Intrabronchial Implants and Related Technologies

Abstract

A suitable intrabronchial implant is provided. According to an embodiment of the present technology, an implant includes a proximal end portion and a distal end portion spaced apart from each other along a longitudinal axis and configured to be deployed in a first and a second airway of a bronchial tree, respectively, the second airway being a generation greater than the first airway. The implant includes wires extending along a wire path within a tubular region aligned coaxially with the longitudinal axis. The wires include first and second sections alternately arranged along the wire path and extending distally and proximally, respectively, in a circumferential direction about the longitudinal axis. The implant is configured to transition from a low-profile delivery state to an expanded, deployed state at a treatment location and to enable mucociliary clearance from immediately distal to an area immediately proximal to the implant while deployed at the treatment location.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of the following applications:

[0002] (a) U.S. Provisional Application No. 63 / 223,546 (filed July 20, 2021)

[0003] (b) U.S. Provisional Application No. 63 / 268,604 (filed February 27, 2022)

[0004] The foregoing applications are incorporated herein by reference in their entirety. To the extent that the foregoing applications and / or any other material incorporated herein by reference conflicts with the present disclosure, the present disclosure will control.

[0005] The present technology relates to implants, such as endobronchial implants, for treating chronic obstructive pulmonary disorder. [Background technology]

[0006] Chronic obstructive pulmonary disorder (COPD) is a disease of impaired lung function. Symptoms of COPD include coughing, wheezing, shortness of breath, and chest tightness. Cigarette smoking is the primary cause of COPD, but long-term exposure to other lung irritants (e.g., air pollution, chemical fumes, dust, etc.) can also cause or contribute to COPD. In most cases, COPD is a progressive disease that worsens over the course of many years. Thus, many people suffer from COPD but are unaware of its progression. COPD is currently the leading cause of death and disability in the United States. Severe COPD can prevent patients from performing even basic activities such as walking, climbing stairs, or bathing. Unfortunately, there is no known cure for COPD. There are also no known medical techniques that can reverse the lung damage associated with COPD.

[0007] In normal breathing, the act of inhalation draws air into the lungs through the nose or mouth and trachea. Within each lung, inhaled air travels into a branching network of progressively smaller airways called bronchi, then into the smallest airways called bronchioles. The bronchioles terminate in numerous tiny, rounded structures called alveoli. Microscopic blood vessels called capillaries extend through the walls of the alveoli. When inhaled air reaches the alveoli, oxygen moves from the alveoli into the blood within the capillaries. Simultaneously, carbon dioxide moves in the opposite direction, from the blood within the capillaries into the alveoli. This process is called gas exchange. In healthy lungs, the airways and alveoli are elastic and stretch to accommodate the intake of air. When air is inhaled, the alveoli fill completely with air, like tiny balloons. When air is exhaled, the alveoli contract. This expansion of the alveoli is an important part of effective gas exchange: alveoli that are free to expand exchange more gas than alveoli that are prevented from expanding.

[0008] In lung tissue affected by COPD, little air flows through the airways for a variety of reasons. The airways and / or alveoli may be relatively inelastic, the walls between the alveoli may be damaged or destroyed, the walls of the airways may be thickened or inflamed, and / or the airways may produce excess mucus, leading to mucus accumulation and airway obstruction. In typical cases of COPD, the disease does not affect all airways and alveoli equally within the lungs. The lungs may have some areas that are significantly more affected than others. In severe cases, airways and alveoli that are not suitable for effective gas exchange may comprise 20 to 30 percent or more of the total lung volume.

[0009] The effects of COPD are often most evident when a patient exercises or engages in other physical exertion that would cause a healthy person to breathe heavily. Patients with COPD may not be able to breathe heavily because the affected portions of the patient's lungs trap air and are unable to fully exhale it. This, in turn, prevents subsequent expansion of healthy lung tissue. Thus, during exercise or other physical exertion, a COPD patient's lungs may operate in a state of dynamic hyperstretch, impairing respiratory mechanics and increasing the respiratory workload. Lung hyperstretch may also impair cardiac filling, leading to dyspnea and / or reducing the patient's exercise performance. These and / or other adverse effects of COPD may ultimately lead to a series of symptoms that impair a patient's quality of life and increase the risk of severe disability and death.

[0010] The term "COPD" includes both chronic bronchitis and emphysema. Approximately 25% of COPD patients suffer from emphysema. Of these emphysema patients, approximately 40% suffer from severe emphysema. Furthermore, COPD patients commonly suffer from both chronic bronchitis and emphysema. In chronic bronchitis, the interior of the airways generally becomes inflamed as a result of continued irritation. This inflammation leads to thickening of the interior of the airways and the production of thick mucus, which can coat and eventually congest the airways. In contrast, emphysema is a pathological diagnosis primarily related to the abnormal, permanent enlargement of the air spaces distal to the terminal bronchioles. In emphysematous lung tissue, small airways and / or alveoli typically lose their structural integrity and / or their ability to maintain optimal shape. For example, damage to or destruction of the alveolar walls may result in fewer but larger alveoli. This can significantly impair normal gas exchange. Within the lungs, lesions or "diseased" areas of emphysematous lung tissue, characterized by the absence of distinct alveolar walls, can be referred to as alveoli. These relatively inelastic pockets of dead space often exceed 1 cm in diameter and do not significantly contribute to gas exchange. Alveoli tend to retain air, thereby creating hyperstretched lung segments that limit the ability of healthy lung tissue to fully expand in response to inspiration. Thus, in patients with emphysema, not only does the diseased lung tissue no longer significantly contribute to respiratory function, but it also impairs the function of healthy lung tissue.

[0011] Pharmacological treatments are often prescribed for COPD. Treatment algorithms involving bronchodilators, B2 agonists, muscarinic agonists, corticosteroids, or a combination thereof may provide short-term relief of COPD symptoms. However, these treatments do not cure COPD or significantly slow disease progression. Non-pharmaceutical management solutions such as home oxygen, noninvasive positive pressure ventilation, and pulmonary rehabilitation are also common but have only modest therapeutic benefits. Another treatment option for patients with severe emphysema is lung volume reduction surgery (LVRS). This surgery involves removing poorly functioning portions of the lung (typically up to 20–25 percent of lung volume), thereby reducing the overall size of the lung and freeing up more volume within the thoracic cavity available for expansion of relatively healthy lung tissue. With more available volume for expansion, the lung tissue remaining after LVRS has an improved capacity for effective gas exchange. A clear drawback of LVRS is its highly invasive nature. Therefore, LVRS is usually considered a last resort option suitable for only a small percentage of emphysema patients.

[0012] There are also procedures for lung volume reduction that do not involve surgical removal of diseased lung tissue. Examples include using coils or clips to capture and physically compact diseased lung tissue. These procedures can reduce the overall volume of the lung, with an effect similar to that of LVRS. However, the potential of these procedures is limited because the proximal positioning of the coils or clips tends to isolate not only the diseased portion of the lung, but also healthy portions. Furthermore, these procedures are often associated with serious complications, such as pneumothorax and a chronic increased risk of respiratory infections.

[0013] Another device-based treatment for COPD involves the placement of one-way stent-valves in airways proximal to emphysematous tissue. These valves allow air to flow out of the lung but not into the overstretched portion. This approach is recommended only for patients with little or no collateral ventilation (i.e., ventilation of alveoli through pathways that bypass normal airways). Unfortunately, fewer than 20% of patients with emphysema lack collateral ventilation. Therefore, one-way stent-valves are not suitable for most emphysema patients. Also, like endobronchial coils and clips, proximal positioning of one-way stent-valves can isolate healthy portions of the lung as well as diseased portions.

[0014] Bronchoscopic thermal vapor ablation (BTVA) is yet another suboptimal COPD treatment option. BTVA involves the introduction of heated water vapor into affected lung tissue. This produces a thermal reaction that leads to an initial local inflammatory response, followed by permanent fibrosis and atelectasis. Similar to thermal therapies like BTVA, biochemical therapies also exist that involve the injection of adhesive glues or sealants into affected lung tissue. Both thermal and biochemical procedures can accelerate remodeling, resulting in tissue and air volume reduction in targeted areas of hyperstretched lung. However, these procedures are known to cause local toxicity and associated complications that compromise their potential therapeutic benefits.

[0015] Although not traditionally used to treat COPD, stents are sometimes used intraluminally in central airways (i.e., trachea, main bronchi, lobar bronchi, and / or segmental bronchi) to temporarily improve the patency of these airways. For example, stents may be used to temporarily improve patency in central airways affected by benign or malignant obstruction. Central airway stenting is not an effective treatment for emphysema because central airways have little or no effect on the overall airway obstruction and / or airway narrowing associated with emphysema. Furthermore, conventional stents, when placed in the airways, are plagued by obstruction challenges, including granulation tissue formation and mucus plugging.

[0016] Some other known COPD treatments involve bypassing obstructed airways. For example, perforation of the outer portion of the lung through the chest wall can be used to create a direct connection (i.e., a bypass tract) between the affected alveoli and the outside of the body. If no other steps are taken, these bypass tracts will close, either through normal healing or through the formation of granulation tissue, thereby eliminating the therapeutic benefit. Placing a tubular prosthesis within the bypass tract can temporarily extend the therapeutic benefit. However, such a prosthesis ultimately induces a foreign body reaction and accelerates the formation of granulation tissue. Creating a bypass tract also tends to be difficult and time-intensive. Once created, the bypass tract can also be uncomfortable, inconvenient, and / or exhausting for the patient.

[0017] COPD is a major public health challenge. In the United States alone, there are over one million patients suffering from severe emphysema and severe hyperextension. The vast majority of these patients are underserved by currently available treatments. The unmet clinical need worldwide, including in countries with high rates of smoking-related respiratory disease, exceeds that in the United States by many times. As discussed above, conventional approaches to treating COPD are associated with serious complications, have limited efficacy, are suitable for only a small percentage of COPD patients, and / or have other significant drawbacks. Given the prevalence of the disease and the inadequacy of conventional treatments, there is a great need for innovation in this field. Summary of the Invention [Means for solving the problem]

