system according to any one of examples 123-124, further comprising a transbronchial retrieval tool adapted to transbronchially retrieve the implant from the bronchus.
[0468] Example 126. The system according to any one of examples 123-125, wherein the implant is configured to maintain the obstructor stationary during inhalation and exhalation.
[0469] Example 127. The system according to any one of examples 123-126, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 20 percent.
[0470] Example 128. The system according to example 127, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 40 percent.
[0471] Example 129. The system according to example 128, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by at least 70 percent.
[0472] Example 130. The system according to any one of examples 123-129, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 70 percent.
[0473] Example 131. The system according to example 130, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 40 percent.
[0474] Example 132. The system according to example 131, wherein the implant is configured such that, while the implant is disposed within the bronchus, during each exhalation by the subject, the obstructor reduces the outflow by no more than 20 percent.
[0475] Example 133. The system according to any one of examples 123-132, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 20 percent of a cross-sectional area of the bronchus.
[0476] Example 134. The system according to example 133, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0477] Example 135. The system according to example 134, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0478] Example 136. The system according to any one of examples 123-135, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0479] Example 137. The system according to example 136, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 40 percent of a cross-sectional area of the bronchus.
[0480] Example 138. The system according to example 137, wherein the implant is configured such that, at least during exhalation by the subject, the obstructor obstructs no more than 20 percent of a cross-sectional area of the bronchus.
[0481] Example 139. The system according to any one of examples 123-138, wherein the obstructor comprises a valve that: (i) partially obstructs the outflow of air by closing responsively to exhalation by the subject, and / or (ii) facilitates inflow of air past the obstructor by opening responsively to inhalation by the subject.
[0482] Example 140. The system according to example 139, wherein the implant is configured such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0483] Example 141. The system according to example 139, wherein the valve partially obstructs the outflow of air by closing incompletely responsively to exhalation by the subject.
[0484] Example 142. The system according to example 19, wherein: (i) the valve facilitates inflow of air past the obstructor by, responsively to inhalation by the subject, opening such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 20 percent.
[0485] Example 143. The system according to example 20, wherein the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 40 percent.
[0486] Example 144. The system according to example 21, wherein the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by at least 70 percent.
[0487] Example 145. The system according to example 19, wherein: (i) the valve facilitates inflow of air past the obstructor by, responsively to inhalation by the subject, opening suchthat the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 70 percent.
[0488] Example 146. The system according to example 23, wherein the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 40 percent.
[0489] Example 147. The system according to example 24, wherein the valve partially obstructs the outflow of air by, responsively to exhalation by the subject, closing in a manner that reduces the cross-sectional area of the orifice by no more than 20 percent.
[0490] Example 148. The system according to example 139, wherein the valve is a duckbill valve.
[0491] Example 149. The system according to example 139, wherein the valve comprises multiple leaflets.
[0492] Example 150. The system according to example 149, wherein the valve is a bileaflet valve.
[0493] Example 151. The system according to example 149, wherein the valve is a trileaflet valve.
[0494] Example 152. The system according to example 139, wherein the valve is a diaphragm valve.
[0495] Example 153. The system according to example 139, wherein the valve is a butterfly valve.
[0496] Example 154. The system according to example 139, wherein the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (a) outflow of air past the obstructor flows peripherally past the valve, and / or (b) inflow of air past the obstructor flows both (i) peripherally past the valve and (ii) through the valve.
[0497] Example 155. The system according to example 139, wherein the valve is mounted within the implant such that, when the implant is implanted within the bronchus: (i) outflow of air past the obstructor flows through the valve, and / or (ii) inflow of air past the obstructor flows through the valve.
[0498] Example 156. The system according to example 139, wherein the implant is configured to seal against a bronchial wall of the bronchus such that any outflow of air past the obstructor passes through the valve.
[0499] Example 157. The system according to example 139, wherein the valve is a linear check valve.
[0500] Example 158. The system according to example 157, wherein the valve is a piston check valve.
[0501] Example 159. The system according to example 157, wherein the linear check valve is spring loaded.
[0502] Example 160. The system according to example 157, wherein the linear check valve comprises a disk.
[0503] Example 161. The system according to any one of examples 123-160, wherein the obstructor is shaped to obstruct exhalation to a greater extent than inhalation.
[0504] Example 162. The system according to example 161, wherein the obstructor does not move responsively to inhalation or exhalation.
[0505] Example 163. The system according to example 161, wherein the obstructor comprises a baffle, configured to favor inflow of air more than outflow of air.
