Improved airflow in the lungs

Abstract

To provide devices, systems and methods for improving an airflow within an airway.SOLUTION: A method for treating a subject includes (1) placing an expandable object in one or more airways of the bronchial tree of the subject, (2) expanding the expandable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is expanded, and (3) placing a stent in the airway such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.SELECTED DRAWING: Figure 8

Description

[Technical field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Non-provisional Patent Application No. 14 / 852,609, entitled "IMPROVING LUNG AIRFLOW," filed September 13, 2015, which is incorporated by reference in its entirety. [Background technology]

[0002] Obstructive pulmonary diseases, including emphysema, chronic bronchitis, asthma, and others, can result in various obstructions and / or narrowing of airways in the bronchial trunk. Airways affected by obstructive pulmonary diseases can include, for example, any of the trachea, main bronchi, lobar bronchi, segmental bronchi, subsegmental bronchi, bronchioles, conducting bronchioles, terminal bronchioles, and respiratory bronchioles. Airway obstruction can include the formation of mucus in the airway and / or the formation of scars in the airway. Airway narrowing can be characterized by, among other examples, loss of radial tension of the airway, thickening of the airway wall, and / or bronchoconstriction. Additionally, obstructive pulmonary diseases can lead to the collapse of alveolar walls.

[0003] As the airways or alveoli become damaged, patients find it increasingly difficult to exhale. Among other effects of the disease, patients suffering from obstructive pulmonary disease may also face loss of muscle strength and an inability to perform common daily activities. More detailed aspects of obstructive pulmonary disease, including additional aspects of the lungs, bronchial trunk, and airways, are further described below.

[0004] There have been many attempts to treat and / or improve the damage of the bronchial trunk caused by obstructive pulmonary disease. Other attempts have been made to relieve the blockage and / or stenosis caused by obstructive pulmonary disease. Still other attempts have been made to improve the airflow into and out of the alveoli of the lungs. However, so far, these attempts have faced many challenges.

[0005] Some treatments include placing prostheses, such as conventional stents, in the central airways (i.e., trachea, main bronchi, lobar bronchi, and / or segmental bronchi) in an attempt to maintain the patency of these airways. Unfortunately, the central airways contribute only a portion of the total airway obstruction and / or narrowing seen in patients with obstructive pulmonary disease. Furthermore, when prostheses are placed in the bronchial airways, they are subject to obstruction problems, including the formation of granulation tissue and mucus plugs. Thus, treatments involving the placement of conventional stents in the airways often result in only short-term improvement for the patient, as the stents eventually become obstructed.

[0006] Other treatments include attempts to bypass the blocked bronchial airways by creating a hole through the chest wall in the outer portion of the lung, thereby creating a direct connection (i.e., bypass ducts) between the diseased alveoli and the outside of the body. Without other measures, these bypass ducts will close due to normal healing or the formation of granulation tissue. Treating physicians may attempt to extend the duration of patency by placing a tubular hollow prosthesis within the bypass duct. However, such a prosthesis may induce a foreign body reaction and accelerate the formation of granulation tissue, which may ultimately cause the bypass duct to become blocked. Moreover, performing such bypass surgery is difficult, time-consuming, uncomfortable, inconvenient, and debilitating for the patient.

[0007] Still other treatments include creating a perforation between a selected central airway, such as the main or lobar bronchi, and the diseased alveolus in an attempt to bypass the obstructed connecting airway. If no other measures are taken, the perforation usually heals and closes, minimizing the long-term effectiveness of such treatments. Attempts have been made to maintain the patency of the perforation by placing a supportive stent in the lumen of the perforation. The stent may also be covered with silicone and / or coated with an anti-proliferative drug to minimize the effects of the normal healing response and / or foreign body reactions, including the formation of granulation tissue. Unfortunately, however, these measures are usually insufficient, and the supportive stent again induces a foreign body reaction, including the formation of granulation tissue, which frequently occludes the stent and leads to closure of the perforation. Also, mucus produced by glands in the central airway frequently occludes the stent and leads to closure of the perforation.

[0008] These and other problems continue to plague existing treatments for obstructive pulmonary disease, and reliable methods of avoiding such problems have not yet been developed. Thus, it would be desirable to develop treatments that more reliably avoid the problems faced by existing treatments for the challenges posed by obstructive pulmonary disease, including exemplary truncal airway obstruction and narrowing. Summary of the Invention

[0009] The present disclosure includes various devices, systems and methods useful for improving airflow in the bronchial trunk and / or into and out of the alveoli of the lungs. In some instances, airways connecting the central airways to the alveoli are enlarged to improve airflow between the central airways and the alveoli. In some cases, the connecting airways connecting the central airways to the alveoli may be enlarged beyond their normal size to further improve airflow. In still other cases, when the airways are enlarged beyond their normal size, some walls of the airways may become perforated, allowing communication between additional alveoli adjacent to the connecting airways and the central airways.

[0010] A first aspect of the disclosure includes an open stent that, when placed in a patient's lungs, generally promotes airflow to and / or from certain alveoli and more central airways, and also promotes minimization and localization of granulation tissue formation. Advantageously, the open stent of the first aspect also takes advantage of collateral airflow between certain alveoli and surrounding alveoli that is normally present in the lung, prominent in obstructed lungs, and even more prominent in emphysema-bearing lungs. In particular, because the open stent improves airflow between certain alveoli and more central airways, more collateral airflow is also able to enter the central airways.

[0011] A second aspect of the disclosure includes an expandable object that, when placed in a patient's lungs, may expand one or more airways beyond their normal diameter. The expansion of the airway may cause perforation or rupture of the airway wall, thereby forming a direct communication between the airway and the surrounding alveoli, and the expansion of the airway may thereby increase airflow in and out of the airway, including from the alveoli surrounding the airway, as well as from the alveoli normally connected to the airway. In one example, the expandable object is an expansion balloon. In another example, the expandable object is an expansion cryoballoon. In another example, the expandable object is a wire basket. In another example, the expandable object is a stent in an open form. Other examples exist.

[0012] A third aspect of the present disclosure includes a method of treating a patient with a stent (in some instances, the stent in an open form) and an expandable object. According to such a method, the expandable object may be used to dilate one or more obstructed airways and / or to perforate or dehisce (i.e., open) the walls of the airways, after which a stent may be placed within the airways to further promote airflow within the airways. The stent may be placed indefinitely or may be removed after a given period of time.

[0013] In some instances, a stent may be used to improve airflow without the use of an expandable object, hi other instances, an expandable object may be used to improve airflow without the use of a stent.

[0014] As described in more detail below, the present disclosure also includes other aspects, some of which include and / or incorporate the above three aspects.

[0015] An exemplary embodiment includes a method of treating a subject, the method including: (1) placing an expandable object in one or more airways of the truncus bronchus of the subject, (2) expanding the expandable object in at least one of the one or more airways such that at least a portion of the wall of the one or more airways is expanded, and (3) placing the stent in the one or more airways such that a portion of the stent is adjacent to the portion of the wall of the one or more dilated airways. In some examples, the method includes: (1) placing an expandable object in two or more airways of a truncus bronchus of a subject, wherein a first end of the expandable object is located in the first airway of the truncus bronchus and a second end of the expandable object is located in a second airway of the truncus bronchus; (2) expanding the expandable object in at least two of the two or more airways such that at least a portion of a wall of the two or more airways is expanded; and (3) placing the stent in the at least two of the two or more airways such that a portion of the stent is adjacent to the portion of the wall of the two or more dilated airways.