[0018] Certain aspects of the present technology are described in this Summary section as examples, which are numbered for convenience (1, 2, 3, etc.). These are examples only. They are not intended to limit the present technology. Example 1 1. An implant configured to be deployed at a treatment site within the bronchial tree of a human subject, comprising: a proximal end portion configured to be deployed in a first airway of a bronchial tree, the first airway being a generation 2 or greater; a distal end portion spaced from the proximal end portion along a longitudinal axis of the implant and configured to be deployed in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; an intermediate portion between the proximal and distal end portions along the longitudinal axis; a wire extending along a continuous wire path within a tubular region coaxially aligned with the longitudinal axis, the wire path in an intermediate portion including at least three windings about the longitudinal axis; Equipped with the wire comprises first and second sections arranged alternately along the wire path, the first sections extending distally in a circumferential direction about the longitudinal axis and the second sections extending proximally in a circumferential direction; the implant is configured to allow mucociliary clearance from a location immediately distal to the implant to a location immediately proximal to the implant while the implant is deployed at the treatment site; The implant is configured to resiliently transition from a low-profile delivery state in which the implant has a first average diameter perpendicular to the longitudinal axis to an expanded, deployed state in which the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times larger than the first average diameter. Example 2 10. An implant according to any preceding or following embodiment claim, wherein the intermediate portion consists essentially of a wire. Example 3 10. An implant as claimed in any preceding or following example, wherein the proximal and distal end portions consist essentially of wire. Example 4 10. An implant according to any preceding or following embodiment, wherein the implant is a single wire implant. Example 5 the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; the wire includes an untethered first end at a first end of the wire path; the wire includes an untethered second end at a second end of the wire path; 10. An implant as claimed in any of the preceding or following examples. Example 6 the first end is at the most proximal end of the implant; The second end is proximal to the distal-most end of the implant. 10. An implant as claimed in any of the preceding or following examples. Example 7 the wire includes a first atraumatic tip at a first end; the wire includes a second atraumatic tip at the second end; 10. An implant as claimed in any of the preceding or following examples. Example 8 the wire includes a given one of the first sections at a first end of the wire path; the wire includes a given one of the second sections at a second end of the wire path; 10. An implant as claimed in any of the preceding or following examples. Example 9 10. The implant of any preceding or following example claim, wherein an average length of the first sections in the intermediate portion is different from an average length of the second sections in the intermediate portion. Example 10 10. The implant of any preceding or following example claim, wherein an average length of the first sections in the intermediate portion is greater than an average length of the second sections in the intermediate portion. Example 11 10. The implant of any preceding or following example claim, wherein the average length of the first section in the middle portion is 20% to 50% greater than the average length of the second section in the middle portion. Example 12 The ratio of the average length of the first sections in the intermediate portion to the average length of the second sections in the intermediate portion is at least [ka] and 10. An implant as claimed in any preceding or following example, wherein n = the average number of first sections per turn of the wire path around the longitudinal axis in the intermediate portion. Example 13 the wire includes first and second apex portions that are alternately disposed along the wire path; the first apex portion faces distally; the second apex portion faces proximally; the respective first and second sections being interspersed between the respective first and second apex portions along the wire path; 10. An implant as claimed in any of the preceding or following examples. Example 14 a first apex portion in the intermediate portion defining a first helix; a second apex portion in the intermediate portion defining a second helix; the implant defines a helical band between the first helix and the second helix; Successive windings of the helical band are spaced apart from one another along the longitudinal axis when the implant is in a deployed state. 10. An implant as claimed in any of the preceding or following examples. Example 15 10. An implant as claimed in any preceding or following example, wherein successive windings of the helical band are spaced apart from one another along the longitudinal axis when the implant is in a delivery state. Example 16 10. An implant as claimed in any preceding or following example, wherein successive windings of the helical band overlap when the implant is in a delivery state. Example 17 An implant as claimed in any preceding or following example, wherein the average width of the spiral band parallel to the longitudinal axis is within the range of 30% to 75% of the average pitch of the wire path in the intermediate portion when the implant is in a deployed state. Example 18 10. The implant of any preceding or following embodiment, wherein the wire occupies 5% to 30% of the total area of ​​the helical band when the implant is in a deployed state. Example 19 10. The implant of any preceding or following embodiment claim, wherein the wire consists essentially of first and second sections and first and second apex portions. Example 20 10. The implant of any preceding or following example claim, wherein the first apex portion and the second apex portion have an average radius of curvature in the range of 0.35 mm to 0.60 mm. Example 21 any given three of the first apex portions of respective adjacent windings of the wire path in the intermediate portion are within 5 degrees of circumferential alignment with each other; any given three of the second apex portions in respective adjacent windings of the wire path in the intermediate portion are within 5 degrees of circumferential alignment with each other; 10. An implant as claimed in any of the preceding or following examples. Example 22 given three of the first apex portions are within 5 degrees of circumferential alignment with one another both when the implant is in the delivery state and when the implant is in the deployed state; a given three of the second apex portions are within five degrees of circumferential alignment with one another both when the implant is in the delivery state and when the implant is in the deployed state; 10. An implant as claimed in any of the preceding or following examples. Example 23 the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing between successive vertices along the wire path in the intermediate portion is within the range of 35 degrees to 95 degrees; 10. An implant as claimed in any of the preceding or following examples. Example 24 the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing between successive vertices along the wire path in the intermediate portion is within the range of 55 degrees to 65 degrees; 10. An implant as claimed in any of the preceding or following examples. Example 25 the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing in degrees between successive vertices along the wire path in the intermediate portion when the implant is in the delivery state differs by no more than 5% from when the implant is in the deployed state; 10. An implant as claimed in any of the preceding or following examples. Example 26 the respective first vertex portions are at respective first vertices along the wire path; the respective second vertex portions are at respective second vertices along the wire path; a line between a pair of first vertices that are adjacent to one another along the wire path is angled from an intervening one of the second vertices along the wire path; The angle is in the range of -20 degrees to 20 degrees when the implant is in the delivery state; The angle is in the range of 20 degrees to 90 degrees when the implant is in the deployed state. 10. An implant as claimed in any of the preceding or following examples. Example 27 the angle is a first angle, a line between a pair of second vertices that are adjacent to one another along the wire path forms a second angle from an intervening one of the first vertices along the wire path; the second angle is within the range of −20 degrees to 90 degrees when the implant is in a delivery state; The second angle is in the range of 20 degrees to 90 degrees when the implant is in the deployed state. 10. An implant as claimed in any of the preceding or following examples. Example 28 the implant is configured to define an unobstructed mucociliary clearance region extending along a continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant while the implant is deployed at the treatment site; the average width of the mucociliary clearance region parallel to the longitudinal axis exceeds the average cross-sectional diameter of the wire perpendicular to the wire path by at least 10 times; 10. An implant as claimed in any of the preceding or following examples. Example 29 10. An implant according to any preceding or following embodiment, wherein the implant consists essentially of wire, the wire not branching throughout the entire wire path. Example 30 10. The implant of any preceding or following example claim, wherein the wire is not tethered throughout the wire path. Example 31 An implant as claimed in any of the preceding or following examples, wherein the average pitch of the wire paths in the intermediate portion when the implant is in an unconstrained state exceeds the average cross-sectional diameter of the wires perpendicular to the wire paths in the intermediate portion by at least 10 times. Example 32 An implant as claimed in any preceding or following example claim, wherein the average pitch of the wire path in the intermediate portion when the implant is in an unconstrained state is within the range of 50% to 110% of the average diameter of the implant in the intermediate portion perpendicular to the longitudinal axis when the implant is in an unconstrained state. Example 33 An implant as claimed in any of the preceding or following examples, wherein the average pitch of the wire paths in the intermediate portion when the implant is in an unconstrained state is greater than the average pitch of the wire paths in the distal end portion when the implant is in an unconstrained state. Example 34 An implant as claimed in any of the preceding or following examples, wherein the average pitch of the wire paths in the proximal end portion when the implant is in an unconstrained state is greater than the average pitch of the wire paths in the distal end portion when the implant is in an unconstrained state. Example 35 An implant as claimed in any preceding or following example, wherein any given plane in the intermediate portion, perpendicular to the longitudinal axis, intersects at least three circumferentially spaced points along the wire path when the implant is in an unconstrained state. Example 36 An implant as claimed in any preceding or following example, wherein any given plane in the intermediate portion, perpendicular to the longitudinal axis, intersects three to five circumferentially spaced points along the wire path when the implant is in an unconstrained state. Example 37 the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; any given plane perpendicular to the distal-most 5% of the length of the implant along the longitudinal axis intersects at least five circumferentially spaced points along the wire path when the implant is in an unconstrained state; 10. An implant as claimed in any of the preceding or following examples. Example 38 any given plane perpendicular to the central 50% of the length of the implant along the longitudinal axis intersects at least a first number of circumferentially spaced points along the wire path when the implant is in an unconstrained state; any given plane perpendicular to the distal-most 5% of the length of the implant along the longitudinal axis intersects at least a second number of circumferentially spaced points along the wire path when the implant is in an unconstrained state; the second number of circumferentially spaced points is greater than the first number of circumferentially spaced points; 10. An implant as claimed in any of the preceding or following examples. Example 39 the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter is at least four times larger than the first average diameter; 10. An implant as claimed in any of the preceding or following examples. Example 40 the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter is at least five times larger than the first average diameter; 10. An implant as claimed in any of the preceding or following examples. Example 41 10:1〜80:1。 An implant according to any preceding or following claim, wherein the ratio of the radial spring constant of the implant to the longitudinal spring constant of the implant is in the range of 10:1~80:1. Example 42 10. The implant of any of the preceding or following claims, wherein the length of the implant along its longitudinal axis when the implant is in an unconstrained state is in the range of 50 mm to 200 mm. Example 43 10. The implant of any preceding or following embodiment, wherein the length of the implant along its longitudinal axis when the implant is in an unconstrained state is in the range of 70 mm to 120 mm. Example 44 10. An implant as claimed in any preceding or following example, wherein the average diameter of the implant perpendicular to its longitudinal axis when the implant is in an unconstrained state is in the range of 5 mm to 15 mm. Example 45 the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; The ratio of the third average diameter to the length of the implant along the longitudinal axis when the implant is in an unconstrained state is within the range of 1:10 to 1:30. 10. An implant as claimed in any of the preceding or following examples. Example 46 the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter at the proximal end portion differs from the third average diameter at the distal end portion by no more than 10%; 10. An implant as claimed in any of the preceding or following examples. Example 47 the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter varies by no more than 10% throughout the length of the implant along the longitudinal axis; 10. An implant as claimed in any of the preceding or following examples. Example 48 10. An implant as claimed in any preceding or following example, wherein the wire is uncoated. Example 49 10. The implant of any preceding or following example claim, wherein the ratio of the radial spring constant of the implant in Newton meters to the longitudinal shear modulus of the implant in Pascals is in the range of 0.005 to 0.100. Example 50 10. The implant of any preceding or following example claim, wherein the ratio of the implant's longitudinal spring constant in Newton meters to the implant's longitudinal shear modulus in Pascals is in the range of 0.5 to 5.0. Example 51 1. A method for increasing patency at a low or non-patent treatment site within the bronchial tree of a human subject diagnosed with chronic obstructive pulmonary disorder, comprising: moving the implant intraluminally within the bronchial tree toward a treatment site while the implant is in a low-profile delivery state, the implant being elongated and having a longitudinal axis, the implant including springs and connectors interspersed between the springs, the implant being more resiliently biased at the springs than at the connectors while the implant is in the delivery state; transitioning the implant from a delivery state to an expanded, deployed state at the treatment site, where transitioning the implant includes releasing at least some of the resilient bias of the implant; and maintaining a therapeutically effective increase in patency at the treatment site throughout a continuous maintenance period of at least three months while the implant is in a deployed state at the treatment site. A method comprising: Example 52 the implant in a delivery state during travel within the bronchial tree has a first average diameter that is perpendicular to the longitudinal axis; The implant in the deployed state during the maintenance period has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times larger than the first average diameter. 10. A method as claimed in any of the preceding or following Examples. Example 53 10. The method of any of the preceding or following examples, further comprising expanding a wall segment of the bronchial tree coextensive with the length of the implant along the longitudinal axis to an average expanded diameter at least three times greater than the average native diameter of the wall segment. Example 54 transitioning the implant expands a wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis to a first average expanded diameter; The method further comprises: expanding the balloon at the treatment location to expand the wall portion and the implant to a second average expanded diameter greater than the first average expanded diameter; removing the balloon from the treatment site prior to the continuous maintenance period; Including, 10. A method as claimed in any of the preceding or following Examples. Example 55 10. The method of any preceding or following example claim, wherein the second average expanded diameter is greater than the average unconstrained diameter of the implant. Example 56 10. The method of any preceding or following example claim, wherein expanding the wall portion from a first average expanded diameter toward a second average expanded diameter creates and / or increases a bronchial fenestration within the wall portion. Example 57 A method according to any of the preceding or following examples, wherein maintaining a therapeutically effective increase in patency comprises maintaining a therapeutically effective increase in patency without the presence of a drug-eluting material between the connection at the treatment site and the wall portion of the bronchial tree. Example 58 dilating a first wall portion of the bronchial tree coextensive with the distal-most 10% of the length of the implant along the longitudinal axis to a first average dilated diameter; expanding a second wall portion of the bronchial tree coextensive with the most proximal 10% of the length of the implant along the longitudinal axis to a second average expanded diameter, wherein the ratio of the first average expanded diameter of the first wall portion to its average native diameter exceeds the ratio of the second average expanded diameter of the second wall portion to its average native diameter; 10. The method of any claim in the preceding or following examples, further comprising: Example 59 10. The method of any preceding or following example claim, wherein the ratio of the first average expanded diameter of the first wall portion to its average native diameter is at least 8 times greater than the ratio of the second average expanded diameter of the second wall portion to its average native diameter. Example 60 10. The method of any preceding or following example, wherein the first average expanded diameter differs from the second average expanded diameter by between 0% and 20%. Example 61 During the maintenance period, a first area of ​​a wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis is in direct contact with the implant, and a second area of ​​the wall portion is not in direct contact with the implant; The second area is at least five times larger than the first area. 10. A method as claimed in any of the preceding or following Examples. Example 62 10. The method of any preceding or following example claim, wherein the second area is at least 8 times larger than the first area. Example 63 expanding the wall portion to an average expanded diameter; maintaining maximum invagination of the wall portion in the second area of ​​no more than 50% of the average dilated diameter throughout the maintenance period; 10. The method of any claim in the preceding or following examples, further comprising: Example 64 Transitioning the embedding expanding a proximal end portion of the implant in a first airway of the bronchial tree, the first airway being a generation 2 or greater; expanding a distal end portion of the implant in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; 10. The method of any claim in the preceding or following examples, comprising: Example 65 10. The method of any preceding or following example claim, wherein the generation of the second airway exceeds the generation of the first airway by at least two. Example 66 10. The method of any preceding or following example claim, wherein the second airway generation exceeds the first airway generation by at least three. Example 67 10. The method of any preceding or following example claim, wherein the second airway generation exceeds the first airway generation by at least four. Example 68 the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; expanding the proximal end portion includes contacting a wall of the first airway with an untethered first end of the wire; Expanding the distal end portion includes contacting the untethered second end of the wire with a wall of the second airway. 10. A method as claimed in any of the preceding or following Examples. Example 69 contacting the wall of the first airway with the untethered first end of the wire includes contacting the wall of the first airway with the untethered first end of the wire at a portion of the wall of the first airway at a proximal-most end of the implant; contacting the wall of the second airway with the untethered second end of the wire includes contacting the wall of the second airway with the untethered second end of the wire at a portion of the wall of the second airway that is proximal to the distal-most end of the implant; 10. A method as claimed in any of the preceding or following Examples. Example 70 the wire includes first sections and second sections that are alternately arranged along the wire path; The connector is located in the first and second sections; the first section extends circumferentially distally about the longitudinal axis while the implant is in a deployed state at the treatment site; the second section extends circumferentially proximally while the implant is in a deployed state at the treatment site; expanding the proximal end portion includes contacting a wall of the first airway with a given one of the first sections at the first end of the wire pathway; Expanding the distal end portion includes contacting a wall of the second airway with a given one of the second sections at the second end of the wire pathway. 10. A method as claimed in any of the preceding or following Examples. Example 71 the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire includes first and second sections and apex portions between the first and second sections, the first and second sections being alternately arranged along the wire path; The connector is located in the first and second sections; The spring is at the apex, Transitioning the implant includes increasing the mean curvature of the wire path at the apex portion. 10. A method as claimed in any of the preceding or following Examples. Example 72 the apical portion includes a first apical portion that faces distally while the implant is in a deployed state at the treatment site and a second apical portion that faces proximally while the implant is in a deployed state at the treatment site; transitioning the implants includes transitioning the implants while a given three of the first apex portions of respective adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other and a given three of the second apex portions of respective adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other. 10. A method as claimed in any of the preceding or following Examples. Example 73 The individual vertex portions are at individual vertices along the wire path; transitioning the implant includes transitioning the implant while the average circumferential spacing between successive vertices along the wire path is within a range of 35 degrees to 95 degrees. 10. A method as claimed in any of the preceding or following Examples. Example 74 The individual vertex portions are at individual vertices along the wire path; transitioning the implant includes transitioning the implant while the average circumferential spacing between successive vertices along the wire path is within a range of 55 degrees to 65 degrees. 10. A method as claimed in any of the preceding or following Examples. Example 75 The individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing in degrees between successive vertices along the wire path changes by 5% or less; 10. A method as claimed in any of the preceding or following Examples. Example 76 the apical portion includes a first apical portion that faces distally while the implant is in a deployed state at the treatment site and a second apical portion that faces proximally while the implant is in a deployed state at the treatment site; the first apex portion defines a first helix; the second apex portion defines a second helix; the implant defines a helical band between the first helix and the second helix; transitioning the implant includes decreasing a width of the spiral band parallel to the longitudinal axis while transitioning the implant; 10. A method as claimed in any of the preceding or following Examples. Example 77 10. The method of any preceding or following embodiment, wherein the wire occupies between 5% and 30% of the total area of ​​the helical band during the maintenance period. Example 78 10. The method of any of the preceding or following examples, further comprising maintaining a mucociliary clearance region at the treatment site substantially free of granulation tissue and mucus plugging throughout the maintenance period, wherein the mucociliary clearance region extends along a continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant. Example 79 The method of any of the preceding or following Examples, wherein maintaining the mucociliary clearance region further comprises maintaining the mucociliary clearance region substantially free of inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis during the maintenance period. (Example 80) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at a proximal end portion of the implant and an opposing second end at a distal end portion of the implant; Transitioning the implant includes transitioning the implant such that no portion of the wire intersects with the mucociliary clearance pathway; 10. A method as claimed in any of the preceding or following Examples. Example 81 10. The method of any of the preceding or following Examples, wherein maintaining the mucociliary clearance region comprises maintaining the mucociliary clearance region at an average width parallel to a longitudinal axis perpendicular to the wire path that is at least 10 times greater than the average cross-sectional diameter of the wire. Example 82 The implant, in a delivery state while traveling within the bronchial tree, has a first length; the implant in the deployed state immediately after transitioning the implant has a second length that differs from the first length by no more than 10%. 10. A method as claimed in any of the preceding or following Examples. Example 83 10. The method of any of the preceding or following examples, further comprising, after transitioning the implant, applying a force of at least 0.05 megapascals per unit contact area with the implant against the wall of the bronchial tree at the treatment site. Example 84 The method of any of the preceding or following examples, further comprising, after transitioning the implant, resisting elongation of the implant along the longitudinal axis with a resistance force that is less than the friction force between the implant at the treatment location and the walls of the bronchial tree during a complete respiratory cycle by the subject. Example 85 10. The method of any of the preceding or following examples, wherein the bronchial tree distal to the treatment location has collateral ventilation. Example 86 10. The method of any of the preceding or following examples, further comprising releasing air trapped within the bronchial tree distal to the treatment location. Example 87 Transitioning the embedding expanding a distal end portion of the implant; expanding a middle portion of the implant after expanding the distal end portion, the middle portion being proximal to the distal end portion along the longitudinal axis; expanding a proximal end portion of the implant after expanding the intermediate portion, the proximal end portion being proximal to the intermediate portion along the longitudinal axis; 10. The method of any claim in the preceding or following examples, comprising: Example 88 A method according to any of the preceding or following examples, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at three or more circumferentially spaced portions of the wall while expanding an intermediate portion. Example 89 A method as claimed in any preceding or following example, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at five or more circumferentially spaced portions of the wall while expanding the distal end portion. Example 90 Transitioning the embedding while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall of the bronchial tree at a first number of circumferentially spaced portions of the wall; while expanding the distal end portion, simultaneously increasing contact between the implant and the wall at a second number of circumferentially spaced portions of the wall, the second number of circumferentially spaced portions of the wall being greater than the first number of circumferentially spaced portions of the wall; 10. The method of any claim in the preceding or following examples, comprising: Example 91 10. The method of any of the preceding or following examples, wherein the ratio of the average diameter of the implant perpendicular to the longitudinal axis immediately after transitioning the implant to the length of the implant immediately after transitioning the implant is in the range of 1:10 to 1:30. Example 92 10. The method of any preceding or following example claim, further comprising: while moving the implant, constraining radial expansion of the implant within a sheath extending around the implant, wherein transitioning the implant comprises causing relative movement between the implant and the sheath. Example 93 10. The method of any preceding or following example claim, further comprising constraining longitudinal expansion of the implant via a shaft extending longitudinally through the implant while moving the implant. Example 94 Restraining the longitudinal expansion of the implant includes restraining the longitudinal expansion of the implant via a pad on the shaft; The pad is disposed between the implant and the core of the shaft while the implant is being moved; The pad is more elastic than the core, 10. A method as claimed in any of the preceding or following Examples. Example 95 1. A method for improving lung function in a human subject, comprising: While the implant is in a low-profile delivery state, moving the implant intraluminally within the subject's bronchial tree toward a treatment location within the bronchial tree, wherein a portion of the bronchial tree distal to the treatment location is emphysematous and has collateral ventilation; transitioning the implant from a delivery state to an expanded, deployed state at the treatment site, where transitioning the implant includes expanding an expandable structure within a helical band extending around a longitudinal axis of the implant, where expanding the expandable structure increases a helical length of the helical band; increasing the subject's forced expiratory volume in one second by at least 5% after implant deployment compared to before implant deployment; A method comprising: Example 96 the implant is a first implant; the treatment location is a first treatment location; the delivery state is a first delivery state; the deployed state is a first deployed state, the expandable structure is a first expandable structure; the spiral band is a first spiral band; The method further comprises: While the second implant is in a low-profile second delivery state, moving the second implant intraluminally within the bronchial tree toward a second treatment location within the bronchial tree, wherein a portion of the bronchial tree distal to the second treatment location is emphysematous and has collateral ventilation; transitioning the second implant from the second delivery state to an expanded second deployed state at the second treatment location, where transitioning the second implant includes expanding a second expandable structure within a second helical band extending around a longitudinal axis of the second implant, where expanding the second expandable structure increases a helical length of the second helical band; Including, Increasing the subject's forced expiratory volume in one second includes increasing the subject's forced expiratory volume in one second after deploying the first and second implants compared to before deploying the first and second implants. 10. A method as claimed in any of the preceding or following Examples. Example 97 moving the third implant intraluminally within the bronchial tree toward a third treatment location within the bronchial tree, while the third implant is in a low-profile third delivery state, wherein a portion of the bronchial tree distal to the third treatment location is emphysematous and has collateral ventilation; transitioning the third implant from the third delivery state to an expanded third deployed state at the third treatment location, wherein transitioning the third implant includes expanding a third expandable structure within a third helical band extending around a longitudinal axis of the third implant, wherein expanding the third expandable structure increases a helical length of the third helical band; further comprising Increasing the subject's forced expiratory volume in one second includes increasing the subject's forced expiratory volume in one second after deploying the first, second, and third implants compared to before deploying the first, second, and third implants. 10. A method as claimed in any of the preceding or following Examples. Example 98 Example 99. The method of any preceding or following example, wherein increasing the subject's forced expiratory volume in one second comprises increasing the subject's forced expiratory volume in one second by at least 10%. 10. The method of any preceding or following embodiment, wherein transitioning the implant comprises releasing at least some resilient bias on the implant in the expandable structure. Example 100 the implant in a delivery state during travel within the bronchial tree has a first average diameter that is perpendicular to the longitudinal axis; the implant in the deployed state after transitioning the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times greater than the first average diameter; 10. A method as claimed in any of the preceding or following Examples. Example 101 10. The method of any of the preceding or following examples, further comprising expanding a wall segment of the bronchial tree coextensive with the length of the implant along the longitudinal axis to an average expanded diameter at least three times greater than the average native diameter of the wall segment. Example 102 dilating a first wall portion of the bronchial tree coextensive with the distal-most 10% of the length of the implant along the longitudinal axis to a first average dilated diameter; expanding a second wall portion of the bronchial tree coextensive with the most proximal 10% of the length of the implant along the longitudinal axis to a second average expanded diameter, wherein the ratio of the first average expanded diameter of the first wall portion to its average native diameter exceeds the ratio of the second average expanded diameter of the second wall portion to its average native diameter; 10. The method of any claim in the preceding or following examples, further comprising: (Example 103) 10. The method of any preceding or following example claim, wherein the ratio of the first average expanded diameter of the first wall portion to its average native diameter is at least 8 times greater than the ratio of the second average expanded diameter of the second wall portion to its average native diameter. Example 104 10. The method of any preceding or following example, wherein the first average expanded diameter differs from the second average expanded diameter by between 0% and 20%. Example 105 after transitioning the implant, a first area of ​​the wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis is in direct contact with the implant and a second area of ​​the wall portion is not in direct contact with the implant; The second area is at least five times larger than the first area. 10. A method as claimed in any of the preceding or following Examples. Example 106 10. The method of any preceding or following example claim, wherein the second area is at least 8 times larger than the first area. (Example 107) Transitioning the embedding expanding a proximal end portion of the implant in a first airway of the bronchial tree, the first airway being a generation 2 or greater; expanding a distal end portion of the implant in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; 10. The method of any claim in the preceding or following examples, comprising: Example 108 10. The method of any preceding or following example claim, wherein the generation of the second airway exceeds the generation of the first airway by at least two. Example 109 10. The method of any preceding or following example claim, wherein the second airway generation exceeds the first airway generation by at least three. Example 110 the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; expanding the proximal end portion includes contacting a wall of the first airway with an untethered first end of the wire; Expanding the distal end portion includes contacting the untethered second end of the wire with a wall of the second airway. 10. A method as claimed in any of the preceding or following Examples. Example 111 contacting the wall of the first airway with the untethered first end of the wire includes contacting the wall of the first airway with the untethered first end of the wire at a portion of the wall of the first airway at a proximal-most end of the implant; contacting the wall of the second airway with the untethered second end of the wire includes contacting the wall of the second airway with the untethered second end of the wire at a portion of the wall of the second airway that is proximal to the distal-most end of the implant; 10. A method as claimed in any of the preceding or following Examples. Example 112 the wire includes first sections and second sections that are alternately arranged along the wire path; the first section extends circumferentially distally about the longitudinal axis while the implant is in a deployed state at the treatment site; the second section extends circumferentially proximally while the implant is in a deployed state at the treatment site; expanding the proximal end portion includes contacting a wall of the first airway with a given one of the first sections at the first end of the wire pathway; Expanding the distal end portion includes contacting a wall of the second airway with a given one of the second sections at the second end of the wire pathway. 10. A method as claimed in any of the preceding or following Examples. Example 113 the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire includes first and second sections alternately disposed along the wire path and an apex portion between the first and second sections; The expandable structure is located at the apex portion; Transitioning the implant includes increasing the mean curvature of the wire path at the apex portion. 10. A method as claimed in any of the preceding or following Examples. Example 114 the apical portion includes a first apical portion that faces distally while the implant is in a deployed state at the treatment site and a second apical portion that faces proximally while the implant is in a deployed state at the treatment site; transitioning the implants includes transitioning the implants while a given three of the first apex portions of respective adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other and a given three of the second apex portions of respective adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other. 10. A method as claimed in any of the preceding or following Examples. Example 115 The individual vertex portions are at individual vertices along the wire path; transitioning the implant includes transitioning the implant while the average circumferential spacing between successive vertices along the wire path is within a range of 35 degrees to 95 degrees. 10. A method as claimed in any of the preceding or following Examples. Example 116 The individual vertex portions are at individual vertices along the wire path; transitioning the implant includes transitioning the implant while the average circumferential spacing between successive vertices along the wire path is within a range of 55 degrees to 65 degrees. 10. A method as claimed in any of the preceding or following Examples. Example 117 The individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing in degrees between successive vertices along the wire path changes by 5% or less; 10. A method as claimed in any of the preceding or following Examples. Example 118 the apical portion includes a first apical portion that faces distally while the implant is in a deployed state at the treatment site and a second apical portion that faces proximally while the implant is in a deployed state at the treatment site; the first apex portion defines a first helix; the second apex portion defines a second helix; the first and second helices define a helical band; transitioning the implant includes decreasing a width of the spiral band parallel to the longitudinal axis while transitioning the implant; 10. A method as claimed in any of the preceding or following Examples. Example 119 10. The method of any preceding or following embodiment, wherein the wire occupies 5% to 15% of the total area of ​​the helical band after transitioning the implant. Example 120 10. The method of any of the preceding or following examples, further comprising maintaining a mucociliary clearance region at the treatment site substantially free of granulation tissue and mucus plugging throughout a continuous maintenance period of at least three months while the implant is in a deployed state at the treatment site, wherein the mucociliary clearance region extends along the continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant. Example 121 The method of any of the preceding or following Examples, wherein maintaining the mucociliary clearance region further comprises maintaining the mucociliary clearance region substantially free of inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis during the maintenance period. Example 122 the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at a proximal end portion of the implant and an opposing second end at a distal end portion of the implant; Transitioning the implant includes transitioning the implant such that no portion of the wire intersects with the mucociliary clearance pathway; 10. A method as claimed in any of the preceding or following Examples. Example 123 10. The method of any of the preceding or following Examples, wherein maintaining the mucociliary clearance region comprises maintaining the mucociliary clearance region at an average width parallel to the longitudinal axis that is at least 10 times greater than the average cross-sectional diameter of the wire perpendicular to the wire path. Example 124 10. The method of any claim in the preceding or following examples, wherein maintaining a mucociliary clearance zone comprises maintaining a mucociliary clearance zone without the presence of a drug-eluting material between the expandable structure and a wall portion of the bronchial tree at the treatment location. Example 125 The implant, in a delivery state while traveling within the bronchial tree, has a first length; the implant in the deployed state immediately after transitioning the implant has a second length that differs from the first length by no more than 10%. 10. A method as claimed in any of the preceding or following Examples. Example 126 10. The method of any of the preceding or following examples, further comprising, after transitioning the implant, applying a force of at least 0.05 megapascals per unit contact area with the implant against the wall of the bronchial tree at the treatment site. Example 127 The method of any of the preceding or following examples, further comprising, after transitioning the implant, resisting elongation of the implant along the longitudinal axis with a resistance force that is less than the friction force between the implant at the treatment location and the walls of the bronchial tree during a complete respiratory cycle by the subject. Example 128 10. The method of any of the preceding or following examples, further comprising releasing air trapped within a portion of the bronchial tree distal to the treatment location. Example 129 Transitioning the embedding expanding a distal end portion of the implant; expanding a middle portion of the implant after expanding the distal end portion, the middle portion being proximal to the distal end portion along the longitudinal axis; expanding a proximal end portion of the implant after expanding the intermediate portion, the proximal end portion being proximal to the intermediate portion along the longitudinal axis; 10. The method of any claim in the preceding or following examples, comprising: Example 130 A method according to any of the preceding or following examples, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at three or more circumferentially spaced portions of the wall while expanding an intermediate portion. Example 131 A method as claimed in any preceding or following example, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at five or more circumferentially spaced portions of the wall while expanding the distal end portion. Example 132 Transitioning the embedding while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall of the bronchial tree at a first number of circumferentially spaced portions of the wall; while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall at a second number of circumferentially spaced portions of the wall that is greater than the first number of circumferentially spaced portions of the wall; 10. The method of any claim in the preceding or following examples, comprising: Example 133 10. The method of any of the preceding or following examples, wherein the ratio of the average diameter of the implant perpendicular to the longitudinal axis immediately after transitioning the implant to the length of the implant immediately after transitioning the implant is in the range of 1:10 to 1:30. Example 134 10. The method of any preceding or following example claim, further comprising: while moving the implant, constraining radial expansion of the implant within a sheath extending around the implant, wherein transitioning the implant comprises causing relative movement between the implant and the sheath. Example 135 10. The method of any preceding or following example claim, further comprising constraining longitudinal expansion of the implant via a shaft extending longitudinally through the implant while moving the implant. Example 136 Restraining the longitudinal expansion of the implant includes restraining the longitudinal expansion of the implant via a pad on the shaft; The pad is disposed between the implant and the core of the shaft while the implant is being moved; The pad is more elastic than the core, 10. A method as claimed in any of the preceding or following Examples. Example 137 transitioning the implant expands a wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis to a first average expanded diameter; The method further comprises: expanding the balloon at the treatment location to expand the wall portion and the implant to a second average expanded diameter greater than the first average expanded diameter; Removing the balloon from the treatment site; 10. The method of any claim in the preceding or following examples, comprising: Example 138 10. The method of any preceding or following example claim, wherein the second average expanded diameter is greater than the average unconstrained diameter of the implant. Example 139 10. The method of any preceding or following example claim, wherein expanding the wall portion from a first average expanded diameter toward a second average expanded diameter creates and / or increases a bronchial fenestration within the wall portion. Example 140 1. An implant configured to be deployed at a treatment site within the bronchial tree of a human subject, comprising: an expansion means for expanding the implant from a low-profile delivery state to an expanded deployed state at the treatment site; a stabilizing means for stabilizing the implant in a deployed state at the treatment site during breathing by the subject; An implant comprising: Example 141 10. An implant as claimed in any preceding or following example, further comprising placement means for increasing placement accuracy of a distal end portion of the implant during deployment of the implant at a treatment site. Example 142 10. An implant according to any preceding or following claim, further comprising a retrieval means for retrieving the implant after deployment of the implant at the treatment site. (Example 143) 1. A system for deploying an implant at a treatment site within the bronchial tree of a human subject, comprising: an implant configured to be deployed at a treatment site; a radial restraint means for restraining radial expansion of the implant while the implant is moving intraluminally within the bronchial tree toward the treatment site; a longitudinal restraining means for restraining longitudinal expansion of the implant while the implant is moving intraluminally within the bronchial tree toward the treatment site; A system comprising: Example 144 1. An implantable device for placement within a bronchial airway lumen for the treatment of obstructive pulmonary disease, comprising: a first end portion, a second end portion, and a longitudinal axis extending therebetween, the first end portion configured to be positioned within a distal region of a bronchial airway and the second end portion configured to be positioned within a proximal region of the bronchial airway, the distal region comprising more generations than the proximal region; the device includes an elongate member comprising a resilient material and wound about a longitudinal axis of the device in a series of unbroken loops, each loop having a plurality of peaks and a plurality of valleys, the device having a continuous opening extending between the loops from a first end portion to a second end portion; The implantable device has a compressed state and an expanded state, and is configured to be delivered in the compressed state through a catheter to a bronchial airway lumen in a distal region, and to self-expand to appose with the inner surface of the wall in the bronchial airway lumen, thereby compressing radially outward on the wall and allowing the distal region to expand to a diameter that is at least twice the diameter of the bronchial airway lumen in the distal region prior to expansion of the device. Example 145 1. An implant configured to be deployed at a treatment site within a body lumen of a human subject, comprising: a proximal end portion configured to be deployed at a proximal location within a body lumen; a distal end portion spaced from the proximal end portion along a longitudinal axis of the implant and configured to be deployed at a distal location within a body lumen; an intermediate portion along the longitudinal axis between the proximal and distal end portions; a wire extending along a continuous wire path within a tubular region coaxially aligned with the longitudinal axis, the wire path in an intermediate portion including at least three windings about the longitudinal axis; Equipped with the wire comprises first and second sections arranged alternately along the wire path, the first sections extending distally in a circumferential direction about the longitudinal axis and the second sections extending proximally in a circumferential direction; the wire path further comprises a series of unbroken loops, each loop comprising a plurality of peaks, a plurality of valleys, and a continuous opening extending between the loops from the proximal end portion to the distal end portion; The implant is configured to resiliently transition from a low-profile delivery state in which the implant has a first average diameter perpendicular to the longitudinal axis to an expanded, deployed state in which the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times larger than the first average diameter. Example 146 10. An implant as claimed in any of the preceding or following examples, wherein the implant is configured for placement within the bronchial airways of a human subject for the treatment of emphysema. Example 147 10. An implant as claimed in any of the preceding or following examples, wherein the implant is configured for placement within the central airway of a human subject for the treatment of tracheobronchomalacia (TBM). Example 148 10. An implant as claimed in any of the preceding or following examples, wherein the implant is configured for placement within the urethra of a human subject for the treatment of benign prostatic hyperplasia (BPH). Example 149 10. The implant of any of the preceding or following examples, wherein the implant is configured to maintain at least a portion of the treatment site substantially free of granulation tissue, mucus plugging, inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis. The present invention provides, for example, the following items. (Item 1) 1. An implant configured to be deployed at a treatment site within the bronchial tree of a human subject, said implant comprising: a proximal end portion configured to be deployed in a first airway of the bronchial tree, the first airway being a generation 2 or greater; a distal end portion spaced from the proximal end portion along a longitudinal axis of the implant and configured to be deployed in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; an intermediate portion between the proximal and distal end portions along the longitudinal axis; a wire extending along a continuous wire path within a tubular region coaxially aligned with the longitudinal axis, the wire path in the intermediate portion including at least three windings about the longitudinal axis; Equipped with the wire includes first and second sections arranged alternately along the wire path, the first sections extending distally in a circumferential direction about the longitudinal axis and the second sections extending proximally in the circumferential direction; the implant is configured to allow mucociliary clearance from a location immediately distal to the implant to a location immediately proximal to the implant while the implant is deployed at the treatment site; The implant is configured to resiliently transition from a low-profile delivery state in which the implant has a first average diameter perpendicular to the longitudinal axis to an expanded, deployed state in which the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times larger than the first average diameter. (Item 2) Item 2. The implant of item 1, wherein the intermediate portion consists essentially of the wire. (Item 3) 3. The implant of claim 2, wherein the proximal end portion and the distal end portion consist essentially of the wire. (Item 4) Item 1, wherein the implant is a single wire implant. (Item 5) the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; the wire includes an untethered first end at a first end of the wire path; the wire includes an untethered second end at a second end of the wire path; Item 1. The implant according to item 1. (Item 6) the first end is at the most proximal end of the implant; the second end is proximal to the distal-most end of the implant; Item 5. An implant according to item 5. (Item 7) the wire includes a first atraumatic tip at the first end; the wire includes a second atraumatic tip at the second end; Item 5. An implant according to item 5. (Item 8) the wire includes a given one of the first sections at a first end of the wire path; the wire includes a given one of the second sections at a second end of the wire path; Item 5. An implant according to item 5. (Item 9) Item 2. The implant of item 1, wherein the average length of the first section in the intermediate portion is different from the average length of the second section in the intermediate portion. (Item 10) 10. The implant of claim 9, wherein the average length of the first section in the intermediate portion is greater than the average length of the second section in the intermediate portion. (Item 11) Item 10. The implant according to item 9, wherein the average length of the first section in the intermediate portion is 20% to 50% longer than the average length of the second section in the intermediate portion. (Item 12) The ratio of the average length of the first sections in the intermediate portion to the average length of the second sections in the intermediate portion is at least (Number 1) JPEG2026042022000003.jpg1618 and 10. The implant of claim 9, wherein n = the average number of first sections per turn of the wire path around the longitudinal axis in the intermediate portion. (Item 13) the wire includes first and second apex portions alternately disposed along the wire path; the first apex portion faces distally; the second apex portion faces proximally; the respective first and second sections being interspersed between the respective first and second apex portions along the wire path; Item 1. The implant according to item 1. (Item 14) the first apex portion of the intermediate portion defines a first helix; the second apex portion of the intermediate portion defines a second helix; the implant defines a helical band between the first and second helices; successive windings of the helical band are spaced apart from one another along the longitudinal axis when the implant is in the deployed state. Item 14. The implant according to item 13. (Item 15) Item 15. The implant of item 14, wherein successive windings of the helical band are spaced apart from one another along the longitudinal axis when the implant is in the delivery state. (Item 16) Item 15. The implant of item 14, wherein successive windings of the spiral band overlap when the implant is in the delivery state. (Item 17) Item 15. The implant according to item 14, wherein the average width of the spiral band parallel to the longitudinal axis is in the range of 30% to 75% of the average pitch of the wire path in the intermediate portion when the implant is in the deployed state. (Item 18) Item 15. The implant according to item 14, wherein the wire occupies 5% to 30% of the total area of ​​the spiral band when the implant is in the deployed state. (Item 19) Item 14. The implant of item 13, wherein the wire consists essentially of the first and second sections and the first and second apex portions. (Item 20) Item 14. The implant according to item 13, wherein the first apex portion and the second apex portion have an average radius of curvature within a range of 0.35 mm to 0.60 mm. (Item 21) any given three of the first apex portions in respective adjacent windings of the wire path in the intermediate portion are within 5 degrees of circumferential alignment with one another; any given three of the second apex portions in respective adjacent windings of the wire path in the intermediate portion are within 5 degrees of circumferential alignment with one another. Item 14. The implant according to item 13. (Item 22) given three of the first apex portions are within five degrees of circumferential alignment with one another both when the implant is in the delivery state and when the implant is in the deployed state; a given three of the second apex portions are within five degrees of circumferential alignment with one another both when the implant is in the delivery state and when the implant is in the deployed state; Item 22. The implant according to item 21. (Item 23) the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing between successive vertices along the wire path in the intermediate portion is in the range of 35 degrees to 95 degrees; Item 14. The implant according to item 13. (Item 24) the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing between successive vertices along the wire path in the intermediate portion is within a range of 55 degrees to 65 degrees; Item 14. The implant according to item 13. (Item 25) the respective first and second vertex portions are at respective vertices along the wire path; the average circumferential spacing in degrees between successive vertices along the wire path in the intermediate portion when the implant is in the delivery state differs by no more than 5% from when the implant is in the deployed state; Item 14. The implant according to item 13. (Item 26) the respective first vertex portions are at respective first vertices along the wire path; the respective second vertex portions are at respective second vertices along the wire path; a line between a pair of the first vertices that are adjacent to one another along the wire path forms an angle with an intervening one of the second vertices along the wire path; the angle is within the range of −20 degrees to 20 degrees when the implant is in the delivery state; The angle is in the range of 20 degrees to 90 degrees when the implant is in the deployed state. Item 14. The implant according to item 13. (Item 27) the angle is a first angle, a line between a pair of the second vertices that are adjacent to one another along the wire path forms a second angle from an intervening one of the first vertices along the wire path; the second angle is within a range of −20 degrees to 90 degrees when the implant is in the delivery state; The second angle is within a range of 20 degrees to 90 degrees when the implant is in the deployed state. Item 27. The implant according to item 26. (Item 28) the implant is configured to define an unobstructed mucociliary clearance region extending along a continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant while the implant is deployed at the treatment site; the average width of the mucociliary clearance region parallel to the longitudinal axis is at least 10 times greater than the average cross-sectional diameter of the wire perpendicular to the wire path; Item 1. The implant according to item 1. (Item 29) 2. The implant of claim 1, wherein the implant consists essentially of the wire, and the wire is unbranched throughout the wire path. (Item 30) 30. The implant of claim 29, wherein the wire is not tethered throughout the wire path. (Item 31) Item 1. The implant of item 1, wherein the average pitch of the wire paths in the intermediate portion when the implant is in an unconstrained state is at least 10 times greater than the average cross-sectional diameter of the wires perpendicular to the wire paths in the intermediate portion. (Item 32) 2. The implant of claim 1, wherein the average pitch of the wire paths in the intermediate portion when the implant is in an unconstrained state is within the range of 50% to 110% of the average diameter of the implant in the intermediate portion perpendicular to the longitudinal axis when the implant is in the unconstrained state. (Item 33) 2. The implant of claim 1, wherein the average pitch of the wire paths in the intermediate portion when the implant is in an unconstrained state is greater than the average pitch of the wire paths in the distal end portion when the implant is in the unconstrained state. (Item 34) 2. The implant of claim 1, wherein the average pitch of the wire paths at the proximal end portion when the implant is in an unconstrained state is greater than the average pitch of the wire paths at the distal end portion when the implant is in the unconstrained state. (Item 35) Item 1. The implant of item 1, wherein any given plane perpendicular to the longitudinal axis at the intermediate portion intersects at least three circumferentially spaced points along the wire path when the implant is in an unconstrained state. (Item 36) Item 1. The implant of item 1, wherein any given plane perpendicular to the longitudinal axis at the intermediate portion intersects three to five circumferentially spaced points along the wire path when the implant is in an unconstrained state. (Item 37) the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; any given plane perpendicular to the distal-most 5% of the length of the implant along the longitudinal axis intersects at least five circumferentially spaced points along the wire path when the implant is in an unconstrained state; Item 1. The implant according to item 1. (Item 38) any given plane perpendicular to the central 50% of the length of the implant along the longitudinal axis intersects at least a first number of circumferentially spaced points along the wire path when the implant is in an unconstrained state; any given plane perpendicular to the distal-most 5% of the length of the implant along the longitudinal axis intersects at least a second number of circumferentially spaced points along the wire path when the implant is in the unconstrained state; the second number of circumferentially spaced points is greater than the first number of circumferentially spaced points; Item 1. The implant according to item 1. (Item 39) the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter is at least four times larger than the first average diameter; Item 1. The implant according to item 1. (Item 40) the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter is at least 5 times larger than the first average diameter; Item 1. The implant according to item 1. (Item 41) Item 2. The implant according to item 1, wherein the ratio of the radial spring constant of the implant to the longitudinal spring constant of the implant is in the range of 10:1 to 80:1. (Item 42) 2. The implant according to item 1, wherein the length of the implant along the longitudinal axis when the implant is in an unconstrained state is within a range of 50 mm to 200 mm. (Item 43) 2. The implant according to item 1, wherein the length of the implant along the longitudinal axis when the implant is in an unconstrained state is within a range of 70 mm to 120 mm. (Item 44) Item 2. The implant according to item 1, wherein the average diameter of the implant perpendicular to the longitudinal axis when the implant is in an unconstrained state is in the range of 5 mm to 15 mm. (Item 45) the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; a ratio of the third average diameter to the length of the implant along the longitudinal axis when the implant is in the unconstrained state is in the range of 1:10 to 1:30; Item 1. The implant according to item 1. (Item 46) the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter at the proximal end portion differs from the third average diameter at the distal end portion by no more than 10%; Item 1. The implant according to item 1. (Item 47) the implant has a third average diameter perpendicular to the longitudinal axis when the implant is in an unconstrained state; the third average diameter varies by no more than 10% throughout the length of the implant along the longitudinal axis; Item 1. The implant according to item 1. (Item 48) Item 1, wherein the wire is uncoated. (Item 49) Item 2. The implant of item 1, wherein the ratio of the radial spring constant of the implant in units of Newton meters to the longitudinal shear modulus of the implant in units of Pascals is in the range of 0.005 to 0.100. (Item 50) Item 2. The implant of item 1, wherein the ratio of the longitudinal spring constant of the implant in units of Newton meters to the longitudinal shear modulus of the implant in units of Pascals is in the range of 0.5 to 5.0. (Item 51) 1. A method for increasing patency at a low or non-patent treatment site within the bronchial tree of a human subject diagnosed with chronic obstructive pulmonary disorder, said method comprising: moving the implant intraluminally within the bronchial tree toward the treatment site while the implant is in a low-profile delivery state, the implant being elongated and having a longitudinal axis, the implant including springs and connectors interspersed between the springs, the implant being more resiliently biased at the springs than at the connectors while the implant is in the delivery state; transitioning the implant from the delivery state to an expanded, deployed state at the treatment site, wherein transitioning the implant includes releasing at least some of the resilient bias of the implant; maintaining a therapeutically effective increase in patency at the treatment site throughout a continuous maintenance period of at least three months while the implant is in the deployed state at the treatment site. A method comprising: (Item 52) the implant in the delivery state during travel within the bronchial tree has a first average diameter perpendicular to the longitudinal axis; the implant in the deployed state during the maintenance period has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times greater than the first average diameter; Item 51. The method according to item 51. (Item 53) 52. The method of claim 51, further comprising expanding the wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis to an average expanded diameter at least three times greater than the average native diameter of the wall portion. (Item 54) transitioning the implant expands a wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis to a first average expanded diameter; The method further comprises: expanding a balloon at the treatment location to expand the wall portion and the implant to a second average expanded diameter greater than the first average expanded diameter; removing the balloon from the treatment site prior to the continuous maintenance period; Item 52. The method according to Item 51, comprising: (Item 55) 55. The method of claim 54, wherein the second average expanded diameter is greater than the average unconstrained diameter of the implant. (Item 56) 55. The method of claim 54, wherein expanding the wall portion from the first average expanded diameter toward the second average expanded diameter creates and / or increases a bronchial fenestration within the wall portion. (Item 57) 52. The method of claim 51, wherein maintaining the therapeutically effective increase in patency comprises maintaining the therapeutically effective increase in patency without the presence of a drug-eluting material between the connection and a wall portion of the bronchial tree at the treatment site. (Item 58) expanding a first wall portion of the bronchial tree coextensive with the distal-most 10% of the length of the implant along the longitudinal axis to a first average expanded diameter; expanding a second wall portion of the bronchial tree coextensive with the most proximal 10% of the length of the implant along the longitudinal axis to a second average expanded diameter, wherein a ratio of the first average expanded diameter of the first wall portion to its average native diameter is greater than a ratio of the second average expanded diameter of the second wall portion to its average native diameter; 52. The method of claim 51, further comprising: (Item 59) 59. The method of claim 58, wherein the ratio of the first average expanded diameter to the average native diameter of the first wall portion is at least 8 times greater than the ratio of the second average expanded diameter to the average native diameter of the second wall portion. (Item 60) Item 59. The method of item 58, wherein the first average expanded diameter differs from the second average expanded diameter by 0% to 20%. (Item 61) during the maintenance period, a first area of ​​the wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis is in direct contact with the implant, and a second area of ​​the wall portion is not in direct contact with the implant; the second area is at least five times larger than the first area; Item 51. The method according to item 51. (Item 62) Item 62. The method of item 61, wherein the second area is at least 8 times larger than the first area. (Item 63) expanding the wall portion to an average expanded diameter; maintaining a maximum invagination of the wall portion in the second area of ​​no more than 50% of the average dilated diameter throughout the maintenance period. Item 62. The method of item 61, further comprising: (Item 64) transitioning the embedding expanding a proximal end portion of the implant in a first airway of the bronchial tree, the first airway being a generation 2 or greater; expanding a distal end portion of the implant in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; Item 52. The method according to Item 51, comprising: (Item 65) Item 65. The method of item 64, wherein the second airway generation is at least two times greater than the first airway generation. (Item 66) Item 65. The method of item 64, wherein the second airway generation exceeds the first airway generation by at least three. (Item 67) 65. The method of claim 64, wherein the second airway generation is at least four times greater than the first airway generation. (Item 68) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; expanding the proximal end portion includes contacting a wall of the first airway with an untethered first end of the wire; Expanding the distal end portion includes contacting a wall of the second airway with an untethered second end of the wire. Item 65. The method according to item 64. (Item 69) contacting the wall of the first airway with the untethered first end of the wire includes contacting the wall of the first airway with the untethered first end of the wire at a portion of the wall of the first airway at a proximal-most end of the implant; contacting the wall of the second airway with the untethered second end of the wire includes contacting the wall of the second airway with the untethered second end of the wire at a portion of the wall of the second airway that is proximal to the distal-most end of the implant. Item 68. The method according to item 68. (Item 70) the wire includes first and second sections that are alternately arranged along the wire path; the connection portion is in the first and second sections; the first section extends circumferentially distally about the longitudinal axis while the implant is in the deployed state at the treatment site; the second section extends proximally in the circumferential direction while the implant is in the deployed state at the treatment site; expanding the proximal end portion includes contacting a wall of the first airway with a given one of the first sections at the first end of the wire pathway; expanding the distal end portion includes contacting a wall of the second airway with a given one of the second sections at the second end of the wire pathway; Item 68. The method according to item 68. (Item 71) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire includes first and second sections alternately disposed along the wire path and apex portions between the first and second sections; the connection portion is in the first and second sections; the spring is at the apex portion; transitioning the implant includes increasing the mean curvature of the wire path at the apex portion. Item 51. The method according to item 51. (Item 72) the apical portion includes a first apical portion that faces distally while the implant is in the deployed state at the treatment location, and a second apical portion that faces proximally while the implant is in the deployed state at the treatment location; transitioning the implants includes transitioning the implants while a given three of the first apex portions in different adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other, and while a given three of the second apex portions in different adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other. Item 71. The method according to item 71. (Item 73) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing between successive vertices along the wire path is within a range of 35 degrees to 95 degrees. Item 71. The method according to item 71. (Item 74) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing between successive vertices along the wire path is within a range of 55 degrees to 65 degrees. Item 71. The method according to item 71. (Item 75) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing in degrees between successive vertices along the wire path changes by 5% or less. Item 71. The method according to item 71. (Item 76) the apical portion includes a first apical portion that faces distally while the implant is in the deployed state at the treatment location, and a second apical portion that faces proximally while the implant is in the deployed state at the treatment location; the first apex portion defines a first helix; the second apex portion defines a second helix; the implant defines a helical band between the first and second helices; transitioning the implant includes decreasing a width of the spiral band parallel to the longitudinal axis while transitioning the implant. Item 71. The method according to item 71. (Item 77) Item 77. The method of item 76, wherein the wire occupies 5% to 30% of the total area of ​​the spiral band during the maintenance period. (Item 78) maintaining a mucociliary clearance region at the treatment site substantially free of granulation tissue and mucus plugging throughout the maintenance period, the mucociliary clearance region extending along a continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant; 52. The method of claim 51, further comprising: (Item 79) 79. The method of claim 78, wherein maintaining the mucociliary clearance region further comprises maintaining the mucociliary clearance region substantially free of inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis during the maintenance period. (Item 80) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at a proximal end portion of the implant and an opposing second end at a distal end portion of the implant; transitioning the implant includes transitioning the implant such that no portion of the wire intersects the mucociliary clearance pathway. Item 79. The method according to item 79. (Item 81) 81. The method of claim 80, wherein maintaining the mucociliary clearance region comprises maintaining the mucociliary clearance region at an average width parallel to the longitudinal axis that is at least 10 times greater than an average cross-sectional diameter of the wire perpendicular to the wire path. (Item 82) the implant in the delivery state during travel within the bronchial tree has a first length; Immediately after transitioning the implant, the implant in the deployed state has a second length that differs from the first length by no more than 10%. Item 51. The method according to item 51. (Item 83) 52. The method of claim 51, further comprising, after transitioning the implant, applying a force of at least 0.05 megapascals per unit contact area with the implant against the wall of the bronchial tree at the treatment location. (Item 84) 52. The method of claim 51, further comprising, after transitioning the implant, resisting elongation of the implant along the longitudinal axis with a resistance force that is less than the friction force between the implant at the treatment location and the wall of the bronchial tree during a complete respiratory cycle by the subject. (Item 85) 52. The method of claim 51, wherein the bronchial tree distal to the treatment location has collateral ventilation. (Item 86) 52. The method of claim 51, further comprising releasing air trapped within the bronchial tree distal to the treatment location. (Item 87) transitioning the embedding expanding a distal end portion of the implant; expanding a middle portion of the implant after expanding the distal end portion, the middle portion being proximal to the distal end portion along the longitudinal axis; expanding a proximal end portion of the implant after expanding the intermediate portion, the proximal end portion being proximal to the intermediate portion along the longitudinal axis; Item 52. The method according to Item 51, comprising: (Item 88) Item 88. The method of item 87, wherein transitioning the implant comprises simultaneously increasing contact between the implant and the wall of the bronchial tree at three or more circumferentially spaced portions of the wall while expanding the intermediate portion. (Item 89) Item 88. The method of item 87, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at five or more circumferentially spaced portions of the wall while expanding the distal end portion. (Item 90) transitioning the embedding while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall of the bronchial tree at a first number of circumferentially spaced portions of the wall; while expanding the distal end portion, simultaneously increasing contact between the implant and the wall at a second number of circumferentially spaced portions of the wall, the second number of circumferentially spaced portions of the wall being greater than the first number of circumferentially spaced portions of the wall; Item 89. The method of item 89, comprising: (Item 91) Item 52. The method of item 51, wherein the ratio of the average diameter of the implant perpendicular to the longitudinal axis immediately after transitioning the implant to the length of the implant immediately after transitioning the implant is in the range of 1:10 to 1:30. (Item 92) Item 52. The method of item 51, further comprising constraining radial expansion of the implant within a sheath extending around the implant while moving the implant, wherein transitioning the implant includes causing relative movement between the implant and the sheath. (Item 93) Item 93. The method of item 92, further comprising constraining longitudinal expansion of the implant via a shaft extending longitudinally through the implant while moving the implant. (Item 94) constraining the longitudinal expansion of the implant includes constraining the longitudinal expansion of the implant via a pad on the shaft; The pad is disposed between the implant and the core of the shaft while the implant is being moved; the pad is more resilient than the core; Item 93. The method according to item 93. (Item 95) 1. A method for improving lung function in a human subject, the method comprising: While the implant is in a low-profile delivery state, moving the implant intraluminally within the subject's bronchial tree toward a treatment location within the bronchial tree, wherein a portion of the bronchial tree distal to the treatment location is emphysematous and has collateral ventilation; transitioning the implant from the delivery state to an expanded, deployed state at the treatment site, wherein transitioning the implant includes expanding an expandable structure within a helical band extending around a longitudinal axis of the implant, wherein expanding the expandable structure increases a helical length of the helical band; increasing the subject's forced expiratory volume in one second by at least 5% after deploying the implant compared to before deploying the implant; A method comprising: (Item 96) the implant is a first implant; the treatment location is a first treatment location; the delivery state is a first delivery state; the deployed state is a first deployed state, the expandable structure is a first expandable structure; the spiral band is a first spiral band, The method further comprises: moving the second implant intraluminally within the bronchial tree toward the second treatment location within the bronchial tree while the second implant is in a low-profile second delivery state, wherein a portion of the bronchial tree distal to the second treatment location is emphysematous and has collateral ventilation; transitioning the second implant from the second delivery state to an expanded second deployed state at the second treatment location, wherein transitioning the second implant includes expanding a second expandable structure within a second helical band extending around a longitudinal axis of the second implant, and expanding the second expandable structure increases a helical length of the second helical band; Including, Increasing the subject's forced expiratory volume in one second includes increasing the subject's forced expiratory volume in one second after deploying the first and second implants compared to before deploying the first and second implants. Item 95. The method according to item 95. (Item 97) moving the third implant intraluminally within the bronchial tree toward a third treatment location within the bronchial tree while the third implant is in a low-profile third delivery state, wherein a portion of the bronchial tree distal to the third treatment location is emphysematous and has collateral ventilation; transitioning the third implant from the third delivery state to an expanded third deployed state at the third treatment location, wherein transitioning the third implant includes expanding a third expandable structure within a third helical band extending around a longitudinal axis of the third implant, wherein expanding the third expandable structure increases a helical length of the third helical band; further comprising Increasing the subject's forced expiratory volume in one second includes increasing the subject's forced expiratory volume in one second after deploying the first, second, and third implants compared to before deploying the first, second, and third implants. Item 97. The method according to item 96. (Item 98) 96. The method of claim 95, wherein increasing the subject's forced expiratory volume in one second comprises increasing the subject's forced expiratory volume in one second by at least 10%. (Item 99) Item 96. The method of item 95, wherein transitioning the implant includes releasing at least some of the resilient bias on the implant in the expandable structure. (Item 100) the implant in the delivery state during travel within the bronchial tree has a first average diameter perpendicular to the longitudinal axis; the implant in the deployed state after transitioning the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times greater than the first average diameter; Item 95. The method according to item 95. (Item 101) Item 96. The method of item 95, further comprising expanding the bronchial tree wall segments coextensive with the length of the implant along the longitudinal axis to an average expanded diameter at least three times greater than the average native diameter of the wall segments. (Item 102) expanding a first wall portion of the bronchial tree coextensive with the distal-most 10% of the length of the implant along the longitudinal axis to a first average expanded diameter; expanding a second wall portion of the bronchial tree coextensive with the most proximal 10% of the length of the implant along the longitudinal axis to a second average expanded diameter, wherein a ratio of the first average expanded diameter of the first wall portion to its average native diameter is greater than a ratio of the second average expanded diameter of the second wall portion to its average native diameter; Item 96. The method of item 95, further comprising: (Item 103) 103. The method of claim 102, wherein the ratio of the first average expanded diameter to the average native diameter of the first wall portion is at least 8 times greater than the ratio of the second average expanded diameter to the average native diameter of the second wall portion. (Item 104) Item 103. The method of item 102, wherein the first average expanded diameter differs from the second average expanded diameter by 0% to 20%. (Item 105) after transitioning the implant, a first area of ​​the wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis is in direct contact with the implant, and a second area of ​​the wall portion is not in direct contact with the implant; the second area is at least five times larger than the first area; Item 103. The method according to item 102. (Item 106) Item 106. The method of item 105, wherein the second area is at least 8 times larger than the first area. (Item 107) transitioning the embedding expanding a proximal end portion of the implant in a first airway of the bronchial tree, the first airway being a generation 2 or greater; expanding a distal end portion of the implant in a second airway of the bronchial tree, the second airway being a generation greater than the first airway; Item 96. The method according to Item 95, comprising: (Item 108) 108. The method of claim 107, wherein the second airway generation is at least two times greater than the first airway generation. (Item 109) Item 108. The method of item 107, wherein the second airway generation exceeds the first airway generation by at least three. (Item 110) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at the proximal end portion and an opposing second end at the distal end portion; expanding the proximal end portion includes contacting a wall of the first airway with an untethered first end of the wire; Expanding the distal end portion includes contacting a wall of the second airway with an untethered second end of the wire. Item 107. The method according to item 107. (Item 111) contacting the wall of the first airway with the untethered first end of the wire includes contacting the wall of the first airway with the untethered first end of the wire at a portion of the wall of the first airway at a proximal-most end of the implant; contacting the wall of the second airway with the untethered second end of the wire includes contacting the wall of the second airway with the untethered second end of the wire at a portion of the wall of the second airway proximal to the distal-most end of the implant. Item 111. The method according to item 110. (Item 112) the wire includes first and second sections that are alternately arranged along the wire path; the first section extends circumferentially distally about the longitudinal axis while the implant is in the deployed state at the treatment site; the second section extends proximally in the circumferential direction while the implant is in the deployed state at the treatment site; expanding the proximal end portion includes contacting a wall of the first airway with a given one of the first sections at the first end of the wire pathway; expanding the distal end portion includes contacting a wall of the second airway with a given one of the second sections at the second end of the wire pathway; Item 111. The method according to item 110. (Item 113) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire includes first and second sections alternately disposed along the wire path and apex portions between the first and second sections; the expandable structure is in the apex portion; transitioning the implant includes increasing the mean curvature of the wire path at the apex portion. Item 95. The method according to item 95. (Item 114) the apical portion includes a first apical portion that faces distally while the implant is in the deployed state at the treatment location, and a second apical portion that faces proximally while the implant is in the deployed state at the treatment location; transitioning the implants includes transitioning the implants while given three of the first apex portions in different adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other, and while given three of the second apex portions in different adjacent turns of the wire path remain within 5 degrees of circumferential alignment with each other. Item 113. The method according to item 113. (Item 115) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing between successive vertices along the wire path is within a range of 35 degrees to 95 degrees. Item 113. The method according to item 113. (Item 116) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing between successive vertices along the wire path is within a range of 55 degrees to 65 degrees. Item 113. The method according to item 113. (Item 117) the individual vertex portions are at individual vertices along the wire path; transitioning the fill material includes transitioning the fill material while the average circumferential spacing in degrees between successive vertices along the wire path changes by 5% or less. Item 113. The method according to item 113. (Item 118) the apical portion includes a first apical portion that faces distally while the implant is in the deployed state at the treatment location, and a second apical portion that faces proximally while the implant is in the deployed state at the treatment location; the first apex portion defines a first helix; the second apex portion defines a second helix; the first and second helices define the helical band; transitioning the implant includes decreasing a width of the spiral band parallel to the longitudinal axis while transitioning the implant. Item 113. The method according to item 113. (Item 119) Item 119. The method of item 118, wherein the wire occupies 5% to 15% of the total area of ​​the spiral band after transitioning the implant. (Item 120) 96. The method of claim 95, further comprising maintaining a mucociliary clearance region at the treatment site substantially free of granulation tissue and mucus plugging throughout a continuous maintenance period of at least three months while the implant is in the deployed state at the treatment site, wherein the mucociliary clearance region extends along a continuous mucociliary clearance pathway from a location immediately distal to the implant to a location immediately proximal to the implant. (Item 121) 121. The method of claim 120, wherein maintaining the mucociliary clearance region further comprises maintaining the mucociliary clearance region substantially free of inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis during the maintenance period. (Item 122) the implant includes a wire extending along a wire path within a tubular region coaxially aligned with the longitudinal axis; the wire path has a first end at a proximal end portion of the implant and an opposing second end at a distal end portion of the implant; transitioning the implant includes transitioning the implant such that no portion of the wire intersects the mucociliary clearance pathway. Item 120. The method according to item 120. (Item 123) 123. The method of claim 122, wherein maintaining the mucociliary clearance region comprises maintaining the mucociliary clearance region at an average width parallel to the longitudinal axis that is at least 10 times greater than an average cross-sectional diameter of the wire perpendicular to the wire path. (Item 124) Item 121. The method of item 120, wherein maintaining the mucociliary clearance region comprises maintaining the mucociliary clearance region without the presence of a drug-eluting material between the expandable structure and a wall portion of the bronchial tree at the treatment location. (Item 125) the implant in the delivery state during travel within the bronchial tree has a first length; Immediately after transitioning the implant, the implant in the deployed state has a second length that differs from the first length by no more than 10%. Item 95. The method according to item 95. (Item 126) Item 96. The method of item 95, further comprising, after transitioning the implant, applying a force of at least 0.05 megapascals per unit contact area with the implant against the wall of the bronchial tree at the treatment location. (Item 127) 128. The method of claim 95, further comprising, after transitioning the implant, resisting elongation of the implant along the longitudinal axis with a resistance force that is less than the friction force between the implant at the treatment location and the wall of the bronchial tree during a complete respiratory cycle by the subject. 96. The method of claim 95, further comprising releasing air trapped within the portion of the bronchial tree distal to the treatment location. (Item 129) transitioning the embedding expanding a distal end portion of the implant; expanding a middle portion of the implant after expanding the distal end portion, the middle portion being proximal to the distal end portion along the longitudinal axis; expanding a proximal end portion of the implant after expanding the intermediate portion, the proximal end portion being proximal to the intermediate portion along the longitudinal axis; Item 96. The method according to Item 95, comprising: (Item 130) Item 130. The method of item 129, wherein transitioning the implant comprises simultaneously increasing contact between the implant and the wall of the bronchial tree at three or more circumferentially spaced portions of the wall while expanding the intermediate portion. (Item 131) Item 130. The method of item 129, wherein transitioning the implant includes simultaneously increasing contact between the implant and the wall of the bronchial tree at five or more circumferentially spaced portions of the wall while expanding the distal end portion. (Item 132) transitioning the embedding while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall of the bronchial tree at a first number of circumferentially spaced portions of the wall; while expanding the intermediate portion, simultaneously increasing contact between the implant and the wall at a second number of circumferentially spaced portions of the wall that is greater than the first number of circumferentially spaced portions of the wall; Item 129. The method of item 129, comprising: (Item 133) Item 96. The method of item 95, wherein the ratio of the average diameter of the implant perpendicular to the longitudinal axis immediately after transitioning the implant to the length of the implant immediately after transitioning the implant is in the range of 1:10 to 1:30. (Item 134) Item 96. The method of item 95, further comprising constraining radial expansion of the implant within a sheath extending around the implant while moving the implant, wherein transitioning the implant includes causing relative movement between the implant and the sheath. (Item 135) Item 135. The method of item 134, further comprising constraining longitudinal expansion of the implant via a shaft extending longitudinally through the implant while moving the implant. (Item 136) constraining the longitudinal expansion of the implant includes constraining the longitudinal expansion of the implant via a pad on the shaft; The pad is disposed between the implant and the core of the shaft while the implant is being moved; the pad is more resilient than the core; Item 135. The method according to item 135. (Item 137) transitioning the implant expands a wall portion of the bronchial tree coextensive with the length of the implant along the longitudinal axis to a first average expanded diameter; The method further comprises: expanding a balloon at the treatment location to expand the wall portion and the implant to a second average expanded diameter greater than the first average expanded diameter; removing the balloon from the treatment site; and Item 96. The method according to Item 95, comprising: (Item 138) Item 138. The method of item 137, wherein the second average expanded diameter is greater than the average unconstrained diameter of the implant. (Item 139) 138. The method of claim 137, wherein expanding the wall portion from the first average expanded diameter toward the second average expanded diameter creates and / or increases a bronchial fenestration within the wall portion. (Item 140) 1. An implant configured to be deployed at a treatment site within the bronchial tree of a human subject, said implant comprising: expansion means for expanding the implant from a low-profile delivery state to an expanded, deployed state at the treatment site; stabilizing means for stabilizing the implant in the deployed state at the treatment site during breathing by the subject; An implant comprising: (Item 141) Item 141. The implant of item 140, further comprising placement means for increasing placement accuracy of a distal end portion of the implant during deployment of the implant at the treatment site. (Item 142) Item 141. The implant of item 140, further comprising a retrieval means for retrieving the implant after deployment of the implant at the treatment site. (Item 143) 1. A system for deploying an implant at a treatment site within the bronchial tree of a human subject, the system comprising: an implant configured to be deployed at the treatment site; a radial restraint means for restraining radial expansion of the implant while the implant moves intraluminally within the bronchial tree toward the treatment site; longitudinal restraint means for restraining longitudinal expansion of the implant while the implant is moving intraluminally within the bronchial tree toward the treatment site; A system comprising: (Item 144) 1. An implantable device for placement within a bronchial airway lumen for the treatment of obstructive pulmonary disease, said implantable device comprising: a first end portion, a second end portion, and a longitudinal axis extending therebetween, the first end portion configured to be positioned within a distal region of the bronchial airway and the second end portion configured to be positioned within a proximal region of the bronchial airway, the distal region comprising more generations than the proximal region; the device includes an elongate member comprising a resilient material and wound about a longitudinal axis of the device in a series of unbroken loops, each loop having a plurality of peaks and a plurality of valleys, the device having a continuous opening extending between the loops from the first end portion to the second end portion; The implantable device has a compressed state and an expanded state, and is configured to be delivered in the compressed state through a catheter to the bronchial airway lumen at the distal region, and is allowed to self-expand into apposition with the inner surface of the wall in the bronchial airway lumen, thereby compressing radially outward on the wall and expanding the distal region to a diameter that is more than twice the diameter of the bronchial airway lumen at the distal region prior to expansion of the device. (Item 145) 1. An implant configured to be deployed at a treatment site within a body lumen of a human subject, the implant comprising: a proximal end portion configured to be deployed at a proximal location within the body lumen; a distal end portion spaced from the proximal end portion along a longitudinal axis of the implant and configured to be deployed at a distal location within the body lumen; an intermediate portion between the proximal and distal end portions along the longitudinal axis; a wire extending along a continuous wire path within a tubular region coaxially aligned with the longitudinal axis, the wire path in the intermediate portion including at least three windings about the longitudinal axis; Equipped with the wire includes first and second sections arranged alternately along the wire path, the first sections extending distally in a circumferential direction about the longitudinal axis and the second sections extending proximally in the circumferential direction; the wire path further comprises a series of unbroken loops, each loop comprising a plurality of peaks, a plurality of valleys, and a continuous opening extending between the loops from the proximal end portion to the distal end portion; The implant is configured to resiliently transition from a low-profile delivery state in which the implant has a first average diameter perpendicular to the longitudinal axis to an expanded, deployed state in which the implant has a second average diameter perpendicular to the longitudinal axis, the second average diameter being at least three times larger than the first average diameter. (Item 146) 146. The implant of claim 145, wherein the implant is configured for placement within the bronchial airways of the human subject for the treatment of emphysema. (Item 147) 146. The implant of claim 145, wherein the implant is configured for placement within the central airway of the human subject for the treatment of tracheobronchomalacia (TBM). (Item 148) Item 146. The implant of item 145, wherein the implant is configured for placement within the urethra of the human subject for the treatment of benign prostatic hyperplasia (BPH). (Item 149) Item 146. The implant of item 145, wherein the implant is configured to maintain at least a portion of the treatment site substantially free of granulation tissue, mucus plugging, inflammation, inflammatory cells, fibrosis, fibrotic cells, tissue hyperplasia, and tissue necrosis. [Brief explanation of the drawings]