[0506] Example 164. The system according to example 161, wherein the obstructor is streamlined in a manner which favors inflow of air more than outflow of air.
[0507] Example 165. The system according to example 161, wherein the obstructor has an aerodynamic face and a drag-inducing face, and the implant is configured to be implanted with the aerodynamic face pointing toward a shallower part of the bronchus and the draginducing face pointing to a deeper part of the bronchus.
[0508] Example 166. The system according to any one of examples 123-165, wherein the obstructor is mounted in a mount, the mount being securable to a bronchial wall of the bronchus.
[0509] Example 167. The system according to example 166, wherein the mount comprises a self-expanding frame.
[0510] Example 168. The system according to example 166, wherein the mount comprises a balloon-expandable frame.
[0511] Example 169. The system according to example 166, wherein the mount is securable to the bronchial wall by the mount exerting an outwards radial force against the bronchial wall.
[0512] Example 170. The system according to example 166, wherein the mount defines at least one grip that is adapted to grip the bronchial wall.
[0513] Example 171. The system according to example 166, wherein the mount comprises a frame and a covering that covers the frame.
[0514] Example 172. The system according to example 166, wherein the mount is configured to seal against the bronchial wall.
[0515] Example 173. The system according to example 166, wherein the mount comprises an open frame configured to allow airflow between the obstructor and the bronchial wall.
[0516] Example 174. The system according to example 173, wherein the obstructor partially obstructs inflow of air past the obstructor by allowing airflow between the obstructor and the bronchial wall, but not through the obstructor.
[0517] Example 175. The system according to example 166, wherein the implant is deliverable into the bronchus while the mount is in a collapsed state, and expandable within the bronchus towards an expanded state in which the mount presses radially outwards against the bronchial wall.
[0518] Example 176. The system according to example 175, wherein the mount defines two expandable portions, the obstructor being disposed axially between the expandable portions.
[0519] Example 177. The system according to example 176, wherein, in the expanded state of the frame, the frame has an hourglass form defined by two bulbs connected by a neck, the obstructor being disposed at the neck.
[0520] Example 178. The system according to example 177, wherein one of the bulbs defines an inlet for outflow of air and the other of the bulbs defines an outlet for outflow of air.
[0521] Example 179. The system according to example 176, wherein at least one of the expandable portions is articulatable with respect to the obstructor.
[0522] Example 180. The system according to example 176, wherein at least one of the expandable portions is articulatable with respect to the other expandable portion.
[0523] Example 181. The system according to any one of examples 123-180, wherein the system further comprises a transbronchial delivery device for implanting the implant within the bronchus.
[0524] Example 182. The system according to example 181, wherein the transbronchial delivery device comprises a bronchoscope.
[0525] Example 183. The system according to example 181, wherein the transbronchial delivery device is adapted to retrieve the implant out of the bronchus.
[0526] Example 184. A method comprising: (i) identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or (ii) responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that, during each exhalation by the subject, the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0527] Example 185. The method according to example 184, wherein: (i) the lung is a first lung, and / or (ii) implanting the obstructor within the bronchus of the lung comprises implanting the obstructor within the bronchus of the first lung without implanting an obstructor within a second lung of the subject.
[0528] Example 186. The method according to any one of examples 184-185, wherein the bronchus is a bronchus of an inferior lobe of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the inferior lobe of the lung.
[0529] Example 187. The method according to any one of examples 184-186, wherein the bronchus is an inferior lobar bronchus of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the inferior lobar bronchus of the lung.
[0530] Example 188. The method according to any one of examples 184-187, wherein the lung is a left lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the left lung.
[0531] Example 189. The method according to any one of examples 184-188, wherein the lung is a right lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the right lung.
[0532] Example 190. The method according to any one of examples 184-189, wherein: (i) the bronchus is a secondary bronchus, and / or (ii) implanting the implant within the bronchus comprises implanting the implant within the secondary bronchus.
[0533] Example 191. The method according to any one of examples 184-190, wherein: (i) the bronchus is a primary bronchus, and / or (ii) implanting the implant within the bronchus comprises implanting the implant within the primary bronchus.
[0534] Example 192. The method according to any one of examples 184-191, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to left heart disease (PH-LHD).
[0535] Example 193. The method according to any one of examples 184-192, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary arterial hypertension.
[0536] Example 194. The method according to any one of examples 184-193, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to lung disease.