[0016] Another exemplary embodiment includes a system for use in treating a subject, the system including: (1) an expandable object; (2) a stent; and (3) instructions for improving airflow in one or more airways of a truncus bronchus of the subject using the expandable object and the stent. The instructions for improving airflow in the airways of the truncus bronchus of the subject using the expandable object and the stent may, in one example, include: (a) positioning an expandable object in one or more airways of the truncus bronchus of the subject; (b) expanding the expandable object in at least one of the one or more airways such that at least a portion of the wall of the one or more airways is expanded; and (c) positioning the stent in the one or more airways such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.

[0017] These and other embodiments, aspects and advantages, as well as alternatives, will become apparent to those of ordinary skill in the art upon reading the following detailed description in conjunction with the appropriate accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1] 1 illustrates an exemplary patient embodiment.

[0019] [Diagram 2] 1 illustrates an embodiment of a distal portion of an exemplary truncus bronchus.

[0020] [Figure 3A] 1 illustrates an exemplary embodiment of a stent in an open configuration.

[0021] [Figure 3B] 1 illustrates an embodiment of a stent in an exemplary open configuration within an airway.

[0022] [Figure 4A] 1 illustrates an embodiment of an airway having an exemplary stent in an open configuration disposed within the airway. [Figure 4B] 1 illustrates an embodiment of an airway having an exemplary stent in an open configuration disposed within the airway.

[0023] [Figure 4C] 1 illustrates an embodiment of an airway having an exemplary stent in a closed configuration disposed within the airway. [Figure 4D] 1 illustrates an embodiment of an airway having an exemplary stent in a closed configuration disposed within the airway.

[0024] [Figure 5A] 1 illustrates an exemplary embodiment of a stent in an open configuration. [Figure 5B] 1 illustrates an exemplary embodiment of a stent in an open configuration.

[0025] [Figure 5C] 1 illustrates an embodiment of a stent in an exemplary open configuration within an airway.

[0026] [Figure 6A] 1 illustrates aspects of an example extensible object. [Figure 6B] 1 illustrates aspects of an example extensible object.

[0027] [Figure 7A] 1 illustrates an embodiment of an expandable object within an airway. [Figure 7B] 1 illustrates an embodiment of an expandable object within an airway.

[0028] [Figure 7C] 1 illustrates aspects of an example extensible object.

[0029] [Figure 8] 1 illustrates an exemplary method for improving airflow in an airway.

[0030] [Figure 9A] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 9B]1 illustrates an exemplary embodiment of an exemplary method. [Figure 9C] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 9D] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 9E] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 9F] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 9G] 1 illustrates an exemplary embodiment of an exemplary method.

[0031] [Figure 10A] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 10B] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 10C] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 10D] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 10E] 1 illustrates an exemplary embodiment of an exemplary method. [Figure 10F] 1 illustrates an exemplary embodiment of an exemplary method.

[0032] [Figure 11] 1 illustrates an exemplary method for improving airflow in an airway.

[0033] [Figure 12] 1 illustrates an exemplary method for improving airflow in an airway.

[0034] [Figure 13] An exemplary treatment protocol is shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] In the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. In these drawings, like symbols typically identify like components unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the invention(s) set forth herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings, may be organized, substituted, combined, separated, and / or designed in a variety of different configurations, all of which are contemplated herein.

[0036] The devices, systems and methods described herein may be used to improve airflow in the truncus bronchus. More specifically, some of the devices, systems and methods described herein include stents and expandable objects that may be used to improve airflow in the truncus bronchus airway of a patient. However, it should be understood that such application is only one particular application of the devices, systems and methods described herein, and that other applications are certainly possible.

[0037] In general, the devices, systems and methods described herein may provide improved airflow in a manner that is relatively effective, efficient and redundant when compared to other techniques. As an example, the devices, systems and methods described herein may minimize granulation tissue and / or minimize blockage problems associated with other known techniques involving the use of foreign bodies. The devices, systems and methods described herein may also avoid certain discomforts and inconveniences associated with some known techniques involving the use of bypass pathways. Thus, many of the shortcomings of other techniques aimed at attempting to improve airflow may be avoided. 1. [Example patient]

[0038] For purposes of illustration and explanation, Figure 1 depicts an embodiment of an example patient 100. As shown, present within the patient 100 is a lung 102. Generally, a treating physician may access the lung 102 via the patient's trachea 104, perhaps with a bronchoscope, catheter, or other such delivery device introduced into the patient's trachea through the mouth or nose.

[0039] The patient's lungs include a portion of the patient's truncus 106. The truncus 106 includes a number of airways, including central airways such as the left and right main and lobar bronchi, intermediate airways such as a number of segmental and subsegmental bronchi, and non-central peripheral airways such as the bronchioles, conducting bronchioles, terminal bronchioles, and respiratory bronchioles, which are described further below.

[0040] The illustrated exemplary truncus also includes a diseased portion 108 located at the end of the truncus. In some exemplary circumstances, the diseased portion 108 may be understood to be affected by an obstructive pulmonary disease, such as emphysema, among other examples.

[0041] The lesion may be characterized as damage that impairs the passage of air between the airways and the alveoli, ultimately impairing the passage of gases in and out between the air outside the patient and the patient's lungs and bloodstream. For example, certain airways within the lesion may be blocked, narrowed, and / or otherwise constricted. At the same time, the alveolar walls within the alveoli of the lesion may be disrupted.

[0042] To fully understand the deleterious effects of obstructive pulmonary disease, a review of the function of the lungs may be useful. One function of the lungs is to remove carbon dioxide from the blood and exchange it for oxygen, thereby allowing the exchange of the two gases. To facilitate this gas exchange, the lungs transfer oxygen and carbon dioxide between the air outside the patient's body and the blood by bulk conduction from the bronchial trunk to the alveoli and by diffusion across the blood-gas interface within the patient's alveoli.

[0043] Air is transported through the patient's truncus bronchiolar airways to the patient's alveoli and contained within the patient's lungs. The truncus bronchiolar airways include branching airways that become narrower, shorter and more numerous as the truncus bronchiolar airways penetrate deeper into the lungs. As noted above, the trachea branches into left and right main bronchi, which differentiate into numerous conducting airways, beginning with the lobar bronchi, intermediate airways such as segmental and subsegmental bronchi, peripheral airways such as bronchioles, conducting bronchioles, and finally terminal bronchioles.

[0044] Each terminal bronchiole gives rise to several respiratory bronchioles, which divide into multiple alveolar ducts, the number of which often ranges from 2 to 11. Figure 2 shows an embodiment of the distal portion of an exemplary truncus bronchioles, including examples of such smaller bronchioles.

[0045] The exemplary truncus bronchioles 200 include bronchioles 202 that divide into terminal bronchioles 204. The terminal bronchioles 204 then divide into respiratory bronchioles 206. Also shown are exemplary alveoli 208, which include alveolar sacs 210. As shown, various alveoli 212 may also be present along the length of the respiratory bronchioles 206.

[0046] The terminal bronchioles 204 are the smallest airways that do not contain alveoli. The function of the bronchi and bronchioles is to provide conducting airways that convey air to and from the alveoli. However, the conducting airways do not contain alveoli and do not participate in gas exchange. Rather, gas exchange occurs in the alveoli, which begin at the respiratory bronchioles, located distal to the conducting airways.

[0047] It is common to refer to or characterize the various airways of the truncus by "generation." For example, the trachea is referred to as "generation 0" of the truncus. The various levels of the bronchi, including the left and right main bronchi, are referred to as "generation 1." The lobar bronchi are referred to as "generation 2." The segmental bronchi are referred to as "generation 3." The various bronchioles are referred to as "generations 4 through 19." For example, the terminal bronchioles are approximately "generations 14-18." For example, the respiratory bronchioles are approximately "generations 16-20." Additionally, it is common to refer to the airways extending from the trachea to the terminal bronchi as "conducting airways."