[0019] Many aspects of the present technology can be better understood with reference to the following drawings. Relative dimensions within the drawings may be to scale for some embodiments of the present technology. For other embodiments, the drawings may not be to scale. The drawings may also be arbitrarily enlarged. For clarity, reference numeral labels of similar components or features may be omitted when the appropriate reference numeral label for such similar components or features is clear in the overall context of the specification and drawings considered together. Furthermore, the same reference numerals may be used to identify similar components or features in multiple described embodiments.

[0020] [Figure 1] FIG. 1 is a schematic diagram of the bronchial tree of a human subject within the subject's thoracic cavity.

[0021] [Figure 2] FIG. 2 is a schematic diagram of the bronchial tree of a human subject in isolation.

[0022] [Figure 3] FIG. 3 is an enlarged view of the terminal portion of the bronchial tree shown in FIG.

[0023] [Figure 4] FIG. 4 is a table showing an example of the dimensions and ages of different parts of the bronchial tree of a human subject.

[0024] [Figure 5] FIG. 5 is a diagram showing lung volumes during normal lung function.

[0025] [Figure 6] FIG. 6 is a table showing airway wall composition in different parts of the bronchial tree of a human subject.

[0026] [Figure 7] FIG. 7 is an anatomical diagram of the airway wall composition in different parts of the bronchial tree in a human subject.

[0027] [Figure 8] FIG. 8 is an anatomical diagram showing small airway narrowing in emphysematous lung tissue.

[0028] [Figure 9] FIG. 9 is an anatomical diagram showing alveolar wall damage in emphysematous lung tissue.

[0029] [Figure 10] FIG. 10 is an anatomical diagram showing normal airway patency during exhalation in healthy lung tissue.

[0030] [Figure 11] FIG. 11 is an anatomical diagram showing airway collapse during exhalation in emphysematous lung tissue.

[0031] [Figure 12] FIG. 12 is an anatomical diagram showing a normal acinar region.