[0537] Example 195. The method according to any one of examples 184-194, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic obstructive pulmonary disease.
[0538] Example 196. The method according to any one of examples 184-195, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic blood clots in the lungs.
[0539] Example 197. The method according to any one of examples 184-196, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having idiopathic pulmonary hypertension.
[0540] Example 198. The method according to any one of examples 184-197, wherein: (i) the obstructor is shaped to obstruct inhalation to the same extent as exhalation, and / or (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
[0541] Example 199. The method according to any one of examples 184-198, further comprising transbronchially retrieving the obstructor from the bronchus.
[0542] Example 200. The method according to any one of examples 184-199, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor remains stationary during each inhalation and exhalation by the subject.
[0543] Example 201. The method according to any one of examples 184-200, the method further comprising transbronchially delivering the obstructor to the bronchus via the airways of the subject.
[0544] Example 202. The method according to any one of examples 184-201, wherein: (i) the obstructor is a first obstructor, (ii) the bronchus is a first bronchus, and / or (iii) the method further comprises implanting a second obstructor within a second bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
[0545] Example 203. The method according to example 202, the method further comprising implanting a third obstructor in a third bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, the second obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
[0546] Example 204. The method according to any one of examples 184-203, wherein: (i) the obstructor is a first obstructor, (ii) the bronchus is a first bronchus of a first lung, and / or (iii) the method further comprises implanting a second obstructor within a second bronchus of a second lung of the subject such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
[0547] Example 205. The method according to example 204, the method further comprising implanting a third obstructor in another bronchus of the second lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, the second obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
[0548] Example 206. The method according to any one of examples 184-205, wherein implanting the obstructor within the bronchus comprises implanting the obstructor withinthe bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
[0549] Example 207. The method according to example 206, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
[0550] Example 208. The method according to example 207, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
[0551] Example 209. The method according to any one of examples 184-208, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
[0552] Example 210. The method according to example 209, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
[0553] Example 211. The method according to example 210, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
[0554] Example 212. The method according to any one of examples 184-211, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 20 percent of the cross-sectional area of the bronchus.
[0555] Example 213. The method according to example 212, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
[0556] Example 214. The method according to example 213, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus suchthat during each exhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
[0557] Example 215. The method according to any one of examples 184-214, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 70 percent of a cross-sectional area of the bronchus.
[0558] Example 216. The method according to example 215, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 40 percent of the cross-sectional area of the bronchus.
[0559] Example 217. The method according to example 216, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 20 percent of the cross-sectional area of the bronchus.
[0560] Example 218. The method according to any one of examples 184-217, wherein: (i) the obstructor comprises a valve, (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that: (a) during each exhalation by the subject, the valve partially obstructs the outflow of air by closing responsively to the exhalation, and / or (b) during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation.
[0561] Example 219. The method according to example 218, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
[0562] Example 220. The method according to example 218, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve partially obstructs the outflow of air by closing incompletely responsively to exhalation by the subject.
[0563] Example 221. The method according to example 98, wherein: (i) during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 20 percent.
[0564] Example 222. The method according to example 99, wherein during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by at least 40 percent.
[0565] Example 223. The method according to example 100, wherein the valve partially obstructs the outflow of air, responsively to exhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by at least 70 percent.
[0566] Example 224. The system according to example 98, wherein: (i) during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation such that the valve defines an orifice therethrough having a cross-sectional area, and / or (ii) during each exhalation by the subject, the valve partially obstructs the outflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 70 percent.
[0567] Example 225. The method according to example 102, wherein during each inhalation by the subject, the valve partially obstructs the inflow of air by closing incompletely to reduce the cross-sectional area of the orifice by no more than 40 percent.
[0568] Example 226. The method according to example 103, wherein the valve partially obstructs the outflow of air, responsively to exhalation by the subject, by closing incompletely to reduce the cross-sectional area of the orifice by no more than 20 percent.
[0569] Example 227. The method according to any one of examples 184-226, wherein: (i) the obstructor is shaped to obstruct exhalation to a greater extent than inhalation, and / or (ii) implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor allows inhaled air to flow past the obstructor.
[0570] Example 228. The method according to example 227, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor does not move responsively to inhalation or exhalation.