[0048] Obstructive lung diseases, especially emphysema, are characterized by irreversible destruction of the alveolar walls, which contain elastic fibers that maintain outward radial traction on the small airways and are useful in inhalation and exhalation. When these elastic fibers are damaged, these small airways are no longer subjected to outward radial traction and may shrink, especially during exhalation. Therefore, when these fibers are damaged, air may become trapped in the lungs and cannot be completely expelled during exhalation. Emphysema leads to hyperinflation of the lungs (air trapping) and the inability of the person to exhale. In this situation, the lungs cannot exchange gases at a satisfactory rate, and the lungs become hyperinflated, pressuring the chest wall, diaphragm, and surrounding structures, causing the person to become weak.

[0049] A further aspect of the destruction of the alveolar walls is increased airflow between nearby air sacs, known as collateral ventilation or collateral airflow, however this alone provides little or no benefit to the patient as air is still unable to flow in and out of the lungs through the narrowed and blocked airways.

[0050] Chronic bronchitis is characterized by excessive mucus production in the bronchial trunk. There is usually a generalized large enlargement (hypertrophy) of the larger bronchi and inflammatory changes in the smaller airways. Excessive amounts of mucus are found in the airways, and semi-solid plugs of mucus can obstruct the smaller bronchi. The smaller airways are also usually narrowed and exhibit inflammatory changes.

[0051] Generally, the devices, systems and methods described herein may be used to improve airflow from hyperinflated alveoli in diseased portions of the lungs 108 affected by obstructive pulmonary disease, such as emphysema and / or bronchitis, to the central airways of the bronchial trunk. Thus, exemplary stents and expandable objects, described in more detail below, may be delivered to and positioned within airways connecting the central airways to the distal airways and alveoli of diseased portions 108. 2. [Illustrative open stent]

[0052] FIG. 3A illustrates an embodiment of an exemplary open configuration stent 300. As illustrated, the open configuration stent may generally have an open configuration in the form of a coil-like structure or a spring-like structure. The coil may be understood to be characterized by a continuous outer diameter. For purposes of illustration and explanation herein, the outer diameter of the coil may sometimes be referred to as the "open configuration wall." It should be understood that as a result of the open configuration of the stent, no portion of the open configuration stent completely separates a given region of the open configuration wall. In other words, the open configuration wall comprises a continuous open helical surface, which will be described in more detail below in connection with FIGs. 4A and 4B.

[0053] 3B illustrates an embodiment of a stent 352 in an open configuration within an airway 350. One of skill in the art will appreciate that the surface of the airway 350 may be characterized by mucociliary structures (or "elevators") on its interior walls that can clear mucus within the airway. The mucociliary structures may include cilia that continuously move mucus along the airway and ultimately to the exterior of the airway. Because no portion of the stent 350 in an open configuration completely isolates a given area of ​​the interior wall of the airway 350, generally the natural mucociliary processes of the airway may not be inhibited with the stent in an open configuration in place.

[0054] As described in more detail below with reference to Figures 4C and 4D, a conventional closed stent configuration may impede the function of the mucociliary structures by preventing full exposure of mucus to the mucociliary structures and / or by blocking certain areas of the airway wall, such that mucus cannot advance any further along the airway. However, the open stent configuration shown in Figures 3A and 3B allows exposure of the airway wall to the interior of the airway even when the stent is deployed in place, and does not completely block the mucociliary structures in any one direction. Thus, even when the open stent configuration is deployed in place, the mucociliary structures may continue to facilitate the removal of mucus along a helical path extending through the center of the coil.

[0055] As another advantage, the open stent may be characterized by a certain amount of flexibility and recoil, so that the open stent minimizes mechanical toxicity in the airway, especially when expanding across multiple airways. Given the flexibility of the open stent, the stent may bend and move with the airway, thereby minimizing foreign body reaction in the airway. As a result, the open stent minimizes inflammation and minimizes the formation of granulation tissue in the airway. Furthermore, any inflammation and granulation tissue that does form is concentrated near the contact of the stent with the airway wall, so that air and / or mucus can still move along the airway in the open spiral space of the stent.

[0056] As yet another advantage, because an open configuration stent is characterized by open walls that do not close off the exterior of the stent from the interior of the stent, the open configuration stent may allow collateral airflow from side passageways, such as guide perforations connecting to the alveoli or other surrounding alveoli, into the main lumen of the airway.

[0057] The stent in the open configuration may be made of any suitable material. For example, the stent in the open configuration may be made of a silicone polyester material. Examples include urethane, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and polyether ether ketone (PEEK). In other cases, the stent in the open configuration may be made of a metallic material. Examples include stainless steel and nitrile. Other examples of suitable materials exist.

[0058] The stent in the open configuration may be coated with one or more suitable coatings. In one example, the stent in the open configuration may be coated with an anti-proliferative agent, such as sirolimus, everolimus, zotarolimus, paclitaxel, taxotere, mitomycin-C, among others. In another example, the stent in the open configuration may be coated with an anti-mucolytic agent, such as atropine, ipratropium, tiotropium, or a steroid. In yet another example, the stent in the open configuration may be coated with a mucolytic material, such as N-acetylcysteine ​​or guaifenesin. In yet another example, the stent in the open configuration may be coated with a hydrophilic material. Other examples of suitable coatings exist.

[0059] 3A, an exemplary stent 300 in an open configuration has a given length 302, which may be any suitable length and may vary depending on the application, including the airway into which the stent in the open configuration will ultimately be placed. In one example, the length 302 may be in the range of 2 cm to 10 cm in length. For example, the length 302 may be approximately 6 cm in length. Other lengths may also be suitable.

[0060] 3A, the exemplary open stent 300 has a height or diameter 304, which may be any suitable diameter and may vary depending on the application, including the airway into which the open stent will ultimately be placed. In one example, the diameter 304 may be in the range of 1 mm to 10 mm. For example, the diameter may be in the range of 4 mm to 8 mm. In other cases, the diameter may be approximately 6 mm. Other diameters may also be suitable.

[0061] Additionally, the exemplary open configuration stent 300 may include hooks 306 at one or both ends. The hooks may be looped at one or both ends to form a closed configuration. Alternatively and / or additionally, the open configuration stent 300 may include smooth rounded balls at one or both ends. Such structures, such as hooks, loops, or balls, may be used to aid in accessibility and / or maneuverability of the open configuration stent during placement of the open configuration stent within an airway. Additionally, such structures may be used to limit trauma that the ends of the open stent may cause to tissue. For example, such structures may further limit the formation of granulation tissue, or such structures may prevent the formation of a pneumothorax if an end of the open configuration stent comes into contact with the visceral pleura, and / or such structures may prevent pain if an end of the open configuration stent comes into direct or indirect contact with the parietal pleura.

[0062] FIG. 4A illustrates an embodiment of a stent 402 in an open configuration within an airway 400. Also illustrated in FIG. 4A is a continuous helical path along the wall of the airway 400 that remains when the stent 402 in an open configuration is disposed within the airway 400. As indicated by the various arrows in FIG. 4A, a continuous helical path exists along the open wall of the stent in an open configuration, which allows relatively unhindered traversal movement of the inner wall of the airway along the helical path. As noted above, mucus may be removed along this helical path by the mucociliary structure of the airway 400. It should be noted that although the stent 402 in an open configuration is illustrated only within a single portion of the airway 400, it should be understood that the stent 402 in an open configuration may extend to other portions of the airway 400 and / or to other airways entirely.