[0032] [Figure 13] FIG. 13 is an anatomical diagram showing centrilobular emphysema.

[0033] [Figure 14] FIG. 14 is an anatomical diagram showing panlobular emphysema.

[0034] [Figure 15] FIG. 15 is an anatomical diagram showing perilobular emphysema.

[0035] [Figure 16] FIG. 16 is a side view of an implant in accordance with at least some embodiments of the present technology.

[0036] [Figure 17] FIG. 17 is a schematic end view of the implant shown in FIG.

[0037] [Figure 18]FIG. 18 is a side view of a portion of an implant in an airway, in accordance with at least some embodiments of the present technology.

[0038] [Figure 19] FIG. 19 is a side view of an implant in accordance with at least some embodiments of the present technology.

[0039] [Figure 20] FIG. 20 is a perspective view of the implant shown in FIG.

[0040] [Figure 21] 21-23 are side views of individual implants in accordance with at least some embodiments of the present technology. [Figure 22] 21-23 are side views of individual implants in accordance with at least some embodiments of the present technology. [Figure 23] 21-23 are side views of individual implants in accordance with at least some embodiments of the present technology.

[0041] [Figure 24] FIG. 24 is a perspective view of the implant shown in FIG.

[0042] [Figure 25] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 26] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 27] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 28] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 29] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 30]25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 31] 25-31 are perspective views of individual implants in accordance with at least some embodiments of the present technology.

[0043] [Figure 32] 32 and 33 are side views of individual implants in accordance with at least some embodiments of the present technology. [Figure 33] 32 and 33 are side views of individual implants in accordance with at least some embodiments of the present technology.

[0044] [Figure 34] FIG. 34 is a perspective view of an implant in accordance with at least some embodiments of the present technology.

[0045] [Figure 35] FIG. 35 is a side view of an implant in accordance with at least some embodiments of the present technology.

[0046] [Figure 36] FIG. 36 is a perspective view of an implant in accordance with at least some embodiments of the present technology.

[0047] [Figure 37] FIG. 37 is a side view of a uniformly tapered wire for use with an implant, in accordance with at least some embodiments of the present technology.

[0048] [Figure 38] FIG. 38 is a side view of a segmented tapered wire for use with an implant, in accordance with at least some embodiments of the present technology.

[0049] [Figure 39] FIG. 39 is a cross-sectional side view of a tapered tube for use with an implant, in accordance with at least some embodiments of the present technology.

[0050] [Figure 40] FIG. 40 is an end view of a first end of an elongate member in accordance with at least some embodiments of the present technology.

[0051] [Figure 41] 41 is an end view of the second end of the elongate member of FIG.

[0052] [Figure 42] 42-46 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 43] 42-46 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 44] 42-46 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 45] 42-46 are perspective views of individual implants in accordance with at least some embodiments of the present technology. [Figure 46] 42-46 are perspective views of individual implants in accordance with at least some embodiments of the present technology.

[0053] [Figure 47] FIG. 47 is a side view of a bent portion of the implant shown in FIG.

[0054] [Figure 48] FIG. 48 is a side view of a mandrel configured for use in manufacturing an implant, in accordance with at least some embodiments of the present technology.

[0055] [Figure 49] FIG. 49 is a perspective view of the implant shown in FIG. 46 in radial compression around a delivery member.

[0056] [Figure 50]FIG. 50 is a perspective view of the implant shown in FIG. 46 in the radial compression state shown in FIG. 49, with a portion of the implant highlighted for finite element analysis.

[0057] [Figure 51] FIG. 51 is a perspective view of an implant in accordance with at least some embodiments of the present technology.

[0058] [Figure 52] FIG. 52 is a perspective view of a bronchoscope for use with an implant, in accordance with at least some embodiments of the present technology.

[0059] [Figure 53] 53 and 54 are diagrams illustrating different individual times during deployment of an implant, in accordance with at least some embodiments of the present technology. [Figure 54] 53 and 54 are diagrams illustrating different individual times during deployment of an implant, in accordance with at least some embodiments of the present technology.

[0060] [Figure 55A] FIG. 55A is a cross-sectional view of a delivery system in accordance with at least some embodiments of the present technology.

[0061] [Figure 55B] FIG. 55B is a supplementary explanation corresponding to FIG. 55A.

[0062] [Figure 56A] FIG. 56A is a perspective view of an implant in an unconstrained state, in accordance with at least some embodiments of the present technology.

[0063] [Figure 56B] Figures 56B-56F are supplementary explanations corresponding to Figure 56A. [Figure 56C] Figures 56B-56F are supplementary explanations corresponding to Figure 56A. [Figure 56D] Figures 56B-56F are supplementary explanations corresponding to Figure 56A. [Figure 56E] Figures 56B-56F are supplementary explanations corresponding to Figure 56A. [Figure 56F] Figures 56B-56F are supplementary explanations corresponding to Figure 56A.

[0064] [Figure 57A] FIG. 57A is an end view of the implant shown in FIG. 56A in an unconstrained state.

[0065] [Figure 57B] FIG. 57B is a supplementary explanation corresponding to FIG. 57A.

[0066] [Figure 58] FIG. 58 is a profile view of the implant shown in FIG. 56A in an unconstrained state.

[0067] [Figure 59] FIG. 59 is a cross-sectional view of the implant shown in FIG. 56A in an unconstrained state taken along line AA of FIG.

[0068] [Figure 60] FIG. 60 is a cross-sectional view of the implant shown in FIG. 56A in an unconstrained state taken along line BB of FIG.

[0069] [Figure 61] FIG. 61 is a cross-sectional view of the implant shown in FIG. 56A in an unconstrained state taken along line CC of FIG.

[0070] [Figure 62] FIG. 62 is a cross-sectional view of the implant shown in FIG. 56A in an unconstrained state taken along line DD of FIG.

[0071] [Figure 63] FIG. 63 is a profile view of an implant in an unconstrained state juxtaposed with a schematic diagram of a portion of the wire path in a mid-section of the implant, in accordance with at least some embodiments of the present technology.

[0072] [Figure 64A] 64A-65B are diagrams showing different individual angles formed associated with the implant shown in FIG. [Figure 64B] 64A-65B are diagrams showing different individual angles formed associated with the implant shown in FIG.

[0073] [Figure 65] FIG. 65 is a profile view of the implant shown in FIG. 63 in a deployed state within the airway region. [Figure 65A] 64A-65B are diagrams showing different individual angles formed associated with the implant shown in FIG. [Figure 65B] 64A-65B are diagrams showing different individual angles formed associated with the implant shown in FIG.

[0074] [Figure 66] FIG. 66 is a schematic diagram illustrating certain forces and dimensions associated with an implant, in accordance with at least some embodiments of the present technology.

[0075] [Figure 67] FIG. 67 is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of a simple coil.

[0076] [Figure 68] FIG. 68 is a schematic diagram illustrating the maximum distance between a point on the airway wall and the wire path of the implant, in accordance with at least some embodiments of the present technology.

[0077] [Figure 69] FIG. 69 is an anatomical view of an airway region in which an implant in accordance with at least some embodiments of the present technology may be deployed.

[0078] [Figure 70]70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology. [Figure 71] 70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology. [Figure 72] 70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology. [Figure 73] 70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology. [Figure 74] 70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology. [Figure 75] 70-75 are partial schematic illustrations of different discrete times during deployment of an implant in the airway region shown in FIG. 69, in accordance with at least some embodiments of the present technology.

[0079] [Figure 76] FIG. 76 is an anatomical view of the airway region shown in FIG. 69, showing certain native and expanded dimensions.

[0080] [Figure 77] FIG. 77 is a block diagram showing a method for improving lung function in a human subject in accordance with at least some embodiments of the present technology.

[0081] [Figure 78] FIG. 78 is an image of an experimental setup used to test implants in accordance with at least some embodiments of the present technology.

[0082] [Figure 79]FIG. 79 is an image of a first simple coil, having a relatively high winding density, in the apparatus shown in FIG. 78 set at atmospheric pressure.

[0083] [Figure 80] FIG. 80 is an image of the first simple coil shown in FIG. 79 in the apparatus shown in FIG. 78 set to a pressure of 80 inches of water.

[0084] [Figure 81] FIG. 81 is an image of a second simple coil, having a relatively low winding density, in the apparatus shown in FIG. 78 set at atmospheric pressure.

[0085] [Figure 82] FIG. 82 is an image of the second simple coil shown in FIG. 81 in the apparatus shown in FIG. 78 set to a pressure of 80 inches of water.

[0086] [Figure 83] FIG. 83 is an image of an implant in accordance with at least some embodiments of the present technology within the device shown in FIG. 78 set at atmospheric pressure.

[0087] [Figure 84] FIG. 84 is an image of the implant shown in FIG. 83 in the apparatus shown in FIG. 78 set to a pressure of 80 inches of water.

[0088] [Figure 85] FIG. 85 is a chart showing results from an ex vivo human emphysematous lung study in which implants according to at least some embodiments of the present technology were tested against control implants for their capacity to improve lung function. DETAILED DESCRIPTION OF THE INVENTION

[0089] Detailed Description As discussed above, existing approaches to treating COPD are either highly invasive (e.g., lung volume reduction surgery), ineffective for most patients (e.g., one-way stent valves), excessively affect gas exchange with healthy lung tissue (e.g., endobronchial coils and clips), carry a high risk of complications (e.g., bronchoscopic thermal vapor ablation), have poor long-term effectiveness (e.g., bypass prostheses), and / or suffer from one or more other major limitations. Overcoming these limitations presents a significant technical challenge. As discussed in detail below, the inventors have developed new approaches to treating COPD that address at least some of the deficiencies of conventional approaches. In at least some cases, these new approaches are surprisingly effective in establishing and maintaining airway patency. This is expected to be true for both emphysema patients without and with collateral ventilation. Approaches to treating COPD according to at least some embodiments of the present technology include the use of innovative endobronchial implants. Aside from potential clinical benefits, these implants may have better deliverability, retrievability, and / or safety characteristics than conventional devices. Given the prevalence and severity of COPD, innovative endobronchial implants and other aspects of COPD treatment according to various embodiments of the present technology have great potential to have a significant positive impact on global public health.

[0090] At least some embodiments of the present technology are directed to establishing and maintaining patency within obstructed and / or narrowed portions of one or more airways in the lung. This can have therapeutic benefits for patients diagnosed with COPD, including those diagnosed with emphysema and / or chronic bronchitis. At least some of the therapeutic benefits can be associated with promoting the release of air from the hyperextended and / or diseased lung portion, in addition to a corresponding increase in intrathoracic volume available for gas exchange with other lung portions. Implants according to at least some embodiments of the present technology are configured to be positioned intraluminally within the airway and expand against the airway wall, thereby widening and / or expanding the airway and increasing the cross-sectional area of ​​the airway lumen. In at least some cases, the implant is configured to increase the airway beyond its normal size.

[0091] In at least some cases, implants according to embodiments of the present technology have relatively little (e.g., minimal) surface contact with the airway wall and / or are configured to maintain stable contact with the airway wall during breathing. These and other features disclosed herein may reduce or eliminate progressive airway obstruction due to biological processes (e.g., inflammation, fibrosis, granulation tissue, mucus plugging, etc.) that would otherwise limit the efficacy of implants for the treatment of COPD. An overview of the relevant anatomy and physiology of the lung, as well as additional details regarding implants according to embodiments of the present technology, are discussed below.

[0092] Many specific details of devices, systems, and methods according to various embodiments of the present technology are disclosed herein. While these devices, systems, and methods may be disclosed primarily or entirely in the context of treating COPD (and sometimes, particularly, emphysema), other contexts in addition to those disclosed herein are within the scope of the present technology. For example, preferred features of the described devices, systems, and methods can be implemented in the context of treating tracheobronchomalacia (TBM) or benign prostatic hyperplasia (BPH), among other examples. Furthermore, it should be understood that other devices, systems, and methods in addition to those disclosed herein are generally within the scope of the present technology. For example, devices, systems, and methods according to embodiments of the present technology can have different and / or additional configurations, components, and procedures than those disclosed herein. Also, those skilled in the art will understand that devices, systems, and methods according to embodiments of the present technology may do without one or more of the configurations, components, and / or procedures disclosed herein without departing from the present technology.

[0093] Anatomy and Physiology FIG. 1 is a schematic diagram of the bronchial tree of a human subject within the subject's thoracic cavity. As shown in FIG. 1, the bronchial tree includes a trachea T, which extends downward from the nose and mouth and divides into a left main bronchus LMB and a right main bronchus RMB. The left and right main bronchi each branch to form lobar bronchi LB, segmental bronchi SB, and subsegmental bronchi SSB, which subsequently have smaller diameters and shorter lengths as they extend distally. FIG. 2 is a schematic diagram of the bronchial tree in isolation. As shown in FIG. 2, the subsegmental bronchi continue to branch to form bronchioli BO, conducting bronchioli CBO, and finally terminal bronchioli TBO, the smallest airways that do not contain alveoli. The terminal bronchioli branch into respiratory bronchioli RBO, which divide into alveolar ducts AD. FIG. 3 is an enlarged view of the terminal portion of the bronchial tree. As shown in Figure 3, the alveolar duct terminates in a cul-de-sac containing two or more small clusters of alveoli A, called alveolar sacs AS. Various single alveoli may also be located along the length of the respiratory bronchioles.

[0094] The bronchi and bronchioles are conducting airways that transport air to and from the alveoli. They do not participate in gas exchange. Rather, gas exchange occurs within the alveoli, which are found distal to the conducting airways, originating from the respiratory bronchioles. It is common to refer to the various airways of the bronchial tree as "generations" depending on the degree of branching proximally. For example, the trachea is referred to as "generation 0" of the bronchial tree, the various levels of bronchi, including the left main bronchus and right main bronchus, are referred to as "generation 1," the lobar bronchi are referred to as "generation 2," and the segmental bronchi are referred to as "generation 3." Furthermore, it is common to refer to any of the airways extending from the trachea to the terminal bronchioles as "conducting airways." Figure 4 is a table showing examples of the dimensions and generations of different parts of the bronchial tree.

[0095] Respiratory bronchioles, alveoli, and alveolar sacs receive air through more proximal portions of the bronchial tree and participate in gas exchange, oxygenating blood pumped from the heart through the pulmonary arteries, branching vessels, and capillaries to the lungs. A thin, semipermeable membrane separates the oxygen-depleted blood in the capillaries from the oxygen-rich air in the alveoli. The capillaries wrap around and extend between the alveoli. Oxygen from the air diffuses through the membrane into the blood. Carbon dioxide from the blood diffuses through the membrane into the air in the alveoli. The newly oxygenated blood then flows from the alveolar capillaries to the heart through the branching vessels of the pulmonary venous system. The heart pumps the oxygen-rich blood throughout the body. The oxygen-depleted air in the lungs is exhaled when the diaphragm and intercostal muscles relax, allowing the lungs and chest wall to elastically return to their normal relaxed state. In this way, air flows through the branching bronchioles, segmental bronchi, lobar bronchi, main bronchi, and trachea, and is finally expelled through the mouth and nose.

[0096] Figure 5 is a schematic diagram showing lung volume during normal lung function. Approximately one-tenth of the total lung capacity is used at rest. A larger volume is used as needed (e.g., with exercise). The tidal volume (TV) is the volume of air that is inhaled and exhaled without conscious effort. The additional volume of air that can be exhaled with maximal effort after normal inspiration is the inspiratory reserve volume (IRV). The additional volume of air that can be forcibly exhaled after normal expiration is the expiratory reserve volume (ERV). The total volume of air that can be exhaled after maximal inspiration is the vital capacity (VC). VC is equal to the sum of the TV, IRV, and ERV. The residual volume (RV) is the volume of air remaining in the lungs after maximal expiration. The lungs can never be completely emptied. The total lung capacity (TLC) is the sum of the VC and RV. Pulmonary function assessment can be used to determine patient eligibility for therapy and to evaluate the efficacy of therapy.

[0097] Figure 6 is a table showing the airway wall composition in different parts of the bronchial tree. Figure 7 is an anatomical diagram of the airway wall composition in different parts of the bronchial tree. As shown in Figures 6 and 7, the walls of bronchi, bronchioles, alveolar ducts, and alveoli contain epithelium, connective tissue, goblet cells, mucus glands, club cells, smooth muscle elastic fibers, and hyaline cartilage, with nerves, blood vessels, and inflammatory cells interspersed throughout. Most of the epithelium (from the nose to the bronchi) is lined with ciliated pseudostratified columnar epithelium, commonly referred to as respiratory epithelium. Cilia located on these epithelia beat unidirectionally, moving mucus and foreign particles, such as dust and bacteria, from more distal airways to more proximal airways and ultimately to the throat, where the mucus and / or foreign particles are cleared by swallowing or expectoration. Moving down the bronchioles, the cells become more cuboidal in shape but remain ciliated.

[0098] The proportions and nature of various components of the airway wall vary depending on the location within the bronchial tree. For example, mucus glands are abundant in the trachea and main bronchi but begin to be absent from the bronchioles (e.g., approximately generation 10). In the trachea, cartilage is present as C-shaped rings of hyaline cartilage, while in the bronchi, cartilage takes the form of scattered plates. As branching continues through the bronchial tree, the amount of hyaline cartilage within the wall decreases until it is absent in the bronchioles. Smooth muscle originates in the trachea, where it joins the C-shaped rings of cartilage. It continues through the bronchi and bronchioles, which it completely surrounds. Instead of stiff cartilage, the bronchi and bronchioles are composed of elastic tissue. As cartilage decreases, the amount of smooth muscle increases. The mucosa also undergoes a transition from ciliated pseudostratified columnar epithelium to simple cuboidal epithelium to simple squamous epithelium.

[0099] Pulmonary disease Figure 8 is an anatomical diagram showing small airway narrowing in emphysematous lung tissue. Figure 9 is an anatomical diagram showing alveolar wall damage in emphysematous lung tissue. Figure 10 is an anatomical diagram showing normal airway patency during exhalation. Figure 11 is an anatomical diagram showing airway collapse during exhalation in emphysematous lung tissue. COPD, particularly emphysema, is characterized by irreversible destruction of alveolar walls, which contain elastic fibers that maintain radially outward static friction on small airways and are useful during inhalation and exhalation. As shown in Figures 8-11, when these elastic fibers are damaged, small airways are no longer under radially outward static friction and collapse, particularly during exhalation. Furthermore, emphysema destroys alveolar walls. As shown in Figure 9, this results in a larger air space and reduces the surface area available for gas exchange. The lungs are therefore unable to perform gas exchange at a satisfactory rate, which causes a decrease in oxygenated blood. In addition, the large air spaces in the affected lungs combined with the collapsed airways result in lung hyperextension (air trapping) and an inability to fully exhale. The hyperextended lungs also exert constant pressure on the chest wall, diaphragm, and surrounding structures, which can cause shortness of breath and prevent patients from walking short distances or performing daily tasks. Both the quality of life and life expectancy for patients with late-stage emphysema are extremely low, with fewer than half of patients surviving for another five years.

[0100] There are three types of emphysema: centrilobular, panlobular, and perilobular. Figure 12 is an anatomical diagram showing a normal acinar area. Figure 13 is an anatomical diagram showing centrilobular emphysema, with alveoli and airways within the central acini, including destruction of alveoli within the walls of the respiratory bronchioles and alveolar ducts. Figure 14 is an anatomical diagram showing panlobular emphysema, characterized by destruction of alveoli, alveolar ducts, and respiratory bronchiolar tissue. This produces a highly uniform enlargement of air spaces throughout the acini and uniformly distributed emphysematous changes across the acini and secondary lobules. Figure 15 is an anatomical diagram showing perilobular emphysema, characterized by increased air spaces at the periphery of the acini, primarily resulting from destruction of the alveoli and alveolar ducts. The distribution of perilobular emphysema is usually limited, most commonly occurring along the posterior surface of the upper lung. It often coexists with other forms of emphysema.

[0101] A further aspect of the progression of emphysema and the associated alveolar wall destruction is increased airflow between neighboring alveoli, known as collateral ventilation or collateral airflow. Collateral ventilation can significantly interfere with the clinical utility of endobronchial valves. As discussed above, these valves are designed to allow one-way air passage, causing atelectasis of the affected lobe. However, collateral ventilation causes lobe expansion, thereby preventing atelectasis.

[0102] New intrabronchial implant Described herein are devices, techniques, and methods for treating patients with pulmonary diseases, such as severe emphysema. At least some embodiments of the present technology involve intrabronchial placement of an implant to establish or improve airway patency. The implant can be placed at a treatment location, including a previously collapsed airway, such as a previously collapsed distal airway. Deployment of the implant can release air trapped within a hyperextended portion of the lung and / or reduce or prevent subsequent trapping of air within this portion of the lung. In at least some cases, it is desirable for the treatment site where the implant is deployed to include (distal to proximal) generation 4 or higher / deeper airways, such as respiratory bronchioles, terminal bronchioles, conducting bronchioles, or subsegmental bronchi, and then extend proximally to more central, larger airways (e.g., generation 6 or higher / lower), such as subsegmental bronchi, segmental bronchi, lobar bronchi, and main bronchi. A single implant can create a seamless pathway from distal to proximal, reliably creating a passage for trapped air. In alternative embodiments, multiple discrete implants can be used instead of a single, longer implant. Multiple discrete implants may be placed in bronchial airways that are collapsed or at risk of collapse. The use of multiple discrete implants within selected locations within the bronchial tree may have the advantage of using less material, thereby reducing contact stress and foreign body response (discussed above), and allowing for more flexibility and customization of therapy. For example, a single implant embodiment may extend from a distal, higher generation airway to a proximal, lower generation airway, whereas a multiple, discrete implant system may allow for placement of implants within multiple airways of the same generation.

[0103] The devices, systems, and methods described herein can be applied to different bronchopulmonary segments to release trapped air from regions of the lung in the safest and most efficient manner possible. For example, treatment of the left lung may involve one or more of the following segments: the upper lobe (superior, i.e., apical, posterior, and anterior; lingual, i.e., superior and inferior); and the lower lobe, i.e., superior, anterior-medial, and lateral-basal. Treatment of the right lung may involve one or more of the following segments: the upper lobe, i.e., apex, anterior, posterior; the middle lobe, i.e., medial, lateral; and the lower lobe, i.e., superior, anterior-medial, and lateral-basal. The treatments described herein may involve placement of a single implant in a single lung (right or left), a single implant in each lung, or multiple implants in each lung. Treatment within a particular lung may involve placing an implant within a specific lobe (e.g., the upper lobe) and a specific segment within such a lobe, or it may involve placing at least one implant within multiple lobes, segments within a lobe, or subsegments within a segment. The determination of the portion of the lung to treat can be made by a clinical operator (e.g., a pulmonologist or surgeon) with the aid of imaging (e.g., CT, ultrasound, radiography, or bronchoscopy) to assess the presence and pathology of disease and its effect on lung function and airflow dynamics.

[0104] FIG. 16 is a side view of expandable device 100 configured to be positioned within an airway lumen, shown in an expanded, unconstrained state. FIG. 17 is an end view of device 100. As shown in FIG. 16, device 100 can comprise a generally tubular structure configured to be positioned within an airway lumen. For example, device 100 can be configured to be implanted within an airway lumen such that device 100 maintains a lumen of a minimum desired diameter within the airway. Device 100 has a first end portion 100a, a second end portion 100b opposite first end portion 100a, and a central longitudinal axis L1 extending between first end portion 100a and second end portion 100b. As used herein, the term "longitudinal" can refer to a direction along an axis extending through the lumen of the device while in a tubular configuration, the term "circumferential" can refer to a direction along an axis that is perpendicular to the longitudinal axis and extends around the circumference of the device when in a tubular configuration, and the term "radial" can refer to a direction along an axis that is perpendicular to the longitudinal axis and extends toward or away from the longitudinal axis.

[0105] The device 100 can include an elongate member 102 wound about a longitudinal axis L1 of the device 100. In some embodiments, the elongate member 102 is heat-set into a novel three-dimensional (3D) configuration such that the elongate member 102 is configured to self-expand into a preset configuration. In some embodiments, the elongate member 102 is not configured for heat-setting and / or self-expanding. For example, the elongate member 102 is balloon-expandable. In some embodiments, the elongate member 102 is both balloon-expandable and self-expanding. The elongate member 102 has a first end 102a and a second end 102b opposite the first end 102a along the longitudinal axis L2 of the elongate member 102. The elongate member 102 can comprise a wire, coil, tube, filament, single woven filament, multiple braided filaments, laser cut sheet, laser cut tube, thin film formed via a deposition process, and other suitable elongate structures and / or methods, such as cold working, bending, EDM, chemical etching, water jetting, etc. The elongate member 102 can be formed using materials such as nitinol, stainless steel, cobalt chromium alloy (e.g., 35N LT®, MP35N (Fort Wayne Metals, Fort Wayne, Indiana)), Elgiloy, magnesium alloy, tungsten, tantalum, platinum, rhodium, palladium, gold, silver, or combinations thereof, or one or more polymers, or combinations of polymers and metals. In some embodiments, the elongate member 102 may include one or more drawn filled tube ("DFT") wires including an inner material surrounded by a different outer material. The inner material may be, for example, a radiopaque material, and the outer material may be a superelastic material.

[0106] 16 includes a single elongate member 102, device 100 may include any number of elongate members 102. A single elongate member, such as a single wire expandable device, may be easier to remove and / or reposition because an operator can grasp the elongate member on one end and pull it through the working channel of the scope. The elongate member will extend linearly within the balloon in either an expandable or self-expanding configuration.

[0107] 16, the elongate member 102 may be wound about the longitudinal axis L1 of the device 100 into a series of turns or loops 104, four of which are shown in FIG. 16 and individually labeled 104a-104d. Each of the loops 104 may extend around the longitudinal axis L1 of the device 100 between a first end 106 and a second end 108. In some embodiments, the loops 104 are connected end-to-end, for example, such that the second end 108 of the first loop 104a is the first end 106 of the second loop 104b. The second end 108 may be positioned approximately 360 degrees from the first end 106 about the longitudinal axis L1 of the device 100. That is, the first and second ends 106, 108 may be positioned at approximately equal circumferential positions relative to the longitudinal axis L1 of the device 100. In some embodiments, device 100 has a circular cross-sectional shape. In other embodiments, device 100 may have other suitable cross-sectional shapes (e.g., oval, square, triangular, polygonal, irregular, etc.). The cross-sectional shape of device 100 may be generally the same or vary along the length of device 100 and / or from loop to loop.

[0108] The expanded cross-sectional dimension of device 100 may generally be constant or vary along its length and / or between loops. For example, as discussed herein, device 100 can have variable cross-sectional dimensions along its length to accommodate different portions of the airway. For example, device 100 can have a first cross-sectional dimension along a first portion configured to be positioned within a more distal portion of the airway (e.g., within the terminal bronchioles and / or emphysematous areas of a collapsed and / or collapsed airway) and a second cross-sectional dimension along a second portion configured to be positioned more proximally (e.g., within an uncollapsed main bronchus and / or another portion). The second portion can be configured to be positioned within a portion of the airway that is less emphysematous than the collapsed distal portion and / or has cartilage within the airway wall (preferably, rings of cartilage, not plates), which may occur at the lobar (generation 2) or segmental (generation 3) level, for example.

[0109] In some embodiments, the expanded cross-sectional dimension of device 100, in its unconstrained (i.e., removed from catheter or airway constraint), expanded state, is increased relative to the diameter of the native airway lumen. For example, the expanded, unconstrained cross-sectional dimension of device 100 can be at least 1.5 times the original (uncollapsed) diameter of the airway lumen in which it is intended to be positioned. In some embodiments, device 100 has an expanded cross-sectional dimension that is about 1.5 to 6 times, 2 to 5 times, or 2 to 3 times the diameter of the original airway lumen. Without being bound by theory, it is believed that expanding the airway lumen to the largest possible diameter without tearing the airway wall will provide the greatest improvement in lung function (e.g., as measured by outflow, FEV1, and others).

[0110] 16 , as the elongate member 102 winds around the longitudinal axis L1 of the device 100, it may be undulating along its longitudinal axis L2, forming a plurality of alternating peaks 110 (closer to the second end portion 100b of the device 100) and valleys 112 (closer to the first end portion 100a of the device 100). At least some of the valleys 112 can be at a different location along the longitudinal axis L1 of the device 100 than at least some of the peaks 110. Additionally or alternatively, at least some of the valleys 112 can be at a different longitudinal location than at least some other of the valleys 112, and / or at least some of the peaks 110 can be at a different longitudinal location than at least some other of the peaks 110.

