Improvement in pulmonary airflow

Abstract

To provide devices, systems and methods for improving airflow within an airway.SOLUTION: One example embodiment includes a method for treating a subject. The method includes (1) placing an expandable object into 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 herein by reference in its entirety. [Background technology]

[0002] Obstructive pulmonary diseases, including emphysema, chronic bronchitis, asthma, and others, can cause various obstructions and / or narrowing of airways within 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 within the airway and / or the formation of scars within the airway. Airway narrowing can be characterized by, among other things, loss of radial tension in the airway, thickening of the airway wall, and / or bronchoconstriction. Furthermore, 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 experience 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 to the bronchial trunk caused by obstructive pulmonary disease. Other attempts have been made to alleviate 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, to date, these attempts have faced many challenges.

[0005] Some treatments involve the placement of prostheses, such as conventional stents, in the central airways (i.e., the 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 airway narrowing seen in patients with obstructive pulmonary disease. Furthermore, when prostheses are placed within the bronchial airways, they are prone to obstruction problems, including the formation of granulation tissue and mucus plugs. Thus, treatments involving the placement of conventional stents within the airways often result in only short-term improvement for patients, as the stents eventually become obstructed.

[0006] Other treatments include attempting to bypass the obstructed bronchial airways by creating a perforation through the chest wall into the outer portion of the lung, thereby creating a direct connection (i.e., a bypass duct) 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 sometimes attempt to extend the duration of patency by placing a hollow tubular prosthesis within the bypass duct. However, such prostheses can induce a foreign body reaction and accelerate the formation of granulation tissue, ultimately obstructing the bypass duct. Furthermore, performing such bypass surgery is difficult, time-consuming, uncomfortable, inconvenient, and debilitating for the patient.

[0007] Yet other treatments include creating a perforation between a selected central airway, such as a main or lobar bronchus, and the affected alveolus in an attempt to bypass the obstructed connecting airway. Without other measures, the perforation typically 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 support stent within the lumen of the perforation. Stents may also be coated with silicone and / or antiproliferative drugs to minimize the effects of the normal healing response and / or foreign body reactions, including granulation tissue formation. Unfortunately, these measures are usually insufficient, and support stents again induce foreign body reactions, including granulation tissue formation, which frequently occlude the stent and lead to closure of the perforation. Furthermore, mucus produced by glands in the central airway frequently occludes the stent, leading 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. Therefore, 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 truncobronchial airway obstruction and narrowing. Summary of the Invention

[0009] The present disclosure includes various devices, systems, and methods useful for improving airflow within the truncus bronchi 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, 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, the walls of some of the airways may become perforated, allowing communication between the central airways and additional alveoli adjacent to the connecting airways.

[0010] A first aspect of the present disclosure includes an open stent that, when placed within a patient's lungs, generally promotes airflow to and / or from specific 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 specific alveoli and surrounding alveoli, which is normally present in the lung, accentuated in obstructed lungs, and even more so in emphysematous lungs. In particular, because the open stent improves airflow between specific alveoli and more central airways, it also allows more collateral airflow to enter the central airways.

[0011] A second aspect of the present disclosure includes an expandable object that, when placed within a patient's lungs, may expand one or more airways beyond their normal diameter. Expanding the airways may cause perforations or breaches in the walls of the airways, thereby creating direct communication between the airways and the surrounding alveoli, and expanding the airways may thereby increase airflow into and out of the airways, including from the alveoli surrounding the airways, as well as from the alveoli normally connected to the airways. In one example, the expandable object is a dilatation 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 configuration. Other examples exist.

[0012] A third aspect of the present disclosure includes a method of treating a patient using a stent (in some examples, a stent in an open configuration) 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 create perforations or dehiscences (i.e., openings) in 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, while in 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 within one or more airways of the truncus bronchus 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 the wall of the one or more airways is dilated, and (3) placing the stent within 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 dilated; 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 using the expandable object and the stent to improve airflow in one or more airways of a truncus bronchus of the subject. The instructions for using the expandable object and the stent to improve airflow in the airways of the truncus bronchus of the subject, in one example, may 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 dilated; 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 dilated airways.

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

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

[0019] [Figure 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 exemplary open stent embodiment within an airway.

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

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

[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 exemplary open stent embodiment within an airway.

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

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

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

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

[0035] During the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. In these drawings, like symbols generally 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 utilized, 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 within 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 within a patient's truncus bronchus airway. However, it should be understood that such application is but one particular application of the devices, systems, and methods described herein, and that other applications are certainly possible.