[0063] FIG. 4B illustrates an embodiment of a stent 452 in an open configuration within an airway 450. Similar to the stent 402 in an open configuration, the stent 452 in an open configuration is characterized by a continuous helical pathway present along the wall of the open configuration. Also illustrated in FIG. 4B is the presence of granulation tissue along the structure of the stent 452 in the open configuration, as indicated by the various X indicators along the stent 452 in the open configuration. As shown, the formation of granulation tissue is localized along the structure of the stent in the open configuration itself. As a result, the continuous helical pathway along the wall of the open configuration remains intact. Thus, despite the formation of granulation tissue, the mucociliary structure of the airway 450 is not inhibited from functioning to clear mucus from the airway, and an unobstructed pathway for air movement along the airway remains intact.

[0064] FIG. 4C illustrates an embodiment of a closed stent 462 known in the art within an airway 460. In contrast to the exemplary open stent illustrated in FIGS. 4A and 4B, the closed stent 462 does not provide a continuous helical path along the wall of the airway 460. Instead, the structure of the closed stent 462 includes a wrapping structure along its length to inhibit movement across the inner wall of the airway. Although FIG. 4C illustrates a particular exemplary structure as a closed wire frame, one of ordinary skill in the art will appreciate that there are other known closed stents, including stents characterized as single-walled (non-wire frame).

[0065] FIG. 4D illustrates an embodiment of a stent 472 in a closed configuration within an airway 470. Similar to the closed stent 462, the closed stent 472 does not provide a continuous helical path along the wall of the airway 470. Also, as shown in FIG. 4D, granulation tissue is present along the structure of the closed stent 472, as indicated by the various X indicators along the closed stent (not all of the closed stent structure is shown to have typical granulation tissue). As shown, the granulation tissue formation is localized along the structure of the closed stent, but because the closed stent includes structures that cover it along its length, the granulation tissue formation also covers the length of the closed stent. Thus, unlike the open stent shown in FIGS. 4A and 4B, the formation of granulation tissue along the closed stent 472 further inhibits the mucociliary structures of the airway 470 from functioning to clear mucus from the airway.

[0066] 5A-5C show alternative exemplary open configuration stents. Figure 5A shows an exemplary open configuration stent 500 characterized as having relatively fewer turns per unit length than those shown above with reference to Figures 3A and 3B. In one implementation, the coil structure of the open configuration stent 500 may be combined with at least one additional coil structure to form an open configuration stent characterized by at least a double helical structure.

[0067] 5B shows an example of an exemplary double helical open stent 550. As shown, the exemplary open stent is formed of a first coil structure 552 and a second coil structure 554. In some embodiments, the first coil structure 552 and the second coil structure 554 may connect to one or both ends of the open stent, thereby forming a loop. Such a loop may aid in placement or removal, and may also eliminate potential sharp ends of the first coil 552 and the second coil 554, thereby reducing trauma that the open stent may cause to the airway and surrounding tissue. This double coil open stent may provide the same stent-airway wall contact area as a single coil open stent, however, it may provide less angularity of the multiple coil wires to the airway compared to the contact area provided by a single coil stent. Thereby, the dual coil open form stent may allow a more direct path for the movement of air and mucus along the airway, and indeed such a dual helix open form stent may be placed in the truncus bronchial airway to improve airflow.

[0068] 5C, a double helical open configuration stent 582 is positioned within airway 580. It should be noted that, although open configuration stent 582 is only shown within a single portion of airway 580, it should be understood that the open configuration stent may extend into other portions of airway 580 and / or into other airways entirely. 3. [Example dilatation balloon]

[0069] 6A illustrates an embodiment of an example expandable object 600. As illustrated, in general, the expandable object may be characterized as an elastically flexible sphere or other open body that encloses an interior space.

[0070] The expandable object 600 may have a closed first end 602 and an open second end 604. However, in another example, the first end may also be open. One or both open ends may be coupled to other expandable bodies or connecting objects, such as tubes, that allow communication of fluids, such as gases and / or liquids, into and out of the interior space of the expandable object 600.

[0071] The expandable object may be formed of any suitable material. For example, the expandable object may be formed of one or more of silicone, polyvinyl chloride (PVC), nylon, polyethylene terephthalate (PET), polyether block amide (PEBAX), mylar, and / or latex. Other example suitable materials exist.

[0072] The expandable object may be coated with any suitable material. For example, the expandable object may be coated with an anti-proliferative agent (such as taxotere, paclitaxel, and / or sirolimus, among other examples). Of note, generally, such anti-proliferative agents may help maintain patency of any dehiscences or perforations formed in the airway wall with the expandable object. In this manner, such anti-proliferative agents may help ensure the efficacy of treatment, especially when the treatment does not involve the placement of a stent. Additionally and / or alternatively, the expandable object may be coated with one or more of an anti-mucolytic agent, a mucolytic agent, and a hydrophilic agent. Other examples of suitable coatings exist.

[0073] With reference to Figure 6A, an expandable object 600 is shown in a relaxed state when not expanded. In comparison, with reference to Figure 6B, an example expandable object 650 is shown in an expanded state.

[0074] As described in more detail below, in operation, the expandable object may be placed in an airway, or in a number of connected airways that form a pathway from a more central airway to a more peripheral airway or alveoli, and then expanded, thereby causing the airway or the number of connected airways to also expand, and therefore the expandable object may sometimes be referred to herein as a "dilatation balloon."

[0075] In some applications, the dilatation balloon may be used intentionally to dilate a portion of an airway or a number of connected airways beyond its normal or natural diameter. In such circumstances, the dilatation balloon may perforate, rupture, or otherwise damage the wall of the airway or a number of connected airways. In some cases, the dilatation of the dilatation balloon operates to form a generally longitudinal tear in the wall of the airway or a number of connected airways. Of note, such longitudinal tears tend to run generally parallel to the blood vessels, which themselves tend to run along the length of the airway. As a result, trauma to the blood vessels themselves is minimized, and therefore bleeding is also minimized.

[0076] 7A and 7B show an example expandable object within an airway. With reference to FIG. 7A, the expandable object 700 is shown being introduced into the airway 702 in a relaxed state. With reference to FIG. 7B, the expandable object 700 is shown in an expanded state within the airway 702. As shown, the expandable object 700 causes the airway 702 to expand beyond its normal size and introduces an opening 704 in the wall of the airway 702. This effect may occur in the wall of a single airway or for one or more walls of multiple connected airways. It should be noted that although the expandable object 700 is only shown within a single portion of the airway 702, it should be understood that the expandable object 700 may extend into other portions of the airway 702 and / or into other airways entirely.

[0077] Although the exemplary expandable object is shown in the drawings as having a certain shape, other shapes may be possible. For example, the balloon may taper in size from one end to the other. As another example, the balloon may include a bulbous end that is relatively larger than other portions of the balloon body. As yet another example, the balloon may include two bulbous ends. As yet another example, the balloon may include one or more irregular mountings, such as protrusions or other ridges, on its outer surface that may concentrate the forces generated during pressurization and expansion of the balloon and may allow the balloon to more easily pierce the airway wall upon expansion. Generally, the irregular shape of the balloon may serve the purpose of expanding the airway in a desired manner to introduce a desired opening into the airway.