[0111] As an example, the three peaks 110 and four valleys 112 of the first loop 104a are labeled peaks 110a-110c and valleys 112a-d, respectively. As shown in Figures 16 and 17, with respect to the first loop 104a in the direction of wrapping W, the elongate member 102 extends from the first end 106 of the elongate member 102, including the first valley 112a of the first loop 104a, toward the second end portion 100b of the device 100, along a first longitudinal direction to the first peak 110a of the first loop 104a. The elongated member 102 can then extend along a second longitudinal direction opposite to the first longitudinal direction from the first peak 110a to the second valley 112b, along the first longitudinal direction from the second valley 112b to the second peak 110b, along the second longitudinal direction from the second peak 110b to the third valley 112c, along the first longitudinal direction from the third valley 112c to the third peak 110c, and along the second longitudinal direction from the third peak 110c to the fourth valley 112d (which is also the second end 108 of the first loop 104a). Thus, when progressing in the direction of winding W around a given loop 104, rather than progressing consistently from the first end portion 100a of the device 100 to the second end portion 100b of the device 100 (or vice versa), the loop 104 is undulating such that along some portions of its length the loop 104 is progressively closer to the first end portion 100a of the device 100 and along other portions of its length the loop is progressively closer to the second end portion 100b of the device 100.

[0112] The first and second ends 106, 108 of one of the loops 104 may be generally circumferentially aligned, but the first and second ends 106, 108 are offset longitudinally. The first peak 110a can be closer to the second end portion 100b of the device 100 than the first valley 112a. The second valley 112b can be closer to the first end portion 100a of the device 100 than the first peak 110a and / or the first valley 112a. The second peak 110b can be closer to the second end portion 100b of the device 100 than the second valley 112b, the first peak 110a, and / or the first valley 112a. The third valley 112c can be closer to the first end portion 100a of the device 100 than the second peak 110b and / or closer to the second end portion 100b of the device 100 than the first valley 112a and / or the second valley 112b. In some embodiments, the third valley 112c can be generally longitudinally aligned with the first peak 110a. The third peak 110c can be closer to the second end portion 100b of the device 100 than the third valley 112c, the second peak 110b, the second valley 112b, the first peak 110a, and / or the first valley 112a. The fourth valley 112d can be closer to the first end portion 100a of the device 100 than the third peak 110c and / or closer to the second end portion 100b of the device 100 than the third valley 112c, the second valley 112b, the first peak 110a, and / or the first valley 112a. In some embodiments, the fourth valley 112d can be generally longitudinally aligned with the second peak 110b.

[0113] 16 and 17 show device 100 with four loops 104, each having four peaks 110 and four valleys 112, in some embodiments, one or more of the loops 104 have more or fewer peaks 110 and / or more or fewer valleys 112. For example, in some embodiments, one or more of the loops 104 have 1, 2, 3, 4, 5, 6, 7, 8, etc. peaks 110 per loop 104 and 1, 2, 3, 4, 5, 6, 7, 8, etc. valleys 112 per loop 104. The loops 104 may have the same or different numbers of peaks 110, and the loops 104 may have the same or different numbers of valleys 112. The circumferential distance (e.g., angular separation) between adjacent peaks 110 and valleys 112 can be uniform or non-uniform within a given loop 104. In some embodiments, adjacent peaks 110 and valleys 112 can be spaced about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 210 degrees, about 240 degrees, about 270 degrees, about 300 degrees, and / or about 330 degrees apart around the circumference of the device 100. Additionally, the amplitude of the peaks 110 can be the same or different along and / or between a given loop 104, and the amplitude of the valleys 112 can be the same or different along and / or between a given loop 104. Also, the peaks 110 and valleys 112 can have the same or different amplitudes.

[0114] 16 , the portions of the elongate member 102 between adjacent peaks 110 and valleys 112 can be linear, curved, or both. The adjacent portions of the elongate member 102 between two sets of adjacent peaks 110 and valleys 112 can form a V-shaped and / or U-shaped structure. At least some of the valleys 112 can be concave toward the second end portion 100b of the device 100, and / or at least some of the peaks 110 can be concave toward the first end portion 100a of the device 100.

[0115] In some embodiments, elongate member 102 can extend around the circumference of device 100 and / or along longitudinal axis L1 of device 100 without substantially extending radially away from or toward longitudinal axis L1, as shown in FIG. 16 . Additionally, in some embodiments, device 200 can include elongate members 202 that are undulating radially relative to longitudinal axis L1 of device 200. As shown in FIG. 18 , for example, elongate member 202 can form peaks 799 and / or valleys 799 that are located closer to longitudinal axis L1 than the intermediate portion of elongate member 202 between peaks 799 and valleys 799. The apex of each “V” can be bent radially inward toward the center of the lumen such that only the longitudinally extending portion of elongate member 202 touches the bronchial wall. Such a configuration can prevent the stent from obstructing mucus flow along the bronchial wall.

[0116] The radial mechanism of expansion allows the expandable device 700 to be easily designed and delivered by both self-expansion and balloon expansion. The zigzag patterns of the devices disclosed herein, including the example shown in FIG. 16, are configured to conform to different diameter airways using a single design, whereas conventional coils are fixed diameter. This is particularly advantageous for achieving gradual airway expansion over time. The expandable device stores expansion potential within the stent design, achieved through beams where elastic potential is established. The expandable device in its balloon-expandable form, when geometrically designed in this manner, also has the unique potential to form a coil by expanding the zigzag in a straight line.

[0117] In some embodiments, as shown in FIGS. 19 and 20 , for example, the device 400 comprises an elongate member 402 wound about two or more axes that are angled relative to one another. In FIGS. 19 and 20 , the elongate member 402 is wound about a first axis A1 to form a first loop 404a, about a second axis A2 to form a second loop 404b, about the first axis A1 to form a third loop 404c, and so on. In some embodiments, the second axis A2 is a central longitudinal axis. Additionally or alternatively, the first axis A1 can be substantially perpendicular to the second axis A2. The elongate member 402 can be partially wound about each axis such that each loop 404 comprises an open loop. In some embodiments, the elongate member 402 is wound such that each of the elongate members 402 in the loops 404 forms a V-shape or a U-shape.

[0118] FIG. 21 depicts an expandable device 500 comprising an elongate member 502 wound about a longitudinal axis L1 of the device 500 such that the elongate member 502 forms one or more loops 504. At least one of the loops 504 can comprise a first end 506 and a second end 508. The second end 508 can be located at a circumferential position substantially equal to the first end 506. In some embodiments, the second end 508 is longitudinally spaced from the first end 506, as shown in FIG. 21 for example. The second end 508 of one of the loops 504 can be connected to the first end 506 of an adjacent one of the loops 504 by a connecting portion 510. In some embodiments, the connecting portion 510 extends along the longitudinal axis L1 of the device 500 without extending substantially around the circumference of the device 500.

[0119] FIG. 22 depicts an expandable device 600 comprising an elongate member 602 wound about a longitudinal axis L1 of the device 600 such that the elongate member 602 forms one or more loops 604. Each of the loops 604 can comprise a first end 606 and a second end 608. Similar to the loop 504 shown in FIG. 21 , the first end 606 and the second end 608 can be aligned generally circumferentially. However, as shown in FIG. 22 , unlike the loop 504, the first end 606 and the second end 608 can be aligned longitudinally such that the loop 604 is substantially closed.

[0120] In some embodiments, for example, as shown in Figures 21 and 22, a device can have loops that are each wound about the same axis. Additionally, or alternatively, at least some of the loops can be wound about different axes. For example, Figures 23 and 24 depict a device 700 having a first central longitudinal axis L1. The device 700 includes an elongate member 702 that forms loops 704. As shown in Figures 23 and 24, alternate ones of the loops 704 can be wound about distinctly different axes. For example, the first loop 704a is wound around the second longitudinal axis L2, the second loop 704b is wound around the third longitudinal axis L3, the third loop 704c is wound around the second longitudinal axis L2, the fourth loop 704d is wound around the third longitudinal axis L3, and the fifth loop 704e is wound around the second longitudinal axis L2. The second longitudinal axis L2 and / or the third longitudinal axis L3 can be substantially parallel to the first longitudinal axis L1.

[0121] According to various aspects of the present technology, an expandable device can include two or more loops wound about non-parallel axes. For example, the expandable device 800 shown in FIG. 25 includes a first elongate member 802a wound about a first axis A1 to form a first loop 804a. The device 800 can also include a second elongate member 802b wound about a second axis A2 to form a second loop 804b. In some embodiments, the second axis A2 is approximately perpendicular to the first axis A1. Additionally or alternatively, the second axis A2 can be disposed at any suitable angle relative to the first axis A1, such as, but not limited to, between 0° and 90°, between 10° and 80°, between 20° and 70°, between 30° and 60°, between 40° and 50°, about 0°, about 5°, about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, or about 90°. As shown in FIG. 25 , the second loop 804b can be formed at least in part by winding the second elongate member 802b about the second axis A2 along the winding direction W, winding the second elongate member 802b into a complete loop about the first elongate member 802a along the winding direction W, and winding the second elongate member 802b about the second axis A2 along the winding direction W. The device 800 can be configured to be positioned within the airway such that the first and second elongate members 802a, 802b contact the airway wall and maintain a minimum desired diameter of the airway lumen.

[0122] As shown in FIG. 25 , in some embodiments, the first dimension D1 of device 800 along first axis A1 is greater than the second dimension D2 of device 800 along second axis A2. The second loop 804b can have a generally oval two-dimensional (2D) shape, while the first loop 804a has a generally rounded 2D shape. Additionally or alternatively, the device can include first and second loops 804a, 804b having substantially similar 2D shapes. For example, the device 900 shown in FIG. 26 includes first and second loops 902a, 902b that both have generally rounded 2D shapes, and the device 1000 shown in FIG. 27 includes first and second loops 1002a, 1002b that both have generally oval 2D shapes.

[0123] 28, 29, and 30 depict expandable devices 1500, 1600, and 1700, respectively, configured in accordance with some embodiments of the present technology. As shown in FIGS. 28-30, expandable devices (e.g., device 1500, device 1600, device 1700, etc.) can include one or more loops having a saddle shape. In embodiments in which the device includes multiple saddle-shaped loops, the loops can be connected end-to-end (see, e.g., FIG. 29) and / or overlap (see, e.g., FIG. 30). The devices shown in FIGS. 28-30 are configured to provide a scaffold with as little structure as possible. The devices are configured to contact and hold open the airway walls, helping to support the airway and allow air to pass freely.

[0124] In some embodiments, as shown in FIGS. 31 and 32 , for example, an expandable device of the present technology can include two or more support portions connected by one or more connector portions. FIG. 31 depicts a device 1100 including a first support portion 1102 a and a second support portion 1102 b (collectively, “support portions 1102”) interconnected by a connector portion 1104. The first support portion 1102 a and / or the second support portion 1102 b can be similar to devices 800-1000 shown in FIGS. 25-27 . For example, as shown in FIG. 31 , the support portions 1102 can each include two loops 1106, each wound about a substantially orthogonal axis. In some embodiments, the connector portion 1104 extends along a central longitudinal axis L1 of the device 1100. The support portion 1102 can be configured to contact the airway wall and maintain a minimum desired diameter of the airway lumen, while the connection portion 1104 can be configured not to contact the airway wall and to reduce inflammation of the airway wall due to contact between the device 1100 and the airway wall.

[0125] 31 , in some embodiments, device 1100 includes two support portions 1102 and one connecting portion 1104. However, other numbers of support portions 1102 and connecting portions 1104 are also possible. For example, FIG. 32 depicts device 1200 including four support portions 1202 disposed along a central longitudinal axis L1 of device 1200, with adjacent ones of support portions 1202 connected by connecting portions 1204.

[0126] Expandable devices according to some embodiments of the present technology can be configured to be positioned within the lumen of an airway such that the expandable device increases the diameter of the lumen, thereby facilitating and / or improving gas transport through the airway. In some embodiments, the expandable device can be positioned within an airway lumen that has been collapsed, narrowed, or otherwise reduced in diameter. The expandable devices of the present technology can have a radial resistance force (RRF) that resists compression of the expandable device by the airway wall and / or a chronic outward force (COF) applied by the expandable device to the airway wall. The RRF and / or COF of the expandable device can be significantly large so that the expandable device is configured to maintain a minimum desired diameter of the airway lumen. The expandable device and / or one or more portions thereof of the present technology can comprise a stent, a braid, a mesh, a woven material, a fabric, a coil, a tube, a valve, and / or another suitable device configured to be positioned within an anatomical passageway, an airway lumen, or a vessel and to provide support to the passageway and / or another medical device and / or modify the biological tissue of the passageway.

[0127] In some applications, it may be desirable for the expandable device to be configured to contact a large surface area of ​​the wall of the passageway. For example, coronary stents are often designed so that the stent is configured to contact a large surface area of ​​the wall of a patient's coronary artery. Such a design may be advantageous for an expandable device configured to be positioned within a blood vessel to prevent or limit adverse outcomes associated with interaction between the expandable device and the patient's blood (e.g., expandable device thrombosis, neoatherosclerosis, etc.). However, because airways are configured to transport air rather than blood, there is no risk of clotting within the airways. Also, while clotting is not a risk within the airways, excess granulation tissue may form within the airways due to contact and / or relative motion between the expandable device and the airway wall. Such excess granulation tissue may narrow the airway lumen and inhibit gas transport through the airways. Therefore, it may be advantageous for an expandable device configured to be positioned within an airway to be configured to contact a smaller surface area of ​​the airway lumen, prevent or limit granulation tissue formation, promote mucus clearance from the airway, etc.

[0128] FIG. 33 depicts an expandable device 2000 configured to be positioned within the lumen of an airway such that the expandable device 2000 maintains a minimum desired diameter of the airway lumen. The expandable device 2000 depicted in FIG. 33 can be configured to contact a smaller area of ​​the airway wall compared to a conventional stent when the device 2000 is positioned within the airway lumen. As shown in FIG. 33 , the expandable device 2000 can comprise a first end portion 2000 a, a second end portion 2000 b, and a longitudinal dimension L1 extending between the first end portion 2000 a and the second end portion 2000 b. The expandable device 2000 can comprise one or more connecting portions 2002 and one or more support portions 2004. The support portion 2004 can be connected to and / or monolithic with the connecting portion 2002. In some embodiments, the expandable device 2000 comprises a plurality of connecting portions 2002 and a plurality of support portions 2004. Additionally or alternatively, at least some of the connecting portions 2002 can be positioned between adjacent support portions 2004. The expandable device 2000 can comprise the same number of connecting portions 2002 and support portions 2004, more connecting portions 2002 than support portions 2004, or more support portions 2004 than connecting portions 2002 (see, e.g., FIG. 33 ). In some embodiments, the expandable device 2000 comprises an elongate member 2006 that can be wound about the longitudinal dimension L1. The elongate member 2006 can comprise a wire, a coil, a braid, a tube, and / or another suitable elongate member. Such a flexible construction of the expandable device 2000 can allow for longitudinal compression and / or extension of the expandable device 2000, which can prevent or limit relative movement between the expandable device 2000 and the airway wall as the airway deforms longitudinally during breathing, which in turn can prevent or limit granulation tissue formation.

[0129] Because some degree of granulation tissue formation is expected with any foreign body in the airway, it should be understood that the goal of the expandable device is not to eliminate granulation tissue formation but rather to minimize any clinically meaningful obstruction caused by granulation tissue and / or mucus. It is expected that expandable devices with a significantly smaller contact area will experience a localized foreign body response that will not cause obstruction of the primary or distal airways. This localized response may actually be beneficial, as partial or complete encapsulation of the expandable device may provide greater mechanical reinforcement of the airway lumen and / or help to anchor the expandable device and resist movement due to breathing or coughing.

[0130] The expandable device 2000 can have a collapsed, low-profile state in which the expandable device 2000 is configured for delivery through an elongated shaft (e.g., a catheter, etc.) to a treatment location within a patient's airway. Additionally or alternatively, the expandable device 2000 can have an expanded state in which the connector portion 2002 has a first cross-sectional dimension 2008a and the support portion 2004 has a second cross-sectional dimension 2008b. In some embodiments, the second cross-sectional dimension 2008b is greater than the first cross-sectional dimension 2008a.

[0131] In these and other embodiments, the expandable device 2000 can be configured to be positioned within the airway lumen such that the support portion 2004 contacts the airway wall and the connecting portion 2002 does not contact the airway wall. In embodiments in which only the support portion 2004 is configured to contact the airway wall, friction applied by the expandable device 2000 to the airway wall due to longitudinal deformation will be limited to the length of the support portion 2004, thereby reducing the risk of granulation tissue formation for expandable devices with larger coverage areas. In some embodiments, the expandable device 2000 can be configured to be positioned within the airway lumen such that the connecting portion 2002 and the support portion 2004 both contact the airway wall. When the expandable device 2000 is positioned within the airway lumen, the support portion 2004 can be configured, at least at the support portion 2004, to resist compression by the airway wall and / or apply a radially outward force to the airway wall so that a minimum desired diameter of the airway lumen is maintained. In some embodiments, the second cross-sectional dimension 2008b can correspond substantially to the smallest desired diameter of the airway lumen.

[0132] The minimum desired diameter of the airway lumen can be based on a desired capacity for airflow through the airway. In some embodiments, the minimum desired diameter of the airway lumen is based, at least in part, on a nominal diameter of the lumen of a corresponding airway in a healthy patient. In some embodiments, the nominal diameter is based on measurements obtained from healthy patients of similar demographics (e.g., gender, age, race, etc.). Additionally, or alternatively, the minimum desired diameter of the airway lumen can be based, at least in part, on the diameter of one or more airway lumens in a specific patient. In some embodiments, the minimum desired diameter of the airway is at least as large as the diameter of the lumen of a corresponding generation of healthy airways. The minimum desired diameter of the airway lumen can be about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. In some embodiments, the minimum desired diameter of the airway is at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, at least 0.9 mm, at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, at least 11 mm, at least 12 mm, at least 13 mm, at least 14 mm, at least 15 mm, at least 16 mm, at least 17 mm, at least 18 mm, at least 19 mm, at least 20 mm, at least 21 mm, at least 22 mm, at least 23 mm, at least 24 mm, or at least 25 mm.

[0133] Because airflow resistance through an airway is proportional to the inverse fourth power of the radius of the airway lumen, even a small increase in the diameter of the airway lumen can significantly improve the airway's airflow capacity. Also, because a patient may have multiple collapsed airways with extremely high airflow resistance, it may be advantageous for the airways treated with the expandable device of the present technology to have sufficient airflow capacity to compensate for multiple non-functioning airways. Therefore, it may be advantageous for the expandable device 2000 to be configured to maintain an airway lumen diameter that exceeds the nominal diameter of the lumen of a corresponding healthy airway. Thus, the second cross-sectional dimension 2008b can be at least as large as such nominal diameter. For example, the second cross-sectional dimension 2008b can be about 0.1 mm larger than the nominal diameter, about 0.5 mm larger than the nominal diameter, about 1 mm larger than the nominal diameter, about 1.5 mm larger than the nominal diameter, about 2 mm larger than the nominal diameter, about 2.5 mm larger than the nominal diameter, about 3 mm larger than the nominal diameter, or more.

[0134] In some embodiments, the minimum desired diameter of the airway can be based, at least in part, on a desired functional and / or outcome measure and / or a desired change in a functional or outcome measure. Such functional and outcome measures include, but are not limited to, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 seconds (FEV6), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), diffusing capacity of the lung for carbon monoxide (D L , CO ), (P a , O2 ), arterial oxygen saturation (S p ,O2), health-related quality of life (HRQoL), other relevant functional and / or outcome measures, or a combination thereof. For example, it may be acceptable for the minimum desired diameter of the airway lumen to be less than the nominal diameter of a corresponding healthy airway lumen if the minimum desired diameter is associated with a desirable and / or sufficient improvement in functional and / or outcome measures.

[0135] In some embodiments, it may be beneficial to perform diagnostic airflow measurements within the airways before, during, and / or after administration of the expandable device to confirm improvements in expiratory flow and lung function. Traditional pulmonary function tests, such as spirometry, can be administered separately from the procedure to administer the expandable device, or interventional diagnostics can be administered perioperatively to measure bronchial airflow and pressure (e.g., Chartis® Pulmonary Assessment System). Data obtained from these tests can help inform decisions related to initial treatment, the appropriateness of the treatment administered, and the extent and location of additional expandable devices, if further treatment is required.

[0136] Implants according to at least some embodiments of the present technology are configured to be placed across multiple airway generations. These implants can have the same or different properties in different axial regions. Expandable devices according to at least some embodiments of the present technology include multiple treatment zones, each with an expanded cross-sectional dimension, hoop strength, length, and / or flexibility tailored to the specific portion of the airway in which it is intended to reside. Referring again to FIG. 33 , the expandable device 2000 can be positioned within a patient's airway so that it spans multiple generations and intersects one or more bifurcation points where the proximal airway bifurcates into the distal airway. In such embodiments, discrete regions of the first airway bifurcation within each generation spanned by the expandable device 2000 can be supported by discrete support portions 2004. The connection portion 2002 can be designed to span the bifurcation points between airway generations. Thus, in some embodiments, interface portion 2002 can be configured to allow the passage of air, mucus, etc. through device 2000 and into a second airway branch within each generation that does not contain device 2000. With respect to device 2000 and any of the devices disclosed herein, the minimalist design (and low wire gauge) is particularly advantageous so as not to obstruct the attachment opening to the distal airway and create an obstruction risk therefor.

[0137] 34 depicts an expandable device 2100 in accordance with some embodiments of the present technology. The expandable device 2100 can be similar to any of the expandable devices disclosed herein, except as detailed below. The expandable device 2100 can comprise a first end portion 2100a, a second end portion 2100b, and a longitudinal dimension L2 extending between the first end portion 2100a and the second end portion 2100b. The expandable device 2100 can comprise one or more connecting portions 2102 and one or more support portions 2104 connected to the connecting portions 2102. In some embodiments, the connecting portions 2102 can have a first radial dimension 2106a, and the support portions 2104 have a second radial dimension 2106b. The second radial dimension 2106b can be greater than the first radial dimension 2106a.

[0138] As shown in FIG. 34, the expandable device 2100 can include alternating connecting portions 2102 and support portions 2104. The expandable device 2100 can include the same number of connecting portions 2102 and support portions 2104 (see FIG. 34), more connecting portions 2102 than support portions 2104, or more supporting portions 2104 than connecting portions 2102. In some embodiments, for example, as shown in FIG. 34, the first end portion 2100a of the expandable device 2100 includes connecting portions 2102, while the second end portion 2100b of the expandable device 2100 includes supporting portions 2104. The first end portion 2100a can include connecting portions 2102 or supporting portions 2104, and the second end portion 2100b can include connecting portions 2102 or supporting portions 2104.

[0139] The connecting portion 2102 of the expandable device 2100 can comprise an elongate member 2108, where the elongate member 2108 is configured to exhibit flexibility, facilitate movement of the expandable device 2100 with the airway during breathing, and prevent or limit granulation tissue formation. For example, as shown in FIG. 34 , the elongate member 2108 can comprise a coil. Additionally or alternatively, the elongate member can comprise a wire, a tube, a braid, a scaffold, a filament, or the like. In some embodiments, one or more of the support portions 2104 can comprise an anchoring member 2110 and one or more support members 2112. The anchoring member 2110 can be configured to anchor the support member 2112 to one or more of the connecting portions 2102. For example, the fixation member 2110 can have a sidewall defining a lumen (e.g., the fixation member 2110 can be tubular, etc.), and the lumen of the fixation member 2110 can be configured to receive the elongate member 2108. The fixation member 2110 can be welded, crimped, glued, adhesive, threaded, melted, or otherwise secured to the elongate member 2108. The support member 2112 can be welded, crimped, glued, adhesive, threaded, melted, or otherwise secured to the fixation member 2110. In some embodiments, the support member 2112 is monolithic with the fixation member 2110. Additionally or alternatively, the support member 2112 can be secured directly to the elongate member 2108. In these and other embodiments, one or more of the support portions 2104 of the expandable device 2100 may not include a fixation member 2110.

[0140] One or more of the support portions 2104 can comprise one or more support members 2112, for example, one support member 2112, two support members 2112, three support members 2112 (see FIG. 34), four support members 2112, five support members 2112, six support members 2112, seven support members 2112, eight support members 2112, nine support members 2112, ten support members 2112, or more support members 2112. The support members 2112 of one support portion 2104 can be evenly spaced around the circumference of the expandable device 2100, or the support members 2112 of one support portion 2104 can be non-uniformly spaced around the circumference of the expandable device 2100. Additionally or alternatively, the support members 2112 of one of the support portions 2104 can be circumferentially aligned or circumferentially offset relative to the support members 2112 of another of the support portions 2104.

[0141] 34, the support members 2112 can protrude radially outward relative to the connector portion 2102 so that when the expandable device 2100 is positioned within the airway lumen, the support members 2112 contact the airway walls and maintain the diameter of the airway lumen. In some embodiments, one or more of the support members 2112 have a shape that is generally arcuate, circular, elliptical, oval, spherical, rectangular, or another suitable shape. One or more of the support members 2112 can comprise a generally one-dimensional (1D), two-dimensional (2D), or three-dimensional (3D) shape.

[0142] The support members 2112 can be formed from wire, coils, sheets, tubes, deposited material, and / or another suitable base material. For example, as shown in FIG. 34, the support members 2112 can each comprise a wire that is bent into a desired shape. Additionally or alternatively, the support members 2112 can be formed via additive manufacturing (e.g., 3D printing, thin film deposition, etc.) and / or subtractive manufacturing (e.g., CNC milling, machining, laser cutting, water etching, etc.).

[0143] 35 and 36 depict expandable device 2200 in accordance with various embodiments of the present technology. Expandable device 2200 can be similar to any of the expandable devices described herein (e.g., expandable devices 2000, 2100, etc.), except as described below. Expandable device 2200 can comprise a first end portion 2200a, a second end portion 2200b, and a longitudinal dimension L3 extending between first end portion 2200a and second end portion 2200b. Expandable device 2200 can comprise a connection portion 2202 and one or more support portions 2204. 35 and 36, the connector portion 2202 can have a first radial dimension 2206a, and the support portion 2204 can have a second radial dimension 2206b, which can be less than, equal to, or greater than the first radial dimension 2206a. The connector portion 2202 can include an elongate member 2208, which can include a hypotube, a coil, a braid, a mesh, a wire, and / or another suitable structure. For example, as shown in FIGS. 35 and 36, in some embodiments, the elongate member 2208 at least partially comprises a hypotube defining one or more openings 2210 extending through a sidewall of the hypotube. The openings 2210 can increase the flexibility of the elongate member 2208, which can facilitate passage of the expandable device 2200 through tortuous airways. The openings 2210 can be uniformly and / or non-uniformly sized, shaped, and spaced along the longitudinal dimension L3 of the device 2200 and / or can be spaced around the circumference of the elongate member 2208.

[0144] The support portion 2204 of the device 2200 can comprise one or more support members 2212. In some embodiments, the support members 2212 can be directly attached to the elongate member 2208, as shown in FIG. 35 , for example. The support members 2212 can be attached to the sidewalls of the elongate member 2208 between the openings 2210. Thus, the distribution of the support members 2212 about the circumference of the elongate member 2208 and / or about the longitudinal dimension L3 of the elongate member 2208 can be based, at least in part, on the corresponding distribution of the openings 2210. In various embodiments, the support members 2212 can be welded, crimped, glued, adhered, fused, fastened, threaded, or otherwise attached to the elongate member 2208.

[0145] It may be beneficial for one or more parameters of the expandable device of the present technology to be based, at least in part, on the properties of the airway within which the device is configured to be positioned. For example, it may be desirable for the stiffness of the expandable device to correspond to the stiffness of the airway to prevent or limit granulation tissue formation due to relative movement between the device and the airway. It may also be advantageous for the expandable device of the present technology to be configured to span multiple airway generations when implanted to facilitate transport of air trapped within the patient's hyperstretched parenchymal tissue out of the patient's body via the airway. However, this presents several technical challenges because the mechanical and biological properties of the respiratory system vary from proximal extraparenchymal airways (e.g., trachea, main bronchi, etc.) to distal intraparenchymal airways (e.g., bronchioles, etc.). For example, the walls of proximal airways contain cartilage and are internally supported, but the amount of hyaline cartilage within the airway walls decreases from proximal to distal. As a result, distal intraparenchymal airways are highly compliant, and expansion and contraction of these airways is controlled by alveolar attachments that are tethered to the airways. To accomplish the design objectives and overcome the challenges described above, expandable devices configured in accordance with some embodiments of the present technology can have one or more parameters that vary along the length of the expandable device.