[0037] Generally, the devices, systems, and methods described herein may provide improved airflow in a relatively effective, efficient, and redundant manner 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. Additionally, the devices, systems, and methods described herein may avoid certain discomfort and inconvenience 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 exemplary patient 100. As shown, present within patient 100 are lungs 102. Generally, a treating physician may access lungs 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 bronchus 106. The truncus 106 includes numerous airways, including central airways such as the left and right main and lobar bronchi, intermediate airways such as numerous 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 between 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 in the lesion may be disrupted.

[0042] To fully understand the deleterious effects of obstructive pulmonary disease, a review of lung function may be helpful. One function of the lungs is to remove carbon dioxide from the blood and exchange it for oxygen, thereby enabling 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 truncus bronchioles to the alveoli and by diffusion across the blood-gas interface within the patient's alveoli.

[0043] Air travels through a patient's truncus bronchioles to the patient's alveoli and is contained within the patient's lungs. The truncus bronchioles include branching airways that become smaller, shorter, and more numerous as the truncus penetrates 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 in turn divide into multiple alveolar ducts, the number of which often ranging from 2 to 11. Figure 2 shows an embodiment of the distal portion of an exemplary truncus bronchiole, 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] 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, conducting airways do not contain alveoli and do not participate in gas exchange. Rather, gas exchange occurs in the alveoli, which begin in the respiratory bronchioles, located distal to the conducting airways.

[0047] It is common to refer to or characterize the various airways of the truncus bronchus by "generation." For example, the trachea is referred to as "generation 0" of the truncus bronchus. 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 pulmonary diseases, particularly emphysema, are characterized by irreversible destruction of the alveolar walls, which contain elastic fibers that maintain outward radial traction on small airways and are useful in inhalation and exhalation. When these elastic fibers are damaged, these small airways no longer experience 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 (air trapping) of the lungs and the inability of the individual 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 weakness.

[0049] A further aspect of alveolar wall destruction 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 obstructed airways.

[0050] Chronic bronchitis is characterized by excessive mucus production in the bronchial trunk. There is usually a generalized large enlargement (hypertrophy) of the large 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 lung segments 108 affected by obstructive pulmonary diseases such as emphysema and / or bronchitis to the central airways of the truncus bronchioles. Accordingly, exemplary stents and expandable objects, described in more detail below, may be delivered to and positioned within the airways connecting the central airways to the distal airways and alveoli of diseased segments 108. 2. [Illustrative open stent]

[0052] FIG. 3A illustrates an exemplary embodiment of a stent 300 in an open configuration. As shown, 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 continuously open helical surface, as will be described in more detail below in connection with FIGS. 4A and 4B.

[0053] 3B shows an embodiment of a stent 352 in an open configuration within an airway 350. Those skilled 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 its open configuration completely isolates a given area of ​​the interior wall of the airway 350, the natural mucociliary processes of the airway generally may not be inhibited with the stent in its open configuration in place.

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

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

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

[0057] The stent in the open configuration may be formed from any suitable material. For example, the stent in the open configuration may be formed from 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 formed from 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 antiproliferative agent such as sirolimus, everolimus, zotarolimus, paclitaxel, taxotere, or mitomycin-C, among others. In another example, the stent in the open configuration may be coated with an antimucolytic 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 example suitable coatings exist.

[0059] As shown in FIG. 3A, the exemplary open stent 300 has a given length 302, which may be any suitable length and may vary depending on the application, including the airway into which the open stent 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] Also shown in FIG. 3A, the exemplary open configuration 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 configuration stent will ultimately be placed. In one example, 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 a smooth, rounded ball 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 within an airway. Furthermore, such structures may be used to limit trauma that the ends of the open configuration stent may cause to tissue. For example, such structures may further limit the formation of granulation tissue, or may prevent the formation of a pneumothorax if one end of the open configuration stent comes into contact with the visceral pleura, and / or may prevent pain if one 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, which remains intact when the stent 402 in an open configuration is positioned within the airway 400. As indicated by the various arrows in FIG. 4A , a continuous helical path exists along the wall of the stent in an open configuration, allowing relatively unimpeded traversal movement of the interior 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 while 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 stent 402 in an open configuration, stent 452 in an open configuration is characterized by a continuous spiral pathway along its wall in the open configuration. Also shown in FIG. 4B, granulation tissue is present along the structure of stent 452 in the open configuration, as indicated by the various X indicators along stent 452 in the open configuration. As shown, the granulation tissue formation is localized along the structure of the stent in the open configuration itself. As a result, the continuous spiral pathway along the wall in the open configuration remains intact. Therefore, despite the formation of granulation tissue, the mucociliary structure of 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 stents shown 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 covering structure along its length to inhibit movement across the interior wall of the airway. While FIG. 4C illustrates a particular exemplary structure as a closed wire frame, those skilled in the art will appreciate that other known closed stents exist, including stents characterized as single-walled (non-wire frame) structures.