[0078] In some applications, the use of dilatation balloons described herein may differ from prior art uses of expandable objects in bronchial trunks, such as dilatation balloons used in bronchoplasty. For example, in bronchoplasty applications, expandable objects are typically placed in central airways, while dilatation balloons described herein may be used in more peripheral airways, such as those described above with reference to FIG. 2. As another example, in bronchoplasty applications, expandable objects are typically used to expand blocked airways to their normal size, while dilatation balloons described herein may be used to expand airways beyond their normal size, and in some instances may create openings in the airway wall or one or more connected airways. Thus, the openings introduced in the airway wall may help improve airflow between the alveoli and other more central airways.

[0079] Introducing openings, such as perforations and / or dehiscences, into the surface of the airway may result in exposing additional openings in the airway to the alveoli. In this manner, airflow within the airway to the alveoli may be advantageously increased. Furthermore, because small airways are characterized by relatively little mucosa, obstruction of the perforations and / or dehiscences will be minimized.

[0080] To this end, introduction of the dilation balloon into the small airways may be accomplished using a relatively quick and efficient medical procedure in which the dilation balloon may be placed directly into the airways through a bronchoscope placed in the trachea or other airway, through an endotracheal tube placed in the trachea, or through a laryngeal mask placed in the hypopharynx, among other access methods. In some instances, the procedure may be accomplished as an outpatient procedure. As such, the procedure may be much more convenient and much less intrusive than other techniques for improving airflow.

[0081] In one example, the expandable object may take the form of a cryoballoon. FIG. 7C illustrates several embodiments of an exemplary cryoballoon 780 fluidly coupled to a delivery catheter 782. As shown, the catheter 782 may include a fluid delivery passageway 784 and a fluid drain passageway 786. Each of the walls of the catheter 782, the fluid delivery passageway 784, and the fluid drain passageway 786 may be made of materials known to those of skill in the art. For purposes of illustration and explanation, the exemplary cryoballoon 780 embodiment has been simplified. The cryoballoon 780 may include other embodiments as will be understood by those of skill in the art.

[0082] In use, the cryoballoon 780 may be placed into a desired airway or multiple connected airways of a bronchial trunk. Coolant may then be released into the balloon from a pressurized cartridge, container and / or pump (not shown) through the fluid delivery passage 784 to cool the airway to an appropriate degree for the application. In some cases, the coolant may be sprayed into the balloon through the fluid delivery passage 784, a separate sprayer or other suitable element. The balloon may be inflated (e.g., with the coolant) to a desired pressure (corresponding to a desired size). As a result, the temperature of the airway may be reduced. The resulting temperature may be below body temperature, below 0° C., which may provide improved results, or well below 0° C., which may provide even further improved results. By reducing the temperature of the balloon well below 0° C., the temperature of the surrounding tissue may also be reduced well below 0° C. Lowering the temperature of the surrounding tissue below 0° C. dries the blood in the tissue and surrounding blood vessels, thereby stemming its flow and thereby destroying mucus cells in the airway walls, reducing the subsequent formation of granulation tissue and minimizing bleeding. The coolant may then be later evacuated from the balloon through fluid drain passage 786.

[0083] The inflation fluid is an ethanol mixture or a saline mixture, or N 2 O or CO 2 The liquid may be any suitable low freezing point liquid, such as a liquefied gas such as liquid N 2 may be used as a general purpose coolant. 2 When is used, N 2 may be delivered to the balloon in the liquid phase, and in the liquid phase, N 2 The fluorocarbon vaporizes at the exit of the fluid delivery passage 784 and enters the balloon as a gas. 2 O gas and CO 2 Gas may also be used as a coolant. Other coolants may be used, such as cold saline, Fluisol, or a mixture of saline and ethanol. Other example coolants exist.

[0084] Although the exemplary expandable object is described above as taking the form of an expansion balloon, this is not required. The expandable object may take other forms as well. In one alternative, the expandable object may take the form of a wire basket capable of being decompressed and compressed. Such a wire basket may be well suited to causing perforations and / or tears in the airway wall in addition to expanding the airway wall. 4. First Exemplary Method

[0085] FIG. 8 generally illustrates an exemplary method 800 for improving airflow in an airway.

[0086] For clarity, the method 800 in FIG. 8 may be described herein with reference to the above figures. However, it should be understood that this is for purposes of illustration and explanation only, and that the operation of the method is not limited by these figures. The method 800 may include one or more operations, functions, or acts as shown in one or more of the blocks in each figure. Although the blocks are shown in sequence, these blocks may be performed in parallel and / or in a different order than shown herein. Also, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired embodiment.

[0087] Generally, method 800 includes placing an expandable object in one or more airways of a truncobronchial tree of a subject at block 802. Block 804 includes expanding the expandable object in the airways. Block 806 includes placing a stent in the airways. As shown, additionally / optionally, method 800 may include identifying a lesion site to be treated at block 801.

[0088] Each of these blocks is described in more detail below. a. [Identify the area of ​​the lesion to be treated]

[0089] Block 801 involves identifying a lesion site to be treated. Block 801 allows a treating physician to identify a lesion site in a truncus bronchus using any suitable technique, including any such suitable technique known to one of skill in the art. In one example, a treating physician may identify a lesion site such as region 108 shown in FIG. b. [Place the expandable object into the subject's truncobronchial airway]

[0090] Block 802 includes placing an expandable object in one or more airways of a truncus bronchus of a subject. By block 802, the subject may be understood as a patient 100. In one example, the truncus bronchus may be a truncus bronchus 106, and one or more airways, or at least a portion of one or more airways, may be part of an airway or multiple connected airways within a diseased region 108 of the lung. In one example, block 802 includes placing an expandable object at the site of the disease identified in block 801.

[0091] In some examples, positioning the expandable object may include positioning the expandable object within two or more airways of the truncus bronchus of the subject, In such a situation, a first end of the expandable object is placed within the first airway of the truncus bronchus and a second end of the expandable object is placed within the second airway of the truncus bronchus.

[0092] The expandable object may be any suitable expandable object, including, but not limited to, any of the example expandable objects described above with reference to Figures 6A, 6B, 7A, 7B, and 7C.

[0093] In one example, the expandable object may include a dilatation balloon. In some examples, such a dilatation balloon may be a cryoballoon. In one example, the dilatation balloon may include a bulbous configuration at a distal end. In another example, the dilatation balloon may include at least a portion of its outer surface that is non-uniform. For example, the outer surface may include ridges and / or other protuberances to aid in dilatation and / or formation of openings in the airway wall.

[0094] In one example, positioning the expandable object may include positioning the expandable object using a delivery device, such as a catheter, a guidewire, a bronchoscope, or the like. In some examples, positioning the expandable object may additionally include identifying a target region of the diseased lung and directing the expandable region toward the target region such that at least a portion of the expandable object is located proximate the diseased portion of the lung. As will be appreciated by those skilled in the art, the expandable object may be attached to a distal end of a delivery catheter. The treating physician may then introduce the expandable object into the patient's trachea 104. The treating physician may then use the delivery catheter to guide the expandable object through the truncus bronchus and into the peripheral airways of the truncus bronchus. The distal end of the expandable object may ultimately be delivered to the peripheral diseased area 108 and into the respiratory bronchioles 206, while the proximal end of the expandable object remains within the more proximal airways, such as the terminal bronchioles, conducting bronchioles, bronchioles, subsegmental bronchi, segmental bronchi, or lobar bronchi.

[0095] 9A and 9B, aspects of block 802 are shown. With reference to Fig. 9A, an expandable object 900 is shown being guided into an airway 902. With reference to Fig. 9B, an expandable object 900 is shown positioned at a desired location in the airway 902.