[0146] The expandable device of the present technology can have at least one region having a stiffness based, at least in part, on the mechanical properties of a portion of the patient's airway. For example, because the distal airway is more compliant than the upper airway, a low COF and / or RRF may be sufficient to maintain a desired minimum diameter of the distal airway lumen. Additionally or alternatively, it may be advantageous for the stiffness of a region of the expandable device to be based, at least in part, on the airway stiffness to prevent or limit granulation tissue formation friction between the device and the airway. For example, because airways typically decrease in stiffness from proximal to distal airways, it may be advantageous for the expandable device to also have a stiffness that decreases along its length. In some embodiments, the distal end of the expandable device configured to be positioned in an intraparenchymal airway can have a lower stiffness than the proximal end of the expandable device configured to be positioned in an extraparenchymal airway. In some embodiments, the proximal end of the expandable device configured to be positioned in an intraparenchymal airway can have a lower stiffness than the distal end of the expandable device configured to be positioned in an extraparenchymal airway.

[0147] In some embodiments, the expandable device, or one or more portions thereof, can comprise a wire (see, e.g., FIGS. 33 and 34). In such embodiments, the stiffness of the device can be based, at least in part, on the thickness of the wire. For example, as shown in FIG. 37, wire 2300 can have a first end portion 2300a and a second end portion 2300b opposite first end portion 2300a along longitudinal dimension L4 of wire 2300. First end portion 2300a can be a proximal end portion or a distal end portion. Wire 2300 can have a first thickness 2302a at first end portion 2300a and a second thickness 2302b at second end portion 2300b. In some embodiments, first thickness 2302a can be greater than second thickness 2302b. Additionally or alternatively, as shown in FIG. 37, the wire 2300 can be tapered along the longitudinal dimension L4.

[0148] As shown in FIG. 37, wire 2300 can be linearly or non-linearly tapered. Additionally, or alternatively, an expandable device can include a wire having one or more regions of distinct thicknesses. For example, FIG. 38 depicts wire 2400 having first region 2402a, second region 2402b, and third region 2402a (collectively, "regions 2402") arranged sequentially along longitudinal dimension L5 of wire 2400. 38 depicts three regions 2402, the wire 2400 can have one region 2402, two regions 2402, three regions 2402, four regions 2402, five regions 2402, six regions 2402, seven regions 2402, eight regions 2402, nine regions 2402, ten regions 2402, fifteen regions 2402, twenty regions 2402, or more regions 2402. As shown in FIG. 38, the first region 2402a can have a first thickness 2404a, the second region 2402b can have a second thickness 2404b, and / or the third region 2402c can have a third thickness 2404c.

[0149] In some embodiments, first thickness 2404a, second thickness 2404b, and / or third thickness 2404c of wire 2400 shown in FIG. 38 are different. For example, as shown in FIG. 38, first thickness 2404a can be greater than second thickness 2402b and / or third thickness 2404c. In some embodiments, second thickness 2404b is greater than third thickness 2404c. Thus, first end portion 2400a can be stiffer than second end portion 2404b. In embodiments where first region 2402a is configured to be positioned in a proximal airway and third region 2402c is configured to be positioned in a distal airway, an expandable device including wire 2400 can have a stiffness gradient that more closely mimics the stiffness gradient of an airway.

[0150] In some embodiments, wire 2400 comprises one or more transition regions 2406 between regions 2402 of distinct thickness. For example, as shown in FIG. 38 , wire 2400 can comprise a first transition region 2406 a between first region 2402 a and second region 2402 b, and a second transition region 2406 b between second region 2402 b and third region 2402 c. In some embodiments, the thickness of wire 2400 can vary across the length of at least one of transition regions 2406 (see FIG. 38 ). The thickness can vary linearly or non-linearly along the length of transition region 2406. In some embodiments, one or more of transition regions 2406 can be omitted such that the thickness of wire 2400 increases in a stepwise manner.

[0151] In some embodiments, the expandable device of the present technology can comprise a tubular elongate member. For example, as described above with respect to FIGS. 35 and 36 , the expandable device 2200 can comprise a connector portion 2202 comprising an elongate member, which in some embodiments may comprise a hypotube. In some embodiments, the stiffness of the expandable device can be based, at least in part, on one or more parameters of the elongate member. As described in more detail below, such parameters can include the thickness of the elongate member's sidewall, the diameter of the elongate member's lumen, the width of the elongate member's struts, the material properties of the elongate member, or another relevant parameter.

[0152] 39 is a cross-sectional view of an elongate member 2500 that can be used to form an expandable device or one or more portions thereof of the present technology. The elongate member 2500 can include a sidewall 2502 that defines a lumen 2504 of the elongate member 2500. As shown in FIG. 39 , in some embodiments, a diameter 2506a of the lumen 2504 at a first end portion 2500a of the elongate member 2500 can be smaller than a diameter 2506b of the lumen 2504 at a second end portion 2500b of the elongate member 2500. As a result, a first thickness 2508a of the sidewall 2502 at the first end portion 2500a can be greater than a second thickness 2508b of the sidewall 2502 at the second end portion 2500b. As shown in FIG. 39 , first and second thicknesses 2508 a, 2508 b can be defined between the luminal surface 2510 of the elongate member 2500 and the abluminal surface 2512 of the sidewall 2502. In such embodiments, the first end portion 2500 a of the elongate member 2500 can be stiffer than the second end portion 2500 b. As shown in FIG. 39 , the thickness of the sidewall 2502 can decrease continuously (e.g., the diameter of the lumen 2504 can increase) across the longitudinal dimension L6 of the elongate member 2500. Additionally or alternatively, the thickness of the sidewall 2502 can vary along the longitudinal dimension L6 of the elongate member 2500 in discrete steps (e.g., as described with reference to the wire with regions of distinct thickness in FIG. 38 ).

[0153] In some embodiments, an expandable device can comprise an elongate member defining one or more openings extending through a sidewall of the elongate member (see, e.g., FIGS. 35 and 36). The elongate member can comprise one or more struts formed with portions of the sidewall located between the openings. According to various embodiments, the stiffness of such an expandable device can be based, at least in part, on the width of the struts. For example, in some embodiments, it can be advantageous for a first end portion of the expandable device to have a higher stiffness, and therefore a larger strut width, than a second end portion of the expandable device. FIGS. 40 and 41 depict an elongate member 2600 having a sidewall 2602 defining a lumen 2604 of the elongate member 2600. Specifically, FIG. 40 is an end view of a first end 2600a of the elongate member 2600, and FIG. 41 is an end view of a second end 2600b of the elongate member 2600. The first end 2600a can be the proximal end and / or the distal end of the elongate member 2600. As shown in FIG. 40 , the first strut 2602a of the elongate member 2600 can have a first width 2606a between the first circumferential surface 2608a and the second circumferential surface 2610a of the first strut 2602a. The second strut 2602b of the elongate member 2600 can have a second width 2606b between the first circumferential surface 2608b and the second circumferential surface 2610b of the second strut 2602b.

[0154] It may be advantageous for the diameter of the expandable device of the present technology to be based, at least in part, on the diameter of the airway in which it is configured to be positioned. Sizing the diameter of the expandable device based on the diameter of the airway can facilitate anchoring and retention of the device, limit damage within the airway wall due to excess strain, limit granulation tissue formation, and / or improve functional and clinical outcomes. Thus, in some embodiments, the expandable device of the present technology can have a diameter based, at least in part, on one or more diameters of the airway in which it is configured to be positioned. However, like stiffness, the diameter of the airway varies from proximal to distal. The trachea has a nominal diameter of about 10 mm to about 25 mm in adults, while the smallest distal airway has a diameter of less than 1 mm. Thus, in some embodiments, the diameter of the expandable device may vary along the length of the expandable device.

[0155] FIG. 42 depicts an expandable device 2700 configured in accordance with some embodiments of the present technology. The expandable device 2700 can have a first end portion 2700a and a second end portion 2700b opposite the first end portion 2700a along the longitudinal dimension L8 of the device 2700. As shown in FIG. 42, in some embodiments, the first radial dimension 2702a of the expandable device 2700 at the first end portion 2700a exceeds the second radial dimension 2702b of the expandable device 2700 at the second end portion 2700b. In some embodiments, the radial dimension of the device 2700 can vary linearly along the longitudinal dimension L8 (see FIG. 42). Additionally or alternatively, the radial dimension of the device 2700 can vary in an exponential manner, a parabolic manner, a stepwise manner, and / or another suitable manner along the longitudinal dimension L8 of the device 2700.

[0156] FIG. 43 depicts an expandable device 2800 having a first end portion 2800a and a second end portion 2800b opposite the first end portion 2800a along the longitudinal dimension L9 of the device 2800. The expandable device 2800 can be similar to any of the expandable devices disclosed herein, except as described in detail below. As shown in FIG. 43, in some embodiments, the radial dimension 2802 of the expandable device 2800 can vary along the longitudinal dimension L9. For example, the radial dimension 2802 can be greater at the first end portion 2800a than at the second end portion 2800b. In some embodiments, the expandable device 2800 comprises an elongate member 2804 wound about the longitudinal dimension L9 to form a loop 2806 that extends circumferentially about the device 2800. For example, as shown in FIG. 43, the expandable device 2800 can include a first loop 2806a, a second loop 2806b, a third loop 2806c, a fourth loop 2806d, and a fifth loop 2806e arranged sequentially along the longitudinal dimension L9.

[0157] In some embodiments, the radial dimension 2802 of the device 2800 can vary in one or more of the loops 2806. In FIG. 43 , the radial dimension 2802 at the first loop 2806a is greater than the radial dimension 2802 at the fifth loop 2806e, which is greater than the radial dimension 2802 at the fourth loop 2806d, which is greater than the radial dimension 2802 at the third loop 2806c, which is greater than the radial dimension 2802 at the second loop 2806b. Thus, the radial dimension 2802 can decrease from the first end portion 2800a of the device 2800 to the second end portion 2800b of the device 2800. Additionally or alternatively, the radial dimension 2802 can increase from the first end portion 2800a of the device 2800 to the second end portion 2800b of the device 2800. In various embodiments, the radial dimension 2802 at any one of the loops 2806 can be greater than the radial dimension 2802 at any other one or more loops 2806.

[0158] In some embodiments, at least some of the differences between the radial dimensions 2802 in adjacent loops 2806 can be the same (e.g., the difference between the radial dimension 2802 in the first loop 2806a and the radial dimension 2802 in the second loop 2806b is the same as the difference between the radial dimension 2802 in the second loop 2806b and the radial dimension 2802 in the third loop 2806c). Additionally or alternatively, at least some of the differences between the radial dimensions 2802 in adjacent loops 2806 can be different.

[0159] In some embodiments, for example, as shown in FIG. 43 , the distance 2808 between each of the loops 2806 along the longitudinal dimension L9 can be substantially the same. However, the length of one airway, proximal and / or distal to the airway, may differ from the length of the other airway (e.g., the distal airway may be shorter than the proximal airway, etc.). Therefore, it may be beneficial for the expandable device of the present technology to have a design based, at least in part, on the length of one or more airways. FIG. 44 shows an example of such an expandable device 2900. The expandable device 2900 can be similar to any of the expandable devices disclosed herein, except as described in more detail below. For example, the expandable device 2900 can comprise a first end portion 2900 a and a second end portion 2900 b opposite the first end portion 2900 a along the longitudinal dimension L10 of the device 2900. The first end portion 2000a can comprise a proximal end portion or a distal end portion. The expandable device 2900 can comprise an elongate member 2902 wound about the longitudinal dimension L10 to form loops 2904. For example, as shown in FIG. 44, the device 2900 can comprise a first loop 2904a, a second loop 2904b, a third loop 2904c, a fourth loop 2904d, a fifth loop 2904e, and / or a sixth loop 2904f arranged sequentially along the longitudinal dimension L10.

[0160] Adjacent ones of the loops 2904 can be spaced apart according to a distance 2906. For example, the first and second loops 2904a, 2904b can be spaced apart according to a first distance 2906a, the second and third loops 2904b, 2904c can be spaced apart according to a second distance 2906b, the third and fourth loops 2904c, 2904d can be spaced apart according to a third distance 2906c, the fourth and fifth loops 2904d, 2904e can be spaced apart according to a fourth distance 2906d, and / or the fifth and sixth loops 2904e, 2904f can be spaced apart according to a fifth distance 2906e. In contrast to the device 2800 depicted in FIG. 43 , in which the distances 2808 between the loops 2806 have the same magnitude, the device 2900 can have at least two of the distances 2906 having different magnitudes (e.g., the first distance 2906a has a different magnitude than the second distance 2906b, the third distance 2906b has a different magnitude than the fifth distance 2906e, etc.). The distances 2906 can decrease from the first end portion 2900a of the device to the second end portion 2900b of the device (see FIG. 44 ), or vice versa. In some embodiments, the distances 2906 do not vary in the same direction along the longitudinal dimension L10 (e.g., the second distance 2906b can exceed both the first and third distances 2906a, 2906c). The distances 2906 can vary linearly or nonlinearly along the longitudinal dimension L10.

[0161] FIG. 45 depicts an expandable device 3000 comprising a first elongate member 3002a and a second elongate member 3002b (collectively, "elongate members 3002") wound about a longitudinal axis L1 of the device 3000. As shown in FIG. 45, the elongate members 3002 can have the same helical winding direction W. In some embodiments, the first elongate member 3002a can begin at a different circumferential position than the second elongate member 3002b such that the elongate members 3002 do not overlap as the elongate members 3002 wind about the longitudinal axis L1.

[0162] In any of the above-described embodiments, it may be beneficial to incorporate drug delivery technologies, features, and capabilities to counteract aggressive foreign body responses that may result in blockage in the absence of such drug delivery. Broncus Technologies, involved in the development of the Exhale stent for airway bypass procedures, has developed bare metal stents and paclitaxel-eluting stents. A study in 25 dogs demonstrated rapid loss of patency with bare metal stents and maintenance of patency with paclitaxel-eluting stents. However, a subsequent human clinical study in over 200 patients showed that the rapid improvement in pulmonary function did not persist for 30 days, and stent blockage was suspected as the primary cause of failure. Therefore, an expandable device with a more innovative drug delivery system may be beneficial.

[0163] For any of the implants and expandable devices described herein, it may be advantageous to introduce one or more therapeutic agents to address local healing and / or foreign body responses that may result in complete or partial obstruction, compromising the duration of therapeutic benefit. A utility for controlled, localized drug delivery over a sustained period may preemptively avoid or slow the formation of granulation tissue and mucus, thereby reducing the risk of obstruction. This utility may be a formulation of a carrier (e.g., polymer, liposome, lipid, etc.) and a therapeutic agent administered in proximity to the treatment site within the airway. This administration of the formulation may occur separately from the treatment described herein (e.g., needle injection before or after), be integrated into the primary procedure (e.g., formulation loaded into a delivery system (e.g., balloon)), or be integrated into the implant itself (e.g., an expandable device having a polymer drug coating).

[0164] The carriers described herein can adhere to a therapeutic agent to form a matrix. Features may be incorporated into this matrix to achieve controlled and sustained release of the therapeutic agent. One such feature is a release agent configured to dissolve when contacted by bodily fluids, such that such dissolution will create porosity in the matrix, thereby allowing for controlled diffusion and release of the therapeutic agent.Suitable release agents for use in the present technology include polysorbates such as polysorbate 80, polysorbate 60, polysorbate 40, and polysorbate 20, sorbitan monostearate (Span® 60), sorbitan tristearate (Span® 65), sorbitan trioleate (Span® 85), sorbitan monooleate (Span® 86), and sorbitan hydroxybenzoate (Span® 87). 80), sorbitan fatty acid esters such as sorbitan monopalmitate, sorbitan monostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan trioleate, and sorbitan tribehenate, sucrose esters such as sucrose monodecanoate, sucrose monolaurate, sucrose distearate, and sucrose stearate, castor oils such as polyethoxylated castor oil, polyoxyl hydrogenated castor oil, polyoxyl 35 castor oil, polyoxyl 40 hydrogenated castor oil, polyoxyl 40 castor oil, Cremophor® RH60, and Cremophor® RH40, Labrasol®, Labrifil® Polyoxyethylene fatty acid esters such as polyethylene glycol ester glycerides such as 1944, poloxamer, polyoxyethylene polyoxypropylene 1800, polyoxyl 20 stearyl ether, diethylene glycol octadecyl ether, glyceryl monostearate, triglycerol monostearate, polyoxyl 20 stearate, polyoxyl 40 stearate, polyoxyethylene sorbitan monoisostearate, polyethylene glycol 40 sorbitan diisostearate, oleic acid, sodium desoxycholate, sodium lauryl sulfate, myristic acid, stearic acid, vitamin E-TPGS (vitamin E d-alpha-tocopherol polyethylene glycol succinate), saturated polyglycolized glycerides such as Gelucire® 44 / 14 and Gelucire® 50 / 13, and polypropoxylated stearyl alcohols such as Acconon® MC-8 and Acconon® CC-6.

[0165] Another such feature is the ratio of therapeutic agent to carrier, which can be 1:10, 1:5, 3:10, 2:5, 1:2, 3:5, 7:10, 4:5, 9:10, 1:1, 10:9, 5:4, 10:7, 5:3, 2:1, 5:2, 10:3, 5:1, or 10:1. Another such feature is a substantially impermeable coating of a matrix, which will prevent release of the therapeutic agent only through portions of the matrix that are uncoated (i.e., directional release). Another such feature is the use of multiple layers of coatings or matrices, each layer having either a substantially impermeable coating, a matrix comprising at least one therapeutic agent and a polymer, or a matrix without a therapeutic agent, to control and optimize the release profile of one or more therapeutic agents.

[0166] Therapeutic agents may include one or more of the following classes of drugs: (a) antiproliferative agents, (b) antimucolytic agents, (c) mucolytic agents, (d) corticosteroids, (e) antibiotics, (f) anti-inflammatory agents, and (g) antibacterial agents. Examples of antiproliferative agents include sirolimus (rapamycin), everolimus, zotarolimus, paclitaxel, taxotere (docetaxel), mitomycin C, gemcitabine, vincristine (leurocristine), and doxorubicin. Examples of antimucolytic agents include atropine, ipratropium, and tiotropium. Examples of mucolytic agents include N-acetylcysteine ​​and guaifenesin. Examples of corticosteroids include cortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, hydrocortisone, and others. Examples of anti-inflammatory agents include steroids, prednisone, betamethasone, cortisone, dexamethasone, hydrocortisone and methylprednisolone, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, ibuprofen, naproxen sodium, diclofenac, diclofenac-misoprostol, celecoxib, piroxicam, indomethacin, meloxicam, ketoprofen, sulindac, diflunisal, nabumetone, oxaprozin, tolmetin, salsalate, etodolac, fenoprofen, flurbiprofen, ketorolac, meclofenamate, mefenamic acid, COX-2 inhibitors, and others.

[0167] In some embodiments, the therapeutic agent can be an antibiotic, antifungal, and / or antibacterial agent, including amoxicillin, amoxicillin / clavulanate, cephalexin, ciprofloxacin, clindamycin, metronidazole, azithromycin, levofloxacin, sulfamethoxazole / trimethoprim, tetracycline, minocycline, tigecycline, doxycycline, rifampin, triclosan, chlorhexidine, penicillin, aminoglycosides, quinolones, fluoroquinolones, vancomycin, gentamicin, cephalosporins, carbapenems, imipenem, ertapenem, antibacterial peptides, cecropin-melittin, magainin, dermaseptin, cathelicidin, alpha defensins, and alpha protegrin, ketoconazole, clotrimazole, miconazole, econazole, itraconazole, fluconazole, bifonazole, terconazole, butaconazole, tioconazole, oxiconazole, sulconazole, saperconazole, voriconazole, terbinafine, amorolfine, naftifine, griseofulvin, haloprogin, butenafine, tolnaftate, nystatin, cyclohexamide, ciclopirox, flucytosine, terbinafine, amphotericin B, and others.

[0168] In some embodiments, the expandable device does not include a drug-eluting substance. This can be useful, for example, to simplify the manufacturing and regulatory compliance of the expandable device. Furthermore, as discussed elsewhere in this disclosure, the expandable device according to at least some embodiments of the present technology has one or more other features (e.g., structural and / or performance features) that reduce or eliminate the need for drugs to suppress the foreign body response. In these and other cases, the expandable device may include an uncoated wire, such as a bare metal wire.

[0169] Airway wall modification In some of the embodiments described herein, it may be advantageous for the expandable device to modify and / or alter the airway wall. In one example, the expandable device has the ability to self-expand (e.g., a nitinol construction), whereby deployment of the expandable device results in the application of a chronic outward force to the airway wall, causing gradual widening of the airway wall and expansion of the airway lumen. In this example, self-expansion of the expandable device will cause the airway wall to expand beyond its natural diameter. Additionally, or alternatively, expansion of the expandable device can be facilitated by a balloon configured to be stretched to force expansion of the expandable device. Forced expansion of the expandable device via a balloon (either incorporated as part of a delivery system or separate from the delivery system) may be advantageous because the size and pressure of the balloon can be adjusted to control the expansion of the expandable device.

[0170] Controlled expansion of the expandable device is desirable in that such controlled expansion would allow for controlled modification of the airway wall. In one example, it may be desirable to cause the airway wall to expand so as to increase the cross-sectional area of ​​the airway lumen, but without causing substantial injury to the airway wall. The increased cross-sectional area would improve expiratory flow, thereby providing therapeutic benefit in emphysema patients. In other examples, it may be desirable to cause greater expansion of the airway wall to create tears, perforations, and / or fenestrations in the airway wall. These tears, perforations, and / or fenestrations may create openings for other pockets of trapped air within the diseased parenchyma adjacent to the airway, thereby improving expiratory flow and lung function. Furthermore, these tears, perforations, and / or fenestrations, if substantially sufficient in size and number, may prevent the obstruction that has resulted in the aforementioned attempts to release trapped air. Thus, the expandable devices disclosed herein can have self-expanding and / or balloon-expandable characteristics and capabilities to best achieve the desired modification of the airway wall.

[0171] FIG. 46 is a perspective view of an expandable device 4600 configured in accordance with some embodiments of the present technology. In FIG. 46, the device 4600 is shown in an expanded, unconstrained state. The device 4600 has a proximal end portion 4600a, a distal end portion 4600b, and a longitudinal axis L1 extending between the distal end portion 4600a and the proximal end portion 4600b. The device 4600 can comprise a generally tubular structure formed from a wire 4601 wrapped around the longitudinal axis to form a series of cuffs 4602 (individually labeled 4602a-4602f), each comprising a 360-degree winding of the wire 4601. The device 4600 further includes a distal structure 4610 distal to the distal-most cuff 4602f and a proximal structure 4612 proximal to the proximal-most cuff 4602a. The wire 4601 is undulating between the ends of a given strip 4602 such that each strip 4602 has a plurality of alternating peaks 4604 (individually labeled 4604a-4604c) and valleys 4606 (individually labeled 4606a-4606c) connected by struts 4608 (individually labeled 4608a-4608f). The peaks 4604 can comprise bending apexes within a given strip 4602 that are closer to and / or pointing toward the second end portion 4600b of the device 4600, and the valleys 4606 can comprise bending apexes within a given strip 4602 that are closer to and / or pointing toward the first end portion 4600b of the device 4600. The serpentine configuration of each winding of wire 4601 makes it easier to radially compress device 4600 onto and / or within a delivery system and to accurately deploy device 4600, as discussed in more detail below.

[0172] Each band 4602 can have first, second, and third peaks 4604a, 4604b, and 4604c, first, second, and third valleys 4606a, 4606b, and 4606c, and first, second, third, fourth, fifth, and sixth struts 4608a, 4608b, 4608c, 4608d, 4608e, and 4608f. The bands 4602 are connected end to end so that each band 4602 starts at a first valley 4606a and ends where the sixth strut 4608f meets the first valley 4606a of the next band 4602 (or, in the case of the sixth band 4602f, where the sixth strut 4608f meets the first valley 4606a of the distal structure 4610). Starting at a first valley 4606a and moving distally in a clockwise direction, each band 4602 includes a first strut 4608a extending distally from the first valley 4606a to a first peak 4604a, then a second strut 4608b extending proximally from the first peak 4604a to a second valley 4606b, and then a second strut 4608b extending distally from the second valley 4606b to a second peak 4604b. 46 includes a third strut 4608c, then a fourth strut 4608d extending proximally from the second peak 4604b to the third valley 4606c, then a fifth strut 4608e extending distally from the third valley 4606c to the third peak 4604c, and then a sixth strut 4608f extending proximally from the third peak 4604 to terminate at the first valley 4606a of the next band 4602. Although the device 4600 shown in FIG. 46 includes three peaks and three valleys per turn, in other embodiments, the device 4600 can have any number of peaks and valleys per turn. Also, although all of the bands 4602 have the same number of peaks and valleys, in other embodiments, some or all of the bands 4602 within the same device can have different numbers of peaks and valleys.

[0173] Along the length of the device 4600, and within a given band 4602, the wire 4601 has struts 4608 that extend both proximally and distally in the direction of the wire windings. For example, following the wire 4601 in a clockwise direction around the windings, the device 4601 has struts 4608 that extend distally, then proximally, then distally, then proximally, then distally, thereby forming multiple localized V-shaped braces that, when placed within the airway, serve to support the airway walls and lift and open the airway lumen. This is in contrast to a simple coil, where the wire extends continuously distally as it wraps around each winding. In some embodiments, for example, as shown in FIG. 46 , each of the first and fifth struts 4608a and 4608e can be longer than each of the second, third, fourth, and sixth struts 4608b, 4608c, 4608d, and 4608f. In other embodiments, the struts 4608 can have different lengths or configurations. The strut length can be measured along the longitudinal axis of the wire 4601. Similarly, each of the second, third, and fourth struts 4608b, 4608c, and 4608d can be longer than the sixth strut 4608f. In some embodiments, the length of the struts 4608 can be determined by equation 3a-3b=1 / pitch, where "a" is the longer strut and "b" is the shorter strut 4608.

[0174] As previously mentioned, the bands 4602 are connected to each other using only a single continuous wire. Advantageously, all of the peaks 4604 and valleys 4606 are free peaks and valleys, meaning that none of the peaks 4604 and valleys 4606 are connected to a peak, valley, or other portion of a longitudinally adjacent band 4602. This lack of interconnectivity between axially adjacent structures provides the device 4600 with improved axial flexibility and extension capabilities compared to conventional stents that include one or more bridges or other links between longitudinally adjacent struts and / or apices. This flexible configuration allows the device 4600 to stretch and flex with the airway in response to different loads (e.g., bending, twisting, tension) associated with various anatomical conditions (e.g., airway bifurcation, curvature, etc.) and physiological conditions (e.g., breathing, coughing, etc.), thereby allowing the device to move with the airway and minimize relative motion while still maintaining a threshold radial force. In some embodiments, the device 4600 has a ratio of radial force to longitudinal stiffness that exceeds that of conventional stents. This longitudinal and bending flexibility for moving with the airway also has the benefit of limiting relative motion between the device 4600 and the airway wall during other movements, such as breathing and coughing. Relative motion of the device 4600 against the airway wall can cause inflammation and granulation tissue formation, which, over time, can partially or completely block the newly opened lumen, thereby obstructing airflow and defeating the purpose of treatment. Without being bound by theory, longitudinal connections and / or elimination of closed bubbles along the length of the device 4600 may help maintain perfusion of the treated portion of the airway wall, as closed bubbles may obstruct blood flow.

[0175] As described herein, there are several aspects of the device that contribute to minimizing granulation tissue formation. One aspect is the self-expanding structure and increased size relative to the airway diameter, which creates a chronic outward force against the airway wall, promoting wall engagement and apposition, thereby minimizing relative motion. A second aspect is the absence of interconnectivity from free peaks and valleys, which allows for considerable flexibility, allowing the device to move with the airway and minimize relative motion. A third aspect is the low material density and high porosity, which creates less surface area contact with the airway wall, thereby generating little tissue reaction. A fourth aspect is the wire pattern, which does not have any closed cells to maintain perfusion, thereby minimizing tissue necrosis and local inflammatory response.

[0176] Another benefit of the lack of interconnectivity associated with free peaks and valleys of an expandable device is the low tensile force required to detach the device from the airway wall. A tensile axial load (i.e., pulling) applied to the wire will cause elongation, reducing the diameter of each loop or strap, thereby moving it away from the airway wall. This detachment from the airway wall can facilitate retrievability of the device following implantation with minimal trauma or disturbance to the airway wall.