[0571] Example 229. The method according to example 227, wherein the obstructor comprises a baffle, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the baffle favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
[0572] Example 230. The method according to example 227, wherein the obstructor is streamlined, and wherein implanting the obstructor within the bronchus comprisesimplanting the obstructor within the bronchus such that the obstructor favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
[0573] Example 231. The method according to example 227, wherein the obstructor has an aerodynamic face and a drag-inducing face, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the aerodynamic face points toward a shallower part of the bronchus and the drag-inducing face points toward a deeper part of the bronchus.
[0574] Example 232. The method according to any one of examples 184-231, wherein the obstructor is mounted in a mount, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus by securing the mount to a bronchial wall of the bronchus.
[0575] Example 233. The method according to example 232, wherein the mount comprises a self-expanding frame, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises allowing the frame to self-expand within the bronchus such that the mount becomes secured to the bronchial wall.
[0576] Example 234. The method according to example 232, wherein: (i) the mount comprises a balloon-expandable frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises using a balloon to expand the frame within the bronchus.
[0577] Example 235. The method according to example 232, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by positioning the mount against the bronchial wall such that the mount exerts an outwards radial force against the bronchial wall.
[0578] Example 236. The method according to example 232, wherein the mount defines at least one grip that is adapted to grip the bronchial wall, and wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises inserting the grip into the bronchial wall .
[0579] Example 237. The method according to example 232, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus such that the mount seals against the bronchial wall.
[0580] Example 238. The method according to example 232, wherein: (i) the mount comprises an open frame, and / or (ii) implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by securing the frame to the bronchial wall in a manner that allows airflow between the obstructor and the bronchial wall.
[0581] Example 239. The method according to example 232, the method further comprising: (i) delivering the obstructor to the bronchus while the mount is in a collapsed state, and / or (ii) expanding the mount within the bronchus such that the mount presses radially outwards against the bronchial wall.
[0582] Example 240. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate inhaled air being inhaled past the implant, and (ii) closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
[0583] Example 241. A method comprising: (a) identifying a subject (e.g., a real or simulated subject) as having pulmonary hypertension, and / or (b) responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each inhalation by the subject, the valve opens to facilitate inhaled air being inhaled past the implant, and (ii) during each exhalation by the subject, the valve closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
[0584] Example 242. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising: (i) an implant that comprises an obstructor, and / or (ii) a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from flowing past the obstructor.
[0585] Example 243. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from being exhaled beyond the obstructor.
[0586] Example 244. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such thatthe obstructor partially obstructs outflow of air past the obstructor outwardly with respect to the respiratory system.
[0587] Example 245. A system for use with a respiratory system of a subject (e.g., a real or simulated subject), the system comprising an implant that comprises: (a) a mount, configured to secure the implant within a bronchus of a lung of the respiratory system; and / or (b) a valve, secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) opens to facilitate air flowing through the bronchus past the implant in a first direction, and (ii) closes incompletely to partially obstruct air from flowing through the bronchus past the implant in a second, opposite direction.
[0588] Example 246. The system according to example 245, wherein the valve is secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) responsively to exhalation, opens to facilitate exhaled air to flow through the bronchus past the implant, and (ii) responsively to inhalation, closes incompletely to partially obstruct inhaled air from flowing through the bronchus past the implant.
[0589] Example 247. The system according to example 245, wherein the valve is secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) responsively to inhalation, opens to facilitate inhaled air to flow through the bronchus past the implant, and (ii) responsively to exhalation, closes incompletely to partially obstruct exhaled air from flowing through the bronchus past the implant.
[0590] The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub -combinations with one another. For example, the obstructors described herein may be used in place of each other (e.g. in combination with any of the mounts described herein), and the mounts described herein may be used in place of each other (e.g. in combination with any of the obstructors described herein). The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, apparatuses, devices, methods, etc. require that any one or more specific advantages be present or problems be solved.
[0591] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that thismanner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.
[0592] The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
Claims
CLAIMS1. A method comprising: identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting, within a bronchus of a lung of the subject, a valve that is configured to (i) open responsively to inhalation by the subject, and (ii) incompletely close responsively to exhalation by the subject, such that: during each inhalation by the subject, the valve facilitates inhaled air flowing through the valve, and during each exhalation by the subject, the valve partially obstructs exhaled air from flowing past the valve.
2. A method comprising: identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that, during each exhalation by the subject, the obstructor partially obstructs exhaled air from flowing past the obstructor.
3. The method according to claim 2, wherein: the lung is a first lung, and implanting the obstructor within the bronchus of the lung comprises implanting the obstructor within the bronchus of the first lung without implanting an obstructor within a second lung of the subject.