[0096] As described above and further below with reference to FIGURE 9G, alternative placements of the expandable object may include placing the expandable object within a truncus bronchus such that the expandable object spans multiple types of airways. For example, as shown in FIGURE 9G, an expandable object 912 is placed within a truncus bronchus 910 such that a distal end of the expandable object 912 is placed within a respiratory bronchiole and a proximal end extends proximally to the larger, more central airways. c. Expanding an expandable object within the airway

[0097] Block 804 includes expanding the expandable object within the airway such that at least a portion of the airway or at least a portion of a plurality of connected airways is expanded. In some cases, as a result of the expansion of the expandable object, at least one opening is formed in a wall of the airway.

[0098] In some examples, expanding the expandable object may include expanding the expandable object in at least two of the two or more airways such that at least a portion of a wall of the two or more airways is expanded.

[0099] As described above, the expandable object may be expanded by introducing a fluid, such as a liquid and / or a gas, into the expandable object. For example, in one example where the expandable object is a cryoballoon, the cryoballoon may be expanded by introducing a fluid, such as a liquid and / or a gas, into the expandable object. 2 It may be expanded by introducing O into the cryoballoon.

[0100] 9C, an embodiment of block 804 is illustrated. As shown in FIG. 9C, the expandable object 900 is expanded such that the airway 902 is expanded beyond its normal size. As a result, in the particular example illustrated, the expandable object tears the airway 902 open such that an opening now exists in the airway wall.

[0101] Although a breach is shown formed in the airway 902, it should be understood that in all embodiments an opening is not required, and in some embodiments it may be desirable and / or sufficient to allow the airway to expand without breaching it.

[0102] Additionally, although a single breach is shown formed in the airway 902, it should be understood that more than one breach may be formed, i.e., block 804 may include forming at least one opening in the airway wall.

[0103] 9G, the expandable object 912 may be expanded such that multiple regions of the airway of the truncus bronchus 910 are expanded, in which case multiple lacerations and / or perforations may be formed in multiple regions of the airway.

[0104] In some embodiments, after the expandable object is expanded, the expandable object may then be removed. As shown with reference to Figure 9D, the expandable object 900 is returned to a relaxed state. The expandable object 900 may then be guided out of the airway, back through the truncus bronchus, and out the patient's trachea. d. [Placing a stent in the airway]

[0105] Block 806 includes positioning a stent within the airway such that a portion of the stent is adjacent a portion of a wall of the one or more dilated airways. In an embodiment in which an airway wall has been disrupted by block 804, positioning the stent may include positioning the stent within the airway such that a portion of the stent is adjacent at least a portion of an opening in the wall of the airway.

[0106] In some examples, placing the stent may include placing the stent in at least two of the two or more airways such that a portion of the stent is adjacent to a portion of the two or more dilated airways.

[0107] The stent may be any suitable stent, including, but not limited to, any of the stents in open configuration described above with reference to Figures 3A, 3B, 4A, 4B, 5A, 5B and 5C.

[0108] For example, at least a portion of the stent in the open configuration may include a coil. In some cases, the stent may include both a first coil and a second coil.

[0109] In one example, the open configuration stent has an open configuration wall as described above, in such an example, for at least a certain length of the open configuration stent, no portion of the open configuration wall completely separates a given region of the open configuration wall, and thus the open configuration wall may have a continuous open helical surface along its length.

[0110] Although the examples described herein include deployment of a stent in an open configuration, it should be understood that in some cases the method may be performed with a more traditional closed stent, in which case block 806 may include deploying the stent in a closed configuration.

[0111] 9E and 9F, aspects of block 806 are shown. Referring to FIG. 9E, a stent 904 is shown in an open configuration being guided into airway 902. As shown, the open stent may be held in a compressed configuration to aid in maneuverability through the truncus while being guided into position. Referring to FIG. 9E, the stent 904 is shown in an open configuration positioned at a desired location in airway 902 and ready to expand. As shown, the stent 904 in an open configuration is positioned adjacent an opening in airway 902.

[0112] The stent 904 in its open configuration may then be left in the airway indefinitely and / or until the treating physician decides to remove the stent in its open configuration. Alternatively, the stent in its open configuration may be placed temporarily and removed after a certain pre-determined period of time. In this manner, removal of the stent in its open configuration may leave an open tissue tract between the central airway and the alveoli.

[0113] In the above example, one embodiment of method 900 is described where the expandable object is removed from the airway before the stent is placed in the airway. However, this is not required. In another embodiment of method 900, the expandable object may be placed together with the stent. Exemplary aspects of such an embodiment are illustrated with reference to Figures 10A, 10B, 10C, 10D, 10E, and 10F.

[0114] 10A, prior to placement of the expandable object 1000, a stent 1002 may be positioned to surround at least a portion of the expandable object. In this manner, the expandable object 1000 and the stent 1002 form a package that may be guided together into the airway.

[0115] 10B, the package of expandable object 1000 and stent 1002 may then be guided into the airway 1004. As shown in FIG 10C, the package of expandable object 1000 and stent 1002 is positioned at a desired location in the airway.

[0116] 10D, the expandable object 1000 may then be expanded. As shown, the stent 1002 may be configured to increase in size as the expandable object 1000 expands. After expansion of the expandable object 1000, an opening is formed in the airway 1004.

[0117] Referring to Fig. 10E, the expandable object 1000 may then be returned to a relaxed state. At the same time, the stent 1002 in the open form may maintain a decompressed form, such that the stent 1002 in the open form now exerts radial tension on a portion of the airway or multiple connected airways. As shown in Fig. 10E, the stent 1004 in the open form may exert such radial tension on a portion of the airway or multiple connected airways adjacent at least a portion of the at least one opening formed. Once the expandable object 1000 is returned to the relaxed state, the expandable object 1000 may be guided out of the airway, back through the truncus bronchus, and out of the patient's trachea.

[0118] 10F, once the expandable object 1000 is removed from the airway, the stent 1002 may be left in place within the airway 1004 or a portion of multiple connected airways. Additionally, in some instances, the stent 1002 may be left in place within the truncus bronchus such that the stent spans multiple types of airways. For example, in some ways similar to the expandable object 912 shown in FIG. 9G, the stent 1002 may be positioned within the truncus bronchus such that the distal end of the stent is placed within a respiratory bronchiole and the proximal end extends proximally to the larger, more central airways. 5. Second Exemplary Method

[0119] It should be understood that although the various functions described above are at times described as being performed together as part of the same method, this is not required. In some cases, for example, the stents described herein may be used without an expandable object. On the other hand, the expandable objects described herein may be used without a stent. Other examples may exist.

[0120] FIG. 11 generally illustrates another exemplary method 1100 for improving airflow within an airway or a portion of a series of multiple connected airways.

[0121] For clarity, the method 1100 in FIG. 11 may be described herein with reference to various other figures. However, it should be understood that this is for purposes of illustration and explanation only, and that the operation of the method is not limited by these figures. The method 1100 may include one or more operations, functions, or acts as shown in one or more of the blocks in each figure. Although the blocks are shown in sequence, these blocks may be performed in parallel and / or in a different order than shown herein. Also, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired embodiment.

[0122] The method 1100 generally includes sizing a stent in an open configuration, at block 1102. Block 1104 includes deploying the stent in the open configuration. a. [Stent Sizing]

[0123] Block 1102 includes sizing the stent. The size of the stent may be characterized by an estimate of both the diameter of the stent and the length of the stent.

[0124] The stent in the open configuration may be any suitable stent, including, but not limited to, any of the stents in the open configuration described above with reference to Figures 3A, 3B, 4A, 4B, 5A, 5B and 5C.

[0125] Per block 1102, the stent may be sized by any suitable technique.