[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 (although typical granulation tissue is not shown along the entire structure of the closed stent). As shown, the granulation tissue formation is localized along the structure of the closed stent, but because the closed stent includes structures that cover 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 illustrate alternative exemplary open configuration stents. FIG. 5A illustrates an exemplary open configuration stent 500 characterized as having relatively fewer turns per unit length than those illustrated above with reference to FIGS. 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 helix structure.

[0067] FIG. 5B shows an example of an exemplary double-helix open configuration stent 550. As shown, the exemplary open configuration 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 configuration stent, thereby forming a loop. Such a loop may aid in placement or removal and may also eliminate potentially sharp ends of the first coil 552 and the second coil 554, thereby reducing the trauma the open configuration stent may cause to the airway and surrounding tissue. This double-coil open configuration stent may provide the same stent-airway wall contact area as a single-coil open configuration stent; however, it may provide fewer angular portions of the multiple coil wires against the airway compared to the contact area provided by a single-coil stent. The dual coil open stent may thereby allow a more direct path for air and mucus movement along the airway, and indeed such a dual helix open stent may be placed within the truncus bronchial airway to improve airflow.

[0068] 5C, a double helix 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 shown, the expandable object may generally be characterized as a resiliently flexible bulb or other open body enclosing 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 another expandable body or a connecting object, such as a tube, that allows fluids, such as gases and / or liquids, to communicate with and / or exit 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). It should be noted that, generally, such anti-proliferative agents may help maintain patency of any dehiscences or perforations formed in the airway wall using the expandable object. In this manner, such anti-proliferative agents may help ensure the effectiveness of treatment, particularly 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 example suitable coatings exist.

[0073] Referring to Figure 6A, an expandable object 600 is shown in a relaxed state when not expanded. By comparison, referring 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 multiple connected airways that form a pathway from more central airways to more peripheral airways or alveoli, and then expanded, thereby also expanding the airway or multiple connected airways. As such, the expandable object may sometimes be referred to herein as a "dilatation balloon."

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

[0076] 7A and 7B illustrate an exemplary expandable object within an airway. Referring to FIG. 7A, the expandable object 700 is shown being introduced into the airway 702 in a relaxed state. Referring to FIG. 7B, the expandable object 700 is shown in an expanded state within the airway 702. As shown, the expandable object 700 expands the airway 702 beyond its normal size, introducing an opening 704 in the wall of the airway 702. This effect may occur in the wall of a single airway or in one or more walls of multiple connected airways. It should be noted that while the expandable object 700 is illustrated only 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 are possible. For example, a balloon may taper in size from one end to the other. As another example, a balloon may include a bulbous end that is relatively larger than other portions of the balloon body. As yet another example, a balloon may include two bulbous ends. As yet another example, a balloon may include one or more irregular features, such as protrusions or other ridges, on its outer surface, which may concentrate forces generated during inflation and inflation of the balloon and may allow the balloon to more easily puncture the airway wall upon inflation. 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 dilation balloons described herein may differ from prior art uses of expandable objects within bronchial trunks, such as dilation balloons used in bronchoplasty. For example, in bronchoplasty applications, expandable objects are typically placed within central airways, while dilation 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 obstructed airways to their normal size, while dilation 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, openings introduced into 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 airways may result in exposing additional openings in the airways to the alveoli. In this manner, airflow within the airways to the alveoli may be advantageously increased. Furthermore, because small airways are characterized by relatively little mucosa, obstruction of perforations and / or dehiscences is minimized.

[0080] To this end, introducing a dilation balloon into the peripheral 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 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 skilled 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 skilled in the art.

[0082] In use, the cryoballoon 780 may be placed within 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 airways to a degree appropriate 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 coolant) to a desired pressure (corresponding to a desired size). Consequently, the temperature of the airways 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 stopping its flow and thereby destroying mucus cells in the airway wall, 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 may be any suitable low-freezing point liquid, such as an ethanol or saline mixture, or a liquefied gas such as N2O or CO2. Liquid N2 may be used as a general-purpose coolant. When N2 is used, it may be delivered to the balloon in liquid phase, where it evaporates at the exit of the fluid delivery passage 784 and enters the balloon as a gas. Freon, N2O gas, and CO2 gas may also be used as coolants. Other coolants may be used, such as cold saline, Fluisol, or a mixture of saline and ethanol. Other example coolants exist.