4. The method according to claim 2, wherein the bronchus is a bronchus of an inferior lobe of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the inferior lobe of the lung.
5. The method according to claim 2, wherein the bronchus is an inferior lobar bronchus of the lung, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the inferior lobar bronchus of the lung.
6. The method according to claim 2, wherein the lung is a left lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the left lung.
7. The method according to claim 2, wherein the lung is a right lung of the subject, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus of the right lung.
8. The method according to claim 2, wherein: the bronchus is a secondary bronchus, and implanting the implant within the bronchus comprises implanting the implant within the secondary bronchus.
9. The method according to claim 2, wherein: the bronchus is a primary bronchus, and implanting the implant within the bronchus comprises implanting the implant within the primary bronchus.
10. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to left heart disease (PH-LHD).
11. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary arterial hypertension.
12. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to lung disease.
13. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic obstructive pulmonary disease.
14. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having pulmonary hypertension due to chronic blood clots in the lungs.
15. The method according to claim 2, wherein identifying the subject as having pulmonary hypertension comprises identifying the subject as having idiopathic pulmonary hypertension.
16. The method according to claim 2, wherein: the obstructor is shaped to obstruct inhalation to the same extent as exhalation, andimplanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
17. The method according to claim 2, further comprising transbronchially retrieving the obstructor from the bronchus.
18. The method according to claim 2, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor remains stationary during each inhalation and exhalation by the subject.
19. The method according to claim 2, the method further comprising transbronchially delivering the obstructor to the bronchus via the airways of the subject.
20. The method according to claim 2, wherein: the obstructor is a first obstructor, the bronchus is a first bronchus, and the method further comprises implanting a second obstructor within a second bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
21. The method according to claim 20, the method further comprising implanting a third obstructor in a third bronchus of the lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor, the second obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
22. The method according to claim 2, wherein: the obstructor is a first obstructor, the bronchus is a first bronchus of a first lung, and the method further comprises implanting a second obstructor within a second bronchus of a second lung of the subject such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the first obstructor and the second obstructor partially obstructs exhaled air from flowing past the second obstructor.
23. The method according to claim 22, the method further comprising implanting a third obstructor in another bronchus of the second lung such that, during each exhalation by the subject, the first obstructor partially obstructs exhaled air from flowing past the firstobstructor, the second obstructor partially obstructs exhaled air from flowing past the second obstructor, and the third obstructor partially obstructs exhaled air from flowing past the third obstructor.
24. The method according to claim 2, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 20 percent.
25. The method according to claim 24, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 40 percent.
26. The method according to claim 25, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by at least 70 percent.
27. The method according to claim 2, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 70 percent.
28. The method according to claim 27, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 40 percent.
29. The method according to claim 28, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor reduces the inflow by no more than 20 percent.
30. The method according to claim 2, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 20 percent of the cross-sectional area of the bronchus.
31. The method according to claim 30, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs at least 40 percent of the cross-sectional area of the bronchus.
32. The method according to claim 31, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during eachexhalation by the subject, the obstructor obstructs at least 70 percent of the cross-sectional area of the bronchus.
33. The method according to claim 2, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 70 percent of a cross- sectional area of the bronchus.
34. The method according to claim 33, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 40 percent of the cross- sectional area of the bronchus.
35. The method according to claim 34, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each exhalation by the subject, the obstructor obstructs no more than 20 percent of the cross- sectional area of the bronchus.
36. The method according to claim 2, wherein: the obstructor comprises a valve, implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that: during each exhalation by the subject, the valve partially obstructs the outflow of air by closing responsively to the exhalation, and during each inhalation by the subject, the valve facilitates inflow of air past the obstructor by opening responsively to the inhalation.
37. The method according to claim 36, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve occupies at least 90 percent of the cross-sectional area of the bronchus.
38. The method according to claim 36, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the valve partially obstructs the outflow of air by closing incompletely responsively to exhalation by the subject.
39. The method according to claim 2, wherein: the obstructor is shaped to obstruct exhalation to a greater extent than inhalation, andimplanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that during each inhalation by the subject, the obstructor allows inhaled air to flow past the obstructor.
40. The method according to claim 39, wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor does not move responsively to inhalation or exhalation.
41. The method according to claim 39, wherein the obstructor comprises a baffle, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the baffle favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
42. The method according to claim 39, wherein the obstructor is streamlined, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the obstructor favors inflow of air due to inhalation of the subject more than outflow of air due to exhalation of the subject.