[0126] In one example, the stent may be sized based on the approximate size of the airway in which the stent is to be placed, for example, a size corresponding to the average size of a respiratory bronchiole may be used, or as another example, a size corresponding to the diameter of the most proximal airway in which the stent is to be placed may be used.

[0127] In another example, the stent in its open form may be sized based on an image of a given patient's truncus. For example, the patient's truncus may be imaged using known imaging techniques prior to placement of the stent, and the stent may be sized according to the size indicated by the image. Or, for example, the distance of the patient's chest during the actual procedure may be estimated from images generated using known imaging techniques.

[0128] In yet another example, the stent may be sized using an expandable object, such as the expandable objects described elsewhere herein. For example, the expandable object may be placed in the airway and expanded prior to placement of the stent. The size of the expandable object in its expanded state may then be used to infer the appropriate size of the stent. In one example, the pressure of the expandable object may be measured when the expandable object is in its expanded state. The pressure may be measured using a pressure gauge located at the proximal end of a delivery system of the expandable object. The measured pressure may be correlated to the appropriate size of the stent. b. [Placing an open stent]

[0129] Block 1104 includes placing a stent in one or more airways. The stent may be placed in any suitable manner by block 1104. For example, the stent may be placed according to the description above with respect to Figures 9E and 9F. 6. [Third Exemplary Method]

[0130] FIG. 12 generally illustrates another exemplary method 1200 for improving airflow within an airway.

[0131] For clarity, the method 1200 in FIG. 12 may be described with reference to various other figures herein. However, it should be understood that this is for purposes of illustration and explanation only, and that the operation of the method is not limited by these figures. The method 1200 may include one or more operations, functions, or acts as illustrated in one or more of the blocks in each figure. Although the blocks are shown in sequence, these blocks may be performed in parallel and / or in a different order than shown herein. Also, various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed based on the desired embodiment.

[0132] Generally, method 1200 includes placing an expandable object in one or more airways of a truncobronchial tree of a subject at block 1202. Block 1204 includes expanding the expandable object from a relaxed state to an expanded state within at least one of the one or more airways. Block 1206 includes returning the expandable object from the expanded state to the relaxed state. And, block 1208 includes removing the expandable object from the bronchioles. a. [Place an expandable object into the subject's truncobronchial airway]

[0133] Block 1202 includes placing an expandable object within one or more airways of a truncobronchial tree of a subject. The expandable object may be placed using any suitable technique, including those described herein above. For example, the expandable object may be placed as shown above with reference to Figures 9A and 9B or 10B and 10C. b. [Expanding an expandable object into an expanded state within the airway]

[0134] Block 1204 includes expanding an expandable object within at least one of the one or more airways from a relaxed state to an expanded state such that at least a portion of the airway or the multiple connected airways is expanded. In some cases, as a result of the expansion of the expandable object, at least one opening is formed in a wall of the one or more airways. The expandable object may be expanded within the airway using any suitable technique, including those described herein above. For example, the expandable object may be expanded as shown above with reference to Figures 9C and 10D.

[0135] In some instances, the expandable object may be sized to assume an outer diameter when expanded, similar to that described above for stents. c. [Return the expandable object to its relaxed state]

[0136] Block 1206 includes returning the expandable object from the expanded state to a relaxed state. The expandable object may be returned to the relaxed state using any suitable technique, including those described herein above. For example, the expandable object may be returned to the relaxed state as shown above with reference to Figures 9D and 10E. d. [Remove expandable objects from airways]

[0137] Block 1208 includes removing the expandable object from one or more airways. The expandable object may be removed using any suitable technique, including those techniques described herein. For example, the expandable object may be removed as shown above with reference to Figures 9D and 10E. 7. Exemplary Treatment Protocol

[0138] 13 generally illustrates an exemplary treatment protocol 1300 that may be used in conjunction with various techniques described herein for improving airflow within the airways. Although specific functions are described with respect to treatment protocol 1300, it should be understood that additional and / or other functions may also be performed.

[0139] The treatment protocol 1300 begins at block 1302 where a pulmonary history and physical exam is performed on the patient. If the pulmonary history (Hx) and / or physical exam indicate that possible pulmonary disease is present, the protocol continues to block 1304.

[0140] At block 1304, the patient is administered pulmonary function tests (PFTs). PFTs may include a series of tests including, but not limited to, spirometry, static lung volume measurements, diffusing capacity for carbon monoxide, airway resistance, respiratory muscle strength, and arterial blood gases, among other examples.

[0141] At block 1306, it is determined whether the ratio of the patient's forced expiratory volume in one second (FEV) to forced vital capacity (FVC) is greater than 0.7. If no, the protocol proceeds to block 1308 where it ends. If yes, the protocol proceeds to block 1310. It should be noted that other criteria may be used at the decision point at block 1306. For example, if there is evidence of severe hyperinflation (ratio of residual volume (RV) to total lung capacity (TLC) is greater than or equal to 0.65), the protocol may proceed to block 1310.

[0142] The patient undergoes a CT scan at block 1310. The CT scan images and data are then analyzed by the treating physician.

[0143] At block 1312, it is determined whether the patient's CT scan chart indicates that the patient has lung disease, whether homogeneous or heterogeneous, such as emphysema. If no, the protocol proceeds to block 1314, where it ends. If yes, the protocol proceeds to block 1316. In some circumstances, before proceeding to block 1316, it may be further determined whether there is no evidence of significant airway disease or isolated airway disease in conjunction with the emphysema.

[0144] At block 1315, the treating physician identifies the lesion site to be treated. Per block 1315, the treating physician may identify the lesion site in the truncus bronchus using any suitable technique, including any such suitable technique known to one of skill in the art. In one example, the treating physician may identify a lesion site, such as region 108 as shown in FIG.

[0145] At block 1316, the treating physician treats one or more airways in the patient's truncobronchial tree to improve airflow. The airways may be treated by any method for improving airflow in the airways, including, for example, one or more of methods 800, 1100, and 1200 described herein.

[0146] At block 1318 it is determined whether the treatment was successful in improving airflow. If yes, the protocol proceeds to block 1320 where it ends. If no, block 1316 is repeated to improve airflow. 8. Exemplary Treatment Protocol

[0147] In one embodiment, according to various methods described herein, a system may be provided that may include one or more of an expandable object, a stent, and instructions for improving airflow within a truncus bronchial airway.

[0148] The stent may be any of the stents described herein above with reference to Figures 3A, 3B, 4A, 4B, 5A, 5B, and 5C. The expandable object may be any of the expandable objects described herein above with reference to Figures 6A, 6B, 7A, 7B, and 7C. The instructions for improving airflow may correspond to any of the exemplary methods for improving airflow described herein, such as any of methods 800, 1100, and 1200.