[0084] While the exemplary expandable object is described above as taking the form of a dilation 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 that can be decompressed and compressed. Such a wire basket may be well suited to causing perforations and / or tears in the airway wall in addition to dilating the airway wall. 4. [First Exemplary Method]

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

[0086] For clarity, 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 description only, and that the operation of the method is not limited by these figures. Method 800 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 illustrated sequentially, these blocks may be performed in parallel and / or in a different order than illustrated herein. Also, various blocks may be combined into fewer blocks, divided into additional blocks, and / or eliminated based on the desired implementation.

[0087] Generally, method 800 includes placing an expandable object in one or more airways of a truncus bronchus 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, method 800 may additionally / optionally 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 lesion to be treated]

[0089] Block 801 involves identifying a lesion site to be treated. According to block 801, a treating physician may 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. 1. b. [Place the expandable object into the subject's truncobronchial airway]

[0090] Block 802 includes placing an expandable object within one or more airways of a truncus bronchus of a subject. By block 802, the subject may be understood as the patient 100. In one example, the truncus bronchus may be a truncus 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, wherein a first end of the expandable object is positioned within the first airway of the truncus bronchus and a second end of the expandable object is positioned 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 the 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 near the diseased portion of the lung. As one skilled in the art will appreciate, the expandable object may be attached to the 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 bronchi and into the distal airways of the truncus bronchi. 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 placement 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 the distal end of the expandable object 912 is positioned within a respiratory bronchiole and the 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 noted above, an 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 NO into the cryoballoon.

[0100] Referring to Figure 9C, an embodiment of block 804 is illustrated. As shown in Figure 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 shown, the expandable object tears the airway 902 open so that an opening now exists in the airway wall.

[0101] Although a breach formed in the airway 902 is shown, it should be understood that an opening is not required in all embodiments, and in some embodiments, it may be desirable and / or sufficient to dilate the airway 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 portions of the airway of the truncus bronchus 910 are expanded, where multiple lacerations and / or perforations may be formed within the multiple portions 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 FIG. 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 the wall of the one or more dilated airways. In an embodiment in which an airway wall has been dehiscenced 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 the 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. 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 using a more conventional closed stent, in which case block 806 may include deploying the stent in a closed configuration.

[0111] 9E and 9F, embodiments of block 806 are illustrated. Referring to FIG. 9E, a stent 904 in an open configuration is shown being guided into an airway 902. As shown, the stent in an open configuration 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 in an open configuration is shown positioned at a desired location in the airway 902 and ready to expand. As shown, the stent 904 in an open configuration is positioned adjacent an opening in the airway 902.

[0112] The stent 904 in its open configuration may then be left in place within the airway indefinitely and / or until a treating physician decides to remove the stent in its open configuration. Alternatively, the stent in its open configuration may be temporarily placed and removed after a predetermined 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 deployed within the airway. However, this is not required. In another embodiment of method 900, the expandable object may be deployed along with the stent. Exemplary aspects of such an embodiment are shown with reference to FIGS. 10A, 10B, 10C, 10D, 10E, and 10F.

[0114] 10A, a stent 1002 may be positioned to surround at least a portion of the expandable object 1000 prior to placement of the expandable object 1000. 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 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] 10E, the expandable object 1000 may then be returned to its relaxed state. At the same time, the stent 1002 in its open configuration may maintain its decompressed configuration, such that the stent 1002 in its open configuration now exerts radial tension on a portion of the airway or multiple connected airways. As shown in FIG. 10E, the stent 1004 in its open configuration 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 that was formed. Once the expandable object 1000 is returned to its 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 remain in place within the airway 1004 or within a portion of multiple connected airways. Additionally, in some instances, the stent 1002 may remain in place within a 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 a truncus bronchus such that the distal end of the stent is located within a respiratory bronchiole and the proximal end extends proximally to the larger, more central airways. 5. [Second Exemplary Method]

[0119] While the various functions described above are sometimes described as being performed together as part of the same method, it should be understood that 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 sequentially, these blocks may be performed in parallel and / or in a different order than shown herein. Additionally, various blocks may be combined into fewer blocks, divided into additional blocks, and / or eliminated based on the desired implementation.

[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 involves sizing the stent, which 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 into which the stent is to be placed, for example, a size corresponding to the average size of a respiratory bronchiole, or, as another example, a size corresponding to the diameter of the most proximal airway into which the stent is to be placed.