[0177] Placing the implants described herein in the distal airways of emphysematous lungs can be clinically advantageous. One traditional challenge with conventional catheter-delivered implants (e.g., stents, braided structures) is foreshortening that occurs during deployment and implantation. Such foreshortening can make it difficult to accurately deliver the implant to the intended treatment site. Foreshortening is often the result of elongation of the implant during radial compression to a reduced profile for minimally invasive delivery. The elongation results from the structural design and high material density of the implant (i.e., due to the structure and amount of material, the implant cannot remain in the same axial plane when radially compressed). In the devices described herein, the absence of longitudinal bridges between axially adjacent structures and the relatively low material density (as described below) provide radial compression in the delivery configuration with little or no elongation (e.g., 0%, 5% or less, 10% or less), thereby allowing the device 4600 to be deployed with little or no change in length. Thus, unlike braids and some stents, the device 4600 does not undergo foreshortening when radially expanded. The length of the device 4600 in the compressed delivery state (see, e.g., FIG. 49 ) is substantially identical to the length of the device 4600 in the expanded, unconstrained state. As a result, the device 4600 can be deployed more predictably and with greater landing accuracy.

[0178] As shown in FIG. 46 , the device 4600 can have a winding density, measured by the number of turns per inch along one circumference (i.e., 360 degrees) of the device 4600. It can be advantageous to have a winding density that is low enough to allow sufficient spacing between adjacent turns and / or straps 4602 of the wire 4601 (e.g., adjacent turns spaced further apart longitudinally) so that the device 4600 can be compressed onto and / or into a delivery system, and low enough so that the resulting surface area contact over the length of the device 4600 does not induce an adverse tissue response. However, it can also be beneficial to have a winding density that is high enough (e.g., adjacent turns closer together longitudinally) to prevent sagging and / or invagination of the airway wall between adjacent turns (particularly during expiratory flow (e.g., exhalation) when ambient pressure outside the airway is higher than pressure within the airway) and ensure sufficient surface area contact to reduce and / or avoid relative movement and / or migration. Thus, the winding density of the present technology can be optimized for delivery system loading capacity, minimal invagination of the airway wall between windings, minimal relative movement, and minimal local inflammatory response. In some embodiments, device 4600 has a winding density of about 1 to about 4 turns per inch. In some embodiments, device 4600 has a winding density of about 1.2 to about 3.5 turns per inch. In certain embodiments, device 4600 has a winding density of about 1.8 to about 3 turns per inch. In FIG. 46, device 4600 has a winding density of 3. FIG. 51 shows device 5100 with a lower winding density of 1.8.

[0179] The expanded cross-sectional dimension of device 4600 may be generally constant or may vary along the length of device 4600 and / or between loops. For example, as discussed herein, device 4600 may have various cross-sectional dimensions along its length to accommodate different portions of the airway. For example, in some embodiments, device 4600 may have a diameter that decreases distally, thereby better approximating the natural distal narrowing of the airway lumen. The diameter may increase distally over the length of device 4600, or device 4600 may have discrete portions with different diameters. For example, device 4600 may have a first portion and a second portion along its length. The first portion may have a first cross-sectional dimension configured to be positioned within a more distal portion of the airway (e.g., within the terminal bronchioles and / or emphysematous areas of a collapsed and / or collapsed airway, etc.). The second portion can have a second cross-sectional dimension that exceeds the first cross-sectional dimension and is configured to be positioned more proximally (such as in the uncollapsed main bronchus and / or another portion). The second portion can be configured to be positioned, for example, in a portion of the airway that is less emphysematous than the collapsed distal portion and / or has cartilage (preferably rings of cartilage, not plates) in the airway wall, which can occur at the lobar (generation 2) or segmental (generation 3) level.

[0180] In some embodiments, device 4600 can have a diameter that increases distally. The diameter may decrease proximally over the length of device 4600, or device 4600 may have discrete portions with different diameters. For example, device 4600 can have a generally uniform diameter over most of its length and then a larger diameter over the last one to three distal turns (which may be band 4602 and / or distal structure 4610). In some embodiments, device 4600 has a first portion and a second portion along its length. The first portion can have a first cross-sectional dimension configured to be positioned within a more distal portion of the airway (e.g., within the terminal bronchioles and / or emphysematous areas of a collapsed and / or collapsed airway, etc.). The second portion can have a second cross-sectional dimension that is less than the first cross-sectional dimension and configured to be positioned more proximally (e.g., within an uncollapsed main bronchus and / or another portion, etc.). The second portion can be configured to be positioned in a portion of the airway that is less emphysematous than the collapsed distal portion and / or has cartilage (preferably a ring of cartilage, not a plate) in the airway wall, which may occur at the lobar (generation 2) or segmental (generation 3) level, for example. Having an increased diameter in the distal portion of device 4600 can be beneficial to apply more radial force on the distal airway to produce more expansion, or in some cases, to also create a tear in the airway wall. According to some embodiments, it may be beneficial for device 4600 to be configured to create a tear only along the portion of the airway engaged by device 4600. Additionally or alternatively, if the lung is particularly diseased, the distal augmentation may better contact the emphysematous lung and help anchor the device.

[0181] In some embodiments, wire 4601 has a circular cross-sectional shape. In other embodiments, wire 4601 may have other suitable cross-sectional shapes along its length (e.g., oval, rectangular, square, triangular, polygonal, irregular, etc.). In some embodiments, the cross-sectional shape of wire 4601 varies along its length. Varying the cross-sectional shape of wire 4601 can be beneficial for varying the mechanical performance of device 4600 along its length (e.g., transitioning from lower to higher radial strength from proximal to distal, or vice versa). Alternatively, or in addition, different cross-sectional shapes allow for different distributions of contact forces on the airway wall. For example, a wire with an oval cross-sectional shape will have a larger contact area, a wider distribution of contact forces, and therefore lower contact stress at any point on device 4600, compared to a circular cross-section. Without being bound by theory, it is believed that utilizing a cross-sectional shape with rounded edges may be beneficial because rounded edges may present a less traumatic surface to the airway wall than straight edges. For example, while wires having rectangular cross-sectional shapes and linear corners can be used with the present technology, in some cases it may be advantageous to utilize rectangular wires with curved corners.

[0182] The wire 4601 can have a generally constant cross-sectional area along its length, or it may have a variable cross-sectional area along its length. It may be beneficial to vary the cross-sectional area of ​​the wire 4601, for example, to vary its radial force and / or flexibility along the length of the device 4600. For example, the device 4600 will have a lower radial force and / or higher flexibility along portions where the wire 4601 has a smaller cross-sectional area than along portions where the wire 4601 has a larger cross-sectional area. In some embodiments, the wire 4601 has a diameter of 0.005 inches or less, 0.006 inches or less, 0.007 inches or less, 0.008 inches or less, 0.009 inches or less, 0.01 inches or less, 0.011 inches or less, 0.012 inches or less, 0.013 inches or less, 0.014 inches or less, and 0.015 inches or less.

[0183] In some embodiments, the expanded cross-sectional dimension of device 4600 in its unconstrained, expanded state (i.e., removed from the delivery shaft, airway constraint, and resting on a table) can be increased relative to the diameter of the native airway lumen. For example, the expanded, unconstrained cross-sectional dimension of device 4600 can be at least 1.5 times the original (uncollapsed) diameter of the airway lumen in which it is intended to be positioned. In some embodiments, device 4600 has an expanded cross-sectional dimension that is approximately 1.5 to 6 times, 2 to 5 times, or 2 to 3 times the diameter of the original airway lumen. Without being bound by theory, it may be clinically beneficial to expand the airway lumen to its maximum possible diameter. A larger airway diameter may allow for more efficient release of trapped air, thereby optimizing improvements in lung function (e.g., as measured by outflow volume, FEV1, and the like). Additionally, there may be clinical benefits to controlled expansion of the airway wall by the implantable device 4600 to create one or more tears in the airway wall, with or without the assistance of an expandable device (e.g., a balloon), to further facilitate the release of air trapped within the surrounding emphysematous lung.

[0184] Given that cartilage support within the bronchial airways tends to decrease from proximal to distal, it may be beneficial to have a device with a variable winding density, with the winding density in the most distal portion of the device being greater than the winding density in the most proximal portion of the device. This device configuration with a higher winding density distally and a lower winding density proximally may optionally include a lower radial stiffness distally and a higher radial stiffness proximally.

[0185] The distal structure 4610 is the first portion of the device 4600 to be deployed within the airway lumen. As a result, the distal structure 4610 can be similar to the cuff 4602 but adapted to provide a higher circumferential force and a soft, atraumatic landing structure. The final apex 4616 of the wire 4601 can have a larger radius of curvature in its relaxed, unconstrained state than the other apexes, for example, angled to orient the distal end 4620 of the wire 4601 proximally and to provide a rounder, softer bend for initial contact with the airway wall. In some embodiments, the distal apex 4616 has approximately the same radius of curvature as the rest of the apexes in the relaxed, unconstrained state. Additionally or alternatively, the distal end portion 4620 of the wire 4601 can comprise other atraumatic elements, such as a ball (having a cross-sectional dimension that is only slightly greater than the cross-sectional dimension of the wire 4601) and / or a looped portion of the wire 4601. To enable greater anchoring forces at the distal end portion 4600b of the device 4600, the third valley 4606c of the distal structure 4610 can have a larger radius of curvature to substantially align the final apex 4616 (which is the apex) of the distal structure 4610 with the penultimate apex 4604b.

[0186] The proximal end portion 4600a of the device 4600 can include a single proximally extending strut 4624 and a free proximal end 4622. Like the distal end 4620, the proximal end 4622 can extend proximally to limit trauma to the airway wall. The free proximal end can also be useful for retrieval of the device 4600, if necessary.

[0187] The wire 4601 can be any elongate element, such as a wire (e.g., having a circular or oval cross-sectional shape), a coil, a tube, a filament, a single woven elongate element, multiple braided and / or twisted elongate elements, a ribbon (having a square or rectangular cross-sectional shape), and / or the like. Accordingly, as used herein, the term "wire" refers to the conventional definition of wire (e.g., metal drawn into the form of a thin, flexible thread or rod) and other elongate elements detailed herein. The wire 4601 can be cut from a sheet of material and then wound into a three-dimensional configuration around a mandrel. In some embodiments, the device 4600 is formed by cutting a tube so that only the remaining portion of the tubular sidewall constitutes the wire 4601. The sheet and / or tube can be cut via laser cutting, electrical discharge machining (EDM), chemical etching, water jet, air jet, etc. The wire 4601 can also comprise a thin film formed via a deposition process. The elongate member 102 can be formed using materials such as nitinol, stainless steel, cobalt chromium alloy (e.g., 35N LT®, MP35N (Fort Wayne Metals, Fort Wayne, Indiana)), Elgiloy, magnesium alloy, tungsten, tantalum, platinum, rhodium, palladium, gold, silver, or combinations thereof, or one or more polymers, or combinations of polymers and metals. In some embodiments, the wire 4601 may include one or more drawn filled tube ("DFT") wires including an inner material surrounded by a different outer material. The inner material may be, for example, a radiopaque material and the outer material may be a superelastic material.

[0188] The cross-sectional area of ​​the wire 4601 can be selected based on several factors, such as winding density, radial force, and ability to radially compress for delivery. All other things being equal (winding density, wire length, wire material, etc.), the larger the cross-sectional area of ​​the wire 4601, the greater the radial force imparted on the airway wall. However, the larger the cross-sectional area and associated radial force of the wire 4601, the more difficult it is to compress the device 4600 into and / or onto a delivery system. Thus, the wire 4601 of the present technology, in addition to the winding density of the wire 4601, has a cross-sectional area that provides the device 4600 with sufficient radial force to maintain airway patency, resist strain and associated cyclic fatigue from anatomical loads during breathing and coughing, and reduce and / or eliminate relative movement, while still allowing the device 4600 to be compressed to a diameter of less than 3 mm, and in some cases less than 2 mm.

[0189] Because relative motion can irritate wall tissue and cause a foreign body response that can contribute to airway obstruction, it can be advantageous to have a sufficiently high radial force to resist migration and reduce relative motion between the device 4600 and the airway wall through improved wall apposition. The radial force must also be sufficient to maintain airway patency and, in some cases, expand the airway to a diameter greater than the airway's natural diameter (e.g., this can be two to three times greater). The radial force imparted by the device 4600 on the airway wall is determined, at least in part, by the winding density of the device 4600 and the cross-sectional area of ​​the wire 4601. For example, the larger the cross-sectional area of ​​the wire 4601, the greater the radial force. The higher the winding density of the device 4600, the greater the radial force. Similarly, the smaller the cross-sectional area of ​​the wire 4601, the smaller the radial force. The lower the winding density of the device 4600, the smaller the radial force. The device 4600 of the present technology can have a radial force per unit length of 7 g / mm or less, 6 g / mm or less, 5 g / mm or less, 4 g / mm or less, 3 g / mm or less, 2 g / mm or less, or 1 g / mm or less. In some embodiments, the device 4600 has a radial force per unit length of about 1 to about 5 g / mm. The radial force required to hold a collapsed airway open and maintain patency during breathing is less than that required by stents used to push or hold back tumor growths or atherosclerotic lesions. Such conventional stents typically have a radial force per unit length of about 10 g / mm or more.

[0190] The device 4600 may be configured to have minimal surface area contact with the airway wall to reduce the amount of foreign body response (such as inflammation and granulation tissue) and the risk of airway obstruction. As used in this discussion, "contact surface area" refers to the surface area of ​​the portion of the device 4600 that contacts the inner surface of the airway wall that is less than the total surface area of ​​the wire 4601. Minimizing the contact surface area of ​​the device 4600 can also be beneficial to limit and / or avoid obstruction of other distal branch openings and to enable more efficient mucociliary clearance. However, the contact surface area of ​​the device 4600 also affects the device's ability to resist migration and relative motion. Thus, the device 4600 of the present technology can be configured to have a contact surface area that is small enough to minimize (or localize) adverse tissue reaction and enable sufficient mucociliary clearance, yet large enough to provide good contact with the airway and resist motion. The device 4600 of the present technology can have a contact surface area of, for example, 20% or less, 19% or less, 18% or less, 17% or less, 16% or less, 15% or less, 14% or less, 13% or less, 12% or less, 11% or less, 10% or less, 9% or less, 8% or less, 7% or less, 6% or less, or 5% or less. In other words, the porosity of the device 4600 can be at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, or at least 95%.

[0191] In some embodiments, regardless of whether wire 4601 is made from and / or includes a radiopaque material, device 4600 can include one or more radiopaque markers. Radiopaque markers can be located, for example, on one or both ends of device 4600 to facilitate accurate positioning and placement.

[0192] In some embodiments, the device 4600 is fabricated by winding the wire 4601 around a mandrel according to a predetermined winding pattern, and then heat-setting the wire 4601 while held in place on the mandrel, so that the wire 4601 substantially maintains its shape on the mandrel when removed from the mandrel. FIG. 48 shows a mandrel 4800 configured for use in fabricating a device of the present technology. As shown in FIG. 48, the mandrel 4800 is generally cylindrical and can include multiple posts 4802 extending radially away from the outer surface of the mandrel 4800. The posts 4802 can be arranged in a pattern to produce a desired winding geometry. The radius of curvature of the posts 4802 can determine, for example, the radius of curvature of the apex. FIG. 47 shows a portion of the wire 4601 wound around one of the posts 302. Different vertices along the device 4600 can have the same radius of curvature or different radii of curvature.

[0193] In some cases, it may be beneficial to use posts with a radius of curvature that closely resembles the shape of the apex when the device 4600 is compacted onto and / or into a delivery system. FIG. 49 shows the device 4600 in radial compression positioned over an elongated delivery member 4900. As the device 4600 is radially compressed, the two posts 4608 adjacent to any given apex 4604 or valley 4606 pinch together, thereby imposing a strain on the attached apex. FIG. 50 shows a finite element analysis performed on the device 4600 to calculate cyclic strain, for example, as the device 4600 will exhibit cyclic strain during breathing, coughing, and other forms of breathing once implanted. As shown in FIG. 50, the strain amplitude was greatest in the distal portion, where the apex 4616 was heat-set to have a radius of curvature that exceeded that of the other apexes (such as the apex 4604 and valley 4606). It was predicted that apexes, heat-set around smaller diameter posts (having a smaller radius of curvature), would experience less strain and fatigue when forced into compression compared to the distal apex 4616. Thus, it may be desirable for the apex to have an average radius of curvature of 2.5 mm or less (e.g., 2.5 mm or less, 2 mm or less, 1 mm or less, 0.5 mm or less, or in the range of 0.35 mm to 0.60 mm).

[0194] The device 4600 can be configured for delivery through a working channel of a bronchoscope. An exemplary bronchoscope 5200 is shown in FIG. 52. As shown, the bronchoscope 5200 can have a handle with an eyepiece or camera head 5202, a cable 5204 for a light source used for imaging, a suction portion 5206, and a working channel port 5208. The bronchoscope includes an elongated shaft 5210 configured to be advanced through a patient's nose, down their trachea, and into the lungs. The shaft 5210 includes several lumens, including a lumen 5216 that supports a camera or fiber optic cable bundle, a lumen 5214 that supports a light source, and an outlet for the working channel 5212. The working channel lumen can have a diameter of about 3 mm or less.

[0195] As shown in FIG. 53, the elongated shaft 5210 of the bronchoscope 5200 can be advanced through the trachea and bronchial tree until the diameter of the elongated shaft 5210 approximately matches that of the dilated airway and can no longer be advanced. The point at which the elongated shaft 5210 stops advancing depends on the bronchoscope being used. For a typical bronchoscope with a diameter of 5-6 mm, this will occur within the third to sixth generation bronchi in most patients. The device 4600 can then be deployed in a distal-to-proximal direction. FIG. 54 shows the device 4600 after deployment. The distal end portion 4600b of the device 4600 can be placed in a distal airway (e.g., a 12th to 15th generation having a natural diameter of 3 mm or less, including less than 1 mm in some cases), with the proximal end portion 4600a of the device 4600 positioned in a proximal airway (e.g., a 2nd to 4th generation having a natural diameter of approximately 4 to 8 mm). In some embodiments, it may be beneficial to position the proximal end portion 4600a of the device 4600 in a portion of the airway with more cartilaginous tissue (e.g., a cartilage-reinforced airway) for better anchoring. The device 4600 and / or wire 4601 can be configured to self-expand to a preset configuration and / or diameter. In some embodiments, the wire 4601 is not heat-set and / or is not configured to self-expand. For example, in some embodiments, the device 4600 and / or wire 4601 is balloon-expandable. In some embodiments, device 4600 and / or wire 4601 are balloon expandable and self-expanding.

[0196] In some embodiments, the device 4600 can be deployed to discrete lengths (e.g., 20, 30, 40, 50, 60 cm, etc.), or, given the axial flexibility of the device 4600, the device 4600 and / or delivery system can be designed for variable length deployment to accommodate variability in patient anatomy (e.g., each device can be designed to be deployed up to + / - 5 cm of its nominal length). According to some embodiments, the technology includes multiple devices 4600 delivered in series. Devices placed in series may have different lengths to accommodate and match different treatment lengths. Multiple devices can overlap, touch, or be spaced apart. If spaced apart, the devices may be spaced apart no more than a predetermined distance (e.g., 5 mm, 1.0 cm, 1.5 cm, 2.0 cm) within the airway.

[0197] 55A shows a distal portion of a delivery system 5500 configured in accordance with some embodiments of the present technology. The delivery system 5500 can be configured for delivery through a working channel of a bronchoscope. For example, in some embodiments, the delivery system 5500 has an outer diameter of 3 mm or less. In some embodiments, the delivery system 5500 has an outer diameter of 2 mm or less. The system 5500 can include an outer sheath 5502, an inner sheath 5508 configured to be slidably disposed within the outer sheath 5502, and an elongated shaft or other delivery member 5506 disposed within the inner sheath 5508. The outer sheath 5502 encloses the entire delivery system and can be configured to engage with the working channel 5212 of the bronchoscope 5200. For example, in some embodiments, the proximal end of the outer sheath 5502 is secured to a handle (not shown) of the delivery system 5500. The inner sheath 5508 is configured to be retracted to expose and deploy the device 4600. In at least some embodiments, the axial position of the delivery member 5506 is fixed relative to the axial position of the outer sheath 5502. For example, the proximal end of the delivery member 5506 can be fixed to the handle of the delivery system 5500. Alternatively, the entire delivery system 5500, excluding the inner sheath 5508, can be fixed to the bronchoscope 5200. In other embodiments, the counterpart delivery system can have other suitable combinations of movable and fixed components.

[0198] In some embodiments, the system 5500 optionally includes a tapered atraumatic tip 5512 at the distal end of the elongate member 5506. The system 5500 can further include a proximal stop 5504 positioned around the elongate member 5506 and within the inner sheath 5508. The proximal stop 5504 can have a distally facing surface 5514 configured to abut the proximal end of the device 4600. In some embodiments, the system 5500 optionally includes a pad or other conformable member 5510 positioned radially between the device 4600 and the elongate member 5506. The conformable member 5510 can be more resilient than the elongate member 5506. The conformable member 5510 can be in tight engagement with the device 4600 when radially compressed. 55B, the conformable member 5510 can form an indentation 5516 around the device 4600 that helps the device 4600 maintain its axial position. In this or another manner, the device 4600 can be "clipped" within the conformable member 5510, holding it in place until the inner sheath 5508 is fully retracted.

[0199] In at least some cases, the delivery system 5500 includes features to facilitate visualization under fluoroscopy and / or bronchoscopy during delivery and / or deployment of the implant 4600. For example, the delivery system 5500 can include a first radiopaque marker 5518 at the distal-most portion of the tip 5512 to indicate the distal-most feature of the delivery system 5500. The first radiopaque marker 5518 can be, for example, a cap or an embedded plug. The delivery system 5500 can further include a second radiopaque marker 5520 at the distal-most portion of the inner sheath 5508 to facilitate estimating the location of the distal end of the device 4600 during delivery and deployment. The second radiopaque marker 5520 can be, for example, an annular band. Additionally or alternatively, the delivery system 5500 can include a pad-printed line or other visual feature (not shown) on the outer surface of the inner sheath 5508. These features can facilitate visualization under a bronchoscope. For example, one line can be at the proximal end of device 4600 to indicate where, relative to the airway region, the proximal end of device 4600 will be located after deployment. Additionally, different indicators can be used to indicate the proximal ends of devices of different lengths. For example, one circumferential line can indicate the proximal end of a 70 mm device, two circumferential lines can indicate the proximal end of an 85 mm device, three circumferential lines can indicate the proximal end of a 100 mm device, etc.

[0200] The elongated shaft 5210 of the bronchoscope 5200 can be advanced through the trachea and bronchial tree until the diameter of the elongated shaft 5210 approximately matches that of the dilated airway and can no longer be advanced. The location at which the elongated shaft 5210 stops advancing can vary depending on the bronchoscope being used. For a typical bronchoscope with a diameter of 5-6 mm, this will occur within the third to sixth generation bronchi in most patients. The delivery system 5500 can then be advanced distally through the distal opening of the working channel 5212 so that the outer sheath 5502 is exposed within the airway lumen. The delivery system 5500 can be advanced distally until the distal end portion of the outer sheath 5502 is positioned within a distal portion of the airway (e.g., within the terminal bronchioles and / or emphysematous areas of a collapsed and / or collapsed airway). With the outer sheath 5502 and elongate delivery member 5506 held in place, the inner sheath 5508 can be retracted to expose and deploy the device 4600 at the desired location.

[0201] It should be understood that other delivery systems are within the scope of the present technology. Additionally, the bronchoscope 5200 and delivery system 5500 can be used in conjunction with any of the expandable devices disclosed herein.

[0202] Additional examples of expandable devices, systems, and methods for treating COPD and / or devices, systems, and methods for modifying airway walls can be found, for example, in U.S. Patent No. 9,592,138, filed September 13, 2015, entitled "PULMONARY AIRFLOW," which is incorporated herein by reference in its entirety.

[0203] Additional Examples Figures 56A, 57A, and 58 are perspective, end, and profile views, respectively, of an implant 5600 in accordance with at least some embodiments of the present technology. Figures 56B-56F are supplemental text corresponding to Figure 56A. Figure 57B is supplemental text corresponding to Figure 57A. In Figures 56A-58, the implant 5600 is in an unconstrained state. This can be the state the implant 5600 assumes in the absence of an external source of constraint, such as a sheath during delivery of the implant 5600 or the walls of the bronchial tree after deployment of the implant 5600. Features of the implant 5600 are described herein with reference to the implant 5600 in this unconstrained state, unless otherwise specified. Referring together to Figures 56A-58, the implant 5600 can elongate along its longitudinal axis 5601. The implant 5600 can include a proximal end portion 5602 and a distal end portion 5603 spaced apart from one another along a longitudinal axis 5601. Between the proximal end portion 5602 and the distal end portion 5603 along the longitudinal axis 5601, the implant 5600 can include an intermediate portion 5604. The entire implant 5600 can be configured to be deployed at a treatment location within the bronchial tree of a human subject. Aspects of this deployment example are described in detail below. In at least some cases, the proximal end portion 5602 and the distal end portion 5603 are configured to be deployed in different, individual airways. For example, the proximal end portion 5602 can be configured to be deployed in a first airway, and the distal end portion 5603 can be configured to be deployed in a second airway that is a generation greater than the first airway. The individual generations of the first and second airways can vary by 1, 2, 3, 4, 5, 6, or even greater numbers depending on characteristics such as the length and diameter of the implant 5600. The first airway can be of generation 2 or greater, such as 2, 3, 4, 5, or 6.

[0204] The implant 5600 may further include a wire 5605 extending along a wire pathway 5606. The wire pathway 5606 may extend between a first end 5607 at the proximal end portion 5602 and an opposing second end 5608 at the distal end portion 5603. The wire pathway 5606 may be continuous between the first end 5607 and the second end 5608. Further, the wire 5605 may include a first end 5609 at the first end 5607 and a second end 5610 at the second end 5608. The wire pathway 5606 may extend in a circumferential direction 5612 about the longitudinal axis 5601. Some, most, or all of the wire 5605 and wire pathway 5606 may be within a tubular region 5611 that is coaxially aligned with the longitudinal axis 5601. In the illustrated embodiment, the tubular region 5611 has a circular cross-sectional shape that is perpendicular to the longitudinal axis 5601. In other embodiments, the counterpart of the tubular region 5611 can have another suitable shape that is oval, triangular with rounded corners, square with rounded corners, another polygonal shape with rounded corners, or perpendicular to the counterpart of the longitudinal axis 5601. Furthermore, while the longitudinal axis 5601 and the tubular region 5611 are straight in the illustrated embodiment, in other embodiments, the longitudinal axis 5601 and the tubular region 5611 can be curved. For example, the counterpart of the implant 5600 can be curved, angled, serpentine, or have another suitable non-linear shape. Such a non-linear shape can be selected, for example, to correspond to the shape of the airway region in which the counterpart of the implant 5600 will be deployed.

[0205] 56A-58 , in the illustrated embodiment, the entire wire path 5606 between the first end 5607 and the second end 5608 includes seven turns about the longitudinal axis 5601. In other embodiments, the corresponding wire path 5606 can include another suitable number of turns, such as another suitable number of turns corresponding to the desired pitch and overall length of the corresponding implant 5600. In at least some embodiments, the wire path 5606 in the intermediate portion 5604 includes three or more turns, such as four turns, five turns, six turns, or more. In these and other embodiments, the wire path 5606 in the proximal end portion 5602 can include one turn closest to the first end 5607. Similarly, the wire path 5606 in the distal end portion 5603 can include one turn closest to the second end 5608. The boundaries between the proximal end portion 5602, the distal end portion 5603, and the intermediate portion 5604 can be based on turns and / or based on sections of the longitudinal axis 5601. For example, the proximal end portion 5602 can be coextensive with the most proximal 10% of the longitudinal axis 5601, the distal end portion 5603 can be coextensive with the most distal 10% of the longitudinal axis 5601, and the intermediate portion can be coextensive with the middle 80% of the longitudinal axis 5601. Alternatively, the proximal end portion 5602 can be coextensive with the most proximal 15% of the longitudinal axis 5601, the distal end portion 5603 can be coextensive with the most distal 15% of the longitudinal axis 5601, and the intermediate portion can be coextensive with the middle 70% of the longitudinal axis 5601. Other suitable boundaries are also possible.