[0149] The system may further include other objects. One example includes a cartridge containing compressed and / or liquefied gas used to expand the expandable object. Another example includes a pressure gauge used to monitor pressure within the expandable object. Yet another example includes one or more delivery catheters used to guide the expandable object and / or stent within the bronchial trunk. 9.[Conclusion]

[0150] While various aspects and embodiments are disclosed herein, other aspects and embodiments will be apparent to those of ordinary skill in the art. The various aspects and embodiments disclosed herein are intended to be illustrative, and not limiting, of the true scope and spirit of the following claims. [Item 1] placing an expandable object within two or more connected airways of a truncus bronchus of a subject, a distal end of the expandable object being placed within a first airway of the truncus bronchus and a proximal end of the expandable object being placed within a second airway of the truncus bronchus, the second airway being a lower generation airway within the truncus bronchus than the first airway; expanding the expandable object within at least two of the two or more connected airways such that at least a portion of a wall of the two or more connected airways is expanded; and positioning the stent in at least two of the two or more connected airways such that a portion of the stent is adjacent a portion of the wall of the two or more dilated airways. [Item 2] 2. The method of claim 1, wherein expanding the expandable object in the at least two of the two or more connected airways comprises expanding the expandable object in the at least two of the two or more connected airways such that at least one opening is formed in at least the portion of the wall of the two or more connected airways. [Item 3] 3. The method according to item 1 or 2, wherein the stent is in an open form. [Item 4] 4. The method of claim 3, wherein the open configuration stent has an open configuration wall, the open configuration wall having a continuous open helical surface. [Item 5] 4. The method of claim 3, wherein the stent in the open configuration has a coil. [Item 6] 6. The method of claim 5, wherein the coil has a diameter within the range of 4 millimeters (mm) to 10 mm. [Item 7] 7. The method of any one of claims 1 to 6, wherein the expandable object comprises an expansion balloon. [Item 8] 8. The method of claim 7, wherein the dilatation balloon comprises a cryoballoon. [Item 9] 8. The method according to claim 7, wherein the dilatation balloon has a diameter within the range of 4 millimeters (mm) to 10 mm. [Item 10] 10. The method of any one of items 1 to 9, wherein the expandable object comprises an anti-proliferative agent. [Item 11] 11. The method of any one of items 1 to 10, wherein prior to placing the expandable object, the stent is positioned to surround at least a portion of the expandable object. [Item 12] shrinking the expandable object after deploying the stent; 12. The method of claim 11, further comprising removing the expandable object from the two or more connected airways. [Item 13] 13. The method of any one of claims 1 to 12, further comprising removing the expandable object from the two or more connected airways prior to deploying the stent. [Item 14] 14. The method of any one of claims 1 to 13, wherein during the steps of positioning the expandable object and expanding the expandable object in the at least two of the two or more connected airways, no portion of the expandable object extends outside of an airway wall of each of the two or more connected airways. [Item 15] Expandable objects, A stent; and instructions for using the expandable object and the stent to improve airflow in one or more airways of a subject's truncus bronchus. [Item 16] The instructions for improving airflow within the one or more airways of the truncus bronchus of the subject using the expandable object and the stent include: placing the expandable object within one or more airways of the truncus bronchus of the subject; expanding the expandable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is expanded; and positioning the stent within the airway such that a portion of the stent is adjacent to the portion of the wall of the one or more dilated airways. [Item 17] 17. The system of claim 16, wherein the stent is in an open configuration. [Item 18] Item 17. The system of item 16, wherein the dilatation balloon comprises a cryoballoon. [Item 19] 20. The system of claim 18, wherein the dilatation balloon comprises an antiproliferative agent. [Item 20] placing an expandable object within two or more airways of a truncus bronchus of a subject; expanding the expandable object from a relaxed state to an expanded state within at least two of the two or more airways such that at least one opening is formed in a wall of the two or more airways; returning the expandable object from the expanded state to the relaxed state; removing the expandable object from the one or more airways; and positioning the stent in at least two of the two or more airways such that a portion of the stent is adjacent to the at least one opening. [Item 21] 21. The method of claim 20, wherein the stent is in an open configuration. [Item 22] 22. The method of claim 20 or 21, wherein the expandable object comprises an expansion balloon. [Item 23] identifying a lesion site in a truncus bronchus of the subject; and treating two or more connected airways in the truncus of the subject, the step of treating the two or more connected airways comprising: placing an expandable object within the two or more connected airways of the truncus bronchus of the subject, a distal end of the expandable object being located within a first airway of the truncus bronchus and a proximal end of the expandable object being located within a second airway of the truncus bronchus, the second airway being a lower generation airway within the truncus bronchus than the first airway, and at least one of the distal end or the proximal end of the expandable object being located within the identified lesion site of the truncus bronchus; expanding the expandable object within at least two of the two or more connected airways such that at least a portion of a wall of the two or more connected airways is expanded; and positioning the stent in at least two of the two or more connected airways such that a portion of the stent is adjacent to the portion of the wall of the two or more dilated airways. [Item 24] 24. The method of claim 23, wherein the stent is in an open configuration. [Item 25] 25. The method of claim 23 or 24, wherein the expandable object comprises an expansion balloon.

Claims

1. 1. A medical device for use in treating a subject having a diseased portion of the lung indicative of an obstructive pulmonary disease, the medical device comprising: Embeddable object having a first end and a second end Equipped with the embeddable object is configured to be positioned across multiple generations of connected airways such that the first end is positioned in a first airway within a truncus bronchus and the second end is positioned in a second airway within the truncus bronchus, the second airway being a higher generation than the first airway; the implantable object is further configured to be expandable in a manner to expand at least a portion of the plurality of generations of connected airways from a first diameter before the implantable object is placed to a second diameter greater than the first diameter. Medical devices.

2. The medical device of claim 1 , wherein the implantable object comprises a stent.

3. 2. The medical device of claim 1, wherein the implantable object includes a wall that does not close off an exterior of the implantable object from an interior of the implantable object, thereby allowing airflow from a side passageway into a main lumen of an airway when the implantable object is positioned across the multiple generations of connected airways.

4. 4. The medical device of claim 1, wherein the implantable object includes walls that have a certain level of flexibility such that when the implantable object is positioned across the multiple generations of connected airways, the implantable object is able to bend and move with the airways.

5. 5. The medical device of claim 1, wherein the implantable object includes a wall configured to allow an airway wall to be exposed to an interior of the airway when the implantable object is positioned across the multiple generations of connected airways.

6. The medical device of claim 1 , wherein the implantable object comprises a coil-like structure or a spring-like structure.

7. The medical device of claim 1 , wherein the implantable object comprises an open shaped wall having a continuously open spiral surface.

8. The medical device of claim 1 , wherein the implantable object comprises a metal.

9. 9. The medical device of claim 1 , wherein the embeddable object is sized based on a size of one or more airways within the multiple generations of connected airways in which the embeddable object is placed.

10. The medical device of claim 1 , wherein the embeddable object is sized based on an image of the bronchial trunk.

11. The medical device of claim 10 , wherein the image is a computed tomography (CT) image.

12. The medical device of claim 1 , wherein the embeddable object is sized using an extensible object.

13. the first airway in the central portion of the truncus includes one of a lobar bronchus or a segmental bronchus; the second airway in the distal portion of the truncus includes a bronchiole in which the diseased portion of the lung is located; A medical device according to any one of claims 1 to 12.

14. 14. The medical device of claim 1, wherein the implantable object is configured to exert radial tension on the multiple generations of connected airways.

15. 15. The medical device of any one of claims 1-14, wherein the second diameter of the portion of the multiple generations of connected airways comprises a diameter equal to or greater than a normal, pre-disease diameter of the portion of the multiple generations of connected airways.

16. 16. The medical device of claim 1, wherein the second diameter of the portion of the multiple generations of connected airways is at least 2 millimeters.

17. 17. The medical device of claim 1, wherein the implantable object includes a longitudinal axis extending between the first end and the second end, the implantable object being formed from a single strand extending about the longitudinal axis.

18. The medical device of claim 1 , wherein the medical device is used to treat a subject having a diseased portion of the lung having at least one of an obstruction or narrowing of the airway.

19. 19. The medical device of claim 1 , wherein the medical device is used to treat a subject with chronic bronchitis.

20. 20. The medical device of claim 1 , wherein the medical device is used to treat a subject having asthma.

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