43. The method according to claim 39, wherein the obstructor has an aerodynamic face and a drag-inducing face, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus such that the aerodynamic face points toward a shallower part of the bronchus and the drag-inducing face points toward a deeper part of the bronchus.
44. The method according to claim 2, wherein the obstructor is mounted in a mount, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus by securing the mount to a bronchial wall of the bronchus.
45. The method according to claim 44, wherein the mount comprises a self-expanding frame, and wherein implanting the obstructor within the bronchus comprises implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises allowing the frame to self-expand within the bronchus such that the mount becomes secured to the bronchial wall.
46. The method according to claim 44, wherein: the mount comprises a balloon-expandable frame, and implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises using a balloon to expand the frame within the bronchus.
47. The method according to claim 44, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by positioning the mount against the bronchial wall such that the mount exerts an outwards radial force against the bronchial wall.
48. The method according to claim 44, wherein the mount defines at least one grip that is adapted to grip the bronchial wall, and wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises inserting the grip into the bronchial wall.
49. The method according to claim 44, wherein implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus such that the mount seals against the bronchial wall.
50. The method according to claim 44, wherein: the mount comprises an open frame, and implanting the obstructor within the bronchus by securing the mount to the bronchial wall comprises implanting the obstructor within the bronchus by securing the frame to the bronchial wall in a manner that allows airflow between the obstructor and the bronchial wall.
51. The method according to claim 44, the method further comprising: delivering the obstructor to the bronchus while the mount is in a collapsed state, and expanding the mount within the bronchus such that the mount presses radially outwards against the bronchial wall.
52. A system for use with a respiratory system of a subject, the system comprising an implant that comprises a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate inhaled air being inhaled past the implant, and (ii) closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
53. A method comprising : identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each inhalation by the subject, the valve opens to facilitate inhaled air being inhaled past the implant, and (ii) during each exhalation by the subject, thevalve closes incompletely to partially obstruct exhaled air from being exhaled past the implant.
54. A system for use with a respiratory system of a subject, the system comprising: an implant that comprises an obstructor, and a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from flowing past the obstructor.
55. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs exhaled air from being exhaled beyond the obstructor.
56. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such that the obstructor partially obstructs outflow of air past the obstructor outwardly with respect to the respiratory system.
57. A system for use with a respiratory system of a subject, the system comprising an implant that comprises: a mount, configured to secure the implant within a bronchus of a lung of the respiratory system; and a valve, secured to the mount and configured such that, when the implant is secured within the bronchus, the valve alternatingly (i) opens to facilitate air flowing through the bronchus past the implant in a first direction, and (ii) closes incompletely to partially obstruct air from flowing through the bronchus past the implant in a second, opposite direction.
58. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the lung.
59. A method comprising:identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting an obstructor within a bronchus of a lung of the subject such that, during each inhalation by the subject, the obstructor partially obstructs inhaled air from flowing past the obstructor.
60. A system for use with a respiratory system of a subject, the system comprising an implant that comprises a valve, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the valve repeatedly (i) opens to facilitate exhaled air being exhaled past the implant, and (ii) closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
61. A method comprising : identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting a valve within a bronchus of a lung of the subject, such that (i) during each exhalation by the subject, the valve opens to facilitate exhaled air being exhaled past the implant, and (ii) during each inhalation by the subject, the valve closes incompletely to partially obstruct inhaled air from being inhaled past the implant.
62. A system for use with a respiratory system of a subject, the system comprising: an implant that comprises an obstructor, and a delivery tool, configured to implant the implant within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from flowing past the obstructor.
63. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs inhaled air from being inhaled beyond the obstructor.
64. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a trachea of the respiratory system such that the obstructor partially obstructs inflow of air past the obstructor deeper into the respiratory system.
65. A system for use with a respiratory system of a subject, the system comprising an implant that comprises an obstructor, the implant being configured to be implanted within a bronchus of a lung of the respiratory system such that the obstructor partially obstructs outflow of air past the obstructor.
66. A method comprising: identifying a subject as having pulmonary hypertension, and responsively to the identifying, implanting, within a bronchus of a lung of the subject, a valve that is configured to (i) open responsively to exhalation by the subject, and (ii) incompletely close responsively to inhalation by the subject, such that: during each exhalation by the subject, the valve facilitates exhaled air flowing through the valve, and during each inhalation by the subject, the valve partially obstructs inhaled air from flowing past the valve.