[0127] In another example, a stent in its open configuration may be sized based on an image of a given patient's truncus. For example, prior to placement of the stent, the patient's truncus may be imaged using known imaging techniques, and the stent may be sized according to the size indicated by the image. Or, for example, distances in 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 those 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 estimate the appropriate size of the stent. In one example, the pressure of the expandable object may be measured while the expandable object is in its expanded state. The pressure may be measured using a pressure gauge positioned at the proximal end of the expandable object's delivery system. The measured pressure may be correlated to the appropriate size of the stent. b. [Placing an open stent]

[0129] Block 1104 involves 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 sequentially, these blocks may be performed in parallel and / or in a different order than shown herein. Additionally, various blocks may be combined into fewer blocks, divided into additional blocks, and / or eliminated based on the desired implementation.

[0132] Generally, method 1200 includes placing an expandable object within one or more airways of a truncus bronchioles 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 the expandable object into the subject's truncobronchial airway]

[0133] Block 1202 includes placing an expandable object within one or more airways of the subject's truncus bronchus. 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 the 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 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 the 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 FIGS. 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 FIGS. 9D and 10E. d. [Removing expandable objects from the airway]

[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 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. While specific functions are described for treatment protocol 1300, it should be understood that additional and / or other functions may also be performed.

[0139] 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 indicates that a 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 (the ratio of residual volume (RV) to total lung capacity (TLC) is 0.65 or greater), 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] In 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 evidence of significant airway disease or isolated airway disease concurrent with the emphysema.

[0144] At block 1315, the treating physician identifies the lesion site to be treated. According to 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 those of skill in the art. In one example, the treating physician may identify the lesion site, such as region 108 as shown in FIG. 1.

[0145] At block 1316, the treating physician treats one or more airways within the patient's truncus bronchus to improve airflow. The airways may be treated by any method for improving airflow within 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 the various methods described herein, a system may be provided, which 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 skilled in the art. The various aspects and embodiments disclosed herein are intended to be illustrative, but 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, wherein a distal end of the expandable object is located within a first airway of the truncus bronchus and a proximal end of the expandable object is located within a second airway of the truncus bronchus, the second airway being a lower-level 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 placing the stent in at least two of the two or more connected airways such that a portion of the stent is adjacent to 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 configuration. [Item 4] Item 4. The method of item 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] Item 6. The method according to item 5, wherein the coil has a diameter in the range of 4 millimeters (mm) to 10 mm. [Item 7] 7. The method of any one of items 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 item 7, wherein the dilatation balloon has a diameter in 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 antiproliferative agent. [Item 11] 11. The method of any one of items 1 to 10, wherein prior to deploying the expandable object, the stent is positioned to surround at least a portion of the expandable object. [Item 12] after deploying the stent, contracting the expandable object; 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 items 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 items 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] Extensible objects and A stent, and instructions for using the expandable object and the stent to improve airflow within one or more airways of a truncus bronchus of a subject. [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 bronchi 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] Item 17. The system of item 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] Item 19. The system of item 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 placing the stent in at least two of the two or more airways so 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 a dilation balloon. [Item 23] identifying a lesion site in a truncus bronchus of the subject; treating two or more connected airways within the truncus of the subject, wherein treating the two or more connected airways comprises: placing an expandable object within the two or more connected airways of the truncus bronchus of the subject, wherein a distal end of the expandable object is located within a first airway of the truncus bronchus and a proximal end of the expandable object is 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 is 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 placing the stent in at least two of the two or more connected airways so 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 a dilation balloon.

Claims

1. 1. A medical device for use in improving airflow in a portion of a hyperinflated emphysematous lung of a subject, the medical device comprising: Embeddable object having a first end and a second end Equipped with the implantable 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 of the hyperinflated emphysematous lung 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 multiple 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. The medical device of claim 2 , wherein the stent is in an open configuration.

4. 4. The medical device of claim 1, wherein the implantable object includes a wall that does not close off the exterior of the implantable object from the 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.

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

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

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

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

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

10. 10. The medical device of claim 1, wherein the implantable object is sized based on the size of one or more airways within the multiple generations of connected airways into which the implantable object is placed.

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

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

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

14. 14. The medical device of any one of claims 1 to 13, wherein the implantable object is configured to exert radial tension on the multiple generations of connected airways.

15. 15. The medical device of claim 1, 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. The medical device of any one of claims 1 to 15, wherein the implantable object has a diameter of between 1 mm and 10 mm.

17. The medical device of any one of claims 1 to 16, wherein the implantable object has a length of between 2 cm and 10 cm.

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

19. 19. 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 a narrowed airway.

20. 20. The medical device of claim 1, wherein the medical device is used to treat a subject with severe emphysema.

21. 21. The medical device of any one of claims 1 to 20, wherein the medical device is used to treat a subject with severe COPD.

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