[0206] The wire 5605 may include first sections 5614 (individually identified as first sections 5614a-5614w) and second sections 5616 (individually identified as second sections 5616a-5616w) arranged in alternating fashion along the wire path 5606. The first sections 5614a-5614w may extend distally in the circumferential direction 5612, while the second sections 5616a-5616w extend proximally in the circumferential direction 5612. In the illustrated embodiment, all of the first sections 5614a-5614w and all of the second sections 5616a-5616w have these defined orientations. In other embodiments, counterparts of wire 5605 can include only counterparts of some (e.g., most, all but one, all but two, etc.) of first sections 5614a-5614w and / or counterparts of second sections 5616a-5616w having a defined orientation. For example, counterparts of wire 5605 can include counterparts of first sections 5614a-5614w and counterparts of second sections 5616a-5616w having a defined orientation only in counterparts of intermediate portion 5604, but not in counterparts of proximal end portion 5602 and / or not in counterparts of distal end portion 5603. Furthermore, in the illustrated embodiment, and at least some other embodiments, first sections 5614a-5614w and second sections 5616a-5616w and their counterparts can have any suitable features of corresponding portions of other devices described herein.

[0207] 56A-58 , wire 5605 can include first vertex portions 5618 (individually identified as first vertex portions 5618a-5618w) disposed at respective first vertices 5619 along wire path 5606. Wire 5605 can also include second vertex portions 5620 (individually identified as second vertex portions 5620a-5620v) disposed at respective second vertices 5621 along wire path 5606. In at least some cases, first sections 5614a-5614w and second sections 5616a-5616w are alternately disposed along wire path 5606. Further, the first sections 5614a-5614w and second sections 5616a-5616w can be interspersed between the first apex portions 5618a-5618w and the second apex portions 5620a-5620v along the wire path 5606. As shown in FIG. 56A , the first apex portions 5618a-5618w can face distally (i.e., further along the longitudinal axis 5601 toward the distal end portion 5603 than toward the proximal end portion 5602). Correspondingly, the portion of the wire 5605 closest to the first apex portions 5618a-5618w can extend proximally, away from the first apex portions 5618a-5618w. Similarly, the second apex portions 5620a-5620v can face proximally (i.e., more toward the proximal end portion 5602 along the longitudinal axis 5601 than toward the distal end portion 5603). Correspondingly, the portion of the wire 5605 nearest the second apex portions 5620a-5620v can extend distally, away from the second apex portions 5620a-5620v. In the illustrated embodiment, and at least some other embodiments, the first apex portions 5618a-5618w and second apex portions 5620a-5620v and their counterparts can have any suitable features of the corresponding portions of other devices described herein.

[0208] The entire implant 5600, i.e., the proximal end portion 5602, the distal end portion 5603, and / or the intermediate portion 5604, can consist essentially of the wire 5605. Furthermore, the wire 5605 throughout the implant 5600 at the proximal end portion 5602, the distal end portion 5603, and / or the intermediate portion 5604 can consist essentially of various combinations of first sections 5614a-5614w, second sections 5616a-5616w, first apex portions 5618a-5618w, and second apex portions 5620a-5620v. In the illustrated embodiment, proximal end portion 5602 includes four of first sections 5614 (first sections 5614a-5614d), three of second sections 5616 (second sections 5616a-5616c), three of first apex portions 5618 (first apex portions 5618a-5618c), and three of second apex portions 5620 (second apex portions 5620a-5620c). These components correspond to the portion of wire 5605 that extends along a single turn of wire path 5606 closest to first end 5607, although first section 5614d extends slightly beyond this turn along wire path 5607 toward second end 5608. In the illustrated embodiment, distal end portion 5603 includes three of first sections 5614 (first sections 5614u-5614w), three of second sections 5616 (second sections 5616u-5616w), three of first apex portions 5618 (first apex portions 5618u-5618w), and two of second apex portions 5620 (second apex portions 5620u-5620v). These components correspond to the portion of wire 5605 that extends along a single turn of wire path 5606 closest to second end 5608, while second section 5616u extends slightly beyond this turn along wire path 5606 toward first end 5607.Finally, in the illustrated embodiment, intermediate portion 5604 includes sixteen of the first sections 5614 (first sections 5614e-5614t), seventeen of the second sections 5616 (second sections 5616d-5616t), seventeen of the first apex portions 5618 (first apex portions 5618d-5618t), and seventeen of the second apex portions (second apex portions 5620d-5620t). These components correspond to portions of wire 5605 that extend along the five turns of wire path 5606. In other embodiments, as discussed above, counterparts of proximal end portion 5602, distal end portion 5603, and intermediate portion 5604 can have other suitable boundaries. Furthermore, these counterparts can include other suitable quantities and / or types of components.

[0209] In at least some cases, the wire 5605 is not bifurcated throughout the wire path 5606. For example, the wire 5605 can lack a bifurcation, a trifurcation, or other type of junction where the wire 5605 splits. Additionally or alternatively, the wire 5605 can be untethered throughout the wire path 5606. For example, the wire 5605 can lack bridges or other structural connections between different portions of the wire 5605 that are spaced apart from one another along the wire path 5606 and / or between the wire 5605 and other implant components. Using non-constraining theory, these features, alone or in combination with other features described herein, can be useful for reducing a foreign body response associated with the implant 5600, for increasing the longitudinal flexibility of the implant 5600, and / or for one or more other reasons. In other embodiments, counterparts of wire 5605 may be branched, tethered, and / or present with other implant components.

[0210] Referring again to Figures 56A-58, the first end 5609 and / or the second end 5610 can be untethered. In contrast, wire ends in conventional implants are typically tethered in some manner, such as by being tethered or otherwise joined to other wire segments. This tethering is intuitive because untethered wire ends are traditionally expected to have a higher potential for causing trauma, migrating, and / or exhibiting other undesirable behavior after implant deployment than tethered wire ends. Referring again to Figures 56A-57B, the inventors recognized that leaving the first end 5609 and / or the second end 5610 untethered had potential benefits, and that associated problems could be reduced or even eliminated using other implant features. Among the benefits is supporting mucociliary clearance. The inventors have recognized that, as discussed above, the absence of branches and / or tethers in other portions of the wire 5605 and / or the absence of structures of the implant 5600 other than the wire 5605 may also assist in this objective. Additionally, without wishing to be bound by this theory, the inventors have identified mucociliary clearance as being useful for supporting long-term use of the implant 5600 without loss of airway patency due to mucous plugging or granulation tissue accumulation. Thus, the implant 5600 can be configured to allow mucociliary clearance from a location immediately distal to the implant 5600 to a location immediately proximal to the implant 5600 while the implant 5600 is deployed at a treatment location within the bronchial tree.

[0211] As shown in most detail in FIG. 58 , the first end portion 5609 can be at the proximal-most end of the implant 5600. Correspondingly, the implant 5600 can include a given one of the first sections 5614 at the first end 5607 of the wire pathway 5606. Furthermore, the pitch of the wire pathway 5606 at the proximal end portion 5602 can be approximately the same (e.g., within 10% of) the pitch of the wire pathway 5606 at the intermediate portion 5604. These features and the absence of tethers at the first end portion, alone or in combination, can facilitate the retrievability of the implant 5600. For example, while the implant 5600 is expected to be suitable for indefinite use, in some cases it may be useful to remove the implant 5600 from the treatment site after deployment. This may be the case, for example, when a clinician improperly deploys the implant 5600, or when an unexpected, abnormal biological process causes the airway region in which the implant 5600 is deployed to ultimately lose patency. Retrieving the implant 5600 may include grasping the wire 5605 at or near the first end 5609 and pulling the wire 5605 proximally. The described features of the first end 5609 can facilitate grasping access and can help guide the wire 5605 away from the airway wall in response to a pulling force. For example, the implant 5600 generally, and particularly the proximal end portion 5602, can be configured to uncoil and stretch during retrieval rather than maintaining the same shape perpendicular to the longitudinal axis 5601. Thus, rather than being dragged proximally across the airway wall, the implant 5600 can tend to disengage inward and then move proximally during retrieval, which can reduce or eliminate excess trauma.

[0212] 59, 60, 61, and 62 are cross-sectional views of the implant 5600 taken along lines AA, BB, CC, and DD, respectively, of FIG. 58. As shown in FIGS. 59-62, planes perpendicular to the longitudinal axis 5601 at different portions of the implant 5600 can intersect more than one circumferentially spaced apart portion of the implant 5600. This is in contrast to a simple coil. The inventors have discovered that contacting more than one circumferentially spaced apart portion of the wall of the airway region can be useful for establishing and maintaining airway patency. The portions of the implant 5600 intersected by planes perpendicular to the longitudinal axis 5601 can correspond to portions of the implant 5600 that contact the wall of the airway region when the implant 5600 is deployed. 58-62, the implant 5600 can contact three circumferentially spaced portions of the wall of the airway region in a plane perpendicular to the longitudinal axis 5601 at line AA, five such portions at line BB, three such portions at line CC, and six such portions at line DD. Lines AA, BB, and CC lie in the intermediate portion 5604, while line DD lies in the distal end portion 5603. In at least some cases, any given plane perpendicular to the longitudinal axis 5601 in the intermediate portion 5604 and / or the central 50% of the length of the implant 5600 along the longitudinal axis 5601 intersects at least three (e.g., 3-5) circumferentially spaced points along the wire path 5606.

[0213] 59-62 suggest, the implant 5600 can be configured to contact more circumferentially spaced portions of the wall of the airway region in a plane perpendicular to the longitudinal axis 5601 at the distal end portion 5603 than in a plane perpendicular to the longitudinal axis 5601 at the intermediate portion 5604. For example, the implant 5600 can be configured to intersect at least a first number of circumferentially spaced points along the wire path 5606 in any given plane that is perpendicular to the central 50% of the length of the implant 5600 along the longitudinal axis 5601, and to intersect at least a second number of circumferentially spaced points along the wire path 5606 in any given plane that is perpendicular to the distal-most 5% of the length of the implant 5600 along the longitudinal axis 5601. In at least some cases, the second number of circumferentially spaced points is at least five. Furthermore, among circumferentially spaced points along the wire path 5606 at which any given plane, perpendicular to the distal-most 5% of the length of the implant 5600 along the longitudinal axis 5601, intersects the implant, the maximum circumferential spacing between any circumferentially neighboring pair of points can be 180 degrees or less, such as 120 degrees or less. Conversely, there can be a minimum circumferential spacing of at least 60 degrees, such as at least 90 degrees, 120 degrees, or 150 degrees, for at least one neighboring pair of circumferentially spaced points.

[0214] The inventors have recognized that positioning a relatively large number and / or relatively circumferentially balanced contact points between the distal end portion 5603 and the airway region is potentially useful for facilitating deployment of the implant 5600. For example, in at least some cases, the implant 5600 is deployed by causing relative movement between the sheath and the implant 5600 such that the implant 5600 is progressively unsheathed and allowed to radially expand. In these and other cases, the distal end portion 5603 may expand before other portions of the implant 5600. When this expansion begins, the distal end portion 5603 may not have an established connection to the airway region. If the counterpart of the distal end portion 5603 initiated and / or propagated a connection with the airway region at a single point, the force applied to the airway region at that point would potentially cause asymmetric expansion of the airway region. This, in turn, would potentially cause the counterpart of the distal end portion 5603 to move unpredictably during deployment, leading to potential trauma and / or suboptimal control of positioning. In contrast, referring again to FIG. 62 , the distal end portion 5603 can be configured to apply force (corresponding to arrows 5622) at a sufficient number of circumferentially spaced portions of the airway region to cause a relatively uniform expansion of the airway region, thereby reducing potential trauma and / or improving control of positioning. After its deployment, the distal end portion 5603 can anchor the implant 5600 such that further radial expansion of the implant 5600 does not cause trauma or unduly compromise control of the positioning of the implant 5600, even if such further expansion propagates along a relatively small number of points and / or relatively circumferentially non-equilibrium points.

[0215] Implant geometry and contact density 63 is a profile view of an implant 6300 in an unconstrained state, in accordance with at least some embodiments of the present technology, juxtaposed with a schematic diagram illustrating certain geometric aspects of the implant 6300. The implant 6300 is generally similar to the implant 5600 described above, except that the implant 6300 has fewer turns and different wire termination features. Referring to FIGS. 56A-56F together, the implant 6300 is shown at least generally including a longitudinal axis 5601 of the implant 5600, a proximal end portion 5602, a distal end portion 5603, an intermediate portion 5604, a wire 5605, a wire path 5606, a circumferential direction 5612, a first section 5614, a second section 5616, a first apex portion 5618, a first apex 5619, a second apex portion 5620, and a second apex 5621, respectively. 1, may include or define a longitudinal axis 6301, a proximal end portion 6302, a distal end portion 6303, an intermediate portion 6304, a wire 6305, a wire path 6306, a circumferential direction 6312 (as shown in the page and curved), a first section 6314, a second section 6316, a first apex portion 6318, a first apex 6319, a second apex portion 6320, and a second apex 6321.

[0216] 63, the wire path 6306 is shown in a two-dimensional unwound representation, with portions of the wire path 6306 corresponding to three successive turns 6322 (individually identified as turns 6322a-6322c) of the wire path 6306 in the intermediate portion 6304. The vertical axis in the schematic diagram corresponds to circumferential position and spacing in the circumferential direction 6312 about the longitudinal axis 6301. The horizontal axis in the schematic diagram corresponds to longitudinal position and spacing along the longitudinal axis 6301. The implant 6300 can define a length 6324 along the longitudinal axis 6301, a pitch 6326 along the longitudinal axis 6301, and a diameter 6328 perpendicular to the longitudinal axis 6301. In the schematic diagram, a first section 6330 of the wire path 6306 corresponds to the length of the first section 6314. Similarly, the second section 6332 of the wire path 6306 corresponds to the length of the second section 6316. For simplicity, the first and second sections 6330, 6332 are represented as straight lines between adjacent first and second vertices.

[0217] In the illustrated embodiment, the length 6324 is approximately 50 mm, the average pitch 6326 at the intermediate portion 6304 is approximately 8.1 mm, and the average diameter 6328 is approximately 10 mm. In other embodiments, these dimensions can vary. For example, the corresponding length 6324 can be in a range of 50 mm to 200 mm, such as 70 mm to 200 mm or 70 mm to 120 mm. Alternatively, the corresponding length 6324 can be less than 50 mm or greater than 200 mm. The corresponding average pitch 6326 at the intermediate portion 6304 can be in a range of 4 mm to 12 mm, such as 6 mm to 12 mm or 6 mm to 10 mm. Alternatively, the corresponding average pitch 6326 can be less than 4 mm or greater than 12 mm. The corresponding average diameter 6328 can be in a range of 2 mm to 20 mm, such as 4 mm to 20 mm or 5 mm to 15 mm. Alternatively, the counterpart of the average diameter 6328 can be less than 2 mm or greater than 20 mm. In other embodiments, the counterpart of the implant 6300 can have yet other suitable dimensions.

[0218] Referring again to the illustrated embodiment, the average pitch 6326 at the distal end portion 6303 can be less than the average pitch 6326 at the middle portion 6304, which in turn can be less (e.g., 10% to 50% less) than the average pitch 6326 at the proximal end portion 6302. This pitch difference can correspond to a greater number of circumferentially spaced portions of the wire 6305 along which contact between the implant 6300 and the airway wall simultaneously propagates during deployment of the distal end portion 6303 relative to deployment of the middle portion 6304. Additionally or alternatively, this pitch difference can correspond to a greater degree of circumferential balance between the portions of the wire 6305 along which contact between the implant 6300 and the airway wall simultaneously propagates during deployment of the distal end portion 6303 relative to deployment of the middle portion 6304. As discussed above, the number of contact areas and / or the circumferential balance of these contact areas can be useful to reduce potential trauma during deployment of the implant and / or improve positioning control.

[0219] The pitch 6326 can also relate to performance characteristics of the implant 6300, such as improving mucociliary clearance. In at least some cases, the implant 6300 is configured to define an unobstructed mucociliary clearance region that extends along a continuous mucociliary clearance pathway 6334 from a location just distal to the implant 6300 to a location just proximal to the implant 6300 while the implant 6300 is deployed at a treatment location within the bronchial tree of a human subject. As shown in FIG. 63 , the mucociliary clearance pathway 6334 can extend between successive turns of the wire pathway 6306. The average width of the mucociliary clearance region, parallel to the longitudinal axis 6301, can significantly exceed the average cross-sectional diameter of the wire 6305, perpendicular to the wire pathway 6306. This can correspond to a synergistic combination of a relatively small contact area between the implant 6300 and the airway wall, thereby providing a foreign body response and a relatively large area available for mucociliary clearance. These features, alone or together, can increase (potentially indefinitely) the amount of time the airway region during which the implant 6300 is deployed remains patent. In at least some cases, the average width of the mucociliary clearance region, parallel to the longitudinal axis 6301, is at least 10 times (e.g., in the range of 10-20 times) the average cross-sectional diameter of the wire 6305, perpendicular to the wire path 6306. Additionally or alternatively, the average pitch 6326 can be in the range of 50%-110% (e.g., 70%-90%) of the average diameter 6328. This can be true, for example, in the mid-section 6304 and / or throughout the entire implant 6300.

[0220] The implant 6300 can be configured to transition elastically from a low-profile delivery state to an expanded, deployed state. The mean diameter 6328 can vary significantly between these states. Using non-binding theory, the inventors have found that this feature has great potential for promoting the establishment and maintenance of a patent airway. The expansion of the airway well beyond its natural diameter creates a relatively large free passage area that is less likely, or at least more slowly, to become blocked due to mucus plugging or granulation tissue accumulation. In some embodiments, the mean diameter 6328 when the implant 6300 is in the deployed state is at least three times (e.g., at least 3.5 times, at least 4 times, at least 4.5 times, or at least 5 times) the mean diameter 6328 when the implant 6300 is in the delivery state. In these and other embodiments, the average diameter 6328 when the implant 6300 is in the illustrated unconstrained state is at least four times (e.g., at least 4.5 times, at least 5 times, at least 5.5 times, or at least 6 times) the average diameter 6328 when the implant 6300 is in the delivery state. Additionally, the ratio of the average diameter 6328 to the length 6324 can be in the range of 1:5 to 1:30, such as 1:10 to 1:30.

[0221] In the illustrated embodiment, the diameter 6328 is consistent throughout the length 6324. In at least some cases, the diameter 6328 varies by no more than 5% or no more than 10% throughout the length 6324. Relatedly, the average diameter 6328 at the proximal end portion 6302 can differ by no more than 5% or no more than 10% from the average diameter 6328 at the distal end portion 6303. This may be counterintuitive because the distal end portion 6303 is configured to be deployed in a more distal portion of the bronchial tree than the proximal end portion 6302. More distal airway regions of the bronchial tree are typically narrower than more proximal portions. However, having the diameter 6328 relatively consistent throughout the length 6324 can be beneficial for establishing and / or maintaining airway patency. For example, it may be beneficial for the degree of relative hyperexpansion of the walls of the airway region to be greater distally than proximally. This is expected to follow from deployment of an implant of consistent diameter within distally narrowing airway regions. Other advantages are also possible. Furthermore, in other embodiments, the diameter 6328 may be inconsistent along the length 6324. For example, the diameter 6328 may increase or decrease along the length 6324. In these cases, the average diameter 6328 of the counterpart proximal end portion 6302 can be smaller or larger than the average diameter 6328 of the counterpart distal end portion 6303.

[0222] Referring again to FIG. 63 , the first apex portion 6318 in the intermediate portion 6304 can define a first helix 6336. Similarly, the second apex portion 6321 in the intermediate portion 6304 can define a second helix 6338. In at least some cases, the longitudinal axis 6301 is an axis of symmetry about which the first and second helices 6336, 6338 are wound. The implant 6300 can define a first helical band 6340 between the first helix 6336 and the second helix 6338. In the illustrated embodiment, successive windings of the first helical band 6340 are spaced from one another along the longitudinal axis 6301 such that the implant 6300 defines a second helical band 6342 that is intertwined with the first helical band 6340. In at least some cases, the average width of the first helical band 6340 is within a range of 30% to 75% of the average pitch 6326 in the intermediate portion 5604 when the implant 6300 is in the deployed state. As the implant 6300 transitions from the delivery state toward the deployed or unconstrained state, the average width of the first helical band 6340 parallel to the longitudinal axis 6301 can decrease, and the average width of the second helical band 6342 parallel to the longitudinal axis 6301 can increase. Conversely, as the implant 6300 transitions from the deployed or unconstrained state toward the delivery state, the average width of the first helical band 6340 parallel to the longitudinal axis 6301 can increase, and the average width of the second helical band 6342 parallel to the longitudinal axis 6301 can decrease.

[0223] In some cases, it is useful for the second helical band 6342 to still be present when the implant 6300 is in the delivery state. In other words, in these cases, it may be useful for successive turns of the first helical band 6340 to be spaced apart from one another along the longitudinal axis 6301 when the implant 6300 is in the d...

Claims

1. 1. An implant configured to be deployed at a treatment site within a bronchial airway of a human subject, the implant comprising: a proximal portion and a distal portion, the distal portion spaced apart from the proximal portion along a longitudinal axis of the implant, the proximal portion configured to be positioned within a proximal region of the bronchial airway, and the distal portion configured to be positioned within a distal region of the bronchial airway, the distal region comprising more generations than the proximal region; a single wire extending along a continuous helical wire path, the single wire having an untethered proximal end at an end of the proximal portion and an untethered distal end at an end of the distal portion; Equipped with the wire path comprises a series of unbroken windings, each winding comprising first and second sections alternating along the wire path, the first sections extending in a distal direction and the second sections facing in a proximal direction, at least one first section and at least one second section meeting at an apex portion facing in a longitudinal direction along the longitudinal axis; the implant includes a continuous opening extending between the turns of the wire path from the end of the proximal portion to the end of the distal portion; The implant is configured to resiliently transition from a low-profile delivery state to an expanded, unconstrained state, the implant having a first average diameter in the low-profile delivery state and a second average diameter in the expanded, unconstrained state, the second average diameter being at least three times larger than the first average diameter.

2. The implant of claim 1 , wherein the wire is untethered along the wire path.

3. The implant of claim 1 , wherein the average length of the first section is different from the average length of the second section.

4. An implant as described in claim 1, wherein the second average diameter is at least four times larger than the first average diameter.

5. The implant of claim 1 , wherein the implant has a substantially constant diameter between the distal and proximal portions when in the expanded, unconstrained state.

6. The implant of claim 1, wherein the distal portion has a third mean diameter in the expanded, unconstrained state, the proximal portion has a fourth mean diameter in the expanded, unconstrained state, and the implant is configured such that the ratio of the third mean diameter to the mean natural diameter of the distal region of the bronchial airway exceeds the ratio of the fourth mean diameter to the mean natural diameter of the proximal region of the bronchial airway.

7. The implant described in claim 1, wherein the distal portion has a third average diameter in the expanded, unconstrained state and the proximal portion has a fourth average diameter in the expanded, unconstrained state, the third average diameter differing from the fourth average diameter by no more than about 5%.

8. The implant of claim 1 , wherein each of the proximal and distal ends comprises an atraumatic element.

9. 10. The implant of claim 1, wherein the wire path comprises a winding density of at least 3 turns per 25.4 millimeters along the longitudinal axis of the implant.

10. 2. The implant of claim 1, wherein the wire comprises first and second apex portions alternately arranged along the wire path, the first and second apex portions including the apex portion facing in the longitudinal direction, the first apex portion facing in a distal direction and the second apex portion facing in a proximal direction.

11. 11. The implant of claim 10, wherein the wire path comprises at least three turns, and wherein the first apex portions of the at least three turns are within 5 degrees of circumferential alignment with each other and the second apex portions of the at least three turns are within 5 degrees of circumferential alignment with each other both when the implant is in the low-profile delivery state and when the implant is in the expanded, unconstrained state.

12. The first apex portion defines a first spiral; the second apex portion defines a second helix; 11. The implant of claim 10, wherein the implant comprises a helical band defined between the first helix and the second helix, successive windings of the helical band being spaced apart along the longitudinal axis of the implant when the implant is in the expanded, unconstrained state.

13. An implant as described in claim 12, wherein the wire occupies approximately 5% to approximately 30% of the total area of ​​the spiral band portion when the implant is in the expanded, unconstrained state.

14. 11. The implant of claim 10, wherein the first and second apex portions comprise a structural bond, the structural bond consisting of the single wire.

15. 2. The implant of claim 1, wherein the continuous openings form a mucociliary clearance region having an average width at least 10 times greater than the average cross-sectional diameter of the wire, the average width being measured parallel to the longitudinal axis of the implant.

16. 10. The implant of claim 1, wherein the average pitch of the wire paths when the implant is in the expanded, unconstrained state is about 50% to about 110% of the average diameter of the implant when the implant is in the expanded, unconstrained state.

17. An implant as described in claim 1, wherein the ratio of the radial spring constant of the implant to the longitudinal spring constant is from about 10:1 to about 80:

1.

18. 10. The implant of claim 1, wherein the ratio of the radial spring constant of the implant in Newton meters to the longitudinal shear modulus of the implant in Pascals is from about 0.005 to about 0.

100.

19. 10. The implant of claim 1, wherein the ratio of the longitudinal spring constant of the implant in Newton meters to the longitudinal shear modulus of the implant in Pascals is from about 0.5 to about 5.

0.

20. 1. An implant configured to be deployed at a treatment site within a bronchial airway of a human subject, the implant comprising: a proximal portion and a distal portion, the distal portion spaced apart from the proximal portion along a longitudinal axis of the implant, the proximal portion configured to be positioned within a proximal region of the bronchial airway, and the distal portion configured to be positioned within a distal region of the bronchial airway, the distal region comprising more generations than the proximal region; a single wire extending along a continuous helical wire path, the single wire having an untethered proximal end at an end of the proximal portion and an untethered distal end at an end of the distal portion; Equipped with the wire path comprises a series of unbroken windings, each winding comprising first and second sections alternating along the wire path, the first sections extending in a distal direction and the second sections facing in a proximal direction, at least one first section and at least one second section meeting at an apex portion facing in a longitudinal direction along the longitudinal axis; the implant is configured to resiliently transition from a low-profile delivery state to an expanded, unconstrained state, the implant having a first average diameter in the low-profile delivery state and a second average diameter in the expanded, unconstrained state, the second average diameter being at least three times larger than the first average diameter; The implant, wherein the ratio of the second average diameter to the length of the implant between the proximal end and the distal end is from about 1:5 to about 1:

30.

21. 21. The implant of claim 20, wherein the average length of the first section is different from the average length of the second section.

22. 21. The implant of claim 20, wherein the implant has a substantially constant diameter between the distal and proximal portions when in the expanded, unconstrained state.

23. The implant of claim 20, wherein the distal portion has a third mean diameter in the expanded, unconstrained state and the proximal portion has a fourth mean diameter in the expanded, unconstrained state, and the implant is configured such that the ratio of the third mean diameter to the mean natural diameter of the distal region of the bronchial airway exceeds the ratio of the fourth mean diameter to the mean natural diameter of the proximal region of the bronchial airway.

24. the wire includes first and second apex portions alternating along the wire path, the first apex portion facing a distal direction and the second apex portion facing a proximal direction; the first apex portion defines a first helix; the second apex portion defines a second helix; 21. The implant of claim 20, wherein the implant comprises a helical band defined between the first helix and the second helix, successive windings of the helical band being spaced apart along the longitudinal axis of the implant when the implant is in the expanded, unconstrained state.

25. An implant as described in claim 24, wherein the wire occupies approximately 5% to approximately 30% of the total area of ​​the spiral band portion when the implant is in the expanded, unconstrained state.

26. An implant as described in claim 20, wherein the implant has a continuous opening extending between the turns of the wire path, the continuous opening forming a mucociliary clearance region having an average width at least 10 times greater than the average cross-sectional diameter of the wire, the average width being measured parallel to the longitudinal axis of the implant.

27. 21. The implant of claim 20, wherein the average pitch of the wire paths when the implant is in the expanded, unconstrained state is about 50% to about 110% of the average diameter of the implant when the implant is in the expanded, unconstrained state.

28. An implant as described in claim 20, wherein the ratio of the radial spring constant of the implant to the longitudinal spring constant is from about 10:1 to about 80:

1.

29. 21. The implant of claim 20, wherein the ratio of the radial spring constant of the implant in Newton meters to the longitudinal shear modulus of the implant in Pascals is from about 0.005 to about 0.

100.

30. 21. The implant of claim 20, wherein the ratio of the longitudinal spring constant of the implant in Newton meters to the longitudinal shear modulus of the implant in Pascals is from about 0.5 to about 5.0.

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